CN102499939A - Pharmaceutical compositions of fat-soluble vitamins for injection and water-soluble vitamins for injection and preparation method thereof - Google Patents
Pharmaceutical compositions of fat-soluble vitamins for injection and water-soluble vitamins for injection and preparation method thereof Download PDFInfo
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- CN102499939A CN102499939A CN2011103876606A CN201110387660A CN102499939A CN 102499939 A CN102499939 A CN 102499939A CN 2011103876606 A CN2011103876606 A CN 2011103876606A CN 201110387660 A CN201110387660 A CN 201110387660A CN 102499939 A CN102499939 A CN 102499939A
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Abstract
The invention relates to pharmaceutical compositions of fat-soluble vitamins for injection and water-soluble vitamins for injection, in particular to a combined application package including two types, namely the fat-soluble vitamins for injection and the water-soluble vitamins for injection. Water for injection or glucose injection is firstly used for dissolution and intravenous drip is further respectively performed during the use. The combined application package disclosed by the invention can comprehensively supplement the vitamins required for a human body, avoid the defects caused by the use of the single vitamin and greatly improve the treatment effect.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of injection vitamin, be specifically related to compositions and the method for making and the application packages of a kind of fat-soluble vitamin for injection and water soluble vitamins, belong to medical technical field.
Background technology
Vitamin is the humans and animals one type trace organic substance essential for keeping normal physiological function; In people's bulk-growth, metabolism, growth course, play an important role; Can not normal growth when humans and animals is deficient in vitamin, and specific lesions, promptly so-called avitaminosis take place.
Vitamin has another name called vitamin, and is popular, and the material that promptly earns a bare living is to keep the necessary type organic matter of human life activity, also is the important active substances that keeps health.Vitamin content in vivo seldom, and is but indispensable.Though the chemical constitution of various vitamin and character are different, they have following common ground: 1. vitamin all is present in the food with the form of provitamin (previtamin).2. vitamin is not the constituent that constitutes body tissue and cell, and it can produce power yet, and its effect mainly is the adjusting of participation organism metabolism.3. most vitamin, body can not synthesize or the synthetic quantity deficiency, can not satisfy the needs of body, must be often through obtaining in the food.4. human body is very little to the requirement of vitamin, and daily requirement often calculates with milligram (mg) or microgram (μ g), but in case shortage will cause corresponding avitaminosis, health is caused damage.Vitamin and carbohydrate, fat are different with protein 3 big materials, in natural food, only account for minor proportion, but are that human body institute is essential.Some vitamin such as B6 and K etc. can be synthetic by the antibacterial in the animal intestinal, and synthetic quantity can satisfy the needs of animal.Zooblast can become nicotinic acid (a kind of vitamin B group) with tryptophan transfer, needs but growing amount is deposited; Vitamin C is except that primates (comprising the mankind) and the Cavia porcellus, and other animals can self be synthesized.Plant and most microorganism can both own synthetic vitamins, needn't be by external supply.Many vitamin are ingredients of prothetic group or coenzyme.
Vitamin is humans and animals nutrition, necessary some a small amount of organic compound of growth, and metabolism, growth, growth, the health of body is had effect of the utmost importance.If certain vitamin of long-term lacking will cause the physiological function obstacle and certain disease takes place.
Vitamin is a requisite organic compound in the body metabolism.Human body is constantly carrying out various biochemical reactions just as a very complicated chemical plant.Its reaction has substantial connection with the catalytic action of enzyme.Enzyme will produce activity, must have coenzyme to participate in.Known many vitamin are the coenzyme of enzyme or the ingredient of coenzyme.Therefore, vitamin is the important substance of keeping and regulating the body homergy.Can think that best vitamin is with the form of " bioactive substance ", is present in the tissue.
