Published in Chinese Pharmacopoeia 2015 with 7 major changes

Source: sabilan 2015-06-11 June 10, the National Pharmacopoeia Committee issued a notice that according to the drug administration law of the people's Republic of China, the Pharmacopoeia of the people's Republic of China (2015 version, hereinafter referred to as Pharmacopoeia) was reviewed and approved by the plenary session of the Executive Committee of the 10th Pharmacopoeia Committee, which was issued and implemented from December 1, 2015 Pharmacopoeia is one of the most important documents in the pharmaceutical industry, and its revision has been attracting much attention 2015 edition is the tenth edition of Pharmacopoeia since the first edition of pharmacopoeia in 1953 According to the public information, on February 4, 2015, the Executive Committee of the 10th Pharmacopoeia Committee considered and adopted the 2015 version draft of China Pharmacopoeia Wu Zhen, vice chairman of the Pharmacopoeia Committee and deputy director of the State Food and drug administration, made a summary of the meeting He pointed out that the 2015 edition of the Pharmacopoeia has reached a new level in terms of the collection of Pharmacopoeia varieties, the scope of standard updating, the improvement of test methods, the setting of test limits, the improvement of standard system and the overall improvement of quality control level The promulgation and implementation of "Chinese Pharmacopoeia" reflects the level of drug use, pharmaceutical level and regulatory level in China Therefore, we should continue to strengthen the work of Pharmacopoeia standards, play its leading and normative role The next edition of the Pharmacopoeia will be the 2020 edition We should do a good job in planning the 2020 edition of the Pharmacopoeia, so that the level of the 2020 edition of the Pharmacopoeia can reach a new level Zhang Wei, Secretary General of the State Pharmacopoeia Committee, introduced seven changes in the seven major changes of the pharmacopoeia in the later stage of the preparation of China Pharmacopoeia 2015 Since Zhang Wei was still not the final one, some specific figures may change in this change, but the overall spirit can still be used for reference First, the growth rate of harvest varieties reached 27.4% There are 5800 varieties to be included in Pharmacopoeia 2015, more than 1200 more than Pharmacopoeia 2010, and 751 revised varieties (if this figure is the final figure, it has to be corrected by the insiders) Second, through the comprehensive revision of the general principles, general rules and general principles of the Pharmacopoeia, the requirements for drug quality control have been further improved on the whole, the technical provisions of the pharmacopoeia standard have been improved, and the pharmacopoeia standard has been more systematic and standardized Third, the drug standard system has been improved In particular, the number of varieties of pharmaceutical excipients increased to 260 (sabilan note: 270 kinds were finally announced, with a larger increase), and relevant guidelines were added On the basis of induction, verification and specification, the common detection methods of all parts of the Chinese Pharmacopoeia were coordinated and unified Fourth, the appendix (general principles) and excipients of Pharmacopoeia 2015 are independent volumes, which constitute the main contents of the fourth part of Chinese Pharmacopoeia Fifthly, the number of drug excipients increased significantly It is planned to add 128, 260 in total, with a growth rate of 97% (note to cypress blue: 270 species were finally announced, with a larger increase rate.) sixth, the safety control project was greatly improved Traditional Chinese medicine: it has formulated the limit standards of sulfur dioxide residues in traditional Chinese medicine and decoction pieces, promoted the establishment and improvement of the limit standards for the detection of heavy metals and harmful elements, aflatoxins, pesticide residues and other substances, and strengthened the control of heavy metals and toxic and harmful substances in traditional Chinese medicine Chemical drugs: related substances strengthen the research of qualitative and quantitative determination methods of impurities, realize the differential control of known impurities and unknown impurities, optimize the determination methods of antibiotic polymers, set reasonable control limits, and further improve the scientificity and rationality of related substance projects as a whole Biological products: increase the requirements of relevant general theory, and strictly control the quality of biological products in the whole process to ensure the safety and effectiveness of products At the same time, add the "general technical requirements for quality control of raw and auxiliary materials used in the production of biological products", strengthen the source control, and minimize the safety risks Seventh, further strengthen the effectiveness control Chinese herbal medicine strengthens the identification of specific properties and the setting of content determination items Chemical drugs appropriately increase the index of controlling the effectiveness of preparations, and establish scientific and reasonable inspection methods Biological products further improve the standardization of potency test methods, strengthen the research and application of in vitro method instead of in vivo method, and ensure the accuracy and operability of potency test methods Author: situ Yangming