胃苏口服液制备工艺的优选

Optimization of Preparation Process of Weisu Oral Liquid

目的:优选胃苏口服液的制备工艺。方法:采用正交设计法,考察提取时间、次数、加水量及ZTC1+1Ⅲ型在药液中的使用浓度等4个因素;以黄芪甲苷含量为指标成分。结果:ZTC-Ⅲ型絮凝法能代替醇沉法用于胃苏口服液的澄清工艺,最佳制备工艺为:选用ZTC-Ⅲ型B组分(A组分为B组分的一半)在药液中浓度为2%的浓度,加药材12倍量的水提取3次,每次3h。结论:制剂工艺简便、稳定,质量可控。

OBJECTIVE： To optimize the preparation process of Weisu Oral Liquid. METHODS： By orthogonal design, the preparation process of Weisu Oral Liquid was optimized with extraction time, extraction times, the amount of water added and the working concentration of ZTC1 ＋ 1 Ⅲ as factors and with astragaroside content as index. RESULTS： ZTC ＋Ⅲ flocculence could substitute for alcohol precipitation method as the clarification process for Weisu Oral Liquid. The optimum process was as follows： extracting ZTCⅢ constituent B （constituent A is half of the constituent B） at a concentration of 2% in the physic liquor for 3 times （3 hours/each time） by adding 12 - fold amount of water. CONCLUSION： The preparation process is simple and stable and the quality is controlled.