中药注射剂溶血与凝聚试验方法研究

Study on the hemolgsis and agglutination test for CTM injections

目的:修订现行国家标准中规定的溶血与凝聚试验方法。方法:以现行国家标准中溶血与凝聚试验方法和本文提出的修订方法对几种常见中药注射剂进行溶血与凝聚对比考察。结果:香丹注射液、清开灵注射液、黄芪注射液、丹参注射液、生脉注射液、参麦注射液采用两种方法试验结果一致,双黄连注射液、双黄连粉针剂、丹参滴注液采用两种方法试验结果不同。结论:本文提出的溶血与凝聚试验修订法更符合中药注射剂临床用药实际情况,部分中药注射剂临床用法应作适当修改。

Objective： Compile,revise the standard of hemolysis and agglutination test for Chinese traditional medicine injections.Method： Base on the clinical use state about Chinese traditional medicine injections,we put forward a new method of hemolysis and agglutination test,and then use the new method and the standard method to examine for some Chinese traditional medicine injections.Result： A great number of injections can satisfy two methods,but a few results have dissimilarities.Conclusion： The new method is a good test method of hemolysis and agglutination test,it accord with the clinical use state,the methods of clinical use for some CTM injections will be revised.