Production process of levocarnitine injection

Abstract

The invention belongs to the technical field of medicine production, and discloses a levocarnitine injection production process which comprises the following steps: S1, a preparation stage: firstly, preparing raw materials levocarnitine hydrochloric acid and water for injection; s2, a liquid preparation stage: injecting the water for injection and the raw material levocarnitine into a liquid preparation tank, adding HCl during stirring to adjust the pH value of the liquid medicine until all the components are fully dissolved and uniformly mixed, and ensuring that the prepared liquid meets the requirements; according to the device, through the cooperation of structures such as the rotating disc and the leakage holes, hydrochloric acid can be conveniently and automatically injected in a small amount and multiple times, hydrochloric acid enters the liquid preparation tank through the leakage holes and the fan-shaped grooves in a small amount and multiple times through transmission, the pH value of liquid medicine is automatically adjusted, and by limiting the inlet amount and frequency of the hydrochloric acid, the operation is convenient. The situation that a large amount of hydrochloric acid is injected at a time, and consequently the pH value of the liquid medicine is sharply decreased is avoided, only part of hydrochloric acid enters the liquid preparation tank each time, the pH value of the liquid medicine can be gradually decreased with a small amplitude, and accurate control is easier.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine production, in particular to a production process of L-carnitine injection. Background Art

[0002] Carnitine plays a key role in the human body's energy metabolism. It is mainly involved in the β-oxidation of fatty acids and is essential for the energy supply of tissue cells such as myocardial cells and skeletal muscle cells. Clinically, L-carnitine can be used to treat a series of complications caused by secondary carnitine deficiency in patients with chronic renal failure and long-term hemodialysis, such as cardiomyopathy, skeletal myopathy, arrhythmia, hyperlipidemia, hypotension and intradialytic muscle spasm. With the deepening of understanding of these diseases and the increase in the number of patients, the demand for L-carnitine injection is also growing, which has promoted the continuous development of its production process.

[0003] Most of the existing L-carnitine injection production equipments add hydrochloric acid manually, which is not only cumbersome to operate, but also prone to errors due to human factors. For example, due to operating errors, a large amount of hydrochloric acid is added at one time, which causes a drastic change in the pH value of the liquid medicine, resulting in excessive acidification of the liquid medicine. Therefore, a L-carnitine injection production equipment is proposed. Summary of the invention

[0004] In order to solve the problem that hydrochloric acid is mostly added manually in the above background technology, which is not only cumbersome to operate, but also prone to errors due to human factors, such as adding a large amount of hydrochloric acid at one time due to operational errors, causing the pH value of the drug solution to change drastically and leading to excessive acidification of the drug solution, the present invention provides a production process for L-carnitine injection.

[0005] To achieve the above object, the present invention provides the following technical solution: a production process of L-carnitine injection, wherein the production method is as follows: S1, preparation stage: first prepare the raw material L-carnitine, 2mol / L hydrochloric acid and 40-50℃ water for injection; S2, liquid preparation stage: Then, in a clean liquid preparation area, 52.0 kg of 40-50 ° C water for injection and the raw material L-carnitine are injected into the liquid preparation tank, and the raw materials are stirred by a stirrer until they are completely dissolved visually, and then the pH value is measured. If the measured pH value is not within the qualified range of 6.1-6.4, 2 mol / L HCL is added under stirring to adjust to 6.1-6.4, and water for injection is added to a total of 68.3 kg, and then mechanically stirred for 10 minutes, and a stirring device is used to fully dissolve and mix the components. At the same time, various parameters of the solution are tested by a pH meter to ensure that the liquid preparation meets the requirements; S3, packaging stage: the drug solution is then sterilized and filtered before being filled into pre-cleaned and sterilized packaging containers. The filling volume needs to be strictly controlled during the filling process to ensure that the volume of injection in each container meets the specified standards and the error is within the allowable range. After sealed packaging, labeling and finished product inspection, the production of L-carnitine injection is completed.

