CN109557270A - A kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation - Google Patents
A kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation Download PDFInfo
- Publication number
- CN109557270A CN109557270A CN201811649069.1A CN201811649069A CN109557270A CN 109557270 A CN109557270 A CN 109557270A CN 201811649069 A CN201811649069 A CN 201811649069A CN 109557270 A CN109557270 A CN 109557270A
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- CN
- China
- Prior art keywords
- dissolution
- oral cavity
- quality evaluation
- pharmaceutical formulations
- simple type
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- Pending
Links
- 210000000214 mouth Anatomy 0.000 title claims abstract description 22
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 14
- 238000013441 quality evaluation Methods 0.000 title claims abstract description 14
- 238000004090 dissolution Methods 0.000 claims abstract description 59
- 239000012530 fluid Substances 0.000 claims abstract description 17
- 239000007788 liquid Substances 0.000 claims abstract description 13
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 13
- 238000012360 testing method Methods 0.000 claims abstract description 12
- 238000000034 method Methods 0.000 claims abstract description 11
- 230000002572 peristaltic effect Effects 0.000 claims abstract description 11
- 239000003814 drug Substances 0.000 claims abstract description 10
- 229940079593 drug Drugs 0.000 claims abstract description 9
- 239000007787 solid Substances 0.000 claims abstract description 8
- 238000001914 filtration Methods 0.000 claims abstract description 7
- 238000010992 reflux Methods 0.000 claims abstract description 4
- 239000012738 dissolution medium Substances 0.000 claims description 10
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 4
- 239000000243 solution Substances 0.000 claims description 3
- 239000002904 solvent Substances 0.000 claims description 3
- 239000000120 Artificial Saliva Substances 0.000 claims description 2
- 239000008363 phosphate buffer Substances 0.000 claims description 2
- 239000007974 sodium acetate buffer Substances 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- BHZOKUMUHVTPBX-UHFFFAOYSA-M sodium acetic acid acetate Chemical compound [Na+].CC(O)=O.CC([O-])=O BHZOKUMUHVTPBX-UHFFFAOYSA-M 0.000 claims 1
- 239000000203 mixture Substances 0.000 abstract description 6
- 238000005259 measurement Methods 0.000 abstract description 4
- 238000004088 simulation Methods 0.000 abstract description 3
- 238000002360 preparation method Methods 0.000 abstract description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 6
- 238000009472 formulation Methods 0.000 description 5
- 229910052742 iron Inorganic materials 0.000 description 3
- 230000029087 digestion Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 238000001514 detection method Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 230000031891 intestinal absorption Effects 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 239000007937 lozenge Substances 0.000 description 1
- 239000006190 sub-lingual tablet Substances 0.000 description 1
- 229940098466 sublingual tablet Drugs 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 235000021419 vinegar Nutrition 0.000 description 1
- 239000000052 vinegar Substances 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
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- 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)
- Medicinal Preparation (AREA)
Abstract
The present invention provides a kind of simple type devices for oral cavity partial release pharmaceutical formulations quality evaluation, it is characterised in that it includes: dissolution fluid reservoir, the constant peristaltic pump of flow, dissolution release pipe, dissolution collection composition.Dissolution release pipe is double-layer structure, and internal layer discharges process for the dissolution of pharmaceutical preparation, and bottom is filtering sand core structure, and solid pharmaceutical preparation is placed on sand core, and outer layer is hollow reflux layer, external isothermal liquid reflux.Dissolution collection is multiple scale test tubes, is used for quantitative collection dissolution fluid.The dissolution of this unit simulation pharmaceutical preparation in the oral cavity discharges process, by the measurement of the dissolution fluid drug content to collection, to evaluate the pharmaceutical solid preparation dissolution curve feature of oral cavity partial release.
Description
Technical field
The present invention relates to pharmaceutical preparation detection device technical fields, and in particular to one kind discharges drug system for oral cavity partial
The simple type device of agent quality evaluation.
Background technique
Dissolution rate and the dissolution curve measurement of pharmaceutical preparation are the piths of its quality evaluation, and many pharmaceutical preparations are especially
It is oral solid formulation, the fast jogging speed of dissolution rate and dissolution curve directly affects the therapeutic effect of drug, thus by imitative
Pharmacy and the former dissolution curve for grinding medicine compare, and are the important means of modern medicines preparation curative effect Conformance Assessment.
