CN101424677B - Medicament dissolution instrument capable of on-line degassing - Google Patents
Medicament dissolution instrument capable of on-line degassing Download PDFInfo
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- CN101424677B CN101424677B CN 200810105704 CN200810105704A CN101424677B CN 101424677 B CN101424677 B CN 101424677B CN 200810105704 CN200810105704 CN 200810105704 CN 200810105704 A CN200810105704 A CN 200810105704A CN 101424677 B CN101424677 B CN 101424677B
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- dissolution medium
- mode
- digestion instrument
- dissolution
- heating
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- 238000004090 dissolution Methods 0.000 title claims abstract description 12
- 239000003814 drug Substances 0.000 title abstract description 14
- 238000007872 degassing Methods 0.000 title description 3
- 239000012738 dissolution medium Substances 0.000 claims abstract description 42
- 230000029087 digestion Effects 0.000 claims description 27
- 238000010438 heat treatment Methods 0.000 claims description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 25
- 238000005057 refrigeration Methods 0.000 claims description 24
- 125000004122 cyclic group Chemical group 0.000 claims description 12
- 238000002604 ultrasonography Methods 0.000 claims description 11
- 230000000694 effects Effects 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 4
- 230000002452 interceptive effect Effects 0.000 claims description 2
- 230000006641 stabilisation Effects 0.000 claims description 2
- 238000011105 stabilization Methods 0.000 claims description 2
- 238000012360 testing method Methods 0.000 abstract description 6
- 230000007547 defect Effects 0.000 abstract 1
- 239000007789 gas Substances 0.000 description 18
- 238000007922 dissolution test Methods 0.000 description 11
- 239000002609 medium Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 238000002525 ultrasonication Methods 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 1
- 238000009506 drug dissolution testing Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 239000001307 helium Substances 0.000 description 1
- 229910052734 helium Inorganic materials 0.000 description 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
Landscapes
- Degasification And Air Bubble Elimination (AREA)
Abstract
The invention belongs to a medicine dissolution speed checker in the field of medical check, particularly to a medicine dissolution meter which has on-line deaeration. The medicine dissolution meter is characterized in that the medicine dissolution meter can simultaneously carry out on-line deaeration when heats dissolution media without separately deaerating the dissolution media. Because medicine dissolution meter can carry out on-line deaeration and no other deaeration device is required, the use of other deaeration devices is reduced, the labor intensity is lowered, the time is saved, and the efficiency is increased. Meanwhile, the dissolution meter avoids the defect that the deaeration of the dissolution media is not complete caused by the gas goes into the dissolution media again, and improves the uniformity and the accuracy of the test.
Description
Technical field
The invention belongs to the dissolution testing instrument in the medicine inspection field, more specifically say a kind of can be online degassed medicament dissolution instrument.
Background technology
China's pharmacopeia regulation is made dissolution test to hundreds of kind medicine, from now on medicine is carried out will getting more and more of dissolution test.When medicine carried out dissolution test, the gas in the dissolution medium had a great impact the stripping behavior of medicine, so China and the world's each edition pharmacopeia be when all stipulating to carry out dissolution test, and dissolution medium will carry out degassed processing.Therefore carry out needing to carry out degassed to dissolution medium first before the medicine dissolving out experimental, taken off and put into again digestion instrument behind the gas and heat, test again after reaching set point of temperature (37 ℃ ± 0.5 ℃) in medium, before testing, need so setup time of growing, and increased labour intensity, and dissolution medium carry out degassed after, can enter into dissolution medium by some gas again in the process of putting into digestion instrument, particularly sometimes degassedly do not put into stripping rotor immediately after complete and just put into digestion instrument after having placed a period of time and test, because it is a dynamic process that gas dissolves in water, can some gas dissolve in the dissolution medium again in the put procedure, therefore cause degassed not exclusively, affect Tasting repeatability.
Summary of the invention
The objective of the invention is to overcome above-mentioned shortcoming, digestion instrument is carried out degassed online in the process to dissolution medium heating and insulation, owing to carrying out degassed online, can be degassed more complete, simultaneously separately dissolution medium is not carried out degassed processing at needs, therefore reduce labour intensity, reduced test setup time, improved work efficiency.
