CN104510709A - Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof - Google Patents
Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof Download PDFInfo
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- CN104510709A CN104510709A CN201310461213.XA CN201310461213A CN104510709A CN 104510709 A CN104510709 A CN 104510709A CN 201310461213 A CN201310461213 A CN 201310461213A CN 104510709 A CN104510709 A CN 104510709A
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Abstract
The invention discloses a small-volume propyl gallate freeze-dried powder injection, a preparation method and a producing apparatus thereof. A 7ml tube-made penicillin bottle is filled with the small-volume propyl gallate freeze-dried powder injection, wherein a volume below a water mark position is 2.0ml. Compared with the prior art, the invention is advantaged in that the preparation method and the producing apparatus can improve product quality, can effectively increase a production yield and reduce energy consumption, can reduce a package volume, thereby reducing costs in packaging and transportation, can reduce a filling amount which is only 2.0ml, can greatly reduce a freeze-drying evaporation energy consumption and further can reduce a cost.
Description
Technical field
The present invention relates to a kind of freeze-dried powder and preparation method thereof and process units field, particularly relate to small size PG freeze-dried powder and preparation method thereof and process units.
Background technology
PG (specification: 60mg) freeze-dried powder commercially available at present uses the fill of 10ml control cillin bottle, thus it is large to there is inner container volume, cause the shortcoming that every series-produced product yield is low, because the water solublity of PG itself is bad, thus need by a large amount of solvents just solubilized in preparation process, to make PG freeze-dried powder.Original preparing process does not use ultrasound wave hydrotropy, strengthen at the consumption of dense timing solvent, and add the water yield also comparatively large (700 times of water for principal agent) cause PG to be separated out, thus increase that fill amount causes that the dissolubility of product is undesirable, output 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 PG freeze-dried powder and simple, the easy-operating preparation method of technique thereof and process units.
Described small size PG freeze-dried powder is contained in 7ml control cillin bottle, and its washmarking position take lower volume as 2.0ml.
The preparation method of described small size PG freeze-dried powder, comprises the following steps:
(1) add in solvent at 20 DEG C ~ 25 DEG C by PG, stirring, ultrasonic wave concussion, make concentrated wiring liquid, be fully stirred to dissolve, obtain B liquid;
(2) at 20 DEG C ~ 25 DEG C, excipient is dissolved in water for injection, obtains A liquid;
(3) B liquid is added in A liquid, regulate pH=3.0 ~ 5.0, add active carbon, stirring and adsorbing, filter with the decarburization of titanium rod, fine straining;
(4) join in the solution that step (3) obtains at 20 DEG C ~ 25 DEG C waters for injection by residue amount of preparation, make rare dosing, be incubated 20 DEG C ~ 25 DEG C, fill is in 7ml control cillin bottle, and lyophilizing, tamponade, rolls lid and get final product.
Described concentrated wiring liquid contains the PG of 0.24 ~ 0.29g/mL;
Described excipient preferred mass ratio is mannitol and the disodium edetate composition of 1000: 1 ~ 10;
Described rare dosing concentration contains the PG of 0.041 ~ 0.052g/mL;
Excipient in step (2) and water for injection routinely ratio mix;
PH is regulated to adopt conventional pH regulators in step (3).
The process units of described small size PG freeze-dried powder, the insulation dispensing canister connected by utilidor successively, the second Grandfos pump, pump 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.
Compared with prior art, the present invention has following beneficial effect:
Improve product quality, effectively increase output and reduce energy consumption, reduce packaging volume, thus reduce packaging, cost of transportation; Reduce fill amount and be only 2.0ml, greatly reduce lyophilizing evaporation energy consumption, reduce further cost.
Accompanying drawing explanation
Fig. 1 is production line structural representation of the present invention.
In figure: 1, be incubated Agitation Tank; 2, titanium rod filter; 3, sterile 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
For the character of PG dissolubility in water, PEG400, disodium edetate, the mannitol of screening different amounts, water for injection is ultrasonic and not ultrasonic contrasts, and the results are shown in Table 1; And investigate solvent load change after, the ultrasonic impact on PG and mixed with excipients stability of solution, the results are shown in Table 2.
Under not commensurability solvent, PG 60g and excipient is dissolved under the condition that table 1 is ultrasonic and not ultrasonic
Impact on principal agent PG level stability under same solvent different amounts after table 2 fully dissolves
(PG content, undue toxicity)
As can be seen from Table 2, the 2# prescription stability that PG dissolves by experiment investigation is ultrasonic in the solvent of same solvent different amounts is best, so we select this prescription to be final prescription, PG 60g, PEG400 240g, mannitol 300g, disodium edetate 0.90g, water for injection 900ml.
Get PG and the PEG400 of recipe quantity, add in container to open and stir, ultrasonic wave concussion, temperature controls to make concentrated wiring liquid at 23 ± 3 DEG C, is fully stirred to dissolve (for B liquid); Meanwhile taking water for injection adds in preparing tank, takes disodium edetate, mannitol adds, and temperature controls at 23 ± 3 DEG C, to all dissolving (for A liquid);
Slowly poured in A liquid by B liquid, add hydrochloric acid, the control pH that stirs is 4 ± 1.Add 0.1%(W/V) activated carbon decolorizing 30 minutes.