Country's common drug digestion instrument carries out dissolution rate and the dissolution curve measurement of pharmaceutical preparation at present, and equipment is closing
Disintegration and the process in leaching in stomach are simulated in environment, in addition to digestion instrument, American-European pharmacopeia has recorded flow cell method measurement dissolution rate
And dissolution curve, but above equipment can reach good simulation to the drug of stomach dissolution release, intestinal absorption, but to human body mouth
Chamber locally carries out the drug of dissolution release, such as oral disnitegration tablet, lozenge, sublingual tablet, oral film agent solid, semisolid system
Agent, course of dissolution are open continued dissolution state, and above equipment is then unable to reach simulation effect, i.e., can not be really anti-
The dissolution state of oral cavity partial release pharmaceutical formulations is answered, is surveyed not yet for the dissolution of oral cavity partial release pharmaceutical formulations both at home and abroad
Determine quality evaluation device.
Summary of the invention
A kind of quality of oral cavity partial release pharmaceutical formulations is provided the purpose of the present invention is to solve the above problem
Simple type device is evaluated, which can be according to pharmaceutical preparation feature, selection dissolution medium, controllable drug release process temperature,
Solvent flow velocity there is structure to be simple and convenient to operate, lower-price characteristic.
To achieve the above object, the present invention adopts the following technical scheme that a kind of for oral cavity partial release pharmaceutical formulations
The simple type device of quality evaluation, it is characterised in that it includes: 1. dissolution fluid reservoir, for providing dissolution medium；2. flow
Constant peristaltic pump, for providing the dissolution medium of flow speed stability；3. dissolution release pipe, by the constant peristaltic pump of flow and described
Dissolution fluid reservoir connection, for simulating release process of the solid pharmaceutical preparation in human oral cavity；4. dissolving out collection, use
In quantitative collection drug-eluting liquid.
Further, dissolution medium used in the dissolution fluid storing liquid is 0.1mol/L hydrochloric acid solution, pH4.5 vinegar
One of acid-sodium-acetate buffer, pH6.8 phosphate buffer, artificial saliva, water.
Further, the flow velocity of the constant peristaltic pump control dissolution medium of the flow is 0.7-2.3ml/min.
Further, dissolution release pipe is double-layer structure, and dissolution of the internal layer for pharmaceutical preparation discharges process, bottom
Portion is filtering sand core structure, and solid pharmaceutical preparation is placed on sand core, and outer layer is hollow reflux layer, and external isothermal liquid flows back.
Further, the release that goes out is managed, and external isothermal liquid temperature control is at 35-38 degrees Celsius.
Further, the dissolution collection is multiple scale test tubes, is used for quantitative collection dissolution fluid, test tube volume
In 1-5ml.
The following describes the present invention in detail with reference to the accompanying drawings and specific embodiments.
Detailed description of the invention
Fig. 1 is the structural diagram of the present invention
1. dissolution fluid reservoir in attached drawing, the constant peristaltic pump of 2. flows, 3. dissolution release pipes, 4. filtering sand cores, 5. dissolutions
Collection, 6. iron stands, 7. test formulations
Specific embodiment
With reference to the accompanying drawing, technical solution of the present invention is described in detail.
It can be seen from the figure that of the present invention a kind of for the simple of oral cavity partial release pharmaceutical formulations quality evaluation
Type device includes dissolution fluid reservoir 1, the constant peristaltic pump 2 of flow, dissolution release pipe 3, dissolution collection 5, fixed iron stand
6.The dissolution fluid reservoir 1 is the high borosilicate bottle of tool lid tool sieve, and volume is 500mL to 2L, is led to by the constant peristaltic pump 2 of flow
Conduit connection is crossed, one end is inserted into dissolution fluid reservoir 1, and in one end insertion dissolution release pipe 3, insertion depth is distance test system
7 height of agent is 2 centimetres, and it is highly 10 centimetres that dissolution release pipe 3, which is double-layer structure glass tube, and internal layer diameter is 13 millimeters, outer layer
Diameter is 25 millimeters, is fixed on iron stand 6, and a smallmouth is respectively welded to connect constant temperature in dissolution release 3 outer layer both ends of pipe
The inlet and outlet (for lower mouth for connecting isothermal liquid entrance, upper mouth as isothermal liquid to export) of liquid, dissolution discharges in pipe 3
Layer bottom is filtering sand core structure 4, and height is 2 centimetres, and filtering 4 lower part of sand core structure is conduit connection dissolution collection 5,
The dissolution collection 5 is multiple scale test tubes, is used for quantitative collection dissolution fluid, test tube solvent is in 1-5ml.
