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感冒灵胶囊质量标准的研究
引用本文:况开星,程民. 感冒灵胶囊质量标准的研究[J]. 黑龙江医药, 2013, 0(5): 746-750
作者姓名:况开星  程民
作者单位:1. 安徽东升医药物流有限公司 淮北235000
2. 淮北市食品药品检验所 淮北235000
摘    要:目的:建立感冒灵胶囊的质量标准。方法:以2-4苦、金盏银盘以及岗梅为对照药材进行薄层鉴别;采用C18色谱柱,流动相为乙腈-0.03mol/1磷酸氢二铵(磷酸调pH至3.1)(12:88),进样量10μl,柱温为20℃,检测波长214nm,流速为1.0ml.min^-1。结果:薄层图谱斑点清晰,阴性对照无干扰;对乙酰氨基酚、咖啡因、马来酸氯苯那敏分别在101.17~2023.40μg/ml、2.00-40.09μg/ml和2.05~40.93μg/ml范围内线性关系良好,精密度RSD分别为0.05%、0.09%、0.17%(n=8),平均回收率分别为100.4%、99.6%、99.6%。结论:结果准确,方法重复性好,可作为该制剂的质量控制指标。

关 键 词:感冒灵胶囊  三叉苦  金盏银盘  岗梅  对乙酰氨基酚  马来酸氯苯那敏  咖啡因  薄层色谱  HPLC

Study on Quality Standard of Ganmaoling capsules
Affiliation:Kuang Kaixing',te al 1.Anhui Dongsheng Pharmaceutical Logistics limited company(Huaibei 235000)
Abstract:Objective:To establish the quality standard for Ganmaoling capsules (Hillock mei, JinZhan silver plate,Trigeminal bit- ter, Acetaminophen, etc. ). Methods: To regard JinZhan silver plate, hillock mei, and trigeminal bitter as control medicinal materials to conduct thin-layer identification;To adopt C 18 Chromatographic column,The phase is A cetonitrile-0.03mol/I, Diammonium hydrogen phosphate, ( Use Phosphoric acid to control pH to 3.1 ), ( 12:88 )The Sample volume is 10 ix 1, The column temperature is 20℃,The de- tection wavelength is 214rim,the fluid rate is 1.0ml/min, Results: TLC spots developed were fairly clear, and the blank test showed no interference.Acetaminophen ,caffeine,and chlorpheniramine maleate all show good linear relationship respectively within the range be- tween 101.17 and 2023.40μ g/ml, 2.00 and 40.09μ g/ml, 2.05 and 40.93 μ g/ml ; The Precision is0.05%, 0.09%, 0.17%respectively, The average recovery rate is 100.4%, 99.6%, 99.6% respectively. Conclusion: The result is accurate, the method has good reproducibility, It an be used to control the quality of this preparation.
Keywords:Ganmaolingcapsule  Hillock mei  JinZhan silver plate  Trigeminal suffering  Acetaminophen  chlorpheniramine maleate  Caffeine  TLC  HPLC
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