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Duloxetine hydrochloride enteric-coated tablets and preparation method thereof

A loxetine enteric and hydrochloric acid technology, applied in the direction of pharmaceutical formulation, coating, pill delivery, etc., can solve the problems of slow onset of action, instability to light, instability, etc., to reduce the fluctuation of blood drug concentration, improve The effect of bioavailability and great application value

Inactive Publication Date: 2017-05-10
HUNAN DONGTING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug has a matrix-type sustained-release function of intestinal erosion, but it is difficult for patients to quickly reach the effective blood concentration after taking the drug, resulting in slow onset of action
Because duloxetine hydrochloride is unstable to light, has poor solubility in water, is unstable in acid, and is easily degraded into naphthol. In order to ensure that the drug does not react with acidic substances, the preparation needs to be further improved

Method used

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  • Duloxetine hydrochloride enteric-coated tablets and preparation method thereof
  • Duloxetine hydrochloride enteric-coated tablets and preparation method thereof
  • Duloxetine hydrochloride enteric-coated tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Duloxetine Hydrochloride Enteric-coated Tablets:

[0035]

[0036] The specification of duloxetine hydrochloride enteric-coated tablet of the present invention is:

[0037] 20mg based on duloxetine.

[0038] Another object of the present invention provides the preparation method of described a kind of duloxetine hydrochloride enteric-coated tablet, and this method comprises the following steps:

[0039] (1) Crushing of raw and auxiliary materials: mixing the raw and auxiliary materials of duloxetine hydrochloride, starch, and microcrystalline cellulose into 100-mesh pulverization;

[0040] (2) Adhesive preparation: Weigh 0.315kg pregelatinized starch, slowly add freshly boiled purified water (2.835kg) cooled to room temperature under stirring, stir to dissolve, and make 10% pregelatinized starch pulp spare;

[0041] (3) Granulation: Add the crushed raw and auxiliary materials into the high-speed mixing granulator, close the body, turn on low-speed stirri...

Embodiment 2

[0053] Example 2 Duloxetine Hydrochloride Enteric-Coated Tablets:

[0054]

[0055] The specification of duloxetine hydrochloride enteric-coated tablet of the present invention is:

[0056] 60mg based on duloxetine.

[0057] The preparation method comprises the following steps:

[0058] (1) Crushing of raw and auxiliary materials: mixing the raw and auxiliary materials of duloxetine hydrochloride, starch, and microcrystalline cellulose into 100-mesh pulverization;

[0059] (2) Adhesive preparation: Weigh 0.33kg pregelatinized starch, slowly add freshly boiled purified water (2.97kg) cooled to room temperature under stirring, stir to dissolve, and make 10% pregelatinized starch pulp spare;

[0060] (3) Granulation: Add the crushed raw and auxiliary materials into the high-speed mixing granulator, close the body, turn on low-speed stirring and mixing for 6 minutes to make the material uniform, add pregelatinized starch slurry, turn on low-speed stirring (3 minutes) and the...

Embodiment 3

[0071] Embodiment 3 The research design test of the present invention:

[0072] (1) Formula screening

[0073] Quality characteristics of raw materials:

[0074] API contains C 18 h 19 NOS·HCl shall not be less than 98.5% (calculated on dry basis). Duloxetine hydrochloride is white or off-white crystalline powder, almost non-hygroscopic; this product is easily soluble in methanol, chloroform or glacial acetic acid, soluble in acetonitrile, slightly soluble in water, and soluble in ethyl acetate or hydrochloric acid solution Very slightly soluble, almost insoluble in sodium hydroxide solution.

[0075] Compatibility of APIs and excipients:

[0076] (1) Tablet core accessories

[0077] The basis for the selection of excipients

[0078] The commonly used excipients of the tablet are optimally combined, and the formula composition is determined as the main ingredient, starch, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. ...

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Abstract

The invention provides duloxetine hydrochloride enteric-coated tablets. The tablets are prepared from components in parts by weight shown in the specification. The duloxetine hydrochloride enteric-coated tablets are seldom affected by food delivery rhythm of digestive tracts, the distribution area on intestinal tract surfaces is increased, so the drugs are completely absorbed, the bioavailability of the drugs is increased, and the plasma concentration fluctuation is reduced. The method is suitable for industrial production and has higher application value.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to an enteric-coated tablet and a preparation method thereof, in particular to a duloxetine hydrochloride enteric-coated tablet and a preparation method thereof. Background technique [0002] Epidemiological surveys found that the global incidence of depression is as high as 5% to 12% (Jie Weiwei, Zhao Jingping and other multi-center randomized double-blind controlled clinical studies on the treatment of depression with duloxetine enteric-coated tablets. Chinese Journal of New Drugs and Clinics, 2013, 32(8): 632-636.), the incidence rate of depression in China is 3%-5%, and 10%-15% of patients eventually die by suicide. With the development of society, the pace of life accelerates, the competition increases, the pressure increases, and the incidence of depression will further increase. At present, depression has become the fourth largest disease in the world, and it is expected that ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/381A61P25/24A61P25/02A61P7/12
CPCA61K9/2866A61K31/381
Inventor 侯奇伟杨爱华李晓云罗微
Owner HUNAN DONGTING PHARMA
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