《大蒜素制剂的制备与质量研究》-毕业论文设计（学术).docVIP

PAGE 1 大蒜素制剂的制备及质量研究 摘 要 目的：制备大蒜素片剂，并对其做质量研究 方法：制备：以乳糖、微晶纤维素、淀粉、羧甲基淀粉纳等做为辅料，采用湿法制粒制备大蒜素片剂。质量研究：采用紫外分光光度法测定大蒜素片中大蒜素的含量(检测波长为289nm)：预先用无水乙醇提取分离样品中的大蒜素，稀释到一定浓度并在289nm波长处测定大蒜素含量。采用转篮法考察大蒜素片剂释放度：以去离子水为介质,水浴温度为37±0.5℃,分别在15min、30min、45min时抽取5ml溶液，采用紫外分光光度法在289nm波长处测定大蒜素吸光度，算的溶出度并绘制溶出曲线。 结果：测定大蒜素片中大蒜素含量为2.42%（RSD=0.07%，n=2），大蒜素在20.8μg/ml-41.6μg/ml浓度范围内呈良好的线性关系，线性方程为y=0.0215x-0.15603（r=0.999168）。测得大蒜素片最终平均溶出度为73.57%（RSD=0.42%，n=3）。大蒜素片剂的溶出能达到中国药典2005年版附录对溶出度的要求。 关键词：大蒜素制剂、紫外分光光度法、含量测定、释放度测定 ABSTRACT Objective: Prepare the allicin tablets and make quality research . Methods: Preparation: use lactose, microcrystalline cellulose and starch, sodium carboxymethyl starch as excipient, prepare allicin tablets with the method of wet legal system grain. Quality research: determine the content of allicin in tablets by the method of UV spectrophotometry.（detection wavelength at 289nm）: use anhydrous alcohol extraction and separation of allicin from the tablet .diluted sample to certain concentration and detect the wavelengths absorbency at 289nm of allicin. Test the dissolution by basket method: The basket method (100 r/min) was adopted with the dissolution medium of deionized water and sampling 5ml (add 5ml deionized water into the dissolution medium) after 15,30,45 minutes. Determine the allicin wavelenghs absorbency by the method of UV spectrophotometry at 289nm. Calculating the dissolution and draw the dissolving curve. Results: the content of allicin in tablet is 2.42% (RSD = 0.07%, n = 2), The standard curve was linear within the range of20.8μg/ml-41.6μg/ml with the correlation coefficient of 0.999168．The allicin tablets measured of final average dissolution test is 73.57% (RSD = 0.42%, n = 3). The dissolution of allicin tablets could according with regulation of dissolution in pharmacopeia2005 of china. KEYWORDS：Allicin preparations, UV spectrophotometry, Analysis, Dissolution rate 1 绪论 大蒜素是大蒜中的有效成分提取物，俗称“蒜黄金”，是一种天然来源的药物，临床应用领域广泛，被誉为天然广谱抗生素，且杀菌力强，抗菌谱广。除了有上述抗细菌真菌、保肝、降血压血脂、抗肿