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Preparation method of phenoxymethylpenicillin potassium tablet

A technology of penicillin V and sodium carboxymethyl starch, applied in the field of medicine, can solve the problems of rising related substances of penicillin V potassium tablets, unqualified disintegration time limit of intermediate products, etc., and achieve the effect of solving the rising of related substances and good stability

Active Publication Date: 2015-05-20
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the Penicillin V Potassium Tablets obtained by the above-mentioned preparation method have increased related substances during the storage period, and the disintegration time limit of the intermediate product has a higher probability of failure.

Method used

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  • Preparation method of phenoxymethylpenicillin potassium tablet
  • Preparation method of phenoxymethylpenicillin potassium tablet
  • Preparation method of phenoxymethylpenicillin potassium tablet

Examples

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preparation example Construction

[0021] The invention provides a kind of preparation method of penicillin V potassium tablet, comprises the following steps:

[0022] A) Mix the ethanol solution of penicillin V potassium, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and povidone K30, and carry out wet granulation to obtain wet granules;

[0023] B) After the wet granules are dried and sized, they are mixed with magnesium stearate, micropowder silica gel and sodium starch glycolate, compressed into tablets and coated to obtain penicillin V potassium tablets.

[0024] The finished penicillin V potassium tablets of the present invention are film-coated tablets, wherein, every 1000 tablets contain 236 g of penicillin V potassium, 40-60 g of pregelatinized starch, 30-50 g of microcrystalline cellulose, and 20-20 g of sodium carboxymethyl starch. 40g, 2-4g magnesium stearate, 4-6g micropowder silica gel, 80-120g 7.5% povidone K30 ethanol solution, 7-15g LE coating agent.

[0025] In th...

Embodiment 1

[0043] 1. Prepare the raw and auxiliary materials of penicillin V potassium according to the following table, wherein the penicillin V potassium is the pure amount in dry form.

[0044] Name of raw material

Feeding amount

Penicillin V Potassium

23600g

pregelatinized starch

5000g

microcrystalline cellulose

4000g

sodium starch glycolate

3000g

Magnesium stearate

300g

Micropowder silica gel

500g

Co-made

100,000 pieces

[0045] 2. Crushing and sieving of raw and auxiliary materials: first put penicillin V potassium, pregelatinized starch, microcrystalline cellulose, and sodium carboxymethyl starch into a universal pulverizer for pulverization, pass through an 80-mesh vibrating sieve to form fine powder, and mix the materials Weigh for use.

[0046] Weighing preparation: penicillin V potassium, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, magnesium st...

Embodiment 2

[0056] 1. Prepare the raw and auxiliary materials of penicillin V potassium according to the following table, wherein the penicillin V potassium is the pure amount in dry form.

[0057] Name of raw material

Feeding amount

Penicillin V Potassium

47200g

pregelatinized starch

10000g

microcrystalline cellulose

8000g

sodium starch glycolate

6000g

Magnesium stearate

600g

Micropowder silica gel

1000g

Co-made

200,000 pieces

[0058] 2. Crushing and sieving of raw and auxiliary materials: first put penicillin V potassium, pregelatinized starch, microcrystalline cellulose, and sodium carboxymethyl starch into a universal pulverizer to pulverize, pass through an 80-mesh vibrating sieve, and form a fine powder, and then process the materials Weigh for use.

[0059] Weighing preparation: penicillin V potassium, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, ma...

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Abstract

The invention provides a preparation method of a phenoxymethylpenicillin potassium tablet. The preparation method comprises the following steps of (A) mixing phenoxymethylpenicillin potassium, microcrystal fibers, pregelatinized starch, carboxymethyl starch sodium and an ethanol solution of povidone K30, and carrying out wet granulation to obtain wet granules; (B) drying the wet granules, carrying out size stabilization, then, mixing the wet granules, magnesium stearate, superfine silica powder and carboxymethyl starch sodium, tabletting and coating to obtain the phenoxymethylpenicillin potassium tablet. According to the preparation method, carboxymethyl starch sodium is divided into two parts, wherein one part is used for granulating phenoxymethylpenicillin potassium, and the other part is used for totally mixing and tabletting after granulating; and due to the adoption of the operation, the phenoxymethylpenicillin potassium tablet prepared by using the preparation method provided by the invention is good in stability within a storage period, and the problems that related substances are increased within the storage period of the phenoxymethylpenicillin potassium tablet and the disintegration time limit of an intermediate product is unqualified are solved.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method of penicillin V potassium tablets. Background technique [0002] Penicillin V Potassium Tablets are suitable for the treatment of mild, moderate and severe infections sensitive to penicillin G, suitable for surgical operations and prevention of recurrence of rheumatic fever and cholera, as well as prevention of bacterial endocarditis, ear, nose and ear infections caused by sensitive bacteria. Pharyngeal infection (such as adenitis, pharyngitis, otitis media), respiratory infection (such as pneumonia), skin infection (such as erysipelas, erysipelasoid and erythema migratory; scarlet fever), prevention of recurrence of acute rheumatic fever, prevention of dental, oral, Endocarditis after jaw and upper airway surgery, etc. The toxicity of penicillin antibiotics is very small, and they are absorbed quickly after oral administration. The influence o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/43A61P31/04A61K47/38
Inventor 李全学逯佩荣廖孝曙彭朝晖刘志军彭建杨邦刘思川程志鹏万阳浴葛均友
Owner HUNAN KELUN PHARMA
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