Preparation method of pure indissolvable drug nanoparticles (crystals) and application thereof

A technology of insoluble drugs and nanoparticles, which is used in pharmaceutical formulations, devices for making drugs into special physical or taking forms, and medical preparations containing active ingredients, etc., which can solve complex processes, poor reproducibility, and high costs. problem, to achieve the effect of simple process operation, cost saving and absorption promotion

Inactive Publication Date: 2018-03-16
JINZHOU MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problems existing in the existing preparation technology include complex process, small scale, poor reproducibility, high cost, etc.
Compared with the current nanocrystal preparation technology, there is no report on the application of electrostatic spray technology to the preparation of pure insoluble drug nanoparticles (crystals)

Method used

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  • Preparation method of pure indissolvable drug nanoparticles (crystals) and application thereof
  • Preparation method of pure indissolvable drug nanoparticles (crystals) and application thereof
  • Preparation method of pure indissolvable drug nanoparticles (crystals) and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Weigh 150mg of dabigatran etexilate crude drug and add 1mL of dichloromethane solution in the EP tube, shake the drug solution to make it dissolve to form a clear solution. Draw a certain amount of drug solution into a micro-volume constant-velocity syringe, connect the spray device, turn on the power supply for spraying, and obtain pure dabigatran etexilate nanoparticles on the receiving device. The distance is 20cm. Its scanning electron microscope picture is shown in 1. Dabigatran etexilate pure drug nanoparticles with different particle sizes can be realized by adjusting the specifications of the spray needle.

Embodiment 2

[0034] Weigh 1.5 g of the fenofibrate bulk drug and add it into 1 mL of chloroform solution to dissolve all the drug to form a clear drug solution. Draw a certain amount of drug solution into a micro-volume constant-velocity syringe, connect the spray device, turn on the power to spray, and get pure fenofibrate nanoparticles on the receiving device. The specific parameters are voltage 25KV, needle No. 28, and receiving distance 30cm. The collected pure fenofibrate nanoparticles take an appropriate amount of 0.002g / mL HPMC aqueous solution, ultrasonic 10min to make it dispersed, its transmission electron microscope picture is shown in 2.

Embodiment 3

[0036] Weigh 350mg of paclitaxel and dissolve it in 1mL of chloroform solution, connect the electrostatic spray device, set the specific parameters as voltage 20KV, select No. 27 needle, and receive distance 25cm. Collect pure paclitaxel nanoparticles, take an appropriate amount of pure paclitaxel nanoparticles and disperse them in an SDS aqueous solution lower than the SDS critical micelle concentration, ultrasonically disperse them, and observe their morphology through a transmission electron microscope, as shown in image 3 shown.

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Abstract

The invention provides a preparation method of pure indissolvable drug nanoparticles (crystals) by an electrostatic spraying technology. The method comprises the following steps: bulk drugs of the indissolvable drug with a certain concentration are dissolved in a good solvent, and a clarified drug solution is formed; the clarified drug solution is added in a constant-speed injection apparatus, anda nozzle of the injection apparatus is the stainless steel flat needles with different specifications; the injection apparatus is connected with an electrostatic spraying apparatus, a whole apparatusis in an enclosing state, a switch of high voltage supply is turned on, electrostatic spraying is carried out, and the pure indissolvable drug nanoparticles (crystals) powder can be collected on a collection plate. The electrostatic spraying technology is used for preparing the pure indissolvable drug nanoparticles (crystals), water solubility of the indissolvable drug is increased, absorption ispromoted, and bioavailability is improved. The technical operation is simple, cost is saved, and the method provides base for industrial production of the pure indissolvable drug nanoparticles (crystals).

Description

technical field [0001] The invention belongs to the fields of electrostatic spraying and pharmacy, and particularly provides a preparation method and application of pure insoluble drug nanoparticles (crystals). Background technique [0002] In innovative drug research, about 40% of drugs are poorly soluble drugs. According to the characteristics of BCS class II and class IV drugs, the problems of water solubility and membrane permeability have greatly affected the efficacy of drugs. How to use new technologies or new carriers to improve their water solubility and bioavailability is a key issue for new drug creation and current practice. There are major scientific issues that need to be solved urgently to improve the efficacy of drugs. [0003] With the development of nanotechnology, drug nanocrystals provide a new idea for improving the water solubility of poorly soluble drugs. It can be used in various modes of administration such as oral administration and intravenous ad...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61J3/02A61K31/337A61K31/4439A61K31/216
CPCA61J3/02A61K9/14A61K31/216A61K31/337A61K31/4439
Inventor 吴超高宇刘影
Owner JINZHOU MEDICAL UNIV
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