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机构地区:[1]渭南市中心医院,陕西渭南714000 [2]陕西康惠制药有限公司,陕西咸阳712000
出 处:《现代中医药》2007年第1期43-45,共3页Modern Chinese Medicine
摘 要:目的选择测定消肿片中士的宁含量的快速有效的方法,便于大生产过程中产品质量的控制,进而确保药品临床疗效。方法采用高效液相色谱法,以不同的色谱条件、不同的样品制备方法,分别测定消肿片中士的宁的含量。结果采用高效液相色谱仪,以C18柱(5μm,250mm×4.6mm ID)为色谱柱;流动相:乙腈-0.01mol/L庚烷磺酸钠与0.02mol/L磷酸二氢钾等量混合溶液(用10%磷酸调节PH值为2.8)(21:79)为流动相;检测波长为254nm。样品制备采用超声处理后再萃取,作为测定消肿片中士的宁的含量,方法简单,结果准确,检验成本低。结论经对比研究,确定可行的测定方法,能够有效的控制产品的质量,保证患者用药安全,同时适用于大生产,降低生产成本。Objective To select a fast and effective method for the determination of the content of strychnine in antioncoli pills for the product's quality control during bigroduction, so that the clinical efficacy of the medicine could be insured. Methods High performance liquid chromatography was used, under different chromatogram conditions and with different sample preparation methods, to determine the content of strychnine in antioncoti pills respectively. Results Using high performance liquid chromatography, C18 column (5μm,2.50mm ×4.6mm ID) as its chromatographic column; mobile phase: mixed solution ( adjust PH value as 2.8 with 10% phosphoric acid) (21:79) of methyl cyanide -0.01 mol/L , heptanc sodium sulfonatc and 0. 02mol/L potassium dihydrogcn phosphate with the same amount as mobile phase; determination wavelength was 254nm. Samples were prepared by extraction after ultrasonic processing to determine the content of strychnine in antioncoti pills. The method was simple, the result was accurate and the cost was low. Conclusion The determination of feasible measuring method by comparative study can effectively control the quality of the products is applicable in bigproduction, and can lower the cost at the same time.
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