CN219142637U - Flow cell method dissolution test device - Google Patents
Flow cell method dissolution test device Download PDFInfo
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- CN219142637U CN219142637U CN202223266500.9U CN202223266500U CN219142637U CN 219142637 U CN219142637 U CN 219142637U CN 202223266500 U CN202223266500 U CN 202223266500U CN 219142637 U CN219142637 U CN 219142637U
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Abstract
The utility model discloses a device for a dissolution test by a flow cell method, which comprises a flow cell, wherein the upper part of the flow cell is connected with a filter, the middle part of the flow cell is cylindrical, the lower part of the flow cell is in an inverted cone shape, and the bottom of the inverted cone shape is provided with a liquid inlet; the middle part is equipped with the cylinder mould that fixed sample was used in the flow cell, the cylinder mould periphery is connected several spinal branch vaulting poles, and several spinal branch vaulting poles are the transmission form, and annular supporting ring is connected to the other end of bracing piece, and annular supporting ring is used for fixing and supporting the cylinder mould. According to the test device disclosed by the utility model, the sample is fixed through the net cage, so that the position of the sample is kept relatively fixed, particularly, the high-solubility medicine which is easy to float and adhere in a dissolution (release) medium is prevented from being different in position in a flow cell due to floating or adhesion, the measurement deviation caused by the fact that the contact area between the sample and the dissolution medium is reduced and the like is avoided, and the problems of poor detection accuracy of medicine dissolution, small distinguishing force of samples with different masses and weak correlation with in-vivo dissolution are solved.
Description
Technical Field
The utility model relates to the technical field of experimental equipment, in particular to a device for a flow cell method dissolution test.
Background
The drug dissolution (release) test is an in vitro detection method for controlling the quality of a drug preparation, and is a necessary means for researching the prescription composition, auxiliary material variety, production process and the like of solid preparations and semisolid preparations. The method can evaluate the internal quality, the effectiveness and the safety of the medicine by collecting and analyzing comprehensive and deep in-vitro dissolution (release) test research data, thereby improving the accurate judgment of the correlation of in-vivo and in-vitro dissolution (release) data and effectively improving the success rate of bioequivalence tests.
The dissolution (release) test device is a device for simulating the action of human digestive tract organs on medicines, and can simulate the peristalsis of the stomach and the small intestine by adopting a rotating basket and paddle method, a rotating speed changing method in the operation process and other means. The existing dissolution (release) instrument generally adopts basket method, paddle method, small cup method, paddle-disc method, rotary drum method, reciprocating drum method, flow pool method and the like to collect dissolution (release) test data. Among them, the flow cell method is more and more widely applied to drug dissolution (release) behavior research due to the advantages of mild dissolution (release) conditions, large force difference for different quality samples, etc., so as to find better in vivo-in vitro correlation, in particular to a semisolid preparation with high dissolution and easy adhesion; compared with other methods, the flow cell method can reduce the conditions of reduced contact surface area with dissolution (release) medium, influence dissolution (release) speed and the like of a sample due to the fact that the surface of the sample contacts smooth and flat parts such as a cup wall and the like by adding glass beads.
As disclosed in chinese patent No. CN 206096097U, each flow cell is provided with a column-shaped glass bottle, a constant temperature water jacket layer is provided on the glass bottle, a filter is provided at the upper port of the glass bottle, a circular bayonet and a stainless steel mesh are provided inside the glass bottle, and a solid preparation is placed on the mesh. However, for drugs which are easily floating and easily adhered in a dissolution (release) medium, the above-mentioned device still has measurement deviation caused by the decrease of the contact area with the dissolution (release) medium due to the adhesion of the sample to the inner wall of the flow cell and/or the filter, particularly when a large number of bubbles are present in the sample, the floating sample floats due to the relative density being smaller than that of the dissolution (release) medium, and the floating sample such as the adhesion to the inner wall of the flow cell and/or the filter causes a difference in dissolution (release) results due to the above-mentioned reasons; if the glass beads are used for pressing the sample, the contact area between the sample and the dissolution (release) medium is reduced, the dissolution (release) speed is further influenced, the dissolution (release) curve of the preparation is poor in reproducibility, the result is unstable, and the like, so that the quality of the research preparation cannot be effectively distinguished. When the dissolution (release) degree detection is carried out by other conventional devices (such as basket method, paddle method, small cup method and the like), the dissolution (release) device is easy to float or adhere, so that the contact area between the medicine and the dissolution (release) medium is changed, or/and the medicine is different due to different stirring force (or force generated in other dissolution (release) processes) at different parts, so that the dissolution (release) speed is different, the accuracy and reproducibility of the dissolution (release) degree detection result are seriously affected, the resolution of the dissolution (release) method on different quality samples is small, and the correlation between the medicine in-vitro dissolution (release) and in-vivo dissolution (release) cannot be accurately evaluated, so that the quality controllability and the effectiveness of the medicine cannot be ensured.
