清肺注射液的药学研究

【作者】 兰姗；

【导师】 王玥琦；

【作者基本信息】 北京中医药大学 ， 临床中药学， 2007， 硕士

【摘要】 肺炎是目前临床常见和多发病之一,在中医学上属于风温肺热病范筹。中医现代研究认为:风热犯肺,肺气壅塞,失于清肃是其发病特点,辨证属“热毒壅肺”之证,应早期运用清热解毒方药急挫热势,清肺散邪,防止传变。本方根据中医药理论及临床实践,选用栀子和黄芩提取物相配伍,具有清热解毒之功。根据方中药味的化学成分及该方的临床特点,本方制成静脉注射液,暂命名为清肺注射液。本论文的内容主要包括:第一部分文献综述综述一、二分别介绍了栀子、黄芩的研究概况,对栀子、黄芩的化学成分、分析方法、药理作用进行了系统综述。综述三介绍了超滤技术在中药领域应用的研究进展情况。第二部分:清肺注射液的制剂学研究考察了药液溶解的pH值和冷藏时间;采用正交试验优选了活性炭工艺;采用析因试验考察了超滤法除热原的工艺;考察了pH值和灭菌条件对注射液质量的影响;确定了等渗调节剂氯化钠的用量。第三部分清肺注射液的质量标准研究根据《中药注射剂研究的技术要求》、《中药注射剂指纹图谱研究的技术要求(暂行)》和《中华人民共和国药典》2005版一部起草了清肺注射液的质量标准,对栀子苷、黄芩苷的含量测定方法进行了方法学考察,并对注射液、栀子半成品及原料的指纹图谱进行了初步研究。第四部分:清肺注射液细菌内毒素检查的研究参照《中华人民共和国药典》2005版一部,研究并确定了本注射细菌内毒的检查方法。更多还原

【Abstract】 Pneumonia is one of the common and multiplex diseases in clinical practice. It belongs to the“wind-warm and lung heat syndrome”in Chinese medicine,modern research shows :wind-heat attacking lung leeds to pulmonary qi obstruction which causes the failure of lung’s purifying function,which is the prominent feature of the disease .Disease differentiation is“heat toxin accumulating in lung”,in the early stage we should apply the method of clearing heat and removing toxin .According to the theories of traditional chinese medicine and clinical practice, we choose prescription made of Gardenia and the extract of Scutellaria,which is effective in clearing heat and removing toxin.we make them into intravenous injection according to their chemical constituents and clinical traits,and name it as Qingfei Injection. This thesis mainly includes four parts: Part I Literature reviewReview I and II is an introduction of our research on the Gardenia and Scutellaria, which includes the chemical constituents, analysis method and pharmacological action. ReviewⅢdicusses the development of the application of ultra filtration technology in Chinese medicine. Part II research on Qingfei injectionsExaming the pH of medical dissolution and frozen time; optimizing activated carbon technology by orthogonal test; Screening the ultra-filtration method to get rid of the original thermal process by factorial experiments;Investigating how PH and condition of asepsis influence the quality of the injection; determining dosage of regulator isotonic sodium chloride.Part III Quality standard of Qingfei injectionAccording to“the technical standard of the study of injuection of traditional Chinese medicine”,“the technical requirements of the fingerprint study about injection of traditional Chinese medicine”and“People’s Republic of China Pharmacopoeia(2005 version)”,we have set up quality standards of Qingfei injection , methodological study of testing geniposide, baicalin content and conducting a preliminary fingerprinting study on injection,semi-manufactured and the crude drugs.Part IV: Bacterial endotoxin testing study of Qingfei injectionDetermining the method of testing bacterial drug injection according to the“People’s Republic of China Pharmacopoeia”.更多还原