CN102743345B - Small size tranexamic acid freeze-dried powder, its preparation method and process units thereof - Google Patents
Small size tranexamic acid freeze-dried powder, its preparation method and process units thereof Download PDFInfo
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- CN102743345B CN102743345B CN201210211176.2A CN201210211176A CN102743345B CN 102743345 B CN102743345 B CN 102743345B CN 201210211176 A CN201210211176 A CN 201210211176A CN 102743345 B CN102743345 B CN 102743345B
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Abstract
The invention belongs to freeze-dried powder preparing technical field, relate to a kind of small size tranexamic acid freeze-dried powder, its preparation method and process units thereof.Described small size tranexamic acid freeze-dried powder, tranexamic acid lyophilized powder is contained in 7ml control cillin bottle, tranexamic acid content in tranexamic acid freeze-dried powder is 0.1g or 0.2g, its preparation process is as follows: tranexamic acid and the adjuvant of getting recipe quantity, add water for injection to be down to 28 DEG C ~ 30 DEG C and to make concentrated wiring liquid, add active carbon to stir, filter rear also fine straining with the decarburization of titanium rod; By the water for injection of residue amount of preparation, water temperature 28 DEG C ~ 30 DEG C, adds in Agitation Tank, filters rear also fine straining by titanium rod; Gained filtrate is mixed and made into rare dosing, is incubated 28 DEG C ~ 30 DEG C, fill is in 7ml control cillin bottle, and lyophilizing, tamponade, to roll lid obtained.Present invention decreases the packaging volume of tranexamic acid freeze-dried powder, thus effectively increase output, reduce energy consumption, while reducing packaging, cost of transportation, greatly reduce lyophilizing evaporation energy consumption.
Description
Technical field
The invention belongs to freeze-dried powder preparing technical field, relate to a kind of small size tranexamic acid freeze-dried powder, its preparation method and process units thereof.
Background technology
0.25g tranexamic acid freeze-dried powder commercially available at present and 0.5g tranexamic acid freeze-dried powder, 10ml is all used to be molded cillin bottle fill, thus it is large to there is inner container volume, thus the volume in freeze drying box shared by every bottle is just large, cause the shortcoming that every series-produced product yield is low, because the water solublity of tranexamic acid itself is bad, thus need by a large amount of solvents just solubilized in preparation process, to make tranexamic acid freeze-dried powder.Original preparing process does not have temperature to control, in dense timing temperature generally at 20 DEG C ~ 25 DEG C, therefore the 50 times of water adding principal agent are needed just can be dissolved, thus increase fill amount, in order to ensure the rate of sublimation of moisture in freeze-drying process, use 10ml to be molded cillin bottle fill, cause that the output often criticized reduces, the moisture multipotency consumption of lyophilizing increases, packaging and cost of transportation increase.
Summary of the invention
The object of this invention is to provide a kind of small size tranexamic acid freeze-dried powder, its preparation method and process units thereof, the method makes the volume-diminished of tranexamic acid freeze-dried powder, output rising, energy consumption reduce, and decreases packaging and cost of transportation.
Small size tranexamic acid freeze-dried powder of the present invention, be contained in by tranexamic acid lyophilized powder in 7ml control cillin bottle, the tranexamic acid content in tranexamic acid freeze-dried powder is 0.25g or 0.5g.
Described 0.25g small size tranexamic acid freeze-dried powder, its washmarking position with lower volume for 2.1 ~ 2.3ml.
Described 0.5g small size tranexamic acid freeze-dried powder, its washmarking position with lower volume for 4 ~ 4.2ml.
The preparation method of described small size tranexamic acid freeze-dried powder, is characterized in that comprising the steps:
(1) get tranexamic acid and the adjuvant of recipe quantity, add water for injection and be down to 25 DEG C ~ 30 DEG C and make concentrated wiring liquid, be fully stirred to dissolve, add active carbon and stir, filter with the decarburization of titanium rod, fine straining;
(2) by the water for injection of residue amount of preparation, water temperature 25 DEG C ~ 30 DEG C, adds in Agitation Tank, after being filtered by titanium rod, and fine straining;
(3) step (2) gained filtrate and step (1) gained filtrate are mixed and made into rare dosing, are incubated 25 DEG C ~ 30 DEG C, fill is in 7ml control cillin bottle, and lyophilizing, tamponade, to roll lid obtained.
