[Objective] This study was conducted to establish a microbial limit test method for Bupi Qiangli Ointment. [Method] The conventional method and medium dilution method were used for bacterial, mold and yeast counting i...[Objective] This study was conducted to establish a microbial limit test method for Bupi Qiangli Ointment. [Method] The conventional method and medium dilution method were used for bacterial, mold and yeast counting in sample recovery test. [Result] The medium dilution method （1：10 test solution, 0.5 ml/plate） could effectively eliminate the inhibition effect of the Bupi Qiangli Ointment, and the recovery of Staphylococcus aureus was greater than 70% in the 3 batches of samples; and the conventional method exhibited the recoveries of E. coil, Bacillus subtilis, Candida albicans and Aspergillus greater than 70% in the 3 batches of samples. [Conclusion] Due to Bupi Qiangli Ointment has strongly antibacterial effect on Staphylococcus au- reus, the medium dilution method was used for bacterial counting, and the conventional method was used for mold and yeast counting; and the conventional method was used for controlled bacterium examination of E. coll.展开更多
[Objectives] This study was conducted to establish microbial limit test methods for traditional Chinese medicine preparations Yunpi Granules and Bupi Qiangli Paste. [Methods] According to General Rules of Part IV of C...[Objectives] This study was conducted to establish microbial limit test methods for traditional Chinese medicine preparations Yunpi Granules and Bupi Qiangli Paste. [Methods] According to General Rules of Part IV of Chinese Pharmacopoeia, applicability tests were conducted on microbial limit test methods for the above two traditional Chinese medicine preparations by the plate method. [Results] The established methods showed recovery values in the range of 0.5-2.0 for both experimental strains, and the control bacteria could be detected in the experimental group, but not in the negative control group. [Conclusions] The microbial limit test methods were reliable for the two traditional Chinese medicine preparations and could be used for quality control.展开更多
[Objectives]This study was conducted to establish a microbial limit test method for Qingyan Zhisou Powder.[Methods]Applicability tests were carried out according to Microbial Limit Tests of Non-sterile Products,Genera...[Objectives]This study was conducted to establish a microbial limit test method for Qingyan Zhisou Powder.[Methods]Applicability tests were carried out according to Microbial Limit Tests of Non-sterile Products,General Rules 1105-1107 of Part IV of Chinese Pharmacopoeia,2020.[Results]Qingyan Zhisou Powder had a strong bacteriostatic effect on Pseudomonas aeruginosa.After increasing the dilution ratio(1:40),the bacteriostatic effect was obviously eliminated.When the total number of aerobic microbes was determined by the test liquid dilution method(1:40),the recovery values were in the range of 50%-200%;and when using the test liquid(1:10)to determine the total number of mold and yeasts,the recovery ranged from 50%to 200%.Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria were detected by both the routine method and dilution method in experimental groups.[Conclusions]The microbial limit test of Qingyan Zhisou Powder adopted the test liquid dilution method,and the routine method could be used for the test of Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria.The applicability test of the method is feasible,with scientific and accurate results,and the method can effectively control the quality of the preparation and is recommended for popularization.展开更多
[ Objectives] This study was conducted to establish a method for microbial limit test of Tongmai Tangyanming Capsule. [ Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules, the microb...[ Objectives] This study was conducted to establish a method for microbial limit test of Tongmai Tangyanming Capsule. [ Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules, the microbiological limits of non-sterile products were verified. [ Results] Tongmai Tangyanming Capsule has a strong inhibitory effect on Bacillus subtilis and Candida albicans. The antimicrobial activity was significantly eliminated after increasing the diluent （ 1 ： 20） ; and the recoveries were in the range of 0.5 -2 when the total quantities of aerobic microbes were determined by dilution method （1：20）. When the total quantities of mould and yeast were determined by dilution method （1：20）, the recoveries were from 0.5 to 2, and Escherichia coli, cholate-tolerant Gram-negative bacteria and Salmonella can be detected by the test solution dilution method. [ Condusions] With the plate method, the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent, and conventional method was used for examination of control bacteria including E. coli, cholatetolerant Gram-negative bacteria and Salmonella. This method has been proved effective for microbial limit test of Tongmai Tangyanming Capsule, and can effectively control the quality of the preparation. The method is accurate and reliable.展开更多
