浅析《中国药典2005年版二部附录增修订内容》草案暨注射剂中不溶微粒检查法

The Brief Analysis of the Testing Method of Insoluble Granules in Injection of the Protocol of《The Revised Content of Chinese Pharmacopoeia Edition2005》

国家药品标准是对上市药品进行监督的基础,药典作为国家药品标准的主体,应反映我国制药工业的整体水平,反映世界制药工业的发展趋势;药典附录应反映现实国际药品质量控制的技术和方法,应体现科学,实用,规范,质量可控性,标准先进性原则。本文将按以上原则对《中国药典2005年版二部附录增修订内容》草案中的“注射剂中不溶微粒检查法”的内容进行讨论,笔者希望在《中国药典2005年版二部》正式实施之前,对该方法的试验提供少许借鉴作用。

The State Drug Standards are the bases for supervising the drugs on the market.As the principal part of the Drug Standards of China,ChP should reflect the general level of the pharmaceutical industry in China as well as the developing trend of the pharmaceutical industry in the world.The appendix of ChP should reflect the current technology and methods for the quality control of the drugs in the world,embodying the principle including seientificalness, practicality,normative,quality controllability and the standard progress.From the point of the quality control,the thesis discussed the Testing Methdo of Insoluble Granules in Injection of the Protocal of《The Supplemented and Revised Content of Chinese Pharmacopoeia Edition 2005》. It may provide use for reference to implement the method before《Chinese Pharmacopoeia Edition 2005 Part Ⅱ》is offic- ially executed.