CN106176594A - A kind of oxaliplatin formula mannitol injection liquid and preparation technology thereof - Google Patents
A kind of oxaliplatin formula mannitol injection liquid and preparation technology thereof Download PDFInfo
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- CN106176594A CN106176594A CN201610792339.9A CN201610792339A CN106176594A CN 106176594 A CN106176594 A CN 106176594A CN 201610792339 A CN201610792339 A CN 201610792339A CN 106176594 A CN106176594 A CN 106176594A
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- 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
- A61K9/08—Solutions
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- 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
- A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
The present invention relates to a kind of oxaliplatin formula mannitol injection liquid and preparation technology thereof.Preparation technology concretely comprises the following steps: add recipe quantity 30% water for injection and the mannitol of recipe quantity in dense preparing tank, add the needle-use activated carbon of moistening, after stirring is boiled, continue stirring to mannitol and all dissolve, after cooling in titanium rod filter decarbonization filtering to dilute preparing tank；Opening dense preparing tank water for injection valve and shower valve, rinse dense preparing tank with recipe quantity 20 40% water for injection by several times, flushing water all adds dilute preparing tank；Mend and inject water to the 95% of recipe quantity, after cooling, with pH value regulator regulation pH value to 5.0 6.0, add the oxaliplatin of recipe quantity, after stirring is all dissolved to raw material, add the needle-use activated carbon of moistening, benefit adds to the full amount of water for injection, and is circulated 30 40 minutes；Fill, sterilizing, packaging.Compared with prior art, oxaliplatin formula mannitol injection liquid stable in properties in the present invention, drug loading is high.
Description
Technical field
The invention belongs to field of medicine preparing technology, it particularly relates to a kind of oxaliplatin formula mannitol injection liquid and
Its preparation technology.
Background technology
Oxaliplatin belongs to new platinum kind anti-cancer drugs, wherein pt atom and 1,2 diamino hexamethylene (DACH) and an oxalic acid
Base junction is closed.Oxaliplatin is single enantiomorph.Cis-oxalic acid (anti-form-1-1-1,2-DACH) platinum.White or off-white color
Lyophilizing is loosened block, is usually used in metastatic colorectal carcinoma treatment, or auxiliary treatment primary tumor excise completely after three phases
(Dukes C) colon cancer.Oxaliplatin is combined with DNA rapidly, at most needs 15 minutes；And the combination of cisplatin and DNA is divided into two
Phase, including a delay phase after 4-8 hour.After people's vivo medicine-feeding one hour, by measuring in leukocyte
Adduct, can show that it exists.DNA synthesis in reproduction process, the synthesis of the separation of DNA, RNA and cell protein thereafter
The most suppressed.Some cell line to cisplatin resistance, oxaliplatin treatment is the most effective.Oxaliplatin aqueous solution to thermally labile,
Fluid temperature guarantee quality of liquid medicine must be controlled before finding during conventional production to add raw material, and oxaliplatin is in aqueous
Dissolubility own is the lowest, and under low temperature, oxaliplatin is often difficult to dissolve completely, causes oxaliplatin content on the low side.
Summary of the invention
For solve above-mentioned technical problem, the invention provides a kind of high drug load oxaliplatin formula mannitol injection liquid and
Preparation technology.
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described preparation technology concretely comprises the following steps:
1) in dense preparing tank, add recipe quantity 30% water for injection and the mannitol of recipe quantity, add the needle-use activated carbon of moistening,
After stirring is boiled, continue stirring to mannitol and all dissolve, after cooling in titanium rod filter decarbonization filtering to dilute preparing tank；Open
Dense preparing tank water for injection valve and shower valve, rinse dense preparing tank by several times with recipe quantity 20～40% water for injection, and flushing water is whole
Add dilute preparing tank；2) benefit injects water to the 95% of recipe quantity, after cooling, with pH value regulator regulation pH value to 5.0-6.0,
Add the oxaliplatin of recipe quantity, after stirring is all dissolved to raw material, add the needle-use activated carbon of moistening, add water for injection
To full dose, it is circulated 30-40 minute；3) fill, sterilizing, packaging.
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described step 1) in decarburization prodrug liquid temperature
Degree need to be down to 50-55 DEG C；
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described step 1) in activated carbon addition
0.05wt%-0.1wt% for water for injection recipe quantity.
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described step 2) in oxaliplatin raw material
Need through micronization processes before addition.
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described step 2) in activated carbon addition
0.01wt%-0.03wt% for water for injection recipe quantity.
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described step 2) in needle-use activated carbon
The Herba Leonuri being adsorbed with 3-5wt% folds olefin(e) acid ester A.
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described step 2) in water for injection cooling
During to 40-45 DEG C, then put into oxaliplatin.
