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Racecadotril granules and preparation method thereof

A racecadotril and granule technology, which is applied to the digestive system, pharmaceutical formulations, medical preparations of inactive ingredients, etc. Short time, simple preparation method, good quality effect

Active Publication Date: 2018-03-20
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The Chinese invention patent application with the application number 201110103125.3 discloses a racecadotril granule and its production process. This method uses microcapsules to mask the taste, and the process is complicated. During the production process, there will be different sizes of microcapsule particles, resulting in dissolution Poor degree, slow absorption

Method used

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  • Racecadotril granules and preparation method thereof
  • Racecadotril granules and preparation method thereof
  • Racecadotril granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Prescription: based on 1000 bags, including raw materials and pharmaceutical excipients in the following weights:

[0048]

[0049] Steps:

[0050] (1) Adopt superfine pulverization technology to pulverize racecadotril into nano fine powder, cross 200 mesh sieves, and set aside;

[0051] (2) Weigh 52.1 g of 95% ethanol and 46.9 g of purified water and mix evenly, add 1 g of hypromellose and stir to dissolve to obtain 1% hypromellose 50% ethanol;

[0052](3) Ethanol and coconut oil are mixed and stirred to form a microemulsion, add racecadotril nano fine powder and 5g mannitol, 7g sucrose, put into a three-dimensional motion mixer and mix for 10 minutes, mix evenly to obtain a mixture;

[0053] (4) Add the remaining mannitol and sucrose into the fluidized bed, set the inlet air temperature to 50°C, and the air inlet volume to 70m 3 / h, the spray speed is 1g / min, and the spray gun atomization pressure is 0.3Mpa, sprays into the mixture that step (3) obtains, finally ...

Embodiment 2

[0055] Prescription: based on 1000 bags, including raw materials and pharmaceutical excipients in the following weights:

[0056]

[0057] Steps:

[0058] (1) Adopt superfine pulverization technology to pulverize racecadotril into nano fine powder, cross 200 mesh sieves, and set aside;

[0059] (2) Weigh 52.1 g of 95% ethanol and 46.9 g of purified water and mix evenly, add 1 g of hypromellose and stir to dissolve to obtain 1% hypromellose 50% ethanol;

[0060] (3) Ethanol and coconut oil are mixed and stirred to form a microemulsion, add racecadotril nano fine powder and 10g mannitol, 10g sucrose, put into a three-dimensional motion mixer and mix for 15 minutes, mix evenly to obtain a mixture;

[0061] (4) Add the remaining mannitol and sucrose into the fluidized bed, set the inlet air temperature to 55°C, and the air inlet volume to 60m 3 / h, the spray speed is 1.5g / min, the spray gun atomization pressure is 0.5Mpa, spray into the mixture that step (3) obtains, finally ...

Embodiment 3

[0063] Prescription: based on 1000 bags, including raw materials and pharmaceutical excipients in the following weights:

[0064]

[0065] (1) Adopt superfine pulverization technology to pulverize racecadotril into nano fine powder, cross 300 mesh sieves, and set aside;

[0066] (2) Weigh 52.1 g of 95% ethanol and 46.9 g of purified water and mix evenly, add 1 g of hypromellose and stir to dissolve to obtain 1% hypromellose 50% ethanol;

[0067] (3) Ethanol and coconut oil are mixed and stirred to form a microemulsion, add racecadotril nano fine powder and 3g mannitol, 5g sucrose, put into a three-dimensional motion mixer and mix for 10 minutes, mix evenly to obtain a mixture;

[0068] (4) Add the remaining mannitol and sucrose into the fluidized bed, set the inlet air temperature to 60°C, and the air inlet volume to 180m 3 / h, the spray speed is 2g / min, and the spray gun atomization pressure is 0.5Mpa, sprays into the mixture that step (3) obtains, finally sprays into 1% ...

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Abstract

The invention discloses racecadotril granules. Based on 100 bags, the racecadotril granules comprise the following raw medicinal materials and medicinal auxiliary materials in parts by weight: 5g-15gof racecadotril, 1g-5g of coconut oil, 800g-1200g of filler, 100g-200g of an adhesive and 100g-200g of ethanol. The invention also discloses a preparation method of the racecadotril granules. The preparation method comprises the following steps: mixing and stirring ethanol and coconut oil to form a micro-emulsion to increase the solubility of racecadotril; and then adding 1-5% of filler, wherein asmall amount of filler can play a role in a cosolvent accidently, so that the dissolution rate of the racecadotril granules is improved greatly. By adding a lot of filler to modify the taste and cover the bitterness of racecadotril, so that the taste of a drug is improved. The racecadotril granules avoid phenomena that the racecadotril granules prepared by an existing preparation method are poorin taste, poor in dissolution rate and hard to store, and the percent of pass of the product is improved greatly.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to racecadotril granules and a preparation method thereof. Background technique [0002] The main drug of this product, racecadotril, is an enkephalinase inhibitor, which is a white or off-white crystalline powder, which can selectively and reversibly inhibit enkephalinase, thereby protecting endogenous enkephalins from Degrade and prolong the physiological activity of endogenous enkephalins in the digestive tract. In peripheral tissues, racecadotril taken by IZ1 was rapidly hydrolyzed to acetofen, a more effective enkephalin inhibitor. Inhibition of enkephalinase by acetophene increases opioid utilization, activates intestinal opioid receptors, and leads to decreased mucosal levels of cAMP, thereby reducing excessive secretion of water and electrolytes. Moreover, the drug acts on peripheral enkephalins, does not affect the activity of enkephalinases in the central nervo...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K47/26A61K47/10A61K47/44A61K47/38A61K31/265A61P1/12
CPCA61K9/1617A61K9/1623A61K9/1652A61K9/1682A61K31/265
Inventor 刘景萍刘全国陈克领林文君王家李党
Owner HAINAN HULUWA PHARMA GRP CO LTD
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