A biopharmaceutical detection device and method

Abstract

The present invention discloses a biopharmaceutical detection device and method, belonging to the field of drug detection. A biopharmaceutical detection device includes a detection box and a microscopic detection camera fixed on the inner wall of the detection box, a detection table is rotatably connected in the detection box, a culture dish is plugged in the detection table, a medicine tank and a culture liquid tank are respectively fixedly connected on both sides of the top of the detection box, and the output pipes of the medicine tank and the culture liquid tank are both inserted through the detection box to extend above the culture dish, and also includes: an air cleaning component; the present invention filters the external fresh air flow, disinfects and purifies it through the rotation of the air guide blade, and then introduces it into the detection box, so that the detection box is in a sterile state, reducing the impact of the unqualified gas environment on the detection result, and effectively improving the detection accuracy; and the repulsion between the second magnetic plate and the first magnetic plate is used to make the dust filter net vibrate, and the dust impurities attached to it are shaken off, thereby improving the filtering effect and ensuring the ventilation efficiency.

Description

Technical Field

[0001] The present invention relates to the technical field of drug detection, and in particular to a detection device and method for biopharmaceuticals. Background Art

[0002] In the pharmaceutical manufacturing process, bacterial detection in medicines is the most important and critical indicator for drug safety testing. Drugs that fail bacterial detection and are injected into the human body can cause severe reactions and death. Pharmacopoeias of various countries stipulate that no biologically active bacteria should be detected in injectable medicines to ensure the safety of drug injections.

[0003] At present, in the process of testing whether there are bacteria in medicines, the medicines are generally placed directly under a microscope. This operation has the following shortcomings. First, during the process of sampling the medicines and loading and placing them under the microscope, bacteria in the air may enter the medicines, thereby affecting the test results. In addition, when the amount of bacteria in the medicines is very small, the observation of the manual microscope may be negligent or unclear, which will also affect the final accuracy of the test. Therefore, a detection device and method for biopharmaceuticals are proposed. Summary of the invention

[0004] The purpose of the present invention is to solve the problem in the prior art that during the process of bacteria detection, bacteria in the air may affect the test results, and when the amount of bacteria is extremely small, the observation under the artificial microscope may be negligent or unclear, thereby resulting in poor accuracy of the final test results. A detection device and method for biopharmaceuticals are proposed.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions:

[0006] A detection device for biopharmaceuticals, comprising a detection box and a microscopic detection camera fixed to the inner wall of the detection box, wherein a detection table is rotatably connected inside the detection box, a culture dish is inserted into the detection table, a medicine tank and a culture liquid tank are respectively fixedly connected to the top two sides of the detection box, the output pipes of the medicine tank and the culture liquid tank both pass through the detection box and extend to above the culture dish, and also includes: an air purification component, which is arranged in the detection box and is used to improve the cleanliness of the air in the detection box to meet the detection requirements.

[0007] In order to improve the gas quality in the detection box, preferably, the air purification component includes a purification box, which is fixed on the side wall of the detection box, and an air inlet groove and an air outlet groove are respectively opened inside the purification box, the input end of the air inlet groove is connected with the outside, the output end of the air outlet groove is connected with the inner cavity of the detection box, and the air inlet groove and the air outlet groove are connected through an air guide groove, and an air guide blade is rotatably connected in the air guide groove, and a driving motor is fixedly connected to the side wall of the purification box, and the output shaft of the driving motor is fixedly connected to the end of the rotating shaft of the air guide blade.

[0008] Furthermore, a dust filter is slidably connected to the output end of the air inlet groove, and positioning blocks are fixedly connected at the corners of the inner wall of the output end of the air inlet groove, a first spring is fixedly connected between the dust filter and the positioning block, a first air groove is opened in the purification box above the air guide groove, a first magnetic plate is slidably connected to the first air groove, a second spring is fixedly connected between the first magnetic plate and the first air groove, a second magnetic plate is fixedly connected to the end of the air guide blade, and the second magnetic plate and the first magnetic plate repel each other magnetically, a piston cylinder is fixedly connected to the air inlet groove, the piston cylinder is communicated with the inner cavity of the first air groove, a piston push rod is slidably connected to the piston cylinder, and a third spring is sleeved on the outer wall of the piston push rod.

[0009] Furthermore, two groups of liquid baffles that are staggered with each other are fixedly connected to the inner wall of the air outlet groove, a water filter plate is fixedly connected to the output end of the air outlet groove, a waterproof and breathable membrane is used in the water filter plate to filter water and allow ventilation, a downward-inclined exhaust groove is also provided on the side wall of the detection box, a dust baffle is rotatably connected to the exhaust groove, and the dust baffle is arranged parallel to the bottom of the exhaust groove.

