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High-stability famciclovir tablet and preparation method thereof

A technology of famciclovir and high stability, which is applied in the field of high stability famciclovir tablets and its preparation, can solve the problems of intolerance to storage and high impurities of famciclovir tablets, and achieve the effect of high dissolution rate and high stability

Active Publication Date: 2017-03-22
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

[0005] However, there is little research on the long-term stability of famciclovir tablets in the prior art, resulting in high impurities in the existing famciclovir tablets, which are not storage-resistant

Method used

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  • High-stability famciclovir tablet and preparation method thereof
  • High-stability famciclovir tablet and preparation method thereof
  • High-stability famciclovir tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] (1) Famciclovir, mannitol, carboxymethyl starch sodium and sodium bicarbonate are mixed, and the weight ratio of described famciclovir, mannitol, carboxymethyl starch sodium and sodium bicarbonate is 3:1:0.5:0.8;

[0022] (2) Add carmellose ethanol solution of 3.5% by weight to the resultant of step (1) to make soft material, granulate through a 14 mesh sieve, dry at 65-75° C., and then sieve through a 20 mesh sieve grain;

[0023] (3) add magnesium stearate and crospovidone to step (2) gained, the add-on of magnesium stearate is 5% of famciclovir weight, the add-on of crospovidone is 3% of famciclovir weight , carry out tabletting, that is to say.

Embodiment 2

[0025] (1) Famciclovir, mannitol, carboxymethyl starch sodium and sodium bicarbonate are mixed, and the weight ratio of described famciclovir, mannitol, carboxymethyl starch sodium and sodium bicarbonate is 5:1.5:0.6:1;

[0026] (2) Add carmellose ethanol solution of 2.8% by weight to the result of step (1) to make soft material, pass through 14 mesh sieve to granulate, dry at 65-75°C, and then sieve through 20 mesh grain;

[0027] (3) add magnesium stearate and crospovidone to step (2) gained, the add-on of magnesium stearate is 8% of famciclovir weight, the add-on of crospovidone is 5% of famciclovir weight , carry out tabletting, that is to say.

Embodiment 3

[0029] (1) Famciclovir, mannitol, carboxymethyl starch sodium and sodium bicarbonate are mixed, and the weight ratio of described famciclovir, mannitol, carboxymethyl starch sodium and sodium bicarbonate is 4.6:1.3:0.55:0.85;

[0030] (2) Add carmellose ethanol solution of 3% by weight to the result of step (1) to make a soft material, pass through a 14 mesh sieve to granulate, dry at 65-75°C, and then sieve through a 20 mesh sieve grain;

[0031] (3) add magnesium stearate and crospovidone to step (2) gained, the add-on of magnesium stearate is 6% of famciclovir weight, the add-on of crospovidone is 4% of famciclovir weight , carry out tabletting, that is to say.

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Abstract

The invention provides a preparation method of a high-stability famciclovir tablet. The method comprises the following steps: (1) mixing famciclovir, mannitol, sodium carboxymethyl starch and sodium bicarbonate according to a weight ratio of (3-5) to (1-1.5) to (0.5-0.6) to (0.8-1); (2) adding a carboxypropyl methyl cellulose ethanol solution, which is 2.8-3.5% in weight percentage, to a material obtained in the step (1), preparing a soft material, preparing granules by virtue of a 14-mesh sieve, drying the granules at 65-75 DEG C, and straightening the granules by virtue of a 20-mesh sieve; and (3) adding magnesium stearate and cross-linked povidone to a material obtained in the step (2), and conducting tabletting, so that the famciclovir tablet is obtained. The invention also provides the famciclovir tablet prepared by the method. The famciclovir tablet provided by the invention is high in dissolution rate, and the dissolution rate, within 5min, can reach 99.2% or above; the famciclovir tablet is low in content of impurities, and a total impurity content is just 0.21-0.23% and an individual impurity content is within 0.10%; and the prepared famciclovir tablet, under an accelerated test condition, is quite high in stability, and the content of impurities is basically not increased.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical engineering, and in particular relates to a highly stable famciclovir tablet and a preparation method thereof. Background technique [0002] Famciclovir (Famciclovir) is the diethyl acyl ester of the 6-deoxy derivative of penciclovir (penciclovir), molecular formula is C 14 h 19 N 5 o 4 , good oral absorption and high bioavailability. [0003] Famciclovir has good bioavailability and long duration of action. In addition to anti-herpes virus, it also has certain effects on hepatitis B virus, and has been regarded as the first-line drug against hepatitis B virus. [0004] At present, in the prior art, some research has been done on famciclovir preparations, mainly focusing on improving the dissolution rate and reducing the sticking problem during tablet making. For example, in Chinese patent 201310432394.3, by using the aqueous solution of famciclovir and sodium bicarbonate as a lubrican...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/52A61K47/36A61P31/22A61P31/20A61P1/16
CPCA61K9/2059A61K31/52
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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