[Objectives]This study aims to establish the quality standard of Fuzheng Wangan granules.[Methods]The qualitative identification of Radix Bupleuri and Radix Paeoniae Alba was carried out by the thin layer chromatograp...[Objectives]This study aims to establish the quality standard of Fuzheng Wangan granules.[Methods]The qualitative identification of Radix Bupleuri and Radix Paeoniae Alba was carried out by the thin layer chromatography(TLC).The content of ginsenosides Rg1,Re and Rb was determined by the high performance liquid chromatography(HPLC).[Results]The spots of Radix Bupleuri and Radix Paeoniae Alba were clear,and the negative control had no interference.The total content of ginsenoside Rg1,Re and Rb ranged from 0.0762 to 0.0739 mg/g.[Conclusions]The method for the quality control of Fuzheng Wangan granules established in this study is stable and feasible.展开更多
[Objectives] To establish the preparation process and quality standard of Rougan Huaxian ointment.[Methods] The L_(9)(3^(4)) orthogonal test was employed to optimize the preparation process by considering the multipli...[Objectives] To establish the preparation process and quality standard of Rougan Huaxian ointment.[Methods] The L_(9)(3^(4)) orthogonal test was employed to optimize the preparation process by considering the multiplication of water addition, extraction time, and extraction frequency as influencing factors. The dry paste yield was utilized as the evaluation criterion, in conjunction with the actual production conditions. Thin layer chromatography was employed to identify Radix Astragali, Lycii Fructus, Herba Dendrobii, and Rhizoma Polygoni Cuspidati. Ethanol served as the solvent for the determination of ethanol-soluble extractives using the cold immersion method.[Results] The preparation process was conducted as follows: the specified quantity of medicinal materials was combined with water for extraction purposes, performed in two separate stages. In each stage, eight times the amount of water was added. The first extraction lasted for 1.5 h, while the second extraction was completed in 1.0 h. The resulting liquid was then concentrated into a thick paste with a relative density ranging from 1.25 to 1.30 at a temperature of 60 ℃. The thin-layer chromatography analysis of Radix Astragali, Lycii Fructus, Herba Dendrobii, and Rhizoma Polygoni Cuspidati demonstrated distinct spots, effective separation, and the absence of interference from negative samples. Additionally, the ethanol-soluble extractives yielded a minimum of 8.0% in terms of dry weight.[Conclusions] The preparation process for Rougan Huaxian ointment is both stable and feasible. Furthermore, the quality standards established for this preparation are unique and reproducible, thereby facilitating effective quality control.展开更多
[Objectives]Some Chinese medicinal materials of Jianjin Zhuanggu Paste were microscopically identified,and several active ingredients were studied by thin-layer identification,which provides reference for further impr...[Objectives]Some Chinese medicinal materials of Jianjin Zhuanggu Paste were microscopically identified,and several active ingredients were studied by thin-layer identification,which provides reference for further improving the quality standards of hospital preparations.[Methods]The effective components of Jianjin Zhuanggu Paste were qualitatively identified by thin-layer chromatography(TLC).[Results]The microscopic identification of the three Chinese medicinal materials in Jianjin Zhuanggu Paste showed the microscopic characteristics of Radix Codonopsis,Radix Astragali and Radix Notoginseng.TLC identification showed that there were characteristic spots of Radix Codonopsis,Radix Astragali,Radix Rehmanniae Preparata and Radix Notoginseng in Jianjin Zhuanggu Paste.[Conclusions]This study established the quality standard research method of Jianjin Zhuanggu Paste,which further strengthens the safety standards of hospital preparations,and improves the clinical efficacy of drugs,as well as the quality standards of hospital preparations to a certain extent.展开更多
This study explores the development of quality standards for leadership and organizational development in higher education to addresses the challenges posed by globalization and digitalization. By analyzing current si...This study explores the development of quality standards for leadership and organizational development in higher education to addresses the challenges posed by globalization and digitalization. By analyzing current situations and proposing a strategic framework, this study offers standard-based solutions for improving leadership quality and organizational performance in universities. The proposed quality standards align institutional goals with educational objectives, ensuring that higher education institutions are able to meet demands of modern education.展开更多
Ambient air quality standards are the core strategic goal of ambient air quality management.Countries worldwide have given importance to research on the development of ambient air quality standards.To understand the h...Ambient air quality standards are the core strategic goal of ambient air quality management.Countries worldwide have given importance to research on the development of ambient air quality standards.To understand the history of the development of China’s ambient air quality standards,this study analyzed the background associated with all previous formulations and revisions of the standards,classification of functional areas,standard grading,pollutants,and evolution of the standard limits over the past 40 years.The results show that since the initial release of the“Ambient Air Quality Standard”by China in 1982,it has been supplemented once,revised twice,and modified twice.The first ambient air quality standard specified the standard limits of six pollutants commonly found in ambient air.With the development of ambient air quality management,the number of pollutants has increased to ten.Since the release of the“Ambient Air Quality Standards”in 2012,the ambient air quality in China has significantly improved.However,the proportion of cities meeting these standards is still low.At present,China is suitably positioned to make the standards associated with 24 hr SO2concentrations more stringent such that it meets the values defined in the World Health Organization(WHO)interim target-2 and the WHO air quality guideline(AQG).We further suggested that the SO2standard should be revised promptly.Simultaneously,regions with a relatively high proportion of cities meeting the standard are encouraged to introduce more stringent interim target limits in due course to manage the local ambient air quality.展开更多
