High-pressure-resistant in-vitro release device
By designing a high-pressure resistant in vitro release device and using a gas compression device and a pressure relief valve to maintain a high-pressure environment, the problem in the existing technology that it is difficult to measure the release of microsphere preparations in a high-pressure environment has been solved, and the sustained-release microspheres under high pressure have been achieved. Accurate release testing.
Patent Information
- Application Number
- CN202421244781.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-06-03
- Publication Date
- 2025-01-21
- Estimated Expiration
- 2034-06-03
AI Technical Summary
The existing methods for measuring the in vitro release degree of microsphere preparations cannot guarantee sealing, making it difficult to maintain a high pressure state under a high pressure environment, and the device material cannot withstand high pressure, and there is a risk of air leakage, liquid leakage or even explosion.
A high-pressure resistant in vitro release device is designed, including a bottle, a gas compression device, a pressure gauge, a pressure relief valve and a valve system. The compressed gas is transported into the bottle through the compressed gas device, and the pressure relief valve is used to maintain the high-pressure environment, and the valve is used to maintain the high-pressure environment. The system controls the addition and removal of release media and microspheres.
It achieves accurate release testing of sustained-release microspheres in a high-pressure environment, avoids the risk of air leakage, liquid leakage and explosion, and facilitates subsequent experimental analysis.
Smart Images
Figure CN222379533U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of in vitro release determination of microsphere preparations, in particular to a high-pressure resistant in vitro release device. Background Art
[0002] The different dissolution and release test methods currently included in the pharmacopoeias of various countries are mainly due to the differences in dissolution test equipment. The design of dissolution test equipment mainly has two basic technical principles: stirring method and flow method. The stirring method is to place the sample in a container filled with a fixed volume of dissolution medium, and use a stirring device to mechanically stir the medium in the dissolution cup; the flow method is to place the sample in a flow cell and allow the specified dissolution medium to pass through the flow cell at a certain flow rate.
[0003] There are three main methods for determining the in vitro release of microsphere preparations: (1) direct release method, including shaking table method and constant temperature water bath static method; (2) flow cell method; and (3) dialysis membrane diffusion method.
[0004] The existing circulation cell method, dialysis membrane diffusion method, shaking table method and constant temperature water bath static method in direct drug release cannot ensure sealing due to their instrument structure, resulting in difficulty in maintaining high pressure after pressurization, or the material of the device cannot withstand high pressure, resulting in risks such as air leakage, liquid leakage and even explosion. Utility Model Content
[0005] In order to solve the problem that sustained-release microspheres are difficult to simulate the release at special administration sites such as high pressure, the utility model provides a high-pressure resistant in vitro release device, and the technical solution adopted is as follows:
[0006] A high pressure resistant in vitro release device, comprising:
[0007] A bottle body, wherein the upper end of the bottle body is sealedly connected to a bottle cap, the bottle cap is provided with a feeding tube for a microsphere to be tested and a liquid feeding tube for a release medium connected to the inside of the bottle body, and the feeding tube for the microsphere to be tested and the liquid feeding tube for the release medium are respectively provided with a first switch valve and a second switch valve;
[0008] A gas compression device, wherein the gas outlet of the gas compression device is connected to the upper part of the bottle body through a gas delivery pipe, and a third switch valve is provided on the gas delivery pipe;
[0009] Also included is a pressure gauge connected to the inside of the bottle body for detecting the gas pressure inside the bottle body;
[0010] and a pressure relief valve connected to the interior of the bottle.
[0011] Furthermore, a check valve is provided on the gas pipeline.
[0012] Furthermore, a drain pipe is connected to the lower part of the bottle body, and a fourth switch valve is arranged on the drain pipe.
[0013] Furthermore, a filter screen is provided on the drain pipe.
[0014] Furthermore, the pore size of the filter is 0.45-10 μm.
[0015] Furthermore, a discharge pipe is provided below the bottle body, and a discharge valve is provided on the discharge pipe.
[0016] The beneficial effects of the utility model are:
[0017] 1. Deliver compressed gas into the bottle through the compressed gas device until the pressure gauge shows that the pressure reaches the preset value of the experiment, and when the gas pipe is normally open, the pressure relief valve is used to maintain the high pressure environment in the bottle to improve the accuracy of the release test of the sustained-release microspheres under the preset pressure;
[0018] 2. A liquid discharge pipe and a material discharge pipe are arranged at the lower part of the bottle body, both of which are provided with switch valves, and a filter screen is also arranged on the liquid discharge pipe. Through the arrangement of this structure, after the experiment is completed, the releasable medium and the sustained-release microspheres can be taken out separately, which is convenient for subsequent experimental analysis. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Figure 1 This is a schematic diagram of the structure of the utility model
[0020] Among them, 1-bottle body, 2-bottle cap, 3-sustained-release microsphere feeding tube, 4-release medium feeding tube, 5-connecting tube, 6-pressure gauge, 7-pressure relief valve, 8-liquid discharge pipe, 9-discharge pipe, 10-filter screen, 11-first switch valve, 12-second switch valve, 13-third switch valve, 14-fourth switch valve, 15-discharge valve, 16-compressed gas tank, 17-gas transmission pipe, 18-check valve. DETAILED DESCRIPTION
[0021] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.
[0022] In the description of the utility model, it is necessary to understand that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the viewing direction or position relationship, and are only for the convenience of describing the utility model, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the utility model.
