摘要
目的:考察影响水杨酸滴丸制备的因素,确立其最佳成型工艺。方法:考察环境因素、加热温度、基质配比与试验步骤对滴丸制备工艺的影响。以丸重差异、溶出时限及外观质量为综合评价指标,通过正交试验进一步优化滴丸的制备工艺。结果:基质单独加热熔化后再与药液在避光密封的条件下进行混合,可防止药液迅速氧化变红。滴丸的最佳制备工艺为:聚乙二醇400与聚乙二醇6000的比例为1∶5,药液温度为50℃,滴距为8 cm,滴制速度为70滴·min-1。结论:该工艺简单可行,制得滴丸的丸重差异、溶出时限及外观质量均符合质量要求。
Objective： To study the influencing factors in the preparation of salicylic acid dropping pills, and determine the opti- mum preparation process. Methods： The environmental factors, heating temperature, matrix ratio and preparation steps of salicylic acid drop pills were observed. With pill weight difference, dissolution time and appearance quality as the indices, an orthogonal test was adopted to optimize the preparation process. Results： Salicylic acid and the matrix should be separately heated to prevent red oxide. The optimized preparation process of drop pills was as follows ： the ratio of PEG 400 and PEG 6000 was 1 ： 5, the temperature of drug solution was 50℃, the dropping distance was 8cm and the dropping rate was 70 drops per minute. Conclusion： The preparation process is simple and practicable. The pill weight difference, dissolution time and appearance quality all meet the quality require- ments.
出处
《中国药师》
CAS
2016年第6期1200-1202,共3页
China Pharmacist
关键词
水杨酸
滴丸
制备工艺
正交试验
Salicylic acid
Drop pills
Preparation process
Orthogonal test
