甲磺酸二氢麦角碱缓释片的制备与体外释放特性研究

发布时间：2018-03-22 23:39

本文选题：甲磺酸二氢麦角碱　切入点：缓释片　出处：《中国药房》2015年10期 　论文类型：期刊论文

【摘要】：目的:制备甲磺酸二氢麦角碱缓释片,研究其体外释放特性。方法:以羟丙甲基纤维素(HPMC-K4M)为骨架材料,采用湿法制粒制备甲磺酸二氢麦角碱缓释片。以释放速率、累积释放度为指标,以载药材料(HPMC-K4M)、填充剂(乳糖、磷酸氢钙)和微环境p H调节剂(酒石酸)的用量为因素,采用单因素试验和正交试验对甲磺酸二氢麦角碱缓释片处方进行优化并验证;采用《中国药典》释放度测定方法比较进口和最优处方所制甲磺酸二氢麦角碱缓释片的体外释放特性。结果:最优处方为甲磺酸二氢麦角碱2.5 mg,HPMC-K4M 40 mg,乳糖70 mg,磷酸氢钙80 mg,酒石酸40 mg;所制甲磺酸二氢麦角碱缓释片可体外持续释药12h以上,12 h累积释放度为97.1%,与进口片剂比较累积释放度无明显变化,体外释药行为符合Higuchi方程。结论:成功制得具有缓释作用的甲磺酸二氢麦角碱缓释片。
[Abstract]:Objective: to prepare sustained-release tablets of dihydroergol mesylate and study their release characteristics in vitro. Methods: hydroxy propylcellulose (HPMC-K4M) was used as matrix material to prepare sustained-release tablets of dihydroergotoxine mesylate by wet granulation. The cumulative release rate was determined by the dosage of the drug carrier HPMC-K4MN, the filler (lactose, calcium hydrogen phosphate) and the microenvironment pH regulator (tartaric acid). Single factor test and orthogonal test were used to optimize and verify the formulation of dihydroergotoxine mesylate sustained-release tablets. The in vitro release characteristics of sustained-release tablets of dihydroergol mesylate prepared by Chinese Pharmacopoeia were compared with those of imported tablets and those prepared by the optimal formulation. Results: the optimal formulation was 2.5 mg of HPMC-K4M, 70 mg of lactose, and 70 mg of phosphorus. Calcium hydrogen acid 80 mg, tartaric acid 40 mg. The cumulative release rate of sustained-release tablets of dihydroergol mesylate was 97.1g after 12 hours of sustained release in vitro, but there was no significant change in cumulative release rate compared with imported tablets. Conclusion: the sustained-release tablets of dihydroergol mesylate were successfully prepared.
【作者单位】：合肥工业大学生物化工系;
【分类号】：R943

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