The present invention realizes in the following manner: the basis at existing digestion instrument increases degas system, can be degassed online to carrying out in the dissolution medium heating, thus no longer need again dissolution medium to be carried out separately degassed processing.
Described degas system can adopt the ultrasonic degas mode; The heat de-airing mode; The vacuum outgas mode.Described degas system also can adopt: the ultrasonic degas mode, and the heat de-airing mode adds the degassed mode of helium, any two kinds of combinations in the vacuum outgas mode; Or all combinations; Remove more thoroughly purpose of gas thereby arrive.
Described ultrasonic degas mode is: by ultrasonic generator, can launch ultrasound wave at the digestion instrument dress in water bath, by hyperacoustic effect, thereby reach the purpose that the gas in the dissolution medium is removed.
Described heat de-airing mode is: with heat-barrier material water bath is divided into two parts, be provided with valve between two parts, valve-off can become two parts with the moisture in the water bath, two parts water can fully mix after opening valve, a part has refrigeration cycle, a part has Heating Cyclic, stripping rotor is in Heating Cyclic, heating and refrigeration switch are by Single-chip Controlling, when starting digestion instrument, the heating of Heating Cyclic part beginning raises the temperature of dissolution medium, refrigeration cycle partly begins refrigeration, and the coolant-temperature gage in the refrigeration cycle is reduced; The stable of dissolution medium reaches 40 ℃-60 ℃ after a period of time, because the effect of heating, thereby arrive the purpose that the gas in the dissolution medium is removed, at this moment opening valve mixes the water of thermal cycle part and the water of cold cyclic part, the dissolution medium temperature reduces, by Single-chip Controlling heating and refrigeration switch, the temperature stabilization that the control water temperature makes dissolution medium can carry out dissolution determination at 36.5 ℃-37.5 ℃.
Described vacuum outgas mode is: being provided with packoff can link to each other with stripping rotor, and has a vacuum generating device of being equipped with, vacuum generating device links to each other with packoff by pipeline, can produce vacuum on the top of stripping rotor after opening vacuum plant, thereby reach the purpose that the gas in the molten medium is removed.
Described ultrasound wave occurring mode can adopt: unifrequency is sent out the mode of shaking, and changes the amplitude mode, interactive frequency change mode, and colleague's multi-frequency is sent out the mode of shaking, and energy collecting type is sent out the mode of shaking.
Described refrigeration modes can adopt: material freezing by change of state mode, gas expansion refrigeration modes, adiabatic delivery refrigeration of gases mode, some refrigeration heat mode, air whirl refrigeration modes.
Described vacuum generating device can adopt vacuum generator, vacuum pump.
Effect of the present invention: because the present invention can be degassed online, and do not need other degassing equipment, therefore reduced the use of other degassing equipment, reduced laborer's labour intensity, owing to when carrying out heat tracing, carrying out degassed, therefore saved the time, improved efficient, simultaneously because this device is degassed online, has avoided the gas secondary to enter and caused dissolution medium degassed not exclusively in the dissolution medium, therefore this digestion instrument has improved the accuracy of test, and homogeneity.
Embodiment
To further instruction of the present invention, but these embodiment can not produce any restriction to the present invention with following embodiment for we.
Embodiment 1
The online degassed digestion instrument of ultrasound wave
In the water bath of present stripping, ultrasonic generator is housed, during work in the dissolution medium heating, open degassed switch, then ultrasonic generator is to the water bath emission ultrasound wave of digestion instrument, because the gas that hyperacoustic effect is contained in the dissolution medium in the stripping rotor is removed, then can carry out dissolution test after being heated to design temperature, the ultrasonic circuit switch is by Single-chip Controlling simultaneously, in case dissolution test begins, then Single-chip Controlling is cut off ultrasonic circuit, even press the ultrasonic degas switch this moment, ultrasonic generator can not worked yet, prevent when carrying out dissolution test, push the wrong to build and cause occuring ultrasonication.
