| 刘阿敏,丁 斌,王 磊,等.盐酸他喷他多缓释片的研制及体外释放考察[J].安徽医药,2015,19(11):2069-2073. |
| 盐酸他喷他多缓释片的研制及体外释放考察 |
| Preparation and in vitro release study on tapentadol hydrochloride sustained-release tablets |
| 投稿时间：2015-05-08 |
| DOI： |
| 中文关键词: 盐酸他喷他多 混合骨架材料 处方工艺 释药机制 |
| 英文关键词: apentadol hydrochloride mixed skeleton material prescription technology drug release mechanism |
| 基金项目:安徽中医药大学千人计划培养资助作者简介:刘阿敏,女,硕士研究生 |
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| 中文摘要: |
| 目的 研制盐酸他喷他多12 h缓释片并对其体外释放机制进行初步研究。方法 以HPMC与CMC-Na为混合骨架材料制备缓释片,以单因素试验法对缓释片释放因素进行考察,通过f2相似因子与累积释放度综合评分进行评价,采用正交试验设计筛选最优处方,将自制缓释片与参比制剂的体外释放参数进行比较。结果 最优处方以HPMC K15M和CMC-Na作为混合骨架材料,质量分数各占总质量的40%和12%,乳糖作为致孔剂,质量分数占总质量的12%,微晶纤维素为填充剂,质量分数占总质量的11%。制备的盐酸他喷他多缓释片释放规律符合Ritger-Peppas方程曲线,释药机制为药物扩散和骨架溶蚀协同作用,自制缓释片与参比制剂体外释放行为相似度较高。结论 制得的盐酸他喷他多缓释片有良好的12 h体外释药行为,制备工艺简单、可行,与参比制剂体外释放行为接近,符合缓释制剂要求。 |
| 英文摘要: |
| Objective To prepare 12 hours tapentadol hydrochloride sustained-release tablets and investigate its in vitro release mechanism preliminarily.Methods Sustained-release tablets were made with HPMC and CMC-Na as mixed skeleton material. The single factor test method was used to evaluate release profile of sustained-release tablets. Evaluation was carried out through f2 similarity factor and the cumulative release degree comprehensive score, and orthogonal test design was used to choose the optimal prescription. Then in vitro release parameters of self-made sustained-release tablets and reference preparations were compared.Results The mass fraction of optimal prescription with HPMC K15M and CMC-Na as mixed skeleton material were respectively 40% and 12% of the total quality. It was 12% of the total mass with lactose as pore agent and 11% of the total quality with microcrystalline cellulose as the filling agent. The release characteristics of prepared tapentadol hydrochloride sustained-release tablets was in coincidence with the Ritger-Peppas equation curve, drug release mechanism was the synergistic effects of drug release and skeleton dissolution, and self-made sustained-release tablets had a higher similarity in in vitro release with reference preparations.Conclusions Prepared tapentadol hydrochloride sustained-release tablets had good in vitro release behavior for 12h, and its preparation technology was simple and feasible which was more closed to reference preparations and was in coincidence with sustained-release preparations. Therefor, the prescribing meets the general requirements of the design. |
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