国产与日本西尼地平片溶出曲线相似性评价及溶出度区分力的研究  

Similarity Evaluation of the Dissolution Curves of Domestic and Imported Cilnidipine Tablets and Study on Dissolution Method with Discriminatory Power

作　　者：王建 曾红霞[1,2] 李佳妮[2] 陈悦 

机构地区：[1]浙江省食品药品检验研究院,杭州310052 [2]浙江工业大学,杭州310014

出　　处：《中国药学杂志》2016年第17期1493-1497,共5页Chinese Pharmaceutical Journal

摘　　要：目的研究西尼地平片的溶出行为,评价国内3家片剂产品与原研片溶出曲线的相似性;建立对不同处方工艺有区分力的新溶出度检查方法。方法用含0.4%SDS的p H 1.2溶液、p H 4.0缓冲液、p H 6.8缓冲液和水4种溶出介质,以原研样品作参比制剂,采用相似因子法评价国内3家片剂产品与原研片溶出曲线的相似性;新溶出度检查方法为:桨法,75 r·min-1,溶出介质为含0.5%SDS的p H 6.8磷酸盐缓冲液900 m L,60 min取样,HPLC测定,限度均为标示量的70%。结果结果国内3家制药公司产品,仅1家制药公司的产品与日本味之素公司原研样品一致,在4种溶出介质中的溶出曲线均相似;新建立的溶出度检查方法,能区分先进工艺和普通工艺的产品。结论采用p H 6.8磷酸盐缓冲液为溶出介质,对难溶性西尼地平片的处方工艺有区分力,能有效的控制本品的质量。OBJECTIVE To study the dissolution behavior of cilnidipine tablets, evaluate the consistency of dissolution behavior between three domestic products and the original tablets, and develop a new dissolution method with discriminatory power for prescription process. METHODS The dissolution media were hydrochloric acid solution （ pH 1.2） , acetate buffer （ pH 4.0） , phosphate buffer （ pH 6.8） and water, all containing 0. 4% SDS. Using original tablets as the reference preparation, the dissolution curve of the test and reference preparations was compared by the similarity factor method. Apparatus 2 was used for the new method of dissolution test, using 900 mL phosphate buffer with 0. 5% SDS （pH 6. 8） as the dissolutive medium,at the rate of 75 r·min^-1. The dissolution solution was taken at 60 min and analyzed by HPLC. The dissolution limit was set at 70%. RESULTS For the three domestic pharma-ceutical products, only one had consistent dissolution curves in the four dissolution media with the original product from Japanese Ajinomoto Co.. The new method of dissolution test could distinguish the products manufactured by advanced technology from those by process of general level. CONCLUSION The new dissolution method has discriminatory power for prescription process of insoluble cilnidipine tablets when using phosphate buffer （ pH 6. 8） as the dissolutive medium, and the quality of the product can be effectively controlled.

关 键 词：西尼地平片 溶出度 溶出曲线 一致性评价 相似因子法 区分力 

分 类 号：R917[医药卫生—药物分析学]