Preparation method of thymopetidum injection

Abstract

The invention discloses a preparation method of a thymopetidum injection, comprising the following steps of: mixing and grinding thymic tissues of calves or pigs and an aqueous sodium chloride solution; regulating a pH value to 3.5-4.5; freezing at the temperature from 15 DEG C below zero to 22 DEG C below zero; thawing and heating frozen mixed and ground fluid to the temperature of 33-37 DEG C; homogenizing the liquid to obtain homogenate; heating the homogenate to the temperature of 80 DEG C; insulating for 30 minutes; separating to obtain supernatant fluid; mixing the supernatant fluid and ethanol; standing; separating again; concentrating; regulating a pH value of concentrated fluid to 7.5-8.5; then, heating the concentrated fluid to the temperature of 80 DEG C; insulating for 30 minutes; cooling and centrifugally separating to obtain third supernatant fluid; after hyperfiltering and clarifying by an ultrafiltration membrane step by step, obtaining a thymopetidum solution; adding water for injection into the thymopetidum solution in order to regulate thymopetidum content of 2.5mg or 5mg or 10mg in each milliliter of the thymopetidum solution; adding a stabilizing agent; and obtaining the thymopetidum injection after being sterilized. In the prepared thymopetidum injection, the content of high polymer substances is smaller than 0.5 percent and is further lower than a standard rule of China.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals, and in particular relates to a preparation method of thymosin injection. Background technique [0002] Thymosin Injection, formerly known as: Thymosin Injection, Thymus Factor Injection, Thymus Factor D Injection, is a polypeptide aqueous solution with a molecular weight less than 10,000 Daltons extracted from healthy pig or calf thymus tissue. This product has the function of regulating and enhancing the immune function of the human body, and can promote the maturation of T-lymphocytes. It is used for the treatment of various primary or secondary T cell deficiency diseases, some autoimmune diseases, various diseases with low cellular immune function and adjuvant treatment of tumors. [0003] At present, some preparation techniques related to thymosin have been disclosed, including processes such as freeze-thaw cell breakdown, centrifugation, ultrafiltration, and concentration. Usually include...

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Problems solved by technology

[0004] The above-mentioned process only removes miscellaneous proteins through thermal denaturation, but cannot fully and effectively remove various miscellaneous proteins. Failure to effectively remove miscellaneous proteins may cause allergic reactions; secondly, the thermal denaturation time is short, and various animal-derived viruses cannot be effectively removed, making the preparation There is a risk of virus contamination; in addition, amino acids and small peptides in the injection are prone to polymerize into macromolecular substances and precipitate, making the preparation unstable and prone to allergic reactions

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