[0006] The L-carnitine injection production equipment includes a main body and also includes: A feeding mechanism, wherein the feeding mechanism is arranged above the main body mechanism; Among them, the feeding mechanism includes a motor, gears, a turntable, a leakage hole, a partition and a top cover. The bottom of the motor is meshed with the side of the turntable through gears. The turntable is provided with a plurality of leakage holes for adding hydrochloric acid. The top cover is provided with a feeding port. The inside of the feeding port is fixedly connected with a partition for separating hydrochloric acid. The bottom of the top cover is provided with a fan-shaped groove for releasing hydrochloric acid. The inside of the fan-shaped groove is provided with a baffle for blocking hydrochloric acid. The inside of the top cover is provided with a sliding groove for limiting the sliding of the baffle.

[0007] Preferably, a water injection pipe is fixedly connected to the top of the top cover, a raw material inlet is provided on the top of the top cover, the bottom of the motor is fixedly connected to the top of the top cover, the motor is located between the feed port and the water injection pipe, the gear and the turntable are rotatably connected to the inner wall of the top cover respectively, the axis of the turntable and the center of the feed port are located on the same vertical axis, and the size of the turntable is twice the size of the gear.

[0008] Preferably, several leakage holes are combined with each other to form a fan-shaped area, several leakage holes are opened on the partition, the several leakage holes on the partition and the several leakage holes on the turntable are respectively aligned, the slide groove is located below the feed port, the slide groove is communicated with the fan-shaped groove, the baffle plate passes through the inner wall of the slide groove and extends to the side of the top cover, and the baffle plate is provided with a handle.

[0009] Preferably, a stirring mechanism is arranged below the feeding mechanism, and the stirring mechanism includes a rotating shaft and a supporting shell, and two first bevel gears are fixedly connected to the rotating shaft, wherein a transmission bevel gear is meshed on the side of one of the first bevel gears, and second bevel gears are meshed on both sides of the other first bevel gear, and the two sides of the two second bevel gears away from each other are fixedly connected to stirring rods through connecting rods, and a stirring paddle is fixedly connected to the bottom of the rotating shaft, and an anti-blocking paddle is fixedly connected to the bottom of the stirring paddle.

[0010] Preferably, the first bevel gear meshing with the transmission bevel gear and the transmission bevel gear are both located inside the supporting shell, the transmission bevel gear is rotatably connected to the inner wall of the supporting shell, the rotating shaft passes through the supporting shell and extends to the bottom of the supporting shell, the first bevel gear meshing with the second bevel gear is located below the supporting shell, the stirring paddle is located below the stirring rod, the bottom of the gear is fixedly connected to the top of the first bevel gear through a connecting rod, and the top of the supporting shell is fixedly connected to the bottom of the top cover.

[0011] Preferably, a cleaning mechanism is provided on the outside of the stirring mechanism, and the cleaning mechanism includes a driven bevel gear rotatably connected to the inner wall of the supporting shell, the bottom of the driven bevel gear is fixedly connected to the rotating shell, and both sides of the rotating shell are fixedly connected to scrapers through connecting rods, the outer shape of the rotating shell is a "cross" shape, and the outer shape of the scraper is a spiral shape, and an inclined surface is provided on the scraper and the inclined surface is located below the scraper.

[0012] Preferably, the rotating shaft and the second bevel gear are both rotatably connected to the inner wall of the rotating shell, the stirring paddle is located below the rotating shell, the two stirring rods are respectively located on both sides of the rotating shell, and the two stirring rods are staggered with the two scrapers.

[0013] Preferably, the main structure includes a liquid preparation tank, a discharge port is provided at the bottom of the liquid preparation tank, a filter is fixedly connected to the inside of the discharge port, an electric valve is provided inside the discharge port, and a pH detector for detecting the pH value of the medicine solution inside the liquid preparation tank is provided on the side of the liquid preparation tank.

[0014] Preferably, the filter is located above the electric valve, the top of the liquid mixing tank is clamped with the bottom of the top cover, the side of the scraper away from the rotating shell is fitted with the inner wall of the liquid mixing tank, the bottom of the stirring paddle is fitted with the bottom of the inner wall of the liquid mixing tank, the anti-blocking paddle is located inside the discharge port, and the bottom of the discharge port is fitted with the top of the filter.

