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Taste masked suspension prescription for treating infant cold and method for preparing same

A technology for dry suspension and infant cold, which is applied in the field of preparation of taste-masked dry suspension, can solve the problems of medicine affecting taste-masking, small sedimentation volume, unqualified, etc., and achieves the effects of rapid drug release and palatable taste.

Active Publication Date: 2007-05-30
浙江康德药业集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the dry suspension particles are too large, they will settle quickly. If the sedimentation volume ratio is too small, it is unqualified. If the dry suspension particles are too small, the drug will be easily released into the mouth and affect the taste.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] prescription:

[0015] Acetaminophen 80g

[0016] Pseudoephedrine Hydrochloride 7.5g

[0017] Dextromethorphan Hydrobromide 2.5g

[0018] Glyceryl Behenate 5g

[0019] Sucrose 1860g

[0020] Sodium Carboxymethyl Cellulose 25g

[0021] povidone k90 10g

[0022] Magnesium Stearate 5g

[0023] Orange flavor 5g

[0024] Lemon yellow 0.2g

[0025] Made in packs of 1000

[0026] Process:

[0027] Crush the three raw materials separately, pass through a 80-mesh sieve, weigh the prescription amount and mix evenly, then add glyceryl behenic acid, mix well, heat in a water bath at 60-80°C, stir for 15 minutes, take it out and continue stirring to room temperature, pass through 45 mesh screen. Mix the remaining auxiliary materials with the above-mentioned fine powder, dry squeeze through a 16-mesh sieve to granulate, and pack separately to obtain.

Embodiment 2

[0029] prescription:

[0030] Acetaminophen 80g

[0031] Pseudoephedrine Hydrochloride 7.5g

[0032] Dextromethorphan Hydrobromide 2.5g

[0033] Glyceryl Stearate 10g

[0034] Sucrose 1000g

[0035] Carboxypropyl cellulose 25g

[0036] povidone k30 15g

[0037] Micronized silica gel 5g

[0038] Orange flavor 5g

[0039] Stevia 2g

[0040] Made in packs of 1000

[0041] Process:

[0042] Grind the three raw materials separately, pass through a 80-mesh sieve, weigh the prescription amount and mix evenly, then add glyceryl stearate, mix well, heat in a water bath at 50-70°C and stir for 15 minutes, take it out and continue stirring to room temperature, pass through 45 mesh screen. Mix the remaining auxiliary materials with the above-mentioned fine powder, dry squeeze through a 16-mesh sieve to granulate, and pack separately to obtain.

experiment example 1

[0044] Human body bioequivalence test of dry suspension of the present invention

[0045] Research purpose: To evaluate the human bioequivalence between the dry suspension (test preparation T) of the present invention and the aminophenol Mami syrup (trade name Xiaobai, reference preparation R) produced by Dongsheng Science and Technology Qidong Gaitianli Pharmaceutical Co., Ltd. sex.

[0046] Evaluation criteria: Evaluate the bioequivalence between the test preparation and the reference preparation, from the two aspects of drug absorption degree and absorption speed, and evaluate the three pharmacokinetic parameters that reflect these two aspects, namely AUC0→t, Cmax and Whether Tmax meets the equivalent standard.

[0047] Judgment criteria: the AUC0-τ of the test preparation after logarithmic transformation is within the range of 80%-125% of the reference preparation, and the Cmax of the test preparation is within the range of 70%-143% of the reference preparation. The t-te...

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Abstract

The invention discloses a taste-masking typed children-influenza dry-mixing suspension and making method, which is characterized by the following: adopting acetamidophenol, ephedrine hydrochloride, hydrobromic acid dextromethorphan and auxiliary drug material as raw material; cladding drug through glyceride compound to mask taste.

Description

technical field [0001] The invention relates to a preparation method of a taste-masking cold dry suspension for children. More specifically, the present invention relates to a method for preparing a taste-masking dry suspension specially used for treating colds in children, which is composed of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and pharmaceutical excipients. Background technique [0002] Flu is the acute upper respiratory disease that is caused by cold virus, is common disease and frequently-occurring disease. Due to the immature immune system and poor resistance, children are susceptible to external cold virus infection, and children have a higher chance of getting sick, especially in seasons with changing climates. According to health agency statistics, more than 80% of children have at least 6 colds every year. Among them, children under the age of 3 have the most cases, and most of them are severe: high fever, loss of appetite,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61K47/14A61P11/00A61P29/00A61P31/00A61K31/167A61K31/137
Inventor 胡增仁于庆明冯荣权封思阳刁勇
Owner 浙江康德药业集团股份有限公司
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