CN114931559A - Optimized coating process method of nifedipine sustained-release tablets - Google Patents
Optimized coating process method of nifedipine sustained-release tablets Download PDFInfo
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- CN114931559A CN114931559A CN202210621321.8A CN202210621321A CN114931559A CN 114931559 A CN114931559 A CN 114931559A CN 202210621321 A CN202210621321 A CN 202210621321A CN 114931559 A CN114931559 A CN 114931559A
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- 238000000576 coating method Methods 0.000 title claims abstract description 65
- 238000000034 method Methods 0.000 title claims abstract description 27
- 229960001597 nifedipine Drugs 0.000 title claims abstract description 21
- HYIMSNHJOBLJNT-UHFFFAOYSA-N nifedipine Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1[N+]([O-])=O HYIMSNHJOBLJNT-UHFFFAOYSA-N 0.000 title claims abstract description 21
- 239000007939 sustained release tablet Substances 0.000 title claims abstract description 21
- 239000003826 tablet Substances 0.000 claims abstract description 53
- 239000011248 coating agent Substances 0.000 claims abstract description 49
- 238000005507 spraying Methods 0.000 claims abstract description 30
- 239000002002 slurry Substances 0.000 claims abstract description 23
- 238000004519 manufacturing process Methods 0.000 claims abstract description 17
- 238000007599 discharging Methods 0.000 claims abstract description 13
- 230000002572 peristaltic effect Effects 0.000 claims description 26
- 239000007941 film coated tablet Substances 0.000 claims description 8
- 230000008569 process Effects 0.000 claims description 7
- 239000007921 spray Substances 0.000 claims description 7
- 239000007788 liquid Substances 0.000 claims description 5
- 238000012544 monitoring process Methods 0.000 claims description 5
- 238000001816 cooling Methods 0.000 claims description 3
- 238000009434 installation Methods 0.000 claims description 3
- 239000002932 luster Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 2
- 229940079593 drug Drugs 0.000 abstract 1
- 238000004140 cleaning Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 229940127291 Calcium channel antagonist Drugs 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 239000002220 antihypertensive agent Substances 0.000 description 1
- 229940127088 antihypertensive drug Drugs 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 239000000480 calcium channel blocker Substances 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000005580 one pot reaction Methods 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/005—Coating of tablets or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Abstract
The invention relates to the technical field of medicines, in particular to an optimized coating process method of nifedipine sustained-release tablets, which comprises the following process steps: firstly, installing and debugging coating machine equipment and performing no-load test operation; secondly, rechecking and checking the tablet cores, and putting the tablet cores into a coating machine by a lifting feeder; thirdly, preheating the coated tablet core to 40 degrees; fourthly, spraying the slurry, and fifthly, observing the surface of the film every 10 minutes after spraying the slurry for 30 minutes, and stopping spraying the slurry when the surface of the film-coated film is dry, the film-coated film is not damaged, and the film-coated film is flat, smooth, uniform in color and neat in edge; sixthly, airing the slices; and seventhly, discharging. The method provided by the invention has high production efficiency and stable coating quality.
Description
Technical Field
The invention relates to the technical field of medicine production, in particular to an optimized coating process method of nifedipine sustained-release tablets.
Background
Nifedipine sustained release tablets are long-acting antihypertensive drugs, can stably reduce blood pressure, belong to calcium channel blockers, and are mainly used for treating hypertension, coronary heart disease and the like. The general nifedipine sustained-release tablets are yellow film-coated tablets, the tablet cores are yellow light round tablets, and the two surfaces are smooth. In the existing nifedipine sustained-release tablet production coating process, because the temperature and the pressure can not be monitored at any time, the negative pressure and the temperature control are unstable, and the tablet is added and taken out manually, the production efficiency is low and the coating quality is unstable.
Disclosure of Invention
The invention aims to solve the technical problem of providing an optimized coating process method of nifedipine sustained-release tablets, which has high production efficiency and stable coating quality.
