目的 优化胃乃安新制剂的醇沉工艺，为胃乃安制剂二次开发的生产提供参考。方法 以总皂苷、总黄酮、总多糖收率及总固体去除率为综合评分指标，考察醇沉工艺的初始药液浓度、乙醇浓度等工艺参数，并以盐酸乙醇致急性胃溃疡、NaOH致胃黏膜损伤模型比较胃乃安新制剂供试品与原剂型的药效强弱。结果 综合评分由高至低的初始药液浓度分别为0.857，0.429，1.285 g·mL-1，综合评分及溃疡抑制率由高至低的乙醇浓度分别为50 %、70 %、60 %，胃乃安新制剂供试品抗盐酸乙醇致急性胃溃疡与NaOH致胃黏膜损伤的药效作用均优于原剂型。结论 采用0.857 g·mL-1药液浓度、50 %醇沉浓度可较好去除杂质、减少服用量、增强药效作用，可为胃乃安新制剂的生产工艺提供科学参考。

Objective To optimize the alcohol precipitation technology of Weinai’an new preparation for providing scientific reference to its further development and production. Methods With the yield of total saponins，total flavonoids and polysaccharide，and with the total solid removal rate as the comprehensive indexes，the initial concentration of the preparation and alcohol concentration for the alcohol precipitation technology were investigated comprehensively. Then the acute gastric ulcer model induced by hydrochloric acid ethanol and acute gastric injury model caused by NaOH were used to evaluate the pharmacological action of the optimized Weinai’an new preparation and its initial preparation. Results The initial concentration of the preparation at 0.857，0.429，1.285 g·mL-1 presented the comprehensive scores of 62.17，61.41 and 59.58， and comprehensive scores and ulcer-inhibition rate were in decreasing sequence when the alcohol concentration was at 50 %，70 %，60 %. The effects of the optimized Weinai’an new preparation were better than those of the initial preparation on the two kinds of animal models. Conclusion The alcohol precipitation process with the initial concentration of the preparation at 0.857 g/mL and alcohol concentration at 50 % shows better effect on removing impurity，reducing dose and enhancing pharmacological action，which will provide scientific references to new preparation of Weinai’an.

R284.1

粤港关键领域重点突破招标项目(GDDRC2007ZY002)；上海市教委E-研究院建设计划项目资助(E03008)。