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Lamivudine preparation and preparation method thereof

A technology for lamivudine and preparations, which is applied to pharmaceutical formulations, antiviral agents, and pill delivery, and can solve problems such as low initial dissolution rate, poor content uniformity, and uneven particle size distribution of drug-containing particles. Simple and easy-to-operate effects

Active Publication Date: 2011-12-21
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the production process of lamivudine solid preparations, uneven particle size distribution and many fine powders often appear, which may easily cause defects such as uneven filling, large differences in loading, and poor content uniformity. In addition, in In the dissolution process of lamivudine solid preparation, the phenomenon that the initial dissolution rate is often on the low side, in order to solve the above problems, the inventor has developed a set of simple and feasible production technology through a large number of experiments, solved the above problems, and realized the preparation good dissolution

Method used

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

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Embodiment 1

[0026] components weight Lamivudine 100g microcrystalline cellulose 20g lactose 10g Sodium carboxymethyl starch 3g 2.5% ethanol solution of povidone 30ml Micropowder silica gel 1g Magnesium stearate 1g

[0027] Preparation:

[0028] (1) Separately sieve lamivudine, lactose, microcrystalline cellulose, and sodium carboxymethyl starch, and mix well to obtain a mixed powder;

[0029] (2) Add 2.5% povidone ethanol solution into the mixed powder to make soft material, granulate, granulate after drying, add micropowder silica gel and magnesium stearate, and mix well;

[0030] (3) Packed into capsules or compressed tablets;

Embodiment 2

[0032] components weight Lamivudine 100g pregelatinized starch 15g lactose 8g Low-substituted hydroxypropyl cellulose 2g 2.5% ethanol solution of povidone 20ml Micropowder silica gel 1g Magnesium stearate 1g

[0033] Preparation method is the same as embodiment 1

Embodiment 3

[0035] components weight Lamivudine 100g microcrystalline cellulose 30g lactose 15g Croscarmellose Sodium 5g 2.5% ethanol solution of povidone 40ml Micropowder silica gel 2g

[0036] Preparation method is the same as embodiment 1

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Abstract

The invention relates to a lamivudine preparation and a preparation method thereof. In the method, lactose is added into the prescription. Lactose has a pore-causing effect and can promote the disintegration and dissolution of the lamivudine preparation. In addition, because lactose has a certain viscosity , it is easy to form granules during the preparation process, so that the lamivudine preparation has little difference in loading and good content uniformity. At the same time, the method is simple to operate and is suitable for large-scale industrial production.

Description

field of invention [0001] The invention relates to a drug lamivudine preparation for treating hepatitis B and a preparation method thereof. Background technique [0002] Lamivudine, chemical name (2R-cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-1H-pyrimidin-2-one , the chemical structural formula is: [0003] [0004] Lamivudine is a nucleoside antiviral drug developed by GlaxoSmithKline. Lamivudine has a strong inhibitory effect on hepatitis B virus (HBV) in vitro and in experimentally infected animals. The results of serum HBV DNA detection in most patients with hepatitis B showed that lamivudine can rapidly inhibit HBV replication, and its inhibitory effect lasts throughout the course of treatment, while reducing serum aminotransferase to normal. Long-term application can significantly improve the necrotic and inflammatory changes of the liver, and reduce or prevent the progression of liver fibrosis. Nucleotides are the raw materials for the synthesis of hum...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/513A61K9/20A61K9/48A61P31/20
Inventor 产运霞李泳耿玉先
Owner BEIJING WINSUNNY PHARMA CO LTD
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