目的 建立异烟肼片体外溶出度HPLC检测方法及溶出曲线评价。方法 溶出度试验采用桨法，转速50 r/min；以pH1.2盐酸缓冲液、pH4.5醋酸盐缓冲液、pH6.8磷酸盐缓冲液、水900 mL为溶出介质；HPLC法测定溶出量。结果 异烟肼在0.198 1~0.990 4 μg线性良好（r=0.999 3），平均回收率为100.2%；精密度、重复性、专属性均良好。在测定的16家企业中，有4家企业水中溶出曲线与参比制剂山德士异烟肼片不相似。结论 HPLC测定方法简单方便，提高了异烟肼溶出量测定的准确性和专属性；溶出方法具有较强的区分力，该溶出度测定方法可用于异烟肼片溶出曲线的测定。

Objective To establish a method for determining the dissolution of isoniazid tablet in vitro and evaluate the dissolution profiles.Methods The paddle method was used for the dissolution test and the rotation rate was set at 50 r/min. The hydrochloric acid solution (pH 1.2), acetate buffer solution (pH 4.5), phosphate buffer solution (pH 6.8) and water (900 mL) were used as the dissolution media. HPLC was used for the determination of dissolution quantity.Results There was a good linear relationship between the quality concentration of isoniazid and peak area in the range of 0.198 1-0.990 4 μg (r=0.999 3). The average recovery was 100.2%. Precision, reproducibility, and specificity tests were good. Among the determination of 16 manufactures, the dissolution profiles in water of four manufactures were not similar with Sandoz reference preparation.Conclusion The HPLC method is simple. The accuracy and specificity of determination of isoniazid dissolution are improved. There is significant difference in the dissolution profiles between different manufactures. The method can be used for the determination of dissolution curves for isoniazid tablets.