茶多酚分散片的药学研究和初步药效学研究-药剂学专业论文.docxVIP

成都中医药大学硕士学位论文 成都中医药大学硕士学位论文 PAGE PAGE 4 摘 要 茶多酚分散片是由茶叶提取物茶多酚制成的制剂，用于治疗家禽沙门氏菌或 空肠弯曲杆菌感染。本论文根据大量的文献资料以及临床用药的要求，结合药物 性质，对原料药质量标准、制剂制备工艺、质量标准、稳定性、初步药效学试验 进行了系统研究。 本论文拟定了茶多酚原料的质量标准。在制备工艺研究中，以崩解时限为 指标，采用单因素试验和正交试验的方法，对辅料种类、用量、加入方式等和制 备工艺参数进行了优选。质量标准研究中采用理化鉴别法对制剂中的茶多酚进行 定性鉴别，考察了制剂的体外溶出行为，建立了多酚类的含量测定方法，制定了 制剂质量标准。稳定性研究中，对三批中试产品进行了 0～3 月的考察，结果各 项指标均符合规定。药效学试验采用试管二倍稀释法，测定了本制剂对沙门氏菌 和空肠弯曲杆菌的抑菌作用，测定结果显示茶多酚分散片对沙门氏菌的 MIC 为 6.25mg/mL,对空肠弯曲杆菌的 MIC 为 25mg/mL。 研究结果表明，该制剂制备工艺科学、合理、稳定、可行，质量标准可控， 成品性质稳定，制剂对沙门氏菌和空肠弯曲杆菌有一定的抑菌效果。 关键词：茶多酚分散片；制备工艺；质量标准；稳定性； Abstract The tea polyphenols dispersible tablet comes from tea leaves extractive—tea polyphenols, using to cure Salmonella or Campylobacter jejuni infection.Through analyzing the related literature ,on the basis of the function and treatment as well as clinical medication requests, studied the quality tea polyphenols’criteria、quality standard、stability、initial pharmacodynamics experiment of the crude drug. This study determined the quality standard of the tea polyphenols crude drug. In the preparation route, selecting the disintegration time as the index, use one-facor experimental design and orthogonal experiment to optimize the preparation parameter, such as the type、dosage and the adding way of the adjuvants. The quality standard study using Physical and Chemical identification method to identify the tea polyphenols and testing its dissolution,also established the content assay method for Polyphenols and the quality standard. In the stability study was done to the 3 bacths of semi-works production for 3 months,and every indicator accoded with the definition. The pharmacodynamics experiment using tube dilution method determined the MIC,Salmonella 6.25mg/ml is and Campylobacter jejuni 25mg/ml. A systematic study on the procedure,quality standards and the preliminary pharmacodynamics on The tea polyphenols dispersible tablet has been carried out .it is a good basisi for register of new medicine.the pharmaceutics is effect to Salmonella