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Valnemulin hydrochloride sustained-release granules and preparation method and application thereof

A technology of warnemulin hydrochloride and sustained-release granules, which can be applied in the direction of pharmaceutical formulations, block delivery, and active ingredients of esters, etc., and can solve the problems of cumbersome clinical application of injections, difficulty in mixing uniform feed, gastric mucosal irritation, etc. , to achieve the effect of solving the problem of drug palatability, prolonging the maintenance time of effective blood drug concentration, and stabilizing blood drug concentration

Active Publication Date: 2016-07-27
JINHE ANIMAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the general premixes and powders have poor fluidity and low dispersibility, and are not easy to mix evenly with the feed; the injection forms belong to individual administration and are not taken orally. Although there is no problem of poor palatability, due to the clinical The application is relatively cumbersome, and its applicability is poor in intensive large-scale breeding production. Once the disease breaks out on a large scale, it will not be possible to make warnemulin hydrochloride effectively exert its maximum effect
[0004] The way of mixed feeding and drug administration is relatively simple for the prevention and treatment of highly infectious diseases, but the drug itself of warnemulin hydrochloride has a bitter taste, strong irritation, and is irritating to the gastric mucosa, and the palatability of animals is poor. The effect of mixed feeding directly with nimulin dosage form is not good

Method used

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  • Valnemulin hydrochloride sustained-release granules and preparation method and application thereof
  • Valnemulin hydrochloride sustained-release granules and preparation method and application thereof
  • Valnemulin hydrochloride sustained-release granules and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1 Preparation of Warnemulin Hydrochloride Sustained Release Granules

[0044] The preparation steps are as follows:

[0045] S1. Weigh each carrier auxiliary material according to the following formula ratio (based on the total mass as 100g):

[0046] Warnemulin hydrochloride 20%;

[0047] Stearyl alcohol 75%;

[0048] Beeswax 5%;

[0049] Heat to melt at 80°C and mix well;

[0050] S2. adding warnemulin hydrochloride to the carrier auxiliary material obtained in S1, and stirring evenly to obtain a mixed material;

[0051] S3. Cool the mixed material obtained in S2 to 60-80°C, and perform the stage of fluidized bed spray granulation and spheroidization, the temperature of the fluidized air in the granulation and spheroidization stage is 25°C; the fluidized bed spray droplets The line speed is 10-160 m / s;

[0052] S4. Cool, sieve, and collect to obtain 20% warnemulin hydrochloride sustained-release granules.

Embodiment 2

[0053] Example 2 Preparation of Warnemulin Hydrochloride Sustained Release Granules

[0054] The preparation steps are as follows:

[0055] S1. Weigh each carrier auxiliary material according to the following formula ratio (based on the total mass as 100g):

[0056] Warnemulin hydrochloride 10%;

[0057] Glyceryl monostearate 80%;

[0058] Beeswax 10%;

[0059] Heat to melt at 70°C and mix well;

[0060] S2. adding warnemulin hydrochloride to the carrier auxiliary material obtained in S1, and stirring evenly to obtain a mixed material;

[0061] S3. Cool the mixed material obtained in S2 to 60-80°C, and carry out the stage of fluidized bed spray granulation and spheroidization, the temperature of the fluidized air in the granulation and spheroidization stage is 20°C; The line speed is 40-80 m / s;

[0062] S4. Cool, sieve, and collect to obtain 10% warnemulin hydrochloride sustained-release granule preparation.

Embodiment 3

[0063] Example 3 Preparation of Warnemulin Hydrochloride Sustained Release Granules

[0064] The preparation steps are as follows:

[0065] S1. Weigh each carrier auxiliary material according to the following formula ratio (based on the total mass as 100g):

[0066] Warnemulin hydrochloride 25%;

[0067] Animal fat 70%;

[0068] Carnauba wax 5%;

[0069] Heat to melt at 95°C and mix well;

[0070] S2. adding warnemulin hydrochloride to the carrier auxiliary material obtained in S1, and stirring evenly to obtain a mixed material;

[0071] S3. Cool the mixed material obtained in S2 to 60-80°C, and carry out the stage of fluidized bed spray granulation and spheroidization, the fluidized air temperature in the granulation and spheroidization stage is 30°C; the fluidized bed spray droplets The line speed is 40-80 m / s;

[0072] S4. Cool, sieve, and collect to obtain 25% warnemulin hydrochloride sustained-release granule preparation.

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Abstract

The invention discloses valnemulin hydrochloride sustained-release granules and a preparation method and application thereof.The valnemulin hydrochloride sustained-release granules are prepared from, by mass, 5-50% of valnemulin hydrochloride and the balance carrier auxiliary materials through the fluidized spraying technology.The carrier auxiliary materials are one or more of animal fat, beewax, carnauba wax, hydrogenated vegetable oil, stearyl alcohol, fatty acid monoglyceride, fatty acid di-glyceride and paraffin.The valnemulin hydrochloride sustained-release granules solve the problem that medicine stability is poor, improve product quality and stability, and prolong service life.The problems that medicine powder is high in irritation and poor in palatability are solved.The granules and feed are mixed to be supplied, the medicine is released slowly, effective blood concentration maintenance time is longer, the administration frequency is reduced, the bioavailability of valnemulin hydrochloride is improved, and the clinical use effect is remarkable.

Description

technical field [0001] The invention belongs to the technical field of animal medicines. More specifically, it relates to a warnemulin hydrochloride sustained-release granule and its preparation method and application. Background technique [0002] Valnemulin (VLM) is a second-generation pleuromutilin-specific antibiotic for animals. It is a homologue with tiamulin and belongs to the bimectin group. It plays an antibacterial role by inhibiting protein synthesis and has a broad antibacterial spectrum. It has strong antibacterial activity, and has good antibacterial activity against different types of Mycoplasma, Mycoplasma, Streptococcus, Staphylococcus aureus, Actinobacillus, Pasteurella, Treponema hyodysenteriae and Treponema colonic piliformis, etc. With a short withdrawal period and high safety, it is the first veterinary drug premix approved by Europe and listed as a veterinary prescription drug. It has great effects in the prevention and treatment of chicken chronic re...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/22A61P31/04
CPCA61K9/0002A61K9/1617A61K31/22
Inventor 李帅鹏黄显会路赟邢海龙李荣顺
Owner JINHE ANIMAL PHARMA
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