The discovery of vitamin is that the greatness in 20th century one of is found.1897, Ai Keman (Christian Eijkman) found that in the Java rice only eat correct grinding can suffer from vitamin B1 deficiency, can treat this disease without the brown rice of milling.And find to control beriberic material ability water or alcohol extraction, claimed at that time that this material was " water solublity B ".Contain " cofactor " beyond isolating protein, lipid, carbohydrate, inorganic salt and the water in the proof foods in 1906, its amount is very little, but is that growth of animal institute is essential.1911 Casimir Feng Ke (KazimierzFunk) identify that in brown rice, to resist beriberic material be amine (one type of nitrogenous chemical compound), it be earn a bare living necessary, so suggestion called after " Vitamine ".Be Vital (life) amine (amine), the Chinese meaning is " life amine ".Find many vitamin later on successively, their chemical property is different, and physiological function is different, finds that also many vitamin do not contain amine, and is nonnitrogenous, but the name of Feng Ke continuity used, just last alphabetical " e " is removed.The initial vitamin B of finding turned out to be the vitamin B complex afterwards, separate through purifying and find, be several kinds of materials, just character and the distributional class in food seemingly, and majority is a coenzyme.The quantity delivered that has must balance each other, and like vitamin B1, B2 and PP, otherwise can influence physiological action.The vitamin B complex comprises: pantothenic acid, nicotinic acid, biotin, folic acid, vitamin B1 (thiamine), vitamin B2 (riboflavin), pyridoxol (vitamin B6) and cobalamin (vitamin B12).Someone also is included in choline, inositol, PABA (para-amino benzoic acid), carnitine, thioctic acid in the B complex.
Vitamin is extended familys, the present known kind more than 20 that just has, and people are divided into water soluble vitamins and fatsoluble vitamin two big classes to vitamin by its deliquescent difference.Fatsoluble vitamin comprises four kinds of A, D, E, K, and water soluble vitamins comprises vitamin B group (B1, B2, B6, B12 etc.) and vitamin C.
Because the vitamin kind is more, character is different, the vitamin preparation of therefore present domestic production is in the majority with separate constituent, and Cernevit-12 is less, and dosage form is main with tablet and capsular oral formulations.
CN200910061812.6 discloses a kind of injection complex vitamin freeze-dried powder injection in the prior art, and it is formulated by fatsoluble vitamin, water soluble vitamins, solubilizing agent and plasticizer.CN200810138322.7 discloses a kind of stable, aqueous solution preparation that contains fatsoluble vitamin and water soluble vitamins.CN200710190669.1 discloses method for preparing and the production technology that the invention discloses a kind of 13 kinds of composite vitamin injections, and this injection adopts two dosage forms.In fact above-mentioned mix preparation does not solve the technical barrier of vitamin stability well, but also causes the curative effect of vitamin to reduce.
For the curative effect with fatsoluble vitamin and Vitamin H is penetrated in better performance, the inventor has proposed a kind of pharmaceutical composition with fat-soluble vitamin for injection and Vitamin H and has carried out the Combination application packing according to this situation; Preparation so respectively; Assembly packaging has not only made things convenient for patient's application clinically, and multivitamin is used simultaneously; Therapeutic effect is better, and stability of formulation is also better.
Summary of the invention
One of the object of the invention provides the pharmaceutical composition of a kind of fat-soluble vitamin for injection and Vitamin H, and fat-soluble vitamin for injection and Vitamin H are aseptic freeze-dried injectable powder.
One of the object of the invention provides the drug regimen application packages of a kind of fat-soluble vitamin for injection and Vitamin H, comprises fat-soluble vitamin for injection and Vitamin H.
Combination application packing provided by the invention, usage are earlier with water for injection or glucose injection dissolving, intravenous drip respectively again.
In the Combination application packing of the present invention; Fat-soluble vitamin for injection comprises fat-soluble vitamin for injection (I) and two specifications of fat-soluble vitamin for injection (II); Wherein, fat-soluble vitamin for injection (I) per unit dosage is mainly by 3-Hydroxyretinol 10～415.0 μ g, vitamin D
24.50～6.00 μ g, vitamin E 2.90～3.50mg, vitamin K
190.0～120.0 μ g, 150g Tween 80,50g polysorbas20,80g dehydrated alcohol, 160g mannitol are processed; Fat-soluble vitamin for injection (II) per unit dosage is mainly by vitamin A 0.891～1.089mg, vitamin D
24.5～5.5 μ g, vitamin E 8.19～10.01mg, vitamin K
10.135～0.165mg, 200g Tween 80,60g polysorbas20,120g dehydrated alcohol, 160g mannitol are processed.