Embodiment 2
Heat online degassed digestion instrument
With heat-barrier material water bath is divided into two parts, be provided with valve between two parts, valve-off can become two parts with the moisture in the water bath, two parts water can fully mix after opening valve, a part has refrigeration cycle, a part has Heating Cyclic, stripping rotor is in Heating Cyclic, heating and refrigeration switch are by Single-chip Controlling, when starting digestion instrument, the heating of Heating Cyclic part beginning raises the temperature of dissolution medium, refrigeration cycle partly begins refrigeration, and the coolant-temperature gage in the refrigeration refrigeration cycle is reduced; The stable of dissolution medium reaches to 40 ℃-60 ℃ after a period of time, because the effect of heating, thereby arrive the purpose that the gas in the dissolution medium is removed, at this moment opening valve mixes the water of thermal cycle part and the water of cold cyclic part, the dissolution medium temperature reduces, by Single-chip Controlling heating and refrigeration switch, the temperature that the control water temperature makes dissolution medium can be carried out dissolution determination surely at 36.5 ℃-37.5 ℃.
Embodiment 3
The online degassed digestion instrument of vacuum
Being provided with packoff at present digestion instrument can link to each other with stripping rotor, and has a vacuum generating device of being equipped with, vacuum generating device links to each other with packoff by pipeline, can produce vacuum on the top of stripping rotor behind the unlatching vacuum plant, thereby reach the purpose that the gas in the molten medium is removed.Remove packoff to be taken off after complete and carry out normal dissolution test.
Embodiment 4
The ultrasonic online degassed digestion instrument of vacuum
In the water bath of present stripping, ultrasonic generator is housed, during work in the dissolution medium heating, open degassed switch, then ultrasonic generator is to the water bath emission ultrasound wave of digestion instrument, because the gas that hyperacoustic effect is contained in the dissolution medium in the stripping rotor is removed, the while instrument is provided with packoff and can links to each other with stripping rotor, and has a vacuum generating device of being equipped with, vacuum generating device links to each other with packoff by pipeline, can produce vacuum on the top of stripping rotor after opening vacuum plant, thereby reach the purpose that the gas in the molten medium is removed.This two mode is also used, can more effectively remove the gas in the dissolution medium, remove packoff to be taken off after complete and carry out normal dissolution test, the ultrasonic circuit switch is by Single-chip Controlling, in case dissolution test begins, then Single-chip Controlling is cut off ultrasonic circuit, even press the ultrasonic degas switch this moment, ultrasonic generator can not worked yet, and prevents when carrying out dissolution test, pushes the wrong to build to cause occuring ultrasonication.
Claims (10)
1. one kind can be carried out online degassed digestion instrument to dissolution medium, comprise water bath, stripping rotor, also comprise online degas system, can in to the dissolution medium heating, carry out degassed online, thereby no longer need again dissolution medium to be carried out separately degassed processing, described degas system adopts ultrasonic degas mode or vacuum outgas mode; It is characterized by: with heat-barrier material water bath is divided into two parts, be provided with valve between two parts, valve-off can become two parts with the moisture in the tank, two parts water can fully mix after opening valve, a part has refrigeration cycle, a part has Heating Cyclic, stripping rotor is in Heating Cyclic, heating and refrigeration switch are by Single-chip Controlling, when starting digestion instrument, the heating of Heating Cyclic part beginning raises the temperature of dissolution medium, refrigeration cycle partly begins refrigeration, and the coolant-temperature gage in the refrigeration cycle is reduced; The stable of dissolution medium reaches 40 ℃-60 ℃ after a period of time, because the effect of heating, thereby arrive the purpose that the gas in the dissolution medium is removed, at this moment opening valve mixes the water of thermal cycle part and the water of cold cyclic part, the dissolution medium temperature reduces, by Single-chip Controlling heating and refrigeration switch, the temperature stabilization that the control water temperature makes dissolution medium can carry out dissolution determination at 36.5 ℃-37.5 ℃.
2. digestion instrument claimed in claim 1 is characterized by: ultrasonic generator is housed, can launches ultrasound wave in water bath, by hyperacoustic effect, thereby reach the purpose that the gas in the dissolution medium is removed.
3. digestion instrument claimed in claim 2, it is characterized by: being provided with packoff can link to each other with stripping rotor, and vacuum generating device is housed, vacuum generating device links to each other with packoff by pipeline, can produce vacuum on the top of stripping rotor after opening vacuum plant, thereby reach the purpose that the gas in the dissolution medium is removed.
