复方甲亢胶囊的药学研究

【作者】 毕晓黎；

【导师】 郑国华；

【作者基本信息】 湖北中医学院 ， 中药学， 2004， 硕士

【摘要】 复方甲亢胶囊是以黄芪、白芍等益气养阴中药为主配以少量西药甲巯咪唑组成的中西合方制剂，用于治疗甲状腺功能亢进症，具有益气养阴、柔肝理气、散结消瘿之功效。本课题对该制剂的制备工艺、质量标准进行了系统的试验研究，并进行了初步药效学研究。 一、制备工艺研究 在提取工艺条件方面，以芍药苷含量及浸膏得率为评价指标，考察了加水量、浸泡时间、煎煮时间和煎煮次数对提取效果的影响，采用正交试验法优选提取工艺条件。结果提取工艺条件为：方中九味中药补足1.5倍吸水量后，加8倍量水浸泡3小时，提取2次，每次煎煮1.5小时。 在分离纯化工艺条件方面，分别考察了采用醇沉及ZTC1+1天然澄清剂进行除杂的最佳工艺条件，并对两者的除杂效果进行比较，结果确定分离纯化工艺条件为：将提取液浓缩至生药：水=1：3后，将浓缩液置于80℃水浴中，加入6％组分B，搅拌，使其均匀分散，并保温5～10分钟后，将温度降至60℃，加入3％组分A，搅拌，使均匀分散，并保温5～10分钟后，于室温下放置24小时，滤取上清液。 在此基础上，用对比试验考察不同辅料对浸膏粉吸湿性的影响，结果：以羧甲基淀粉钠和微晶纤维素（1：2）混合降低浸膏粉吸湿性的效果最好，临界相对湿度为72％。 二、质量标准研究 采用薄层层析法对制剂中黄芪、玄参、钩藤、五味子、郁金五味中药进行了鉴别。采用HPLC对芍药苷和西药甲巯咪唑进行了含量测定，并进行了方法学考察，平均回收率分别为95.74％、99.02％，RSD分别为1.04％、1.86％，证明所用方法准确、可靠，可用于制剂的含量测定。 三、药效学研究 在工艺条件固定的基础上，对复方甲亢胶囊进行了初步药效学研究，分别考察了低、中、高三个剂量组，并与中药甲亢胶囊组和西药甲巯咪唑组进行对比，用放射免疫法测定血清TT₃、TT₄，结果发现复方甲亢胶囊各组大鼠甲亢症状明显改善，体重明显增加，血清TT₃、TT₄含量明显下降，表明其疗效明显优于等剂量的纯中药及纯西药制剂。更多还原

【Abstract】 Jiakang compound capsule , which is made from Radix Astragali , Radix Paeoniae Alba , other seven kinds of herbs and Thiamazoli , is an effective prescription of combination of traditional Chinese and Western medicine , for treating hyperparathyroidism by reinforcing Qi, nourishing Yin , smoothing liver , regulating Qi , dispelling nodule and eliminating wart . The author has made an experimental study on its preparation, quality standards and primary pharmacodynamics .1.Study of the preparationIn the point of preparation technology, we used the content of Paeoniflorin and extracting ratio as evaluating indexes and investigated the optimum preparing and refining conditions by the orthogonal test method and parallel test . The optimum extracting condition was : soaking the nine herbs with water for 3 hours and boiling 1.5 hours for two times , the amount of water used was 9.5 , 8 times of the drug mixture respectively . Then concentrating the extracting liquid and adding the ZTCl+1 natural clarifier in the concentration in order to purify it . On the basis of these studies , we selected the mixture of carboxymethyl starch sodium(CMS-Na) and microcrystalline cellulose(MCC) as the excipients to reduce the hygroscopy and increase the fluidity of extracting powder .2. Study of quality standardThe Radix Astragali , Radix Scrophulariae , Ramulus Uncariae Cum Uncis , Fructus Schisandrae Chinensis and Radix Curcumae were indentified by TLC . For the sake of assays of Paeoniflorin and Thiamazoli ,the new high performance liquid chromatography methods were developed . The average recovery rates were 95.74% and 99.02% respectively while RSD were 1.04% and 1.86% respectively . Assay methods were validated in the research of contert . On the basis of the above-mentioned quantitative analysis menthods for Paeoniflorin and Thiamazoli, the quality standard of Jiakang compound capsule was drafted .3. Study of primary pharmacodynamicsOn the basis of steady preparation technology , we engaged in experimental study to prove the preparation’s curative effect . We set up three groups which have different dosages of Jiakang compound capsule ,and compared their effect with Traditional Chinese medicinal group and western medicinal group . The results show that Jiakang compound capsule can relieve hyperthyroidism symptom ,increase avoirdupois , and decrease the content of TT3, TT4 . The functions of it are more powerful than those of Traditional Chinese medicine and western medicine .更多还原