CN100486583C - Diabetin for injection and its preparation process - Google Patents
Diabetin for injection and its preparation process Download PDFInfo
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- CN100486583C CN100486583C CNB2004100703357A CN200410070335A CN100486583C CN 100486583 C CN100486583 C CN 100486583C CN B2004100703357 A CNB2004100703357 A CN B2004100703357A CN 200410070335 A CN200410070335 A CN 200410070335A CN 100486583 C CN100486583 C CN 100486583C
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- fructose
- powder
- weight
- injection
- mannitol
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- 238000002347 injection Methods 0.000 title claims abstract description 28
- 239000007924 injection Substances 0.000 title claims abstract description 28
- 238000002360 preparation method Methods 0.000 title claims description 17
- VDTNNGKXZGSZIP-UHFFFAOYSA-N carbutamide Chemical compound CCCCNC(=O)NS(=O)(=O)C1=CC=C(N)C=C1 VDTNNGKXZGSZIP-UHFFFAOYSA-N 0.000 title 1
- 229930091371 Fructose Natural products 0.000 claims abstract description 71
- 239000005715 Fructose Substances 0.000 claims abstract description 71
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims abstract description 69
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 10
- 239000003814 drug Substances 0.000 claims abstract description 6
- 239000000843 powder Substances 0.000 claims description 57
- 239000003610 charcoal Substances 0.000 claims description 32
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 29
- 229930195725 Mannitol Natural products 0.000 claims description 29
- 239000000594 mannitol Substances 0.000 claims description 29
- 235000010355 mannitol Nutrition 0.000 claims description 29
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 28
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 28
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 23
- 238000001914 filtration Methods 0.000 claims description 23
- 229940105082 medicinal charcoal Drugs 0.000 claims description 23
- 238000006243 chemical reaction Methods 0.000 claims description 14
- 238000002425 crystallisation Methods 0.000 claims description 14
- 230000008025 crystallization Effects 0.000 claims description 14
- 239000007787 solid Substances 0.000 claims description 14
- 238000005406 washing Methods 0.000 claims description 14
- 239000007788 liquid Substances 0.000 claims description 13
- 238000012856 packing Methods 0.000 claims description 12
- 238000001291 vacuum drying Methods 0.000 claims description 12
- 239000012528 membrane Substances 0.000 claims description 9
- 239000000243 solution Substances 0.000 claims description 9
- 238000004108 freeze drying Methods 0.000 claims description 7
- 239000013078 crystal Substances 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000003756 stirring Methods 0.000 claims description 4
- 238000001694 spray drying Methods 0.000 claims description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 abstract description 8
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 abstract description 6
- 239000008103 glucose Substances 0.000 abstract description 6
- 102000004877 Insulin Human genes 0.000 abstract description 4
- 108090001061 Insulin Proteins 0.000 abstract description 4
- 229940125396 insulin Drugs 0.000 abstract description 4
- 208000015181 infectious disease Diseases 0.000 abstract description 3
- 229940079593 drug Drugs 0.000 abstract description 2
- 206010052428 Wound Diseases 0.000 abstract 1
- 208000027418 Wounds and injury Diseases 0.000 abstract 1
- 239000012530 fluid Substances 0.000 abstract 1
- 238000001802 infusion Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 238000005728 strengthening Methods 0.000 abstract 1
- 230000001502 supplementing effect Effects 0.000 abstract 1
- 239000000706 filtrate Substances 0.000 description 12
- 239000000203 mixture Substances 0.000 description 7
- 238000005303 weighing Methods 0.000 description 7
- 210000004185 liver Anatomy 0.000 description 3
- 102000003793 Fructokinases Human genes 0.000 description 2
- 108090000156 Fructokinases Proteins 0.000 description 2
- 229920002527 Glycogen Polymers 0.000 description 2
- LKDRXBCSQODPBY-ZXXMMSQZSA-N alpha-D-fructopyranose Chemical compound OC[C@]1(O)OC[C@@H](O)[C@@H](O)[C@@H]1O LKDRXBCSQODPBY-ZXXMMSQZSA-N 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940096919 glycogen Drugs 0.000 description 2
- 230000000968 intestinal effect Effects 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 230000002980 postoperative effect Effects 0.000 description 2
- 239000013589 supplement Substances 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 102000014914 Carrier Proteins Human genes 0.000 description 1
- 108010078791 Carrier Proteins Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000001105 Phosphofructokinases Human genes 0.000 description 1
