CN203551543U - Device for measuring disintegration time of rapid disintegrating preparation - Google Patents
Device for measuring disintegration time of rapid disintegrating preparation Download PDFInfo
- Publication number
- CN203551543U CN203551543U CN201320556650.5U CN201320556650U CN203551543U CN 203551543 U CN203551543 U CN 203551543U CN 201320556650 U CN201320556650 U CN 201320556650U CN 203551543 U CN203551543 U CN 203551543U
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- Prior art keywords
- hanging basket
- determinator
- screen cloth
- internal diameter
- disintegration time
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 36
- 239000011521 glass Substances 0.000 claims abstract description 22
- 239000004744 fabric Substances 0.000 claims description 22
- 239000002184 metal Substances 0.000 claims description 15
- 238000010438 heat treatment Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 description 20
- 238000012360 testing method Methods 0.000 description 15
- 239000003826 tablet Substances 0.000 description 9
- 239000007788 liquid Substances 0.000 description 6
- 238000003556 assay Methods 0.000 description 5
- 210000000214 mouth Anatomy 0.000 description 3
- 230000033228 biological regulation Effects 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 239000007948 fast release tablet Substances 0.000 description 2
- 238000012550 audit Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 239000002662 enteric coated tablet Substances 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000007937 lozenge Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000003928 nasal cavity Anatomy 0.000 description 1
- 239000006191 orally-disintegrating tablet Substances 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 239000006190 sub-lingual tablet Substances 0.000 description 1
- 229940098466 sublingual tablet Drugs 0.000 description 1
- 239000007940 sugar coated tablet Substances 0.000 description 1
- 210000001215 vagina Anatomy 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
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Abstract
The utility model relates to a device for measuring the disintegration time of a rapid disintegrating preparation. The device mainly comprises an operation and control panel, a water bath tank, a heating component, liftable metallic brackets, hanging baskets, glass tubes, vessels and a base, wherein the lower ends of the hanging baskets are inlaid with sieves. The device is simple in structure, easy in industrialization and convenient in operation, and a result measured by the device has the characteristics of good reproducibility, resolution, correlation and universality.
Description
Technical field
The utility model relates to a kind of fast disintegrating preparations disintegration time mensuration device.
Background technology
Fast disintegrating preparations is a kind of novel form that development in recent years is got up, and it gets final product rapid disintegration after meeting a small amount of water, can be used for the administration of the different parts such as oral cavity, nasal cavity, rectum and vagina.The fast disintegrating preparations having gone on the market at present has oral disnitegration tablet, fast-release tablet, oral cavity dispersing tablet and oral freeze-dried slices.What at present Chinese Pharmacopoeia adopted for the assay method of disintegration time limited is disintegration tester determination method, this instrument and assay method thereof are mainly for disintegration conventional tablet and designing slowly, comprise: Film coated tablets, sugar coated tablet, Enteric coated tablets, lozenge, sublingual tablet etc., lack correlative study and applicability for fast disintegrating preparations.Fast disintegrating preparations is a kind of special tablet, and its disintegration rate and conventional tablet difference are huge, adopts determinator and the assay method of the disintegration time limited of conventional tablet obviously cannot effectively differentiate its external disintegration time.At present due to also comparatively deficient for the external disintegration time determinator of fast disintegrating preparations and the research of assay method in the world, the resolution of existing apparatus and method is lower both at home and abroad, reappearance is poor, inside and outside correlativity is very undesirable, make the levels of audit quality difference of fast disintegrating preparations on market larger, be unfavorable for very much the standardized administration of this novel formulation.From Chinese pharmacopeia and governing principle, for disintegration time limited of fast disintegrating preparations adopting which kind of device to measure, do not provide concrete regulation, for operation, do not carry out standardized regulation yet.The assay method of fast disintegrating preparations disintegration time limited of introducing in bibliographical information and patent at present includes dissolution rate improved method, disintegration tester improved method, graduated cylinder settled process, surface plate method, microslide method, standing test tube method, beaker method, filter paper draws wet method, wetting arching pushing and the tablet puncture method etc. of collapsing, and Chinese patent ZL200420115932.2, CN200510070951.7, CN200510070950.2, the home-made contrivance adopting in CN200710072127.4, at disintegration medium consumption, granularity is controlled, static test condition, temperature is controlled, inside and outside correlativity, resolution, in operability one or a few Xiang Shangjun exist and need to improve part.Therefore all determinator and the method for comparatively ideal external fast disintegrating preparations disintegration time limited are at present in the urgent need to address to develop a kind of versatility, inside and outside correlativity, reappearance, resolution and operability.
