The newspaper news (by Jia Xiaohong) national medicine supervises the bureau to announce today that in 2010 version "China Pharmacopoeia" has established to complete, will implement on next July 1. According to the national medicine supervises bureau spokesman Yan Jiangying today, update "China Pharmacopoeia" is divided into the traditional Chinese medicine, chemistry medicine and biological preparations three, gathers the variety 4600 kinds, increases 1300 kinds, covers the national basic drug table of contents variety and national medical insurance table of contents variety basically.
It is reported that update "China Pharmacopoeia" pays attention to the drugs security, besides strengthens the secure inspection general demand in the appendix, dramatically increases or the consummation security inspection project in the variety main text standard, further enhances to the high risk variety standard, further strengthens to the heavy metal or the harmful element, impurity, the residual resolver the control, and stipulated that the eye requests with the preparation according to the aseptic preparation.
The update pharmacopoeia especially took seriously, to increase chemistry medicine injection secure inspection method application guiding principle the high risk drugs; In preparation general rule osmole of density inspection as injection must examine the project; Increased the heavy metal and harmful element limit standard to a pharmacopoeia gathering traditional Chinese medicine injection variety completely; In addition increased regarding the other injection varieties\’ standard also varying degrees to product safety, validity and quality controllability and other aspect the natures controls the request, these measures regarding the solution injection, are the traditional Chinese medicine injection secure question will certainly to play the positive role specially.
The update pharmacopoeia gathers the traditional Chinese medicine, traditional Chinese medicine tablets ready for decoction, traditional Chinese medicine and traditional Chinese medicine extract standard drastically promotes. The update pharmacopoeia has altogether gathered 2136 traditional Chinese medicine varieties, compared to increased 900 many kinds. Strengthens the secure inspection general demand in the traditional Chinese medicine appendix, increases or the consummation security inspection project in the traditional Chinese medicine main text standard, for instance to peach kernel, almond which other additional flavacol examinations is easy to get moldy and spoil, the method and limit with international consistent and so on. In the heavy metal and harmful element control aspect, uses in the inductive coupling plasma mass spectrum determination traditional Chinese medicine the arsenic, quicksilver, lead, cadmium and copper content; To all traditional Chinese medicine injections and fruit of the Chinese wolfberry, Chinese hawthorn, ginseng, codonopsis pilosula and other medication time are long, child\’s commonly used variety increased the heavy metal and harmful element limit standard.
An update pharmacopoeia\’s main feature is, dramatically increased the traditional Chinese medicine tablets ready for decoction standard gathering quantity, initially solved the long-term puzzle traditional Chinese medicine tablets ready for decoction industrial development national standards to be few, place to concoct the standard not to unify and other questions. The traditional Chinese medicine tablets ready for decoction dramatically increases the cross section or the powder micro distinction. In 2005 version pharmacopoeia altogether gathered the micro distinction 620 items; In 2010 the version only increases micro distinction to reach 633 items, all raw materials for medicine and tablets ready for decoction and increased the specificity very strong cross section or the powder micro distinction including the fresh medicinal powder\’s traditional Chinese medicine basically. At the same time, in standard massive use specificity strong ography authenticating technology. J146 (This article originates: Beijing Evening News)
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