The 2010 edition of Chinese Pharmacopoeia standards for the preparation of drugs to further improve the completion of

2010 edition of "Chinese Pharmacopoeia" had been established, by the end of Chinese Medicine Science and Technology Publishing House, next year July 1 officially implemented.

"Chinese Pharmacopoeia" is the state to ensure drug quality control, ensuring drug safety and effectiveness of the people by law to develop drugs code, is a pharmaceutical research and development, production, operation, use and management must be in strict compliance with the statutory basis for the national drug standards system The core is the development of international exchanges and cooperation in important content.

2010 edition of "Chinese Pharmacopoeia" is the new China was founded 60 years to organize the preparation of the ninth edition of Pharmacopoeia, the new edition of Pharmacopoeia Pharmacopoeia summing up the calendar, based on the domestic and international pharmaceutical standards for full use of resources in recent years, focusing on innovation and development, and realistically reflects the China's pharmaceutical industry and the level of clinical drug development situation, in order to further strengthen drug supervision and management provides a strong technical support.

2010 edition of "Chinese Pharmacopoeia" is divided into three publications, one for the Chinese medicine, two chemical drugs, biological products for the three. 2010 edition of "Chinese Pharmacopoeia" varieties containing more than 4,600 kinds of income, of which more than 1,300 kinds of new, basic coverage of National Essential Drugs List species and varieties of national health insurance directory.

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

1, drug safety has been further protect the

In the drug safety is concerned, except in the Appendix to strengthen the general requirements, security checks, in the body of the standard varieties are also a significant increase or improve the security of test items, and further enhance the high-risk types of standards, to further strengthen the heavy metals or harmful elements, impurities, residual solvents such as control and provides sterile ophthalmic preparations preparations according to the requirements specific for burns or severe trauma sterile topical formulations according requirements. New version of the appendix and the Legend Pharmacopoeia of generic and basic technical requirements and requirements of the Pharmacopoeia of all listed drugs are outside the direct role and influence.

In the effectiveness and quality of controllability, in addition to new and amendments to the relevant inspection methods and guiding principles, the body of the standard varieties, to increase or improve the effectiveness of the inspection items have greatly increased in line with the characteristics of proprietary Chinese medicine identification, content was measured by a special property of a stronger inspection methods to increase the dissolution, content uniformity and other inspection items.

2010 edition of "Chinese Pharmacopoeia" Drug Standards focus on the systematic improve work on particular importance in high-risk drugs. New pharmacopoeia drug injections to increase chemical safety test for application of the guiding principles; Lieutenant General in the preparation osmotic molar concentration tests as a necessary injection inspection projects; a resumption of the pharmacopoeia contains all varieties of traditional Chinese medicine injections increased the limits of heavy metals and harmful elements standards; In addition, other types of injections are also different degrees, to increase the standard of product safety, efficacy and quality control and other aspects of the quality control requirements, these measures solve the injection, especially in traditional Chinese medicine injection safety issues will play an active role.

Second, standards for Chinese medicine to enhance the overall level of comprehensive

(A) the number of varieties of traditional Chinese medicine containing substantial increase in income

New Pharmacopoeia containing Chinese herbs, Chinese Herbal Pieces, medicine and traditional Chinese medicine extract standards to increase substantially in one fell swoop to change and reverse the long-term income contained less variety foundation is poor, especially the lack of standard Chinese Herbal Pieces situation. In Chinese medicine and related resource protection standards of technical innovation to be leaps and bounds.

(B) increased and improved varieties of traditional Chinese medicine the security nature of the control target.

First, traditional Chinese medicine in the appendix the general requirements to strengthen security checks. General preparations, such as in the appendix, the addition of methanol, a limited examination of oral tincture, rubber, ointments not detected pathogens was first proposed inspection requirements, etc.; in the Appendix detection methods, the new Determination of sulfur dioxide residue, aflatoxin method of determining the osmotic pressure Determination of molar concentration, abnormal toxicity test for, step-down physical inspection method, test for allergic reactions, hemolytic and cohesion of the inspection law.