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described step 2) in pH value regulator be
1mol/l sodium hydroxide solution.
A kind of oxaliplatin formula mannitol injection liquid preparation technology of the present invention, described preparation technology concretely comprises the following steps:
1) in dense preparing tank, add recipe quantity 30% water for injection and the mannitol of recipe quantity, add the 0.05wt%-of moistening
0.1wt% needle-use activated carbon, after stirring boils 20 minutes, continues stirring and all dissolves to mannitol for 10 minutes, be cooled to 50-55
After DEG C in titanium rod filter decarbonization filtering to dilute preparing tank；Open dense preparing tank water for injection valve and shower valve, with recipe quantity 20
～the injection moisture being cooled to 40-45 DEG C of 40% rinses dense preparing tank 3 times, flushing water all adds dilute preparing tank；2) note is added
Penetrate 95% with water to recipe quantity, when being cooled to 40-45 DEG C, with 1mol/l sodium hydroxide solution regulation pH value to 5.0-6.0, add
Enter the micronized oxaliplatin of recipe quantity, stir 30 minutes, after visual raw material all dissolves, add the 0.01wt%-of moistening
0.03wt% needle-use activated carbon, benefit adds to the full amount of water for injection, and is circulated 30-40 minute；3) fill, fill temperature controls
40-45 DEG C, 115 DEG C of sterilizings 30 minutes or 121 DEG C of sterilizings 10 minutes, quick spraying cooling, temperature is down to less than 40 DEG C and offers for sale,
Packaging after lamp inspection is qualified.
Oxaliplatin formula mannitol injection liquid of the present invention, the ultimate density of the oxaliplatin in described injection is
0.5mg/ml, mannitol ultimate density is 51mg/ml.
Compared with prior art, oxaliplatin formula mannitol injection liquid preparation technology of the present invention is simple, and equipment needed thereby is all
For conventional equipment, it is suitable for pharmaceutical factory and produces, and the oxaliplatin formula mannitol injection liquid stable in properties of gained, drug loading is high.
Detailed description of the invention
Below in conjunction with specific embodiment oxaliplatin formula mannitol injection liquid of the present invention and preparation technology thereof done into
One step explanation, but protection scope of the present invention is not limited to this.
Embodiment 1
Preparation: 1) in dense preparing tank, add 30L water for injection and 5.1kg mannitol, add the 0.05kg pin of moistening
With activated carbon, after stirring boils 20 minutes, continue stirring and within 10 minutes, all dissolve to mannitol, through titanium rod mistake after being cooled to 50 DEG C
Filter decarbonization filtering is in dilute preparing tank.Open dense preparing tank water for injection valve and shower valve, be cooled to the injection of 40 DEG C with 20L
Moisture rinses dense preparing tank 3 times, and flushing water all adds dilute preparing tank；2) benefit injects water to 95L, when being cooled to 40 DEG C, uses
1mol/l sodium hydroxide solution regulation pH value, to 5.4, adds the 50g oxaliplatin of micronization processes, stirs 30 minutes, the most former
After material dissolves, adding the 0.01kg needle-use activated carbon of moistening, benefit adds to the full amount of water for injection, and is circulated 40 minutes；3) fill
Dress, fill temperature controls at 40 DEG C, 115 DEG C of sterilizings 30 minutes, quick spraying cooling, and temperature is down to less than 40 DEG C and is offerd for sale, lamp inspection
Packaging after qualified.
Embodiment 2
Preparation: 1) in dense preparing tank, add 30L water for injection and 5.1kg mannitol, add the 0.05kg pin of moistening
With activated carbon, after stirring boils 20 minutes, continue stirring and within 10 minutes, all dissolve to mannitol, through titanium rod mistake after being cooled to 50 DEG C
Filter decarbonization filtering is in dilute preparing tank.Open dense preparing tank water for injection valve and shower valve, be cooled to the injection of 40 DEG C with 20L
Moisture rinses dense preparing tank 3 times, and flushing water all adds dilute preparing tank；2) benefit injects water to 95L, when being cooled to 40 DEG C, uses
1mol/l sodium hydroxide solution regulation pH value, to 5.4, adds the 50g oxaliplatin of micronization processes, stirs 30 minutes, the most former
After material dissolves, add being adsorbed with of 0.01kg moistening and account for the Herba Leonuri of its quality 4% and fold the needle-use activated carbon of olefin(e) acid ester A, mend
Add to the full amount of water for injection, be circulated 40 minutes；3) fill, fill temperature controls at 40 DEG C, 115 DEG C of sterilizings 30 minutes, soon
Speed spraying cooling, temperature is down to less than 40 DEG C and is offerd for sale, and packs after lamp inspection is qualified.
