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配方用天麻冲服饮片的药学研究
【作者】 胡原;
【导师】 宋英;
【作者基本信息】 成都中医药大学 , 药剂学, 2007, 硕士
【摘要】 天麻是临床常用药物,功效平肝息风止痉,用于头痛眩晕,肢体麻木,小儿惊风,癫痫抽搐,破伤风。临床配方应用包括煎服和冲服,其中冲服法无统一标准,影响了天麻的临床应用。本研究在中医基础理论指导下,参考中药散剂和中药配方颗粒的研究模式,对配方用天麻冲服饮片进行了系统的研究。天麻冲服饮片由天麻单味中药加工而成,根据临床用药需要,结合天麻所含化学成分分析,采用超微粉碎技术,以粒度分布和冲调性这两个指标,确定了本品可行的制备工艺条件,并制定出操作性较强的工艺流程。同时,对质量标准进行了系统研究,主要研究了鉴别(薄层鉴别),检查(粒度分布,分散性等),含量测定(本品每克含天麻素(C13H18O7)计,不得少于1.653mg/g。)等。并对该冲服饮片进行了常温留样稳定性研究,结合本品采用的现有包装,产品质量在实验期间无明显变化,各项指标均较稳定。比较了小鼠灌胃天麻冲服饮片和天麻细粉的急性毒性反应,评价了天麻冲服饮片的安全性。实验结果表明:制备工艺合理可行,质量标准稳定可控,成品安全、有效、稳定。
【Abstract】 Tian Ma is common medication in clinic ,Its function is calming the liver to stop wind and relieving convulsion , its indications is vertigo ,numbness of the limbs, infantile convulsion ,twitching due to epileptic,tetanus.Take the medication including decoction and mixing with water .Affecting its clinic application due to no uniform standard in preparing procedure. The study has been complete and deep done according to the guidance of the theory of Traditional Chinese Medicinc and pharmacy(TCMP) and the standard related law.Instant Tian Ma ultra-fine powder is made up of Tian Ma cut crude druge, Considering clinical demand of taking medicine and the component in the Tian Ma,we studied the mean particle size and the Dissolving quality of Tian Ma Ultra-fine powder.We not only confirmed the feasible preparing procedure according to mean particle size and Dissolving quality, but also established process route.At the same time,we finished a complete and deep study on the quality evaluation of Instant Tian Ma ultra-fine powder ,Including the name , ingredient , procedure , description, identification,otherrequirements,assay action,indication, useage&dosage , specification,storage and. Precaution The steability was fulfilled,which indicate that the prepare technique of the sample was steady on the whole as well.
【Key words】 Instant Tianma ultra-fine powder; Preparation procedure; Quality standard; Stability; safety research;