氧氟沙星片溶出度考察

STUDY OF THE DISSOLUTION RATE OF OFLOXACIN TABLETS BY UV-SPECTROPHOTOMETRY

本文采用紫外分光光度法对日本及国内两个厂家的3批氧氟沙星片在不同介质中进行了体外溶出度测定.结果表明,以 0.1mol/L NaOH为介质时溶出快,但不同厂家的产品溶出速度亦有差异.在此介质中,NJ的产品溶出最快,在4min已达98%;而JP产品在15min时才达溶出98%;BJ产品溶出最慢,15min时仅67.49%.3批氧氟沙星片T_(500,Td具有极显著差异(P<0.01),因此建议控制制剂质量并规定溶出标准.

This paper describes the test of dissolution rate of ofloxacin tablets manufactured by three factories with spectrophotometry in different media. As a result, ofloxacin tablets dissolve rapidly in the medium of 0.01mol/L NaOH, but the dissolution rate of different factories' product is different. In the medium,the NJ's product dissolves rapidest, 98% of it can dissolve within 4min; JP's product needs 15min for the same dissolution; among them, BJ's product has the slowest dissolution, it dissolves only 67. 47% at the 15 thmin. The parameters (T50,Td)of these sameptes have very significant difference (P<0.01). therefore , it is necessary to make dissolution standard of ofloxacin tablets and control the quality.