4. digestion instrument claimed in claim 2 is characterized by: described ultrasound wave occurring mode adopts: unifrequency is sent out the mode of shaking.
5. digestion instrument claimed in claim 2 is characterized by: described ultrasound wave occurring mode employing: change the amplitude mode.
6. digestion instrument claimed in claim 2 is characterized by: described ultrasound wave occurs and can adopt: interactive frequency change mode.
7. digestion instrument claimed in claim 2 is characterized by: described ultrasound wave occurring mode adopts: multi-frequency is sent out the mode of shaking simultaneously.
8. digestion instrument claimed in claim 2 is characterized by: described ultrasound wave occurring mode adopts: energy collecting type is sent out the mode of shaking.
9. digestion instrument claimed in claim 3 is characterized by: described vacuum generating device, employing vacuum generator.
10. digestion instrument claimed in claim 3 is characterized by: described vacuum generating device, employing vacuum pump.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN 200810105704 CN101424677B (en) | 2008-05-05 | 2008-05-05 | Medicament dissolution instrument capable of on-line degassing |
Applications Claiming Priority (1)
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CN 200810105704 CN101424677B (en) | 2008-05-05 | 2008-05-05 | Medicament dissolution instrument capable of on-line degassing |
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CN101424677A CN101424677A (en) | 2009-05-06 |
CN101424677B true CN101424677B (en) | 2013-04-24 |
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Families Citing this family (2)
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CN103048182A (en) * | 2011-10-15 | 2013-04-17 | 四川汇利实业有限公司 | Deoxidizing device capable of rapidly testing solubility |
CN104473887A (en) * | 2014-11-12 | 2015-04-01 | 广东东阳光药业有限公司 | Method for improving reproducibility of rivaroxaban tablet dissolution curve |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN2098320U (en) * | 1991-06-07 | 1992-03-11 | 天津市医疗器械研究所 | Degassing unit for solvent |
US6170980B1 (en) * | 1999-04-09 | 2001-01-09 | Source For Automation, Inc. | Automated tablet dissolution apparatus |
US6336739B1 (en) * | 2001-03-02 | 2002-01-08 | Luke Lee | Air bath dissolution tester |
US6580506B2 (en) * | 2001-02-10 | 2003-06-17 | Leap Technologies, Inc. | Fiber optic probes apparatus for spectrophotometry |
CN2777541Y (en) * | 2005-02-02 | 2006-05-03 | 天大天发科技有限公司 | Vacuum degassing instrument |
CN2859529Y (en) * | 2005-12-16 | 2007-01-17 | 叶大林 | Direct heating integrated water bath of medicine dissolving out instrument |
-
2008
- 2008-05-05 CN CN 200810105704 patent/CN101424677B/en active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN2098320U (en) * | 1991-06-07 | 1992-03-11 | 天津市医疗器械研究所 | Degassing unit for solvent |
US6170980B1 (en) * | 1999-04-09 | 2001-01-09 | Source For Automation, Inc. | Automated tablet dissolution apparatus |
US6580506B2 (en) * | 2001-02-10 | 2003-06-17 | Leap Technologies, Inc. | Fiber optic probes apparatus for spectrophotometry |
US6336739B1 (en) * | 2001-03-02 | 2002-01-08 | Luke Lee | Air bath dissolution tester |
CN2777541Y (en) * | 2005-02-02 | 2006-05-03 | 天大天发科技有限公司 | Vacuum degassing instrument |
CN2859529Y (en) * | 2005-12-16 | 2007-01-17 | 叶大林 | Direct heating integrated water bath of medicine dissolving out instrument |
Non-Patent Citations (2)
Title |
---|
俞信真.药品溶出度测定结果偏离分析.《医药导报》.2006,第25卷(第1期),66-67. * |
刘树春.溶出度测定仪系统适用性试验方法的发展.《天津药学》.2003,第15卷(第1期),69-71. * |
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Effective date of registration: 20201208 Address after: No.138, South Zhaoyang Road, Rizhao Economic Development Zone, Shandong Province Patentee after: Tekang Pharmaceutical Group Co., Ltd Address before: 100070, Haidian District, Fuxing Road, No. 83, East nine, building 535, Beijing Patentee before: Wang Leibo |