The device of the small size tranexamic acid freeze-dried powder described in manufacture, the insulation dispensing canister connected by utilidor successively, the second Grandfos pump, titanium rod filter, the second degerming filter element, aseptic insulation liquid storage tank, the first Grandfos pump, the first degerming filter element, filling machine and freeze dryer form.
Research process:
One, for the character of tranexamic acid dissolubility in water, select the water for injection of three kinds of different temperatures to dissolve, dissolve the injection water yield needed for 2.5g tranexamic acid at different temperatures in table 1; After abundant stirring and dissolving, investigate the impact of its solution temperature on tranexamic acid and adjuvant mixed solution stability, represent with tranexamic acid content, the results are shown in Table 2.
Table 1 solution temperature and water for injection volume synopsis
| Solution temperature DEG C | Water for injection |
| 45℃ | 12ml |
| 35℃ | 16ml |
| 25℃ | 22ml |
On the impact of principal agent tranexamic acid stability under table 2 different temperatures
As can be seen from Table 2, tranexamic acid is 12 hours intensive amount stability in the aqueous solution of different temperatures, the water for injection of 45 DEG C does not affect the stability of tranexamic acid as can be seen here, therefore adopts the water for injection of 25 DEG C ~ 30 DEG C can not affect the stability of principal agent tranexamic acid.
Two, for the character of tranexamic acid dissolubility in water, select the water for injection of three kinds of different temperatures to dissolve, dissolve the injection water yield needed for 5g tranexamic acid at different temperatures in table 3.After abundant stirring and dissolving, investigate the impact of its solution temperature on tranexamic acid and adjuvant mixed solution stability; The results are shown in Table 4.
Table 3 solution temperature and water for injection volume synopsis
| Solution temperature DEG C | Water for injection |
| 45℃ | 22ml |
| 35℃ | 32ml |
| 25℃ | 36ml |
On the impact of principal agent tranexamic acid stability under table 4 different temperatures
As can be seen from Table 4, tranexamic acid is 12 hours intensive amount stability in the aqueous solution of different temperatures, the water for injection of 45 DEG C does not affect the stability of tranexamic acid as can be seen here, therefore adopts the water for injection of 25 DEG C ~ 30 DEG C can not affect the stability of principal agent tranexamic acid.
Compared with prior art, the invention has the beneficial effects as follows:
Present invention decreases the packaging volume of tranexamic acid freeze-dried powder, thus effectively increase output, reduce energy consumption, while reducing packaging, cost of transportation, greatly reduce lyophilizing evaporation energy consumption.
Accompanying drawing explanation
Fig. 1 is apparatus structure schematic diagram of the present invention;
Wherein: 1, be incubated dispensing canister; 2, titanium rod filter; 3, aseptic insulation liquid storage tank; 4, freeze dryer; 5, filling machine; 6, the first Grandfos pump; 7, the first degerming filter element; 8, the second degerming filter element; 9, the second Grandfos pump; 10, utilidor.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described further.
Embodiment 1
The preparation method of 0.25g small size tranexamic acid freeze-dried powder:
Formula is as follows, makes 1000:
Tranexamic acid 250g
PEG400 40g
Water for injection 2150ml
Add water for injection and be cooled to 27 ± 1 DEG C, then add tranexamic acid, feed temperature remains between 27 ± 1 DEG C.Feed liquid molten clear after, the PEG400 taking recipe quantity adds, and is stirred to dissolving, and it is that 7.0 ± 0.5(requires to control between 6.0 ~ 7.5 that sampling detects material liquid pH value), add 0.1%(W/V) activated carbon decolorizing 30 minutes.