Summary of the invention
Technical problem to be solved in the utility model is the shortcoming for above-mentioned existence, and a kind of device that is used for measuring disintegration time of orally disintegrating tablets that can improve the defect of prior art existence is provided.This device not only simple in structure, be easy to industrialization, result easy to operate but also that adopt this device to record has more good reappearance, resolution, correlativity and versatility.
The inventor finds to adopt in test in 2010 editions two of Chinese Pharmacopoeias and measures the device of disintegration time limited, or is only simply some parameters to be adjusted and improved words, can not make the method have good reappearance, resolution and inside and outside correlativity.On this basis, the inventor has carried out the experimental study of magnanimity for above-mentioned defect, for the scope of each parameter in device, carry out the screening of permutation and combination intersection, the internal diameter size of glass tube in final surprised discovery hanging basket, when the distance that liftable metal support moves up and down in mensuration process and decline, screen cloth is to affect reappearance in subsurface position, the key factor of resolution and inside and outside correlativity, these three parameters only have given scope in the utility model of use, guarantee measurement result has good reappearance, resolution and inside and outside correlativity.
The technical solution of the utility model is:
The determinator of a kind of fast disintegrating preparations disintegration time limited, it is characterized in that this device mainly comprises control panel, water bath is positioned at the below of control panel, in controlled container made, the automatic temperature control system of water temperature is immersed in water bath, and water bath top has hole, and container immerses water bath by circular hole, hanging basket is put into container, the lower end of hanging basket studs with screen cloth, and the inside of hanging basket is 8-20mm glass tube with internal diameter, hanging basket with can move up and down distance and be connected for the liftable metal support of 5-20mm.
The screen cloth internal diameter that in said apparatus, hanging basket lower end studs with is 300 μ m-1800 μ m, preferably 500 μ m-850 μ m, most preferably 710 μ m; The preferred 10-16mm of internal diameter of glass tube, most preferably 13mm; Liftable metal support moves up and down distance for preferred 8mm-15mm, most preferably 11mm.
Said apparatus is characterised in that, its using method comprises the following steps:
(a) hanging basket is put into the container that water is housed, the water temperature in container is controlled at 37 ℃ ± 2 ℃;
(b) regulate hanging basket position, screen cloth 9-24mm under liquid level when it is declined, the water in glass tube is 1-3ml;
(c) test sample is set up in the glass tube of stating hanging basket, set liftable metal support up and down frequency be per minute 15-35 time, start disintegration tester and check, with stopwatch, record the complete disintegration of test sample and by the screen cloth time used.
Said apparatus is characterised in that, its using method comprises the following steps:
(a) hanging basket is put into the container that water is housed, the water temperature in container is controlled at 37 ℃ ± 2 ℃;
(a) regulate hanging basket position, screen cloth 12-19mm under liquid level when it is declined, the water in glass tube is 1.5-2.5ml;
(b) test sample is set up in the glass tube of stating hanging basket, set liftable metal support up and down frequency be per minute 20-32 time, start disintegration tester and check, with stopwatch, record the complete disintegration of test sample and by the screen cloth time used.
