CN103852200B - The determinator of a kind of solid preparation turgor pressure and assay method - Google Patents
The determinator of a kind of solid preparation turgor pressure and assay method Download PDFInfo
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- CN103852200B CN103852200B CN201410023573.6A CN201410023573A CN103852200B CN 103852200 B CN103852200 B CN 103852200B CN 201410023573 A CN201410023573 A CN 201410023573A CN 103852200 B CN103852200 B CN 103852200B
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Abstract
The present invention relates to the determinator of a kind of solid preparation turgor pressure and assay method, this determinator includes probe and the pressure receptor that the internal diameter of fixing seat, height adjusting structure, mould and mould matches, described mould is connected by height adjusting structure and fixing seat are fixing, pressure receptor is fixing with fixing seat to be connected, die top is additionally provided with permeable structure, described permeable structure is connected by locking mechanism and mould are fixing, and described permeable structure is made up of water permeable membrane and permeable pad or is only made up of permeable pad；Described assay method is as follows: 1) selects mould and probe, measures the contact area S of sample and probe；2) assembling sample；3) zeroing；4) initial pressure F is set0；5) adding water, pressure receptor returns to zero, the registration F of record different time points pressure receptor, calculates corresponding turgor pressure P according to P=F/S, obtains t-P curve。Determinator and the assay method of the present invention are highly sensitive, easy and simple to handle, have good scientific research and economic worth。
Description
Technical field
The invention belongs to pharmaceutical preparation and mechanics field, be specifically related to determinator and the assay method of a kind of solid preparation turgor pressure。
Background technology
There is the turgor pressure of many literature research tablets and capsule at present both at home and abroad, it is intended to control product quality or realize the various new functions such as pulse, but so far still without the corresponding detecting device quantified。(the BussemerT such as Bussemer, DashevskyA, BodmeierR.Apulsatiledrugdeliverysystembasedonrupturablec oatedhardgelatincapsules [J] .JControlledRelease, 2003, 93:331-339.) research design one is with the drug-supplying system of hard gelatin capsule medicine carrying, it is divided into medicated core from inside to outside, expanding layer and insoluble polymer outer layer clothing film, the contact extender when moisture passes through outer layer clothing film to infiltration in system, expansive force once hydration swelling agent exceedes the tensile strength of outer layer clothing film, film starts to break, thus discharging medicated core, form a kind of pulsed release, the time of medicated core release can be controlled by the thickness and the label bulbs of pressure changing outer layer clothing film。
At present disclosed document only with respect to rock expansion pressure measuring unit and method (Chen Wanhong. rock expansion Instrument for Pressure introduces [J]. hydrogeological engineering geology, 1984,4.) device is made up of sample container, pressue device and measurement system three part: 1, sample container is made up of water box, the several folded ring of wall thickness 10mm, permeable stone and pressing plate；2, pressue device is by reaction frame, external screw rod and manipulator's wheel form in one group；3, mensuration system is made up of with the amesdial being furnished with Magnetic gauge stand pressure transducer, static resistance deformeter, and the method and device are only suitable for large-scale and hard objects mensuration。Solid preparation normally shape is irregular, and volume is little, and turgor pressure is little cannot press detection on the equipment such as instrument at existing rock expansion；The turgor pressure of solid preparation produces speed simultaneously is affected very big by moisture admission velocity and original pressure level etc., and existing detecting instrument cannot be carried out simulation。。So far the device and method measured about solid preparation turgor pressure there is no report。
Summary of the invention
It is an object of the invention to the deficiency solving do not have solid preparation turgor pressure determinator and method in prior art, it is provided that the determinator of a kind of solid preparation turgor pressure and assay method。
The technical solution adopted for the present invention to solve the technical problems is:
A kind of determinator of solid preparation turgor pressure, the probe matched including the internal diameter of fixing seat, height adjusting structure, mould and mould and pressure receptor, described mould is connected by height adjusting structure and fixing seat are fixing, pressure receptor is fixing with fixing seat to be connected, die top is additionally provided with permeable structure, described permeable structure is connected by locking mechanism and mould are fixing, and described permeable structure is made up of water permeable membrane and permeable pad or is only made up of permeable pad。
The technology of the present invention is contemplated that: pass through permeable structure, mould, three parts of popping one's head in are to control volume and the height of sample, realize sample determine volume or determine the mensuration of high level expansion pressure, not pressure in the same time is read after sample water suction by pressure receptor, and then obtain through time turgor pressure curve, when permeable structure is made up of water permeable membrane and permeable pad, the microporous filter membrane of the optional different pore size of water permeable membrane, may be used without free film prepared by different coating solution, by the speed that water permeable membrane adjusting water content passes through, permeable pad has good water penetration and mechanicalness, water permeable membrane deforms to be possible to prevent solid preparation to cause when expanding；When permeable structure is only made up of permeable pad, choose the permeable pad of smaller aperture due, also can control the speed that moisture content passes through。
As preferably, described mould detects mould, the diameter of the described internal diameter determining volume detection mould and probe and the equal diameters of testing sample for determining volume, and the volumetric expansion pressure of determining for matrix type sample or film controlling type sample measures；
It addition, described mould can also is that determines height detection mould, this determines the first half internal diameter diameter more than probe of height detection mould, and the internal diameter of lower half equals to or more than probe diameter；The diameter of probe is more than or equal to the diameter of testing sample, and the high level expansion pressure of determining for film controlling type sample measures。
As shown in Fig. 2-1, this determine height detection mould the first half internal diameter more than probe diameter, the internal diameter of the latter half equal to probe diameter；As shown in Fig. 2-2, the internal diameter that this upper and lower half determining height detection mould is divided is all higher than the internal diameter of probe, placing a washing basin when this determinator uses in advance on pressure receptor, the upper surface of this washing basin and mould can form a confined space and ensure that moisture content does not run off。
As preferably, the diameter of described probe is 5 ~ 12mm, and probe end is plane or deep arc or shallow arc。The mensuration of difformity sample can be met。
As preferably, longitudinal trimming precision of described height adjusting structure is 0.0001mm-0.1mm, it is preferable that 0.01mm。Different initial pressures can be realized by arrangement for adjusting height。
As preferably, the precision of described pressure receptor is 0.0001g-1g, it is preferable that 0.01g, and the range of pressure receptor is 50g-1000g, it is preferable that 200g。
As preferably, described pressure receptor is connected with data handling system by data wire。
The assay method of a kind of solid preparation turgor pressure, described assay method comprises the following steps:
1) character per sample and shape, selects mould and probe, measures the diameter R of label in the diameter of matrix type testing sample or film controlling type testing sample, according to S=p(R/2)2Calculate the contact area S of testing sample and probe；
2) matrix type or film controlling type testing sample are placed on probe, load and determine volume detection mould, regulate the fixing permeable structure of locking mechanism；Or film controlling type testing sample is placed on probe, load and determine height detection mould, regulate the fixing permeable structure of locking mechanism；
3) pressure receptor is opened, zeroing；
4) regulate height adjusting structure, initial pressure is set, is designated as F0, according to P0=F0/ S calculates corresponding initial pressure P0；
5) add water, zeroing, the registration F of record different time points pressure receptor, calculate corresponding turgor pressure P according to P=F/S, obtain t-P curve。
The solid preparation turgor pressure determinator of the present invention and assay method, it is possible to record the turgor pressure of solid preparation quickly and easily, the screening for prescription provides convenient。