Traditional Chinese medicine (TCM) has been widely used in China for thousands of years, and has received more and more recognition worldwide. Indigoplant (Folium Polygoni Tinctorii), a TCM, has been used in vario...Traditional Chinese medicine (TCM) has been widely used in China for thousands of years, and has received more and more recognition worldwide. Indigoplant (Folium Polygoni Tinctorii), a TCM, has been used in various diseases. In our study, we established a quality standard of Indigoplant according to the European Pharmacopoeia, and this standard has passed the early audit stages of the European Pharmacopoeia Commission. The lndigoplant samples were identified with high performance thin layer chromatography (HPTLC), qualified with RP-HPLC quantitation, and analyzed with a series of quality tests. An accurate, reliable and robust HPLC method with gradient elution for quantitation was developed and validated with a one-variable-at-a-time (OVAT) robustness approach. Several tests, including the loss on drying, total ash and ash insoluble in hydrochloric acid of Indigoplant, were performed for quality analysis. Furthermore, six batches of the Indigoplant samples were appraised with this quality standard. In conclusion, the established quality standard was more internationally normative and applicable for the quality control of Indigoplant in practical application.展开更多
As a traditional Chinese medicine (TCM), Dictamni Cortex is widely used for the treatment of rheumatism and skin diseases. To promote the internationalization of Dictarnni Cortex, we established a recommended qualit...As a traditional Chinese medicine (TCM), Dictamni Cortex is widely used for the treatment of rheumatism and skin diseases. To promote the internationalization of Dictarnni Cortex, we established a recommended quality standard of Dictamni Cortex according to the European Pharmacopoeia (EP) in the present study. Foreign matter, loss on drying, total ash and ash insoluble in hydrochloric acid were determined according to the procedures of EP 8.0. The thin layer chromatography (TLC) identification method was established by using obacunone and fraxinellone as the reference substances. The content of dictarnnine, obacunone and fraxinellone was assayed by reversed phase high performance liquid chromatography (RP-HPLC). Furthermore, we tested 21 batches of the prepared slices of Dictamni Cortex from different regions. The results indicated that the established quality standard was specific, accurate and internationalized, which could be used for the quality control of Dictamni Cortex.展开更多
With rapid economic development and urbanization in recent decades, China has experienced the worsening of ambient air quality. For better air quality management to protect human health, Chinese government revised nat...With rapid economic development and urbanization in recent decades, China has experienced the worsening of ambient air quality. For better air quality management to protect human health, Chinese government revised national ambient air quality standards (NAAQS) for particulate matter (PM) in 2012 (GB3095-2012). To assess the effectiveness of current NAAQS for PM on public health in Chinese population, we conducted a meta- analysis on published studies examining the mortality risk of short-term exposure to PM with aerodynamic diameters less than 10 and 2.5μm (PM10 and PM2.5) in China. The reported 24-hour concentrations of PM10 and PM2.5 in studies ranged from 43.5 to 150.1 μg/m^3 and 37.5 to 176.7 μg/m^3. In the pooled excess, mortality risk estimates of short-term exposure to PM. In specific, per 10 μg/m^3 increase in PM10, we observed increases of 0.40% (95%CI: 0.33%, 0.47%), 0.57% (95%CI: 0.44%, 0.70%) and 0.49% (95%CI: 0.40%, 0.58%) in total, respiratory and cardiovascular mortality, per 10/μg/m^3 increase in PM2.5, we observed increases of 0.51% (95% CI: 0.38%, 0.63%), 0.62% (95%CI: 0.52%, 0.73%) and 0.75% (95%CI: 0.54%, 0.95%) in total, respiratory and cardiovascular mortality. Finally, we derived 125 μg/m^3 for PM10 and 62.5 μg/ m^3 for PM2.5 as 24-hour recommendation values based on the pooled estimates. Our results indicated that current Chinese NAAQS for PM could be sufficient in mitigating the excess mortality risk from short-term exposure to ambient PM. However, future research on long-term exposure cohort studies in Chinese population is also essential in revising annual averages for PM in Chinese NAAQS.展开更多
The quality standards for Fructus Comi have been established based on the effects of the manufacturing processes.Three critical process parameters(CPPs)of extraction,filtration,and concentration to prepare Fructus Com...The quality standards for Fructus Comi have been established based on the effects of the manufacturing processes.Three critical process parameters(CPPs)of extraction,filtration,and concentration to prepare Fructus Comi concentrate were identified by Plackett-Burman design with a single batch of Fructus Corni,which were heating medium temperature,extraction time,and water addition.Morroniside yield,loganin yield,and dry matter yield were process critical quality attributes(CQAs).CPPs arranged with a Box-Behnken design were applied to treat different batches of Fructus Comi After constructing a model that included CPPs,material propertie s,and process CQAs,loganin content was found to be the critical material attribute(CMA).The design space was calculated with a probability method.According to the limits of process CQAs,the minimum content of loganin in Fructus Corni was calculated with an error propagation method,which was 6.92 mg·g^(-1).When the content of loganin in Fructus Corni reaches up to 6.92 mg·g^(-1),the material is considered high-quality and is most suitable for the process.High-quality material can be used for production of Fructus Comi concentrate.This method can also be used to set material quality standards for other Chinese medicines.展开更多
[Objectives]This study was conducted to optimize the preparation process of Tianlu Tongluo Granules and establish its quality standard.[Methods]Tianlu Tongluo Granules was prepared by an orthogonal test.TLC was used t...[Objectives]This study was conducted to optimize the preparation process of Tianlu Tongluo Granules and establish its quality standard.[Methods]Tianlu Tongluo Granules was prepared by an orthogonal test.TLC was used to identify Radix Astragali preparata,Radix Paeoniae Alba,Scutellariae Radix and Acori Tatarinowii Rhizoma in the granules,and the content of paeoniflorin in the finished product was determined by HPLC.[Results]The extraction process of Tianlu Tongluo Granules was as follows:adding 6 times of water,and decocting twice,1 h/time.In the forming process,the optimal ratio of thick paste to excipients as 10∶8.6,and the optimal ratio of excipients dextrin:starch:colloidal silicon dioxide was 6.5∶0.5∶1.6.The results showed that TLC spots were obvious,the separation was significant,and the specificity was strong.The paeoniflorin content had a good linear relationship in the concentration range of 5.9048-590.48 mg/L(r=0.9999).The average sample recovery was 101.10%,and the RSD was 1.18%.[Conclusions]The preparation process is stable and reasonable,and the established quality control method is specific and reproducible,and can be used for the quality control of Tianlu Tongluo Granules.展开更多
[Objectives]This study was conducted to establish the quality standard of Danshen Jianxin Capsules.[Methods]Orthogonal design was adopted to optimize the water extraction process by taking the amount of water added,ex...[Objectives]This study was conducted to establish the quality standard of Danshen Jianxin Capsules.[Methods]Orthogonal design was adopted to optimize the water extraction process by taking the amount of water added,extraction time and extraction times as factors,and the content of tanshinone I as the index.Salviae Miltiorrhizae,Notoginseng Radix Et Rhizoma and Radix Astragali in the capsules were qualitatively identified by TLC,and the content of tanshinone I in the capsules was determined by HPLC.[Results]The best water extraction process included the steps of adding 12 times of water each time,extracting the materials twice,for 1 h each time.In TLC identification,the test samples showed spots of the same color at the positions corresponding to tanshinone II A,ginsenoside Rg1,notoginsenoside R1 and astragaloside IV reference samples.[Conclusions]Danshen Jianxin Capsules was prepared by the water extraction method,which is characterized by high efficiency and being suitable for mass production.The quality control method is reliable,fast and accurate,which can effectively control the quality of the product.展开更多
