CN107537428B - Production method of aminophylline granular raw material medicine - Google Patents
Production method of aminophylline granular raw material medicine Download PDFInfo
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- CN107537428B CN107537428B CN201710932209.5A CN201710932209A CN107537428B CN 107537428 B CN107537428 B CN 107537428B CN 201710932209 A CN201710932209 A CN 201710932209A CN 107537428 B CN107537428 B CN 107537428B
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- tank body
- aminophylline
- ethylenediamine
- stirring
- tank
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- 229960003556 aminophylline Drugs 0.000 title claims abstract description 36
- FQPFAHBPWDRTLU-UHFFFAOYSA-N aminophylline Chemical compound NCCN.O=C1N(C)C(=O)N(C)C2=C1NC=N2.O=C1N(C)C(=O)N(C)C2=C1NC=N2 FQPFAHBPWDRTLU-UHFFFAOYSA-N 0.000 title claims abstract description 36
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 22
- 239000003814 drug Substances 0.000 title claims abstract description 20
- 239000002994 raw material Substances 0.000 title claims abstract description 20
- 238000003756 stirring Methods 0.000 claims abstract description 42
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 claims abstract description 40
- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000000463 material Substances 0.000 claims abstract description 14
- 229960000278 theophylline Drugs 0.000 claims abstract description 11
- 239000002245 particle Substances 0.000 claims abstract description 10
- 238000007259 addition reaction Methods 0.000 claims abstract description 8
- 238000004821 distillation Methods 0.000 claims abstract description 8
- 239000011344 liquid material Substances 0.000 claims abstract description 5
- 238000000746 purification Methods 0.000 claims abstract description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 25
- 238000005507 spraying Methods 0.000 claims description 10
- 239000003638 chemical reducing agent Substances 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 5
- 238000001704 evaporation Methods 0.000 claims description 4
- 239000010865 sewage Substances 0.000 claims description 4
- 230000005540 biological transmission Effects 0.000 claims description 3
- 238000006243 chemical reaction Methods 0.000 claims description 3
- 238000001816 cooling Methods 0.000 claims description 3
- 230000008020 evaporation Effects 0.000 claims description 3
- 238000010992 reflux Methods 0.000 claims description 3
- 238000010298 pulverizing process Methods 0.000 claims description 2
- 239000007921 spray Substances 0.000 claims description 2
- 239000000126 substance Substances 0.000 abstract description 4
- 239000008187 granular material Substances 0.000 abstract description 3
- 238000005469 granulation Methods 0.000 abstract description 3
- 230000003179 granulation Effects 0.000 abstract description 3
- 239000007788 liquid Substances 0.000 abstract description 2
- 239000000843 powder Substances 0.000 abstract description 2
- 238000002156 mixing Methods 0.000 abstract 1
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000013256 coordination polymer Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
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Abstract
The invention relates to a production method of aminophylline granular raw material medicine, belonging to the technical field of chemical and chemical pharmacy. The production method of the aminophylline granular raw material medicine comprises the steps of ethylenediamine reduced pressure distillation purification, mixing addition reaction, crushing granulation and the like. The invention prepares the aminophylline granules with different particle types by optimizing and improving the original aminophylline production method, using the improved addition equipment and combining with granulation equipment, and meets the production requirements of different products. According to the invention, the ethylenediamine liquid is sprayed into the tank body by utilizing compressed air, and the theophylline powder material in the tank body is fully contacted and reacted with the ethylenediamine liquid material under the stirring action, so that the high-quality aminophylline raw material medicine can be rapidly prepared.
Description
Technical Field
The invention relates to a production method of a raw material medicine, in particular to a production method of an aminophylline granular raw material medicine, and belongs to the technical field of chemical and chemical pharmacy.
Background
At present, the aminophylline raw material medicine is powdery, and the production method can only produce the aminophylline powdery raw material medicine, and cannot meet the requirement of further promotion of subsequent products. In order to better serve the production of subsequent products, the problem to be solved urgently is to seek a method for producing the aminophylline granular raw material medicine.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a production method of granular aminophylline raw material medicine, and the method can produce granular aminophylline raw material medicine.
