CN219455856U - Suspension preparation redispersibility measuring device - Google Patents
Suspension preparation redispersibility measuring device Download PDFInfo
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- CN219455856U CN219455856U CN202223527981.4U CN202223527981U CN219455856U CN 219455856 U CN219455856 U CN 219455856U CN 202223527981 U CN202223527981 U CN 202223527981U CN 219455856 U CN219455856 U CN 219455856U
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- suspension preparation
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P70/00—Climate change mitigation technologies in the production process for final industrial or consumer products
- Y02P70/10—Greenhouse gas [GHG] capture, material saving, heat recovery or other energy efficient measures, e.g. motor control, characterised by manufacturing processes, e.g. for rolling metal or metal working
Abstract
The utility model discloses a device for measuring the redispersibility of a suspension preparation, which comprises a closed camera bellows (1), wherein one end of an inner cavity of the closed camera bellows (1) is provided with a laser generator (2), a static laser pipeline (3) is arranged at a light outlet of the laser generator (2), a rotatable sample pipeline (4) is sleeved outside the laser pipeline (3), one end of the sample pipeline (4) far away from the laser generator (2) can be fixedly connected with a sample bin (5) with a built-in sample bottle (6), a light through hole on the sample bin (5) is opposite to the sample bottle (6), one end of the laser pipeline (3) adjacent to the sample bin (5) is provided with a Fourier lens (7), and the other end of the inner cavity of the closed camera bellows (1) is provided with a photoelectric detector (8), and the photoelectric detector (8) is used for monitoring the intensity of laser transmitted through the sample bottle (6). The device of the present utility model is capable of assessing the redispersibility of the formulation by varying the shade.
Description
Technical Field
The utility model relates to the technical field of drug evaluation, in particular to a device for measuring redispersibility of a suspension preparation.
Background
The suspension type medicine refers to a non-uniformly dispersed liquid preparation formed by dispersing insoluble solid medicine in a dispersion medium in a particle state, wherein when the medicine preparation is stored and preserved, the insoluble medicine particles are generally settled at the bottom of a preparation container, and the settled medicine particles are uniformly mixed by means of vibration, shaking, overturning and the like before use.
The suspension type medicine is divided into single-dose and multi-dose packages, and when the single-dose packages are used, the single-dose packages are required to be uniformly dispersed, so that a user can smoothly take enough solid active ingredients; when the multi-dose package is used, the settled solid medicine is uniformly dispersed and then used, so that the uniformity of medicine delivery can be ensured, overdose caused by excessive local solid active ingredients can be prevented, and poor treatment effectiveness caused by too low local active ingredient content can also be prevented.
There is no device for evaluating the redispersibility of the suspension pharmaceutical preparation in the market at present, and the existing middle and outer literature has a redispersibility evaluation method by manual shaking and manual observation, so that the subjectivity is strong, the influence of personnel on each detection is large, and the detection is difficult to realize under the same and fixed conditions; in addition, a mode of using a mixing instrument is adopted, so that samples horizontally roll on a machine, whether mixing is carried out or not is observed manually, judgment on a detection end point is subjective, meanwhile, the method is different from an environment where the method is actually used, the mode of mixing suspension in actual use is mainly shaking and overturning, horizontal rolling operation is not carried out, the correlation is poor, on-line monitoring cannot be carried out, and the method cannot be used for guiding the use mode of a suspension preparation.
Disclosure of Invention
The utility model aims at solving the problems in the prior art and provides a device for measuring the redispersibility of a suspension preparation, which is used for evaluating the uniform dispersing capability of insoluble drugs in the suspension type drug preparation and is taken as a means for quality control in the research and development and production of the suspension type drug.
