Low-concentration atropine sulfate eye drop and preparation method thereof

Abstract

The invention provides a low-concentration atropine sulfate eye drop and a preparation method thereof. The low-concentration atropine sulfate eye drop is 1000ml of 0.004 percent of atropine sulfate eye drop, prepared from 40mg of atropine sulfate, 9g of sodium chloride and an appropriate amount of injection water. The preparation method of the low-concentration atropine sulfate eye drop comprisesthe following steps: dissolving the sodium chloride and the atropine sulfate to obtain a dissolved solution; filtering the dissolved solution; adding the injection water from an automatic filter to reach 1000ml; performing sterilization and filtration; aseptically subpackaging an obtained solution into eye drop tubes which has functions of multiple dosage, single direction and sterile air filtration. The 0.004 percent of atropine sulfate eye drop is suitable for treating myopia spuria and extending treatment time, and also can be used for treating low true myopia in teenagers; and meanwhile, the multi-dose preservative-free eye drop has the advantages of being low in production cost and being economic in using, and can effectively avoid damage of ocular surfaces caused by preservatives.

Description

technical field [0001] The invention relates to an atropine medicine eye drop, in particular to a low-concentration atropine sulfate eye drop and a preparation method thereof. Background technique [0002] Myopia not only affects the quality of life of patients, but also increases the risk of blinding eye diseases such as retinal detachment, macular degeneration, and open-angle glaucoma with the increase of the degree of eye axis. May cause vision loss or blindness. Myopia among children and adolescents in my country shows a trend of high incidence and younger age, seriously affecting the physical and mental health of children and adolescents, and has become the focus of attention of the whole society. [0003] Studies have confirmed that atropine drugs are currently the most effective drugs for preventing myopia in adolescents and children. Through the treatment with atropine drugs, the originally tense ciliary muscles of adolescents and children can be quickly restored, ...

AI Technical Summary

Problems solved by technology

But at the same time, in the course of clinical research, it was found that high concentrations of atropine drugs will be accompanied by many adverse reactions and side effects, such as allergic dermatitis, dry eye syndrome, decreased eye adjustment, strong mydriasis, and increased intraocular pressure , myopia rebound, allergic blepharitis, allergic conjunctivitis (such as blurred vision, photophobia, tearing and other symptoms), blurred vision, mydriasis, retinal light damage, etc. Hazards and potential safety hazards, leading to restrictions on the wide application of atropine drug eye drops