Background The bacterial endotoxins test （BET） is a method used to detect or quantify endotoxins （lipo-polysaccharide,LPS） and is widely used in the quality control of parenteral medicines/vaccines and clinical di...Background The bacterial endotoxins test （BET） is a method used to detect or quantify endotoxins （lipo-polysaccharide,LPS） and is widely used in the quality control of parenteral medicines/vaccines and clinical dialysis fluid.It is also used in the diagnosis of endotoxemia and in detection of environment air quality control.Although BET has been adopted by most pharmacopoeias,result judgment algorithms （RJAs） of the test for interfering factors in the BET still differ between certain pharmacopoeias.We have evaluated RJAs of the test for interfering factors for the revision of BET described in the Chinese Pharmacopoeia 2010 （CHP2010）.Methods Original data from 1 748 samples were judged by RJAs of the Chinese Pharmacopoeia 2010,the Japanese Pharmacopoeia 2011 （JP2011）,the European Pharmacopoeia 7.0 （EP7.0）,the United States Pharmacopoeia 36 （USP36）,and the Indian Pharmacopoeia 2010 （IP2010）,respectively.A SAS software package was used in the statistical analysis.Results The results using CHP2010 and USP36,JP2011,EP7.0,and IP2010 had no significant difference （P=-0.7740）.The results using CHP2010 of 1 748 samples showed that 132 samples （7.6%） required an additional step; nevertheless there was no such requirement when using the other pharmacopeias.The kappa value of two RJAs （CHP2010 and EP7.0） was 0.6900 （0.6297-0.7504） indicating that the CHP2010 and other pharmacopoeias have good consistency.Conclusions The results using CHP2010 and USP36,JP2011,EP7.0,and IP2010 have different characteristics.CHP2010 method shows a good performance in Specificity,mistake diagnostic rate,agreement rate,predictive value for suspicious rate,and predictive value for passed rate.The CHP2010 method only had disadvantages in sensitivity compared with other pharmacopeias.We suggest that the Chinese pharmacopoeia interference test be revised in accordance with the USP36,JP2011,EP7.0,and IP2010 judgment model.展开更多
TCM reference standard(TCM RS)plays an important role in identification,characterization and quality control of herbal raw material,slices,extracts and finished products.It is widely used in:1)authentication of TCM ma...TCM reference standard(TCM RS)plays an important role in identification,characterization and quality control of herbal raw material,slices,extracts and finished products.It is widely used in:1)authentication of TCM material;2)quantitative determination of herbal chemicals and marker compounds;and 3)limit tests of toxic impurities.TCM RS are provided in three different categories in the form展开更多
Publication of scientific documents as research reports and original papers has an important place in displaying the authors’ knowledge, integrity, responsibility, and honesty. The same is true for the reviewers and ...Publication of scientific documents as research reports and original papers has an important place in displaying the authors’ knowledge, integrity, responsibility, and honesty. The same is true for the reviewers and editors. The authority of a publisher strongly depends on the qualifications of the experts who review the manuscripts, and the recommendations they provide to the authors and editors. The honesty of the authors, reviewers, and editors is of the utmost importance. The author of the paper titled “Analytical Methods in Quality Control of Scientific Publications”, which was published in theAmerican Journal of Analytical Chemistry, 2012, 3, 443-447 (DOI: 10.4236/ajac.2012.36058) had criticized the paper published by Dongreet al., “Application of GC-EI-MS for the Identification and Investigation of Positional Isomer in Primaquine, an Antimalarial Drug, ”Journal of Pharmaceutical and Biomedical Analysis, 2005, 39, 111-116 (DOI: 10.1016/j.jpba.2005.03.019), for presenting falsifications in this publication. Neither the reviewer northe Edi-tor-in-Chief Bezhan Chankvetadze of the Journal of Pharmaceutical and Biomedical Analysishas reacted to accusations of falsification. If a reviewer and editor are poorly qualified, unprincipled, or even corrupt, as was suggested by Bob Grant inThe Scientistmagazine (http://www.the-scientist.com/display/55679/#ixzz0mmsPoMIS), it is not good enough to consider simply that the publisher / journal has a high ranking and is indexed in PubMed or the Institute for Scientific Information (ISI). In this editorial, we report a profound misunderstanding oralack of knowledge by the authors Shixue G., Zhuoyu L., and Wei W., in their paper published in ZhongguoYaoye China Pharmaceuticals, Vol. 14, No. 4, 2005, pp. 36-37 and a similar lack of professionalism by reviewers and editors. The influence and the role of internationally used pharmacopeias, such as The British Pharmacopoeia, European Pharmacopoeia, The United States Pharmacopeial Convention, and United States Pharmacopeia are shown as the main initiators and drivers of these misunderstandings.展开更多
