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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 develop Uncaria total alkaloids sustained-release dropping pills. Methods: Based on the comprehensive score of dropping pills’ release and appearance quality, taking the total amount of rhynchophylline and propylene glycol in the prescription, the ratio of stearic acid to polyethylene glycol (PEG) 6000, the dropping temperature and The drip rate was taken as the investigation factor. The orthogonal test was used to optimize the preparation of rhynchophylline sustained release dropping pills. The content of rhynchophylline in the preparation was determined by high performance liquid chromatography. Results: The optimal prescription was that 45% rhynchophylla total alkaloids were mixed with propylene glycol, the ratio of stearic acid to PEG6000 was 1: 4, the dropping temperature was 70 ℃ and the dropping speed was 45 drops · min-1. The prepared drops The content of total alkaloids in Uncaria rhynchophylla was (85.8 ± 4.2)%. The release process was consistent with Higuchi’s equation. Conclusion: The preparation method of rhynchophylla total alkaloids sustained-release dropping pills is feasible and the preparation quality can be controlled.