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OBJECTIVE: Molecular weight determinations of heparin sodium and heparin calcium were added in Chinese Pharmacopoeia (2015).To establish the 1st national standards of heparin molecular weight calibrant and heparin for system suitability of molecular weight determinations were needed to establish. METHODS: An national collaborative study involving twelve laboratories had taken place, organized by National Institutes for Food and Drug Control(NIFDC)to provide supporting data for the establishment of the 1st batches of heparin molecular weight calibrant and heparin for system suitability of molecular weight determinations standard. The method of heparin molecular weight determinations in Chinese Pharmacopoeia (2015) was used in the national collaborative study. The USP heparin sodium molecular weight calibrant RS (F0L483) was used as molecular weight calibrant. The USP heparin sodium identification RS(G1L413) was used as the standard of system suitability. The candidate national standards of heparin molecular weight calibrant (140819-201501) and the candidate heparin for system suitability of molecular weight determination standard(140818-201501) were tested in the study. RESULTS: To be calculated the cumulative percent of peak area at the 20 molecular points from 5 000-42 000 of the candidate national standard of heparin molecular weight calibrant (140819-201501). Based on the statistical analysis, the candidate gave low intra-and inter-laboratories variations. In laboratories, standard deviations (SD) of two laboratories ranged from 1% to 2%,others were less than 1%.Between laboratories, SD were all less than 1%,relative standard deviation(RSD) was all less than 10%. The intra-lab SD of the test to determine the molecular weight of the candidate heparin for system suitability of molecular weight determinations standard(140818-201501) was less than 180,except Lab 2. The inter-lab SD was 180. The RSD was 1.1%. CONCLUSION: After the examination of the expert committee on pharmaceutical standardization, the candidate (140819-201501) is approved as the first national standard of heparin molecular weight calibrant, provides the broad standard table. The candidate(140818-201501) is approved as the first national standard of heparin for system suitability of molecular weight determinations, with an assigned molecular weight (Mw) of 16 200. The two national standards can be used in the test of heparin molecular weight determinations in Chinese Pharmacopeia(2015).
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OBJECTIVE: In June 2017, the National Pharmacopoeia Committee published on the internet the draft of national standards for dalteparin sodiumenoxaparin sodium and nadroparin calcium. As the new monographs to be added to the Chinese Pharmacopoeia in 2020. To establish the first batch national standards of low molecular weight calirantdalteparin sodiumenoxaparin sodium and nadroparin calcium for system suitability. METHODS: A national collaborative study involving thirteen laboratories had taken place, organized by National Institutes for Food and Drug Control(NIFDC)to provide supporting data for the establishment of the 1st national standards of low molecular weight heparin for molecular weight calibrantdalteparin sodium enoxaparin sodium and nadroparin calcium for system suitability of molecular weight determinations. The molecular weight determination methods in draft standards were used in the national collaborative study. The 2nd international standard low molecular weight heparin for molecular weight calibration(05/112) were used as molecular weight calibrant. The candidate national standards of low molecular weight heparin for molecular weight calibration (140820-201801) and the candidate dalteparin sodium(140811-201801) enoxaparin sodium(140810-201801) nadroparin calcium(140812-201801)for system suitability of molecular weight determination were tested in the study. RESULTS: The cumulative percent of peak area at the 18 molecular points from 600-18 000 of the candidate national standard of low molecular weight heparin for molecular weight calibration (140820-201801) were calculated. Based on the statistical analysis, the candidate gave low intra- and inter-laboratories variations.Of all 13 laboratories, standard deviations (SD) of two laboratories ranged from 1% to 2%,the others were less than 1%.Between laboratories, SD were all less than 1%,relative standard deviation(RSD) were all less than 5% except two points of the small molecular. The intra-lab SD of the test to determine the molecular weight of the candidate dalteparin sodium(140811-201801) enoxaparin sodium(140810-201801) nadroparin calcium(140812-201801)for system suitability of molecular weight determination was between 4 and 110,RSD was less than 2.5%. The inter-lab SD were less than 30, RSD was less than 1.0%. CONCLUSION: After the examination of the expert committee on pharmaceutical standardization, the candidate (140820-201801) was approved as the first national standard of low molecular weight heparin for molecular weight calibration, the broad standard table is also provided the broad standard table. The candidate(140811-201801) is approved as the first national standard of dalteparin sodium for system suitability of molecular weight determination, with an assigned molecular weight (Mw) of 6 268. The candidate(140810-201801) is approved as the first national standard of enoxaparin sodium for system suitability of molecular weight determination, with an assigned molecular weight (Mw) of 4 435. The candidate(140812-201801) was approved as the first national standard of nadroparin calcium for system suitability of molecular weight determination, with an assigned molecular weight (Mw) of 4 832.
