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The number of standard pharmaceutical excipients need to be further expanded

2016-06-21 14:57:39 浏览次数:201

2005 edition of "Chinese Pharmacopoeia" collection contains pharmaceutically acceptable excipients 72, 2010 edition collection contains 132, 2015, is expected to be significantly increased to more than 300, the number of collection contains increasing. However, China is still the standard pharmaceutical excipients can not fully meet the needs of the domestic pharmaceutical industry ,, urgent need to further improve. Mainly reflected in the standard varieties less in number for further expansion.

At present, China's foreign pharmacopoeia pharmacopoeia still a certain gap in the collection contains far fewer than the number of species in Europe and America pharmacopoeia. Such as "USP" will be divided into several functional pharmaceutical excipients ten categories, including both traditional medicinal materials, including the preparation of modern materials, collection contains about 500 species. China Pharmacopoeia on pharmaceutical excipients high standard pharmaceutical excipients, injectable and biological products in high-risk species still far from meeting the requirements.

Anhui mountains and rivers of medicinal materials Co., Ltd., said the new pharmacopoeia should increase overseas has been widely used in recent years has been the introduction of some new domestic start using pharmaceutical excipients. Meanwhile, the response standard for refinement, to distinguish between the use of the route, such as oral and injectable grade level should be separated, and some varieties depending on its function should be separated the new specifications, such as hydroxypropyl cellulose and low-substituted high substitutional type. State Pharmacopoeia Commission Operations Branch Zhao new proposal, the special nature of the management of pharmaceutical excipients, accessories variety of national standards should be phased, sub-categories to steadily. National drug regulatory authority should as soon as possible to promote the national pharmaceutical excipients basic situation of research work, the provinces of medicinal materials production, variety registration materials, accessories local standards, the use of materials thoroughly. For more information accessories varieties each pharmaceutical manufacturers in the pharmaceutical formulation used in the production process, the implementation of standards investigation; through questionnaires, field visits, seminars workshops and other means, to understand how many provinces have special medicinal materials production enterprises, How many medicinal materials production as the main business of pharmaceutical manufacturers; grasp pharmaceutical excipients place the symbol and local standards approved by the provinces; through the above research activities, you can basically grasp the basic conditions of the production and use of pharmaceutical excipients, provide a reference for the expansion of pharmaceutical excipient species reproduces range.