CN105784952A - Simple type test device for dissolution rate of flowing pool - Google Patents
Simple type test device for dissolution rate of flowing pool Download PDFInfo
- Publication number
- CN105784952A CN105784952A CN201610350457.4A CN201610350457A CN105784952A CN 105784952 A CN105784952 A CN 105784952A CN 201610350457 A CN201610350457 A CN 201610350457A CN 105784952 A CN105784952 A CN 105784952A
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- Prior art keywords
- flow cell
- simple type
- filter
- dissolution rate
- storage bottle
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- Pending
Links
- 238000004090 dissolution Methods 0.000 title claims abstract description 25
- 238000012360 testing method Methods 0.000 title claims abstract description 23
- 239000002904 solvent Substances 0.000 claims abstract description 34
- 230000002572 peristaltic effect Effects 0.000 claims abstract description 21
- 238000010438 heat treatment Methods 0.000 claims abstract description 19
- 238000007789 sealing Methods 0.000 claims abstract description 5
- 239000011521 glass Substances 0.000 claims description 10
- 230000008676 import Effects 0.000 claims description 5
- 229920002379 silicone rubber Polymers 0.000 claims description 5
- 239000004945 silicone rubber Substances 0.000 claims description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 4
- 238000001514 detection method Methods 0.000 claims description 4
- 229910002027 silica gel Inorganic materials 0.000 claims description 4
- 239000000741 silica gel Substances 0.000 claims description 4
- 229960001866 silicon dioxide Drugs 0.000 claims description 4
- 239000000178 monomer Substances 0.000 claims description 3
- 239000003814 drug Substances 0.000 abstract description 14
- 229940079593 drug Drugs 0.000 abstract description 8
- 239000003405 delayed action preparation Substances 0.000 abstract description 5
- 238000011160 research Methods 0.000 abstract description 5
- 239000007943 implant Substances 0.000 abstract description 4
- 239000004005 microsphere Substances 0.000 abstract description 3
- 238000000034 method Methods 0.000 description 12
- 239000007788 liquid Substances 0.000 description 3
- -1 microplate Substances 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 238000004458 analytical method Methods 0.000 description 2
- 239000011324 bead Substances 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000002502 liposome Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 230000002459 sustained effect Effects 0.000 description 2
- 239000002699 waste material Substances 0.000 description 2
- 101000809257 Homo sapiens Ubiquitin carboxyl-terminal hydrolase 4 Proteins 0.000 description 1
- 102100038463 Ubiquitin carboxyl-terminal hydrolase 4 Human genes 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000003365 glass fiber Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Analytical Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Abstract
The invention discloses a simple type test device for a dissolution rate of a flowing pool. The simple type test device comprises the flowing pool, a filter, a multichannel peristaltic pump, a heating pool, a solvent storage bottle and a controller, wherein an upper opening of the flowing pool is in sealing connection with one opening of the filter; the other opening of the filter is communicated with the solvent storage bottle through a hose a; a lower opening of the flowing pool is connected with one end of a hose b; the other end of the hose b is connected with an outlet of the multichannel peristaltic pump; an inlet of the multichannel peristaltic pump is communicated with the solvent storage bottle through a hose c; the flowing pool is arranged in the heating pool. The simple type test device can work in an open or closed form; the heating temperature and the solvent flow rate are controlled; the simple type test device has the characteristics of simple structure, convenience in operation, low cost, and the like and is fit for determining the releasing rate of various drug sustained-release preparations, such as drug release brackets, implants, microspheres, microchips, lipidosome, of institutions of colleges, research institutions, pharmaceutical factory, and the like.
Description
Technical field
The invention belongs to drug dissolution experimental technique field, particularly to a kind of simple type flow cell Dissolution Rate Testing device.
