止血灵胶囊质量标准的研究

Studies on Quality Standard of Zhixueling Capsule

摘要:

目的:修订并提高止血灵胶囊的质量控制方法。方法:用薄层色谱法对其中地榆、蒲公英进行了定性鉴别;用薄层光密度法对黄芪中有效成分进行了含量测定。结果:表明本品定性鉴别色谱特征明显,易于区别;黄芪甲甙含量测定线性范围为0.6～3.6μg,平均回收率102.68%,RSD为2.5%。结论:建立了该制剂的质量标准,其鉴别与含量测定方法简便、可靠、实用。

Abstract:

Objective:a method for the quality control of Zhixueling capsule was modified and improved.Method:Radix sanguisorbae,Heaba taraxaci were identified by TLC.A method of thin layer densitometry to determine astragalin-A,the main effective component from Radix astragali in the capsule,was developed.Result:The studies on the quality control showed that the characteristics for identification by TLC were distinct.The quantification method had the linear range of 0.6～3.6μg.The average recovery was 102.68% and its RSD was 3.2%.Conclusion:The quality standard of the capsule was modified and improved.The methods for identification and quantification were simple,reproducible and realizable.