中国药典2005年版二部附录分散片分散均匀性检查方法的探讨___
Discussion on the method for fineness of dispersion of dispersible tablets in appendix ChP2005(Vol. Ⅱ)
分类号:
出版年·卷·期(页码):2009,29 (12):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------
目前仅中国药典2005年版、BP2009和欧洲药典现行版收载了分散片剂型,并均规定了分散均匀性检查,但操作细节有所不同。本文对上述药典现行版进行对比,并对中国药典2005年版二部附录中分散片的分散均匀性检查进行了探讨,建立了分散均匀性检查方法,并对7种产品进行了考察。与原中国药典方法相比,该法具有更好的区分力和可操作性,为中国药典2010年版提供参考。
-----英文摘要:---------------------------------------------------------------------------------------
Currently,only ChP2005,BP2009 and EP6.0 include the dosage form of dispersible tablets,and this three all specify the methods for fineness of dispersion.This article compared the differences in operation details among them,and investigated the method for fineness of dispersion of dispersible tablets in Appendix ChP2005( Vol. Ⅱ),established a method for fineness of dispersion and experiment on 7 samples.The new method can be more discriminable and exercisable .
-----参考文献:---------------------------------------------------------------------------------------
1 ChP(中国药典).2005.VolⅡ(二部) :Appendix I A (附录I A)
2 BP2009 . Volume Ⅲ .2256
3 EP6.0 . 2008.Volume I .750
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