CN102525959B - Fat-soluble vitamin composition for injection and preparation method thereof - Google Patents
Fat-soluble vitamin composition for injection and preparation method thereof Download PDFInfo
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- CN102525959B CN102525959B CN201210010878.4A CN201210010878A CN102525959B CN 102525959 B CN102525959 B CN 102525959B CN 201210010878 A CN201210010878 A CN 201210010878A CN 102525959 B CN102525959 B CN 102525959B
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- 229940088594 vitamin Drugs 0.000 title claims abstract description 47
- 229930003231 vitamin Natural products 0.000 title claims abstract description 47
- 235000013343 vitamin Nutrition 0.000 title claims abstract description 47
- 239000011782 vitamin Substances 0.000 title claims abstract description 47
- 150000003722 vitamin derivatives Chemical class 0.000 title claims abstract description 46
- 238000002347 injection Methods 0.000 title claims abstract description 38
- 239000007924 injection Substances 0.000 title claims abstract description 38
- 239000000203 mixture Substances 0.000 title claims abstract description 32
- 238000002360 preparation method Methods 0.000 title abstract description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 40
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims abstract description 38
- VYGQUTWHTHXGQB-FFHKNEKCSA-N Retinol Palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C VYGQUTWHTHXGQB-FFHKNEKCSA-N 0.000 claims abstract description 38
- 239000008215 water for injection Substances 0.000 claims abstract description 33
- VYGQUTWHTHXGQB-UHFFFAOYSA-N Retinol hexadecanoate Natural products CCCCCCCCCCCCCCCC(=O)OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C VYGQUTWHTHXGQB-UHFFFAOYSA-N 0.000 claims abstract description 19
- 229930003427 Vitamin E Natural products 0.000 claims abstract description 19
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims abstract description 19
- 238000000034 method Methods 0.000 claims abstract description 19
- 235000019172 retinyl palmitate Nutrition 0.000 claims abstract description 19
- 229940108325 retinyl palmitate Drugs 0.000 claims abstract description 19
- 239000011769 retinyl palmitate Substances 0.000 claims abstract description 19
- 239000011709 vitamin E Substances 0.000 claims abstract description 19
- 235000019165 vitamin E Nutrition 0.000 claims abstract description 19
- 229940046009 vitamin E Drugs 0.000 claims abstract description 19
- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 claims abstract description 11
- MECHNRXZTMCUDQ-UHFFFAOYSA-N Vitamin D2 Natural products C1CCC2(C)C(C(C)C=CC(C)C(C)C)CCC2C1=CC=C1CC(O)CCC1=C MECHNRXZTMCUDQ-UHFFFAOYSA-N 0.000 claims abstract description 5
- 229960002061 ergocalciferol Drugs 0.000 claims abstract description 5
- 235000001892 vitamin D2 Nutrition 0.000 claims abstract description 5
- 239000011653 vitamin D2 Substances 0.000 claims abstract description 5
- 239000000243 solution Substances 0.000 claims description 70
- 238000003756 stirring Methods 0.000 claims description 40
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 21
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 15
- 238000004108 freeze drying Methods 0.000 claims description 14
- 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 9
- 229930195725 Mannitol Natural products 0.000 claims description 9
- 238000001914 filtration Methods 0.000 claims description 9
- 239000000594 mannitol Substances 0.000 claims description 9
- 235000010355 mannitol Nutrition 0.000 claims description 9
- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 claims description 9
- 229930003316 Vitamin D Natural products 0.000 claims description 8
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims description 8
- 229930003448 Vitamin K Natural products 0.000 claims description 8
- 235000019166 vitamin D Nutrition 0.000 claims description 8
- 239000011710 vitamin D Substances 0.000 claims description 8
- 150000003710 vitamin D derivatives Chemical class 0.000 claims description 8
- 235000019168 vitamin K Nutrition 0.000 claims description 8
- 239000011712 vitamin K Substances 0.000 claims description 8
- 150000003721 vitamin K derivatives Chemical class 0.000 claims description 8
- 229940046008 vitamin d Drugs 0.000 claims description 8
- 229940046010 vitamin k Drugs 0.000 claims description 8
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 claims description 7
- 241000143437 Aciculosporium take Species 0.000 claims description 7
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 7
- 229910052782 aluminium Inorganic materials 0.000 claims description 7