- 108010069341 Phosphofructokinases Proteins 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000006555 catalytic reaction Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 150000002231 fructose derivatives Chemical class 0.000 description 1
- BJHIKXHVCXFQLS-UYFOZJQFSA-N fructose group Chemical group OCC(=O)[C@@H](O)[C@H](O)[C@H](O)CO BJHIKXHVCXFQLS-UYFOZJQFSA-N 0.000 description 1
- 230000034659 glycolysis Effects 0.000 description 1
- 150000002402 hexoses Chemical class 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 210000002490 intestinal epithelial cell Anatomy 0.000 description 1
- ZKLLSNQJRLJIGT-UYFOZJQFSA-N keto-D-fructose 1-phosphate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)C(=O)COP(O)(O)=O ZKLLSNQJRLJIGT-UYFOZJQFSA-N 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
Landscapes
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
The invention discloses an injection fructose and its preparing method, making fructose and minstra into an injection fructose containing the fructose in weight percent of 50-100%. It is applied to making fluid infusion on the patients in need of supplementing water and energy sources in the condition of insulin resisting or being unsuitable to use glucose because of burns and wounds, operation, infection, etc. It enriches the forms of the fructose, extremely strengthening the drug stability and simultaneously more convenient to transport and store.
Description
Technical field
The present invention relates to a kind of fructose for injection and preparation method thereof.
Background technology
Fructose is a kind of levorotatory hexose, because of extensively existing in the various fruit, so be called fructose.Fructose enters and can combine absorption with the intestinal epithelial cell carrier protein behind the human body and enter in the body, participates in internal metabolism with the effect of specificity fructokinase in liver, kidney, small intestinal.Fructose mainly generates fructose 1-phosphate through fructokinase catalysis in liver, kidney and small intestinal; Fructose can be converted into glucose or synthetic glycogen in vivo, but glucose or synthetic glycogen can not reversely be converted into fructose; Cause and effect sugar can be walked around the rate-limiting enzyme (phosphofructokinase) in the glycolysis, satisfies at liver, and the decomposition rate of fructose is faster than glucose; The metabolic intensity of fructose depends on fructose concentration, is not subjected to the influence of insulin.
Fructose is applicable to that insulin resistant states such as burning wound, postoperative and infection down or need keep the skin wet when being not suitable for using glucose or the patient's of the energy fluid-supplement therapy.
The domestic fructose preparation that has gone on the market is a fructose injection, and manufacturer is a Jiangsu Province Huanghai Sea pharmaceutcal corporation, Ltd.This fructose injection is not easy to transportation, storage.
Summary of the invention
The invention provides a kind of fructose for injection of transporting, preserving and preparation method thereof of being convenient to.
A kind of fructose for injection of the present invention is made up of fructose and mannitol, and the weight percent concentration of contained fructose is 50～100%.
The preparation method of a kind of fructose for injection of the present invention may further comprise the steps:
In ten thousand grades of clean area proportioning room, fructose, dehydrated alcohol are dropped into reaction bulb by weight the ratio that is 1:5-10; Heating is also stirred, and dissolves to solid; The medicinal charcoal that adds amount of liquid medicine 0.5% by weight stirs filtered while hot; Filtrate is placed crystallization in hundred grades of purifying areas; With its filtration, use dehydrated alcohol drip washing; The crystal drying gets fructose aseptic powder;
Mannitol is added injection water dissolving, by weight/the volume ratio meter is made into 10% solution, adds the medicinal charcoal of 0.1% (w/v), adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, qualified after, drying gets the mannitol aseptic powder.
In hundred grades of clean areas, fructose aseptic powder and mannitol aseptic powder are mixed in proportion, packing is promptly.
The optimal technical scheme of the preparation method of a kind of fructose for injection of the present invention is:
Fructose, dehydrated alcohol are dropped into reaction bulb by weight the ratio that be 1:8, and heating slowly is warmed up to 70 ℃ and stirrings, dissolves to solid; The medicinal charcoal that adds amount of liquid medicine 0.5% (w/w) by weight stirred 30 minutes;
Filtrate is placed crystallization in 60～80 hours in hundred grades of purifying areas;
When it is filtered, with the dehydrated alcohol drip washing of 1 times of amount;
Crystal got fructose aseptic powder after 50 ℃ of-55 ℃ of following vacuum dryings, lyophilization or spray drying 8-12 hours.
