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Oral liquid sustained-release preparation containing codeine and chlorphenamine and preparation method thereof

A technology of chlorpheniramine and sustained-release preparations, which is applied in the preparation field of compound codeine oral sustained-release suspension and its industrial application, can solve the problem of increasing industrial production difficulty and production cost, being expensive and difficult to break through. Slow-release microcapsule coating and other problems, to achieve the effect of low production cost, good taste and stable performance

Active Publication Date: 2009-07-08
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In actual industrial production, the industrialized method of fluidized bed powder coating in the prior art is difficult to break through the slow-release microcapsule coating of fine particles below 100 microns
In addition, a whole set of fluidized bed equipment is very expensive; in order to ensure that the prepared liquid preparation has good quality characteristics, small particle size ion exchange resin is the first choice; but because codeine and chlorpheniramine resin complexes belong to fine particles, The realization of its slow-release performance requires a large amount of slow-release coating materials, even more than 100%, which increases the difficulty and production cost of industrial production

Method used

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  • Oral liquid sustained-release preparation containing codeine and chlorphenamine and preparation method thereof
  • Oral liquid sustained-release preparation containing codeine and chlorphenamine and preparation method thereof
  • Oral liquid sustained-release preparation containing codeine and chlorphenamine and preparation method thereof

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preparation example Construction

[0019] In the preparation method of the present invention, the active ingredients codeine and chlorpheniramine are respectively placed on the ion exchange resin to form microparticles with an average particle diameter of 50 microns; after the two kinds of microparticles are mixed according to the prescription amount, the compound formula is prepared by modifying the surface of the slow-release material Codeine-chlorpheniramine slow-release microparticles; slow-release microparticles are mixed with suspending agents, acidity regulators, heavy metal ion complexing agents, preservatives, flavoring agents, coloring agents and purified water commonly used in preparations to prepare Form a compound codeine-chlorpheniramine sustained-release suspension liquid preparation. The principle of the surface modification process is to use the slow-release material with ion-exchange ability groups to directly combine with the free groups after the ion-exchange resin adsorbs the drug, and form ...

Embodiment 1

[0029] Embodiment 1, 1000ml of oral liquid sustained-release preparation containing codeine and chlorpheniramine, formula:

[0030] Codeine Phosphate 1.48g

[0031] Chlorpheniramine Maleate 0.1g

[0032] Styrene strongly acidic cation exchange resin 1.0g

[0033] Xanthan Gum 3.0g

[0034] Disodium edetate 0.1g

[0035] Sodium dihydrogen phosphate 1.0g

[0036] Acrylic resin 0.01g

[0037] Hydroxypropyl Methyl Cellulose 1.2g

[0038] Microcrystalline Cellulose 1.0g

[0039] Paraben ethyl ester 2.7g

[0040] Sodium Benzoate 2.0g

[0041] Pigment 0.02g

[0042] Flavor 0.07g

[0043] Purified water up to 1000ml

[0044] Such as figure 1 with figure 2 As shown, the statistical mean diameter of the particle size is 50.39 microns.

Embodiment 2

[0045] Embodiment 2, 1000ml of oral liquid sustained-release preparation containing codeine and chlorpheniramine, formula:

[0046] Codeine Phosphate 14.8g

[0047] Chlorpheniramine Maleate 1.0g

[0048] Styrene strongly acidic cation exchange resin 105.0g

[0049] Sucrose 212.5g

[0050] EDTA 22.0g

[0051] Citric acid 50.0g

[0052] Sodium citrate 35.0g

[0053] Microcrystalline Cellulose 4.8g

[0054] Xanthan Gum 3.6g

[0055] Sodium Carboxymethyl Cellulose 1.2g

[0056] RL30D 52g

[0057] Paraben methyl ester 2.7g

[0058] Propylparaben 0.6g

[0059] Pigment 0.05g

[0060] Flavor 0.07g

[0061] Purified water up to 1000ml

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Abstract

The invention discloses an oral liquid sustained-release preparation containing codein and chlorphenamine and a preparation method thereof, aiming at solving the technical problem of realizing sustained-release micro-capsules coating of subparticle with the particle size being less than 100 microns. The oral liquid sustained-release preparation comprises the ingredients based on the following proportion by weight: 0.1-1.0% of codein, 0.01-1.0% of chlorphenamine, 0.1-10.0% of ion exchange resin, 0.5-30.0% of suspending aid, 0.001-5.0% of sustained-release material, 0.1-5% of acidity regulators, 0.01-5% of heavy metal ion complexing agent and the rest of water. The preparation method comprises: compound codein, chlorphenamine resin particles and medium are stirred to be prepared. Compared with the prior art, the invention adopts a surface-modified method to combine the sustained-release material with ion exchange property radical and empty radical which is obtained after the medicine is absorbed by the ion exchange resin, a layer of compact sustained-release film is formed at the outer layer of medicine resin to control the releasing action of the medicine, thus realizing the sustained-release micro-capsule coating of subparticle with the particle size being less than 100 microns.

Description

technical field [0001] The invention relates to a western medicine oral slow-release liquid preparation and a preparation method thereof, in particular to a compound codeine oral slow-release suspension and a preparation method for industrial application thereof. Background technique [0002] Liquid sustained-release preparations have the safety of drug sustained release and the convenience of dose division, especially suitable for special groups such as children and the elderly who have difficulty swallowing. It has always been a hot spot in the field of pharmaceutical preparations. Release preparations, such as tablets and capsules, are rarely available on the market because liquid sustained-release preparations are restricted by technical bottlenecks such as high difficulty in industrial application and high cost. The compound sustained-release liquid preparation can exert the synergistic effect of two active drugs at the same time, greatly improve the curative effect, an...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/485A61K31/4402A61K47/30A61P11/14A61P11/00
Inventor 闫志刚曾环想王孟黄凯
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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