Preparation And Preliminary Pharmacodynamics Research Of Transfer Factor Gel Injection

As a small molecule compounds,Transfer factor is a kind of non-toxic,no species specificity,which could enhance the immune effect,indeed.Transfer factor is a natural,safe and immune-enhancing drugs,which was usually used to prevent and treat of immune suppression diseases.Chitosan is a kind of natural polymer material with good biodegradability,which can form hydrogels to encapsulate small molecule drugs and achieve sustained release effect.In this study,we aimed at the shortcomings of the traditional dosage forms,such as transfer factor injection and oral liquid and the frequent administration times.a new type of transfer factors sustained-release gel injection with chitosan was constructed to achieve the long-term efficicacy and increase immunity.The main components of the transfer factor are peptides and ribose.A standard curve was established by the Folin-Phenol method and the dihydroxytoluene,which was used to quantify the polypeptide and ribose content.The porcine spleen transfer factor was extracted by dialysis,and the effects of freezing and thawing times,pH of homogenate,dialysis time,and ratio of dialysis on the extraction factor polypeptide and ribose extraction efficiency were examined by single factor and orthogonal experiments.The most transfer factor was obtained.Good extraction process for the study of transfer factor gel injection.The preparation of chitosan-glycerin-borax temperature-sensitive gel was optimized with chitosan as the gel material.The optimal prescription of transfer factor gel injection was obtained.The gelation time,viscosity,stability,sustained-release characteristics of the injection were investigated.The optimal TF gel injection was prepared by mixing 2% chitosan and glycerol in a ratio of 32:10 and adjusting to pH 6.7 with 7.5% borax solution.Quality evaluation of TF gel injection was well implemented.The gel temperature of TF gel injection is 36 ? with the gel time of 20 min,while the viscosity was 195mPa·S.The sterility test showed that the injection was qualified with good stability.The in vitro drug release assay showed that the cumulative release was 95% within 12 h.The study of abnormal toxicity showed that the transfer factor gel injection had no abnormal toxicity to normal mice,and could improve the organ index of the main immune organ thymus and spleen.Through the phagocytosis of the peritoneal macrophage,the transfer factor gel can improve the phagocytic capacity of macrophages in mice,and the effect is better than that of the transfer factor solution.The preparation method of the transfer factor thermosensitive gel injection is simple and repeatable.The quality is controllable,and it has the characteristics of natural safety,good stability and sustained release,etc.,and has a better application prospect.