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Codein and chlorphenamine compound sustained release capsules

A technology for compound chlorpheniramine and sustained-release capsules, which is applied in the directions of capsule delivery, pharmaceutical formulations, respiratory diseases, etc., can solve the problems that sustained-release capsules cannot meet the requirements of codeine release, and achieve drug bioavailability. High, reducing addiction and other side effects, less medication

Active Publication Date: 2011-04-13
SINOPHARM GRP ZHIJUN SHENZHEN PINGSHAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Sustained-release capsules prepared by this method can not meet the requirements of codeine release degree

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The composition of the compound codeine sustained-release capsule of the present invention (percentage by weight, the same below): 10.6% of codeine phosphate, 2.1% of chlorpheniramine maleate, 74.5% of hydroxypropylmethylcellulose K-4M, acrylic resin RSPO 10.8%, magnesium stearate 2%.

[0026] The preparation method is as follows: pass the prescribed amount of codeine phosphate, chlorpheniramine maleate, hydroxypropylmethylcellulose K-4M, and acrylic resin RSPO through an 80-mesh sieve respectively, mix them evenly in a mixer, and add 8% PVP Aqueous ethanol solution (6:4) is used as a binder and stirred to make a soft material, granulated through a 18-mesh sieve, dried at 50°C for 1 hour, granulated at 18 mesh, and then added with the prescribed amount of magnesium stearate, mixed evenly, Capsules.

[0027] Implementation Effect:

[0028] The resulting granules were relatively hard, with a content of 0.188 g. According to the Chinese Pharmacopoeia 2005 edition two ap...

Embodiment 2

[0030] The composition of the compound codeine sustained-release capsule of the present invention (percentage by weight, the same below): 10.6% of codeine phosphate, 2.1% of chlorpheniramine maleate, 63.8% of hydroxypropylmethylcellulose K-15M, acrylic resin RSPO 21.5%, magnesium stearate 2%.

[0031] The preparation method is as follows: pass the prescribed amount of codeine phosphate, chlorpheniramine maleate, hydroxypropyl methylcellulose K-15M, acrylic resin RSPO, and lactose through an 80-mesh sieve, put in a mixer and mix evenly, and add 8% The ethanol aqueous solution (6:4) of PVP is used as binder and stirred to make soft material, crosses 18 mesh sieves and granulates, granules are dried at 60 DEG C for 1 hour, 18 mesh granules, then add the magnesium stearate of recipe quantity, mix Mix evenly and pack into capsules.

[0032] Implementation Effect:

[0033] The obtained granule powder is more, and the content is 0.188g. According to the Chinese Pharmacopoeia 2005 ...

Embodiment 3

[0035] The composition of the compound codeine sustained-release capsule of the present invention (percentage by weight, the same below): 10.6% of codeine phosphate, 2.1% of chlorpheniramine maleate, 53.8% of hydroxypropylmethylcellulose K-100M, acrylic resin RSPO 31.5%, magnesium stearate 2%.

[0036] The preparation method is as follows: pass the prescribed amount of codeine phosphate, chlorpheniramine maleate, hydroxypropyl methylcellulose K-100M, acrylic resin RSPO, and lactose through an 80-mesh sieve, put in a mixer to mix evenly, and add 8% The ethanol aqueous solution (6:4) of PVP is used as binder and stirred to make soft material, crosses 18 mesh sieves and granulates, granules are dried at 60 DEG C for 1 hour, 18 mesh granules, then add the magnesium stearate of recipe quantity, mix Mix evenly and pack into capsules.

[0037] Implementation Effect:

[0038] The obtained granule powder is more, and the content is 0.188g. According to the Chinese Pharmacopoeia 2005...

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PUM

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Abstract

The invention discloses codein and chlorphenamine compound sustained release capsules. The sustained release granules are made from the following raw materials by weight: 10-11.1 parts of codein, 2-2.2 parts of chlorphenamine, 1-2 parts of a lubricant, 18.9-86 parts of a sustained release matrix material and 0-12.4 parts of a filling agent. The sustained release matrix material is two or three ofhydroxypropyl emthylcellulose, acrylic resin and ethyl cellulose, wherein, the acrylic resin and the ethyl cellulose totally accounts for 10.9-31.5%. The capsules are obtained by the following steps:evenly mixing the codein, the chlorphenamine and the sustained release matrix material; adding a binder to prepare a soft material and sieving with a 6-24-mesh sieve; preparing damp granules, drying and granulating; and adding the lubricant, evenly mixing and then encapsulating to obtain the finished product.

Description

Technical field: [0001] The invention relates to a drug dosage form, in particular to a compound drug sustained-release capsule and a preparation method thereof. Background technique: [0002] Codeine, as an opioid analgesic and antitussive drug, can directly inhibit the cough center of the medulla oblongata, and has a rapid and powerful antitussive effect. It is suitable for severe dry cough and irritating cough caused by various reasons, especially for severe cough accompanied by chest pain. dry cough. Codeine is rapidly and completely absorbed after oral administration, and its bioavailability is 40% to 70%. The plasma concentration reaches its peak about 1 hour after a single oral administration of 15 mg, and the half-life is about 3 to 4 hours. It is mainly combined with glucuronic acid in the liver, and about 15% is demethylated into morphine. Its metabolites are mainly excreted through urine. [0003] Chlorpheniramine is a hydroxylamine antihistamine, which is char...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/485A61K31/4402A61K9/52A61K9/58A61K9/62A61J3/07A61P29/00A61P11/14
Inventor 陆振举
Owner SINOPHARM GRP ZHIJUN SHENZHEN PINGSHAN PHARMA CO LTD
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