Production process of vitamin K1 injection

Abstract

The invention relates to the field of pharmacy, in particular to a production process of a vitamin K1 injection, which comprises the following steps: S1, weighing 80-120 parts by weight of vitamin K1, 650-750 parts by weight of polysorbate 80 (II), 200-220 parts by weight of propylene glycol, 25-35 parts by weight of sodium pyrosulfite, 1-3 parts by weight of activated carbon, 80-120 parts by weight of sodium acetate, 2-6 parts by weight of 36% acetic acid and 10L of water for injection; s2, concentrated preparation; s3, diluting and encapsulating; and S4, sterilizing, detecting leakage, performing light inspection and packaging. The raw materials and auxiliary materials comprise vitamin K1, polysorbate 80 (II), propylene glycol, sodium pyrosulfite and the like, and polysorbate 80 (II) is used as an emulsifier, so that the composition has the characteristics of good solubilizing effect, high stability, low toxicity and the like, the dissolving effect is remarkably improved, the vitamin K1 raw material medicine is fully dispersed, the pH value of the product is controlled within a proper range, the composition can resist terminal sterilization, and the composition does not contain components such as preservatives and the like, and is suitable for industrial production. Toxic and side effects are avoided, and the product safety is good.

Description

Technical Field

[0001] The invention relates to the pharmaceutical field, in particular to a production process of vitamin K1 injection. Background Art

[0002] Vitamin K1 injection is mainly used to treat bleeding caused by vitamin K deficiency, such as bleeding caused by obstructive jaundice, bile fistula, chronic diarrhea, hypoprothrombinemia caused by coumarins, sodium salicylate, etc., neonatal hemorrhage and vitamin K deficiency in the body caused by long-term use of broad-spectrum antibiotics.

[0003] Vitamin K1 injection requires a decarbonization filter during the production process to decolorize the prepared medicine solution. Activated carbon is a consumable item. During the continuous production process, the activated carbon needs to be removed from the decarbonization filter in a timely manner to avoid excessive accumulation that affects the filtration speed of the medicine solution. The existing decarbonization filter has a low efficiency in removing activated carbon, and cleaning the activated carbon can easily cause the medicine solution to contact the external environment, thereby causing the injection solution to be contaminated by the external environment. Summary of the invention

[0004] The purpose of the present invention is to provide a production process of vitamin K1 injection to solve the problems raised in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical solutions: The present invention provides a production process of vitamin K1 injection, comprising the following steps: S1. Calculated by weight, weigh 80-120 parts of vitamin K1, 650-750 parts of polysorbate 80 (II), 200-220 parts of propylene glycol, 25-35 parts of sodium metabisulfite, 1-3 parts of activated carbon, 80-120 parts of sodium acetate, 2-6 parts of 36% acetic acid, and 10L of water for injection; S2. Under nitrogen protection, add water for injection to the concentrated preparation tank, add vitamin K1, polysorbate 80 (II), activated carbon, sodium metabisulfite, sodium acetate and propylene glycol to the concentrated preparation tank, stir evenly, filter through a decarbonization filter and send to a dilute preparation tank; S3. Add water for injection to the dilution tank, add 36% acetic acid solution to adjust the pH value to 5.5-6.0, stir and reflux, take samples for testing, filter through a sterilizing filter and send to a filling machine for filling; S4. Sterilization leak detection, light inspection, and packaging; Preferably, a filter element is provided in the sterilizing filter, and the filter element comprises two parts, and the diameters thereof are 0.45 μm and 0.22 μm respectively.

[0006] Preferably, the time interval from the beginning of the concentrated formulation to the end of the diluted formulation does not exceed 4 hours.

[0007] Preferably, the time interval from the end of dilution to the end of potting should not exceed 8 hours.

[0008] Preferably, the sterilization condition is 100° C. in a water bath for 20-40 min.

[0009] Preferably, the equipment used in the above-mentioned production process includes a concentrated preparation tank, a dilute preparation tank, a decarbonization filter, a filling machine, and a sterilization leak detection machine. The decarbonization filter includes a filter cartridge, a feed pipe is installed in the center of the filter cartridge for lifting and lowering, and a dispersion table is rotatably installed at the bottom end of the feed pipe. After the vitamin K injection reaches the bottom end of the feed pipe, it disperses and flows onto the dispersion table. A flexible film is arranged between the bottom end of the dispersion table and the filter cartridge. When the feed pipe is located at the end point of the lifting stroke, it drives the flexible film to bulge upward or sink downward. A filtering mechanism is arranged at the bottom end of the dispersion table, and a recovery mechanism is arranged on the outside of the connection part between the flexible film and the filter cartridge.

[0010] Preferably, a top cover is provided on the filter cartridge, the feed pipe is centrally plugged into the top cover, an air inlet pipe and an air outlet pipe are respectively provided on the top cover and the filter cartridge, the air inlet pipe and the air outlet pipe are connected to the interior of the filter cartridge and nitrogen is introduced into the air, an inclined hole one is evenly provided on the bottom end of the feed pipe, the inclined hole one points to the surface of the dispersion cone, the surface of the dispersion cone is evenly provided with guide grooves, the flexible film is rotatably mounted on the bottom end of the feed pipe, and an inclined hole two is evenly provided on the side wall of the filter cartridge, the inclined hole two points to the recovery mechanism.