[Objectives] This study was conducted to establish a method for microbial limit test of Compound Gangbangui Capsule. [Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules,the microbiol...[Objectives] This study was conducted to establish a method for microbial limit test of Compound Gangbangui Capsule. [Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules,the microbiological limits of non-sterile products were verified. [Results]Compound Gangbangui Capsule has a strong inhibitory effect on S. aureus,and the antimicrobial activity was significantly eliminated after increasing the diluent( 1∶ 20); and the recoveries were in the range of 0. 5-2. 0 when the total quantities of aerobic microbes were determined by dilution method( 1∶ 20). When the total quantities of mould and yeast were determined by conventional method( 1∶ 20),the recoveries were from 0. 5 to 2. 0,and Escherichia coli can be detected in experimental groups by the test solution dilution method. [Conclusions]With the plate method,the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent and conventional method,respectively,and control bacteria,E. coli was examined by conventional method. This method has been proved effective for microbial limit test of Compound Gangbangui Capsule,and can effectively control the quality of the preparation. The method is accurate and reliable.展开更多
[Objectives] This study was conducted to establish a method for microbial limit test of Compound Yu E Nose Drops.[Methods] According to the Chinese Pharmacopoei (General Rules in the fourth part of the 2015 edition),t...[Objectives] This study was conducted to establish a method for microbial limit test of Compound Yu E Nose Drops.[Methods] According to the Chinese Pharmacopoei (General Rules in the fourth part of the 2015 edition),the microbial limit test method for Compound Yu E Nose Drops was verified.[Results] Compound Yu E Nose Drops has a strong inhibitory effect on Staphylococcus aureus and Bacillus subtilis,and the inhibitory activity was significantly eliminated after increasing the diluent (1∶ 20).The recoveries were all in the range of 0.5-2.0 when the total quantities of aerobic microbes were determined by the dilution method (1∶ 20).When the total quantities of mould and yeast were determined by the conventional method,the recoveries were both in the range of 0.5-2.0.When examining control bacteria,Escherichia coli,S.aureus and Pseudomonas aeruginosa can all be detected in the test groups by the test liquid dilution method.[Conclusions] For Compound Yu E Nose Drops,the total quantities of aerobic microbe can be counted by the dilution method;the quantities of mould and yeast can be examined by the conventional plate method;and the conventional method can be used for control microbe examination.展开更多
Plane-strain forming limit strain （also known as FLD0） is an important data point on a forming limit diagram （FLD）. The effects of friction coefficients and material parameters on the specimen width associated wit...Plane-strain forming limit strain （also known as FLD0） is an important data point on a forming limit diagram （FLD）. The effects of friction coefficients and material parameters on the specimen width associated with the FLDo （W FLD0） in Marciniak test were studied by finite element simulation. WFLD0 was expressed as a function of the Lankford coefficients, n-value, k-value and sheet thickness and validated with various sheet materials. The determination of W FLD0 is of significance not only to reduce iterative attempts to accurately obtain FLDo, but also to obtain a full valid FLD with the least number of test specimens, which largely increases the efficiency and reduces cost to experimentally measure valid FLDs.展开更多
The conventional forming limit diagram （FLD） is described as a plot of major strain versus minor strain. However, FLD is dependent on forming history and strain path. In the present study, a forming limit stress-bas...The conventional forming limit diagram （FLD） is described as a plot of major strain versus minor strain. However, FLD is dependent on forming history and strain path. In the present study, a forming limit stress-based diagram （FLSD） has been adopted to predict the fracture limit of aluminum alloy （AA） 5052-O1 sheet. Nakazima test is simulated by plastic constitutive formula derived from the modified Gurson-Tvergaard-Needleman （GTN） model. An in situ tensile test with scanning electron microscope （SEM） is proposed to determine the parameters in GTN model. The damage evolution is observed and recorded, and