益气宁心颗粒的质量标准研究

The Study on Quality Control Standard of Yi Qi Ning Xin Granule

目的:建立益气宁心颗粒质量标准;方法:用薄层色谱法对制剂所含甘草、黄芪、麦冬、当归、紫草进行鉴别,以HPLE法对组方药物赤芍所含芍药苷进行含量测定;结果:甘草等5味组方药物被鉴识,在HPLC法中,芍药苷在0.655μg-5.24μg间,呈线性关系,γ=0.9992,加样回收率为98.71％,RSD=2.12％,两批样品含芍药苷分别为0.132％、0.111％,平均含量0.1215％;结论:用薄层色谱法对益气宁心颗粒中甘草、黄芪、麦冬、当归、紫草的鉴别及HPLC法对芍药苷的含量测定,可作为该制剂的质控方法。

Aim : The purpose is to develop a quality control standard for Yi Qi Ning Xin granule. Methods : The five kinds of traditional Chinese meteria medica, included Radix Glycyrrhizae, Radix Astragali, Radix Ophiopogonis, Radix Angelicae Sinensis, Radix Arnebiae in this preparation, were identified by the thin - layer chromatography. The content of paeonifiorin, which existed in another herb Radix Paeoniae rubra from this preparation, was assayed by PR - HPLC. Results : The five a-bove - mentioned herbs such as Radix Glycyrrhizae etc. Were identified sensitively by the thin - layer chromatography. In other hand, the relationship between response and the concentration of paeonifiorin was linear well in the range of 0. 655 - 5. 24μg with the correlation coefficient of 0.9992, the average recovery was 98.71% , and the RSD was 2.12% ( n = 5 ). The contents of paeonifiorin were 0.132% , 0.111% in two batch of sample product respectively, and the average content of paeonifiorin was 0.1215%. Conclusion : The thin - layer chromatography for identification of the five above - mentioned herbs such as Radix Glycyrrhiza etc. and the PR - HPLC assay for determination of paeonifiorin were simple, sensitive and specific. These methods can be applied to the quality control for this preparation.