不同厂家洛索洛芬钠片溶出度比较

Comparison of Dissolution of Loxoprofen Sodium Tablets from Different Manufacturers

关键词:  洛索洛芬钠片  溶出度  溶出曲线  相似因子

Key words:  loxoprofen sodium tablets  dissolution  dissolution curve  similar factor

摘要:

目的 比较5个厂家洛索洛芬钠片在4种溶出介质中的溶出曲线，以评价该药品的质量。方法 采用桨法、转速50 r·min^-1、溶出介质900 mL进行体外溶出试验，分别考察不同厂家洛索洛芬钠片在盐酸溶液、pH 4.5醋酸盐缓冲液、水和pH 6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为，测定溶出曲线并采用相似因子法与原研药进行比较分析。结果 5个厂家洛索洛芬钠片在盐酸溶液中的溶出曲线基本一致，4个厂家的样品与原研药在水中的溶出曲线差异较大，2个厂家样品批间差异明显。结论 仿制药厂家生产的药品与原研药存在质量差异，建议结合生物等效性试验改进处方及生产工艺，提高该药品质量。

Abstract:

OBJECTIVE To compare the dissolution profiles of loxoprofen sodium tablets from 5 manufacturers in 4 dissolution media to evaluate the quality of the drug. METHODS The dissolution test was carried out with paddle method in dissolution medium at a volume of 900 mL and the rotating speed was 50 r·min^-1. The dissolution profiles of loxoprofen sodium tablets from different manufacturers in the 4 dissolution mediums of hydrochloric acid solution, pH 4.5 acetate buffer solution, water and pH 6.8 phosphate buffer solution were determined, and the dissolution curves were compared with the innovator drug product by the similar factor method. RESULTS The dissolution profiles of loxoprofen sodium tablets from 5 pharmaceutical manufacturers in hydrochloric acid solution were similar. The dissolution curves of the samples from the 4 manufacturers and the original drug in the water were quite different. There were significant differences between the batches of the 2 manufacturers. CONCLUSION There are differences in the quality of the drugs produced by generic manufacturers and the original drugs. It is recommended to improve the prescription and production process in combination with bioequivalence tests to improve the quality of the drugs.