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Stable insulin glargine injection and preparation method thereof

A technique for insulin glargine and injection, applied in the field of insulin glargine injection and its preparation, capable of solving problems such as prone to allergic reactions

Active Publication Date: 2015-06-10
TONGHUA DONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the insulin glargine injection prepared by this method contains surfactants, which can easily cause allergic reactions when administered by injection, especially in the case of long-term uninterrupted administration.

Method used

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  • Stable insulin glargine injection and preparation method thereof
  • Stable insulin glargine injection and preparation method thereof
  • Stable insulin glargine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0045] Preparation method 2 (the preferred 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, adjust the rotating speed to 200-400 rpm, stir to make Glycerin is dissolved and prepared into a glycerin solution; (2) the glycerol solution obtained in step 1 is divided into four parts of 180mL, 300mL, 60mL and 60mL (volume ratio 3:5:1:1), and insulin glargine and m-cresol are added respectively , phenol and zinc chloride, stirred to obtain insulin glargine-glycerol solution, m-cresol-glycerol solution, phenol-glycerin injection and zinc chloride-glycerol solution; (3) the insulin glargine obtained in step 2- Glycerol solution, m-cresol-glycerol solution and phenol-glycerol solution are mixed, stirred evenly to obtain mixed solution I; (4) under stirring, add 0.1mol / L hydrochloric acid solution to the mixed solution I until pH=3.0~ 3.1, make the insulin glargine dissol...

Embodiment 1

[0051] Example 1 A stable insulin glargine injection

[0052] The insulin glargine injection described in this implementation contains insulin glargine 100IU / mL, zinc 30μg / mL, m-cresol 1.6mg / mL, phenol 1.2mg / mL, glycerin 16mg / mL, hydrochloric acid, sodium hydroxide and water for injection, pH=4; prepared by preparation method 1.

Embodiment 2

[0053] Example 2 A stable insulin glargine injection

[0054] The insulin glargine injection described in this implementation contains insulin glargine 100IU / mL, zinc 30 μg / mL, m-cresol 2.0 mg / mL, phenol 0.9 mg / mL, glycerol 17 mg / mL, hydrochloric acid, sodium hydroxide and water for injection, pH=4; prepared by preparation method 1.

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PUM

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Abstract

The invention discloses a stable insulin glargine injection and a preparation method thereof. The stable insulin glargine injection comprises the following components: 100IU / mL of insulin glargine, 10-100 mu g / mL of zinc, 1.5-3.5 mg / mL of metacresol, 0.7-1.8 mg / mL of phenol, 15-20 mg / mL of glycerin, and hydrochloric acid and / or sodium hydroxide and injection water, the pH value is 3.8-4.2. By means of modifying the raw material components and the preparation process of the insulin glargine injection, the stability of the insulin glargine injection is increased and the quality of the preparation is improved, and the insulin glargine injection does not have allergic reactions and the safety is good.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable insulin glargine injection and a preparation method thereof. Background technique [0002] Insulin glargine is a long-acting analogue of human insulin, which can form a stable hexamer after subcutaneous injection, 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 predictable , Long-acting, stable, no peak plasma concentration / time characteristics, clinically used in adults and children with type I diabetes and adult type II diabetes. Because of its long-acting nature, insulin glargine only needs to be administered by subcutaneous injection once a day at a fixed time. Type 1 diabetic patients and type 2 diabetic patients whose oral hypoglycemic drugs fail need to use insulin products for life to control blood sugar. Therefore, it is parti...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/28A61K47/10A61P5/48
Inventor 王文娜郭银汉詹巾卓秦丽静武晓丽赵颖唐伟举牛丁
Owner TONGHUA DONGBAO PHARMA
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