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Doxycycline injection and preparation method thereof

A technology of doxycycline and doxycycline hydrochloride, which is applied in the field of animal injections, can solve the problems that the development level needs to be further improved, and achieve the effect of good stability

Active Publication Date: 2015-05-20
TIANJIN ZHONGSHENG TIAOZHAN BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the existing doxycycline injection, metal ions such as calcium, magnesium, zinc, etc. are generally combined to form complexes, and antioxidants are added to increase its stability. However, this stabilization method still cannot solve the problem of 4-doxycycline. The situation that the content of cycline increases gradually with time and temperature
[0005] Due to the above-mentioned problems of doxycycline injection, its development level needs to be further improved

Method used

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  • Doxycycline injection and preparation method thereof
  • Doxycycline injection and preparation method thereof
  • Doxycycline injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Preparation of doxycycline magnesium N-acetylglycinate

[0032] a. Dissolve 100 g (0.195 mol) of doxycycline hydrochloride in 500 mL of water;

[0033] b. Add magnesium chloride hexahydrate 39.6g (0.195mol), stir and dissolve;

[0034] c. Add 22.8g (0.195mol) of N-acetylglycine and stir to dissolve;

[0035] d. 1000 mL of ethanol was added dropwise, stirred overnight, and a crystalline solid was precipitated, filtered, and vacuum-dried to obtain 116 g of doxycycline magnesium N-acetylglycinate.

[0036] (2) Preparation of doxycycline injection

[0037] Weigh 10.6g of doxycycline magnesium N-acetylglycinate, 0.2g of sodium bisulfite, 0.2mL of benzyl alcohol, 50mL of α-pyrrolidone, and make up to 100mL of propylene glycol according to the formula, mix well and filter to make 10mL / An ampoule bottle filled with nitrogen, sealed and sterilized for doxycycline injection.

Embodiment 2

[0039] (1) Preparation of doxycycline zinc N-acetylthreonine salt

[0040] a. Dissolve 100 g (0.195 mol) of doxycycline hydrochloride in 500 mL of water;

[0041] b. Add anhydrous zinc chloride 26.6g (0.195mol), stir and dissolve;

[0042] c. Add 31.4 g (0.195 mol) of N-acetylthreonine and stir to dissolve;

[0043] d. 700 mL of methanol was added dropwise, stirred overnight, and a crystalline solid was precipitated, filtered, and vacuum-dried to obtain 120 g of doxycycline zinc N-acetylthreoninate.

[0044] (2) Preparation of doxycycline injection

[0045] Weigh 11.2g of doxycycline zinc N-acetylthreoninate, 0.2g of diaobaikuai, 0.2mL of benzyl alcohol, 50mL of N-methylpyrrolidone, and polyethylene glycol 300 to 100mL according to the formula, and mix well After filtering, make 10mL / support ampoule bottle, fill with nitrogen, fill and seal, sterilize doxycycline injection.

Embodiment 3

[0047] (1) Preparation of doxycycline calcium N-acetylglycine salt

[0048] a. Dissolve 100 g (0.195 mol) of doxycycline hydrochloride in 500 mL of water;

[0049] b. Add 28.7g (0.195mol) of calcium chloride dihydrate and stir to dissolve;

[0050] c. Add 22.8g (0.195mol) of N-acetylglycine and stir to dissolve;

[0051] d. 1200 mL of isopropanol was added dropwise, stirred overnight, and a crystalline solid was precipitated, filtered, and vacuum-dried to obtain 116 g of doxycycline calcium N-acetylglycinate.

[0052] (2) Preparation of doxycycline injection

[0053] Weigh 10.9g of doxycycline calcium N-acetylglycinate, 0.2g of sodium metabisulfite, 0.2g of benzoic acid, 50mL of N,N-dimethylacetamide, and polyethylene glycol 400 to make up to 100mL, mix After homogenization, filter to make 10mL / ampoules, fill with nitrogen, fill and seal, and sterilize doxycycline injection.

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Abstract

The invention relates to doxycycline injection and belongs to the field of injection for animals. The doxycycline injection comprises the following components: 5-20% (W / V) of a doxycycline metal complex N-acetylamino acid salt, 0.1-0.2% (W / V) of an antioxidant, 0.1-0.2% of an antiseptic, 40-60% (V / V) of an organic solvent I, and the balance of an organic solvent II. The invention also provides a preparation method of the doxycycline injection. The prepared doxycycline injection can be used for inhibiting production of a doxycycline degradation product 4-epi-doxycycline, and stability of the doxycycline injection is improved.

Description

technical field [0001] The invention belongs to the field of animal injections, in particular to a doxycycline injection and a preparation method thereof. Background technique [0002] Doxycycline, English name Doxycycline, is a semi-synthetic tetracycline antibiotic obtained by deoxygenation of oxytetracycline at the 6α-position. Listeria multiforme, Clostridium, Nocardia, Vibrio, Brucella, Campylobacter, Yersinia, etc. are all effective, and the effect on Gram-positive bacteria is better than that of Gram-negative bacteria. Doxycycline is absorbed quickly and completely when taken orally, and is widely distributed. It can pass through the blood-brain barrier, and most of it is excreted into the intestinal tract through bile to form an obvious enterohepatic circulation. In veterinary clinics, doxycycline is made into injection, tablet, soluble powder and injection powder for the treatment of poultry respiratory tract, gastrointestinal tract and urinary system infection. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/65A61K47/48A61P31/04
Inventor 王勇王猛王建张宁程雪娇赵健陈美琳焦晓军余贵菊崔志刚张立会甄盼盼
Owner TIANJIN ZHONGSHENG TIAOZHAN BIOTECH