Novel olopatadine hydrochloride eye drop and preparation method thereof

A technology of olopatadine hydrochloride and eye drops, applied in the field of medicine, can solve problems such as no reports of olopatadine hydrochloride eye drops and the like

Inactive Publication Date: 2013-01-23
JIANGSU JIBEIER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, Olopatadine Hydrochloride Eye Drops has been listed in the domestic market, but there is no report of Olopatadine Hydrochloride Eye Drops with sodium hyaluronate

Method used

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  • Novel olopatadine hydrochloride eye drop and preparation method thereof
  • Novel olopatadine hydrochloride eye drop and preparation method thereof
  • Novel olopatadine hydrochloride eye drop and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020]

[0021] Preparation method:

[0022] Dissolve olopatadine hydrochloride and related auxiliary materials in appropriate amount of water for injection respectively.

[0023] Take the prescribed amount of sodium hyaluronate in water for injection, stir continuously at 60-70°C to make it fully swell, boil, and filter while hot with a microporous membrane.

[0024] Slowly add the filtered sodium hyaluronate solution into the olopatadine hydrochloride solution, stir evenly while adding, add water for injection to a sufficient amount, filter to obtain a clarified solution, sub-package, quality test, and only if it is qualified.

Embodiment 2

[0026] prescription:

[0027]

[0028]

[0029] Preparation method:

[0030] Take olopatadine hydrochloride, sodium chloride and related auxiliary materials and dissolve them in appropriate amount of water for injection respectively.

[0031] Take the prescribed amount of sodium hyaluronate in water for injection, stir continuously at 60-70°C to make it fully swell, boil, and filter while hot with a microporous membrane.

[0032] Slowly add the filtered sodium hyaluronate solution into the olopatadine hydrochloride solution, stir evenly while adding, add water for injection to a sufficient amount, filter to obtain a clarified solution, sub-package, quality test, and only if it is qualified.

Embodiment 3

[0034] prescription:

[0035]

[0036] Preparation method:

[0037] Take olopatadine hydrochloride, sodium chloride and related auxiliary materials and dissolve them in appropriate amount of water for injection respectively.

[0038] Take the prescribed amount of sodium hyaluronate in water for injection, stir continuously at 60-70°C to make it fully swell, boil, and filter while hot with a microporous membrane.

[0039] Slowly add the filtered sodium hyaluronate solution into the olopatadine hydrochloride solution, stir evenly while adding, add water for injection to a sufficient amount, filter to obtain a clarified solution, sub-package, quality test, and only if it is qualified.

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Abstract

The invention discloses a novel olopatadine hydrochloride eye drop and a preparation method thereof. The preparation method of the eye drop disclosed by the invention comprises the steps of: dissolving olopatadine hydrochloride and relevant accessories in water; adding a swelled sodium hyaluronate aqueous solution to the liquid medicine and then uniformly stirring; adding a sufficient amount of water; and finally, filtering and dispensing so as to obtain the eye drop. According to the novel olopatadine hydrochloride eye drop and the preparation method thereof, the defects of the current olopatadine hydrochloride eye drop are overcome; the residence time of the medicine on ocular surface is prolonged by the physical thickening and moisturizing lubrication effects of sodium hyaluronate; and furthermore, the medicine seldom flows into mouth and nasal cavity so as to reduce medicine loss and avoid bitterness from the olopatadine hydrochloride eye drop, and therefore, compliance of patients is increased and clinical curative effect is ensured.

Description

Technical field: [0001] The invention relates to the technical field of medicine, and discloses a new olopatadine hydrochloride eye drop and a preparation method thereof. Background technique: [0002] Olopatadine hydrochloride, chemical name: 11-(Z)-[-3-(dimethylamino)propane]-6-11-dihydrodibenzo[b.e]oxazepine-2-acetate Salt, chemical structural formula: [0003] [0004] Molecular formula: C 21 h 24 ClNO 3 , molecular weight: 373.88. [0005] Allergic conjunctivitis (allergic conjunctivitis) is a common ocular surface allergic disease, which is mainly caused by type I and type IV allergies. The main symptom of the disease is eye itching, often accompanied by conjunctival hyperemia, edema, nipple, follicular hyperplasia and other signs. [0006] Olopatadine hydrochloride is a new type of selective dibenzoxepin-2-acetic acid histamine H1 receptor inhibitor, which can inhibit tachykinin and other chemical transmitters, such as histamine, arachidene The release of ac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/335A61K47/36A61P27/02A61P37/08
Inventor 魏福荣陈进高瑞银聂丽云吴修艮
Owner JIANGSU JIBEIER PHARMA
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