Test device for strong light irradiation of drugs

Abstract

The device comprises an illumination box, a medicine test cavity is formed in the illumination box, the upper portion of the medicine test cavity is connected with a cross beam, the cross beam is connected with a height adjusting structure through a power supply assembly installed in a sliding mode, and the bottom of the height adjusting structure is connected with a light source. The light source is electrically connected with the sliding installation power supply assembly; a platform for placing medicines is arranged at the lower part of the medicine test cavity, and an illuminometer is arranged on the top surface of the platform and is electrically connected with a display screen located outside the illumination box. According to the hard light irradiation test device for the medicine, the height difference between the medicine and the light source can be accurately adjusted, so that the stability of the same medicine under different illumination conditions is observed, and researchers can more accurately judge the characteristics of the medicine.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of drug strong light irradiation test, in particular to a device for drug strong light irradiation test. BACKGROUND

[0002] Drug strong light irradiation test is an important part of drug stability study, which belongs to a kind of compulsory degradation test, and is mainly used for evaluating the stability of raw materials or preparations under strong light exposure. The main purpose of the test is to evaluate the potential effect of light on the quality of the drug, guide the selection of storage conditions (such as whether to store in the dark) and packaging material design (such as whether to use brown bottles).

[0003] Irradiance refers to the light flux received per unit area, and the height distance between the light source and the illuminated surface will affect the size of the irradiance, specifically, the irradiance is inversely proportional to the square of the height of the light source. In the traditional drug strong light irradiation test box, although the drug can be tested by installing the light source to irradiate the drug, the position of the light source is basically fixed, and the distance between the light source and the drug can only be changed by raising the position of the drug, which cannot be accurately adjusted. Without changing the light source, when observing the stability of the same drug under different irradiance conditions, multiple tests are required, which not only makes it difficult to quickly and accurately adjust the height difference between the light source and the drug each time, but also consumes a lot of time. In addition, since only one irradiation area is provided in a single drug strong light irradiation test box, when multiple drugs need to be tested under strong light, they need to be tested in turn, which takes a long time.

[0004] In addition, when the drug is subjected to light stability test, the conventional light influence factor test is to carry out light test on the raw materials or preparations in a naked state, but it is easy to be affected by air humidity, and the water content increases, thereby affecting the state of the drug, and the physical and chemical properties of the drug change, for example, the hardness of the tablet decreases. At the same time, due to the increase of moisture, it will cause the growth of microorganisms, leading to long bacteria and mildew, thereby reducing the accuracy of the test results. SUMMARY

[0005] The purpose of the present application is to provide a device for drug strong light irradiation test, which can accurately adjust the height difference between the drug and the light source, so as to observe the stability of the same drug under different irradiance conditions, which helps researchers to have a more accurate judgment on the characteristics of the drug.

[0006] To achieve the above objectives, the present invention provides a device for testing pharmaceuticals under strong light irradiation, comprising an irradiation box, wherein a pharmaceutical testing chamber is provided inside the irradiation box, a crossbeam is connected to the upper part of the pharmaceutical testing chamber, a height adjustment structure is connected to the crossbeam via a sliding power supply assembly, a light source is connected to the bottom of the height adjustment structure, and the light source is electrically connected to the sliding power supply assembly; a platform for placing pharmaceuticals is provided at the lower part of the pharmaceutical testing chamber, an illuminance meter is placed on the top surface of the platform, and the illuminance meter is electrically connected to a display screen located outside the irradiation box.

[0007] As a further improvement of the present invention, the top surface of the platform is divided into at least two horizontally arranged drug testing areas by a light-blocking partition, and each drug testing area is equipped with an illuminance meter placed on the platform.

[0008] As a further improvement of the present invention, the light-blocking partition is detachably connected to the top surface of the platform; the top surface of the platform is provided with at least two parallel sliding grooves, and the bottom of the light-blocking partition is slidably inserted into the sliding grooves.

[0009] As a further improvement of the present invention, the sliding power supply assembly includes a matching track socket and a socket adapter. The track socket is installed on the top surface of the crossbeam, and the socket adapter is inserted into the strip track opening of the track socket from top to bottom. The socket adapter can slide laterally along the strip track opening and is electrically connected to the track socket. The upper end of the height adjustment structure is connected to the socket adapter, and the light source is located directly below the crossbeam.

