本文選題：漢防己甲素固體分散體 + 分散片��； 參考：《中國藥房》2016年07期

【摘要】：目的:優(yōu)選漢防己甲素固體分散片的制備處方。方法:采用直接壓片法制備漢防己甲素固體分散片。采用單因素試驗篩選常用輔料,以崩解時間為指標,以交聯(lián)聚乙烯吡咯烷酮(PVPP)用量、乳糖-微晶纖維素比例、微粉硅膠用量為因素,采用正交試驗對處方進行優(yōu)化,并進行驗證。比較所制片劑與漢防己甲素普通片的溶出度,測定最優(yōu)處方所制片劑的含量。結(jié)果:最優(yōu)處方為以9.5%PVPP為崩解劑、乳糖-微晶纖維素(1∶2)為填充劑,混勻,加入1%的微粉硅膠為潤滑劑,粉末直接壓片。所制3批片劑的崩解時間分別為79、81、78 s,占標示量百分含量分別為98.66%、99.24%、99.85%,RSD分別為0.72%、1.16%、1.33%。與漢防己甲素普通片比較,所制片劑的溶出度明顯提高。結(jié)論:成功制得漢防己甲素固體分散片,且處方合理、重復(fù)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.
【作者單位】： 廣西壯族自治區(qū)食品藥品審評查驗中心;廣西醫(yī)科大學(xué)藥學(xué)院;
【基金】：廣西科學(xué)研究與技術(shù)開發(fā)計劃項目(No.桂科合1346011-22) 南寧市科學(xué)研究與技術(shù)開發(fā)計劃項目(No.20123117)
【分類號】：R943

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