CN102429864B - Medicinal compound of fat-soluble vitamin injection (II) and water-soluble vitamin for injection and preparation method thereof - Google Patents
Medicinal compound of fat-soluble vitamin injection (II) and water-soluble vitamin for injection and preparation method thereof Download PDFInfo
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- CN102429864B CN102429864B CN 201110387733 CN201110387733A CN102429864B CN 102429864 B CN102429864 B CN 102429864B CN 201110387733 CN201110387733 CN 201110387733 CN 201110387733 A CN201110387733 A CN 201110387733A CN 102429864 B CN102429864 B CN 102429864B
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Abstract
The invention relates to a medicinal compound of fat-soluble vitamin injection (II) and a water-soluble vitamin for injection, in particular to a combined application package. The medicinal compound comprises the fat-soluble vitamin injection (II) and the water-soluble vitamin for the injection. When in use, the medicinal compound is dissolved or thinned by using water for the injection or glucose injection liquid first, and then is respectively instilled in a venous way. By using the combined application package provided by the invention, the vitamins needed by a human body are comprehensively replenished; the defects caused by the usage of a single vitamin are avoided; and the treatment effect is improved greatly.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of injection vitamin, be specifically related to compositions and method for making and the application packages of a kind of fatsoluble vitamin injection (II) and Vitamin H, belong to medical technical field.
Background technology
Vitamin is that humans and animals is to keep normal physiological function and an essential class trace organic substance, 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, i.e. so-called avitaminosis occur.
Vitamin has another name called vitamin, and is popular, and the material that namely sustains life 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.Although 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 consists of body tissue and cell, and it can produce power yet, and its effect mainly is the adjusting that participates in organism metabolism.3. most vitamin, body can not synthesize or synthetic quantity not enough, can not satisfy the needs of body, must be often by 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 large materials, only account for minor proportion in natural food, but essential by human body.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 tryptophan transfer nicotinic acid (a kind of vitamin B group), need to but growing amount is deposited; Vitamin C is except primates (comprising the mankind) and 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 occurs.
Vitamin is 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) can suffer from vitamin B1 deficiency at the rice that correct grinding is only eaten in the Java discovery, can treat this disease without the brown rice of milling.And find to control beriberic substance water or alcohol extraction, claimed at that time this material to be " water solublity B ".Contained " cofactor " beyond isolating protein, lipid, carbohydrate, inorganic salt and the water in the proof food in 1906, its amount is very little, but essential by growth of animal.1911 Casimir Feng Ke (KazimierzFunk) identify that to resist beriberic material in brown rice be amine (chemical compound that a class is nitrogenous), it be sustain life necessary, so suggestion called after " Vitamine ".Be Vital(life) amine(amine), the Chinese meaning is " life amine ".Find successively later on many vitamin, 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 vitamin B complex afterwards, separate through purifying and find, be several materials, just character and the distributional class in food seemingly, and majority is coenzyme.The quantity delivered that has must balance each other, and such as vitamin B1, B2 and PP, otherwise can affect physiological action.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, para-aminobenzoic acid (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 large 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, therefore in the majority with separate constituent of the vitamin preparation of at present domestic production, Cernevit-12 is less, and dosage form is take the oral formulations of Tablet and Capsula as main.
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 preparation method 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.
Curative effect for better performance fatsoluble vitamin injection and Vitamin H, the inventor is according to this situation, propose a kind of pharmaceutical composition with fatsoluble vitamin injection (II) and Vitamin H and carried out the applied in any combination packing, so respectively preparation, assembly packaging has not only made things convenient for the application on the patient clinical, and multivitamin is used simultaneously, therapeutic effect is better, and the stability of preparation is also better.
Summary of the invention
One of purpose of the present invention provides the pharmaceutical composition of a kind of fatsoluble vitamin injection (II) and Vitamin H, and fatsoluble vitamin injection (II) is sterile water solution, and Vitamin H is aseptic freeze-dried injectable powder.
One of purpose of the present invention provides the drug regimen application packages of a kind of fatsoluble vitamin injection (II) and Vitamin H, comprises fatsoluble vitamin injection (II) and Vitamin H.
Applied in any combination packing provided by the invention, usage with water for injection or glucose injection dissolving or dilution, is distinguished intravenous drip for first again.
