Amoxicillin/clavulanate potassium enteric-coated preparation composition and preparation method thereof

A technology of potassium clavulanate and amoxicillin, which is applied in the field of medicine, can solve problems such as the preparation method of the amoxicillin/potassium clavulanate enteric-coated preparation composition that has not been reported, and achieve the controllability and stability of the preparation process quality good sex effect

Inactive Publication Date: 2010-11-24
北京瑞伊人科技发展有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] According to the search results of relevant patents and prior art literature, there are no related reports on the amoxicillin / potassium clavulanate enteric-coated preparation composition and its preparation method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Enteric-coated capsules (specification: amoxicillin / clavulanic acid 0.125g / 0.03125g)

[0028] prescription:

[0029] Amoxicillin 125.00g

[0030] Potassium clavulanate 37.21g (calculated as clavulanic acid 31.25g)

[0031] Microcrystalline Cellulose 25.00g

[0032] Dextrin 13.00g

[0033] 4% polyvinylpyrrolidone 85% ethanol solution appropriate amount

[0034]

[0035] Makes 1000 capsules

[0036] Preparation Process:

[0037] Pass amoxicillin, potassium clavulanate, microcrystalline cellulose and dextrin through 80-mesh sieve respectively, weigh microcrystalline cellulose and dextrin according to the prescription amount, put them in a mixer, and mix them with amoxicillin and carat Potassium tretinoin was mixed according to the method of equal increments, and an appropriate amount of 4% polyvinylpyrrolidone and 85% ethanol solution was added to make a soft material, granulated in a granulator, and the granules were d...

Embodiment 2

[0039] Enteric-coated pellets and capsules (specification: amoxicillin / clavulanic acid 0.25g / 0.03125g)

[0040] Prescription: Su Micropills

[0041] Amoxicillin trihydrate 286.99g (calculated as amoxicillin 250.00g)

[0042] Potassium clavulanate 37.21g (calculated as clavulanic acid 31.25g)

[0043] Lactose 15.00g

[0044] Magnesium Stearate 3.00g

[0045]4% polyvinylpyrrolidone 85% ethanol solution appropriate amount

[0046]

[0047] Makes 1000 capsules

[0048] Prescription: film coating solution

[0049] Opadry 1.50g

[0050] Absolute ethanol 180mL

[0051] Prescription: enteric coating solution

[0052] 4 parts talcum powder

[0053] Titanium dioxide 6 parts

[0054] Polyacrylic resin II 20 parts

[0055] Polyacrylic resin III 10 parts

[0056] Tween 80 1.5 parts

[0057] 3 parts propylene glycol

[0058] 50% ethanol solution appropriate amount

[0059] Preparation Process:

[0060] Pass amoxicillin trihydrat...

Embodiment 3

[0062] Enteric-coated Granules (Specification: Amoxicillin / Clavulanic Acid 0.6g / 0.043g)

[0063] Prescription: vegetarian granules

[0064] Amoxicillin 600.00g

[0065] Potassium clavulanate 51.20g (calculated as clavulanic acid 43.00g)

[0066] Polyvinylpyrrolidone 40.00g

[0067] Lactose 128.00g

[0068] Starch 170.80g

[0069] Magnesium Stearate 10.00g

[0070] 50% ethanol solution appropriate amount

[0071]

[0072] Make 1000 bags

[0073] Prescription: film coating solution

[0074] Opadry 1.50g

[0075] Absolute ethanol 180mL

[0076] Prescription: enteric coating solution

[0077] 4 parts talcum powder

[0078] Titanium dioxide 6 parts

[0079] Hypromellose Phthalate 35 parts

[0080] Tween 80 1 serving

[0081] 3 parts propylene glycol

[0082] 50% ethanol solution appropriate amount

[0083] Preparation Process:

[0084] Pass amoxicillin, potassium clavulanate, polyvinylpyrrolidone, lactose, starch, and mag...

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PUM

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Abstract

The invention discloses an amoxicillin/clavulanate potassium enteric-coated preparation composition and a preparation method thereof. The preparation composition is mainly prepared from amoxicillin, clavulanate potassium and an appropriate auxiliary material. Compared with the common amoxicillin/clavulanate potassium preparation, the amoxicillin/clavulanate potassium enteric-coated preparation provided by the invention has the advantages of less irritation to the stomach so as to reduce adverse reaction, and the like. The amoxicillin/clavulanate potassium enteric-coated preparation composition is particularly suitable for patients with stomach upset. The invention provides a novel formulation which has higher safety and better curative effect compared with those of the conventional amoxicillin/clavulanate potassium related preparations; and the preparation process has the advantages of high quality controllability and stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an amoxicillin / potassium clavulanate enteric-coated preparation composition and a preparation method thereof. Background technique [0002] Amoxicillin / potassium clavulanate, their chemical names are: (2S, 5R, 6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4 -Hydroxyphenyl)acetamido]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and (Z)-(2S,5R)-3 Potassium -(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate. [0003] Amoxicillin / potassium clavulanate compound preparation is composed of amoxicillin and potassium clavulanate. It is a broad-spectrum enzyme-resistant and highly effective first-line anti-infective drug for severe infections commonly seen in clinical practice. Among them, amoxicillin is a broad-spectrum penicillin β-lactam semi-synthetic antibiotic, the mechanism of action is to inhibit the synthesis of bacterial cell walls, has ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61J3/10A61J3/07A61K47/34A61K47/38A61P31/04A61K47/10
Inventor 安英张慧英张玲玲
Owner 北京瑞伊人科技发展有限公司
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