CN103317747B - Drug particles mixing feed compressing tablet all-in-one - Google Patents
Drug particles mixing feed compressing tablet all-in-one Download PDFInfo
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- 239000003814 drug Substances 0.000 title claims abstract description 49
- 229940079593 drug Drugs 0.000 title claims abstract description 48
- 238000002156 mixing Methods 0.000 title claims abstract description 40
- 239000002245 particle Substances 0.000 title claims abstract description 18
- 239000000463 material Substances 0.000 claims description 10
- 239000000203 mixture Substances 0.000 claims 3
- 238000007599 discharging Methods 0.000 claims 1
- 239000008187 granular material Substances 0.000 abstract description 34
- 238000000034 method Methods 0.000 abstract description 19
- 238000004519 manufacturing process Methods 0.000 abstract description 6
- 238000005550 wet granulation Methods 0.000 abstract description 4
- 229940126534 drug product Drugs 0.000 abstract description 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 239000000843 powder Substances 0.000 description 10
- 238000009475 tablet pressing Methods 0.000 description 8
- 238000007906 compression Methods 0.000 description 5
- 230000006835 compression Effects 0.000 description 5
- 238000007907 direct compression Methods 0.000 description 5
- 238000003825 pressing Methods 0.000 description 3
- 238000001514 detection method Methods 0.000 description 2
- 239000000284 extract Substances 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical compound O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 description 1
- 235000019700 dicalcium phosphate Nutrition 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B30—PRESSES
- B30B—PRESSES IN GENERAL
- B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
- B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
- B30B11/08—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B30—PRESSES
- B30B—PRESSES IN GENERAL
- B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
- B30B15/30—Feeding material to presses
- B30B15/302—Feeding material in particulate or plastic state to moulding presses
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
本发明创造涉及对药物颗粒进行压片的设备。为了高效实现对药物颗粒的混合和压片，制成含量均匀的药物成品，给出药物颗粒混合给料压片一体机，有混合机输出到压片机，有上料机为混合机分批上料，混合机分批混合，在混合机与压片机之间接有在每批混合完成后进行送料的送料机构，压片机分批压片。其自动对药物颗粒分批，按时间先后对各批药物颗粒进行一体加工，对每批药物颗粒的一体加工包括依次进行的上料、混合和压片操作。由于每次压片量小于对整批进行压片，药物颗粒在压片时就不容易解离或离析，使得药物成品含量均匀。药物颗粒混合给料压片一体机自动完成混合和压片的加工过程，且无需增加湿法制粒工序，故提高了生产效率。
The invention relates to an apparatus for tableting pharmaceutical granules. In order to efficiently realize the mixing and tableting of drug granules, and make finished drug products with uniform content, an integrated drug granule mixing, feeding and tableting machine is provided, with the output of the mixer to the tablet press, and the feeding machine for batch batching of the mixer Feeding, the mixer mixes in batches, a feeding mechanism is connected between the mixer and the tablet machine for feeding after each batch of mixing is completed, and the tablet machine compresses tablets in batches. It automatically divides the drug granules into batches, and performs integrated processing of each batch of drug granules according to time. The integrated processing of each batch of drug granules includes sequential feeding, mixing and tableting operations. Since the amount of tableting each time is less than that of the whole batch, the drug particles are not easy to dissociate or segregate during tableting, so that the content of the finished drug is uniform. The drug granule mixing, feeding and tableting machine automatically completes the processing process of mixing and tableting, and does not need to increase the wet granulation process, so the production efficiency is improved.
Description
技术领域 technical field
本发明创造涉及对药物颗粒进行压片的设备，具体给出药物颗粒混合给料压片一体机。 The invention relates to equipment for tableting drug granules, and specifically provides an integrated machine for mixing, feeding and tableting drug granules.
背景技术 Background technique
全粉末直接压片工艺是未来制药工业上片剂生产的发展方向，将取代目前的湿法制粒压片法，因在压片工艺上减少了混合-制软材-干燥-整粒等繁琐工序，具有省时节能、工艺简便、工序少等特点，可大大降低片剂生产成本，提高生产效率。国外制药工业主要通过改变辅料来实施全粉末直接压片工艺，尚未有基于压片机的技术改良这一思路进行直压工艺研究。 The whole powder direct compression process is the development direction of tablet production in the pharmaceutical industry in the future, and will replace the current wet granulation tableting method, because the cumbersome processes such as mixing-soft material-drying-granulation are reduced in the tableting process , which has the characteristics of time-saving and energy-saving, simple process and less process, which can greatly reduce the production cost of tablets and improve production efficiency. The foreign pharmaceutical industry mainly implements the whole powder direct compression process by changing the excipients, and there is no research on the direct compression process based on the technical improvement of the tablet machine.
