Test method and device for improving in-vivo and in-vitro correlation of inhaled preparation

A technology for inhaled preparations and testing equipment, which is applied in the field of testing and equipment to improve the in-vivo and in-vitro correlation of inhaled preparations, and can solve problems such as obvious gaps, inability to be simulated by cascade impactors, and inability to represent different groups of people.
CN110514384APending Publication Date: 2019-11-29SUZHOU SINGMED MEDICAL DEVICE SCI & TECH LTD
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Patent Information

Authority / Receiving Office
CN Β· China
Patent Type
Applications(China)
Current Assignee / Owner
SUZHOU SINGMED MEDICAL DEVICE SCI & TECH LTD
Publication Date
2019-11-29

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Abstract

In order to solve a plurality of defects of the aerodynamic characteristic determination of the micro-particles of the preparation by adopting a cascade impactor, the invention provides a test devicefor improving the in-vivo and in-vitro correlation of an inhaled preparation. The device comprises a drug delivery device 1, a human respiratory tract model 2 and a breathing simulator 3, wherein thehuman respiratory tract model 2 comprises an adapter 21 and a real human respiratory tract 3D solid model 22, the breathing simulator 3 comprises a connection control assembly 31, a piston type movement device 32, a control system 33 and a breathing data acquisition device 34, and the device is characterized in that the real human respiratory tract 3D solid model 22 is provided with a plurality offirst quick-connection interfaces 221, the plurality of first quick-connection interfaces 221 are finally converged into a total air path through a plurality of air paths and then connected to the inlet end of the connection control assembly 31, the outlet end of the connection control assembly 32 is connected to the piston type movement device 32; and the connection control assembly 31 comprisesa first solenoid valve 311, a second solenoid valve 312, a third solenoid valve 313, an electronic flow meter 315, and a main body air path.
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Description

technical field

[0001] The invention belongs to the technical field of medical devices. More specifically, the invention relates to a test method and equipment for improving the in vitro and in vivo correlation of inhalation preparations. The test method and equipment are used to evaluate the deposition of inhalation preparations in the human respiratory tract in vitro Improve the correlation between in vitro test results and in vivo test results, improve the accuracy of in vitro evaluation of inhalation preparations, and reduce the development time and in vivo test costs of inhalation preparations. Background technique

[0002] The respiratory system is an important part of the human body and an important way for the human body to exchange substances with the outside world. Of course, it is also the way for external particles to enter the respiratory tract. There are many diseases caused by the respiratory process, such as: asthma, chronic obstructive pulmonary disease (COP...

Claims

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