A small molecule API production system
By designing a small molecule API production system and using pipeline connections to achieve equipment sharing, the problem of equipment redundancy in existing technologies has been solved, and flexible production of multiple APIs and improved equipment utilization have been achieved.
Patent Information
- Application Number
- CN202111410649.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-11-25
- Publication Date
- 2025-09-26
- Estimated Expiration
- 2041-11-25
AI Technical Summary
In the existing technology, API production lines are dedicated and difficult to flexibly produce a variety of small molecule APIs, resulting in equipment redundancy and high fixed investment.
A small molecule API production system is designed, including a solvent distribution system, a process material distribution system, a reaction module, a crystallization separation module, a crystallization drying module, a clean area module, and a vacuum module. Pipeline connections enable equipment sharing and support the production of multiple APIs.
It has achieved flexible production of a variety of small molecule APIs, reduced the number of equipment, lowered fixed investment, and improved equipment utilization.
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Figure CN114177854B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of raw material medicine production systems, and in particular to a small molecule raw material medicine production system. Background Art
[0002] APIs are the active ingredients in various pharmaceutical preparations. These substances, produced through chemical synthesis, plant extraction, or biotechnology, are powders, crystals, extracts, and other forms used for medicinal purposes, but are not intended for direct patient administration. Chemical synthesis is a primary method for obtaining small-molecule APIs. Currently, an API synthesis workshop is typically set up as a dedicated production line for a specific API. Producing different APIs requires additional production lines. Summary of the Invention
[0003] The purpose of the present invention is to provide a small molecule raw material drug production system in response to the deficiencies in the prior art.
[0004] In order to achieve the above-mentioned purpose, the present invention adopts the following technical solutions:
[0005] The present invention provides a small molecule API production system, comprising a solvent distribution system, a process material distribution system 1, a process material distribution system 2, four reaction modules, two crystallization separation modules, a crystallization separation drying module, a clean area module and a vacuum module;
[0006] The solvent distribution system is connected to the four reaction modules, the two crystallization separation modules, the crystallization separation drying module, and the clean area module through a number of solvent pipelines, and the solvent distribution system is also connected to a solvent feed pipeline; the four reaction modules are respectively connected to the process material distribution system one through a process material pipeline; the process material distribution system one is respectively connected to the four reaction modules through a first process material conveying pipeline, and the process material distribution system one is also respectively connected to the two crystallization separation modules through a second process material conveying pipeline; the two crystallization separation modules are respectively connected to the process material distribution system two through a mother liquor conveying pipeline, and the process material distribution system two is connected to the process material distribution system one through a process material distribution system connecting pipeline, and the process material distribution system two is also respectively connected to the crystallization separation drying module and the clean area module through a third process material conveying pipeline; the crystallization separation drying module is connected to the process material distribution system two through a first mother liquor conveying pipeline, and the clean area module is connected to the process material distribution system two through a second mother liquor conveying pipeline;
[0007] The vacuum module is connected to the four reaction modules, the two crystallization separation modules, the crystallization separation drying module, and the clean area module through vacuum pipes, and the exhaust pipe of the vacuum pump is merged into the tail gas pipe.
[0008] Furthermore, the process material distribution system 1 is also connected to a first reaction product delivery pipeline.
[0009] Furthermore, the second process material distribution system is also connected to a second reaction product delivery pipeline.
[0010] Furthermore, the solvent distribution system, the process material distribution system 1, the process material distribution system 2 and the vacuum module are all connected to waste liquid discharge pipelines respectively.
[0011] Furthermore, the solvent distribution system, the process material distribution system 1 and the process material distribution system 2 are respectively connected to compressed air pipelines.
[0012] Furthermore, the crystallization separation module is also connected to a wet material delivery pipeline.
[0013] Furthermore, the crystallization separation and drying module is also connected to a first dry material delivery pipeline, and the clean area module is also connected to a second dry material delivery pipeline.
