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Racecadotril double-phase releasing preparation and preparation method thereof

A technology of racecadotril and racecadotril, which is applied in medical preparations containing active ingredients, medical preparations without active ingredients, and digestive system, etc. Exceeding the standard and high equipment requirements, to achieve the effects of low equipment requirements, improved dissolution, and simple preparation process

Active Publication Date: 2017-06-13
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

U.S.Pat.No.6919093 B2 first discloses the use of coating material Eudragit The water dispersion is granulated, and the bitterness of racecadotril is masked by using high-dose apricot flavor essence, etc., but this method requires high equipment, and it is difficult to achieve the effect of taste masking and effective release at the same time. The complex composition of emulsifier and apricot flavor essence in the water dispersion can easily cause problems such as excessive impurities in the finished product; CN 102166197 A discloses the microencapsulation treatment of racecadotril with sodium alginate and other materials by spraying method, so as to achieve Taste masking effect, but this method is complex and costly

Method used

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  • Racecadotril double-phase releasing preparation and preparation method thereof
  • Racecadotril double-phase releasing preparation and preparation method thereof
  • Racecadotril double-phase releasing preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription

[0027] (1) Prescription composition of drug-containing granules

[0028]

[0029]

[0030] The preparation process and process of drug-containing granules are as follows: crush the drug and sucrose to a certain particle size range, mix the drug, sucrose, ethyl cellulose or hypromellose in a wet granulator for 5 minutes; add purified water to prepare Soft material; then put the soft material into a 40-mesh sieve of a swinging granulator to granulate; the formed granules are dried in a vacuum drying oven at 50±5°C until the moisture content is less than 1%, and then granulated with a 40-mesh sieve to obtain .

[0031] (2) Composition of racecadotril biphasic drug release preparation

[0032]

[0033] Put the sustained-release drug-containing granules and quick-release drug-containing granules, peach flavor essence, and fumed silicon dioxide in a mixer according to the above-mentioned proportions and mix until uniform, and divide into bags so that...

Embodiment 2

[0035] prescription

[0036] (1) Prescription composition of drug-containing granules

[0037]

[0038]

[0039] The preparation process and process of drug-containing granules are as follows: crush the drug and sucrose to a certain particle size range, mix the drug, sucrose, ethyl cellulose or hypromellose in a wet granulator for 5 minutes; add purified water to prepare Soft material; then put the soft material into a 40-mesh sieve of a swinging granulator to granulate; the formed granules are dried in a vacuum drying oven at 50±5°C until the moisture content is less than 1%, and then granulated with a 40-mesh sieve to obtain .

[0040] (2) Composition of racecadotril biphasic drug release preparation

[0041]

[0042] Put the sustained-release drug-containing granules and quick-release drug-containing granules, peach flavor essence, and fumed silicon dioxide in a mixer according to the above-mentioned proportions and mix until uniform, and divide into bags so that...

Embodiment 3

[0044] prescription

[0045] (1) Prescription composition of drug-containing granules

[0046]

[0047]The preparation process and process of drug-containing granules are as follows: crush the drug and sucrose to a certain particle size range, mix the drug, sucrose, ethyl cellulose or hypromellose in a wet granulator for 5 minutes; add purified water to prepare Soft material; then put the soft material into a 40-mesh sieve of a swinging granulator to granulate; the formed granules are dried in a vacuum drying oven at 50±5°C until the moisture content is less than 1%, and then granulated with a 40-mesh sieve to obtain .

[0048] (2) Composition of racecadotril biphasic drug release preparation

[0049]

[0050] Put the sustained-release drug-containing granules and quick-release drug-containing granules, peach flavor essence, and fumed silicon dioxide in a mixer according to the above-mentioned proportions and mix until uniform, and divide into bags so that each bag con...

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Abstract

The invention relates to the field of medicines, in particular to a racecadotril double-phase releasing preparation and a preparation method thereof. The racecadotril double-phase releasing preparation is prepared from medicine-containing particles with different slow-release properties and the like in percentage by mass: 10 to 90% of slow-release medicine-containing particles, 10 to 90% of quick-release medicine-containing particles, 0.1 to 0.5% of lubricant, and 0.1 to 1.0% of flavoring agent. The racecadotril double-phase releasing preparation has the advantages that the bitter taste of the racecadotril is effectively covered, the effective plasma concentration is guaranteed, the preparation technology is simple, the reproducibility is good, and the racecadotril double-phase releasing preparation is suitable for industrialized production.

Description

technical field [0001] The invention relates to a racecadotril preparation, in particular to a biphasic release preparation containing racecadotril and a preparation method thereof. [0002] technical background [0003] Diarrhea has always been a gastrointestinal disease that has attracted much attention, with a high incidence, especially in infants and the elderly. Compared with other antidiarrheal drugs, racecadotril (Racecadotril) is an antidiarrheal drug with a new mechanism of action, which can selectively and reversibly inhibit enkephalinase and prolong the endogenous enkephalinase in the digestive tract. Physiological activity, thereby inhibiting the excessive secretion of water and electrolytes to exert its antidiarrheal effect, has a high specific antisecretory effect, is suitable for symptomatic treatment of various diarrhea, and is easy to absorb, has rapid onset, small adverse reactions, and safety High, especially suitable for infant patients. Therefore, racec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38A61K31/265A61K9/00A61K9/16A61P1/12
CPCA61K9/0002A61K9/0053A61K9/1652A61K31/265A61K47/38
Inventor 兰颐杨琳吴学萍李树英何淑旺王文笙谢璇刘长涛
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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