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Isradipine rapidly disintegrating oral tablet and preparation method thereof

A technology of orally disintegrating tablets and isradipine, which is applied in the field of preparation of isradipine orally disintegrating tablets, can solve the problems affecting the compliance of drug treatment and the difficulty of swallowing tablets and capsules, and achieve considerable economic and social benefits , quick onset and easy to carry

Inactive Publication Date: 2015-12-23
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is estimated that approximately 50% of the population has difficulty swallowing tablets and capsules, affecting compliance with drug therapy

Method used

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  • Isradipine rapidly disintegrating oral tablet and preparation method thereof
  • Isradipine rapidly disintegrating oral tablet and preparation method thereof
  • Isradipine rapidly disintegrating oral tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Each tablet contains isradipine 2.5mg, and the composition of 1000 isradipine orally rapidly disintegrating tablets is:

[0032]

[0033]

[0034] The preparation method is as follows:

[0035] (1) Pulverize the raw material isradipine, cross a 100-mesh sieve, pulverize with a jet mill, and the particle size range is controlled at D 50 1-5um, D 90 5-20um;

[0036] (2) Weigh 0.8g sodium lauryl sulfate, add 200g purified water and stir to dissolve, add 2.5g isradipine raw material, mix well, add 69g sorbitol, 23g lactose and 1.2g aspartame, add bicarbonate Sodium to adjust the pH to 6.5, as liquid a;

[0037] (3) Weigh 3 g of polyvinyl alcohol in the prescribed amount, add 50 g of purified water, stir to dissolve, pass through a 100-mesh sieve, and use it as liquid b.

[0038] (4) Slowly add liquid b into liquid a under stirring, and stir for 10-20 minutes after adding liquid b;

[0039] (5) after medicinal liquid measures isradipine content, will contain 2.5mg...

Embodiment 2

[0043] Each tablet contains isradipine 2.5mg, and the composition of 1000 isradipine orally rapidly disintegrating tablets is:

[0044]

[0045]

[0046] The preparation method is as follows:

[0047] (1) Pulverize the raw material isradipine, cross a 100-mesh sieve, pulverize with a jet mill, and the particle size range is controlled at D 50 1-5um, D 90 5-20um;

[0048] (2) Weigh 0.8g sodium lauryl sulfate, add 200g purified water and stir to dissolve, add 2.5g isradipine raw material, mix well, add 92g sorbitol and 1.2g aspartame, add sodium bicarbonate to adjust pH to 6.5, as liquid a;

[0049] (3) Weigh 3 g of polyvinyl alcohol in the prescribed amount, add 50 g of purified water, stir to dissolve, pass through a 100-mesh sieve, and use it as liquid b.

[0050] (4) Slowly add liquid b into liquid a under stirring, and stir for 10-20 minutes after adding liquid b;

[0051] (5) after medicinal liquid measures isradipine content, will contain 2.5mg isradipine medicin...

Embodiment 3

[0055] Each tablet contains isradipine 2.5mg, and the composition of 1000 isradipine orally rapidly disintegrating tablets is:

[0056]

[0057] The preparation method is as follows:

[0058] (1) Pulverize the raw material isradipine, cross a 100-mesh sieve, pulverize with a jet mill, and the particle size range is controlled at D 50 1-5um, D 90 5-20um;

[0059] (2) Weigh 0.8g sodium lauryl sulfate, add 200g purified water and stir to dissolve, add 2.5g isradipine raw material, mix well, add 46g sorbitol, 46g lactose and 1.2g aspartame, add bicarbonate Sodium to adjust pH to 6.5, as liquid a;

[0060] (3) Weigh 3 g of polyvinyl alcohol in the prescribed amount, add 50 g of purified water, stir to dissolve, pass through a 100-mesh sieve, and use it as liquid b.

[0061] (4) Slowly add liquid b into liquid a under stirring, and stir for 10-20 minutes after adding liquid b;

[0062] (5) after medicinal liquid measures isradipine content, will contain 2.5mg isradipine medi...

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Abstract

The invention discloses an isradipine rapidly disintegrating oral tablet and a preparation method thereof, belonging to the field of preparation of an isradipine rapidly disintegrating oral tablet. The invention discloses firstly an isradipine rapidly disintegrating oral tablet; the isradipine rapidly disintegrating oral tablet consists of the following components: isradipine, a framework material, a suspending aid, a surfactant, a flavoring agent and a pH regulating agent, wherein the parts of the various components by weight are as follows: 2.5-10 parts of isradipine, 60-95 parts of framework material, 1-10 parts of suspending aid, 0.1-5 parts of surfactant, 0.1-5 parts of flavoring agent and 0.1-2 parts of pH regulating agent. The isradipine rapidly disintegrating oral tablet disclosed by the invention is good in appearance, low in friability, good in taste, short in dissolving time limit, rapid to take effect, convenient to take and good in medication compliance.

Description

technical field [0001] The invention relates to an orally disintegrating tablet, and also relates to a preparation method of the orally disintegrating isradipine tablet, which belongs to the field of isradipine orally disintegrating tablets. Background technique [0002] Hypertension (essentialhypertension, EH) is the most common cardiovascular disease. According to the research results of the Center for Chronic and Non-communicable Diseases Prevention and Control of the Chinese Center for Disease Control and Prevention, the prevalence of hypertension in Chinese adults was as high as 33.5% in 2010. According to this estimate The total number of patients has exceeded 330 million! [0003] Isradipine is a new type of dihydropyridine calcium channel blocker for the treatment of essential hypertension. It has a strong vasodilation effect, but no cardiac inhibition, and hardly causes reflex tachycardia. Clinical and animal experiments have proved that the drug has obvious antih...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4439A61P9/12
Inventor 杨贤龙张亮亮何勇吴宗好柳锁栓冯栓
Owner HEFEI HUAFANG PHARMA SCI & TECH
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