Medicinal preparation compatibility experimental device

Abstract

The invention provides a pharmaceutical preparation compatibility experiment device, which comprises a box body, laminates are arranged in the box body, and the interior of the box body is divided into a plurality of lofting areas by the laminates; an illumination lamp is arranged on the inner top surface of each lofting area; a sample placing plate is arranged in the sample placing area and can slide in the sample placing area; a sealing plate A is fixed at one end of the sample placing plate, and a sealing plate B is fixed at the other end; a pressure sensor is arranged at the position where the lofting area is in contact with the sealing plate A, and the pressure sensor is connected with a controller A; the controller A is connected with the relay, and the relay controls the illumination lamp. By using the experimental device, the standardization of lofting and sampling can be improved, the conditions of sample confusion and sample pollution are avoided, and the illumination uniformity and the accuracy of samples are ensured.

Description

Technical Field

[0001] The present invention relates to the technical field of drug compatibility experiments, and specifically relates to a drug preparation compatibility experiment device. Background Art

[0002] Drug compatibility experiments include compatibility experiments between active pharmaceutical ingredients and excipients, compatibility experiments between drugs and packaging materials, compatibility experiments between drugs and production equipment, etc.; among them, the compatibility experiment between active pharmaceutical ingredients and excipients aims to ensure that there are no harmful physical, chemical and other effects between the active pharmaceutical ingredient (main drug) and the excipient during the preparation process and storage period, and to ensure the safety, effectiveness and stability of the drug.

[0003] The compatibility experiment between active pharmaceutical ingredients and excipients includes oxidation experiment, hydrolysis experiment and photolysis experiment. The mixture of active pharmaceutical ingredients and excipients is treated under forced degradation conditions, and then by regularly sampling and analyzing, the compatibility between the active pharmaceutical ingredient and the excipient is judged, so as to screen out the optimal excipient combination.

[0004] According to the ICH Q1B photostability test guidelines and the methods of photostability tests for active pharmaceutical ingredients and preparations in the Chinese Pharmacopoeia, ultraviolet-visible light sources are used to conduct photolysis experiments on active pharmaceutical ingredients, preparations, and mixtures of active pharmaceutical ingredients and excipients. Stage sampling is adopted, such as 24h, 48h, 72h, 96h, 5 days, etc., to observe and measure the samples; among them, during the sample placement process, different samples are placed in glass dishes (such as petri dishes) with a thickness ≤ 3mm to make the light more uniform.

[0005] Existing photolysis chambers mainly include a chamber body, with a partition inside the chamber body and a lighting lamp on the inner top surface of the chamber body; there is a chamber cover on the side of the chamber body; through the chamber cover, the side of the chamber body is closed to make the chamber body in a relatively closed state; during use, the petri dish containing the sample is manually placed from the inside to the outside of the partition in sequence; during sampling, according to the experimental settings, the chamber cover of the photolysis chamber is opened multiple times, and samples are taken from the outside to the inside of the partition in sequence; during this process, since the distance between each layer of partitions is limited and the petri dish has an open structure, when sampling, the sample may be touched as the arm reaches into the lighting chamber, and the back-and-forth movement of the arm may contaminate the open sample; in addition, since the position of each layer of partition from the light source is different, the photolysis effect of the sample may vary; furthermore, when the amount of samples is large, the samples taken out at the same time need to be stored in the dark additionally, which is likely to cause problems such as sample confusion and increased probability of sample contamination. Summary of the Invention

[0006] In view of this, the present invention provides a drug preparation compatibility experiment device, specifically an experiment device provided with a movable sample placement plate, with sealing plates A and B at both ends of the sample placement plate, and a pressure sensor outside the sample placement area. This experiment device has the advantages of reasonable design, strong practicability and convenient use.