[0014] Compared with the prior art, the present invention has the following advantages:
[0015] The small molecule API production system of the present invention can selectively produce three different small molecule APIs. The production lines for producing each API do not operate continuously at the same time, so the equipment between the various production lines can be shared. Because the equipment can be shared, the overall number of equipment is small and the fixed investment is small.
[0016] It should be pointed out that the above three different small molecule APIs refer to a class of APIs prepared using the same production line. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Figure 1 Schematic diagram of the small molecule API production system of the present invention;
[0018] The accompanying drawings are as follows:
[0019] 1- compressed air pipeline, 2- solvent feed pipeline, 3- waste liquid discharge pipeline, 4- solvent distribution system, 5- solvent pipeline, 6- reaction module, 7- process material pipeline, 8- first process material delivery pipeline, 9- first reaction product product delivery pipeline, 10- process material distribution system one, 11- second process material delivery pipeline, 12- process material distribution system connecting pipeline, 13- crystallization separation module, 14- wet material delivery pipeline, 15- mother liquor delivery pipeline, 16- process material distribution system two, 17- second reaction product product delivery pipeline, 18- third process material delivery pipeline, 19- first dry material delivery pipeline, 20- crystallization separation drying module, 21- clean area module, 22- second dry material delivery pipeline, 23- first mother liquor delivery pipeline, 24- second mother liquor delivery pipeline, 25- vacuum module, 26- tail gas pipeline, 27- vacuum pipeline. DETAILED DESCRIPTION
[0020] The present invention will be described in detail and specifically below through specific examples to provide a better understanding of the present invention, but the following examples do not limit the scope of the present invention.
[0021] Example 1
[0022] refer to Figure 1 This embodiment provides a small molecule API production system, including a solvent distribution system 4, a process material distribution system 10, a process material distribution system 2 16, four reaction modules 6, two crystallization separation modules 13, a crystallization separation drying module 20, a clean area module 21, and a vacuum module 25;
[0023] The solvent distribution system 4 is connected to four reaction modules 6, two crystallization separation modules 13, a crystallization separation drying module 20, and a clean area module 21 through a plurality of solvent pipelines 5. The solvent distribution system 4 is also connected to a solvent feed pipeline 2; the four reaction modules 6 are respectively connected to a process material distribution system 10 through a process material pipeline 7; the process material distribution system 10 is respectively connected to the four reaction modules 6 through a first process material delivery pipeline 8, and the process material distribution system 10 is also respectively connected to the two crystallization separation modules 13 through a second process material delivery pipeline 11; the two crystallization separation modules 13 are connected to the solvent distribution system 4 through a plurality of solvent pipelines 5. The separation module 13 is connected to the second process material distribution system 16 via a mother liquor delivery pipeline 15, and the second process material distribution system 16 is connected to the first process material distribution system 10 via a process material distribution system connecting pipeline 12. The second process material distribution system 16 is also connected to the crystallization separation and drying module 20 and the clean area module 21 via a third process material delivery pipeline 18; the crystallization separation and drying module 20 is connected to the second process material distribution system 16 via a first mother liquor delivery pipeline 23, and the clean area module 21 is connected to the second process material distribution system 16 via a second mother liquor delivery pipeline 24;
[0024] The process material distribution system 10 is also connected to the first reaction product delivery pipeline 9, the process material distribution system 2 16 is also connected to the second reaction product delivery pipeline 17, the crystallization separation module 13 is also connected to the wet material delivery pipeline 14, the crystallization separation drying module 20 is also connected to the first dry material delivery pipeline 19, and the clean area module 21 is also connected to the second dry material delivery pipeline 22;
[0025] The vacuum module 25 is connected to the four reaction modules 6, the two crystallization separation modules 13, the crystallization separation drying module 20, and the clean area module 21 through vacuum pipes 27. The exhaust pipe of the vacuum pump is merged into the exhaust pipe 26.
[0026] The solvent distribution system 4, process material distribution system 1 10, process material distribution system 2 16 and vacuum module 25 are respectively connected to the waste liquid discharge pipeline 3; the solvent distribution system 4, process material distribution system 1 10 and process material distribution system 2 16 are respectively connected to the compressed air pipeline 1.
