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目的:确定祖师麻总香豆素缓释片的处方,并评价其体外释药特征。方法:采用羟丙基甲基纤维素(HPMC K4M)为骨架材料,乳糖为填充剂,在处方单因素考察的基础上,选择对缓释片释放行为影响较大的2个处方因素—HPMC用量和乳糖用量,以累积释放度为指标,利用星点设计-效应面法优化处方,并评价释药特征。结果:最优处方组成为祖师麻总香豆素200 mg,HPMCK4M为80 mg,乳糖60 mg,MCC60 mg;其在2、6、12 h的体外累积释放度均值分别为31.41%、60.85%、81.56%,满足缓释片释放要求;缓释片体外释放符合Higuchi方程,释放机制为扩散和骨架溶蚀的双重机制。结论:本方法制备的祖师麻总香豆素缓释片工艺简单易行,具有较好的缓释性能。
OBJECTIVE: To determine the prescription of total coumarin sustained release tablets and evaluate its in vitro release characteristics. Methods: Using hydroxypropyl methyl cellulose (HPMC K4M) as matrix material and lactose as filler, we chose two prescription factors-HPMC dosage which had a great influence on the release behavior of sustained-release tablets on the basis of the single factor prescription And lactose dosage, cumulative release as an indicator, the use of star point design - response surface optimization prescription, and evaluation of drug release characteristics. RESULTS: The optimal formulation consisted of 200 mg of total coumarin, 80 mg of HPMCK4M, 60 mg of lactose and 60 mg of MCC. The mean cumulative release in vitro was 31.41% and 60.85% at 2,6 and 12 h, respectively. 81.56%, satisfying the release requirements of sustained-release tablets. The release in vitro of sustained-release tablets was in line with Higuchi’s equation, and the release mechanism was the dual mechanism of diffusion and skeleton erosion. Conclusion: The process of preparation of total coumarin coumarin sustained release tablets is simple and easy, with good sustained-release properties.