[0007] The technical solution of the present invention is as follows: A compatibility experiment device for pharmaceutical preparations includes a box body. A shelf is provided inside the box body, and the shelf divides the interior of the box body into multiple sample placement areas; On the inner top surface of each sample placement area, a lighting lamp is provided for photolysis treatment of the samples; A sample placement plate is provided in the sample placement area, and the sample placement plate can slide within the sample placement area; A sealing plate A is fixed at one end of the sample placement plate, and a sealing plate B is fixed at the other end; When the sample placement plate is completely located within the sample placement area, the sealing plate A closes the entrance of the sample placement area; When the sample placement plate moves towards the outside of the sample placement area, the sealing plate B can reduce the gas heat exchange between the inside and outside of the sample placement area, and try to maintain the temperature stability inside the experimental device, so that the photolysis experiment can be carried out under continuous and relatively stable conditions; A pressure sensor is provided at the position where the sample placement area contacts the sealing plate A, and the pressure sensor is connected to a controller A; the controller A is connected to a relay, and the relay controls the lighting lamp; When the sealing plate A closes the sample placement area, the lighting lamp starts to work; this setting can avoid the problem that the lighting lamp is not turned off during sampling and improve the safety of operation; During use, pull the sample placement plate to make it located outside the sample placement area, place the glass dish containing the powdered sample on the sample placement plate, and push the sample placement plate to make the sample enter the sample placement area for placement; when the sample needs to be taken out, just pull the sample placement plate to take the sample, which avoids problems such as easy contamination of the sample and sample spillage caused by the current manual stretching into the experimental device; in addition, the setting of multiple sample placement areas can place the samples in different sample placement areas according to the sampling time requirements, which is conducive to subsequent sampling according to needs, avoids opening the experimental device multiple times and affecting the internal placement environment, and ensures the accuracy of the placement result; turn on the power switch to make the controller A, lighting lamp and pressure sensor all in the standby state.

[0008] Preferably, a sealing plate C and a sealing ring A are provided on the inner side surface of the sealing plate A, and the sealing ring A is located around the sealing plate C; when the sealing plate A closes the import of the sample placement area, the sealing ring A contacts the inner side surface at the import of the sample placement area, and the sealing plate C and the sealing ring A are used to achieve a sealed closure inside the sample placement area.

[0009] Preferably, since the glass dish has a certain sliding property and the powdered sample needs to have a uniform thickness to obtain a sample with uniform illumination, a silica gel pad is provided on the top surface of the sample placement plate; when the glass dish moves with the sample placement plate, its movement can be reduced, so that the sample can maintain the state when it is placed as much as possible, thereby ensuring the lighting effect.

[0010] Preferably, a spherical groove is provided at the bottom of the sample placing plate, and a rolling ball is provided in the spherical groove. The rolling ball contacts the bottom plate of the sample placing area. Through the movement of the rolling ball, the sample placing plate is more stable during movement, maintaining the state of the sample as much as possible and ensuring the lighting effect.

[0011] Preferably, a limiting rod is provided on the inner side surface of the sealing plate A, a groove is provided in the bottom plate of the sample placing plate, and a spring is provided in the groove. The end of the spring is connected to the end of the limiting rod. When the sample placing plate reciprocates, the limiting rod can play a role in limiting and supporting, making the movement of the sample placing plate more stable.

[0012] Preferably, a partition plate is provided in the box body, and the partition plate is arranged vertically. The inner end surface of the layer plate is connected to the partition plate. The partition plate and the rear side plate of the box body form a placement cavity. A temperature control module is provided in the placement cavity, and through holes are provided on the partition plate. Through the temperature control module, the temperature in the sample placing area is controlled.

[0013] Preferably, a telescopic device is provided in the placement cavity, and the telescopic end of the telescopic device passes through the partition plate and is connected to the sealing plate B. The telescopic device can smoothly push and pull the sealing plate B, realizing the entry and exit of the sample placing plate into and out of the sample placing area.

