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范文编号:ZY076 范文字数:9349,页数:25 摘 要：药物是一类特殊的商品，尤其是中药制剂，成分复杂，而且大多数中药的有效成分尚不十分清楚，其质量的优劣，不但直接影响预防和治疗疾病的效果，而且密切关系到人民的健康与生命安全。因此，药物质量的研究对于保障药物的安全性和有效性具有重要的意义。本范文通过对YBGY胶囊的质量标准进行了研究，建立了定量分析方法。采用反相高效液相色谱法对其君药YC中的两个有效成分进行了定量分析，流动相为0.025mol/L H3PO4(用三乙胺调节pH为3.0)-甲醇-乙腈（75:26:15），检测波长为345nm,流速：1.0ml/min，柱温：30℃，结果表明6,7-二甲氧基香豆素的线性范围为1.3-13μg/ml，回收率为96.62%；6-羟基-7-甲氧基香豆素的线性范围为2.36-23.6μg/ml，回收率为96.50%，分析方法简便、灵敏度高、重现性好，为评价YBGY胶囊质量提供了定量依据。 Abstract: Medicinal drug is a special kind of commodity, especially for chinese materia medica preparation , complex sentence , and most effective elements of traditional chinese medicine is not very clear ,its quality directly connected to people’s health and life. Therefore, it is of great significance to research on the qualification control of drug to ensure its safety and effectiveness. We have developed a quantitative method. HPLC was applied to determinate the two effective components in the chief herb-YC, with the liquid phase 0.025mol/L H3PO4(pH was adjusted to 3.0 with triethylamine)-methol-acetonitrile; the detection wavelength:345nm, the rate:1.0 ml/min and the column temperature:30℃. Results showed that the linear range of 6,7-dimedthoxycoumarin is 1.3-13ug/ml with the recovery of 96.62%; the linear range of 6-hydroxy-7-methoxycoumarin is 2.36-23.6ug/ml with the recovery of 96.50%. The analytical method is simple, sensitive and high reproducibility, thus provide qualitative and quantitative proof for the quality control of Capsule YBGY. 目 录
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