郁可欣胶囊质量控制研究

Study on quality standard of Yukexin capsules

目的：建立郁可欣胶囊质量标准。方法：采用薄层色谱法和紫外分光光度法对郁可欣胶囊内容物进行鉴别。含量测定采用反相高效液相色谱法（RP-HPLC），用Zorbax ODS C18色谱柱（250min×4．6mm，5μm）。以甲醇-5％磷酸-三乙胺（45：55：0．35，V／V）为流动相，检测波长：360nm，流速：1mL·min^-1。结果：郁可欣胶囊内容物薄层色谱、紫外光谱与对照品金丝桃苷基本一致。金丝桃苷的保留时间为4．9min，且与其他峰的分离度大于1．5，金丝桃苷的线性范围为0．005-0．0625g·L^-1（r=0．9999），最低检测限为2．0ng，最低定量限为7．5ng，平均回收率和RSD分别为98．91％和1．62％。结论：该方法简便快速，结果准确可靠，可为郁可欣胶囊的质量评价提供有效手段。

OBJECTIVE To establish a quality standard for Yukexin Capsules. METIIOI）S Thin layer chromatography （TLC） and ultraviolet spectrophotometry（UV） were used for the identification of the content of the capsules, hyperoside in the capsules was determined using. RP-HPLC was used for the determination of hyperoside. The chromatographic procedure was carried out using Zorbax ODS C18 （250 mm × 4. 6 mm, 5μm） as an analytical column and a mixture of 45 volume of methanol, 55 volume of 5% phosphoric acid, 0. 35 volume of triethylamine as a mobile phase at a flow rate of 1. 0 mL·min^-1. The detec lion wave length was set at 360 nm. RESULTS TLC chromatogram and UV spectrum of Yukexin capsule content were same as the hyperoside standard sample. The tR of hyperoside was about 4. 9 minutes. Resolution between hyperoside and other peaks was more than 1.5 and its linear range was between 0. 005 and 0. 062 5 g·L^-1 （r= 0. 999 9）. The detection limit was 2. 0 ng and the quontitation limit was 7. 5 ng. The average recovery and RSD value of hyperoside were 98.91% and 1.62%, respectively. CONCLUSION This method is sensitive and can be used for the quality control of Yukexin capsules.