[0010] In order to improve the efficiency of bacterial reproduction, preferably, a second air groove is opened in the purification box located below the air guide groove, a third magnetic plate is slidably connected in the second air groove, a fourth spring is fixedly connected between the bottom of the third magnetic plate and the second air groove, and the third magnetic plate and the first magnetic plate repel each other magnetically, the side wall of the rotating shaft of the detection table is rotatably connected to a drive box, the drive box is fixedly connected to the bottom of the detection box, a drive impeller is fixedly connected to the outer wall of the rotating shaft of the detection table located in the detection box, the side wall of the second air groove is fixed and connected to an air guide pipe, and the other end of the air guide pipe is connected to the inner cavity of the drive box.

[0011] Furthermore, a guide ball is fixedly connected to the middle section of the air guide tube, a side wall of the guide ball is fixed and connected to an exhaust pipe, a one-way valve is provided in the exhaust pipe and the air guide tube below the guide ball, an air outlet is provided on the top of the drive box, the fourth spring is made of resistance wire and is electrically connected to an external power supply, and a temperature sensor is fixedly connected to the bottom of the detection platform.

[0012] In order to improve the stability of the culture dish, preferably, a snap-in groove is opened on the inner wall of the detection table, and four groups of the snap-in grooves are evenly distributed along the central ring of the detection table, and a snap-in plate is slidably connected in each group of the snap-in grooves, a fifth spring is fixedly connected between the side wall of the snap-in plate and the snap-in groove, and the outer end of the snap-in plate is set with an arc-shaped rounded corner.

[0013] In order to facilitate filtering out bacteria in the medicine, preferably, a bacteria collecting filter is fixedly connected to the bottom of the culture dish, a drain pipe is fixed at the center of the bottom of the culture dish and is connected to it, a drain trough is opened at the center of the rotating shaft of the detection table, the drain trough extends downward and passes through the detection box, the drain trough extends upward to the surface of the detection table, the drain pipe is aligned with the drain trough up and down, and the outer diameter of the drain pipe is equal to the inner diameter of the drain trough.

[0014] Furthermore, solenoid valves are provided in the output pipes and drainage pipes of the medicine tank and the culture fluid tank.

[0015] A biopharmaceutical detection method, the steps are as follows:

[0016] Step 1: After installing the culture dish in the test box, purify the air in the test box;

[0017] Step 2: Add the test agent to the culture dish through the agent tank, filter out the bacteria in the agent, and use a microscopic detection camera to perform preliminary bacterial detection;

[0018] Step 3: Add culture solution to the culture dish through the culture solution tank to make the filtered bacteria multiply rapidly;

[0019] Step 4: Use a microscopic detection camera to observe the filtrate of the drug to be tested after cultivation, complete further detection of drug bacteria, and thus determine whether the drug meets the sterility standard.

[0020] Compared with the prior art, the present invention provides a biopharmaceutical detection device and method, which has the following beneficial effects:

[0021] 1. The biopharmaceutical detection equipment filters, disinfects and purifies the fresh air flow from the outside and then introduces it into the detection box through the rotation of the air guide blades, so that the detection box is in a sterile state, reducing the impact of the unqualified gas environment on the detection results, and effectively improving the detection accuracy; and using the repulsive effect of the second magnetic plate and the first magnetic plate, the dust filter net vibrates to shake off the dust and impurities attached to it, thereby improving the filtering effect and ensuring the ventilation efficiency.

[0022] 2. The biopharmaceutical detection equipment utilizes the cooperation between the bacteria filter, the drain pipe and the drain trough to filter the bacteria in the medicine, and through the repulsion between the third magnetic plate and the first magnetic plate, the gas is continuously rushed into the drive box along the air guide tube, thereby driving the detection table to rotate, making it convenient for the micro-detection camera to perform a comprehensive inspection of the culture dish, so as to accurately detect whether there are bacterial residues in the culture dish after the medicine is filtered, thereby improving the detection effect and accuracy.

[0023] 3. The biopharmaceutical detection equipment continuously introduces clean air into the detection box through the rotation of the air guide blades, and cooperates with the rotation of the culture dish to enable bacteria to better contact with oxygen and culture fluid, and the air flow flowing in the air guide tube can export the heat generated by the power supply of the fourth spring to the detection box, and cooperate with the temperature sensor to increase the temperature suitable for bacterial growth and reproduction. In summary, the growth and reproduction rate of bacteria is effectively improved, thereby improving the efficiency of drug detection.

[0024] 4. The biopharmaceutical testing equipment cooperates with the setting of the first magnetic plate, the second magnetic plate and the third magnetic plate during the rotation of the air guide blade to fully utilize the rotation force. During the rotation process, the dust filter is cleaned and the detection table is driven to rotate, which improves the utilization effect of the driving force and achieves good energy saving. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a schematic diagram of the overall structure of a biopharmaceutical detection device proposed by the present invention;

[0026] Figure 2 A schematic diagram of the internal structure of a detection box of a biopharmaceutical detection device proposed by the present invention;

[0027] Figure 3 A biopharmaceutical detection device proposed by the present invention Figure 2 A schematic diagram of the enlarged structure of the middle A area;

[0028] Figure 4 A schematic diagram of a half-section structure of a biopharmaceutical detection device proposed by the present invention;

[0029] Figure 5 A biopharmaceutical detection device proposed by the present invention Figure 4 Schematic diagram of the enlarged structure of the middle B area;

[0030] Figure 6 A biopharmaceutical detection device proposed by the present invention Figure 4 Schematic diagram of the enlarged structure of the middle C area;

[0031] Figure 7 This is a schematic diagram of the internal structure of the air guide slot of a biopharmaceutical detection device proposed by the present invention;

[0032] Figure 8 This is a schematic diagram of the enlarged structure of a detection platform of a biopharmaceutical detection device proposed by the present invention;

[0033] Fig. 9 This is a schematic diagram of the internal structure of a detection platform of a biopharmaceutical detection device proposed by the present invention.