The invention is realized by the following technical scheme:
an optimized coating process method of nifedipine sustained-release tablets is characterized by comprising the following process steps:
step one, installing and debugging coating machine equipment and no-load test running;
secondly, rechecking and checking the tablet cores, and putting the tablet cores into a coating machine by a lifting feeder;
thirdly, preheating the coated tablet core to 40 degrees;
fourthly, spraying slurry, namely uniformly spraying the prepared coating liquid through a plurality of spray guns at the same time, setting the rotating speed of a main machine to 6 revolutions per minute at the beginning of spraying slurry, setting the flow of a peristaltic pump to 160ml per minute, setting the temperature to 50 ℃, starting a slurry spraying device, confirming that coating is started after the slurry is sprayed out, gradually increasing the rotating speed of the main machine to 10 revolutions per minute and the flow of the peristaltic pump to 300ml per minute at the initial stage of coating, monitoring the temperature, the humidity and the air quantity of a tablet core in real time in the slurry spraying process, keeping the temperature of the tablet core at 40-45 ℃, keeping the negative pressure at-50 to-120 Pa, keeping the temperature range of inlet air at 50-65 ℃ and the temperature range of outlet air at 40-55 ℃;
fifthly, after spraying the slurry for 30 minutes, observing the surface of the film piece every 10 minutes, and stopping spraying the slurry when the surface of the film piece is dry and the film piece is not damaged, flat, smooth, uniform in color and neat in edge;
sixthly, airing the slices: setting the rotating speed of a main machine to 1-2 r/min, and cooling until the temperature of a tablet core reaches 26 ℃;
and seventhly, automatically discharging by a discharging device.
And optimally, the installation, debugging and no-load test running time of the coating machine in the first step is 5 minutes.
And further, when the core of the coating machine is preheated in the third step, the temperature is 65 ℃, the rotating speed of the main machine is 2 r/min, and the core starts to be sprayed when the temperature reaches 40 ℃.
And further, during the fourth step of guniting, firstly setting the rotating speed of the host to 6 revolutions per minute, setting the flow of a peristaltic pump to 160ml per minute, setting the temperature to 50 ℃, starting guniting equipment, increasing the rotating speed of the host to 7 revolutions per minute after 5 minutes of guniting, setting the flow of the peristaltic pump to 180ml per minute, increasing the rotating speed of the host to 8 revolutions per minute after 10 minutes of guniting, setting the flow of the peristaltic pump to 300ml per minute, increasing the rotating speed of the host to 9 revolutions per minute after 15 minutes of guniting, keeping the flow of the peristaltic pump unchanged, increasing the rotating speed of the host to 10 revolutions per minute after 20 minutes of guniting, and controlling the temperature of the tablet core to be 40-45 ℃ when the flow of the peristaltic pump is increased to 300ml per minute and the rotating speed of the coating machine is increased to 10 revolutions per minute.
And optimally, stopping spraying when the surface of the yellow film-coated tablet is dry, the yellow film-coated tablet is not damaged, and the yellow film-coated tablet is flat, smooth, uniform in color and neat in edge.
Further, automatically cleaning the pot wall after discharging, and then putting the pot into production.
Advantageous effects of the invention
The optimal coating process method of the nifedipine sustained-release tablets comprises the steps of preheating a tablet core of the coating, controlling and adjusting the rotating speed of a main engine at the initial stage of guniting and the flow of a peristaltic pump, and monitoring the temperature, humidity and air volume of the tablet core in real time in the guniting process, so that the temperature of the tablet core is kept at 40-45 ℃, the negative pressure is kept at-50 to-120 Pa, the air inlet temperature range is 50-65 ℃, and the air outlet temperature range is 40-55 ℃, so that the coating quality of the nifedipine sustained-release tablets is very stable, and the prepared coating liquid is uniformly gunited by a plurality of spray guns at the same time due to the fact that the tablet core is coated in one pot in the whole batch, so that the uniformity of guniting is further ensured, the guniting efficiency is improved, the tablet core is put into the coating machine by a lifting feeder, and the tablet is automatically discharged by a discharging device, so that the production efficiency is improved, and the coating quality is further ensured.
