匹卡米隆分散片的制备及质量研究

Preparation and quality investigation of pcamilon sodium dispersible tablets

目的:制备匹卡米隆分散片并评价其质量。方法:以崩解时间为指标,筛选崩解剂的种类和用量,采用正交试验设计优化最佳处方和制备工艺,通过初步稳定性考察认证处方组成的合理性。结果:优化处方组成:主药匹卡米隆50 mg、磷酸氢钙120 mg、崩解剂羧甲基淀粉钠和低取代羟丙基纤维素分别为16 mg,粘合剂2%聚维酮K30水溶液适量。采用内外加法联合使用低取代羟丙基纤维素和羧甲基淀粉钠,片剂崩解效果最好。最佳处方崩解时间为95 s,10 min溶出百分率明显高于普通片(P<0.05),初步稳定性试验结果表明,加速和室温留样6个月制剂质量稳定,各项指标符合质量标准要求。结论:匹卡米隆分散片处方组成合理,工艺稳定,体外溶出速率明显优于普通片。

Objective： To prepare and evaluate the quality of Picamilon sodium dispersible tablets. Methods： Different disintegrants were screened and the best formulation was optimized by orthogon experiment design using the disintegration time as index, and the best formulation of Picamilon sodium dispersible tablets was authenticated by the initial stability experiment. Results： The best formulation of Picamilon sodium dispersible tablets was composed of Picamilon sodium 50mg, brushite 120 mg, Ldisplace-hydroxypropyl cellulose and sodium carboxymethyl starch 16mg and 2% polyvidone k30 queous solution quantity sufficient. The effect of disintegration was very optimized, Ldisplace-hydroxypropyl cellulose and sodium carbexymethyl starch were used in coordination with exterior addition and interior addition. The result showed that the disintegration time of optimized prescription formulation was 95s, and the dissolution percent at 10rain of it was obviously super to that of the conventional tablets（ P 〈 0.05）, and the quality of the dispersible tablets was very well by stability test. Conclusion： The dispersible tablets of Picamilon sodium have a higher dissolution speed than conventional tablet.