Said apparatus is characterised in that, its using method comprises the following steps:
(a) hanging basket is put into the container that water is housed, the water temperature in container is controlled at 37 ℃ ± 2 ℃;
(b) regulate hanging basket position, screen cloth 15mm under liquid level when it is declined, the water in glass tube is 2ml;
(c) test sample is set up in the glass tube of stating hanging basket, set liftable metal support up and down frequency be per minute 30 times, start disintegration tester and check, with stopwatch, record the complete disintegration of test sample and by the screen cloth time used.
Determinator described in the utility model can be used for measuring the disintegration time limited of fast disintegrating preparations.
Fast disintegrating preparations described in the utility model includes but not limited to oral disnitegration tablet, fast-release tablet, oral cavity dispersing tablet, oral freeze-dried slices.
The disintegration time mensuration device that the utility model provides not only simple in structure, be easy to industrialization, result easy to operate but also that adopt this device to record has more good reappearance, resolution, correlativity and versatility.
Accompanying drawing explanation
Fig. 1 is the stereographic map of disintegration time mensuration square law device described in the utility model.
Fig. 2 is the front elevation of disintegration time mensuration square law device described in the utility model.
Fig. 3 is the vertical view of disintegration time mensuration square law device described in the utility model.
Wherein, 1. screen cloth, 2. glass tube, 3. hanging basket, 4. liftable metal frame, 5. control panel, 6. automatic temperature control system, 7. water bath, 8. container, 9. base.
Embodiment
The determinator of a kind of fast disintegrating preparations disintegration time limited, it is characterized in that this device mainly comprises control panel, water bath is positioned at the below of control panel, in controlled container made, the automatic temperature control system of water temperature is immersed in water bath, and water bath top has hole, and container immerses water bath by circular hole, hanging basket is put into container, the lower end of hanging basket studs with screen cloth, and the inside of hanging basket is 8-20mm glass tube with internal diameter, hanging basket with can move up and down distance and be connected for the liftable metal support of 5-20mm.
The screen cloth internal diameter that in said apparatus, hanging basket lower end studs with is 300 μ m-1800 μ m, preferably 500 μ m-850 μ m, most preferably 710 μ m; The preferred 10-16mm of internal diameter of glass tube, most preferably 13mm; Liftable metal support moves up and down distance for preferred 8mm-15mm, most preferably 11mm.
Using method of the present utility model comprises the following steps:
(a) adopt disintegration time mensuration device as above;
(b) hanging basket is put into the container that water is housed, the water temperature in container is controlled at 37 ℃ ± 2 ℃;
(c) regulate hanging basket position, screen cloth 9-24mm under liquid level when it is declined, the water in glass tube is 1-3ml;
(d) test sample is set up in the glass tube of stating hanging basket, set liftable metal support up and down frequency be per minute 15-35 time, start disintegration tester and check, with stopwatch, record the complete disintegration of test sample and by the screen cloth time used.
Using method of the present utility model comprises the following steps:
(a) adopt disintegration time mensuration device as above;
(b) hanging basket is put into the container that water is housed, the water temperature in container is controlled at 37 ℃ ± 2 ℃;
(c) regulate hanging basket position, screen cloth 12-19mm under liquid level when it is declined, the water in glass tube is 1.5-2.5ml;
(d) test sample is set up in the glass tube of stating hanging basket, set liftable metal support up and down frequency be per minute 20-32 time, start disintegration tester and check, with stopwatch, record the complete disintegration of test sample and by the screen cloth time used.
Using method of the present utility model comprises the following steps:
(a) adopt disintegration time mensuration device as above;
(b) hanging basket is put into the container that water is housed, the water temperature in container is controlled at 37 ℃ ± 2 ℃;
(c) regulate hanging basket position, screen cloth 15mm under liquid level when it is declined, the water in glass tube is 2ml;
(d) test sample is set up in the glass tube of stating hanging basket, set liftable metal support up and down frequency be per minute 30 times, start disintegration tester and check, with stopwatch, record the complete disintegration of test sample and by the screen cloth time used.
