Enteric sustained release granules containing duloxetine hydrochloride and preparation method of enteric sustained release granules

A technology of duloxetine hydrochloride and loxetine intestine, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of strict technical parameters for the preparation of enteric-coated pellets It is unfavorable for large-scale industrial production and long preparation time, and achieves the effects of improving medication compliance, reducing the number of medications, and reducing costs

Inactive Publication Date: 2017-12-01
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the enteric-coated pellet capsule can achieve the advantages of rapid release in the small intestine, the preparation process parameters of the enteric-coated pellet are strict, and the process is cumbersome, the preparation time is long, and it does not use industrialized large-scale production.

Method used

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  • Enteric sustained release granules containing duloxetine hydrochloride and preparation method of enteric sustained release granules
  • Enteric sustained release granules containing duloxetine hydrochloride and preparation method of enteric sustained release granules
  • Enteric sustained release granules containing duloxetine hydrochloride and preparation method of enteric sustained release granules

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Experimental program
Comparison scheme
Effect test

Embodiment

[0018] Duloxetine hydrochloride: 1:2 hydroxypropyl β-cyclodextrin

[0019]

[0020] Preparation Process:

[0021] In an aqueous medium containing 50% ethanol, react duloxetine hydrochloride with hydroxypropyl β-cyclodextrin according to the prescription ratio, filter the resulting solution through a microporous membrane until clarified, separate the clathrate from the mixture Pass the duloxetine hydrochloride inclusion compound through a 100-mesh sieve, and crush the rest of the auxiliary materials through a 80-mesh sieve; accurately weigh the raw and auxiliary materials in the prescribed amount, mix them evenly, and add an appropriate amount of water to make the mixture into a wet material. Sieve and granulate, dry at 60°C, and coat the obtained granules with enteric-coated material in a fluidized bed to obtain enteric-coated sustained-release granules.

[0022] In this application, specific excipients were selected to prepare duloxetine hydrochloride inclusion compound e...

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Abstract

The invention discloses enteric sustained release granules containing duloxetine hydrochloride and a preparation method of the enteric sustained release granules. According to the preparation disclosed by the invention, duloxetine hydrochloride is prepared into a clathrate compound, and then the clathrate compound is prepared into enteric granules. The enteric sustained release granules comprise the duloxetine hydrochloride clathrate compound and acceptable auxiliary materials, wherein the auxiliary materials at least comprise a macromolecular sustained-release material, a release speed regulating ingredient and an enteric outer-layer coating material, the medicine has erosion and release in the intestinal tract, the action time is lasting, the side reaction occurrence rate caused by rapid release of the medicines after medicine taking is remarkably reduced, so that the blood drug concentration and the drug effect are stable and durable, and the medication compliance and clinical treatment effect of patients are enhanced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a duloxetine hydrochloride enteric-coated granule and a preparation method thereof. Background technique [0002] Duloxetine Hydrochloride is a compound that has dual inhibitory effects on the uptake of 5-hydroxytryptamine (5-HT) and norepinephrine (NE). Existing research data have shown that the drug has a certain effect on depression, pain caused by diabetic peripheral neuropathy, and stress urinary incontinence. [0003] Duloxetine hydrochloride is a white or off-white crystalline powder with poor photostability, poor solubility in water and unstable in acidic environment, easy to degrade. In view of this, in order to ensure that the drug does not react with acidic substances, duloxetine hydrochloride is suitable for making enteric-coated preparations. Therefore, a preparation that can increase the solubility of the drug and ensure that it does...

Claims

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Application Information

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IPC IPC(8): A61K9/58A61K9/62A61K31/381A61K47/69A61K47/38A61K47/12A61K47/32A61P25/24A61P3/10A61P25/02A61P13/00
CPCA61K9/0002A61K9/5026A61K9/5042A61K31/381A61K47/12A61K47/32A61K47/38
Inventor 刘冲王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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