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机构地区:[1]江苏南通精华制药股份有限公司,江苏南通226005 [2]广州中医药大学中药学院,广州510006
出 处:《中药新药与临床药理》2009年第1期47-49,共3页Traditional Chinese Drug Research and Clinical Pharmacology
基 金:广东省关键技术领域重点突破项目(2003A30908)。
摘 要:目的建立抗病毒口服液中芒果苷和连翘苷的含量测定方法,为抗病毒口服液质量标准的再提高提供依据。方法采用RP-HPLC法同时测定抗病毒口服液中芒果苷和连翘苷的含量。色谱柱:Kromasil RP-C18柱(4.6mm×250mm,5μm);流动相:乙腈-0.1%醋酸(15∶85);流速0.80mL·min-1;检测波长:时间-波长程序(0→25min:258nm,25→30min:277nm);理论塔板数按芒果苷计算应不低于6000,按连翘苷计算应不低于5000。结果芒果苷线性范围48.8ng~1525ng,r=0.9994;连翘苷线性范围56ng~1750ng,r=0.9995。芒果苷、连翘苷的平均回收率分别为97.65%、99.21%。10批次样品中芒果苷的含量范围在14.40~20.41μg·mL-1,连翘苷的含量范围在28.70~36.01μg·mL-1。结论该测定方法具有操作简便、稳定、专属性强、可重复的特点,可用于抗病毒口服液的质量控制。Objective To establish a method for the determination of chimoni and forsythiaside in Kangbingdu Oral Liquid (KOL) and to develop a new quality standard for KOL. Methods A RP - HPLC method was adopted for the determination of chimonin and forsythiaside of KOL. The chromatographic conditions were as follows: Kromasil RP - C18 (250 mm × 4.6 ram, 5μm) column was used, a mixture of acetonitrile -0. 1% acetic acid (15 : 85, v/v) served as mobile phase, the flow rate was 0. 80 mL· min^-1, and detective wavelengths of time process were 0→25 min: 258 nm, and 25→30 min: 277 nm. Theoretical plate number of chimoni was over 6000 and that of forsythiaside was over 5000. Results The ehimonin showed a good linearity in the range of 48.8ng - 1525 ng( r = 0. 999 4), and the linear range of forsythiaside was in the ranged of 56ng - 1750 ng ( r = 0. 999 5). The mean recovery of ehimonin and forsythiaside was 97.65 % and 99.21% respectively. The content of chimonin in the 10 batches of samples was in the range of 14.40 - 20.41μg·mL^-1, and that of forsythiaside was in the range of 28.70 -36.01μg·mL^-1. Conclusion The developed method has been proven to be simple, stable and reproducible, and can be applied for quality control of the Kangbingdu Oral Liquid.
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