复方栀子注射液的制剂学及质量标准研究

【作者】 吕茂平；

【导师】 王玥琦；

【作者基本信息】 北京中医药大学 ， 中药学， 2003， 硕士

【摘要】 心脑血管疾病是目前临床常见和多发病之一，而中风病又是一种具有较高发病率、病死率及致残率的心脑血管疾病。中医现代研究认为：“毒损脑络”是中风病发病的重要机理，中药对其显示了良好的效果。本方根据中医药理论和临床实践，选用栀子和人参茎叶总皂苷配伍，解毒和通络相配合恢复脑络功能，使气血得养脑神。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，暂命名为复方栀子注射液。本论文的内容主要包括：第一部分：为文献综述。综述一介绍了栀子的研究概况，对栀子的化学成分、药理作用、提取工艺和分析方法进行了系统综述。综述二介绍了中药及中药注射剂指纹图谱的研究进展情况。第二部分：对注射液的制剂工艺进行了研究：比较了栀子的提取方法，并用正交优选了其提取工艺和水沉工艺，比较了大孔树脂和颗粒活性炭对栀子苷纯化效果的影响，并对颗粒活性炭的工艺包括吸附量、洗脱方法等进行了考察，并用正交确定了炭柱纯化工艺。注射液的成型工艺中对pH值和灭菌条件对质量的影响进行了考察，并确定了等渗调节剂氯化钠的用量。第三部分：对复方栀子注射液的质量标准进行了研究，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》2000版一部起草了注射液的质量标准，并对栀子苷的含量测定方法进行了方法学考察，研究并制订了注射液、栀子半成品和栀子药材的指纹图谱。 第四部分：对复方栀子注射液的稳定性进行了研究，按照《中药新药研究的技术要求》考察了其初步稳定性。更多还原

【Abstract】 Cardiovascular disease is one of the common and multiplex clinical diseases, of which stroke is a big problem due to its high mortality and rate of deformity. Modern research of traditional Chinese medicine advanced that "toxin injuring collaterals of the brain" is the important mechanism causing stroke and Chinese material medicine have had great effect on it. According to traditional Chinese medicinal theory and clinical practice, we choose prescription made of Gardenia and matched with crude saponins of Gingseng stem and leaf which can remove toxin, activate collaterals and recover the function collaterals of the brain, nurture cerebra. we prepared them into injection for vein according to their chemical constituents and clinical trait, and named it Fufang Zhizi Injection. The paper mainly include : The first part： this part is the summarization of documents: Section one summarized the study survey of Gardenia, which included the chemical constituents、pharmacology、extract technology and analysis methods. Section two summarized the study evolution of fingerprint about traditional Chinese medicine and their injection.The second part: we investigated the preparation of the injection, compared two different extract technology of Gardenia and optimized its best method by orthogonal test, also its precipitation method by water. we compared the purification effect between macroporous resin and granule active carbon to extraction content of Gardenia and examined the influential factors including absorption quantity and washing method and so on, besides we confirmed the best purification way of granule active carbon to Gardenia by orthogonal test. About molding technology we investigated the effect of pH and methods of extinguish bacterium to quality of the injection, and quantity of regulation of Nacl. The third part: we drafted out the quality standard of the injection according to the technical demand of the study about injection of traditional Chinese medicine,the technical demand of the fingerprint about injection of traditional Chinese medicine and pharmacopoeia of the People’s Republic of China(1st section of 2000 edition).We also made the methodology investigation of content determination about geniposide.We formulated the fingerprint’s examination standard of the injection,also investigated the fingerprint about semi-manufactured goods of the injection and the crude drugs of Gardenia fixed producing area. The fourth part: we investigated the injection’s stability in normal temperature according to the technical demand of new drug study about traditional<WP=5>Chinese medicine.更多还原