Thymopent aqueous solution preparation and use thereof

Abstract

The present invention discloses a thymopent aqueous solution preparation, wherein thymopent is adopted as an active component raw material, a pharmaceutical adjuvant and water are added, and mixing is performed to prepare the thymopent aqueous solution preparation, wherein the adjuvant comprises an acetic acid-sodium acetate buffer solution adopted as a pH value adjustment agent, calcium sodium ethylene diaminetetracetate adopted as a protection agent, and sodium chloride adopted as an osmotic pressure adjustment agent, the thymopent amount is 0.1-100 mg / ml, the acetic acid-sodium acetate buffer solution amount is 1.5-1500 mg / ml, the calcium sodium ethylene diaminetetracetate amount is 0.1-40 mg / ml, and the sodium chloride amount is 0.3-300 mg / ml. The thymopent aqueous solution preparation has characteristics of stable low temperature long-time storage, stable room temperature storage, and stability under a strong illumination condition, and does not generate significant change after storing for 5 days at a high temperature of 60 DEG C so as to reduce transportation requirements, provide convenience for drug transportation, substantially reduce a drug cost, and timely provide drug requirements for patients.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to an aqueous solution preparation of thymopentin and its application in the preparation of medicines for treating chronic viral hepatitis, tumors and other immune diseases, and belongs to the field of medicines. Background technique [0002] Thymopentin (TP-5) consists of 5 amino acid residues (Arg-Lys-Asp-Val-Tyr), which is similar to 32-36 of the 49 amino acids of thymopoietin (TP) The bit sequence is the same, and it has been proved that TP-5 is a functionally active fragment of TP, and TP-5 has similar physiological activities of TP. [0003] Pharmacological effects of thymopentin: it is an immunomodulatory drug, one of its functions is to induce T cell differentiation. It selectively induces the conversion of Thy-1- prothymocytes into Thy-1+ T cells. Its T cell differentiation is mediated by increased intracellular cAMP levels. Another basic role of thymopentin is to bind to ...

AI Technical Summary

Problems solved by technology

[0010] From the above patent information, it can be seen that by adding protective agents, antioxidants, pH regulators and other auxiliary materials in combination with the active ingredients of thymopentin, it can stabilize the thymopentin aqueous solution as a whole, especially at low temperatures of 2-10 °C , are easy to store stably, but as the temperature rises, such as at room temperature, the time of stable storage is significantly shortened, and at an environment higher than room temperature, especially higher than 40 ° C, the stability of the solution cannot be basically maintained sex

[0011] During the transportation of medicines in summer, the outdoor temperature is often above 40°C. The use of special transportation vehicles with cooling equipment not only increases the cost, but also has great limitations. Therefore, it is necessary to provide a thymopentin water-soluble preparation with higher stability, especially at a higher temperature of 40°C.

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