甘草浓缩丸的制备及质量控制.doc

甘草浓缩丸的制备及质量控制

包括外文翻译

摘    要
甘草为重要的常用中药，又名美草、蜜草，素有“国老”之称，具止咳化痰、解毒清热及调和诸药等作用。浓缩丸是丸剂改进的一种剂型，由于其是药粉和浸膏混合后泛丸，既符合中医药用药特点，又适应机械化生产，并可节约辅料。该制剂崩解性良好，易于吸收，临床疗效确切，方便患者服用，提高了药品的依从性，而且服用剂量小，因此深受广大患者欢迎，如能上市将比其他同类产品更具竞争力。
本文首先比较了超声波辅助提取法、加热回流法和冷浸法提取总黄酮的提取率，确定加热回流法为本实验的提取工艺，采用紫外分光光度计检测了甘草中总黄酮的含量；然后考察了浓缩丸最重要的黏合剂蜂蜜的炼制工艺；最后对甘草浓缩丸的最佳处方和制备工艺进行了研究，选用羧甲基淀粉钠（CMS-Na）作为崩解剂，以体外崩解时间为评价指标，正交优化处方，并测定溶出度等质量评价指标。优选处方为浸膏：蜂蜜为1:1.6，和药温度70℃，浸膏(密度为1.41），蜂蜜（密度为1.36）。结果表明，制备的浓缩丸均在35min内崩解，本实验所得处方和工艺可以制备性能优良的甘草浓缩丸。

关键词 甘草；总黄酮；浓缩丸；制剂检查
Preparation and quality control of Licorice
 concentrated pill
Abstract
Licorice is important and frequently used in Traditional Chinese Medicine, also known as grass, honey grass, and the "old country," with refreshment, and detoxification of various drugs such as heat and harmonic role. Concentrated pill of a improved dosage form, is a powder and extract because of its mixture of pan-pill medication which is consistent with the characteristics of Traditional Chinese Medicine, but also adapting mechanical production and saving accessories. The pharmaceutical preparation has the following characteristics: a good disintegration, easy to absorb, the curative clinical and convenience for patients’ taking. In addition, the increased drug adherence and the small doses are also the characteristics of this preparation. As to these, it is welcomed by the majority of patients. If marketed, it may be more competitive than other similar products.
In this paper, the ultrasonic assisted extraction method, heating reflux method and the extraction of total flavonoids of infusion extraction rate of return method were compared to determine heat-based extraction experiments. UV spectrophotometer was used to detect the total flavonoids in licorice. Then inspected the refining process of honey, which is the most important adhesive of the pill. Finally, the best licorice pill prescription and preparation process were studied. The vitro disintegration time and dissolution were served as index, CMS-Na was selected as a disintegrating agent, and the optimal condition for prescription was selected by orthogonal test. Preferred prescription extract: honey (1:1.6), and drug temperature 70 ℃, extract (density 1.41), honey (density 1.36), prepared in the 35min in both pill and collapse. The results were shown that it could be prepared from prescription and process excellent liquorice pill.
Key words: Licorice; flavonoids; concentrated pill ; check preparation
目  录
摘    要 I
Abstract II
第1章 绪  论 1
1.1 课题背景 1
1.2 甘草的研究进展 1
1.2.1 甘草的概述 1
1.2.2 甘草总黄酮的化学成分 2
1.2.3 甘草总黄酮的药理作用 2
1.3 浓缩丸的研究进展 3
1.3.1 浓缩丸的概述 3
1.3.2 浓缩丸的常用辅料 4
1.3.3 浓缩丸的制备方法 5
1.4 本课题研究的目的和内容 6
1.4.1 研究的目的 6
1.4.2 研究的内容 7
第2章 甘草总黄酮的提取及含量测定 8
2.1 实验材料 8
2.1.1 实验仪器 8
2.1.2 实验试剂 8
2.2 甘草总黄酮的提取工艺 9
2.2.1 超声波辅助提取法 9
2.2.2 加热回流提取法 9
2.2.3 冷浸法 9
2.3 甘草总黄酮的含量测定 9
2.3.1 芦丁对照品溶液的制备 9
2.3.2 芦丁标准品最大吸收峰的确定 9
2.3.3 芦丁标准品标准曲线的绘制 10
2.3.4 芦丁标准品精密度试验 10
2.3.5 芦丁标准品稳定性试验 11
2.3.6 样品测定 11
2.3.7 加样回收率试验 11
2.4 结果与讨论 12
2.5 本章小结 12
第3章 甘草浓缩丸的制备工艺的研究 13
3.1 实验材料 13
3.1.1 药品 13
3.1.2 仪器 13
3.2 蜂蜜炼制工艺的研究 13
3.2.1 实验样品的处理 14
3.2.2 含水量的测定 14
3.2.3 加热时间与含水量 14
3.3 甘草总黄酮浸膏的制备 14
3.3.1 甘草总黄酮浸膏的制备工艺 14
3.3.2 甘草总黄酮出膏率 14
3.4 甘草浓缩丸处方的确定 15
3.4.1 甘草浓缩丸单因素考察 15
3.4.2 正交试验 17
3.5 结果与讨论 18
3.6 本章小结 19
第4章 浓缩丸的质量标准研究 20
4.1 试验材料 20
4.1.1 药品 20
4.1.2 仪器 20
4.2 处方的扩大 20
4.3 浓缩丸的质量检查 20
4.3.1 外观检查 20
4.3.2 水分检测 21
4.3.3 重量差异的检查 21
4.3.4 崩解时限的检测 21
4.3.5 溶出度的检测 21
4.4 结果与讨论 23
4.5 本章小结 23
结  论 24
致  谢 25
参考文献 26
附录 A 28
附录 B 32