Low-concentration tropane drug eye drops and preparation method

Abstract

The invention belongs to the technical field of drugs, and particularly relates to low-concentration tropane drug eye drops. The low-concentration tropane drug eye drops are prepared from 0.0005-0.5%of tropane drug, 0-10% of solute which achieves inclusion and is capable of reducing irritation, 0.01-5% of solute which increases the viscosity of drug liquid, an acidifying or alkalizing agent, an osmotic regulation agent, 0.01-0.05% of bacteriostatic agent and the balance water for injection, wherein the use amount of the acidifying or alkalizing agent enables the pH to be adjusted to be 4.0-6.5, and the use amount of the osmotic regulation agent enables the osmotic pressure to be regulated to 280-330 mOsm / L. The preparation method comprises the steps of S1, the solute which achieves inclusion and is capable of reducing irritation is weighed in proportion and solved into water, the tropane drug is added, and ultrasonic mixing is conducted for 30 minutes in an ultrasonic shake cleaning machine, so that the tropane drug is included by the solute which achieves inclusion and is capable of reducing irritation; S2, ethylparaben, sodium chloride and sodium hyaluronate are weighed in proportion and solved into the water for injection at 40-75 DEG C; S3, the solutions obtained in S1 and S2 are mixed; S4, filtration, sterilization and subpackage are conducted, and the low-concentration tropane drug eye drops are obtained.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a low-concentration tropane drug eye drop and a preparation method thereof. Background technique [0002] Atropine sulfate eye drops are included in the second edition of Western Medicine Preparations in the "Chinese Hospital Preparation Standards", which have three concentrations of 0.5%, 1% and 2%. The prescription composition is as follows: [0003] [0004] Preparation method: Dissolve ethylparaben in an appropriate amount of hot water for injection, add sodium chloride to dissolve, let cool, add atropine sulfate to dissolve, filter, add water for injection from the filter to make 1000mL, stir well, 100 Sterilize by circulating steam at ℃ for 30 minutes, and then pack aseptically. [0005] Functions and purposes: Mydriasis. Used to check fundus and corneal ulcers, keratitis, iridocyclitis. The atropine sulfate eye drops of this prescription is owing to mai...

AI Technical Summary

Problems solved by technology

The atropine sulfate eye drops of this prescription is owing to main agent concentration height, is 0.5% (w / v) to 2% (w / v), can cause follicular conjunctivitis on the one hand, eyelid skin eczema and Local allergic reactions such as eye congestion and erosion. On the other hand, after the liquid enters the mouth through the lacrimal duct, it will cause dry mouth, flushed face, and even cause symptoms such as elevated body temperature, resulting in poor patient compliance and affecting treatment.

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