Recombinant hirudin eye drops and preparation method thereof

Abstract

The invention provides recombinant hirudin eye drops taking sodium hyaluronate as an auxiliary material and a preparation method thereof. The recombinant hirudin eye drops are technically characterized by containing sodium hyaluronate which has the effects of preventing liquid medicine from overflowing and running off, and enabling the medicine to be retained on lesion for a long time. The invention also discloses a preparation method of the recombinant hirudin eye drops. The method ensures the clarity and stability of the eye drops. In addition to recombinant hirudin and sodium hyaluronate, the recombinant hirudin eye drops prepared by the preparation method also contain an isotonic regulator, a metal complexing agent, a preservative and a pharmaceutically acceptable carrier. The preparation method comprises the following specific steps: dissolving sodium hyaluronate, the isotonic regulator, the metal complexing agent and the preservative in the pharmaceutically acceptable carrier to form blank matrix of eye drops, then dissolving the recombinant hirudin in the blank matrix of eye drops, and preparing the recombinant hirudin eye drops by filtering, sterilizing and sub-packaging. The pH value of the prepared recombinant hirudin eye drops is 4.0-7.5. Experimental results in the pharmacodynamics show that the recombinant hirudin eye drops prepared by the preparation method have the functions of preventing and treating cataract.

Description

technical field [0001] The invention relates to a recombinant hirudin eye drop containing sodium hyaluronate 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 American Berlex Laborato...

AI Technical Summary

Problems solved by technology

[0006] 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 also make it lose its viscosity. Multiple incompatibility

Cellulose derivatives such as hypromellose, polyvinyl alcohol, and polyvinylpyrrolidone are used as thickeners for eye drops. The main disadvantage is that they belong to Newtonian fluids, and their viscosity increases with the increase of concentration but is not subject to shear. Influenced by force (such as shear force when blinking), sometimes in order to produce obvious thickening effect, it must be added to a certain concentration, but when the viscosity reaches a certain level, it will make the eyelids difficult to blink and sensitive to the eye tissue Irritating, unbearable to the user [1]

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