吲达帕胺片仿制药与原研药的溶出度一致性评价

中国药物警戒 ›› 2016, Vol. 13 ›› Issue (7): 403-407.

吲达帕胺片仿制药与原研药的溶出度一致性评价

张翔¹, 宋金春^1*, 陈莉²

1 武汉大学人民医院，湖北武汉 430060;
2 武汉大学药学院，湖北武汉 430072

收稿日期:2016-06-06 修回日期:2018-07-17 出版日期:2016-07-20 发布日期:2018-07-17
通讯作者: 宋金春，男，博士，主任药师，教授·硕导，临床药学。E-mail:songjc1234@126.com
作者简介:张翔，男，在读硕士，临床药学。

Consistency Evaluation of Dissolubility of Indapamide Tablets between Generic and Original Preparation

ZHANG Xiang¹, SONG Jin-chun¹, CHEN Li²

1Renmin Hospital of Wuhan University, Hubei Wuhan 430060, China;
2School of Pharmacy, Wuhan University, Hubei Wuhan 430072, China

Received:2016-06-06 Revised:2018-07-17 Online:2016-07-20 Published:2018-07-17

摘要/Abstract

摘要： 目的比较国内3种不同吲达帕胺片仿制药与原研药的体外溶出度，并将溶出曲线进行比较评价一致性。方法采用高效液相色谱法。色谱柱为Agilent TC-C18，流动相为甲醇-水-冰醋酸（55:45:0.1），流速1 mL·min^-1，检测波长为240 nm，柱温为30 ℃，进样量为20 μL。采用桨法，溶出介质体积为900 mL，转速为50 rpm，分别以水、pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液为溶出介质测定溶出度，并通过计算相似因子(f2)评价二者溶出曲线的相似性。结果仅仿制药C与参比制剂D的溶出曲线基本相似，A和B与参比制剂溶出一致性差。结论部分国内仿制药与国外参比制剂溶出一致性较差，制备工艺有待改善。

关键词: 吲达帕胺, 仿制药, 原研药, 溶出曲线

Abstract: Objective To compare the dissolubility of three different domestic indapamide tablets with the original preparation in vitro, so as to evaluate the consistency. Methods HPLC method was adopted. The column was Agilent TC-C18, mobile phase was methanol-water-glacial acetic acid (55:45:0.1, V/V) with a flow rate of 1 mL·min^-1, the detection wavelength was 240 nm, the column temperature was 30℃, the injection volume was 20 μL. The stirring paddle method was adopted, volume of dissolution medium was 900 mL and roating rate was 50 rpm. The dissolution mediums were water, hydrochloric acid solution (pH1.2), acetic acid-sodium acetate buffer solution (pH4.0) and phosphate buffer solution (pH6.8). The similarity of dissolution profile was evaluated by calculating similar factor (f2). Results Only the generic drug C has similar dissolution profile from reference preparation D, the consistency of dissolubility of A and B was considerablely different. Conclusion The dissolution profiles of some domestic indapamide tablets are not consistent with its original product in vitro, the production process needs to be further improved.

Key words: indapamide tablet, generic preparation, original preparation, dissolution profile

中图分类号:

R943

张翔, 宋金春, 陈莉. 吲达帕胺片仿制药与原研药的溶出度一致性评价[J]. 中国药物警戒, 2016, 13(7): 403-407.

ZHANG Xiang, SONG Jin-chun, CHEN Li . Consistency Evaluation of Dissolubility of Indapamide Tablets between Generic and Original Preparation[J]. Chinese Journal of Pharmacovigilance, 2016, 13(7): 403-407.

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