Disclosure of Invention
In order to solve the defects in the prior art, the utility model provides a device for a flow cell method dissolution test, which is used for effectively fixing a sample in the middle of a flow cell and preventing a drug which is easy to float and adhere from adhering to the inner wall of the flow cell and/or a filter to influence the accuracy and reproducibility of a detection result.
In order to achieve the technical purpose, the utility model adopts the following technical scheme:
the device for the dissolution test of the flow cell method comprises a flow cell, wherein the upper part of the flow cell is connected with a filter, the middle part of the flow cell is cylindrical, the lower part of the flow cell is in an inverted cone shape, and the bottom of the inverted cone shape is provided with a liquid inlet; the middle part is equipped with the cylinder mould that fixed sample was used in the flow cell, the cylinder mould periphery is connected several spinal branch vaulting poles, and several spinal branch vaulting poles are the transmission form, and annular supporting ring is connected to the other end of bracing piece, and annular supporting ring is used for fixing and supporting the cylinder mould.
Further, the net cage is formed by stainless steel wire mesh and is provided with an opening and closing net door.
Further, the diameter of the steel wire of the net cage is 0.1-0.2mm, and the aperture is about 1-2mm.
Further, the inverted conical interior of the flow cell is filled with glass beads.
Further, the supporting rods are in a divergent shape from top to bottom, the supporting ring is used as a base, the outer diameter of the supporting ring is slightly smaller than the inner diameter of the middle part of the flow cell, and the supporting ring is arranged above the glass beads.
Further, the position of the netpen is different according to the length and inclination of the support rods.
Further, the support rod is in a transverse emission shape, the support ring and the support rod are located on the same plane, a circular buckle is arranged on the inner side wall of the flow cell, and the support ring is clamped in a bayonet of the side wall of the flow cell.
Preferably, the four support rods are uniformly distributed along the circumferential direction of the net cage.
Further, the volume and shape of the netpen are designed according to the shape of the sample, and are slightly larger than the sample volume.
Preferably, the netpen is cylindrical, square, cuboid or irregularly shaped.
Compared with the prior art, the utility model has the beneficial effects that:
according to the test device disclosed by the utility model, the sample is fixed through the net cage, so that the position of the sample is kept relatively fixed, particularly, the high-solubility medicine which is easy to float and adhere in the dissolution (release) medium is avoided, the problem that the sample is different in position in a flow cell due to floating or adhesion, and the measurement deviation caused by the reasons of reduced contact area with the dissolution (release) medium and the like, the problems of poor detection accuracy of the dissolution (release) degree of the medicine, small discrimination of samples with different masses and weak correlation with dissolution (release) in vivo are solved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered limiting the scope, and that other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic diagram of an embodiment of the present utility model;
FIG. 2 is a schematic diagram of another embodiment of the present utility model;
FIG. 3 dissolution profiles of different mass samples using the device of the present utility model:
figure 4 shows different mass sample dissolution profiles using prior art devices.
Reference numerals: 1-flow cell, 2-net cage, 3-support bar, 4-support ring, 5-glass beads and 6-filter.
Detailed Description
For the purposes of making the objects, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application, which are generally described and illustrated in the figures herein, may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present application, as provided in the accompanying drawings, is not intended to limit the scope of the application, as claimed, but is merely representative of selected embodiments of the application. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments herein without making any inventive effort, are intended to be within the scope of the present application.