In the applied in any combination packing of the present invention, fatsoluble vitamin injection (II) per unit dosage is mainly by vitamin A 0.99mg, vitamin D
25 μ g, vitamin E 9.1mg, vitamin K
10.15mg, injection soybean oil 1g, injection lecithin 0.12g, glycerol 0.22g make.
In the applied in any combination packing of the present invention, Vitamin H per unit dosage is mainly by vitamin B
13.1mg, vitamin B
24.9mg, nicotiamide 40mg, vitamin B
64.9mg, sodium pantothenate 16.5mg, sodium ascorbate 113mg, biotin 60 μ g, folic acid 0.4mg, vitamin B
125 μ g, glycine 300mg, Calcium Disodium Versenate 0.5mg, methyl parahydroxybenzoate 0.5mg make.
Another object of the present invention has provided the method for making of a kind of fatsoluble vitamin injection (II), may further comprise the steps:
(1) takes by weighing VitAVitE, the vitamin D of recipe quantity
2, vitamin K
1, injection soybean oil, injection lecithin and glycerol, fully mix to principal agent and dissolve fully, add again 90% water for injection, stir, benefit adds to the full amount of water for injection, and stirs;
(2) regulate pH value between the 6.5-9.0 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, fill, 10ml/ props up;
(4) sterilization, 121 ℃ of pressure sterilizings 15 minutes.
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 respectively the supplementary material of recipe quantity, the water for injection of adding 80%, stir, sodium hydroxide solution or hydrochloric acid solution with 1mol/L are regulated about pH value to 5.8, supplementary material dissolves fully, benefit adds to the full amount of water for injection, and adds 0.03%(g/ml) active carbon adsorb, filter decarburization;
(2) fine straining, packing;
(3) lyophilization.
As the preferred embodiment of the present invention, further, freeze-dry process is:
A, pre-freeze: will divide the medicinal liquid that installs to be cooled to-50～-35 ℃ by 1 ~ 3 ℃ of/minute speed, and be incubated freezing 3 hours;
B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, then uniform speed slow is warming up to-22～-18 ℃ in 7～9 hours, is incubated 1～2 hour, at the uniform velocity is warming up to 10 ~ 15 ℃ again in 4～6 hours;
C, drying: the medicine after the complete stage that will distil finishes at the uniform velocity was warming up to 30 ℃ in 4 hours, and heat preservation and dryness 3 hours detects qualified rear packing warehouse-in.
Preferably:
A, pre-freeze: will divide the medicinal liquid that installs to be cooled to-40 ℃ by 2 ℃ of/minute speed, and be incubated freezing 3 hours;
B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, then uniform speed slow is warming up to-20 ℃ in 8 hours, is incubated 2 hours, at the uniform velocity is warming up to 10 ℃ again in 5 hours;
C, drying: the medicine after the complete stage that will distil finishes at the uniform velocity was warming up to 30 ℃ in 4 hours, and heat preservation and dryness 3 hours detects qualified rear packing warehouse-in.
The present invention also provides the application of pharmaceutical composition in preparation treatment vitamins nutritional supplementation medicine of a kind of fatsoluble vitamin injection (II) and Vitamin H, in order to satisfy the physiological need of every day to vitamin of being grown up.
The present invention also provides the pharmaceutical composition of a kind of fatsoluble vitamin injection (II) and Vitamin H at the adult patient that preparation treatment multivitamin lacks, and has better effect.
Fatsoluble vitamin injection (II) be applicable to adult and ten one-year-old above children, every day 10ml.Under aseptic condition, this product is joined in 500ml fat emulsion injection or 5% glucose injection before using, jog shakes up rear infusion, and is finished in 24 hours.This product can be used for dissolving Vitamin H, before the use, under aseptic condition, this product 10ml is added one bottle of Vitamin H, joins in the fat emulsion injection after the dissolving again.