同类研究工作国内外研究现状：目前市场上压片机，如：德国KROSH高速压片机和国内的压片机，主要工作部分有：机台、压轮、片重调节器、压力调节器、加料斗、饲粉器、吸尘器、保护装置等。机台分为三层，机台的上层装有若干上冲，在中层的对应位置上装着模圈，在下层的对应位置装着下冲。上冲与下冲各自随机台转动并沿着固定的轨道有规律地上、下运动，当上冲与下冲随机台转动，分别经过上、下压轮时，上冲向下、下冲向上运动，并对模孔中的物料加压；机台中层的固定位置上装有刮粉器，片重调节器装于下冲轨道的刮粉器所对应的位置，用以调节下冲经过刮粉器时的高度，以调节模孔的容积；用上下压轮的上下移动位置调节压缩压力。其压片过程如下：①填充：当下冲转到饲粉器之下时，其位置最低，颗粒填入模孔中；当下冲行至片重调节器之上时略有上升，经刮粉器将多余的颗粒刮去；②压片：当上冲和下冲行至上、下压轮之间时，两个冲之间的距离最近，将颗粒压缩成片；③推片：上冲和下冲抬起，下冲将片剂抬到恰与模孔上缘相平，药片被刮粉器推开，如此反复进行。 Domestic and foreign research status of similar research work: Tablet presses currently on the market, such as: German KROSH high-speed tablet presses and domestic tablet presses, the main working parts are: machine table, pressing wheel, tablet weight regulator, pressure regulator, Hopper, powder feeder, vacuum cleaner, protection device, etc. The machine is divided into three layers. The upper layer of the machine is equipped with several upper punches, the corresponding position of the middle layer is equipped with die rings, and the corresponding position of the lower layer is equipped with lower punches. The upper punch and the lower punch are rotated by the random table respectively and move up and down regularly along the fixed track. When the upper punch and the lower punch are rotated by the random table and pass the upper and lower pressure rollers respectively, the upper punch moves downward and the lower punch moves upward. , and pressurize the material in the die hole; a powder scraper is installed on the fixed position of the middle layer of the machine, and the sheet weight regulator is installed at the position corresponding to the powder scraper on the lower punch track to adjust the lower punch to pass through the powder scraper The height at the time is used to adjust the volume of the die hole; the compression pressure is adjusted by the up and down movement position of the upper and lower pressure rollers. The tabletting process is as follows: ①Filling: When the lower punch is transferred under the powder feeder, its position is the lowest, and the particles are filled into the die hole; Scrape off the excess particles; ② Tablet pressing: When the upper punch and the lower punch go between the upper and lower pressing wheels, the distance between the two punches is the shortest, and the particles are compressed into tablets; ③ Pushing tablet: The upper punch and the lower punch The punch is lifted, the lower punch lifts the tablet to the level with the upper edge of the die hole, the tablet is pushed away by the powder scraper, and so on.
存在的问题：在压片之前，对整批药物颗粒进行混合；在对整批对整批药物颗粒压片的过程中，由于压片机的振动，采用全粉末直压压片时，药物颗粒容易解离或离析，导致批内产品含量差异大，甚至引起不合格。采用湿法制粒压片虽然可以解决以上问题，但增加了混合制软材-过筛-干燥-整粒等工序，使得片剂全粉末直压工艺无法推广。由于药物颗粒流动性差、片重差异大，颗粒压片容易造成裂片等缺点，目前主要通过价格相对昂贵的微晶纤维素、可压性淀粉、喷雾干燥乳糖、磷酸氢钙二水合物、微粉硅胶等辅料来改善，但是添加辅料会带来片剂的机械强度降低、药物体内崩解时间延长、有效成分变动系数增大等问题，同时也增加了制药企业成本。 Existing problems: before tableting, the whole batch of drug granules is mixed; in the process of tableting the whole batch of drug granules, due to the vibration of the tablet machine, when using full powder direct compression, the drug granules It is easy to dissociate or segregate, resulting in large differences in the content of products within a batch, and even causing unqualified. Although the above problems can be solved by wet granulation and tabletting, the process of mixing soft materials-screening-drying-granulation and other processes is added, which makes the full powder direct compression process of tablets unable to be promoted. Due to the poor fluidity of the drug granules, the large difference in tablet weight, and the granule tableting is easy to cause cracks and other shortcomings. At present, the relatively expensive microcrystalline cellulose, compressible starch, spray-dried lactose, calcium hydrogen phosphate dihydrate, and micropowder silica gel are mainly used. However, the addition of excipients will reduce the mechanical strength of the tablet, prolong the disintegration time of the drug in the body, and increase the coefficient of variation of the active ingredient, which will also increase the cost of pharmaceutical companies.
