急支平喘软胶囊的质量标准研究

Quality standards for Jizhipingchuan Soft Capsule

目的急支平喘软胶囊是按中药六类研究的新药,文中建立完善了急支平喘软胶囊的质量标准。方法采用薄层色谱法(thin layer chromatography,TLC)法对制剂中的木蝴蝶、没药、冰片进行了定性鉴别;采用高效液相色谱(high-performance liquid chromatography,HPLC)法测定木蝴蝶中黄芩苷的含量。结果 TLC鉴别色谱斑点清晰,阴性无干扰;含量测定中黄芩苷在0.1456～1.456μg范围内线性关系良好(r=0.999 9),平均加样回收率为98.71%,相对标准偏差(relativestandard deviation,RSD)为1.18%(n=6);急支平喘软胶囊中黄芩苷的含量为1.92%～2.02%。结论实验建立的定性及定量方法简单可行,结果准确可靠,重现性好,能有效控制急支平喘软胶囊的质量。

Objective Jizhipingchuan Soft Capsule（JSC） is a new Chinese medicinal preparation developed according to the criteria of Class Ⅵ Chinese drugs.This paper introduces the establishment and improvement of the quality standards for JSC.MethodsWe conducted qualitative identification of the ingredients oroxylum indicum,myrrha and borneol using thin layer chromatography（TLC）,and determined the content of baicalin in oroxylum indicum by high-performance liquid chromatography（HPLC）.Results The spots on the TLC plates were clear without interference of the negative control.Baicalin showed a linear correlation within the concentration range of 0.145 6-1.456 μg（r=0.999 9）.The average standard recovery rate was 98.71%,and the relative standard deviation（RSD） was 1.18%（n=6）.The content of baicalin in JSC was 1.92%-2.02%.Conclusion The qualitative and quantitative methods established in this study are simple,feasible,accurate and reproducible.It can be used as the quality standard for JSC.