The utility model aims at solving the problems through the following technical scheme:
a device for measuring redispersibility of a suspension preparation, comprising: the device comprises a closed camera bellows, a laser generator is arranged at one end of an inner cavity of the closed camera bellows, a stationary laser pipeline is arranged at an optical outlet of the laser generator, a sample pipeline which can rotate is sleeved outside the laser pipeline, one end of the sample pipeline, far away from the laser generator, can be fixedly connected with a sample bin of a built-in sample bottle, a light through hole on the sample bin is opposite to the sample bottle, a Fourier lens is arranged at one end, close to the sample bin, of the laser pipeline, and a photoelectric detector is arranged at the other end of the inner cavity of the closed camera bellows and used for monitoring the intensity of laser transmitted by the sample bottle.
A transparent glass window is arranged between the sample bin and the photoelectric detector.
The closed camera bellows is provided with a rotating speed sensor for monitoring the rotating speed of the sample pipeline.
One side of the sample bin is provided with a hollow extending connecting part, the extending connecting part is connected with the corresponding end of the sample pipeline, and the connecting mode comprises various easy-to-detach connections such as buckle connection, threaded connection and the like.
The main body part of the sample bin is used for accommodating a sample bottle, and the sample bottle is fixedly embedded in the inner cavity of the main body part of the sample bin.
An optical path bearing is arranged between the outer wall of the laser pipeline and the inner wall of the sample pipeline, and the optical path bearing can ensure that the sample pipeline rotates and the laser pipeline keeps static.
And a support bearing is arranged between the sample pipeline and the pipeline support seat.
The pipeline supporting seats are arranged in pairs.
The sample pipeline is sleeved with a driven piece, the driven piece is meshed with a driving piece, and the driving piece is arranged on an output shaft of the variable-frequency servo motor.
The output shaft of the variable frequency servo motor is connected with the driving part through the speed reducer, and the variable frequency servo motor drives the sample pipeline to rotate at the rotating speed of 10-100rpm through the speed reducer, the driving part and the driven part.
The light outlet of the laser generator is provided with a movable light shielding plate.
Suspension type medicines include, but are not limited to, eye drops, dry suspensions, injections, inhalants, liniments, nasal sprays.
Shading, also known as optical concentration, is the ratio of the shading cross section of a particle in a beam to the total area of the beam, expressed as the percentage of light scattered, absorbed by the particle, to the total amount of output light (minus background scattering). The specific calculation method is that the difference between the light intensity I0 of the center point of the detector after the laser penetrates through the pure medium and the light intensity Ii of the center point of the detector after the sample is added is divided by the light intensity I0, namely, the shading degree= (I0-Ii)/I0 x100 percent.
Compared with the prior art, the utility model has the following advantages:
the device can effectively evaluate the redispersibility of the suspension preparation, generates a signal of corresponding light intensity by passing laser through the suspension which is being turned and mixed evenly, judges whether insoluble medicine particles are evenly dispersed, and the speed and time of rolling or oscillating required by even dispersion by changing the shading degree, evaluates the redispersibility of the preparation, thereby screening an excellent prescription in product development, effectively controlling the quality of the product in production and providing accurate use guidance for patients.
Drawings
FIG. 1 is a schematic diagram showing the structure of a device for measuring redispersibility of a suspension preparation according to the present utility model.
Wherein: 1-sealing a camera bellows; 2-a laser generator; 3-a laser pipeline; 4-sample line; 5, a sample bin; 6, a sample bottle; 7-a fourier lens; 8-a photodetector; 9-a transparent glazing; 10, a rotation speed sensor; 11-an extended connection; 12-an optical path bearing; 13-a support bearing; 14-a pipeline supporting seat; 15-a passive element; 16-a driving part; 17-a variable frequency servo motor; 18-a speed reducer; 19-a light shielding plate; 20-locking means.
Detailed Description
The utility model is further described below with reference to the drawings and examples.
As shown in fig. 1: the device comprises a closed camera bellows 1, a laser generator 2 is arranged at one end of an inner cavity of the closed camera bellows 1, a stationary laser pipeline 3 is arranged at a light outlet of the laser generator 2, a rotatable sample pipeline 4 is sleeved outside the laser pipeline 3, the laser pipeline 3 and the sample pipeline 4 are coaxially arranged, one end of the sample pipeline 4, far away from the laser generator 2, can be fixedly connected with a sample bin 5 of a built-in sample bottle 6, a light through hole on the sample bin 5 is arranged opposite to the sample bottle 6, a Fourier lens 7 is arranged at one end of the laser pipeline 3, close to the sample bin 5, and a photoelectric detector 8 is arranged at the other end of the inner cavity of the closed camera bellows 1, and is used for monitoring the laser intensity transmitted by the sample bottle 6, and a transparent glass window 9 can be further arranged between the sample bin 5 and the photoelectric detector 8.
