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·min-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.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
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 ]