Open the decarburization of the second Grandfos pump 9 titanium rod filter 2 to filter, feed liquid is degerming by the second degerming filter element 8, be transported in sterile liquid basin 3 and store.Aseptic filtration is complete, is added by remaining water in insulation dispensing canister 1, is transported to after titanium rod filter 2 degerming by the second degerming filter element 8 again through utilidor 10, be transported to sterile liquid basin 3, unlatching sterile liquid is store, 3 feed liquid circulating pumps, and feed liquid is through the degerming filter element 7 of the first Grandfos pump 6, first, by filling machine 5 fill, by the fill of 2ml/ bottle in 7ml control cillin bottle, lyophilizing, tamponade, roll lid, packaging.
Fall all near-40 DEG C of products temperature ,-40 DEG C, goods maintain 2 hours, after condensation tube temperature is down to-45 DEG C, set refrigerant temperature as-10 DEG C, maintain 20 hours.Rise 40 DEG C, medium again, maintain 6 hours, open the gas source switch input filtrated air of casing after final drying, by " freeze dryer standard operating procedure " tamponade.
Adopt the small size PG freeze-dried powder product that the method is obtained, described small size PG lyophilizing is contained in 7ml control cillin bottle.Can reach washmarking position take lower volume as 2.0ml.
Claims (6)
1. a small size PG freeze-dried powder, its feature is: described small size PG freeze-dried powder is contained in 7ml control cillin bottle, and its washmarking position take lower volume as 2.0ml.
2. a preparation method for small size PG freeze-dried powder according to claim 1, is characterized in that, comprise the following steps:
(1) add in solvent at 20 DEG C ~ 25 DEG C by PG, stirring, ultrasonic wave concussion, make concentrated wiring liquid, be fully stirred to dissolve, obtain B liquid;
(2) at 20 DEG C ~ 25 DEG C, excipient is dissolved in water for injection, obtains A liquid;
(3) B liquid is added in A liquid, regulate PH=3.0 ~ 5.0, add active carbon, stirring and adsorbing, filter with the decarburization of titanium rod, fine straining;
(4) to be added water by the solution that step (3) obtains at 20 DEG C ~ 25 DEG C and make rare dosing, insulation, fill is in 7ml control cillin bottle, and lyophilizing, tamponade, rolls lid and get final product.
3. the preparation method of small size PG freeze-dried powder according to claim 2, is characterized in that, described concentrated wiring liquid contains the PG of 0.24 ~ 0.29g/mL.
4. the preparation method of small size PG freeze-dried powder according to claim 2, is characterized in that, described excipient by mass ratio be 1000: 1 ~ 10 mannitol and disodium edetate form.
5. the preparation method of small size PG freeze-dried powder according to claim 2, is characterized in that, described rare dosing concentration contains the PG of 0.041 ~ 0.052g/mL.
6. the process units according to the arbitrary described small size PG freeze-dried powder of claim 1, it is characterized in that, the insulation dispensing canister connected by utilidor successively, the second Grandfos pump, pump 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310461213.XA CN104510709A (en) | 2013-09-30 | 2013-09-30 | Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310461213.XA CN104510709A (en) | 2013-09-30 | 2013-09-30 | Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof |
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| CN104510709A true CN104510709A (en) | 2015-04-15 |
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| CN201310461213.XA Pending CN104510709A (en) | 2013-09-30 | 2013-09-30 | Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110680807A (en) * | 2019-08-01 | 2020-01-14 | 广东健信制药股份有限公司 | Preparation method of propyl gallate for injection |
| CN113101275A (en) * | 2021-05-27 | 2021-07-13 | 海南通用康力制药有限公司 | Propyl gallate freeze-dried powder injection for injection and its preparation method |
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| CN1555790A (en) * | 2003-12-31 | 2004-12-22 | 王景成 | Propyl gallate injection liquid and its preparation method |
| CN1559395A (en) * | 2004-02-17 | 2005-01-05 | 福建省闽东力捷迅药业有限公司 | Freezing-drying compound contg. water-soluble gallopropylate and its prepn. method |
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| CN102743346A (en) * | 2012-06-25 | 2012-10-24 | 瑞阳制药有限公司 | Small-size fat-soluble vitamin freeze-dried powder injection and preparation method and preparation device thereof |
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| CN1596885A (en) * | 2003-09-18 | 2005-03-23 | 北京博尔达生物技术开发有限公司 | Propyl gallate freeze-dried powder-injection and its preparation method |
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| CN1559395A (en) * | 2004-02-17 | 2005-01-05 | 福建省闽东力捷迅药业有限公司 | Freezing-drying compound contg. water-soluble gallopropylate and its prepn. method |
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| CN102743345A (en) * | 2012-06-25 | 2012-10-24 | 瑞阳制药有限公司 | Small-size tranexamic acid freeze-dried powder injection, preparation method and production device thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110680807A (en) * | 2019-08-01 | 2020-01-14 | 广东健信制药股份有限公司 | Preparation method of propyl gallate for injection |
| CN110680807B (en) * | 2019-08-01 | 2021-07-13 | 广东健信制药股份有限公司 | Preparation method of propyl gallate for injection |
| CN113101275A (en) * | 2021-05-27 | 2021-07-13 | 海南通用康力制药有限公司 | Propyl gallate freeze-dried powder injection for injection and its preparation method |
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Application publication date: 20150415 |