[Objectives] This study was conducted to establish the quality control standards for Laportea bulbifera(Sieb. et Zucc.) Wedd. [Methods] Microscopic identification and thin layer chromatography were used to identify an...[Objectives] This study was conducted to establish the quality control standards for Laportea bulbifera(Sieb. et Zucc.) Wedd. [Methods] Microscopic identification and thin layer chromatography were used to identify and determine the moisture, total ash and extract contents. [Results] According to the microscopic results, the stem transection is round and has five longitudinal edges at which the cell wall is obviously thickened. Bristles can be observed. A series of collenchyma cells are arranged closely inside the epidermis. There are several rows of parenchyma cells. The vascular bundles are of different sizes;and the ray part is wide, and at the junction of the ray and the cortex, there are often scattered secretory cells. The center is a broad medulla. The powder is brown. There are many starch grains. The bristles are unicelluar, and have warty protrusions and expanded base. The fibers are bundled, and the cells are large. The epidermal cells are in the shape of an elongated spindle, in a mosaic arrangement, and the cell wall is slightly thickened. From the thin layer identification chromatograms of tested L. bulbifera, it can be seen that spots were observed at the same positions as the control medicinal material, and the durability of the method was good. The extract content should not be less than 12.00% by hot extraction with water as solvent, and not be less than 3.00% by cold extraction with ethanol as solvent. The moisture content should not be more than 16.50%. The total ash content should not be more than 14.00%. The acid-insoluble ash content should not be more than 2.50%. [Conclusions] The microscopic identification results are reliable and can be used as the identification basis of L. bulbifera. The thin layer identification method and the test results can provide a basis for quality control of L. bulbifera.展开更多
Both national and local governments have been paying great attention to the work of industrial standardization with the enormous increase in international trade after China joined WTO. According to the standards r... Both national and local governments have been paying great attention to the work of industrial standardization with the enormous increase in international trade after China joined WTO. According to the standards revising plan of Standardization Administration Committee of China (SAC),TC54 has already revised a series of national standards and industrial standards for foundry operations,and proposed some new ones. As a result,some old fashioned standards containing low-level techniques have been gradually discontinued or replaced with new versions.……展开更多
Objective:To establish the quality standard of Danmu exract syrup.Methods:TLC method was used to qualitatively identify Nauclea officinalis in Danmu exract syrup.The content of strictosamide and chlorogenic acid in Da...Objective:To establish the quality standard of Danmu exract syrup.Methods:TLC method was used to qualitatively identify Nauclea officinalis in Danmu exract syrup.The content of strictosamide and chlorogenic acid in Danmu exract syrup was determined by high efficiency axillary chromatography.Results:The spots were clear and there was no negative interference.The linear relationship of strictosamide was good in the range of 100~300ug/ml(R^(2)=0.9997).The average recovery was 99.1%and RSD was 1.16%(n=9).Chlorogenic acid had a good linear relationship in the range of 6.7~20.2ug/ml(R^(2)=0.9991).The average recovery was 99.9%and RSD was 1.10%(n=9).Conclusion:The standard is safe and reasonable,the method is simple,accurate and reproducible,and it can be used for the quality control of Danmu exract syrup.展开更多
[Objectives] To establish the quality standard of Corydalis tomentella Franch. [Methods] The medicinal materials are identified from the perspectives of morphology,characters,microscopic characteristics and TLC of the...[Objectives] To establish the quality standard of Corydalis tomentella Franch. [Methods] The medicinal materials are identified from the perspectives of morphology,characters,microscopic characteristics and TLC of the plants. The contents of moisture,total ash and water extract are determined. The content of dehydrocavidine is determined by HPLC. The determination is performed on Agilent C18 column with mobile phase consisted of acetonitrile-phosphate buffer solution( containing 20 mmol/L monopotassium phosphate,10 mmol/L diethylamine,0. 1% phosphoric acid)( 28∶ 72,V/V) at the flow rate of 1. 0 m L/min. The detection wavelength is set at 347 nm,and the column temperature is 35℃. The sample size is 10 μL. [Results] The original plants are perennial herbs,and as produced into medicinal materials,they are hairy and shrink into balls with conical principal roots,and obvious cracks on the tubers and roots,curved and fragmented leaves,yellowish white flowers. The quasi-circular pollen grains contain square and columnar crystals,there are substantial nonglandular hairs,and also bordered pits,spiral and reticulate vessels,as well as wood fibers. TLC spots are clear and well-separated. The content of moisture is7. 5%-18. 5%,total ash 20. 5%-26. 2%,and water extract 29. 9%-46. 4%. The linear range of dehydrocavidine is 0. 040 08-2. 404 8 μg( r =0. 999 9); RSD of precision,stability and reproducibility tests is lower than 2. 0%. The recoveries are 95. 6%-102. 5%( RSD =2. 3%,n = 9). [Conclusions] The established standard can be used for quality evaluation of C. tomentella Franch..展开更多
In China,the water quality standards in operation include the Environmental Quality Standard for Surface Water(GB3838-2002)and Water Quality Standards for Seawater(GB3097-1997).However,these two standards are curr...In China,the water quality standards in operation include the Environmental Quality Standard for Surface Water(GB3838-2002)and Water Quality Standards for Seawater(GB3097-1997).However,these two standards are currently not suitable for the estuarial zones of China because of the unique properties of water environment in estuaries.We proposed preliminarily a basic idea and technical workflow in formulating water quality standards for the estuaries of China based on analyzing the water environment properties of estuaries comprehensively and comparing various parameters and their standard values mentioned in these two standards above.Issues pertinent to the formulation of the water quality standards for estuaries,e.g.nutrient,heavy metals and persistent organic pollutants(POPs),are highly concerned.The objective of this paper is to provide technical support for the formulation of scientific water quality standards and the assessment of water quality of the estuaries of China.展开更多
