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Preparation of medicinal disintegrating agent with biological enzymatic isolation method

A bio-enzyme and disintegrant technology, which is applied in the field of bio-enzymatic hydrolysis to prepare pharmaceutical disintegrants, can solve the problems of affecting the efficacy of drugs, increasing costs, and poor disintegration performance

Inactive Publication Date: 2008-01-23
SIPING DONGYI INNOVATION TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, some pharmaceutical factories are still using traditional disintegrant products, which have poor disintegration performance and affect the normal performance of drug efficacy.
In order to improve the grade of medicines, domestic pharmaceutical groups use imported disintegrants, which greatly increases the cost and restricts my country's pharmaceutical industry from being in line with international standards to a certain extent.

Method used

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  • Preparation of medicinal disintegrating agent with biological enzymatic isolation method
  • Preparation of medicinal disintegrating agent with biological enzymatic isolation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] In the stainless steel enzymatic hydrolysis kettle, add 100Kg of starch to make 40% starch milk, start stirring, add 5Kg of α-amylase, heat up to 50°C, react for 5 minutes, centrifuge and deliquify, then add to the stainless steel etherification kettle, Add 250Kg ethanol, 0.25Kg sodium trimetaphosphate, add dropwise 52Kg of 25% sodium hydroxide solution, alkalinize and crosslink for 1 hour at 40°C, and add etherification agent dropwise three times every 20 minutes (by, 50Kg ethanol, 30Kg Chloroacetic acid, 25% sodium hydroxide solution 52Kg preparation) carries out etherification, and jacket feeds hot water heating, and material temperature is maintained at 50 ℃, and after keeping warm for 10 hours, drops to room temperature, neutralization, washing, drying, Crushed into finished products.

Embodiment 2

[0039] Taking the preparation method of producing 1 ton of super disintegrant as an example, add 1000Kg of starch to make 40% starch milk in a stainless steel enzymatic hydrolysis kettle, start stirring, add 50Kg of α-amylase, heat up to 50°C, and react for 5 minutes. After centrifugation and dehydration, add to the stainless steel etherification kettle, add 2500Kg ethanol, 2.5Kg sodium trimetaphosphate, 520 kg of 25% sodium hydroxide solution, alkalinize and cross-link for 1 hour at 40 ° C, and divide it into three times with an interval of 20 minutes each time Etherifying agent (500 kilograms of ethanol, 300 kilograms of chloroacetic acid, 520 kilograms of 25% sodium hydroxide solution) is added dropwise to carry out etherification, and the jacket is passed into hot water for heating, and the material temperature is kept at 50° C. to room temperature, neutralized, washed, dried and pulverized to obtain the finished product.

[0040] Figure 2 is a schematic diagram of the dis...

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Abstract

The invention discloses a medical additives added into a medicine, in particular to a method to produce medicinal disintegration by biological enzymic method. The main technique is that: taking corn starch as the main material and ethanol as the dispersing agent. Making use of the selectivity of the biological enzyme Alpha-amylase to make the starch interrupt the chain structure under the effect of the biological active enzyme. By means of a plurality of compound degeneration ways such as alkalization, crosslinking and etherification, the starch is made into a new network structure and strong suction group. The invention has the advantages of the excellent efficacy, high absorbent, quick disintegration and controllable release, and can be widely used as releasing medicinal disintegration in tablets, capsules, controlled-release agent and granules.

Description

technical field [0001] The present invention relates to a kind of excipient added in the medicine, more specifically, it can play a role in making the medicine solid preparation have rapid disintegration and slow-control slow-release. . Background technique [0002] The method of preparing pharmaceutical disintegrants by biological enzymatic hydrolysis is a highly efficient, powerful, slow-controlled and slow-release pharmaceutical disintegrant developed in recent years abroad. Due to the excellent properties of strong water absorption, rapid disintegration and controlled and sustained release, the disintegrant has been widely used in preparations such as tablets, capsules, slow-controlled release agents and granules, and has become a solid pharmaceutical preparation at home and abroad. important pharmaceutical excipients. The invention uses cornstarch as the main raw material and adopts bio-enzyme degradation compound denaturation technology to produce, which is a fundame...

Claims

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Application Information

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IPC IPC(8): A61K47/36A61K47/10
Inventor 黄雅典李雪晶
Owner SIPING DONGYI INNOVATION TECH
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