柏竭净屑软膏制备工艺优化  

Optimization of Preparation Technology of Baijie Jingxie Ointment

作　　者：黄梅 李江 肖娟 王有福 李正芬 徐智 余晓玲 HUANG Mei;LI Jiang;XIAO Juan;WANG Youfu;LI Zhengfen;XU Zhi;YU Xiaoling(College of Traditional Chinese Medicine,Yunnan University of Chinese Medicine,Kunming 650500,China;Department of Pharmacy,the Third Affiliated Hospital of Yunnan University of Chinese Medicine(Kunming Municipal Hospital of Traditional Chinese Medicine),Kunming 650599,China;Environmental Laboratory,Cloud Testing Quality Inspection Ltd.,Kunming 650201,China)

机构地区：[1]云南中医药大学中药学院,云南昆明650500 [2]云南中医药大学第三附属医院(昆明市中医医院)药学部,云南昆明650599 [3]云南云测质量检验有限公司环境检验所,云南昆明650201

出　　处：《现代中药研究与实践》2025年第1期60-65,共6页Research and Practice on Chinese Medicines

基　　金：国家自然科学基金地区科学基金项目(82360844);云南省科技厅科技计划项目(202101AZ070001-126);云南省科技厅科技计划项目(202101AZ070001-173)。

摘　　要：目的对柏竭净屑洗剂进行剂型改良并优化其制备工艺,为柏竭净屑软膏的质量控制研究奠定基础。方法以盐酸小檗碱转移率和干膏得率综合评分为指标,采用单因素试验优选提取工艺;以盐酸小檗碱保留率为评价指标,对不同浓缩方式进行比较;以软膏外观均匀性、延展涂布性、耐寒稳定性、耐热稳定性和离心稳定性为评价指标,采用AHP-CRITIC混合加权法确定各评价指标的权重系数,结合星点设计(central composite design,CCD)-效应面优化法筛选柏竭净屑处方中对基质质量影响较大的3个因素黄凡士林、羊毛脂、液状石蜡的用量,验证优化后的工艺。结果最佳提取工艺液料比为18∶1、提取时间1 h,提取3次,常压浓缩;AHP-CRITIC混合加权法得到外观均匀性、延展涂布性、耐寒稳定性、耐热稳定性、离心稳定性权重分别为0.1898、0.2193、0.0843、0.2016、0.3051。软膏成型工艺基质用量为凡士林13.0 g、羊毛脂6.0 g、液状石蜡0.3 g。结论优选的出柏竭净屑软膏制备工艺简单、合理,所得制剂具有良好的外观均匀性、延展涂布性和稳定性。Objective The dosage form of the Baijie Jingxie ointment was improved and the preparation process was optimized,in order to lay a foundation for the research on quality control of Baijie Jingxie ointment.Methods The comprehensive score of berberine hydrochloride transfer rate and dry paste yield was used as the index,one-way test was used to optimize the extraction process;using berberine hydrochloride retention rate as the evaluation indexes,comparison of different concentration methods of Baijie Jingxie ointment was optimized;using the uniformity of the appearance of the ointment,the ductility of spreading,the stability of cold-resistant,heat-resistant,and centrifugal stability as the evaluation indexes,theAHP-CRITIC mixed weighting method was used to determine the weight coefficients of each evaluation index,and combined with the central composite design(CCD)-effective surface optimization method to screen the three factors that have a greater impact on the quality of the substrate in the Baijie Jingxie ointment:the amount of yellow petroleum jelly,lanolin,and liquid paraffin,the optimized process was validated.Results The material-liquid ratio of optimal extraction process was 18:1 extraction time 1h,extraction 3 times,with atmospheric pressure concentration;according to the AHP-CRITIC mixed weighting method to obtain the appearance of uniformity,ductile coating,cold stability,heat stability,centrifugal stability weights were 0.1898,0.2193,0.0843,0.2016,0.3051,respectively.The dosage of matrix in the molding process was 13.0 g of petroleum jelly,6.0 g of lanolin,and 0.3 g of liquid paraffin.Conclusion The preparation process of the Baijie Jingxie ointment is simple and reasonable,and the preparation has good uniformity of appearance,ductile spreadability and stability.

关 键 词：柏竭净屑软膏 星点设计-响应面试验 AHP-CRITIC混合加权法 制备工艺 

分 类 号：R283.2[医药卫生—中药学]