When specifically used, test formulation 7 is placed in dissolution release pipe 3, dissolution medium measures after ultrasound and filtering
500mL to 2L is fitted into dissolution fluid reservoir 1, and after having connected pipeline according to working method, the constant peristaltic pump 2 of flow is connected electricity
Source, coutroi velocity 0.7-2.3ml/min, after dissolution medium flows into dissolution release pipe 3, test formulation 7 starts to discharge, and works as dissolution
Liquid stream starts timing when entering to dissolve out collection 5, continues to collect every 1 to 5 minute replacement receiving flask, test formulation 7 is released completely
After putting or dissolving, stop collecting.
Claims (6)
1. a kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation, it is characterised in that include: in device
1. dissolution fluid reservoir, for providing dissolution medium；2. the constant peristaltic pump of flow, the dissolution for providing flow speed stability is situated between
Matter；3. dissolution release pipe, is connect, for simulating solid drugs system with the dissolution fluid reservoir by the constant peristaltic pump of flow
Release process of the agent in human oral cavity；4. dissolving out collection, it to be used for quantitative collection drug-eluting liquid.
2. a kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation as described in claim 1, special
Sign be dissolution medium used in dissolution fluid storing liquid be 0.1mol/L hydrochloric acid solution, pH4.5 Acetic acid-sodium acetate buffer,
One of pH6.8 phosphate buffer, artificial saliva, water.
3. a kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation as described in claim 1, special
Sign is that the flow velocity of the constant peristaltic pump control dissolution medium of flow is 0.7-2.3ml/min.
4. a kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation as described in claim 1, special
Sign is that dissolving out release pipe is double-layer structure, and internal layer discharges process for the dissolution of pharmaceutical preparation, and bottom is filtering sand core structure,
Solid pharmaceutical preparation is placed on sand core, outer layer is hollow reflux layer, and external isothermal liquid flows back.
5. a kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation as claimed in claim 4, special
Sign is the control of isothermal liquid temperature at 35-38 degrees Celsius.
6. a kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation as described in claim 1, special
Sign is that dissolving out collection is multiple scale test tubes, is used for quantitative collection dissolution fluid, test tube solvent is in 1-5ml.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811649069.1A CN109557270A (en) | 2018-12-30 | 2018-12-30 | A kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811649069.1A CN109557270A (en) | 2018-12-30 | 2018-12-30 | A kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109557270A true CN109557270A (en) | 2019-04-02 |
Family
ID=65872212
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811649069.1A Pending CN109557270A (en) | 2018-12-30 | 2018-12-30 | A kind of simple type device for oral cavity partial release pharmaceutical formulations quality evaluation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109557270A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110045072A (en) * | 2019-04-19 | 2019-07-23 | 禄根仪器(镇江)有限公司 | A kind of drug absorption system and its absorb sampling method |
| CN110554158A (en) * | 2019-08-28 | 2019-12-10 | 齐鲁理工学院 | Traditional chinese medicine chemistry verifying attachment with safeguard function |
| 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 |
| CN113777253A (en) * | 2021-10-25 | 2021-12-10 | 四川大学 | Visualization device and method for evaluating in-vitro quality of medicine |
-
2018
- 2018-12-30 CN CN201811649069.1A patent/CN109557270A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110045072A (en) * | 2019-04-19 | 2019-07-23 | 禄根仪器(镇江)有限公司 | A kind of drug absorption system and its absorb sampling method |
| CN110045072B (en) * | 2019-04-19 | 2023-12-05 | 禄根仪器(镇江)有限公司 | Drug absorption system and absorption sampling method thereof |
| CN110554158A (en) * | 2019-08-28 | 2019-12-10 | 齐鲁理工学院 | Traditional chinese medicine chemistry verifying attachment with safeguard function |
| 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 |
| CN113777253A (en) * | 2021-10-25 | 2021-12-10 | 四川大学 | Visualization device and method for evaluating in-vitro quality of medicine |
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Application publication date: 20190402 |
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