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Sustained-release tablet containing dual-layer tablet core

A sustained-release tablet and double-layer tablet core technology, which is applied to medical preparations containing active ingredients, medical preparations with non-active ingredients, coatings, etc., can solve the problems of reducing production costs and drug prices, drug control difficulties and Risk, complex preparation process and other issues, to achieve the effect of reducing the burden of medication, complete and smooth appearance, and uniform color

Inactive Publication Date: 2016-08-10
华益泰康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This patent document uses a relatively complicated preparation process, which is not conducive to reducing production costs and drug prices, and also makes the control of the drug production process more difficult and risky

Method used

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  • Sustained-release tablet containing dual-layer tablet core
  • Sustained-release tablet containing dual-layer tablet core
  • Sustained-release tablet containing dual-layer tablet core

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] The prescription is shown in Table 1:

[0065] Table 1: Prescription for 1000 tablets of paroxetine hydrochloride enteric-coated sustained-release tablets (37.5mg / tablet)

[0066]

[0067] Preparation:

[0068] 1) Preparation of the mixed powder of the drug-containing layer:

[0069] Put paroxetine hydrochloride, lactose and hydroxypropyl methylcellulose K4M in the wet mixing granulator according to the prescription amount in the above table, set the stirring speed at 150-250 rpm, and the cutting knife speed at 2000-3000 rpm After dry mixing, gradually add appropriate amount of purified water to make granules of suitable size. The prepared wet granules were moved to a fluidized bed for drying at a material temperature of 50° C., and passed through a 1.5 mm sieve to obtain granules containing paroxetine hydrochloride. The prescription amount of magnesium stearate is passed through a 20-mesh sieve and mixed evenly with the above-mentioned paroxetine hydrochloride gr...

Embodiment 2

[0077] The prescription is as shown in Table 2:

[0078] Table 2: Prescription for 1000 tablets of paroxetine hydrochloride enteric-coated sustained-release tablets (37.5mg / tablet)

[0079]

[0080]

[0081] The preparation method is the same as in Example 1.

Embodiment 3

[0083] The prescription is shown in Table 3:

[0084] Table 3: Prescription for 1000 tablets of paroxetine hydrochloride enteric-coated sustained-release tablets (12.5mg / tablet)

[0085]

[0086] The preparation method is the same as in Example 1.

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Abstract

The invention belongs to the technical field of medicine preparations, and particularly relates to a sustained-release tablet containing a dual-layer tablet core. The sustained-release tablet comprises the dual-layer tablet core and an enteric layer, wherein the dual-layer table core comprises a medicated layer and a blank layer; the enteric layer coats the dual-layer tablet core; and a plasticizer in the blank layer is one or more of hexadecanol or polyethylene glycol. A specific plasticizer is added to the blank layer, and the blank layer is not separated from the medicated layer within a certain period of time, so that stable medicine release is achieved, and burst release is avoided. Compared with an existing sustained-release tablet, the sustained-release tablet is relatively low in cost and invariable in quality after being stored for a long period of time.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a slow-release tablet containing double-layer tablet cores. Background technique [0002] Paroxetine is a selective serotonin reuptake inhibitor type antidepressant, belonging to the third generation of antidepressants, with few side effects. The drug was launched in the United States in 1997, and its chemical name is (-)-(3S,4S)-4-(4-fluorophenyl)-3-[[3,4-(methyleneoxy)phenoxy] Methyl] piperidine. In medicine, paroxetine usually exists in forms such as hydrochloride hemihydrate or hydrochloride anhydrate, and the structural formula of its hydrochloride is as follows: [0003] [0004] However, because paroxetine can cause some irritation to the stomach, and the use cycle is long. Therefore, it is necessary to prepare enteric-coated sustained-release tablets. Compared with ordinary immediate-release dosage forms, this dosage form can enable the human bo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/34A61K47/38A61K31/4525A61P25/24
CPCA61K9/284A61K9/0002A61K9/2031A61K9/2054A61K9/2086A61K31/4525
Inventor 徐国杰高春荣蒋传真谭海松诸弘刚
Owner 华益泰康药业股份有限公司
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