The second is the body of standards in Chinese medicine to increase or improve the safety of inspection items. If Yi moldy peach kernel, almond and other new aflatoxin detection, methods and limits of international consensus; in the body of standards, the complete ban of benzene as a solvent; right process using organic solvents have been inspected by an organic solvent residue; right-chuan Wu, Aconitum, and other highly toxic brucine Pieces, using high performance liquid chromatography (HPLC) and other more advanced, more accurate method of checking to be limited.

Third, heavy metals and harmful elements in the control, the new version of USP using inductively coupled plasma mass spectrometry (ICP-MS) determination of arsenic in traditional Chinese medicine, mercury, lead, cadmium, copper content; a right to all traditional Chinese medicine injection agents and wolfberry fruit, hawthorn, ginseng, Codonopsis and other medication for a long time the varieties commonly used for children had increased the limits of the standard of heavy metals and harmful elements.

(C) solve the Chinese Herbal Pieces standards.

2010 edition of "Chinese Pharmacopoeia" a key feature is that a substantial increase in the income of Chinese Herbal Pieces standard load, the initial resolution of a long plagued Chinese Herbal Pieces industry standard of less developed countries, local issues such as cooked up by non-uniform standards. Pieces of Chinese medicine for improving the quality of the clinical use of drugs to ensure safe and effective traditional Chinese medicine to promote the healthy development of Chinese Herbal Pieces industry will play a positive role.

(D) a substantial increase in line with the characteristics of proprietary Chinese medicine identification.

New pharmacopoeia of Chinese medicine characterized by a substantial increase in line with the special properties of identification.

First, the use of traditional Chinese medicine is no longer the standard color or precipitation of chemical reactions and spectral identification methods.

Second, a substantial increase in cross-section of the standard or powder microscopic identification. Pharmacopoeia 2005 edition contains microscopic identification received a total of 620; 2010 edition of only new microscopic identification reached 633, all the herbs and Pieces and proprietary Chinese medicines containing raw powder have increased the basic properties of a strong cross-section of professionals or powder microscopic identification.

Third, extensive use of proprietary standards, a strong thin-layer chromatography (TLC) identification techniques. Pharmacopoeia 2005 edition contained a total income TLC 1507; 2010 edition of Pharmacopoeia just add TLC reached 2494, in addition to mineral drugs are specific and outside the TLC method.

Third, wider use of modern analytical techniques

First, expand the new technology of sophisticated methods of containing relevant. If the appendix added Ion chromatography, nuclear magnetic resonance spectroscopy method, Raman spectroscopy and guiding principles. Varieties of traditional Chinese medicine using liquid chromatography / mass spectrometry, DNA molecular identification, TLC - bioautography technology and other methods to improve the analytical sensitivity and specificity, the solution of conventional analysis methods can not solve problems. New Drug microbiological testing an alternative method validation guidelines, microbial limit test for application of the guiding principles, drug Microbiology Laboratory Practice guidelines, in order to reduce the laid down in the micro-organisms and foreign pharmacopoeia gap.

Second, to further expand the application of new technologies. In addition to expanding the income set out in Appendix sophisticated new technology methods, varieties of the body to further expand the application of new technologies.

Pharmacopoeia of Chinese medicine according to a complex composition theory and the characteristics of traditional Chinese medicine, traditional Chinese medicine as a whole reflects the characteristics of the establishment of the method, reflected the changes in the intrinsic quality of the overall chromatographic fingerprint technology to pharmaceutical standards to ensure quality, the stability of the uniform.

Pharmacopoeia kinds of drugs used in the separation of higher-performance ion chromatography and capillary electrophoresis; infrared spectroscopy in bulk drugs and formulations identified in the application and further expanded; Determination of total organic carbon and electrical conductivity measurement method was used to purify water, water for injection and other standards; gas chromatography has been widely used to detect residual solvent.

Pharmacopoeia biological products and gradually replace animal testing in vitro method for bio-products activity / potency, using a higher sensitivity of virus inactivation validation methods.

2010 edition of "Chinese Pharmacopoeia" The promulgation and implementation in China will comprehensively improve the quality of the course of drugs play an active and important role, and will further expand and enhance our pharmacopoeias positive impact in the international arena.