[0010] As a further improvement of the present invention, the height adjustment structure includes a suspension rod and a fixed seat connected sequentially from top to bottom. The upper end of the suspension rod is connected to the socket adapter. The upper section of the suspension rod is curved and bypasses both the crossbeam and the track socket on one side, while the lower section of the suspension rod is vertically arranged. The fixed seat is slidably provided with at least two screws, each screw having two nuts threaded onto it. The two nuts are located on the upper and lower sides of the fixed seat, respectively. The height adjustment structure also includes a lifting seat located below the fixed seat, which is fixedly connected to each screw. The lifting seat is detachably connected to the light source.

[0011] As a further improvement of the present invention, the lifting seat is also connected to a clamp, and the top of the light source is provided with a dovetail-shaped protrusion, and the clamp is clamped on both sides of the dovetail-shaped protrusion; the hanging rod is a hollow structure, and wires are threaded through it. The upper end of the wires is electrically connected to the socket adapter, and the lower end of the wires is electrically connected to the light source.

[0012] As a further improvement of the present invention, a vacuum pump is also installed on the light box, and the input end of the vacuum pump is connected to the drug test chamber.

[0013] Beneficial effects Compared with the prior art, the advantages of the device for testing pharmaceuticals under strong light irradiation according to the present invention are as follows: 1. Because the crossbeam of the drug testing chamber is connected to a height adjustment structure via a sliding power supply assembly, and a light source is connected to the bottom of the height adjustment structure, the height difference between the drug and the light source can be precisely adjusted. This allows for observation of the stability of the same drug under different illumination conditions, helping researchers to make more accurate judgments about the characteristics of the drug. The sliding power supply assembly allows for the installation of one or at least two light sources as needed. When at least two light sources are installed, the spacing between adjacent light sources is adjustable. When the illumination from a single light source is insufficient, the illumination can be increased by adding more light sources, and the number of light sources can be easily increased or decreased.

[0014] 2. The platform's top surface is divided into at least two horizontally arranged drug testing areas by light-blocking partitions, each equipped with a lux meter. When the same drug is placed in different testing areas with the same light source, the lux value received by the drug can be adjusted by changing the height of the light source in each testing area. The lux value can be displayed on a screen, facilitating the determination of the drug's stability under different lux levels after testing. When different types of drugs are placed in different testing areas, each drug can undergo simultaneous strong light irradiation testing, improving testing efficiency and shortening the total testing time. The light-blocking partitions significantly reduce the probability of light interference between adjacent testing areas, improving the accuracy of test results. The installation position of the light-blocking partitions is optional, allowing personnel to create different numbers and widths of drug testing areas as needed.

[0015] 3. The sliding installation power supply assembly includes a compatible track socket and socket adapter. The socket adapter can be installed at any position along the length of the track socket's strip opening, making operation convenient. The socket adapter is inserted into the track socket's strip opening from top to bottom, with the light source located directly below the crossbeam. This ensures that the centers of gravity of the light source and the socket adapter are roughly on the same vertical line, preventing the socket adapter from detaching from the track socket and ensuring uninterrupted power to the light source without accidental drop.

[0016] 4. In the height adjustment structure, the height of the light source is adjusted by the cooperation of the nut and the screw, which makes the adjustment more precise.

[0017] 5. The height-adjustable lifting base is fixed to the light source by a clip, making it easy to install and remove. When the light source cannot emit light normally or when it is necessary to switch to a different type of light source, it is convenient for personnel to replace the light source.

[0018] 6. By using a vacuum pump to extract the air from the drug testing chamber, a high vacuum environment is created for the drug, which greatly reduces the impact of air and moisture on the drug. The drug can be placed stably in this state to complete the entire test process; at the same time, the influence of other factors on the light test is avoided, and the test data is more accurate.

