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A preparation method of drug-additive mode composite micropowder

A technology of additives and drugs, applied in the field of drug-additive mode composite micropowder preparation

Active Publication Date: 2018-05-25
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 indicate that fumed silica, especially modified fumed silica, is a good candidate material for pharmaceutical dry powder inhaler additives, but there is no research report on its application in pharmaceutical dry powder inhaler additives

Method used

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  • A preparation method of drug-additive mode composite micropowder
  • A preparation method of drug-additive mode composite micropowder
  • A preparation method of drug-additive mode composite micropowder

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Experimental program
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Effect test

Embodiment 1

[0028] figure 1 It is the scanning electron microscope microscopic morphology of fumed silica. The geometric particle size of fumed silica particles is 5-20nm, the shape is irregular, and there is obvious agglomeration between particles.

Embodiment 2

[0030] figure 2 It is the scanning electron microscope microscopic morphology of fumed silica modified by hexamethylcyclotrisilazane. Hexamethylcyclotrisilazane modified fumed silica particles have a geometric particle size of 10-20nm, a regular spherical shape, and no obvious agglomeration.

[0031] Modifier hexamethylcyclotrisilazane modified fumed silica process: add 10g of fumed silica to the reactor, stir continuously at room temperature, add 1g of modifier dropwise, and the reaction by-product ammonia is condensed by reflux After the modifier is added dropwise, continue to stir for 1 hour; after the modification, nitrogen gas is introduced to completely remove the residual ammonia; centrifuge and wash with ethanol for 2-3 times, and dry to constant weight.

[0032] When the same modification process is adopted, the hexamethyldisilazane-modified fumed silica particles have a geometric particle size of 10-30 nm, a regular spherical shape, and no obvious agglomeration. T...

Embodiment 3

[0034] 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%. After recrystallization, it is fully dried and ground. Its macroscopic appearance is white powder. The microscopic appearance of the scanning electron microscope is blocky particles. Scanning electron microscope microscopic appearance as image 3 shown.

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Abstract

The invention discloses a preparing method of medicine-additive mode composite micro powder. The composite micro powder is structurally characterized in that medicine particles with the geometric particle size of 1-10 microns are located in the centers, additive modified gas-phase white carbon black with the geometric particle size of 10-65 nm are adsorbed to the surfaces of the medicine particles, and the aerodynamics particle size of particles of the composite micro powder is smaller than 10 microns. The preparing method with pentoxyverine as representative medicine includes the following steps that a modifying agent for the modified gas-phase white carbon black is prepared from one or more of hexamethyldisilazane, cyclo-silazane and octyltriethoxysilane, and the geometric particle size of the modified gas-phase white carbon black is 10-65 nm; pentoxyverine turbid liquid is prepared, wherein the geometric particle size of turbid particles is 1-10 microns; the modified gas-phase white carbon black is added into the turbid liquid, wherein the mass percent of the additive to the medicine is 10-70%:30-90%; the mixed turbid liquid is subjected to spray drying, and the composite micro powder is obtained. The preparing method is simple in technology, low in cost and short in period. Compared with carrier-free-mode micro powder, the composite micro powder has the more excellent aerodynamics performance, the more excellent lung deposition performance, the more excellent fluidity and the more excellent dispersion degree.

Description

technical field [0001] The invention relates to a method for preparing a drug-additive 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-additi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K9/72A61K31/205A61K47/04A61K47/24A61P11/14
CPCA61K9/0073A61K9/145A61K31/205
Inventor 陈博钟辉黄永鹏邹传品焦剑岚何小伟孟祥燕王普慧唐慧刘利辉高振华郭永彪
Owner 中国人民解放军63975部队
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