[0011] The filtering mechanism comprises an annular receiving frame fixedly mounted on the edge of the dispersion truncated cone, wherein leakage holes are evenly arranged in the annular receiving frame, a filtering film is installed on the upper side of the leakage hole, a switching ring is embedded and rotatably installed in the position of the leakage hole in the annular receiving frame, an intermediate hole is arranged on the position of the switching ring corresponding to the leakage hole, an inner gear ring is arranged on the inner side of the switching ring, a driving gear 2 is arranged in cooperation with the inner gear ring, a motor 2 is connected to the driving gear 2, a receiving bottom groove is arranged at the bottom of the annular receiving frame, a sliding card block 1 is arranged on the receiving bottom groove, the receiving bottom groove is rotatably mounted with the bottom of the annular receiving frame through the sliding card block 1, the sliding card block 1 is positioned and installed between the annular receiving frame through the annular positioning plate, the bottom of the receiving bottom groove is evenly arranged with collecting holes, the collecting holes are connected with collecting pipes, a central pipe is connected between the collecting pipes, the central pipe is movably installed for lifting, an installation ring is arranged between the collecting pipes, and the motor 2 is fixedly installed between the installation ring.

[0012] Furthermore, the recovery mechanism includes an external threaded portion arranged on the outside of the filter cartridge, the external threaded portion is threadedly connected with a collecting groove, the collecting groove is installed in close contact with the filter cartridge on a side close to the filter cartridge, an outer ring of the collecting groove is provided with an external gear ring, a motor four is fixedly installed on the outer wall of the filter cartridge, the motor four is connected to a driving gear four, and the driving gear four is meshed with the external gear ring.

[0013] Furthermore, a rotation drive mechanism is provided between the dispersion cone and the feed pipe, and the rotation drive mechanism includes a clamping frame arranged at the end of the feed pipe, a sliding clamping block 2 is provided on the top of the dispersion cone, and the sliding clamping block 2 is rotatably mounted with the bottom of the clamping frame, an annular gear ring is fixedly connected to the upper end edge of the dispersion cone, a mounting plate is provided on the side wall of the feed pipe, a motor 1 is provided on the mounting plate, the motor 1 is connected to a driving gear 1, and the driving gear 1 is meshed with the annular gear ring.

[0014] Furthermore, the feed pipe is connected to a lifting assembly, which includes a vertical rack arranged on the outside of the feed pipe. A mounting frame is fixedly connected to the inner wall of the filter cylinder. A driving gear three is rotatably installed in the mounting frame. The driving gear three is meshed with the vertical rack. A motor three is arranged on the mounting frame, and the motor three is connected to the driving gear three.

[0015] Furthermore, the central tube is connected to a telescopic adjustment component, which includes a mounting plate 1 arranged on the outside of the central tube, plug-in columns are evenly arranged on the bottom of the mounting plate 1, a fixed tube is connected to the bottom of the filter cartridge, a folded telescopic tube is arranged between the fixed tube and the central tube, a mounting plate 2 is arranged on the outside of the fixed tube, and the plug-in columns are plugged into the mounting plate 2.

[0016] Furthermore, guide protrusions are provided at both ends of the bottom edge of the leakage hole, and the guide protrusions point to the inner side of the receiving bottom groove. A swivel clamp ring is rotatably installed on the edge of the annular receiving frame, and the inner ring of the flexible film is sealed with the outer ring of the swivel clamp ring. The outer ring of the flexible film is connected to the inner bottom edge of the inclined hole 2.

[0017] Furthermore, a plugging portion is inserted into one end of the feed pipe located inside the filter cartridge, a conical dispersion portion is provided on the upper side of the plugging portion, a lifting rod is connected to the conical dispersion portion, and the lifting rod passes through the feed pipe and is connected to a lifting motor.

[0018] Compared with the prior art, the present invention has the following beneficial effects: 1. The raw and auxiliary materials of the present invention include vitamin K1, polysorbate 80 (II), propylene glycol, sodium metabisulfite, etc. The emulsifier uses polysorbate 80 (II), which has the characteristics of good solubilization effect, strong stability, low toxicity, etc., significantly improves the dissolution effect, fully disperses the vitamin K1 raw material, controls the pH value of the product within a suitable range, can withstand terminal sterilization, does not contain components such as preservatives, does not produce toxic side effects, and has good product safety.

[0019] 2. The liquid medicine is fed into the filter cylinder through the feed pipe, and is dispersed and transported to the dispersion table through the inclined hole at the end of the feed pipe for further dispersion and diversion treatment. The dispersed liquid medicine is diverted to the filter mechanism through the dispersion table for filtration to separate the liquid medicine and activated carbon. The side wall of the dispersion table is evenly provided with diversion grooves, and the dispersion table and the end of the feed pipe are rotatably installed. The setting of the diversion groove can increase the flow speed of the liquid medicine along the diversion groove when the dispersion table rotates, so that the liquid medicine rushes to the filter mechanism faster, thereby increasing the filtration speed of the liquid medicine.