[ Objective] The research aimed to study the quality standard of Compound Quanchangning Capsule. [ Method] Coptis, Phelledendron, Pulsatilla and Astragalus in Compound Quanchangning Capsule were indentified qualitativ...[ Objective] The research aimed to study the quality standard of Compound Quanchangning Capsule. [ Method] Coptis, Phelledendron, Pulsatilla and Astragalus in Compound Quanchangning Capsule were indentified qualitatively by thin layer chromatography ( TLC), and the content of berberine hydrochloride was determined by high performance liquid chromatography (HPLC), to study the quality standard of Compound Quanchangning Capsule. [ Result] TLC identification showed that the tested product was clear and well-separated with no interference. Berberine hydrechloride showed a good linear relationship with peak area at the injection volume of 10.92 - 163.74 ~Lg/mL, and the regression equation was Y = 39 611X -2 387. 9 (R2 = 0. 999 8) ; the average recovery was 97.60%, and the relative standard deviation was 1.64% (n =6). [ Conclusion] The standard is simple in operation and good in specificity, stability and repeatability, which is prompted as a favorable method for quality control of Compound Quanchangning Capsule.展开更多
[Objectives] To systematically identify and analyze pharmacognostical features of Mongolian medicine Shoushen and Naishoushen( dairy tablets) to provide scientific basis for the establishment and identification of its...[Objectives] To systematically identify and analyze pharmacognostical features of Mongolian medicine Shoushen and Naishoushen( dairy tablets) to provide scientific basis for the establishment and identification of its quality standard. [Methods] According to relevant methods specified in Appendix to 2010 Chinese Pharmacopoeia,the water content,total ash,and extracts of Shoushen and Naishoushen were detected,and thin layer chromatography( TLC) was applied to make qualitative identification. Gastrodin was used as the reference substance,extracted with 70% methanol,and then sprayed with ethyl acetate-formic acid-water( 9∶ 1∶ 0. 2) as the developing solvent,and then sprayed with 10% phosphomolybdic acid ethanol solution and heated at 105℃ to clear spot color. UV-Visible spectrophotometry and high performance liquid chromatography( HPLC) were used to analyze the content of polysaccharides and gastrodins in Shoushen and Naishoushen. The chromatographic column was a ZOBB AX eclipse XDB-C_(18)( 4. 6 mm × 250 mm,5 cm) column with the methanol-0. 04% phosphoric acid solution( 8∶92) as the mobile phase,the flow rate of 1. 0mL/min,the detection wavelength of 222 nm,and the column temperature of 30℃.[Results]In the thin-layer chromatography test,spots of the same color appeared at the positions corresponding to the chromatogram of the reference substance. Gastrodin eluted under high pressure reached baseline separation. Gastrodin had a good linearity in the concentration range of 0. 009-0. 09 mg/m L. The regression equation was Y = 586 866 X + 425 821( R^2= 0. 999 6),and the average recovery rate was100. 1%. Precision test,reproducibility test,and stability test conformed to the requirements. The results of extracts of three batches of samples were 26. 13%-42. 58%,water content was 3. 47%-5. 31%,and total ash was 5. 43%-6. 33%. [Conclusions] The quality control method has high reliability,high sensitivity,high specificity,high accuracy,and high stability. The results are expected to provide a scientific basis for the identification,resource utilization,and improvement of quality standard for Shoushen and Naishoushen.展开更多
[Objectives]This study was conducted to explore the quality control method and establish the quality standard of Zhuang medicine Buddlejae Flos.[Methods]The microscopic identification method was adopted to identify th...[Objectives]This study was conducted to explore the quality control method and establish the quality standard of Zhuang medicine Buddlejae Flos.[Methods]The microscopic identification method was adopted to identify the characters and microscopic characteristics of dried Buddlejae Flos in combination with traditional experience.The moisture,ash,acid-insoluble components and extracts of Buddlejae Flos were determined with reference to general rules of Chinese Pharmacopoeia(2015 edition).TLC identification was performed.Liquid chromatography-mass spectrometry(LC-MS)was used to determine the contents of linarin and verbascoside in Buddlejae Flos,and gas chromatography-mass spectrometry(GC-MS)was adopted to detect pesticide residues in Buddlejae Flos.Heavy metal elements As,Cd and Pb were detected by inductively coupled plasma mass spectrometry(ICP-MS).[Results]The established method is simple and accurate.Clear spots were observed on the thin layer chromatograms,and the resolution was good.The average value of moisture content was 12.24%;the average value of ash content was 5.1%;the average value of acid-insoluble content was 7.5%;and the average value of extract content was 27.3%.The regression equation of rutin in Buddlejae Flos was y=11.896x-0.0049,R^(2)=0.9996,and the contents of linarin and verbascoside were 5680 and 2080 mg/kg,respectively.No pesticide residues and heavy metals were detected in the medicinal materials of Buddlejae Flos.[Conclusions]This study can provide reference for the quality standard control of Guangxi Zhuang medicine Buddlejae Flos.展开更多
Objective:To establish the quality standard of Li folk medicine callicarpa nudiflora powder by modern analytical method.Methods:TLC was used to identify the powder.Five heavy metals and harmful elements(Pb,Cd,As,Hg an...Objective:To establish the quality standard of Li folk medicine callicarpa nudiflora powder by modern analytical method.Methods:TLC was used to identify the powder.Five heavy metals and harmful elements(Pb,Cd,As,Hg and Cu)in the powder were determined by flame atomic absorption spectrometry and hydride atomic fluorescence spectrometry.The content of luteolin and Mullein glycoside in the powder was determined by HPLC.Results:the fluorescent spots of TLC identification of powder were clear,and the separation of the two main components was good.It has good specificity,reproducibility and durability,which can be used for the identification of the powder.The inspection items of heavy metals for the identification of powder were established.It was stipulated that:according to the determination method,the lead should not exceed 5 mg/kg;the cadmium should not exceed 0.3 mg/kg;the arsenic should not exceed 2 mg/kg;the mercury should not exceed 0.2 mg/kg;the copper should not exceed 20 mg/kg.The content of luteolin and Mullein glycoside in the powder were determined by HPLC and the content inspection item of the powder was established.It was stipulated that the content of luteolin and Mullein glycoside in the powder should not be less than 0.48%and 5.83%,which can be used for the content limit inspection of the powder.Conclusion:the quality standard method established by our institute is advanced and operable,and can be used for the quality control of the powder.展开更多
基金Supported by the Project for the Development and Promotion of Appropriate Technology of Traditional Chinese Medicine in Guangxi(GZSY2024017).