[0027] Example 2
[0028] This embodiment provides a process for producing small molecule APIs A, B, and C using the small molecule API production system in the above-mentioned embodiment 1.
[0029] 1. Production of small molecule API A:
[0030] Four 500L reactors and two 1000L crystallizers are required. The solid filter cake after crystallization and centrifugation is sent out as waste solid, and the mother liquor is the final product A. In other words, this process uses four reaction modules and two crystallization separation modules.
[0031] The specific steps include:
[0032] a. A variety of raw liquid solvents are fed from the solvent feed pipe 2 through the solvent distribution system 4 and then distributed as needed through the solvent pipe 5 into the reaction module 6. The four reaction modules 6 are operated in parallel;
[0033] b. The reacted material stream enters the process material distribution system 10 through the process material pipeline 7. After distribution, a portion of the material is returned to the reaction module 6 through the first process material delivery pipeline 8 to react again, and the other portion of the reacted material stream is sent to the crystallization separation module 13 through the second process material delivery pipeline 11;
[0034] c. After the crystallization and centrifugal separation, the solid filter cake is sent as waste solid through the wet material delivery pipeline 14 for external treatment. The mother liquor passes through the mother liquor delivery pipeline 15 and the process material distribution system 2 16. A portion of the unqualified mother liquor passes through the process material distribution system connecting pipeline 12 and the process material distribution system 1 10 and returns to the reaction module 6 again; the qualified mother liquor passes through the process material distribution system 2 16 and is sent out of the workshop as the final product through the reaction product delivery pipeline 17;
[0035] The purging process involves purging the internal pipes of the solvent distribution system 4 and the process material distribution systems 10 and 16 before each distribution. This purging process involves introducing compressed air through the compressed air pipe 1 to remove any remaining liquid from the pipes through the waste liquid discharge pipe 3 and discharge it to the wastewater treatment system.
[0036] 2. Production of small molecule API B:
[0037] Two 500L reactors and one 1000L crystallizer are required. After crystallization and centrifugation, the solid filter cake is dried to obtain the final product B. This process uses two reaction modules and one crystallization, separation, and drying module.
[0038] The specific steps include:
[0039] a. A plurality of raw liquid solvents are distributed from the solvent feed pipe 2 through the solvent distribution system 4 as needed and then enter a reaction module 6 through the solvent pipe 5;
[0040] b. The reaction flow enters the process material distribution system through the process material pipeline 7 to 10, and then enters the next reaction module 6 through the first process material delivery pipeline 8 for secondary reaction;
[0041] c. After the two-stage reaction, the logistics enters the process material distribution system 10 through the process material distribution system connecting line 12 and is sent to the process material distribution system 16, and finally enters the crystallization separation drying module 20 through the third process material delivery pipeline 18;
[0042] d. After the crystallization and centrifugal drying of the material, the solid filter cake is sent as the final product through the first dry material delivery pipeline 19, the mother liquor passes through the first mother liquor delivery pipeline 23 and the process material distribution system 16, and finally as a by-product through the second reaction product product delivery pipeline 17 to be sent outside the workshop.
[0043] The purging process involves purging the internal pipes of the solvent distribution system 4 and the process material distribution systems 10 and 16 before each distribution. This purging process involves introducing compressed air through the compressed air pipe 1 to remove any remaining liquid from the pipes through the waste liquid discharge pipe 3 and discharge it to the wastewater treatment system.
[0044] 3. Production of small molecule API C:
[0045] One 500L reactor and one 1000L crystallizer are required. After the solids are dried in a Class D clean area, the final product C is obtained. This process uses one reactor module and one clean area module (the 1000L crystallizer is located within the clean area module).
