The revision of the new Chinese Pharmacopoeia drives the medical instrument market to be hot

On March 28, 2014, the National Pharmacopoeia Committee issued a notice on the public consultation for the 2015 Pharmacopoeia (draft). According to the notice, the relevant professional committees of the National Pharmacopoeia Committee have completed the research work on the preparation and coding of the General Regulations (Appendix), and in January 2014, they consulted the Pharmacopoeia Committees through the Pharmacopoeia Forum of the National Pharmacopoeia Committee.

The Symposium on Drug Standard System Construction and Drug Development, hosted by the China Pharmaceutical Press Association, was held in Hangzhou. At this meeting, Zhou Fu, deputy secretary-general of the State Pharmacopoeia, made an introduction to the revision of the 2015 edition of the Chinese Pharmacopoeia. He pointed out: "The 2015 edition of the Chinese Pharmacopoeia revised the line of thought and said that the most important characteristic of drugs is ' Safe, effective, uniform, stable, and controllable. Therefore, the formulation of drug standards should establish the basic concepts and ideas for system considerations; the pharmacopoeia is a code, and China should improve the national drug standards management system with the Chinese Pharmacopoeia as its core. Strengthen the guiding role of national standards and promote the improvement of drug quality."

Through the "Chinese Pharmacopoeia" 2015 edition of the General Rules and the revised content, it can be seen that the 2015 edition of the Chinese Pharmacopoeia has updated the inductively coupled plasma mass spectrometry, (new) Raman spectroscopy, supercritical fluid chromatography, Instrumental test methods such as critical point chromatography; at the same time, the pesticide residue determination method and aflatoxin determination method have been added, and the antibacterial efficacy test method, the histamine substance inspection method, and the DNA barcode molecular identification of Chinese herbal medicines have been added. Methods such as methods, elemental forms, and valence determination methods.

Drug quality control is an important foundation for the sustainable development of pharmaceutical industry in China and the safety of drug use. In recent years, some regional and specific areas of drug quality and drug safety have emerged in China. The related researches on drug development, production process improvement, raw material use, pharmaceutical excipient addition, transportation and storage are all related to drug standards to varying degrees. Therefore, drug standards are undoubtedly the key to ensuring drug safety.

In January this year, China’s first National Drug Safety 12th Five-Year Plan (hereinafter referred to as the “Planning”) clearly requires: after five years of hard work, the drug standards and drug quality have been greatly improved, the drug regulatory system has been further improved, and drug development The production, circulation order and use behavior were further standardized, and the drug safety guarantee capability as a whole was close to the international advanced level. The drug safety level and the people's medication safety satisfaction were significantly improved. In the main tasks and key projects, the Plan proposes to comprehensively improve national drug standards, implement national drug standards improvement action plans, and comprehensively improve the quality of generic drugs.

In order to ensure the safety of drugs, China has done a lot of meticulous work in the formulation of drug standards and made great progress. Compared with the 2005 edition of the Chinese Pharmacopoeia, the 2010 edition of the Chinese Pharmacopoeia significantly increased the drug standard loading capacity and carried out a larger range of standard revisions. For example, from the 2005 edition of the 3,217 drug standards, to the 2010 edition of 4,567, including 1,386 new varieties, 2,237 revisions, and removed 36 varieties that do not meet the needs.

The new edition of the Chinese Pharmacopoeia focuses on the characteristics of traditional Chinese medicine and expresses the characteristics of traditional Chinese medicine: it attaches importance to the standards of Chinese herbal medicines and traditional Chinese medicine decoction pieces; it greatly increases the application of the special identification technology that conforms to the characteristics of traditional Chinese medicines. For example, microscopic powder identification technology is widely used, and thin layer chromatography is used for identification. Technology, one-test multi-evaluation technology, multi-indicator component quantification, and effective use of features and fingerprinting techniques. A series of effective measures have been taken to comprehensively improve the scientificity, effectiveness and practicality of drug standards, thus eliminating the appearance of inferior products due to standard defects.

On the basis of the 2010 edition of the Chinese Pharmacopoeia, the revision of the 2015 edition of the Chinese Pharmacopoeia further emphasizes that drugs are “safe, effective, uniform, stable and controllable”, but there is still much work to be done to achieve this goal. .