盐酸左西替利嗪咀嚼片的制备及其稳定性考察  

Preparation and Stability of Levocetirizine Hydrochloride Chewable Tablets

作　　者：伦志彩 

机构地区：[1]山东省莒县中医医院,山东莒县276500

出　　处：《中国药房》2015年第28期3977-3979,共3页China Pharmacy

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。OBJECTIVE：To prepare Levocetirizine hydrochloride chewable tablets,and to investigate the stability. METH-ODS：Levocetirizine hydrochloride chewable tablets were prepared with wet granulation. Using accumulative dissolution rate within 45 min as index,the formulation of Levocetirizine hydrochloride chewable tablets was optimized by orthogonal design with the in-ternal and external ratio of MCC and carboxymethyl starch sodium,the amount of magnesium stearate as factors. The dissolution rate and content uniformity of optimized tablet were verified. The appearance,dissolution rate,related substance and content change of the tablet were investigated within 10 d under the condition of high temperature（60 ℃）,high light（4 500 lx）and high moisture （92.5%）. RESULTS：The optimized formulation of the tablet was as levocetirizine hydrochloride 5 mg,lactose 30 mg, microcrystalline cellulose 90 mg（internal-external ratio 4∶5）,mannitol 60 mg,aspartame 10 mg,carboxymethyl starch sodium 12 mg（internal-external ratio 1∶1）and magnesium stearate 1.0%. The accumulative dissolution rates of 3 batches of optimized tablet were（97.23±1.21）%,（98.49±1.28）% and（98.15±1.94）%. The content uniformity were 2.30,2.34 and 2.60. Those indicators had no significant change except related substance increased slightly under high temperature on 10th day and high moisture on 5th day. CONCLUSIONS：Levocetirizine hydrochloride chewable tablets is prepared successfully with good stability.

关 键 词：盐酸左西替利嗪 咀嚼片 正交试验 高温 高湿 强光 

分 类 号：R943[医药卫生—药剂学]