阿托伐他汀钙片生产批量成倍放大工艺研究

Study on multiplying and enlarging technology of Atorvastatin Calcium Tablets production batch

目的研究阿托伐他汀钙片生产批量成倍放大的质量变化,并和市售制剂做释放行为比较。方法对生产批量中连续3个锅次制备的软材、颗粒及片剂进行质量对比研究,观察各锅次质量变化情况,并采用紫外分光光度(UV)法测定不同锅次的自制产品与参比制剂溶出曲线。结果生产批量成倍放大后,自制产品与参比制剂溶出曲线相似。结论随着批量增加,各锅次质量略有变化,按此趋势,批量不能无限制放大,但批量由20万增加至60万,工艺稳定可行。

Objective To study the mass changes of Atorvastatin Calcium Tablets in production batches and compare them with the release behavior of commercial preparations.Methods The quality of soft materials,granules and tablets prepared in three batches of production batch was compared,and the quality changes of each pot were observed,The dissolution curves of homemade products and reference preparations of different cooking times were determined by UV. Results The results showed that the dissolution curves of homemade products and reference products were similar.Conclusion With the increase of batch volume,the quality of each pot changed slightly. According to this trend,the batch can not be enlarged without limit,but the batch volume was increased from 200 000 to 600 000,and the process was stable and feasible,which was consistent with the release behavior of the referenced preparation.