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Doxycycline hydrochloride injection for animals and preparation method for doxycycline hydrochloride injection

A technology for doxycycline hydrochloride and doxycycline, which is applied in the directions of active ingredients of tetracycline, medical preparations of non-active ingredients, pharmaceutical formulas, etc., can solve the problem of lack of stability test data, no long-term effect, and difficulty in preparation technology And other issues

Active Publication Date: 2014-04-16
CHINA INST OF VETERINARY DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, doxycycline injections, especially high-concentration doxycycline injections, have certain difficulties and many problems in the preparation technology. For example, US3674859 and US 3957980 relate to low-concentration injections, and the dosage is large; In US 4086332, the amount of antioxidant sodium formaldehyde sulfoxylate used is relatively large, which can easily affect the safety of injections
CN101062013A, CN101062014A and CN101822817A relate to low-concentration injections, do not use metal ion complexation, use EDTA-2Na as an antioxidant, have no long-term effect, and lack stability test data
The antioxidant described in CN101703464A is suitable for weakly acidic liquid medicine, and the antioxidant effect is weak under the condition of pH7.5~9; CN 101416974A discloses that the long-acting effect of its preparation is not obvious; CN 101804062A and CN102144967A lack in vivo animal tests and stability Experimental data support its long-term effect

Method used

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  • Doxycycline hydrochloride injection for animals and preparation method for doxycycline hydrochloride injection
  • Doxycycline hydrochloride injection for animals and preparation method for doxycycline hydrochloride injection
  • Doxycycline hydrochloride injection for animals and preparation method for doxycycline hydrochloride injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090] Embodiment 1: Preparation of veterinary doxycycline hydrochloride injection

[0091] Its implementation steps are as follows:

[0092] A, with 0.25 gram formaldehyde sulfoxylate sodium antioxidant and 5.0 gram polyvinylpyrrolidone PVPK 17 The water-soluble polymer compound stabilizer was dissolved in water for injection to obtain an aqueous solution, pipetted 60% of the aqueous solution by volume, added to 45 grams of α-pyrrolidone organic solvent, and mixed uniformly to obtain a mixed solution;

[0093] B. Add MgCl successively to the mixed solution obtained in step A 2 ·6H 2 O complexing agent and 15 grams of doxycycline hydrochloride in terms of doxycycline, the molar ratio of its complexing agent to doxycycline is 1.3:1; use hydrochloric acid or ethanolamine regulator to adjust the pH at a temperature of 55°C Adjust the value to 3.0 and stir until a yellow transparent liquid is obtained;

[0094] C, then, keep warm at a temperature of 55° C. for 5 minutes; then ...

Embodiment 2

[0095] Embodiment 2: Preparation of veterinary doxycycline hydrochloride injection

[0096] Its implementation steps are as follows:

[0097] A. Mix 1.0 grams of sodium formaldehyde sulfoxylate and sodium bisulfite (weight ratio 3:2) antioxidant and 1.0 grams of polyvinylpyrrolidone PVPK 30 Dissolve the water-soluble polymer compound stabilizer in water for injection to obtain an aqueous solution, pipette 68% of the aqueous solution by volume, add 60 grams of α-pyrrolidone and dimethylacetamide (volume ratio 2:1) to compound In an organic solvent, mix uniformly to obtain a mixed solution;

[0098] B, in the mixed liquor that step A obtains, add MgO complexing agent and the doxycycline hydrochloride of 25 grams in doxycycline successively, the mol ratio of its complexing agent and doxycycline is 1.8: 1; Adjust the pH value to 6.0 with hydrochloric acid and ethanolamine pH regulator at a temperature of 64°C, and stir until a yellow transparent liquid is obtained;

[0099] C, ...

Embodiment 3

[0100] Embodiment 3: Preparation of veterinary doxycycline hydrochloride injection

[0101] Its implementation steps are as follows:

[0102] A, 0.50 gram of sodium formaldehyde sulfoxylate and sodium metabisulfite (weight ratio 3:2) antioxidant and 3.5 gram of poloxamer 407 water-soluble polymer compound stabilizers are dissolved in water for injection to obtain an aqueous solution, Pipette 75% of the aqueous solution by volume, add it to 50 grams of α-pyrrolidone and dimethylacetamide (volume ratio 2:1) composite organic solvent, and mix evenly to obtain a mixed solution;

[0103] B. Add MgSO to the mixed solution obtained in step A 4 Complexing agent and 20 grams of doxycycline hydrochloride in terms of doxycycline, the molar ratio of its complexing agent to doxycycline is 1.2:1; use hydrochloric acid and ethanolamine regulator to adjust the pH value at a temperature of 58°C Adjust to 3.5, stir until a yellow transparent liquid is obtained;

[0104] C, then, be incubated...

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Abstract

The invention relates to a doxycycline hydrochloride injection for animals and a preparation method for the doxycycline hydrochloride injection. The method comprises the following steps of: adding a proper amount of antioxygen and a proper amount of stabilizing agent into water for injection; then adding an aqueous solution into an organic solvent; adding doxycycline hydrochloride and a complexing agent; adjusting the pH; preserving the heat; then adding a metal ion chelant and partial antioxygen; and filtering, filling nitrogen and sterilizing to obtain the doxycycline hydrochloride injection for animals. The doxycycline hydrochloride injection prepared by the method is safe and stable; the half-life period is about 30 to 39 hours; the working time of the medicament in the body is prolonged, and the medicating frequency and the using amount are reduced; the treating effect and the treating efficiency are improved; and the doxycycline hydrochloride injection has a wide veterinary clinical application prospect.

Description

【Technical field】 [0001] The invention belongs to the technical field of veterinary medicine. More specifically, the present invention relates to a high-concentration long-acting doxycycline hydrochloride injection for veterinary use, and also relates to a preparation method of the injection. 【Background technique】 [0002] Doxycycline Hydrochloride is a tetracycline antibiotic, also known as deoxyoxytetracycline hydrochloride and doxycycline hydrochloride. Its antibacterial activity in vivo and in vitro is stronger than similar drugs oxytetracycline and tetracycline. The drug is not only effective against most Gram-positive bacteria and negative bacteria, but also effective against spirochetes, actinomycetes, mycoplasma, chlamydia, rickettsia and some protozoa (such as amoeba, coccidia, etc.) Inhibitory effect is also effective for tetracycline and oxytetracycline-resistant bacteria. It is used to treat chronic respiratory diseases, mycoplasma diseases, colibacillosis, sal...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/65A61K47/04A61K47/02A61K47/18A61P31/04
Inventor 胡海燕徐士新王亦琳黄耀凌徐倩朱馨乐孙雷毕言峰张聪敏徐秉恩汪霞张骊朱明文
Owner CHINA INST OF VETERINARY DRUG CONTROL