[0019] The invention will become clearer from the following description, taken in conjunction with the accompanying drawings, which are used to explain embodiments of the invention. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a front view of the apparatus used for testing pharmaceuticals under intense light irradiation. Figure 2 This is a partial sectional view of the front view of the device used for testing pharmaceutical strong light irradiation. Figure 3 for Figure 2 AA view; Figure 4 Top view of the sliding-mount power supply assembly; Figure 5 Front view of the sliding-mount power supply assembly, height adjustment structure, and light source; Figure 6 Left view of the sliding power supply assembly, height adjustment structure, and light source; Figure 7 These are control photos of the three groups of samples. Detailed Implementation

[0022] Embodiments of the present invention will now be described with reference to the accompanying drawings.

[0023] Example Specific embodiments of the present invention are as follows: Figures 1 to 6 As shown, a device for testing pharmaceuticals under strong light includes a light box 1, which is entirely made of opaque sheet metal. The light box 1 contains a pharmaceutical testing chamber 11. The front of the pharmaceutical testing chamber 11 has a door 13 that is hinged to the light box 1, and the door 13 seals against the edge of the opening of the pharmaceutical testing chamber 11 when closed. A crossbeam 12 is connected to the upper part of the pharmaceutical testing chamber 11; specifically, both ends of the crossbeam 12 are fixedly connected to the side walls of the pharmaceutical testing chamber 11. A height adjustment structure 5 is connected to the crossbeam 12 via a sliding power supply assembly 4. A light source 6 is connected to the bottom of the height adjustment structure 5, and the light source 6 is electrically connected to the sliding power supply assembly 4. A platform 2 for placing pharmaceuticals is located at the lower part of the pharmaceutical testing chamber 11. An illuminance meter 8 is placed on the top surface of the platform 2, and the illuminance meter 8 is electrically connected to a display screen 9 located outside the light box 1.

[0024] Light source 6 primarily uses the D65 illuminator, also known as the international standard illuminator D65, which is a light source that simulates average Northern Hemisphere sunlight. Its spectral distribution is designed to approximate natural light, with a color temperature of 6500K, to provide standard lighting conditions for various visual evaluation and color measurement applications. The D65 illuminator has wide applications in color science, printing, photography, and other fields requiring accurate color reproduction.

[0025] The top surface of platform 2 is divided into at least two horizontally arranged drug testing areas 30 by a light-blocking partition 3. Each drug testing area 30 is equipped with an illuminance meter 8 placed on platform 2. The illuminance meter 8 is connected to a wire. The tester can place the illuminance meter 8 on the table surface of the corresponding drug testing area 30 according to the number and location of the drug testing area 30. The tray 10 containing the drug is placed on platform 2 of the drug testing area 30 and located next to the illuminance meter 8, so that the illuminance value of the illuminance meter 8 can reflect the illuminance received by the drug in the tray 10 as accurately as possible.

[0026] The light-blocking partition 3 is detachably connected to the top surface of the platform 2. Specifically, the top surface of the platform 2 is provided with at least two parallel sliding grooves 21, and the bottom of the light-blocking partition 3 is slidably inserted into the sliding grooves 21. The sliding grooves 21 are arranged longitudinally, with their front end located on the front side wall of the platform 2 and their rear end basically flush with the rear side wall of the drug testing chamber 11. The lower edge of the light-blocking partition 3 is inserted from the front end of the sliding groove 21 until the rear edge of the light-blocking partition 3 is basically in contact with the rear side wall of the drug testing chamber 11, thereby completing the installation of the light-blocking partition 3. The light from the light source 6 shines downwards, and the maximum height of the light source 6 does not exceed the upper height of the light-blocking partition 3. This method can significantly reduce the problem of mutual light interference between adjacent drug testing areas 30.

[0027] The sliding power supply assembly 4 includes a matching track socket 41 and a socket adapter 42. The track socket 41 is mounted on the top surface of the crossbeam 12 and is electrically connected to an external power source. The socket adapter 42 is inserted from top to bottom into the strip-shaped track opening 43 of the track socket 41. The socket adapter 42 can slide laterally along the strip-shaped track opening 43 and is electrically connected to the track socket 41. The upper end of the height adjustment structure 5 is connected to the socket adapter 42, and the light source 6 is located directly below the crossbeam 12. The matching method of the track socket 41 and the socket adapter 42 is prior art, disclosed in, for example, CN218850035U, CN218887736U, and CN116391301B.

