水蔓菁止咳滴丸的质量标准和药效学研究

【作者】 刁海鹏；

【导师】 丁红；

【作者基本信息】 山西医科大学 ， 药剂学， 2006， 硕士

【摘要】 本文利用HPLC技术和可见分光光度法制定合理、准确、方便可行的水蔓菁浸膏质量标准和水蔓菁滴丸的质量标准，使其能够对中药质量进行控制，反映中药新药的安全性和有效性；同时从动物实验、体外抑菌实验两方面，对原药材、水蔓菁浸膏及水蔓菁止咳滴丸进行药效学研究。 1、质量标准研究 目的 水蔓菁浸膏和水蔓菁滴丸质量标准的研究。 方法 (1) 采用质谱法定性确定水蔓菁浸膏及水蔓菁滴丸的水解产物中的化学成分。 (2) 采用分光光度法对水蔓菁药材、浸膏及水蔓菁滴丸中总黄酮含量进行含量测定。 (3) 采用反相高效液相色谱法对水蔓菁药材、水蔓菁浸膏及水蔓菁滴丸中的木犀草素进行含量测定。 (4) 采用原子吸收法对水蔓菁药材、水蔓菁浸膏及水蔓菁滴丸中重金属(Pb)含量进行测定。 结果与讨论 (1) 利用质谱法，确定水蔓菁浸膏及水蔓菁滴丸的水解产物中含有木犀草素。 (2) 采用分光光度法在410nm处测得水蔓菁药材中总黄酮含量为2.02％；浸膏中总黄酮含量为20.60％，水蔓菁止咳滴丸中每丸含总黄酮为2.52mg(以芦丁计)。线性回归方程为Y=0.0349X-0.0005，r=0.9999(n=5)，表明芦丁浓度在3.1μg/mL～24.8μg／mL范围内与吸光度线性关系良好，相关系数0.9999，精密度RSD为0.32％，回收率99.82％。 (3) 采用反相高效液相色谱法，用乙腈-0.4％磷酸(30:70)为流动相，流速：1.0mL／min，测定波长：350nm，柱温：23℃，用外标峰面积法定量，测得水蔓菁药材中木犀草素的含量为0.23％，水蔓菁浸膏中木犀草素的含量为0.42％；水蔓菁滴丸每丸含木犀草素为0.09mg。以峰面积(Y)对进样量(X)回归计算，线性方程：Y=2863820.99X—7169.2，r=0.9994，X在0.0064～0.128μg范围内，进样量和峰面积呈良好线性关系。 (4) 采用原子吸收法测得，水蔓菁药材中Pb含量为3.1μg／g，水蔓菁浸膏中Pb含量为2.8μg/g，水蔓菁滴丸中Pb含量为1.7μg／g。 2、药效学研究 目的 从动物实验、体外抑菌实验两方面对水蔓菁浸膏和水蔓菁滴丸进行药效学研究。 方法 (1) 动物实验：采用镇咳药物实验法、祛痰药物实验法、抗炎实验法对水蔓菁药材、水蔓菁浸膏和水蔓菁滴丸进行镇咳、祛痰、抗炎药效的研究。 (2) 体外抑菌实验：对水蔓菁药材、水蔓菁浸膏和水蔓菁滴丸进行抑菌研究。更多还原

【Abstract】 This paper established the reasonable, accurate, convenient and feasible quality standard of Veronica linariifolia intermediate and drop pills that can control the quality of Chinese traditional medicine and can reflect the safety and validity of Chinese new medicine by HPLC and visible Spectrophotometry. It simultaneously study the pharmacodynamics of original medicinal materials, intermediate and drop pills of Veronica linariifolia from aspects of animal and invitro antibacterial experiment. 1.The Study of Quality StandardsObjective quality standard research of the intermediate and drop pills of Veronica linariifolia Method (1) Adopting MS to qualitatively ascertain the good merchantable quality of hydrolysate of the intermediate and drop pills of Veronica linariifolia.(2) Adopting Spectrophotometry to determine total flavone content of the medicinal materials, intermediate and drop pills of Veronica linariifolia.(3) Adopting RP- HPLC to determine luteolin content of medicinal materials, the intermediate and drop pills of Veronica linariifolia.(4) Adopting Atomic Absorption Method to determine heavy metal Pd content of medicinal materials, the intermediate and drop pills of Veronica linariifolia.Result and Discussion(l)Utilizing MS to ascertain luteolin content of hydrolysate of the intermediate and drop pills of Veronica linariifolia.(2)Adopting Spectrophotometry to determine that total flavone content of medicinal materials is 2.02%, total flavone content of intermediate of Veronica linariifolia is 20.6%, that total flavone content of the drop pills of Veronica linariifolia is 2.52mg. equation of linear regression is Y=0.0123+0.0299X, r =0.9995 (n=5), this indicates that the linear relationship is good in the concentration scope of 3.1μg/mL-24.8μg/mL, that the correlation coefficient is 0.9995, that the precision (RSD) is 0.33%, and that the rate of recovery is 99.82%. (3)Adopting RP- HPLC to quantitatively determine by right of external standard peak area method that luteolin content of medicinal materials of Veronica linariifolia is 0.23%, that luteolin content of the intermediate of Veronica linariifolia is 0.42%, that luteolin content of the drop pills of Veronica linariifolia is 0.09mg. Mobile phase: acetonitrile-0.4% phosphorous acid, velocity of flow: 1.0mL/min, wavelength: 350nm, column temperature: 23°C. equation of linear regression is Y=2863820.99X—7169.2, r=0.9994, x is in range of 0.0064-0.128μg, this take on the good linear relationship between peak area and sample size.(4)Adopting Atomic Absorption Method to determine that Pd content of medicinal materials of Veronica linariifolia is 3.1μg/g , that Pd content of the intermediate of Veronica linariifolia is更多还原