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Urapidil sustained release preparation and preparation method thereof

A technology of urapidil and sustained-release preparations, which is applied in the field of urapidil sustained-release preparations and its preparation, can solve the problems of inability to release drugs continuously, and achieve superior protective effects, no sudden release phenomenon, and good stability

Inactive Publication Date: 2020-08-25
北京华氏开元医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the existing urapidil sustained-release preparations cannot completely avoid the burst release phenomenon, and cannot continuously, uniformly and slowly release the drug

Method used

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  • Urapidil sustained release preparation and preparation method thereof
  • Urapidil sustained release preparation and preparation method thereof
  • Urapidil sustained release preparation and preparation method thereof

Examples

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Effect test

preparation example Construction

[0059] On the other hand, the present invention also provides a preparation method of urapidil sustained-release preparation, comprising the steps of:

[0060] Prepare drug-containing pellets, the step of preparing drug-containing pellets includes:

[0061] Step S10, weighing the adhesive according to the prescription amount and dissolving it in the solvent at the first temperature, and then adding an anti-adhesive agent to obtain an adhesive solution;

[0062] Step S20, weighing the urapidil and the diluent according to the prescription amount and passing through the first-mesh sieve to obtain the urapidil and the diluent meeting the particle size requirements;

[0063] Step S30, mixing the urapidil meeting the particle size requirement with the diluent, and mixing uniformly to obtain the first mixed powder;

[0064] Step S40, weighing the blank core of the first mass and placing it in a centrifugal coating granulator, and then adding the binder solution and the first mixed ...

Embodiment 1

[0091] In order to study the effect of the isolation layer on the dissolution of sustained-release capsules under high temperature conditions, two kinds of pellets were prepared: drug-containing pellets without isolation layer and drug-containing pellets with isolation layer B, and then poured into capsules to obtain sustained-release capsules A and sustained-release capsules. Capsule B was placed in a closed container at a high temperature of 60°C at the same time, and the dissolution results were investigated for 10 days.

[0092] One, the preparation of sustained-release capsule A

[0093] 1. Preparation of drug-containing pellets:

[0094] Medicated pellets contain the following ingredients:

[0095]

[0096]

[0097] Described preparation process comprises the steps:

[0098] Step S1: Add hypromellose to a container filled with purified water at 80°C to 90°C, stir to disperse, let cool, then stir, then add talcum powder to obtain a 3% hypromellose solution;

[00...

Embodiment 2

[0144] 1. Preparation of drug-containing pellets:

[0145] Medicated pellets contain the following ingredients:

[0146] name Dosage per capsule (mg) Batch (g) blank core 75 375 Uradil 30 150 microcrystalline cellulose 30 150 Povidone K30 7 35 talcum powder 3 15 water Appropriate amount Appropriate amount

[0147] Described preparation process comprises the steps:

[0148] Step S1: Weigh Povidone K30 according to the prescription amount and add it into a container filled with purified water at 80°C to 90°C, stir to disperse, let cool, then stir, and then add talcum powder to obtain a 3% Povidone K30 solution;

[0149] Step S2: Weigh urapidil and microcrystalline cellulose according to the prescription and pass through a 100-mesh sieve, and mix the two substances evenly to obtain the first mixed powder;

[0150] Step S3: Weigh 500g of the blank pellet core and place it in the centrifugal coating granulator, set the ...

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Abstract

The invention belongs to the field of medicine, and particularly relates to a urapidil sustained release preparation and a preparation method thereof. The urapidil sustained release preparation consists of a medicine-containing small pill, an isolation coating layer and a sustained release coating layer, wherein the medicine-containing small pill comprises a blank pellet, a main medicine layer anda solvent; the main medicine layer comprises 20 to 40 parts of urapidil, 7 to 15 parts of a bonding agent, 30 to 40 parts of a diluent and 3 to 10 parts of an anti-sticking agent through being metered in parts by mass; the isolation coating layer comprises an isolation coating material, talcum powder and a solvent; and the sustained release coating layer comprises 70 to 85 parts of a sustained release coating material, 0 to 8 parts of triethyl citrate, 6 to 15 parts of talcum powder and a solvent through being metered in parts by mass. The invention develops a novel urapidil sustained releasepreparation recipe, and has the advantages of high product stability and no burst release phenomenon; meanwhile, the continuous uniform and sustained medicine release of the medicine can be ensured;and in addition, the urapidil sustained release preparation has the characteristics of simple preparation process and high efficiency.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to an urapidil sustained-release preparation and a preparation method thereof. Background technique [0002] Urapidil, also known as peruredin, is a new type of antihypertensive drug with dual mechanisms of action both peripherally and centrally. Urapidil has a blocking effect on the post-synaptic α1 receptor, and has a slight blocking activity on the β1 receptor and a blocking effect on the presynaptic α2 receptor, and has a central antihypertensive effect similar to clonidine . Urapidil also has the effect of lowering peripheral resistance and blood pressure. Urapidil does not cause reflex tachycardia while reducing blood pressure, and the cardiac output slightly increases or remains unchanged, and the blood flow of the kidney and spleen increases. Urapidil can also reduce peripheral vascular resistance, pulmonary arterial pressure and left ventricular end-diastolic pressur...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K9/36A61K9/52A61K47/38A61K47/32A61K31/513A61P9/12
CPCA61K9/2866A61K9/2846A61K9/2886A61K9/4875A61K9/4808A61K31/513A61P9/12
Inventor 潘海群黄巧萍马跃中郝东方苏小庭戴信敏
Owner 北京华氏开元医药科技有限公司
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