酚氨咖敏颗粒质量标准研究

目的完善酚氨咖敏颗粒的质量标准。方法采用薄层色谱(TLC)法对乙酰氨基酚、氨基比林、咖啡因及马来酸氯苯那敏进行定性鉴别。采用气相色谱(GC)法同时测定4种成分的含量,色谱柱为TR-1弹性石英毛细管柱(30 m×0. 32 mm,0. 25μm),程序升温(起始温度为180℃,保持1 min,再以8℃/min的速率升至240℃,保持2 min),氢火焰离子化检测器温度为260℃。结果 TLC法可同时鉴别酚氨咖敏颗粒中4种成分。对乙酰氨基酚、氨基比林、咖啡因及马来酸氯苯那敏质量浓度线性范围分别为186. 3~5 960μg/m L(r=0. 999 9),124. 9~3 996μg/m L(r=0. 999 9),38. 24~1 224μg/m L(r=1. 000 0)和2. 525~80. 80μg/m L(r=0. 999 9);平均加样回收率分别为98. 69%,99. 45%,99. 52%,101. 40%,RSD分别为1. 36%,1. 62%,1. 20%,1. 25%(n=9)。结论该方法简便快速、准确可靠,适用于酚氨咖敏颗粒中4种成分的定性、定量分析,可更全面地控制该制剂的质量。

Quality Standard of Paracetamol Aminophenazone Caffeine and Chlorphenamine Maleate Granules

Objective To improve the quality standard of Paracetamol Aminophenazone Caffeine and Chlorphenamine Maleate Granules. Methods Paracetamol,aminophenazone,caffeine and chlorphenamine maleate were identified by thin-layer chromatography( TLC)method. The contents of the four components were simultaneously determined by gas chromatography( GC) method on a TR-1 sillica capillary column( 30 m × 0. 32 mm,0. 25 μm),and a programming temperature was used with a flame ionization detector( FID) of260 ℃ . The column temperature was kept at 180℃ for 1 min and then rose at a rate of 8 ℃/min to 280 ℃ and maintained for 2 min.Results TLC could be used to identify the four components. The linear ranges of paracetamol,aminophenazone,caffeine and chlorphenamine maleate were 186. 3-5 960 μg/m L( r = 0. 999 9),124. 9-3 996 μg/m L( r = 0. 999 9),38. 24-1 224 μg/m L( r = 1. 000 0) and 2. 525-80. 80 μg/m L( r = 0. 999 9),respectively. The average recoveries were 98. 69%,99. 45%,99. 52%,101. 40 %,RSDs were 1. 36 %,1. 62 %,1. 20 %,1. 25 %,respectively( n = 9). Conclusion This method is simple,quick,accurate and reliable for the qualitative and quantity analysis of Paracetamol Aminophenazone Caffeine and Chlorphenamine Maleate Granules,which can be used for the quality control of the preparation.