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Entecavir dispersible tablet and preparation thereof

A technology for entecavir and dispersible tablets, applied in the field of entecavir dispersible tablets and their preparation, can solve the problems of unresolved content uniformity, poor content uniformity of dispersible tablets, and complicated operation of an equal amount incremental preparation method, and achieves the preparation method. Simple and easy, good content uniformity

Inactive Publication Date: 2008-08-20
上海国创医药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the content uniformity of this kind of dispersible tablets is not good; and the operation of the method of adding equal amounts is also too cumbersome
Patent application CN 1732944A discloses another kind of entecavir dispersible tablet, yet it still adopts the conventional equal-volume incremental method, and the above-mentioned problem of content uniformity has not been solved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] composition:

[0045] Entecavir 0.5g

[0046] Lactose 80g

[0047] Microcrystalline cellulose 10g

[0048] PVP 5g

[0049] Sodium Carboxymethyl Starch 10g

[0050] Magnesium stearate 0.5g

[0051] Sweet orange flavor 1g

[0052] Aspartame 0.5g

[0053]

[0054] 1000 pieces

[0055] Preparation:

[0056] Mix water and absolute ethanol at a volume ratio of 60:40, add the amount of PVP to make a 5% (W / V) solution, and add entecavir to dissolve for later use. Mix lactose and microcrystalline cellulose uniformly, use the above solution to make wet granules, and dry at 60°C for 1.5-2 hours. Then add the remaining excipients, determine the content, and press 0.5 mg of entecavir dispersible tablets (A) per tablet according to the content.

Embodiment 2

[0058] composition:

[0059] Entecavir 0.5g

[0060] Lactose 50g

[0061] Microcrystalline cellulose 30g

[0062] HPMC 6g

[0063] Sodium Carboxymethyl Starch 10g

[0064] Magnesium stearate 1g

[0065] Sweet orange flavor 1g

[0066] Aspartame 1g

[0067]

[0068] 1000 pieces

[0069] Preparation:

[0070] Mix water and absolute ethanol in a volume ratio of 20:80, add the amount of HPMC to make an 8% (W / V) solution, and add entecavir to dissolve it for later use. Mix lactose and microcrystalline cellulose uniformly, use the above solution to make wet granules, and dry at 60°C for 1.5-2 hours. Then add the remaining excipients, determine the content, and press 0.5 mg of entecavir dispersible tablets (B) per tablet according to the content.

Embodiment 3

[0072] composition:

[0073] Entecavir 0.5g

[0074] 70g lactose

[0075] Microcrystalline cellulose 20g

[0076] PVP 1g

[0077] Sodium Carboxymethyl Starch 7g

[0078] Magnesium stearate 0.5g

[0079] Orange flavor 0.5g

[0080] Aspartame 0.5g

[0081]

[0082] 1000 pieces

[0083] Preparation:

[0084] Mix water and absolute ethanol at a volume ratio of 70:30, add the amount of PVP to make a 5% (W / V) solution, and add entecavir to dissolve it for later use. Mix lactose and microcrystalline cellulose uniformly, use the above solution to make wet granules, and dry at 60°C for 1.5-2 hours. Then add the remaining excipients, determine the content, and press 0.5 mg of entecavir dispersible tablets (C) per tablet according to the content.

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PUM

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Abstract

The invention relates to an Entecavir dispersible tablet and the preparation method; wherein, the Entecavir dispersible tablet comprises Entecavir, binder, filler, disintegrating agent, and lubricant; the uniformity of dosage units (A+1.8S) is not larger than 10.0. The preparation method for the dispersible tablet in the invention has the advantages of simple process, and suitability for large-scale industrial production.

Description

Technical field [0001] The invention relates to an entecavir preparation, in particular to an entecavir dispersible tablet and a preparation method thereof. Background technique [0002] Entecavir is a kind of guanine nucleotide analogue with anti-hepatitis B effect and has inhibitory effect on hepatitis B virus (HBV) polymerase. It can be phosphorylated into an active triphosphate, the half-life of the triphosphate in the cell is 15 hours, and the effect is longer. [0003] Entecavir's oral dosage forms include soft capsules, dispersible tablets, dripping pills, etc. In various dosage forms, the content ratio of entecavir is relatively small, for example, the content in a single dose is 0.5 mg. On the one hand, such a low dose usually makes it difficult for the content of active ingredients in various formulations, especially dispersible tablets, to be kept constant between individual doses (in fact, the Pharmacopoeia specifically requires inspections for small-dose oral solid f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/522A61K47/38A61K47/32A61P31/20A61P1/16
Inventor 蔡新楼金芳严洪兵
Owner 上海国创医药股份有限公司
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