The device for the dissolution (release) test of the flow cell method is shown in fig. 1 and 2, and comprises a flow cell 1, wherein the upper part of the flow cell 1 is connected with a filter 6, the middle part of the flow cell is cylindrical, the lower part of the flow cell is in an inverted cone shape, the bottom of the inverted cone shape is provided with a liquid inlet, and glass beads 5 are filled in the inverted cone shape; the middle part in the flow cell 1 is provided with a net cage 2 for fixing samples, the periphery of the net cage 2 is connected with a plurality of support rods 3, the support rods 3 are in a radial shape, the other ends of the support rods 3 are connected with an annular support ring 4, and the support ring 4 is used for fixing and supporting the net cage 2 so as to enable the positions of the samples to be relatively fixed; the net cage 2 is formed by adopting a stainless steel wire net and is provided with an opening and closing net door which can be opened and closed, the net door is opened to facilitate the addition of a sample, and the net door is closed after the sample is added; the diameter of the steel wire is about 0.1-0.2mm, and the aperture is about 1-2mm; the mesh cages with different pore diameters can be selected to be suitable for different sample measurement.
In one embodiment, as shown in fig. 1, the supporting rod 3 diverges from top to bottom, the supporting ring 4 is used as a base, the outer diameter of the supporting ring 4 is slightly smaller than the inner diameter of the middle part of the flow cell 1, and the supporting ring 4 is arranged above the glass beads 5. The position of the netpen is changed according to the change of the length and the inclination of the support rod.
In another embodiment, as shown in fig. 2, the support rods 3 are in a transverse emission shape, the support rings 4 and the support rods 3 are located on the same plane, and the support rings 4 are clamped in bayonets on the side walls of the flow cell 2.
The mesh cage 2 can be designed according to the shape, size/volume of the sample, such as a cylinder, an ellipsoid, a rectangle, etc., and the mesh cage is similar to the sample in size and shape and slightly larger than the sample in volume, and has a small amount of movable space after the sample is added.
Test 1: dissolution (release) degree reproducibility
Experimental materials and instruments: qualified self-grinding sample R; flow cell method dissolution (release) system (RT 7, shenzhen Sharpy instruments Co., ltd.); ultraviolet spectrophotometers (UV-260, shimadzu); the other reagents were all analytically pure.
The experimental method comprises the following steps:
experimental group: taking 6 qualified self-grinding samples in the same batch, and respectively putting the 6 qualified self-grinding samples into the net cages of the flow cell;
control group: taking 6 qualified self-grinding samples in the same batch, and respectively putting the 6 qualified self-grinding samples into a conventional bracket of a flow cell in the prior art;
experiments were performed under the conditions shown below, taking an appropriate amount of the solution, measuring absorbance at 278nm wavelength using a quartz cuvette according to ultraviolet spectroscopy-visible spectrophotometry, calculating the dissolution (release) degree, and calculating RSD of 6 samples at the same sampling point.
Elution (Release) condition and detection condition Table
Experimental results:
experimental group:
| time (min) | 10 | 15 | 20 | 25 | 30 | 35 | 40 | 45 | 50 | 60 | 70 | 80 | 100 |
| RSD(％) | 6.9 | 5.7 | 3.9 | 3.4 | 2.8 | 4.4 | 3.6 | 1.8 | 2.2 | 2.7 | 1.5 | 2.9 | 1.4 |
Control group:
| time (min) | 10 | 15 | 20 | 25 | 30 | 35 | 40 | 45 | 50 | 60 | 70 | 80 | 100 |
| RSD(％) | 17.3 | 14.6 | 9.3 | 7.2 | 6.8 | 5.7 | 5.0 | 7.1 | 4.3 | 5.5 | 3.7 | 4.9 | 2.6 |
Conclusion: the results show that the dissolution (release) results are good in repeatability by adopting the device provided by the utility model; with conventional devices in the prior art, the dissolution (release) results are less reproducible.
Test 2: similarity f2 factor evaluation of dissolution (Release) curves for self-grinding samples
Experimental materials and instruments: qualified self-grinding sample R, self-grinding sample T mixed with a large number of bubbles; flow cell method dissolution (release) system (RT 7, shenzhen Sharpy instruments Co., ltd.); ultraviolet spectrophotometers (UV-260, shimadzu); the other reagents were all analytically pure.
