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Dorzolamide hydrochloride eye drop and preparation method thereof

A technology of dorzolamide hydrochloride and eye drops, which is applied in the field of medicine, can solve the problems of difficulty in filtration and reduction of formation, and achieve the effects of simple preparation method, lower viscosity, and reduction of formation of related substances

Inactive Publication Date: 2020-05-01
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The second object of the present invention is to provide a kind of preparation method of dorzolamide hydrochloride eye drops, this preparation method sets out from the ingredients of raw and auxiliary materials in the formula, coordinates the thickener solution filtration temperature and thickener solution pH in the preparation process, solves It solves the problem of difficult filtration in the prior art, and reduces the formation of related substances

Method used

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  • Dorzolamide hydrochloride eye drop and preparation method thereof
  • Dorzolamide hydrochloride eye drop and preparation method thereof
  • Dorzolamide hydrochloride eye drop and preparation method thereof

Examples

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Embodiment 1

[0057] The consumption of each raw material of the dorzolamide hydrochloride eye drops of the present embodiment is as follows:

[0058] Dorzolamide hydrochloride 111.3g, sodium citrate dihydrate 14.7g, mannitol 120g, hypromellose (model: E4M) 40g, benzalkonium chloride 0.375g, after preparation, add water for injection and dilute to 5000mL.

[0059] The preparation method of the dorzolamide hydrochloride eye drops of the present embodiment may further comprise the steps:

[0060] (1) Take 50% of the total volume of water for injection, heat it to keep the water temperature at 80°C, add hypromellose under stirring, and continue stirring for 30 minutes; under stirring, sterilize at 121°C for 15 minutes; cool the liquid to 30°C ℃, then filter, and collect the filtrate into the liquid mixing tank;

[0061] (2) Take 40% of the total volume of water for injection into another liquid mixing tank, add dorzolamide hydrochloride, sodium citrate dihydrate, mannitol, and benzalkonium ch...

Embodiment 2

[0065] This example refers to the amount of raw materials used in Example 1. The difference lies in the preparation method. The only difference between the preparation method of this example and the preparation method of Example 1 is: in step (1), the liquid is cooled to 40 ° C, and then filtered. Collect the filtrate into the liquid distribution tank.

Embodiment 3

[0067] This example refers to the amount of raw materials used in Example 1. The difference lies in the preparation method. The only difference between the preparation method of this example and the preparation method of Example 1 is: in step (1), the liquid is cooled to 50 ° C, and then filtered. Collect the filtrate into the liquid distribution tank.

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Abstract

The invention relates to the technical field of medicines, in particular to a dorzolamide hydrochloride eye drop and a preparation method thereof. The dorzolamide hydrochloride eye drops are mainly prepared from dorzolamide hydrochloride, a buffer agent, an osmotic pressure regulator, a thickener and water. Wherein the thickener comprises hydroxypropyl methylcellulose. The preparation method comprises the following steps: uniformly mixing hydroxypropyl methylcellulose with water at 70-90 DEG C, sterilizing, cooling to 30-50 DEG C, filtering, and collecting a filtrate I; uniformly mixing dorzolamide hydrochloride, a buffer agent, an osmotic pressure regulator and water at 40-70 DEG C, filtering, and collecting a filtrate II; and mixing the filtrate I and the filtrate II, adjusting the pH value to 5.5-5.8, and adjusting the dorzolamide hydrochloride to the prescription dosage. When the thickener solution is prepared, the specific filtering temperature is adopted, the viscosity of the liquid medicine is reduced, the filterability is improved, the thickening agent is effectively filtered into the liquid medicine, the viscosity stability and the drug effect stability of eye drops in batches are improved, and the formation of related substances is reduced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a dorzolamide hydrochloride eye drop and a preparation method thereof. Background technique [0002] Dorzolamide hydrochloride, its chemical name is (4S,6S)-4-ethylamino-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide -7,7-dioxide hydrochloride, which has the following structure: [0003] [0004] Dorzolamide hydrochloride eye drops were originally developed by Merck Pharmaceuticals, and were first approved for marketing in the United States in 1994. The trade name is "Trusopt", and the specification of the eye drops is 2%. Merck has successively launched this product in many countries, including the United States, Europe and Japan. [0005] In May 2003, Merck Pharmaceuticals imported dorzolamide hydrochloride eye drops in China. The trade name was "Tian Su De". The specification of the eye drops was 5mL: 0.1g. elevated intraocular pressure and open-angle glau...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/382A61K47/38A61P27/06
CPCA61K9/0048A61K9/08A61K31/382A61K47/38A61P27/06
Inventor 胡奎于艳春郭亚兵杨波
Owner WUHAN WUYAO SCI & TECH
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