Isradipine controlled release tablet and preparation method thereof

A preparation and weight ratio technology, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of soft material adhesion, high residual organic solvent, long drying time, etc.

Active Publication Date: 2019-10-15
DEZHOU DEYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the patent and document formulation of isradipine controlled-release tablets, polyoxyethylene is added to the drug layer and the booster layer. Polyoxyethylene is highly hygroscopic, and granulation is prone to soft material adhesion, sticking to the net, and agglomeration. The problem is that it is difficult to dry the solvent in the granulation process. Because the drying temperature is usually low, it is easy to cause the problem of high residual organic solvents. If the drying is relatively complete, it will take a relatively long drying time, which is critical for the smooth progress of mass production. have a certain impact

Method used

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  • Isradipine controlled release tablet and preparation method thereof
  • Isradipine controlled release tablet and preparation method thereof
  • Isradipine controlled release tablet and preparation method thereof

Examples

Experimental program
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example 1

[0012] The preparation of example 1. isradipine controlled release tablet

[0013] (1) Preparation of double-layer core

[0014] ① drug layer

[0015] Isradipine 5g

[0016] Carbomer 70g

[0017] Povidone 30g

[0018] Silica 1g

[0019] Magnesium Stearate 1g

[0020] Mix the isradipine, carbomer and povidone in the above prescription amount evenly, prepare a soft material with an appropriate amount of 60-80% ethanol, granulate it with a 18-mesh nylon net, and ventilate and dry the prepared granules at 50°C. Then add silicon dioxide and magnesium stearate, mix well, and set aside.

[0021] ② Booster layer

[0022] Low-substituted hydroxypropyl cellulose 30g

[0023] Cross-linked sodium carboxymethyl starch 60g

[0024] Sodium chloride 20g

[0025] Red Iron Oxide 2g

[0026] Silica 1g

[0027] Magnesium Stearate 1g

[0028] Mix the low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, sodium chloride, and red iron oxide in the above prescription quan...

example 2

[0046] The preparation of example 2. isradipine controlled-release tablets

[0047] (5) Preparation of double-layer core

[0048] ① drug layer

[0049] Isradipine 10g

[0050] Carbomer 90g

[0051] Povidone 45g

[0052] Silica 1g

[0053] Magnesium Stearate 1g

[0054] Mix the isradipine, carbomer and povidone in the above prescription amount evenly, prepare a soft material with an appropriate amount of 60-80% ethanol, granulate it with a 18-mesh nylon net, and ventilate and dry the prepared granules at 50°C. Then add silicon dioxide and magnesium stearate, mix well, and set aside.

[0055] ② Booster layer

[0056] Cross-linked sodium carboxymethyl starch 70g

[0057] Hypromellose 40g

[0058] Sodium chloride 22g

[0059] Red Iron Oxide 2g

[0060] Silica 1g

[0061] Magnesium Stearate 1g

[0062] Mix the hydroxypropylmethyl cellulose, cross-linked sodium carboxymethyl starch, sodium chloride, and red iron oxide in the above prescription amount evenly, prepare sof...

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Abstract

The invention provides an isradipine controlled release tablet and a preparation method thereof. The tablet includes a double-layer tablet consisting of a medicine layer and a booster layer, a controlled release semipermeable membrane, drug releasing pores and a moisture-proof coating. The medicine layer includes the main medicine that is isradipine and a carrier, and the carrier mainly includes vinylpyrrolidone and/or vinylpyrrolidone copolymer. The booster layer mainly includes a substance promoting permeation, an insoluble polymer, an osmotic pressure promoter, and the like. The controlledrelease semipermeable membrane mainly includes cellulose acetate, a plasticizer and a pore-foaming agent. Through application of the polymer, the isradipine after being orally taken is released at a controlled speed so that the purpose of maintaining 24 hours of medicine release only by one time of medicine taking each day is achieved, the blood medicine concentration is stabilized, and clinical treatment effects of the medicine are improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a single-chamber double-layer osmotic pump-type controlled-release preparation containing the active drug isradipine and a preparation method thereof, which enables isradipine to release the drug at a controlled rate in the gastrointestinal tract, Realize stable blood drug concentration in the body and improve clinical treatment effect. Background technique [0002] Isradipine (also known as: Isradipine), chemical name: isopropylmethyl (±)-4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl -3,6-Pyridinedicarboxylate. Isradipine is a new type of dihydropyridine calcium channel blocker, like other dihydropyridine drugs, by blocking the influx of transmembrane calcium ions, it can effectively and selectively inhibit the contraction caused by depolarization in the It plays a role in cardiac muscle and vascular smooth muscle, has high selectivity of blood vessels, and can relax...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/44A61K47/38A61K47/32A61K47/02A61K47/10A61K31/4439A61P9/12A61P9/10A61P9/04
CPCA61K9/28A61K9/2072A61K9/2086A61K9/2054A61K9/2027A61K9/2009A61K9/2031A61K9/0004A61K31/4439A61P9/12A61P9/10A61P9/04
Inventor 卞建钢潘秀芝李成文刘静孔晨曦张华巍马浩刘伟
Owner DEZHOU DEYAO PHARMA
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