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Pediatric paracetamol, cow-bezoar and chlorphenamine maleate granules and quality control method thereof

A technology of Pediatric Paracetamol Huangnamin Granules and a quality control method, which is applied to measurement devices, pharmaceutical formulations, color/spectral property measurement, etc. Safety and efficacy issues, ensuring safe and reliable effects

Inactive Publication Date: 2011-07-20
文永盛 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the prescription of commercially available varieties is composed of paracetamol: artificial bezoar: chlorpheniramine maleate, because artificial bezoar is artificially synthesized, its active ingredients are very different from natural bezoar (Chinese Pharmacopoeia 2005 edition: the function of artificial bezoar is heat-clearing, detoxification, phlegm-resolving, convulsion-relieving; the functions of natural bezoar are clearing the heart, removing phlegm, resuscitating, cooling the liver, dispelling wind, and detoxifying), and the impurity composition is unstable, and the corresponding impurities and residues will inevitably be brought in during the synthesis process. Medication brings potential safety hazards and confusion about the curative effect. Pediatric Anphen Huang Namin Granules are used for children, and children belong to special populations. Therefore, it deserves more attention in terms of drug safety and efficacy.
However, natural bezoar resources are in short supply, and the price is very expensive, and only a few special medicines are allowed to use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1: Select 30 mice of 18-22 g, divide them into three groups, 10 in each group, and fast for 12 hours without food or water. The first group was not administered, and it was used as a blank control. The second group was given the commercially available infantile paraffin huangnamin granule solution (containing artificial bezoar 0.5mg) by intragastric administration, and the third group was intragastrically administered the new formula infantile paracetamol huangnamin. Sensing granule solution (containing 0.5 mg of in vitro cultured bezoar), and 0.5 ml of 7.05 mmol / L phenol red solution was injected intraperitoneally at the same time, executed 30 minutes after administration, fixed on the operating board, inserted into the trachea about 0.3 cm with a No. Tight, use a 1ml syringe to draw 0.5ml of 2.24mmol / L sodium bicarbonate solution, lavage the respiratory tract back and forth through the needle for 3 times, collect the lavage fluid, repeat the operation 3 times, ...

Embodiment 2

[0022] Example 2: 30 big-eared rabbits were selected, randomly divided into three groups, 10 in each group, and placed in a laboratory at 18°C. Inject the pentavalent vaccine 2ml / kg into the ear vein to cause a high fever pathological model, measure the body temperature after 2 hours, and use the ones with an increase of more than 1°C as experimental animals. The first group was not administered as a blank group, the second group was given the commercially available Pediatric Aminophenol Huang Namin Granules solution (containing artificial bezoar 5 mg) by intragastric administration, and the third group was administered the new formula Pediatric Aminophenol Huang Namin Granules by intragastric administration. solution (containing in vitro cultured bezoar 5mg). Body temperature was measured at 2, 4, and 6 hours after administration, and the results were as follows:

[0023]

[0024] The normal body temperature of rabbits is about 39°C. Experiments show that the heat-...

Embodiment 3

[0026] Pediatric paracetamol Huang Namin granules are composed of the following raw materials:

[0027] Paracetamol 125g, in vitro cultured bezoar 5g, chlorpheniramine maleate 0.5g.

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Abstract

The invention discloses pediatric paracetamol, cow-bezoar and chlorphenamine maleate granules and a quality control method thereof. The granules are prepared from paracetamol, in-vitro cultivated cow-bezoar and chlorphenamine maleate in a ratio of 125:5:0.5. The quality control method combines identification, thin-layer chromatography, thin-layer scanning, and ultraviolet spectroscopy. In the granules, in-vitro cultivated cow-bezoar is used to replace natural cow-bezoar, so as to greatly reduce raw material cost of medicine while ensuring pesticide effect. In addition, the replacement of in-vitro cultivated cow-bezoar for artificial cow-bezoar so that the medicament safety and pesticide effect problems can be solved, and is favorable for comprehensive quality control of the pediatric paracetamol, cow-bezoar and chlorphenamine maleate granules.

Description

technical field [0001] The invention relates to a western medicine preparation and a quality control method thereof, in particular to a pediatric paraffin huangnamin granule and a quality control method thereof. Background technique [0002] Pediatric paracetamol Huang Namin granule is a chemical drug that has been produced and sold in the market at present, and is used to treat fever, headache, sore limbs, sneezing, runny nose, nasal congestion, sore throat and other diseases caused by colds in children. At present, the prescription of commercially available varieties is composed of paracetamol: artificial bezoar: chlorpheniramine maleate, because artificial bezoar is artificially synthesized, its active ingredients are very different from natural bezoar (Chinese Pharmacopoeia 2005 edition: the function of artificial bezoar is heat-clearing, detoxification, phlegm-resolving, convulsion-relieving; the functions of natural bezoar are clearing the heart, removing phlegm, resus...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/413A61P11/00A61P29/00G01N30/90G01N21/33A61K31/4402A61K31/167
Inventor 文永盛汤明昌蒋平
Owner 文永盛
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