均匀设计优选小剂量阿司匹林肠溶片释放度测定条件  

Studies on dissolution conditions for low dosage aspirin enteric-coated tablet by uniform design

作　　者：祝莉莎 程雪梅 郭拓云 佟庆玉 张靖丽 

机构地区：[1]新疆维吾尔自治区药品检验所,新疆乌鲁木齐830002

出　　处：《中国药学杂志》2003年第3期198-200,共3页Chinese Pharmaceutical Journal

基　　金：国家药典委员会资助课题 [药典业发 ( 2 0 0 1)第 493号 ]

摘　　要：目的　建立小剂量阿司匹林肠溶片 (LDAET)释放度的质量标准。方法　采用小杯法测定LDAET的释放度。以释放度差值Yb a为考察指标 ,用均匀设计法以溶出介质量、转速及溶出时间等为三因素四水平 ,筛选LDAET释放度的测定条件。结果　均匀设计法优选出LDAET释放度的测定条件为转速 10 0r·min-1、溶出介质量 10 0mL。 9批样品中有 6批在 45min时溶出 70 %以上 ,1h溶出基本完全 ,有 3批 1h时仅溶出 8%～ 5 0 %。OBJECTIVE: To establish a method for determining the dissolution of low dosage aspirin enteric-coated tablets (LDAET). METHODS: The cup method was used to determine the dissolution of LDAET. The uniform design was employed to select the conditions of dissolution determination of LDAET, in which the dissolution volume, the rotational speed, and dissolution time were three main factors in four levels and the differential value of dissolution of Yb-a was the inspecting index. RESULTS: The dissolution conditions of LDAET were optimized as the rotational speed 100 r&middotmin-1 and dissolution volume 100 mL. The dissolution of LDAET in six of nine batches was over 70% within 45 minutes and completed within 1 hour, but three in nine batches was only of 8%-50%. CONCLUSION: The experiment results showed that the dissolution conditions of LDAET could be defined as the standard.

关 键 词：均匀设计 阿司匹林 释放度 小杯法 

分 类 号：R971.1[医药卫生—药品]