中国药师
中國藥師
중국약사
China Pharmacist
2015年
10期
1682-1684
,共3页
光纤法%进口药品注册标准法%甲磺酸多沙唑嗪缓释片%释放度
光纖法%進口藥品註冊標準法%甲磺痠多沙唑嗪緩釋片%釋放度
광섬법%진구약품주책표준법%갑광산다사서진완석편%석방도
Fiber-optic method%Imported drug registration standard method%Doxazosin mesylate extended release tablets%Dis-solution
目的:比较光纤法与进口药品注册标准法对甲磺酸多沙唑嗪缓释片的释放度测定结果. 方法:采用 FODT-601型光纤药物溶出度实时测定仪,以氯化钠的盐酸水溶液为溶出介质,桨法,转速75 r·min-1 ,246 nm作为测定波长,550 nm作为参比波长,测定光程为5. 0 mm. 比较光纤法与进口药品注册标准法的释放度. 结果: 甲磺酸多沙唑嗪在0. 468 1~11. 700 0 μg ·ml-1浓度范围内线性关系良好,r均大于0. 999 5,日内、日间精密度RSD(n=6)分别为1. 6%和2. 0%,平均加样回收率为99. 0%,RSD为1. 4%(n=9);比较光纤法与进口药品注册标准法,两者的释放度测定结果有一定差异. 结论: 光纤法获得的数据信息完整,实时反映,药物的体外溶出过程,在速释和缓、控释制剂的释放度测定中优势尤为突出,但该方法尚不能替代进口药品注册标准法.
目的:比較光纖法與進口藥品註冊標準法對甲磺痠多沙唑嗪緩釋片的釋放度測定結果. 方法:採用 FODT-601型光纖藥物溶齣度實時測定儀,以氯化鈉的鹽痠水溶液為溶齣介質,槳法,轉速75 r·min-1 ,246 nm作為測定波長,550 nm作為參比波長,測定光程為5. 0 mm. 比較光纖法與進口藥品註冊標準法的釋放度. 結果: 甲磺痠多沙唑嗪在0. 468 1~11. 700 0 μg ·ml-1濃度範圍內線性關繫良好,r均大于0. 999 5,日內、日間精密度RSD(n=6)分彆為1. 6%和2. 0%,平均加樣迴收率為99. 0%,RSD為1. 4%(n=9);比較光纖法與進口藥品註冊標準法,兩者的釋放度測定結果有一定差異. 結論: 光纖法穫得的數據信息完整,實時反映,藥物的體外溶齣過程,在速釋和緩、控釋製劑的釋放度測定中優勢尤為突齣,但該方法尚不能替代進口藥品註冊標準法.
목적:비교광섬법여진구약품주책표준법대갑광산다사서진완석편적석방도측정결과. 방법:채용 FODT-601형광섬약물용출도실시측정의,이록화납적염산수용액위용출개질,장법,전속75 r·min-1 ,246 nm작위측정파장,550 nm작위삼비파장,측정광정위5. 0 mm. 비교광섬법여진구약품주책표준법적석방도. 결과: 갑광산다사서진재0. 468 1~11. 700 0 μg ·ml-1농도범위내선성관계량호,r균대우0. 999 5,일내、일간정밀도RSD(n=6)분별위1. 6%화2. 0%,평균가양회수솔위99. 0%,RSD위1. 4%(n=9);비교광섬법여진구약품주책표준법,량자적석방도측정결과유일정차이. 결론: 광섬법획득적수거신식완정,실시반영,약물적체외용출과정,재속석화완、공석제제적석방도측정중우세우위돌출,단해방법상불능체대진구약품주책표준법.
Objective:To compare the dissolution results of doxazosin mesylate extended release tablets determined by a fiber-optic method and the imported drug registration standard method. Methods:The drug release process was determined directly with a FODT-601 fiber-optic medicine dissolution/ release rate process monitoring system. Aqueous solution of hydrochloric acid and sodium chloride was used as the dissolution medium, the paddle rotation rate was 75 r·min-1 , the detection wavelength was set at 246 nm while the reference wavelength was 550 nm. The detection length was 5 mm. Results:The standard curve of doxazosin mesylate was linear within the concentration range of 0. 468 1-11. 700 0μg·ml-1 and r values were greater than 0. 999 0. The intra-and inter-day RSD (n=6) was 1. 6% and 2. 0%, respectively. The recovery of doxazosin mesylate was 99. 0% and RSD was 1. 4(n=9). The results determined by the fiber-optic method were generally higher than those determined by the standard method, and there were some differences in the measurement results. Conclusion:Fiber-optic method shows the whole dissolution process objectively. It is particularly prominent in the research on the dissolution of rapid, extended and controlled release preparations. However, it can not replace the standard method yet.
