返魂草缓释滴丸的制备工艺研究  

Study on the Preparation Technology of Fanhuncao Sustained-release Dropping Pills

作　　者：张宏梅[1] 崔佰吉[1] 郭淑英[1] 

机构地区：[1]吉林医药学院药学院,吉林吉林132013

出　　处：《中国药房》2015年第34期4837-4840,共4页China Pharmacy

基　　金：吉林省教育厅"十二五"科学技术研究项目(No.吉教科合字〔2014〕第549号)

摘　　要：目的:研究返魂草缓释滴丸的制备工艺。方法:以水溶性速释材料聚乙二醇(PEG)6000、PEG4000和缓释材料单硬脂酸甘油酯(GM)为主要载体材料,采用正交试验和单因素试验,以滴丸的圆整度、丸质量差异、外观质量为主要考察指标,以GM-PEG质量比、药液温度、管口温度、滴速、滴距、滴头内径等为考察因素,优选返魂草滴丸制备的工艺条件并进行验证试验。结果:最优条件为GM-PEG质量比3∶7、药液温度85℃、滴速40滴/min、滴距4 cm、管口温度15℃、滴头内径4 mm。验证试验中3批滴丸各指标的RSD值均≤0.58%(n=3),绿原酸的平均含量为0.14 mg/g,丸质量差异平均值为3.21%,圆整度评分平均值为9.43,外观质量平均分为4.33;1 h累计释放百分率(Q1 h)平均值分别为23.4%、24.4%、23.3%(n=6),Q12 h平均值分别为89.6%、91.2%、91.5%(n=6)。结论:优选的制备工艺稳定、简便,适于返魂草缓释滴丸的工业化生产。OBJECTIVE：To study the preparation technology of Fanhuncao sustained-release dropping pills. METHODS：The preparation technology of Fanhuncao sustained-release dropping pills was optimized by orthogonal design and single factor test with PEG4000,PEG6000 and glycerol monostearate（GM）as carrier materials,using sphericity,pill weight difference and appearance quality as index,GM-PEG weight ratio,liquid temperature,nozzle temperature,dipping speed,dropping distance,diameter of emitter as factors and the verification test was conducted. RESULTS：The optimal technology was that the ratio of GM-PEG was 3 ∶7;the temperature of drug mixture was 85 ℃;the dropping speed was 40 drop/min;dropping distance was 4 cm;and the condensate temperature was 15 ℃;diameter of emitter was 4 mm. RSD of each index of 3 batches of dripping pills were all ≤0.58%（n=3）in verification test;the average content of chlorogenic acid was 0.14 mg/g;the average pill weight difference was 3.21%;the average sphericity was 9.43;and the average appearance quality was 4.33. Q1 hwere 23.4%,24.4% and 23.3% in average（n=6）,and Q12 hwere 89.6%,91.2% and 91.5%（n=6）. CONCLUSIONS：The optimal preparation technology is stable and simple,and can be used for industrial production of Fanhuncao sustained-release dropping pills.

关 键 词：返魂草 缓释滴丸 体外释放 制备工艺 优化 

分 类 号：R283[医药卫生—中药学]