Preparation method of rebamipide aqueous suspension

Abstract

The invention discloses a preparation method of a rebamipide aqueous suspension. The preparation method comprises the following steps: (1), a suspending agent and a deflocculant are dissolved in part of water for injection, then rebamipide is added for pulverization and dispersion, and a primary liquid of a concentrated rebamipide aqueous suspension is obtained; (2), the preliminary liquid, obtained in the step (1), of the oncentrated rebamipide aqueous suspension is subjected to sterilization after high-pressure homogenization, and the concentrated rebamipide aqueous suspension is obtained; (3), an osmotic pressure regulator and a pH regulator are dissolved in part of the water for injection, sterilization filtration is performed, and a regulator aqueous suspension is obtained; (4), the regulator aqueous suspension obtained in the step (3) and residual water for injection are added to the concentrated rebamipide aqueous suspension obtained in the step (2), volume fixing and uniform stirring are performed, and the rebamipide aqueous suspension is obtained. Compared with the prior art, the particle size of the rebamipide aqueous suspension prepared with the method after high-temperature sterilization changes little cannot be increased after the suspension is stored for a long time.

Description

technical field [0001] The invention relates to the field of preparation of eye drops, in particular to a preparation method of rebamipide aqueous suspension. Background technique [0002] Rebamipide: It is an odorless and bitter white crystalline powder, very slightly soluble in methanol and ethanol, almost insoluble in water, CAS registration number: 90098-04-7. Rebamipide can improve gastric motility and has a significant effect on gastric mucosal damage caused by gastric ulcer, acute gastritis or acute exacerbation of chronic gastritis. It also has the effect of increasing the density of goblet cells in the eye, the effect of increasing the mucus in the eye, and the effect of increasing the fluid of the lacrimal gland. [0003] Dry eye is a common chronic eye disease that can lead to corneal and conjunctival epithelial damage due to the lack of natural tears and ocular mucous fluid. If left untreated, dry eye can cause corneal ulcers or loss of vision. [0004] Rebami...

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Problems solved by technology

[0008] At present, rebamipide is usually superfinely pulverized and then added to a solution of high-molecular polymers such as suspending agent and suspending agent to prepare rebamipide aqueous suspension. The granules will aggregate into granules or the crystalline grains will increase, and the precipitated suspended particles will not be easily dispersed into fine granules. When dripped into the eyes, there will be a feeling of sand and irritation, and the patient will feel uncomfortable.

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