Dextromethorphan hydrobromide sustained-release suspension and preparation method thereof

A technology of dextromethorphan hydrobromide and sustained-release suspension, which is applied in the field of medicine, can solve problems such as difficulty in adapting to divided doses, inaccurate divided doses, and unpleasant taste, so as to reduce the number of medications, overcome taste discomfort, Reasonable composition of ingredients

Inactive Publication Date: 2019-05-21
JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, among the more than 3,500 kinds of chemical preparations in my country, 90% of the medicines do not have dosage forms for children, and less than 100 kinds are specially used for children.
In this way, it is difficult for tablets or capsule solid preparations to adapt to sub-dose
However, conventional suspensions or oral liquids often need three times a day, which is extremely unfavorable for children who go to kindergarten or go to school.
Therefore, in order to overcome the problems of solid preparations such as taste discomfort, difficulty in swallowing, and inaccurate dosage, as well as to facilitate the taking of medicine and enhance the therapeutic effect of children, an oral liquid sustained and controlled release preparation with better sustained release effect and therapeutic effect was developed. very important

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A dextromethorphan hydrobromide sustained-release suspension, which is made of the following raw materials in mass percentage: 85% of suspension matrix, 1.5% of coating resin, 0.5% of drug-loaded resin, 0.08% of EDTA, Surfactant 0.3%, balance is water; This drug-loaded resin is to be made by the raw material of following mass percent: dextromethorphan hydrobromide crude drug 1%, polystyrene sulfonate sodium type cation exchange resin 3%, pure Made of 96% water, the raw materials for the preparation of the coating resin include 8% impregnating resin, 85% dichloromethane, 1% vegetable oil, 3% ethyl cellulose and 3% acetone, the raw materials for preparing the impregnating resin include polyethylene glycol Alcohol 10%, pure water 75% and prepared drug-loaded resin 15%.

[0019] Wherein, the suspension base is made of the following raw materials in mass percentage: 0.1% citric acid, 0.002% FD&C edible yellow pigment No. 6, 0.11% orange flavor, 25% high fructose corn syrup, ...

Embodiment 2

[0026]A dextromethorphan hydrobromide sustained-release suspension, which is made of the following raw materials in mass percentage: 92% of suspension matrix, 1.25% of coating resin, 0.32% of drug-loaded resin, 0.05% of EDTA, Polysorbate 80 0.19%, the balance is water; the drug-loaded resin is made of the following raw materials in mass percentage: 2% of dextromethorphan hydrobromide raw material, 3.8% of polystyrene sodium sulfonate type cation exchange resin, Made of 94.2% pure water, the raw materials for the preparation of the coating resin include 11.58% of impregnating resin, 77% of dichloromethane, 0.38% of vegetable oil, 5.4% of ethyl cellulose and 5.64% of acetone, and the preparation raw materials of the impregnating resin include polyethylene 18% of diol, 73% of pure water and 9% of prepared drug-loaded resin.

[0027] Among them, the suspension base is made of the following raw materials in mass percentage: 0.3% citric acid, 0.0015% FD&C food yellow coloring No. 6,...

Embodiment 3

[0030] A dextromethorphan hydrobromide sustained-release suspension, which is made of the following raw materials in mass percentage: 95% of suspension base, 0.5% of coating resin, 0.1% of drug-loaded resin, 0.01% of EDTA, Surfactant 0.1%, balance is water; This drug-loaded resin is to be made by the raw material of following mass percent: dextromethorphan hydrobromide crude drug 5%, sodium polystyrene sulfonate type cation exchange resin 5%, pure Made of 90% water, the raw materials for the preparation of the coating resin include 15% impregnating resin, 70% dichloromethane, 0.2% vegetable oil, 6.8% ethyl cellulose and 8% acetone. The raw materials for preparing the impregnating resin include polyethylene glycol Alcohol 30%, pure water 65% and prepared drug-loaded resin 5%.

[0031] Wherein, the suspension base is made of the following raw materials in mass percentage: 0.4% citric acid, 0.001% FD&C food yellow coloring No. 6, 0.045% orange flavor, 46.5% high fructose corn syr...

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PUM

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Abstract

The invention discloses a dextromethorphan hydrobromide sustained-release suspension. The suspension is prepared from, by mass, 85-95% of a suspension matrix, 0.5-1.5% of coated resin, 0.1-0.5% of drug-loaded resin, 0.01-0.08% of EDTA, 0.1-0.3% of a surface active agent and the balance water, wherein the drug-loaded resin is prepared from a dextromethorphan hydrobromide crude drug, sodium polystyrenesulfonate type cation exchange resin and purified water; the coated resin is prepared from impregnating resin, dichloromethane, vegetable oil, ethyl cellulose and acetone, and the impregnating resin is prepared from polyethylene glycol, purified water and the prepared drug-loaded resin. The invention further discloses a preparation method of the dextromethorphan hydrobromide sustained-release suspension. The sustained-release effect is good, the drug treating effect is lasting, the treatment effect is good, the number of drug applying times can be obviously reduced, the problems that a solid sustained-release preparation is poor in taste, difficult to swallow and inaccurate in fractional dose are solved, and the dextromethorphan hydrobromide sustained-release suspension is convenient for children patients to take.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a dextromethorphan hydrobromide sustained-release suspension and a preparation method thereof. Background technique [0002] At present, among the more than 3,500 kinds of chemical preparations in my country, 90% of the medicines do not have dosage forms for children, and less than 100 kinds are specially used for children. And there are fewer liquid preparations for children. Among the only less than 10% of children's medicines, most of them are also imported or produced by joint ventures. Many domestic drug manufacturers refer to clinical research reports done abroad or only give general dosage conversion methods. In this way, it is difficult for tablets or capsule solid preparations to adapt to sub-dose. Conventional suspensions or oral liquids often need three times a day, which is extremely unfavorable for children who go to kindergarten or go to school. Therefore, in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/10A61K47/38A61K31/485
Inventor 江永红丁月萍袁菊凤徐益明
Owner JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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