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Prof. Meng Moody and his professional career, especially his experience in Peking Union Medical College Hospital over 1925 to 1931 was briefly reviewed. He took the Interim Director of the Pharmacy Department in 1926 and 1930, respectively, while John Cameron left for vacation. Regarding to his dedications to Chinese Pharmacopeia in 1930's and after the founding of P. R. China, respectively, he played major role there.
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OBJECTIVE: To guide pharmaceutical manufacturing to pay full attention to and implement the quality control and overall requirements of preparation production based on the analysis of the revision work and major changes of the Dosage Forms General Chapters of the 2020 edition of the Chinese Pharmacopoeia. METHODSE: This article mainly introduces the compilation progress of the Dosage Forms General Chapters of the 2020 edition of the Chinese Pharmacopoeia. RESULTS: The analysis is helpful to improve the integrity, advancement and readability of the Dosage Forms General Chapters of the 2020 edition of the Chinese Pharmacopoeia. CONCLUSION: The improvement of the Dosage Forms General Chapters of the 2020 edition of the Chinese Pharmacopoeia will play an important role in improving the overall level of Chinese pharmacopoeia standards, strengthening drug quality control and improving drug quality.
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OBJECTIVE： To provide reference for standardizing rational use of set prescription preparation containing Coptis chinensis and its processed product. METHODS： By retrieving 2015 edition of Chinese Pharmacopeia·Guidelines for Clinical Drug Use（volume of TCM set prescription）， the inclusion of set prescription preparation containing C. chinensis and its processed product were summarized and analyzed. RESULTS&CONCLUSIONS： There were 127 set prescription preparations containing C. chinensis and its processed product included in 2015 edition of Chinese Pharmacopeia·Guidelines for Clinical Drug Use（volume of TCM set prescription）， among which， there were 83， 5， 2， 8， 4， 11， 6， 5 and 3 set prescription preparations for internal medicine， surgery， gynecology， pediatrics， dermatology， ophthalmology， pharyngology， stomatology， orthopedics and traumatology， respectively. There were 120 set prescription preparations containing C. chinensis（94.49％）， 2， 4 and 1 set prescription preparations containing prepared C. chinensis with vino， prepared C. chinensis with ginger and prepared C. chinensis with Euodia rutaecarpa， respectively. There were 39， 59 and 29 kinds of set prescription preparations with C. chinensis as main symptoms medicine， assists medicine and complication medicine， which were mainly for clearing heat， drying dampness， purging fire and detoxifying（104 kinds， 81.89％）. Main types included Shexiang niuhuang pills， Gegen cenlian tablets， Kaiwei jianpi pills， etc. By comparing the efficacy of C. chinensis and its processed product， it was found that the names of processed products were not standardized， the labeling of C. chinensis and its processed products were not uniform and the application was not standardized； the related contents still needed to be further improved. It is necessary to strengthen the research on the pharmacodynamic basis and processing standard of C. chinensis and carry out the investigation and correction of relevant publications in order to help improve the rational drug use level of set prescription preparations containing C. chinensis and its processed products.
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OBJECTIVE: To introduce the application of the residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition. METHODS: Determination of the residual solvents of cefathiamidine was chosen as an example to indicate that how to use the residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition when the methods for the determination of residual solvent in monograph of cefathiamidine did not work. RESULTS: The residual solvents in cefathiamidine from different manufactures were determined accurately using methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition. CONCLUSION: The residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 can be used to screening and confirm the unknown peaks by the two opposite polar column systems, which can help to establish the residual solvents method.
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Monographs of Chinese medicine into the United States Pharmacopeia and the European Pharmacopoeia is the prerequisite and foundation for the aim of Chinese medicine standards leading the international standard-set-ting. By comparative analysis of the key issues of quality standards among Chinese, American and European Phar-macopoeia, thoughts and suggestions are proposed on how to implement the construction of international quality stan-dard of traditional Chinese medicine. Meanwhile, under the pressure of the present international environment, the pa-per can also provide some reference and advices which can help to break down the difficult situation for the process of internationalization of traditional Chinese medicine.