降脂胶囊的质量标准提升研究  

Study on the Improvement of Quality Standard of Jiangzhi Capsule

作　　者：曾芳俐 张磊 冯华 ZENG FangLi;ZHANG Lei;FENG Hua(Zunyi Product Quality Inspection and Testing Institute,Zunyi 563000,China)

机构地区：[1]遵义市产品质量检验检测院,贵州遵义563000

出　　处：《中国民族民间医药》2020年第17期35-38,共4页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：贵州省科技计划项目(黔科合平台人才[2018]5744号);遵义市创新人才团队培养项目(遵市科合(2016)7号)。

摘　　要：目的:建立降脂胶囊的质量标准研究。方法:采用薄层色谱法鉴别制剂中的葛根及葛根素;采用高效液相色谱法对制剂中的活性成分葛根素进行含量测定,用Diamosil C18(4.6 mm×250 mm,5μm)为色谱柱,甲醇-水(30∶70)为流动相,流速1.0 mL/min,检测波长为250 nm,柱温35℃。结果:在薄层鉴别色谱中,葛根和葛根素斑点清晰分离,效果好,Rf值达到要求,阴性对照无干扰。含量测定中葛根素在32.32~290.88μg的范围内与峰面积呈良好的线性关系,r=0.9999;专属性强、重现性好,平均回收率为99.15%、RSD为0.66%(n=6)。结论:所建立的鉴别方法操作简单,专属性强;定量方法稳定灵敏,重现性良好,该标准可以作为降脂胶囊的质量控制。Objective To establish the quality standard of Jiangzhi capsule.Methods Radix puerariae and puerarin in the preparation were identified by TLC,and the content of Puerarin in the preparation was determined by HPLC.Diamosil C18(4.6 mm×250 mm,5μm)was used as the column,methanol water(30∶70)as the mobile phase,the flow rate was 1.0 mL/min,the detection wavelength was 250nm,the column temperature was 35℃.Results In TLC,the spots of puerarin and puerarin were separated clearly,the effect was good,RF value met the requirements,and negative control had no interference.In the content determination,puerarin has a good linear relationship with peak area in the range of 32.32-290.88μg,r=0.9999;It has strong specificity and good reproducibility,with an average recovery of 99.15%and RSD of 0.66%(n=6).Conclusion The established identification method is simple and specific,and the quantitative method is stable,sensitive and reproducible,which can be used as the quality control of Jiangzhi capsule.

关 键 词：降脂胶囊 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R268[医药卫生—中医外科学]