[0015] Compared with the prior art, the present invention has the following beneficial effects: The present invention facilitates the automatic injection of hydrochloric acid in small amounts and multiple times by arranging the cooperation of structures such as a rotating disk and a leak hole, and allows the hydrochloric acid to enter the liquid preparation tank in small amounts and multiple times through the leak hole and the fan-shaped groove by transmission, so as to automatically adjust the pH value of the liquid medicine. By limiting the amount and frequency of the hydrochloric acid entering, the situation in which the pH value of the liquid medicine drops sharply due to the one-time injection of a large amount of hydrochloric acid is avoided. Only part of the hydrochloric acid enters the liquid preparation tank each time, so that the pH value of the liquid medicine can be gradually reduced with a smaller amplitude, which is easier to accurately control, and the baffle blocks the fan-shaped groove to prevent the hydrochloric acid from continuing to enter the liquid preparation tank and causing the liquid medicine to be over-acidified. The present invention facilitates rapid stirring of the liquid medicine in the liquid preparation tank by arranging the anti-blocking paddle and the rotating shell and other structures. The motor is started to drive the stirring paddle and the anti-blocking paddle to stir in the horizontal direction, and the stirring rod to stir in the vertical direction, so as to break the concentration gradient in the vertical direction, fully stir the water for injection at different heights, mix the water in the upper and lower layers, and avoid stratification. The rotating shell is rotated in the opposite direction, so that the water for injection can achieve a more uniform and thorough mixing effect under the combined action of shear force and stirring force in different directions, and ensure that all parts of the water for injection can be fully contacted and mixed in the entire three-dimensional space. At the same time, it can also destroy the formation of vortexes formed by the rotation of the stirring blade, change the flow direction of the water flow, and continuously redistribute the materials to different flow areas, avoiding the mixing dead zone caused by local vortexes, so that the raw material L-carnitine can be quickly and evenly dissolved in the water for injection. At the same time, due to the automatic addition of hydrochloric acid in small amounts and multiple times, the newly added hydrochloric acid can be quickly and evenly dispersed in the liquid medicine under the above stirring action, so that the pH value of the entire liquid medicine changes evenly, avoiding the situation where the local pH value is too low, which helps to ensure the chemical stability of L-carnitine in the liquid medicine and prevent the decomposition of L-carnitine or other adverse reactions caused by uneven pH value. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic diagram of the structure of the present invention; Figure 2 It is a schematic diagram of the top view of the feeding mechanism of the present invention; Figure 3 It is a schematic diagram of the cross-sectional structure of the main mechanism of the present invention; Figure 4 For the present invention Figure 3 The enlarged structural diagram at A in the middle; Figure 5 This is a schematic diagram of the structural relationship between the scraper and the mixing chamber of the present invention; Figure 6 It is a schematic diagram of the three-dimensional structure of the cleaning mechanism of the present invention; Figure 7 It is a schematic diagram of the structural relationship between the driving bevel gear and the driven bevel gear of the present invention; Figure 8 It is a bottom view of the structure of the stirring mechanism of the present invention.

[0017] In the figure: 1. feeding mechanism; 101. motor; 102. gear; 103. turntable; 104. leakage hole; 105. baffle; 106. top cover; 107. feeding port; 108. partition; 109. fan-shaped groove; 110. slide; 111. water injection pipe; 112. raw material inlet; 2. stirring mechanism; 201. rotating shaft; 202. first bevel gear; 203. transmission bevel gear; 204. supporting shell; 205. second bevel gear; 206. stirring rod; 207. stirring paddle; 208. anti-blocking paddle; 3. cleaning mechanism; 301. driven bevel gear; 302. rotating shell; 303. scraper; 4. main mechanism; 401. liquid dispensing tank; 402. discharge port; 403. filter; 404. electric valve; 405. PH detector. DETAILED DESCRIPTION

