复方金刚痛风颗粒中菝葜的鉴别与质量研究

目的:建立复方金刚痛风颗粒中菝葜的TLC鉴别方法和含量测定方法。方法:以薯蓣皂苷元为对照品,采用氯仿-乙酸乙酯(10:1)为展开剂,10%硫酸乙醇溶液为显色剂,对复方金刚痛风颗粒中的菝葜进行了TLC鉴别;采用大连依利特C18色谱柱(Hypersil ODS,5μm,4.6×250mm),乙腈-水(90:10)为流动相,流速为1mL.min-1,203nm为检测波长,柱温为35℃,测定了复方金刚痛风颗粒中薯蓣皂苷元的含量。结果:薯蓣皂苷元斑点清晰,阴性对照无干扰。薯蓣皂苷元线性范围为0.212μg～1.908μg(r=0.9999),平均回收率为100.50%,RSD为1.49%。方法灵敏度高、结果准确、重现性好。结论:所建立的方法简便可行、重现性好,为复方金刚痛风颗粒质量控制提供了有效途径。

Study on Identification and Quality for Smilax China L of Compound Gout Granules

Objective： To establish TLC identification method and HPLC assay method for Smilax China L of compound gout granules. Methods.. Smilax china L were identified by TLC respectively, using diosgenin as reference substances, and （10： 1） as mobile phases. Diosgenin were determined by HPLC using the Hpersil ODS reversed-phase column of C18 （4. 6 × 250mm, 59m）, the mobile phase was a combination of acetonitrile and water （90：10） at the flow rate of 1.0mL · min-1 ,and the eluate was monitored with UV absorption at 203nm, retention at 35 degrees. Result. The TLC chromatograms of diosgenin were of clearness, good separation, and no interference. The diosgenin contents in Compound gout granules by HPLC, in the linear range of 0. 2129g to 1. 908μg （r= 0. 9999） and the recoveries of 100. 50% （RSD= 1.49%）. Conclusion： The established methods are simple, feasible and reproducible. This study provide a method for the quality control of compound gout granules.