Ciclosporin medicament composition for injection administration

Abstract

The invention relates to ciclosporin medicine composition of injection drug administration, comprising ciclosporin which serves as an active ingredient, Carmowax15-hydroxystearate (solutol HS 15) which serves as a solubilizer, alcohols or esters which serve as latent solvent and water for injection which serves as solvent. The medicine composition can be prepared into injecta or lyophilized preparation. The medicine composition of the invention not only solves the problem that severe anaphylactic reaction exists as the existing ciclosporin injecta contains much Cremophor EL, but also preventssevere anaphylactic reaction from occurring and causes little acrimony; the medicine composition also solves the problem that the previous technology can not solve the stability and solubility of theciclosporin injecta and avoids the insufficiencies of complex preparation technique and low cost caused by the adoption of technologies such as nanometer technology and lipidosome technology; the medicine composition further solves the technical problem of the stability and solubility of lyophilized powder injecta, which can not be solved by the previous technology, as a result, the medicine composition features good stability and solubility; the preparation technique of the injecta is simple, the quality control is simple and convenient, the production cost is relatively low, thus greatly reducing economic burden of the patients in terms of medicine use.

Description

technical field [0001] The invention relates to a pharmaceutical composition for injection with cyclosporine as an active ingredient, in particular to an injection and a freeze-dried powder for injection pharmaceutical composition with cyclosporine as an active ingredient. Background technique [0002] Cyclosporin is a cyclic polypeptide containing 11 amino acids produced by fungal metabolism, which can prolong the survival of allograft organs and tissues such as skin, heart, kidney, pancreas, bone marrow, small intestine and lung, and is a third-generation highly effective immunosuppressant . Studies have shown that cyclosporine can inhibit cell-related reactions, delayed hypersensitivity of the skin, anti-host transplantation diseases and T cell-dependent antibody production, and is widely used clinically to prevent and treat rejection after organ transplantation and bone marrow transplantation and graft-versus-host disease. Compared with other immunosuppressants, cyclos...

AI Technical Summary

Problems solved by technology

[0009] In view of the above-mentioned deficiencies in the prior art, the purpose of the present invention is to provide a cyclosporine pharmaceutical composition for injection that does not contain polyoxyethyl castor oil Cremophor EL, to overcome the serious problems of existing cyclosporine injections. Insufficiencies such as toxic and side effects solve the stability and resolubility problems of cyclosporine injections that cannot be solved in the prior art, and provide patients with a drug with low toxic and side effects, simple production process, low cost, high stability, and high solubility. Cyclosporine injection with good quality, convenient storage and transportation, and high clinical drug compliance

Images