银杏内酯滴丸处方和工艺探讨

Formulation and Preparation Technique of Ginkgolides Drop Pills

采用单因素试验设计,以沉降速度和溶散时限为评价指标,筛选银杏内酯滴丸的处方和制备工艺,并对中试成品的质量稳定性进行考察。试验结果表明:以聚乙二醇4000为基质,二甲基硅油为冷却剂,提取物与基质的配比为1∶4,所制得的滴丸沉降速度适中,外形圆整,大小均匀,溶散时限符合规定;3批样品经初步稳定性实验考察,各项考核项目均符合规定。该工艺能够有效地解决银杏内酯滴丸溶散时限不合格的问题,适用于大批量生产。

The single factor experimental design was made to formulate and prepare Ginkgolides drop pills with settling velocity and disintegration time limit as the evaluation index. The quality stability in the pills was examined. The results showed that with the PEG 4000 as matrix, dime- thicone as coolant and the ratio of active ingredients and exeipient 1 ： 4, the pills were spherical vesicles with an expected size, and their settling velocity and disintegration time limit were saris- fled. Investigation on three batches of the pills showed that they were stable. The method can el- ： %ctively meet the disintegration time limit of the pills.