The invention has the beneficial effects as follows:
(1) the invention provides and determine volumetric expansion and determine two kinds of turgor pressure detecting devices of high level expansion and detection method, solve the little non-square sample of volume, problem that the different sample in corner cannot detect；Solve the problem that turgor pressure small sample cannot detect；Solve control moisture content enter sample velocities and apply the problems such as initial pressure。
(2) present invention is that matrix type sample provides and determines volumetric expansion pressure determinator and method, provides for film controlling type sample and determines volume and determine high level expansion to press determinator and method；Product of the present invention provide selectable permeable structure, determine, on the basis of volume or fixed highly desired machinery holding power, to meet the different sample requirement to water penetration in guarantee。
(3) determinator provided by the invention and method are highly sensitive, easy and simple to handle, have good scientific research and economic worth。
Accompanying drawing illustrates:
Fig. 1: determine the structural representation of volumetric expansion pressure determinator；
Fig. 2-1: determine a kind of structural representation of high level expansion pressure determinator；
Fig. 2-2: determine the another kind of structural representation of high level expansion pressure determinator；
Fig. 3: the matrix type sample of application examples 1 turgor pressure measurement result curve in determining volumetric expansion pressure determinator；
Fig. 4: the film controlling type sample of application examples 2 turgor pressure measurement result curve in determining volumetric expansion pressure determinator；
Fig. 5: the film controlling type sample of application examples 3 turgor pressure measurement result curve in determining high level expansion pressure determinator；
Fig. 6: the film controlling type sample of application examples 4 turgor pressure measurement result curve in determining high level expansion pressure determinator。
Wherein: 1-fixes seat, 2-arrangement for adjusting height, 3-mould, and 4-pops one's head in, 5-pressure receptor, 6-permeable structure, 7-locking mechanism。
Detailed description of the invention
Below by specific embodiment, technical scheme is described in further detail。
Embodiment 1: determine volumetric expansion pressure determinator
As shown in Figure 1 determine volumetric expansion pressure determinator include fixing seat 1, height adjusting structure 2, mould 3 and mould 3 with the use of probe 4 and pressure receptor 5, height adjusting structure 2 is made up of screw rod and nut, described mould 3 is fixed with fixing seat 1 with coordinating of nut by screw rod, pressure receptor 5 is fixed with fixing seat 1, mould 3 top is also equipped with permeable structure 6, this permeable structure 6 is made up of water permeable membrane 61 and permeable pad 62, permeable structure 6 is fixed with mould 3 by locking mechanism 7, and wherein locking mechanism 7 is made up of screw rod, nut and briquetting。
In the present embodiment, the diameter of probe 4 is 5-12mm, the internal diameter of mould 3 is equal to the diameter of probe 4, longitudinal trimming precision of height adjusting structure 2 is 0.01mm, pressure receptor 5 precision be 0.01g, range is 0-200g, fixing seat 1, height adjusting structure 2, mould 3, probe 4 and locking mechanism 7 all adopt stainless steel to make, and the end of probe is shallow arc。
Embodiment 1 determine volumetric expansion pressure determinator can be not only used for matrix type sample also can use film controlling type sample determine volumetric expansion pressure measure。
Embodiment 2: fixed high degree type turgor pressure determinator
Fixed high degree type as shown in Fig. 2-1 includes fixing seat 1 for film controlling type sample turgor pressure determinator, height adjusting structure 2, mould 3, the probe 4 matched with the internal diameter of mould 3 and pressure receptor 5, height adjusting structure 2 is made up of screw rod and nut, described mould 3 is fixed with fixing seat 1 with coordinating of nut by screw rod, pressure receptor 5 is fixed with fixing seat 1, mould 3 top is also equipped with permeable structure 6, this permeable structure 6 is made up of permeable pad 62, permeable structure 6 is fixed with mould 3 by locking mechanism 7, wherein locking mechanism 7 is by screw rod, nut and briquetting composition, fixing seat 1, height adjusting structure 2, mould 3, probe 4 and locking mechanism 7 all adopt stainless steel to make, the end of probe is shallow arc。
