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Objective:To compare the microbial count method described in Chinese Pharmacopoeia ( ChP) 2010 edition and 2015 edition. Methods:The bacterial count and total aerobic microbial count for 15 samples of Jingfang granule with the same batch were tested respectively by the method described in ChP 2010 edition and 2015 edition, the average number, uncertainty, colony distribu-tion range of samples and qualified rate from the two testing items were analyzed and compared. Results:The average number of colo-nies for the bacterial count and total aerobic microbial count was 720 and 830 cfu·g-1 , the expand uncertainty of 95％ confidence in-tervals was 0. 067 and 0. 061, the colony distribution range of samples was 620-840 cfu·g-1 and 720-960 cfu·g-1 , and the qualified rate was 90％ and 100％, respectively. Conclusion:The microbial count method described in Chp 2015 edition is more sensitive with more reasonable result evaluation, which can guarantee the stability of inspection reports.
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Objective:To interpret the main revision about the test method for bacteriostat effect in Chinese Pharmacopoeia(2015 edition). Methods:The main difference of the bacteriostat effect test method in Chinese Pharmacopoeia(2015 edition) and (2010 edi-tion) was compared. Results:The bacteriostat effect test method in the 2015 edition was revised at a comparatively large scale in the positioning of bacteriostat effect test, product classification, assessment criteria and so on. Conclusion: The bacteriostat effect test method in Chinese Pharmacopoeia (2015 edition) gradually improves the check standards in line with the international standards.
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Objective:To interpret the main revision of the microbiological examination for nonsterile products:tests for specified microorganisms in Chinese Pharmacopoeia (2015 edition). Methods:The microbiological examination for nonsterile products:tests for specified microorganisms in Chinese Pharmacopoeia (2015 edition) was compared with the relevant content in the 2010 edition, and then the differences were investigated. Results:Microbiological examination for nonsterile products:tests for specified microorganisms in Chinese Pharmacopoeia (2015 edition) had been revised at a comparatively large scale in the inspection items, test method, micro-bial culture system, the quality control concept and so on. Conclusion:Microbial inspection system in Chinese Pharmacopoeia (2015 edition) is gradually improved to become a high standard check system in line with the international standards.
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To introduce the stylistic rules and layout of Chinese Pharmacopoeia 2015 Edition, innovation of catalogue coding and general chapters frames of volume 4. Introduce the changes, features, revised and enlarged contents, backgrounds, principles and ranges of application of preparations and analytical methods general chapters and guides of Chinese Pharmacopoeia 2015 Edition.
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The author summarized the national drug standards of radiopharmaceutical preparations and analyzed the existing problems, and gave a brief introduction about the revision in the Chinese Pharmacopoeia 2015 edition.
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Depending on the elaboration work to the national drug standards, the writer gives some comments on how to carry out the monographs in Chinese Pharmacopoeia 2015 edition Volume II. The comments is in the items order of national drug standards. The writer also gives the reasons and considerations for some monograph's revision and elaboration so that the stockholders can understand and carry out the new edition pharmacopoeia quickly and exactly.
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Based on the work for the elaboration of Chinese Pharmacopoeia 2015 edition, the writers give an introduction on the procedure, drug selection and mainly revision of monographs and general notice by some examples.
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Unscramble the updated and revised standards of Traditional Chinese Medicines in the Chinese Pharmacopoeia of 2015 edition. Reflect the progress in the quality control of TCMs, and make a kind of help to understand and implement the monographs of the new upcoming Pharmacopoeia.
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Microbial control is one of the important parts of drug safety guarantee system. Chinese pharmacopoeia 2015 edition has constructed a complete system for pharmaceutical microbial control after continuous efforts since the 2005 edition. The new edition Chinese pharmacopoeia not only achieves the unity of three parts, but also makes harmonization between Chinese pharmacopoeia and ICH, thus is fully in line with international quality control system. In this paper, the revision progress of the last several editions of Chinese pharmacopoeia is reviewed. The main characteristics of pharmaceutical microbial control system in Chinese pharmacopoeia 2015 edition is clarified by revealing the formation process. The trend of this field in China is outlined by discussion on some hot issues.
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OBJECTIVE: To investigate the microbial contamination in Anemones Raddeanae Rhizoma and Taxilli Herba to provide a reference for microbiological examination of Chinese herbal medicines. METHODS: Anemones Raddeanae Rhizoma and Taxilli Herba were analyzed according to the Chinese Pharmacopoeia 2015 Edition (publicity draft) and the methods of National Institutes for Food and Drug Control for thermoduric bacteria and specified microoganisms. RESULTS: The microbial contamination in 23 batches samples of the two Chinese herbal medicines was serious. CONCLUSION: There is an urgent need to control the microbial contamination of Chinese herbal medicines and Chinese medicines to improve their quality.