发明内容 Contents of the invention
本发明创造的要解决的技术问题是如何高效实现对药物颗粒的混合和压片，制成含量均匀的药物成品。 The technical problem to be solved by the present invention is how to efficiently realize the mixing and tableting of drug granules to make finished drug products with uniform content.
为此给出药物颗粒混合给料压片一体机，包括压片机，其特征是，有混合机输出到所述压片机，有上料机为混合机分批上料，混合机分批混合，在混合机与压片机之间接有在每批混合完成后进行送料的送料机构，压片机分批压片。 For this reason, a drug granule mixing and feeding tablet press machine is provided, including a tablet press, which is characterized in that a mixer is output to the tablet press, and a feeder is provided to feed the mixer in batches, and the mixer is fed in batches. Mixing, a feeding mechanism for feeding after each batch of mixing is connected between the mixer and the tablet machine, and the tablet machine compresses tablets in batches.
药物颗粒混合给料压片一体机自动对药物颗粒分批，按时间先后对各批药物颗粒进行一体加工，对每批药物颗粒的一体加工包括依次进行的上料、混合和压片操作。由于每次压片量小于对整批进行压片，药物颗粒在压片时就不容易解离或离析，使得药物成品含量均匀。药物颗粒混合给料压片一体机自动完成混合和压片的加工过程，且无需增加湿法制粒工序，故提高了生产效率。 The drug granule mixing, feeding and tablet pressing machine automatically batches the drug granules, and processes each batch of drug granules sequentially in time. The integrated processing of each batch of drug granules includes sequential feeding, mixing and tableting operations. Since the amount of tableting each time is less than that of the whole batch, the drug particles are not easy to dissociate or segregate during tableting, so that the content of the finished drug is uniform. The drug granule mixing, feeding and tableting machine automatically completes the processing process of mixing and tableting, and does not need to increase the wet granulation process, so the production efficiency is improved.
附图说明 Description of drawings
图1是药物颗粒混合给料压片一体机的结构示意图。 Fig. 1 is a schematic structural view of an all-in-one machine for mixing, feeding and tableting medicine particles.
具体实施方式 detailed description
药物颗粒混合给料压片一体机如图1，上料机1为混合机2分批上料，混合机2分批混合。送料机构5接在混合机2与压片机3之间，在每批混合完成后打开其中的阀门进行送料，让药物颗粒从混合机2输出到压片机3，压片机3分批压片。本实施例中，混合机2位于压片机3上方，药物颗粒依靠重力自动落到压片机3。药物颗粒混合给料压片一体机中各个部分的联动由控制单元6统一控制。药物颗粒混合给料压片一体机可有以下两种工作模式。 The all-in-one machine for mixing, feeding and tableting of drug granules is shown in Figure 1. Feeding machine 1 feeds materials in batches to mixer 2, and mixer 2 mixes in batches. The feeding mechanism 5 is connected between the mixer 2 and the tablet press 3. After each batch of mixing is completed, the valve therein is opened for feeding, so that the drug granules are output from the mixer 2 to the tablet press 3, and the tablet press 3 is pressed in batches. piece. In this embodiment, the mixer 2 is located above the tablet press 3, and the drug particles automatically fall to the tablet press 3 by gravity. The linkage of each part in the drug particle mixing, feeding and tablet pressing machine is uniformly controlled by the control unit 6 . The drug granule mixing feeding tablet machine can have the following two working modes.