[0046] The specific steps include:
[0047] a. A plurality of raw liquid solvents are distributed from the solvent feed pipe 2 through the solvent distribution system 4 as needed and then enter a reaction module 6 through the solvent pipe 5;
[0048] b. The reaction stream enters the process material distribution system 10 through the process material distribution pipeline 7, is sent to the process material distribution system 16 through the process material distribution system connecting line 12, and finally enters the clean area module 21 through the third process material delivery pipeline 18;
[0049] c. After crystallization and centrifugation, and after drying in a Class D clean area, the solid filter cake is delivered as the final product through the second dry material delivery pipeline 22, and the mother liquor passes through the second mother liquor delivery pipeline 24 and the process material distribution system 16, and is finally delivered to the outside of the workshop as a by-product through the second reaction product product delivery pipeline 17.
[0050] The purging process involves purging the internal pipes of the solvent distribution system 4 and the process material distribution systems 10 and 16 before each distribution. This purging process involves introducing compressed air through the compressed air pipe 1 to remove any remaining liquid from the pipes through the waste liquid discharge pipe 3 and discharge it to the wastewater treatment system.
[0051] The above description is only a preferred embodiment of the present invention and does not limit the implementation mode and protection scope of the present invention. For those skilled in the art, it should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the contents of the present invention specification should be included in the protection scope of the present invention.
Claims
1. A small molecule API production system, characterized in that: It comprises a solvent distribution system (4), a process material distribution system 1 (10), a process material distribution system 2 (16), four reaction modules (6), two crystallization separation modules (13), a crystallization separation drying module (20), a clean area module (21) and a vacuum module (25); The solvent distribution system (4) is connected to the four reaction modules (6), the two crystallization separation modules (13), the crystallization separation drying module (20), and the clean area module (21) through a plurality of solvent pipelines (5), and the solvent distribution system (4) is also connected to a solvent feed pipeline (2); the four reaction modules (6) are respectively connected to the process material distribution system (10) through a process material pipeline (7); the process material distribution system (10) is respectively connected to the four reaction modules (6) through a first process material delivery pipeline (8), and the process material distribution system (10) is also respectively connected to the two crystallization separation modules (13) through a second process material delivery pipeline (11); The two crystallization separation modules (13) are respectively connected to the process material distribution system 2 (16) through the mother liquor conveying pipeline (15), the process material distribution system 2 (16) is connected to the process material distribution system 1 (10) through the process material distribution system connecting pipeline (12), and the process material distribution system 2 (16) is also connected to the crystallization separation drying module (20) and the clean area module (21) through the third process material conveying pipeline (18); the crystallization separation drying module (20) is connected to the process material distribution system 2 (16) through the first mother liquor conveying pipeline (23), and the clean area module (21) is connected to the process material distribution system 2 (16) through the second mother liquor conveying pipeline (24); The vacuum module (25) is connected to the four reaction modules (6), the two crystallization separation modules (13), the one crystallization separation drying module (20), and the one clean area module (21) respectively through a vacuum pipe (27), and the exhaust pipe of the vacuum pump is merged into the exhaust pipe (26).
2. The small molecule API production system according to claim 1, characterized in that: The process material distribution system 1 (10) is also connected to a first reaction product delivery pipeline (9).
3. The small molecule API production system according to claim 1, characterized in that: The second process material distribution system (16) is also connected to a second reaction product delivery pipeline (17).
4. The small molecule API production system according to claim 1, characterized in that: The solvent distribution system (4), the process material distribution system 1 (10), the process material distribution system 2 (16) and the vacuum module (25) are all connected to a waste liquid discharge pipeline (3).
5. The small molecule API production system according to claim 1, characterized in that: The solvent distribution system (4), the process material distribution system 1 (10) and the process material distribution system 2 (16) are all connected to a compressed air pipeline (1) respectively.
6. The small molecule API production system according to claim 1, characterized in that: The crystallization separation module (13) is also connected to a wet material delivery pipeline (14).
7. The small molecule API production system according to claim 1, characterized in that: The crystallization separation and drying module (20) is further connected to a first dry material delivery pipeline (19), and the clean area module (21) is further connected to a second dry material delivery pipeline (22).
Citation Information
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