Thymalfasin compound and novel preparation method thereof

Abstract

The invention discloses a thymalfasin compound prepared by the following processing steps: dissolving a thymalfasin crude product in an alcohol solvent or trifluoroacetic acid, adding a buffer solution at the pH of 2.0-4.0, adding activated carbon to perform adsorption, filtering, collecting filtrate, and carrying out decompression concentration; utilizing a preparation type neutral alumina chromatographic column to perform separating purification to the concentrated solution, collecting eluent, sequentially using a plate frame and a filter membrane to perform filtration, utilizing an ultrafiltration membrane to perform ultrafiltration concentration of the filtrate, and obtaining secondary concentrated solution; slowing adding ethyl ether into the obtained concentrated solution, mixing, performing gradient cooling, precipitating thymalfasin, performing centrifuged washing to the precipitated thymalfasin, and obtaining the purified thymalfasin after drying through a solid drier. The thymalfasin obtained by the method is high in purity, toxic and side effects of prepared medicines for curing chronic hepatitis B and illness causing damage of various immunity functions in the using process are reduced, product quality of a preparation is improved, and the thymalfasin is suitable for industrial mass production.

Description

technical field [0001] The invention relates to a novel thymus compound and a new preparation method thereof, through which high-purity thymus farsin can be obtained, and belongs to the technical field of medicine. Background technique [0002] Thymosin α1 (Thymosin α1, also known as thymosin α1) is the main biologically active component of thymosin, an important immunomodulatory substance in the body, a polypeptide composed of 28 amino acids acetylated at the nitrogen end, calculated as a dry product, containing thymosin α1 (C 129 h 215 N 33 o 55 ) is not less than 95.0%. Studies have shown that thymus fasin promotes the development and differentiation of bone marrow stem cells into pro-lymphocytes and pro-lymphocytes; induces the differentiation and maturation of T lymphocytes, and further differentiates mature T cells into several different subgroups, such as killer cells and memory cells , effector cells, counseling T lymphocytes, etc., and produce various soluble m...

AI Technical Summary

Problems solved by technology

[0006] It can be seen that the methods in the prior art have many steps and are not suitable for industrial production; or the yield is low, a large amount of raw materials are consumed, resulting in high costs, or toxic solvents are used, resulting in toxic residues of the drug, which affects the preparation products quality

[0007] In addition, although the highest purity of thymus fasin currently obtained can reach 99.6% or even higher, this can only be obtained through special purification methods. The purity of thymus fasin obtained by general preparation or extraction methods is due to improper control of the production process, etc. It is not high, so it is not suitable for direct use, and even if the purified thymus fasin is improperly stored or stored for a long time, the content of active ingredients of the drug will decrease, the color will be strengthened, and the content of related substances will increase, especially If there are high molecular impurities, there will be sensitization and unknown physiological reactions