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Compound amoxicillin powder and its production process

A technology of amoxicillin powder and production process, which is applied in the field of veterinary medicine, can solve problems such as unsatisfactory demand, decreased content, cumbersome production process, etc., and achieve the effects of improving stability and safety, high production efficiency, and good fluidity

Active Publication Date: 2017-07-11
HENAN SOAR VETERINARY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, potassium clavulanate has strong hygroscopicity and extremely poor stability. It is easy to change color, agglomerate, and reduce content in the form of powder.
At present, although some amoxicillin compound preparations are disclosed in the Chinese patent database, most of them are tablets or capsules, which have certain advantages for human use, but are very inconvenient for veterinary medicine
Patents such as CN103127099A and CN102614174A respectively provide dry suspensions of potassium amoxicillin and clavulanate. The production process of these preparations is cumbersome and there are too many auxiliary materials, and the water solubility is not very ideal, so it is not suitable for large-scale promotion
[0004] In addition, the transportation and storage environment of veterinary drugs is often relatively harsh, and factors such as rough loading and unloading and humid environment are inevitable
Therefore, the production of veterinary drugs with reference to the production methods of human drugs often cannot meet the demand

Method used

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  • Compound amoxicillin powder and its production process
  • Compound amoxicillin powder and its production process
  • Compound amoxicillin powder and its production process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] In this embodiment, six batches of samples were prepared according to the proportions in Table 1.

[0020] Table 1 Weight ratio of each batch

[0021]

[0022] Among them, the production process of batch 14010101 is: control the production environment temperature below 25°C and relative humidity below 20%, and perform the following operations:

[0023] (1) Grind mannitol, micropowder silica gel and anhydrous glucose separately and pass through an 80-mesh sieve, mix in a dry mixer at 80±5°C for 1 hour, and cool to room temperature naturally;

[0024] (2) Add amoxicillin and clavulanate potassium 4:1 mixed powder into the dry mixer and continue mixing for 20 minutes;

[0025] (3) After being vacuum-packed in aluminum foil bags, then packed in plastic-aluminum composite bags.

[0026] The production process of the remaining batches is the same as the steps, and the differences are shown in Table 2.

[0027] Table 2 Production process parameters of each batch

[0028...

Embodiment 2

[0030] In order to investigate the feasibility of the present invention, this embodiment extracts 6 batches of samples in Example 1 and carried out a stability investigation. The method is: take different batches of samples and place them under the accelerated conditions of temperature 42°C and humidity 75%. A 6-month stability study was carried out under the following conditions, and samples were taken at the 0th, 1st, 3rd, and 6th months according to the "National Standards for Veterinary Drugs" (Chemical Drugs, Traditional Chinese Medicine Volume 1 Volume 1) Quality Standards for Compound Amoxicillin Powder. See Table 3.

[0031] Table 3 Accelerated test results of different batches of compound amoxicillin powder

[0032]

[0033] Tests have confirmed that the compound amoxicillin powder of the present invention is under the control of new process conditions, and through accelerated test verification, the content of traits, amoxicillin and clavulanic acid does not change...

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Abstract

The invention belongs to the technical field of veterinary drugs and relates to compound amoxicillin powder and a production process thereof. The compound amoxicillin powder comprises the following components in percentage by weight: 15-18 percent of mixed powder with a ratio of 4:1 of amoxicillin to potassium clavulanate, 30-40 percent of mannitol, 0.5-1 percent of superfine silica powder and the balance of glucosum anhydricum. The production process comprises the following steps: controlling the temperature of a production environment to be 25 DEG C or below, controlling the relative humidity to be 20 percent or below, and performing the following operations: (1) respectively grinding mannitol, superfine silica powder and glucosum anhydricum, allowing the powder to pass through a sieve with the granularity of 80 meshes, mixing in a drying mixer at the temperature of 80+ / -5 DEG C for 1-2 hours, and naturally cooling to room temperature; (2) adding the mixed powder with the ratio of 4:1 of amoxicillin to potassium clavulanate into the drying mixer, and continuously mixing for 20-30 minutes; and (3) performing vacuum packaging by using an aluminum foil bag, and packaging by using a plastic aluminum composite bag. According to the invention, auxiliary materials are carefully selected, a relatively stable product is obtained through fewer auxiliary materials with high safety, and the prepared product is high in liquidity, low in moisture content and difficult in moisture absorption, can completely meet pharmacopoeia detection and accords with the national drug administration policy.

Description

technical field [0001] The invention belongs to the technical field of veterinary medicine, and in particular relates to a compound amoxicillin fraction, and also relates to a production process thereof. Background technique [0002] With the rapid development of my country's aquaculture industry and the irrational use of antibiotics, drug-resistant strains are gradually increasing. Bacteria develop resistance to antibiotics through a variety of pathways, among which the production of β-lactamase to hydrolyze the β-lactam ring in drugs (such as penicillins, cephalosporins, etc.) is the main method. Potassium clavulanate has a strong and broad-spectrum inhibitory effect on β-lactamase, and when used in conjunction with amoxicillin, it can inhibit β-lactamase to prevent amoxicillin from being destroyed, thus expanding the antibacterial spectrum of amoxicillin and enhancing Its antibacterial strength has the advantages of good curative effect and low incidence of side effects,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/43A61K47/26A61K47/04A61P31/04A61K31/424
Inventor 管倩李灵娟李凌峰刘胜强刘升吕凤霞
Owner HENAN SOAR VETERINARY PHARMA