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Lamivudine tablet and preparation method thereof

A lamivudine tablet and lamivudine technology are applied in the directions of antiviral agents, pharmaceutical formulations, medical preparations with non-active ingredients, etc., and can solve the problem that diseases cannot be effectively and timely treated, tablet hardness is reduced, problems such as poor tablet stability, to achieve the effect of ensuring drug efficacy, rapid dissolution, and good compatibility

Active Publication Date: 2013-07-03
BEIJING UNION PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, lamivudine and its compound preparations are exclusively sold by GlaxoSmithKline, and no other domestic company has been approved to produce lamivudine tablets. Due to its high price, each tablet is about 17 yuan. The cost of the annual cycle of treatment is more than 6,000 yuan, which makes it unaffordable for most hepatitis B patients in China, and the disease cannot be treated effectively and in time
[0010] Most of the preparation of existing lamivudine tablets adopts wet granulation and then dry tabletting, and the operation is more complicated, such as Chinese invention patent "a kind of preparation method of lamivudine tablets" (application number 200910116030.8, authorized announcement On April 20th, 2011), adhesives need to be added during preparation, and the prepared tablet dissolves slowly, and the tablet is easy to absorb moisture, resulting in a decrease in tablet hardness and moisture absorption spots on the surface, which ultimately affects the curative effect. poor drug stability

Method used

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  • Lamivudine tablet and preparation method thereof
  • Lamivudine tablet and preparation method thereof
  • Lamivudine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] This embodiment is used to illustrate the preparation method of the lamivudine tablet provided by the invention.

[0042] Tablet core raw materials: lamivudine 1000g, compressible microcrystalline cellulose 1100g, sodium carboxymethyl starch 100g, silicon dioxide 30g, magnesium stearate 20g

[0043] Film coating raw materials: polyvinyl alcohol 80g, Tween 80 10ml, titanium dioxide 10g, water 1000ml

[0044] Preparation:

[0045] (1) Get the compressible microcrystalline cellulose, sodium carboxymethyl starch, and silicon dioxide of the above weight parts, and cross a 65-mesh sieve to obtain a tablet filler;

[0046] (2) get the lamivudine of above-mentioned weight portion, cross 65 mesh sieves, mix with tablet filler uniformly to obtain compound;

[0047] (3) Add the above-mentioned magnesium stearate by weight before tableting, mix evenly with the mixture, put it on the tablet press and press it into tablets, 10000 tablets can be prepared, each tablet contains 100mg ...

Embodiment 2

[0051] This embodiment is used to illustrate the preparation method of the lamivudine tablet provided by the invention.

[0052] Tablet core raw materials: lamivudine 500g, compressible microcrystalline cellulose 600g, sodium carboxymethyl starch 36g, silicon dioxide 10g, magnesium stearate 7.5g

[0053] Film coating raw materials: Colorcon moisture-proof gastric soluble coating powder 90g, water 800ml

[0054] Preparation:

[0055] Using the preparation method of Example 1, 5000 lamivudine tablets can be prepared, each containing 100 mg of active ingredient.

Embodiment 3

[0057] This embodiment is used to illustrate the preparation method of the lamivudine tablet provided by the invention.

[0058] Tablet core raw materials: lamivudine 1000g, compressible lactose 1300g, sodium carboxymethyl starch 30g, cross-linked polyvinylpyrrolidone 40g, talcum powder 17.5g

[0059] Film coating raw materials: hydroxypropyl methylcellulose 30g, Tween 8015ml, 2% lemon yellow aqueous solution 5ml, 1% carmine aqueous solution 3ml, absolute ethanol 500ml and water 500ml

[0060] Preparation:

[0061] Using the preparation method of Example 1, 10,000 lamivudine tablets can be prepared, each containing 100 mg of active ingredient.

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Abstract

The invention discloses a lamivudine tablet, which is characterized in that a tablet core contains the followed raw materials by weight: 100 parts of lamivudine, 70-150 parts of filler, 0.1-10 parts of disintegrating agent, 0-5 parts of flow aid, and 0.1-3 parts of lubricant. The invention further provides a method for preparing the lamivudine tablet. The tablet core of the lamivudine tablet of the invention is prepared by directly pressing a mixture of active component lamivudine and accessories, so the dissolving-out speed is faster. Further, the tablet core of the invention is coated with a film coating, thereby preventing the tablet core form moisture absorption, and guaranteeing the medicine curative effect. The stability of the tablet is better. The method for preparing the lamivudine tablet in the invention, has advantages of simple technology, convenient operation and low production cost.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a lamivudine tablet and a preparation method thereof. Background technique [0002] Lamivudine, the chemical name is (2R-cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-1H-pyrimidine-2- Ketones have the following chemical structure: [0003] [0004] Lamivudine is a nucleoside antiviral drug, which has a strong inhibitory effect on hepatitis B virus (HBV) in vitro and in experimentally infected animals, and metabolizes triphosphate in HBV-infected cells and normal cells , which is its active form, is both an inhibitor of HBV polymerase and a substrate of this polymerase. This component penetrates into the viral DNA chain and blocks the synthesis of viral DNA, but does not interfere with the metabolism of deoxynucleosides in normal cells. It has a weak inhibitory effect on mammalian DNA polymerase α and β, and has almost no effect on the DNA cont...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/513A61K47/32A61P31/20
Inventor 何秀峰赵立敏刘冬王爱国孙宇
Owner BEIJING UNION PHARMA FACTORY
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