Background technology
Dissolution Rate Testing is the standard detection project of drug quality security system, and regardless of whether the biological effect of dissolution result with medicine has dependency, the Dissolution Rate Testing of standard is to investigate a kind of simple, the cheap method whether medicine physical characteristic is consistent.Flow cell method is the technology grown up for the difficulty that cannot overcome in existing dissolution test method, it is applicable not only to the dissolution determination of the oral administration solid regular pharmaceutics such as tablet, capsule, is particularly suited for the drug release determination of the various medicine sustained and controlled release preparations such as drug releasing stent, implant, microsphere, microplate, liposome.Flow cell method has caused the attention of various countries, its method has been recorded in the existing pharmacopeia annex such as American and Britain, day, Europe, its device has been carried out developmental research, SOTAX company of Switzerland is proposed First flow cell method instrument the seventies, develops CE7smart subsequently and automatically flows pond method (USP4) dissolution instrument.But, the flow cell method instrument price sold at present is much more expensive, and the application development, particularly China that hinder flow cell method are just at the early-stage to the research of flow cell method, domestic develops research but without to its device.
Summary of the invention
The invention aims to solve above-mentioned existing issue and a kind of simple type flow cell Dissolution Rate Testing device is provided, this device is operable with open or closed, heating-up temperature, solvent flow velocity can be controlled, there is simple in construction, easy to operate, lower-price characteristic.
For achieving the above object, the technical solution adopted in the present invention is: a kind of simple type flow cell Dissolution Rate Testing device, it includes flow cell, filter, Heating pool, solvent storage bottle, multi-channel peristaltic pump and controller thereof, described flow cell upper port and filter Single port are tightly connected, the another port of filter connects with described solvent storage bottle through flexible pipe a, described flow cell lower port is connected with flexible pipe b one end, the flexible pipe b other end is connected with the outlet of multi-channel peristaltic pump, the import of multi-channel peristaltic pump connects with described solvent storage bottle through flexible pipe c, described flow cell is placed in Heating pool.
Further, the mid portion of described flow cell is column type glass, and top is the annulus of section frosted, bottom is inverted cone shape, the inside filling glass pearl, column type glass medial wall is provided with round bayonet socket, and bayonet socket is arranged over the support for placing sample.
Further, described filter is conical filter, arranges that silicagel pad sealing screw rod is fixing to be connected between flow cell upper port with inverted filter upper port, and the lower port of filter is provided with joint a, joint a connects flexible pipe a one end, and the flexible pipe a other end inserts in solvent storage bottle.
Further, the import connected between described multi-channel peristaltic pump and described solvent storage bottle is provided with microflow sensor through flexible pipe c.
Further, described solvent storage bottle has thermostatic heater.
Further, silicone rubber hot plate and temperature sensor it are provided with bottom described Heating pool.
Further, described controller includes interconnective single-chip microcomputer, LCD touch screen, temperature detection and control circuit, peristaltic pump drive circuit and Switching Power Supply.
Further, 6 set flow cell monomers it are provided with in described Heating pool.
Owing to adopting said structure, when carrying out Dissolution Rate Testing, being placed on the support in flow cell by sample such as solid preparation, Heating pool temperature is maintained at 37 DEG C, carries out medicine release when solvent flows continuously.Medium in solvent storage bottle bottom up through flow cell under the effect of peristaltic pump flows through flow cell, and with filter by insoluble particulate leaching, the bead filled up bottom flow cell ensures liquid stream retaining layer stream mode.
This device working method has open and closed, and evolution formula does not limit solvent volume, and only some is used for analyzing eluate, and other is then drained as waste liquid.Open being generally used for needs to change pH value or automatic sampling and analysis for long period test.When working in open, the solvent flowed out through flow cell is discharged in waste liquid bottle, when sampling, utilizes sample bottle to be directly connected to effluent.Microflow sensor detects solvent flow velocity constantly, and peristaltic pump flow rate regulation ranges for 1～30mL/min.Closed circulate in each flow cell for solvent, be generally used for small size dissolution or the dissolution of some unique dosage forms, such as powder, granule, micropill, implant etc..When working in closed, solvent circulates through solvent storage bottle, when needs sample, takes sample analysis to be detected with liquid-transfering gun from solvent storage bottle.
