Lacidipine tablets and preparation method thereof

A technology of lacidipine and flat tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Qualified, affecting the efficacy of the product and other issues, to achieve the effect of maintaining drug activity, taking convenience, and improving bioavailability

Inactive Publication Date: 2010-02-24
哈药集团人民同泰医药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Since lacidipine is a small-dose, insoluble drug, the dissolution rate and uniformity index of lacidipine tablets prepared by traditional tablet production technology can not reach the ideal value.
And adopt solvent dispersion method to prepare lacidipine tablet, the one,...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0018] Raw material ratio:

[0019] Lacidipine 4g

[0020] Lactose 133g

[0021] Hypromellose 62g

[0022] Poloxamer 4.4g

[0023] Magnesium stearate 0.6g

[0024] Preparation:

[0025] 1. Weigh 4.4g of poloxamer, dissolve it in 50-70g of purified water, and prepare it into an adhesive;

[0026] 2. The racidipine raw material and lactose are superfinely pulverized in a weight ratio of 1:1, and mixed evenly, and the mixture is evenly mixed with the remaining lactose and hydroxypropyl cellulose, and a binder made of poloxamer is added. Make a suitable soft material, granulate through a 18-mesh sieve, dry at 40-60°C, granulate with a 16-mesh sieve, add magnesium stearate, mix well, and press into 1000 tablets.

Embodiment approach 2

[0028] Raw material ratio:

[0029] Lacidipine 6g

[0030] Lactose 98g

[0031] Hypromellose 93g

[0032] Poloxamer 6.1g

[0033] Magnesium stearate 0.9g

[0034] The preparation method is the same as the specific embodiment one.

Embodiment approach 3

[0036] Raw material ratio:

[0037] Lacidipine 2g

[0038] Lactose 168g

[0039] Hypromellose 31g

[0040] Poloxamer 2.4g

[0041] Magnesium stearate 0.6g

[0042] The preparation method is the same as the specific embodiment one.

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PUM

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Abstract

The invention provides lacidipine tablets and a preparation method thereof. The lacidipine tablets comprise 1-4% of lacidipine, 14-32% of hydroxypropyl cellulose or microcrystalline cellulose, 1-3% ofpoloxamer or sodium dodecyl sulfate or povidone or copovidone, 0.25-2% of magnesium stearate and the balance of lactose by weight percent, and the preparation method comprises the following steps ofevenly mixing raw material of the lacidipine with the lactose according to the weight ratio of 1:1 after ultra-fine smashing, further evenly mixing the mixture with the balance of the lactose and thehydroxypropyl cellulose or the microcrystalline cellulose, adding a water solution bonding agent prepared by the poloxamer or the odium dodecyl sulfate or the povidone or the copovidone, preparing appropriate soft materials, passing a 18-mesh sieve for granulation, drying at the temperature of 40-60 DEG C, passing a 16-mesh sieve for size stabilization, adding the magnesium stearate, evenly mixingand pressing tablets, thereby preparing products. The method can effectively improve the dissolution of the lacidipine tablets and lead the evenness index to achieve the more ideal value. The methodcan further improve the bioavailability of the lacidipine tablets and has the advantages of fast absorption, convenient administration and significant efficacy.

Description

(1) Technical field [0001] The present invention relates to a kind of medicine, and the present invention also relates to a kind of preparation method of medicine, specifically a kind of lacidipine tablet and preparation method thereof. (2) Background technology [0002] Lacidipine is a new type of dihydropyridine calcium antagonist, which can strongly inhibit calcium channels, has high selectivity to blood vessels, and has a long-lasting antihypertensive effect, especially when it is only taken once a day (4-6mg). Highly potent and long-lasting antihypertensive activity. Lacidipine, as an ideal drug for treating hypertension, has the advantages of definite curative effect, high selectivity to blood vessels, long-lasting antihypertensive effect, small toxic and side effects, low price, and few times of taking (only one tablet per day). [0003] Because lacidipine is a small-dose, insoluble drug, the dissolution rate and uniformity index of lacidipine tablets prepared by tra...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4422A61K47/38A61P9/12
Inventor 范宁张红梅
Owner 哈药集团人民同泰医药股份有限公司
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