Recipe of valnemulin hydrochloride enteric-coated pellet and preparation method thereof

A technology of warnimulin hydrochloride and enteric-coated pellets, which is applied in the direction of medical preparations, pharmaceutical formulations, antibacterial drugs, etc. of non-active ingredients, and can solve gastric mucosal irritation, fine powder, environmental assessment and safety impact and other issues to achieve the effects of reducing costs, improving stability, improving bioavailability and efficacy

Inactive Publication Date: 2010-11-03
广东大华农动物食品保健品股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the pellets prepared by this method have a wide range of particle sizes and many fine powders, which is not conducive to the uniform inclusion of the particles by the coating solution, and the taste-masking effect has certain limitations, and the coating solution selected by the method The prepared Wonimulin hydrochloride pellets can be dissolved and released in the stomach of livestock and poultry, and have a strong stimulating effect on the gastric mucosa. Long-term use is likely to cause side effects such as gastric mucosal hyperemia, ulcers, and bleeding, and it is easy to cause reactions such as vomiting and anorexia. , affecting the feed intake of livestock and poultry
In addition, the resin involved in the film-forming material of the coating liquid in this patent needs to be dissolved with more than 65% ethanol solution, which has a great impact on environmental assessment and safety in actual production

Method used

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  • Recipe of valnemulin hydrochloride enteric-coated pellet and preparation method thereof
  • Recipe of valnemulin hydrochloride enteric-coated pellet and preparation method thereof
  • Recipe of valnemulin hydrochloride enteric-coated pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1: Preparation of 10% vornemulin hydrochloride enteric-coated pellets

[0043] 1. The main drug and auxiliary materials of Warnemulin Hydrochloride Drug-loaded Vegetable Pills are as follows by weight:

[0044] Vernemulin hydrochloride: 10%

[0045] Starch: 55%

[0046] Microcrystalline Cellulose: 20%

[0047] Sodium carboxymethyl starch: 10%

[0048] 2. The weight ratio of each component of the enteric coating solution to the solid matter is:

[0049] Ratio of methacrylic acid to methyl methacrylate: 5:5; 30%

[0050] Triethyl citrate: 5%

[0051] Talc: 25%

[0052] Glyceryl Stearate: 3%

[0053] Appropriate amount of purified water.

[0054] 3. Preparation of Suwan Granules

[0055] Pass the main drug and auxiliary materials through a 100-mesh sieve and mix according to the formula ratio, add an appropriate amount of purified water to prepare a soft material, extrude through a sieve plate of an extruder with an aperture of 0.6mm, and place the strip m...

Embodiment 2

[0060] Example 2: Preparation of 25% vornemulin hydrochloride enteric-coated pellets

[0061] 1. The main drug and auxiliary materials of Warnemulin Hydrochloride Drug-loaded Vegetable Pills are as follows by weight:

[0062] Warnemulin hydrochloride: 25%

[0063] Starch: 45%

[0064] Microcrystalline Cellulose: 20%

[0065] Sodium carboxymethyl starch: 5%

[0066] 2. The weight ratio of each component of the enteric coating solution to the solid matter is:

[0067] Ratio of methacrylic acid to methyl methacrylate: 5:5; 30%

[0068] Triethyl citrate: 5%

[0069] Talc: 25%

[0070] Glyceryl Stearate: 3%

[0071] Appropriate amount of purified water.

[0072] 3. Preparation of Suwan Granules

[0073] Pass the main drug and auxiliary materials through a 100-mesh sieve and mix according to the formula ratio, add an appropriate amount of purified water to prepare a soft material, extrude through a sieve plate of an extruder with an aperture of 0.6mm, and place the strip ma...

Embodiment 3

[0078] Example 3: Preparation of 45% vornemulin hydrochloride enteric-coated pellets

[0079] 1. The main drug and auxiliary materials of Warnemulin Hydrochloride Drug-loaded Vegetable Pills are as follows by weight:

[0080] Warnemulin hydrochloride: 45%

[0081] Starch: 25%

[0082] Microcrystalline Cellulose: 20%

[0083] Sodium carboxymethyl starch: 5%

[0084] 2. The weight ratio of each component of the enteric coating solution to the solid matter is:

[0085] Ratio of methacrylic acid to methyl methacrylate: 5:5; 30%

[0086] Triethyl citrate: 5%

[0087] Talc: 25%

[0088] Glyceryl Stearate: 3%

[0089] Appropriate amount of purified water.

[0090] 3. Preparation of Suwan Granules

[0091] Pass the main drug and auxiliary materials through a 100-mesh sieve and mix according to the formula ratio, add an appropriate amount of purified water to prepare a soft material, extrude through a sieve plate of an extruder with an aperture of 0.6mm, and place the strip ma...

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Abstract

The invention provides a recipe of a valnemulin hydrochloride enteric-coated pellet and a preparation method thereof, wherein, acrylic resin water dispersion is taken as coating liquid, and water is taken as a solvent, thus changing the method that the existing resin coating liquid selects high concentration alcohol as the solvent, lowering cost and overcoming the defect of environmental influence due to evaporation of a large amount of alcohol during the coating process. The preparation method of the valnemulin hydrochloride enteric-coated pellet comprises the steps of preparation of the valnemulin hydrochloride medicine carrying pellet, preparation of the coating liquid and preparation of valnemulin hydrochloride coating. By adopting an extrusion-spheronization process procedure, the preparation method solves the defects of a one-step fluidized bed granulating method such as coarse and loose particles, large particle size range, a large amount of dust; and the pellet prepared by the method has even particle size and narrower distribution range, thus being beneficial to uniform saturation of the coating liquid on the particles, and improving the taste masking effect.

Description

technical field [0001] The invention relates to the field of preparation of warnemulin hydrochloride, a special-purpose pleuromutilin antibiotic for animals, in particular to the preparation of warnemulin hydrochloride coated particles. Background technique [0002] Micropills refer to various pills with a diameter of less than 2.5mm, which can be prepared into sustained-release or controlled-release preparations according to different needs, and can also be further compressed into tablets, capsules, etc. As a new member of multi-unit type drug delivery system, sustained and controlled release pellets have become a hot spot in the research of sustained and controlled release preparations in recent years due to their unique advantages. Compared with a single-unit drug delivery system (such as a tablet), micropills have the following advantages: 1. Small inter-individual differences in body absorption and good reproducibility of absorption kinetics; 2. High bioavailability and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/22A61K47/38A61K47/32A61P31/04
Inventor 方炳虎陈瑞爱杨利军刘小艳陈兴荣时书宁袁照红
Owner 广东大华农动物食品保健品股份有限公司
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