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 that per kilogram of body weight 1ml(is rear with following solution 10ml dissolving), intravenous drip.Under aseptic condition, this product can be dissolved with following solution 10ml when compatibility is guaranteed: (1) fatsoluble vitamin injection (II) (for the child of adult and ten more than one-year-old); (2) fat emulsion injection; (3) without electrolytical glucose injection; (4) water for injection; Need add behind the fat emulsion injection again through venoclysis with the mixed liquor of above-mentioned (1) and (2) preparation, also can add in the fat emulsion injection in the sugared injection of glucose again through venoclysis and can add with the mixed liquor of method (3) or (4) preparation.After this product dissolving, should under aseptic condition, add in the transfusion immediately, and in 24 hours, be finished.
Usage and dosage according to above fatsoluble vitamin injection (II) 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 clinically more a kind of composite reagent at present, the inventor is according to this situation, the inventor has proposed a kind of pharmaceutical composition with fatsoluble vitamin injection (II) and Vitamin H and has carried out the applied in any combination packing, the vitamin that needed by human body is wanted has carried out replenishing in all directions, so not only made things convenient for the application on the patient clinical, avoid the defective of using single vitamin to cause, greatly improved therapeutic effect.
Benefit of the present invention:
(1) applied in any combination packing of the present invention greatly facilitates the application on the patient clinical, has improved the safety that the patient uses.
(2) applied in any combination of the present invention packing has been saved cost to the buying of medication unit with make up a prescription very large convenience also is provided.
(3) applied in any combination of the present invention packing matching while using is of great benefit to the stability of each drug alone, can improve clinical practice quality and the bioavailability of medicine.
(4) combination of the present invention is used for the treatment of the adult patient that multivitamin lacks, and has better effect.
The specific embodiment
Embodiment 1The preparation of assembly packaging medicine
1, the preparation of fatsoluble vitamin injection (II)
(1) takes by weighing vitamin A 0.99g, vitamin E 9.1g, the vitamin D of recipe quantity
25mg, vitamin K
10.15g and injection soybean oil 1000g, injection lecithin 120g, glycerol 220g, fully mix to principal agent and dissolve fully, add again the water for injection of 9000ml, stir, add water for injection to 10000ml, stir;
(2) regulate pH value to 8.0 with the sodium hydroxide solution of 1mol/L, add the active carbon stirring and adsorbing of 3g, filter decarburization;
(3) fine straining, fill, 10ml/ props up;
(4) sterilization, 121 ℃ of pressure sterilizings 15 minutes.
2, the preparation of Vitamin H
(1) takes by weighing respectively vitamin B
13.1g, vitamin B
24.9g, nicotiamide 40g, vitamin B
64.9g, sodium pantothenate 16.5g, sodium ascorbate 113g, biotin 60mg, folic acid 0.4g, vitamin B
125mg, glycine 300g, Calcium Disodium Versenate 0.5g, methyl parahydroxybenzoate 0.5g, add 2400ml water for injection, stir, sodium hydroxide solution or hydrochloric acid solution with 1mol/L are regulated pH value to 6.0, 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: will divide the medicinal liquid that installs to be cooled to-40 ℃ by 2 ℃ of/minute speed, and be incubated freezing 3 hours; B, distillation: the medicine evacuation that pre-freeze is good, to 15Pa, then uniform speed slow is warming up to-20 ℃ in 8 hours, is incubated 2 hours, at the uniform velocity is warming up to 10 ℃ again in 5 hours; C, drying: the medicine after the complete stage that will distil finishes at the uniform velocity was warming up to 30 ℃ in 4 hours, and heat preservation and dryness 3 hours detects qualified rear packing warehouse-in.
3, assembly packaging
With fatsoluble vitamin injection (I) and the Vitamin H difference labeling of preparation, then respectively get 1 and be loaded in the packing box, and get final product.
Comparative Examples 1
Comparative Examples 1 is identical with both compositions of embodiment 1.
Difference is: (1) with water for injection dissolving injection soybean oil, injection lecithin and glycerol, adds active component VitAVitE, vitamin D first again
2, vitamin K
1(2) fatsoluble vitamin injection (II) is regulated pH value to 6.0;
(3)Freeze-dry process is different, is the disposable step of freeze drying of routine,, with dividing the medicinal liquid that installs to be cooled to-45 ℃ by 2 ℃ of/minute speed, is incubated freezing 3 hours that is, and heat preservation and dryness 3 hours detects qualified rear packing warehouse-in.