the parameters of GTN model are identified through counting void fraction at three damage stages of AA5052-O 1. According to the experimental results, the original void volume fraction, the volume fraction of potential nucleated voids, the critical void volume fraction, the void volume fraction at the final failure of material are assigned as 0.002 918, 0.024 9, 0.030 103, 0.048 54, respectively. The stress and strain are obtained at the last loading step before crack. FLSD and FLD of AA5052-O 1 are plotted. Compared with the experimental Nakazima test and uniaxial tensile test, the predicted results show a good agreement. The parameters determined by in situ tensile test can be applied to the research of the forming limit for ductile metals.展开更多
Background: When continuous scale measurements are available, agreements between two measuring devices are assessed both graphically and analytically. In clinical investigations, Bland and Altman proposed plotting sub...Background: When continuous scale measurements are available, agreements between two measuring devices are assessed both graphically and analytically. In clinical investigations, Bland and Altman proposed plotting subject-wise differences between raters against subject-wise averages. In order to scientifically assess agreement, Bartko recommended combining the graphical approach with the statistical analytic procedure suggested by Bradley and Blackwood. The advantage of using this approach is that it enables significance testing and sample size estimation. We noted that the direct use of the results of the regression is misleading and we provide a correction in this regard. Methods: Graphical and linear models are used to assess agreements for continuous scale measurements. We demonstrate that software linear regression results should not be readily used and we provided correct analytic procedures. The degrees of freedom of the F-statistics are incorrectly reported, and we propose methods to overcome this problem by introducing the correct analytic form of the F statistic. Methods for sample size estimation using R-functions are also given. Results: We believe that the tutorial and the R-codes are useful tools for testing and estimating agreement between two rating protocols for continuous scale measurements. The interested reader may use the codes and apply them to their available data when the issue of agreement between two raters is the subject of interest.展开更多
基金Supported by Traditional Chinese Medicine and Ethnic Minority Medicine Technology Research Subject of Guizhou Administrative Bureau(QZYY2013-70,QZYY-2014-026)Joint Application of Basic Research Fund of Science and Technology Department o Yunnan Province-Guiyang University of Chinese Medicine(QKHLHZ[2014]7323)~~
文摘[Objective] This study was conducted to establish a microbial limit test method for Bupi Qiangli Ointment. [Method] The conventional method and medium dilution method were used for bacterial, mold and yeast counting in sample recovery test. [Result] The medium dilution method （1：10 test solution, 0.5 ml/plate） could effectively eliminate the inhibition effect of the Bupi Qiangli Ointment, and the recovery of Staphylococcus aureus was greater than 70% in the 3 batches of samples; and the conventional method exhibited the recoveries of E. coil, Bacillus subtilis, Candida albicans and Aspergillus greater than 70% in the 3 batches of samples. [Conclusion] Due to Bupi Qiangli Ointment has strongly antibacterial effect on Staphylococcus au- reus, the medium dilution method was used for bacterial counting, and the conventional method was used for mold and yeast counting; and the conventional method was used for controlled bacterium examination of E. coll.
基金Supported by Science and Technology Planning Project of Guiyang CityGuizhou Province (ZKHT [2019]-9-4-15)+2 种基金Green Seedling Research Startup Foundation of The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine (GZEYK-Y[2022]29)Research and Development CenterThe Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine(3040-04020001406)。
文摘[Objectives] This study was conducted to establish microbial limit test methods for traditional Chinese medicine preparations Yunpi Granules and Bupi Qiangli Paste. [Methods] According to General Rules of Part IV of Chinese Pharmacopoeia, applicability tests were conducted on microbial limit test methods for the above two traditional Chinese medicine preparations by the plate method. [Results] The established methods showed recovery values in the range of 0.5-2.0 for both experimental strains, and the control bacteria could be detected in the experimental group, but not in the negative control group. [Conclusions] The microbial limit test methods were reliable for the two traditional Chinese medicine preparations and could be used for quality control.
