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A kind of preparation method of florfenicol injection

A technology of florfenicol and injection, which is applied in the field of preparation of florfenicol injection, can solve the problems of recurrent infection, complicated process, large dosage, etc., and achieves reducing the pressure of filtration, prolonging the use period, and preparing the process. simple effect

Active Publication Date: 2021-01-01
SICHUAN OUBANG ANIMAL PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The solubility of Florfenicol in water is extremely low, only about 1.30mg / ml at room temperature, which not only affects the oral absorption of Florfenicol, but also further affects its bioavailability; Large, high cost and easy to cause drug residues and induce recurrent infections of drug-resistant strains
[0006] In view of the above reasons, solving the problem of poor solubility of florfenicol in water has always been a hot spot in the field of veterinary medicine.
At present, there are two kinds of methods for improving the water solubility of florfenicol in reports: one is physical methods, including β-cyclodextrin inclusion complexes, hydroxypropyl-β-cyclodextrin inclusion complexes and preparation of solid dispersions, etc. The process is complex and requires a large number of special excipients, which are difficult to meet the needs of preparations and clinical use; the other is a chemical method, which is to make florfenicol into an inactive prodrug, which will be metabolized into florfenicol to play a role after entering the animal body. The characteristic is that the water solubility is much greater than the physical method, but the pharmacokinetic characteristics of the drug will be changed due to structural changes, resulting in some unpredictable effects

Method used

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  • A kind of preparation method of florfenicol injection
  • A kind of preparation method of florfenicol injection
  • A kind of preparation method of florfenicol injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The preparation process of Florfenicol Injection:

[0041] Concentrated liquid:

[0042] 1) Wash the containers and utensils used for liquid preparation twice with water for injection.

[0043] 2) The water for injection used for dosing must be kept fresh (not exceeding 8 hours).

[0044] 3) Add florfenicol, dimethylacetamide, and polyethylene glycol-400 according to the prescription and stir to fully dissolve and mix well. Add water to 100L, stir for another 15 minutes, mix well, and filter.

[0045] 3) The concentrated medicinal liquid passes through a titanium rod filter and is filtered to a dilute tank.

[0046] Dilute solution:

[0047] 1) Notify the QA personnel to take samples and test the content. After passing the test, nitrogen protection is introduced into the liquid mixing tank.

[0048] filter:

[0049] 1) Before filtering, a complete inspection of the sterilizing filter should be carried out, and it should be cleaned after passing the test.

[0050]...

Embodiment 2

[0060] A preparation method of Florfenicol, the specific preparation steps are as follows:

[0061] Add 300L of methanol to the 2000L reaction kettle, start stirring, add the crude product of Florfenicol, heat to 80°C, and wait until the solid dissolves completely to form a methanol mixture with a concentration of 50mg / ml of Florfenicol, and pump the mixture to In the refining tank, start stirring and add 900L water dropwise, start stirring and cool down to 25°C at a rate of 6°C / h, keep stirring at 25°C for 30 minutes, then cool down to the initial 5°C at a rate of 6°C / h, keep stirring at 5°C for 40 minutes Afterwards, centrifuge. The solid obtained by centrifugation was rinsed with 180Kg of water. The wet product is vacuum-dried at 60°C for 6 hours, and the vacuum degree is ≥0.08MPa. The refined yield of the final product is 93.1%, the solvent residual methanol is 120ppm, and the Dv(90) is controlled to be 56 μm. The solubility of the florfenicol crystals prepared by the m...

Embodiment 3

[0063] A preparation method of Florfenicol, the specific preparation steps are as follows:

[0064] Add 300L of acetamide to the 2000L reaction kettle, start stirring, add the crude product of Florfenicol, heat to 80°C, wait until the solid is completely dissolved and configure the concentration of the methanol mixture of Florfenicol to be 80mg / ml, pump the mixture To the refining tank, start stirring and add 1200L water dropwise, start stirring and cool down to 28°C at a rate of 10°C / h, keep stirring at 28°C for 40min, then cool down to the initial 7°C at a rate of 10°C / h, keep stirring at 7°C After 60 min, centrifuge. The solid obtained by centrifugation was rinsed with 200Kg of water. The wet product is vacuum-dried at 70°C for 6-10h, and the vacuum degree is ≥0.08MPa. The refined yield of the final product is 94.8%, the solvent residual acetamide is 107ppm, and the Dv(90) is controlled to be 40μm. The solubility of the florfenicol crystals prepared by this method in wat...

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Abstract

The invention specifically relates to a preparation method of florfenicol injection. The method includes: mixing florfenicol with dimethyl acetamide and polyethylene glycol, then adding water to a constant volume of 100L, performing stirring, and conducting filtering to obtain the florfenicol injection. The particle size Dv(90) of florfenicol is 30-75micrometer. The flufenicol injection finished product prepared by the method provided by the invention has high solubility in water and low residual solvent content, and the process operation is simple.

Description

technical field [0001] The invention relates to the field of veterinary medicine, in particular to a preparation method of florfenicol injection. Background technique [0002] Florfenicol, also known as fluthiamphenicol or fluchloramphenicol, is a monofluorinated derivative of thiamphenicol with a molecular formula of C 12 h 14 C 12 FNO 4 S, with a molecular weight of 358.2, is mostly crystalline powder, white in color, odorless and non-toxic. It is easily soluble in dimethylformamide (DMF), good in methanol and acetone, slightly soluble in acetic acid, and very slightly soluble in chloroform and water. Its structural formula is as follows: [0003] [0004] Florfenicol produces a broad-spectrum antibacterial effect by inhibiting the activity of peptide acyltransferase, and its antibacterial scope includes various Gram-negative and positive bacteria, mycoplasma and chlamydia, etc. Clinically, it has a strong effect on sensitive bacteria such as Escherichia coli, Rick...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/165A61P31/04C07C315/06C07C317/32
CPCA61K9/0019A61K9/08A61K31/165A61P31/04C07C315/06C07C317/32
Inventor 杨宏伟赵桂莲谭维
Owner SICHUAN OUBANG ANIMAL PHARMA CO LTD
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