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Lamivudine tablet composition and preparation method thereof

A technology of lamivudine tablets and lamivudine, which is applied in the field of medicine, can solve problems such as unsatisfactory disintegration effects of preparations, and achieve the effects of good appearance, improved dissolution effect, and delicate appearance

Active Publication Date: 2013-02-13
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, it has been found in clinical practice that the disintegration effect of the above-mentioned preparations is not ideal.

Method used

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  • Lamivudine tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Get 50% ethanol solution 100ml of lamivudine 100g, microcrystalline cellulose 70g, starch 25g, sodium starch glycolate 18g, magnesium stearate 2g, 5% povidone K30. Get above-mentioned auxiliary material and pass through 80 mesh sieves, get povidone K30, prepare the 50% ethanol solution of 5% povidone K30, standby, take by weighing the microcrystalline cellulose of prescription quantity lamivudine, starch, 10 / 13 and The carboxymethyl starch sodium of 5 / 7, mixes evenly and makes mixed powder, gets 5 / 7 of mixed powder weight, adds 8 / 13 and makes soft material in the 50% ethanol solution of 5% Povidone K30 prepared, makes granules, dried and sized to obtain primary granules with a particle size of about 200-250 mesh. Continue granulating the primary granules, remaining 2 / 7 of the mixed powder and remaining 5 / 13 of the povidone ethanol solution in a fluidized bed until the remaining powder and povidone ethanol solution are completely consumed to obtain intermediate granules,...

Embodiment 2

[0063] Get 50% ethanol solution 100ml of lamivudine 100g, microcrystalline cellulose 70g, starch 25g, sodium starch glycolate 18g, magnesium stearate 2g, 5% povidone K30. Get above-mentioned adjuvant and cross 90 mesh sieves, get povidone K30, prepare 50% ethanol solution of 5% povidone K30, standby, take by weighing the microcrystalline cellulose of prescription quantity lamivudine, starch, 10 / 13 and The carboxymethyl starch sodium of 5 / 7, mixes evenly and makes mixed powder, gets 5 / 7 of mixed powder weight, adds 8 / 13 and makes soft material in the 50% ethanol solution of 5% Povidone K30 prepared, makes granules, dried and sized to obtain primary granules with a particle size of about 200-250 mesh. Continue granulating the primary granules, remaining 2 / 7 of the mixed powder and remaining 5 / 13 of the povidone ethanol solution in a fluidized bed until the remaining powder and povidone ethanol solution are completely consumed to obtain intermediate granules, dried and Whole gra...

Embodiment 3

[0065] Get 50% ethanol solution 100ml of lamivudine 100g, microcrystalline cellulose 70g, starch 25g, sodium starch glycolate 18g, magnesium stearate 2g, 5% povidone K30. Get above-mentioned auxiliary material and pass through 95 mesh sieves, get povidone K30, prepare the 50% ethanol solution of 5% povidone K30, standby, take by weighing the microcrystalline cellulose of prescription quantity lamivudine, starch, 10 / 13 and The carboxymethyl starch sodium of 5 / 7, mixes evenly and makes mixed powder, gets 5 / 7 of mixed powder weight, adds 8 / 13 and makes soft material in the 50% ethanol solution of 5% Povidone K30 prepared, makes granules, dried and sized to obtain primary granules with a particle size of about 200-250 mesh. Continue granulating the primary granules, remaining 2 / 7 of the mixed powder and remaining 5 / 13 of the povidone ethanol solution in a fluidized bed until the remaining powder and povidone ethanol solution are completely consumed to obtain intermediate granules,...

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Abstract

The invention relates to a lamivudine tablet composition. The core of the lamivudine tablet composition is prepared from the following components: 80-120 parts of lamivudine, 50-90 parts of microcrystalline cellulose, 20-30 parts of starch, 14-22 parts of sodium starch glycolate, 1-4 parts of magnesium stearate and 70-130ml of 50% ethanol solution of 5% povidone K30. The preparation method of thelamivudine tablet composition comprises the following steps: screening; weighing povidone K30, and preparing into a 50% ethanol solution of 5% povidone K30 for later use; weighting lamivudine, starchand part of microcrystalline cellulose, and uniformly mixing to obtain mixed powder; adding the mixed powder obtained in the previous step into the 50% ethanol solution of 5% povidone K30 to prepare a soft material, pelletizing, drying, and granulating to obtain particles; adding sodium starch glycolate, magnesium stearate and the rest of microcrystalline cellulose into the particles obtained in the previous step, and totally mixing; after determining that the lamivudine content is qualified, calculating the required weight of each tablet; tabletting, and coating with coating layers; and carrying out full inspection, and packaging.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a lamivudine tablet composition and a preparation method thereof. Background technique [0002] Viral hepatitis and HIV have incidence and prevalence all over the world. In recent decades, due to the rapid increase of social population, dense urban population, frequent social interpersonal communication, and accelerated pace of life, the chances of virus infection have increased. The development and use of antibiotics have effectively controlled the infection and spread of bacteria, while the chances of viral infection have increased relatively. These have all led to the rising incidence of viral diseases (such as HIV, HBV, etc.). [0003] Lamivudine is a dideoxynucleoside analog, a reverse transcriptase inhibitor, initially used to treat HIV infection, and later found to have an inhibitory effect on HBV replication. Its main antiviral mechanism is: after lamivudine enters virus-infect...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/513A61K47/38A61P31/18A61P31/20
Inventor 李明杰李华曹传
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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