芎冰滴丸药学

川芎是川产道地大宗药材,具有活血行气,祛风止痛的功能,主要用于治疗月经不调,经闭痛经,腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。为了实现对川芎药材资源的综合利用,在中医药基本理论的指导下,结合现代药理结果,本课题选择川芎挥发油和冰片配伍作为研究对象,制成芎冰滴丸,治疗偏头痛,以迅速减轻患者痛苦,丰富临床剂型,更好地为人类健康怎么写作。本实验首先以挥发油得率和藁本内酯含量为指标,采用单因素实验法对不同的川芎挥发油提取工艺进行了比较,确定选用共水蒸馏法进行提取,进而通过正交实验优化工艺条件,在最佳工艺条件下得到的川芎挥发油得率为0.45%左右,藁本内酯含量为61%左右。对川芎挥发油的质量标准进行了研究,结果表明挥发油中功能基主要有酚类、羰基类、内酯类、不饱和类等化合物,其相对密度为0.9909左右,折光率为1.5128左右,pH值为4.26左右,酸值为27.6左右,皂化值为223左右,藁本内酯含量为61%左右;为了保证制剂质量和临床疗效,采用留样观察法对川芎挥发油的稳定性进行了研究,结果表明,应将其置于-20℃避光、密闭条件下保存。采用小鼠扭体反应和热板法对川芎挥发油和冰片的配伍剂量进行了研究,结果表明,成人一日临床剂量可初步定为川芎挥发油40mg、冰片13mg;通过单因素实验法和正交实验法优选处方组成和制备工艺,确定了最佳处方为:药物(含占挥发油10%的淀粉及0.1%的维生素E)与基质比例为1:2,基质为PEG4000与PEG6000(1:1)的混合物。通过对滴丸的质量标准如含量测定、溶出度的研究表明滴丸具有可控性、稳定性。通过对溶出速率的测定,并以药物的β-CD包合物制得的普通片和胶囊为比较对象进行研究,发现滴丸的溶出速率明显优于普通片和胶囊。实验证明芎冰滴丸工艺稳定,质量可控,与其他口服固体制剂相比,具有速效的特点。

【Abstract】wWw.shuoshilunwen.com Chuanxiong,as a genuine staple herb of Sichuan,has a function of activating Qi and blood circulation,expelling Wind and alleviating pain.It’s clinical using lies mainly in treatment of disharmony of menses,amenorrhea and dyenorrhea,pain in abdomen,punctuating pain between the chest and hypochondrium,galls caused by tumbling,headache,torpid pain caused by rheumati.Under the guidance of basic theory of TCM,in combination of modern pharmacology and clinical experimental results,in this research,we chose naphtha of Chuanxiong matched with bormeol as study object,made them transdermal delivery system to improve the suffers’ acclimatization,reduce ill effections,enrich clinic dosage forms to serve people better, so as to realize the comprehensive utility of Chnanxiong.Aiming at the above problems,first,content of naphtha and ligustilide was chosen as indexes,single factor experiment as experimental method to compare various extraction technics of naphtha in Chuanxiong,and water-steaming extraction was determined;second,technical condition was optimized,and it is proved that under the best condition,extraction ratio of naphtha can be around 0.45%,while the content of ligustilide can be around 61%.Research into quality standard of naphtha in Chuanxiong was carried out,and the consequences showed that compounds such as hydroxybenzenes,carbonies,lactones, unsaturations were found in the naphtha,the relative density of which is about 0.9909,refraction ratio about 1.5128,pH value about 4.26,acid number about 27.6,saponification unmber about 223,content of ligustilide about 61%;leing-sample observation was adopted to study the stability of naphtha in Chuanxiong,and the results signified that the quality and clinical curative effect can be conserved under the circumstance of -20℃,oiding light,obturation.The pain threshold test and hot plate test were used to work over the matching dosage of Chuanxiong naphtha and borneol,and the outcome showed that the adults can take respectively 40mg and 13mg each day.We used the method of single fractor experiment and orthogonal design to optimize the prescription,finding out that the best prescription should be:the proportion of host herb(including starch and Vit E those occupying the proportion of 10%and 0.1%of the naphtha in Chuanxiong)and auxiliary material is 1:2;and the auxiliary material is the mixing of PEO4000 and PEG6000(1:1).The ligustilide pill’s quality was estimated synthetically by the study of quality standard,which proved that XiongBing-pill is stable and controllable.It was found that through determination of dissolution rate,comparing withβ-CD tablets of the content of naphtha and,XiongBing-pill is better than the other two ones concerning in dissolubility.The research verified that XiongBing-pill’s procedure is stable and the quality is controllable.Comparing with the other oral solid preparation,XiongBing-pill he fast reaction.

【关键词】 川芎;挥发油;藁本内酯;冰片;滴丸;偏头痛;
【Key words】 chuangxiong;naphtha;bornel;ligustilide;XiongBing-pill;one-sided headache;

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