Drawings
FIG. 1 is a process flow diagram of the present invention
Detailed Description
An optimized coating process method of nifedipine sustained-release tablets is characterized by comprising the following process steps:
firstly, installing and debugging coating machine equipment and performing no-load test operation; after no load for 5 minutes, the middle station material dispatching personnel is informed to start material dispatching after the normal operation of the coating machine is confirmed, so that the smooth production can be ensured, and the loss of the tablet core and the quality risk caused by machine faults are prevented.
Secondly, rechecking and checking the tablet cores, and putting the tablet cores into a coating machine by a lifting feeder; before the tablet cores are put in, the product name, specification, batch number and quantity need to be checked to be consistent, each barrel of tablet cores are rechecked and weighed barrel by using an electronic scale and are consistent with the barrel labels, the tablet cores are prevented from being wrongly put in or the quantity of the tablet cores is not correct, and the tablet cores are put in by adopting a lifting feeder, so that the labor intensity of workers can be reduced, and the production efficiency is improved.
Thirdly, preheating the coated tablet core to 40 degrees; the heating of the tablet core at the later stage can be more uniform, the film forming of the tablet core is facilitated, and the stability of the coating quality is improved.
Fourthly, spraying slurry, namely uniformly spraying the prepared coating liquid through a plurality of spray guns at the same time, setting the rotating speed of a spraying starting host machine to 6 revolutions per minute, setting the flow of a peristaltic pump to 160ml per minute, setting the temperature to 50 ℃, starting a slurry spraying device, confirming that coating is started after the slurry is sprayed out, gradually increasing the rotating speed of the host machine to 10 revolutions per minute within 20 minutes of the initial coating, and gradually increasing the flow of the peristaltic pump to 300ml per minute, monitoring the temperature, the humidity and the air quantity of a tablet core in real time in the slurry spraying process, keeping the temperature of the tablet core at 40-45 ℃, keeping the negative pressure at-50 to-120 Pa, keeping the temperature range of inlet air at 50-65 ℃ and the temperature range of outlet air at 40-55 ℃, and measuring the temperature of the tablet core, and realizing real-time monitoring at a fixed position, and matching of the plurality of spray guns with the corresponding peristaltic pumps to realize one gun and one pump and better control the consistency of the flow of the slurry, the temperature of the tablet core is controlled to be 40-50 ℃, the film is rapidly formed, and the guniting efficiency is improved. The temperature, the humidity and the air quantity of the tablet core are automatically monitored in real time in the guniting process, the temperature of the tablet core is controlled to be kept at 40-45 ℃, the negative pressure is kept at-50 to-120 Pa, the air inlet temperature range is 50-65 ℃, the air outlet temperature range is 40-55 ℃, so that the quality of a tablet core coating is stable and uniform, the film coated tablet is not damaged, the surface is smooth and clean, the color is uniform, the edge is neat, and the production efficiency is high.
And fifthly, observing the surface of the tablet every 10 minutes after spraying for 30 minutes, and stopping spraying when the surface of the tablet is dry and the film-coated tablet is not damaged, flat, smooth, uniform in color and neat in edge, so that the spraying time is shortened, the spraying efficiency is improved, and the phenomenon that the coating quality is unstable due to excessive spraying is prevented.
Sixthly, airing the slices; when the tablet is dried, the pan door of the coating machine is opened, and the rotating speed of the main machine is set to be 1-2 turns
And (3) cooling, namely starting to cool for 0.5-1 hour, and discharging when the temperature of the tablet core reaches 26 ℃ to ensure the stability of the coating.
And seventhly, automatically discharging by using a discharging device. During the ejection of compact, install the discharger on the pot mouth, set for 6 revolutions per minute with the host computer rotational speed, start the coating machine automatic discharging, labour saving and time saving more improves production efficiency.
And optimally, the installation and debugging and no-load test running time of the coating machine in the first step is 5 minutes, and the normal running of the equipment is checked.
And further, when the core of the coating machine is preheated in the third step, the temperature is 65 ℃, the rotating speed of the main machine is 2 r/min, and the core starts to spray when the temperature reaches 40 ℃, so that the coating effect and quality are ensured.
