清肺抑火片的质量标准提升研究

Study on the Improvement of Quality Standard of Qingfei Yihuo Pian

目的提高清肺抑火片的质量标准。方法采用显微鉴别法,薄层色谱(TLC)法对制剂中的大黄、桔梗,黄柏、苦参进行定性鉴别;采用高效液相色谱(HPLC)法对栀子中栀子苷进行定量分析。结果在显微鉴别中检出草酸钙簇晶大,直径60~140μm(大黄)。联结乳管直径14~25μm,含淡黄色颗粒状物(桔梗);在薄层色谱中检出黄柏.苦参;栀子苷进样量在0.154~3.083μg范围内线性关系良好,r=0.9999,平均加样回收率99.80%,RSD=0.43%(n=6)。结论所建立的方法准确,可靠,专属性强,可有效控制该制剂的质量。

Objective To improve the quality standard of Qingfei Yihuo pian.Methods Microscopic identification and TLC were used to qualitatively identify rhubarb,platycodon,phellodendron,andsophora flavescens in the preparation;HPLC was used to quantitatively analyze geniposide ingardenia.Results The large clusters of calcium oxalate were detected in the microscopicidentification,with a diameter of 60~140μm(rhubarb).The connecting milk tube has a diameter of 14~25μm and contains light yellow granular material(platycodon);Phellodendron and Sophoraflavescens were detected in TLC;the injection amount of geniposide has a good linear relationshipwithin the range of 0.154~3.083μg.r=0.9999,The average sample recovery rate was 99.80%,RSD=0.43%(n=6).Conclusion The established method is accurate,reliable and specific,and caneffectively control the quality of the preparation.