减肥胶囊显微鉴别及含量测定方法研究

Study on the Microscopic Identification and Content Determination of Slimming Capsules

目的为完善减肥胶囊质量标准,增加该制剂中番泻叶、虎杖的显微鉴别项,建立番泻苷A、番泻苷B、虎杖苷的含量测定方法。方法显微观察番泻叶、虎杖的组织特征;以双波长HPLC法同时测定番泻苷A、番泻苷B、虎杖苷的含量。采用SVEA opal C18(4.6 mm×250 mm,5μm)色谱柱,以乙腈-[醋酸-醋酸钠缓冲液(pH5.0)](23∶77)为流动相,检测波长为260 nm(番泻苷A和番泻苷B)、306 nm(虎杖苷),柱温为30℃,流速为1.0 mL/min,进样量为10μL。结果番泻叶、虎杖粉末的主要显微特征明显、专属性强,在制剂中易于检出;番泻苷A、番泻苷B、虎杖苷分别在0.0409~0.8184μg(r=1.0000)、0.0303~0.9297μg(r=0.9987)、0.0101~0.3033μg(r=0.9980)范围内线性关系良好,精密度、重复性、稳定性良好,平均回收率分别为97.0%(RSD=1.29%)、96.7%(RSD=1.51%)、96.5%(RSD=1.36%)。结论该分析方法准确可行,可为进一步提高减肥胶囊质量标准提供参考。

Objective In order to improve the quality standard of slimming capsules,the microscopic identification items of senna leaf and giant knotweed rhizome in the preparation were added,and the content determination methods of sennoside A,sennoside B and polydatin were established.Methods The histological characteristics of senna leaf and giant knotweed rhizome were observed microscopically;simultaneous determination of sennoside A,sennoside B and polydatin by dual wavelength HPLC.The determination was performed on SVEA opal C18 column(4.6 mm×250 mm,5μm)with acetonitrile-[acetate-sodium acetate buffer(pH5.0)](23:77)as the mobile phase.The detection wavelengths were 260 nm(sennoside A and sennoside B)and 306 nm(polydatin).The column temperature was 30℃.The flow rate was 1.0 mL/min and the injection volume was 10μL.Results The main microscopic characteristics of senna leaf and giant knotweed rhizome powder were obvious and specific,which were easy to be detected in preparation.Sennoside A,sennoside B and polydatin had good linear relationships in the range of 0.0409-0.8184μg(r=1.0000),0.0303-0.9297μg(r=0.9987),0.0101-0.3033μg(r=0.9980),respectively.Good precision,repeatability and stability,and the average recoveries were 97.0%(RSD=1.29%),96.7%(RSD=1.51%),and 96.5%(RSD=1.36%),respectively.Conclusion The analysis method is accurate and feasible,and can provide reference for further improving the quality standard of slimming capsules.