Liquid preparation for dosing eyes and method for making the same

A technology for liquid preparation and eye administration, applied in the field of medicine

Inactive Publication Date: 2010-03-17
广州达信生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no report about ophthalmic rupatadine composition

Method used

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  • Liquid preparation for dosing eyes and method for making the same
  • Liquid preparation for dosing eyes and method for making the same
  • Liquid preparation for dosing eyes and method for making the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Example 1 Preparation of Rupatadine Eye Drops

[0054] Main drug and excipient name dosage

[0055] Rupatadine 0.625g

[0056] Borax 0.14g

[0057] Boric acid 0.10g

[0058] Ethylparaben 0.03g

[0059] Sulfobutyl ether-β-cyclodextrin 1.50g

[0060] Distilled water to 100mL

[0061] Preparation method: Dissolve borax, boric acid, sulfobutyl ether-β-cyclodextrin and ethylparaben in 90mL distilled water, add rupatadine to the above solution after crushing it through an 80-mesh sieve, and add distilled water to 100 mL, fully shake to dissolve rupatadine, the pH is between 4.5 and 5.0, and filter through a 0.45 μm microporous membrane to obtain rupatadine eye drops. Flow-through steam sterilizable, dispensed in multi-dose delivery devices.

Embodiment 2

[0062] Example 2 Preparation of Rupatadine Ophthalmic Gel

[0063] Main drug and excipient name dosage

[0064] Rupatadine 10.0g

[0065] Sulfobutyl ether-β-cyclodextrin 10.0g

[0066] Ethylparaben 0.03g

[0067] Boric acid 0.18g

[0068] Borax 0.12g

[0069] Carbopol 940 0.01g

[0070] Distilled water to 100mL

[0071] Preparation method: Sprinkle Carbopol 940 into 10mL of distilled water several times to make it slowly swell to obtain Carbopol 940 water dispersion. After crushing rupatadine through an 80-mesh sieve, add ethylparaben, borax, boric acid and sulfobutyl ether-β-cyclodextrin into 80mL water, shake fully to dissolve completely, and its pH is 5.0~ 5.5, and then added to Carbopol 940 aqueous dispersion, added distilled water to 100mL, and stirred evenly to obtain rupatadine ophthalmic gel. Flow-through steam sterilizable, dispensed in multi-dose delivery devices.

Embodiment 3

[0072] Example 3. Preparation of Rupatadine Eye Drops

[0073] Main drug and excipient name dosage

[0074] Rupatadine 0.20g

[0075] Hydroxypropyl-β-cyclodextrin 2.00g

[0076] Chlorobutanol 0.05g

[0077] Boric acid 0.10g

[0078] Borax 0.08g

[0079] Distilled water to 100mL

[0080] Preparation method: Dissolve chlorobutanol, borax, boric acid and hydroxypropyl-β-cyclodextrin in 90mL distilled water, add rupatadine to the above solution after pulverizing it through an 80-mesh sieve, and add distilled water to 100mL, shake fully to dissolve rupatadine, the pH is between 4.5 and 5.0, and filter through a 0.45μm microporous membrane to obtain rupatadine eye drops. Flow-through steam sterilizable, dispensed in multi-dose delivery devices.

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Abstract

The invention relates to a liquid preparation for dosing eyes, which comprises 0.1 to 25 g/100 mL of rupatadine and 0.5 to 30 g/100 mL of cyclodextrin compound. The invention also relates to a methodfor making the liquid preparation. The liquid preparation of the invention has the characteristics of rapid absorption, convenient use, obvious curative effect and stability, and has excellent curative effect for treating conjunctivitis, in particular for treating allergic conjunctivitis.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a liquid preparation containing rupatadine for ophthalmic administration and a preparation method thereof. Background technique [0002] Conjunctivitis is a relatively common eye disease. According to the etiology, it is mainly divided into two categories: infectious and non-infectious. Infectious conjunctivitis is mainly caused by bacteria, viruses, Chlamydia trachomatis, etc. It can be caused by air, dust, water or pollution. Infection from hands, towels, etc., can also be affected by adjacent tissue lesions, such as inflammation of the eyelids and lacrimal organs; non-infectious conjunctivitis is stimulated by mechanical, physical (heat, radiation), chemical (acid-base) and other substances , Conjunctivitis caused by allergic reactions is also common, such as vernal conjunctivitis, drug-induced conjunctivitis, etc. Conjunctival hyperemia and increased secretions are the basic characte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/48A61K31/4545A61K47/40A61P27/02A61K47/61A61K47/69
Inventor 阴元魁雍智全谭培陈宝林胡文慧韩为跃闻亚磊
Owner 广州达信生物技术有限公司
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