The invention has the beneficial effects as follows, one is provided to be operable with open or enclosed simple type flow cell Dissolution Rate Testing device, this device can control heating-up temperature, solvent flow velocity, there is simple in construction, easy to operate, lower-price characteristic, it is adaptable to the drug release determination of the various medicine sustained and controlled release preparations such as the drug releasing stent of the units such as colleges and universities, research institution, pharmaceutical factory, implant, microsphere, microplate, liposome.
Below in conjunction with the drawings and specific embodiments, the present invention is described in detail.
Accompanying drawing explanation
Fig. 1 is the structural representation of the present invention.
1. joint a, 2. filter, 3. screw rod, 4. silicagel pad in accompanying drawing, 5. bayonet socket and support, 6. flow cell, 7. temperature sensor, 8. silicone rubber hot plate, 9. sealing gasket, 10. flexible pipe b, 11 multi-channel peristaltic pumps, 12. controllers, 13. microflow sensor, 14. thermostatic heaters, 15. solvent storage bottle, 16. flexible pipe c, 17. flexible pipe a, 18. samples, 19. Heating pool, 20. beades, 21. joint b.
Detailed description of the invention
A kind of simple type flow cell Dissolution Rate Testing device, it includes flow cell 6, filter 2, Heating pool 19, solvent storage bottle 15, multi-channel peristaltic pump 11 and controller 12 thereof.The centre of described flow cell 6 is column type glass, and volume is 20mL, and top is the annulus of section frosted, and internal radius is 22mm, and bottom is inverted cone shape, the inside filling glass pearl 20.Set bayonet socket and support 5 in column type glass, be namely provided with round bayonet socket in glass medial wall, bayonet socket support disposed above, support is placed sample mouth 18, such as solid preparation.Described filter 2 is conical filter, arrange silicagel pad 4 between flow cell 6 upper port with inverted filter 2 upper port seal and use that screw rod 3 is fixing to be connected, the lower port of filter 2 is provided with joint a1, joint a1 connects 1/8 inch hose a17 one end, and the flexible pipe a17 other end inserts in solvent storage bottle 15；Flow cell 6 cone lower end is provided with joint b21, flexible pipe b10 one end is connected by joint b21, the flexible pipe b10 other end through with Heating pool 19 body after connecting multi-channel peristaltic pump 11 export, it is provided with waterproof sealing gasket 9 between flexible pipe b10 and Heating pool 19 body, multi-channel peristaltic pump 11 import connects flexible pipe c16, the flexible pipe c16 other end inserts in solvent storage bottle 15 by microflow sensor 13, is provided with thermostatic heater 14 bottom solvent storage bottle 15.Be provided with bottom described Heating pool 19 silicone rubber hot plate 8 and in set temperature sensor 7；6 set flow cell 6 monomers can be provided with in described Heating pool 19.Described controller 12 includes interconnective single-chip microcomputer, LCD touch screen, temperature detection and control circuit, peristaltic pump drive circuit and Switching Power Supply, and controller 12 connects control multi-channel peristaltic pump 11, microflow sensor 13, temperature sensor 7, silicone rubber hot plate 8.
Time specifically used, having connected pipeline according to working method, placed sample medicine, put in Heating pool after upper filter in flow cell, water temperature is 37 DEG C.When fluid needs laminar flow, in the cone of flow cell lower end, fill up diameter 1～3mm bead.Select suitable solvent storage bottle according to solvent volume, generally take 50～100mL, select the filter membrane in suitable aperture to prevent excessive negative pressure, suitable material will be selected, such as glass fibre, cellulose, woollen goods etc..
The present invention is described by embodiment, and those skilled in the art know, without departing from the spirit and scope of the present invention, it is possible to these features and embodiment carry out various change or equivalence is replaced.It addition, under the teachings of the present invention, it is possible to modify these features and embodiment to adapt to concrete situation and material without departing from the spirit and scope of the present invention.Therefore, the present invention is not limited to the particular embodiment disclosed, and the embodiment within the scope of fallen with claims hereof broadly falls into protection scope of the present invention.