[0014] Preferably, a baffle is provided on the inner top surface of the sample placing area, near the inlet of the sample placing area. A sealing ring B is provided on the side of the baffle close to the lighting lamp. When the sealing plate B moves towards the inlet of the sample placing area with the sample placing plate and reaches the baffle, the sealing plate B is stuck on the sealing ring B. At this time, the sealing plate B seals the inside of the sample placing area as much as possible, reducing the influence of the external environment temperature on the internal temperature of the sample placing area during sampling.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: The internal part of the box body is divided into multiple relatively independent sample placing areas by the layer plate, which is conducive to sampling separately according to the sampling time requirements and reducing the influence of the sampling process on the lighting of the sample. The cooperation of the sample placing plate with the sealing plate A and the sealing plate B enables the sample to be placed and sampled by pushing and pulling methods, avoiding problems such as easy sample spilling and sample contamination caused by manual reaching into the sample placing area for sampling. When the number of samples is large, the method of sampling in batches after turning off the light source can be adopted to ensure the accuracy of the sample. In addition, the cooperation of the pressure sensor, the controller A and the lighting lamp can avoid manual opening and closing of the lighting lamp. First, it avoids the irradiation of the light on the human body and improves the operation safety. Second, it improves the degree of intelligence and the convenience of using the experimental device. The above settings make the experimental device have the advantages of reasonable design, strong practicability and convenient use. Using this experimental device can improve the standardization of sampling and sample taking, avoid the situation of sample confusion and sample contamination, and ensure the lighting uniformity and accuracy of the sample. Description of the Drawings

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0017] Figure 1 It is a schematic side view of the experimental device of the present invention.

[0018] Figure 2 It is the front view of the experimental device of the present invention.

[0019] Figure 3 It is a schematic structural view of the sample placing plate, sealing plate A and sealing plate B.

[0020] In the figure, 1 - box body, 2 - shelf board, 3 - sample placing area, 4 - illumination lamp, 5 - sample placing plate, 6 - sealing plate A, 7 - sealing plate B, 8 - sealing plate C, 9 - sealing ring A, 10 - silica gel pad, 11 - rolling ball, 12 - limiting rod, 13 - groove, 14 - spring, 15 - pressure sensor, 16 - partition board, 17 - telescopic device, 18 - baffle plate, 19 - sealing ring B. Detailed implementation manners

[0021] In order to enable those in the technical field to better understand the technical solutions in the present invention, the following will clearly and completely describe the technical solutions of the present invention in combination with the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the scope of protection of the present invention.

