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Lacildipine tablet and preparation method thereof

A kind of technology of lacidipine and plain tablet

Active Publication Date: 2019-05-31
浙江长典药物技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dissolution rate of the dispersible tablet is fast, but the average dissolution rate is not high; at the same time, the mechanical strength, especially the hardness, of the dispersible tablet is still difficult to meet the needs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] The formula of lacidipine tablets is as follows, according to the dosage per 1000 tablets:

[0057] Lassidipine micropowder 4g;

[0058] Process agar 50g;

[0059] Glycine 25g;

[0060] Erythritol 70g;

[0061] Magnesium stearate 0.5g;

[0062] Povidone K-30 1.5g.

[0063] The preparation process is as follows: take the formulated amount of lacidipine micropowder, add povidone K-30, modified agar, erythritol, and glycine in sequence according to the same amount of addition method, mix evenly, add appropriate amount of purified water to moisten, prepare soft Material, 30-mesh sieve granulation; wet granules dried at 60℃ to a weight loss of less than 3%, 30-mesh sieve granulation; adding formula amount of magnesium stearate, direct compression under 120MPa pressure to obtain the Raschig of Example 1 Flat tablets.

Embodiment 2

[0065] The formula of lacidipine tablets is as follows, according to the dosage per 1000 tablets:

[0066] Lassidipine micropowder 4g;

[0067] Process agar 60g;

[0068] Glycine 20g;

[0069] Erythritol 80g;

[0070] Magnesium stearate 0.4g;

[0071] Povidone K-30 2g.

[0072] The preparation process is as follows: take the formulated amount of lacidipine micropowder, add povidone K-30, modified agar, erythritol, and glycine in sequence according to the same amount of addition method, mix evenly, add appropriate amount of purified water to moisten, prepare soft Material, 30 mesh sieve granulation; wet granules are dried at 50 ℃ to a weight loss of less than 3%, 30 mesh sieve granulation; adding formula amount of magnesium stearate, directly compressed under 160MPa pressure to obtain the Raschig of Example 2 Flat tablets.

Embodiment 3

[0074] The formula of lacidipine tablets is as follows, according to the dosage per 1000 tablets:

[0075] Lassidipine micropowder 4g;

[0076] Process agar 40g;

[0077] Glycine 40g;

[0078] Erythritol 60g;

[0079] Magnesium stearate 0.8g;

[0080] Povidone K-30 1g.

[0081] The preparation process is as follows: take the formulated amount of lacidipine micropowder, add povidone K-30, modified agar, erythritol, and glycine in sequence according to the same amount of addition method, mix evenly, add appropriate amount of purified water to moisten, prepare soft Material, 30 mesh sieve granulation; wet granules dried at 70 ℃ to a weight loss of less than 3%, 30 mesh sieve granulation; adding formula amount of magnesium stearate, direct compression under a pressure of 100MPa to obtain the Raschig of Example 3 Flat tablets.

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PUM

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Abstract

The invention discloses a lacidipine tablet including the raw materials of lacidipine micropowder and processed agar. The lacidipine micropowder is submicron micropowder. In addition, a preparation method of the lacildipine tablet is also disclosed. The lacidipine tablet provides high mechanical strength, is short in disintegration time limit and high in dissolution rate, and the average dissolution rate is obviously improved.

Description

Technical field [0001] The invention belongs to the technical field of medicine; it relates to a preparation method of lacidipine tablets, in particular to a lacidipine tablet and a preparation method thereof. Background technique [0002] Lassidipine belongs to the third generation of long-acting calcium ion antagonist and belongs to the dihydropyridine compound. Lassidipine was first developed by the British company GSK, and was approved to be listed in Italy in 1991 under the trade name Lacipil. [0003] The chemical name of lacidipine is: (E)-4-{2-[3-(carboxyl tert-butyl)-3-oxo-1-propenyl]-phenyl}-1,4-dihydro-2 ,6-Dimethyl-3,5-pyridine-dicarboxylic acid diethyl ester, its molecular weight is 455.6. Lassidipine is a white or almost white crystalline powder, odorless and tasteless, easily soluble in ethyl acetate and acetone, slightly soluble in methanol and ethanol, and almost insoluble in water. Lassidipine is included on page 125 of Volume 41 of the Standards for New Drugs ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/18A61K47/26A61K47/36A61K9/14A61P9/12
Inventor 陈宇东
Owner 浙江长典药物技术开发有限公司