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Alcatadine composition, its preparation method and use

A technology of alcaftadine and its composition, which is applied in the field of alcatadine composition, can solve the problems of waste of raw materials, etc., and achieve the effects of improving product quality, high stability, and reducing impurities

Active Publication Date: 2020-03-27
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The inventor of the present invention found in the research and development process of alcaftadine eye drops prescription, under the situation that contains non-ionic surfactant, the solubility of alcaftadine improves greatly, usually can dissolve completely, this solves the problem Solved the problem of waste of raw materials caused by excessive feeding in the preparation process

Method used

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  • Alcatadine composition, its preparation method and use
  • Alcatadine composition, its preparation method and use
  • Alcatadine composition, its preparation method and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] The preparation method of alcatadine composition:

[0057] (1) Weigh the nonionic surfactant according to the prescription amount, dissolve it in water for injection, then add the prescription amount of alcaftadine, stir to dissolve completely, and obtain solution I;

[0058] (2) Take another appropriate amount of water for injection, heat it until it boils, dissolve the pharmaceutically acceptable excipient in it, stir to dissolve completely, and obtain solution II;

[0059] (3) Combine solution II with solution I after cooling to room temperature, and add water for injection to the full amount to obtain solution III;

[0060] (4) Adjust the pH value of the solution III to 6.0-7.0, and filter through a 0.22 μm microporous membrane to obtain the alcaftadine composition.

[0061] The concrete composition of alcaftadine composition is as shown in the table below:

[0062]

Embodiment 2

[0064] Prepare different alcaftadine eye drops according to the following prescriptions and preparation processes, and use the HPLC method to detect the content of alcatadine before and after filtration:

[0065] Preparation Process:

[0066] (1) Weigh the nonionic surfactant according to the prescription amount, dissolve it in water for injection, then add the prescription amount of alcaftadine, stir to dissolve completely, and obtain solution I;

[0067] (2) Take another appropriate amount of water for injection, heat it until it boils, dissolve the pharmaceutically acceptable excipient in it, stir to dissolve completely, and obtain solution II;

[0068] (3) Combine solution II with solution I after cooling to room temperature, and add water for injection to the full amount to obtain solution III;

[0069] (4) Adjust the pH value of the solution III to 6.0-7.0, and filter through a 0.22 μm microporous membrane to obtain the alcaftadine composition.

[0070] Table 1: Prescr...

Embodiment 3

[0080] Embodiment 3 Alcaftadine eye drops toxicology test

[0081] 1. Purpose of the test

[0082] In this experiment, through the multiple administration eye irritation test (28 days) of the test sample of alcaftadine eye drops, the eye irritation reaction of the test sample of acarftadine eye drops to rabbit eyes was observed. The total score and histopathological examination results were used to evaluate the degree of eye irritation.

[0083] 2. Test samples

[0084] Prepare the sample according to prescription 7 in the above-mentioned embodiment 1, pack according to the market, and the specification is: 3.0ml (trial production).

[0085] In accordance with the requirements of "Chinese Pharmacopoeia" 2010 Edition, the second appendix eye drops, the main drug content, related substance content, pH value, visible foreign matter, and appearance inspection are all qualified test samples.

[0086] 3. Test method and process

[0087] Select 4 common-grade rabbits qualified fo...

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Abstract

The invention discloses an alcaftadine composition. The alcaftadine composition contains 0.005-10 w / v% of adcasatadine, 0.001-10 w / v% of a nonionic surfactant, and other suitable amounts of a pharmaceutically acceptable excipient and water for injection. The composition can ensure that the alcaftadine is fully dissolved in an aqueous solution without overdosing the main drug alcaftadine, and can also improve the stability of the alcaftadine in the aqueous solution; and compared with commercially available eye drops, an eye drop adopting a prescription containing the composition has the advantages of no irritation and good safety. The invention also discloses the preparation method of the alcaftadine composition. The method has the advantages of reasonable process, simplicity, and easinessin implementation.

Description

technical field [0001] The application relates to an alcatadine composition, which belongs to the technical field of medicines. [0002] technical background [0003] Allergic conjunctivitis, also known as allergic conjunctivitis, is a hypersensitivity reaction of the conjunctiva to external allergens. It mainly includes type I allergy and type IV allergy, among which allergic conjunctivitis caused by type I allergy is the most common. Allergic conjunctivitis caused by type Ⅰ allergy is immediate, mainly referring to allergic conjunctivitis including seasonal allergic conjunctivitis, perennial allergic conjunctivitis, giant papillary conjunctivitis, vernal keratoconjunctivitis, atopic Keratoconjunctivitis, etc.; allergic conjunctivitis caused by type Ⅳ allergy was delayed, mainly bullous conjunctivitis. [0004] The most common symptom of allergic conjunctivitis is eye itching, which can occur in almost all patients with allergic conjunctivitis, but eye itching is not a uni...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/55A61K9/08A61K9/06A61K47/14A61P27/02A61P37/08A61P11/02A61P29/00A61P27/16A61P17/04A61P43/00A61P9/00
CPCA61K9/00A61K9/0048A61K9/06A61K9/08A61K31/55A61K47/34
Inventor 周晶晶于艳春吴娟郭婷婷杨波郭亚兵
Owner WUHAN WUYAO SCI & TECH