钩藤总碱缓释滴丸的制备、含量测定和释放度考察  

Investigation of Preparation,Content Determination and Drug Release of Rhomotoxine Sustained-release Dropping Pills

作　　者：刘卫[1] 王盟[1] 杨雪萍[1] 张强[1] 王中师[1] 孙昕[1] 

机构地区：[1]解放军第88医院药剂科,泰安市271000

出　　处：《中国药房》2011年第31期2905-2907,共3页China Pharmacy

基　　金：山东省科技发展计划项目(2008GG2NS02006)

摘　　要：目的:研制钩藤总碱缓释滴丸。方法:以滴丸释放度、外观质量的综合评分为指标,以钩藤总碱与丙二醇混合后在处方中的用量、硬脂酸与聚乙二醇(PEG)6000的比例、滴制温度和滴速为考察因素,用正交试验优选处方,制备钩藤总碱缓释滴丸;用高效液相色谱法测定制剂中钩藤碱含量;用转篮法测定制剂的释放度。结果:优选的处方为钩藤总碱与丙二醇混合后占45%,硬脂酸与PEG6000的比例为1∶4,滴制温度为70℃,滴速为45滴·min-1;制备的滴丸中钩藤总碱的含量为(85.8±4.2)%;释放过程符合Higuchi方程。结论:钩藤总碱缓释滴丸制备方法可行,制剂质量可控。OBJECTIVE：To prepare Rhomotoxine sustained-release dropping pills.METHODS：Orthogonal design was employed to optimize the formula of Rhomotoxine sustained-release dropping pills using appearance and drug release as index and with amount of rhomotoxine and propylene glycol,ratio of stearic acid and PEG 6000,preparation temperature and dropping speed as factors.HPLC was used to determine the content of rhynchophylline and rotating basket method was used to determine the drug release of preparation.RESULTS：Optimized formula was as follows：rhomotoxine and propylene glycol accounted for 45% respectively;ratio of stearic acid and PEG 6000 was 1：4;preparation temperature was 70 ℃;dropping speed was 45 drops/min.The content of rhomotoxine in preparation was（85.8±4.2）%.Drug release process was up to the Higuchi equation.CONCLUSION：Preparation method of Rhomotoxine sustained-release dropping pill is practicable and its quality is controllable.

关 键 词：钩藤总碱 钩藤碱 缓释制剂 滴丸 释放度 

分 类 号：R284.2[医药卫生—中药学] R283.62[医药卫生—中医学]