【作者】 苏瑾；

【导师】 于敏；

【作者基本信息】 佳木斯大学 ， 生药学， 2007， 硕士

【摘要】 目的:通过实验筛选逐瘀通脉滴丸的最佳制备工艺,研究质量控制方法,按《中国药典》(2005年版)规定项目进行质量检查;探讨逐瘀通脉滴丸对高粘血症及心脑血管疾病的治疗作用,为该制剂的应用提供临床前研究资料。方法:通过单因素筛选和正交实验,进行逐瘀通脉滴丸制备工艺及中试制备条件的研究;用薄层色谱法(TLC)、高效液相色谱法(HPLC)对逐瘀通脉滴丸进行定性鉴别和含量测定;测定滴丸的丸重差异及崩解时限,按《中国药典》(2005年版)规定项目进行质量检查;在逐瘀通脉滴丸对高粘血症及心脑血管疾病治疗作用的研究中,采用大鼠皮下注射大剂量肾上腺素(Adr),以冰水浸泡建立急性血瘀模型,采用小鼠尾静脉注射胶原蛋白—肾上腺素混合诱导剂形成小鼠体内血栓,以ADP诱导血小板聚集,以断颅法造成小鼠脑循环障碍模型,应用垂体后叶素造成大鼠心肌缺血,观察逐瘀通脉滴丸的药效作用。结果:得出不同的基质配比、药物与基质的配比、滴头大小、滴距、滴速是影响滴丸成型的主要因素,筛选出逐瘀通脉滴丸的最佳制备工艺;大黄素、大黄酚的定性鉴别和含量测定方法可以作为滴丸的质量控制方法;动物实验表明逐瘀通脉滴丸可以明显降低血小板聚集率,改善血液流变性和心脏功能,延长动物的出血时间和凝血时间,具有很强的活血化瘀作用。结论:逐瘀通脉滴丸对高粘血症、血栓具有较好的治疗作用,有良好的开发前景。更多还原

【Abstract】 Objective : To establish the optimum preparation process for Zhuyutongmai drop pills. Study its standard for quality control and test 3 batches of product according to ChP2005. To investigate the therapeutic effects of Zhuyutongmai drop pills on hyperviscosity and cardiovascular and cerebrovascular diseases (CVD) which laid a foundation for application in medical domain.Methods : To investigate the preparation technique and optimal formulation of Zhuyutongmai drop pills based on the studies of influential factors, optimal formulation was obtained by the orthogonal design. The pills was identified by TLC.The HPLC method was used to determine the content of chrysophanol . To determine the the weight deviation and disintegration time of the drop pills according to ChP2005. Studied the therapeutic effects of Zhuyutongmai drop pills on hyperviscosity and cardiovascular and cerebrovascular diseases (CVD) with the acute blood stasis model which was made by immersing the rats into ice-water bath and injecting adrenalin hydrochloride(i.p.). The thrombus formation in mice was induced by i.v injection of a mixture of collagen and epinephrine.Platelet aggregation was induced by ADP . The model of disturbance of cerebral circulation in mice was established by cutting mice’s heads, and acute myocardium ischemia rat model was made by sublingual venous injection of Pit.Results :The main factors for drop pills′moulding technics were the choice of substrate、itsproportion of substrate to drug、the dropping and cooling agent temperature and dropping speed. The identified and determined of chrysophanol could be the standard for quality control. The results of experiment showed that Zhuyutongmai drop pills has the pharmacological action of promoting circulation to remove blood stasis.It could significantly inhibit the maximal aggregation rate of plateles, improve hemorheology and ischemic cardiac muscle, prolong the bleeding time and clotting time.Conclusion : Zhuyutongmai drop pills has significantly therapeutic effects on hyperviscosity and thrombus which is worthy of exploitation.更多还原