[0018] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0019] The production process of L-carnitine injection is as follows: S1, preparation stage: first prepare the raw material L-carnitine, 2mol / L hydrochloric acid and 40-50℃ water for injection; S2, liquid preparation stage: Then, in a clean liquid preparation area, 52.0 kg of 40-50° C. water for injection and raw material L-carnitine are injected into the liquid preparation tank 401, and the raw materials are stirred by a stirrer until they are completely dissolved visually, and then the pH value is measured. If the measured pH value is not within the qualified range of 6.1-6.4, 2 mol / L HCL is added under stirring to adjust the pH value to 6.1-6.4, and water for injection is added to a total amount of 68.3 kg, and then mechanically stirred for 10 minutes, and a stirring device is used to fully dissolve and mix the components, and at the same time, various parameters of the solution are tested by a pH meter to ensure that the liquid preparation meets the requirements; S3, packaging stage: the drug solution is then sterilized and filtered before being filled into pre-cleaned and sterilized packaging containers. The filling volume needs to be strictly controlled during the filling process to ensure that the volume of injection in each container meets the specified standards and the error is within the allowable range. After sealed packaging, labeling and finished product inspection, the production of L-carnitine injection is completed.

[0020] like Figures 1 to 8 As shown, the present invention provides a L-carnitine injection production device, including a main body mechanism 4, and also includes: A feeding mechanism 1, which is arranged above the main body mechanism 4; Among them, the feeding mechanism 1 includes a motor 101, a gear 102, a turntable 103, a leakage hole 104, a partition 108 and a top cover 106. The bottom of the motor 101 is meshed with the side of the turntable 103 through the gear 102. The turntable 103 is provided with a plurality of leakage holes 104 for adding hydrochloric acid. The top cover 106 is provided with a feeding port 107. The inside of the feeding port 107 is fixedly connected with a partition 108 for separating hydrochloric acid. The bottom of the top cover 106 is provided with a fan-shaped groove 109 for releasing hydrochloric acid. The inside of the fan-shaped groove 109 is provided with a baffle 105 for blocking hydrochloric acid. The inside of the top cover 106 is provided with a sliding groove 110 for limiting the sliding of the baffle 105.

[0021] The top of the top cover 106 is fixedly connected with a water injection pipe 111, and a raw material inlet 112 is arranged on the top of the top cover 106. The bottom of the motor 101 is fixedly connected with the top of the top cover 106. The motor 101 is located between the feed port 107 and the water injection pipe 111. The gear 102 and the turntable 103 are rotatably connected with the inner wall of the top cover 106 respectively. The axis of the turntable 103 and the center of the feed port 107 are located on the same vertical axis. The size of the turntable 103 is the gear 1 02, a plurality of leakage holes 104 are combined to form a fan-shaped area, a plurality of leakage holes 104 are opened on the partition 108, a plurality of leakage holes 104 on the partition 108 and a plurality of leakage holes 104 on the turntable 103 are respectively aligned, a chute 110 is located below the feed port 107, the chute 110 is communicated with the fan-shaped groove 109, a baffle 105 passes through the inner wall of the chute 110 and extends to the side of the top cover 106, and a handle is provided on the baffle 105.

[0022] The above scheme is adopted: the cooperation of the structures such as the turntable 103 and the leakage hole 104 is set, so as to facilitate the automatic injection of hydrochloric acid in small amounts and multiple times. Starting the motor 101 to rotate the gear 102 will drive the turntable 103 to rotate. The rotation of the turntable 103 will cause the leakage hole 104 on the turntable 103 to be misaligned with the leakage hole 104 on the partition 108, so that the hydrochloric acid cannot fall into the liquid preparation tank 401 through the leakage hole 104. Because the size of the turntable 103 is twice the size of the gear 102, when the gear 102 drives the stirring mechanism 2 to stir the liquid for two circles, the leakage hole 104 on the turntable 103 will be aligned with the leakage hole 104 on the partition 108 once, so that part of the hydrochloric acid passes through the leakage hole 104 and the fan-shaped groove 10 9 enters the liquid preparation tank 401 and is quickly mixed with the liquid medicine under the stirring of the stirring mechanism 2, and the pH value of the liquid medicine is automatically adjusted. By limiting the amount and frequency of hydrochloric acid entering, the situation in which a large amount of hydrochloric acid is injected at one time and the pH value of the liquid medicine drops sharply is avoided. Only part of the hydrochloric acid enters the liquid preparation tank 401 each time, so that the pH value of the liquid medicine can be gradually reduced by a smaller amplitude, which is easier to accurately control. When the staff observes that the data on the pH detector 405 reaches the qualified range, it only needs to move the baffle 105 in the direction close to the motor 101, so that the baffle 105 blocks the fan-shaped groove 109 to prevent the hydrochloric acid from continuing to enter the liquid preparation tank 401 and causing the liquid medicine to be over-acidified.

