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Biological degradable polymer-solid liposome sustained-release storing system and preparation method thereof

A technology for degrading polymers and solid lipids, used in pharmaceutical formulations, drug delivery, peptide/protein components, etc., can solve problems such as being difficult to adapt to industrialized large-scale production, prone to inflammation and infection, and toxic organic solvent residues. The effect of sustained and smooth release, improved stability, and simple preparation process

Inactive Publication Date: 2009-12-09
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Implants are often accompanied by surgical trauma, and the implant site is prone to inflammation and infection, which brings some pain to the patient
In addition, microsphere preparations often have problems of sudden release and toxic organic solvent residues. In addition, the preparation process is complicated and it is difficult to be suitable for large-scale industrial production.

Method used

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  • Biological degradable polymer-solid liposome sustained-release storing system and preparation method thereof
  • Biological degradable polymer-solid liposome sustained-release storing system and preparation method thereof
  • Biological degradable polymer-solid liposome sustained-release storing system and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034]Dissolve 10% (w / v) PLGA (molecular weight 10,000, monomer ratio 70:30) and 1% (w / v) risperidone in N-methylpyrrolidone, and then add 1% (w / v) / v) Solid lipid, shaken to form matrix.

Embodiment 2-11

[0036] Repeat the steps of Example 1 with different types of polymers, solid lipids, and organic solvents, as shown in the following table:

[0037] Table 1: Description of reservoir morphology composed of different types of polymers, solid lipids, and organic solvents.

[0038] implement

[0039] 70∶30)

Embodiment 12

[0041] Get 100ml benzyl alcohol (BA) and 900ml benzyl benzoate (BB) and mix uniformly, accurately weigh 10g risperidone and 10g glyceryl monostearate and dissolve in the mixed solvent of benzyl alcohol and benzyl benzoate, and then Take 100 g of PLGA (70:30 molecular weight: 5w) and add it to the above mixed solution, shake at 37° C. until all dissolved to form a transparent and uniform solution.

[0042] In vitro release test conditions: take 1ml of the above homogeneous solution, transfer it into a dialysis bag, shake in 250ml of normal saline, and shake at 37°C for in vitro release test.

[0043] Results: The drug can be continuously and steadily released for 25 days, and the cumulative release amount is greater than 80%.

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Abstract

The invention discloses a sustained-release storage system composed of medicine, biodegradable polymer, solid lipid and organic solvent and a preparation method. In the invention, the biodegradable polymer is dissolved in a single or mixed organic solvent, and the solid lipid and medicine are dissolved or dispersed in the polymer solution to form a slow-release storage system together. The release time of the drug can be maintained for several days to several weeks. The rate of drug release can be adjusted by changing the composition of the organic solvent, the concentration of the polymer, the ratio of each part of the polymer, the molecular weight, the type and amount of solid lipid, and the drug in the preparation. Content and other factors to control. The sustained-release storage system can be used for subcutaneous and intramuscular administration of water-soluble and water-insoluble chemical drugs or protein and polypeptide drugs. The preparation method is simple and environmentally friendly, and meets the requirements of industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of a biodegradable polymer-solid lipid slow-release storage that can be injected subcutaneously and intramuscularly. technical background [0002] Biodegradable polymers can be degraded into small molecular substances inherent in the body under the action of the body itself. It is safe and reliable as a drug delivery system carrier. For example, the safety of poly(lactic acid-glycolic acid) copolymer (PLGA) has been obtained. FDA approval. At present, PLGA is mainly used as the matrix of sustained-release drug delivery system for microspheres, implants, etc. PLGA microsphere preparations already on the market include ARESTIN TM 、LUPRON Sandostatin Wait. The patented PLGA implants include peptide PLGA implants (US Patent No 6,620,422) and hydroxyapatite PLGA implants (US Patent No 5,766,618, No 5,626,861). Implants are often accom...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/34A61K47/36A61K47/10A61K47/12A61K9/08A61K38/16
Inventor 梁文权董思宇孙晓译
Owner ZHEJIANG UNIV
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