Pediatric paracetamol granule and quality control method

A technology of Pediatric Aminophen Huang Namin Granules and quality control methods, which is applied in measuring devices, pharmaceutical formulas, color/spectral characteristics measurement, etc., can solve the problems of hidden dangers in children's drug safety, efficacy, confusion, and high price, and achieve the goal of solving drug problems. Safety and efficacy issues, ensuring safe and reliable effects

Inactive Publication Date: 2009-12-23
文永盛
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prescription composition of the currently commercially available varieties is acetaminophen: artificial bezoar: chlorpheniramine maleate. Since artificial bezoar is artificially synthesized, its active ingredients are quite different from natural bezoar. To clear away heat, detoxify, resolve phlegm, calm convulsions; natural bezoar has the functions of clearing heart, clearing phlegm, resuscitation, cooling liver, calming wind, detoxification, and the impurity composition is unstable, and t...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1. Comparative experiment of expectorant effect:

[0020] 1.1 Experimental method: Select 30 mice of 18-22g, 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 need...

Embodiment 2

[0030] Pediatric paracetamol Huang Namin granules are composed of the following raw materials:

[0031] Paracetamol 125g, in vitro cultured bezoar 5g, chlorpheniramine maleate 0.5g.

Embodiment 3

[0033] Quality control method:

[0034] The quality control method of Xiao'er'anfen Huang Na Min Granules is to use the combination of trait method, thin-layer chromatography, thin-layer scanning method and ultraviolet spectrophotometry to control the quality of Xiao'er's Anfen Huang Na Min Granules.

[0035] Pediatric paracetamol Huang Namin granules This product is white or off-white granules; sweet in taste.

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PUM

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Abstract

The invention discloses a pediatric paracetamol granule and a quality control method. The formulation is as follows: acetaminophen: in-vitro-cultured calculus bovis: chlorpheniramine maleate (125:5:0.5); the quality control method which combines a character method, thin-layer chromatography, thin layer chromatography scanning, and ultraviolet spectrophotometry is adopted; in the invention, in-vitro-cultured calculus bovis replaces natural calculus bovis to be used for the pediatric paracetamol granule, thus greatly reducing raw material cost of medicines while guaranteeing drug effect; in addition, in-vitro-cultured calculus bovis is used for replacing natural calculus bovis to be used for pediatric paracetamol granule, thus solving medicinal safety and drug effect problem, and simultaneously being beneficial to roundly controlling the quality of the pediatric paracetamol 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. The prescription composition of the currently commercially available varieties is acetaminophen: artificial bezoar: chlorpheniramine maleate. Since artificial bezoar is artificially synthesized, its active ingredients are quite different from natural bezoar. To clear away heat, detoxify, resolve phlegm, calm convulsions; natural bezoar has the functions of clearing heart, clearing phlegm, resuscitation, cooling liver, calming wind, detoxification, and the impurity compositi...

Claims

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Application Information

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IPC IPC(8): A61K35/413A61K9/16A61P11/00A61P29/00G01N30/90G01N21/33A61K31/167A61K31/4402
Inventor 文永盛
Owner 文永盛
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