Embodiment 3
Preparation: 1) in dense preparing tank, add 30L water for injection and 2.5kg mannitol, the 0.1kg pin adding moistening is used
Activated carbon, after stirring boils 20 minutes, continues stirring and all dissolves to mannitol for 10 minutes, filter through titanium rod after being cooled to 55 DEG C
Device decarbonization filtering is in dilute preparing tank.Open dense preparing tank water for injection valve and shower valve, be cooled to the water for injection of 45 DEG C with 20L
Dividing 3 times and rinse dense preparing tanks, flushing water all adds dilute preparing tank；2) benefit injects water to 95L, when being cooled to 45 DEG C, uses 1mol/
L sodium hydroxide solution regulation pH value, to 6.0, adds the 50g oxaliplatin of micronization processes, stirs 30 minutes, and visual raw material is molten
Xie Hou, adds the needle-use activated carbon of 0.03kg moistening, and benefit adds to the full amount of water for injection, and is circulated 30 minutes；3) fill, fills
Dress temperature controls at 45 DEG C, and 115 DEG C of sterilizings 30 minutes, quick spraying cooling, temperature is down to less than 40 DEG C and is offerd for sale, after lamp inspection is qualified
Packaging.
Embodiment 4
Preparation: 1) in dense preparing tank, add 30L water for injection and 2.1kg mannitol, add the 0.08kg pin of moistening
With activated carbon, after stirring boils 20 minutes, continue stirring and within 10 minutes, all dissolve to mannitol, through titanium rod mistake after being cooled to 52 DEG C
Filter decarbonization filtering is in dilute preparing tank.Open dense preparing tank water for injection valve and shower valve, be cooled to the injection of 42 DEG C with 20L
Moisture rinses dense preparing tank 3 times, and flushing water all adds dilute preparing tank；2) benefit injects water to 95L, when being cooled to 42 DEG C, uses
1mol/l sodium hydroxide solution regulation pH value, to 5.4, adds the 50g oxaliplatin of micronization processes, stirs 30 minutes, the most former
After material dissolves, adding the needle-use activated carbon of 0.02kg moistening, benefit adds to the full amount of water for injection, and is circulated 35 minutes；3) fill
Dress, fill temperature controls at 40 DEG C, 121 DEG C of sterilizings 10 minutes, quick spraying cooling, and temperature is down to less than 40 DEG C and is offerd for sale, lamp inspection
Packaging after qualified.
Embodiment 5
Preparation: 1) in dense preparing tank, add 30L water for injection and 3.1kg mannitol, add the 0.01kg pin of moistening
With activated carbon, after stirring boils 20 minutes, continue stirring and within 10 minutes, all dissolve to mannitol, through titanium rod mistake after being cooled to 55 DEG C
Filter decarbonization filtering is in dilute preparing tank.Open dense preparing tank water for injection valve and shower valve, be cooled to the injection of 45 DEG C with 20L
Moisture rinses dense preparing tank 3 times, and flushing water all adds dilute preparing tank；2) benefit injects water to 95L, when being cooled to 45 DEG C, uses
1mol/l sodium hydroxide solution regulation pH value, to 5.4, adds the 50g oxaliplatin of micronization processes, stirs 30 minutes, the most former
After material dissolves, adding the needle-use activated carbon of 0.01kg moistening, benefit adds to the full amount of water for injection, and is circulated 40 minutes；3) fill
Dress, fill temperature controls at 40 DEG C, 121 DEG C of sterilizings 10 minutes, quick spraying cooling, and temperature is down to less than 40 DEG C and is offerd for sale, lamp inspection
Packaging after qualified.
Stability test: embodiment 1-5 is accelerated experiment, and method is: temperature is 40 ± 2 DEG C, humidity 75 ± 5%
Under the conditions of, embodiment is investigated, the time is 6 months, respectively at 0,1,3, sampling in June, Testing index is the most insoluble
Microgranule, visible foreign matters, content and have related substance.The results are shown in Table 1.
Table 1 embodiment 1-5 stability experiment result.
Result above shows: the finished product prepared according to embodiment 1-5, through the investigation of 6 months, and preparation insoluble micro-
Grain, visible foreign matters, content and have related substance and compare when 0, substantially without significant change, product quality is more stable, and the present invention is described
Having good stability of preparation.
Claims (10)
1. an oxaliplatin formula mannitol injection liquid preparation technology, it is characterised in that described preparation technology concretely comprises the following steps: 1) exist
Dense preparing tank adds recipe quantity 30% water for injection and the mannitol of recipe quantity, adds the needle-use activated carbon of moistening, stirring
After boiling, continue stirring to mannitol and all dissolve, after cooling in titanium rod filter decarbonization filtering to dilute preparing tank；Open dense joining
Tank water for injection valve and shower valve, rinse dense preparing tank by several times with recipe quantity 20～40% water for injection, and flushing water all adds
Dilute preparing tank；2) benefit injects water to the 95% of recipe quantity, after cooling, with pH value regulator regulation pH value to 5.0-6.0, adds
The oxaliplatin of recipe quantity, after stirring is all dissolved to raw material, adds the needle-use activated carbon of moistening, mends and inject water to entirely
Amount, is circulated 30-40 minute；3) fill, sterilizing, packaging.
