氟哌酸制剂的含量及溶出度测定

A Determinatio of Quantity and Dissolution Rate of Norfloxacin Preparation

本文采用紫外分光光度法对氟哌酸制剂的含量进行测定,测定结果准确可靠,平均回收率为100.49％,CV=1.358％。并用转篮法测定了三厂家四批号胶囊剂的体外溶出度,数据用单指数分布函数拟合,用拟合直线的斜率计算溶出速率常数Ki值。经统计学处理,表明不同厂家的同一剂型或同一厂家而不同批号的产品,其溶出速率常数Ki值间有显著性差异。合理的处方工艺是保证药品质量的关键。

The quantities of norfloxacin preparations are measured by UV Spect-rophotometry in this study. It is accurate and reliable, the average reco-very is 100.49%, CV is 1.358%. The capsules of morfloxacin from 3 fae-tories(4 batches)are also measured on dissoluble rate of outside body with rotating-basket assembly. The data are treated by single-exponential distri-bution function and the dissoluble rate constant Ki is obtained by the slope of regression line. With statistical calculation, it shows that among the products with the same dosage-form of different factories or the different batches of the same factory, there are significant differences in Ki.