马西替坦片剂的研制及质量评价
发布时间：2018-12-14 08:06
【摘要】：以自制马西替坦片和原研制剂(Opsumit)在含0.1%十六烷基三甲基溴化铵(CTAB)的pH 6.8磷酸盐缓冲液中溶出曲线的相似因子f_2为主要考察指标,片剂的性质(如颗粒流动性、崩解时间等)为辅助指标,采用单因素试验和正交设计筛选了马西替坦片片芯的最优处方,即过200目筛的原料药30 g,一水乳糖116.9 g,聚维酮K30 6.6 g,微晶纤维素和羧甲淀粉钠在制湿颗粒前加入11.7和4.2g,在整粒后加入剩余的35.1和4.2 g,黏合剂采用0.2%Tween-80溶液。经包薄膜衣后得到3批优化自制片,与原研制剂相比,在pH 1.0盐酸、pH 4.5乙酸盐缓冲液、pH 6.8磷酸盐缓冲液及水中溶出曲线的相似因子(f_2)值均大于65。影响因素试验结果显示自制片具有较好的稳定性。
[Abstract]:The dissolving curve similarity factor f2 of maxititan tablets and (Opsumit) in pH 6.8 phosphate buffer solution containing 0.1% cetyltrimethylammonium bromide (CTAB) was used as the main index of investigation. The properties of the tablets (such as particle fluidity, disintegration time, etc.) were used as auxiliary indexes. The optimal formulation of Masititan tablets core was screened by single factor test and orthogonal design. The microcrystalline cellulose and sodium carboxymethyl starch were added 11.7 and 4.2 g before the wet granules, and the remaining 35.1 and 4.2 g were added after the whole grain. The adhesive was 0.2%Tween-80 solution. Three batches of optimized tablets were obtained by coating the film. Compared with the original preparation, the similar factor (f _ 2) of pH 1.0 hydrochloric acid, pH 4.5 acetate buffer, pH 6.8 phosphate buffer and water dissolution curve (f _ 2) were all greater than 65. The experimental results show that the self-made sheet has good stability.
【作者单位】： 中国医药工业研究总院上海医药工业研究院上海药物合成工艺过程工程技术研究中心;中国药科大学;
【分类号】：R943
，
本文编号：2378258
[Abstract]:The dissolving curve similarity factor f2 of maxititan tablets and (Opsumit) in pH 6.8 phosphate buffer solution containing 0.1% cetyltrimethylammonium bromide (CTAB) was used as the main index of investigation. The properties of the tablets (such as particle fluidity, disintegration time, etc.) were used as auxiliary indexes. The optimal formulation of Masititan tablets core was screened by single factor test and orthogonal design. The microcrystalline cellulose and sodium carboxymethyl starch were added 11.7 and 4.2 g before the wet granules, and the remaining 35.1 and 4.2 g were added after the whole grain. The adhesive was 0.2%Tween-80 solution. Three batches of optimized tablets were obtained by coating the film. Compared with the original preparation, the similar factor (f _ 2) of pH 1.0 hydrochloric acid, pH 4.5 acetate buffer, pH 6.8 phosphate buffer and water dissolution curve (f _ 2) were all greater than 65. The experimental results show that the self-made sheet has good stability.
【作者单位】： 中国医药工业研究总院上海医药工业研究院上海药物合成工艺过程工程技术研究中心;中国药科大学;
【分类号】：R943
，
本文编号：2378258
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