A sustained-release homatropine hydrobromide eye drop and a preparation method and a detection method thereof

By preparing sustained-release homatropine hydrobromide eye drops containing poloxamer-chitosan composite hydrogel and hyaluronic acid-modified nanoliposomes, the problem of poor stability of homatropine hydrobromide eye drops was solved, and the stability and sustained-release performance were improved, side effects were reduced, and the therapeutic effect and patient compliance were improved.

CN122097256APending Publication Date: 2026-05-29CHENGDU FIRST PHARMACEDTICAL CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
CHENGDU FIRST PHARMACEDTICAL CO LTD
Filing Date
2026-03-05
Publication Date
2026-05-29

AI Technical Summary

Technical Problem

Existing homatropine hydrobromide eye drops have poor stability, are easily decomposed, have high levels of impurities, accumulate preservatives, cause eye irritation and allergic reactions, and have short-lasting therapeutic effects, requiring frequent administration and resulting in poor patient compliance.

Method used

A sustained-release hamatopine hydrobromide eye drop was prepared using poloxamer-chitosan composite hydrogel, hyaluronic acid-modified nanoliposomes, hydroxypropyl methylcellulose, and other components. Preservatives were avoided. Hyaluronic acid-modified nanoliposomes served as the drug carrier, combined with the poloxamer-chitosan composite hydrogel to provide sustained-release properties. The pH was adjusted to 5.0–6.0, and sodium dihydrogen phosphate and disodium edetate were added to stabilize the solution. Sodium chloride was used to maintain ocular osmotic pressure balance.

Benefits of technology

It improves the stability and sustained-release properties of eye drops, reduces side effects, prolongs the duration of drug action, enhances patient comfort and therapeutic effect, reduces the frequency of administration, and meets ICH impurity level requirements.

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Abstract

The application relates to the technical field of medicine and chemical industry, in particular to a sustained-release homatropine hydrobromide eye drop, a preparation method and a detection method thereof, the sustained-release homatropine hydrobromide eye drop comprises the following components: homatropine hydrobromide, poloxamer-chitosan composite hydrogel, hydroxypropyl methyl cellulose, hyaluronic acid modified nano-liposome, sodium dihydrogen phosphate, disodium edetate, sodium chloride, a pH regulator, water for injection, and the pH value of the eye drop is 5.0-6.0. The sustained-release homatropine hydrobromide eye drop provided by the application is stable in quality, the impurity level meets the ICH requirement, can realize slow release after use, has the characteristics of slow release, small side effect, good treatment effect and the like, and can enhance the clinical patient applicability. In a myopia model experiment of a white rabbit, it is found that the spherical diopter value of the model animal after administration has an obvious rising trend compared with that before administration, and the myopia degree of the model animal is obviously improved, so the preparation has market application prospect.
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