[0034] In the figure: 1, test box; 2, microscopic test camera; 3, test table; 31, snap-in slot; 32, snap-in plate; 33, fifth spring; 34, drain slot; 4, culture dish; 41, bacteria filter; 42, drain pipe; 5, medicine tank; 51, culture liquid tank; 6, air cleaning component; 61, purification box; 62, air inlet slot; 621, dust filter; 622, positioning block; 623, first spring; 63, air outlet slot; 631, liquid baffle plate; 632, water filter plate; 64, air guide slot; 6 41. air guide blade; 642. driving motor; 65. first air groove; 651. first magnetic plate; 652. second spring; 653. second magnetic plate; 66. piston cylinder; 661. piston push rod; 662. third spring; 67. second air groove; 671. third magnetic plate; 672. fourth spring; 673. air guide pipe; 68. air guide ball; 681. exhaust pipe; 7. exhaust groove; 71. dust shield; 8. driving box; 81. driving impeller; 82. air outlet; 9. temperature sensor. DETAILED DESCRIPTION

[0035] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments.

[0036] In the description of the present invention, it is necessary to understand that the terms "upper", "lower", "front", "back", "left", "right", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0037] Embodiment 1:

[0038] Reference Figure 1-Figure 9, a biopharmaceutical detection equipment, comprising a detection box 1 and a microscopic detection camera 2 fixed on the inner wall of the detection box 1, a detection table 3 is rotatably connected in the detection box 1, a clamping groove 31 is opened on the inner wall of the detection table 3, and four groups of clamping grooves 31 are distributed in a ring-shaped manner along the center of the detection table 3 at equal intervals, and a clamping plate 32 is slidably connected in each group of clamping grooves 31, and a fifth spring 33 is fixedly connected between the side wall of the clamping plate 32 and the clamping groove 31, and the outer end of the clamping plate 32 is an arc-shaped fillet setting, when the culture dish 4 is installed on the detection table 3, its side wall will squeeze the surrounding clamping plates 32, so that the clamping plates 32 retract into the clamping groove 31, and finally, under the rebound action of the fifth spring 33, the culture dish 4 will be stably fixed on the detection table 3; a culture dish 4 is inserted in the detection table 3, and a bacteria collecting filter 41 is fixedly connected to the bottom of the culture dish 4, and the bottom center of the culture dish 4 is fixed and connected to a drainage Liquid pipe 42, a drainage groove 34 is provided at the center of the rotating shaft of the detection table 3, the drainage groove 34 extends downward and passes through the detection box 1, and the drainage groove 34 extends upward to the surface of the detection table 3, the drainage pipe 42 is aligned with the drainage groove 34 up and down, and the outer diameter of the drainage pipe 42 is equal to the inner diameter of the drainage groove 34, so that the drainage pipe 42 can be just plugged into the drainage groove 34, which not only improves the plug-in and fixing effect of the culture dish 4, but also facilitates the discharge of the medicine and ensures the sealing; the top two sides of the detection box 1 are respectively fixedly connected with the medicine tank 5 and the culture liquid tank 51, the output pipes of the medicine tank 5 and the culture liquid tank 51 both pass through the detection box 1 and extend above the culture dish 4, and the output pipes of the medicine tank 5 and the culture liquid tank 51 and the drainage pipe 42 are all provided with electromagnetic valves; it also includes: an air purification component 6, the air purification component 6 is arranged in the detection box 1, and is used to improve the cleanliness of the air in the detection box 1 to meet the detection requirements.

