Preparation method of stable protein drug-loaded microparticle system

A technology of drug-loaded particles and proteins, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, anti-tumor drugs, etc., can solve problems such as loss of protein activity, unknown and unsafe product quality, and affect the quality of pharmaceutical products. Effects of mildness, increased stability and practicality, and simple preparation method

Inactive Publication Date: 2015-04-29
程树海
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, whether it is high pressure, high temperature, or chemical denaturants, there are unknown and unsafe factors in product quality.
Either there is a loss of protein activity, or it affects the quality of drugs and products, and there are certain defects

Method used

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  • Preparation method of stable protein drug-loaded microparticle system
  • Preparation method of stable protein drug-loaded microparticle system
  • Preparation method of stable protein drug-loaded microparticle system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Dissolve 10mg of mitomycin in 1ml of N,N-dimethylacetamide, then add 1ml of 5% sodium chloride solution and mix well, and finally add 20% human serum albumin solution dissolved in pH 7.8 phosphate buffer 2ml to form a homogeneous solution. At 0°C, the homogeneous solution was directly freeze-dried into a powder injection preparation, and the final powder injection product was diluted with saline, and the particle size was measured by Malvern particle size analyzer ZS90 and the drug loading was determined by HPLC. The results show that the average particle size of the human serum albumin-loaded mitomycin microparticle system is 290.9nm, and the particle size and particle size distribution diagram are shown in figure 1 . The drug loading of microparticles reached 2.1%.

Embodiment 2

[0034] Dissolve 1 mg of bortezomib in 1 ml of tert-butanol, then add 0.5 ml of 2% sodium chloride solution and mix well, and finally add 0.5 ml of 2% bovine serum albumin solution to form a homogeneous solution. At room temperature, the homogeneous solution was directly freeze-dried into a powder injection preparation, and the final powder injection product was diluted with normal saline, and the particle size was measured with a Malvern particle size analyzer ZS90 and the drug loading of the microparticles was determined by HPLC. The results showed that the prepared microparticle system averaged The particle size is 164nm, and the drug loading capacity of the microparticles reaches 7.8%.

Embodiment 3

[0036] Dissolve 10mg of decitabine in 1ml of dimethyl sulfoxide, then add 1ml of 1% sodium phosphate solution and mix well, and finally add 0.4ml of 50% bovine serum albumin solution dissolved in pH 7.0 phosphate buffer to form a homogeneous phase solution. At room temperature, the homogeneous solution was directly freeze-dried into a powder injection preparation, and the final powder injection product was diluted with normal saline, and the particle size was measured with a Malvern particle size analyzer ZS90 and the drug loading of the microparticles was determined by HPLC. The results showed that the prepared microparticle system averaged The particle size is 264nm, and the drug loading capacity of the microparticles reaches 4.1%.

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Abstract

The invention provides a preparation method of a stable protein drug-loaded microparticle system. The system can be used in a protein microparticle system to deliver a drug into body in order to perform the curative effect. The preparation method comprises the following steps: 1, mixing an organic phase containing the drug with a water phase containing proteins by using a bridging agent to form a homogeneous solution; and 2, directly freeze-drying the homogeneous solution at 0-80DEG C to form a freeze-dried powder injection preparation, carrying out compatibility dilution by using 5% glucose or normal saline or other diluents in clinic use to form the stable protein drug loaded particle; or rapidly diluting the homogeneous solution to reduce the concentration of the bridging agent in order to make the drug rapidly embedded by the proteins and assembled to form the microparticle system. The stable protein drug loaded microparticle system can be used to deliver the drug into body in order to perform the curative effect. The method for preparing the stable protein drug-loaded microparticle system by using the bridging agent has the advantages of mild and simple conditions, suitableness for industrialization, and good application prospect.

Description

technical field [0001] The invention discloses a preparation method of a stable protein drug-loaded microparticle system, which can be used to deliver drugs to lesion sites in vivo to exert drug effects, and belongs to the technical field of biopharmaceuticals. Background technique [0002] The use of protein drug-loaded particle system for drug delivery is a hot research topic at present. Drugs can be delivered to the lesion site through proteins with good in vivo compatibility, targeted to the lesion for slow release, which can prolong the half-life of the drug and reduce the toxicity of the drug, thereby improving the curative effect and reducing the toxicity of the drug. drug toxicity. [0003] Protein particles are a research hotspot, and there are many reports on the preparation methods of protein particles, including thermal cross-linking, chemical cross-linking, emulsification and so on. The typical representative of these preparation methods is the emulsification h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K9/19A61K9/08A61P35/00A61K31/706A61K31/337
Inventor 程树海
Owner 程树海
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