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Dihydrocodeine tartrate sustained-release dropping pill and preparation method thereof

A technology of dihydrocodeine tartrate and sustained-release dripping pills, which can be applied to medical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of not having the advantage of controlled release, Achieve the effect of being conducive to labor protection and environmental protection, convenient operation, and accurate drug dosage

Inactive Publication Date: 2013-03-13
北京博智绿洲医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It shows that the controlled-release tablets produced abroad that currently rely on imports do not have the advantage of controlled release, and it is urgent to develop new dosage forms to improve the curative effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Based on the total weight of 100g, weigh 35% of the matrix PEG4000, 30% of PEG6000, 10% of PEG10000, 10% of stearic acid, 5% of glyceryl monostearate, and 10% of the raw material dihydrocodeine tartrate; place the matrix in Heat and stir in the heating container to make it melt, add the corresponding proportion of dihydrocodeine tartrate, stir well, use the dropping pill machine, under the condition of heat preservation, drop the melted or mixed liquid medicine into the dimethylformamide In the condensation column of base silicone oil, the temperature when heating and melting is 80°C, the temperature of the upper part of the condensate is 20°C, and the temperature of the bottom is -2°C; take it out after molding,

[0039] The obtained product has a 2-hour cumulative release percentage of 38%-49%, a 6-hour cumulative release percentage of 51%-71%, and a 10-hour cumulative release percentage of 73%-100%. The release degree is qualified and the roundness is good.

Embodiment 2

[0041] Based on the total weight of 100g, weigh the matrix PEG4000 40%, PEG6000 20%, PEG10000 10%, stearic acid 5%, glyceryl monostearate 10%, raw material dihydrocodeine tartrate 15%; Heat and stir in the heating container to melt, add the corresponding proportion of dihydrocodeine tartrate, stir well, use the dropping pill machine, under the condition of heat preservation, drop the molten or mixed liquid medicine into the two In the condensation column of methyl silicone oil, the temperature when heating and melting is 85°C, the temperature of the upper part of the condensate is 25°C, and the temperature of the bottom is 1°C; take it out after molding,

[0042] The obtained product has a 2-hour cumulative release percentage of 49%-61%, a 6-hour cumulative release percentage of 63%-76%, and a 10-hour cumulative release percentage of 77%-99%. The release degree is qualified and the roundness is good.

Embodiment 3

[0044] Based on the total weight of 100g, weigh the matrix PEG4000 48%, PEG6000 25%, sodium carboxymethyl starch 15%, stearic acid 2%, raw material dihydrocodeine tartrate 10%; place the matrix in a heating container to heat And stir to make it melt, add the corresponding proportion of dihydrocodeine tartrate, after fully stirring, use a dropping pill machine, under the condition of heat preservation, drop the molten or mixed liquid medicine into the condensation column filled with liquid paraffin , wherein, the temperature during heating and melting is 80°C, the temperature of the upper part of the condensate is 24°C, and the temperature of the bottom is 1°C; take it out after molding,

[0045] The obtained product has a 2-hour cumulative release percentage of 46%-55%, a 6-hour cumulative release percentage of 57%-88%, and a 10-hour cumulative release percentage of 89%-100%. The release degree is qualified and the roundness is good.

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PUM

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Abstract

The invention relates to a dihydrocodeine tartrate sustained-release dropping pill for treatment of moderate pain and a preparation method thereof. The invention aims to solve the defects of an oral preparation, and provides the dihydrocodeine tartrate sustained-release dropping pill, which has advantages of high bioavailability, rapid effectiveness, long action time, low frequency of drug taking, convenient administration, little toxic or side effect, convenient storage and transportation, and suitability for oral administration, and the preparation method thereof.

Description

technical field [0001] The invention relates to a drug dihydrocodeine tartrate slow-release preparation for treating moderate pain and a preparation method thereof. Background technique [0002] Sodium dihydrocodeine tartrate is a compound containing C18H23NO3.C4H6O6, its molecular weight is 451.47, and its chemical name is: 4,5-epoxy-3-methoxy-17-methyl-morphan-6-ol (5α,6α)-2,3-Dihydrotartrate. [0003] This product is colorless crystal or white crystalline powder, odorless or almost odorless. [0004] This product is soluble in water, slightly soluble in ethanol, almost insoluble in ether. [0005] Dihydrocodeine tartrate is a new type of narcotic analgesic developed by Beijing Mengdi Pharmaceutical Co., Ltd. It was launched in the United Kingdom and the United States in 1988, and its analgesic effect is higher than that of codeine. In 1998, the Ministry of Health of my country approved the clinical verification. In 2004, it issued the approval document for importing dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/485A61K47/34A61K47/36A61P25/04
Inventor 曲韵智王金强振君
Owner 北京博智绿洲医药科技有限公司
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