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A kind of liquid sustained-release preparation and preparation method thereof

A slow-release preparation and liquid technology, applied in the field of medicine, can solve the problems of low drug yield, poor coating reproducibility, difficult industrialization, etc., and achieve the effects of reducing the peak concentration of the drug, complete coating, and conducive to scale-up production.

Active Publication Date: 2019-06-14
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The inventor provides an oral sustained-release suspension containing ion exchange resin and hydrophilic colloid and its preparation process, which does not require microparticle coating or impregnation granulation to solve the problem of poor coating reproducibility in the existing microparticle coating technology , Difficulty in industrialization, low drug yield, use of organic solvents, etc.

Method used

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  • A kind of liquid sustained-release preparation and preparation method thereof
  • A kind of liquid sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] [embodiment 1] the preparation of ambroxol hydrochloride-resin complex

[0051] (1) Dissolve 400g of Ambroxol hydrochloride in 4L of deionized water; (2) Slowly add 8000g of Amberlite under continuous mixing TM IRP-69 resin, at 50°C, continuously stirred for 12 hours, let it stand, and poured off the supernatant to obtain the drug-resin complex; (3) Add 4L deionized water to the drug-resin complex obtained in (2) , stirred for 10 min, washed off the unbound free drug, left to stand, and poured off the supernatant; repeat step (3) twice; (4) dry the drug-resin complex obtained in (3) at 60°C, That is, the drug-resin complex is obtained.

Embodiment 2

[0052] [embodiment 2] the preparation of the impregnated acyclovir-resin complex

[0053] (1) Dissolve 140g of acyclovir in 20L of 0.01mol / L hydrochloric acid solution; (2) Slowly add 1400g of JK006 ion exchange resin under continuous mixing, stir continuously for 8h at 25°C, let stand, and pour off the clear liquid to obtain the drug-resin complex; (3) add 20L deionized water to the drug-resin complex obtained in (2), stir for 30min, wash off the unbound free drug, let it stand, and pour off the supernatant ; Repeat step (3) to operate 4 times; (4) dry the drug-resin complex obtained in (3) to a water content of 20% at 60°C; (5) add 2.6g triacetin to 165g Kollicoat SR 30D In the polymer, stir at room temperature for 1 h to obtain an impregnating agent; (6) place the drug-resin compound obtained in step (4) in a wet granulator, add 167.6 g of impregnating agent to the drug-resin compound, stir, and shear , to form a uniform material; (7) drying the impregnated drug-resin comp...

Embodiment 3

[0054] [embodiment 3] the preparation of the impregnated topiramate-resin complex

[0055] (1) Dissolve 200g of Topiramate in 40L of deionized water; (2) Slowly add 10g of Amberlite with continuous mixing TM IRP-69 ion exchange resin, at 40°C, continuously stirred for 2 hours, let it stand, and poured off the supernatant to obtain the drug-resin complex; (3) Add 40 L to the drug-resin complex obtained in (2). Ionized water, stirring for 30min, washing away unbound free drug, standing still, decanting the supernatant; repeating step (3) for 3 times; (4) placing the drug-resin complex obtained in (3) at 40°C Dry to a water content of 3%; (5) add 5.3g triacetin to 334g Kollicoat SR 30D polymer, stir at room temperature for 1h to obtain an impregnating agent; (6) place the drug-resin complex obtained in step (4) in a wet In the French granulator, add 340g of impregnating agent into the drug-resin compound, stir and shear to form a uniform material; (7) dry the impregnated drug-re...

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Abstract

The invention discloses a slow-release preparation containing ion exchange resin and hydrophilic gel and a preparation method of the slow-release preparation. The slow-release preparation is made of a medicine-ion exchange resin composite and a suspension substrate, the medicine-ion exchange resin composite is made of active medicine capable of being combined with ion exchange resin and medically acceptable ion exchange resin, and the medicine-ion exchange resin composite can further contain insoluble polymer and plasticizer; the suspension substrate is composed of hydrophilic gel, acidity regulator, a thickening agent, preservative, antioxygen, a wetting agent, a coloring agent and a sweetening agent.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to an oral sustained-release suspension containing ion-exchange resin and hydrophilic colloid and a preparation method thereof. Background technique [0002] In recent years, with the deepening of theoretical research on drug delivery systems and the development of polymer material science, the research on drug delivery systems has been increasing from varieties to dosage forms. Although oral sustained-release solid preparations can effectively delay the absorption of drugs in the body, thereby stabilizing the blood drug concentration, reducing side effects, and improving the effectiveness, safety and compliance of drugs. However, oral sustained-release solid preparations mostly rely on the functional sustained-release material to have a certain shape, and cannot be broken or ground into fine powder before taking. It is not suitable for children and elderly patients with dysphagia....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K47/58A61K47/61A61K47/26A61K47/36A61K31/522A61K31/4422A61K31/137
CPCA61K9/10A61K31/137A61K31/4422A61K31/522A61K47/26A61K47/36
Inventor 王春玲尚丽霞陶秀梅
Owner NKD PHARMA CO LTD
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