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Method and device for preparing medicament particles with nano-micro structure

A technology for preparing a device and a drug, which is applied in the field of preparing nano-micro structure drug particles, can solve the problems of inability to meet nano-micro structure requirements, difficult to control particle size, incomplete product crystallization, etc. control, the effect of narrow particle size distribution

Active Publication Date: 2010-06-09
BEIJING UNIV OF CHEM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when the device is applied to a drug crystallization system with a long nucleation induction characteristic time, the resulting product has incomplete crystallization, poor crystallinity, and low yield.
Crystals will continue to grow during subsequent processing, making particle size difficult to control and unable to achieve the required nanostructure requirements

Method used

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  • Method and device for preparing medicament particles with nano-micro structure
  • Method and device for preparing medicament particles with nano-micro structure
  • Method and device for preparing medicament particles with nano-micro structure

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The reaction apparatus used is as figure 1 As shown, the volume of the cavity 3 is 1200mL, and the filler 2 is an ordinary wire mesh.

[0039] Accurately weigh 10.0 ± 0.1g salbutamol raw material drug, dissolve it in isopropanol (IPA) at 25°C, and prepare a 0.04mol / L salbutamol IPA solution with a volume constant to 1000mL, and add it into the internal circulation RPB through the feed port 1 Cavity 3 (hereinafter referred to as cavity 3). Water at 25° C. is passed continuously into the RPB jacket 8 . Turn on the digital frequency regulator that controls the motor to 50Hz. The albuterol IPA solution continuously circulates in the cavity 3 under the joint action of the lifter 10 and the rotor 5 . The porosity of the packing layer 2 is 90%. When the number displayed on the frequency controller rises from 0 to 50 Hz and displays stably for 10 seconds, 10 mL of 2.0 mol / L sulfuric acid is quickly added to the internal circulation RPB through the feed port 1, fully mixed w...

Embodiment 2

[0042] The internal circulation RPB used is the same as that in Example 1.

[0043] Accurately weigh 3.0±0.1g (0.01mol) of sumatriptan raw material and dissolve it in tetrahydrofuran (THF), and use the prepared sumatriptan THF solution to 500mL, and add it into the internal circulation RPB through feed port 1 . Turn on the digital frequency regulator controlling the motor to 50 Hz, and the porosity of the packing layer 2 is 90%. Accurately weigh 2.4±0.1g (0.02mol) of succinic acid (also called succinic acid) and dissolve it in tetrahydrofuran (THF), and dilute to 200mL to prepare a succinic acid THF solution. When the number displayed on the FM instrument rises from 0 to 50Hz and displays stably for 10 seconds, quickly add the above-mentioned succinic acid THF solution into the internal circulation RPB through the feed port 1, and fully mix with the sumatriptan THF solution , the reaction crystallized to generate the desired sumatriptan succinate. The mixing time was 6 min,...

Embodiment 3

[0045] The internal circulation RPB used is the same as that in Example 1.

[0046] Accurately weigh 3.0±0.1g (0.01mol) of sumatriptan raw material and dissolve it in tetrahydrofuran (THF), and use the prepared sumatriptan THF solution to 500mL, and add it into the internal circulation RPB through feed port 1 . Turn on the digital frequency regulator controlling the motor to 50 Hz, and the porosity of the packing layer 2 is 90%. Accurately weigh 2.4±0.1g (0.02mol) of succinic acid (also called succinic acid) and dissolve it in tetrahydrofuran (THF), and dilute to 200mL to prepare a succinic acid THF solution. When the number displayed on the FM instrument rises from 0 to 50Hz and displays stably for 10 seconds, quickly add the above-mentioned succinic acid THF solution into the internal circulation RPB through the feed port 1, and fully mix with the sumatriptan THF solution , the reaction crystallized to generate the desired sumatriptan succinate. The mixing time was 6 min,...

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Abstract

The invention provides a method and a device for preparing medicament particles with a nano-micro structure and belongs to the field of medicament preparation. The method comprises the following steps that: an internal circulation rotary filling bed is used as a precipitation-crystallization device; and in a cavity, liquid materials are lifted from the bottom to the inner wall of a rotor by a lifter, and the rotor is driven to rotate by a motor to generate centrifugal force, so that the material liquid passes a material filling layer, is thrown out from the outer wall of the rotor and then isreturned to the bottom of the cavity under the gravity action. The steps are cycled. The volume ratio of two kinds of material liquid is 1:2 to 1:100, and the two kinds of material liquid are fully mixed on the material filling layer to form crystallization suspension; the frequency of the motor is 25 to 50Hz, the mixed time is 5 to 20 minutes, and the crystallization temperature is 0 and 25 DEG C; and the crystallization suspension is filtered, washed and dried to form the medicament powder with the nano-micro structure. In the method, by adjusting the volume ratio, crystallization temperature, mixed time, frequency of the motor and the like of the two crystallization systems and the two kinds of material liquid, the medicament particles, which have the uniform nano-micro structure and of which the average grain size is controllable, can be obtained; and the method also has the advantages of simple process, safe operation, energy conservation, low cost and the like.

Description

technical field [0001] The invention belongs to the field of medicine preparation, and in particular relates to a preparation method and device of nanostructure medicine particles. Background technique [0002] Compared with traditional drug particles, nano-microstructured drug particles have the advantages of good solubility, high bioavailability, less toxic and side effects, and targeted delivery. Therefore, the research and development of nano-microstructure drugs has become one of the important directions in the development of modern pharmacy. [0003] Currently, the most common method for obtaining drug particles in the pharmaceutical industry is liquid phase crystallization. Liquid phase crystallization can be divided into cooling crystallization, evaporation crystallization, and precipitation crystallization according to the different principles of crystal precipitation. Among them, precipitation crystallization is the most widely used in the preparation of nano-micr...

Claims

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Application Information

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IPC IPC(8): A61J3/02
Inventor 陈建峰胡婷婷赵宏初广文王洁欣乐园沈志刚
Owner BEIJING UNIV OF CHEM TECH
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