Recombinant hirudin eye drop and preparation method thereof

A technology of recombinant hirudin and eye drops, which is applied in the direction of drug combinations, pharmaceutical formulas, and medical preparations of non-active ingredients, etc., can solve problems such as difficult process control, pain, eye tissue irritation, etc., and achieve simple preparation methods Effect

Inactive Publication Date: 2015-09-16
广西复鑫益生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, some of these thickeners are Newtonian, painful to blink, and sensitive to pH and/or temperature, while others have more incompatibility issues
For example, poloxamer temperature-sensitive gel, although it can change from liquid phase to semi-solid above 25 ° C, but when it returns to low temperature, the semi-solid gel is difficult to return to liquid state, so it is used for mass production of other gels. Process is difficult to control
In addition, carbomer gel can reduce its viscosity due to salt electrolytes, alkaline earth metal ions and cationic polymers can also be combined with it to form insoluble salts, and strong acids can al

Method used

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  • Recombinant hirudin eye drop and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The formula of eye drops of the present invention:

[0022] Recombinant Hirudin 0.02g

[0023] Sodium Hyaluronate 0.1g

[0024] Borax 0.19g

[0025] Sodium chloride 0.22g

[0026] Disodium edetate 0.5g

[0027] Methylparaben 0.03g

[0028] Dilute to 100ml with water for injection

[0029] Preparation Process:

[0030] 1. In a water bath at 60-80°C, stir quickly and slowly add 0.1g of sodium hyaluronate into 70ml of water for injection to make it completely dispersed and fully swell, so as not to make it stick together, stir for about 30 minutes can be completely dissolved.

[0031] 2. Add borax, sodium chloride, sodium edetate and methyl p-hydroxybenzoate to the above-mentioned sodium hyaluronate solution, stir well to dissolve, and then set the volume to 100ml to obtain eye drops with a pH of 7.0 Blank matrix.

[0032] 3. Add the recombinant hirudin to the blank matrix of the above-mentioned eye drops, stir well to dissolve, filter and sterilize through a 0.2...

Embodiment 2

[0034] The formula of eye drops of the present invention:

[0035] Recombinant Hirudin 0.02g

[0036] Sodium Hyaluronate 0.1g

[0037] Borax 1.5g

[0038] Disodium edetate 0.5g

[0039] Ethyl p-hydroxybenzoate 0.03g

[0040] Dilute to 100ml with water for injection

[0041] Preparation Process:

[0042] 1. In a water bath at 60-80°C, stir quickly and slowly add 0.1g of sodium hyaluronate into 70ml of water for injection to make it completely dispersed and fully swell, so as not to make it stick together, stir for about 30 minutes can be completely dissolved.

[0043] 2. Add borax, sodium edetate and ethyl p-hydroxybenzoate to the above-mentioned sodium hyaluronate solution, stir well to dissolve, and then set the volume to 100ml to obtain a blank matrix of eye drops with pH 7.1.

[0044] 3. Add the recombinant hirudin to the blank matrix of the above-mentioned eye drops, stir well to dissolve, filter and sterilize through a 0.22um filter, and then sub-package to obtain...

Embodiment 3

[0046] The formula of eye drops of the present invention:

[0047] Recombinant Hirudin 0.02g

[0048] Sodium Hyaluronate 0.1g

[0049] Phosphate buffer 1.0g

[0050] Sodium chloride 0.5g

[0051] Disodium edetate 0.5g

[0052] Benzalkonium Bromide 0.03g

[0053] Dilute to 100ml with water for injection

[0054] Preparation Process:

[0055] 1. In a water bath at 60-80°C, stir quickly and slowly add 0.1g of sodium hyaluronate into 70ml of water for injection to make it completely dispersed and fully swell, so as not to make it stick together, stir for about 30 minutes can be completely dissolved.

[0056] 2. Add phosphoric acid, sodium chloride, sodium edetate and benzalkonium bromide to the above-mentioned sodium hyaluronate solution, stir well to dissolve, and then set the volume to 100ml to obtain the blank matrix of eye drops with pH 7.2 .

[0057] 3. Add the recombinant hirudin to the blank matrix of the above-mentioned eye drops, stir well to dissolve, filter an...

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PUM

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Abstract

The invention discloses a recombinant hirudin eye drop. The recombinant hirudin eye drop takes recombinant hirudin as an effective component and sodium hyaluronate as a thickening agent, and also contains an isoosmotic adjusting agent, a metal complexing agent, a preservative and a pharmaceutically acceptable carrier; and the mass ratio of the sodium hyaluronate to the recombinant hirudin to the isoosmotic adjusting agent to the metal complexing agent to the preservative in the eye drop is 10 to 2 to 15.27 to 50 to 3. The preparation method comprises the following steps: dissolving the sodium hyaluronate, the isoosmotic adjusting agent, the metal complexing agent and the preservative into the pharmaceutically acceptable carrier to prepare a blank matrix of the eye drop, dissolving the recombinant hirudin into the blank matrix of the eye drop, mixing evenly, filtering, degerming and sub-packaging to prepare the recombinant hirudin eye drop. According to the eye drop disclosed by the invention, on one hand, the recombinant hirudin can be retainedin a focal zone for a long period of time; on the other hand, irritation is not generated to sensitive eye tissues; and meanwhile, the storage stability of the recombinant hirudin eye drop can also be ensured.

Description

technical field [0001] The invention belongs to the field of pharmacy, and specifically relates to a recombinant hirudin eye drop and a preparation method thereof. Background technique [0002] Hirudin is a kind of polypeptide substance composed of 65-66 amino acids that was originally isolated from the salivary glands of medical leeches. There are mainly three isomers with high homology (HV1, HV2, and HV3). Hirudin can effectively inhibit the formation of arterial and venous thrombosis and disseminated intravascular coagulation (DIC) by directly inhibiting the activity of thrombin. Therefore, hirudin is effective in preventing and treating deep venous thrombosis, coronary artery thrombosis, and angina pectoris. It has high application value. [0003] At present, there are two recombinant hirudin products approved for marketing abroad: 1. Desirudin (trade name: Revasc, product of Novartis, Switzerland); 2. Lepirudin (trade name: Refludan, product of British Pharmion and Ame...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/58A61K47/36A61K47/16A61P27/12
Inventor 谢海林
Owner 广西复鑫益生物科技有限公司
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