盐酸左西替利嗪咀嚼片的制备及其稳定性考察

发布时间：2018-04-22 06:22

  本文选题：盐酸左西替利嗪 + 咀嚼片　； 参考：《中国药房》2015年28期

【摘要】：目的:制备盐酸左西替利嗪咀嚼片,并考察片剂稳定性。方法:采用湿法制粒制备盐酸左西替利嗪咀嚼片。以45 min内的累积溶出度为指标,以微晶纤维素内-外加比例、羧甲淀粉钠内-外加比例及硬脂酸镁的用量为因素,正交试验优化处方;验证最优处方所制片剂的溶出度和含量均匀度,考察其高温(60℃)、强光(4 500 lx)、高湿(湿度92.5%)下10 d内的外观、溶出度、有关物质和含量变化。结果:每片片剂的最优处方为盐酸左西替利嗪5 mg、乳糖30 mg、微晶纤维素90 mg(内外加入量比例为4∶5)、甘露醇60 mg、阿斯巴甜10 mg、羧甲基淀粉钠12 mg(内外加入量比例为1∶1)、硬脂酸镁1.0%。3批最优处方所制片剂的累积溶出度分别为(97.23±1.21)%、(98.49±1.28)%、(98.15±1.94)%,含量均匀度分别为2.30、2.34、2.60,稳定性考察除高温下10 d、高湿下5 d时有关物质略有升高外其他指标均无明显变化。结论:成功制得盐酸左西替利嗪咀嚼片,且稳定性较好。
[Abstract]:Objective: to prepare levcetirizine hydrochloride chewable tablets and to investigate the stability of the tablets. Methods: levcetirizine hydrochloride chewable tablets were prepared by wet granulation. Taking the cumulative dissolution within 45 min as the index, the proportion of microcrystalline cellulose and the proportion of sodium carboxymethyl starch and the dosage of magnesium stearate as the factors, the prescription was optimized by orthogonal experiment. To verify the dissolution and content uniformity of the tablets prepared by the best prescription, the changes of appearance, dissolution, related substances and contents in 10 days under the conditions of high temperature (60 鈩，

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