Oxaliplatin formula mannitol injection liquid preparation technology the most according to claim 1, it is characterised in that described step 1) in
Before decarburization, fluid temperature need to be down to 50-55 DEG C.
Oxaliplatin formula mannitol injection liquid preparation technology the most according to claim 1, it is characterised in that described step 1) in
Activated carbon addition is the 0.05wt%-0.1wt% of water for injection recipe quantity.
Oxaliplatin formula mannitol injection liquid preparation technology the most according to claim 1, it is characterised in that described step 2) in
Oxaliplatin raw material needs through micronization processes before adding.
Oxaliplatin formula mannitol injection liquid preparation technology the most according to claim 1, it is characterised in that described step 2) in
Activated carbon addition is the 0.01wt%-0.03wt% of water for injection recipe quantity.
Oxaliplatin formula mannitol injection liquid preparation technology the most according to claim 1, it is characterised in that described step 2)
The Herba Leonuri being adsorbed with 3-5wt% in middle needle-use activated carbon folds olefin(e) acid ester A.
Oxaliplatin formula mannitol injection liquid preparation technology the most according to claim 1, it is characterised in that described step 2) in
When water for injection is cooled to 40-45 DEG C, then put into oxaliplatin.
Oxaliplatin formula mannitol injection liquid preparation technology the most according to claim 1, it is characterised in that described step 2) in
PH value regulator is 1mol/L sodium hydroxide solution.
Oxaliplatin formula mannitol injection liquid preparation technology the most according to claim 1, it is characterised in that described preparation technology
Concretely comprise the following steps: 1) in dense preparing tank, add recipe quantity 30% water for injection and the mannitol of recipe quantity, add moistening
0.05wt%-0.1wt% needle-use activated carbon, after stirring boils 20 minutes, continues stirring and all dissolves to mannitol for 10 minutes, fall
After warm to 50-55 DEG C in titanium rod filter decarbonization filtering to dilute preparing tank；Open dense preparing tank water for injection valve and shower valve, use
Recipe quantity 20～3 flushing dense preparing tanks of injection moisture being cooled to 40-45 DEG C of 40%, flushing water all adds dilute preparing tank；
2) benefit injects water to the 95% of recipe quantity, when being cooled to 40-45 DEG C, with 1mol/l sodium hydroxide solution regulation pH value extremely
5.0-6.0, adds the micronized oxaliplatin of recipe quantity, stirs 30 minutes, after visual raw material all dissolves, add moistening
0.01wt%-0.03wt% needle-use activated carbon, benefit adds to the full amount of water for injection, and is circulated 30-40 minute；3) fill, fill
Temperature controls at 40-45 DEG C, and 115 DEG C of sterilizings 30 minutes or 121 DEG C of sterilizings 10 minutes, quick spraying cooling, temperature is down to 40
Offer for sale below DEG C, packaging after lamp inspection is qualified.
10. the oxaliplatin formula mannitol injection liquid prepared according to described preparation technology arbitrary in claim 1-9, its feature exists
In, the ultimate density of the oxaliplatin in described injection is 0.5mg/mL, and mannitol ultimate density is 51mg/mL.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610792339.9A CN106176594A (en) | 2016-08-31 | 2016-08-31 | A kind of oxaliplatin formula mannitol injection liquid and preparation technology thereof |
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| CN201610792339.9A CN106176594A (en) | 2016-08-31 | 2016-08-31 | A kind of oxaliplatin formula mannitol injection liquid and preparation technology thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113521000A (en) * | 2021-08-16 | 2021-10-22 | 远大医药（中国）有限公司 | Tirofiban injection and preparation method thereof |
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| CN104523674A (en) * | 2014-12-11 | 2015-04-22 | 杨玉廷 | Injection composition with oxaliplatin as main medicine component |
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2016
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| CN1954811A (en) * | 2005-10-26 | 2007-05-02 | 四川美大康佳乐药业有限公司 | Oxaliplatin intravenous injection and its preparation method |
| KR20070067768A (en) * | 2005-12-23 | 2007-06-29 | 주식회사 삼양사 | Stable oxaliplatin composition and method for the same |
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| CN103720649A (en) * | 2013-12-27 | 2014-04-16 | 辰欣药业股份有限公司 | Method for preparing alanyl-glutamine injection |
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