[0020] 3. After the liquid medicine passes through the dispersion truncated cone and falls onto the annular receiving rack, the annular receiving rack and the downwardly concave flexible film form a storage area. The liquid medicine carrying activated carbon passes through the filter film and enters the receiving bottom tank along the leakage hole. It is transported to the central tube in combination with the collecting pipe for the next process production. The activated carbon left after filtration remains on the surface of the filter film. After the liquid medicine is filtered, the built-in switching ring is controlled by motor 2 to rotate so that the leakage hole and the middle hole are staggered, so that the switching ring blocks the leakage hole. At this time, the feed pipe switches to deliver injection water and raises the dispersion truncated cone at the same time, so that the flexible film is in an upward convex state. At this time, the injection water rushes along the dispersion truncated cone to the activated carbon on the annular receiving rack and washes the activated carbon onto the flexible film. Finally, it rushes out along the inclined hole 2 and is recovered by the recovery mechanism.

[0021] 4. When filtering the liquid medicine inside the filter cartridge, the side of the collection tank close to the filter cartridge blocks the inclined hole 2 to prevent the nitrogen in the filter cartridge from leaking out of the inclined hole 2. When cleaning the activated carbon after filtration, the motor 4 and the drive gear 4 drive the collection tank to rotate around the outside of the filter cartridge, so that the collection tank moves along the axial direction of the filter cartridge, thereby opening the inclined hole 2, and the injection water carrying the activated carbon flows out of the inclined hole 2 and falls into the collection tank for centralized treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a flow chart of the present invention.

[0023] Figure 2 It is a schematic diagram of the overall structure of the present invention.

[0024] Figure 3 It is a schematic diagram of the internal structure of the filter cartridge of the present invention.

[0025] Figure 4 It is a schematic diagram of the installation of the flexible film in the present invention.

[0026] Figure 5 It is a schematic diagram of the connection structure between the rotary drive mechanism and the dispersion truncated table in the present invention.

[0027] Figure 6 It is a schematic diagram of the cross-section structure of the connection portion between the feed pipe and the dispersion cone in the present invention.

[0028] Figure 7 It is a schematic diagram of the cross-section structure of the filtering mechanism in the present invention.

[0029] Figure 8 It is a schematic diagram of the installation of the switching ring in the present invention.

[0030] Fig. 9 It is a schematic diagram of the installation of the collecting pipe in the present invention.

[0031] Fig.10 It is a schematic diagram of the structure of the lifting assembly in the present invention.

[0032] Fig.11 It is a structural schematic diagram of the recovery mechanism in the present invention.

[0033] Fig.12 It is a schematic diagram of the connection structure between the flexible film and the inclined hole in the present invention.

[0034] In the figure: 1, filter cartridge; 10, top cover; 11, feed pipe; 110, inclined hole 1; 111, conical dispersion part; 112, blocking part; 113, lifting rod; 20, air inlet pipe; 21, air outlet pipe; 3, dispersion cone; 30, guide groove; 4, filter mechanism; 40, annular receiving frame; 400, leakage hole; 41, filter film; 42, receiving bottom groove; 43, sliding block 1; 44, annular positioning plate; 45, rotating clamp ring; 46, collecting hole; 47, switching ring; 470, middle hole; 471, inner gear ring; 48, guide protrusion; 49, driving gear 2; 410, motor 2; 411, mounting ring; 4 12. Collecting pipe; 413. Center pipe; 414. Mounting plate one; 415. Plug-in column; 416. Fixed pipe; 417. Folding telescopic pipe; 418. Mounting plate two; 5. Rotary drive mechanism; 50. Mounting plate; 51. Motor one; 52. Drive gear one; 53. Annular gear ring; 54. Snap-on frame; 55. Sliding block two; 6. Lifting assembly; 60. Vertical rack; 61. Mounting frame; 62. Drive gear three; 63. Motor three; 7. Flexible film; 8. Recovery mechanism; 80. Collecting trough; 81. External gear ring; 82. External threaded portion; 83. Inclined hole two; 84. Drive gear four; 85. Motor four. DETAILED DESCRIPTION

[0035] The technical solution of the present invention is further described in detail below in conjunction with specific implementation methods.