- 239000004411 aluminium Substances 0.000 claims description 7
- 238000007689 inspection Methods 0.000 claims description 7
- 238000012856 packing Methods 0.000 claims description 7
- 238000012859 sterile filling Methods 0.000 claims description 7
- 239000003643 water by type Substances 0.000 claims description 7
- 229940068088 vitamin k 1 Drugs 0.000 claims description 3
- 238000004090 dissolution Methods 0.000 description 7
- 239000011772 phylloquinone Substances 0.000 description 7
- 230000007774 longterm Effects 0.000 description 6
- 239000000843 powder Substances 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 4
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- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- ABSPRNADVQNDOU-UHFFFAOYSA-N Menaquinone 1 Natural products C1=CC=C2C(=O)C(CC=C(C)C)=C(C)C(=O)C2=C1 ABSPRNADVQNDOU-UHFFFAOYSA-N 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 description 1
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 description 1
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- MBWXNTAXLNYFJB-LKUDQCMESA-N phylloquinone Chemical compound C1=CC=C2C(=O)C(C/C=C(C)/CCCC(C)CCCC(C)CCCC(C)C)=C(C)C(=O)C2=C1 MBWXNTAXLNYFJB-LKUDQCMESA-N 0.000 description 1
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention discloses a fat-soluble vitamin composition for injection and a preparation method thereof. The major components of the fat-soluble vitamin composition for injection include vitamin A palmitate, vitamin D2, vitamin E and vitamin k1. The major components are dissolved by a special method and then mixed with water for injection at an appropriate temperature, and the mixture is stirred to disperse and dissolve. The clarity and content stability of the sample are further guaranteed to make the quality of the sample more stable and controllable.
Description
Technical field
The present invention relates to a kind of injection freeze-dried powder composition and method of making the same, particularly a kind of fat-soluble vitamin for injection composition and method of making the same.
Background technology
Vitamin is to maintain the necessary class nutrient of humans and animals body health, and this product is low-molecular-weight organic compound.The daily requirement amount of vitamin is few (often in milligram or microgram) very, they are neither form the raw material of body tissue, the material of energy supply in neither body, yet at Auto-regulator metabolism, enhancing development with maintain the aspects such as physiological function and but play an important role, if certain vitamin of long-term lacking, will cause disease.
Vitamin is divided into water soluble vitamins and fatsoluble vitamin by the difference of dissolution properties, and wherein fatsoluble vitamin comprises altogether: A, D, E, tetra-kinds of K.After human body is subject to larger wound, in blood, Serum Vitamin A, E content significantly descend, and lower than normal value, simple diet is taken in and can not be met the requirement of vitamin under stress state.Vitimin supplement A can strengthen the function of Human Epithelial Cells, to control, infects significant; Vitamin E has many physiological functions; it all has powerful antioxidation in vivo and in vitro; can make unsaturated fatty acid on the biological cell membrane structure avoid the attack of free radical; the structure of complete, the stabilate film of Cell protection film; simultaneously, also protect life macromolecule material (DNA) to exempt from the destruction that free radical is attacked.
Fatsoluble vitamin is subject to the destruction of temperature, moisture, illumination, therefore the problem that fat-soluble vitamin for injection often there will be content to descend in put procedure.In order to guarantee clinical drug safety, the stability that improves fat-soluble vitamin for injection is to need the problem solved.
Summary of the invention
The object of the invention is to disclose a kind of fat-soluble vitamin for injection compositions; Another purpose of the present invention is to disclose the preparation method of this fat-soluble vitamin for injection freeze-dried powder.
Fat-soluble vitamin for injection composition material of the present invention consists of:
Fatsoluble vitamin composition material composition of the present invention is preferably:
Fat-soluble vitamin for injection composition material composition of the present invention is preferably:
The raw material of above-mentioned fat-soluble vitamin for injection injects water to 3000 parts by volume in forming, and it is g/ml that described weight portion and parts by volume are closed.
