正交试验法优化黄芩苷缓释滴丸的制备工艺  

Optimized preparation of baicalin sustained-release dropping pills by orthogonal test

作　　者：夏海建[1,2] 张振海[1] 徐凤娟[1] 贾晓斌[1,2] 

机构地区：[1]江苏省中医药研究院国家中医药管理局中药释药系统重点研究室,南京210028 [2]南京中医药大学,南京210046

出　　处：《中华中医药杂志》2013年第10期2937-2941,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：江苏省中医药领军人才专项;江苏省高等学校大学生创新训练计划项目(No.011042004000)~~

摘　　要：目的:制备黄芩苷缓释滴丸,考察药物的体外释放度,优化其制备工艺。方法:以单硬脂酸甘油酯和聚乙二醇-4000为载体材料,采用熔融法制备黄芩苷缓释滴丸,以圆整度、重量差异和体外释放度为评价指标,采用正交试验优选滴丸的最佳成型工艺。结果:黄芩苷缓释滴丸优选的最佳制备工艺为:黄芩苷和基质的比例为1∶9,单硬脂酸甘油酯和聚乙二醇-4000的质量比为1.0∶2.5,药液温度80-85℃,滴距3cm。该缓释滴丸12h的最大累积释放百分率可达90%。结论:所制备的黄芩苷缓释滴丸在提高药物溶出度的同时还具有良好的缓释效果,验证试验结果表明该制备工艺稳定可行。Objective： To prepare the baicalin sustained-release dropping pills, investigate dissolution in vitro and itspreparation technology. Methods： The baicalin sustained-release dropping pills were prepared by melting method with glycerol monostearate and PEG-4000 as materials. With the roundness, weight difference, and in vitro release as the evaluations, orthogonal design was conducted to optimize the forming technology of baicalin sustained-release dropping pills. Results： The optimal preparation conditions were as follows： the ratio of baicalin and materials was 1：9 and the ratio of glycerol monostearate and PEG- 4000 was 1.0：2.5, dropping temperature was 80℃ to 85℃ and dropping distance was 3cm. The cumulative release amount of baicalin at 12h was 90%. Conclusion： The prepared baicalin sustained-release dropping pills have a high dissolution as well as a good sustained-release effect and the preparation technology is stable and feasible.

关 键 词：黄芩苷 缓释滴丸 体外释放度 制备工艺 

分 类 号：TQ461[化学工程—制药化工] R286.0[医药卫生—中药学]