鱼腥草浓缩丸的制备.doc

鱼腥草浓缩丸的制备

鱼腥草浓缩丸的制备
摘    要
鱼腥草（Herba houttuyniae）别名紫蕺、臭猪巢、侧耳根、猪鼻拱，为三百草科多年生草本植物蕺菜的干燥水上部分，产于我国长江流域以南各省。鱼腥草的药理活性表明，鱼腥草具有提高机体免疫力、抗菌、抗病毒、利尿等临床应用。然而传统的鱼腥草制剂多以片剂为主，不适宜幼儿等特定人群服用，而且影响崩解和溶出，不利于药物的吸收，研究鱼腥草浓缩丸剂型有利于改善上述不利因素，具有很好的开发前景。
本文分别以水、70%乙醇作为提取溶剂，采用热回流提取鱼腥草内的药用活性物质总黄酮，进行验证比较，选择最佳提取方法是70%乙醇溶剂提取。然后应用旋转蒸发仪对提取液进行浓缩，经过浓缩丸处方摸索，通过正交试验确定最佳处方工艺，主药、蜂蜜、填充剂的质量比为1:1.5:2.5，加蜜温度60℃，并且应用紫外分光光度计、崩解时限仪、溶出仪器进行了检测试验。实验结果表明：崩解时间为29 min，符合2010版一部药典各项标准。

关键词  鱼腥草；浓缩丸；质量控制；制备工艺

Preparation of herba houttuyniae condensed pill
Abstract
Herba houttuyniae Synonyms is named purple Houttuynia cordata Thunb、smelly pig nest、ear root、pig nose arch. It is the dry part of the Houttuyniae cordata that belongs to saururaceae. It is produced in the provinces south of Yangtze River in China. Pharmacological activity of Houttuynia indicates that Houttuynia has increased immunity, antibacterial, antiviral, diuretic and other clinical applications. However, tablet of Houttuynia is mainly form in the traditional formulations, and is not suitable for children as a specific group of people with using them, but also it affects the disintegration and dissolution, is not conducive to drug absorption. Concentrated pill will help to improve the above-mentioned negative factors, with good development prospects.
In This experiment it was studied by making water and 70% ethanol as extraction solvent and refluxing to extract the total flavonoids of medicinal active substance within Houttuynia. This paper determined the optimal extraction proce. The results were shown that: the best extraction solvent was 70% ethanol. Afterwards the Rotary Evaporator was applied by extracting and going on with enrichment, the prescriptions of concentrated pill about Houttuynia was groped by the orthogonal test to determine the optimum formulation process, the main drug, honey and filler mass ratio was 1:1.5:2.5, temperature by adding honey was 60 ℃. This word used ultraviolet spectrophotometer, disintegration time apparatus, dissolution test apparatus to go on testing. The results showed that: the disintegration time was 29 min and was in accordance with the standard 2010 version of Pharmacopoeia of China.
Keywords: Herba houttuyniae;condensed pill;quality control; preparation technology
 
目  录
摘  要 I
Abstract II
第1章 绪  论 1
1.1 课题研究背景 1
1.2 相关知识简介 1
1.2.1 鱼腥草简介 1
1.2.2 浓缩丸简介 3
1.3 浓缩丸研究进展 5
1.3.1 浓缩丸的优点 5
1.3.2 浓缩丸的特点 6
1.3.3 浓缩丸存在的问题 7
1.3.4 前景及展望 7
1.4 本实验研究主要内容 7
第2章 总黄酮的提取 8
2.1 试剂与仪器 8
2.1.1 试剂 8
2.1.2 仪器 8
2.2 实验部分 9
2.2.1 总黄酮的提取方法比较 9
2.2.2 总黄酮的含量测定 9
2.2.3 方法学考察 10
2.3 讨论 11
2.4 本章小结 12
第3章 浓缩丸的制备 13
3.1 出膏率的测定 13
3.2 处方的确定 13
3.2.1 单因素考察 13
3.2.2 正交实验确定最佳处方工艺 15
3.2.3 最佳处方工艺验证 16
3.2.4 本实验浓缩丸处方 16
3.3 浓缩丸质量控制检测 17
3.3.1 崩解时限检测 17
3.3.2 溶出度检测 17
3.4 讨论 19
3.5 本章小结 20
结  论 21
致  谢 22
参考文献 23
附录 A 25
附录 B 30