In order to solve the technical problems, the technical scheme adopted by the invention is as follows:
a production method of aminophylline granular raw material medicine comprises the following steps:
(1) purifying ethylenediamine by reduced pressure distillation
Opening a vacuum pump, checking the vacuum system to be well sealed, and keeping the vacuum degree of the evaporation reflux system to be more than or equal to 0.06MPa through operation; opening a condensing device, opening an external coil pipe of a distilling device and a steam inlet valve, starting distilling and purifying the ethylenediamine material, closing a system after the usage amount is reached, and detecting that the content of the distilled ethylenediamine is more than or equal to 99.5%;
(2) mixed addition reaction
The mixed addition reaction is carried out in an addition tank for producing the aminophylline granular raw material medicine, and the addition tank comprises a tank body and a cover body; a jacket is arranged on the outer wall of the tank body, and a bottom head jacket is arranged at the bottom of the outer wall of the tank body; a motor, a speed reducer and a magnetic coupler are arranged above the cover body, and the magnetic coupler is fixedly arranged on a flange at the top of the cover body and is coaxial with the tank body; the tank body is internally provided with a stirring shaft and a stirring paddle, the bottom end of the stirring shaft is fixedly connected with the stirring paddle, and the motor, the speed reducer, the magnetic coupler and the top end of the stirring shaft are sequentially in transmission connection; a feeding pipe is arranged on the cover body, a spraying valve is arranged on the feeding pipe, and an ethylene diamine pressure tank is arranged on the feeding hole of the feeding pipe; the upper part of the tank body is provided with a water inlet pipe, and the water inlet of the water inlet pipe is connected with an external low-temperature water coil pipe; a discharge pipe is arranged in the middle of the bottom of the tank body, and a butterfly valve is arranged on the discharge pipe; the top end of the stirring shaft is fixedly connected with the output shaft of the magnetic coupler through a shaft pair; the feeding pipe is arranged vertically downwards; a manhole is also arranged on the cover body; the ethylene diamine pressure tank is provided with a feeding interface and an air supply interface, and the air supply interface is connected with an air compressor; the upper part of the jacket is provided with an ear seat; a sewage discharge pipe is also arranged at the bottom of the tank body;
adding prepared theophylline into a tank body, starting a motor, stirring the added theophylline by using a stirring shaft and a stirring paddle, opening an external low-temperature water coil pipe in the stirring process, injecting low-temperature water into the tank body through a water inlet pipe, cooling, and keeping the temperature of the mixed addition reaction to be less than or equal to 20 ℃; injecting the ethylene diamine subjected to distillation and purification in the step (1) into an ethylene diamine pressure tank, and supplying air into the ethylene diamine pressure tank through an air compressor; stirring the theophylline in the tank body for 30 minutes, opening a spray valve on a feeding pipe, spraying ethylenediamine into the tank body, controlling the spraying pressure of the ethylenediamine to be 0.08-0.15 MPa, continuously stirring for 30 minutes after the ethylenediamine is completely sprayed, ensuring that the reaction temperature is less than or equal to 15 ℃, and fully contacting and reacting the powdery material in the tank body with the liquid material under the stirring action to prepare aminophylline;
(3) pulverizing and granulating
And (3) feeding the aminophylline obtained in the step (2) into a swing granulator to periodically rotate in a reciprocating manner, controlling and extruding particles by a screen and a rotor gap, wherein the production capacity of the aminophylline continuously changes along with the difference of the moisture, the type, the viscosity and the mesh of the material, and can be used for producing particles with various specifications.
Adopt the produced beneficial effect of above-mentioned technical scheme to lie in:
through optimizing and improving the original aminophylline production method, and using the improved addition equipment and combining with granulation equipment, aminophylline granules with different particle types are prepared, and the production requirements of different products are met. According to the invention, the ethylenediamine liquid is sprayed into the tank body by utilizing compressed air, and the theophylline powder material in the tank body is fully contacted and reacted with the ethylenediamine liquid material under the stirring action, so that the high-quality aminophylline raw material medicine can be rapidly prepared.