The preparation method of fat-soluble vitamin for injection compositions of the present invention comprises the steps:
A. take the vitamin K of formula ratio
1add in polyoxyethylene sorbitan monoleate, stirring and dissolving, obtain solution A;
B. take the vitamin D of formula ratio
2join in solution A, stirring and dissolving, obtain solution B;
C. the vitamin E that takes formula ratio joins in solution B, and stirring and dissolving, obtain solution C;
D. the vitamin A palmitate that takes formula ratio joins in solution C, stirring and dissolving, and the water for injection that adds 500-2000 parts by volume temperature to be, stir to clarify; Obtain solution D
E. formula ratio mannitol is dissolved in 30 ℃ of-40 ℃ of waters for injection of 500-1000 parts by volume, is stirred to dissolving, add 0.05% (g/ml) needle-use activated carbon, stir 15 minutes under room temperature, coarse filtration, obtain solution E;
F. solution D is mixed homogeneously with solution E, regulate pH value to 7.5～9.0 with the 0.1mol/L sodium hydroxide solution, add water for injection to 3000 parts by volume, aseptic filtration, after the intermediate passed examination, sterile filling is in cillin bottle, every bottled amount is 3 parts by volume, press half plug, be placed in the freeze drying box lyophilization, tamponade, lock aluminium lid, the qualified rear packing of full inspection, obtain the fat-soluble vitamin for injection compositions.
The preparation method of fat-soluble vitamin for injection compositions of the present invention is preferably as follows step:
A. take the vitamin K of formula ratio
1add in polyoxyethylene sorbitan monoleate, stirring and dissolving, obtain solution A;
B. take the vitamin D of formula ratio
2join in solution A, stirring and dissolving, obtain solution B;
C. the vitamin E that takes formula ratio joins in solution B, and stirring and dissolving, obtain solution C;
D. the vitamin A palmitate that takes formula ratio joins in solution C, stirring and dissolving, and the water for injection that adds 1000 parts by volume temperature to be, stir to clarify, and obtains solution D;
E. formula ratio mannitol is dissolved in 30 ℃ of-40 ℃ of waters for injection of 1000 parts by volume, is stirred to dissolving, add 0.05% (g/ml) needle-use activated carbon, stir 15 minutes under room temperature, coarse filtration, obtain solution E;
F. solution D is mixed homogeneously with solution E, regulate pH value to 7.8～8.3 with the 0.1mol/L sodium hydroxide solution, add water for injection to 3000 parts by volume, aseptic filtration, after the intermediate passed examination, sterile filling is in cillin bottle, every bottled amount is 3 parts by volume, press half plug, be placed in the freeze drying box lyophilization, tamponade, lock aluminium lid, the qualified rear packing of full inspection, obtain the fat-soluble vitamin for injection compositions.
The invention provides a kind of composition and method of making the same.After in the present invention, the principal agent vitamin A palmitate of fat-soluble vitamin for injection, vitamin D2, vitamin E, vitamin k 1 are pressed the ad hoc approach dissolving, add again the water for injection dispersed with stirring of preference temperature to dissolve, further guarantee the clarity of sample and the stability of content, make the more stable quality of sample controlled.
Experimental example 1 fatsoluble vitamin dissolution studies
In the fat-soluble vitamin for injection compositions, comprise: vitamin A palmitate, vitamin D2, vitamin E, vitamin K1, these four kinds of materials are all water insoluble, need to first be dissolved in polyoxyethylene sorbitan monoleate, redispersion is in water, due to the good solubilization of polyoxyethylene sorbitan monoleate, dispersing and dissolving, in water, forms settled solution.Experimental example is investigated the situation in whole course of dissolution.In Table one.
