Eye drops for delaying treatment of juvenile myopia and preparation method thereof

Abstract

The invention belongs to the technical field of eye drops, and particularly relates to eye drops for delaying treatment of juvenile myopia and a preparation method thereof. The eye drops are preparedfrom the following components in percentage by weight: 0.005 to 1 percent of atropine or pharmaceutically acceptable salt thereof, 0.1 to 10 percent of a thickening agent, 0.001 to 0.5 percent of a complexing agent, 0.001 to 0.05 percent of a bacteriostatic agent, a pH value regulator, 0.1 to 0.9 percent of an osmotic pressure regulator and a proper amount of water for injection, wherein the pH value regulator is used for regulating the pH value of the eye drops to 3.5 to 6.5. According to the preparation method, hydroxypropyl methylcellulose sprayed by a spray gun A is fused by the water forinjection sprayed by a spray gun B, and meanwhile, a solution in a rectangular pool forms liquid rotational flow under the impact of the water for injection, so that the solution flows in the rectangular pool, the dissolving efficiency of the hydroxypropyl methylcellulose is improved, and the preparation efficiency of the eye drops for delaying treatment of juvenile myopia is further improved.

Description

technical field [0001] The invention belongs to the technical field of eye drop preparation, in particular to an eye drop for delaying the treatment of juvenile myopia and a preparation method thereof. Background technique [0002] At present, the treatment methods used for myopia include wearing glasses, surgery, drugs, etc. RPG mirrors and OK mirrors have certain effects in the treatment of myopia, but their prices are relatively expensive, and they need to be taken out and put on again every day, and the operation is cumbersome; It is very easy to cause inconvenience to the study and life of young people; therefore, for some patients with low myopia or myopic astigmatism who are expected to effectively control or cure the diopter progression, it is a very meaningful attempt to use 0.01% atropine eye drops for treatment. The method is economical, simple and easy to implement; atropine is an anticholinergic drug in clinical practice, and is mainly used for relieving smooth ...

AI Technical Summary

Problems solved by technology

[0002] At present, the treatment methods used for myopia include wearing glasses, surgery, drugs, etc. RPG mirrors and OK mirrors have certain effects in the treatment of myopia, but their prices are relatively expensive, and they need to be taken out and put on again every day, and the operation is cumbersome; It is very easy to cause inconvenience to the study and life of young people; therefore, for some patients with low myopia or myopic astigmatism who are expected to effectively control or cure the diopter progression, it is a very meaningful attempt to use 0.01% atropine eye drops for treatment. The method is economical, simple and easy to implement; atropine is an anticholinergic drug in clinical practice, and is mainly used for relieving smooth muscle spasm, improving microcirculation, inhibiting glandular secretion, and relieving the inhibition of the vagus nerve on the heart; according to clinical records, the atropine sulfate ophthalmic preparation The pharmacological effect is good, it has quite high selectivity to the M receptor, and blocks the M choline receptor, relaxes the pupillary sphincter and ciliary muscle, and forms a pupil dilating mechanism to achieve the therapeutic effect; low concentration of atropine sulfate controls The development effect of children's myopia is good, and it is easy to use, and the rebound after drug withdrawal is relatively light; however, the preparation method of the thickener in low-concentration atropine sulfate is to put hypromellose into the rectangular pool, and then pour the injection water into the rectangular pool. In the tank, the stirring rod is finally used to stir and mix. After standing still, the clear liquid is the thickener. This kind of preparation method is easy to form agglomerated lumps during the preparation process, resulting in low production efficiency of the thickener, which in turn affects the delayed treatment of juvenile myopia. The preparation efficiency of eye drops cannot meet the market demand

[0003] In the prior art, there are also some technical solutions about eye drops for delaying the treatment of myopia in adolescents and their preparation methods. For example, a Chinese patent with application number CN201911338604.6 discloses an eye drop for treating myopia and its preparation method, the eye drops in the technical proposal include atropine sulfate, a thickener, a pH regulator, an osmotic pressure regulator and a metal ion chelating agent, and the solvent is water; wherein, the content of the atropine sulfate is 0.001-0.1wt% The eye drops for the treatment of myopia provided by this technical scheme are low-concentration atropine sulfate eye drops, which are selected to add metal ion chelating agents, and cooperate with pH regulators, osmotic pressure regulators, thickeners and other auxiliary materials to improve the stability of atropine sulfate , significantly improved the stability of low-concentration atropine sulfate solution, has good safety, can effectively prevent and delay the occurrence of myopia in young people, and has little irritation to eye tissue cells, and is especially suitable for young people with myopia below 400 degrees; but this The technical solution does not take into account the fact that the thickener is prone to agglomeration during the preparation process, which makes the preparation of the thickener inefficient, thereby affecting the preparation efficiency of eye drops for delaying the treatment of juvenile myopia, and thus causing the limitations of the solution

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