附片胶囊制备工艺研究

Research on the Preparing Technology of Monkshood Capsule

目的 :制备附片胶囊剂。方法 :采用水提醇沉法制备 ,选择赋形剂 ,并作质量控制。结果 :提取浓缩时间不得少于4h;乙醇沉淀浓度为 75 % ;苡仁粉为赋形剂 ;以生物碱颜色反应及乌头碱的限量检查为质控条件。结论 :附片胶囊剂制备工艺简单 ,制剂质量可控 ,用药安全 ,服用方便。

Purpose: To prepare monkshood capsule. Method: Aqueous extraction of ethanol precipitation, selection of excipient, and quality control. Result: The time of extraction and concentration must not be less than 4 hours; the density of the ethanol precipitation is 75%; powder of Job's tears seed being the excipient; alkaloid color reaction and quantification of aconitine are employeed to control the quality. Conclusion: The preparation technology of monkshood capsule is simple; the quality of the preparation can be controled; the pharmacy is safe and easy to be taken.