Drawings
FIG. 1 is a front view of the structure of an addition tank for producing aminophylline granular drug substance in accordance with the present invention;
in the figure: 1. the device comprises a tank body, a cover body, a low-temperature water coil pipe, a feeding pipe, a discharging pipe, a butterfly valve, a bottom head jacket, an ethylene diamine pressure tank, a stirring paddle, a jacket, a compressor, a stirring shaft, a lug, a shaft pair, a spraying valve, a water inlet pipe, a manhole, a flange, a magnetic coupler, a motor, a speed reducer, a sewage discharge pipe and a water outlet pipe, wherein the tank body is 2, the cover body is 3, the low-temperature water coil pipe is 4, the.
Detailed Description
The present invention will be described in further detail with reference to specific embodiments, but the present invention is not limited thereto.
1. Main production equipment
| Name (R) | Specification and model | Main body material | Quantity (table) |
| Ethylenediamine evaporating pot | 500L | 304 | 1 |
| Addition tank for producing aminophylline granular raw material medicine | 800L | 304 | 1 |
| Swing granulator | YK-160 | Stainless steel | 1 |
2. Production method of aminophylline granular raw material medicine
2.1 distillation purification of Ethylenediamine
And (3) reduced pressure distillation: opening a vacuum pump, checking the vacuum system to be well sealed, and keeping the vacuum degree of the evaporation reflux system to be more than or equal to 0.06MPa through operation; opening a condensing device, opening an external coil pipe of a distilling device to enter a steam valve, starting distilling and purifying the ethylenediamine material until the usage amount reaches 45 +/-3.5 Kg, closing the system, and detecting that the content of the distilled ethylenediamine is more than or equal to 99.5 percent.
2.2 Mixed addition
As shown in fig. 1, the addition tank for producing aminophylline granular raw material medicine comprises a tank body 1 and a cover body 2; a jacket 10 is arranged on the outer wall of the tank body 1, and a bottom head jacket 7 is arranged at the bottom of the outer wall of the tank body 1; the upper part of the jacket 10 is provided with an ear seat 13. A motor 20, a speed reducer 21 and a magnetic coupler 19 are arranged above the cover body 2, and the magnetic coupler 19 is fixedly arranged on a flange 18 at the top of the cover body 2 and is coaxial with the tank body 1; a stirring shaft 12 and a stirring paddle 9 are arranged in the tank body 1, the bottom end of the stirring shaft 12 is fixedly connected with the stirring paddle 9, and the motor 20, the speed reducer 21, the magnetic coupler 19 and the top end of the stirring shaft 12 are sequentially in transmission connection; the top end of the stirring shaft 12 is fixedly connected with the output shaft of the magnetic coupler 19 through a shaft pair 14. A manhole 17 and a feeding pipe 4 are arranged on the cover body 2, the feeding pipe 4 is arranged vertically downwards, a spraying valve 15 is arranged on the feeding pipe 4, and an ethylenediamine pressure tank 8 is arranged on a feeding hole of the feeding pipe 4; the ethylenediamine pressure tank 8 is provided with a feeding port and an air supply port, and the air supply port is connected with an air compressor 11. The upper part of the tank body 1 is provided with a water inlet pipe 16, and the water inlet of the water inlet pipe 16 is connected with an external low-temperature water coil pipe 3; the middle of the bottom of the tank body 1 is provided with a discharge pipe 5, and the discharge pipe 5 is provided with a butterfly valve 6. The bottom of the tank body 1 is also provided with a sewage draining pipe 22.
The technical parameters are as follows:
rotating speed: 110 rpm
Motor power: 11kw
Production capacity: 100-400kg/h
Volume 800L
Adding prepared theophylline 140 into the tank body 1, starting the motor 20, stirring the added theophylline by using the stirring shaft 12 and the stirring paddle 9, opening the external low-temperature water coil pipe 3 in the stirring process, injecting low-temperature water into the tank body 1 through the water inlet pipe 16, cooling, and keeping the temperature of the mixed addition reaction to be less than or equal to 20 ℃. The ethylene diamine purified by distillation is injected into an ethylene diamine pressure tank 8, and air is supplied to the ethylene diamine pressure tank 8 through an air compressor 11. After the theophylline in the tank body 1 is stirred for 30 minutes, the spraying valve 15 on the feeding pipe 4 is opened, the ethylenediamine is sprayed into the tank body 1, the spraying pressure of the ethylenediamine is controlled to be 0.08-0.15 MPa, the stirring is continued for 30 minutes after all the prepared ethylenediamine is sprayed, the reaction temperature is guaranteed to be less than or equal to 15 ℃, the powdery material in the tank body 1 is fully contacted and reacted with the liquid material under the stirring action, the aminophylline is prepared, the yield is 95 +/-2%, and the quality meets the Chinese CP standard.
