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

A technology for insulin glargine and injection, which is applied to medical preparations containing active ingredients, pharmaceutical formulas, metabolic diseases, etc. It can solve the problems of decreased stability of insulin glargine, reduce the probability of adverse reactions, and reduce the preparation time Shortening, suitable for long-term use

Active Publication Date: 2017-11-17
TONGHUA DONGBAO PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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

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preparation example Construction

[0041] Preparation method 1 (preparation method provided by the present invention): (1) take a 1L beaker, add a rotor, place it on a magnetic stirrer, add glycerin and 600mL water for injection, and dissolve the glycerin under stirring to obtain a glycerin solution; (2) Pre-dissolve the glycerol solution described in 180mL, 300mL, and 120mL of refined insulin, m-cresol, and zinc chloride respectively to obtain insulin glargine-glycerol solution, m-cresol-glycerol solution and zinc chloride-glycerol solution; (3) the The insulin glargine-glycerin solution is mixed with the m-cresol-glycerin solution, and stirred evenly to obtain a mixed solution I; (4) under stirring, add 0.1mol / L hydrochloric acid solution to the mixed solution I until pH=3.0~ 3.5, insulin glargine dissolves rapidly, and the solution is clear; (5) Add zinc chloride-glycerin solution, stir evenly; (6) Dilute to 900mL with water for injection, add 0.1mol / L sodium hydroxide solution to adjust pH=4.0 (7) Dilute to...

Embodiment 1

[0046] Example 1 Insulin glargine injection prepared by different methods

[0047] The insulin glargine injection described in this implementation contains insulin glargine 100IU / mL, glycerol 17mg / mL, m-cresol 2.7mg / mL, zinc 30μg / mL, hydrochloric acid, sodium hydroxide and water for injection, pH=4; Preparation method 1, preparation method 2, preparation method 3 and preparation method 4 were used to prepare insulin glargine injection respectively, and the time required for the preparation cycle was recorded, and the results are shown in Table 1.

Embodiment 2

[0048] Example 2 Insulin glargine injection prepared by different methods

[0049] The insulin glargine injection described in this implementation contains insulin glargine 100IU / mL, glycerol 16mg / mL, m-cresol 3.2mg / mL, zinc 27μg / mL, hydrochloric acid, sodium hydroxide and water for injection, pH=4. According to the above-mentioned preparation method 1, preparation method 2, preparation method 3 and preparation method 4, respectively prepare insulin glargine injection, and record the time required for the preparation cycle. The results are shown in Table 1.

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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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K38/28A61K47/10A61P3/10
Inventor 王文娜郭银汉武晓丽牛丁唐伟举詹巾卓秦丽静孙洪艳
Owner TONGHUA DONGBAO PHARMA
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