A kind of preparation method of insulin glargine injection and insulin glargine injection prepared thereof

Abstract

The invention provides a preparation method of insulin glargine injection and the prepared insulin glargine injection. The preparation method comprises: dissolving glycerin with part of water for injection, preparing a glycerol solution, and then dividing it into three parts, adding insulin glargine, m-cresol and zinc chloride respectively; Glycerin solution is mixed evenly to obtain mixed solution I; then hydrochloric acid solution is added to the mixed solution I to pH=3.0~3.5, then zinc chloride-glycerin solution is added, stirred evenly, then sodium hydroxide solution is added to pH= 3.5-4.5; finally dilute to the final volume with water for injection. The preparation method of the present invention can rapidly dissolve insulin glargine and other auxiliary materials, significantly shorten the preparation cycle time, reduce process impurities generated during the preparation process, improve the quality of insulin glargine injection, reduce process energy consumption, and improve production efficiency , more suitable for large-scale production needs.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a method for preparing insulin glargine injection and the prepared insulin glargine injection. Background technique [0002] Insulin glargine is a long-acting analog of human insulin used in adults and children with type 1 diabetes and in adults with type 2 diabetes. After subcutaneous injection, it can form a stable hexamer, increase the binding force between molecules, delay the time of dissolution and absorption, and release a small amount of insulin glargine continuously, so it has a predictable, long-acting, stable, and no peak Plasma concentration / time profile. Because of its long-acting nature, insulin glargine only needs to be administered by subcutaneous injection once a day at a fixed time. However, patients with type 1 diabetes and type 2 diabetes who fail to take oral hypoglycemic drugs need to use insulin products for life to control blood sug...

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Problems solved by technology

[0004] Since the stability of insulin glargine will be greatly reduced in an overacid and overalkaline environment, the tendency of aggregation due to heat and physical and mechanical stress will increase, and physical means such as stirring will inevitably be used in the preparation of injections, which will bring pressure to the preparation. unwanted impurities

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