紫草栓剂的制备

Preparation of Lithospermum Suppository

以热熔法制备紫草栓剂,以栓剂的颜色均匀度、硬度、色泽、完整度为评价指标,采用单因素实验筛选考察了不同基质组成比例、紫草加入量、过筛筛目、制备温度对紫草栓剂的影响。采用正交试验法优选紫草栓剂的最佳处方组成,确定制备紫草栓剂的最优条件。得到最佳条件:以聚乙二醇400、聚乙二醇4000和甘油作为栓剂基质,并按1∶2∶1的比例制备,加入7%经125μm(120目)筛网过筛的紫草粉,温度以70℃为宜。该制备方法设计合理,质量稳定,工艺可行。

The Lithospermum suppository is prepared by hot melting method.The color uniformity,hardness,color and integrity of the suppository are used as evaluation indexes.The effects of different matrix composition ratio,Lithospermum addition amount,sieve mesh and preparation temperature on Lithospermum suppository are investigated by single factor experiment.The optimum prescription composition of Lithospermum suppository is optimized by orthogonal experiment,and the optimum conditions for preparing Lithospermum suppository are determined.The optimum conditions are as follows,polyethylene glycol 400,polyethylene glycol 4000 and glycerol are used as suppository matrix and prepared at a ratio of 1∶2∶1,and 7%Arnebia euchroma powder screened by 125μm(120 mesh)sieve is added,the temperature should be 70℃.The preparation method has reasonable design,stable quality and feasible process.