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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 process for the preparation of Weinaan, and provide a reference for the secondary development of Weinaan Preparation. Methods Total saponin, total flavonoids, total polysaccharide yield and total solids removal rate as a comprehensive score index, alcohol sedimentation process of the initial liquid concentration, ethanol concentration and other process parameters, and ethanol induced acute gastric ulcer, NaOH caused by stomach Mucosal lesion model compares the efficacy of Weinaan’s new preparation with the original dosage form. Results The concentration of initial drug solution from high to low was 0.857,0.429,1.285 g · mL-1, respectively. The comprehensive scores and the concentration of ethanol with high to low ulcer inhibition rate were 50%, 70%, 60%, respectively Is a new preparation for the test of anti-hydrochloric acid-induced acute gastric ulcer caused by NaOH and gastric mucosal injury efficacy are better than the original dose. Conclusion With 0.857 g · mL-1 drug solution concentration, 50% alcohol concentration can remove impurities, reduce the dosage and enhance the effect of drug. It can provide a scientific reference for the production process of Weina’an new preparation.