基金Supported by Traditional Chinese Medicine and Ethnic Minority Medicine Technology Research Subject of Guizhou Administrative Bureau(QZYY-2018-095)。
文摘[Objectives]This study was conducted to establish a microbial limit test method for Qingyan Zhisou Powder.[Methods]Applicability tests were carried out according to Microbial Limit Tests of Non-sterile Products,General Rules 1105-1107 of Part IV of Chinese Pharmacopoeia,2020.[Results]Qingyan Zhisou Powder had a strong bacteriostatic effect on Pseudomonas aeruginosa.After increasing the dilution ratio(1:40),the bacteriostatic effect was obviously eliminated.When the total number of aerobic microbes was determined by the test liquid dilution method(1:40),the recovery values were in the range of 50%-200%;and when using the test liquid(1:10)to determine the total number of mold and yeasts,the recovery ranged from 50%to 200%.Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria were detected by both the routine method and dilution method in experimental groups.[Conclusions]The microbial limit test of Qingyan Zhisou Powder adopted the test liquid dilution method,and the routine method could be used for the test of Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria.The applicability test of the method is feasible,with scientific and accurate results,and the method can effectively control the quality of the preparation and is recommended for popularization.
基金Supported by Special Fund for Research and Development of Traditional Chinese Medicine Modern Science and Technology Industry of Guizhou Province(qkhzyz[2011]5012)
文摘[ Objectives] This study was conducted to establish a method for microbial limit test of Tongmai Tangyanming Capsule. [ Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules, the microbiological limits of non-sterile products were verified. [ Results] Tongmai Tangyanming Capsule has a strong inhibitory effect on Bacillus subtilis and Candida albicans. The antimicrobial activity was significantly eliminated after increasing the diluent （ 1 ： 20） ; and the recoveries were in the range of 0.5 -2 when the total quantities of aerobic microbes were determined by dilution method （1：20）. When the total quantities of mould and yeast were determined by dilution method （1：20）, the recoveries were from 0.5 to 2, and Escherichia coli, cholate-tolerant Gram-negative bacteria and Salmonella can be detected by the test solution dilution method. [ Condusions] With the plate method, the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent, and conventional method was used for examination of control bacteria including E. coli, cholatetolerant Gram-negative bacteria and Salmonella. This method has been proved effective for microbial limit test of Tongmai Tangyanming Capsule, and can effectively control the quality of the preparation. The method is accurate and reliable.
基金Supported by Traditional Chinese Medicine and Ethnic Minority Medicine Technique Research Subject of Guizhou Administrative Bureau of TCM(QZYY2011-40)
文摘[Objectives] This study was conducted to establish a method for microbial limit test of Compound Gangbangui Capsule. [Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules,the microbiological limits of non-sterile products were verified. [Results]Compound Gangbangui Capsule has a strong inhibitory effect on S. aureus,and the antimicrobial activity was significantly eliminated after increasing the diluent( 1∶ 20); and the recoveries were in the range of 0. 5-2. 0 when the total quantities of aerobic microbes were determined by dilution method( 1∶ 20). When the total quantities of mould and yeast were determined by conventional method( 1∶ 20),the recoveries were from 0. 5 to 2. 0,and Escherichia coli can be detected in experimental groups by the test solution dilution method. [Conclusions]With the plate method,the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent and conventional method,respectively,and control bacteria,E. coli was examined by conventional method. This method has been proved effective for microbial limit test of Compound Gangbangui Capsule,and can effectively control the quality of the preparation. The method is accurate and reliable.
