复方前列安颗粒质量标准分析.docVIP

复方前列安颗粒质量标准分析 　　[摘要] 目的：建立复方前列安颗粒的质量标准。方法：采用薄层色谱法对复方前列安颗粒中的药材淫羊霍、泽泻、延胡索的成分进行定性鉴别；并应用高效液相色谱法测定制剂中芍药苷成分的含量。色谱柱：Kromasil KR100-5 C18 ODS柱(250 mm×4.6 mm，5 μm)；流动相：0.01%磷酸水-乙腈（83∶17）；检测波长：230 nm；流速：1.0 ml/min。结果：利用薄层色谱鉴别可检测出药材淫羊霍、泽泻及延胡索。同时测定制剂中芍药苷成分在1.704~8.520 μg范围内呈良好线性关系，r=0.999 4，平均回收率为97.45%，RSD=1.78%(n=6)。结论：该方法简便、准确、灵敏度高，可作为复方前列安颗粒的质量控制方法。 　　[关键词] 复方前列安颗粒；质量标准；薄层色谱法；高效液相色谱法；芍药苷 　　[中图分类号] R917 [文献标识码] A [文章编号] 1673-7210（2011）06（c）-078-03 　　 　　Quality standard analysis of Fufang Qianliean Keli 　　CHEN Yihua1, YANG Zhihua2 　　1. Shantou Hospital of Traditional Chinese Medicine, Guangdong Province, Shantou 515041, China; 2.Shantou Hospital of Skin Disease Prevention and Cure, Guangdong Province, Shantou 515041, China 　　[Abstract] Objective: To establish the quality standard of Fufang Qianliean Keli. Methods: Epimedium brevicornu, Alisma orientale and Corydaliis turtschaninovii were identified by TLC; and the content of paeoniflorin in Fufang Qianliean Keli was determined by HPLC. The colum was Kromasil Kp100-5 C18 ODS(250 mm×4.6 mm,5 μm); the mobile phase consisted of 0.01%H3PO4-acetonitrile(83∶17); the detection wavelength was set at 230 nm; the flow rate was 1.0 ml/min. Results: The Epimedium brevicornu, Alisma orientale and Corydaliis turtschaninovii could be distinguished respectively by TLC; while the linear range of paeoniflorin was 1.704-8.520 μg(r=0.999 4), the average recovery rate was 97.45%, RSD=1.78%(n=6). Conclusion: The method is simply operation, accurate and highly sensitive. It can be used for quality control of Fufang Qianliean Keli. 　　[Key words] Fufang Qianliean Keli; Quality standard; TLC; HPLC; Paeoniflorin 　　 　　复方前列安颗粒制剂是汕头市中医医院制剂室自制药品，已取得汕头市临床科研用药（试用）项目，批准文号为粤该产品由赤芍、淫羊霍、泽泻、延胡索、制乳香、王不留行等药味组成，具有活血??瘀、理气通络之功效，适用于气滞血瘀型的前列腺炎、前列腺增生等病症。其颗粒采用醇提和传统的水提工艺相结合，再经过浓缩、干燥、一步制粒等现代先进技术制备而成，为了控制复方前列安颗粒的质量，本文参照文献[1-4] 一方面采用薄层色谱法对该制剂中的淫羊霍、泽泻、延胡索药材进行了定性鉴别分析；另一方面采用高效液相色谱法进一步测定制剂中的主要成分之一芍药苷的含量，为控制复方前列安颗粒的药品内在质量提供有效的保证。 　　1 仪器与试药 　　1.1 仪器 　　薄层铺板器