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作 者:郭怀忠[1,2] 庞晓敏[1] 王进文[1] 姜文月[1] 张春梅[1]
机构地区:[1]河北大学药学院,河北保定071002 [2]河北省药物质量分析控制重点实验室,河北保定071002
出 处:《中成药》2011年第7期1178-1182,共5页Chinese Traditional Patent Medicine
基 金:国家自然科学基金(2090501921011140338);河北省自然科学基金(B2010000209);河北大学自然科学基金(2007-111)
摘 要:目的建立维C银翘片(金银花、连翘、维生素C、对乙酰氨基酚、马来酸氯苯那敏等)中维生素C、对乙酰氨基酚和马来酸氯苯那敏3种西药成分的溶出度测定方法。方法采用桨法,以0.1 mol/L HCl溶液为溶出介质,转速为75 r/min,90 min取样。液相色谱柱为Welchrom-C18柱(4.6 mm×150 mm,5μm),流动相为A 0.05 mol/L磷酸二氢钾(含0.5%四丁基溴化铵,磷酸调pH至3.5);B乙腈,梯度洗脱。体积流量为0.8 mL/min,检测波长为260 nm。结果维生素C、对乙酰氨基酚和马来酸氯苯那敏分别在19.8~118.8μg/mL、42~252μg/mL、0.42~2.52μg/mL范围内呈良好的线性关系,平均回收率均不低于98%。不同厂家维C银翘片的溶出度差异较大。结论该方法简便快捷、结果准确可靠,可用于维C银翘片中3种西药成分的溶出度测定。AIM To establish a method for determining the dissolution of Vitamin C,paracetamol and chlorphenamine maleate in Vitamin C Yinqiao Tablet(Lonicerae japonicae Flos,Forsythiae Fructus,Vitamin C,para-cetamol,chlorphenamine maleate,etc).METHODS Paddle method was applied,and 0.1 mol/L HCl solution was used as the dissolvent,the rotation speed was kept at 75 r/min,90 min sampling time.HPLC conditions included Welchrom-C18 column(4.6 mm × 150 mm,5 μm),mobile phase of A 0.05 mol/L potassium dehydrogenized phosphate(containing 0.5% tetra butyl ammonium bromide,phosphoric acid adjusted pH to 3.5);B acetonitrile.Gradient elution was employed.The flow rate was 0.8 mL/min and the detection wavelength was set at 260 nm.RESULTS It presented a good linearity of Vitamin C,paracetamol and chlorphenamine maleate in the ranges of 19.8-118.8 μg/mL、42-252 μg/mL、0.42-2.52 μg/mL,respectively.Their average recoveries were not less than 98%.Vitamin C Yinqiao Tablet from different pharmaceutical factories had different dissolution.CONCLUSION The method is rapid,simple and accurate,and it can be used for the determination of dissolution of Vitamin C Yinqiao Tablet.
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