Table one
| Form 1 | Form 2 | Form 3 | |
| Vitamin A palmitate | 1.885g | 1.885g | 1.885g |
| Vitamin D 2 | 0.005g | 0.005g | 0.005g |
| Vitamin E | 9.1g | 9.1g | 9.1g |
| Vitamin K 1 | 0.15g | 0.15g | 0.15g |
| Polyoxyethylene sorbitan monoleate | 50g | 50g | 50g |
| Water for injection | 100ml | 300ml | 500ml |
| The water for injection dilution | To 3000ml | To 3000ml | To 3000ml |
Vitamin A palmitate, vitamin D
2, vitamin E, vitamin K
1add in polyoxyethylene sorbitan monoleate, mix homogeneously, add the water for injection of 30 ℃ of left and right to stir according to design, observes the state in course of dissolution, the time of recording dissolve complete, and observe the now clarity of each solution, the results are shown in Table two.
Table two
Experimental example shows vitamin A palmitate, vitamin D
2, vitamin E, vitamin K
1it is after 80s that these four kinds of fatsoluble vitamiies are dissolved in Polysorbate, adds water for injection to dissolve, and the amount of water for injection should be more than or equal to 1/6 of total amount, is beneficial to like this dispersing and dissolving.
Experimental example 2 fatsoluble vitamin solution temperature researchs
Experimental example is investigated vitamin A palmitate, vitamin D
2, vitamin E, vitamin K
1these four kinds of material dissolutions in polyoxyethylene sorbitan monoleate, redispersion in water, the impact of water temperature on dissolution velocity and clarity.
Compositions is composed as follows:
The water for injection Temperature Setting is: 5 ℃, 10 ℃, 20 ℃, 40 ℃, 50 ℃, 60 ℃.
Vitamin A palmitate, vitamin E, vitamin D
2, vitamin K
1add in polyoxyethylene sorbitan monoleate, mix homogeneously, add the water for injection 500ml of design temperature, stirs, and observes the state in course of dissolution, the time of recording dissolve complete, observes the clarity after the water for injection full dose adds.
The results are shown in Table three:
Because the content of fatsoluble vitamin is more responsive to temperature, in conjunction with the result of experimental example 2, we think vitamin A palmitate, vitamin D
2, vitamin E, vitamin K
1it is after 80s that these four kinds of fatsoluble vitamiies are dissolved in Polysorbate, adds water for injection to dissolve, and the temperature of water for injection should be at 20 ℃～40 ℃.
The impact of experimental example 3 fat-soluble vitamin for injection principal agent addition sequences on stability
Compositions is composed as follows:
Technique is in Table four
The finished product that above-mentioned three techniques are made carries out the long term test study on the stability: the sample lot number of technique one is 090601; The sample lot number of technique two is 090602; The sample lot number of technique three is 090603;
Experimental condition: put under the condition of 2 ℃-10 ℃ of temperature and preserve, timing sampling, measure indices,
The results are shown in Table five
Table five
The fat-soluble vitamin for injection long-term test results
Fat-soluble vitamin for injection long term test assay (%) result (090601 technique one)
Fat-soluble vitamin for injection long term test assay (%) result (090602 batch of technique two)
Fat-soluble vitamin for injection long term test assay (%) result (090603 batch of technique three)
From the above results, the sample that technique one and technique two make was placed after 24 months under the condition of 2 ℃-10 ℃, vitamin A palmitate, vitamin D
2with the content of vitamin K, can descend about 6-8%, and each main constituent content of the sample that technique three makes does not have significant change, and clarity obviously is better than the sample of two other technique.The sample of visible technique three is than the more stable quality of the sample of technique one and technique two, controlled.
Following embodiment all can prove the effect of above-mentioned experimental example.
The specific embodiment
Embodiment 1: fat-soluble vitamin freeze-dried powder needle of the present invention
A. take the vitamin K of formula ratio
1add in polyoxyethylene sorbitan monoleate, stirring and dissolving, obtain solution A;
B. take the vitamin D of formula ratio
2join in solution A, stirring and dissolving, obtain solution B;
C. the vitamin E that takes formula ratio joins in solution B, and stirring and dissolving, obtain solution C;
D. the vitamin A palmitate that takes formula ratio joins in solution C, stirring and dissolving, and the water for injection that adds 1000 parts by volume temperature to be, stir to clarify, and obtains solution D;
E. mannitol is dissolved in 30 ℃ of-40 ℃ of waters for injection of 1000 parts by volume, is stirred to dissolving; Add the solution D mix homogeneously, add the nearly full dose of water for injection, measure pH, use the 0.1mol/L sodium hydroxide solution to regulate pH value to 7.8-8.2, add water for injection to 3000 parts by volume, aseptic filtration, after the intermediate passed examination, sterile filling is in cillin bottle, every bottled amount is 3 parts by volume, press half plug, be placed in the freeze drying box lyophilization, tamponade, lock aluminium lid, the qualified rear packing of full inspection, obtain the fat-soluble vitamin for injection compositions.
