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Self-assembled composite membrane controlled sustained-release preparation and preparation method thereof

A technology for sustained-release preparations and complexes, applied in the field of medicine, can solve problems such as high cost and complex process

Inactive Publication Date: 2010-12-08
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the disadvantage of membrane-controlled preparations is that the process is complex and needs to be realized in multiple steps, and the cost is relatively high

Method used

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  • Self-assembled composite membrane controlled sustained-release preparation and preparation method thereof
  • Self-assembled composite membrane controlled sustained-release preparation and preparation method thereof
  • Self-assembled composite membrane controlled sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Theophylline Sustained Release Tablets

[0038] Theophylline 15.0g

[0039] Chitosan 7.1g

[0040] Sodium alginate 7.1g

[0041] Microcrystalline Cellulose 0.9g

[0042] Magnesium stearate 0.03g

[0043]

[0044] Makes 100 pieces

[0045] Preparation Process:

[0046] The drug and auxiliary materials are sieved through 100 sieves, mixed uniformly in equal increments, and compressed into tablets with an average tablet weight of 300 mg. The chitosan is chitosan with a molecular weight of 400kDa and a deacetylation degree of 86.5%. The sodium alginate is sodium alginate with a molecular weight of 400kDa and a G / M ratio of 40:60. The dissolution results of the preparation in the simulated gastrointestinal fluid are shown in the appendix figure 2 (dissolution conditions are attached figure 1 ).

[0047]Theophylline sustained-release tablets made by the above-mentioned method meet the requirements of the relevant testing items st...

Embodiment 2

[0049] Theophylline Sustained Release Tablets

[0050] Theophylline 10.0g

[0051] Chitosan 6.6g

[0052] Sodium alginate 6.6g

[0053] Lactose 6.0g

[0054] Microcrystalline Cellulose 0.9g

[0055] Magnesium stearate 0.03g

[0056]

[0057] Makes 100 pieces

[0058] Preparation Process:

[0059] Pass the drug and auxiliary materials through 100 sieves, mix them uniformly in equal increments, and compress them into tablets with an average tablet weight of 300 mg. The chitosan is chitosan with a molecular weight of 400kDa and a deacetylation degree of 86.5%. The sodium alginate is sodium alginate with a molecular weight of 350kDa and a G / M ratio of 40:60. The lactose in the prescription can be replaced by any one of starch, polyethylene glycol 4000, polyethylene glycol 6000, sucrose, mannitol, and polyvinylpyrrolidone. The dissolution results of the preparation in the simulated gastrointestinal fluid and the comparison with the ...

Embodiment 3

[0062] Theophylline Sustained Release Tablets / Granules

[0063] Theophylline 15.0g

[0064] Chitosan 3.6g

[0065] Sodium Carboxymethyl Cellulose 10.5g

[0066] Microcrystalline Cellulose 0.9g

[0067] Magnesium stearate 0.03g

[0068]

[0069] Makes 100 pieces

[0070] Preparation Process:

[0071] Pass the drug and auxiliary materials through a 100-mesh sieve, mix theophylline, chitosan, sodium carboxymethylcellulose and microcrystalline cellulose in equal amounts, and use 70% ethanol as a soft material to pass through a 14-mesh sieve Granules, dried in an oven at 30°C, granulated through a 12-mesh sieve to obtain sustained-release granules, or granulated by extrusion, spheronization, etc., mixed with magnesium stearate, and compressed into average tablets Tablets weighing 300 mg were obtained as sustained-release tablets. The chitosan is chitosan with a molecular weight of 200kDa and a deacetylation degree of 86.5%. The molecula...

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Abstract

The invention belongs to the technical field of medicinal preparations, and in particular relates to a self-assembled composite membrane controlled sustained-release preparation and a preparation method thereof. The self-assembled composite membrane controlled sustained-release preparation comprises 2.5 to 67 percent of medicament, 12 to 76 percent of cationic polymer, 12 to 76 percent of anionic polymer and the balance of other auxiliary materials. Through the traditional process, matrix tablets or granules are prepared from polymers such as chitosan, sodium alga acid, carrageenan, sodium carboxymethylcellulose and the like with different charges; and in the releasing process, based on physiology pH change of a human body, two or more polymers with the different charges are reacted with each other to form an insoluble composite membrane on the surface of the tablet, and the matrix system is automatically converted into self-assembled composite membrane controlled sustained-release tablets or granules. The method can prepare medicaments with good controlled sustained-release effect by a simple process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a self-assembled composite membrane controlled sustained-release preparation and a preparation method thereof. Background technique [0002] At present, the sustained and controlled release preparations on the market are mainly matrix type and membrane-controlled type, and these two types of preparations have their own advantages and disadvantages. Skeletal sustained-release preparations mainly include hydrophilic polymers such as hydroxypropylmethylcellulose, starch, sodium carboxymethyl starch, and carbomer, and water-insoluble or The erodible material is a tablet, granule, etc. prepared from a drug-loaded matrix. This type of sustained-release preparation is characterized by a simple preparation process, but the drug release behavior is greatly affected by environmental pH, ionic strength, enzymes and other conditions. The basic preparation process of film-contr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/22A61K47/36A61K47/38
Inventor 毛世瑞张婷婷
Owner SHENYANG PHARMA UNIVERSITY
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