乙型肝炎论文：益肝颗粒剂的制备工艺和质量标准的研究

1、乙型肝炎论文：益肝颗粒剂的制备工艺和质量标准的研究【中文摘要】乙型肝炎又称为血清性肝炎、乙型病毒性肝炎(简称乙肝),是由乙型肝炎病毒(HBV)引起的一种世界性疾病。目前我国有乙肝患者3000万。多数乙肝患者无明显临床症状,仅其中1/3出现肝损害的临床表现。乙型肝炎肝脏病变最明显,弥散于整个肝脏。基本病变为肝细胞变性、坏死、炎性细胞侵润,肝细胞再生,纤维组织增生。乙型肝炎的最终状态是肝硬化。而肝硬化患者感染乙肝病毒有可能发展肝癌。乙型肝炎对病患本人造成生活、工作以及正常的人际交往造成诸多不便,且其后期治疗费用无论对病患还是其家庭都将作为一项极大的经济支出。因此防治乙型肝炎具有重要意义。益肝颗粒剂

2、是中医临床治疗急性和慢性乙肝瘀热证的有效方,由丹参、五味子、苦参三味中药组成,为方便用药、提高药物稳定性,本课题通过系统科学的研究将其制成中药新药供患者选用。方法：以传统中医药理论为指导原则,根据处方功能主治和药物成分的性质,结合中药新药研究的有关要求,运用现代制剂技术,采用比较和正交试验法,研究确定益肝颗粒的制备工艺和质量标准；并采用留样观察法考察其初步稳定性。结果：筛选出最佳制备工艺为：丹参,以8倍量80%乙醇加热回流提取3次,每次1h,合并药液,滤过,滤液于60以下减压回收乙醇,浓缩成相对密度1.02-1.06的清膏。苦参药材和丹参醇提后的药渣加10倍量水共同煎煮次3次,每次1h,合并各

3、次煎液,浓缩至适量,加入乙醇使含醇量达55%,静置24h,滤过,滤液减压回收乙醇无醇味。将两份清膏合并混匀,浓缩,干燥,制成干浸膏粉,加入五味子细粉,制粒,整粒,干燥,得到成品。即得。结论：结果表明,益肝颗粒制备工艺合理可行,质量标准可控,成品质量基本稳定。【英文摘要】Hepatitis B, also known as serum hepatitis, hepatitis B (HBV for short), is by the hepatitis B virus (HBV) caused a worldwide disease.Currently, there are 30 million

4、 hepatitis B patients. Most patients with no clinical symptoms of hepatitis B, only 1/3 of the clinical manifestations of hepatic damage occurred. The most obvious of hepatitis B liver disease, diffuse throughout the liver. Basic lesions of liver cell degeneration, necrosis, inflammatory cell infilt

5、ration, liver regeneration, fibrosis. The final status of hepatitis B cirrhosis. The hepatitis B virus infection in patients with cirrhosis may develop liver cancer. Hepatitis B patients have cause to live, work and normal interpersonal inconvenience caused, and its post-treatment costs for both the

6、 patients or their families as a great economic costs. Therefore, prevention and treatment of hepatitis B is important.Yigan granule is Chinese medicine clinical treatment of acute and chronic hepatitis B stasis heat of effective parties, which is is composed by Salvia, Flavescens and Schisandra.To

7、facilitate the drug, increased drug stability, the subject of scientific research through the system to system more patients into the new Chinese medicine for use. Methods:Traditional Chinese medicine theory as the guiding principle, according to prescription medicines and Indication and nature, com

8、bined with Chinese drug research of the requirements, use of modern preparation technology, more and orthogonal test method used to study the preparation process to determine Yigan granule and its quality standards; and sample observation method used to stay the preliminary investigation of their st

9、ability. Results:The best preparation technique selected:Salvia to 8 times the amount of 80% ethanol reflux for 3 times, 1h, combined liquid, filtration, the filtrate was below 60and decompression recovery of ethanol, concentrated into a relative density of 1.021.06 clear grease. Salvia Sophora flav

10、escens and residue after ethanol plus 10 times the amount of co-boiling water 3 times, each time 1h, combined decoction of all times, to the appropriate concentration, volume of ethanol to 55% with alcohol, standing 24h, filtration, the filtrate vacuum recovery of pure alcohol without flavor. Will m

11、erge the two clear cream mix, condensed, dry, powder made from dried extract add Schisandra powder, granulation, whole, dried, be finished. Conclusion:The results showed that the liver and granule preparation reasonably practicable, controlled quality standards, product quality stable【关键词】乙型肝炎 益肝颗粒 制备工艺 质量标准【英文关键词】Hepatitis B Yigan granule preparation quality standards【目录】益肝颗粒剂的制备工艺和质量标准的研究摘要3-4ABSTRACT4-5前言6-8第一章 文献综述8-16一、乙型肝炎概述8-12二、处方来源、组成及分析12-13三、处方药物来源与现代研究概况13-16第二章 实验研究16-45一、益肝颗粒剂的工艺研究16-29(一) 剂型的选择16(二) 制备工艺路线的拟定16-17(三) 提取工艺条件筛选17-231、实验药材的来源与鉴定172、吸水率的测定17-183、丹参乙醇回流正交工艺研究