In the Combination application packing of the present invention, Vitamin H per unit dosage is mainly by vitamin B
12.8～3.4mg, vitamin B
24.4～5.4mg, nicotiamide 36～44mg, vitamin B
64.4～5.4mg, sodium pantothenate 14.8～18.1mg, sodium ascorbate 102～124mg, biotin 54～66 μ g, folic acid 0.36～0.44mg, vitamin B
124.5～6.0 μ g, glycine 270～330mg, Calcium Disodium Versenate 0.45～0.55mg, methyl parahydroxybenzoate 0.45～0.55mg process.
Another object of the present invention has provided a kind of fat-soluble vitamin for injection (I) or method for making (II), may further comprise the steps:
(1) takes by weighing vitamin A, vitamin E, the vitamin D of recipe quantity
2, vitamin K
1, and Tween 80, polysorbas20 and dehydrated alcohol, fully mix to principal agent and dissolve fully, add 90% water for injection again, stir, add recipe quantity mannitol, stir and make its dissolving, benefit adds to the full amount of water for injection;
(2) regulate pH value between the 5.0-6.5 with the sodium hydroxide solution of 1mol/L, add the active carbon stirring and adsorbing of 0.03% (g/ml), filter decarburization;
(3) fine straining, packing;
(4) lyophilization.
As the preferred embodiment of the present invention, further, freeze-dry process is:
A, pre-freeze: the medicinal liquid that branch is installed is cooled to-50～-35 ℃ by 1～3 ℃ of/minute speed, is incubated freezing 3 hours;
B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 7～9 hours, at the uniform velocity slowly be warming up to-22～-18 ℃ then, be incubated 1～2 hour, in 4～6 hours, at the uniform velocity be warming up to 10～15 ℃ again;
C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
Preferably:
A, pre-freeze: the medicinal liquid that branch is installed is cooled to-40 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours;
B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 8 hours, at the uniform velocity slowly be warming up to-20 ℃ then, be incubated 2 hours, in 5 hours, at the uniform velocity be warming up to 10 ℃ again;
C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
Another object of the present invention provides a kind of method for making of Vitamin H, may further comprise the steps:
(1) takes by weighing the supplementary material of recipe quantity respectively; The water for injection of adding 80% stirs, and regulates about pH value to 5.8 with sodium hydroxide solution or the hydrochloric acid solution of 1mol/L; Supplementary material dissolves fully; Benefit adds to the full amount of water for injection, and the active carbon that adds 0.03% (g/ml) adsorbs, and filters decarburization;
(2) fine straining, packing;
(3) lyophilization.
As the preferred embodiment of the present invention, further, freeze-dry process is:
A, pre-freeze: the medicinal liquid that branch is installed is cooled to-50～-35 ℃ by 1～3 ℃ of/minute speed, is incubated freezing 3 hours;
B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 7～9 hours, at the uniform velocity slowly be warming up to-22～-18 ℃ then, be incubated 1～2 hour, in 4～6 hours, at the uniform velocity be warming up to 10～15 ℃ again;
C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
Preferably:
A, pre-freeze: the medicinal liquid that branch is installed is cooled to-40 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours;
B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 8 hours, at the uniform velocity slowly be warming up to-20 ℃ then, be incubated 2 hours, in 5 hours, at the uniform velocity be warming up to 10 ℃ again;
C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
The product of above-mentioned freeze-dry process, active component finally exist with solid form, have better stability than injection, and be more secure to drug quality.
The application of the pharmaceutical composition that the present invention also provides a kind of fat-soluble vitamin for injection and Vitamin H in preparation treatment vitamins nutritional supplementation medicine is in order to satisfy adult or the child every day physiological need to vitamin.