文摘[Objectives]This study aims to establish the quality standard of Fuzheng Wangan granules.[Methods]The qualitative identification of Radix Bupleuri and Radix Paeoniae Alba was carried out by the thin layer chromatography(TLC).The content of ginsenosides Rg1,Re and Rb was determined by the high performance liquid chromatography(HPLC).[Results]The spots of Radix Bupleuri and Radix Paeoniae Alba were clear,and the negative control had no interference.The total content of ginsenoside Rg1,Re and Rb ranged from 0.0762 to 0.0739 mg/g.[Conclusions]The method for the quality control of Fuzheng Wangan granules established in this study is stable and feasible.
基金Supported by Guangxi Key R&D Programme Project(GK AB21196057)National Old Pharmacist Inheritance Studio Construction Project.
文摘[Objectives] To establish the preparation process and quality standard of Rougan Huaxian ointment.[Methods] The L_(9)(3^(4)) orthogonal test was employed to optimize the preparation process by considering the multiplication of water addition, extraction time, and extraction frequency as influencing factors. The dry paste yield was utilized as the evaluation criterion, in conjunction with the actual production conditions. Thin layer chromatography was employed to identify Radix Astragali, Lycii Fructus, Herba Dendrobii, and Rhizoma Polygoni Cuspidati. Ethanol served as the solvent for the determination of ethanol-soluble extractives using the cold immersion method.[Results] The preparation process was conducted as follows: the specified quantity of medicinal materials was combined with water for extraction purposes, performed in two separate stages. In each stage, eight times the amount of water was added. The first extraction lasted for 1.5 h, while the second extraction was completed in 1.0 h. The resulting liquid was then concentrated into a thick paste with a relative density ranging from 1.25 to 1.30 at a temperature of 60 ℃. The thin-layer chromatography analysis of Radix Astragali, Lycii Fructus, Herba Dendrobii, and Rhizoma Polygoni Cuspidati demonstrated distinct spots, effective separation, and the absence of interference from negative samples. Additionally, the ethanol-soluble extractives yielded a minimum of 8.0% in terms of dry weight.[Conclusions] The preparation process for Rougan Huaxian ointment is both stable and feasible. Furthermore, the quality standards established for this preparation are unique and reproducible, thereby facilitating effective quality control.
基金Supported by The Self-financing Project of Guangxi Zhuang Autonomous Region Administration of Traditional Chinese Medicine(GZZC2020496)Wuzhou Science and Technology Planning Project(201902214)Scientific Research Project of Health Commission of Wuzhou(WZWS-Z2023036).
文摘[Objectives]Some Chinese medicinal materials of Jianjin Zhuanggu Paste were microscopically identified,and several active ingredients were studied by thin-layer identification,which provides reference for further improving the quality standards of hospital preparations.[Methods]The effective components of Jianjin Zhuanggu Paste were qualitatively identified by thin-layer chromatography(TLC).[Results]The microscopic identification of the three Chinese medicinal materials in Jianjin Zhuanggu Paste showed the microscopic characteristics of Radix Codonopsis,Radix Astragali and Radix Notoginseng.TLC identification showed that there were characteristic spots of Radix Codonopsis,Radix Astragali,Radix Rehmanniae Preparata and Radix Notoginseng in Jianjin Zhuanggu Paste.[Conclusions]This study established the quality standard research method of Jianjin Zhuanggu Paste,which further strengthens the safety standards of hospital preparations,and improves the clinical efficacy of drugs,as well as the quality standards of hospital preparations to a certain extent.
基金funded by the Party Building Research Project of Lanzhou University,“Research on Quality Evaluation Standards for Party Building Work in Universities in the New Era”[grant number LZUDJ–202309]
文摘This study explores the development of quality standards for leadership and organizational development in higher education to addresses the challenges posed by globalization and digitalization. By analyzing current situations and proposing a strategic framework, this study offers standard-based solutions for improving leadership quality and organizational performance in universities. The proposed quality standards align institutional goals with educational objectives, ensuring that higher education institutions are able to meet demands of modern education.
基金supported by the National Key Research and Development Program of China(Nos.2019YFC0214800,2020YFC1806303 and 2016YFC0208100)the Fundamental Research Funds for the Central Public-interest Scientific Institution(No.2021YSKY-06)。
文摘Ambient air quality standards are the core strategic goal of ambient air quality management.Countries worldwide have given importance to research on the development of ambient air quality standards.To understand the history of the development of China’s ambient air quality standards,this study analyzed the background associated with all previous formulations and revisions of the standards,classification of functional areas,standard grading,pollutants,and evolution of the standard limits over the past 40 years.The results show that since the initial release of the“Ambient Air Quality Standard”by China in 1982,it has been supplemented once,revised twice,and modified twice.The first ambient air quality standard specified the standard limits of six pollutants commonly found in ambient air.With the development of ambient air quality management,the number of pollutants has increased to ten.Since the release of the“Ambient Air Quality Standards”in 2012,the ambient air quality in China has significantly improved.However,the proportion of cities meeting these standards is still low.At present,China is suitably positioned to make the standards associated with 24 hr SO2concentrations more stringent such that it meets the values defined in the World Health Organization(WHO)interim target-2 and the WHO air quality guideline(AQG).We further suggested that the SO2standard should be revised promptly.Simultaneously,regions with a relatively high proportion of cities meeting the standard are encouraged to introduce more stringent interim target limits in due course to manage the local ambient air quality.
基金Program for Liaoning Innovative Research Team in University,Key Technologies in Quality Control of Traditional Chinese Medicines(Grant No.LT2012018)
文摘Traditional Chinese medicine (TCM) has been widely used in China for thousands of years, and has received more and more recognition worldwide. Indigoplant (Folium Polygoni Tinctorii), a TCM, has been used in various diseases. In our study, we established a quality standard of Indigoplant according to the European Pharmacopoeia, and this standard has passed the early audit stages of the European Pharmacopoeia Commission. The lndigoplant samples were identified with high performance thin layer chromatography (HPTLC), qualified with RP-HPLC quantitation, and analyzed with a series of quality tests. An accurate, reliable and robust HPLC method with gradient elution for quantitation was developed and validated with a one-variable-at-a-time (OVAT) robustness approach. Several tests, including the loss on drying, total ash and ash insoluble in hydrochloric acid of Indigoplant, were performed for quality analysis. Furthermore, six batches of the Indigoplant samples were appraised with this quality standard. In conclusion, the established quality standard was more internationally normative and applicable for the quality control of Indigoplant in practical application.