[0036] like Figure 1-Figure 12 As shown, the present invention provides a production process of vitamin K1 injection, comprising the following steps: S1. Calculated by weight, weigh 100 parts of vitamin K1, 700 parts of polysorbate 80 (II), 210 parts of propylene glycol, 30 parts of sodium metabisulfite, 2 parts of activated carbon, 100 parts of sodium acetate, 4 parts of 36% acetic acid, and 10L of water for injection; S2. Add water for injection to the concentrated preparation tank, turn on the steam to heat the water for injection to 75-80℃, add the weighed vitamin K1, polysorbate 80 (II), activated carbon and propylene glycol to the stainless steel barrel, stir in the same direction for 15 minutes to make it uniform, then add it to the concentrated preparation tank, stir evenly, dissolve the weighed sodium metabisulfite and sodium acetate (anhydrous) with appropriate amount of water for injection and add them to the concentrated preparation tank, stir evenly, turn on the self-circulation system of the concentrated preparation tank, circulate for 15 minutes, filter the drug solution through the decarbonization filter and send it to the dilute preparation tank, add water for injection to the concentrated preparation tank, turn on the self-circulation system of the concentrated preparation tank, circulate for 5 minutes, transfer the water for injection in the concentrated preparation tank to the dilute preparation tank, and repeat this operation once; S3. After the concentrated preparation tank transfers all the liquid medicine to the diluted preparation tank, water for injection is added to the diluted preparation tank. The operator takes 100ml of sample from the diluted preparation tank to test the pH value. According to the pH value test result, the prepared 36% acetic acid solution is slowly added to the diluted preparation tank to adjust the pH value to 5.5-6.0. Water for injection is added to the diluted preparation tank to make up to the configured amount. The dilution tank is turned on for self-circulation, stirred and refluxed for 20 minutes, and the cooling water is turned on to cool down to below 35°C. The QA personnel take samples from the circulating sampling port of the dilution tank and send them for inspection of properties, pH value and content. After the intermediate product is sent for inspection, the liquid medicine is filtered from the dilution tank through a sterilizing filter (filter element diameter 0.45µm, 0.22µm) and sent to the filling machine for filling. The residual liquid in each equipment and container is pumped into the dilution tank with clean nitrogen; The time interval from the start of concentrated preparation to the end of diluted preparation for each batch of products shall not exceed 4 hours, and the time interval from the end of diluted preparation to the end of filling shall not exceed 8 hours; S4. Place the filled intermediate products on the sterilization cart according to the placement requirements. If the products are insufficient, use the color water tray to fill them. The color water tray is placed on the upper part of the sterilization cart (except for hot spots). The upper end of the sterilization cart is covered with a stainless steel cover to prevent the leak detection from floating. There are 4 trays on each layer of the sterilization cart. The maximum number of full carts is 12 layers, that is, 48 ​​trays. A full load is to put 4 sterilization carts in sequence, that is, 192 trays. Sterilize in a water bath at 100℃ for 30 minutes. After the sterilization and leak detection procedures are completed (the process is controlled by a computer), open the rear cabinet door, take out the products, remove the unqualified products, hang the status label and send them to the transfer room to wait for light inspection. The drugs sterilized in separate cabinets should be placed separately and labeled. QA takes samples according to the cabinet after the product is sterilized, and QC performs sterility testing. The time from the end of filling to sterilization shall not exceed 4 hours; According to the batch number, the sterilized semi-finished products are pushed from the transfer room to the light inspection room. After checking the product name, specification, batch number and quantity, the light inspector removes the bubble heads, burnt heads, hook heads, broken heads, etc., and then conducts visible foreign matter inspection according to the "Standard Operating Procedures for Visible Foreign Matter Inspection". Needles and medicines containing glass chips, white spots, fibers, turbidity, crystals, precipitation, color spots and other foreign matters visible to the naked eye, as well as waste products such as small capacity, empty bottles, cold explosions, leaking bottles, and colored water bottles are removed. After each light inspection of a tray, the light inspector puts the tray card, and the tray card is marked with the product name, specification, batch number, and work number. The QA will randomly select 200 from every 9 trays. There must be no obvious visible foreign matter and glass chips. If there is one obvious foreign matter, it will be handed over to the operator for re-light inspection, or the JAZ800 / 20 ampoule injection foreign matter automatic light inspection machine will be used for inspection; The operator checks the product name, specification, batch number, quantity, etc. according to the product transfer card, and installs the resin plate according to the product name, specification, batch number (the product name, batch number, and specification are checked by the section manager and QA); After verification, the printing and packaging machine is started, and each ampoule is printed with "product name, specification, batch number, expiration date" and other words; At the same time, check whether the printed words are clear. After printing, the products are packed into cartons through an automatic cartoning machine. Every 10 ampoules are packed into one box. The box is printed with "batch number, production date, and expiration date" (checked by the operator, section manager and QA); "Batch number, production date, expiration date" are printed on both sides of the outer box (checked by the operator, section manager and QA); The upper and lower bottoms of the outer box are sealed with plastic tape and the electronic supervision code is affixed; Further, such as Figure 2 , Figure 3 , Fig.11As shown, the equipment used in the above production process includes a concentrated preparation tank, a dilute preparation tank, a decarbonization filter, a filling machine, and a sterilization leak detection machine. The decarbonization filter includes a filter cartridge 1. A feed pipe 11 is installed in the center of the filter cartridge 1 for lifting and lowering. A dispersion cone 3 is rotatably installed at the bottom end of the feed pipe 11. After the vitamin K1 injection reaches the bottom end of the feed pipe 11, it disperses and flows onto the dispersion cone 3. A flexible film 7 is arranged between the bottom end of the dispersion cone 3 and the filter cartridge 1. When the feed pipe 11 is located at the end point of the lifting stroke, it drives the flexible film 7 to bulge upward or sink downward. A filtering mechanism 4 is arranged at the bottom end of the dispersion cone 3, and a recovery mechanism 8 is arranged on the outside of the connection part between the flexible film 7 and the filter cartridge 1. The filter cartridge 1 is provided with a top cover 10, and the feed pipe 11 is plugged into the center of the top cover 10. The top cover 10 and the filter cartridge 1 are respectively provided with an air inlet pipe 20 and an air outlet pipe 21, and the air inlet pipe 20 and the air outlet pipe 21 are connected to the interior of the filter cartridge 1 and nitrogen is introduced therein. The bottom end of the feed pipe 11 is evenly provided with inclined holes 110, and the inclined holes 110 point to the surface of the dispersion cone 3. The surface of the dispersion cone 3 is evenly provided with guide grooves 30. The flexible film 7 is rotatably mounted on the bottom end of the feed pipe 11, and the side wall of the filter cartridge 1 is evenly provided with inclined holes 83, and the inclined holes 83 point to the recovery mechanism 8.

