Raman system online detection device for sterile injection intermediate

Abstract

The utility model discloses a Raman system on-line detection device for a sterile injection intermediate, which comprises a sample detection tube, a vacuum generator, a compressed air source and a safety tank, an upper end outlet of the sample detection tube is connected with the safety tank, and the safety tank is connected with the vacuum generator. A gas outlet of the compressed air source is respectively connected with a gas inlet of the vacuum generator and a gas inlet of the safety tank, and the lower end of the sample detection tube is connected with a waste liquid discharge tube. According to the utility model, a U-shaped pipe in an existing detection device is omitted, the safety tank, the vacuum generator and the compressed air source are redesigned, and the technical problem that the U-shaped pipe is blocked is solved by utilizing the cooperation of all the parts. And the vacuum degree in the gas path is ensured through the design of the safety tank, and the sample liquid can be prevented from being accumulated at the vacuum generator.

Description

An online detection device for Raman system of sterile injection intermediates Technical Field

[0001] This utility model relates to the field of sterile injection intermediate content detection technology, specifically to an online detection device for sterile injection intermediates using a Raman system. Background Technology

[0002] As sterile injectable solutions are medications that are directly injected into the human bloodstream, their safety is of paramount importance. Various reactions may occur during the synthesis of injectable solution intermediates, affecting product safety.

[0003] For the determination of the content of intermediates in prepared injection solutions, Raman spectroscopy is commonly used. The existing detection device, as shown in Figure 1, involves injecting the sample solution into a glass vial. The vial is equipped with signal detection components such as a Raman probe and a pH electrode, and also features a U-shaped venting tube. After detection, the vial needs to be cleaned by injecting water to rinse it, followed by draining the water. The U-shaped venting tube is for gas only, not water, and is used to expel the gas from the vial to the outside to facilitate water drainage. However, when there is a large amount of water in the vial, water may enter the U-shaped venting tube, causing blockage and preventing gas from escaping, thus affecting the effective drainage of the cleaning water.

[0004] Therefore, this patent application is filed. Summary of the Invention

[0005] In view of the above, and to solve the problems existing in the prior art, this utility model provides an online detection device for Raman system of sterile injection intermediates.

[0006] The technical solution is an online detection device for Raman system of sterile injection intermediates, including a sample detection tube, a vacuum generator, a compressed air source, and a safety tank. The upper outlet of the sample detection tube is connected to the safety tank, and the safety tank is connected to the vacuum generator. The gas outlet of the compressed air source is connected to the gas inlet of the vacuum generator and the gas inlet of the safety tank, respectively. The lower end of the sample detection tube is connected to a waste liquid discharge pipe.

[0007] In an optional embodiment, a solenoid valve A and a pressure reducing valve are provided on the connecting pipeline between the compressed air source and the safety tank.

[0008] In an optional embodiment, a solenoid valve B is provided on the connecting pipe between the sample detection tube and the safety tank, a solenoid valve C is provided on the waste liquid discharge pipe, and a solenoid valve D is provided on the connecting pipe between the compressed air source and the vacuum generator.

[0009] In an optional embodiment, the sample detection tube is made of stainless steel.

[0010] In an optional embodiment, the sample detection tube is provided with a signal detection component, which includes a Raman probe, a pH electrode, and a temperature sensor, all of which are mounted on the sample detection tube.

[0011] In an optional embodiment, two temperature sensors are provided, located at both ends of the sample detection tube, respectively.

[0012] In an optional embodiment, a circulation pump is connected in parallel to the sample detection tube.

[0013] In an optional embodiment, the sample detection tube is provided with a detection liquid inlet, and the detection liquid inlet is equipped with a solenoid valve E.

[0014] In an optional embodiment, a standard solution inlet is further included, which is connected to the lower end of the sample detection tube.

[0015] In an optional embodiment, a ball valve is provided between the standard solution inlet and the sample detection tube.

[0016] 1. This utility model provides an online detection device for Raman system of sterile injection intermediates. It eliminates the U-shaped tube in the existing detection device and redesigns the safety tank, vacuum generator and compressed air source. The technical problem of U-shaped tube blockage is solved by the cooperation of various components.

[0017] 2. The present invention provides an online detection device for Raman system of sterile injection intermediates. By designing a safety tank, it can ensure that the vacuum generation degree is about 100%, so as to ensure that the sample liquid level can be drawn into the sample detector to meet the sample volume requirements. It can also avoid the accumulation of sample liquid at the vacuum generator when the liquid volume exceeds the maximum volume of the sample detector, thus avoiding sample contamination. Attached Figure Description

[0018] Figure 1 is a schematic diagram of the existing Raman system detection device for sterile injection intermediates.

