中国医药指南
中國醫藥指南
중국의약지남
CHINA MEDICINE GUIDE
2014年
35期
1-2
,共2页
张迅%牛琳%刘欣欣%许玉莲%宋翔
張迅%牛琳%劉訢訢%許玉蓮%宋翔
장신%우림%류흔흔%허옥련%송상
硼酸软膏%鉴别%含量测定%质量控制
硼痠軟膏%鑒彆%含量測定%質量控製
붕산연고%감별%함량측정%질량공제
Boric Acid Ointment%Identify%Content determination%Quality control
目的:建立硼酸软膏的质量控制方法。方法采用酸碱滴定法测定硼酸的含量,化学法鉴别硼酸盐,装量差异应符合涂剂项下有关的各项规定(中国药典2010年版二部附录IT)。结果三批样品化学鉴别均呈正反应,阴性对照不干扰测定。硼酸含量测定线性范围为40.16~200.80mg;回归方程为y=6.7221x+2.6546,r=0.9999,平均回收率为99.9%,RSD为1.2%(n=9)。结论本法简便灵敏,重复性好,专属性强,能有效控制硼酸软膏的质量。
目的:建立硼痠軟膏的質量控製方法。方法採用痠堿滴定法測定硼痠的含量,化學法鑒彆硼痠鹽,裝量差異應符閤塗劑項下有關的各項規定(中國藥典2010年版二部附錄IT)。結果三批樣品化學鑒彆均呈正反應,陰性對照不榦擾測定。硼痠含量測定線性範圍為40.16~200.80mg;迴歸方程為y=6.7221x+2.6546,r=0.9999,平均迴收率為99.9%,RSD為1.2%(n=9)。結論本法簡便靈敏,重複性好,專屬性彊,能有效控製硼痠軟膏的質量。
목적:건립붕산연고적질량공제방법。방법채용산감적정법측정붕산적함량,화학법감별붕산염,장량차이응부합도제항하유관적각항규정(중국약전2010년판이부부록IT)。결과삼비양품화학감별균정정반응,음성대조불간우측정。붕산함량측정선성범위위40.16~200.80mg;회귀방정위y=6.7221x+2.6546,r=0.9999,평균회수솔위99.9%,RSD위1.2%(n=9)。결론본법간편령민,중복성호,전속성강,능유효공제붕산연고적질량。
Objective?To?establish?the?method?for?controling?the?quality?of?Boric?Acid?Ointment.?Methods??Use?acid-base?titration?method?to?determinate?the?content?of?boric?acid,?and?chemical?method?to?identify?borate,?and?volume?difference?should?be?conformed?to?pigmentum?of?relevant?provisions?(Chinese?Pharmacopoeia?2010?version?two?of?I?T.).Results Three batches of samples were positive identiifcation of the chemical reaction, the negative control do not interfere?the?determination.?Determination?of?salicylic?acid?was?linear?in?the?range?of?40.16-200.80?mg;?the?regression?equation?was?y=6.7221x+2.6546, r=0.9999,?the?average?recovery?was?99.9%,?RSD?was?1.2%?(n=9).?Conclusion This method is simple, sensitive, good repeatability, strong speciifcity, it can effectively?control?the?quality?of?Boric?Acid?Ointment.