[0037] Specifically, the injection liquid containing activated carbon is introduced from the concentration tank into the decarbonization filter, and then fed into the filter cartridge 1 through the feed pipe 11. The liquid medicine is dispersed and transported to the dispersion cone 3 through the inclined hole 110 at the end of the feed pipe 11, and further dispersed and diverted. The dispersed liquid medicine is diverted to the filter mechanism 4 through the dispersion cone 3 for filtration to separate the liquid medicine and the activated carbon. The side walls of the dispersion cone 3 are evenly provided with guide grooves 30, and the dispersion cone 3 and the end of the feed pipe 11 are rotatably mounted. The setting of the guide grooves 30 can increase the flow speed of the liquid medicine along the guide grooves 30 when the dispersion cone 3 rotates, thereby accelerating the liquid medicine to rush to the filter mechanism 4, thereby increasing the filtration speed of the liquid medicine.

[0038] Further, such as Figure 7 , Figure 8As shown, the filtering mechanism 4 includes an annular receiving frame 40 fixedly mounted on the edge of the dispersion cone 3, the annular receiving frame 40 is evenly provided with leakage holes 400, a filtering film 41 is installed on the upper side of the leakage hole 400, the annular receiving frame 40 is embedded with a switching ring 47 rotatably installed at the position of the leakage hole 400, the switching ring 47 is provided with an intermediate hole 470 at the position corresponding to the leakage hole 400, the inner side of the switching ring 47 is provided with an inner gear ring 471, the inner gear ring 471 is provided with a driving gear 2 49, the driving gear 2 49 is connected to a motor 2 410, and the bottom of the annular receiving frame 40 is provided with A receiving bottom groove 42 is provided with a sliding block 43, and the receiving bottom groove 42 is rotatably installed with the bottom of the annular receiving frame 40 through the sliding block 43, and the sliding block 43 is positioned and installed between the annular receiving frame 40 through the annular positioning plate 44, and the bottom of the receiving bottom groove 42 is evenly provided with collecting holes 46, and the collecting holes 46 are connected with collecting pipes 412, and the collecting pipes 412 are connected with center pipes 413, and the center pipe 413 is installed for lifting and lowering, and a mounting ring 411 is provided between the collecting pipes 412, and the motor 2 410 is fixedly installed with the mounting ring 411.

[0039] Specifically, after the liquid medicine falls onto the annular receiving frame 40 through the dispersion truncated cone 3, the annular receiving frame 40 and the downwardly concave flexible film 7 form a storage area, and the liquid medicine carrying activated carbon passes through the filter film 41 and enters the receiving bottom tank 42 along the leakage hole 400, and is transported to the central pipe 413 in combination with the collecting pipe 412 for the next process production. The activated carbon left after filtration remains on the surface of the filter film 41. After the liquid medicine is filtered, the switch ring 47 installed in the built-in device is controlled by the motor 2 410 to rotate, so that the leakage hole 400 and the middle hole 470 are staggered, so that the switch ring 47 blocks the leakage hole 400. At this time, the feed pipe 11 switches to transport the injection water, and at the same time, the dispersion truncated cone 3 is raised, so that the flexible film 7 is in an upward convex state. At this time, the injection water rushes to the activated carbon on the annular receiving frame 40 along the dispersion truncated cone 3, and washes the activated carbon onto the flexible film 7, and finally rushes out along the inclined hole 2 83 and is recovered by the recovery mechanism 8.

[0040] Further, such as Fig.11 , Fig.12 As shown, the recovery mechanism 8 includes an external threaded portion 82 arranged on the outside of the filter cartridge 1, and the external threaded portion 82 is threadedly connected with a collecting groove 80. The collecting groove 80 is installed in close contact with the filter cartridge 1 on one side thereof. An outer gear ring 81 is provided on the outer ring of the collecting groove 80. A motor 4 85 is fixedly installed on the outer wall of the filter cartridge 1. The motor 4 85 is connected with a driving gear 4 84, and the driving gear 4 84 is meshed with the outer gear ring 81.

[0041] Specifically, when filtering the liquid medicine inside the filter cartridge 1, the side of the collecting tank 80 close to the filter cartridge 1 blocks the inclined hole 2 83 to prevent the nitrogen in the filter cartridge 1 from leaking out of the inclined hole 2 83. When cleaning the activated carbon after filtering, the collecting tank 80 is driven by the motor 4 85 and the driving gear 4 84 to rotate around the outside of the filter cartridge 1, so that the collecting tank 80 moves along the axial direction of the filter cartridge 1, thereby opening the inclined hole 2 83, and the injection water carrying the activated carbon flows out of the inclined hole 2 83 and falls into the collecting tank 80 for centralized treatment.