[0039] Reference Figure 2-Figure 4 and Figure 7The air cleaning component 6 includes a purification box 61, which is fixed on the side wall of the detection box 1. An air inlet groove 62 and an air outlet groove 63 are respectively provided inside the purification box 61. The input end of the air inlet groove 62 is connected to the outside, and the output end of the air outlet groove 63 is connected to the inner cavity of the detection box 1. The air inlet groove 62 and the air outlet groove 63 are connected through an air guide groove 64. An air guide blade 641 is rotatably connected in the air guide groove 64, and a disinfectant liquid of a quarter of the height is filled in the air guide groove 64. A driving motor 642 is fixedly connected to the side wall of the purification box 61. The driving motor 6 The output shaft of the air inlet groove 62 is fixedly connected to the end of the rotating shaft of the air guide blade 641, a dust filter 621 is slidably connected in the output end of the air inlet groove 62, and positioning blocks 622 are fixedly connected at the corners of the inner wall of the output end of the air inlet groove 62. A first spring 623 is fixedly connected between the dust filter 621 and the positioning block 622. A first air groove 65 is opened in the purification box 61 above the air guide groove 64, and a first magnetic plate 651 is slidably connected in the first air groove 65. A second spring 652 is fixedly connected between the first magnetic plate 651 and the first air groove 65, and the end of the air guide blade 641 is fixedly connected to the first magnetic plate 651. A second magnetic plate 653 is fixedly connected to the air inlet groove 62, and the second magnetic plate 653 and the first magnetic plate 651 are magnetically repelled. A piston cylinder 66 is fixedly connected to the air inlet groove 62, and the piston cylinder 66 is connected to the inner cavity of the first air groove 65. A piston push rod 661 is slidably connected to the piston cylinder 66, and a third spring 662 is sleeved on the outer wall of the piston push rod 661. Two groups of liquid baffles 631 distributed in an interlaced manner are fixedly connected to the inner wall of the air outlet groove 63. A water filter plate 632 is fixedly connected to the output end of the air outlet groove 63. A waterproof and breathable membrane is used in the water filter plate 632 to filter water and ventilate. The liquid baffle plate 63 1 can block the gas containing the solution, so that the liquid part in the gas is intercepted, reducing the filtering load of the water filter plate 632, and improving the water filtering effect; the side wall of the detection box 1 is also provided with a downwardly inclined exhaust groove 7, and a dust shield plate 71 is rotatably connected in the exhaust groove 7, and the dust shield plate 71 is arranged parallel to the bottom of the exhaust groove 7. The cooperation between the exhaust groove 7 and the dust shield plate 71 can only make the airflow in the detection box 1 be discharged outward, and prevent the external unpurified airflow from passing through the exhaust groove 7 into the detection box 1, thereby ensuring the cleanliness of the airflow in the detection box 1;

[0040] Through the arrangement of the above structure, when the air guide blade 641 rotates, the external airflow passes through the air inlet groove 62 and enters the air guide groove 64. In the process of the airflow passing through the air inlet groove 62, it will be preliminarily filtered by the dust filter 621 to filter the larger particles of dust in the airflow, thereby improving the cleanliness of the airflow entering the air guide groove 64. In addition, the repulsive effect of the second magnetic plate 653 and the first magnetic plate 651 will cause the piston push rod 661 to extend and squeeze the dust filter 621. Then, under the rebound effect of the first spring 623, the dust filter 621 will rebound and vibrate, and so on. The vibration cleaning of the dust filter 621 is effectively realized, the filtering effect of the dust filter 621 is improved, and the ventilation speed is ensured. Secondly, the rotation of the air guide blade 641 will also bring up the disinfectant liquid filled in the air guide groove 64, so that the disinfectant liquid is in the air guide groove 64. A water wall is formed around the blade 641. When the air flow passes through the water wall, the bacteria contained therein will be disinfected and the fine dust contained therein will be absorbed by the solution, thereby further improving the cleanliness of the air flow. Then, the clean air flow will be discharged along the air outlet groove 63, and the liquid part entrained in the air flow will be filtered by the water filter plate 632, so that only the gas enters the detection box 1. With the continuous inflow of fresh clean air flow, the air pressure in the detection box 1 will increase, thereby pushing open the dust baffle 71 in the exhaust groove 7, so that the original air flow in the detection box 1 is gradually discharged until the detection box 1 is completely filled with fresh clean air flow, so that the detection box 1 is in a sterile state, and the continuous movement of the air flow can also flush and clean the detection table 3 and the culture dish 4, ensuring the cleanliness of the detection table 3 and the culture dish 4, and effectively improving the detection accuracy.

[0041] Reference Figure 4 , Figure 5 and Figure 7 , wherein a second air groove 67 is provided in the purification box 61 located below the air guide groove 64, a third magnetic plate 671 is slidably connected in the second air groove 67, a fourth spring 672 is fixedly connected between the bottom of the third magnetic plate 671 and the second air groove 67, and the third magnetic plate 671 and the first magnetic plate 651 are magnetically repelled, a driving box 8 is rotatably connected to the side wall of the rotating shaft of the detection table 3, the driving box 8 is fixedly connected to the bottom of the detection box 1, a driving impeller 81 is fixedly connected to the outer wall of the rotating shaft of the detection table 3 located in the detection box 1, and an air guide pipe 673 is fixed and connected to the side wall of the second air groove 67, and the other end of the air guide pipe 673 is connected to the inner cavity of the driving box 8;

[0042] Through the arrangement of the above structure, the repulsive effect between the third magnetic plate 671 and the first magnetic plate 651 will be used to squeeze the gas in the second gas groove 67, so that the gas in the second gas groove 67 rushes into the drive box 8 along the air duct 673, thereby pushing the driving impeller 81 to drive the detection table 3 to rotate. At this time, the rotating culture dish 4 can be fully detected through the microscopic detection camera 2, thereby improving the detection effect.