基金Program of Ligusticum Chuanxiong etc.100 kinds of Herbs Recommended International Quality Standards(Grant No.201307002)the Safety Testing Technology and Standard Platform of Traditional Chinese Medicine of Major New Drug Projects(Grant No.2014ZX09304307)
文摘As a traditional Chinese medicine (TCM), Dictamni Cortex is widely used for the treatment of rheumatism and skin diseases. To promote the internationalization of Dictarnni Cortex, we established a recommended quality standard of Dictamni Cortex according to the European Pharmacopoeia (EP) in the present study. Foreign matter, loss on drying, total ash and ash insoluble in hydrochloric acid were determined according to the procedures of EP 8.0. The thin layer chromatography (TLC) identification method was established by using obacunone and fraxinellone as the reference substances. The content of dictarnnine, obacunone and fraxinellone was assayed by reversed phase high performance liquid chromatography (RP-HPLC). Furthermore, we tested 21 batches of the prepared slices of Dictamni Cortex from different regions. The results indicated that the established quality standard was specific, accurate and internationalized, which could be used for the quality control of Dictamni Cortex.
基金supported by the Beijing Natural Science Foundation (No. L150001)National Natural Science Foundation of China (No. 81773381)Ministry of Environmental Protection of the People's Republic of China Fund for National Environmental Criteria Management (No. 2110105)
文摘With rapid economic development and urbanization in recent decades, China has experienced the worsening of ambient air quality. For better air quality management to protect human health, Chinese government revised national ambient air quality standards (NAAQS) for particulate matter (PM) in 2012 (GB3095-2012). To assess the effectiveness of current NAAQS for PM on public health in Chinese population, we conducted a meta- analysis on published studies examining the mortality risk of short-term exposure to PM with aerodynamic diameters less than 10 and 2.5μm (PM10 and PM2.5) in China. The reported 24-hour concentrations of PM10 and PM2.5 in studies ranged from 43.5 to 150.1 μg/m^3 and 37.5 to 176.7 μg/m^3. In the pooled excess, mortality risk estimates of short-term exposure to PM. In specific, per 10 μg/m^3 increase in PM10, we observed increases of 0.40% (95%CI: 0.33%, 0.47%), 0.57% (95%CI: 0.44%, 0.70%) and 0.49% (95%CI: 0.40%, 0.58%) in total, respiratory and cardiovascular mortality, per 10/μg/m^3 increase in PM2.5, we observed increases of 0.51% (95% CI: 0.38%, 0.63%), 0.62% (95%CI: 0.52%, 0.73%) and 0.75% (95%CI: 0.54%, 0.95%) in total, respiratory and cardiovascular mortality. Finally, we derived 125 μg/m^3 for PM10 and 62.5 μg/ m^3 for PM2.5 as 24-hour recommendation values based on the pooled estimates. Our results indicated that current Chinese NAAQS for PM could be sufficient in mitigating the excess mortality risk from short-term exposure to ambient PM. However, future research on long-term exposure cohort studies in Chinese population is also essential in revising annual averages for PM in Chinese NAAQS.
基金Supported by the Open Fund of Key Laboratory of Modern Chinese Medicine Preparations,Ministry of Education,Jiangxi University of Traditional Chinese Medicine and First-class Discipline Construction Project of Jiangxi Province(JXSYLXK-ZHYAO009,JXSYLXK-ZHYAO010)。
文摘The quality standards for Fructus Comi have been established based on the effects of the manufacturing processes.Three critical process parameters(CPPs)of extraction,filtration,and concentration to prepare Fructus Comi concentrate were identified by Plackett-Burman design with a single batch of Fructus Corni,which were heating medium temperature,extraction time,and water addition.Morroniside yield,loganin yield,and dry matter yield were process critical quality attributes(CQAs).CPPs arranged with a Box-Behnken design were applied to treat different batches of Fructus Comi After constructing a model that included CPPs,material propertie s,and process CQAs,loganin content was found to be the critical material attribute(CMA).The design space was calculated with a probability method.According to the limits of process CQAs,the minimum content of loganin in Fructus Corni was calculated with an error propagation method,which was 6.92 mg·g^(-1).When the content of loganin in Fructus Corni reaches up to 6.92 mg·g^(-1),the material is considered high-quality and is most suitable for the process.High-quality material can be used for production of Fructus Comi concentrate.This method can also be used to set material quality standards for other Chinese medicines.
基金Supported by Project of Guiyang Science and Technology Bureau(ZKHT[2020]-18-4).
文摘[Objectives]This study was conducted to optimize the preparation process of Tianlu Tongluo Granules and establish its quality standard.[Methods]Tianlu Tongluo Granules was prepared by an orthogonal test.TLC was used to identify Radix Astragali preparata,Radix Paeoniae Alba,Scutellariae Radix and Acori Tatarinowii Rhizoma in the granules,and the content of paeoniflorin in the finished product was determined by HPLC.[Results]The extraction process of Tianlu Tongluo Granules was as follows:adding 6 times of water,and decocting twice,1 h/time.In the forming process,the optimal ratio of thick paste to excipients as 10∶8.6,and the optimal ratio of excipients dextrin:starch:colloidal silicon dioxide was 6.5∶0.5∶1.6.The results showed that TLC spots were obvious,the separation was significant,and the specificity was strong.The paeoniflorin content had a good linear relationship in the concentration range of 5.9048-590.48 mg/L(r=0.9999).The average sample recovery was 101.10%,and the RSD was 1.18%.[Conclusions]The preparation process is stable and reasonable,and the established quality control method is specific and reproducible,and can be used for the quality control of Tianlu Tongluo Granules.
基金Supported by Self-financed Scientific Research Project of Administration of Traditional Chinese Medicine of Guangxi Zhuang Autonomous Region(GXZYZ20210290)The First Batch of High-level Talent Research Project of Affiliated Hospital of Youjiang Medical University for Nationalities in 2019(Y20196311)Basic Scientific Research Ability Improvement Project for Young and Middle-aged Teachers in Guangxi Universities in 2020(2020KY13034).