[0028] The height adjustment structure 5 includes a suspension rod 51 and a fixed base 52 connected sequentially from top to bottom. The upper end of the suspension rod 51 is fixedly connected to the socket adapter 42. The upper section of the suspension rod 51 is curved and bypasses both the crossbeam 12 and the track socket 41 from the same side, while the lower section of the suspension rod 51 is vertically arranged, such as... Figure 6As shown. Two screws 54 slide vertically through the fixed base 52, and two nuts 55 are threaded onto each screw 54. The two nuts 55 are located on the upper and lower sides of the fixed base 52, respectively. The height adjustment structure 5 also includes a lifting seat 53 located below the fixed base 52, and the lifting seat 53 is fixedly connected to the lower end of each screw 54.

[0029] The lifting base 53 is detachably connected to the light source 6. Specifically, clips 56 are connected to both ends of the lifting base 53. The top of the light source 6 has an upward-protruding dovetail-shaped protrusion 61. The clips 56 clamp onto both sides of the dovetail-shaped protrusion 61 to prevent the light source 6 from falling. The hanging rod 51 has a hollow structure, and wires 57 are threaded through it. The upper end of the wire 57 is electrically connected to the socket adapter 42, and the lower end of the wire 57 is plugged into and electrically connected to the terminal on the light source 6. The wire 57 is made of a soft material and has sufficient length to ensure that changes in the height of the light source 6 will not break the wire 57.

[0030] A vacuum pump 7 is also installed on the light box 1, and the input end of the vacuum pump 7 is connected to the drug test chamber 11.

[0031] Before the experiment, personnel divide the test areas into a corresponding number of drug testing zones 30 using light-blocking partitions 3, based on the drugs to be irradiated in this experiment. The required number of light sources 6 are installed directly above each drug testing zone 30, and the height of the light sources 6 is adjusted according to the readings on the illuminance meter 8. Then, personnel place the trays 10 containing the drugs into the corresponding drug testing zones 30, close the door 13, start the vacuum pump 7 to expel the air from the drug testing chamber 11, and then turn on the light sources 6 to begin the experiment. When the same drug is placed in different drug testing zones 30 and the same light source 6 is used, the illuminance value received by the drug can be adjusted by changing the height of the light sources 6 in different drug testing zones 30. The illuminance value can be displayed on the screen 9, which helps personnel obtain the stability of the drug under different illuminance levels after the experiment. When different types of drugs are placed in different drug testing zones 30, each drug can undergo strong light irradiation simultaneously, improving experimental efficiency and shortening the total time.

[0032] To more intuitively demonstrate the effects of temperature, humidity, and light on powdered pharmaceutical samples, the following QSJD external washing and light irradiation comparison test was conducted: I. Experimental Objective: This study investigates the effects of humidity, temperature, and vacuum level on the light exposure test results of the QSJD external washing diffuser under the same light intensity conditions. It also aims to confirm the effectiveness of the light exposure device used in the light exposure test.

[0033] II. Test Plan: 1. Test Protocol

[0034] 2. Detection indicators

[0035] III. Test Materials and Instruments 1. Test materials

[0036] 2. Test instruments Lighting device (self-made), GX-1000 electronic balance (8.6.5.043), digital illuminance meter (1600943); rapid moisture meter (8.6.3.059) IV. Test Records 1. Period: T = 0 days 1.1 Indicator Testing

[0037] 2. Period: T = 10 days 2.1 Indicator Testing

[0038] Among them, three groups of samples had T=0 days and T=10 days, and their properties, appearance, and uniformity were as follows: Figure 7 As shown.

[0039] III. Experiment Summary Experimental data show that, in the first group of control samples, no significant changes were observed in powder properties, appearance, bulk density, and flowability between day 0 and day 10. The second group of samples (constant light intensity, no intervention) showed an increase in powder moisture and a decrease in bulk density (0.2874→0.2569 g / ml). Furthermore, particle agglomeration led to caking, resulting in poor flowability and demonstrating significant powder stability disadvantages. In contrast, under the same light intensity conditions, the third group of samples (controlled temperature and humidity) performed significantly better than the second group (no temperature and humidity control). Its moisture content decreased (8.94%→7.38%), effectively suppressing moisture absorption. The powder bulk density fluctuated less (0.2874→0.2903 g / ml), and the powder remained uniformly loose, with properties and appearance essentially consistent with its initial state.

