三妙丸工艺的优化及工艺验证

Optimization and Process Validation of Technology for the Preparation of Sanmiao Pills

目的针对三妙丸制丸过程中易出现丸药开裂的情况,优化了三妙丸的制丸工艺参数,并进行了工艺验证。方法首先制得三妙丸粉,然后以丸药外观、水分、溶散时限为评价指标,通过考察不同丸径及干燥温度,优化三妙丸的制丸工艺参数,并进行三批次工艺验证。结果三妙丸制丸工艺参数条件优化为,丸径控制为5.0±0.25mm,泛制成丸,70℃干燥。结论工艺简单可行,产品各项指标稳定。

OBJECTIVE According to the phenomenon of so easy cracking of Sanmiao pills,To optimize the preparative parameters of Sanmiao Pills,and to validate the process.METHODS The powders of Sanmiao Pills were prepared firstly.Then the appearance,humidity and disintegration time of pills were selected as evaluation indexes to optimize the process parameters of Sanmiao Pills.The technology was validated by 3 batches afterwards.RESULTS The process parameters of Sanmiao Pills were optimized as follows:The diameter of pills was controlled as 5.0±0.25 mm,and drying under the 70℃.CONCLUSION The process technology is simple and feasible.The quality of pills is stable.