The two sides of the sample bin 5 are respectively provided with a light through hole, the sample bin 5 comprises a main body part for accommodating the sample bottle 6 and an extending connecting part 11 for connecting the sample pipeline 4, the hollow extending connecting part 11 is used as one light through hole, the extending connecting part 11 is connected with the corresponding end of the sample pipeline 4, and the connecting mode comprises various easily-detachable connection such as buckle connection, threaded connection and the like; the sample bottle 6 is fixedly embedded in the inner cavity of the main body part of the sample bin 5. In addition, a rotation speed sensor 10 for monitoring the rotation speed of the sample pipeline 4 is arranged on the closed camera bellows 1.
It should be noted that, the area of the light-transmitting hole on the sample bin 5 is larger than the area of the laser after being refracted by the fourier lens, and the outer shell of the emitting surface of the sample bottle 6 is thinner, so as to ensure that the scattered laser is not blocked.
In order to be able to ensure that the sample line 4 rotates and that the laser line 3 remains stationary, a light path bearing 12 is arranged between the outer wall of the laser line 3 and the inner wall of the sample line 4, and a support bearing 13 is arranged between the sample line 4 and the line support seats 14 arranged in pairs, respectively, and the sample line 4 can rotate in the line support seats 14 in a stable manner. In order to drive the sample pipeline 4, a driven piece 15 is sleeved on the sample pipeline 4, the driven piece 15 is meshed with a driving piece 16, and the driving piece 16 is arranged on an output shaft of a variable-frequency servo motor 17; further, an output shaft of the variable frequency servo motor 17 is connected with the driving part 16 through the speed reducer 18, and the variable frequency servo motor 17 drives the sample pipeline 4 to rotate at the rotating speed of 10-100rpm through the speed reducer 18, the driving part 16 and the driven part 15.
Examples
A device for measuring the redispersibility of a suspension preparation, which is provided with a rotatable sample bin 5 in a closed camera 1, wherein the rotation is not limited to rotation and swing, and is used for simulating shaking or overturning; the embedded structure for fixing the sample bottle 6 is arranged in the inner cavity of the main body part of the sample bin 5, and comprises but is not limited to a metal clamping piece, damping materials (rubber and the like for increasing friction force); the extending connecting part 11 of the sample bin 5 is fixed at one end of the sample pipeline 4 in a buckling or screw thread mode, so that the sample pipeline 4 drives the sample bin 5 to synchronously rotate, and the sample bin 5 and the sample pipeline 4 are convenient to detach. A circular hole is arranged at the center of the sample bin 5, so that the sample bottle 6 is communicated with the light path. A laser generator 2 is arranged at one end of the closed camera bellows 1, a stationary laser pipeline 3 is arranged at a light outlet of the laser generator 2, a Fourier lens 7 is arranged at an outlet end of the laser pipeline 3, the Fourier lens 7 is used for converging light beams, laser irradiates into a sample bottle 6 after being focused by the Fourier lens 7, a clarified sample in the sample bottle 6 is transmitted to a photoelectric detector 8 in a detection chamber to measure a laser intensity value, the sample bottle 6 is rotated, turbid particles start to be suspended in the sample bottle 6, the laser is transmitted to the detection chamber after being refracted, scattered and diffusely reflected by the sample in the sample bottle 6, and the photoelectric detector 8 measures the laser intensity value which dynamically changes; the detection chamber is closed and is provided with a plurality of photodetectors 8 for detecting the laser intensity. When the laser beam passes through the dispersed particle sample, the change measurement of the suspended particles is completed by measuring the intensity of scattered light, namely the shading degree of the sample, so as to achieve the purpose of dynamically measuring the suspension effect.
