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Device and method for measuring dissolution of inhalation preparation

A technology for inhalation preparations and dissolution rate, which is applied in the field of devices for measuring the dissolution rate of inhalation preparations, can solve problems such as the vacancy of dissolution devices, and achieve the effects of convenient operation, convenient sampling, and simple application

Pending Publication Date: 2019-05-31
SHANGHAI INST FOR FOOD & DRUG CONTROL
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In order to overcome the problems in the prior art, the present invention proposes a device and method for measuring the dissolution rate of inhalation preparations, which solves the problem of the vacancy of the dissolution device in the prior art when the dissolution rate of inhalation administration is measured. The present invention inhales The dissolution device for the drug dissolution test simulates the dissolution environment of the lungs, the dissolution medium is used in a small amount and circulates, the sampling is convenient, and it can accurately and completely determine different types of inhalation drug preparations, with wide applicability

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  • Device and method for measuring dissolution of inhalation preparation
  • Device and method for measuring dissolution of inhalation preparation
  • Device and method for measuring dissolution of inhalation preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0051] This embodiment relates to a device for determining the dissolution rate of inhalation preparations, such as Figure 1~4 As shown, the above-mentioned device includes a DUSA tube 1 for sample collection, a flowmeter connector 2 and a vacuum pump connector 3 installed on both ends of the DUSA tube 1, and a fixed frame 4 for fixing the DUSA tube 1 for storing the dissolution medium The dissolution medium container 10, the heat preservation device 5 for keeping the dissolution medium warm, the dissolution medium pump 6 for driving the dissolution medium to circulate, the flowmeter connector 2, the vacuum pump connector 3 and the dissolution medium pump 6 are respectively connected with First pipeline 7 , second pipeline 8 and third pipeline 9 .

[0052] In a preferred embodiment, the heat preservation device 5 is a water bath. The first pipeline 7, the second pipeline 8 and the third pipeline 9 are all hoses. The dissolution medium pump 6 is a peristaltic pump. The fixi...

Embodiment 2

[0057] This embodiment is a method for measuring the dissolution rate of an inhalation preparation using the device in Example 1, which includes the following steps:

[0058] Step 1. Open the heat preservation device, adjust the dissolution temperature, and place the dissolution medium container in the heat preservation device for heat preservation, wherein the dissolution medium is 0.2mol / L phosphate buffer (pH=7.4);

[0059] Step 2. Take an appropriate amount of inhalation preparation sample, place the DUSA tube in the delivery dose uniformity test device for sampling, after the sampling is completed, remove the DUSA tube from the delivery dose uniformity test device, install the vacuum pump connector, and install it on a fixed On the rack, fill glass beads in the DUSA tube, cover the glass beads with round filter paper, and install the flowmeter connector;

[0060] Step 3: The flow meter connector is connected to the dissolution medium container through the first pipeline; ...

Embodiment 3

[0064] This example is to apply the device described in Example 1 and the method described in Example 2 to carry out the dissolution test of inhalation powder aerosol.

[0065] (1) Purpose: To study the dissolution test method of solid preparations for pulmonary administration, formulate a reasonable measurement method, and compare the in vitro release behavior of domestic and foreign powder aerosols in the market, so as to advance the quality standard of powder aerosols lay the foundation.

[0066] (2) Test object

[0067] There are 4 batches of budesonide powder and salmeterol-ticasone powder, see Table 1 for details.

[0068] Table 1 collects sample information

[0069]

[0070] (3) Progress of dissolution test protocol

[0071] Take an appropriate amount of powder aerosol sample, according to the method under item 0111 of the Four General Rules of the Chinese Pharmacopoeia 2015 Edition, use the delivery dose uniformity measurement device, collect the powder aerosol p...

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Abstract

The invention relates to a device for measuring dissolution of an inhalation preparation. The device comprises a DUSA pipe, a dissolution medium pump and a dissolution medium container, wherein a flowmeter connecting head and a vacuum pump connecting head are respectively mounted at both ends of the DUSA pipe; the flowmeter connecting head is connected with the dissolution medium container througha first pipeline; the dissolution medium container is connected with one end of the dissolution medium pump through a second pipeline; and the vacuum pump connecting head is connected with the otherend of the dissolution medium pump through a third pipeline. The invention further relates to a method for measuring the dissolution of the inhalation preparation by adopting the above device. The dissolution device of the inhalation preparation makes up the vacancy of the existing dissolution device, the dissolution method is simple to operate, simulates the lung dissolution environment, is convenient to sample, adopts closed circulation dissolution in the whole dissolution process, is simple to apply and convenient to operate, and less in use of the dissolution medium in the whole dissolution process, and can select multiple operation parameters according to actual needs, so that the feasibility of a dissolution test of the inhalation preparation and the reliability of a dissolution result are guaranteed.

Description

technical field [0001] The invention relates to the field of medical testing equipment, in particular to a device and method for measuring the dissolution rate of inhalation preparations. Background technique [0002] Inhalation administration refers to the administration method in which one or more drugs enter the lungs deep in the respiratory tract through a special drug delivery device to exert local or systemic effects. In recent years, with the increasing proportion of respiratory diseases and the advantages of inhalation in the treatment of local or systemic diseases, inhalation therapy has been recommended by many countries for the prevention and treatment of asthma, chronic obstructive pulmonary diseases (COPD), etc. Preferred mode of administration for respiratory diseases. After years of research and development, inhalation drug delivery has shown broad application prospects in the treatment of diseases such as tuberculosis, diabetes, viral influenza, pulmonary in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N13/00G01N30/74G01N30/06
Inventor 陈桂良陈钢郑璐侠邵泓严翠霞
Owner SHANGHAI INST FOR FOOD & DRUG CONTROL
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