Fat-soluble vitamin for injection (I) is applicable to child below 11 years old and baby, and every day, per kilogram of body weight was 1/5th, and every day, maximal dose was 2.Under aseptic condition, get 2ml water for injection with syringe and inject bottle before using, slowly jolting to lyophilized powder dissolves.Join infusion in 0.9% sodium chloride or 5% glucose injection, and in 24 hours, use up.Also can unite use with Vitamin H.
Fat-soluble vitamin for injection (II) is applicable to adult and ten one-year-old above children, uses 1 every day.Under aseptic condition, get 2ml water for injection with syringe and inject bottle before using, slowly jolting to lyophilized powder dissolves, and joins then in 0.9% sodium chloride or 5% glucose injection, gets final product infusion after shaking up gently, and in 8 hours, uses up.Also can unite and use or follow the doctor's advice with Vitamin H.
Vitamin H, adult and the above child of body weight 10kg, one bottle of every day; The child of the discontented 10kg of neonate and body weight, the daily requirement amount is per kilogram of body weight 1ml (with following solution 10ml dissolving back), intravenous drip.Under aseptic condition, originally the available following solution 10ml of article dissolves when compatibility is guaranteed: (1) fatsoluble vitamin injection (II) (supplying adult's child's use more than one-year-old with ten); (2) compound recipe fatsoluble vitamin injection (I) (supplying ten one-year-old following children to use); (3) fat emulsion injection; (4) there is not electrolytical glucose injection; 5, water for injection; Need add behind the fat emulsion injection again through venoclysis with above-mentioned (1), (2) and (3) liquid mixture prepared, also can add in the fat emulsion injection in the glucose sugar injection again through venoclysis and can add with method (4) or (5) liquid mixture prepared.After the dissolving of these article, should under aseptic condition, add in the transfusion immediately, and in 24 hours, use up.
Usage and dosage according to above fat-soluble vitamin for injection and Vitamin H can be found out; The two Application of composite has more comprehensively been replenished the needs of human body to vitamin; Also be to use more a kind of composite reagent at present clinically, the inventor is according to this situation, and the inventor has proposed a kind of pharmaceutical composition with fat-soluble vitamin for injection and Vitamin H and carried out the Combination application packing; The vitamin that needed by human body is wanted has carried out replenishing in all directions; So not only make things convenient for patient's application clinically, avoided the defective of using single vitamin to cause, improved therapeutic effect greatly.
Benefit of the present invention:
(1) Combination application packing of the present invention greatly facilitates patient's application clinically, has improved the safety that the patient uses.
(2) Combination application of the present invention packing has been practiced thrift cost to the buying of medication unit with make up a prescription very big convenience also is provided.
(3) Combination application of the present invention packing is existing with joining at present, and the stability of each drug alone is of great benefit to, and can improve the clinical practice quality and the bioavailability of medicine.
(4) combination of the present invention is used to treat the patient that multivitamin lacks, and has better effect.