Claims (8)
1. a simple type flow cell Dissolution Rate Testing device, it is characterized in that including flow cell, filter, Heating pool, solvent storage bottle, multi-channel peristaltic pump and controller thereof, described flow cell upper port and filter Single port are tightly connected, the another port of filter connects with described solvent storage bottle through flexible pipe a, described flow cell lower port is connected with flexible pipe b one end, the flexible pipe b other end is connected with the outlet of multi-channel peristaltic pump, the import of multi-channel peristaltic pump connects with described solvent storage bottle through flexible pipe c, and described flow cell is placed in Heating pool.
2. a kind of simple type flow cell Dissolution Rate Testing device according to claim 1, it is characterized in that the mid portion of described flow cell is column type glass, top is the annulus of section frosted, bottom is inverted cone shape, the inside filling glass pearl, column type glass medial wall is provided with round bayonet socket, and bayonet socket is arranged over the support for placing sample.
3. a kind of simple type flow cell Dissolution Rate Testing device according to claim 1, it is characterized in that described filter is conical filter, arrange between flow cell upper port with inverted filter upper port that silicagel pad sealing screw rod is fixing to be connected, the lower port of filter is provided with joint a, joint a connects flexible pipe a one end, and the flexible pipe a other end inserts in solvent storage bottle.
4. a kind of simple type flow cell Dissolution Rate Testing device according to claim 1, is characterized in that the import connected between described multi-channel peristaltic pump and described solvent storage bottle is provided with microflow sensor through flexible pipe c.
5. a kind of simple type flow cell Dissolution Rate Testing device according to claim 1, is characterized in that described solvent storage bottle has thermostatic heater.
6. a kind of simple type flow cell Dissolution Rate Testing device according to claim 1, is characterized in that being provided with bottom described Heating pool silicone rubber hot plate and temperature sensor.
7. a kind of simple type flow cell Dissolution Rate Testing device according to claim 1, is characterized in that described controller includes interconnective single-chip microcomputer, LCD touch screen, temperature detection and control circuit, peristaltic pump drive circuit and Switching Power Supply.
8. a kind of simple type flow cell Dissolution Rate Testing device according to claim 1, is characterized in that being provided with 6 set flow cell monomers in described Heating pool.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610350457.4A CN105784952A (en) | 2016-05-25 | 2016-05-25 | Simple type test device for dissolution rate of flowing pool |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610350457.4A CN105784952A (en) | 2016-05-25 | 2016-05-25 | Simple type test device for dissolution rate of flowing pool |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105784952A true CN105784952A (en) | 2016-07-20 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610350457.4A Pending CN105784952A (en) | 2016-05-25 | 2016-05-25 | Simple type test device for dissolution rate of flowing pool |
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| Country | Link |
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106442904A (en) * | 2016-09-23 | 2017-02-22 | 梁永革 | Test instrument for dissolution rate of drugs |
| CN107525901A (en) * | 2017-09-20 | 2017-12-29 | 湖南慧泽生物医药科技有限公司 | Differential digestion instrument and pharmaceutical preparation dissolution consistency detecting method |
| CN109212145A (en) * | 2018-10-24 | 2019-01-15 | 东北师范大学 | A kind of novel high time resolution on-line checking drug-eluting process analysis method |
