摘要
目的：研究与建立奥硝唑口腔贴片的质量标准。方法观察贴片的性状及理化性质；以自制的装置测定贴片的粘附力；采用紫外分光光度法测定奥硝唑口腔贴片的释放度；采用高效液相法测定其有关物质及含量。结果奥硝唑口腔贴片的性状及性质稳定，粘附力测定方法方便可重复，释放度测定方法准确度高，且成品在1、2和4h的释放量应分别为标示量的35％～65％、60％～90％及85％以上。高效液相色谱法的分离度、精密度、线性及回收率良好。结论拟定的质量标准可行，可有效的控制奥硝唑口腔贴片质量。
OBJECTIVE To investigate and establish quality standard of Ornidazole oral patch.METHODS Patch characters,physical and chemical propertiesb were observed;The adhesion of patch was determined by the self-made device;The release rate of Ornidazole patch was measured by UV spectrophotometry;Related substances and content were determined by HPLC assay.RESULTS Properties and nature of Ornidazole oral patch was stable,The measurement method of adhesion was convenient and could be repeated,release determination method was accurate, and the release of finished product in 1,2 and 4 hours of the labeled amount,35%to 65%,60%to 90%and more than 85%,respectively.separation,precision,linearity and recovery of HPLC were good.CONCLUSION The fea-sible quality standards can effectively control the quality of Ornidazole oral patch.
出处
《海峡药学》
2015年第4期47-50,共4页
Strait Pharmaceutical Journal