The specific embodiment
Embodiment 1The preparation of assembly packaging medicine
1, the preparation of fat-soluble vitamin for injection (I)
(1) takes by weighing vitamin A 415mg, vitamin E 3.5g, the vitamin D of recipe quantity
26mg, vitamin K
1120mg and 150g Tween 80,50g polysorbas20,80g dehydrated alcohol fully mix to principal agent and dissolve fully, add the water for injection of 1800ml again, stir, and add 160g mannitol, stir and make its dissolving, add water for injection to 2000ml;
(2) regulate pH value to 6.5 with the sodium hydroxide solution of 1mol/L, add the active carbon stirring and adsorbing of 0.6g, filter decarburization;
(3) fine straining, packing, 2ml/ bottle;
(4) lyophilization: a, pre-freeze: the medicinal liquid that branch is installed is cooled to-40 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours; B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 8 hours, at the uniform velocity slowly be warming up to-20 ℃ then, be incubated 2 hours, in 5 hours, at the uniform velocity be warming up to 10 ℃ again; C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
2, the preparation of Vitamin H
(1) takes by weighing vitamin B respectively
13.4g, vitamin B
25.4g, nicotiamide 44g, vitamin B
65.4g, sodium pantothenate 18.1g, sodium ascorbate 124g, biotin 66mg, folic acid 0.44g, vitamin B
126.0mg, glycine 330g, Calcium Disodium Versenate 0.55g, methyl parahydroxybenzoate 0.55g; Add 2400ml water for injection, stir, regulate pH value to 5.9 with sodium hydroxide solution or the hydrochloric acid solution of 1mol/L; Supplementary material dissolves fully; Add water for injection to 3000ml, the active carbon that adds 0.9g adsorbs, and filters decarburization;
(2) fine straining, packing, 3ml/ bottle;
(3) lyophilization: a, pre-freeze: the medicinal liquid that branch is installed is cooled to-40 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours; B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 8 hours, at the uniform velocity slowly be warming up to-20 ℃ then, be incubated 2 hours, in 5 hours, at the uniform velocity be warming up to 10 ℃ again; C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃, heat preservation and dryness 3 hours in 4 hours; Detect qualified back packing warehouse-in.
3, assembly packaging
With the fat-soluble vitamin for injection (I) and the Vitamin H difference labeling of preparation, respectively get 1 then and be loaded in the packing box, promptly get.
Embodiment 2The preparation of assembly packaging medicine
1, the preparation of fat-soluble vitamin for injection (II)
(1) takes by weighing vitamin A 1.089g, vitamin E 10.01g, the vitamin D of recipe quantity
25.5mg, vitamin K
10.165g, fully mix to principal agent and dissolve fully with 200g Tween 80,60g polysorbas20,120g dehydrated alcohol, add the water for injection of 1800ml again, stir, add 160g mannitol, stir and make its dissolving, add water for injection to 2000ml;
(2) regulate pH value to 5.0 with the sodium hydroxide solution of 1mol/L, add the active carbon stirring and adsorbing of 0.6g, filter decarburization;
(3) fine straining, packing, 2ml/ bottle;
(4) lyophilization: a, pre-freeze: the medicinal liquid that branch is installed is cooled to-40 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours; B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 8 hours, at the uniform velocity slowly be warming up to-20 ℃ then, be incubated 2 hours, in 5 hours, at the uniform velocity be warming up to 10 ℃ again; C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
2, the preparation of Vitamin H
(1) takes by weighing vitamin B respectively
13.4g, vitamin B
25.4g, nicotiamide 44g, vitamin B
65.4g, sodium pantothenate 18.1g, sodium ascorbate 124g, biotin 66mg, folic acid 0.44g, vitamin B
126.0mg, glycine 330g, Calcium Disodium Versenate 0.55g, methyl parahydroxybenzoate 0.55g; Add 2400ml water for injection, stir, regulate pH value to 6.0 with sodium hydroxide solution or the hydrochloric acid solution of 1mol/L; Supplementary material dissolves fully; Add water for injection to 3000ml, the active carbon that adds 0.9g adsorbs, and filters decarburization;
(2) fine straining, packing, 3ml/ bottle;
(3) lyophilization: a, pre-freeze: the medicinal liquid that branch is installed is cooled to-40 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours; B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 8 hours, at the uniform velocity slowly be warming up to-20 ℃ then, be incubated 2 hours, in 5 hours, at the uniform velocity be warming up to 10 ℃ again; C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
3, assembly packaging
With the fat-soluble vitamin for injection (I) and the Vitamin H difference labeling of preparation, respectively get 1 then and be loaded in the packing box, promptly get.
Comparative Examples 1
Comparative Examples 1 is identical with both compositions of embodiment 1.
Difference is: freeze-dry process is different, is the disposable step of freeze drying of routine, that is, the medicinal liquid that branch is installed is cooled to-40 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours, and heat preservation and dryness 3 hours detects qualified back packing warehouse-in.
Comparative Examples 2
Comparative Examples 2 is identical with the composition of embodiment 2.