[0043] Reference Figure 1-Figure 6 , wherein the middle section of the air guide tube 673 is fixedly connected with the guide ball 68, the side wall of the guide ball 68 is fixed and connected with the exhaust pipe 681, the exhaust pipe 681 and the air guide tube 673 located below the guide ball 68 are both provided with a one-way valve, the top of the driving box 8 is provided with an air outlet 82, the fourth spring 672 is made of a resistance wire material and is electrically connected to an external power supply, and the bottom of the detection platform 3 is fixedly connected with a temperature sensor 9;

[0044] It should be noted that the one-way valve in the air extraction pipe 681 can only allow the airflow in the detection box 1 to enter the second air groove 67; the one-way valve in the air guide pipe 673 can only allow the gas in the second air groove 67 to enter the drive box 8.

[0045] It should be noted that the temperature sensor 9 and the fourth spring 672 are electrically connected to the external control circuit. During the detection process, the fourth spring 672 will be powered on to generate heat, and under the action of the airflow, the heat will be transported to the detection box 1. The temperature sensor 9 is used to detect the real-time temperature in the detection box 1 to ensure that the temperature is between 36 and 38 degrees, and the control circuit is used to intelligently start and stop the power-on state of the fourth spring 672. The part of the above-mentioned control circuit intelligent start and stop belongs to the current mature technology, so it will not be repeated;

[0046] Through the arrangement of the above structure, when bacteria are propagated and cultured, the fourth spring 672 is energized and generates heat. This part of the heat will be carried into the driving box 8 by the air flow that rushes into the driving box 8, and then discharged into the detection box 1 through the air outlet 82, thereby heating the inside of the detection box 1. In conjunction with the temperature sensor 9, the temperature inside the detection box 1 is controlled between 36 and 38 degrees, which is suitable for bacterial growth, thereby further improving the bacterial reproduction efficiency and further improving the detection efficiency of the drug.

[0047] Reference Figure 1-Figure 9In the present invention, when in use, a clean culture dish 4 is inserted from above the detection platform 3, and the drainage pipe 42 is aligned with the drainage groove 34. Under the squeezing effect of the side wall of the culture dish 4, the surrounding clamping plates 32 will be simultaneously retracted into the clamping groove 31. Finally, after the culture dish 4 is fully inserted, the culture dish 4 will be firmly fixed on the detection platform 3 under the rebound effect of the surrounding fifth springs 33. At this time, the drainage pipe 42 will also be fully inserted into the drainage groove 34, realizing the limited fixation of the culture dish 4, thereby improving the stability of the culture dish 4 during the detection process; then the detection box 1 is sealed, and the driving motor 642 is turned on to drive the air guide blade 641 to move forward. When the air guide blade 64 rotates, suction will be generated in the air guide groove 64 first, so that the external airflow passes through the air inlet groove 62 and enters the air guide groove 64. In the process of the airflow passing through the air inlet groove 62, it will be preliminarily filtered by the dust filter 621 to filter the larger particles of dust in the airflow, thereby improving the cleanliness of the airflow entering the air guide groove 64. In addition, in conjunction with the repulsive effect of the second magnetic plate 653 and the first magnetic plate 651, when the air guide blade 641 rotates, it will push the first magnetic plate 651 to slide in the first air groove 65, thereby compressing the airflow in the first air groove 65, so that this part of the airflow enters the piston cylinder 66, and pushes the piston push rod 661 to extend, thereby pressing the dust filter 621. The first spring 623 is compressed by squeezing, and then when the second magnetic plate 653 and the first magnetic plate 651 are separated from the magnetic area, the dust filter 621 will rebound and vibrate under the rebound effect of the first spring 623, and so on, effectively realizing the vibration cleaning of the dust filter 621, improving the filtering effect of the dust filter 621, and ensuring the ventilation speed; secondly, the rotation of the air guide blade 641 will also bring up the disinfectant liquid filled in the air guide groove 64, so that the disinfectant liquid forms a water wall around the air guide blade 641. At this time, when the airflow passes through the above-mentioned water wall, the bacteria contained therein will be disinfected and the fine dust contained therein will be absorbed by the solution, so as to This further improves the cleanliness of the airflow, and then the clean airflow will be discharged along the air outlet groove 63, and the liquid part entrained in the airflow will be filtered by the water filter plate 632, so that only the gas enters the detection box 1. With the continuous inflow of fresh clean airflow, the air pressure in the detection box 1 will increase, thereby pushing open the dust baffle 71 in the exhaust groove 7, so that the original airflow in the detection box 1 is gradually discharged until the detection box 1 is completely filled with fresh clean airflow, so that the detection box 1 is in a sterile state, and the continuous movement of the airflow can also flush and clean the detection table 3 and the culture dish 4, ensuring the cleanliness of the detection table 3 and the culture dish 4, and effectively improving the detection accuracy.

