Compound allantoin vitamin B6-E and ammoniation ethyl sulfate eye drops and preparation method thereof

Abstract

The invention discloses compound allantoin vitamin B6-E and ammoniation ethyl sulfate eye drops and a preparation method thereof. The compound allantoin vitamin B6-E and ammoniation ethyl sulfate eye drops are proportionally prepared from the main components of chondroitin sulfate, allantoin, taurine, vitamin B6 and vitamin E and the auxiliary materials of edetate disodium, boric acid, borax, polysorbate-80, benzalkonium chloride, natural borneol, ethanol and water for injection, and a preparation method is also provided. After the components of the compound allantoin vitamin B6-E and ammoniation ethyl sulfate eye drops and the eye drops which are prepared from the preparation method are applied, the medicine compatibility problem of five main components is solved, so the liquid medicine is clear, the contents of all the main medicines are stable, the aseptic and visible foreign matter inspection qualification rate of a product is ensured to be high, the cost is low, and the compound allantoin vitamin B6-E and ammoniation ethyl sulfate eye drops are worth being popularized in the industrial production field.

Description

technical field [0001] The invention belongs to the technical field of ophthalmic medication of pharmaceutical preparations, and in particular relates to a compound urine vitamin ammonia eye drop with stable quality and high efficiency and a preparation method thereof. Background technique [0002] Compound urine vitamin ammonia eye drops have the functions of promoting eye wound healing, anti-inflammatory and antibacterial, and enhancing eye nutrition. ), ultraviolet rays or ophthalmia and blepharitis affected by other light; relieve discomfort caused by wearing contact lenses, eye fatigue, eye itching, hazy eyes and other symptoms; also used for adjuvant treatment of decreased eye adjustment function and refractive error ; Its main ingredients are composed of 1.0 grams of chondroitin sulfate, 2.0 grams of allantoin, 2.0 grams of taurine, and vitamin B per 1000 milliliters. 6 0.1 gram, vitamin E 0.1 gram; in clinical application, it has high safety and good effect, and is...

AI Technical Summary

Problems solved by technology

[0002]Compound urine vitamin ammonia eye drops has the effects of promoting eye wound healing, anti-inflammatory and antibacterial, enhancing eye nutrition, etc. It is used to treat chronic conjunctivitis, corneal injury, conjunctival Congestion, prevention of eye diseases (after swimming, blowing dust or sweat into the eyes), ophthalmia and blepharitis affected by ultraviolet rays or other light; relieve discomfort caused by wearing contact lenses, eye fatigue, eye itching, hazy eyes and other symptoms; It is also used for adjuvant treatment of decreased eye adjustment function and refractive errors; the main drug composition is 1.0 grams of chondroitin sulfate, 2.0 grams of allantoin, 2.0 grams of taurine, and vitamin B6 0.1 gram, vitamin E 0.1 gram; high safety and good effect in clinical application, favored by consumers; Acidic mucopolysaccharide, which is a new type of biological drug extracted from animal tissue, has strong hygroscopicity and is easily soluble in water to form a viscous liquid. Its aqueous solution is easily hydrolyzed when heated; Unstable under sunlight and other conditions; vitamin B6 is sensitive to light and strong alkali but stable to heat; vitamin E is stable to heat but sensitive to oxygen; taurine is easily soluble in water and has stable physical and chemical properties, etc. ; According to the conventional preparation method, at first, it is difficult to coordinate various components with different physical and chemical properties together to make a product that meets the requirements of eye drops with uniform and stable properties; The stability of the product is poor, and the content cannot be guaranteed to be qualified within the validity period. Third, the liquid medicine is turbid and not clear enough; although this variety is imported in China, it cannot meet the market demand and the price is high; after searching, no relevant excipients are found. And the preparation method, we carried out preliminary experiments and research according to the general prescription principles and preparation methods of eye drops, and found that because of the complex composition, the liquid medicine is turbid and not clear enough, and the liquid medicine after accelerated tests and long-term retention samples will change color after a period of time. Darkening, poor stability of some main components, etc., the present invention has explored the best combination of auxiliary materials and its suitable dosage and complete and feasible preparation method through repeated tests, successfully solved the above problems, and obtained fully qualified products and harvested High efficiency, low cost, worthy of promotion in industrial production