[0023] like Figure 3 and Figure 8 As shown, a stirring mechanism 2 is arranged below the feeding mechanism 1, and the stirring mechanism 2 includes a rotating shaft 201 and a supporting shell 204, and two first bevel gears 202 are fixedly connected to the rotating shaft 201, wherein a transmission bevel gear 203 is meshed on the side of one of the first bevel gears 202, and second bevel gears 205 are meshed on both sides of the other first bevel gear 202, and the two sides of the two second bevel gears 205 away from each other are fixedly connected to a stirring rod 206 through a connecting rod, and a stirring paddle 207 is fixedly connected to the bottom of the rotating shaft 201, and an anti-blocking paddle 208 is fixedly connected to the bottom of the stirring paddle 207.

[0024] The first bevel gear 202 meshing with the transmission bevel gear 203 and the transmission bevel gear 203 are both located inside the support shell 204, the transmission bevel gear 203 is rotatably connected to the inner wall of the support shell 204, the rotating shaft 201 penetrates the support shell 204 and extends to the bottom of the support shell 204, the first bevel gear 202 meshing with the second bevel gear 205 is located below the support shell 204, the stirring paddle 207 is located below the stirring rod 206, the bottom of the gear 102 is fixedly connected to the top of the first bevel gear 202 through a connecting rod, and the top of the support shell 204 is fixedly connected to the bottom of the top cover 106.

[0025] A cleaning mechanism 3 is provided on the outer side of the stirring mechanism 2, and the cleaning mechanism 3 includes a driven bevel gear 301 rotatably connected to the inner wall of the supporting shell 204, and the bottom of the driven bevel gear 301 is fixedly connected to the rotating shell 302, and scrapers 303 are fixedly connected to both sides of the rotating shell 302 through connecting rods. The outer shape of the rotating shell 302 is a "cross" shape, and the outer shape of the scraper 303 is a spiral shape. An inclined surface is provided on the scraper 303 and the inclined surface is located below the scraper 303. The rotating shaft 201 and the second bevel gear 205 are both rotatably connected to the inner wall of the rotating shell 302, and the stirring paddle 207 is located below the rotating shell 302. The two stirring rods 206 are respectively located on both sides of the rotating shell 302, and the two stirring rods 206 and the two scrapers 303 are staggered.

[0026] The main body mechanism 4 comprises a liquid preparation tank 401, a discharge port 402 is arranged at the bottom of the liquid preparation tank 401, a filter screen 403 is fixedly connected to the inside of the discharge port 402, an electric valve 404 is arranged inside the discharge port 402, a pH detector 405 for detecting the pH value of the liquid in the liquid preparation tank 401 is arranged on the side of the liquid preparation tank 401, the filter screen 403 is located above the electric valve 404, the top of the liquid preparation tank 401 is clamped with the bottom of the top cover 106, the side of the scraper 303 away from the rotating shell 302 is fitted with the inner wall of the liquid preparation tank 401, the bottom of the stirring paddle 207 is fitted with the bottom of the inner wall of the liquid preparation tank 401, the anti-blocking paddle 208 is located inside the discharge port 402, and the bottom of the discharge port 402 is fitted with the top of the filter screen 403.

