中国药典2005年版关于抗生素溶液澄清度、颜色、溶出度、异物、细菌内毒素等检查项目介绍

Introduction of clarity of solution, color of solution, dissolution, particulate matter, test for bacterial endotoxin for antibiotics in the Chinese Pharmacopoeia 2005

对中国药典2005年版中与抗生素检验有关的部分检查项目:溶液澄清度和颜色、溶出度、可见异物、不溶性微粒和细菌内毒素检查法等进行介绍,其中对各项检查控制的意义、2005年版附录增修订情况、品种项下的变化及实际检验中应注意的问题进行重点分析与探讨。与中国药典2000年版相比,2005年版药典中各项检查的标准均有不同程度提高,对药品质量的控制更全面严格,尤其值得指出的是,可见异物检查法首次载入中国药典,其中光散射检查法是本版药典附录中收载的由我国首创的方法。

The chapter introduces the test items related to antibiotics in the Chinese Pharmacopoeia 2005 which include clarity of solution, color of solution, dissolution, visible particles, particulate matter, test for bacterial endotoxin, etc. It focused to discuss the importance of each test item, the revisions and new admissions in appendix, changes in monographs and the problems that may occur in practice. The appendices for these items are more precise, complete and standardized, with rather extensive revision in comparison with previous edition. Especially, it is the first time that test for visible particles is adopted by the Chinese Pharmacopoeia, and light scattering method for visible particles is firstly commenced by China and included in this edition.