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Doxycycline hydrochloride long-acting injection and preparation method

A technology of doxycycline hydrochloride and injection, which is applied in the field of preparation of doxycycline hydrochloride long-acting injection for veterinary use, which can solve the problems of insignificant slow-release effect, tissue damage at the injection site, difficulty in preparing high-concentration preparations, etc., and achieve tissue Less irritation, less irritation, good tissue compatibility

Inactive Publication Date: 2014-01-29
中农华威制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Currently commercialized veterinary doxycycline injections and patented technologies are mostly in the form of solutions, and the preparations need to be stored with nitrogen, and the water, organic solvents, co-solvents, complexing agents, antioxidants, etc. The dosage of additives and the pH value of the preparation are very strict. If there is a slight deviation, the stability of the preparation will be problematic. This dosage form is not easy to prepare a stable high-concentration preparation, and the slow-release effect is not obvious. This dosage form is suitable for injection. tissue damage

Method used

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  • Doxycycline hydrochloride long-acting injection and preparation method
  • Doxycycline hydrochloride long-acting injection and preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0023] Embodiment 1, preparation 20% doxycycline hydrochloride injection

[0024] Preparation composition: Each 100ml injection contains 20g of doxycycline hydrochloride, 18g of SAIB, 1.2g of aluminum stearate, 0.01g of BHA, 0.01g of BHT, and 0.005g of PG, and IPM is added to the final volume.

[0025] Preparation method: (1) Add aluminum stearate to about half the amount of IPM, stir and heat (95-100°C) to prepare an oil gel containing aluminum stearate; (2) Dissolve SAIB in the remaining IPM, Prepare SAIB / IPM solution; (3) mix doxycycline hydrochloride with oil gelatin, cross colloid mill and grind to doxycycline hydrochloride particle size is less than 15 μ m, then mix with SAIB / IPM solution, and add antioxidant, use The high-shear homogenizer is homogenized multiple times under the condition of 15000-21000rpm and then ground by a sand mill to prepare injections with a particle size of less than 5 μm.

Embodiment 2

[0026] Embodiment 2, preparation 20% doxycycline hydrochloride injection

[0027] Preparation composition: Each 100ml injection contains 20g of doxycycline hydrochloride, 18g of SAIB, 0.45g of HCO, 0.01g of BHA, 0.02g of BHT, and 0.05g of PG, and IPM is added to the final volume.

[0028] Preparation method: (1) Mix HCO with half the amount of IPM, heat (80-90°C) to dissolve, and prepare a colloidal liquid containing HCO; (2) Dissolve SAIB in the remaining IPM to prepare a SAIB / IPM solution; (3) Mix doxycycline hydrochloride with colloidal liquid, and grind it through a colloid mill until the particle size of doxycycline hydrochloride is less than 15 μm, then add antioxidant and SAIB / IPM, and use a high-shear homogenizer at 15000-21000rpm After several times of homogenization, it is passed through a sand mill to obtain an injection with a particle size of less than 5 μm.

Embodiment 3

[0029] Embodiment 3, preparation 18% doxycycline hydrochloride injection

[0030]Preparation composition: Each 100ml injection contains 18g of doxycycline hydrochloride, 22g of SAIB, 0.8g of aluminum stearate, 0.01g of BHA, 0.01g of BHT, 0.005g of PG, 30ml of benzyl benzoate, and ethyl oleate to the final volume .

[0031] Preparation method: (1) Add aluminum stearate to ethyl oleate, stir and heat (95-100°C) to prepare a colloidal solution containing aluminum stearate; (2) Dissolve SAIB in benzyl benzoate In, prepare SAIB / benzyl benzoate solution; (3) mix doxycycline hydrochloride with the colloidal solution containing aluminum stearate, cross the colloid mill and grind to doxycycline hydrochloride particle size is less than 15 μ m, then mix with SAIB / The benzyl benzoate solution is mixed, an antioxidant is added, and an injection with a particle size of less than 10 μm is prepared after multiple times of homogenization with a high-shear homogenizer under the condition of 1...

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Abstract

The invention relates to an application of sustained-release material sucrose acetate iso-butyrate used in in-situ gel preparations to preparation of an oil suspension injection for livestock, and in particular relates to a method used for preparing a doxycycline hydrochloride long-acting injection by combining sucrose acetate iso-butyrate and hydrogenated castor oil or aluminium stearate. A dispersion medium of the preparation is isopropyl myristate, benzyl benzoate, ethyl oleate or a mixture of more than one of isopropyl myristate, benzyl benzoate and ethyl oleate. The preparation has good sustained release effects, stable characters and good tissue compatibility, and is easy to prepare.

Description

technical field [0001] The invention belongs to the preparation technology of veterinary drug preparations, and in particular relates to the preparation of doxycycline hydrochloride long-acting injection for veterinary use by combining doxycycline hydrochloride with a slow-release carrier. Background technique [0002] The currently commercialized veterinary doxycycline injections and patented technologies are mostly in the form of solutions, and the preparations need to be stored with nitrogen, and the water, organic solvents, co-solvents, complexing agents, antioxidants, etc. The dosage of the auxiliary agent and the pH value of the preparation are very strict. If there is a slight deviation, the stability of the preparation will be problematic. This dosage form is not easy to prepare a stable high-concentration preparation, and the slow-release effect is not obvious. This dosage form is suitable for injection. The tissue is damaged. Patent CN101862293B discloses a suspen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/44A61K47/26A61K47/12A61K31/65A61P31/04
Inventor 王玉万潘贞德戴晓曦徐飞沈力
Owner 中农华威制药股份有限公司
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