Xiao er Anfen Huang Namin granule and preparation method thereof

A technology of children's paracetamol huangnamin granules and chlorpheniramine acid, which can be applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, and devices that make medicines into special physical or ingestible forms, and can solve the problem of children's drug use. Difficulty, large content fluctuations, uneven content and other problems, to achieve stable and controllable product quality, easy to control, and simple operation

Active Publication Date: 2011-03-02
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 and preparation method thereof

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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 carboxymethyl cellulose 4g, proper amount of flavor and proper amount of ethanol.

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

[0037] Preparation:

[0038] (1) Mix 125 g of paracetamol and 5 g of artificial bezoar fully to obtain the first mixture for use;

[0039] (2) Add 4870 g of sucrose powder to the first mixture prepared in step (1) in two times, each time adding 2435 g, and mixing after each addition to obtain the second mixture for use;

[0040] (3) Dissolve 0.5 g of chlorpheniramine maleate in 0.5 g of ethanol to prepare chlorpheniramine maleate ethanol solution, and add 1.5% (mass percentage concentration) to the chlorpheniramine maleate ethanol solution. ) Aqueous sodium carboxym...

Embodiment 2

[0042] Prescription 2

[0043] Acetaminophen 250g, chlorpheniramine maleate 1g, artificial bezoar 10g, lactose 5000g, povidone K303g, proper amount of flavor and proper amount of ethanol.

[0044] Dissolve 3 g of povidone K30 of the above-mentioned 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) Fully mix 250 g of paracetamol and 10 g of artificial bezoar to obtain the first mixture for use;

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

[0048] (3) Dissolve 1 g of chlorpheniramine maleate in 1.5 g of ethanol to prepare an ethanol solution of chlorpheniramine maleate, and add 3% povidone K30 aqueous solution to the ethanol solution of chlorpheniramine maleate. After mixing, it is mixed...

Embodiment 3

[0049] Prescription 3

[0050] 375g of acetaminophen, 1.5g of chlorpheniramine maleate, 15g of artificial bezoar, 5200g of sucrose, 6g of sodium carboxymethylcellulose, proper amount of flavor and proper amount of ethanol.

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

[0052] Preparation

[0053] (1) Mix 375 g of acetaminophen and 15 g of artificial bezoar fully to obtain the first mixture for use;

[0054] (2) Add 5200 g of sucrose to the first mixture prepared in step (1) in 2 times, each time the addition amount is 2600 g, after each addition, it needs to be mixed and evenly mixed to obtain the second mixture for use;

[0055] (3) Dissolve 1.5 g of chlorpheniramine maleate in 4.5 g of ethanol to prepare chlorpheniramine maleate ethanol solution, and add 1.5% carboxymethyl cellulose to the chlorpheniramine maleate ethanol s...

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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 Granules is one of the commonly used anti-cold drugs in children. Pediatric Paracetamol Huang Namin Granules are non-prescription drugs for colds. They were once used as: Pediatric New, Pediatric Suxiaoganmao Granules, Pediatric Suxiao Ganmaoling or Pediatric Suxiao Cold Granules. Pediatric Paracetamol Huang Namin Granules is a compound preparation, mainly composed of acetaminophen (paracetamol), chlorpheniramine maleate (chlorpheniramine) and artificial bezoar. Acetaminophen is an antipyretic and analgesic. It mainly acts as an antipyretic by inhibiting the synthesis of prostaglandins and increasing the blood flow, sweating and heat loss of the skin. Chlorpheniramine maleate is a histamine H1 receptor antagonist, which can resist ...

Claims

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Application Information

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