Contents, characteristics and technical standards of the 2010 edition of the Chinese Pharmacopoeia

At 10:00 am on Saturday, October 10, 2009, the State Food and Drug Administration held a regular press conference. The spokesperson Yan Jiangyan introduced the contents and characteristics of the 2010 edition of the Chinese Pharmacopoeia and related information on improving the technical standards of medicines, and answered questions from reporters.

Yan Jiangyan:

Good morning, everyone, reporters! Today is the second day after the 11th holiday, and it is also the day of the October press conference. This regular press release will have two themes: The first topic, we have sent a notice to everyone on the Internet to introduce the situation of the Chinese Pharmacopoeia; the second topic is added later, please ask Wang Junzhi of China National Institute for the Control of Pharmaceutical and Biological Products. The deputy director introduced the issuance of the A-type H1N1 flu vaccine. Let me introduce the preparation of the 2010 edition of the Chinese Pharmacopoeia.

2009-10-10 10:00:00

Yan Jiangyan:

The 2010 edition of the Chinese Pharmacopoeia has been completed and will be published by the China Medical Science and Technology Press before the end of the year and will be officially implemented on July 1 next year.

The "Chinese Pharmacopoeia" is a drug code established by the state to ensure the quality of drugs and ensure the safety and effectiveness of people's drugs. It is the statutory basis for the strict development of drug development, production, management, use and management. It is the national drug standard system. The core is an important part of international exchanges and cooperation.

The 2010 edition of the Chinese Pharmacopoeia is the ninth edition of the Pharmacopoeia compiled by the founding of New China for 60 years. The new edition of the Pharmacopoeia is based on the summary of the Pharmacopoeia of the past edition, making full use of the drug standard resources at home and abroad in recent years, focusing on innovation and development, and reflecting truthfully. The development status of China's pharmaceutical industry and clinical drug use level provides a strong technical support for further strengthening drug supervision and management.

2009-10-10 10:02:28

Yan Jiangyan:

The 2010 edition of the Chinese Pharmacopoeia is divided into three sections, one is Chinese medicine, the second is chemical medicine, and the third is biological products. The 2010 edition of the Chinese Pharmacopoeia contains more than 4,600 varieties, of which more than 1,300 are newly added, covering basically the national essential drug catalogue variety and the national medical insurance catalogue.

The 2010 edition of the Chinese Pharmacopoeia has the following main features:

2009-10-10 10:04:16

Yan Jiangyan:

First, the safety of drugs is further guaranteed

In terms of drug safety, in addition to strengthening the overall requirements for safety inspection in the appendix, safety inspection items are also greatly increased or improved in the text standard, further improving the standard requirements for high-risk varieties and further strengthening heavy metals or harmful. Control of elements, impurities, residual solvents, etc., and stipulates that ophthalmic preparations are required for aseptic preparations, and external preparations for burns or severe wounds are prescribed aseptically. The new edition of the Pharmacopoeia's appendices and general principles and basic technical regulations and requirements have direct effects and influence on all listed drugs outside the Pharmacopoeia.

2009-10-10 10:15:55

Yan Jiangyan:

In terms of effectiveness and quality controllability, in addition to new and revised related inspection methods and guiding principles, the effectiveness check items are added or improved in the text body standard, which greatly increases the specificity identification according to the characteristics of traditional Chinese medicine. The test uses a more specific inspection method to increase the dissolution and uniformity of the inspection items.

The systematic improvement of the 2010 edition of the Chinese Pharmacopoeia's key drug standards places particular emphasis on high-risk drugs. The new edition of the Pharmacopoeia has added guidelines for the application of the safety inspection method for chemical injections; in the general provisions of the preparations, the osmolality test was used as an injectable item for injections; the varieties of traditional Chinese medicine injections contained in the Pharmacopoeia all increased the limits of heavy metals and harmful elements. Standards; in addition, the standards for other injectables have increased the quality control requirements for product safety, effectiveness and quality control. These measures are necessary to solve the safety problems of injections, especially Chinese medicine injections. Play a positive role.

2009-10-10 10:20:29

Yan Jiangyan:

Second, the overall level of Chinese medicine standards has been comprehensively improved

(1) The number of varieties of Chinese medicines collected has been greatly improved

The new edition of the Pharmacopoeia contains a significant increase in the standards for Chinese herbal medicines, Chinese herbal medicines, Chinese patent medicines and Chinese medicine extracts. It has changed and reversed the long-term collection of varieties and poor foundations, especially the lack of standards for Chinese herbal medicines. In the protection of Chinese medicine resources and related standards, technological innovation has achieved leapfrog development.

2009-10-10 10:26:45

Yan Jiangyan:

(2) The varieties of traditional Chinese medicines have increased and improved the safety control indicators.

