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A kind of lamivudine tablet and preparation method thereof

A lamivudine tablet, lamivudine technology, applied in the direction of pharmaceutical formulations, antiviral agents, medical preparations of non-active ingredients, etc., can solve problems such as unstable quality, and achieve good fluidity and disintegration Effects of short duration and low friability

Inactive Publication Date: 2011-11-30
北京先通源医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the quality of the current lamivudine tablets is not stable

Method used

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  • A kind of lamivudine tablet and preparation method thereof
  • A kind of lamivudine tablet and preparation method thereof
  • A kind of lamivudine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0043] Experimental Example 1 Comparative Screening Experiment

[0044] 1.1 General ratio and preparation method

[0045] Table 1 uses general proportioning and preparation method gained lamivudine tablet experimental data

[0046]

[0047]

[0048] Results: The disintegration time limit of the tablet was too high, and the tablet disintegrated layer by layer and could not be finely dispersed, which further affected the final dissolution rate of the ingredients.

[0049] 1.2 Improve disintegration by adding sodium carboxymethyl starch inside and outside. The results are shown in Table 2.

[0050] Table 2 Lamivudine tablet experimental data of the present invention (made by embodiment 1)

[0051]

[0052]

[0053] The above experimental data show that the lamivudine tablet of the present invention is well dispersed in the dissolution medium, swells uniformly, and is dispersed into fine particles.

[0054] 1.3 According to the above ratio, a batch of 150,000 pieces ...

experiment example 2

[0059] Experimental Example 2 Accelerated comparative experiment

[0060] Lamivudine tablet of the present invention (made by embodiment 1) compares with listing lamivudine tablet stability

[0061] 2.1 Storage conditions

[0062] Store at a temperature of 40°C±2°C and a relative humidity of 75%±5%, take samples at 0, 1, 3, and 6 months, and check according to the draft quality standard for lamivudine tablets.

[0063] 2.2 Inspection items:

[0064] (1) Properties: visual inspection.

[0065] (2) Dissolution rate: in 30 minutes, the dissolution amount is not less than 80% of the labeled amount.

[0066] (3) Related substances: carboxylic acid impurities with a relative retention time of 0.4 do not exceed 0.3%; salicylic acid does not exceed 0.1%; impurities with a relative retention time of 0.9 do not exceed 0.2%; total impurities do not exceed 0.6%.

[0067] (4) Content: 90% to 110%.

[0068] The results are shown in the table below:

[0069] Table 4 090502 batches of l...

experiment example 3

[0074] Experimental Example 3 Comparative Experiment of Influencing Factors

[0075] This experiment is carried out under more severe conditions than the accelerated experiment. The purpose is to explore the inherent stability of the drug, understand the factors affecting its stability, possible degradation pathways and degradation products, and provide scientific basis for the preparation process, packaging, storage conditions and the establishment of analysis methods for degradation products.

[0076] Experimental conditions: placed under the conditions of high temperature (60°C), high humidity (92.5% RH), and light (4500Lx±500Lx), sampling regularly, and measuring various indicators.

[0077] Table 6 090502 batches of lamivudine tablet influence factor test results of the present invention (high temperature 60 ℃)

[0078]

[0079] Table 7 090502 batches of lamivudine tablet influencing factor test results (light) of the present invention

[0080]

[0081] Table 8 09...

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PUM

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Abstract

The invention discloses a lamivudine tablet composition and a preparation method thereof. The tablet is prepared from the following materials: lamivudine, microcrystalline cellulose, sodium carboxymethyl starch, starch, silicon dioxide, magnesium stearate, hydroxypropyl methylcellulose E-15, talcum powder, titanium dioxide, red iron oxide, yellow iron oxide and propylene glycol. The preparation method comprises the following steps of: sieving raw and subsidiary materials respectively, preparing an adhesive, stirring, palletizing, drying, granulating, lubricating, tabletting, coating and obtaining the lamivudine tablet composition. The lamivudine tablet composition has the advantages of fast dissolving-out speed, moderate hardness and good stability, and is suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a lamivudine tablet and a preparation method thereof. Background technique [0002] Hepatitis B virus (HBV) infection is the cause of acute and chronic hepatitis, liver cirrhosis, and primary cell carcinoma. Lamivudine is used to treat the replication of hepatitis B virus accompanied by chronic hepatitis B virus infection and the liver inflammation caused by it. It is currently the most economical and effective drug for the treatment of chronic hepatitis B. The therapeutic effect of lamivudine does not depend on pretreatment characteristics. In addition, lamivudine is also effective in the patient population who is ineffective on alpha-interferon therapy. [0003] Lamivudine is a nucleoside analog that can be phosphorylated in the cell to become lamivudine triphosphate (L-TP), and is inserted into the virus in the form of cyclic adenosine phosphate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/513A61K47/36A61P1/16A61P31/20A61P31/18
Inventor 齐慧
Owner 北京先通源医药科技股份有限公司
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