氯雷他定口崩片的质量标准研究  

Study on Quality Standard of Orally Disintegrating Tablets of Loratadine

作　　者：李寅[1] 林岱[1] 孙树周 黄静雯[1] 

机构地区：[1]广州市番禺区人民医院,广东广州511400 [2]广州市药检所五分所,广东广州511400

出　　处：《现代食品与药品杂志》2007年第4期68-70,共3页JOurnal of Modern Food and Pharmaceuticals

摘　　要：目的氯雷他定口崩片的制备及其质量标准的研究。方法直接粉末压片法制备氯雷他定口崩片,HPLC法测定含量。用C18柱,甲醇(0.02 mol/L)-NaH2PO4(80∶20)为流动相,紫外检测波长247 nm,氯雷他定进样量在0.1～2.0μg范围内,与峰面积呈良好的线性关系(r=0.9991)。结果辅料交联聚维酮和微晶纤维素的用量分别为10%和35%,片剂的硬度为3.0～3.5 kg/mm2,氯雷他定口崩片崩解时间<30 s,平均回收率为99.7%,RSD=0.90%(n=9)。结论氯雷他定口崩片崩解时间短,溶出速率快,质量标准可用于该品种的质量控制。Objective To prepare orally disintegrating tablets of Loratadine , investigate their dissolution features by small glass methods and content is determined by HPLC. Methods The orthogonal of Loratadine Orally disintegrating tablets designed by optimize the formulation and processing technology and prepared by direct powder compressing method. The dissolution of Loratadine was measured by the small glass cup method and the content of Loratadine is determined by HPLC. Results The crospovidone is 10 percent and microcrystalline cellulose is 35 percent ,The hardness of the tablets was in the range of 3.5 - 4.0 kg/mm^2. The tasty tables disintegration time is less than 30 seconds. The average recovery rate was 99.7%, and the relative standard deviation was 0.90% （ n = 9）. Conclusion The disintegration time and of orally disintegrating tablets of Loratadine is measure up.

关 键 词：氯雷他定 口崩片 质量控制 

分 类 号：R927.11[医药卫生—药学]