正交试验法优选胆黄润肠丸制备工艺

Optimization of Preparation Process for Dan-huang run-chang Pills by Orthogonal Test

目的:优选并确立胆黄润肠丸的最佳制备工艺。方法:以胆黄润肠丸溶散时间为考察指标,采用正交试验法对丸剂制备过程中的药材粉碎度(A)、乙醇浓度(B)、干燥温度(C)、干燥时间(D)4个因素进行优选研究。结果:胆黄润肠丸的最佳制备为:药材粉碎成80目细粉,用50%的乙醇泛丸,制成的丸剂在80℃干燥8 h。经统计学处理,新工艺与老工艺制备的丸剂其溶散时限差异有统计学意义(P<0.01)。结论:该制备工艺科学合理,溶散时限短,为制备胆黄润肠丸的最佳工艺。

Objective：To optimize and establish the preparation process Dan-huang run-chang Pills.Methods：According to the dissolving time limit of Dan-huang run-chang Pills as measure indexes,The orthogonal test was employed to test the effects of the four factors,including crushing degree of medicinal materials（A）,ethanol concentration（B）,drying temperature（C） and drying time（D）.Results：The optimal preparation process ware as follows：medicinal material crushing into 80 mesh powder,pilling with 50％ ethanol and the pills made in drying at 80 ℃ for 8 hours,respectively.There was statistically significant difference in the dissolving time limit between new and old preparation process（P＜0.01）.Conclusion：The preparation process is scientific and reasonable,and the dissolving time limit is short and the best process for Dan-huang run-chang Pills.