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Isosorbide mononitrate sustained-release pellet, and isosorbide mononitrate quick-release and sustained-release pellet capsule adopting it

A technology of isosorbide dinitrate and sustained-release pellets, which is applied in the field of isosorbide mononitrate membrane-controlled sustained-release pellets and isosorbide mononitrate immediate-release-sustained-release pellet capsules, and can solve problems such as decreased release and the like

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

[0005] In order to solve the problem of release decline caused by film aging of isosorbide mononitrate film-controlled sustained-release pellets prepared by aqueous dispersion coating, the present invention provides a film capable of maintaining stable release performance throughout the validity period Controlled isosorbide mononitrate sustained-release pellets and isosorbide mononitrate immediate-sustained-release pellet capsules are characterized in that the core of the sustained-release pellets contains carboxymethyl with high water-swellability Sodium starch, which deforms the slow-release coating film by absorbing water to swell, thereby counteracting the aging of the film

Method used

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  • Isosorbide mononitrate sustained-release pellet, and isosorbide mononitrate quick-release and sustained-release pellet capsule adopting it
  • Isosorbide mononitrate sustained-release pellet, and isosorbide mononitrate quick-release and sustained-release pellet capsule adopting it
  • Isosorbide mononitrate sustained-release pellet, and isosorbide mononitrate quick-release and sustained-release pellet capsule adopting it

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Isosorbide mononitrate membrane-controlled sustained-release pellets with common ball cores and Isosorbide mononitrate immediate-release pellets and capsules using the same

[0034] 1. Prescription (based on 1000 capsules)

[0035] 1. Prescription for sustained-release pill core:

[0036]

[0037] 2. Prescription of sustained-release film coating solution:

[0038]

[0039] 3. Prescription of immediate-release pellets:

[0040]

[0041]

[0042] 4. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0043] Second, the preparation process:

[0044] 1. Preparation process of sustained-release pellet core:

[0045] (1) Isosorbide mononitrate is passed through a 60 mesh sieve;

[0046] (2) Take isosorbide mononitrate and microcrystalline cellulose PH101 of prescription quantity, put in the wet granulator and mix uniformly;

[0047] (3) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft materials;

[0048] (4) Extrude on t...

Embodiment 2

[0075] Example 2 Isosorbide mononitrate film-controlled sustained-release pellets containing 5% sodium carboxymethyl starch and Isosorbide mononitrate immediate-release pellets and capsules using the same

[0076] 1. Prescription (1000 capsules)

[0077] 1. Prescription of sustained-release pill core

[0078]

[0079] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0080] 3. Prescription of immediate-release pellets

[0081]

[0082] 4. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0083] Second, the preparation process:

[0084] 1. Preparation process of sustained-release pellet core:

[0085] (1) Isosorbide mononitrate is passed through a 60 mesh sieve;

[0086] (2) Take isosorbide mononitrate, microcrystalline cellulose PH101, sodium carboxymethyl starch of recipe quantity, put in wet granulator and mix homogeneously;

[0087] (3) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[008...

Embodiment 3

[0108] Example 3 Isosorbide mononitrate film-controlled sustained-release pellets containing 10% sodium carboxymethyl starch and Isosorbide mononitrate immediate-release-sustained-release pellets capsules using it

[0109] 1. Prescription (1000 capsules)

[0110] 1. Prescription for sustained-release pill core:

[0111]

[0112] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0113] 3. Prescription of immediate-release pellets:

[0114]

[0115] 4. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0116] Second, the preparation process:

[0117] 1. Preparation process of sustained-release pellet core: same as in Example 2

[0118] 2. The preparation process of immediate-release pellets: the same as the preparation process of sustained-release pellet cores.

[0119] 3. The preparation process of the slow-release film coating solution: the same as in Example 1

[0120] 4. Coating (sustained release film):

[0121] The slo...

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Abstract

The invention relates to an isosorbide mononitrate sustained-release pellet, and an isosorbide mononitrate quick-release and sustained-release pellet capsule adopting it. The sustained-release film of the sustained-release pellet adopts Eurdragit RS 30D as a film forming material, the core of the sustained-release pellet contains high-expansibility sodium carboxymethyl starch and a pharmaceutically-acceptable excipient commonly used for sustained-release pellets, and optimally, the excipient is microcrystalline cellulose, wherein the weight percentage of sodium carboxymethyl starch in the core of the sustained-release pellet is 5-20%. The sustained-release film of the sustained-release pellet includes the Eurdragit RS 30D, a plasticizer triethyl citrate and an anti-adherent talcum powder, the optimal ratio of the Eurdragit RS 30D to triethyl citrate to the talcum powder is 30:3:4, and the optimal coating weight gain is 19-38%. The core will obviously expand after absorbing water because of the containment of sodium carboxymethyl starch highly expanding after contacting with water, so the sustained-release film is stretched, the thickness of the film is thinned, the apertures of water-pervious micro-pores are increased, the permeability is good, and the permeability decrease caused by film ageing is compensated, thereby the middle and later stage release speed is basically constant, the last stage residue is small, and a stable release performance is always maintained prior to the expiration date.

Description

technical field [0001] The present invention relates to a kind of isosorbide mononitrate sustained-release pellets and isosorbide mononitrate quick-release-sustained-release pellet capsules adopting it, specifically, relate to a kind of mononitrate containing sodium carboxymethyl starch in the pellet core Isosorbide film-controlled sustained-release pellets and isosorbide mononitrate quick-release-sustained-release pellet capsules using the same belong to the field of pharmaceutical preparations. Background technique [0002] Isosorbide mononitrate is a nitrate drug, which can reduce myocardial oxygen consumption, increase oxygen supply, and relieve angina pectoris. It is used for long-term treatment of coronary heart disease, prevention of angina pectoris, and treatment of persistent angina pectoris after myocardial infarction. The basic clinical requirement for this type of drug is that it can control symptoms for a long time. [0003] Isosorbide mononitrate is dissolved ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/52A61K31/34A61K47/36A61P9/10
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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