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Albumin conjugated taxol nanoparticle freeze-dried preparation and preparation method thereof

An albumin-bound, freeze-dried preparation technology, which is applied in the field of albumin-bound paclitaxel nanoparticle freeze-dried preparations and preparations, can solve the problems of drug-induced rashes and allergic reactions in patients, and achieve fewer adverse reactions and prolonged drug use. effect, improve the stability of the

Inactive Publication Date: 2013-02-06
双鹤药业(海南)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The polyoxyethylene castor oil in the prescription will cause the release of histamine in the body, which will lead to drug-induced rash, shortness of breath, bronchospasm, hypotension and other allergic reactions in some patients after administration. Methasone, aminophylline and other glucocorticoids or antihistamines to prevent allergic reactions, but some patients still have allergic reactions after medication

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Sterile paclitaxel (nano grade) 0.5g

[0022] Human serum albumin (nano-scale) 20g

[0023] Soy Lecithin 20g

[0024] olive oil 20g

[0025] Mannitol 30g

[0026] Sodium sulfite 3g

[0027] Preparation Process

[0028] (1) Add 0.5 g of nanoscale sterile paclitaxel to 15 mL of absolute ethanol for dissolution, add 20 g of olive oil, and stir evenly;

[0029] (2) Add 20 g of nanoscale human serum albumin, 20 g of soybean lecithin, 30 g of mannitol, and 3 g of sodium sulfite, add 150 mL of water for injection and stir until dissolved;

[0030] (3) Mix the solutions obtained in the above two steps, stir evenly, add citric acid buffer salt, adjust the pH to 5.0, and filter with a 0.22 μm microporous membrane to obtain a microemulsion solution; freeze-dry the gained microemulsion solution to obtain a A lyophilized formulation of albumin-bound paclitaxel nanoparticles.

[0031] After the above lyophilized preparation is reconstituted with physiological saline, it has an...

Embodiment 2

[0033] Sterile paclitaxel (nano grade) 1.0g

[0034] Human serum albumin (nano-scale) 40g

[0035] Soy Lecithin 40g

[0036] Coix Seed Oil 20g

[0037] Sucrose 30g

[0038] Sodium sulfite 4g

[0039] Preparation Process

[0040] (1) Add 1.0 g of nanoscale sterile paclitaxel into 30 mL of absolute ethanol to dissolve, add 20 g of coix seed oil, and stir evenly;

[0041] (2) Add 40 g of nanoscale human serum albumin, 40 g of soybean lecithin, 30 g of sucrose, and 4 g of sodium sulfite, add 300 mL of water for injection and stir until dissolved;

[0042] (3) Mix the solutions obtained in the above two steps, stir evenly, add hydrochloric acid buffer salt, adjust the pH to 6.0, and filter with a 0.22 μm microporous membrane to obtain a microemulsion solution; freeze-dry the obtained microemulsion solution to obtain a Lyophilized formulation of albumin-bound paclitaxel nanoparticles.

[0043] After the above lyophilized preparation is reconstituted in normal saline, it has a...

Embodiment 3

[0045] Sterile paclitaxel (nano grade) 2.0g

[0046] Human serum albumin (nano-scale) 60g

[0047] Soy Lecithin 60g

[0048] Isopropyl Myristate 40g

[0049] Trehalose 30g

[0050] Sodium sulfite 5g

[0051] Preparation Process

[0052] (1) Add 2.0 g of nanoscale sterile paclitaxel into 50 mL of absolute ethanol for dissolution, add 40 g of isopropyl myristate, and stir evenly;

[0053] (2) Add 60g of nanoscale human serum albumin, 60g of soybean lecithin, 30g of trehalose, and 5g of sodium sulfite into 500mL of water for injection and stir until dissolved;

[0054] (3) Mix the solutions obtained in the above two steps, stir evenly, add phosphate buffered saline, adjust the pH to 7.0, and filter with a 0.22 μm microporous membrane to obtain a microemulsion solution; freeze-dry the obtained microemulsion solution to obtain a Lyophilized formulation of albumin-bound paclitaxel nanoparticles.

[0055] After the above lyophilized preparation is reconstituted in normal salin...

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Abstract

The invention discloses an albumin conjugated taxol nanoparticle freeze-dried preparation and a preparation method thereof. The preparation consists of the following components in percentage by weight: 0.1-2 percent of sterile taxol (nanoscale), 0.2-60 percent of human serum albumin (nanoscale), 0.2-60 percent of a surfactant, 0.2-30 percent of an oil phase, 0.2-60 percent of a freeze-dried framework agent, 0.1-5 percent of a pH regulating agent and 0.1-5 percent of a stabilizing agent. The invention provides an albumin conjugated taxol nanoparticle freeze-dried preparation, which can be used for enhancing the stability and safety of taxol, prolonging the medicament effect and enhancing the targeting capability. Albumin is taken as a carrier and an appropriate mixture ratio is selected, so that medicaments can be protected from being influenced by the environment, active ingredients are isolated, volatility and toxicity are lowered, an appropriate medicament releasing speed can be obtained, a slow and durable action is realized, and untoward effects are reduced.

Description

technical field [0001] The invention relates to a freeze-dried preparation of albumin-bound paclitaxel nanoparticles and a preparation method thereof. Background technique [0002] Paclitaxel is a natural anti-tumor drug isolated and purified from Taxus genus plants. It is a new type of anti-microtubule drug, by promoting tubulin polymerization, inhibiting depolymerization, maintaining tubulin stability, and inhibiting cell mitosis. In vitro experiments have shown that paclitaxel has a significant radiosensitizing effect, which may cause cells to stop in the G2 and M phases that are sensitive to radiotherapy. Pharmacological and clinical studies have found that paclitaxel has broad-spectrum anticancer activity and unique curative effect on ovarian cancer and breast cancer. It is the most promising chemotherapy drug after cisplatin and doxorubicin. One of the most significant achievements of anticancer drugs. Paclitaxel injection is the first-line drug for the treatment of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/48A61K31/337A61P35/00
Inventor 魏雪纹李强
Owner 双鹤药业(海南)有限责任公司
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