目的 建立異煙肼片體外溶出度HPLC檢測(cè)方法及溶出曲線評(píng)價(jià)。方法 溶出度試驗(yàn)采用槳法，轉(zhuǎn)速50 r/min；以pH1.2鹽酸緩沖液、pH4.5醋酸鹽緩沖液、pH6.8磷酸鹽緩沖液、水900 mL為溶出介質(zhì)；HPLC法測(cè)定溶出量。結(jié)果 異煙肼在0.198 1~0.990 4 μg線性良好（r=0.999 3），平均回收率為100.2%；精密度、重復(fù)性、專屬性均良好。在測(cè)定的16家企業(yè)中，有4家企業(yè)水中溶出曲線與參比制劑山德士異煙肼片不相似。結(jié)論 HPLC測(cè)定方法簡(jiǎn)單方便，提高了異煙肼溶出量測(cè)定的準(zhǔn)確性和專屬性；溶出方法具有較強(qiáng)的區(qū)分力，該溶出度測(cè)定方法可用于異煙肼片溶出曲線的測(cè)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.