[0019] Figure 2 is a structural schematic diagram of an online detection device for Raman system of sterile injection intermediates provided by this utility model.

[0020] In the picture:

[0021] 1-Sample detection tube, 2-Vacuum generator, 3-Compressed air source, 4-Safety container, 5-Raman probe, 6-pH electrode, 7-Temperature sensor, 8-Circulation pump, 9-Detection liquid inlet, 10-Standard liquid inlet, 11-Waste liquid discharge pipe, 12-Solenoid valve A, 13-Solenoid valve B, 14-Solenoid valve C, 15-Solenoid valve D, 16-Solenoid valve E, 17-Ball valve, 18-Pressure reducing valve. Detailed Implementation

[0022] The technical solutions of various embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model. In the description of this utility model, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0023] Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0024] The present invention will be further described in detail below through specific embodiments and in conjunction with the accompanying drawings.

[0025] Example 1:

[0026] As shown in Figure 2, an online detection device for Raman system of sterile injection intermediates includes a sample detection tube 1, a vacuum generator 2, a compressed air source 3, and a safety tank 4.

[0027] Sample testing tube 1 is used to hold the liquid sample of the injectable intermediate to be tested. The upper outlet of sample testing tube 1 is connected to a safety container 4. The safety container 4 is hollow and can hold a portion of the test sample, as well as air. The safety container 4 is connected to a vacuum generator 2. The gas outlet of the compressed air source 3 is connected to the gas inlet on the vacuum generator 2 and the gas inlet on the safety container 4, respectively, allowing compressed gas to enter the vacuum generator 2 and the safety container 4. A waste liquid discharge pipe is connected to the lower end of sample testing tube 1.

[0028] During testing, compressed gas is introduced into the vacuum generator 2 to create negative pressure, thereby drawing the gas from the sample detection tube 1 and the safety tank 4, allowing the liquid sample to be tested to smoothly enter the sample detection tube 1. When cleaning is required for the sample detection tube 1, cleaning water is introduced into it. After one cleaning cycle, compressed gas is introduced into the safety tank 4, pressurizing the gas inside. This pressurizes the gas in the safety tank 4 and the gas in the connecting pipe between the sample detection tube 1 and the safety tank 4, forcing the cleaning waste liquid downwards and out through the waste liquid discharge pipe.

[0029] In this embodiment, the U-shaped tube in the existing detection device is eliminated, and the safety tank 4, vacuum generator 2 and compressed air source 3 are redesigned. The technical problem of U-shaped tube blockage is solved by the cooperation of each component.

[0030] In this embodiment, since the sample detector is fully enclosed, a vacuum generator 2 is added above it to displace the air in the sample detector. However, considering that the vacuum degree of the vacuum generator 2 is only about 85% in actual use, it will result in insufficient sample injection volume in the sample detector, affecting the accuracy of the test. If the vacuum generator 2 is used a second time, it will result in excessive sample volume, which will enter the upper gas tube from the top of the sample detector, causing sample contamination and other problems. Therefore, the safety container 4 set in this embodiment can maintain a vacuum degree of about 100% to ensure that the sample liquid can be drawn into the sample detector under this vacuum degree, meeting the sample volume requirements. When the vacuum generator 2 draws liquid, if the liquid volume exceeds the maximum volume of the sample detector, the safety container 4 can effectively prevent liquid from entering the gas tube, avoid the accumulation of sample solution at the vacuum generator 2, and avoid sample contamination.

[0031] Even better, a solenoid valve A12 and a pressure reducing valve 18 are provided on the connecting pipeline between the compressed air source 3 and the safety tank 4. The solenoid valve A12 controls whether the compressed gas enters, while the pressure reducing valve 18 reduces the impact when the gas enters the safety tank 4.

[0032] To better control the flow of liquid in the device's pipelines, a solenoid valve B13 is installed on the connecting pipeline between sample detection tube 1 and safety tank 4, a solenoid valve C14 is installed on the waste liquid discharge pipe, and a solenoid valve D15 is installed on the connecting pipeline between compressed air source 3 and vacuum generator 2. The flow of liquid is controlled by opening and closing each valve and by adjusting its opening degree.