A kind of fructose for injection of the present invention is applicable to that insulin resistant states such as burning wound, postoperative and infection down or need keep the skin wet when being not suitable for using glucose or the patient's of the energy fluid-supplement therapy.
The fructose for injection of the present invention preparation has enriched the dosage form of fructose, has greatly improved stability of drug, be more convenient for transportation, storage of dosage form of the present invention simultaneously.
The specific embodiment
Embodiment 1:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:8 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 60 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 12 hours, obtain fructose aseptic powder;
Get above-mentioned fructose aseptic powder 12.5g, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 12.5g/ props up.
Embodiment 2:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:5 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 70 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 8 hours, fructose aseptic powder;
Get above-mentioned fructose aseptic powder 25g, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 25g/ props up.
Embodiment 3:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:10 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 80 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 9 hours, obtain fructose aseptic powder;
Get above-mentioned fructose aseptic powder 12.5g, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 12.5g/ props up.
Embodiment 4:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:8 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 80 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 10 hours, fructose aseptic powder;
The preparation of mannitol aseptic powder:
Take by weighing mannitol (50g) and add injection water dissolving, be made into 10% solution,, by weight/the volume ratio meter adds 0.1% medicinal charcoal, adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, and is qualified after lyophilization gets aseptic powder.
Get above-mentioned fructose aseptic powder 12.5g, mannitol aseptic powder 12.5g, mix homogeneously, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 12.5g/ props up.
Embodiment 5:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:10 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 80 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 12 hours, fructose aseptic powder;
The preparation of mannitol aseptic powder:
Take by weighing mannitol 50g and add injection water dissolving, be made into 10% solution,, by weight/the volume ratio meter adds 0.1% medicinal charcoal, adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, the spray-dried aseptic powder that gets in qualified back.
Get above-mentioned fructose aseptic powder 20g, mannitol aseptic powder 10g, mix homogeneously, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 20g/ props up.
Embodiment 6:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:10 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 60 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 8 hours, fructose aseptic powder;
The preparation of mannitol aseptic powder:
Take by weighing mannitol 50g and add injection water dissolving, be made into 10% solution, by weight/the volume ratio meter adds 0.1% medicinal charcoal, adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, and is qualified after lyophilization gets aseptic powder.
Get above-mentioned fructose aseptic powder 12.5g, mannitol aseptic powder 6.25g, mix homogeneously, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 12.5g/ props up.
Embodiment 7:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:8 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 70 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 10 hours, obtain fructose aseptic powder;
The preparation of mannitol aseptic powder:
Take by weighing mannitol 50g and add injection water dissolving, be made into 10% solution,, by weight/the volume ratio meter adds 0.1% medicinal charcoal, adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, the spray-dried aseptic powder that gets in qualified back.
Get above-mentioned fructose aseptic powder 25g, mannitol aseptic powder 12.5g, mix homogeneously, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 25g/ props up.
Embodiment 8:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:5 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 80 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 12 hours, obtain fructose aseptic powder;
The preparation of mannitol aseptic powder:
Take by weighing mannitol 50g and add injection water dissolving, be made into 10% solution,, by weight/the volume ratio meter adds 0.1% medicinal charcoal, adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, and is qualified after lyophilization gets aseptic powder.
Get above-mentioned fructose aseptic powder 12.5g, mannitol aseptic powder 1.25g, mix homogeneously, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 12.5g/ props up.
Embodiment 9:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:8 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 60 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 8 hours, fructose aseptic powder;
The preparation of mannitol aseptic powder:
Take by weighing mannitol 50g and add injection water dissolving, be made into 10% solution, by weight/the volume ratio meter adds 0.1% medicinal charcoal, adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, and is qualified after lyophilization gets aseptic powder.
Get above-mentioned fructose aseptic powder 25g, mannitol aseptic powder 2.5g, mix homogeneously, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 25g/ props up.
