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A kind of florfenicol inclusion compound freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and florfenicol, which is applied in the field of florfenicol inclusion compound freeze-dried powder injection and its preparation, can solve the problems of small injection irritation, local injection irritation, poor solubility, etc., and achieve Effects of small injections on irritation, pain relief, and difficulty in administration

Active Publication Date: 2021-09-03
SICHUAN AGRI UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide a kind of florfenicol inclusion compound freeze-dried powder injection and preparation method thereof, this freeze-dried powder injection solves the problem that existing florfenicol preparations have poor solubility and can cause local injection irritation, and can Significantly increase the solubility of florfenicol in water, improve its pharmacokinetic properties, make florfenicol more quickly exert its curative effect, and have less irritating injection, non-hemolytic, and can be used for intravenous injection

Method used

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  • A kind of florfenicol inclusion compound freeze-dried powder injection and preparation method thereof
  • A kind of florfenicol inclusion compound freeze-dried powder injection and preparation method thereof
  • A kind of florfenicol inclusion compound freeze-dried powder injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0040] A florfenicol inclusion compound freeze-dried powder injection, its preparation method is as follows:

[0041] (1) Weigh FF and HPCD, the molar ratio of HPCD and FF is 1:1;

[0042] (2) FF was dissolved in methanol with a concentration of 30%, HPCD was dissolved in an appropriate amount of water, and the mass concentration of HPCD in the aqueous solution was 10%, and the fully dissolved FF methanol solution was slowly added to the HPCD aqueous solution;

[0043] (3) Shake the obtained mixed solution in a constant temperature water bath shaker at 30° C. for 2 hours, the stirring speed is 100 r / min, and the pH of the reaction solution is 5.0;

[0044] (4) Evaporate the solvent completely on a rotary evaporator, and then filter the clathrate aqueous solution with a 0.22 μm microporous membrane;

[0045] (5) Dry in a vacuum freeze dryer, pre-freeze at -30°C for 4 hours, freeze-dry at -50°C for 16 hours, and dry at 30°C for 4 hours to obtain Florfenicol freeze-dried powder ...

Embodiment 2

[0048] A florfenicol clathrate lyophilized powder injection, the preparation process of which is basically the same as in Example 1, the difference is that in step (1), the molar ratio of HPCD to FF is 2:1; in step (2) , the mass concentration of HPCD in the aqueous solution is 15%; in step (3), the temperature is 50°C.

[0049] In Example 2, the drug loading of the clathrate aqueous solution prepared by step (4) was 10.07%, and the encapsulation efficiency was 86.95%; the freeze-dried powder injection obtained by step (5) had good appearance and resolubility, and the The powder is white, smooth and flat, and the solution is clear and transparent after reconstitution.

Embodiment 3

[0051] A florfenicol clathrate lyophilized powder injection, the preparation process of which is basically the same as in Example 1, the difference is that in step (1), the molar ratio of HPCD to FF is 2:1; in step (2) Among them, the mass concentration of HPCD in aqueous solution is 20%, and the concentration of methanol is 40%.

[0052] In Example 3, the drug loading of the clathrate aqueous solution prepared by step (4) was 10.12%, and the encapsulation efficiency was 87.40%; the freeze-dried powder injection obtained by step (5) had good appearance and resolubility, and the The powder is white, smooth and flat, and the solution is clear and transparent after reconstitution.

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Abstract

The invention discloses a florfenicol inclusion compound freeze-dried powder injection and a preparation method thereof. The inclusion compound freeze-dried powder injection is prepared by adding a methanol solution of florfenicol to an aqueous solution of hydroxypropyl cyclodextrin at 30 ~50°C constant temperature to control the pH to 4~6 and shake at 100r / min, remove the solvent, filter through a microporous membrane, pre-freeze at -30°C for 4-8 hours, freeze-dry at -50°C for 16-24 hours, and dry , obtained; wherein, the molar ratio of the florfenicol and hydroxypropyl cyclodextrin is 1:1~1:3; the concentration of the methanol solution is 30~50%; the hydroxypropyl cyclodextrin The mass concentration of essence is 10-20%. The clathrate freeze-dried powder injection of the present invention significantly improves the solubility of florfenicol in water, improves its pharmacokinetic properties, enables florfenicol to exert its curative effect more quickly, and has less injection stimulation Sex, non-hemolytic, can be used for intravenous injection.

Description

technical field [0001] The invention relates to a powder injection, in particular to a florfenicol inclusion compound freeze-dried powder injection and a preparation method thereof. Background technique [0002] Florfenicol (FF) is a kind of amide alcohol broad-spectrum antibiotic specially used for animals. It is widely used in veterinary clinics, such as the treatment of bacterial diseases in aquatic fish, cattle, pigs, dogs, chickens and other livestock and poultry. . Since chloramphenicol was banned from being used in animal-derived food animals, FF, as the same type of broad-spectrum antibiotic that can replace chloramphenicol, not only has high pharmacological activity, but also has a broad antibacterial spectrum and is safer. It has been widely used in aquaculture and animal husbandry Industry. [0003] However, at room temperature, the solubility of FF in water is very low, about 1.25 mg / mL, which greatly limits its wide application. In recent years, scholars at h...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/69A61K31/165A61P31/04
CPCA61K9/0019A61K9/19A61K31/165A61K47/6951A61P31/04
Inventor 符华林凡国庆付菁源张宇宁张伟舒刚彭广能钟志军
Owner SICHUAN AGRI UNIV
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