In the present embodiment, the diameter of probe 4 is 5-12mm, and the internal diameter of mould 3 first half is more than the diameter of probe 4, and the internal diameter of lower half is equal to probe 4 diameters；Longitudinal trimming precision of height adjusting structure 2 is 0.01mm, pressure receptor 5 precision be 0.001g, range is 0-200g。
The fixed high degree type turgor pressure determinator of the present invention also has another kind of structure, as shown in Fig. 2-2, the internal diameter of mould 3 upper and lower half is all higher than the diameter of probe 4, placing a washing basin during use in advance on pressure receptor 5, the upper surface of this washing basin and mould 3 can form a confined space and ensure that moisture content does not run off。
The fixed high degree type turgor pressure determinator of shown in embodiment 2 two kind is only used for the high level expansion pressure of determining of film controlling type sample and measures。
Application examples 1:
Low-substituted hydroxypropyl cellulose and lactose being mixed by weight 1:19, it is matrix type detection sample that direct compression process prepares tablet。
Sheet footpath 7mm, sheet-shaped shallow arc, select the shallow arc probe of 7mm and corresponding mould, sample lifting surface area S=3.14*3.5*3.5=38.47 (mm2)。
By Fig. 1, determinator is installed: be placed on probe by sample, loads mould, regulate the fixing 0.45um microporous filter membrane of locking mechanism and permeable pad, open pressure receptor, zeroing, regulate height adjusting structure and initial pressure F is set0For 98.13g。According to P0=F0/ S calculates corresponding initial pressure P0For 25KPa。
Add water 0.5ml, and pressure receptor returns to zero, the registration F of the pressure receptor of record different time, calculates corresponding turgor pressure P according to P=F/S, draws t-P curve, as shown in Figure 3。
Application examples 2:
Low-substituted hydroxypropyl cellulose and calcium hydrogen phosphate being mixed by weight 1:11, direct compression process prepares label, and pan coating method prepares the film controlling type detection sample of EC coating。
Sheet core diameter 7mm, coating diameter 7.1mm, sheet-shaped shallow arc, select the shallow arc probe of diameter 7.1mm and corresponding mould, sample lifting surface area S=3.14*3.5*3.5=38.47 (mm2)
By Fig. 1, determinator is installed: be placed on probe by sample, loads mould, regulate the fixing 0.45um microporous filter membrane of locking mechanism and permeable pad, open pressure receptor, zeroing, regulate height adjusting structure and initial pressure F is set0For 5g。According to P0=F0/ S calculates corresponding initial pressure P0For 1.27KPa。
Add water 0.5ml, and pressure receptor returns to zero, the registration F of the pressure receptor of record different time, calculates corresponding turgor pressure P according to P=F/S, draws t-P curve, as shown in Figure 4。
Application examples 3:
Low-substituted hydroxypropyl cellulose and calcium hydrogen phosphate being mixed by weight 1:11, direct compression process prepares label, and pan coating method prepares the film controlling type detection sample of EC coating。
Sheet footpath 7.1mm, sheet-shaped shallow arc, select the shallow arc probe of diameter 8mm and corresponding mould, sample lifting surface area S=3.14*3.55*3.55=39.57 (mm2)
By Fig. 2-1, determinator is installed, sample is placed on probe, load mould, regulate locking mechanism and fix permeable pad, open pressure receptor, zeroing, regulate height adjusting structure and initial pressure F is set0For 10g, according to P0=F0/ S calculates corresponding initial pressure P0For 2.55KPa。
Add water 5ml, and pressure receptor returns to zero, the registration F of the pressure receptor of record different time, calculates corresponding turgor pressure P by P=F/S, draws t-P curve, as shown in Figure 5。
Application examples 4:
Low-substituted hydroxypropyl cellulose and calcium hydrogen phosphate being mixed by weight 1:11, direct compression process prepares label, and pan coating method prepares the film controlling type detection sample of EC coating。
Sheet footpath 7.1mm, sheet-shaped shallow arc, select the shallow arc probe of diameter 8mm and corresponding mould, sample lifting surface area S=3.14*3.55*3.55=39.57 (mm2)
By Fig. 2-2, determinator is installed, pressure receptor is placed washing basin one in advance, sample is placed on probe, load mould, regulate locking mechanism and fix permeable pad, open pressure receptor, zeroing, regulate height adjusting structure and initial pressure F is set0For 10g, according to P0=F0/ S calculates corresponding initial pressure P0For 2.55KPa。
Add water 50ml in pond, and pressure receptor returns to zero, the registration F of the pressure receptor of record different time, calculates corresponding turgor pressure P by P=F/S, draws t-P curve, as shown in Figure 6。