Open the second Grandfos pump titanium rod filter decarburization to filter, feed liquid is degerming by the second degerming filter element, and be transported in aseptic insulation liquid storage tank and store.Aseptic filtration is complete, is added by the water for injection of surplus in insulation dispensing canister, degerming by the second degerming filter element again after titanium rod filter, and is transported in aseptic insulation liquid storage tank.Open aseptic insulation liquid storage tank feed liquid circulating pump, feed liquid, through the first Grandfos pump, the first degerming filter element, by filling machine fill, by the fill of 2.1ml/ bottle in 7ml control cillin bottle, then by freeze dryer lyophilizing, through tamponade, rolls lid, and packaging is obtained.
Fall near 0 DEG C of product temperature degree, maintain 1 hour, then shelf is cooled to-17 DEG C, goods are-16 DEG C, maintain 0.5 hour, then fall goods with the speed of 1/0.5 hour, when goods all freeze in fact, products temperature is down to-35 DEG C, then maintains 1 hour, setting refrigerant temperature is 5 DEG C, first falls vacuum to 10Pa, and then rises vacuum to 20-25Pa, before goods distillation, temperature must not higher than-7 DEG C, maintain after 16 ± 2 hours, finally setting refrigerant temperature is 15 DEG C, maintains 5 ± 1 hours.After open the gas source switch input filtrated air of casing after drying, by " freeze dryer standard operating procedure " tamponade.
The device of the small size tranexamic acid freeze-dried powder described in manufacture, the degerming filter element 7 of the first Grandfos pump 6, first of the second Grandfos pump 9 of the insulation dispensing canister 1 connected by utilidor 10 successively, conveying feed liquid, titanium rod filter 2, second degerming filter element 8, aseptic insulation liquid storage tank 3, conveying feed liquid, filling machine 5 and freeze dryer 4 form.The model of described insulation dispensing canister 1: F-1000L; Volume: 1000 liters.
Embodiment 2
The preparation method of 0.5g small size tranexamic acid freeze-dried powder:
Formula is as follows, makes 1000:
Tranexamic acid 500g
PEG400 80g
Water for injection 3600ml
Add water for injection and be cooled to 25 DEG C ~ 30 DEG C, then add tranexamic acid, feed temperature remains between 25 DEG C ~ 30 DEG C.Feed liquid molten clear after, the PEG400 taking recipe quantity adds, and is stirred to dissolving, and it is that 7.0 ± 0.5(requires to control between 6.0 ~ 7.5 that sampling detects material liquid pH value), add 0.1%(W/V) activated carbon decolorizing 30 minutes.
Open the second Grandfos pump titanium rod filter decarburization to filter, feed liquid is degerming by the second degerming filter element, and be transported in aseptic insulation liquid storage tank and store.Aseptic filtration is complete, is added by the water for injection of surplus in insulation dispensing canister, degerming by the second degerming filter element again after titanium rod filter, and is transported in aseptic insulation liquid storage tank.Open aseptic insulation liquid storage tank feed liquid circulating pump, feed liquid, through the first Grandfos pump, the first degerming filter element, by filling machine fill, by the fill of 4.1ml/ bottle in 7ml control cillin bottle, then by freeze dryer lyophilizing, through tamponade, rolls lid, and packaging is obtained.
The device of the 0.5g small size tranexamic acid freeze-dried powder described in manufacture, freeze-dry process and insulation dispensing canister model are as embodiment 1.
