CN102499939B - 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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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 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 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.
For the curative effect of using fatsoluble vitamin and Vitamin H is penetrated in better performance, the inventor is according to this situation, propose a kind of pharmaceutical composition with fat-soluble vitamin for injection 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 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 purpose of the present 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.
Applied in any combination packing provided by the invention, usage with water for injection or glucose injection dissolving, is distinguished intravenous drip for first again.
In the applied in any combination 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 made; 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 made.
In the applied in any combination 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 make.
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 VitAVitE, 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 again 90% water for injection, 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: 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.
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 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: 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 product of above-mentioned freeze-dry process, active component finally exist with the form of solid, 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 child every day to the physiological need of 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, be finished.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 then joins in 0.9% sodium chloride or 5% glucose injection, gets final product infusion after shaking up gently, and is finished in 8 hours.Also can unite with Vitamin H and use or follow the doctor's advice.
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 (after 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) compound recipe fatsoluble vitamin injection (I) (for ten one-year-old following children); (3) fat emulsion injection; (4) without electrolytical glucose injection; 5, water for injection; Need add behind the fat emulsion injection again through venoclysis with the mixed liquor of above-mentioned (1), (2) and (3) 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 (4) or (5) 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 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 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 fat-soluble vitamin for injection 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 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: 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.
2, the preparation of Vitamin H
(1) takes by weighing respectively vitamin B
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, sodium hydroxide solution or hydrochloric acid solution with 1mol/L are regulated pH value to 5.9, 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 ℃, heat preservation and dryness 3 hours in 4 hours; Detect qualified rear packing warehouse-in.
3, assembly packaging
With fat-soluble vitamin for 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.
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 and 200g Tween 80,60g polysorbas20,120g dehydrated alcohol, fully mix to principal agent and dissolve fully, add again the water for injection of 1800ml, 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: 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.
2, the preparation of Vitamin H
(1) takes by weighing respectively vitamin B
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, 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 fat-soluble vitamin for 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: 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-40 ℃ 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.
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,, 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 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, get above-described embodiment 1 and 2 with 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 results are shown in Table 1-2.
Claims (1)
1. drug regimen application packages 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);
Wherein the per unit dosage of 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 made;
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 made;
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 make.
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| CN103656611A (en) * | 2013-12-21 | 2014-03-26 | 吴赣英 | Water-soluble vitamin combination medicament |
| 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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| CN102499939A (en) | 2012-06-20 |
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