Embodiment described above is the one preferably scheme of the present invention, not the present invention is done any pro forma restriction, also has other variant and remodeling under the premise without departing from the technical scheme described in claim。
Claims (7)
1. the determinator of a solid preparation turgor pressure, it is characterized in that: include fixing seat (1), height adjusting structure (2), mould (3), with mould (3) with the use of probe (4) and pressure receptor (5), described mould (3) is connected by height adjusting structure (2) and fixing seat (1) are fixing, pressure receptor (5) is fixing with fixing seat (1) to be connected, mould (3) top is additionally provided with permeable structure (6), described permeable structure (6) is connected by locking mechanism (7) and mould (3) are fixing；
Described mould (3) is determine volume to detect mould, the described internal diameter determining volume detection mould and the diameter of (4) and the equal diameters of testing sample of popping one's head in, and measurement is pressed in the volumetric expansion of determining for matrix type sample or film controlling type sample；Or described mould (3) is for determine height detection mould, the described internal diameter diameter more than probe (4) determining height detection mould, the diameter of probe (4) is more than or equal to the diameter of testing sample, and the high level expansion pressure of determining for film controlling type sample is measured。
2. the determinator of solid preparation turgor pressure according to claim 1, it is characterised in that: described permeable structure (6) is made up of water permeable membrane (61) and permeable pad (62)；Or described permeable structure (6) is only made up of permeable pad (62)。
3. the determinator of solid preparation turgor pressure according to claim 1 and 2, it is characterised in that: the diameter of described probe (4) is 5～12mm, and the end of probe (4) be plane or deeply arc or shallow arc。
4. the determinator of solid preparation turgor pressure according to claim 1 and 2, it is characterised in that: longitudinal trimming precision of described height adjusting structure (2) is 0.0001mm-0.1mm。
5. the determinator of solid preparation turgor pressure according to claim 1 and 2, it is characterised in that: the precision of described pressure receptor (5) is 0.0001-1g, and the range of pressure receptor is 50-1000g。
6. the determinator of solid preparation turgor pressure according to claim 1 and 2, it is characterised in that: described pressure receptor (5) is connected with data handling system by data wire。
7. the assay method of a solid preparation turgor pressure, it is characterised in that: described assay method comprises the following steps:
1) character per sample and shape, selects mould and probe, measures the diameter R of label in the diameter of matrix type testing sample or film controlling type testing sample, according to S=π (R/2)2Calculate the contact area S of testing sample and probe；
2) matrix type or film controlling type testing sample are placed on probe, load and determine volume detection mould, regulate the fixing permeable structure of locking mechanism；Or film controlling type testing sample is placed on probe, load and determine height detection mould, regulate the fixing permeable structure of locking mechanism；
3) pressure receptor is opened, zeroing；
4) regulate height adjusting structure, initial pressure is set, is designated as F0, according to P0=F0/ S calculates corresponding initial pressure P0；
5) adding water, record pressure receptor registration over time, obtains the F of t-F curve, according to P=(F-F0)/S calculates corresponding pressure P, obtains t-P curve。
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| CN104090073B (en) * | 2014-07-03 | 2016-01-20 | 中国石油大学(北京) | High temperature leak stopping gelling performance tester |
| CN105403343B (en) * | 2015-12-10 | 2018-10-16 | 浙江工业大学 | The measurement device and its assay method of capsule turgor pressure |
| CN105890836A (en) * | 2016-04-27 | 2016-08-24 | 中国矿业大学(北京) | Device for measuring expansion pressure of soundless cracking agent |
| CN109142210A (en) * | 2018-06-29 | 2019-01-04 | 浙江工业大学 | A kind of mold, preparation method and application method measuring coating micro-pill turgor pressure |
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| JP4779544B2 (en) * | 2005-09-30 | 2011-09-28 | 日本精工株式会社 | Air pressure abnormality judgment device |
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| CN1301958A (en) * | 1999-12-30 | 2001-07-04 | 中国地质大学（武汉） | Testing method and testing device for expansion pressure of soild expansion material |
| CN1441233A (en) * | 2003-04-08 | 2003-09-10 | 武汉理工大学 | Swelling pressure testing method and device for static rupturing agent |
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