Sample pipeline 4 passes through supporting bearing 13 to be fixed in pipeline supporting seat 14, makes sample storehouse 5 can be stably fixed on pipeline supporting seat 14, rotates simultaneously with the light path as the center, and sample pipeline 4 is connected through sleeve pipe and bearing with laser pipeline 3, and sample pipeline 4 is outside, laser pipeline 3 is including, and laser pipeline 3's both ends are connected with laser generator and Fourier lens respectively, fix on pipeline supporting seat 14, and sample pipeline 4 rotates, and laser pipeline 3 does not rotate. The sample line 4 may be connected to a rotational speed sensor 10 to display the real-time rotational speed.
The rotation driving is provided by a variable frequency servo motor 17, and the sample bin 5 is rotated by a reducer 18 (such as a planetary gear reducer, which has the characteristics of high rigidity, high precision, high transmission efficiency, high torque, volume ratio, life maintenance-free and the like, and is used for reducing rotation speed, improving torque and matching inertia) and a driving part 16 which are meshed and connected with a driven part 15 on the sample pipeline 4. The rotation rate of the sample compartment 5 can be controlled. The rotation and swinging speed has larger influence on detection, the rotation speed of the sample bin 5 is easier to examine in the range of 10-100rpm, and the proper rotation speed is obtained through the speed reducer 18, and meanwhile, larger torque is obtained.
A locking device 20 may also be provided on the sample line 4, and after the locking switch of the locking device 20 is pressed, the sample line 4 is locked against rotation to facilitate replacement of the glass sample bottle 6.
The light outlet of the laser generator 2 is provided with a movable light shielding plate 19, a round hole is formed in the top of the light shielding plate 19 and used for transmitting light, the rest parts are light shielding parts, the light shielding plate 19 is inserted in front of the outer cover of the light outlet of the laser generator 2, and the light shielding plate 19 is required to be closed before the outer cover of the light outlet of the laser generator 2 is opened, so that the damage of a photosensitive element and an operator caused by laser overflow is prevented.
As shown in fig. 1, a suspension preparation redispersibility measurement apparatus is used as follows: loading a proper amount of suspension preparation into a glass sample bottle 6, standing until all particles settle, taking down a top cover of a sample bin 5, inserting the sample bottle 6 into the sample bin 5, clamping and embedding the sample bottle 6 by a metal clamping piece in the sample bin 5, covering the top cover of the sample bin 5, screwing a screw to fix, preventing falling off during rotation, starting a laser generator 2 for preheating, closing a light shielding plate 19 after the laser generator 2 is stabilized, opening an outer cover for closing a camera bellows 1, installing the sample bin 5 to the end part of a sample pipeline 4, closing the outer cover, opening the light shielding plate 19 to enable laser emitted by the laser generator 2 and a sample in the glass sample bottle 6 to form a passage, firstly, measuring an optical signal formed after laser passes through a clarified liquid level in a sample bottle 6, subtracting the optical signal as a background signal, selecting to rotate or swing a sample bin 5, enabling suspension particles in the sample bottle 6 to start to be uniformly mixed, measuring the change condition of the shading degree in the glass sample bottle 6 under the condition that the rotating speed is 10-100rpm, recording data such as the laser intensity, the rotating speed of the sample bin 5, the rotating number of the sample bin 5 and the like, stopping rotating after the target time, the target number of turns or the shading degree are no longer changed, counting a time-shading degree data table, drawing a time-shading degree curve, and evaluating the redispersibility of the suspension preparation. After the measurement is completed, the light shielding plate 19 of the laser light source is closed, the outer cover is opened, the top cover of the sample bin 5 is opened, the glass sample bottle 6 is taken out, the steps are repeated for measuring again after the new sample bottle 6 is replaced, the sample bins 5 with different specifications and the sample bottles 6 made of glass can be replaced according to experimental requirements, the sample bottle 6 is taken out after the detection is completed, and the laser generator 2 is closed.