[0033] Since the sample detection tube 1 needs to be sterilized after cleaning, and the lifespan of the glass bottles in existing devices is significantly shortened under prolonged high-temperature baking, the sample detection tube 1 in this embodiment is made of stainless steel, such as 316 stainless steel, which can better withstand high-temperature environments.

[0034] In this embodiment, a signal detection component is provided on the sample detection tube 1. The signal detection component includes a Raman probe 5, a pH electrode 6, and a temperature sensor 7, all of which are mounted on the sample detection tube 1. Preferably, two temperature sensors 7 are provided, located at opposite ends of the sample detection tube 1. Of course, more temperature sensors 7 can also be provided. The purpose of this arrangement is to detect the temperature of the sample liquid at different locations within the sample detection tube 1, thereby performing temperature compensation and improving the accuracy of the detection results.

[0035] To further improve the accuracy of sample concentration detection, a circulation pump 8 is connected in parallel to the sample detection tube 1. As shown in Figure 2, the upper and lower ends of the sample detection tube 1 are connected to the liquid flow port of the circulation pump 8, respectively. The purpose is to circulate the liquid in the sample detection tube 1 through the circulation pump 8 during the detection process, so as to make the liquid temperature more uniform.

[0036] The sample detection tube 1 is equipped with a detection liquid inlet 9, through which the sample liquid to be tested enters. A solenoid valve E16 is installed at the detection liquid inlet 9. A standard liquid inlet 10 is also included, connected to the lower end of the sample detection tube 1. A ball valve 17 is installed between the standard liquid inlet 10 and the sample detection tube 1. The flow of liquid is controlled by the valve. The standard liquid inlet 10 is designed for calibration of the pH electrode 6.

[0037] The present invention has been described in detail above through specific embodiments and examples, but these are not intended to limit the present invention. Many modifications and improvements can be made by those skilled in the art without departing from the principles of the present invention, and these should also be considered within the scope of protection of the present invention.

Claims

1. An apparatus for online detection of a sterile injectable intermediate Raman system, characterized in that, The sample detection tube (1), vacuum generator (2), compressed air source (3), and safety tank (4) are included. The upper outlet of the sample detection tube (1) is connected to the safety tank (4), and the safety tank (4) is connected to the vacuum generator (2). The gas outlet of the compressed air source (3) is connected to the gas inlet of the vacuum generator (2) and the gas inlet of the safety tank (4), respectively. The lower end of the sample detection tube (1) is connected to a waste liquid discharge pipe.

2. The online detection device for Raman system of sterile injection intermediates according to claim 1, characterized in that, The compressed air source (3) and the safety tank (4) are connected by a solenoid valve A (12) and a pressure reducing valve (18).

3. The online detection device for Raman system of sterile injection intermediates according to claim 1, characterized in that, A solenoid valve B (13) is provided on the connecting pipe between the sample detection tube (1) and the safety tank (4), a solenoid valve C (14) is provided on the waste liquid discharge pipe, and a solenoid valve D (15) is provided on the connecting pipe between the compressed air source (3) and the vacuum generator (2).

4. The online detection device for Raman system of sterile injection intermediates according to claim 1, characterized in that, The sample detection tube (1) is made of stainless steel.

5. The online detection device for Raman system of sterile injection intermediates according to claim 1, characterized in that, The sample detection tube (1) is equipped with a signal detection component, which includes a Raman probe (5), a pH electrode (6), and a temperature sensor (7). The Raman probe (5), pH electrode (6), and temperature sensor (7) are all installed on the sample detection tube (1).

6. An apparatus for online detection of aseptic injection intermediate Raman system according to claim 5, characterized in that, Two temperature sensors (7) are provided, located at both ends of the sample detection tube (1).

7. The online detection device for Raman system of sterile injection intermediates according to claim 1, characterized in that, A circulation pump (8) is connected in parallel to the sample detection tube (1).

8. The online detection device for Raman system of sterile injection intermediates according to claim 1, characterized in that, The sample detection tube (1) is provided with a detection liquid inlet (9), and the detection liquid inlet (9) is equipped with a solenoid valve E (16).

9. The online detection device for Raman system of sterile injection intermediates according to claim 1, characterized in that, It also includes a standard liquid inlet (10), which is connected to the lower end of the sample detection tube (1).

10. The online detection device for Raman system of sterile injection intermediates according to claim 9, characterized in that, A ball valve (17) is provided between the standard solution inlet (10) and the sample detection tube (1).

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