First, strengthen the overall requirements for safety inspection in the appendix of Chinese medicine. For example, in the general preparation of the appendix, the oral tincture is supplemented with a limit test of methanol, and the rubber paste is first proposed not to detect the pathogen test requirements; in the appendix detection method, the new sulfur dioxide residue determination method, aflatoxin determination method, osmotic pressure Molar concentration measurement method, abnormal toxicity test method, antihypertensive substance test method, allergic reaction test method, hemolysis and coagulation test method, and the like.

The second is to increase or improve the safety inspection items in the Chinese herbal medicine standard. For example, the detection of aflatoxin, such as peach kernels and almonds, which are susceptible to mildew, is consistent with the international standards; benzene is completely banned as a solvent in the text standard; organic solvent residues are checked for the use of organic solvents in the process; The highly toxic decoction pieces such as black, grass, and horse money are limitedly inspected by more advanced and precise methods such as high performance liquid chromatography (HPLC).

Third, in the control of heavy metals and harmful elements, the new edition of the Pharmacopoeia uses inductively coupled plasma mass spectrometry (ICP-MS) to determine the content of arsenic, mercury, lead, cadmium and copper in traditional Chinese medicine; for all Chinese medicine injections and scorpions, hawthorn, The long-term use of ginseng and Codonopsis pilosula and the varieties commonly used by children have increased the limits of heavy metals and harmful elements.

2009-10-10 10:27:24

Yan Jiangyan:

(3) Solving the problem of the standard of Chinese medicine decoction pieces.

One of the main features of the 2010 edition of the Chinese Pharmacopoeia is that it has substantially increased the number of Chinese medicine decoction pieces, and initially solved the problems of the national standards that have long plagued the development of the Chinese medicine decoction piece industry and the inconsistency of local processing standards. It will play a positive role in improving the quality of traditional Chinese medicine decoction pieces, ensuring the safety and efficacy of TCM clinical drugs, and promoting the healthy development of TCM decoction pieces industry.

2009-10-10 10:27:44

Yan Jiangyan:

(4) Significantly increase the specificity identification that meets the characteristics of traditional Chinese medicine.

The new edition of the Pharmacopoeia has greatly increased the specificity identification in line with the characteristics of traditional Chinese medicine.

First, the chemical reaction and spectral identification methods of color or precipitation are no longer used in the Chinese medicine standard.

Second, the standard has significantly increased cross-section or powder microscopic identification. In 2005, the Pharmacopoeia contained 620 microscopic identifications; in 2010, only 633 new microscopic identifications were added. All the medicinal materials and decoction pieces and the proprietary Chinese medicines containing biopharmaceutical powders have basically added a highly specific cross section or powder. Microscopic identification.

Third, a large number of highly specialized thin layer chromatography (TLC) identification techniques are used in the standard. In the 2005 edition of the Pharmacopoeia, 1507 items were identified by TLC; the 2010 edition of the Pharmacopoeia only added 2,494 items by thin-layer chromatography. In addition to mineral drugs, there are specific thin layer identification methods.

2009-10-10 10:28:34

Yan Jiangyan:

Third, the wide application of modern analytical techniques

The first is to expand the collection of mature new technology methods. For example, new ion chromatography, nuclear magnetic resonance spectroscopy, and Raman spectroscopy guidelines are added in the appendix. Liquid chromatography/mass spectrometry, DNA molecular identification, and thin-layer auto-development techniques are used in traditional Chinese medicine to improve analytical sensitivity and specificity, and to solve problems that cannot be solved by conventional analytical methods. New guidelines for the verification of alternative methods for microbiological testing of pharmaceuticals, guidelines for the application of microbial limit testing methods, and guidelines for the regulation of microbial laboratory standards to narrow the gap between microbiological and foreign pharmacopoeia.

2009-10-10 10:29:12

Yan Jiangyan:

The second is to further expand the application of new technologies. In addition to expanding the new technology methods in the appendix, the application of new technologies has been further expanded in the text.

According to the characteristics of traditional Chinese medicine and the complex characteristics of traditional Chinese medicine, the Pharmacopoeia establishes a method that reflects the overall characteristics of traditional Chinese medicine, and applies chromatographic fingerprint technology that reflects the overall change of the inherent quality of traditional Chinese medicine to the drug standard to ensure stable and uniform quality.

Ion chromatography and capillary electrophoresis with higher separation efficiency were used in the pharmacopoeial drug varieties; the application of infrared spectroscopy in the identification of drug substances and preparations was further expanded; total organic carbon measurement and conductivity measurement were used to purify water, In the standard of water for injection; gas chromatography technology is widely used to check residual solvents and the like.

Pharmacopoeia biological products gradually adopt in vitro methods instead of animal tests for biological product activity/potency determination, and adopt more sensitive virus inactivation verification methods.

2009-10-10 10:29:29

Yan Jiangyan:

The promulgation and implementation of the 2010 edition of the Chinese Pharmacopoeia will play an active and important role in the overall improvement of drug quality in China, and will further expand and enhance the positive impact of the Chinese Pharmacopoeia on the international market.

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