Salbutamol Sulfate Film-controlled Sustained Release Pellet Capsules

A technology of salbutamol sulfate and sustained-release pellets, which can be used in medical preparations with non-active ingredients, respiratory diseases, organic active ingredients, etc., and can solve problems such as decreased release.

Active Publication Date: 2018-02-02
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

[0007] In order to solve the problem of release decline caused by film aging of salbutamol sulfate film-controlled sustained-release pellets prepared by aqueous dispersion coating, the present invention provides a film-controlled sulfuric acid film capable of maintaining stable release performance throughout the validity period. Salbutamol sustained-release pellet capsules are characterized in that the core of the pellets contains sodium carboxymethyl starch with high water-swellability, and the sustained-release coating film is deformed by water swelling, thereby offsetting the aging of the film

Method used

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  • Salbutamol Sulfate Film-controlled Sustained Release Pellet Capsules
  • Salbutamol Sulfate Film-controlled Sustained Release Pellet Capsules
  • Salbutamol Sulfate Film-controlled Sustained Release Pellet Capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The albuterol sulfate sustained-release pellet capsule of embodiment 1 common ball core

[0031] 1. Prescription

[0032] 1. Pill core prescription (1000 capsules)

[0033]

[0034]

[0035] * Calculated as albuterol is 8g

[0036] 2. Prescription of sustained-release film coating solution

[0037]

[0038] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0039] Second, the preparation process:

[0040] 1. Ball core preparation process:

[0041] (1) Take albuterol sulfate and microcrystalline cellulose PH101 of prescription quantity, put in wet granulator and mix evenly.

[0042] (2) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft materials;

[0043] (3) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0044] (4) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0045] (5) Sieve, and take ball cores between 16 and 30 mesh.

[0046] 2. Prepa...

Embodiment 2

[0069] Example 2 Salbutamol Sulfate Sustained-release Pellet Capsules Containing 5% Sodium Carboxymethyl Starch

[0070] 1. Prescription

[0071] 1. Pill core prescription (1000 capsules)

[0072]

[0073] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0074] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0075] Second, the preparation process:

[0076] 1. Ball core preparation process:

[0077] (1) take by weighing albuterol sulfate, microcrystalline cellulose PH101, sodium carboxymethyl starch of recipe quantity, put in the wet granulator and mix homogeneously;

[0078] (2) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0079] (3) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0080] (4) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0081] (5) Sieve, and take ball cores between 16 and 30 mesh. ...

Embodiment 3

[0097] Example 3 Salbutamol Sulfate Sustained Release Pellet Capsules Containing 10% Sodium Carboxymethyl Starch

[0098] 1. Prescription

[0099] 1. Pill core prescription (1000 capsules)

[0100]

[0101] 2. Prescription of sustained-release film coating solution: same as in Example 1.

[0102] 3. No. 0 stomach-dissolving gelatin capsule shells, 1,000 capsules.

[0103] Second, the preparation process:

[0104] 1. Ball core preparation process: with embodiment 2.

[0105] 2. The preparation process of the slow-release film coating solution: the same as in Example 1.

[0106] 3. Coating (sustained release film):

[0107] 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 20.1% and 25.9%.

[0108] 4, heat treatment: with embodiment 1.

[0109] 5. Capsule filling: the coated pellets are filled into capsules.

[0110] 3. Release, content determination and results

[0111] ...

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Abstract

The invention relates to a salbutamol sulfate film-controlled sustained-release pellet capsule. The sustained-release film of the pellet adopts Kollicoat SR30D as a film-forming material, and the pellet core contains high-expandability sodium carboxymethyl starch, and pharmaceutically acceptable The commonly used excipients of the sustained-release pellets, the excipient is preferably microcrystalline cellulose, wherein, the sodium carboxymethyl starch in the pellet core accounts for 5-20% of the weight of the pellet core. The sustained-release coating film comprises Kollicoat SR30D, plasticizer triethyl citrate and anti-sticking agent talcum powder, and its ratio is preferably Kollicoat SR 30D: triethyl citrate: talcum powder=30:1:4, coating weight gain Preferably it is 19 to 38%. Because the ball core contains sodium carboxymethyl starch, which has high water swelling property, it will swell obviously after absorbing water, resulting in the expansion of the slow-release coating film, the thickness becomes thinner, the pore size of the water-permeable micropores becomes larger, and the permeability becomes better. , which compensates for the decrease in permeability caused by membrane aging, so that the release rate in the middle and late stages is basically constant, and the residue in the end stage is small, which can always maintain a stable release performance within the validity period.

Description

technical field [0001] The invention relates to a salbutamol sulfate membrane-controlled sustained-release pellet capsule, in particular to a salbutamol sulfate membrane-controlled sustained-release pellet capsule with a pellet core containing sodium carboxymethyl starch, belonging to the field of pharmaceutical preparations. Background technique [0002] Salbutamol sulfate is a synthetic beta 2 Receptor agonist, can selectively act on bronchial smooth muscle β 2 -receptor, which has a strong bronchodilation effect, and is used for the treatment of bronchial asthma or asthmatic bronchitis and other respiratory diseases accompanied by bronchospasm. [0003] Salbutamol sulfate is dissolved in water. The salbutamol sulfate osmotic pump controlled-release tablets that are administered twice a day by MURO Company can achieve zero-order release and uniform drug release. The disadvantage is that the semipermeable membrane composed of polymer materials is easy to age. The drug res...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K9/16A61K31/137A61K47/36A61P11/08
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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