YBGY膠囊的定量分析方法的建立

制藥工程論文編號:ZY076    論文字?jǐn)?shù):9349,頁數(shù):25

目  錄
中文摘要 I
英文摘要 II
目錄 III
1. 緒論 1
 1.1  概述 1
 1.2  中藥及其制劑分析的一般程序 1
 1.3  YBGY膠囊的定量分析方法的建立 6
2. 實驗部分 7
 2.1  儀器與試劑 7
 2.2  紫外實驗 7
 2.3  HPLC實驗 7
3. 結(jié)果與討論 10
 3.1  紫外的結(jié)果與討論 10
 3.2  高效液相色譜的結(jié)果與討論 10
4．總結(jié)與展望 18
致謝 19
參考文獻(xiàn) 20

 摘 要：藥物是一類特殊的商品，尤其是中藥制劑，成分復(fù)雜，而且大多數(shù)中藥的有效成分尚不十分清楚，其質(zhì)量的優(yōu)劣，不但直接影響預(yù)防和治療疾病的效果，而且密切關(guān)系到人民的健康與生命安全。因此，藥物質(zhì)量的研究對于保障藥物的安全性和有效性具有重要的意義。本論文通過對YBGY膠囊的質(zhì)量標(biāo)準(zhǔn)進(jìn)行了研究，建立了定量分析方法。采用反相高效液相色譜法對其君藥YC中的兩個有效成分進(jìn)行了定量分析，流動相為0.025mol/L H3PO4(用三乙胺調(diào)節(jié)pH為3.0)-甲醇-乙腈（75:26:15），檢測波長為345nm,流速：1.0ml/min，柱溫：30℃，結(jié)果表明6,7-二甲氧基香豆素的線性范圍為1.3-13μg/ml，回收率為96.62%；6-羥基-7-甲氧基香豆素的線性范圍為2.36-23.6μg/ml，回收率為96.50%，分析方法簡便、靈敏度高、重現(xiàn)性好，為評價YBGY膠囊質(zhì)量提供了定量依據(jù)。
 關(guān)鍵詞：YBGY膠囊；高效液相色譜法；定量分析

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.
Keywords：YBGBcapsule; High Performance Liquid Chromatography(HPLC); quantitative analysis