Low-concentration atropine medicine-containing eye drop and preparation method thereof

Abstract

A low-concentration atropine medicine-containing eye drop comprises the following components: (A) 0.001-1% (w/v) of an atropine medicine, (B) 0-10% (w/v) of a solute with the effects of lubricating, solubilizing and moisturizing, (C) an acidity and alkalinity regulating agent of which the amount is proper to ensure that the pH is regulated to 6.0-8.0, (D) an osmotic pressure buffering agent of which the amount is proper to ensure that the osmotic pressure is regulated to 280-380 mOsm/L, (E) a thickener of which the amount is proper to ensure that the viscosity is regulated to 6-10 mps, (F) 0.001-1% (w/v) of a solute with an atropine medicine stabilizing effect, (G) 0-0.1% (w/v) of a bacteriostatic agent, 0-0.1% (w/v) of one or more of mint, natural borneol, vitamin B6, dipotassium glycyrrhizinate or other substances with auxiliary effects which can be also optionally added under the premise that the safety is ensured and the efficacy of the main medicine is not affected, and the balance of water. The eye drop is good in stability of the main medicine and safe, is unlikely to be contaminated by microorganisms, and can effectively prevent and relieve juvenile myopia.

Description

technical field [0001] The invention relates to atropine drug eye drops, in particular to a low-concentration atropine drug eye drop and a preparation method thereof. Background technique [0002] Eyes are one of the most important organs of human beings and provide a guarantee for people to adapt to social life. With the improvement of people's living standards and the accelerated pace of life, all kinds of electronic products have become necessities of life. People are increasingly relying on computers, TVs and other video display terminals for various activities. People spend more time with their eyes than in the past. Several times more in ten years, less and less time for eyes to rest. Especially for teenagers and children, with the progress of society, the learning tasks are becoming more and more heavy, there is very little time for extracurricular activities, and the time for learning, reading, writing, etc. is getting longer and longer, continuous long-term work or...

AI Technical Summary

Problems solved by technology

[0006] However, during the preparation, production and long-term storage of low-concentration atropine drug eye drops, due to the ester bond contained in the atropine drug molecule, it is unstable. If it is not handled properly, it will be affected by temperature, light, solution pH, storage time etc., and the solution will deteriorate or even fail to produce corresponding alcohol or acid. These products have no clinical efficacy, and when patients use the deteriorated eye drops, there may be certain safety hazards and side effects

[0007] Many eye drops currently on the market, in order to maintain sterility and shelf life, add bacteriostatic agents and trace elemen