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Levocetirizine hydrochloride eye drop composition and preparation method thereof

A technology of levocetirizine hydrochloride and eye drops, which is applied in drug combination, drug delivery, and pharmaceutical formulations, can solve the problems of not showing the effect of antagonizing H1 receptors, and achieve increased drug compliance and antiseptic use. Small amount, increase the effect of the user population

Pending Publication Date: 2021-11-30
南京帝昌医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] To investigate the efficacy of cetirizine enantiomers, cetirizine, levocetirizine, and dexetirizine (Ucb28557) were used in healthy adult volunteers for the treatment of skin allergic reactions induced by histamine. Randomized, double-blind and crossover trials, the results showed that cetirizine and levocetirizine had a significant inhibitory effect on the skin rash and flushing induced by histamine, and the antihistamine activity of 2.5mg levocetirizine was better than that of 5mg Cetirizine, suggesting that levo-cetirizine is more effective than cetirizine, while the other enantiomer, dex-cetirizine, does not show the effect of antagonizing H1 receptors

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Contains the following components:

[0025] Levocetirizine hydrochloride 0.12w / v%, sodium chloride 0.5w / v%, benzalkonium bromide 0.0001w / v%, sodium hydroxide pH to 7.45, add water for injection to 100% volume;

[0026] Prepare levocetirizine hydrochloride eye drops by above-mentioned proportioning, comprise following concrete steps:

[0027] ① First add edetate disodium, stir to dissolve, then add benzalkonium bromide, and continue stirring;

[0028] ② Add sodium chloride to the above solution and stir until dissolved;

[0029] ③ Add levocetirizine hydrochloride and continue to stir until it dissolves completely;

[0030] ④ Add sodium hydroxide dropwise to adjust the pH of the above solution to 7.45, and then add enough water for injection.

[0031] ⑤ After subpackaging, cover and seal the package.

Embodiment 2

[0033] Contains the following components:

[0034] Levocetirizine hydrochloride 0.12w / v%, sodium chloride 0.5w / v%, benzalkonium bromide 0.0002w / v%, sodium hydroxide pH to 7.45, add water for injection to 100% volume;

[0035] The preparation method is the same as in Example 1.

Embodiment 3

[0037] Contains the following components:

[0038] Levocetirizine hydrochloride 0.12w / v%, sodium chloride 0.55w / v%, benzalkonium bromide 0.0001w / v%, sodium hydroxide pH to 7.45, add water for injection to 100% volume;

[0039] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention relates to the technical field of ophthalmic medicines, in particular to levocetirizine hydrochloride eye drops and a preparation method thereof. The levocetirizine hydrochloride eye drops comprise the following components in parts by weight: 15-18 parts of levocetirizine hydrochloride, 50-55 parts of an osmotic pressure regulator, 50-55 parts of a thickening agent, 8-11 parts of a pH regulator and 0.01-0.02 part of a preservative; the pH value of the components is 7.0 to 7.8, and the osmotic pressure molar concentration of the components is 280 mOsmol / kg to 320 mOsmol / kg. According to the invention, the problem of compatibility of benzalkonium chloride and a plastic bottle in the existing levocetirizine hydrochloride eye drops is effectively solved, related substances are obviously superior to those of the existing levocetirizine hydrochloride eye drops, and the long-term stability is better; the dosage of the preservative is less, which is more environment-friendly and low in consumption; the number of contact lens patients is increased, and the medication compliance is improved.

Description

technical field [0001] The invention relates to the technical field of ophthalmic medicine, in particular to a levocetirizine hydrochloride eye drop composition and a preparation method thereof. Background technique [0002] Levocetirizine was developed by UCB Company in Belgium, and it is listed as the third-generation antiallergic drug together with fexofenadine, desloratadine, and eflurazine. Cetirizine is similar, but with fewer side effects. Cetirizine has a mild central nervous system inhibitory effect. Studies have shown that the central nervous system inhibitory effect of cetirizine is mainly due to the interaction between its D-body and related receptors in the brain. A certain affinity is related, so the single optical isomer of cetirizine - levocetirizine skillfully avoids the central nervous system side effects such as sedation and drowsiness of cetirizine, but the antihistamine activity is still similar to that of cetirizine. Similar to Tirizine. The antialler...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/02A61K47/36A61K47/18A61K31/495A61P37/08
CPCA61K9/08A61K9/0048A61K47/02A61K47/36A61K47/186A61K31/495A61P37/08
Inventor 刘小斌胡俊翟洪
Owner 南京帝昌医药科技有限公司
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