The foregoing is only preferred embodiment of the present utility model, not the utility model is imposed any restrictions.All any simple change of doing according to the utility model claim, change and impartial variation and modification, within all should belonging to the protection domain of technical solutions of the utility model.
Claims (8)
1. the determinator of fast disintegrating preparations disintegration time limited, it is characterized in that this device mainly comprises control panel (5), water bath (7) is positioned at the below of control panel (5), in controlled container made, the automatic temperature control system (6) of water temperature is immersed in water bath (7), water bath (7) top has hole, container (8) immerses water bath (7) by circular hole, hanging basket (3) is put into container (8), the lower end of hanging basket (3) studs with screen cloth (1), the inside of hanging basket (3) is 8-20mm glass tube (2) with internal diameter, hanging basket (3) with can move up and down distance and be connected for the liftable metal support (4) of 5-20mm.
2. determinator as claimed in claim 1, is characterized in that the screen cloth internal diameter that hanging basket lower end studs with is 300 μ m-1800 μ m.
3. determinator as claimed in claim 1, is characterized in that the screen cloth internal diameter that hanging basket lower end studs with is 500 μ m-850 μ m.
4. determinator as claimed in claim 1, is characterized in that the screen cloth internal diameter that hanging basket lower end studs with is 710 μ m.
5. determinator as claimed in claim 1, the internal diameter that it is characterized in that glass tube is 10-16mm.
6. determinator as claimed in claim 1, the internal diameter that it is characterized in that glass tube is 13mm.
7. determinator as claimed in claim 1, is characterized in that liftable metal support moves up and down distance for 8mm-15mm.
8. determinator as claimed in claim 1, is characterized in that liftable metal support moves up and down distance for 11mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201320556650.5U CN203551543U (en) | 2013-09-09 | 2013-09-09 | Device for measuring disintegration time of rapid disintegrating preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201320556650.5U CN203551543U (en) | 2013-09-09 | 2013-09-09 | Device for measuring disintegration time of rapid disintegrating preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN203551543U true CN203551543U (en) | 2014-04-16 |
Family
ID=50469640
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201320556650.5U Expired - Lifetime CN203551543U (en) | 2013-09-09 | 2013-09-09 | Device for measuring disintegration time of rapid disintegrating preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN203551543U (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104422756A (en) * | 2013-09-09 | 2015-03-18 | 北京量子高科制药科技有限公司 | Disintegration time limit determination device for rapid disintegration preparation |
| CN107490541A (en) * | 2016-06-12 | 2017-12-19 | 武汉武药科技有限公司 | Paste the detection means and detection method of piece adhesion property in oral cavity |
-
2013
- 2013-09-09 CN CN201320556650.5U patent/CN203551543U/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104422756A (en) * | 2013-09-09 | 2015-03-18 | 北京量子高科制药科技有限公司 | Disintegration time limit determination device for rapid disintegration preparation |
| CN107490541A (en) * | 2016-06-12 | 2017-12-19 | 武汉武药科技有限公司 | Paste the detection means and detection method of piece adhesion property in oral cavity |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: BEIJING QUANTUN HIGH-TECH PHARMACEUTICAL TECHNOLOG Free format text: FORMER OWNER: QUANTUM HI-TECH (BEIJING) RESEARCH INSTITUTE Effective date: 20141017 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20141017 Address after: 102200, Beijing Changping District science and Technology Park, eastern industrial base, Ho Road, No. 8, building 503, room 11 Patentee after: BEIJING QUANTUM HI-TECH PHARMACY TECHNOLOGY Co.,Ltd. Address before: 102200, Changping District Beijing science and Technology Park, eastern industrial base, Ho Road, No. 8, building 11, room 101, room 1 Patentee before: QUANTUM HI-TECH (BEIJING) Research Institute |
|
| CX01 | Expiry of patent term | ||
| CX01 | Expiry of patent term |
Granted publication date: 20140416 |