墨苋涂膜剂的制备及质量控制
The Preparation and Quality Control of Mo Xian Coating Agent
孔鹃 1亓恒芹 2王小宁3
作者信息
- 1. 济宁市皮肤病防治院药剂科制剂室,山东济宁 272100;山东大学药学院,济南 250100
- 2. 济宁市皮肤病防治院药剂科制剂室,山东济宁 272100
- 3. 山东大学药学院,济南 250100
- 折叠
摘要
目的 对墨苋涂膜剂制备优选并进行质量控制研究.方法 以成膜时间、成膜性状、黏度为考察指标,成膜性能综合评分为评价指标,考察成膜材料、增塑剂、促透剂,利用L9(34)正交试验,筛选最优制备工艺;采用薄层色谱法对墨旱莲、马齿苋、冰片进行鉴别;利用高效液相色谱法对蟛蜞菊内酯含量进行测定.结果 最优制备工艺处方为:6%PVA0588,2%甘油,0.5%吐温-80;3 味药材薄层色谱斑点清晰,专属性好,阴性无干扰;蟛蜞菊内酯在4.04～101.09 µg/ml范围内线性关系良好(R2=0.999 6),平均回收率为100.6%,RSD为1.97%(n=9).结论 墨苋涂膜剂制备工艺简单可行,建立的质控方法科学准确、易操作,可用于墨苋涂膜剂的质量控制.
Abstract
Objective To optimize the best preparation and to study the quality control of Mo Xian Coating Agent.Methods The film-forming materials,plasticizers,and transdermal enhancers were investigated,according to the film-forming performance indexes including the film-forming time,the film-forming ability,and viscosity of the solution as investigated indexes,and the optimal preparation process was determined by an orthogonal experiment;Thin layer chromatography(TLC)was used for the identification of Eclipta prostrata,Portulaca Oleraeea,and Borneolum;the component wedelolactone was determined by using liquid chromatography.Results The optimal preparation process was PVA0588(6%),glycerol(2%),and Tween-80(0.5%);the TLC of the three traditional Chinese herbs was clear without interference and has good specificity;Wedelolactone has good linear relationship in the range of 4.04～101.09 μg/ml(R2=0.999 6),The mean recovery was 100.6%and the RSD was 1.97%(n=9).Conclusion The preparation process of Mo Xian Coating Agent is simple and feasible,and the established quality control method is scientific,accurate and easy to operate,which can be used for the quality control of Mo Xian Coating Agent.
关键词
墨苋涂膜剂/制备工艺/正交试验/质量控制/蟛蜞菊内酯Key words
Mo Xian Coating Agent/Preparation process/Orthogonal test/Quality control/Wedelolactone引用本文复制引用
基金项目
国家自然科学基金面上项目(21877071)
出版年
2024
国家科技期刊平台
NSTL
万方数据