第一种工作模式是上料机1从料桶4中抽取一些药物颗粒作为第一批，上料到混合机2中，混合机2混合第一批药物颗粒，第一批混合完成后输出到压片机3进行压片，压片机3完成对一批的压片则触发上料机1对第二批的上料，然后混合机2对第二批进行混合，第二批混合完成后输出到压片机3进行压片，压片机3完成对二批的压片则触发上料机1对第三批的上料，依此类推，其特点是压片机3完成对一批的压片则触发上料机1对下一批的上料，各批次加工在时间上不会重叠，其中一批中途出错不会影响其它批次。 The first working mode is that the feeding machine 1 extracts some drug granules from the material barrel 4 as the first batch, and feeds them into the mixer 2. The mixer 2 mixes the first batch of drug granules, and outputs the first batch to the The tablet press 3 performs tablet compression, and the tablet press 3 completes the tablet pressing of a batch, which triggers the loading of the second batch by the feeder 1, and then the mixer 2 mixes the second batch, and after the second batch of mixing is completed Output to tablet press 3 for tablet pressing, tablet press 3 completes the second batch of tablet pressing, then triggers feeder 1 to load the third batch, and so on. The characteristic is that tablet press 3 completes the first batch The tablet pressing will trigger the feeding machine 1 to load the next batch. The processing of each batch will not overlap in time, and an error in one batch will not affect other batches.
第二种工作模式是上料机1从料桶4中抽取一些药物颗粒作为第一批，上料到混合机2中，混合机2混合第一批药物颗粒，第一批混合完成后输出到压片机3进行压片，与第一种工作模式的区别是，对第二批的上料和混合无需等到压片机3完成对一批的压片再触发，而是压片机3对一批进行压片的同时混合机2已经对第二批进行混合。压片机3完成对第一批的压片，如果此时第二批药物颗粒已经在混合机2中混合完成，就可以输出到压片机3，压片机3随即开始对第二批进行压片，混合机2则开始对第三批进行混合(或者第三批已经混合完成并放在送料机构5中暂存，混合机2开始或正在对第四批进行混合)，依此类推，压片机3对一批进行压片的同时混合机2对随后批次进行混合，生产效率更高。 The second working mode is that the feeder 1 extracts some drug granules from the material barrel 4 as the first batch, and feeds them into the mixer 2. The mixer 2 mixes the first batch of drug granules, and outputs the first batch of mixed granules to the Tablet press 3 performs tablet compression. The difference from the first working mode is that there is no need to wait for tablet press 3 to finish pressing a batch of tablets before triggering the second batch of feeding and mixing. Instead, tablet press 3 While one batch is tableting, mixer 2 is already blending the second batch. Tablet press 3 completes the compression of the first batch. If the second batch of drug granules has been mixed in the mixer 2, it can be output to the tablet press 3, and the tablet press 3 starts to process the second batch immediately. Tablet pressing, mixer 2 then begins to mix the third batch (or the third batch has been mixed and placed in the feeding mechanism 5 for temporary storage, and mixer 2 starts or is mixing the fourth batch), and so on, The tablet press 3 compresses one batch while the mixer 2 mixes the subsequent batches, so the production efficiency is higher.
混合完成与否可以由混合均匀度检测装置20和定时器来判断。混合均匀度检测装置20装在混合机2上，当其检测到一批药物颗粒混合已经足够均匀时，混合机2就停止混合，准备把这批药物颗粒输出到压片机3。定时器设在控制单元6中，操作人员根据一批药物颗粒的份量合理地设置定时时间，混合机2进行混合达到设定时间就停止混合，准备把这批药物颗粒输出到压片机3。 Whether the mixing is completed can be judged by the mixing uniformity detection device 20 and the timer. The mixing uniformity detection device 20 is installed on the mixer 2. When it detects that a batch of drug granules has been mixed uniformly, the mixer 2 stops mixing and is ready to output the batch of drug granules to the tablet press 3. The timer is set in the control unit 6, and the operator reasonably sets the timing time according to the amount of a batch of drug granules, and the mixer 2 stops mixing when the set time is reached, and prepares to output the batch of drug granules to the tablet machine 3.
