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Oxytetracycline preparation and preparation method

A technology for oxytetracycline preparations, which is applied in the field of oxytetracycline preparations and preparations, can solve the problems of drug unevenness, easy precipitation, and influence on drug efficacy, and achieve the effects of shortening production time, high production efficiency, and increasing curative effect

Active Publication Date: 2015-06-24
SICHUAN MEIJIALONG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Oxytetracycline (C 22 h 24 N 2 o 9 ) made into dry powder preparations or suspensions, but there is a tendency to precipitate after the preparations are stored for a long time, and the medicines are not uniform when used, which affects the efficacy or cannot be used

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Magnesium chloride is ultrafinely pulverized, and after pulverization, the pulverization fineness is ≥500 mesh; take part of the water for injection, add 0.5% sodium formaldehyde sulfoxylate and stir to dissolve, and then add 45% of α-pyrrolidone, 30% of oxytetracycline and 2% of magnesium chloride Form a mixed solution, then heat the mixed solution to 60°C, stir continuously, and keep it warm for 35 minutes; use the remaining water for injection to make up the volume, stir evenly, and adjust the pH to 8-9 with 2-5% ethanolamine.

[0024] Water for injection, that is, the water obtained by distilling purified water. Its pH value is 5; ammonia does not exceed 0.0002%; nitrate does not exceed 0.000006%; nitrite does not exceed 0.000002%; conductivity: when 10ml or less, the limit is 25μS / cm; The amount should be less than 0.25EU; microbial limit: no more than 10 bacteria and yeast per 100ml.

Embodiment 2

[0026] Magnesium chloride is ultrafinely pulverized, and after pulverization, the pulverization fineness is ≥500 mesh; take part of the water for injection, add 2% formaldehyde and sodium bisulfite, stir and dissolve, and then add 55% of α-pyrrolidone, 30% of oxytetracycline and 3% of magnesium chloride Form a mixed solution, then heat the mixed solution to 70°C, stir continuously, and keep warm for 25 minutes; use the remaining water for injection to make up the volume, stir evenly, and adjust the pH to 8-9 with 2-5% ethanolamine.

[0027] Water for injection, that is, the water obtained by distilling purified water. Its pH value is 6; ammonia does not exceed 0.0002%; nitrate does not exceed 0.000006%; nitrite does not exceed 0.000002%; conductivity: 10ml or less, the limit is 25μS / cm; The amount should be less than 0.25EU; microbial limit: no more than 10 bacteria and yeast per 100ml.

Embodiment 3

[0029] Superfinely pulverize 2-3% magnesium chloride, after pulverization, the pulverization fineness is ≥500 mesh; take part of the water for injection, add 1.5% sodium formaldehyde sulfoxylate and stir to dissolve, then add α-pyrrolidone 46%, oxytetracycline 30% Make a mixed solution with 2.2% magnesium chloride, then heat the mixed solution to 65°C, keep stirring, and keep it warm for 35 minutes; use the remaining water for injection to make up the volume, stir evenly, and adjust the pH to 8-9 with 2.5% ethanolamine.

[0030] Water for injection, that is, the water obtained by distilling purified water. Its pH value is 7; ammonia does not exceed 0.0002%; nitrate does not exceed 0.000006%; nitrite does not exceed 0.000002%; conductivity: when 10ml or less, the limit is 25μS / cm; The amount should be less than 0.25EU; microbial limit: no more than 10 bacteria and yeast per 100ml.

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Abstract

The invention belongs to the field of medicine, and particularly relates to an oxytetracycline preparation and a preparation method. The oxytetracycline preparation is characterized by comprising, by weight, 30% of oxytetracycline, 2-3% of magnesium chloride, 45-55% of 2-pyrrolidone, 2-5% of cholamine, 0.5-2% of sodium formaldehyde sulfoxylate and the balance water. The oxytetracycline preparation and the preparation method have the advantages that the complexation technology is adopted for preparation of the oxytetracycline preparation, so that the oxytetracycline preparation has stable quality, muddy sediments are not generated, slow release after injection can be achieved, and curative effect is improved; the preparation method is simple, easiness in production operation is achieved, production time is shortened by one hour as compared with common production time, production efficiency is higher, and production cost is reduced.

Description

technical field [0001] The invention relates to oxytetracycline preparations, in particular to an oxytetracycline preparation and a preparation method. Background technique [0002] Oxytetracycline belongs to the tetracycline class and can be used to treat rickettsial diseases, including epidemic typhus, endemic typhus, Rocky Mountain fever, scrub typhus and Q fever, mycoplasma infection and chlamydia infection and other diseases. [0003] Oxytetracycline (C 22 h 24 N 2 o 9 ) made into dry powder preparations or suspensions, but there is a tendency for precipitation to occur after the preparations are stored for a long time, and the preparations are not uniform when used, which affects the efficacy or cannot be used. Contents of the invention [0004] In order to solve the above technical problems, the present invention provides a oxytetracycline preparation and a preparation method thereof. The oxytetracycline preparation has a long storage time, and the oxytetracyc...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/65A61K47/04A61P1/12A61P31/04
Inventor 杨建平
Owner SICHUAN MEIJIALONG BIOTECH
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