[0027] The above scheme is adopted: the anti-blocking paddle 208 and the rotating shell 302 are arranged to cooperate with each other, thereby facilitating the rapid stirring of the liquid in the liquid preparation tank 401, and the motor 101 is started to rotate the gear 102 and the rotating shaft 201. The rotation of the rotating shaft 201 will drive the stirring paddle 207 and the anti-blocking paddle 208 at the bottom thereof to rotate, stirring the water for injection in the horizontal direction, and the rotation of the rotating shaft 201 will drive the second bevel gear 205 to rotate through the first bevel gear 202, so that the stirring rod 206 rotates on both sides of the rotating shell 302, stirring the water for injection in the vertical direction, breaking the concentration gradient in the vertical direction, and fully stirring the water for injection at different heights, so that the water in the upper and lower layers is mixed to avoid stratification, and the rotation of the rotating shaft 201 will also drive the transmission bevel gear 203 to rotate through the first bevel gear 202, and the rotation of the transmission bevel gear 203 will drive the driven bevel gear 301 to rotate in the opposite direction to the rotation of the first bevel gear 202, so that the "cross"-shaped rotating shell 302 is rotated. The stirring paddle 207 rotates in the opposite direction and drives the stirring rod 206 rotating in the vertical direction to rotate in the horizontal direction with the rotating shaft 201 as the axis, so that the injection water can achieve a more uniform and thorough mixing effect under the combined action of shear force and stirring force in different directions, ensuring that all parts of the injection water can fully contact and mix evenly in the entire three-dimensional space. At the same time, it can also destroy the formation of vortexes formed by the rotation of the stirring paddle 207, change the flow direction of the water flow, and continuously redistribute the materials to different flow areas, avoiding the mixing dead zone caused by local vortexes, so that the raw material L-carnitine can be quickly and evenly dissolved in the injection water. At the same time, due to the automatic addition of hydrochloric acid in small amounts and multiple times, the newly added hydrochloric acid can be quickly and evenly dispersed in the liquid medicine under the above stirring action, so that the pH value of the entire liquid medicine changes evenly, avoiding the situation where the local pH value is too low, which helps to ensure the chemical stability of L-carnitine in the liquid medicine, and prevent the decomposition of L-carnitine or other adverse reactions caused by uneven pH value; The scraper 303 can scrape off the liquid medicine attached to the inner wall of the liquid preparation tank 401 during material discharge, so that more liquid medicine can be involved in the material discharge process, thereby improving the yield of the product and reducing material waste. This is particularly important for the production of high-cost drugs such as L-carnitine injection. At the same time, it avoids the situation where residual liquid medicine pollutes the next batch of liquid medicine and reduces the possibility of residual liquid medicine drying up, making it convenient for subsequent cleaning and maintenance of the liquid preparation tank, helping to maintain the good performance and sanitary condition of the liquid preparation tank, and ensuring the cleanliness and safety of the drug production environment.

[0028] The working principle and use process of the present invention are as follows: first, the discharge port 402 is closed through the electric valve 404, and 52.0 kg of 40-50° C. water for injection is injected into the liquid preparation tank 401 through the water injection pipe 111, and then the raw material L-carnitine is poured into the liquid preparation tank 401 through the raw material inlet 112, and at the same time, the motor 101 is started to rotate the gear 102 and the rotating shaft 201, and the rotation of the rotating shaft 201 will drive the stirring paddle 207 and the anti-blocking paddle 208 at the bottom thereof to rotate, and the injection water is stirred in the horizontal direction, and the rotation of the rotating shaft 201 will drive the second bevel gear 205 to rotate through the first bevel gear 202, so that the stirring rod 206 rotates in the rotating housing 30 2 rotates on both sides to stir the water for injection in the vertical direction, breaking the concentration gradient in the vertical direction, fully stirring the water for injection at different heights, and mixing the water in the upper and lower layers. The rotation of the rotating shaft 201 will also drive the transmission bevel gear 203 to rotate through the first bevel gear 202. The rotation of the transmission bevel gear 203 will drive the driven bevel gear 301 to rotate in the opposite direction to the rotation of the first bevel gear 202, so that the "cross"-shaped rotating housing 302 rotates in the opposite direction to the rotation of the stirring paddle 207, and drives the stirring rod 206 rotating in the vertical direction to rotate in the horizontal direction with the rotating shaft 201 as the axis, so that the water for injection and the raw materials can be evenly mixed; The pH meter 405 will detect the pH value of the liquid in the liquid preparation tank 401 in real time and display it on the screen of the pH meter 405 located outside the liquid preparation tank 401. After the raw material L-carnitine is dissolved, the staff can observe the detection data displayed on the pH meter 405. If the measured pH value is not within the qualified range of 6.1-6.4, 2 mol / L hydrochloric acid is injected into the feed port 107, and the baffle 105 is pulled away from the motor 101 to move the part of the baffle 105 located inside the fan-shaped groove 109 out, so that the hydrochloric acid in the feed port 107 can enter the liquid preparation tank 401 through the fan-shaped groove 109, and the rotation of the gear 102 will drive the turntable 103 to rotate, and the rotation of the turntable 103 will cause the leakage hole on the turntable 103 to The leakage hole 104 on the rotating disk 103 is misaligned with the leakage hole 104 on the partition 108, so that the hydrochloric acid cannot fall into the liquid preparation tank 401 through the leakage hole 104. Because the size of the rotating disk 103 is twice the size of the gear 102, when the gear 102 drives the stirring mechanism 2 to stir the liquid for two circles, the leakage hole 104 on the rotating disk 103 will be aligned with the leakage hole 104 on the partition 108 once, so that part of the hydrochloric acid enters the liquid preparation tank 401 through the leakage hole 104 and the fan-shaped groove 109, and is quickly mixed with the liquid under the stirring of the stirring mechanism 2 to adjust the pH value of the liquid. When the staff observes that the data on the pH detector 405 reaches the qualified range, they only need to move the baffle 105 towards the direction close to the motor 101 so that the baffle 105 blocks the fan-shaped groove 109. Finally, the electric valve 404 is opened to allow the liquid in the liquid preparation tank 401 to be initially filtered through the filter screen 403 and then moved to the sterilizing filter through the discharge port 402 .

