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Preparation method of polypeptide/proteinic drug nanoparticle with high drug loading and high encapsulation efficiency

A nanoparticle and protein technology, applied to peptide/protein components, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve problems such as complex preparation methods, adverse effects on the health of operators and users, and low freezing points. The preparation process is simple, easy to scale up in industrial production, and the effect of a wide range of sources

Active Publication Date: 2012-07-11
SUN YAT SEN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to scientific research literature in recent years, the methods for preparing such nanoparticles mainly include amphiphilic polymer self-assembly method in water, mechanical dispersion method, ultrasonic emulsification method, etc.; these methods have more or less low encapsulation efficiency and easy drug leakage. , Drug variability and inactivation during the preparation process, etc. At the same time, the preparation method is complicated, energy-consuming and time-consuming, and it is not easy to carry out industrial production
Wang Ting et al. proposed to prepare insulin nanoparticles by emulsification-co-lyophilization method. This method has the characteristics of simple method and high encapsulation efficiency, but a large amount of dichloromethane and ether are used in the preparation process, which is harmful to operators and users. Health will have adverse effects; at the same time, the freezing point of dichloromethane and ether is very low, and it will consume a lot of energy to remove the organic solvent by lyophilization

Method used

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  • Preparation method of polypeptide/proteinic drug nanoparticle with high drug loading and high encapsulation efficiency
  • Preparation method of polypeptide/proteinic drug nanoparticle with high drug loading and high encapsulation efficiency
  • Preparation method of polypeptide/proteinic drug nanoparticle with high drug loading and high encapsulation efficiency

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: Preparation of Insulin Hyaluronic Acid Nanoparticles

[0037] The formula is as follows:

[0038]

[0039] Preparation:

[0040] (1) Preparation of oil phase and water phase solutions

[0041] Weigh insulin and sodium hyaluronate into a vial, add ultrapure water to dissolve, then add Tween 80 as the water phase; weigh Span 80, put it into a 50ml centrifuge tube and dissolve it in cyclohexane as the oil phase; The phase is slowly dropped into the oil phase under the action of mechanical stirring (10000rpm, 3min) to obtain the drug nanoemulsion.

[0042] (2) Preparation of lyoprotectant emulsion

[0043] Weigh mannitol and dissolve it in ultrapure water, add Tween 80 as the water phase; weigh Span 80 and put it into a 50ml centrifuge tube, dissolve it in cyclohexane as the oil phase. An emulsion is obtained after mechanical dispersion.

[0044] (3) Preparation of protein nanoemulsion and lyoprotectant nanoemulsion mixture

[0045] Add the lyoprotectan...

Embodiment 2

[0049] Embodiment 2: Preparation of bovine serum albumin hyaluronic acid / alginic acid nanoparticles

[0050] The formula is as follows:

[0051]

[0052] Preparation:

[0053] (1) Preparation of oil phase and water phase solutions

[0054] Weigh bovine serum albumin, sodium hyaluronate, and alginic acid into a vial, add ultrapure water to dissolve, then add Tween 80 as the water phase; weigh lecithin into a 50ml centrifuge tube, dissolve in cyclohexane As the oil phase; the water phase is slowly dropped into the oil phase under the action of mechanical stirring (10000rpm, 3min) to obtain the drug nanoemulsion.

[0055] (2) Preparation of lyoprotectant emulsion

[0056] Weigh mannitol and dissolve it in ultrapure water, add Tween 80 as the water phase; weigh lecithin into a 50ml centrifuge tube, dissolve it in cyclohexane as the oil phase. A W / O emulsion is obtained after mechanical dispersion.

[0057] (3) Preparation of protein nanoemulsion and lyoprotectant emulsion m...

Embodiment 3

[0062] Example 3: Preparation of Insulin Hyaluronic Acid Nanoparticles

[0063] The formula is as follows:

[0064]

[0065] Preparation:

[0066] (1) Preparation of oil phase and water phase solutions

[0067] Weigh insulin and sodium hyaluronate into a vial, add ultrapure water to dissolve, add PEG400 monolaurate as the water phase; weigh Span 80, put it into a 50ml centrifuge tube and dissolve it in cyclohexane as the oil phase; Slowly drop the water phase into the oil phase under the action of mechanical stirring (10000rpm, 3min) to obtain the drug nanoemulsion.

[0068] (2) Preparation of lyoprotectant emulsion

[0069] Weigh sorbitol and dissolve it in ultrapure water, add PEG400 monolaurate as the water phase; weigh Span 80 and put it into a 50ml centrifuge tube, dissolve it in cyclohexane as the oil phase. A W / O emulsion is obtained after mechanical dispersion.

[0070] (3) Preparation of protein nanoemulsion and lyoprotectant emulsion mixture

[0071] Add th...

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Abstract

The invention discloses a preparation method of polypeptide / proteinic drug nanoparticle with high drug loading and high encapsulation efficiency. The method provided by the invention comprises the steps of: dissolving the drug, physiological compatible polymer material, cross-linking agent, and surfactant in aqueous phase, dissolving lipophilic surfactant in nonpolar solvent as oil phase, adding the aqueous phase in the oil phase, carrying out mechanical dispersion to form nano-emulsion; adding freeze-drying protective agent emulsion in the nano-emulsion; quick-freezing at an ultra-low temperature, freeze drying and removing water and the non-polar solvent to obtain the polypeptide / proteinic drug nanoparticle. In the method provided by the invention, the non-polar solvent with low toxicity is used, which is characterized of high freezing point and low boiling point, and is easy to be moved; heating process is avoided, and polypeptide or protein is not easily deactivated; the preparation process is simple, and easy for large-scale production; the polypeptide / proteinic drug nanoparticle is high in drug loading and encapsulation efficiency, and good in redispersibility, and is suitable for serving as drug carrier or intermediate.

Description

technical field [0001] The invention belongs to the fields of medicines, biological products and health care products, in particular, the invention relates to a preparation method of polypeptide / protein drug nanoparticles with high drug loading and high encapsulation efficiency. Background technique [0002] In recent years, with the development of genetic engineering and bioengineering, a large number of peptide and protein drugs have been applied clinically. Because this type of drug has the characteristics of small dosage, poor stability, and easy inactivation in the body, wrapping the drug in nanoparticles can not only increase the stability of the drug in the body, but also maintain a long-term blood drug concentration; Modification of nanoparticles can also achieve the purpose of targeted drug delivery. Considering biological safety, the preparation of protein and polypeptide drug nanoparticles with high biocompatibility polymer materials as carriers has been one of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/36A61K47/32A61K47/34A61K47/26A61K47/42A61K47/18A61K38/00A61K38/28A61K38/38
Inventor 冯敏韩丽娜尹丽芳
Owner SUN YAT SEN UNIV
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