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Valnemulin hydrochloride enteric solid dispersion, as well as preparation method and application thereof

A technology of vornimulin hydrochloride and solid dispersion, which is applied in the field of vornimulin hydrochloride enteric-coated solid dispersion and its preparation, can solve the problems of poor palatability, strong pungent odor, easy moisture absorption and hydrolysis, etc. The effect of small amount, large fluidity and small corrosion effect of equipment

Active Publication Date: 2014-04-30
SOUTH CHINA AGRI UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Another object of the present invention is to provide the enteric-coated solid dispersion of warnemulin hydrochloride prepared by the above-mentioned preparation method, which has good fluidity and is easy to mix and administer. In addition, the enteric-coated solid dispersion of warnemulin hydrochloride overcomes the disadvantages of poor palatability, strong pungent smell, and easy moisture absorption and hydrolysis of warnemulin hydrochloride;

Method used

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  • Valnemulin hydrochloride enteric solid dispersion, as well as preparation method and application thereof
  • Valnemulin hydrochloride enteric solid dispersion, as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A kind of warnemulin hydrochloride enteric-coated solid dispersion, its preparation method is as follows:

[0035] a) Stir and mix 1g of warnemulin hydrochloride crude drug and 1g of enteric-coated carrier to make a drug-carrier mixture; the enteric-coated carrier is No. II polyacrylic resin and No. III polyacrylic resin with a weight ratio of 10 : 1 proportioning mixed carrier raw material;

[0036] b) Add the above drug-carrier mixture into 40 mL of organic solvent mixed with ethanol and dichloromethane at a volume ratio of 1:10, stir to completely dissolve the drug-carrier mixture, and obtain a mixed solution of salnemulin hydrochloride and enteric carrier ;

[0037] c) After the above mixed solution was stirred at room temperature for 20 hours, the organic solvent was distilled off under reduced pressure in a water bath at 35°C on a rotary evaporator until the organic solvent was completely evaporated to obtain a blocky translucent solid;

[0038] d) Grinding the ...

Embodiment 2

[0041] A kind of warnemulin hydrochloride enteric-coated solid dispersion, its preparation method is as follows:

[0042] a) Stir and mix 1g of warnemulin hydrochloride crude drug and 1g of enteric carrier to make a drug-carrier mixture; the enteric carrier is polyacrylic acid resin No. II and polyacrylic acid resin No. III in a weight ratio of 2 : 1 proportioning mixed carrier raw material;

[0043] b) Add the above drug-carrier mixture to 20 mL of an organic solvent mixed with ethanol and dichloromethane at a volume ratio of 10:1, stir to completely dissolve the drug-carrier mixture, and obtain a mixed solution of salnemulin hydrochloride and enteric carrier ;

[0044] c) After the above mixed solution was stirred at room temperature for 20 hours, the organic solvent was distilled off under reduced pressure in a water bath at 35°C on a rotary evaporator until the organic solvent was completely evaporated to obtain a blocky translucent solid;

[0045] d) Grinding the above-...

Embodiment 3

[0048] A kind of warnemulin hydrochloride enteric-coated solid dispersion, its preparation method is as follows:

[0049] a) Stir and mix 1 g of warnemulin hydrochloride bulk drug and 1 g of No. II polyacrylic acid resin to prepare a drug-carrier mixture;

[0050] b) Add the above drug-carrier mixture into 30mL of an organic solvent mixed with ethanol and dichloromethane at a volume ratio of 1:1, stir to completely dissolve the drug-carrier mixture, and obtain a mixed solution of salnemulin hydrochloride and enteric carrier ;

[0051] c) After the above mixed solution was stirred at room temperature for 20 hours, the organic solvent was distilled off under reduced pressure in a water bath at 35°C on a rotary evaporator until the organic solvent was completely evaporated, and a blocky translucent solid was obtained;

[0052]d) Grinding the above-mentioned translucent solid and passing it through a 100-mesh medicine sieve to obtain a powdered enteric-coated solid dispersion of ...

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Abstract

The invention belongs to the technical field of special antibacterial preparations for animals, and discloses a valnemulin hydrochloride enteric solid dispersion, as well as a preparation method and application thereof. The preparation method comprises the concrete steps of dissolving valnemulin hydrochloride and an enteric carrier in an organic solvent, and preparing a mixed liquid product by a solvent method; removing the organic solvent by using a rotary evaporator; grinding and screening to obtain the valnemulin hydrochloride enteric solid dispersion. The valnemulin hydrochloride enteric solid dispersion prepared by the method can be used for preparing special antibacterial premixes for animals. The preparation method is low in raw material cost and simple in production equipment and process operation; the prepared valnemulin hydrochloride enteric solid dispersion is stable in property, good in uniformity and large in mobility, does not have pungent smell or hygroscopicity, and is hardly released in an acid medium and almost completely released in a buffer salt medium.

Description

technical field [0001] The invention belongs to the technical field of animal-specific antibacterial drug preparations, and in particular relates to a warnemulin hydrochloride enteric-coated solid dispersion and a preparation method and application thereof. Background technique [0002] Valnemulin hydrochloride (Valnemulin) is a derivative of pleuromutilin, and it is another semi-synthetic antibacterial drug for pleuromutilin after tiamulin. Warnemulin hydrochloride has strong antibacterial activity and is clinically used to treat infectious diseases of livestock and poultry. It has excellent control effect on swine mycoplasma pneumonia and is the drug of choice for the treatment of mycoplasma diseases of livestock and poultry. Econor, the product of Norvatis, was approved for marketing by the European Union in 1999. It is listed as a veterinary prescription drug for the prevention and treatment of porcine enzootic pneumonia caused by Mycoplasma hyopneumoniae and swine dysen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/22A61K47/32A61K47/38A61P31/04
Inventor 汤有志刘雅红陈良柱
Owner SOUTH CHINA AGRI UNIV
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