[0029] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0030] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. The production process of L-carnitine injection is characterized by: The production process is as follows: S1, preparation stage: first prepare the raw material L-carnitine, 2mol / L hydrochloric acid and 40-50℃ water for injection; S2, liquid preparation stage: Then, in a clean liquid preparation area, 52.0 kg of 40-50°C injection water and the raw material L-carnitine are injected into the liquid preparation tank (401), and the raw materials are stirred by a stirrer until they are visually completely dissolved, and then the pH value is measured. If the measured pH value is not within the qualified range of 6.1-6.4, 2 mol / L HCL is added under stirring to adjust the pH to 6.1-6.4, and injection water is added to a total amount of 68.3 kg, and then mechanically stirred for 10 minutes, and a stirring device is used to fully dissolve and mix the components. At the same time, various parameters of the solution are tested by a pH meter to ensure that the liquid preparation meets the requirements; S3, packaging stage: the drug solution is then sterilized and filtered before being filled into pre-cleaned and sterilized packaging containers. The filling volume needs to be strictly controlled during the filling process to ensure that the volume of injection in each container meets the specified standards and the error is within the allowable range. After sealed packaging, labeling and finished product inspection, the production of L-carnitine injection is completed.

2. A L-carnitine injection production device, applied to the liquid preparation stage in the L-carnitine injection production process of claim 1, comprising a main body (4), characterized in that: Also includes: A feeding mechanism (1), wherein the feeding mechanism (1) is arranged above the main body mechanism (4); The feeding mechanism (1) comprises a motor (101), a gear (102), a rotating disk (103), a leaking hole (104), a partition (108) and a top cover (106); the bottom of the motor (101) meshes with the side of the rotating disk (103) through the gear (102); the rotating disk (103) is provided with a plurality of leaking holes (104) for adding hydrochloric acid; the top cover (106) is provided with a feeding port (107); the inside of the feeding port (107) is fixedly connected with a partition (108) for separating hydrochloric acid; the bottom of the top cover (106) is provided with a fan-shaped groove (109) for releasing hydrochloric acid; the inside of the fan-shaped groove (109) is provided with a baffle (105) for blocking hydrochloric acid; and the inside of the top cover (106) is provided with a sliding groove (110) for limiting the sliding of the baffle (105).

3. The L-carnitine injection production equipment according to claim 2, characterized in that: The top of the top cover (106) is fixedly connected to a water injection pipe (111), the top of the top cover (106) is provided with a raw material inlet (112), the bottom of the motor (101) is fixedly connected to the top of the top cover (106), the motor (101) is located between the feed port (107) and the water injection pipe (111), the gear (102) and the turntable (103) are respectively rotatably connected to the inner wall of the top cover (106), the axis of the turntable (103) and the center of the feed port (107) are located on the same vertical axis, and the size of the turntable (103) is twice the size of the gear (102).