Embodiment 10:
In ten thousand grades of clean area proportioning room, fructose (50g), dehydrated alcohol by weight for 1:8 drops into reaction bulb, slowly are warmed up to 70 ℃, be stirred to the solid dissolving, add the 0.25g medicinal charcoal, stirred 30 minutes, filtered while hot, filtrate are positioned in hundred grades of purifying areas, place crystallization in 60 hours.With medical filtration, with the dehydrated alcohol drip washing of 1 times of amount.In 50～55 ℃ of vacuum dryings 8 hours, fructose aseptic powder;
The preparation of mannitol aseptic powder:
Take by weighing mannitol 50g and add injection water dissolving, be made into 10% solution, by weight/the volume ratio meter adds 0.1% medicinal charcoal, adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, and is qualified after lyophilization gets aseptic powder.
Get above-mentioned fructose aseptic powder 25g, mannitol aseptic powder 0.05g, mix homogeneously, at relative humidity below 45%, packing in 100 grades of clean areas of GMP compatible, that is, 25g/ props up.
The invention is not restricted to above-described embodiment.
Claims (3)
1, a kind of fructose for injection sterile powder injection is characterized in that described injectable powder is by making by weight fructose aseptic powder and the mannitol sterilized powder counted for 10:1.
2, the preparation method of a kind of fructose for injection sterile powder injection according to claim 1 is characterized in that may further comprise the steps:
In ten thousand grades of clean area proportioning room, fructose, dehydrated alcohol are dropped into reaction bulb by weight the ratio of 1:5-10; Heating is also stirred, and dissolves to solid; By weight, add the medicinal charcoal of amount of liquid medicine 0.5%, stir filtered while hot; Filtration is placed crystallization in hundred grades of purifying areas; With its filtration, use dehydrated alcohol drip washing; The crystal drying gets the fructose aseptic powder;
Mannitol is added injection water dissolving, be made into 10% solution, by weight/the volume ratio meter adds 0.1% medicinal charcoal, adsorbs 20 minutes, and coarse filtration is taken off charcoal; With the microporous filter membrane fine straining of φ 0.22 μ m, medicinal liquid detects clarity, qualified after, drying gets the mannitol sterilized powder;
In hundred grades of clean areas, fructose aseptic powder and mannitol sterilized powder are mixed in proportion, packing is promptly.
3, the preparation method of a kind of fructose for injection sterile powder injection according to claim 2 is characterized in that may further comprise the steps:
Fructose, dehydrated alcohol are dropped into reaction bulb by weight the ratio that be 1:8, and heating slowly is warmed up to 70 ℃ and stirrings, dissolves to solid; By weight, add the medicinal charcoal of amount of liquid medicine 0.5%, stirred 30 minutes;
Crystallization in 60-80 hour is placed in filtration in hundred grades of purifying areas;
When it is filtered, with the dehydrated alcohol drip washing of 1 times of amount;
Crystal got fructose aseptic powder after 50 ℃ of-55 ℃ of following vacuum dryings, lyophilization or spray drying 8-12 hours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100703357A CN100486583C (en) | 2004-08-02 | 2004-08-02 | Diabetin for injection and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100703357A CN100486583C (en) | 2004-08-02 | 2004-08-02 | Diabetin for injection and its preparation process |
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| Publication Number | Publication Date |
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| CN1602881A CN1602881A (en) | 2005-04-06 |
| CN100486583C true CN100486583C (en) | 2009-05-13 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2007074763A1 (en) * | 2005-12-26 | 2007-07-05 | Kabushiki Kaisha Hayashibara Seibutsu Kagaku Kenkyujo | Porous crystalline glucide, process for producing the same, and use |
| CN104382847A (en) * | 2014-11-06 | 2015-03-04 | 海南通用康力制药有限公司 | Preparation method of injection fructose |
| CN105534892A (en) * | 2016-02-02 | 2016-05-04 | 常州市庆发工业气体有限公司 | Method for preparing high-stability fructose for fructose injection |
| CN108998580A (en) * | 2018-09-10 | 2018-12-14 | 海南通用康力制药有限公司 | A kind of refining methd of fructose |
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2004
- 2004-08-02 CN CNB2004100703357A patent/CN100486583C/en not_active Expired - Fee Related
Non-Patent Citations (2)
| Title |
|---|
| 果糖注射液工艺探讨. 汪茂先.广东药学，第9卷第4期. 1999 |
| 果糖注射液工艺探讨. 汪茂先.广东药学，第9卷第4期. 1999 * |
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