在混合机2、压片机3上共设置三个传感器7、8、9，其在所发出的信号被药物颗粒遮挡时亮，其用于在系统工作过程中实时监测药物颗粒料位的变化，具体地：在混合机2上设有用于感应上料情况的上料位传感器7，上料完毕则混合机2可以开始混合；在混合机2上设有用于感应出料情况的出料位传感器8，出料完毕则混合机2可以接受下一批上料；在压片机3的输入口处设有用于感应送料情况的送料位传感器9，送料完毕则压片机3可以开始压片。 A total of three sensors 7, 8, and 9 are set on the mixer 2 and the tablet press 3, which light up when the signal sent out is blocked by the drug particles, and are used to monitor the change of the drug particle level in real time during the working process of the system , specifically: the mixer 2 is provided with a feed level sensor 7 for sensing the feeding situation, and the mixer 2 can start mixing after feeding is completed; the mixer 2 is provided with a discharge position for sensing the discharge situation Sensor 8, when the material is discharged, the mixer 2 can accept the next batch of materials; the input port of the tablet machine 3 is provided with a feeding level sensor 9 for sensing the feeding situation, and the tablet machine 3 can start tableting after the feeding is completed .
在上料机1、混合机2和压片机3上各设有工作指示灯(图中未示出)，三个传感器7、8、9分别接有工作指示灯70、80、90，这些指示灯用于指示各联动设备的工作情况和上料、混合、压片过程药物颗粒流动情况，一旦设备出现故障，各指示灯的开关情况能够为快速分析故障提供帮助。 On feeder 1, mixer 2 and tablet press 3, respectively be provided with work indicator light (not shown in the figure), three sensors 7,8,9 are connected with work indicator light 70,80,90 respectively, these The indicator lights are used to indicate the working conditions of each linkage equipment and the flow of drug particles during feeding, mixing, and tablet compression. Once the equipment fails, the switching status of each indicator light can provide help for quick analysis of the failure.
Claims (6)
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310107205.5A CN103317747B (en) | 2013-03-29 | 2013-03-29 | Drug particles mixing feed compressing tablet all-in-one |
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|---|---|---|---|
| CN201310107205.5A CN103317747B (en) | 2013-03-29 | 2013-03-29 | Drug particles mixing feed compressing tablet all-in-one |
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| Publication Number | Publication Date |
|---|---|
| CN103317747A CN103317747A (en) | 2013-09-25 |
| CN103317747B true CN103317747B (en) | 2016-02-10 |
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| CN201310107205.5A Expired - Fee Related CN103317747B (en) | 2013-03-29 | 2013-03-29 | Drug particles mixing feed compressing tablet all-in-one |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3238930A1 (en) * | 2016-03-29 | 2017-11-01 | Fette Compacting GmbH | Rotary tabletting press and method for establishing and/or operating a rotary tablet press |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109483940A (en) * | 2018-11-29 | 2019-03-19 | 北京新龙立科技有限公司 | Blanking buffer device |
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| US5762978A (en) * | 1994-08-05 | 1998-06-09 | I.M.A. Industria Macchine Automatiche S.P.A. | Batching device for tablets making compression machine |
| CN201172289Y (en) * | 2007-12-26 | 2008-12-31 | 上海天和制药机械有限公司 | Transition connecting device |
| CN202106563U (en) * | 2011-06-22 | 2012-01-11 | 成都天银制药有限公司 | Tablet press with material mixing device |
| CN202378312U (en) * | 2011-12-31 | 2012-08-15 | 浙江亚太药业股份有限公司 | Dry granulating and tabletting device of amoxicillin potassium clavulanate dispersible tablet |
| CN203557740U (en) * | 2013-03-29 | 2014-04-23 | 广东医学院 | Drug particle mixing and feeding tabletting all-in-one machine |
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2013
- 2013-03-29 CN CN201310107205.5A patent/CN103317747B/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5762978A (en) * | 1994-08-05 | 1998-06-09 | I.M.A. Industria Macchine Automatiche S.P.A. | Batching device for tablets making compression machine |
| CN201172289Y (en) * | 2007-12-26 | 2008-12-31 | 上海天和制药机械有限公司 | Transition connecting device |
| CN202106563U (en) * | 2011-06-22 | 2012-01-11 | 成都天银制药有限公司 | Tablet press with material mixing device |
| CN202378312U (en) * | 2011-12-31 | 2012-08-15 | 浙江亚太药业股份有限公司 | Dry granulating and tabletting device of amoxicillin potassium clavulanate dispersible tablet |
| CN203557740U (en) * | 2013-03-29 | 2014-04-23 | 广东医学院 | Drug particle mixing and feeding tabletting all-in-one machine |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3238930A1 (en) * | 2016-03-29 | 2017-11-01 | Fette Compacting GmbH | Rotary tabletting press and method for establishing and/or operating a rotary tablet press |
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| CN103317747A (en) | 2013-09-25 |
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