[0048] When the air flow cleanliness in the detection box 1 meets the detection requirements, the drug to be detected is first added to the culture dish 4 through the drug tank 5. At this time, the drug will pass through the bacteria filter 41 and be discharged along the drain pipe 42 and the drain groove 34, and the bacteria in the drug will be trapped on the surface of the bacteria filter 41. During the rotation of the air guide blade 641, the repulsive effect between the third magnetic plate 671 and the first magnetic plate 651 will squeeze the gas in the second gas groove 67, so that the gas in the second gas groove 67 rushes into the drive box 8 along the air guide pipe 673, thereby pushing the driving impeller 81 to drive the detection table 3 to rotate. The microscopic detection camera 2 can perform a comprehensive detection on the rotating culture dish 4, thereby improving the detection effect; when the microscopic detection camera 2 does not or does not obviously detect whether there are bacteria in the culture dish 4, the culture liquid is dripped into the culture dish 4 through the culture liquid tank 51, so that the bacteria intercepted in the culture dish 4 can multiply, and at this time, the air guide blade 641 still keeps rotating, firstly, it can always replenish fresh air flow into the detection box 1, ensure the oxygen content in the detection box 1, and increase the growth and reproduction speed of bacteria, and at this time, the culture dish 4 still keeps rotating, so that the bacteria can better interact with the culture dish 4. The culture solution in the dish 4 and the oxygen in the detection box 1 are in contact, thereby improving the reproduction efficiency of bacteria; and when the third magnetic plate 671 and the first magnetic plate 651 are separated from the magnetic area, the third magnetic plate 671 will be reset under the rebound effect of the fourth spring 672, and thereby generate suction in the second air groove 67, so that the airflow in the detection box 1 is supplemented to the second air groove 67, and then the third magnetic plate 671 and the first magnetic plate 651 move to the magnetic area again to generate airflow flowing into the driving box 8, and so on, and in this process, the fourth spring 672 is energized and generates heat, and this part of the heat will be rushed into The airflow in the driving box 8 is brought out to the detection box 1 to heat the inside of the detection box 1, and in conjunction with the temperature sensor 9, the temperature in the detection box 1 is controlled between 36 and 38 degrees, which is suitable for bacterial growth, thereby further improving the bacterial reproduction efficiency and thus improving the detection efficiency of the drug; after the bacteria are cultured for a period of time, the microscopic detection camera 2 is used again to observe the culture dish 4 to complete further detection of drug bacteria. At this time, whether the drug to be tested is truly qualified and whether it meets the sterile production standards is determined by whether there are bacteria in the culture dish 4, which effectively improves the detection accuracy and ensures the production quality of the drug.

[0049] Embodiment 2:

[0050] Basically the same as Example 1, a detection method for biopharmaceuticals is proposed on the basis of Example 1;

[0051] Reference Figure 1-Figure 9 , a biopharmaceutical detection method, the steps are as follows:

[0052] Step 1: After the culture dish 4 is installed in the detection box 1, the air in the detection box 1 is purified;

[0053] Insert a clean culture dish 4 from the top of the detection platform 3, and align the drainage tube 42 with the drainage groove 34. Under the squeezing effect of the side wall of the culture dish 4, the surrounding clamping plates 32 will be retracted into the clamping groove 31 at the same time. Finally, after the culture dish 4 is fully inserted, the culture dish 4 will be firmly fixed on the detection platform 3 under the rebound effect of the surrounding fifth springs 33. At this time, the drainage tube 42 will also be fully inserted into the drainage groove 34, realizing the limited fixation of the culture dish 4, thereby improving the stability of the culture dish 4 during the detection process;

[0054] Then, the detection box 1 is sealed, and the driving motor 642 is turned on to drive the air guide blade 641 to rotate. First, suction will be generated in the air guide groove 64, so that the external airflow passes through the air inlet groove 62 and enters the air guide groove 64. In the process of the airflow passing through the air inlet groove 62, it will be preliminarily filtered by the dust filter 621 to filter the larger particles of dust in the airflow, thereby improving the cleanliness of the airflow entering the air guide groove 64. In addition, with the repulsion between the second magnetic plate 653 and the first magnetic plate 651, the air guide blade When 641 rotates, it will push the first magnetic plate 651 to slide in the first air groove 65, thereby compressing the airflow in the first air groove 65, so that this part of the airflow enters the piston cylinder 66 and pushes the piston push rod 661 to extend, thereby squeezing the dust filter 621, so that the first spring 623 is compressed, and then when the second magnetic plate 653 and the first magnetic plate 651 are separated from the magnetic area, under the rebound action of the first spring 623, the dust filter 621 will rebound and vibrate, and so on, effectively realizing the vibration of the dust filter 621 The air filter 621 is cleaned, which improves the filtering effect of the dust filter 621 and ensures the ventilation speed; secondly, the rotation of the air guide blade 641 will also bring up the disinfectant liquid filled in the air guide groove 64, so that the disinfectant liquid forms a water wall around the air guide blade 641. At this time, when the air flow passes through the above-mentioned water wall, the bacteria contained in it will be disinfected and the fine dust contained in it will be absorbed by the solution, thereby further improving the cleanliness of the air flow. Subsequently, the clean air flow will be discharged along the air outlet groove 63, and the water filter plate 632 will be used to entrain the air in the air flow. The liquid part is filtered, and only the gas is allowed to enter the detection box 1. With the continuous inflow of fresh clean airflow, the air pressure in the detection box 1 will increase, thereby pushing open the dust baffle 71 in the exhaust slot 7, so that the original airflow in the detection box 1 is gradually discharged until the detection box 1 is completely filled with fresh clean airflow, so that the detection box 1 is in a sterile state, and the continuous movement of the airflow can also flush and clean the detection table 3 and the culture dish 4, ensuring the cleanliness of the detection table 3 and the culture dish 4, and effectively improving the detection accuracy.

