海峡药学
海峽藥學
해협약학
STRAIT PHARMACEUTICAL JOURNAL
2015年
4期
47-50
,共4页
奥硝唑%口腔贴片%粘附力%释放度%含量测定
奧硝唑%口腔貼片%粘附力%釋放度%含量測定
오초서%구강첩편%점부력%석방도%함량측정
Ornidazole%Oral patch%Adhesion%Release%Determination
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。
目的：研究與建立奧硝唑口腔貼片的質量標準。方法觀察貼片的性狀及理化性質；以自製的裝置測定貼片的粘附力；採用紫外分光光度法測定奧硝唑口腔貼片的釋放度；採用高效液相法測定其有關物質及含量。結果奧硝唑口腔貼片的性狀及性質穩定，粘附力測定方法方便可重複，釋放度測定方法準確度高，且成品在1、2和4h的釋放量應分彆為標示量的35％～65％、60％～90％及85％以上。高效液相色譜法的分離度、精密度、線性及迴收率良好。結論擬定的質量標準可行，可有效的控製奧硝唑口腔貼片質量。
목적：연구여건립오초서구강첩편적질량표준。방법관찰첩편적성상급이화성질；이자제적장치측정첩편적점부력；채용자외분광광도법측정오초서구강첩편적석방도；채용고효액상법측정기유관물질급함량。결과오초서구강첩편적성상급성질은정，점부력측정방법방편가중복，석방도측정방법준학도고，차성품재1、2화4h적석방량응분별위표시량적35％～65％、60％～90％급85％이상。고효액상색보법적분리도、정밀도、선성급회수솔량호。결론의정적질량표준가행，가유효적공제오초서구강첩편질량。
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.