Difference is: freeze-dry process is different, is the disposable step of freeze drying of routine, that is, the medicinal liquid that branch is installed is cooled to-45 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours, and heat preservation and dryness 3 hours detects qualified back packing warehouse-in.
Test Example 1The influence factor tests contrast
Because most vitamin are to light, thermally labile; And be exposed in the air easy oxidized; Therefore; Brown cillin bottle+butyl rubber plug that freeze-dried powder of the present invention is selected good leak tightness in influence factor test is as inner packing, gets the foregoing description 1 and 2 and the factors influencing of Comparative Examples 1 and 2 definite prescriptions and process high-temperature, illumination.The investigation project mainly comprises pH value, clarity, content etc.
Exposure experiments to light: get the 1st reply and close the vitamin freeze-dried powder injection sample and put into lighting box and carry out exposure experiments to light, respectively at 5 days, sampling in 10 days detected, and light intensity is 4500Lx.
Hot test: get the 1st reply and close the vitamin freeze-dried powder injection sample and put into 60 ℃ of baking ovens and carry out high temperature and investigate test, detect respectively at sampling in 5,10 days.
The result sees table 1-2.
Claims (10)
1. pharmaceutical composition that comprises fat-soluble vitamin for injection and Vitamin H; It is characterized in that fat-soluble vitamin for injection and Vitamin H are aseptic freeze-dried injectable powder, wherein fat-soluble vitamin for injection is selected from fat-soluble vitamin for injection (I) or fat-soluble vitamin for injection (II).
2. pharmaceutical composition that comprises fat-soluble vitamin for injection (I) and Vitamin H, the per unit dosage that it is characterized in that fatsoluble vitamin (I) is mainly by vitamin A 310～415.0 μ g, vitamin D
24.50～6.00 μ g, vitamin E 2.90～3.50mg, vitamin K
190.0～120.0 μ g, 150g Tween 80,50g polysorbas20,80g dehydrated alcohol, 160g mannitol are processed;
Vitamin H per unit dosage is mainly by vitamin B
12.8～3.4mg, vitamin B
24.4～5.4mg, nicotiamide 36～44mg, vitamin B
64.4～5.4mg, sodium pantothenate 14.8～18.1mg, sodium ascorbate 102～124mg, biotin 54～66 μ g, folic acid 0.36～0.44mg, vitamin B
124.5～6.0 μ g, glycine 270～330mg, Calcium Disodium Versenate 0.45～0.55mg, methyl parahydroxybenzoate 0.45～0.55mg process.
3. a pharmaceutical composition that comprises fat-soluble vitamin for injection (II) and Vitamin H is characterized in that fat-soluble vitamin for injection (II) per unit dosage is mainly by vitamin A 0.891～1.089mg, vitamin D
24.5～5.5 μ g, vitamin E 8.19～10.01mg, vitamin K
10.135～0.165mg, 200g Tween 80,60g polysorbas20,120g dehydrated alcohol, 160g mannitol are processed;
Vitamin H per unit dosage is mainly by vitamin B
12.8～3.4mg, vitamin B
24.4～5.4mg, nicotiamide 36～44mg, vitamin B
64.4～5.4mg, sodium pantothenate 14.8～18.1mg, sodium ascorbate 102～124mg, biotin 54～66 μ g, folic acid 0.36～0.44mg, vitamin B
124.5～6.0 μ g, glycine 270～330mg, Calcium Disodium Versenate 0.45～0.55mg, methyl parahydroxybenzoate 0.45～0.55mg process.
4. one kind prepares fat-soluble vitamin for injection (I) or method (II), it is characterized in that may further comprise the steps:
(1) takes by weighing vitamin A, vitamin E, the vitamin D of recipe quantity
2, vitamin K
1, and Tween 80, polysorbas20 and dehydrated alcohol, fully mix to principal agent and dissolve fully, add 90% water for injection again, stir, add recipe quantity mannitol, stir and make its dissolving, benefit adds to the full amount of water for injection;
(2) regulate pH value between the 5.0-6.5 with the sodium hydroxide solution of 1mol/L, add the active carbon stirring and adsorbing of 0.03% (g/ml), filter decarburization;
(3) fine straining, packing;
(4) lyophilization.
