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A kind of preparation method of insulin detemir injection and preparation of insulin detemir injection

A technology for insulin detemir and injections, which is applied to medical preparations containing active ingredients, pharmaceutical formulas, endocrine system diseases, etc., to improve quality, ensure drug safety, and save time

Active Publication Date: 2017-06-23
TONGHUA DONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the increased tendency of insulin detemir to coagulate due to physical and mechanical stress under the preparation conditions, it is inevitable to use physical means such as stirring during the preparation of injections, thereby bringing undesirable impurities to the preparation

Method used

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  • A kind of preparation method of insulin detemir injection and preparation of insulin detemir injection
  • A kind of preparation method of insulin detemir injection and preparation of insulin detemir injection
  • A kind of preparation method of insulin detemir injection and preparation of insulin detemir injection

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preparation example Construction

[0044]Preparation method 1 (preparation method provided by the present invention): (1) take a 1L beaker, add the rotor, place it on a magnetic stirrer, add glycerin and 600mL water for injection, stir to dissolve the glycerin and prepare a glycerin solution; (2) diazepam Insulin, m-cresol, and phenol are pre-dissolved with 180mL, 300mL, and 120mL of the glycerol solution respectively to obtain insulin detemir-glycerol solution, m-cresol-glycerol solution and phenol-glycerol solution; (3) the insulin detemir- Glycerol solution, m-cresol-glycerin solution and phenol-glycerin solution are mixed, stirred evenly, obtain mixed solution I; (4) under stirring, add the sodium hydroxide solution of 0.1mol / L in described mixed solution I to pH= 9.0 to 9.5, so that insulin detemir dissolves rapidly and the solution becomes clear; (5) Take three 25mL beakers, add zinc acetate, sodium chloride and disodium hydrogen phosphate respectively, and add 5mL water for injection to dissolve and prepa...

Embodiment 1

[0048] Example 1 Insulin detemir injection prepared by different methods

[0049] The insulin detemir injection described in this implementation contains insulin detemir 100IU / mL, glycerol 16mg / mL, m-cresol 2.06mg / mL, phenol 1.8mg / mL, zinc 65.4μg / mL, sodium chloride 1.17mg / mL, Disodium hydrogen phosphate 0.89mg / mL, hydrochloric acid, sodium hydroxide and water for injection, pH=7.4; prepare insulin detemir injection according to the above-mentioned preparation method 1, preparation method 2 and preparation method 3, and record the required preparation cycle time, the results are shown in Table 1.

Embodiment 2

[0050] Example 2 Insulin detemir injection prepared by different methods

[0051] The insulin detemir injection described in this implementation contains insulin detemir 100IU / mL, glycerin 17mg / mL, m-cresol 2.2mg / mL, phenol 1.5mg / mL, zinc 65.4μg / mL, sodium chloride 1.1mg / mL, Disodium hydrogen phosphate 0.89mg / mL, hydrochloric acid, sodium hydroxide and water for injection, pH=7.4; prepare insulin detemir injection according to the above-mentioned preparation method 1, preparation method 2 and preparation method 3, and record the required preparation cycle time, the results are shown in Table 1.

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PUM

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Abstract

The invention provides a preparation method of insulin detemir injection and the prepared insulin detemir injection. The main operations of the preparation method include: dissolving glycerol with a part of water for injection to obtain a glycerol solution, dividing into three parts, adding insulin detemir, m-cresol and phenol respectively; first mixing these three solutions uniformly to obtain mixed solution I, using Sodium hydroxide solution to adjust pH=9.0~9.5; Zinc acetate, sodium chloride and disodium hydrogen phosphate are respectively dissolved in part of water for injection, then added to mixed solution I in sequence, and then adjusted pH=7.3~7.5 with hydrochloric acid solution; Make up to final volume with water for injection. The preparation method of the invention can rapidly dissolve the insulin detemir and other auxiliary materials, significantly shorten the preparation cycle time, reduce the process impurities generated in the preparation process, improve the quality of the insulin detemir injection, reduce the process energy consumption, and improve the production speed. , 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 detemir injection and the prepared insulin detemir injection. Background technique [0002] Insulin detemir is a long-acting analog of human insulin used in adults and children with type 1 diabetes and in adults with type 2 diabetes. Insulin detemir can form a stable double hexamer after subcutaneous injection, which has a stable and long-lasting effect, and can also reversibly combine with plasma albumin, and has a relatively gentle time action curve. While effectively controlling fasting blood sugar, it can also cause blood sugar Fluctuation and hypoglycemia adverse reactions are less. Because of its long-acting properties, insulin detemir only needs to be administered by subcutaneous injection 1-2 times a day at a fixed time. Type 1 diabetic patients and type 2 diabetic patients whose oral hypoglycemic drugs fail need to u...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K9/08A61P5/48
Inventor 郭银汉武晓丽王文娜詹巾卓孙洪艳牛丁赵颖秦丽静
Owner TONGHUA DONGBAO PHARMA