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A kind of highly stable lafutidine tablet and preparation technology thereof

A lafutidine tablet and a high-stability technology are applied to the high-stability lafutidine tablet and the field of preparation technology thereof, and can solve the problems of high related substances, poor tablet stability and the like, and achieve low content of related substances, The effect of good dissolution and high stability

Active Publication Date: 2017-01-11
ANHUI BIOCHEM BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent titled "Lafutidine Tablet and Its Preparation Method" (200710022287.8) and the patent titled "An Oral Solid Pharmaceutical Composition Containing Lafutidine" (200810304915.6) both propose the use of adding lactose, Microcrystalline cellulose, starch, etc. are mixed and wet granulated to prepare lafutidine tablets. The prepared tablets have problems of poor stability and high levels of related substances

Method used

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  • A kind of highly stable lafutidine tablet and preparation technology thereof
  • A kind of highly stable lafutidine tablet and preparation technology thereof
  • A kind of highly stable lafutidine tablet and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1 Preparation of Lafutidine Tablets (Single Tablet Specification 10mg) of the present invention

[0026] Lafutidine sheet prescription of the present invention (1000):

[0027]

[0028] Preparation Process:

[0029] (1) Accurately weigh each component according to the above prescription, and set aside;

[0030] (2) Dissolving the povidone K30 weighed in step (1) in water to make an aqueous solution of povidone K30;

[0031] (3) Mix lafutidine, mannitol, and 1 / 2 amount of croscarmellose sodium weighed in step (1) evenly, and add the povidone K30 aqueous solution prepared in step (2) to prepare After making soft material, granulate with 20 mesh sieve, dry at about 55°C, pass through 20 mesh sieve for granulation, and finally add the remaining 1 / 2 amount of croscarmellose sodium and the Magnesium stearate and micropowder silica gel are mixed evenly, and after the semi-finished product is qualified, through tabletting, coating, and packaging, the lafutidine...

Embodiment 2

[0032] Example 2 Preparation of Lafutidine Tablets (Single Tablet Specification 10mg) of the Present Invention

[0033] Lafutidine sheet prescription of the present invention (1000):

[0034]

[0035] Preparation Process:

[0036] (1) Accurately weigh each component according to the above prescription, and set aside;

[0037] (2) Dissolving the povidone K30 weighed in step (1) in water to make an aqueous solution of povidone K30;

[0038] (3) Mix lafutidine, mannitol, and 1 / 3 amount of croscarmellose sodium weighed in step (1), and add the povidone K30 aqueous solution prepared in step (2) to prepare After making soft material, granulate with 20 mesh sieve, dry at about 55°C, pass through 20 mesh sieve for granulation, and finally add the remaining 2 / 3 of croscarmellose sodium and the weighted product in step (1). Magnesium stearate, micropowder silica gel mixing, measure semi-finished product qualified through tabletting, coating, pack, promptly get specification and be...

Embodiment 3

[0039] Example 3 Preparation of Lafutidine Tablets (Single Tablet Specification 10mg) of the Present Invention

[0040] Lafutidine sheet prescription of the present invention (1000):

[0041]

[0042] Preparation Process:

[0043] (1) Accurately weigh each component according to the above prescription, and set aside;

[0044] (2) Dissolving the povidone K30 weighed in step (1) in water to make an aqueous solution of povidone K30;

[0045] (3) Mix lafutidine, mannitol, and 1 / 2 amount of croscarmellose sodium weighed in step (1) evenly, and add the povidone K30 aqueous solution prepared in step (2) to prepare Soft material, after granulating with 20 mesh sieve, dry at about 55°C, pass through 20 mesh sieve for granulation, and finally add the remaining 1 / 2 amount of croscarmellose sodium and the Magnesium stearate, micropowder silica gel mixing, measure semi-finished product qualified through tabletting, coating, pack, promptly get specification and be the lafutidine table...

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PUM

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Abstract

The present invention discloses high stability lafutidine tablets and a preparation process thereof, and belongs to the field of pharmaceutics. The high stability lafutidine tablets comprise lafutidine with the specific weight percentage, mannitol, cross-linked sodium carboxymethyl cellulose, povidone K30, magnesium stearate, and micro-powder silica gel. Compared with the lafutidine tablets of the traditional formula, the lafutidine tablets of the present invention have characteristics of good dissolution rate, low related substance content, high stability and effective assurance of drug quality and patient medication safety.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a highly stable lafutidine tablet and a preparation process thereof. Background technique [0002] Lafutidine, chemical name is (+ / -)-2-[(2-furylmethyl)sulfinyl]-N-[4-[4-(1-piperidinylmethyl)-2- Pyridyl]oxy-(Z)-2-butenyl]acetamide is a new generation of long-acting and potent H2-receptor antagonist, developed by Japan Fuji and Dapeng Pharmaceutical Company, mainly used for the treatment of gastric and ten duodenal ulcer. Studies have shown that lafutidine can sustainably inhibit the basal and nocturnal secretion of human gastric acid and pepsin, and the secretion caused by stimulating factors such as tetrapeptide gastrin, and resist gastric mucosal damage caused by various gastric stimulating factors. Compared with similar drugs, lafutidine has the advantages of small dose, good tolerance and small side effects. [0003] Currently, lafutidine is widely prescribed in ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4545A61K47/38A61P1/04
Inventor 沈蔡月王贺崔颖王辉
Owner ANHUI BIOCHEM BIO PHARMA
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