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Mixed suspension injection liquid containing tylosin and preparation method thereof

A technology for suspension injection and tylosin, which is applied in the field of tylosin-containing suspension injection and its preparation, can solve the problems of few reports and few manufacturers of long-acting preparations, and achieves biocompatibility Good performance, simple and easy preparation process, good stability

Inactive Publication Date: 2011-01-05
GUANGZHOU HUIHUA ANIMAL HEALTH PROD CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Although tylosin has been used for many years at home and abroad, and there are already many manufacturers of tylosin preparations produced in batches at home and abroad, but there are not many manufacturers studying its long-acting preparations, and there are few related reports at home and abroad.

Method used

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  • Mixed suspension injection liquid containing tylosin and preparation method thereof
  • Mixed suspension injection liquid containing tylosin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1: 20% Tylosin Suspension Injection

[0016] [Prescription] Tylosin 20% (W / V)

[0017] Sodium Carboxymethyl Cellulose 0.5% (W / V)

[0018] Tween-80 0.1% (W / V)

[0019] Sodium citrate 0.5% (W / V)

[0020] 1,2-Propanediol 10% (W / V)

[0021] 1N NaOH to pH 7.0

[0022] Methylparaben 0.18% (W / V)

[0023] Propylparaben 0.02% (W / V)

[0024] Add water for injection to 100% (V / V)

[0025] 【preparation】

[0026] Swell and dissolve sodium carboxymethylcellulose, Tween-80, and sodium citrate with water; add the prescribed amount of tylosin tartrate, stir and dissolve; slowly add 1N NaOH dropwise to pH 7.0 to obtain a white milky solution, Stir at the same time; add other additives in the prescribed amount, add water to the full amount, and obtain Tylosin Suspension Injection.

Embodiment 2

[0027] Embodiment 2: Quality Research and Application Test of Tylosin Suspension Injection of the Present Invention

[0028] 1. Quality evaluation

[0029] The tylosin suspension of the present invention has no delamination after being placed for 30 minutes, and the sedimentation volume ratio after being placed for 3 hours is 91%, indicating that the sedimentation speed of the suspension is relatively slow; the re-dispersibility test results show that the suspension is easily dispersed after shaking , no agglomeration; 86.9% of drug particles in the suspension have particle sizes between 2.5 and 15 μm; 8.8% are larger than 15 μm; they meet the requirements for suspension injections.

[0030] 2. Stability test

[0031] Under the conditions of (4500 ± 500) LX strong light irradiation for 10 days, the appearance color of the preparation remains milky white all the time, the sedimentation ratio does not change after one day, and the content of active ingredient TylosinA decreases...

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PUM

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Abstract

The invention relates to a mixed suspension injection liquid containing tylosin and a preparation method thereof, belonging to the technical fields of veterinary antibiotic medicines as well aspreparation methods and an application thereof. The injection liquid comprises medicinal active ingredients, a suspending agent, a surface active agent, a flocculating agent, a pH regulating agent, water and auxiliary agents comprising an antiseptic agent and the like which are added when necessary. Water soluble raw material medicines are selected for the mixed suspension injection liquid containing tylosin, the medicines are separated out by a coacervation method, and the aqueous mixed suspension injection liquid with uniform particle distribution can be prepared. The method has the characteristics of simple and practicable process, no special equipment and lower cost. The dispersion medium of the obtained preparation is water, thus the problem of irritation induced by a conventional injection using an organic solvent is solved, and animal compliance is good. The prepared tylosin mixed suspension injection liquid forms a medicine store in vivo, exerts slow release and long-acting action and can be applied to a veterinary long-acting injection, which has good stability, good biocompatibility and absorption delay effect.

Description

technical field [0001] The invention relates to veterinary antibiotics, in particular to a suspension injection containing tylosin and a preparation method thereof. Background technique [0002] Tylosin (Tylosin) is a macrolide animal-specific antibiotic produced by Streptococcus freundii, which is a mixture of four main macrolide drugs, including tylosin A (>80 %), Tylosin B (desmycosin), tylosin C (macrocin) and tylosin D, these four components account for no less than 90% of the total drug. It mainly acts on Gram-positive bacteria and mycoplasma, and has different degrees of inhibitory effects on some Gram-negative bacteria, spirochetes, livestock coccidia and some fungi. The strong anti-mycoplasma properties of tylosin make it the first choice drug for the treatment of mycoplasma diseases in livestock and poultry, and can effectively prevent and treat mycoplasma diseases in chickens and swine panting diseases. [0003] Although tylosin has been used for many years a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/7048A61P31/04A61P31/10A61P33/02
Inventor 黄显会董斌杨艳玲陈浩文程怀灵张影纯曾振灵
Owner GUANGZHOU HUIHUA ANIMAL HEALTH PROD CO LTD
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