Study On The Quality Standard Of Polaprezinc

Polaprezinc is a complex product formed by the chelation of zinc acetate and L-carnosine.It belongs to the class of defense factor drugs and is widely used in the treatment of gastric ulcers in Japan.Polaprezinc mainly protects and repairs gastric mucosa by reducing inflammatory cytokines,increasing the expression of antioxidant enzymes,growth factors and heat shock proteins.However,there are no pharmacopoeial standards for polaprezinc crude drug and its preparations at home and abroad now.The purpose of this study is to determine various indicators related to the quality control of polaprezinc crude drug,and to lay the foundation for the establishment of its quality standards.According to the guiding principles and method monograph of Chinese Pharmacopoeia(2015 Edition),this project has established a comprehensive quality evaluation system for polaprezinc crude drug through research on physical and chemical properties,identification,general impurity test,residual solvent inspection,free amino acid detection,content determination,related substances inspection and stability studies.The physical and chemical properties of polaprezinc crude drug include appearance,solubility,melting point,hygroscopicity and so on.The identification of polaprezinc crude drug was realized by the combination of chemical method,fourier transform infrared spectra(FTIR),and high-performance liquid chromatography(HPLC).The general impurity test of polaprezinc crude drug includes the inspection of sulfate,chloride,iron salt,loss on drying,burning residue,heavy metals,pH value and so on,and the limits are specified.A headspace gas chromatography(HS-GC)method for the inspection of residual solvents such as methanol,ethanol,and ethyl acetate in polaprezinc crude drug was established,and methodological verification was performed.A high-performance capillary electrophoresis(HPCE)method for the detection of free amino acids in polaprezinc crude drug was established,and its methodology was verified.A hydrophilic interaction chromatography(HILIC)method for the determination of L-carnosine wasestablished,and it was applied to the determination of polaprezinc crude drug and the inspection of its related substances.At the same time,a preliminary study and investigation on the stability of polaprezinc crude drug was conducted in order to provide a reasonable reference for the establishment of expiration date and a series of conditions,such as packaging,storage,transportation,etc.In this project,a complete,effective and applicable quality inspection and control method has been developed and established through the research on the quality attributes of polaprezinc crude drug.It not only lays a foundation for the establishment of the quality standards of polaprezinc crude drug,but also provides a reliable reference for the development of polaprezinc preparations,which is the foundation and guarantee for the research of new drugs.