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Drug composition for treating children upper respiratory tract infection, and preparation method thereof

A technology of upper respiratory tract and composition, applied in the field of pharmaceutical composition and its preparation, which can solve the problems of short action time, profuse sweating, injury to gastric mucosa, etc., achieve rapid onset of action, prolong drug action time, and relieve colds The effect of symptoms

Inactive Publication Date: 2012-05-30
SHINEWAY PHARMA GRP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing children's paracetamol huangnamin preparation has the characteristics of fast onset of action and good antipyretic and analgesic effects, but its action time is short, and it is easy to sweat a lot after taking the medicine, and it can also damage the gastric mucosa

Method used

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  • Drug composition for treating children upper respiratory tract infection, and preparation method thereof
  • Drug composition for treating children upper respiratory tract infection, and preparation method thereof
  • Drug composition for treating children upper respiratory tract infection, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 tablet

[0032] Prepare 1000 tablets

[0033] Component Immediate Release Mixture Extended Release Mixture

[0034] Acetaminophen 50.0g 75.0g

[0035] Chlorpheniramine maleate 0.2g 0.3g

[0036] Artificial Bezoar 2.0g 3.0g

[0037] Microcrystalline Cellulose 12.5g

[0038] Pregelatinized starch 12.5g

[0039] Appropriate amount of starch slurry (10%)

[0040] Hypromellose 50.0g

[0041] PVP solution (5%) appropriate amount

[0042] Magnesium stearate 0.5g 0.7g

[0043] Preparation Process:

[0044] Immediate release part: acetaminophen, chlorpheniramine maleate, artificial bezoar mixed with microcrystalline cellulose and pregelatinized starch, added 10% (g / v) starch slurry to granulate, dried, granulated, and Magnesium stearate mixed well.

[0045] Sustained-release part: acetaminophen, chlorpheniramine maleate, artificial bezoar and hypromellose are mixed evenly, added 5% PVP (g / v) solution to granulate, dried, granulated, and stearic acid The mag...

Embodiment 2

[0046] Embodiment 2 capsules

[0047] Prepare 1000 capsules

[0048] Component Immediate release part Sustained release part

[0049] Acetaminophen 62.5g 62.5g

[0050] Chlorpheniramine Maleate 0.25g 0.25g

[0051] Artificial Bezoar 2.5g 2.5g

[0052] Microcrystalline Cellulose 16.5g

[0053] Pregelatinized starch 16.5g

[0054] Appropriate amount of starch slurry (10%)

[0055] Hypromellose 30.0g

[0056] PVP solution (5%) appropriate amount

[0057] Magnesium stearate 0.6g

[0058] Copolymerized methacrylic acid 6.5g

[0059] Appropriate amount of talcum powder

[0060] Triethyl citrate 1.2g

[0061] Appropriate amount of pure water

[0062] Preparation Process:

[0063] Immediate-release part: acetaminophen, chlorpheniramine maleate, artificial bezoar, mixed with microcrystalline cellulose and pregelatinized starch, added with starch slurry to granulate, dried, granulated, and evenly mixed with magnesium stearate.

[0064] Sustained-release part: acetaminophen...

Embodiment 3

[0065]Embodiment 3 granules prepare 1000 bags

[0066] Component Immediate Release Mixture Extended Release Mixture

[0067] Acetaminophen 50.0g 75.0g

[0068] Chlorpheniramine maleate 0.2g 0.3g

[0069] Artificial Bezoar 2.0g 3.0g

[0070] Hypromellose (E5) 1.5g

[0071] Microcrystalline Cellulose 10.0g

[0072] Hypromellose (K4M) 40.0g

[0073] PVP solution (5%) appropriate amount

[0074] Sucrose Appropriate amount Appropriate amount

[0075] Preparation Process:

[0076] Mix acetaminophen, chlorpheniramine maleate, artificial bezoar, microcrystalline cellulose and hypromellose (K4M) in a slow-release ratio evenly, add PVP solution to granulate, dry, granulate, and use for granules The other part is coated with a suspension made of paracetamol, chlorpheniramine maleate, artificial bezoar and hypromellose (E5), mixed evenly with sucrose, bagged, and obtained.

[0077] Preparations prepared in the above-mentioned examples and common preparations in vitro release curv...

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Abstract

The invention discloses a drug composition for treating children upper respiratory tract infection. Active ingredients in each piece / grain / bag of the drug comprise: 125 mg of paracetamol, 0.5 mg of chlorphenamine maleate, and 5 mg of artificial bezoar, wherein 30-75% of the active ingredients and a slow release agent adjuvant form a slow release mixture, and the remaining active ingredients and a conventional drug adjuvant form a quick release mixture, and the slow release mixture and the quick release mixture are subjected to mixing, and tableting or capsule filling to prepare into the mixed particles. The preparation method comprises: a, mixing 30-75% of the active ingredients of the drug and the slow release agent adjuvant, and pelletizing; b, mixing the remaining active ingredients and the conventional drug adjuvant, and pelletizing according to a conventional method; c, mixing the two particles prepared in the step a and the step b, and carrying out tableting or capsule filling to prepare into the mixed particles. The drug of the present invention has advantages of fast effect, long effective time, and small side effect.

Description

Technical field: [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a pharmaceutical composition for treating children's upper respiratory tract infection and a preparation method thereof. Background technique: [0002] Pediatric acetaminophen and pheniramine is a drug commonly used in clinical treatment of upper respiratory tract infection in children. The drug active ingredients are acetaminophen, chlorpheniramine maleate, and artificial bezoar. The drug is mainly used to relieve fever, headache, sore limbs, sneezing, runny nose, nasal congestion, sore throat and other symptoms caused by common cold and influenza in children. The acetaminophen in this product is evenly distributed in the body after oral absorption, and about 25% is bound to plasma proteins. The peak plasma concentration is reached 0.5-2 hours after oral administration. Half-life (t 1 / 2 ) is generally 1-4 hours (average 2 hours). Pediatric pa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/413A61K9/22A61P11/00A61K31/167A61K31/4402
Inventor 孔德宪姜海魏峰
Owner SHINEWAY PHARMA GRP LTD
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