李晨辉
LI Chen-hui(Guangdong Coastal Institute for Drug Control

• 1:广东省药品检验所

摘要(Abstract)：

目的比较保健食品软胶囊的破裂试验结果与崩解时限检查结果,了解两者的相关性和差异性。方法保健食品软胶囊分别按《美国药典》32版进行破裂试验和《中国药典》2005年版进行崩解时限检查,对结果进行分析比较。结果破裂试验与崩解时限两方法间有一定的相关性,也存在一定差异。结论崩解时限检查合格的保健食品软胶囊,在出口时须按《美国药典》要求进行破裂试验,不应简单以崩解时限替代破裂试验。
Objective To compare the rupture test of soft capsules of dietary supplements with the disintegration test,and to find the correlations and differences.Methods The rupture time and disintegration time of soft capsules were tested by the method in USP 32 and CHP 2005.The results were analyzed.Results There are some correlations and differences between rupture and disintegration of soft capsules.Conclusion The soft capsules of dietary supplements that comply with the disintegration test should go through the rupture test according to the USP when exported,the rupture test could not be replaced by disintegration test.

关键词(KeyWords)： 破裂试验;崩解时限;保健食品;软胶囊
rupture test;disintegration test;dietary supplements;soft capsules

Abstract:

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基金项目(Foundation): 广东省药品检验所科研项目(编号:SN20071312)

作者(Author): 李晨辉
LI Chen-hui(Guangdong Coastal Institute for Drug Control

参考文献(References)：

• [1]国家药典委员会.中国药典(二部)[S].北京:化学工业出版社,2005.
• [2]The United States Pharmacopeial Covention USP 32-NF 27[S].2008.