汉防己甲素固体分散片的制备及处方优化

发布时间：2018-05-02 07:03

本文选题：汉防己甲素固体分散体 + 分散片　；参考：《中国药房》2016年07期

【摘要】：目的:优选汉防己甲素固体分散片的制备处方。方法:采用直接压片法制备汉防己甲素固体分散片。采用单因素试验筛选常用辅料,以崩解时间为指标,以交联聚乙烯吡咯烷酮(PVPP)用量、乳糖-微晶纤维素比例、微粉硅胶用量为因素,采用正交试验对处方进行优化,并进行验证。比较所制片剂与汉防己甲素普通片的溶出度,测定最优处方所制片剂的含量。结果:最优处方为以9.5%PVPP为崩解剂、乳糖-微晶纤维素(1∶2)为填充剂,混匀,加入1%的微粉硅胶为润滑剂,粉末直接压片。所制3批片剂的崩解时间分别为79、81、78 s,占标示量百分含量分别为98.66%、99.24%、99.85%,RSD分别为0.72%、1.16%、1.33%。与汉防己甲素普通片比较,所制片剂的溶出度明显提高。结论:成功制得汉防己甲素固体分散片,且处方合理、重复性好。
[Abstract]:Objective: to optimize the preparation of Tetrandrine solid dispersible tablets. Methods: Tetrandrine solid dispersible tablets were prepared by direct pressing method. A single factor test was used to screen common excipients. The formulation was optimized by orthogonal test with the dosage of crosslinked polyvinylpyrrolidone (PVPP), the ratio of lactose to microcrystalline cellulose and the amount of silica gel. And verify it. The dissolution of the tablets was compared with that of Tetrandrine tablets. Results: the optimal formulation was as follows: 9.5%PVPP as disintegrating agent, lactose microcrystalline cellulose 1: 2) as filler, mixed evenly, 1% silica gel as lubricant, powder pressed directly. The disintegration time of the three tablets was 79 ~ 81g / 78 s, and the percent content of the three tablets was 98.66 ~ 99.24 ~ 99.85%, respectively. The RSD was 0.72% and 1.16% ~ 1.33%, respectively. Compared with Tetrandrine tablets, the dissolution of the tablets was significantly improved. Conclusion: Tetrandrine solid dispersible tablets were successfully prepared and the prescription was reasonable and reproducible.
【作者单位】：广西壮族自治区食品药品审评查验中心;广西医科大学药学院;
【基金】：广西科学研究与技术开发计划项目(No.桂科合1346011-22) 南宁市科学研究与技术开发计划项目(No.20123117)
【分类号】：R943

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