Saponification value is defined as mg KOH needed to neutralize free acids and saponify esters in 1 g of the test substance. A search of the literature showed that the standard saponification methods of the U.S. Pharma...Saponification value is defined as mg KOH needed to neutralize free acids and saponify esters in 1 g of the test substance. A search of the literature showed that the standard saponification methods of the U.S. Pharmacopeia, alcoholic potassium hydroxide were the only saponification reagent. The sample to investigate is saponified with an excess of ethanolic potassium hydroxide solution. After finished saponification the remaining excess of potassium hydroxide is determined by residual titration under Titrimetry , with aqueous volumetric hydrochloric acid. In this study, a test for saponification value has been successfully determined in carnuba wax. The average result has been found 90.9 mg KOH/g substance and, % RPD was 1.65%. This is in contradistinction to the U.S. Pharmacopeia/National Formulary (USP/ NF) Method.展开更多
Biovitrum公司和Pharmacopeia Drug Discovery公司计划就鉴定和优化治疗代谢性疾病的小分子方面展开合作。Biovitrum公司将获得Pharmacopeia公司的专利小分子库及其药物发现专用技术，用于鉴定并优化这些小分子。Pharmacopeia公司将得...Biovitrum公司和Pharmacopeia Drug Discovery公司计划就鉴定和优化治疗代谢性疾病的小分子方面展开合作。Biovitrum公司将获得Pharmacopeia公司的专利小分子库及其药物发现专用技术，用于鉴定并优化这些小分子。Pharmacopeia公司将得到补偿其研究投资的启动资金并将获得完成临床前与临床等重大研究的款项以及这笔交易中任何药物商业化的版税。展开更多
Endotoxins have been credited for over 50% of sepsis cases, with significantly greater mortality.1 A literature indicates wide-spread agreement that early detection of endotoxemia, endotoxin in the bloodstream, is th...Endotoxins have been credited for over 50% of sepsis cases, with significantly greater mortality.1 A literature indicates wide-spread agreement that early detection of endotoxemia, endotoxin in the bloodstream, is the major key for patient survival from sepsis.2 Today the most popular endotoxin detection system is bacterial endotoxins test （BET）, adopted by most pharmacopoeias. Interference test is a part of the bacterial endotoxin inspection method, used to judge whether the sample can be applied in BET. However, Limuloid resources are exhausted in China, which is an important source for LAL. Here, we reported 5 simple models for interfering factors test in the BET, and compared new models with the United States Pharmacopoeia 36 （USP36）.展开更多
In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Count...In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia(Ch P) 2010.Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B(Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party(WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe.This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.展开更多
文摘Background The bacterial endotoxins test （BET） is a method used to detect or quantify endotoxins （lipo-polysaccharide,LPS） and is widely used in the quality control of parenteral medicines/vaccines and clinical dialysis fluid.It is also used in the diagnosis of endotoxemia and in detection of environment air quality control.Although BET has been adopted by most pharmacopoeias,result judgment algorithms （RJAs） of the test for interfering factors in the BET still differ between certain pharmacopoeias.We have evaluated RJAs of the test for interfering factors for the revision of BET described in the Chinese Pharmacopoeia 2010 （CHP2010）.Methods Original data from 1 748 samples were judged by RJAs of the Chinese Pharmacopoeia 2010,the Japanese Pharmacopoeia 2011 （JP2011）,the European Pharmacopoeia 7.0 （EP7.0）,the United States Pharmacopoeia 36 （USP36）,and the Indian Pharmacopoeia 2010 （IP2010）,respectively.A SAS software package was used in the statistical analysis.Results The results using CHP2010 and USP36,JP2011,EP7.0,and IP2010 had no significant difference （P=-0.7740）.The results using CHP2010 of 1 748 samples showed that 132 samples （7.6%） required an additional step; nevertheless there was no such requirement when using the other pharmacopeias.The kappa value of two RJAs （CHP2010 and EP7.0） was 0.6900 （0.6297-0.7504） indicating that the CHP2010 and other pharmacopoeias have good consistency.Conclusions The results using CHP2010 and USP36,JP2011,EP7.0,and IP2010 have different characteristics.CHP2010 method shows a good performance in Specificity,mistake diagnostic rate,agreement rate,predictive value for suspicious rate,and predictive value for passed rate.The CHP2010 method only had disadvantages in sensitivity compared with other pharmacopeias.We suggest that the Chinese pharmacopoeia interference test be revised in accordance with the USP36,JP2011,EP7.0,and IP2010 judgment model.