5. according to the method for claim 4, it is characterized in that the lyophilization of step (4) is preferably:
A, pre-freeze: the medicinal liquid that branch is installed is cooled to-50～-35 ℃ by 1～3 ℃ of/minute speed, is incubated freezing 3 hours;
B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 7～9 hours, at the uniform velocity slowly be warming up to-22～-18 ℃ then, be incubated 1～2 hour, in 4～6 hours, at the uniform velocity be warming up to 10～15 ℃ again;
C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
6. method for preparing Vitamin H is characterized in that may further comprise the steps:
(1) takes by weighing the supplementary material of recipe quantity respectively; The water for injection of adding 80% stirs, and regulates about pH value to 5.8 with sodium hydroxide solution or the hydrochloric acid solution of 1mol/L; Supplementary material dissolves fully; Benefit adds to the full amount of water for injection, and the active carbon that adds 0.03% (g/ml) adsorbs, and filters decarburization;
(2) fine straining, packing;
(3) lyophilization.
7. according to the method for claim 6, it is characterized in that the lyophilization of step (3) is preferably:
A, pre-freeze: the medicinal liquid that branch is installed is cooled to-50～-35 ℃ by 1～3 ℃ of/minute speed, is incubated freezing 3 hours;
B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, in 7～9 hours, at the uniform velocity slowly be warming up to-22～-18 ℃ then, be incubated 1～2 hour, in 4～6 hours, at the uniform velocity be warming up to 10～15 ℃ again;
C, drying: the distillation medicine of stage after finishing that finish at the uniform velocity was warming up to 30 ℃ in 4 hours, heat preservation and dryness 3 hours detects qualified back packing and puts in storage.
8. according to 1 described pharmaceutical composition, it is characterized in that this pharmaceutical composition can pack for Combination application.
9. according to the application of each described pharmaceutical composition of claim 1-8 in preparation treatment vitamins nutritional supplementation medicine, in order to satisfy adult or child every day physiological need to vitamin.
10. according to each described pharmaceutical composition of claim 1-8, it is characterized in that earlier with water for injection or glucose injection dissolving, intravenous drip respectively again.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656611A (en) * | 2013-12-21 | 2014-03-26 | 吴赣英 | Water-soluble vitamin combination medicament |
| CN104382865A (en) * | 2014-10-29 | 2015-03-04 | 武汉汇海医药有限公司 | Water-soluble vitamin pharmaceutical composition for injection |
| CN105394774A (en) * | 2015-11-22 | 2016-03-16 | 威海百合生物技术股份有限公司 | Method for improving solubility of vitamin A acetic ester |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103656611A (en) * | 2013-12-21 | 2014-03-26 | 吴赣英 | Water-soluble vitamin combination medicament |
| CN104382865A (en) * | 2014-10-29 | 2015-03-04 | 武汉汇海医药有限公司 | Water-soluble vitamin pharmaceutical composition for injection |
| CN104382865B (en) * | 2014-10-29 | 2017-01-11 | 武汉汇海医药有限公司 | Water-soluble vitamin pharmaceutical composition for injection |
| CN105394774A (en) * | 2015-11-22 | 2016-03-16 | 威海百合生物技术股份有限公司 | Method for improving solubility of vitamin A acetic ester |
| CN110862344A (en) * | 2019-12-03 | 2020-03-06 | 海南顿斯医药科技有限公司 | 1/20 aquo-vitamin B6 compound |
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| CN102499939B (en) | 2013-03-20 |
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Effective date of registration: 20191216 Address after: 570100 No. C03, Haikou Free Trade Zone, Hainan Province Patentee after: Hainan Yongtian Pharmaceutical Institute Co., Ltd. Address before: 570125 C03, Haikou Free Trade Zone, Hainan, China Patentee before: Hainan Meida Pharmaceutical Co., Ltd. |