【作者】 姚雪莲；

【导师】 苏明武；

【作者基本信息】 湖北中医学院 ， 中药学， 2004， 硕士

【摘要】 银仙通肺宝颗粒是由紫金牛、银杏叶、淫羊藿、黄芪、制首乌、重楼、陈皮、川芎、当归、五味子所组成。经多年的临床实践证明，对慢性支气管炎的治疗有效率达93％。该方是集中医理论、现代研究和临床经验为一体的良好组合。 本课题研究是在临床疗效可靠的前提下，从药学及药效学角度对银仙通肺宝颗粒进行了系统的研究，为把本制剂开发成新药奠定了基础。本课题首先采用正交设计法优选切合实际的最佳制剂工艺。质量标准方面对本品中所含陈皮、黄芪、五味子、淫羊藿、银杏叶进行了薄层色谱定性鉴别的研究；对本品中紫金牛的主要有效成分岩白菜素进行了含量测定研究，初步确定了其含量限度，并对其含量测定方法进行了方法学研究，制订了控制该制剂质量的质控指标；采用加速试验法(40℃，75％)对三批样品进行了初步稳定性考察研究；药效学方面主要考察了本品对二氧化硫熏法建立慢性支气管炎动物模型的抗炎作用，以及该制剂的止咳、平喘、化痰作用。实验研究结果如下： 经筛选的最佳制剂工艺为：处方中陈皮、川芎、当归、五味子的挥发油提取时间为8小时，提取后的药渣再加水煎煮2次，第一次加8倍量的水，煎1小时，第二次加6倍量的水煎0.5小时，合并煎液，合并液浓缩成相对密度约为1.02(80℃)，加入乙醇沉淀，醇沉浓度为60％；处方中银杏叶、紫金牛、淫羊藿、黄芪、制首乌、重楼采用60％乙醇渗漉，渗漉液流速为5mL／min。 质量标准研究结果表明：所得成品中所含陈皮、黄芪、五味子、淫羊藿、银杏叶色谱斑点清晰，特征性强，重现性好，阴性无干扰；本品含紫金牛以岩白菜素计每袋不低于30mg。方法学研究结果表明：该方法的稳定性、精密度、回收率均符合定量分析要求，可作为本品的质控指标； 初步稳定性结果表明：本品性状、鉴别、检查、含量测定等项在三个月内未发生变化，说明本品在二年内质量稳定； 急性毒理学实验结果：通肺宝颗粒剂一次灌胃给药小鼠最大耐受量大于200g／kg。表明本品是一种低毒、安全的中成药制剂。 药效学试验结果表明：1．本品可显著延长豚鼠枸橼酸喷雾引致咳嗽潜伏期，具有镇咳作用；2．银仙通肺宝颗粒可使小鼠气管粘膜排泌的酚红量增加，有化痰作用；3．银仙通肺宝颗粒可显著延长组织胺、乙酰胆碱喷雾引致的豚鼠哮喘潜伏期，具有平喘的作用；4．银仙通肺宝颗粒可减轻小鼠慢性支气管炎模型气管、支气管的慢性炎症病变；5．银仙通肺宝颗粒可减轻豚鼠肺气肿模型的支气管及肺组织的病变；6．银仙通肺宝颗粒MIC试验对肺克杆菌、绿脓杆菌、金黄色葡萄球菌有较强的抑制作用；7．银仙通肺宝颗粒可抑制二甲苯致小鼠耳廓急性炎性肿胀，具有抗炎作用；8．银仙通肺宝颗粒对棉球植入致小鼠肉芽组织增生有显著地抑制作用，具有抗炎作用。更多还原

【Abstract】 Yinxiantongfeibao granules consist of Herba Ardisiae Japonicae Folium Ginkgo, Herba Epimedii, Radix astragali, Pericarpium citri reticulatae, Fructus schisandrae chinensis Radix polygoni multiflori preparata Rhizoma paridis Rhizoma chuanxiong. Radix Angelicae sisensis. It has a good effect treating Chronic Bronchitis according to clinical experimentation for many years .The effective rate is 93%. The TCM formula is better combining the theory of TCM and the modern research and clinical experience into one.On the premise of reliable effect in clinic , It’s pharmaceutics and pharmacology were systematic studied so that setting up the foundation of the preparation standardization and the new medicine’s report to higher body.The first in this study,extrative condition were researched by orthogonl design and the best preparation process were determined. In quality standards studies,the study on TLC identification method for Pericarpium citri reticulatae , Radix astragali , Fructus schisandrae chinensis, Herba Epimedii, Folium Ginkgo was carried out.Then we established the content determination method of Herba Ardisiae Japonicae.Determination the content of Bergenin and the content-limited by HPLC.We also studied the preliminary stability about three types of Yinxiantongfeibao granules by constant temperature acceleration tests(40℃ ,75%).In medical effects,the lowering effect was researched to Chronic Bronchitis of animal made model,in this study ,the effect to Antitussive , De-sputum and Anti-asthma was determined.In acute toxic test,the maximun tolerance dose was also determined.The experimental results have shown that the TLC spots of Pericarpium citri reticulatae, Radix astragali Fructus schisandrae chinensis, Herba Epimedii and Folium Ginkgo were very clear in the prepartion.and had repeatability.The content Bergenin is not lower than 30mg/dai.the stabilities, sensitives, recoveries accord to the demands of qualitative analyses.These method can be used as a quality content method.The preliminary stability result indicated that characters , indentification, test, contentdetermination unchanged in three month.it showed that the quality of Yinxiantongfeibao granules is stabilized.The pharmacological results have proved that this preparation has a better functions to threat Chronic Bronchitis and Obstructive Emphysema. And the acute toxic test results have proved that Yinxiantongfeibao granules is low toxicity,and take it is safety and effective.更多还原