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Two-phase isophane zinc recombinant human insulin injection and preparation method thereof

A technology for recombinant human insulin and protamine, applied in peptide/protein components, pharmaceutical formulations, drug combinations, etc., can solve the problems of slow onset of action, loss of quick-acting effect, poor physical stability, etc., achieve good blood sugar levels, reduce burden, The effect of easy dose control

Inactive Publication Date: 2010-06-16
JIANGSU WANBANG BIOPHARMLS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Protamine recombinant human insulin injection belongs to long-acting insulin, which delays the release of insulin and prolongs the action time, but it has a slow onset and poor physical stability. When it is mixed with fast-acting recombinant human insulin solution, excessive protamine The protein will bind to free recombinant human insulin to form a complex precipitate, thereby losing most of the fast-acting effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Preparation of liquid A:

[0049] For every 150,000 IU of recombinant human insulin, 22g of isotonic agent (glycerin), 4.65g of preservative (m-cresol) and 7.5g of pH regulator (disodium hydrogen phosphate), add a small amount of water for injection to dissolve, and slowly add pH value to adjust to 2.0 Add an appropriate amount of water for injection, stir to dissolve and add, add water for injection to 1500ml, stir well, adjust the pH to 7.1 with 1mol / L hydrochloric acid, and filter through a 0.22um filter to sterilize.

[0050] Preparation of liquid C:

[0051] Dissolve 150,000 IU of recombinant human insulin, 23g of isotonic agent (glycerin), 4.81g of preservative (m-cresol) and 0.8g of protamine sulfate in a small amount of water for injection, then slowly add an appropriate amount of water for injection with pH adjusted to 2.0, and stir Dissolve and add water for injection to 750ml, stir well, and adjust the pH to 3.1.

[0052] Preparation of liquid D:

[0053] ...

Embodiment 2

[0059] Preparation of liquid A:

[0060] For every 200,000 IU of recombinant human insulin, 80g of isotonic agent (glycerin), 15.5g of preservative (m-cresol) and 25g of pH regulator (disodium hydrogen phosphate), add a small amount of water for injection to dissolve, then slowly add an appropriate amount to adjust the pH value to 2.0 In the water for injection, stir to dissolve and then add, add water for injection to 5000ml, stir well, adjust the pH to 7.2 with 1mol / L hydrochloric acid, filter and sterilize through a 0.22um filter membrane.

[0061] Preparation of liquid C:

[0062] For every 200,000 IU of recombinant human insulin, 82g of isotonic agent (glycerin), 15.5g of preservative (m-cresol) and 2.8g of protamine sulfate, add a small amount of water for injection to dissolve, then slowly add an appropriate amount of water for injection whose pH value is adjusted to 2.0, Add after stirring to dissolve, add water for injection to 2500ml, stir well, adjust pH to 3.2.

[...

Embodiment 3

[0070] Preparation of liquid A:

[0071] For every 150,000 IU of recombinant human insulin, 25g of isotonic agent (glycerol), 4.60g of preservative (m-cresol) and 7.2g of pH regulator (disodium hydrogen phosphate), add a small amount of water for injection to dissolve, and slowly add pH value to adjust to 2.0 Add an appropriate amount of water for injection, stir to dissolve and add, add water for injection to 1500ml, stir well, adjust the pH to 7.5 with 1mol / L hydrochloric acid, and filter through a 0.22um filter to sterilize.

[0072] Preparation of liquid C:

[0073] Dissolve 150,000 IU of recombinant human insulin, isotonic agent (glycerin) 22g, preservative (m-cresol) 4.65g, and protamine sulfate 0.9g in a small amount of water for injection, slowly add a proper amount of water for injection to adjust the pH to 2.0, and stir Dissolve, add water for injection to 750ml, stir well, adjust pH to 3.2.

[0074] Solution D: Dissolve 7.5 g of disodium hydrogen phosphate with wa...

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Abstract

The invention relates to a two-phase isophane zinc recombinant human insulin injection and a preparation method thereof. A specification I comprises the following components in part by weight: 300,000IU of recombinant human insulin, 42 to 54g of isosmotic agent, 7.5 to 1.5g of preservative, 14.4 to 15.0g of pH regulator and 0.45 to 0.9g of protamine sulfate. A specification II comprises the following components in part by weight: 400,000IU of recombinant human insulin, 140 to 180g of isosmotic agent, 25 to 35g of preservative, 48 to 50g of pH regulator and 1.5 to 3.0g of protamine sulfate. Both preparation methods of both specifications of the two-phase isophane zinc recombinant human insulin comprise a step of mixing solution A and solution B, wherein the solution A is prepared by adding water for injection into the recombinant human insulin, the isosmotic agent, the preservative and the pH regulator for dissolving; then slowly adding an appropriate amount of water for injection with the pH of 2.0 into the solution until the pH is between 6.9 and 7.8; and filtering the solution with a 0.22 mu m filter membrane and sterilizing; and the mixing ratio of the solution A to the solution B is 10 / 90-75 / 25. The recombinant human insulin is more favorable for absorbing.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a dual-phase low protamine zinc recombinant human insulin injection and a preparation method thereof. Background technique [0002] Recombinant human insulin is insulin produced by recombinant (rDNA) technology, which has the same structure as endogenous human insulin. Due to the lower antigenicity of high-purity insulin, compared with animal insulin, it induces less insulin antibody production. In addition, because recombinant human insulin has stronger hydrophilicity, it absorbs faster than animal insulin. Recombinant human insulin and animal insulin have no significant difference in the level of blood sugar control, but the total bioavailability of human insulin is higher than that of animal insulin. Human insulin shortens the time for high blood sugar control to reach the target time, and from the perspective of daily insulin dosage after reaching the target, The d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/28A61K47/42A61K47/10A61K47/02A61P3/10
Inventor 徐良芹乔德水高雪芹
Owner JIANGSU WANBANG BIOPHARMLS
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