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

A technology of doxycycline hydrochloride and doxycycline, which is applied in the direction of active ingredients of tetracycline, medical preparations of non-active ingredients, pharmaceutical formulas, etc., which can solve the problem of large dosage, safety impact of injection, and no long-term effect And other issues

Active Publication Date: 2012-11-14
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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090] Example 1: Preparation of doxycycline hydrochloride injection for animals

[0091] The implementation steps are as follows:

[0092] A. Combine 0.25 grams of sodium formaldehyde sulfoxylate antioxidant and 5.0 grams of polyvinylpyrrolidone PVPK 17 The water-soluble polymer stabilizer is dissolved in water for injection to obtain an aqueous solution, pipette 60% of the aqueous solution by volume, add it to 45 grams of α-pyrrolidone organic solvent, and mix well to obtain a mixed solution;

[0093] B. Add MgCL to the mixture obtained in step A one by one 2 ·6H 2 O complexing agent and 15 grams of doxycycline hydrochloride based on doxycycline, the molar ratio of 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 the temperature at 55℃ for 5 minutes; then add 0.01 g of EDTA-2Na metal ion chelating ag...

Embodiment 2

[0095] Example 2: Preparation of doxycycline hydrochloride injection for animals

[0096] The implementation steps are as follows:

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

[0098] B. Add MgO complexing agent and 25 grams of doxycycline hydrochloride as doxycycline to the mixed solution obtained in step A, and the molar ratio of complexing agent to doxycycline is 1.8:1; Use hydrochloric acid and ethanolamine pH regulator to adjust the pH to 6.0 at a temperature of 64°C, and stir until a yellow transparent liquid is obtained;

[0099] C. Then, keep it at this temperature for 20 mi...

Embodiment 3

[0100] Example 3: Preparation of doxycycline hydrochloride injection for animals

[0101] The implementation steps are as follows:

[0102] A. Dissolve 0.50 grams of sodium formaldehyde sulfoxylate and sodium metabisulfite (weight ratio 3:2) antioxidants and 3.5 grams of poloxamer 407 water-soluble polymer stabilizer 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, mix well to obtain a mixed solution;

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

[0104] C. Then, keep it at this temperature for 14 minutes; then...

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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 animals, and also relates to a preparation method of the injection. 【Background technique】 [0002] Doxycycline Hydrochloride (Doxycycline Hydrochloride) is a tetracycline antibiotic, also known as doxycycline hydrochloride and doxycycline hydrochloride. Its antibacterial activity in vitro and in vivo is stronger than that of similar drugs oxytetracycline and tetracycline. The drug is not only effective against most gram-positive and negative bacteria, but also against spirochetes, actinomycetes, mycoplasma, chlamydia, rickettsia and certain protozoa (such as amoeba, coccidia, etc.) Inhibition, it is also effective against tetracycline and oxytetracycline resistant bacteria. It is used to treat livestock and poultry chronic respiratory diseases, mycoplasmosis, col...

Claims

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Application Information

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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
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