[0042] Further, such as Figure 5 As shown, a rotation drive mechanism 5 is arranged between the dispersion truncated cone 3 and the feed pipe 11, and the rotation drive mechanism 5 includes a clamping frame 54 arranged at the end of the feed pipe 11, and a sliding block 2 55 is arranged on the top of the dispersion truncated cone 3, and the sliding block 2 55 is rotatably mounted with the bottom of the clamping frame 54, and an annular gear ring 53 is fixedly connected to the upper end edge of the dispersion truncated cone 3, and a mounting plate 50 is arranged on the side wall of the feed pipe 11, and a motor 51 is arranged on the mounting plate 50, and the motor 51 is connected to a driving gear 52, and the driving gear 52 and the annular gear ring 53 are meshed with each other.

[0043] Specifically, the annular gear ring 53 is controlled to rotate by the motor 151 and the driving gear 152, thereby driving the dispersion truncated table 3 to rotate around the end of the feed pipe 11. When the liquid medicine flows out from the inclined hole 110 and falls on the dispersion truncated table 3, the liquid medicine is accelerated to flush downward along the guide groove 30, thereby increasing the speed of the liquid medicine flushing down the filter mechanism 4 and improving the filtering effect. At the same time, it can prevent the liquid medicine from adhering to the dead corner of the dispersion truncated table 3 due to the fixed direction of the inclined hole 110, ensuring that the liquid medicine can be evenly dispersed and flushed to the filter mechanism 4 along the dispersion truncated table 3.

[0044] Further, such as Fig.10 As shown, the feed pipe 11 is connected to a lifting assembly 6, and the lifting assembly 6 includes a vertical rack 60 arranged on the outside of the feed pipe 11. A mounting frame 61 is fixedly connected to the inner wall of the filter cartridge 1. A driving gear three 62 is rotatably installed in the mounting frame 61. The driving gear three 62 is meshed with the vertical rack 60. A motor three 63 is arranged on the mounting frame 61, and the motor three 63 is connected to the driving gear three 62.

[0045] Specifically, after the filtration of the medicinal liquid is completed, the activated carbon left by the filtration is cleaned. At this time, the motor three 63 in the lifting assembly 6 controls the driving gear three 62 to mesh with the vertical rack 60, driving the feed pipe 11 to move upward, thereby carrying the dispersion cone 3 and the filtering mechanism 4, and the rotating drive mechanism 5 to move upward as a whole, so that the flexible film 7 that is concave downward convexes upward, thereby facilitating the introduction of injection water in combination with the feed pipe 11, flushing the activated carbon onto the flexible film 7 and recovering it along the inclined hole two 83 by the recovery mechanism 8.

[0046] Further, such as Fig. 9 As shown, the central tube 413 is connected with a telescopic adjustment component, and the telescopic adjustment component includes a mounting plate 1 414 arranged on the outside of the central tube 413, and plug-in columns 415 are evenly arranged on the bottom of the mounting plate 1 414. A fixed tube 416 is connected to the bottom of the filter cartridge 1, and a folded telescopic tube 417 is arranged between the fixed tube 416 and the central tube 413. A mounting plate 2 418 is arranged on the outside of the fixed tube 416, and the plug-in columns 415 and the mounting plate 2 418 are plugged in.

[0047] Specifically, since the rotating drive mechanism 5 drives the dispersion cone 3 and the annular receiving frame 40 to rotate as a whole, in order to reliably install the receiving bottom groove 42, the center tube 413 is limitedly installed through the fixed tube 416 and the mounting plate 1 414 and the mounting plate 2 418. When the filtering mechanism 4 is raised under the drive of the lifting assembly 6, the receiving bottom groove 42 will carry the collecting pipe 412 and the mounting ring 411 and the center tube 413 to move upward as a whole. The receiving bottom groove 42 before and after lifting can be reliably rotated and installed with the bottom of the annular receiving frame 40, so as to reliably collect and guide the filtered medicine liquid to avoid leakage of the medicine liquid.

[0048] Further, such as Figure 7 As shown, both ends of the bottom edge of the leakage hole 400 are provided with guide protrusions 48, and the guide protrusions 48 point to the inner side of the receiving bottom groove 42. The edge of the annular receiving frame 40 is rotatably mounted with a rotary clamp ring 45. The inner ring of the flexible film 7 is sealedly connected to the outer ring of the rotary clamp ring 45, and the outer ring of the flexible film 7 is connected to the inner bottom edge of the inclined hole 83.

[0049] Specifically, the flexible film 7 is rotatably installed between the rotating clamp ring 45 and the annular receiving frame 40, and the outer ring of the flexible film 7 is fixedly installed on the bottom edge of the inclined hole 83. When the flexible film 7 bulges upward, the injection water carrying activated carbon will flow out along the inclined hole 83 to the recovery mechanism 8.

[0050] Further, such as Figure 6As shown, the feed pipe 11 is located at one end of the filter cartridge 1 and is internally plugged with a plugging portion 112, a conical dispersion portion 111 is provided on the upper side of the plugging portion 112, and the conical dispersion portion 111 is connected to a lifting rod 113, and the lifting rod 113 passes through the feed pipe 11 and is connected to a lifting motor.

[0051] Specifically, the blocking portion 112 can block the portion of the inclined hole 110, thereby stopping the feeding, and the conical dispersion portion 111 can further improve the effect of evenly dispersing the liquid medicine to the dispersion cone 3. The transition portion between the blocking portion 112 and the conical dispersion portion 111 is tangent to the bottom edge of the inner end of the inclined hole 110, thereby preventing the liquid medicine from forming residue at the bottom of the feeding pipe 11.