2.3 grinding and granulating swing granulator YK-160: the technical parameters are as follows:
diameter of the rotating drum: 250
Rotating speed: 65 rpm
Rotation swing angle: 360
Motor power: 5.5kw
Production capacity: 200-500kg/h
The external dimension is as follows: 1350 x 820 x 1300, weight 500kg
Under the action of eccentric crankshaft and lifting rack, the gear shaft with pentagonal hobbing cutter rotates periodically and reciprocally, the material moves continuously and is controlled by screen and rotor gap to extrude out granules.
The sieve plate at the bottom of the swing granulator is replaced by a self-made stainless steel sieve screen with 10 meshes of precision, so that the influence on the material content caused by excessive friction of materials and equipment is avoided.
The aminophylline prepared by the method can meet the requirements of different aminophylline particles that 95% of aminophylline particles pass through 30 meshes, 90% of aminophylline particles pass through 60-90 meshes, 50% of aminophylline particles pass through 100 meshes and the like.
The above description is only presented as an enabling solution for the present invention and should not be taken as a sole limitation on the solution itself.
Claims (1)
1. A production method of aminophylline granular raw material medicine is characterized by comprising the following steps:
(1) purifying ethylenediamine by reduced pressure distillation
Opening a vacuum pump, checking the vacuum system to be well sealed, and keeping the vacuum degree of the evaporation reflux system to be more than or equal to 0.06MPa through operation; opening a condensing device, opening an external coil pipe of a distilling device and a steam inlet valve, starting distilling and purifying the ethylenediamine material, closing a system after the usage amount is reached, and detecting that the content of the distilled ethylenediamine is more than or equal to 99.5%;
(2) mixed addition reaction
The mixed addition reaction is carried out in an addition tank for producing the aminophylline granular raw material medicine, and the addition tank comprises a tank body (1) and a cover body (2); a jacket (10) is arranged on the outer wall of the tank body (1), and a bottom end enclosure jacket (7) is arranged at the bottom of the outer wall of the tank body (1); a motor (20), a speed reducer (21) and a magnetic coupler (19) are arranged above the cover body (2), and the magnetic coupler (19) is fixedly arranged on a flange (18) at the top of the cover body (2) and is coaxial with the tank body (1); a stirring shaft (12) and a stirring paddle (9) are arranged in the tank body (1), the bottom end of the stirring shaft (12) is fixedly connected with the stirring paddle (9), and the motor (20), the speed reducer (21), the magnetic coupler (19) and the top end of the stirring shaft (12) are sequentially in transmission connection; a feeding pipe (4) is arranged on the cover body (2), a spraying valve (15) is arranged on the feeding pipe (4), and an ethylenediamine pressure tank (8) is arranged on a feeding hole of the feeding pipe (4); a water inlet pipe (16) is arranged at the upper part of the tank body (1), and a water inlet of the water inlet pipe (16) is connected with an external low-temperature water coil pipe (3); a discharge pipe (5) is arranged in the middle of the bottom of the tank body (1), and a butterfly valve (6) is arranged on the discharge pipe (5);
adding the prepared theophylline into a tank body (1), starting a motor (20), stirring the added theophylline by using a stirring shaft (12) and a stirring paddle (9), opening an external low-temperature water coil pipe (3) in the stirring process, injecting low-temperature water into the tank body (1) through a water inlet pipe (16), cooling, and keeping the temperature of the mixed addition reaction to be less than or equal to 20 ℃; the ethylene diamine after distillation and purification is injected into an ethylene diamine pressure tank (8), and air is supplied to the ethylene diamine pressure tank (8) through an air compressor (11); stirring the theophylline in the tank body (1) for 30 minutes, opening a spray valve (15) on a feeding pipe (4), spraying ethylenediamine into the tank body (1), controlling the spraying pressure of the ethylenediamine to be 0.08-0.15 MPa, continuing stirring for 30 minutes after all prepared ethylenediamine is sprayed, ensuring that the reaction temperature is less than or equal to 15 ℃, and fully contacting and reacting the powdery material in the tank body (1) with a liquid material under the stirring action to prepare the aminophylline;