The above embodiments are only for illustrating the technical idea of the present utility model, and the protection scope of the present utility model is not limited by the above embodiments, and any modification made on the basis of the technical scheme according to the technical idea of the present utility model falls within the protection scope of the present utility model; the technology not related to the utility model can be realized by the prior art.
Claims (10)
1. A device for measuring redispersibility of a suspension preparation, comprising: the device comprises a closed camera bellows (1), wherein a laser generator (2) is arranged at one end of an inner cavity of the closed camera bellows (1), a static laser pipeline (3) is arranged at a light outlet of the laser generator (2), a rotatable sample pipeline (4) is sleeved outside the laser pipeline (3), one end, far away from the laser generator (2), of the sample pipeline (4) can be fixedly connected with a sample bin (5) of a built-in sample bottle (6), a light passing hole in the sample bin (5) is opposite to the sample bottle (6), a Fourier lens (7) is arranged at one end, close to the sample bin (5), of the laser pipeline (3), and a photoelectric detector (8) is arranged at the other end of the inner cavity of the closed camera bellows (1) and used for monitoring laser intensity transmitted through the sample bottle (6).
2. The suspension preparation redispersibility measurement apparatus according to claim 1, wherein: a transparent glass window (9) is arranged between the sample bin (5) and the photoelectric detector (8).
3. The suspension preparation redispersibility measurement apparatus according to claim 1, wherein: the closed camera bellows (1) is provided with a rotating speed sensor (10) for monitoring the rotating speed of the sample pipeline (4).
4. The suspension preparation redispersibility measurement apparatus according to claim 1, wherein: one side of the sample bin (5) is provided with a hollow extending connecting part (11), and the extending connecting part (11) is connected with the corresponding end of the sample pipeline (4).
5. The device for measuring redispersibility of a suspension preparation according to claim 4, wherein: the main body of the sample bin (5) is used for accommodating a sample bottle (6), and the sample bottle (6) is fixedly embedded in the inner cavity of the main body of the sample bin (5).
6. The suspension preparation redispersibility measurement apparatus according to claim 1, wherein: an optical path bearing (12) is arranged between the outer wall of the laser pipeline (3) and the inner wall of the sample pipeline (4), and the optical path bearing (12) can ensure that the sample pipeline (4) rotates and the laser pipeline (3) keeps static.
7. The suspension preparation redispersibility measurement apparatus according to claim 1 or 6, characterized in that: a support bearing (13) is arranged between the sample pipeline (4) and the pipeline support seat (14); the pipeline supporting seats (14) are arranged in pairs.
8. The suspension preparation redispersibility measurement apparatus according to claim 1, wherein: the sample pipeline (4) is sleeved with a driven piece (15), the driven piece (15) is meshed with a driving piece (16), and the driving piece (16) is arranged on an output shaft of the variable-frequency servo motor (17).
9. The suspension preparation redispersibility measurement apparatus according to claim 8, wherein: an output shaft of the variable-frequency servo motor (17) is connected with the driving part (16) through the speed reducer (18), and the variable-frequency servo motor (17) drives the sample pipeline (4) to rotate at the rotating speed of 10-100rpm through the speed reducer (18), the driving part (16) and the driven part (15).
10. The suspension preparation redispersibility measurement apparatus according to claim 1, wherein: the light outlet of the laser generator (2) is provided with a movable light shielding plate (19).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202223527981.4U CN219455856U (en) | 2022-12-29 | 2022-12-29 | Suspension preparation redispersibility measuring device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202223527981.4U CN219455856U (en) | 2022-12-29 | 2022-12-29 | Suspension preparation redispersibility measuring device |
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| Publication Number | Publication Date |
|---|---|
| CN219455856U true CN219455856U (en) | 2023-08-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202223527981.4U Active CN219455856U (en) | 2022-12-29 | 2022-12-29 | Suspension preparation redispersibility measuring device |
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| CN (1) | CN219455856U (en) |
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2022
- 2022-12-29 CN CN202223527981.4U patent/CN219455856U/en active Active
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