文献类型：期刊文献

中文题名：异烟肼片体外溶出度测定方法的建立及溶出曲线评价

英文题名：Establishment of dissolution test method of isoniazid tablets and evaluation of dissolution profiles

作者：张晓明[1];刘小燕[1];张义福[2];王文丽[1];秦雯雯[1];杨平荣[1]

第一作者：张晓明

机构：[1]甘肃省药品检验研究院,甘肃兰州730070;[2]甘肃中医药大学,甘肃兰州730000

第一机构：甘肃省药品检验研究院,甘肃兰州730070

年份：2017

卷号：40

期号：2

起止页码：169

中文期刊名：药物评价研究

外文期刊名：Drug Evaluation Research

收录：CSTPCD

语种：中文

中文关键词：异烟肼;BCS;溶出度;HPLC;参比制剂;溶出曲线;f2因子

外文关键词：isoniazid; biopharmaceutics classification system; dissolution; HPLC; reference preparation; dissolution curve; f2 factor;

摘要：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 m L为溶出介质;HPLC法测定溶出量。结果异烟肼在0.198 1~0.990 4μg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 m L） 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.