High-stability sertraline hydrochloride capsule and preparation method thereof

A technology of sertraline hydrochloride and high stability, which is applied in the field of high stability sertraline hydrochloride capsules and its preparation, and can solve the problems of poor chemical stability of preparations and failure to obtain better breakthroughs, etc.

Active Publication Date: 2017-01-11
四川省百草生物药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is due to the poor chemical stability of the formulation when formulated as a hard capsule (see Physician’s DeskReference (sertraline) entry)
[0004] In order to improve the...

Method used

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  • High-stability sertraline hydrochloride capsule and preparation method thereof
  • High-stability sertraline hydrochloride capsule and preparation method thereof
  • High-stability sertraline hydrochloride capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] (1) In parts by weight, 20 parts of sertraline hydrochloride, 30 parts of lactose, 25 parts of microcrystalline cellulose, 20 parts of low-substituted hydroxypropyl cellulose and 5 parts of mannitol are mixed;

[0023] (2) Add ethanol (75% mass fraction) to step (1) gain, make soft material, cross 20 mesh sieves and granulate;

[0024] (3) drying the product obtained in step (2) at an environment of 65-75°C; then passing through a 20-mesh sieve for sizing;

[0025] (4) Put the product obtained in step (3) into a hard gelatin capsule shell to obtain the product.

Embodiment 2

[0027] (1) In parts by weight, 25 parts of sertraline hydrochloride, 38 parts of lactose, 30 parts of microcrystalline cellulose, 22 parts of low-substituted hydroxypropyl cellulose and 10 parts of mannitol are mixed;

[0028] (2) Add ethanol (75% mass fraction) to step (1) gain, make soft material, cross 20 mesh sieves and granulate;

[0029] (3) drying the product obtained in step (2) at an environment of 65-75°C; then passing through a 20-mesh sieve for sizing;

[0030] (4) Put the product obtained in step (3) into a hard gelatin capsule shell to obtain the product.

Embodiment 3

[0032] (1) In parts by weight, 22 parts of sertraline hydrochloride, 35 parts of lactose, 27 parts of microcrystalline cellulose, 21 parts of low-substituted hydroxypropyl cellulose and 7 parts of mannitol are mixed;

[0033] (2) Add ethanol (75% mass fraction) to step (1) gain, make soft material, cross 20 mesh sieves and granulate;

[0034] (3) drying the product obtained in step (2) at an environment of 65-75°C; then passing through a 20-mesh sieve for sizing;

[0035] (4) Put the product obtained in step (3) into a hard gelatin capsule shell to obtain the product.

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Abstract

The invention provides a preparation method of a high-stability sertraline hydrochloride capsule. The method comprises the following steps: (1) mixing the following components in parts by weight: 20-25 parts of sertraline hydrochloride, 30-38 parts of lactose, 25-30 parts of microcrystalline cellulose, 20-22 parts of low-substituted hydroxypropyl cellulose and 5-10 parts of mannitol; (2) adding ethanol into the product obtained in the step (1) to prepare a soft material, screening, and granulating; (3) drying the product obtained in the step (2), and then granulating; and (4) filling the product obtained in the step (3) into a hard gelatin capsule shell. The capsule prepared by the invention has long-time stability; the capsule can be preserved for 24 months under the conditions of 30 DEG C and 70% RH (relative humidity), and the total impurity content does not exceed 0.09%; and the capsule can be preserved for 60 days under the conditions of 60 DEG C and 92.5% RH, and the total impurity content does not exceed 0.14%.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a highly stable sertraline hydrochloride capsule and a preparation method thereof. Background technique [0002] Sertraline is a specific serotonin reuptake inhibitor, which can lead to the enhancement of 5-HT effect in vivo. Sertraline had only minimal effects on the reuptake of norepinephrine and dopamine in neurons. Sertraline is clinically used to treat symptoms related to depression, including depression accompanied by anxiety, with or without a history of mania, and can also be used to treat obsessive-compulsive disorder, premenstrual anxiety disorder, panic disorder, borderline personality disorder and other diseases, all of which have Good curative effect and good safety. [0003] At present, the research on the dosage form of sertraline hydrochloride mainly focuses on tablets, and the research and development of capsules (especially hard capsules) is relatively less...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/137A61K47/38A61P25/24
CPCA61K9/1652A61K31/137
Inventor 罗睿杨文朱祖全
Owner 四川省百草生物药业有限公司
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