文摘[Objectives]This study was conducted to establish the quality standard of Danshen Jianxin Capsules.[Methods]Orthogonal design was adopted to optimize the water extraction process by taking the amount of water added,extraction time and extraction times as factors,and the content of tanshinone I as the index.Salviae Miltiorrhizae,Notoginseng Radix Et Rhizoma and Radix Astragali in the capsules were qualitatively identified by TLC,and the content of tanshinone I in the capsules was determined by HPLC.[Results]The best water extraction process included the steps of adding 12 times of water each time,extracting the materials twice,for 1 h each time.In TLC identification,the test samples showed spots of the same color at the positions corresponding to tanshinone II A,ginsenoside Rg1,notoginsenoside R1 and astragaloside IV reference samples.[Conclusions]Danshen Jianxin Capsules was prepared by the water extraction method,which is characterized by high efficiency and being suitable for mass production.The quality control method is reliable,fast and accurate,which can effectively control the quality of the product.
基金Supported by Study on Quality Evaluation and Standards of Guangxi Yao Medicine(MZY2012015)Guangxi Key Laboratory of Zhuang Yao Medicine(GKJZ[2014]32)+2 种基金Zhuang Yao Medicine Collaborative Innovation Center(GJKY[2013]20)High-level-innovation Team and Outstanding Scholar Project of Guangxi Higher Education Institutions:Zhuang Medicine Foundation and Clinical Innovation Team(GJR[2014]07)Student Research Training Program of Guangxi University of Chinese Medicine(NO.2017DXS35).Wei WEI(1981-),male,P.R.China,experimentalist,devoted to research about Tradition Chinese medicine and ethnic drug
文摘[Objectives] This study was conducted to establish the quality control standards for Laportea bulbifera(Sieb. et Zucc.) Wedd. [Methods] Microscopic identification and thin layer chromatography were used to identify and determine the moisture, total ash and extract contents. [Results] According to the microscopic results, the stem transection is round and has five longitudinal edges at which the cell wall is obviously thickened. Bristles can be observed. A series of collenchyma cells are arranged closely inside the epidermis. There are several rows of parenchyma cells. The vascular bundles are of different sizes;and the ray part is wide, and at the junction of the ray and the cortex, there are often scattered secretory cells. The center is a broad medulla. The powder is brown. There are many starch grains. The bristles are unicelluar, and have warty protrusions and expanded base. The fibers are bundled, and the cells are large. The epidermal cells are in the shape of an elongated spindle, in a mosaic arrangement, and the cell wall is slightly thickened. From the thin layer identification chromatograms of tested L. bulbifera, it can be seen that spots were observed at the same positions as the control medicinal material, and the durability of the method was good. The extract content should not be less than 12.00% by hot extraction with water as solvent, and not be less than 3.00% by cold extraction with ethanol as solvent. The moisture content should not be more than 16.50%. The total ash content should not be more than 14.00%. The acid-insoluble ash content should not be more than 2.50%. [Conclusions] The microscopic identification results are reliable and can be used as the identification basis of L. bulbifera. The thin layer identification method and the test results can provide a basis for quality control of L. bulbifera.
文摘 Both national and local governments have been paying great attention to the work of industrial standardization with the enormous increase in international trade after China joined WTO. According to the standards revising plan of Standardization Administration Committee of China (SAC),TC54 has already revised a series of national standards and industrial standards for foundry operations,and proposed some new ones. As a result,some old fashioned standards containing low-level techniques have been gradually discontinued or replaced with new versions.……
基金Key science and technology project of Hainan province(No.ZDKJ201805)。
文摘Objective:To establish the quality standard of Danmu exract syrup.Methods:TLC method was used to qualitatively identify Nauclea officinalis in Danmu exract syrup.The content of strictosamide and chlorogenic acid in Danmu exract syrup was determined by high efficiency axillary chromatography.Results:The spots were clear and there was no negative interference.The linear relationship of strictosamide was good in the range of 100~300ug/ml(R^(2)=0.9997).The average recovery was 99.1%and RSD was 1.16%(n=9).Chlorogenic acid had a good linear relationship in the range of 6.7~20.2ug/ml(R^(2)=0.9991).The average recovery was 99.9%and RSD was 1.10%(n=9).Conclusion:The standard is safe and reasonable,the method is simple,accurate and reproducible,and it can be used for the quality control of Danmu exract syrup.
基金Supported by National Key Science and Technology Project(2014ZX09304307-2)
文摘[Objectives] To establish the quality standard of Corydalis tomentella Franch. [Methods] The medicinal materials are identified from the perspectives of morphology,characters,microscopic characteristics and TLC of the plants. The contents of moisture,total ash and water extract are determined. The content of dehydrocavidine is determined by HPLC. The determination is performed on Agilent C18 column with mobile phase consisted of acetonitrile-phosphate buffer solution( containing 20 mmol/L monopotassium phosphate,10 mmol/L diethylamine,0. 1% phosphoric acid)( 28∶ 72,V/V) at the flow rate of 1. 0 m L/min. The detection wavelength is set at 347 nm,and the column temperature is 35℃. The sample size is 10 μL. [Results] The original plants are perennial herbs,and as produced into medicinal materials,they are hairy and shrink into balls with conical principal roots,and obvious cracks on the tubers and roots,curved and fragmented leaves,yellowish white flowers. The quasi-circular pollen grains contain square and columnar crystals,there are substantial nonglandular hairs,and also bordered pits,spiral and reticulate vessels,as well as wood fibers. TLC spots are clear and well-separated. The content of moisture is7. 5%-18. 5%,total ash 20. 5%-26. 2%,and water extract 29. 9%-46. 4%. The linear range of dehydrocavidine is 0. 040 08-2. 404 8 μg( r =0. 999 9); RSD of precision,stability and reproducibility tests is lower than 2. 0%. The recoveries are 95. 6%-102. 5%( RSD =2. 3%,n = 9). [Conclusions] The established standard can be used for quality evaluation of C. tomentella Franch..
基金Supported by the Special Fund for Environmental Protection Research in the Pubic Interest(201309007)
文摘In China,the water quality standards in operation include the Environmental Quality Standard for Surface Water(GB3838-2002)and Water Quality Standards for Seawater(GB3097-1997).However,these two standards are currently not suitable for the estuarial zones of China because of the unique properties of water environment in estuaries.We proposed preliminarily a basic idea and technical workflow in formulating water quality standards for the estuaries of China based on analyzing the water environment properties of estuaries comprehensively and comparing various parameters and their standard values mentioned in these two standards above.Issues pertinent to the formulation of the water quality standards for estuaries,e.g.nutrient,heavy metals and persistent organic pollutants(POPs),are highly concerned.The objective of this paper is to provide technical support for the formulation of scientific water quality standards and the assessment of water quality of the estuaries of China.
