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A kind of insulin glargine injection and preparation method thereof

An insulin glargine and injection technology, applied in the field of medicine, can solve the problems of increasing product risk, difficult to achieve large-scale production, long production cycle, etc., and achieve the effects of avoiding changes in appearance and properties, saving packaging material costs, and improving production capacity.

Active Publication Date: 2018-02-27
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it does not mention that PEG and insulin are not covalently bonded to the stability of insulin preparations, and its PEGylation preparation steps are too complicated, requiring high equipment conditions and high production costs, making it difficult to achieve large-scale production
[0010] Chinese patent CN102188367A discloses a kind of insulin glargine injection and its preparation method, the purpose of which is to solve the phenomenon of white spots in insulin glargine injection
[0011] The inventors have found in experiments that the appearance of insulin glargine injection will change from a colorless clear liquid to a light blue liquid with flocs under the influence of 60°C. Furthermore, the insulin glargine injection uses Filling with pre-filled syringes, but the cost of packaging materials for pre-filled syringes is high, the production cycle is long, and the requirements for filling and stoppering of equipment are high. The injection is filled in ampoules, but the process of melting and sealing the ampoules at high temperature will also cause the appearance of the insulin glargine injection to change from a colorless clear liquid to a light blue liquid with flocs. Experiments have found that none of the current technologies can solve this problem

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription

[0027]

[0028] Preparation Process:

[0029] Weigh the prescribed amount of zinc chloride, sodium metabisulfite and insulin glargine, add 70% of the prepared volume to the water for injection, stir and mix evenly, adjust the pH of the medicinal solution with a pH regulator, and after the main ingredients are completely dissolved, the pH of the medicinal solution is controlled. When it is 4.9, add glycerin and methylparaben in the prescribed amount, stir and mix evenly, add water for injection to the total amount of preparation, adjust the pH of the medicinal solution with a pH regulator, and control the pH of the medicinal solution to 4.6 after the main drug is completely dissolved. , Stir, filter, fill, melt seal, light check, and pack.

Embodiment 2

[0031] prescription

[0032]

[0033] Preparation Process:

[0034] Weigh the prescribed amount of zinc chloride, sodium metabisulfite and insulin glargine, add 60% of the prepared volume of water for injection, stir and mix evenly, adjust the pH of the liquid medicine with a pH regulator, and after the main ingredients are completely dissolved, the pH of the liquid medicine will be controlled. 4.8, add the prescribed amount of glycerin and methylparaben, stir and mix evenly, add water for injection to the total amount of preparation, adjust the pH of the medicinal solution with a pH regulator, and control the pH of the medicinal solution to 4.6 after the main drug is completely dissolved. , Stir, filter, fill, melt seal, light check, and pack.

Embodiment 3

[0036] prescription

[0037]

[0038] Preparation Process:

[0039] Weigh the prescribed amount of zinc chloride, sodium pyrosulfite and insulin glargine, add 80% of the prepared volume to the water for injection, stir and mix evenly, adjust the pH of the medicinal solution with a pH regulator, and after the main ingredients are completely dissolved, the pH of the medicinal solution is controlled 5, add the prescribed amount of glycerin and methylparaben, stir and mix evenly, add water for injection to the total amount of preparation, adjust the pH of the medicinal solution with a pH regulator, and control the pH of the medicinal solution to 4.6 after the main drug is completely dissolved. , Stir, filter, fill, melt seal, light check, and pack.

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Abstract

The invention belongs to the technical field of medicines, and provides an insulin glargine injection and a preparation method. The insulin glargine injection consists of insulin glargine, glycerin, methylparaben, zinc chloride, sodium pyrosulfite, a pH adjusting agent and injection water. The insulin glargine injection provided by the invention is injected into an ampoule bottle, a formula is adjusted by the inventor, the problem that the appearance and the morphology of the injection are changed because of high-temperature melting sealing in the filling process of the ampoule bottle can be overcome, and the risk that the insulin glargine injection is turbid because of high temperature can be avoided.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an insulin glargine injection and a preparation method thereof. Background technique [0002] In recent years, with the improvement of living standards, changes in dietary structure, increasingly tense pace of life, aging population, less active and more sedentary lifestyle and many other factors, the global incidence of diabetes has increased rapidly, and the age of onset is becoming younger. Diabetes has become the third chronic disease that seriously threatens human health after tumors and cardiovascular diseases. According to the International Diabetes Federation (International Diabetes Federation), the number of people with diabetes worldwide is expected to approach 500 million by 2030. [0003] 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 injec...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K9/08A61K47/14A61P3/10
CPCA61K9/0019A61K9/08A61K38/28A61K47/14
Inventor 张贵民董其松方克忠
Owner LUNAN PHARMA GROUP CORPORATION