维C银翘片中维生素C的体外溶出度比较研究  

Comparative Studies on the Dissolution of Vitamin C in Vitamin C Yinqiao Tablets in vitro

作　　者：胡芳 孙晓军 安斯扬 蒋坤 李星 阳璘魁 潘玉杰 夏文 

机构地区：[1]贵州百灵企业集团制药股份有限公司,安顺561000 [2]贵州大学生命科学学院,贵阳550025

出　　处：《海峡药学》2014年第11期85-89,共5页Strait Pharmaceutical Journal

基　　金：贵州省科技计划重大专项项目(黔科合重大专项字〔2011〕6019)

摘　　要：目的通过对比研究维C银翘片糖衣片和薄膜衣片中化药成分维生素C体外溶出度曲线,以建立确定产品一致性的方法。方法采用浆法,以0.5%亚硫酸氢钠（用磷酸调节p H=1.5）为溶出介质,温度控制在37℃±0.5℃,转速75r·min^-1,以包衣层脱落作为取样时间起点,考察两种规格的产品在90min内各相同取样点的累积溶出度。色谱柱为氨基硅烷键合硅胶柱（250mm×4mm,5μm）;以乙腈-0.01mol·L^-1磷酸二氢钾（用磷酸调节p H值至2.4）（70∶30）为流动相;检测波长246nm;柱温为25℃;流速为1m L·min^-1;进样量10μL。结果维生素C在2.10~210.40μg·m L^-1范围内呈现良好的线性关系,糖衣片、薄膜衣片加样回收率平均值分别为101.75%、100.46%。通过相似因子进行比较,薄膜衣片和糖衣片中维生素C的体外溶出曲线相似。结论该方法可行性、重现性均良好。且可推断二者溶出时间有所差异的原因是包衣材料的不同,这为后期即将进行的生物等效性试验奠定理论数据基础。OBJECTIVE To establish a method to ensure the product consistency through comparative studying on the vitro dissolution curve of the chemical composition of Vitamin C in the sugar-coated tablets and film-coated tablets of Vitamin C Yinqiao Tablets. METHODS Paddle method was used. 0. 5% sodium bisulfitesolution（p H =1. 5） was used as dissolution medium,which adjusted by phosphoric acid. Temperature was at 37℃ ± 0. 5℃. The speed was kept at 75r·min^-1. Coating layer shedding as a starting point of sampling time to examine the two specifications products cumulative dissolution in the same sampling point within 90 min. The HPLC conditions included that aminosilane key silica gel column（250 mm × 4mm,5μm）,mobile phase of acetonitrile-0. 01mol·L^-1potassium dihydrogen phosphate（phosphoric acid adjusted the p H to 2. 4）（70∶ 30）,detection wavelength was set at 246 nm,column temperature was 25℃,the flow rate was 1m L · min^-1,injection volume was 10μL. RESULTS Vitamin C Showed a good linear relationship within the range of 2. 10-210. 40μg·m L^-1,the average plus recoveries of the sugar-coated tablets and the film-coated tablets were 101. 75% and 100. 46% respectively. By comparing the similar factors,the vitamin C in vitro dissolution curve of the sugar-coated tablets and the film-coated tablet was similar. CONCLUSION The feasibility and reproducibility of this method are good. And inferred dissolution time varies of the both tables because of the different coating materials,which will lay the basis of theoretical data for the bioequivalence testing in the upcoming.

关 键 词：维C银翘片 糖衣片 薄膜衣片 维生素C 体外溶出 相似性 

分 类 号：R927.2[医药卫生—药学]