文摘[ Objective] The research aimed to study the quality standard of Compound Quanchangning Capsule. [ Method] Coptis, Phelledendron, Pulsatilla and Astragalus in Compound Quanchangning Capsule were indentified qualitatively by thin layer chromatography ( TLC), and the content of berberine hydrochloride was determined by high performance liquid chromatography (HPLC), to study the quality standard of Compound Quanchangning Capsule. [ Result] TLC identification showed that the tested product was clear and well-separated with no interference. Berberine hydrechloride showed a good linear relationship with peak area at the injection volume of 10.92 - 163.74 ~Lg/mL, and the regression equation was Y = 39 611X -2 387. 9 (R2 = 0. 999 8) ; the average recovery was 97.60%, and the relative standard deviation was 1.64% (n =6). [ Conclusion] The standard is simple in operation and good in specificity, stability and repeatability, which is prompted as a favorable method for quality control of Compound Quanchangning Capsule.
基金Supported by Inner Mongolia Science and Technology Foundation Project(kjt15sf22)
文摘[Objectives] To systematically identify and analyze pharmacognostical features of Mongolian medicine Shoushen and Naishoushen( dairy tablets) to provide scientific basis for the establishment and identification of its quality standard. [Methods] According to relevant methods specified in Appendix to 2010 Chinese Pharmacopoeia,the water content,total ash,and extracts of Shoushen and Naishoushen were detected,and thin layer chromatography( TLC) was applied to make qualitative identification. Gastrodin was used as the reference substance,extracted with 70% methanol,and then sprayed with ethyl acetate-formic acid-water( 9∶ 1∶ 0. 2) as the developing solvent,and then sprayed with 10% phosphomolybdic acid ethanol solution and heated at 105℃ to clear spot color. UV-Visible spectrophotometry and high performance liquid chromatography( HPLC) were used to analyze the content of polysaccharides and gastrodins in Shoushen and Naishoushen. The chromatographic column was a ZOBB AX eclipse XDB-C_(18)( 4. 6 mm × 250 mm,5 cm) column with the methanol-0. 04% phosphoric acid solution( 8∶92) as the mobile phase,the flow rate of 1. 0mL/min,the detection wavelength of 222 nm,and the column temperature of 30℃.[Results]In the thin-layer chromatography test,spots of the same color appeared at the positions corresponding to the chromatogram of the reference substance. Gastrodin eluted under high pressure reached baseline separation. Gastrodin had a good linearity in the concentration range of 0. 009-0. 09 mg/m L. The regression equation was Y = 586 866 X + 425 821( R^2= 0. 999 6),and the average recovery rate was100. 1%. Precision test,reproducibility test,and stability test conformed to the requirements. The results of extracts of three batches of samples were 26. 13%-42. 58%,water content was 3. 47%-5. 31%,and total ash was 5. 43%-6. 33%. [Conclusions] The quality control method has high reliability,high sensitivity,high specificity,high accuracy,and high stability. The results are expected to provide a scientific basis for the identification,resource utilization,and improvement of quality standard for Shoushen and Naishoushen.
基金Supported by Guangxi Key R&D Program(GK AB18221095)Guangxi Key Laboratory of Molecular Pathology of Hepatobiliary Diseases(GXZDSYS-005)+1 种基金Baise Scientific Research and Technological Development Program in 2021(BK 20211810)High-level Talent Scientific Research Project of Youjiang Medical University for Nationalities(01002018079)。
文摘[Objectives]This study was conducted to explore the quality control method and establish the quality standard of Zhuang medicine Buddlejae Flos.[Methods]The microscopic identification method was adopted to identify the characters and microscopic characteristics of dried Buddlejae Flos in combination with traditional experience.The moisture,ash,acid-insoluble components and extracts of Buddlejae Flos were determined with reference to general rules of Chinese Pharmacopoeia(2015 edition).TLC identification was performed.Liquid chromatography-mass spectrometry(LC-MS)was used to determine the contents of linarin and verbascoside in Buddlejae Flos,and gas chromatography-mass spectrometry(GC-MS)was adopted to detect pesticide residues in Buddlejae Flos.Heavy metal elements As,Cd and Pb were detected by inductively coupled plasma mass spectrometry(ICP-MS).[Results]The established method is simple and accurate.Clear spots were observed on the thin layer chromatograms,and the resolution was good.The average value of moisture content was 12.24%;the average value of ash content was 5.1%;the average value of acid-insoluble content was 7.5%;and the average value of extract content was 27.3%.The regression equation of rutin in Buddlejae Flos was y=11.896x-0.0049,R^(2)=0.9996,and the contents of linarin and verbascoside were 5680 and 2080 mg/kg,respectively.No pesticide residues and heavy metals were detected in the medicinal materials of Buddlejae Flos.[Conclusions]This study can provide reference for the quality standard control of Guangxi Zhuang medicine Buddlejae Flos.
基金Innovation research team project of Natural Science Foundation of Hainan Province(No.2018CXTD339)。
文摘Objective:To establish the quality standard of Li folk medicine callicarpa nudiflora powder by modern analytical method.Methods:TLC was used to identify the powder.Five heavy metals and harmful elements(Pb,Cd,As,Hg and Cu)in the powder were determined by flame atomic absorption spectrometry and hydride atomic fluorescence spectrometry.The content of luteolin and Mullein glycoside in the powder was determined by HPLC.Results:the fluorescent spots of TLC identification of powder were clear,and the separation of the two main components was good.It has good specificity,reproducibility and durability,which can be used for the identification of the powder.The inspection items of heavy metals for the identification of powder were established.It was stipulated that:according to the determination method,the lead should not exceed 5 mg/kg;the cadmium should not exceed 0.3 mg/kg;the arsenic should not exceed 2 mg/kg;the mercury should not exceed 0.2 mg/kg;the copper should not exceed 20 mg/kg.The content of luteolin and Mullein glycoside in the powder were determined by HPLC and the content inspection item of the powder was established.It was stipulated that the content of luteolin and Mullein glycoside in the powder should not be less than 0.48%and 5.83%,which can be used for the content limit inspection of the powder.Conclusion:the quality standard method established by our institute is advanced and operable,and can be used for the quality control of the powder.