新健胃片质量控制方法的研究  

Study on quality control methods for Xinjianwei tablets

作　　者：李云霞 郭艳玲 段树卿 胡晓梅 

机构地区：[1]颈复康药业集团有限公司,承德067000 [2]河北省中药新辅料工程技术研究中心,承德067000

出　　处：《药物分析杂志》2014年第1期163-168,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：对新健胃片的质量控制方法进行研究。方法：对新健胃片中黄芩苷和汉黄芩苷的稳定性进行考察;对黄芩苷、汉黄芩苷的对照品在酸碱条件下的稳定性进行研究;采用反相高效液相色谱法测定新健胃片中汉黄芩苷含量。采用Agilent Eclipse Plus C18（4.6 mm×150 mm，5 μm）色谱柱，以1%甲酸（A）-乙腈（B）为流动相进行梯度洗脱（0～15 min，78%A;15～25 min，78%A→75%A；25～40 min，75%A→68%A;40～45 min，68%A→78%A），流速1.0 mL·min^-1，检测波长280 nm。结果：新健胃片中黄芩苷不稳定，同时研究表明，黄芩苷本身不稳定，易受酸碱等因素的影响而受破坏;反相高效液相色谱法测定新健胃片中汉黄芩苷含量，线性范围0.10～0.50 μg（r=0.9999）;精密度试验的RSD（n=6）为0.2%;10 h内RSD（n=10）为0.3%；重复性试验的RSD（n=9）为1.0%;回收率在98.15%～100.7%之间，平均回收率为99.21%。结论：酸碱环境对黄芩苷影响较大，制剂中的黄芩苷以及黄芩苷对照品均不稳定、易分解，而汉黄芩苷几乎不衰减，相对稳定。建议以汉黄芩苷代替黄芩苷作为新健胃片中黄芩的投料量的检测指标;方法简便、可靠，重复性好，可用于新健胃片的质量控制。Objective： To study the quality control method of Xinjianwei tablets. Methods： Stability of baicalin and wogonoside in Xinjianwei tablets was studied,and the stability of two reference substances for baicalin and wogonoside in acid and alkali conditions was also studies.The reversed-phase high performance liquid chromatography was used for determination of wogonoside content in Xinjianwei tablets.The Agilent Eclipse plus C18 chromatographic column（4.6 mm×150 mm,5 μm） was adopted,the mobile phase was 1% formic acid（A）- acetonitrile（B） with gradient elution（0-15 min,78%A;15-25 min,78%A→75%A;25-40 min,75%A→68%A;40-45 min,68%A→78%A） at a flow rate of 1.0 mL·min^-1,the detection wavelength was 280 nm. Results： Baicalin in Xinjianwei tablets was unstable,and the study showed baicalin itself was unstable and vulnerable to the influence of factors such as acid-base damage.A RP-HPLC method was established to determine the wogonoside in Xinjianwei tablets.The linear range was 0.10-0.50 μg（r=0.9999）,RSD（n =6） of precision test was 0.2%,RSD（n=10） within 10 hours was 0.3%,and the repetitive RSD（n =9） was 1.0%.The recovery rate was between 98.15%-100.7%,with an average recovery rate of 99.21%. Conclusion： The acid-base environment has great influence on baicalin.Baicalin and its reference substance in the preparation are unstable and are destroyed easily,while wogonoside is relatively stable which is almost unattenuated.It is recommended to replace baicalin with wogonoside as the inventory rating for Scutellaria in Xinjiewei tablets.The method is simple,reliable and reproducible,which can be used for quality control of Xinjianwei tablets.

关 键 词：新健胃片 黄芩苷 汉黄芩苷 稳定性研究 酸碱条件影响 汉黄芩苷含量测定 反相高效液相色谱 质量标准 质量控制 

分 类 号：R917[医药卫生—药物分析学]