The 2015 edition of the Chinese Pharmacopoeia plans to build a Chinese drug standard mass spectrometry library

China Education Equipment Purchasing News: The 2015 edition of the Chinese Pharmacopoeia has proposed an overall compilation goal. It plans to comprehensively include the national essential drug catalog varieties and the national basic medical insurance, industrial injury insurance and maternity insurance drug category A catalogs. The 2015 edition of the Chinese Pharmacopoeia is the core national drug standard system, with a view to making a comprehensive contribution to leading the international development of Chinese medicine standards, promoting the optimization and upgrading of the pharmaceutical industry structure, and improving the overall quality control of China's medicines.

At the meeting, relevant experts of the National Pharmacopoeia Commission introduced that the 2015 edition of the Chinese Pharmacopoeia will have some changes in style: the pharmacopoeia, the appendix (general principles of preparation, general analysis methods, guiding principles), and pharmaceutical excipients will be integrated into the public part Call it a general or general rule. The main text of the Pharmacopoeia is reserved for one, two and three. A pharmacopoeia is divided into upper and lower volumes. The upper volume contains medicinal materials, decoction pieces, vegetable oils and extracts, and the lower volume contains unilateral and prescription preparations; the second part is chemical drugs; and the third part is biological products.

It is understood that the 2015 edition of the Chinese Pharmacopoeia will be perfected and improved in many ways:

-Solve the problem of multiple standards of the same variety. The use of unified identification, inspection, content determination and other methods and indicators to establish a common standard for the same variety, fundamentally solve and change the problem of multiple standards of the same variety, to reflect the fairness of supervision and maintain the balance of the efficacy of series of varieties.

——Strengthen the physical standards of drugs. Improve the operation mechanism of R & D, production, calibration, verification, release, sales and management of pharmaceutical standard materials, so as to achieve the simultaneous development and implementation of physical standards and text standards. It is planned to build a mass spectrometer library of Chinese drug standards to promote the orderly and effective development of China's drug standard substance industry.

——Improve the safety control level of traditional Chinese medicine. To carry out systematic toxicological studies on Chinese medicinal materials and decoctions marked "big, poisonous, and small poisons" in "Chinese Pharmacopoeia", and propose and formulate safe drug compatibility, dosage and limit range. Conduct safety research on commonly used Chinese herbal medicines and decoction pieces, and establish a database.

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