基金Supported by Traditional Chinese Medicine Modern Technology Industry Research and Development Special Project of Guizhou Province(QKHZYZ[2013]5018)First-class Construction Discipline Project of Guizhou Province(GNYL[2017]008)+1 种基金Traditional Chinese Medicine Characteristic Technology Inheriting Talent Project of State Administration of Traditional Chinese Medicine(GZYYRJH[2019]43)Traditional Chinese Medicine and Ethnic Minority Medicine Technique Research Subject of Guizhou Administrative Bureau of TCM(QZYY2013-75)
文摘[Objectives] This study was conducted to establish a method for microbial limit test of Compound Yu E Nose Drops.[Methods] According to the Chinese Pharmacopoei (General Rules in the fourth part of the 2015 edition),the microbial limit test method for Compound Yu E Nose Drops was verified.[Results] Compound Yu E Nose Drops has a strong inhibitory effect on Staphylococcus aureus and Bacillus subtilis,and the inhibitory activity was significantly eliminated after increasing the diluent (1∶ 20).The recoveries were all in the range of 0.5-2.0 when the total quantities of aerobic microbes were determined by the dilution method (1∶ 20).When the total quantities of mould and yeast were determined by the conventional method,the recoveries were both in the range of 0.5-2.0.When examining control bacteria,Escherichia coli,S.aureus and Pseudomonas aeruginosa can all be detected in the test groups by the test liquid dilution method.[Conclusions] For Compound Yu E Nose Drops,the total quantities of aerobic microbe can be counted by the dilution method;the quantities of mould and yeast can be examined by the conventional plate method;and the conventional method can be used for control microbe examination.
文摘Plane-strain forming limit strain （also known as FLD0） is an important data point on a forming limit diagram （FLD）. The effects of friction coefficients and material parameters on the specimen width associated with the FLDo （W FLD0） in Marciniak test were studied by finite element simulation. WFLD0 was expressed as a function of the Lankford coefficients, n-value, k-value and sheet thickness and validated with various sheet materials. The determination of W FLD0 is of significance not only to reduce iterative attempts to accurately obtain FLDo, but also to obtain a full valid FLD with the least number of test specimens, which largely increases the efficiency and reduces cost to experimentally measure valid FLDs.
基金Aeronautical Science Foundation of China （03H53048）
文摘The conventional forming limit diagram （FLD） is described as a plot of major strain versus minor strain. However, FLD is dependent on forming history and strain path. In the present study, a forming limit stress-based diagram （FLSD） has been adopted to predict the fracture limit of aluminum alloy （AA） 5052-O1 sheet. Nakazima test is simulated by plastic constitutive formula derived from the modified Gurson-Tvergaard-Needleman （GTN） model. An in situ tensile test with scanning electron microscope （SEM） is proposed to determine the parameters in GTN model. The damage evolution is observed and recorded, and the parameters of GTN model are identified through counting void fraction at three damage stages of AA5052-O 1. According to the experimental results, the original void volume fraction, the volume fraction of potential nucleated voids, the critical void volume fraction, the void volume fraction at the final failure of material are assigned as 0.002 918, 0.024 9, 0.030 103, 0.048 54, respectively. The stress and strain are obtained at the last loading step before crack. FLSD and FLD of AA5052-O 1 are plotted. Compared with the experimental Nakazima test and uniaxial tensile test, the predicted results show a good agreement. The parameters determined by in situ tensile test can be applied to the research of the forming limit for ductile metals.
文摘Background: When continuous scale measurements are available, agreements between two measuring devices are assessed both graphically and analytically. In clinical investigations, Bland and Altman proposed plotting subject-wise differences between raters against subject-wise averages. In order to scientifically assess agreement, Bartko recommended combining the graphical approach with the statistical analytic procedure suggested by Bradley and Blackwood. The advantage of using this approach is that it enables significance testing and sample size estimation. We noted that the direct use of the results of the regression is misleading and we provide a correction in this regard. Methods: Graphical and linear models are used to assess agreements for continuous scale measurements. We demonstrate that software linear regression results should not be readily used and we provided correct analytic procedures. The degrees of freedom of the F-statistics are incorrectly reported, and we propose methods to overcome this problem by introducing the correct analytic form of the F statistic. Methods for sample size estimation using R-functions are also given. Results: We believe that the tutorial and the R-codes are useful tools for testing and estimating agreement between two rating protocols for continuous scale measurements. The interested reader may use the codes and apply them to their available data when the issue of agreement between two raters is the subject of interest.