4. The L-carnitine injection production equipment according to claim 3, characterized in that: A plurality of the leakage holes (104) are combined to form a fan-shaped area, a plurality of leakage holes (104) are provided on the partition (108), the plurality of leakage holes (104) on the partition (108) and the plurality of leakage holes (104) on the turntable (103) are aligned respectively, the slide groove (110) is located below the feed port (107), the slide groove (110) is communicated with the fan-shaped groove (109), the baffle (105) passes through the inner wall of the slide groove (110) and extends to the side of the top cover (106), and a handle is provided on the baffle (105).

5. The L-carnitine injection production equipment according to claim 3, characterized in that: A stirring mechanism (2) is arranged below the feeding mechanism (1), the stirring mechanism (2) comprising a rotating shaft (201) and a supporting shell (204), two first bevel gears (202) are fixedly connected to the rotating shaft (201), a transmission bevel gear (203) is meshed on the side of one of the first bevel gears (202), second bevel gears (205) are meshed on both sides of the other first bevel gear (202), a stirring rod (206) is fixedly connected to the sides of the two second bevel gears (205) away from each other via a connecting rod, a stirring paddle (207) is fixedly connected to the bottom of the rotating shaft (201), and an anti-blocking paddle (208) is fixedly connected to the bottom of the stirring paddle (207).

6. The L-carnitine injection production equipment according to claim 5, characterized in that: The first bevel gear (202) meshing with the transmission bevel gear (203) and the transmission bevel gear (203) are both located inside the support shell (204); the transmission bevel gear (203) is rotatably connected to the inner wall of the support shell (204); the rotating shaft (201) penetrates the support shell (204) and extends to the bottom of the support shell (204); the first bevel gear (202) meshing with the second bevel gear (205) is located below the support shell (204); the stirring paddle (207) is located below the stirring rod (206); the bottom of the gear (102) is fixedly connected to the top of the first bevel gear (202) via a connecting rod; and the top of the support shell (204) is fixedly connected to the bottom of the top cover (106).

7. The L-carnitine injection production equipment according to claim 5, characterized in that: A cleaning mechanism (3) is arranged outside the stirring mechanism (2), and the cleaning mechanism (3) comprises a driven bevel gear (301) rotatably connected to the inner wall of the supporting shell (204); the bottom of the driven bevel gear (301) is fixedly connected to a rotating shell (302); both sides of the rotating shell (302) are fixedly connected to scrapers (303) via connecting rods; the rotating shell (302) has a "cross" shape, and the scrapers (303) have a spiral shape; an inclined surface is arranged on the scraper (303) and the inclined surface is located below the scraper (303).

8. The L-carnitine injection production equipment according to claim 7, characterized in that: The rotating shaft (201) and the second bevel gear (205) are both rotatably connected to the inner wall of the rotating shell (302); the stirring paddle (207) is located below the rotating shell (302); the two stirring rods (206) are respectively located on both sides of the rotating shell (302); and the two stirring rods (206) and the two scrapers (303) are staggered.

9. The L-carnitine injection production equipment according to claim 7, characterized in that: The main body (4) comprises a liquid preparation tank (401), a discharge port (402) is arranged at the bottom of the liquid preparation tank (401), a filter screen (403) is fixedly connected to the inside of the discharge port (402), an electric valve (404) is arranged inside the discharge port (402), and a pH detector (405) for detecting the pH value of the liquid in the liquid preparation tank (401) is arranged on the side of the liquid preparation tank (401).

10. The L-carnitine injection production equipment according to claim 9, characterized in that: The filter screen (403) is located above the electric valve (404), the top of the liquid preparation tank (401) is clamped with the bottom of the top cover (106), the side of the scraper (303) away from the rotating shell (302) is in contact with the inner wall of the liquid preparation tank (401), the bottom of the stirring paddle (207) is in contact with the bottom of the inner wall of the liquid preparation tank (401), the anti-blocking paddle (208) is located inside the discharge port (402), and the bottom of the discharge port (402) is in contact with the top of the filter screen (403).

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