Embodiment 2: fat-soluble vitamin freeze-dried powder needle of the present invention
A. take the vitamin K of formula ratio
1add in polyoxyethylene sorbitan monoleate, stirring and dissolving, obtain solution A;
B. take the vitamin D of formula ratio
2join in solution A, stirring and dissolving, obtain solution B;
C. the vitamin E that takes formula ratio joins in solution B, and stirring and dissolving, obtain solution C;
D. the vitamin A palmitate that takes formula ratio joins in solution C, stirring and dissolving, and the water for injection that adds 1000 parts by volume temperature to be, stir to clarify, and obtains solution D;
E. mannitol is dissolved in 30 ℃ of-40 ℃ of waters for injection of 1000 parts by volume, is stirred to dissolving; Add the solution D mix homogeneously, add the nearly full dose of water for injection, measure pH, use the 0.1mol/L sodium hydroxide solution to regulate pH value to 7.8-8.2, add water for injection to 3000 parts by volume, aseptic filtration, after the intermediate passed examination, sterile filling is in cillin bottle, every bottled amount is 3 parts by volume, press half plug, be placed in the freeze drying box lyophilization, tamponade, lock aluminium lid, the qualified rear packing of full inspection, obtain the fat-soluble vitamin for injection compositions.
Embodiment 3: fat-soluble vitamin freeze-dried powder needle of the present invention
A. take the vitamin K of formula ratio
1add in polyoxyethylene sorbitan monoleate, stirring and dissolving, obtain solution A;
B. take the vitamin D of formula ratio
2join in solution A, stirring and dissolving, obtain solution B;
C. the vitamin E that takes formula ratio joins in solution B, and stirring and dissolving, obtain solution C;
D. the vitamin A palmitate that takes formula ratio joins in solution C, stirring and dissolving, and the water for injection that adds 1000 parts by volume temperature to be, stir to clarify, and obtains solution D;
E. mannitol is dissolved in 30 ℃ of-40 ℃ of waters for injection of 1000 parts by volume, is stirred to dissolving; Add the solution D mix homogeneously, add the nearly full dose of water for injection, measure pH, use the 0.1mol/L sodium hydroxide solution to regulate pH value to 7.8-8.2, add water for injection to 3000 parts by volume, aseptic filtration, after the intermediate passed examination, sterile filling is in cillin bottle, every bottled amount is 3 parts by volume, press half plug, be placed in the freeze drying box lyophilization, tamponade, lock aluminium lid, the qualified rear packing of full inspection, obtain the fat-soluble vitamin for injection compositions.
Claims (2)
1. a method for preparing the fat-soluble vitamin for injection compositions, is characterized in that comprising the steps:
Vitamin A palmitate 1.314g
Vitamin D2 0.01g
Vitamin E 6.4g
Vitamin k 1 0.15g
Polyoxyethylene sorbitan monoleate 50g
Mannitol 75g
Water for injection is to 3000ml
A. take the vitamin K of formula ratio
1add in polyoxyethylene sorbitan monoleate, stirring and dissolving, obtain solution A;
B. take the vitamin D of formula ratio
2join in solution A, stirring and dissolving, obtain solution B;
C. the vitamin E that takes formula ratio joins in solution B, and stirring and dissolving, obtain solution C;
D. the vitamin A palmitate that takes formula ratio joins in solution C, stirring and dissolving, and the water for injection that adds 1000 parts by volume temperature to be, stir to clarify, and obtains solution D;
E. mannitol is dissolved in 30 ℃ of-40 ℃ of waters for injection of 1000 parts by volume, is stirred to dissolving; Add the solution D mix homogeneously, add the nearly full dose of water for injection, measure pH, use the 0.1mol/L sodium hydroxide solution to regulate pH value to 7.8-8.2, add water for injection to 3000 parts by volume, aseptic filtration, after the intermediate passed examination, sterile filling is in cillin bottle, every bottled amount is 3 parts by volume, press half plug, be placed in the freeze drying box lyophilization, tamponade, lock aluminium lid, the qualified rear packing of full inspection, obtain the fat-soluble vitamin for injection compositions.