文摘TCM reference standard(TCM RS)plays an important role in identification,characterization and quality control of herbal raw material,slices,extracts and finished products.It is widely used in:1)authentication of TCM material;2)quantitative determination of herbal chemicals and marker compounds;and 3)limit tests of toxic impurities.TCM RS are provided in three different categories in the form
文摘Publication of scientific documents as research reports and original papers has an important place in displaying the authors’ knowledge, integrity, responsibility, and honesty. The same is true for the reviewers and editors. The authority of a publisher strongly depends on the qualifications of the experts who review the manuscripts, and the recommendations they provide to the authors and editors. The honesty of the authors, reviewers, and editors is of the utmost importance. The author of the paper titled “Analytical Methods in Quality Control of Scientific Publications”, which was published in theAmerican Journal of Analytical Chemistry, 2012, 3, 443-447 (DOI: 10.4236/ajac.2012.36058) had criticized the paper published by Dongreet al., “Application of GC-EI-MS for the Identification and Investigation of Positional Isomer in Primaquine, an Antimalarial Drug, ”Journal of Pharmaceutical and Biomedical Analysis, 2005, 39, 111-116 (DOI: 10.1016/j.jpba.2005.03.019), for presenting falsifications in this publication. Neither the reviewer northe Edi-tor-in-Chief Bezhan Chankvetadze of the Journal of Pharmaceutical and Biomedical Analysishas reacted to accusations of falsification. If a reviewer and editor are poorly qualified, unprincipled, or even corrupt, as was suggested by Bob Grant inThe Scientistmagazine (http://www.the-scientist.com/display/55679/#ixzz0mmsPoMIS), it is not good enough to consider simply that the publisher / journal has a high ranking and is indexed in PubMed or the Institute for Scientific Information (ISI). In this editorial, we report a profound misunderstanding oralack of knowledge by the authors Shixue G., Zhuoyu L., and Wei W., in their paper published in ZhongguoYaoye China Pharmaceuticals, Vol. 14, No. 4, 2005, pp. 36-37 and a similar lack of professionalism by reviewers and editors. The influence and the role of internationally used pharmacopeias, such as The British Pharmacopoeia, European Pharmacopoeia, The United States Pharmacopeial Convention, and United States Pharmacopeia are shown as the main initiators and drivers of these misunderstandings.
文摘Saponification value is defined as mg KOH needed to neutralize free acids and saponify esters in 1 g of the test substance. A search of the literature showed that the standard saponification methods of the U.S. Pharmacopeia, alcoholic potassium hydroxide were the only saponification reagent. The sample to investigate is saponified with an excess of ethanolic potassium hydroxide solution. After finished saponification the remaining excess of potassium hydroxide is determined by residual titration under Titrimetry , with aqueous volumetric hydrochloric acid. In this study, a test for saponification value has been successfully determined in carnuba wax. The average result has been found 90.9 mg KOH/g substance and, % RPD was 1.65%. This is in contradistinction to the U.S. Pharmacopeia/National Formulary (USP/ NF) Method.
文摘Biovitrum公司和Pharmacopeia Drug Discovery公司计划就鉴定和优化治疗代谢性疾病的小分子方面展开合作。Biovitrum公司将获得Pharmacopeia公司的专利小分子库及其药物发现专用技术，用于鉴定并优化这些小分子。Pharmacopeia公司将得到补偿其研究投资的启动资金并将获得完成临床前与临床等重大研究的款项以及这笔交易中任何药物商业化的版税。
文摘Endotoxins have been credited for over 50% of sepsis cases, with significantly greater mortality.1 A literature indicates wide-spread agreement that early detection of endotoxemia, endotoxin in the bloodstream, is the major key for patient survival from sepsis.2 Today the most popular endotoxin detection system is bacterial endotoxins test （BET）, adopted by most pharmacopoeias. Interference test is a part of the bacterial endotoxin inspection method, used to judge whether the sample can be applied in BET. However, Limuloid resources are exhausted in China, which is an important source for LAL. Here, we reported 5 simple models for interfering factors test in the BET, and compared new models with the United States Pharmacopoeia 36 （USP36）.
文摘In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia(Ch P) 2010.Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B(Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party(WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe.This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.
