三黄膏制备工艺改进对其体外药物释放特性的影响  

Effect of Improved Preparation Process of Sanhuang Plaster on its Drug Release Characteristics in Vitro

作　　者：王宝才[1] 李俊江[1] 李荣焜 WANG Baocai;LI Junjiang;LI Rongkun(Center for Scientific Research Preparation,Gansu Provincial Hospital of TCM,Lanzhou 730050,China;Gansu University of Chinese Medicine,Lanzhou 730000,China)

机构地区：[1]甘肃省中医院科研制剂中心,甘肃兰州730050 [2]甘肃中医药大学,甘肃兰州730000

出　　处：《中国民族民间医药》2024年第9期40-45,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：白银市科技计划项目(编号:2021-2-25Y)。

摘　　要：目的:考察三黄膏制备工艺改进对其体外药物释放特性的影响。方法:用人工尼龙膜作为半透膜,采用Franz直立式扩散池考察三黄膏的释放特性,应用HPLC测定接收液介质中小檗碱的含量,以美国FDA与欧盟体外释放指南考察三黄膏变更前后质量一致性,并对变更后的三黄膏释放动力学进行拟合。结果:变更前三黄膏(即参比制剂)单位面积累积渗透量(A total)为(556.35±28.65)μg/cm 2,变更后三黄膏(即试验制剂)单位面积累积渗透量(A total)为(507.54±25.07)μg/cm 2。试验制剂与参比制剂的中位体外释放率比值、体外释放率平均值比率、单位面积渗透总量(A total)平均值比率均符合美国FDA与欧盟的体外释放指南要求。释放动力学过程符合零级和Hixson-Crowell释放模型,Hixson-Crowell方程表明小檗碱释放符合被动扩散机制。结论:试验制剂与参比制剂的体外释放具有一致性,三黄膏工艺变更符合预期。Objective Effect of improved preparation process of Sanhuang plaster on its drug release characteristics in vitro.Methods The artificial nylon membrane was used as the semi permeable membrane,and the vertical Franz diffusion cell was used to investigate the release characteristics of Sanhuang plaster.The content of berberine in the receiving medium was determined by HPLC.The quality consistency of Sanhuang plaster before and after the change was investigated according to the in vitro release guidelines of FDA and EU,and the release kinetics of Sanhuang plaster after the change was fitted.Result Before the change,the accumulated permeation amount(A total)per unit area of Sanhuang plaster(reference preparation)was(556.35±28.65)μg/cm 2,after the change,the cumulative permeation amount(A total)per unit area of Sanhuang plaster(test preparation)is(507.54±25.07)μg/cm 2。The median in vitro release rate ratio,average in vitro release rate ratio,and average permeability per unit area(A total)ratio of the test preparation and the reference preparation all conform to the requirements of the in vitro release guidelines of the US FDA and the EU.The release kinetics process conforms to zero order and Hixson Crowell release model.Hixson Crowell equation shows that berberine release conforms to passive diffusion mechanism.Conclusion The in vitro release of the test preparation was consistent with that of the reference preparation,and the process change of Sanhuang plaster was in line with expectations.

关 键 词：三黄膏 体外释放 小檗碱 一致性 工艺变更 

分 类 号：R282.6[医药卫生—中药学]