[0022] Combined with Figures 1 - 2 , a drug preparation compatibility experimental device includes a box body 1, and a shelf board 2 is arranged inside the box body 1. The shelf board 2 divides the interior of the box body 1 into multiple sample placing areas 3; in this embodiment, there are three sample placing areas 3; An illumination lamp 4 is arranged on the inner top surface of each sample placing area 3 for photolysis treatment of the samples; A sample placing plate 5 is arranged in the sample placing area 3, and the sample placing plate 5 can slide in the sample placing area 3; A sealing plate A 6 is fixed at one end of the sample placing plate 5, and a sealing plate B 7 is fixed at the other end; When the sample placing plate 5 is completely located inside the sample placing area 3, the sealing plate A 6 closes the entrance of the sample placing area 3; When the sample placing plate 5 moves outward from the sample placing area 3, the sealing plate B 7 can reduce the gas heat exchange between the inside and the outside of the sample placing area 3, and try to maintain the temperature stability inside the experimental device, so that the photolysis experiment is carried out under continuous and relatively stable conditions. Among them, the sealing plate B7 is a concave plate, and when it moves in the lofting area 3, it will not affect the lighting lamp 4; In this embodiment, a sealing plate C8 and a sealing ring A9 are provided on the inner side surface of the sealing plate A6, and the sealing ring A9 is located around the sealing plate C8; the end of the template 5 is connected to the sealing plate C8; When the sealing plate A6 closes the inlet of the lofting area 3, the sealing ring A9 contacts the inner side surface at the inlet of the lofting area 3, and the sealing plate C8 and the sealing ring A9 are used to realize the sealing of the inside of the lofting area 3; at this time, the sealing plate A6 is closely attached to the side surface of the inlet of the lofting area 3; Since the glassware has a certain sliding property and the powder sample needs to have a uniform thickness to obtain a sample with uniform illumination, a silica gel pad 10 is provided on the top surface of the template 5; when the glassware moves along with the template 5, its movement can be reduced, so that the sample can maintain the state when it is placed as much as possible, thereby ensuring the lighting effect; To further improve the stability of the glassware during movement, a stop bar is also provided on the template, and the stop bar connects the sealing plate B7 and the sealing plate C8; it is beneficial to limit the glassware within a specific range, ensuring uniform illumination and the stability of the sample during movement; A spherical groove (not shown in the figure) is provided at the bottom of the template 5, and a rolling ball 11 is provided in the spherical groove, and the rolling ball 11 contacts the bottom plate of the lofting area 3; through the movement of the rolling ball 11, the template 5 is more stable during movement, and the state of the sample is maintained as much as possible, ensuring the lighting effect; A limiting rod 12 is provided on the inner side surface of the sealing plate A6, and the limiting rod 12 is located below the sealing ring A; a groove 13 is provided in the bottom plate of the template 5, and a spring 14 is provided in the groove 13, and the end of the spring 14 is connected to the end of the limiting rod 12; when the template 5 reciprocates, the limiting rod 12 can play a limiting and supporting role, making the movement of the template 5 more stable; A pressure sensor 15 is embedded on the side surface at the inlet of the lofting area 3, and when the sealing plate A6 closes the inlet of the lofting area 3, the inner side surface of the sealing plate A6 contacts the pressure sensor 15; The pressure sensor 15 is connected to the controller A; the controller A is connected to a relay, and the relay controls the lighting lamp 4; When the sealing plate A6 closes the lofting area 3, the lighting lamp 4 starts to work; this setting can avoid the problem that the lighting lamp 4 is not turned off during sampling and improve the safety of operation; During use, pull the sample placing plate 5 to make it located outside the lofting area 3, place the glass dish with the powdered sample on the sample placing plate 5, push the sample placing plate 5 to make the sample enter the lofting area 3 for lofting; when it is necessary to take out the sample, just pull the sample placing plate 5 to take the sample, avoiding problems such as easy contamination of the sample and sample spillage caused by the current manual stretching into the experimental device; in addition, the setting of multiple lofting areas 3 can loft the samples in different lofting areas 3 according to the sampling time requirements, which is conducive to subsequent sampling according to needs, avoiding multiple openings of the experimental device and affecting the internal lofting environment, and ensuring the accuracy of the lofting results; turn on the power switch to make the controller A, the lighting lamp 4 and the pressure sensor 15 all in the standby state; A partition plate 16 is provided inside the box body 1, and the partition plate 16 is vertically arranged; the inner end face of the shelf board 2 is connected to the partition plate 16; the partition plate 16 and the rear side plate of the box body 1 form a placement cavity; a temperature control module is provided in the placement cavity, and a through hole (not shown in the figure) is provided on the partition plate 16; through the temperature control module, the temperature in the lofting area 3 is controlled; In this embodiment, the temperature control module includes a temperature sensor, a controller B, a PTC heating sheet and a TEC module; A telescopic device 17 is provided in the placement cavity, and the telescopic end of the telescopic device 17 passes through the partition plate 16 and is connected to the sealing plate B7; the telescopic device 17 can smoothly push and pull the sealing plate B7 to realize the entry and exit of the sample placing plate 5 from the lofting area 3; in this embodiment, the telescopic device 17 is an electric push rod; A baffle 18 is provided on the inner top surface of the lofting area 3, and the baffle 18 is close to the inlet of the lofting area 3; a sealing ring B19 is provided on one side of the baffle 18 close to the lighting lamp 4; when the sealing plate B7 moves with the sample placing plate 5 towards the inlet of the lofting area 3 and reaches the baffle 18, the sealing plate B7 is stuck on the sealing ring B19, and at this time, the sealing plate B7 seals the inside of the lofting area 3 as much as possible, reducing the influence of the external environment temperature on the internal temperature of the lofting area 3 during sampling.

