【作者】 白庆云；

【导师】 刘树民；

【作者基本信息】 黑龙江中医药大学 ， 中药学， 2006， 硕士

【摘要】 急支糖浆是一种具有抗菌消炎的新型止咳化痰中成药。为药典方。临床用于急性支气管炎、感冒咳嗽、夜间阵发性咳喘、慢性支气管炎急性发作以及咯痰不爽等症,不仅疗效确切,而且价格便宜。但是由于急支糖浆的剂型为含糖的糖浆剂,致使糖尿病患者不能服用,且市场上只有此一种剂型,严重限制了本产品的使用。为此本课题以市场为导向,以患者为本,将糖浆剂改为滴丸剂。 本实验采用原糖浆剂的药材提取工艺,并将挥发油用β-环糊精包合成包合物,减少了挥发油的损失。以包合物收得率和挥发油包封率为评价指标,对包合温度、时间以及环糊精与挥发油的比例三个因素进行考察,根据正交工艺优选包合条件。实验结果:环糊精与挥发油的比例为8:1,包合温度为50℃,搅拌时间为2小时。以滴丸的圆整度、溶散时限等为指标对基质、冷凝剂、药粉与基质比例进行考察,研究结果:选用PEG4000为基质,二甲基硅油为冷凝剂,药粉与基质比例为1:1.5。以滴丸的溶散时限和重量差异为评价指标,通过正交实验优选滴制条件为:滴温:80℃,滴距:2cm,滴速:20滴/分钟。 在质量标准研究中,对四季青、鱼腥草、麻黄、枳壳进行了鉴别,鉴别方法均采用薄层色谱法,重复性好,专一性强。应用原高效液相色谱法对滴丸剂进行了含量测定,测定以枳壳为对象,以柚皮苷(Naringin)为指标,测定结果:本品每丸含枳壳以柚皮苷(Naringin)计,不少于0.2mg。 药效学实验表明滴丸剂和糖浆剂具有相当的药效作用。对氨水引咳的小鼠有止咳作用,能促进小鼠体内酚红的排出,能延长豚鼠的引咳潜伏期,并具有明显对抗二甲苯耳廓致炎的作用。临床研究证明该中药复方用于治疗急性支气管炎和感冒后咳嗽具有确切的疗效。 本实验研究证明急支滴丸制剂工艺稳定,质量可控,改革更多还原

【Abstract】 Jizhi dropill bring along jizhi syrup.Jizhi syrup is a complex prescription pharmaceutics of Chinese drug which is recorded in pharmacopeia .Come in to mark for many years. Clinical efficacy definite.Its composition are Jinqiaomai , Sijiqing , Yuxingcao , Ziyuan, Qianhu, Zhiqiao, Mahuang and Gancao.To cure acute bronchitis, cough etc.But because jizhi syrup carry defecosaturation, diaabetes people cannt take it.What’s more,it has only a formulation,confine it’s application.So, this thesis chenge the syrup into the dropill guideing in the market and patient-oriented concept.This formulation have so many excellence,for example:highly bioavailability,quik action and convenient take.It fit to all the people cluding diaabetes people. Fabric accommodation simple,cifp low etc.Abstracted art of medicinal material is coincide with syrup,and essential oil is inclused with β-cyclodextrin into inclusion compound so that the bend loss of qualtity of essential oil bring low.With acquisition ratio of inclusion compound and essential oil entrapment efficiency appearing as appraisal index inspect tumperiture 、 tine and proportion btween between β-cyclodextrin and essential oil there factors.According to orthogonal test optimize the inclused condition.The condition :temperiture is 50℃,time is 2 hour and proportion between P-cyclodextrin and essential oil is 8:1.With the granule roundness and solution time of the pills, appearing as appraisal index select The ground plasm and the condensing agent. The results are that PEG4000 appear as ground plasm, simethicone appear as condensing agent ,the proportion between powder of drug and ground plasm is 1:1.5. With time and weight variation ofthe pills appearing as appraisal index,select dropill condition by orthogonal test.The conditions: dropill temperiture is 80"C,dropill distance is 2cm, dropill velocity is 20 drop/min.We identify Sijiqing> Yuxingcao> Mahuang and Zhiqiao with thin layer chromatographic method. Their repeatability is good, and specificity high.With Naringin appearing as object and index, deter-minate content by HPLC.The result of deter-mination is that the jizhi dropill comprise Zhiqiao no lesst han 0.2mg/pill by accounting with Naringin. Pharm-acodynamics test certificate: drug effect is coincide between the dropill and the syrup.They all relieve cough in mice by ammon,loose bronchial plain muscle, prolong latency period of coughing in guinea pig,antagonize astriction of bronchial leading by histamine and phlegmonosis on auricula leading by xylene.Study in clinic certificate this formula had sure curative effects in healing acute bronchitis cough in cold. This test certificate jizhi dropill that its act is anchoring and quality holding. There are coincide in act and curative effects between formulation after reforming and old formulation.What’s more this new formulation not only advance bioavailability, fasten avail, take easementlycarryeasy, fit to all the people eluding diabetic patient,but also fabricate easy, bring low cifp.更多还原