| CN109827875A (en) * | 2019-04-10 | 2019-05-31 | 上海市食品药品检验所 | A kind of device and method for measuring sucking preparation dissolution rate |
| CN112114100A (en) * | 2020-09-02 | 2020-12-22 | 禄亘(上海)国际贸易有限公司 | Automatic drug testing system and method by flow cell method |
| CN112114101A (en) * | 2020-09-02 | 2020-12-22 | 禄亘(上海)国际贸易有限公司 | Coil heating device of flow cell method |
| CN112129903A (en) * | 2020-09-02 | 2020-12-25 | 禄亘(上海)国际贸易有限公司 | Solvent switching system of flow cell method |
| CN112284822A (en) * | 2020-09-30 | 2021-01-29 | 深圳市锐拓仪器设备有限公司 | Automatic sampling device of dissolution instrument by flow cell method |
| CN112285304A (en) * | 2020-09-30 | 2021-01-29 | 深圳市锐拓仪器设备有限公司 | Flow cell device of dissolution instrument by flow cell method |
| CN113092456A (en) * | 2021-03-20 | 2021-07-09 | 河南省科学院地理研究所 | Quick detection device of Tessier ion exchange state hexavalent chromium in soil |
| CN113433277A (en) * | 2021-08-08 | 2021-09-24 | 湖南慧泽生物医药科技有限公司 | Circulating dissolution instrument system for in-vitro dissolution of medicine and method for detecting dissolution of medicine |
| CN113777207A (en) * | 2021-09-09 | 2021-12-10 | 安徽省食品药品检验研究院(安徽国家农副加工食品质量监督检验中心) | Determination method of gliclazide sustained release tablet dissolution curve, similarity evaluation method and application thereof |
| CN114868019A (en) * | 2019-11-15 | 2022-08-05 | 纳米制药有限公司 | In Vitro Release Testing (IVRT) device for oral inhalation of pharmaceutical products |
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Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106442904B (en) * | 2016-09-23 | 2018-08-17 | 梁永革 | A kind of drug dissolution tester |
| CN106442904A (en) * | 2016-09-23 | 2017-02-22 | 梁永革 | Test instrument for dissolution rate of drugs |
| CN107525901A (en) * | 2017-09-20 | 2017-12-29 | 湖南慧泽生物医药科技有限公司 | Differential digestion instrument and pharmaceutical preparation dissolution consistency detecting method |
| CN109212145A (en) * | 2018-10-24 | 2019-01-15 | 东北师范大学 | A kind of novel high time resolution on-line checking drug-eluting process analysis method |
| CN109827875A (en) * | 2019-04-10 | 2019-05-31 | 上海市食品药品检验所 | A kind of device and method for measuring sucking preparation dissolution rate |
| CN114868019A (en) * | 2019-11-15 | 2022-08-05 | 纳米制药有限公司 | In Vitro Release Testing (IVRT) device for oral inhalation of pharmaceutical products |
| CN112114100A (en) * | 2020-09-02 | 2020-12-22 | 禄亘(上海)国际贸易有限公司 | Automatic drug testing system and method by flow cell method |
| CN112114101A (en) * | 2020-09-02 | 2020-12-22 | 禄亘(上海)国际贸易有限公司 | Coil heating device of flow cell method |
| CN112129903A (en) * | 2020-09-02 | 2020-12-25 | 禄亘(上海)国际贸易有限公司 | Solvent switching system of flow cell method |
| CN112284822A (en) * | 2020-09-30 | 2021-01-29 | 深圳市锐拓仪器设备有限公司 | Automatic sampling device of dissolution instrument by flow cell method |
| CN112285304A (en) * | 2020-09-30 | 2021-01-29 | 深圳市锐拓仪器设备有限公司 | Flow cell device of dissolution instrument by flow cell method |
| CN113092456A (en) * | 2021-03-20 | 2021-07-09 | 河南省科学院地理研究所 | Quick detection device of Tessier ion exchange state hexavalent chromium in soil |
| CN113092456B (en) * | 2021-03-20 | 2022-07-19 | 河南省科学院地理研究所 | Quick detection device of Tessier ion exchange state hexavalent chromium in soil |
| CN113433277A (en) * | 2021-08-08 | 2021-09-24 | 湖南慧泽生物医药科技有限公司 | Circulating dissolution instrument system for in-vitro dissolution of medicine and method for detecting dissolution of medicine |
| CN113433277B (en) * | 2021-08-08 | 2022-04-01 | 湖南慧泽生物医药科技有限公司 | Circulating dissolution instrument system for in-vitro dissolution of medicine and method for detecting dissolution of medicine |
| CN113777207A (en) * | 2021-09-09 | 2021-12-10 | 安徽省食品药品检验研究院(安徽国家农副加工食品质量监督检验中心) | Determination method of gliclazide sustained release tablet dissolution curve, similarity evaluation method and application thereof |
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