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Composite medicine containing flucloxacillin magnesium and amoxicillin sodium

A technology of amoxicillin sodium and flucloxacillin magnesium, applied in the field of novel combination drugs, can solve the problems of poor antibacterial activity of Staphylococcus aureus, increased clinical adverse reactions, increased allergic reactions, etc., and achieves low incidence of adverse reactions, Low cost of excipients and the effect of expanding indications

Active Publication Date: 2007-11-07
SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The anti-S. aureus drugs currently in clinical use are generally as follows: both penicillin and first-generation cephalosporins can fight against S. aureus infection, but due to the problem of drug-resistant bacteria, these two types of drugs are no longer as effective as before
The second-generation and third-generation cephalosporins are not as effective as the first-generation cephalosporins against Gram-positive bacteria; macrolides and aminoglycoside antibiotics are also good drugs against Gram-positive bacteria, but their antibacterial activity against Staphylococcus aureus is far inferior Penicillins; vancomycin is a good drug for serious infections caused by Staphylococcus aureus, but due to concerns about the occurrence of vancomycin-resistant strains of Staphylococcus aureus, as well as considerations of toxicity and cost, this drug should only be used for MRSA caused by infection
[0020] 7. Other infections
At the same time, flucloxacillin currently used clinically is a unilateral capsule of sodium salt, which is very unstable and sensitive to temperature and humidity, so problems such as degradation, gas production, and polymerization reactions will occur, resulting in a decrease in content and curative effect. Adverse reactions are greatly increased, especially anaphylaxis, so the present invention adopts more stable flucloxacillin magnesium salt to replace the currently commonly used flucloxacillin magnesium salt

Method used

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  • Composite medicine containing flucloxacillin magnesium and amoxicillin sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] prescription

[0048] Flucloxacillin magnesium (calculated as flucloxacillin) 125g

[0049] Amoxicillin sodium (as amoxicillin) 125g

[0050] Magnesium Stearate 5g

[0051] Proper amount of 50% ethanol solution of 10% povidone K30 (just make the first three raw materials into soft materials, the same below)

[0052] Makes 1000 capsules

[0053] Preparation process

[0054] Pass the main ingredient and auxiliary materials through an 80-mesh sieve for later use. Weigh povidone K30, use 50% ethanol solution to prepare a solution with a concentration of 10%, and set aside. Weigh the main drug in the prescription amount, use 10% povidone K30 alcohol solution to make soft material, granulate through 60 mesh, blast dry below 50°C for 1-2 hours, granulate in 60 mesh, add the prescription amount of auxiliary materials, mix well , measure the content of the main drug in the granules, calculate the average loading, fill in capsules, and pack.

[0055] Selection of excipient...

Embodiment 2

[0072] prescription

[0073] Flucloxacillin magnesium (calculated as flucloxacillin) 75g

[0074] Amoxicillin sodium (as amoxicillin) 500g

[0075] Magnesium Stearate 20g

[0076] Makes 1000 capsules

[0077] Preparation process

[0078] Due to the large amount of the main drug, in order to reduce the volume of the capsule contents, the main drug and auxiliary materials are directly passed through an 80-mesh sieve for future use. Weigh the main drug in the prescribed amount, add the auxiliary materials in the prescribed amount, mix well, measure the content of the main drug, calculate the average loading, fill in capsules, and pack.

[0079] Influencing factor test

[0080] The two kinds of capsules that will make are placed under strong light (4500 ± 500LX), high temperature (60 ℃), high humidity (relative humidity 92.5%) conditions respectively, respectively in 5 days, 10 days sampling, investigate outward appearance, content color and luster, Content, related substanc...

Embodiment 3

[0087] prescription:

[0088] Flucloxacillin magnesium (calculated as flucloxacillin) 500g

[0089] Amoxicillin sodium (as amoxicillin) 125g

[0090] Starch 20g

[0091] Microcrystalline Cellulite (MCC) 35g

[0092] Sodium Carboxymethyl Cellulose 20g

[0093] Magnesium Stearate 5g

[0094] 2.0% HPMC 15CP aqueous solution appropriate amount

[0095] Pressed into 1000 pieces

[0096] Preparation Process:

[0097] (1) Preparation of solution

[0098] Weigh 40g HPMC 15CP, measure 2000ml water to dissolve HPMC K4M completely, set aside.

[0099] (2) Ingredients and mixed powder: take the prescribed amount of medicine and lactose and stir and mix, pass through a 60-mesh sieve to obtain mixed powder A; take the prescribed amount of MCC and CMS-Na, stir and mix, pass through a 60-mesh sieve to obtain mixed powder B ; After stirring and mixing the above two mixed powders, pass through a 60-mesh sieve twice.

[0100] (3) Preparation of soft material and wet granules: Take the ...

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Abstract

An orally taken composite medicine in the form of capsule, tablet, etc for treating the infectious diseases is proportionally prepared from fluclocillin magnesium, amoxycillon sodium, and conventional auxiliary chosen from filler, adhesive, surfactant, lubricant and stabilizer.

Description

technical field [0001] The invention relates to a novel combination drug for treating infectious diseases-a compound drug containing flucloxacillin magnesium salt and amoxicillin sodium salt. Background technique [0002] The general situation of anti-S. aureus drugs currently in clinical use is as follows: both penicillin and first-generation cephalosporins can fight against S. aureus infection, but due to the problem of drug-resistant bacteria, these two types of drugs are no longer as effective as before. The second-generation and third-generation cephalosporins are not as effective as the first-generation cephalosporins against Gram-positive bacteria; macrolides and aminoglycoside antibiotics are also good drugs against Gram-positive bacteria, but their antibacterial activity against Staphylococcus aureus is far inferior Penicillins; vancomycin is a good drug for serious infections caused by Staphylococcus aureus, but due to concerns about the occurrence of vancomycin-re...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/431A61K9/20A61K9/48A61P31/04A61K31/43
Inventor 卞春卫
Owner SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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