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Xiao er Anfen Huang Namin granule

The technology of Pediatric Paracetamol Huang Namin Granules and Paracetamol can be used in respiratory diseases, devices for making medicines into special physical or taking forms, organic active ingredients, etc. Large, uneven content and other problems, to achieve the effect of stable and controllable product quality, easy control and simple operation

Active Publication Date: 2012-07-25
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The traditional preparation method has the problem of uneven mixing of the main drug and auxiliary materials during the granulation process, resulting in unqualified identification items of chlorpheniramine maleate in the finished product, uneven content, large fluctuations in content, and unstable product quality; The ratio is not strictly required, resulting in a bitter taste of the product, especially problems such as difficulty in medication for children

Method used

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  • Xiao er Anfen Huang Namin granule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prescription 1:

[0035] Paracetamol 125g, chlorpheniramine maleate 0.5g, artificial bezoar 5g, sucrose powder 4870g, sodium carboxymethylcellulose 4g, appropriate amount of essence and appropriate amount of ethanol.

[0036] Dissolve 4 g of sodium carboxymethyl cellulose of the above binder into 262.67 g of purified water, stir and dissolve to prepare an aqueous solution of sodium carboxymethyl cellulose with a mass percent concentration of CMC-Na of 1.5%.

[0037] Preparation:

[0038] (1) 125g of paracetamol and 5g of artificial bezoar are fully mixed to obtain the first mixture, which is set aside;

[0039] (2) Add 4870g of sucrose powder to the first mixture prepared in step (1) in 2 times, the amount of each addition is 2435g, after each addition, all need to mix and mix to obtain the second mixture, set aside;

[0040] (3) chlorpheniramine maleate 0.5g is dissolved in 0.5g ethanol, prepares chlorpheniramine maleate ethanol solution, adds 1.5% (mass percentage ...

Embodiment 2

[0042] Prescription 2

[0043] Paracetamol 250g, chlorpheniramine maleate 1g, artificial bezoar 10g, lactose 5000g, povidone K303g, appropriate amount of essence and appropriate amount of ethanol.

[0044] Dissolve 3 g of povidone K30 of the above binder into 97 g of purified water, stir and dissolve to prepare an aqueous solution of povidone K30 with a concentration of 3% by mass.

[0045] Preparation:

[0046] (1) 250g of paracetamol and 10g of artificial bezoar are fully mixed to obtain the first mixture, which is set aside;

[0047] (2) Add 5000 g of lactose to the first mixture prepared in step (1) in 2 times, the amount of each addition is 2500 g, and after each addition, it needs to be mixed and mixed to obtain the second mixture, which is set aside;

[0048] (3) chlorpheniramine maleate 1g is dissolved in 1.5g ethanol, prepares chlorpheniramine maleate ethanol solution, adds 3% povidone K30 aqueous solution earlier in the chlorpheniramine maleate ethanol solution, ...

Embodiment 3

[0049] Prescription 3

[0050]Paracetamol 375g, chlorpheniramine maleate 1.5g, artificial bezoar 15g, sucrose 5200g, sodium carboxymethylcellulose 6g, appropriate amount of essence and appropriate amount of ethanol.

[0051] Dissolve 6 g of sodium carboxymethyl cellulose of the above binder into 394 g of purified water, stir and dissolve to prepare an aqueous solution of sodium carboxymethyl cellulose with a mass percent concentration of CMC-Na of 1.5%.

[0052] Preparation

[0053] (1) 375g of paracetamol and 15g of artificial bezoar are fully mixed to obtain the first mixture, which is set aside;

[0054] (2) Add 5200 g of sucrose to the first mixture prepared in step (1) in 2 times, the amount of each addition is 2600 g, after each addition, all need to mix and mix to obtain the second mixture, and set aside;

[0055] (3) chlorpheniramine maleate 1.5g is dissolved in 4.5g ethanol, prepares chlorpheniramine maleate ethanol solution, adds 1.5% carboxymethylcellulose earlie...

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Abstract

The invention discloses a Xiao er Anfen Huang Namin granule, which is prepared from the following raw materials in terms of 5000g to 5600g of Xiao er Anfen Huang Namin granules through the wet-method granulation: 125 to 375g of acetaminophen, 0.5 to 1.5g of chlorphenamine maleate, 5 to 15g of artificial cow-bezoar, 4500 to 5200g of filler, 3 to 5g of adhesive, and proper amounts of essence and ethanol. The content uniformity and the stability of the granule both meet the requirement, and the product quality is stable and controllable. The invention further discloses a preparation method of the Xiao er Anfen Huang Namin granule, comprising the following steps: dissolving the chlorphenamine maleate in a proper amount of ethanol, adding the adhesive and mixing with the acetaminophen, the artificial cow-bezoar and the filler uniformly, producing the mixture into a soft material, drying, and subpackaging to prepare the Xiao er Anfen Huang Namin granule. The preparation method has simple process flow, can save the energy and the cost, and is suitable for the industrial production.

Description

technical field [0001] The invention relates to the field of granules and their preparation, in particular to a pediatric paracetamol huangnamin granule and a preparation method thereof. Background technique [0002] Pediatric paracetamol Huang Namin granule is one of the commonly used anti-cold medicines for children. Xiaoer's Anphenol Huang Na Min Granules is an over-the-counter medicine for colds. It used to be named: Xiaoerxin, Xiaoer Suxiao Ganmao Granules, Xiaoer Suxiao Ganmao Ling or Xiaoer Suxiao Ganmao Granules. Pediatric paracetamol Huang Namin granule is a compound preparation, mainly composed of acetaminophen (paracetamol), chlorpheniramine maleate (chlorpheniramine) and artificial bezoar. Acetaminophen is an antipyretic and analgesic drug, which mainly acts on antipyretic by inhibiting the synthesis of prostaglandins, increasing skin blood flow, sweating and heat loss. Chlorpheniramine maleate is a histamine H1 receptor antagonist, which can resist telangiecta...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K35/413A61P11/00A61P31/00A61P31/16A61J3/00A61K31/167A61K31/4402
Inventor 刘全国陈克领瞿仁平
Owner HAINAN HULUWA PHARMA GRP CO LTD