基于多指标成分测定昆仙胶囊的体外溶出度

Determination of in Vitro dissolution of Kunxian Capsules based on multi-index components

关键词:  昆仙胶囊  多成分  溶出度  相似因子

Key words:  Kunxian capsules  multi-component  dissolution  similarity factor

摘要:

目的 建立昆仙胶囊多指标成分的溶出度测定方法，以有效控制其内在质量。方法 采用Agilent Zorbax SB-C₁₈色谱柱(250 mm×4.6 mm，5 μm)，以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱，流速为0.8 mL·min^–1，柱温33℃，检测波长270 nm。采用篮法，以900 mL pH 6.8的磷酸盐缓冲液为溶出介质，转速100 r·min^–1，测定昆仙胶囊中朝藿定A、朝藿定B、朝藿定C及淫羊藿苷的溶出度，并通过相似因子(f₂)法对不同批次样品的溶出曲线进行相似性比较。结果 朝藿定A、朝藿定B、朝藿定C及淫羊藿苷在各自范围内线性关系良好(r=0.999 9)，平均回收率分别为100.9%(RSD=1.29%)，102.1%(RSD=1.18%)，100.8%(RSD=1.30%)及99.9%(RSD=0.92%)，不同批次昆仙胶囊中4种成分的溶出曲线相似度较高，相似因子f₂均>67。结论 该法简便、准确、可行，专属性良好，可为昆仙胶囊的质量评价提供实验依据。

Abstract:

OBJECTIVE To effectively control the internal quality of Kunxian capsules by dissolution determination of Kunxian capsules based on multi-index components. METHODS The analysis was performed on Agilent Zorbax SB-C₁₈ column(250 mm×4.6 mm, 5 μm), using acetonitrile and 0.1% phosphoric acid solution as the mobile phase at a flow rate of 0.8 mL^.min^–1for gradient elution. The column temperature was 33 ℃, and the detection wavelength was 270 nm. The dissolution test was carried out with basket method, and using 900 mL pH 6.8 phosphate buffer as the dissolution medium, and the rotation speed was 100 r·min^–1. The dissolution test of epimedin A, epimedin B, epimedin C and icariin in preparations were performed on HPLC, calculate and map the accumulative dissolution curve, and then compared the dissolution of products from different batches through the similarity factor(f₂). RESULTS Good linearity relationships separated with epimedin A, epimedin B, epimedin C and icariin(r=0.999 9), and the average recovery were 100.9%(RSD=1.29%), 102.1%(RSD=1.18%), 100.8%(RSD= 1.30%) and 99.9%(RSD=0.92%), respectively, The dissolution curve of 4 components in Kunxian capsules from different batches had high similarity, the similarity factor(f₂) were all > 67. CONCLUSION The method is convenient, accurate, practicable, it has good specificity, and can help to perfect the equality evaluation system of Kunxian capsule.