A drug-phospholipid/albumin composite nanoparticle and its preparation process

An albumin and nanoparticle technology, which can be used in drug combinations, biological systems, anti-tumor drugs, etc., can solve problems such as protein structure and function changes, and achieve the effect of high encapsulation efficiency, small particle size, and avoiding direct contact.

Active Publication Date: 2020-06-05
上海乐土生命科技有限公司
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Problems solved by technology

[0004] Through investigation, it is found that the existing technology has the following deficiencies: the preparation process of albumin-bound paclitaxel nanoparticles (Abraxane) involves the use of organic solvents, and direct contact between albumin and organic solvents may lead to changes in protein structure and function
There is no report on the preparation method of nanoparticles that does not involve the use of organic solvents; at the same time, there is no study on the effect of pH value on the drug loading and particle size of nanoparticles

Method used

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  • A drug-phospholipid/albumin composite nanoparticle and its preparation process
  • A drug-phospholipid/albumin composite nanoparticle and its preparation process
  • A drug-phospholipid/albumin composite nanoparticle and its preparation process

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Embodiment 1

[0035] Embodiment 1 The preparation technology of a kind of paclitaxel-phospholipid / albumin composite nanoparticle provided by the present invention, its steps are as follows: (1) configure paclitaxel, lecithin, cholesterol and DSPE-PEG 2000 Stock solution; (2) preparing paclitaxel liposome; (3) preparing BSA stock solution; (4) preparing paclitaxel-phospholipid / albumin composite nanoparticles; specifically as follows:

[0036] Prepare 20.4 mg / mL (0.0003 mol / L) albumin stock solution with 0.01 mol / L buffer solution with different pH respectively. Prepare 10mg / mL (0.0117mol / L) paclitaxel, 15.5mg / mL (0.04mol / L) cholesterol, 29.2mg / mL (0.04mol / L) lecithin, 5.6mg / mL (0.002 mol / L) of DSPE-PEG 2000 stock solution;

[0037] Paclitaxel, cholesterol, lecithin, DSPE-PEG 2000 The stock solution was added in a certain proportion to the constantly stirring blank buffer solution at 55°C, stirred for 30 minutes after the addition, and the ethanol was removed by rotary evaporation; the pac...

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Abstract

The present invention provides a paclitaxel-phospholipid / albumin composite nanoparticle and its preparation process, the steps are as follows: (1) configure paclitaxel, phospholipid, cholesterol and DSPE-PEG 2000 stock solution; (2) preparation of paclitaxel liposomes; (3) preparation of albumin (BSA) stock solution; (4) preparation of paclitaxel-phospholipid / albumin composite nanoparticles. The preparation method of the present invention is simple and can solve the problem of poor solubility of insoluble drugs in water. The preparation does not contain Cremophor EL, which avoids the toxic and side effects caused by these solubilizers during injection; the drug-phospholipid / albumin composite nanoparticles prepared by the present invention Unlike ordinary liposomes and albumin nanoparticles, DSPE‑PEG is added to the formulation 2000 The stability of the nanoparticles is increased, and the encapsulation rate is high, the particle size is small and uniform, and the particle size of the nanoparticles does not change significantly after being placed at room temperature for 2 weeks.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a drug-phospholipid / albumin composite nanoparticle and a preparation process. Background technique [0002] Paclitaxel (PTX), as one of the hottest new anticancer drugs after adriamycin, is of great significance in the field of tumor-related treatment. Paclitaxel is a kind of diterpenoid compound with excellent anticancer effect extracted from Taxus genus plants such as Pacific yew. The anti-cancer mechanism of paclitaxel is to promote extremely stable microtubule aggregation while blocking the normal physiological depolymerization of microtubules (in the G2 and M phases of the cell division cycle), thereby leading to cell death and hindering tumor growth. purpose of growth. Currently widely used in non-small cell tumors, ovarian cancer, breast cancer, prostate cancer and so on. However, the solubility of paclitaxel in water is extremely low (about 0.658...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K9/127A61K47/42A61K47/24A61K31/337A61P35/00G16B5/00
Inventor 蔡畅刘敏赵燕娜韩军
Owner 上海乐土生命科技有限公司
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