不同厂家卡马西平片溶出度比较  

Comparison Between Dissolutions of Carbamazepine Tablets from Different Manufactures

作　　者：张梅君[1] 王志强[1] 吴继禹[1] 

机构地区：[1]温州医学院附属第一医院药剂科,浙江温州325000

出　　处：《中国药业》2007年第22期30-31,共2页China Pharmaceuticals

摘　　要：目的建立卡马西平片的溶出度试验方法,对4厂家生产的卡马西平片的含量和溶出度进行测定。方法以稀盐酸24mL加水至1000mL为溶出介质,采用桨法测定溶出度,转速为100r/min,温度为(37.0±0.5)℃;用反相高效液相色谱(RP-HPLC)法测定含量,测定波长为285nm,并对溶出参数进行了统计学处理。结果各厂家卡马西平片的溶出参数(T50,Td,m)有极显著性差异(P<0.01)。结论不同厂家生产的卡马西平片的溶出度明显不一致,进行溶出度检查有助于控制药品质量。Objective To establish a dissolution measurement method for Carbamazepine Tablets, and to determine the contents and dissolution of Carbamazepine Tablets produced in 4 factories. Methods The dissolution was measured in bydroebloride solution as medium, aeeording to the second method described in the appendix XC of Chinese Pharmacopoeia （edition 2005）. The rotational speed was 100 r/min, and the temperature was（37.0±0.5）℃. The contents was measured by HPLC at the wavelength of 285nm. The dissolution parameters of the different products were processed with statistical analysis. Results The dissolution parameters（ T50, Td, m）of Carbamazepine Tablets from the different manufactures bad very significant difference（ P 〈 0.01）. Conclusion The dissolution rate of Carbamazepine Tablets from the different manufactures is remarkably different, the dissolution measurement is necessary for quality control.

关 键 词：卡马西平 含量测定 溶出度 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学] R971.6