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Verapamil hydrochloride film-controlled slow-release pellet capsule

A technology of verapamil hydrochloride film and sustained-release pellets, which is applied in the field of pharmaceutical preparations and can solve problems such as film release decline

Active Publication Date: 2013-07-24
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem of release decline caused by film aging of verapamil hydrochloride film-controlled sustained-release pellets prepared by water dispersion coating, the present invention provides a film capable of maintaining stable release performance throughout the validity period The controlled-release verapamil hydrochloride sustained-release pellet capsule is characterized in that the core of the pellet contains sodium carboxymethyl starch with high water-swellability, and the sustained-release coating film is deformed by water-absorbing swelling, thereby offsetting the membrane aging

Method used

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  • Verapamil hydrochloride film-controlled slow-release pellet capsule
  • Verapamil hydrochloride film-controlled slow-release pellet capsule
  • Verapamil hydrochloride film-controlled slow-release pellet capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The verapamil hydrochloride sustained-release pellet capsule of embodiment 1 common ball core

[0027] 1. Prescription

[0028] 1. Pill core prescription (1000 capsules)

[0029]

[0030] 2. Prescription of sustained-release film coating solution

[0031]

[0032] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0033] Second, the preparation process:

[0034] 1. Ball core preparation process:

[0035] (1) Verapamil hydrochloride is crossed 60 mesh sieves;

[0036] (2) take by weighing verapamil hydrochloride, microcrystalline cellulose PH101 of recipe quantity, put in wet granulator and mix homogeneously;

[0037] (3) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0038] (4) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0039] (5) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0040] (6) Sieve, and take ball cores between ...

Embodiment 2

[0064] Embodiment 2 contains the verapamil hydrochloride slow-release pellet capsule of 5% carboxymethyl starch sodium

[0065] 1. Prescription

[0066] 1. Pill core prescription (1000 capsules)

[0067]

[0068] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0069] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0070] Second, the preparation process:

[0071] 1. Ball core preparation process:

[0072] (1) Verapamil hydrochloride is crossed 60 mesh sieves;

[0073] (2) Verapamil hydrochloride, microcrystalline cellulose PH101, sodium carboxymethyl starch take by weighing recipe quantity, put in the wet granulator and mix homogeneously;

[0074] (3) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0075] (4) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0076] (5) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidi...

Embodiment 3

[0095] Embodiment 3 contains the verapamil hydrochloride sustained-release pellet capsule of 10% carboxymethyl starch sodium

[0096] 1. Prescription

[0097] 1. Pill core prescription (1000 capsules)

[0098]

[0099] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0100] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0101] Second, the preparation process:

[0102] 1. Ball core preparation process: with embodiment 2.

[0103] 2. Preparation process of sustained-release film coating solution:

[0104] With embodiment 1.

[0105] 3. Coating (sustained release film):

[0106] The ball core is placed in a fluidized bed for coating, and the weight gain of the coating film is controlled, and the weight gain of the coating is 21.7% and 27.7%.

[0107] 4, heat treatment: with embodiment 1.

[0108] 5. Filling capsules:

[0109] It is obtained by filling the coated pellets into capsules.

[0110] 3. Release, content dete...

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Abstract

The invention relates to a verapamil hydrochloride film-controlled slow-release pellet capsule. A slow-release film of the verapamil hydrochloride film-controlled slow-release pellet utilizes Eurdragit NE30D as a film-formation material. A pellet core of the verapamil hydrochloride film-controlled slow-release pellet contains sodium carboxymethyl starch having high expansibility, and also contains a pharmaceutically-acceptable common excipient for the slow-release pellet, wherein preferably, the excipient comprises microcrystalline cellulose, and the pellet core comprises 5 to 20wt% of sodium carboxymethyl starch. The slow-release film comprises Eurdragit NE30D and talcum powder as an antiplastering aid, wherein preferably, a ratio of Eurdragit NE30D to talcum powder is 30: 4 and a film weight increasing ratio is in a range of 19 to 35%. The verapamil hydrochloride film-controlled slow-release pellet comprises the pellet core containing sodium carboxymethyl starch having high water expansibility and thus after absorbing water, the verapamil hydrochloride film-controlled slow-release pellet obviously expands so that the slow-release film is stretched; the thickness of the slow-release film is reduced; the water-permeable micropore size is increased; and permeability is improved and the permeability reduction caused by film aging is counteracted. Therefore, in middle and later stages, the verapamil hydrochloride film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept in the period of validity.

Description

technical field [0001] The invention relates to a verapamil hydrochloride film-controlled sustained-release pellet capsule, in particular to a verapamil hydrochloride film-controlled sustained-release pellet capsule whose core contains sodium carboxymethyl starch, which belongs to pharmaceutical preparations field. Background technique [0002] Verapamil hydrochloride is the first-generation calcium antagonist, which exerts its pharmacological effects by regulating the influx of calcium ions on the membranes of myocardial conduction cells, cardiac contractile cells and arterial vascular smooth muscle cells, and is used for the treatment of angina pectoris, arrhythmia and primary Sexual hypertension. The basic clinical requirement for this type of drug is that it can control symptoms for a long time. [0003] Verapamil hydrochloride is dissolved in water, and the earliest listed is a common preparation, which needs to be taken 3-4 times a day. The blood drug concentration f...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K9/16A61K31/277A61K47/36A61P9/10A61P9/06A61P9/12
Inventor 姜庆伟狄媛吕玉珠唐亚坤刘俊轶
Owner 北京天衡药物研究院有限公司
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