Study On Quality Of Thymalfasin

Thymalfasin is 28 amino acid peptide compound, is prepared by solid phase synthesis process and the resin is used as carrier, is a good effect of immune modulator. Thymalfasin has been used to treat patients with immunodeficiency, virus infection and tumor in clinic, it is taken as the first-line drug for treatment of hepatitis B.The paper carried out researches to improve the quality standard of Thymalfasin and its preparation, provide a scientific basis for Chinese Pharmacopoeia Commission to revise quality control projects, explored the feasible methods to further improve the safety and the controllability of the quality standard of Thymalfasin.At present, Thymalfasin is mainly chemical synthesis, therefore in the synthesis process of Thymalfasin, raw materials, intermediate products, residual solvent, by-products and other production-related impurities will be introduced. These impurities affect the quality safety and efficacy of Thymalfasin, The quality standard of Thymalfasin of Pharmacopoeia of the People’s Republic of China(2010) guarantee the safety and effectiveness of this drug. With the improvement of testing technology, the popularity of instrument method and raise awareness of thymalfasin, more reliable method of identification and impurities test were set up.The paper mainly focus on safety and controllability the quality standard of Thymalfasin, and the researches are as follows:The peptide mapping analysis determined by HPLC was established.Because methanol, diethyl ether, acetonitrile, methylene chloride and N, Ndimethylformamide were used as solvents in the synthesis process of Thymalfasin, the method of the residual solvents were tested and validated. The results show that the method is applicable to test residual solvent of Thymalfasin.A molecular-exclusion chromatography method for the determination of polymer in Thymalfasin was developed and validated.A HPLC combined with precolumn derivatization with OPA was set up and validated for the analysis of the amino acid ratio in Thymalfasin.[D-Asn28]-thymalfasin in the system suitability test of the related substances in Thymalfasin was increased, the separation of [D-Asn28]-thymalfasin and [D-Ser1]-thymalfasin with Thymalfasin were greater than 1.2, and the limit of [D-Asn28]-thymalfasin and [D-Ser1]-thymalfasin were drafed.Through the above study, to further enhance and improve the existing legal standards of Thymalfasin, to provide a scientific basis for Chinese Pharmacopoeia Commission to revise quality control standard.