Preparation method of insulin glargine injection and insulin glargine injection prepared by using preparation method

Abstract

The invention provides a preparation method of an insulin glargine injection and the insulin glargine injection prepared by using the preparation method. The preparation method comprises the following steps: dissolving glycerol into part of water for injection to prepare a glycerol solution, then dividing the glycerol solution into three parts, and respectively adding insulin glargine, metacresol and zinc chloride; firstly uniformly mixing an insulin glargine-glycerol solution and a metacresol-glycerol solution to obtain a mixed solution I; then adding a hydrochloric acid solution into the mixed solution I until the pH value is equal to 3.0 to 3.5, then adding a zinc chloride-glycerol solution, uniformly stirring, and then adding a sodium hydroxide solution until the pH value is equal to 3.5 to 4.5; and finally stabilizing the volume to reach a final volume by using the water for injection. By adopting the preparation method provided by the invention, insulin glargine and other auxiliary materials can be rapidly dissolved, the preparation cycle time can be significantly shortened, process impurities produced in a preparation process can be reduced, the quality of the insulin glargine injection can be improved, the process energy consumption can also be reduced, and the production efficiency can be improved; and the preparation method can be more suitable for the requirements of large-scale production.

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...

AI Technical Summary

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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