[0052] The working principle of the embodiment of the present invention is: like Figure 1-Figure 12As shown, the injection liquid containing activated carbon is introduced from the concentration tank into the decarbonization filter, and is fed into the filter cylinder 1 through the feed pipe 11. The liquid medicine is dispersed and transported to the dispersion cone 3 through the inclined hole 110 at the end of the feed pipe 11, and further dispersed and diverted. The dispersed liquid medicine is diverted to the filter mechanism 4 through the dispersion cone 3 for filtration to separate the liquid medicine and the activated carbon. The side wall of the dispersion cone 3 is evenly provided with guide grooves 30, and the dispersion cone 3 and the end of the feed pipe 11 are rotatably installed. The setting of the guide groove 30 can increase the flow speed of the liquid medicine along the guide groove 30 when the dispersion cone 3 rotates, so that the liquid medicine is accelerated to rush to the filter mechanism 4, thereby increasing the filtration speed of the liquid medicine. After the liquid medicine passes through the dispersion truncated cone 3 and falls onto the annular receiving frame 40, the annular receiving frame 40 and the downwardly concave flexible film 7 form a storage area. The liquid medicine carrying activated carbon passes through the filter film 41 and enters the receiving bottom tank 42 along the leakage hole 400, and is transported to the central pipe 413 in combination with the collecting pipe 412 for the next process production. The activated carbon left after filtration remains on the surface of the filter film 41. After the liquid medicine is filtered, the switch ring 47 installed in the built-in device is controlled by the motor 2 410 to rotate, so that the leakage hole 400 and the middle hole 470 are staggered, so that the switch ring 47 blocks the leakage hole 400. At this time, the feed pipe 11 switches to transport injection water, and at the same time, the dispersion truncated cone 3 is raised, so that the flexible film 7 is in an upward convex state. At this time, the injection water rushes along the dispersion truncated cone 3 to the activated carbon on the annular receiving frame 40, and washes the activated carbon onto the flexible film 7, and finally rushes out along the inclined hole 2 83 and is recovered by the recovery mechanism 8. When filtering the liquid medicine inside the filter cartridge 1, the side of the collecting tank 80 close to the filter cartridge 1 blocks the inclined hole 2 83 to prevent the nitrogen in the filter cartridge 1 from leaking out of the inclined hole 2 83. When cleaning the activated carbon after filtering, the collecting tank 80 is driven by the motor 4 85 and the driving gear 4 84 to rotate around the outside of the filter cartridge 1, so that the collecting tank 80 moves along the axial direction of the filter cartridge 1, thereby opening the inclined hole 2 83, and the injection water carrying the activated carbon flows out of the inclined hole 2 83 and falls into the collecting tank 80 for centralized treatment. After the filtration of the medicinal liquid is completed, the activated carbon left by the filtration is cleaned. At this time, the motor three 63 in the lifting assembly 6 controls the driving gear three 62 to engage with the vertical rack 60, driving the feed pipe 11 to move upward, thereby carrying the dispersion cone 3 and the filtering mechanism 4, and the rotating drive mechanism 5 to move upward as a whole, so that the flexible film 7 that is concave downward is convex upward, so that it is convenient to combine with the feed pipe 11 to pass injection water, flush the activated carbon onto the flexible film 7 and recover it along the inclined hole two 83 by the recovery mechanism 8.

[0053] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modification, equivalent substitution, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention. Any reference numeral in a claim shall not be regarded as limiting the claim involved.

[0054] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

Claims

1. A production process of vitamin K1 injection, characterized in that: The steps include: S1. Calculated by weight, weigh 80-120 parts of vitamin K1, 650-750 parts of polysorbate 80 (II), 200-220 parts of propylene glycol, 25-35 parts of sodium metabisulfite, 1-3 parts of activated carbon, 80-120 parts of sodium acetate, 2-6 parts of 36% acetic acid, and 10L of water for injection; S2. Under nitrogen protection, add water for injection to the concentrated preparation tank, add vitamin K1, polysorbate 80 (II), activated carbon, sodium metabisulfite, sodium acetate and propylene glycol to the concentrated preparation tank, stir evenly, filter through a decarbonization filter and send to a dilute preparation tank; S3. Add water for injection to the dilution tank, add 36% acetic acid solution to adjust the pH value to 5.5-6.0, stir and reflux, take samples for testing, filter through a sterilizing filter and send to a filling machine for filling; S4. Sterilization leak detection, light inspection, and packaging; The equipment used in the above production process includes a concentrated preparation tank, a diluted preparation tank, a decarbonization filter, a filling machine, and a sterilization leak detection machine. The decarbonization filter includes a filter cartridge (1). A feed pipe (11) is installed in a lifting manner at the center of the filter cartridge (1). A dispersion table (3) is rotatably installed at the bottom end of the feed pipe (11). After the vitamin K1 injection reaches the bottom end of the feed pipe (11), it is dispersed and flows onto the dispersion table (3). A flexible film (7) is arranged between the bottom end of the dispersion table (3) and the filter cartridge (1). When the feed pipe (11) is located at the end point of the lifting stroke, it drives the flexible film (7) to bulge upward or dent downward. A filtering mechanism (4) is arranged at the bottom end of the dispersion table (3). A recovery mechanism (8) is arranged on the outside of the connection between the flexible film (7) and the filter cartridge (1).

