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目的建立珠芪复肝颗粒的质量控制方法。方法采用薄层色谱(TLC)法对珠芪复肝颗粒方中的黄芪进行定性鉴别,运用高效液相色谱(HPLC)法对该制剂中没食子酸进行含量测定,并对3批珠芪复肝颗粒进行3月的初步稳定性考察。结果珠芪复肝颗粒中黄芪的薄层色谱斑点清晰,且阴性对照无干扰;没食子酸进样量在0.0033~0.0250μg范围内线性关系良好,线性方程为Y=62 059.84X-35 650.77,r=0.9999。平均回收率为100.13%,RSD=1.24%(n=6);各项检验指标均符合规定。结论本试验所建立的检测方法准确、可靠、稳定、重复性好,可用于珠芪复肝颗粒的质量控制,且制剂稳定性良好。
Objective To establish the quality control method of Zhuqi Fugan granule. Methods TLC method was used to identify Astragalus mongholicus in Zhuqifugan Granules. The content of gallic acid in this preparation was determined by high performance liquid chromatography (HPLC) The particles were subjected to a preliminary stability study in March. Results The TLC spots of Astragalus membranaceus in Zhuqi Fugan Granule were clear and there was no interference in the negative control. The linearity of the injected sample was 0.0033 ~ 0.0250μg, the linear equation was Y = 62 059.84X-35 650.77, r = 0.9999. The average recovery rate was 100.13%, RSD = 1.24% (n = 6). All the test indicators were in compliance. Conclusion The test method established in this study is accurate, reliable, stable and reproducible. It can be used for the quality control of Zhuqifugan granules and has good stability.