乙型肝炎論文：益肝顆粒劑的制備工藝和質(zhì)量標(biāo)準(zhǔn)的研究

1、乙型肝炎論文：益肝顆粒劑的制備工藝和質(zhì)量標(biāo)準(zhǔn)的研究【中文摘要】乙型肝炎又稱為血清性肝炎、乙型病毒性肝炎(簡稱乙肝),是由乙型肝炎病毒(HBV)引起的一種世界性疾病。目前我國有乙肝患者3000萬。多數(shù)乙肝患者無明顯臨床癥狀,僅其中1/3出現(xiàn)肝損害的臨床表現(xiàn)。乙型肝炎肝臟病變最明顯,彌散于整個肝臟?；静∽?yōu)楦渭?xì)胞變性、壞死、炎性細(xì)胞侵潤,肝細(xì)胞再生,纖維組織增生。乙型肝炎的最終狀態(tài)是肝硬化。而肝硬化患者感染乙肝病毒有可能發(fā)展肝癌。乙型肝炎對病患本人造成生活、工作以及正常的人際交往造成諸多不便,且其后期治療費用無論對病患還是其家庭都將作為一項極大的經(jīng)濟支出。因此防治乙型肝炎具有重要意義。益肝顆粒劑

2、是中醫(yī)臨床治療急性和慢性乙肝瘀熱證的有效方,由丹參、五味子、苦參三味中藥組成,為方便用藥、提高藥物穩(wěn)定性,本課題通過系統(tǒng)科學(xué)的研究將其制成中藥新藥供患者選用。方法：以傳統(tǒng)中醫(yī)藥理論為指導(dǎo)原則,根據(jù)處方功能主治和藥物成分的性質(zhì),結(jié)合中藥新藥研究的有關(guān)要求,運用現(xiàn)代制劑技術(shù),采用比較和正交試驗法,研究確定益肝顆粒的制備工藝和質(zhì)量標(biāo)準(zhǔn)；并采用留樣觀察法考察其初步穩(wěn)定性。結(jié)果：篩選出最佳制備工藝為：丹參,以8倍量80%乙醇加熱回流提取3次,每次1h,合并藥液,濾過,濾液于60以下減壓回收乙醇,濃縮成相對密度1.02-1.06的清膏?？鄥⑺幉暮偷⒋继岷蟮乃幵?0倍量水共同煎煮次3次,每次1h,合并各

3、次煎液,濃縮至適量,加入乙醇使含醇量達(dá)55%,靜置24h,濾過,濾液減壓回收乙醇無醇味。將兩份清膏合并混勻,濃縮,干燥,制成干浸膏粉,加入五味子細(xì)粉,制粒,整粒,干燥,得到成品。即得。結(jié)論：結(jié)果表明,益肝顆粒制備工藝合理可行,質(zhì)量標(biāo)準(zhǔn)可控,成品質(zhì)量基本穩(wěn)定?！居⑽恼縃epatitis 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【關(guān)鍵詞】乙型肝炎 益肝顆粒 制備工藝 質(zhì)量標(biāo)準(zhǔn)【英文關(guān)鍵詞】Hepatitis B Yigan granule preparation quality standards【目錄】益肝顆粒劑的制備工藝和質(zhì)量標(biāo)準(zhǔn)的研究摘要3-4ABSTRACT4-5前言6-8第一章 文獻(xiàn)綜述8-16一、乙型肝炎概述8-12二、處方來源、組成及分析12-13三、處方藥物來源與現(xiàn)代研究概況13-16第二章 實驗研究16-45一、益肝顆粒劑的工藝研究16-29(一) 劑型的選擇16(二) 制備工藝路線的擬定16-17(三) 提取工藝條件篩選17-231、實驗藥材的來源與鑒定172、吸水率的測定17-183、丹參乙醇回流正交工藝研究