Preparation method and quality test method of pseudoephedrine hydrochloride and dextromethorphan hydrobromide chewable tablets

A chewable tablet and safin technology, applied in the field of pharmaceutical preparations, can solve the problems of material loss, unsuitable for chewing tablets, and large dosage, etc., and achieve the effects of improving content uniformity, good bitterness masking effect, and controllable drug quality

Active Publication Date: 2011-08-31
JIANGXI HERBI SKY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent application number is 200610060163.4 compound dextromethorphan orally disintegrating tablet and its preparation method, which uses β-cyclodextrin or ion exchange resin to mask the taste of dextromethorphan, but the inclusion process of β-cyclodextrin is complicated , when the dosage is large, there are certain safety issues. The ion exchange resin has a certain sandy feeling during the chewing process, and it is not suitable for the preparation of chewable tablets.
The patent application number is 200610154408.X, a kind of flavor-masking cold dry suspension for children and its preparation method. The method uses glyceryl stearate or behenic acid glyceride as the flavor-masking agent, but the chewable Tablets tend to cause drug dissolution during chewing and present a bitter taste
The patent application number is 200610000177.7, taste-masking granules of bad-tasting drugs, chewable preparations and their preparation process. In this process, the active components with bitter taste are coated with acrylic resin and water-soluble glue successively to achieve the purpose of masking the bitter taste of drugs. However, this process must be dried after each coating, the process steps are complicated, and it is easy to cause material loss

Method used

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  • Preparation method and quality test method of pseudoephedrine hydrochloride and dextromethorphan hydrobromide chewable tablets

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Experimental program
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Effect test

Embodiment 1

[0023] Pseudoephedrine hydrochloride 30g, dextromethorphan hydrobromide 15g, lactose 900g, sodium alginate 2g, sucralose 15g, acrylic resin IV 8g, magnesium stearate 10g, sweet orange essence 2g

[0024] The above-mentioned raw materials are made into 1000 pieces, and the preparation method is as follows:

[0025] Take sodium alginate, add appropriate amount of water to make 2% sodium alginate solution, add pseudoephedrine hydrochloride, dextromethorphan hydrobromide and sucralose, stir to dissolve, then add lactose, stir evenly, granulate, and set aside; take acrylic resin IV, add appropriate amount of ethanol to make a 10% ethanol solution of acrylic resin, add the above granules, stir evenly, granulate, dry, add magnesium stearate and sweet orange essence, mix evenly, and press into tablets to obtain.

Embodiment 2

[0027] Pseudoephedrine hydrochloride 30g, dextromethorphan hydrobromide 15g, lactose 850g, sodium alginate 2g, silicon dioxide 30g, sucralose 15g, acrylic resin IV 8g, magnesium stearate 10g, sweet orange essence 2g

[0028] The above-mentioned raw materials are made into 1000 pieces, and the preparation method is as follows:

[0029] Take sodium alginate, add appropriate amount of water to make 2% sodium alginate solution, add pseudoephedrine hydrochloride, dextromethorphan hydrobromide and sucralose, stir to dissolve, then add silicon dioxide and lactose, stir evenly, granulate, and set aside Take acrylic resin IV, add appropriate amount of ethanol to make a 10% ethanol solution of acrylic resin, add the above granules, stir evenly, granulate, dry, add magnesium stearate and sweet orange essence, mix evenly, and press into tablets to obtain.

Embodiment 3

[0031] Pseudoephedrine hydrochloride 30g, dextromethorphan hydrobromide 15g, lactose 850g, calcium gluconate 20g, sodium alginate 2g, sucralose 15g, acrylic resin IV 8g, magnesium stearate 10g, sweet orange essence 2g

[0032] The above-mentioned raw materials are made into 1000 pieces, and the preparation method is as follows:

[0033] Take sodium alginate, add appropriate amount of water to make 2% sodium alginate solution, add pseudoephedrine hydrochloride, dextromethorphan hydrobromide and sucralose, stir to dissolve, then add lactose and calcium gluconate, stir evenly, granulate, and set aside Take acrylic resin IV, add appropriate amount of ethanol to make a 10% ethanol solution of acrylic resin, add the above granules, stir evenly, granulate, dry, add magnesium stearate and sweet orange essence, mix evenly, and press into tablets to obtain.

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PUM

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Abstract

The invention discloses a preparation method and a quality test method of pseudoephedrine hydrochloride and dextromethorphan hydrobromide chewable tablets. The preparation method is characterized in that: medicaments are dispersed in sodium alga acid uniformly first; then auxiliary materials are added, and the mixture is granulated; and finally, the grains are coated with a coating material to isolate the bitterness of medicaments. The quality test method comprises thin layer chromatography and a content measurement method, has high specificity and ensures the preparation process of the invention has high controllability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method and a quality detection method of safin pseudoma chewable tablets. Background technique [0002] Flu, commonly known as "cold", is an acute upper respiratory disease caused by cold viruses, and belongs to commonly encountered diseases and frequently-occurring diseases. Due to the diversity and rapidity of cold virus mutations, the treatment of colds is mainly to relieve symptoms. Pseudoephedrine hydrochloride is an adrenergic receptor agonist, which can constrict the blood vessels of the bronchial mucosa and reduce edema, and has a mild and long-lasting effect, which can relieve asthma and nasal congestion; dextromethorphan hydrobromide is a central cough suppressant, and its strength is equivalent to that of codeine , without addiction. The above two medicines are properly proportioned to form a compound, which can effectively relieve...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/485A61K31/137A61K47/04A61K47/12A61P31/16G01N30/90G01N30/02
Inventor 吴安明艾样开吴孔松陈仁华徐茂宝
Owner JIANGXI HERBI SKY CO LTD
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