[0040] In conclusion, temperature and humidity conditions significantly impact the accuracy of light exposure test results. The light exposure device used in this experiment possesses functions such as heating, air replacement, and vacuuming, effectively controlling the temperature and humidity within the chamber. This significantly reduces or eliminates the interference of temperature on the light exposure test, ensuring the reliability of the test data.

[0041] The present invention has been described above in conjunction with the preferred embodiments, but the present invention is not limited to the embodiments disclosed above, but should cover various modifications and equivalent combinations made in accordance with the essence of the present invention.

Claims

1. A device for testing pharmaceuticals under intense light irradiation, comprising an irradiation chamber (1), characterized in that, The light box (1) is equipped with a drug testing chamber (11). A crossbeam (12) is connected to the upper part of the drug testing chamber (11). A height adjustment structure (5) is connected to the crossbeam (12) via a sliding power supply assembly (4). A light source (6) is connected to the bottom of the height adjustment structure (5). The light source (6) is electrically connected to the sliding power supply assembly (4). A platform (2) for placing drugs is provided at the lower part of the drug testing chamber (11). An illuminance meter (8) is placed on the top surface of the platform (2). The illuminance meter (8) is electrically connected to a display screen (9) located outside the light box (1).

2. The apparatus for testing pharmaceuticals under strong light irradiation according to claim 1, characterized in that, The top surface of the platform (2) is divided into at least two horizontally arranged drug testing areas (30) by a light-blocking partition (3), and each drug testing area (30) is equipped with an illuminance meter (8) placed on the platform (2).

3. The apparatus for testing pharmaceuticals under strong light irradiation according to claim 2, characterized in that, The light-blocking partition (3) is detachably connected to the top surface of the platform (2); the top surface of the platform (2) is provided with at least two parallel sliding grooves (21), and the bottom of the light-blocking partition (3) is slidably inserted into the sliding grooves (21).

4. The apparatus for testing pharmaceuticals under strong light irradiation according to claim 1, characterized in that, The sliding power supply assembly (4) includes a matching track socket (41) and a socket adapter (42). The track socket (41) is installed on the top surface of the crossbeam (12). The socket adapter (42) is inserted into the strip track opening (43) of the track socket (41) from top to bottom. The socket adapter (42) can slide laterally along the strip track opening (43). The socket adapter (42) is electrically connected to the track socket (41). The upper end of the height adjustment structure (5) is connected to the socket adapter (42). The light source (6) is located directly below the crossbeam (12).

5. The apparatus for testing pharmaceuticals under strong light irradiation according to claim 4, characterized in that, The height adjustment structure (5) includes a hanging rod (51) and a fixed seat (52) connected from top to bottom. The upper end of the hanging rod (51) is connected to the socket adapter (42). The upper section of the hanging rod (51) is curved and bypasses both the crossbeam (12) and the track socket (41) on one side. The lower section of the hanging rod (51) is vertically arranged. The fixed seat (52) is slidably provided with at least two screws (54). Each screw (54) is threaded with two nuts (55). The two nuts (55) are located on the upper and lower sides of the fixed seat (52) respectively. The height adjustment structure (5) also includes a lifting seat (53) located below the fixed seat (52). The lifting seat (53) is fixedly connected to each screw (54). The lifting seat (53) is detachably connected to the light source (6).

6. The apparatus for testing pharmaceuticals under intense light irradiation according to claim 5, characterized in that, The lifting seat (53) is also connected to a clip (56), and the top of the light source (6) is provided with a dovetail-shaped protrusion (61). The clip (56) is clamped on both sides of the dovetail-shaped protrusion (61). The hanging rod (51) is a hollow structure, and a wire (57) is threaded through it. The upper end of the wire (57) is electrically connected to the socket adapter (42), and the lower end of the wire (57) is electrically connected to the light source (6).

7. The apparatus for testing pharmaceuticals under strong light irradiation according to claim 1, characterized in that, A vacuum pump (7) is also installed on the light box (1), and the input end of the vacuum pump (7) is connected to the drug test chamber (11).

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