And further, during the fourth step of guniting, firstly setting the rotating speed of the host to 6 revolutions per minute, setting the flow of the peristaltic pump to 160ml per minute, setting the temperature to 50 ℃, starting guniting equipment, increasing the rotating speed of the host to 7 revolutions per minute after 5 minutes of guniting, setting the flow of the peristaltic pump to 180ml per minute, increasing the rotating speed of the host to 8 revolutions per minute after 10 minutes of guniting, setting the flow of the peristaltic pump to 300ml per minute, increasing the rotating speed of the host to 9 revolutions per minute after 15 minutes of guniting, keeping the flow of the peristaltic pump unchanged, increasing the rotating speed of the host to 10 revolutions per minute after 20 minutes of guniting, and not adjusting parameters when the flow of the peristaltic pump is increased to 300ml per minute and the rotating speed of the coating machine is increased to 10 revolutions per minute. During guniting, the rotating speed of the main machine is slow firstly and then fast, and the flow of the peristaltic pump is small firstly and then large secondly, so that the rolling speed of the tablet core in the coating pan and the flow of the guniting are timely adjusted along with time, the coating can be rapidly formed, the coating uniformity is improved, the excessive guniting is prevented from causing waste, and the production cost is increased.
And optimally, in the fifth step, the guniting is stopped when the surface is dry, the yellow film-coated tablet is not damaged, is flat, smooth and clean, has uniform color and neat edge.
Further, automatically cleaning the pot wall after discharging, and then putting the pot into production. After each pot is discharged, automatic cleaning equipment is adopted to automatically clean the pot wall and then carry out the production of putting the pot, so that time and labor are saved, the production efficiency is improved, and the material can be prevented from being adhered to the pot wall to influence the quality of the product of putting the pot.
In conclusion, the optimized coating process method for the nifedipine sustained-release tablets, disclosed by the invention, has the advantages that the tablet core of the coating machine is preheated, the rotating speed of the host and the flow of the peristaltic pump at the initial stage of guniting are adjusted and controlled, the temperature of the tablet core of the coating machine is set, the temperature, humidity and air volume of the tablet core are monitored in real time in the guniting process, the coating quality of the nifedipine sustained-release tablets is very stable, the prepared coating liquid is uniformly guniting through a plurality of spray guns at the same time, the production efficiency is high, and the uniformity of guniting is further ensured.
Various modifications and alterations to this invention will become apparent to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (6)
1. An optimized coating process method of nifedipine sustained-release tablets is characterized by comprising the following process steps:
firstly, installing and debugging coating machine equipment and performing no-load test operation;
secondly, rechecking and checking the tablet cores, and putting the tablet cores into a coating machine by a lifting feeder;
thirdly, preheating the coated tablet core to 40 degrees;
fourthly, spraying slurry, namely uniformly spraying the prepared coating liquid through a plurality of spray guns at the same time, setting the rotating speed of a main machine to 6 revolutions per minute at the beginning of spraying slurry, setting the flow of a peristaltic pump to 160ml per minute, setting the temperature to 50 ℃, starting a slurry spraying device, confirming that coating is started after the slurry is sprayed out, gradually increasing the rotating speed of the main machine to 10 revolutions per minute and the flow of the peristaltic pump to 300ml per minute at the initial stage of coating, monitoring the temperature, the humidity and the air quantity of a tablet core in real time in the slurry spraying process, keeping the temperature of the tablet core at 40-45 ℃, keeping the negative pressure at-50 to-120 Pa, keeping the temperature range of inlet air at 50-65 ℃ and the temperature range of outlet air at 40-55 ℃;
fifthly, after spraying the slurry for 30 minutes, observing the surface of the film piece every 10 minutes, and stopping spraying the slurry when the surface of the film piece is dry and the film piece is not damaged, flat, smooth, uniform in color and neat in edge;
sixthly, airing the slices: setting the rotating speed of a main machine to 1-2 r/min, and cooling until the temperature of a tablet core reaches 26 ℃;
and seventhly, automatically discharging by a discharging device.
2. The optimized coating process method of nifedipine sustained-release tablets according to claim 1, wherein the installation and debugging and no-load test running time of the coating machine in the first step is 5 minutes.