2. The production process of a vitamin K1 injection according to claim 1, characterized in that: The sterilizing filter is provided with a filter element, which includes two parts, and the diameters thereof are 0.45 μm and 0.22 μm respectively.

3. The production process of a vitamin K1 injection according to claim 1, characterized in that: The time interval from the beginning of concentrated mixing to the end of diluted mixing shall not exceed 4 hours.

4. The production process of a vitamin K1 injection according to claim 1, characterized in that: The time interval from the end of dilution to the end of filling shall not exceed 8 hours.

5. The production process of a vitamin K1 injection according to claim 1, characterized in that: The sterilization conditions are 100°C in a water bath for 20-40 minutes.

6. The production process of a vitamin K1 injection according to claim 1, characterized in that: The filter cartridge (1) is provided with a top cover (10), the feed pipe (11) is plugged into the center of the top cover (10), the top cover (10) and the filter cartridge (1) are provided with an air inlet pipe (20) and an air outlet pipe (21) respectively, the air inlet pipe (20) and the air outlet pipe (21) are in communication with the interior of the filter cartridge (1) and nitrogen is introduced therein, the bottom end of the feed pipe (11) is evenly provided with inclined holes (110), the inclined holes (110) point to the surface of the dispersion cone (3), the surface of the dispersion cone (3) is evenly provided with guide grooves (30), the flexible film (7) is rotatably mounted on the bottom end of the feed pipe (11), the side wall of the filter cartridge (1) is evenly provided with inclined holes (83), the inclined holes (83) point to the recovery mechanism (8).

7. The production process of a vitamin K1 injection according to claim 1, characterized in that: The filtering mechanism (4) comprises an annular receiving frame (40) fixedly mounted on the edge of the dispersion truncated table (3), the annular receiving frame (40) being evenly provided with leakage holes (400), the upper side of the leakage holes (400) being provided with a filtering film (41), the annular receiving frame (40) being provided with a switching ring (47) rotatably mounted in the position of the leakage holes (400), the switching ring (47) being provided with an intermediate hole (470) at a position corresponding to the leakage holes (400), the inner side of the switching ring (47) being provided with an inner gear ring (471), the inner gear ring (471) being provided with a second driving gear (49), the second driving gear (49) being connected to a second motor (410), and the bottom of the annular receiving frame (40) being provided with a receiving ring (471). A bottom groove (42), a sliding block (43) is provided on the receiving bottom groove (42), the receiving bottom groove (42) is rotatably installed with the bottom of the annular receiving frame (40) through the sliding block (43), the sliding block (43) is positioned and installed between the annular receiving frame (40) through the annular positioning plate (44), the bottom of the receiving bottom groove (42) is evenly provided with collecting holes (46), the collecting holes (46) are connected with collecting pipes (412), the collecting pipes (412) are connected with a central pipe (413), the central pipe (413) is installed to be lifted and moved, a mounting ring (411) is provided between the collecting pipes (412), and the motor 2 (410) is fixedly installed with the mounting ring (411).

8. The production process of a vitamin K1 injection according to claim 1, characterized in that: The recovery mechanism (8) comprises an external threaded portion (82) arranged on the outside of the filter cartridge (1), the external threaded portion (82) being threadedly connected to a collecting groove (80), the collecting groove (80) being fitted between the filter cartridge (1) and a side thereof close to the filter cartridge (1), an outer ring gear (81) being arranged on the outer ring of the collecting groove (80), a motor (85) being fixedly mounted on the outer wall of the filter cartridge (1), the motor (85) being connected to a driving gear (84), the driving gear (84) being meshed with the outer ring gear (81).

9. The production process of a vitamin K1 injection according to claim 1, characterized in that: A rotary drive mechanism (5) is provided between the dispersion truncated table (3) and the feed pipe (11), the rotary drive mechanism (5) comprising a clamping frame (54) provided at the end of the feed pipe (11), a sliding clamping block 2 (55) is provided at the top of the dispersion truncated table (3), the sliding clamping block 2 (55) is rotatably mounted with the bottom of the clamping frame (54), an annular gear ring (53) is fixedly connected to the upper edge of the dispersion truncated table (3), a mounting plate (50) is provided on the side wall of the feed pipe (11), a motor 1 (51) is provided on the mounting plate (50), the motor 1 (51) is connected to a driving gear 1 (52), and the driving gear 1 (52) and the annular gear ring (53) are meshed with each other.

10. The production process of a vitamin K1 injection according to claim 1, characterized in that: The feed pipe (11) is connected to a lifting assembly (6), and the lifting assembly (6) includes a vertical rack (60) arranged on the outside of the feed pipe (11). A mounting frame (61) is fixedly connected to the inner wall of the filter cartridge (1), and a driving gear three (62) is rotatably mounted in the mounting frame (61). The driving gear three (62) and the vertical rack (60) are meshed with each other. A motor three (63) is arranged on the mounting frame (61), and the motor three (63) is connected to the driving gear three (62).

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