左金丸工艺参数的优化与工艺验证作者：张正光 段丽颖 刘献洋来源：《上海医药》2018年第17期 摘 要 目的：通过优化左金丸的制丸工艺参数，解决左金丸制丸过程中出现的丸药易开裂现象，并进行了工艺验证。方法：首先制得左金丸粉，然后以丸药外观、溶散时限为评价指标，通过考察不同丸径及干燥温度，优化左金丸的工艺参数，并进行3批次工艺验证。结果：左金丸制丸工艺参数条件优化为，丸径控制为5.0 mm（即4.75～5.25 mm），加水量（以药粉计）控制为0.55 L/kg，泛制成丸，70 ℃干燥。结论：本研究确定的工艺简单可行，产品各项指标稳定。 关键词 左金丸 水丸 工艺验证
中图分类号：TQ461； R283.6 文献标志码：A 文章编号：1006-1533（2018）17-0062-04
Optimization and validation of technology for the preparation of Zuojin pills
ZHANG Zhengguang1，2*， DUAN Liying1， LIU Xianyang1
（1. Shanghai Hutchison Pharmaceuticals Co.， Ltd.， Shanghai 201401， China；
2. Shanghai Engineering Research Center for Innovation of Solid Preparations of TCM， Shanghai 201401， China）
ABSTRACT Objective： To solve the cracking of Zuojin pills by the optimization and validation of process parameters. Methods： The powders of medicinal materials were firstly prepared and then the process parameters were optimized by investigating the different diameters and drying temperatures of pill and taking the appearance and dissolving time limit of pills as indicators. The optimal preparation technology was validated with 3 batches of pill samples. Results： The process parameters were optimized as follows： the diameter of pills， the amount of water added during preparation and drying temperature were controlled at 5.0 mm （4.75-5.25 mm）， 0.55 L/kg powders and 70 ℃， respectively. Conclusion： The process established in this stu
dy is simple and feasible and the product indicators are stable.
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