the top end of the stirring shaft (12) is fixedly connected with an output shaft of the magnetic coupler (19) through a shaft pair (14); the feeding pipe (4) is vertically arranged downwards; a manhole (17) is also arranged on the cover body (2); the ethylene diamine pressure tank (8) is provided with a feeding interface and an air supply interface, and the air supply interface is connected with an air compressor (11); the upper part of the jacket (10) is provided with an ear seat (13); a sewage discharge pipe (22) is also arranged at the bottom of the tank body (1);
(3) pulverizing and granulating
And (3) feeding the aminophylline obtained in the step (2) into a swing granulator to periodically rotate in a reciprocating manner, controlling and extruding particles by a screen and a rotor gap, wherein the production capacity of the aminophylline continuously changes along with the difference of the moisture, the type, the viscosity and the mesh of the material, and can be used for producing particles with various specifications.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710932209.5A CN107537428B (en) | 2017-10-10 | 2017-10-10 | Production method of aminophylline granular raw material medicine |
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| CN201710932209.5A CN107537428B (en) | 2017-10-10 | 2017-10-10 | Production method of aminophylline granular raw material medicine |
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| CN107537428A CN107537428A (en) | 2018-01-05 |
| CN107537428B true CN107537428B (en) | 2020-04-17 |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108794476A (en) * | 2018-07-06 | 2018-11-13 | 山东新华制药股份有限公司 | A kind of preparation process of aminophylline anhydrous |
| CN110615791A (en) * | 2019-10-18 | 2019-12-27 | 海南顿斯医药科技有限公司 | 1A1/2Aminophylline compounds |
| CN111939853A (en) * | 2020-07-06 | 2020-11-17 | 江苏奥莱特新材料股份有限公司 | Production device and method of solid alkali-free setting accelerator |
| CN114939393A (en) * | 2022-06-01 | 2022-08-26 | 青岛科技大学 | System and method for continuously producing aminophylline |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN202052546U (en) * | 2011-05-09 | 2011-11-30 | 广东省肇庆市超能实业有限公司 | Medical auxiliary material vacuum dehydration synthesis reaction kettle |
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- 2017-10-10 CN CN201710932209.5A patent/CN107537428B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN202052546U (en) * | 2011-05-09 | 2011-11-30 | 广东省肇庆市超能实业有限公司 | Medical auxiliary material vacuum dehydration synthesis reaction kettle |
Non-Patent Citations (1)
| Title |
|---|
| 氨茶碱;xin triangle;《百度文库》;20170906;第3页 * |
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Inventor after: Feng Zhijun Inventor after: Han Feng Inventor after: Wang Kunli Inventor after: Zhao Xu Inventor after: Chen Lei Inventor after: Ma Xiaojin Inventor after: Guo Shaoqing Inventor before: Feng Zhijun Inventor before: Wang Kunli Inventor before: Zhao Xu Inventor before: Chen Lei Inventor before: Ma Xiaojin Inventor before: Guo Shaoqing |
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Address after: 051430 No.62 Zhangju Road, Luancheng District, Shijiazhuang City, Hebei Province Patentee after: Shiyao Innovation Pharmaceutical Co.,Ltd. Country or region after: China Address before: 051430 No. 36 Fuqiang West Road, Luancheng District, Shijiazhuang City, Hebei Province Patentee before: SHIJIAZHUANG PHARMACEUTICAL GROUP NEW NORWICH PHARMACEUTICAL CO.,LTD. Country or region before: China |