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Dibazol hydrochloride eye drops and preparation method thereof

A technology for dibazole hydrochloride and azole eye drops, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as low pH, achieve solution clarification, improve tolerance, and improve The effect of solubility

Active Publication Date: 2012-12-26
南京艾德加生物制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventor tries to find the solubilizer of dimethazole hydrochloride to overcome the problem that the pH of dimethazole hydrochloride eye drops is too low

Method used

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  • Dibazol hydrochloride eye drops and preparation method thereof
  • Dibazol hydrochloride eye drops and preparation method thereof
  • Dibazol hydrochloride eye drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051]

[0052] Weigh 1 g of dimethazole hydrochloride raw material, add 100 ml of water for injection at a temperature of 60 °C to it, stir and dissolve to obtain a transparent solution A; weigh 100 g of hydroxypropyl-β-cyclodextrin, add 200 ml of water for injection to it, stir Make it dissolve, and stir at room temperature to obtain a transparent solution B; add solution A to solution B while stirring, and gradually add 0.4 g of ethylparaben and PEG-4004 g, stir and dissolve with 1mol / L sodium hydroxide solution, Adjust the pH value of the solution to 6.21, add water for injection to make the volume to 1000ml, and sterilize and filter with a 0.22 μm microporous membrane.

Embodiment 2

[0054]

[0055]

[0056] Weigh 1 g of Dimebazole hydrochloride raw material, add 50 ml of water for injection at 40°C to it, stir and dissolve to obtain a transparent solution A; weigh 500 g of hydroxypropyl-β-cyclodextrin, add 400 ml of water for injection to it, stir Make it dissolve, and stir at 30°C to obtain a transparent solution B; add solution A to solution B while stirring, and gradually add 0.1g of benzalkonium chloride and 2g of PVP-K30, stir and dissolve with 1mol / L sodium hydroxide solution, adjust the pH value of the solution to 6.18, add water for injection to make the volume to 1000ml, and sterilize and filter with a 0.22 μm microporous membrane.

Embodiment 3

[0058]

[0059]Weigh 1g of Dimebazole hydrochloride raw material, add 30ml of water for injection at 80°C to it, stir and dissolve to obtain transparent solution A; weigh 20g of hydroxypropyl-β-cyclodextrin, add 100ml of water for injection to it, stir Make it dissolve, and stir at 5°C to obtain a transparent solution B; add solution A to solution B while stirring, and gradually add 0.15g of benzalkonium chloride and 40g of PVP-K30, stir and dissolve with 1mol / L sodium hydroxide solution, adjust the pH value of the solution to 6.22, add water for injection to make the volume to 1000ml, and sterilize and filter with a 0.22 μm microporous membrane.

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Abstract

The invention relates to the filed of medicinal preparations, and in particular relates to dibazol hydrochloride eye drops and a preparation method thereof. The eye drops are characterized by comprising dibazol, beta-cyclodextrin and injection water, wherein the concentration of the dibazol is between 0.1 and 0.2 percent g / ml, the concentration of the beta-cyclodextrin is between 5 and 30 percentg / ml, and the pH of the eye drops is between 5.5 and 8.0. The dibazol hydrochloride eye drops provided by the invention do not irritate eyes, the eye drops are good in solubility, the liquid is clear, the osmotic pressure is proper, so that the dibazol hydrochloride eye drops are applicable to clinical application.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to dimethazole hydrochloride eye drops and a preparation method thereof. Background technique [0002] Dimethazole hydrochloride is a smooth muscle relaxant, which is mainly used for the treatment of juvenile pseudomyopia. It can directly relax smooth muscle and dilate anterior ciliary arteries and veins. It is beneficial to the blood supply of the ciliary muscle and improves the nutritional status of the ciliary muscle. Currently listed dimethazole hydrochloride is its hydrochloride. [0003] Since the pka value of dimethazole hydrochloride is about 4.0, it cannot be directly made into eye drops with a pH value of 5.5-8.0. The domestic eye drops were developed by Zhengzhou Zhihe Pharmaceutical Co., Ltd., and the product name is Minyue. It was approved for domestic marketing in 2007. The dipazole hydrochloride eye drops developed by the company has a pH range of 4.0 to ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4184A61K47/40A61P27/10
Inventor 王召马荣蔡艳张娜娜贡丽竹
Owner 南京艾德加生物制药科技有限公司
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