儿童清肺口服液和通幽润燥丸的质量控制方法研究

【作者】 郝贵奇；

【导师】 张卓勇； 马群；

【作者基本信息】 首都师范大学 ， 分析化学， 2007， 硕士

【摘要】 中药是中华民族的优秀文化瑰宝，在同疾病的斗争中发挥了重要的作用。中药是一个多组分的复杂体系，加上生产过程中受诸多因素影响，给质量控制带来很多困难。过去由于分析检测技术比较落后，仅凭传统经验感官检查，难以达到控制中药质量的目的。为了保证中药的安全有效，并逐步走向国际市场，中药质量标准的现代化，就成为急需解决的问题。高效液相色谱法具有分离效能高，分离速度快，样品用量少且不受样品挥发性的约束等优点，它在化学和生命科学的应用越来越广。运用高效液相色谱法分离和测定中药的主要有效成分有力地促进了中药质量的规范化和标准化。本文建立了两种中药制剂(儿童清肺口服液、通幽润燥丸)的主要有效成分(黄芩苷、柚皮苷)的高效液相色谱分析方法。分别考察了线性范围、稳定性、重现性和回收率。平均回收率分别为100.39％和101.56％。同时还对回生第一散中的朱砂进行了含量检查。以上的实验结果表明，高效液相色谱法分离速度快，稳定性、重现性的RSD在2％以内。该方法可应用于这两种中药质量标准中的定量。更多还原

【Abstract】 Chinese traditional medicine (CTM) is the Chinese excellent cultural gem and has played an important role in struggling against illness in the past thousands of years. CTM is a complex system with multiple components and might be affected in the production, so it was difficult to control its quality because of the insufficient detection capability in the past. The modernization of the CTM is on the schedule now.High performance liquid chromatography (HPLC) is widely used in chemistry, life science, and many other fields because of its high efficiency, rapid speed, suitable for small amount of sample and not limited by volatilization of sample. Application of HPLC to separation and determination of effective components of TCM promotes the standardization of TCM’s quality. HPLC methods for the separation and determination of the effective components (baicalin and naringin) of four TCMs (Ertong Qingfei oral liquid and Tongyourunzao pill) were established in this thesis. Linear ranges, stability, fidelity and recovery were investigated. The average recovery was 100.39% and 101.56% respectively. The determination of vermillion was performed in this thesis.The results above testify that linear ranges are wide, stability, fidelity and recovery was good. HPLC method is adapted to the control of TCM’s quality.更多还原