Study On The Scale-up Synthesis And Quality Standard Of L-selenocystine

Organic selenium is the main form of selenium in organisms,mainly including selenoamino acids,such as selenomethylselenocysteine（Se Mc）,selenocysteine（SeC）,selenocystine（SeC2）and Selenomethionine（SeMet）.L-SeC2 has important physiological functions,including anti-oxidation,protecting the heart and liver,enhancing the function of the human immune system,stimulating the production of immune proteins and antibodies in the body,and effectively preventing gastrointestinal diseases.There are few reports on the synthesis of L-SeC2.There is currently no pharmacopoeial standard for L-SeC2.Therefore,this project has carried out a scale-up process study on the preparation process of L-SeC2 and established a draft quality standard for APIs.This article specifically includes the following two parts:（1）A L-SeC₂ preparation process route with cheap,easy-to-available raw materials,simple operation,and high yield obtained by our laboratory research was carried out to scale up the study,and the starting material L-serine methyl ester hydrochloride was used for chlorination and hydrolysis.,Replacement and other steps to carry out L-SeC₂ amplification process research.The results showed that the average total yield of L-SeC₂ in the scale-up experiment was 44.2%.The structure of L-SeC₂ can be confirmed by hydrogen nuclear magnetic spectrum,carbon spectrum and mass spectrum.The L-selenocystine method obtained by the synthesis process is economical,efficient,stable and reliable,and can be used for large-scale production to provide raw materials for functional health foods and medicines.（2）Preliminary drafting of L-SeC2 quality standard,and preliminary stability study of L-SeC2.Perform physical and chemical properties,structural confirmation,and general identification tests on L-SeC2;establish methods for content determination,residual solvent determination,general inspection and limit inspection;preliminary investigation of the stability of L-SeC2 in high temperature,high humidity,strong light and accelerated tests Sex.The results show that the general inspection and the general limit inspection are in compliance with the pharmacopoeia limits;the HPLC method is used to determine the content of L-SeC2 to verify the chromatographic method.The method has high accuracy,good precision and good linearity.L-SeC2 is stable under strong light and high humidity,and its content decreases under high temperature.The L-SeC2 quality standard of this study can provide reference for L-SeC2 synthesis control,provide basis for product evaluation,provide data for product packaging,transportation,storage and expiration date,and provide feasible basis for L-SeC2 research,production,and declaration.