Test example 1Influence factor's Experimental Comparison
Because most vitamin are to light, thermally labile, and be exposed in the air easily oxidizedly, therefore, freeze-dried powder of the present invention selects the brown cillin bottle+butyl rubber plug of good leak tightness as inner packing in influence factor's test; Injection selects brown ampoule bottle as inner packing, gets the factors influencing of prescription that above-described embodiment 1 and Comparative Examples 1 determine and process high-temperature, illumination.The investigation project mainly comprises pH value, clarity, content etc.
Exposure experiments to light: get the fatsoluble vitamin injection (II) of embodiment 1 and Comparative Examples 1 preparation and Vitamin H sample and put into lighting box and carry out exposure experiments to light, respectively at sampling detection in 5,10 days, light intensity was 4500Lx.
Hot test: get the fatsoluble vitamin injection (II) of embodiment 1 and Comparative Examples 1 preparation and Vitamin H sample and put into 60 ℃ of baking ovens and carry out high temperature and investigate test, respectively at sampling detection in 5,10 days.
The results are shown in Table 1.
The sample effects factor of table 1 embodiment 1 and Comparative Examples 1 is investigated the result
As shown in Table 1, freeze-dried powder of the present invention is respectively investigated 5 days and 10 days through illumination and 60 ℃ of tests, and Comparative Examples 2 content decrease, and it is muddy that clarity becomes, and pH value descends, and this shows that sample of the present invention has good effect for its stability.
Claims (1)
1. drug regimen application packages that comprises fatsoluble vitamin injection (II) and Vitamin H, it is characterized in that fatsoluble vitamin injection (II) is sterile water solution, Vitamin H is aseptic freeze-dried injectable powder; Wherein, fatsoluble vitamin injection (II) per unit dosage is by vitamin A 0.99mg, vitamin D
25 μ g, vitamin E 9.1mg, vitamin K
10.15mg, injection soybean oil 1g, injection lecithin 0.12g, glycerol 0.22g make;
Vitamin H per unit dosage is by vitamin B
13.1mg, vitamin B
24.9mg, nicotiamide 40mg, vitamin B
64.9mg, sodium pantothenate 16.5mg, sodium ascorbate 113mg, biotin 60 μ g, folic acid 0.4mg, vitamin B
125 μ g, glycine 300mg, Calcium Disodium Versenate 0.5mg, methyl parahydroxybenzoate 0.5mg make.
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103040845B (en) * | 2013-01-21 | 2014-07-16 | 西安安健药业有限公司 | Fat emulsion injection for supplementing fat-soluble vitamins |
| CN103169755B (en) * | 2013-02-04 | 2014-04-16 | 海南百思特医药科技有限公司 | Pharmaceutical composition of water-soluble vitamins for injection, fat-soluble vitamins for injection and fat emulsion injection |
| CN103169756B (en) * | 2013-02-04 | 2014-07-02 | 海南圣欣医药科技有限公司 | Pharmaceutical composition of water-soluble vitamins for injection, fat-soluble vitamin injection and fat emulsion injection |
| CN105663144A (en) * | 2016-01-06 | 2016-06-15 | 施维雅(青岛)生物制药有限公司 | Fat-soluble vitamin water-based preparation for animals and preparing method and use method thereof |
| CN105663145A (en) * | 2016-01-06 | 2016-06-15 | 施维雅(青岛)生物制药有限公司 | Fat-soluble vitamin injection liquid for animals and preparing method and use method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1824309A (en) * | 2005-12-31 | 2006-08-30 | 无锡凯夫制药有限公司 | Method of preparing soluble vitamin for injection using ultra sonic wave oscillation technology and its medicinal preparation |
| 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 |
| CN101537012A (en) * | 2009-04-24 | 2009-09-23 | 武汉普生制药有限公司 | Complex vitamin freeze-dried powder injection and preparation method thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1824309A (en) * | 2005-12-31 | 2006-08-30 | 无锡凯夫制药有限公司 | Method of preparing soluble vitamin for injection using ultra sonic wave oscillation technology and its medicinal preparation |
| 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 |
| CN101537012A (en) * | 2009-04-24 | 2009-09-23 | 武汉普生制药有限公司 | Complex vitamin freeze-dried powder injection and preparation method thereof |
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