[0055] Step 2: drip the drug to be tested into the culture dish 4 through the drug tank 5, filter out the bacteria in the drug, and use the microscopic detection camera 2 to perform preliminary bacteria detection;

[0056] When the airflow cleanliness in the detection box 1 meets the detection requirements, the reagent to be detected is first added to the culture dish 4 through the reagent tank 5. At this time, the reagent will pass through the bacteria filter 41 and be discharged along the drain pipe 42 and the drain groove 34, and the bacteria in the reagent will be trapped on the surface of the bacteria filter 41. During the rotation of the air guide blade 641, the repulsive effect between the third magnetic plate 671 and the first magnetic plate 651 will be used to squeeze the gas in the second gas groove 67, and open the one-way valve in the air guide pipe 673, so that the gas in the second gas groove 67 rushes into the drive box 8 along the air guide pipe 673, thereby driving the driving impeller 81 to drive the detection table 3 to rotate. At this time, the rotating culture dish 4 can be fully detected by the microscopic detection camera 2, thereby improving the detection effect;

[0057] Step 3: dripping culture fluid into the culture dish 4 through the culture fluid tank 51, so that the filtered bacteria can multiply rapidly;

[0058] When the microscopic detection camera 2 in step 2 does not or does not obviously detect whether there are bacteria in the culture dish 4, the culture liquid is dripped into the culture dish 4 through the culture liquid tank 51, so that the bacteria intercepted in the culture dish 4 can reproduce, and at this time, the air guide blade 641 still keeps rotating, firstly, it can always replenish fresh air flow into the detection box 1, ensure the oxygen content in the detection box 1, and increase the growth and reproduction speed of bacteria, and at this time, the culture dish 4 still keeps rotating, so that the bacteria can better contact with the culture liquid in the culture dish 4 and the oxygen in the detection box 1, thereby improving the reproduction efficiency of bacteria; and when the third magnetic plate 671 and the first magnetic plate 651 are separated from the magnetic area, under the rebound effect of the fourth spring 672 Under this condition, the third magnetic plate 671 will be reset, and suction will be generated in the second air groove 67, so that the one-way valve in the exhaust pipe 681 will open, and the airflow in the detection box 1 will be replenished to the second air groove 67, and then the third magnetic plate 671 and the first magnetic plate 651 will move to the magnetic area again to generate airflow flowing into the drive box 8, and so on. In this process, the fourth spring 672 will be energized and generate heat, and this part of heat will be brought out to the detection box 1 by the airflow rushing into the drive box 8, so as to heat the inside of the detection box 1, and cooperate with the temperature sensor 9 to control the inside of the detection box 1 between 36 and 38 degrees, which is suitable for bacterial growth, thereby further improving the bacterial reproduction efficiency and thus improving the detection efficiency of the drug.

[0059] Step 4: Use the microscopic detection camera 2 to observe the filtered product of the drug to be tested after cultivation, and complete further detection of drug bacteria, so as to determine whether the drug meets the sterility standard;

[0060] After culturing the bacteria for a period of time, the microscopic detection camera 2 is used to observe the culture dish 4 again to complete further detection of the bacteria in the medicine. At this time, whether the medicine to be tested is truly qualified and meets the sterile production standards is judged by whether there are bacteria in the culture dish 4, which effectively improves the detection accuracy and ensures the production quality of the medicine.