2. a method for preparing the fat-soluble vitamin for injection compositions, is characterized in that comprising the steps:
Vitamin A palmitate 1.885g
Vitamin D2 0.005g
Vitamin E 9.1g
Vitamin k 1 0.15g
Polyoxyethylene sorbitan monoleate 50g
Mannitol 75g
Water for injection is to 3000ml
A. take the vitamin K of formula ratio
1add in polyoxyethylene sorbitan monoleate, stirring and dissolving, obtain solution A;
B. take the vitamin D of formula ratio
2join in solution A, stirring and dissolving, obtain solution B;
C. the vitamin E that takes formula ratio joins in solution B, and stirring and dissolving, obtain solution C;
D. the vitamin A palmitate that takes formula ratio joins in solution C, stirring and dissolving, and the water for injection that adds 1000 parts by volume temperature to be, stir to clarify, and obtains solution D;
E. mannitol is dissolved in 30 ℃ of-40 ℃ of waters for injection of 1000 parts by volume, is stirred to dissolving; Add the solution D mix homogeneously, add the nearly full dose of water for injection, measure pH, use the 0.1mol/L sodium hydroxide solution to regulate pH value to 7.8-8.2, add water for injection to 3000 parts by volume, aseptic filtration, after the intermediate passed examination, sterile filling is in cillin bottle, every bottled amount is 3 parts by volume, press half plug, be placed in the freeze drying box lyophilization, tamponade, lock aluminium lid, the qualified rear packing of full inspection, obtain the fat-soluble vitamin for injection compositions.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
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| CN1903207A (en) * | 2005-07-29 | 2007-01-31 | 青岛众智医药科技有限公司 | Fat-soluble vitamin freeze-dried prepn. and its prepn. method |
| CN1923207A (en) * | 2005-09-02 | 2007-03-07 | 信谊药厂 | Compound recipe vitamin freeze-dried powder for injection and its preparing process |
| CN101366712A (en) * | 2008-09-26 | 2009-02-18 | 北京博时安泰科技发展有限公司 | Method for preparing fat-soluble vitamin for injection |
| CN101606939A (en) * | 2009-07-27 | 2009-12-23 | 徐新盛 | A kind of fat-soluble vitamin freeze-dried powder needle and preparation method thereof |
| CN101632679A (en) * | 2009-04-20 | 2010-01-27 | 邓盛齐 | Composite vitamin for injection and preparation method thereof |
| CN101940557A (en) * | 2009-07-10 | 2011-01-12 | 华北制药集团制剂有限公司 | Method for preparing fat-soluble vitamin freeze-dried powder injection |
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| CN1903207A (en) * | 2005-07-29 | 2007-01-31 | 青岛众智医药科技有限公司 | Fat-soluble vitamin freeze-dried prepn. and its prepn. method |
| CN1923207A (en) * | 2005-09-02 | 2007-03-07 | 信谊药厂 | Compound recipe vitamin freeze-dried powder for injection and its preparing process |
| CN101366712A (en) * | 2008-09-26 | 2009-02-18 | 北京博时安泰科技发展有限公司 | Method for preparing fat-soluble vitamin for injection |
| CN101632679A (en) * | 2009-04-20 | 2010-01-27 | 邓盛齐 | Composite vitamin for injection and preparation method thereof |
| CN101940557A (en) * | 2009-07-10 | 2011-01-12 | 华北制药集团制剂有限公司 | Method for preparing fat-soluble vitamin freeze-dried powder injection |
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| CN102525959A (en) | 2012-07-04 |
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