[0023] like Figure 1 The high-pressure resistant in vitro release device shown comprises a bottle body 1, a bottle cap 2 and a compressed gas tank 16. The bottle cap 2 is sealed and connected to the top of the bottle body 1. A sustained-release microsphere feeding tube 3, a release medium liquid feeding tube 4, a connecting tube 5 and a gas delivery tube 17 are arranged on the bottle cap 2. The upper end of the sustained-release microsphere feeding tube 3 is an open design, and a first switch valve 11 is arranged on the upper part, and the lower end is located inside the bottle body 1. One end of the release medium feeding tube 4 is located outside the bottle body 1, and the other end extends into the bottom of the bottle body 1. A second switch valve 12 is arranged on the release medium feeding tube 4, and the release medium can be added to the bottle body 1 through the release medium feeding tube 4. The lower end of the connecting tube 5 extends into the bottle body 1 and is located inside the bottle body 1. At the upper part of the bottle body 1, the upper end of the connecting pipe 5 extends to the outside of the bottle body 1 and is connected to a pressure gauge 6 and a pressure relief valve 7. The pressure gauge 6 can display the internal gas pressure of the bottle body 1. When the internal gas pressure of the bottle body 1 is higher than the preset value of the pressure relief valve 7, the internal gas of the bottle body 1 is discharged through the pressure relief valve 7; one end of the gas supply pipe 17 is connected to the compressed gas tank 16, and the other end is located at the upper part of the bottle body 1. The compressed gas enters the bottle body 1 through the gas supply pipe 17, and a third switch valve 13 and a check valve 18 are arranged on the gas supply pipe 17. The on-off of the gas supply pipe 17 is controlled by the third switch valve 13. The setting of the check valve 18 can prevent the gas and liquid from flowing back due to the pressure change inside the bottle body 1.
[0024] In addition, a drain pipe 8 is provided at the bottom of the bottle body 1, and a discharge pipe 9 is provided below. The drain pipe 8 and the discharge pipe 9 are respectively provided with a fourth switch valve 14 and a discharge valve 15, and a filter screen 10 is also provided on the drain pipe 8. The pore size of the filter screen 10 is 0.45 μm. When the sustained-release microspheres in the bottle body 1 are released and analyzed, the release medium liquid is taken out through the drain pipe 8, and the sustained-release microspheres in the liquid are removed through the set filter screen 10. After the liquid is taken out, the sustained-release microspheres in the bottle body 1 are taken out through the discharge pipe 9 for analysis.
[0025] When the sustained-release microsphere dissolution test is performed using the device, all valves are in a closed state. First, the first switch valve 11 is opened, and the sustained-release microspheres are added to the bottle body 1 through the sustained-release microsphere feeding tube 3, and the first switch valve 11 is closed; then the second switch valve 12 is opened, and an appropriate amount of release medium is added to the bottle body 1 through the release medium liquid adding tube 4, and the second switch valve 12 is closed; then the third switch valve 13 is opened, and compressed gas is filled into the bottle body 1 through the gas supply pipe 17 until the pressure gauge 6 displays the required pressure, and during the experiment, the third switch valve 13 is in an open state, and the pressure relief valve 17 is used to control the pressure of the bottle body 1. 7 Ensure that the internal pressure of the bottle body 1 is maintained at a preset high pressure state; the sustained-release microspheres are subjected to a release test under the set pressure. After the experiment, the third switch valve 13 is closed, and the first switch valve 11 is slowly opened to reduce the internal pressure of the bottle body 1 to prevent the liquid pressure inside the bottle body 1 from changing sharply and overflowing. When the pressure gauge 6 shows normal pressure, the fourth switch valve 14 is first opened to take out the release medium through the discharge pipe 8, and then the fourth switch valve 14 is closed, the discharge valve 15 is opened, and the sustained-release microspheres are taken out through the discharge pipe 9. Finally, the taken-out release medium and sustained-release microspheres are analyzed to obtain the dissolution test results.
[0026] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements can be made without departing from the principle of the present invention, and these improvements should also be regarded as the protection scope of the present invention.
Claims
1. A high pressure resistant in vitro release device, characterized in that: include: A bottle body, wherein the upper end of the bottle body is sealedly connected to a bottle cap, the bottle cap is provided with a feeding tube for a microsphere to be tested and a feeding tube for a release medium connected to the inside of the bottle body, and the feeding tube for the microsphere to be tested and the feeding tube for the release medium are respectively provided with a first switch valve and a second switch valve; A gas compression device, wherein the gas outlet of the gas compression device is connected to the upper part of the bottle body through a gas delivery pipe, and a third switch valve is provided on the gas delivery pipe; Also included is a pressure gauge connected to the inside of the bottle body for detecting the gas pressure inside the bottle body; and a pressure relief valve connected to the interior of the bottle.
2. The high pressure resistant in vitro release device according to claim 1, characterized in that: The gas delivery pipe is also provided with a check valve.
3. The high pressure resistant in vitro release device according to claim 1, characterized in that: The lower part of the bottle body is connected with a liquid discharge pipe, and the liquid discharge pipe is provided with a fourth switch valve.
4. The high pressure resistant in vitro release device according to claim 3, characterized in that: The liquid discharge pipe is provided with a filter screen.
5. The high pressure resistant in vitro release device according to claim 4, characterized in that: The pore size of the filter is 0.45-10 μm.
6. The high pressure resistant in vitro release device according to claim 1, characterized in that: A discharge pipe is arranged below the bottle body, and a discharge valve is arranged on the discharge pipe.