[0061] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A biopharmaceutical detection device, comprising a detection box (1) and a microscopic detection camera (2) fixed to the inner wall of the detection box (1), characterized in that: The detection box (1) is rotatably connected to a detection table (3), a culture dish (4) is inserted into the detection table (3), and a medicine tank (5) and a culture liquid tank (51) are respectively fixedly connected to the top two sides of the detection box (1), and the output pipes of the medicine tank (5) and the culture liquid tank (51) both penetrate the detection box (1) and extend to the top of the culture dish (4), and further include: An air cleaning component (6), the air cleaning component (6) being arranged in the detection box (1) and used for improving the cleanliness of the air in the detection box (1) to meet detection requirements; The air cleaning component (6) comprises a purification box (61), the purification box (61) being fixed on the side wall of the detection box (1), the purification box (61) being provided with an air inlet groove (62) and an air outlet groove (63) respectively, the input end of the air inlet groove (62) being in communication with the outside, the output end of the air outlet groove (63) being in communication with the inner cavity of the detection box (1), and the air inlet groove (62) and the air outlet groove (63) being in communication with each other via an air guide groove (64), an air guide blade (641) being rotatably connected in the air guide groove (64), a driving motor (642) being fixedly connected to the side wall of the purification box (61), and the output shaft of the driving motor (642) being fixedly connected to the end of the rotating shaft of the air guide blade (641); A second air groove (67) is provided in the purification box (61) below the air guide groove (64); a third magnetic plate (671) is slidably connected in the second air groove (67); a fourth spring (672) is fixedly connected between the bottom of the third magnetic plate (671) and the second air groove (67); and the third magnetic plate (671) and the first magnetic plate (651) are magnetically repelled from each other; a drive box (8) is rotatably connected to the side wall of the rotating shaft of the detection platform (3); the drive box (8) is fixedly connected to the bottom of the detection box (1); a drive impeller (81) is fixedly connected to the outer wall of the rotating shaft of the detection platform (3) located in the detection box (1); an air guide pipe (673) is fixedly connected to and communicated with the side wall of the second air groove (67); and the other end of the air guide pipe (673) is communicated with the inner cavity of the drive box (8); The middle section of the air guide tube (673) is fixedly connected to a guide ball (68), the side wall of the guide ball (68) is fixedly connected to an exhaust pipe (681), the exhaust pipe (681) and the air guide tube (673) located below the guide ball (68) are both provided with a one-way valve, the top of the drive box (8) is provided with an air outlet (82), the fourth spring (672) is made of a resistance wire material and is electrically connected to an external power supply, and the bottom of the detection platform (3) is fixedly connected to a temperature sensor (9); A dust filter (621) is slidably connected to the output end of the air inlet groove (62); positioning blocks (622) are fixedly connected to the corners of the inner wall of the output end of the air inlet groove (62); a first spring (623) is fixedly connected between the dust filter (621) and the positioning block (622); a first air groove (65) is provided in the purification box (61) above the air guide groove (64); a first magnetic plate (651) is slidably connected to the first air groove (65); the first magnetic plate (651) and the first air groove are connected to each other. (65), a second spring (652) is fixedly connected between the ends of the wind guide blades (641), a second magnetic plate (653) is fixedly connected, the second magnetic plate (653) and the first magnetic plate (651) are magnetically repelled from each other, a piston cylinder (66) is fixedly connected inside the air inlet groove (62), the piston cylinder (66) is communicated with the inner cavity of the first air groove (65), a piston push rod (661) is slidably connected inside the piston cylinder (66), and a third spring (662) is sleeved on the outer wall of the piston push rod (661).

2. A biopharmaceutical detection device according to claim 1, characterized in that: The inner wall of the air outlet groove (63) is fixedly connected to two groups of liquid baffles (631) which are arranged in an interlaced manner. The output end of the air outlet groove (63) is fixedly connected to a water filter plate (632). A waterproof and breathable membrane is used in the water filter plate (632) to filter water and allow air to pass through. The side wall of the detection box (1) is also provided with a downwardly inclined exhaust groove (7). A dust baffle plate (71) is rotatably connected to the exhaust groove (7), and the dust baffle plate (71) is arranged parallel to the bottom of the exhaust groove (7).

3. A biopharmaceutical detection device according to claim 1, characterized in that: The inner wall of the detection platform (3) is provided with a clamping groove (31), and four groups of the clamping grooves (31) are evenly spaced along the center ring of the detection platform (3), and a clamping plate (32) is slidably connected in each group of the clamping grooves (31), and a fifth spring (33) is fixedly connected between the side wall of the clamping plate (32) and the clamping groove (31), and the outer end of the clamping plate (32) is arranged with an arc-shaped rounded corner.

4. A biopharmaceutical detection device according to claim 3, characterized in that: The bottom of the culture dish (4) is fixedly connected to a bacteria collecting filter (41); the center of the bottom of the culture dish (4) is fixed and connected to a drainage pipe (42); the center of the rotating shaft of the detection platform (3) is provided with a drainage groove (34); the drainage groove (34) extends downwardly through the detection box (1); the drainage groove (34) extends upwardly to the surface of the detection platform (3); the drainage pipe (42) is aligned with the drainage groove (34) in vertical direction; and the outer diameter of the drainage pipe (42) is equal to the inner diameter of the drainage groove (34).

5. A biopharmaceutical detection device according to claim 4, characterized in that: Solenoid valves are provided in the output pipes and the drainage pipe (42) of the medicine tank (5) and the culture fluid tank (51).

6. A biopharmaceutical detection method, using a biopharmaceutical detection device as described in any one of claims 1 to 5, characterized in that: Here are the steps: Step 1: After the culture dish (4) is installed in the detection box (1), the air in the detection box (1) is purified; Step 2: dripping the drug to be tested into the culture dish (4) through the drug tank (5), filtering out the bacteria in the drug, and performing preliminary bacterial detection using a microscopic detection camera (2); Step 3: dripping culture fluid into the culture dish (4) through the culture fluid tank (51) to allow the filtered bacteria to multiply rapidly; Step 4: Use the microscopic detection camera (2) to observe the filtrate of the drug to be tested after cultivation, complete further detection of drug bacteria, and thus determine whether the drug meets the sterility standard.

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