[0023] The photodegradation experiment is an experiment to study the degradation degree of the sample under specific lighting conditions; to reduce the influence of temperature on the photodegradation experiment, the photodegradation experiment device is usually temperature-controlled, and the temperature is about 25°C; during batch sampling of the current experimental device, the frequent opening and closing process will affect the temperature inside the experimental device, which is not conducive to the accuracy of the photodegradation experiment results; for this reason, the present invention provides a new experimental device. In this experimental device, the pressure sensor 15 is a patch type piezoresistive sensor (range 0-5 kg, accuracy ±1%, when the pressure value ≥ 0.5 kg, the lighting lamp 4 is turned on; when the pressure value < 0.5 kg, the lighting lamp 4 is turned off). The usage method of this experimental device is as follows: S1. Prepare samples. Prepare samples according to the requirements of the samples to be degraded. At least three samples of the same sample under each condition should be prepared; lay the samples evenly in the glass dish, and the thickness is 2-2.5 mm; S2. Use the telescopic device 17 to push the sample placing plate 5 out into the laying-out area 3. After laying out, the sample placing plate 5 carries the sample into the laying-out area 3. When the pressure sensor 15 detects that the pressure value ≥ 0.5 kg, the lighting lamp 4 starts timing. S3. Use the temperature control module to keep the temperature in the box body 1 constant. When the laying-out time reaches the set time, the telescopic device 17 pushes out the sample placing plate 5. After sampling, if there is no more laying out in the corresponding laying-out area 3, just turn off the power supply of the corresponding laying-out area 3.

[0024] Although the present invention has been described in detail by referring to the preferred embodiments, the present invention is not limited thereto. Without departing from the spirit and essence of the present invention, those of ordinary skill in the art can make various equivalent modifications or substitutions to the embodiments of the present invention, and these modifications or substitutions should all be within the scope covered by the present invention. / Any person skilled in the art within the technical scope disclosed by the present invention can easily think of changes or substitutions, which should all be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A compatibility experiment device for pharmaceutical preparations, comprising a box body, characterized in that, There is a shelf inside the box body, and the shelf divides the interior of the box body into multiple lofting areas; Lighting lamps are provided on the inner top surface of each lofting area; A template is provided in the lofting area, and the template can slide in the lofting area; A sealing plate A is fixed at one end of the template, and a sealing plate B is fixed at the other end; A pressure sensor is provided at the position where the lofting area contacts the sealing plate A, and the pressure sensor is connected to a controller A; the controller A is connected to a relay, and the relay controls the lighting lamp.

2. The drug formulation compatibility experiment device according to claim 1, characterized in that, A sealing plate C and a sealing ring A are provided on the inner side surface of the sealing plate A, and the sealing ring A is located around the sealing plate C.

3. The pharmaceutical preparation compatibility experiment device according to claim 1, characterized in that, A silica gel pad is provided on the top surface of the template.

4. The pharmaceutical preparation compatibility experiment device according to claim 1, characterized in that, A spherical groove is provided at the bottom of the template, and a rolling ball is provided in the spherical groove, and the rolling ball contacts the bottom plate of the lofting area.

5. The drug preparation compatibility experiment device according to claim 1, characterized in that, A limiting rod is provided on the inner side surface of the sealing plate A, a groove is provided in the bottom plate of the template, and a spring is provided in the groove, and the end of the spring is connected to the end of the limiting rod.

6. The pharmaceutical preparation compatibility experiment device according to claim 1, wherein, A partition is provided inside the box body, and the partition is arranged vertically; the inner end surface of the shelf is connected to the partition; the partition and the rear side plate of the box body form a placement cavity; a temperature control module is provided in the placement cavity, and through holes are provided on the partition.

7. The pharmaceutical preparation compatibility experiment device according to claim 1, characterized in that, A telescopic device is provided in the placement cavity, and the telescopic end of the telescopic device passes through the partition and is connected to the sealing plate B.

8. The pharmaceutical preparation compatibility experiment device according to claim 1, wherein, A baffle is provided on the inner top surface of the lofting area, and the baffle is close to the inlet of the lofting area; a sealing ring B is provided on the side of the baffle close to the lighting lamp.

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