甘草濃縮丸的制備及質(zhì)量控制

包括外文翻譯

摘    要
甘草為重要的常用中藥，又名美草、蜜草，素有“國老”之稱，具止咳化痰、解毒清熱及調(diào)和諸藥等作用。濃縮丸是丸劑改進的一種劑型，由于其是藥粉和浸膏混合后泛丸，既符合中醫(yī)藥用藥特點，又適應(yīng)機械化生產(chǎn)，并可節(jié)約輔料。該制劑崩解性良好，易于吸收，臨床療效確切，方便患者服用，提高了藥品的依從性，而且服用劑量小，因此深受廣大患者歡迎，如能上市將比其他同類產(chǎn)品更具競爭力。
本文首先比較了超聲波輔助提取法、加熱回流法和冷浸法提取總黃酮的提取率，確定加熱回流法為本實驗的提取工藝，采用紫外分光光度計檢測了甘草中總黃酮的含量；然后考察了濃縮丸最重要的黏合劑蜂蜜的煉制工藝；最后對甘草濃縮丸的最佳處方和制備工藝進行了研究，選用羧甲基淀粉鈉（CMS-Na）作為崩解劑，以體外崩解時間為評價指標，正交優(yōu)化處方，并測定溶出度等質(zhì)量評價指標。優(yōu)選處方為浸膏：蜂蜜為1:1.6，和藥溫度70℃，浸膏(密度為1.41），蜂蜜（密度為1.36）。結(jié)果表明，制備的濃縮丸均在35min內(nèi)崩解，本實驗所得處方和工藝可以制備性能優(yōu)良的甘草濃縮丸。

關(guān)鍵詞 甘草；總黃酮；濃縮丸；制劑檢查
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  錄
摘    要 I
Abstract II
第1章 緒  論 1
1.1 課題背景 1
1.2 甘草的研究進展 1
1.2.1 甘草的概述 1
1.2.2 甘草總黃酮的化學成分 2
1.2.3 甘草總黃酮的藥理作用 2
1.3 濃縮丸的研究進展 3
1.3.1 濃縮丸的概述 3
1.3.2 濃縮丸的常用輔料 4
1.3.3 濃縮丸的制備方法 5
1.4 本課題研究的目的和內(nèi)容 6
1.4.1 研究的目的 6
1.4.2 研究的內(nèi)容 7
第2章 甘草總黃酮的提取及含量測定 8
2.1 實驗材料 8
2.1.1 實驗儀器 8
2.1.2 實驗試劑 8
2.2 甘草總黃酮的提取工藝 9
2.2.1 超聲波輔助提取法 9
2.2.2 加熱回流提取法 9
2.2.3 冷浸法 9
2.3 甘草總黃酮的含量測定 9
2.3.1 蘆丁對照品溶液的制備 9
2.3.2 蘆丁標準品最大吸收峰的確定 9
2.3.3 蘆丁標準品標準曲線的繪制 10
2.3.4 蘆丁標準品精密度試驗 10
2.3.5 蘆丁標準品穩(wěn)定性試驗 11
2.3.6 樣品測定 11
2.3.7 加樣回收率試驗 11
2.4 結(jié)果與討論 12
2.5 本章小結(jié) 12
第3章 甘草濃縮丸的制備工藝的研究 13
3.1 實驗材料 13
3.1.1 藥品 13
3.1.2 儀器 13
3.2 蜂蜜煉制工藝的研究 13
3.2.1 實驗樣品的處理 14
3.2.2 含水量的測定 14
3.2.3 加熱時間與含水量 14
3.3 甘草總黃酮浸膏的制備 14
3.3.1 甘草總黃酮浸膏的制備工藝 14
3.3.2 甘草總黃酮出膏率 14
3.4 甘草濃縮丸處方的確定 15
3.4.1 甘草濃縮丸單因素考察 15
3.4.2 正交試驗 17
3.5 結(jié)果與討論 18
3.6 本章小結(jié) 19
第4章 濃縮丸的質(zhì)量標準研究 20
4.1 試驗材料 20
4.1.1 藥品 20
4.1.2 儀器 20
4.2 處方的擴大 20
4.3 濃縮丸的質(zhì)量檢查 20
4.3.1 外觀檢查 20
4.3.2 水分檢測 21
4.3.3 重量差異的檢查 21
4.3.4 崩解時限的檢測 21
4.3.5 溶出度的檢測 21
4.4 結(jié)果與討論 23
4.5 本章小結(jié) 23
結(jié)  論 24
致  謝 25
參考文獻 26
附錄 A 28
附錄 B 32