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Doxycycline hyclate injection and preparation process thereof

A technology of doxycycline hydrochloride and injection, which is applied in the field of veterinary medicine, can solve problems such as precipitation, discoloration, and restrictions on the preparation of injections, and achieve the effects of convenient use, short time to peak, and improved therapeutic effect and efficiency

Inactive Publication Date: 2016-07-13
安徽省兽药研发中心
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Doxycycline hydrochloride is easily oxidized and degraded under acidic or alkaline conditions, resulting in discoloration and precipitation. The extreme instability of doxycycline hydrochloride restricts the preparation of its injection

Method used

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  • Doxycycline hyclate injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Dissolve 4.2g of magnesium chloride complexing agent in 10ml of water for injection; sequentially add 20ml of α-pyrrolidone, 20ml of dimethylformamide, and 10ml of glycerin formal and heat to 60°C; add 5g of doxycycline hydrochloride (magnesium chloride and doxyl Cyclocycline molar ratio 1.6:1), stir to dissolve; add 0.1g of antioxidant sodium bisulfite dissolved in 5ml of water for injection; add 5g of co-solvent nicotinamide, keep warm for 15-20 minutes after complete dissolution; add PH regulator ethanolamine Adjust the PH value to 3.0, then make the volume to 100ml by adding water for injection, fill with N 2 Potting, sterilizing, and lamp inspection to prepare 100ml of doxycycline hydrochloride.

Embodiment 2

[0037] Dissolve 8.4g of magnesium chloride complexing agent in 10ml of water for injection, then add 20ml of α-pyrrolidone, 20ml of dimethylformamide, and 10ml of glycerin formal in sequence and heat to 55°C, add 10g of doxycycline hydrochloride, stir to dissolve, Add 0.2g of sodium bisulfite dissolved in 5ml of water for injection, add 10g of nicotinamide, keep warm for 15-20 minutes after complete dissolution, adjust the pH value to 5.0 with ethanolamine, then dilute to 100ml with water for injection, fill with N 2 Potting, sterilizing, and lamp inspection to prepare 100ml of doxycycline hydrochloride.

Embodiment 3

[0039] Dissolve 12.4g of magnesium chloride complexing agent in about 15ml of water for injection, add 20ml of α-pyrrolidone, 20ml of dimethylformamide, and 10ml of glycerin formal in sequence, heat to 60°C, add 15g of doxycycline hydrochloride, and stir to dissolve , add 0.2 g of sodium bisulfite dissolved in 5 ml of water for injection, add 10 g of nicotinamide, keep warm for 15-20 minutes after complete dissolution, and adjust the pH value to 3.0-5.0 with ethanolamine. Then dilute to 100ml with water for injection, fill with N 2 Potting, sterilizing, and lamp inspection to prepare 100ml of doxycycline hydrochloride.

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Abstract

The invention belongs to the technical field of veterinary medicine and discloses doxycycline hyclate injection and a preparation process thereof.Every 100ml of the doxycycline hyclate injection comprises 4.2-12.4g of magnesium chloride complexing agent, 5-15g of doxycycline hyclate, 20-30ml of alpha-pyrrolidone, 10-20ml of dimethyl formamide, 10-20ml of glycerin methylal, 0.1-0.2g of antioxidant, 5-10g of cosolvent and the balance of injection water.The prepared doxycycline hyclate injection has the advantages that the doxycycline hyclate injection is light in color, good in stability, quick in action, definite in curative effect, convenient in veterinary clinical application and easy in dose control, the doxycycline hyclate injection has a certain long-acting effect and cannot be easily affected by other medicine, and the treatment effect and efficiency are increased.

Description

technical field [0001] The invention belongs to the technical field of veterinary medicine, relates to a veterinary long-acting doxycycline hydrochloride injection, and also relates to a preparation method of the injection. Background technique [0002] Doxycycline hydrochloride, also known as deoxyoxytetracycline hydrochloride, is a semi-synthetic broad-spectrum antibiotic. Its antibacterial spectrum is the same as that of tetracycline, but its antibacterial activity in vivo and in vitro is stronger than that of tetracycline and oxytetracycline. It is absorbed quickly and has high bioavailability when taken orally. , the effective blood concentration is maintained for a long time, has strong tissue penetration, and is widely distributed. It is mainly used to treat livestock and poultry diseases caused by Mycoplasma, Escherichia coli, Salmonella, Pasteurella, Staphylococcus, Streptococcus and Eperythrozoon. Because of its unique curative effect and low toxic and side effects...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/65A61K47/04A61P31/04
Inventor 王丽霞陈砀桐余文丁颜秀梅
Owner 安徽省兽药研发中心
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