Experimental group: preparing a test article: respectively taking a qualified self-grinding sample and a proper amount of sample mixed with a large amount of bubbles, and putting the qualified self-grinding sample and the proper amount of sample into a net cage of the flow cell;
control group: preparing a test article: respectively taking a qualified self-grinding sample and a proper amount of sample mixed with a large amount of bubbles, and putting the qualified self-grinding sample and the proper amount of sample into a conventional bracket of a flow cell in the prior art;
experiments were performed under the conditions shown below, and a proper amount of the solution was taken and absorbance was measured at 278nm by ultraviolet-visible spectrophotometry using a quartz cuvette to calculate the dissolution (release) degree.
Dissolution (Release) conditions and detection conditions
Experimental results: the experimental results are shown in the following table, and the graphs are shown in fig. 3 and 4:
similarity f2 factor method evaluation table of dissolution (release) curves of experimental group
Similarity f2 factor method evaluation table of dissolution (release) curves of different quality samples of control group
Conclusion: the results show that with the device provided by the utility model, the f2 value between the dissolution (release) curves is smaller than 50, which indicates that the dissolution (release) behaviors are dissimilar, and the device can distinguish qualified samples from unqualified samples with a large number of bubbles and has strong distinguishing power on different quality samples.
The dissolution (release) degree test is carried out by adopting the device in the prior art, and the f2 value between dissolution (release) curves is larger than 50, which indicates that the dissolution (release) behaviors are similar, and a qualified sample and a disqualified sample with a large number of bubbles cannot be distinguished, so that the distinguishing power of the samples with different qualities is weak.
Of course, the present utility model is capable of other various embodiments and its several details are capable of modification and variation in light of the present utility model by one skilled in the art without departing from the spirit and scope of the utility model as defined in the appended claims.
Claims (10)
1. The device for the dissolution test of the flow cell method comprises a flow cell (1), wherein the upper part of the flow cell (1) is connected with a filter, the middle part of the flow cell is cylindrical, the lower part of the flow cell is in an inverted cone shape, and the bottom of the inverted cone shape is provided with a liquid inlet; the method is characterized in that: the middle part is equipped with cylinder mould (2) that fixed sample was used in flow cell (1), several bracing piece (3) are connected to cylinder mould (2) periphery, and several bracing piece (3) are the transmission form, and annular support circle (4) are connected to the other end of bracing piece (3), and annular support circle (4) are used for fixing and support cylinder mould (2).
2. The flow cell dissolution test apparatus according to claim 1, wherein: the net cage (2) is formed by stainless steel wire mesh and is provided with an opening and closing net door.
3. The flow cell dissolution test apparatus according to claim 2, wherein: the diameter of the steel wire of the net cage (2) is 0.1-0.2mm, and the aperture is 1-2mm.
4. The flow cell dissolution test apparatus according to claim 1, wherein: the inside of the inverted cone of the flow cell is filled with glass beads (5).
5. The flow cell dissolution test apparatus according to claim 4, wherein: the support rods (3) are in a divergent shape from top to bottom, the support ring (4) is used as a base, the outer diameter of the support ring (4) is smaller than the inner diameter of the middle part of the flow cell (1), and the support ring (4) is arranged above the glass beads (5).
6. The flow cell dissolution test apparatus according to claim 5, wherein: the position of the net cage (2) is different according to the change of the length and the inclination of the supporting rod (3).
7. The flow cell dissolution test apparatus according to claim 1, wherein: the support rod (3) is in a transverse emission shape, the support ring (4) and the support rod (3) are located on the same plane, a round buckle is arranged on the inner side wall of the flow cell (1), and the support ring (4) is clamped in a bayonet on the side wall of the flow cell (1).
8. The flow cell dissolution test apparatus according to claim 5 or 7, wherein: the four support rods (3) are uniformly distributed along the circumferential direction of the net cage (2).
9. The flow cell dissolution test apparatus according to claim 2, wherein: the volume and the shape of the net cage (2) are designed according to the shape of the sample and are larger than the volume of the sample.
10. The flow cell dissolution test apparatus according to claim 9, wherein: the net cage (2) is cylindrical, square or cuboid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202223266500.9U CN219142637U (en) | 2022-12-06 | 2022-12-06 | Flow cell method dissolution test device |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202223266500.9U CN219142637U (en) | 2022-12-06 | 2022-12-06 | Flow cell method dissolution test device |
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| Publication Number | Publication Date |
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| CN219142637U true CN219142637U (en) | 2023-06-06 |
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| CN202223266500.9U Active CN219142637U (en) | 2022-12-06 | 2022-12-06 | Flow cell method dissolution test device |
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