Claims (1)
1. a preparation method for small size tranexamic acid freeze-dried powder, is characterized in that:
Formula is as follows, makes 1000:
Tranexamic acid 250g
PEG400 40g
Water for injection 2150ml;
Preparation process is as follows:
Add water for injection and be cooled to 27 ± 1 DEG C, then add tranexamic acid, feed temperature remains between 27 ± 1 DEG C; Feed liquid molten clear after, the PEG400 taking recipe quantity adds, and is stirred to dissolving, and it is 7.0 ± 0.5 that sampling detects material liquid pH value, adds 0.1%(W/V) activated carbon decolorizing 30 minutes;
Open the second Grandfos pump titanium rod filter decarburization to filter, feed liquid is degerming by the second degerming filter element, and be transported in aseptic insulation liquid storage tank and store; Aseptic filtration is complete, is added by the water for injection of surplus in insulation dispensing canister, degerming by the second degerming filter element again after titanium rod filter, and is transported in aseptic insulation liquid storage tank; Open aseptic insulation liquid storage tank feed liquid circulating pump, feed liquid, through the first Grandfos pump, the first degerming filter element, by filling machine fill, by the fill of 2.1ml/ bottle in 7ml control cillin bottle, then by freeze dryer lyophilizing, through tamponade, rolls lid, and packaging is obtained;
Wherein, freeze-drying process is: products temperature is down to 0 DEG C, maintain 1 hour, then shelf is cooled to-17 DEG C, goods are-16 DEG C, maintain 0.5 hour, then lower the temperature to goods with the speed reducing by 1 DEG C per half an hour, when goods all freeze in fact, products temperature is down to-35 DEG C, then maintains 1 hour, setting refrigerant temperature is 5 DEG C, vacuum is first fallen to 10Pa, and then rising vacuum to 20-25Pa, before goods distillation, temperature higher than-7 DEG C, must not maintain after 16 ± 2 hours, finally setting refrigerant temperature is 15 DEG C, maintains 5 ± 1 hours; After open the gas source switch input filtrated air of casing after drying, by " freeze dryer standard operating procedure " tamponade;
The device wherein manufacturing described small size tranexamic acid freeze-dried powder is, the second Grandfos pump (9) of the insulation dispensing canister (1) connected by utilidor (10) successively, conveying feed liquid, titanium rod filter (2), the second degerming filter element (8), aseptic insulation liquid storage tank (3), conveying the first Grandfos pump (6) of feed liquid, the first degerming filter element (7), filling machine (5) and freeze dryer (4) form; The model of described insulation dispensing canister (1): F-1000L; Volume: 1000 liters.
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| CN104510709A (en) * | 2013-09-30 | 2015-04-15 | 瑞阳制药有限公司 | Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof |
| CN104510711A (en) * | 2013-09-30 | 2015-04-15 | 瑞阳制药有限公司 | Small-volume asarin freeze-dried powder injection, preparation method and producing apparatus thereof |
| CN104510710A (en) * | 2013-09-30 | 2015-04-15 | 瑞阳制药有限公司 | Small-volume pefloxacin mesylate freeze-dried powder injection, preparation method and producing device thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0803255A1 (en) * | 1994-06-03 | 1997-10-29 | TSUMURA & CO. | Medicinal composition |
| CN1390539A (en) * | 2002-07-25 | 2003-01-15 | 于航 | Freeze-dried tranexamine powder injection and its preparing prcess |
| CN101199477A (en) * | 2007-12-21 | 2008-06-18 | 北京佳诚医药有限公司 | Ratification of highly purified tranexamic acid injection and quality standard thereof |
| CN101953803A (en) * | 2010-09-02 | 2011-01-26 | 天津市铭泰医药科技有限公司 | Preparation method of small-volume doxofylline freeze-dried powder injection as well as product and device thereof |
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- 2012-06-25 CN CN201210211176.2A patent/CN102743345B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0803255A1 (en) * | 1994-06-03 | 1997-10-29 | TSUMURA & CO. | Medicinal composition |
| CN1390539A (en) * | 2002-07-25 | 2003-01-15 | 于航 | Freeze-dried tranexamine powder injection and its preparing prcess |
| CN101199477A (en) * | 2007-12-21 | 2008-06-18 | 北京佳诚医药有限公司 | Ratification of highly purified tranexamic acid injection and quality standard thereof |
| CN101953803A (en) * | 2010-09-02 | 2011-01-26 | 天津市铭泰医药科技有限公司 | Preparation method of small-volume doxofylline freeze-dried powder injection as well as product and device thereof |
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Address after: 256100 No. 6 Erlang Road, Yiyuan County, Zibo, Shandong Patentee after: Ruiyang Pharmaceutical Co., Ltd Address before: 256100 No. 6 Erlang Road, Yiyuan County, Zibo, Shandong Patentee before: REYOUNG PHARMACEUTICAL Co.,Ltd. |
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