茵胆平肝胶囊的制剂学、质量标准及药效学研究

【作者】 陈纪鹏；

【导师】 李云谷；

【作者基本信息】 北京中医药大学 ， 中药制剂学， 2003， 硕士

【摘要】 酒精性肝损伤是酒精性肝病最常见的3种病理变化(包括酒精性脂肪肝、急性酒精性肝炎和酒精性肝硬化)的前2种，是导致肝硬化的重要原因。现代医学认为酒精性肝病的发病机制主要是酒精及代谢产物对肝细胞的毒性作用，肝脏微循环障碍以及与酒精代谢相关酶和辅酶的变化而引起的肝脏损害。祖国医学依据酒精性肝病的发病特点和病因、病机进行分期和分型论治，已取得了一定疗效。 我们选择茵胆平肝胶囊，对其工艺和质量标准进行实验研究，并对其治疗酒精性肝损伤的适应症进行药效实验研究。 首先，对处方中的猪胆粉进行提取；当归采用正交试验优选醇提取工艺；通过正交试验，优选出较佳水提取工艺；优选辅料配方，采用高效湿法混合制粒和高效沸腾干燥机干燥；并采用新包装材料聚偏二氯乙烯，有效降低药品的吸潮，从而增加药品的稳定性。并通过急性毒性和药效对比试验及中试放大生产进一步验证制剂工艺的合理性、稳定性和安全性。 其次，我们建立包括猪胆粉、栀子、白芍和当归鉴别及黄芩含量测定的质量标准，大大提高了产品的质控水平。 药效学试验证明，茵胆平肝胶囊对脾虚证酒精性肝病有一定的改善肝功能和降低肝脂质的作用，对酒精性肝病有一定的改善肝功能的作用。同时，茵胆平肝胶囊对小鼠乙醇急性中毒肝脏脂质过氧化物(MDA)升高有明显保护作用。更多还原

【Abstract】 Alcoholic liver injury is the most common pathological change of alcoholic hepatosis (include alcoholic fat liver,alcoholic hepatitis, alcoholic cirrhosis). It is important factor leading to alcoholicci rrhosis. According to western medic i ne, alcohol ic liver di sease’s mechanismis a kind of 1 iver trauma caused by the toxicity function of alcohol and its metaholite, 1iver micro-circulation obstruct and the variation of alcohol metabolic enzyme. According to TCM, ALD is treated in phase and type by its characteristic, reason and mechanism, and has obtained some curative effects. We choose Yindan pinggan capsule.We study its process and quality standard. We also study the indication of alcoholic liver injury by Pharmaconamics experiment.The first, Pig s gall powder is extracted.Radix angelicae sinensis’soptimal condition for the process of alcohol extract is established by orthogonal lest.An optimal condition for the process of water extract is established by orthogonal test.To choose the best formula of excipients.To adopt High shear mixer granulator and High boi 1 ing dryer. And using new packi ng material PVDC. The measure reduces the moisture absorption effectively in order to increase the stability of the drug.We also prove the reasonableness, stabil ity and safety of the preparation process by acute toxicity and pharmacodynamic comparing test and the middle scale production. The second, we set up the quality standard, including identification ofPig s gall powder, Fructus gardeniae, Radix paeoniae alba and Radix angelicae sinensis and assay of Radix scutellariae. Largely increasing the quality control level of the drug.Pharmaconamics experiments prove that Yindan pinggan capsule has a certain improvement to liver function and reduced TG on the spleen-deficiency indication of alcoholic hepatosis.And it has a certain improvement to liver function on alcoholic hepatosis. Meanwhile Yindan pinggan capsule has significant protection on the arising of liver MDA in acute poison of little rats.更多还原