Insulin glargine injecta and preparation method thereof

A technology for insulin glargine and injection, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as poor stability of insulin glargine.

Active Publication Date: 2011-09-21
鲁南新时代生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the problem of poor stability of insulin glargine in acidic aqueous solution, and the addition of some surfactants in the prior art to solve its stability and...

Method used

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  • Insulin glargine injecta and preparation method thereof
  • Insulin glargine injecta and preparation method thereof
  • Insulin glargine injecta and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Reference Example 1: Preparation of Insulin Glargine Injection (without PEG)

[0021] First add 10000IU (363.78mg) of insulin glargine to 80% of the prescribed amount of water for injection, add citric acid to adjust the pH of the solution to 3.8 to completely dissolve it, then add the prescribed amount of zinc, m-cresol, and 85% glycerin, and stir Dissolve, add citric acid to adjust the pH to 3.8-4.2, add water for injection to the final volume, the final liquid contains 30 μg / ml of zinc, 2.7 mg / ml of m-cresol, 100 IU / ml of insulin glargine, 20mg / ml of 85% glycerol, the liquid medicine is sterilized and filtered through a 0.22μm filter membrane, subpackaged into 3ml injection vials, crimped caps, and inspected with a lamp.

Embodiment 2

[0022] Reference example 2: preparation of insulin glargine injection (do not adjust pH with citric acid)

[0023] First add 10000IU (363.78mg) of insulin glargine to 70% of the prescribed amount of water for injection, add hydrochloric acid to adjust the pH to 3-4 to make it completely dissolved, then add the prescribed amount of zinc, m-cresol, 15% (w / v dosage) of PEG400, stir to dissolve, adjust the pH to 3.8-4.2 with hydrochloric acid / sodium hydroxide, add water for injection to the final volume, and the final liquid contains 30 μg / ml of zinc, 2.7 mg / ml of m-cresol, Insulin glargine at 100IU / ml and PEG400 at 150mg / ml were sterilized and filtered through a 0.22μm filter membrane, dispensed into 3ml injection vials, crimped and inspected with a lamp.

[0024] Reference Example 3: Preparation of Insulin Glargine Injection (without PEG, and without adjusting pH with citric acid)

[0025] First suspend insulin glargine in a part of water for injection, dissolve it at pH3-4, th...

Embodiment 3

[0040] Embodiment 3: the preparation of insulin glargine injection

[0041] First add 10000IU (363.78mg) of insulin glargine to 30ml of water for injection, adjust the pH of the solution to 3.5 with citric acid, and dissolve it completely, then add 5% w / v of PEG1000, stir and mix evenly, and place at 0°C Stir at low temperature for 24 hours to obtain solution I. In addition, add the prescribed amount of zinc and m-cresol to the remaining 70ml of water for injection, stir to dissolve, add citric acid to adjust the pH to 4.2, and cool to room temperature to obtain solution II. Take solution I and add it all into solution II under stirring, stir evenly, adjust the pH value of the liquid to 3.8-4.2, so that the final liquid contains 30 μg / ml of zinc, 2.7 mg / ml of m-cresol, 100 IU / ml Insulin glargine, 50mg / ml PEG1000, the liquid medicine was sterilized and filtered through a 0.22μm filter membrane, then packed in 3ml injection vials, crimped caps, and checked with a lamp.

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Abstract

The invention relates to insulin glargine injecta and a preparation method thereof. Besides zinc and preservative, the insulin glargine injecta also comprises 0.5 to 50 percent (w/v: weight in volume) of PEG (polyethylene glycol). A pH value of the insulin glargine injecta is regulated into the range of 3.8 to 4.2 by using citric acid. The preparation method of the insulin glargine injecta comprises the following steps of: firstly adding insulin glargine into water for injection, regulating the pH value into the range of 3.5 to 4.5 by using the citric acid and dissolving the insulin glargine; then adding the PEG to obtain a solution I; adding the zinc and the preservative into the rest of water for injection, stirring to dissolve the zinc and the preservative and regulating the pH value into the range of 3.5 to 4.5 by using the citric acid to obtain a solution II; and mixing the solution I and the solution II and filtering and degerming the mixed solution to obtain the insulin glargine injecta. The medicinal insulin glargine injecta provided by the invention has the advantages of stable performance, rapid response and high safety.

Description

technical field [0001] The invention relates to an insulin glargine pharmaceutical preparation and a preparation method thereof, in particular to an insulin glargine injection with stable quality and good safety and a preparation method thereof. Background technique [0002] For patients with type I diabetes, intramuscular injection of insulin is currently the only feasible and effective therapy for the lack of endogenous insulin secretion. Diabetes drug combination treatment plan to achieve better therapeutic effect. [0003] Insulin glargine has the advantages of long-acting and stable effect in lowering blood sugar, low risk of hypoglycemia at night, and only one injection per day. Because insulin glargine exists in the form of dissolution under acidic conditions in water and precipitates out in the physiological pH range, the existing insulin glargine preparations are all injected in the form of acidic, uniform and clear solutions. It is also its disadvantage. As descr...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/28A61K47/12A61K47/34A61P3/10A61K47/10
Inventor 赵志全姜斌
Owner 鲁南新时代生物技术有限公司
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