文档介绍：阿司匹林片剂制备及质量检查
连云港杰瑞药业有限公司许志毅
摘要目的通过化学合成方法实验室制备阿司匹林。方法水杨酸和醋酐为原料,O-酰化反应合成阿司匹林,以三***化铝为催化剂,用量为水杨酸的2%,水杨酸与醋酐的摩尔比为1∶2,反应时间为30分钟,回流温度为85度左右。同时采用湿法制粒压片工艺制备阿司匹林片,并对片剂的外观、硬度、脆碎度、片重差异、崩解时限、溶出度等检查。%。片剂的外观、硬度、脆碎度、片重差异、崩解时限、溶出度等检查均符合药典规定。结论本法快速、简单、经济、无污染,产品质量好,适于工业化生产。
关键字:阿司匹林;湿法制粒;片剂
Abstract Objectives Through the chemical synthesis laboratory preparation aspirin。Methods Salicylic acid and acetic anhydride as raw materials, O-acylation reaction of synthesis aspirin to aluminum chlori de as catalyst, the amount of 2% salicylic acid, salicylic acid and acetic anhydride molar ratio of 1:2 and the reaction time is 30 minutes, the return temperature of 85 degrees Celsius,Meanwhile adopts wet gra nule presser fabrication processes of aspirin tablets, the appearance of the tablet, rigidity, brittle broken degrees, tablet heavy differences, crumbling time limit, dissolving degree of examination。Results aspi rin % yield,Tablet appearance, hardness, brittle broken degrees, tablet heavy differences,crumbling time limit, dissolving degrees etc all accord with pharmacopoeia regulations. Check 。Conclusions This method is fast and simple, economic, no pollution, product quality is good, suitable for industrial production。.
Keyword: Aspirin;Wet Granulator;Tablet;
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