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Preparation method for drug-carrier mode composite micro-powder

A drug and carrier technology, applied in the field of drug-carrier mode compound micropowder preparation

Active Publication Date: 2016-04-06
中国人民解放军63975部队
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above properties show that fumed silica is a good candidate material for drug dry powder inhaler carrier, but there is no research report on the application of fumed silica to drug dry powder inhaler carrier

Method used

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  • Preparation method for drug-carrier mode composite micro-powder
  • Preparation method for drug-carrier mode composite micro-powder
  • Preparation method for drug-carrier mode composite micro-powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] figure 1 It is the scanning electron microscope microscopic morphology of fumed silica. The geometric particle size of individual fumed silica particles is 5-20nm, and the geometric particle size of aggregates is 1-10μm. Fumed silica is divided into two types: hydrophobic and hydrophilic, and the corresponding type is selected according to the properties of the dispersion medium in the preparation of the composite micropowder.

Embodiment 2

[0040] Pentoxyverine citrate is a widely used non-addictive antitussive. In addition to its direct inhibitory effect on the respiratory center, it also has a weak atropine effect, which can slightly inhibit the endobronchial receptors and weaken the cough reflex. It can relax the spastic bronchial smooth muscle, reduce airway resistance, and is suitable for inhalation and local drug administration in the respiratory tract. The raw material of pentoxyverine citrate has a purity higher than 99%. It is fully dried and ground after recrystallization. Its macroscopic appearance is white powder. Scanning electron microscope microscopic appearance as figure 2 shown.

Embodiment 3

[0042] Pentoxyverine citrate suspended particles with a geometric particle size of 10-1000nm were prepared by high-pressure homogenization: disperse pentoxyverine citrate in isopropanol, and the concentration of pentoxyverine citrate was 1.5 twice the concentration of the saturated solution.

[0043] With 750Bar as the homogenization pressure, adjust the number of homogenization: when the number of homogenization is 1-2 times, the homogenization process is not smooth, there is clogging, and the geometric particle size of the suspended particles is greater than 1 μm; when the number of homogenization is 3-4 times, The homogenization process is smooth without clogging, and the geometric particle size of the suspended particles is 400-800nm; when the number of homogenization is 5 times, the geometric particle size of the suspended particles is 100-200nm; continue to increase the number of homogenizations, and choose 10 times of homogenization , 15 times, 20 times, 30 times, the g...

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Abstract

The invention discloses a preparation method for drug-carrier mode composite micro-powder. The composite micro-powder structure takes a fumed silica aggregate as a carrier; the fumed silica aggregate is located in the center of the composite micro-powder particles; drug particles are adsorbed on the surface of the carrier; the geometric particle size of the fumed silica aggregate is 1-30 microns; the geometric particle size of the drug particles is 10-1,000 nm; and the aerodynamic particle size of the composite micro-powder particles is less than 10 microns. The preparation method taking pentoxyverine citrate as a representative drug comprises the following steps: preparing a pentoxyverine citrate suspension with a high-pressure homogenization, reactive precipitation or anti-solvent precipitation method, wherein the geometric particle size of suspension particles is 10-1,000 nm; adding the fumed silica aggregate into the suspension, and mixing uniformly, wherein the mass percentage of the fumed silica aggregate to the pentoxyverine citrate is 15-60% to 40-85%; and spray-drying a mixed suspension to obtain the composite micro-powder. The preparation method is simple in process, low in cost and short in cycle. Compared with carrier-free mode micro-powder, the composite micro-powder has more excellent aerodynamic performance, lung deposition performance, flowability and dispersity.

Description

technical field [0001] The invention relates to a method for preparing a drug-carrier mode composite micropowder, which is used for inhalable drugs such as pentoxyverine citrate and drug dry powder inhalers. Background technique [0002] The drug is prepared into a dry powder inhaler for respiratory tract administration. Compared with traditional oral preparations, it has the advantages of convenient and direct administration, large absorption surface area, short drug exchange distance, high membrane permeability, low local enzyme activity, and avoids liver first pass. One of the key technologies to effectively achieve respiratory drug delivery is to prepare drug micropowders with an aerodynamic particle size of less than 10 μm (optimally less than 2.5 μm) and good dispersion and fluidity. According to the prescription composition of the drug dry powder inhaler, it can be divided into four types: no carrier mode, drug-carrier mode, drug-additive mode and drug-carrier-additiv...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/205A61K47/04A61P11/14
CPCA61K9/0073A61K9/167A61K31/205A61K47/02
Inventor 陈博黄永鹏钟辉焦剑岚邹传品唐慧王普慧何小伟孟祥燕刘利辉高振华郭永彪
Owner 中国人民解放军63975部队
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