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A kind of preparation method of paclitaxel powder spray

A technology for paclitaxel and powder spray, applied in the field of medicine, can solve the problems of complex process, influence on powder stability, crystal structure change, etc., and achieve the effects of simple preparation process, fast dissolution rate and high dissolution rate

Inactive Publication Date: 2019-10-29
ANHUI MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Among them, the high temperature environment in the drying process of the spray drying technology will affect the structure or denature the heat-labile drugs or biomolecules. Control a variety of parameters, such as inlet temperature, atomization pressure, drying wind speed, etc. The change of each parameter may affect the final powder aerosol product, so the process is more complicated; the cost of freeze-drying method is higher because it requires Vacuum and low temperature conditions, so the vacuum freeze dryer should be equipped with a vacuum system and low temperature system, so the investment cost and operating cost are relatively high; the recrystallization method is mainly used for the delivery of hydrophobic drugs, and has limitations for water-soluble drugs properties; micronization is the most direct and effective way to obtain drug inhalation particles, and the most used methods are fluid energy milling, ball milling, jet milling and other methods, but micronization is difficult to control the properties of particles, and it may also make the drug Crystal structure changes, which affects powder stability

Method used

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  • A kind of preparation method of paclitaxel powder spray
  • A kind of preparation method of paclitaxel powder spray
  • A kind of preparation method of paclitaxel powder spray

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A preparation method of paclitaxel powder spray, comprising the steps of:

[0025] (1) After dissolving 2 mg of paclitaxel with 1 ml of absolute ethanol, a paclitaxel solution is obtained;

[0026] (2) Select a nano-sprayer (model: KH1080, manufacturer: Bright Point Technology Co., Ltd.), and evenly spray the paclitaxel solution onto 3.3 g of lactose to obtain drug-loaded lactose;

[0027] (3) Put the drug-loaded lactose into a vacuum drying oven for drying at a drying temperature of 80°C for 2 hours, and then pass through a 120-mesh sieve and a 240-mesh sieve to obtain a powder;

[0028] The scanning electron microscope image of the powder is shown in figure 1 , Paclitaxel powder is adsorbed on the surface of lactose; the particle size of the powder is measured using a Malvern Mastersizer2000 instrument, and the measured particle size is 2.6±0.1 μm.

[0029] (4) Fill the powder into capsules.

[0030] The measured emptying rate of the powder spray is more than 90%, ...

Embodiment 2

[0032] A preparation method of paclitaxel powder spray, comprising the steps of:

[0033] (1) After dissolving 5 mg of paclitaxel with 1 ml of absolute ethanol, a paclitaxel solution is obtained;

[0034] (2) Select a nano-sprayer (model: KH1080, manufacturer: Bright Point Technology Co., Ltd.), and evenly spray the paclitaxel solution onto 3 g of lactose to obtain drug-loaded lactose;

[0035] (3) Put the drug-loaded lactose into a vacuum drying oven for drying at a drying temperature of 70°C for 7 hours, and then pass through a 120-mesh sieve and a 240-mesh sieve to obtain a powder;

[0036] The particle size of the powder was measured using a Malvern Mastersizer 2000 instrument, and the measured particle size was 2.8±0.2 μm.

[0037] (4) Fill the powder into capsules.

Embodiment 3

[0039] A preparation method of paclitaxel powder spray, comprising the steps of:

[0040] (1) After dissolving 3 mg of paclitaxel with 1 ml of acetone, a paclitaxel solution is obtained;

[0041] (2) Select a nano-sprayer (model: KH1080, manufacturer: Bright Point Technology Co., Ltd.), and evenly spray the paclitaxel solution onto 3 g of lactose to obtain drug-loaded lactose;

[0042] (3) Put the drug-loaded lactose into an oven for drying, the drying temperature is 80°C, and the drying time is 2 hours, and then pass through a 120-mesh sieve and a 240-mesh sieve to obtain a powder;

[0043] The scanning electron microscope image of the powder is shown in image 3 , Paclitaxel powder is adsorbed on the surface of lactose; the particle size of the powder is measured using a Malvern Mastersizer2000 instrument, and the measured particle size is 3.1±0.1 μm.

[0044] (4) Fill the powder into capsules.

[0045] The emptying rate of the measured powder mist is more than 90%, which...

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Abstract

The invention relates to a preparation method of a paclitaxel dry powder inhalation and belongs to the technical field of medicines. The preparation method comprises the following steps: firstly, after dissolving paclitaxel with an organic solvent, obtaining a paclitaxel solution; then uniformly spaying the paclitaxel solution on lactose to obtain drug-loading lactose; finally, drying the drug-loading lactose and sieving to obtain powder. The preparation method provided by the invention is simple, complicated technologies and machines are not needed and the cost is low; compared with a traditional spray drying method and the like, the grain diameter of the dry powder inhalation is easier to control; paclitaxel is difficult to dissolve; the paclitaxel dry powder inhalation prepared by the method has high dissolubility and a rapid dissolution speed, and is completely dissolved out within 10min.

Description

technical field [0001] The invention relates to a preparation method of paclitaxel powder, which belongs to the technical field of medicine. Background technique [0002] Paclitaxel is a common antitumor drug with high antitumor activity, and is often used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer, cervical cancer and brain cancer. However, due to paclitaxel's poor water solubility and low oral bioavailability, ethanol and polyoxyethylene castor oil Cremophor-EL are generally used as solvents, but adverse reactions such as hemolysis and allergies may occur. Therefore, when paclitaxel injections are used, glucocorticoids and antihistamines are used in advance, and then PTX is injected slowly for 3 hours to reduce adverse reactions, which brings great inconvenience to patients and increases treatment costs. Delivering anticancer drugs through the lungs with higher bioavailability and fewer adverse effects. In the field of pulmonary drug de...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/26A61K31/337A61P35/00
CPCA61K9/4858A61K31/337A61P35/00
Inventor 汤继辉韩治敏何佳琪柳圆圆郑层层
Owner ANHUI MEDICAL UNIV