3. The optimized coating process method of the nifedipine sustained-release tablets according to claim 1, wherein in the third step, when the core of the coating machine is preheated, the temperature is 65 ℃, the rotating speed of a main machine is 2 r/min, and the core starts to be sprayed when the temperature reaches 40 ℃.
4. The optimized coating process method of nifedipine sustained-release tablets according to claim 1, wherein during the fourth step of spraying, firstly, setting the rotating speed of a host to 6 revolutions per minute, setting the flow of a peristaltic pump to 160ml per minute, setting the temperature to 50 ℃, starting a guniting device, increasing the rotating speed of the host to 7 revolutions per minute after 5 minutes of guniting, setting the flow of the peristaltic pump to 180ml per minute, increasing the rotating speed of the host to 8 revolutions per minute after 10 minutes of guniting, setting the flow of the peristaltic pump to 300ml per minute, increasing the rotating speed of the host to 9 revolutions per minute after 15 minutes of guniting, keeping the flow of the peristaltic pump unchanged, increasing the rotating speed of the host to 10 revolutions per minute after 20 minutes of guniting, keeping the flow of the peristaltic pump unchanged, when the flow of the peristaltic pump is increased to 300 ml/minute and the rotating speed of the coating machine is increased to 10 revolutions/minute, the parameters are not adjusted any more, and the temperature of the tablet core is controlled to be 40-45 ℃.
5. The optimized coating process method of nifedipine sustained-release tablets according to claim 1, wherein in the fifth step, the slurry spraying is stopped when the tablet surface is dry, the yellow film-coated tablet is not damaged, is flat and smooth, has uniform color and luster, and has regular edges.
6. The optimized coating process method for nifedipine sustained-release tablets according to claim 1, wherein the pot wall is automatically cleaned after discharging and then the nifedipine sustained-release tablets enter a lower pot for production.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210621321.8A CN114931559A (en) | 2022-06-02 | 2022-06-02 | Optimized coating process method of nifedipine sustained-release tablets |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210621321.8A CN114931559A (en) | 2022-06-02 | 2022-06-02 | Optimized coating process method of nifedipine sustained-release tablets |
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| CN114931559A true CN114931559A (en) | 2022-08-23 |
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| CN202210621321.8A Pending CN114931559A (en) | 2022-06-02 | 2022-06-02 | Optimized coating process method of nifedipine sustained-release tablets |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120034272A1 (en) * | 2008-11-27 | 2012-02-09 | Bayer Schering Pharma Aktiengesellschaft | Pharmaceutical dosage form comprising nifedipine or nisoldipine and an angiotensin II antagonist and/or a diuretic |
| CN108186593A (en) * | 2018-02-06 | 2018-06-22 | 南京百思福医药科技有限公司 | A kind of Nifedipine sustained release tablets and preparation method thereof |
| CN108653229A (en) * | 2018-06-08 | 2018-10-16 | 华益药业科技(安徽)有限公司 | A kind of tetracycline thin membrane coated tablet and preparation method thereof |
| CN113262206A (en) * | 2021-05-26 | 2021-08-17 | 常州康普药业有限公司 | Preparation process of nifedipine preparation |
-
2022
- 2022-06-02 CN CN202210621321.8A patent/CN114931559A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120034272A1 (en) * | 2008-11-27 | 2012-02-09 | Bayer Schering Pharma Aktiengesellschaft | Pharmaceutical dosage form comprising nifedipine or nisoldipine and an angiotensin II antagonist and/or a diuretic |
| CN108186593A (en) * | 2018-02-06 | 2018-06-22 | 南京百思福医药科技有限公司 | A kind of Nifedipine sustained release tablets and preparation method thereof |
| CN108653229A (en) * | 2018-06-08 | 2018-10-16 | 华益药业科技(安徽)有限公司 | A kind of tetracycline thin membrane coated tablet and preparation method thereof |
| CN113262206A (en) * | 2021-05-26 | 2021-08-17 | 常州康普药业有限公司 | Preparation process of nifedipine preparation |
Non-Patent Citations (1)
| Title |
|---|
| 霍根: "《片剂包衣的工艺和原理》", 31 March 2001, 中国医药科技出版社, pages: 369 - 370 * |
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