CN101953843A

CN101953843A - Compound vitamin composition for injection and preparation method thereof

Info

Publication number: CN101953843A
Application number: CN2009100889734A
Authority: CN
Inventors: 李奇
Original assignee: Beijing Rundekang Medical Technology Co Ltd
Current assignee: Beijing Rundekang Medical Technology Co Ltd
Priority date: 2009-07-15
Filing date: 2009-07-15
Publication date: 2011-01-26

Abstract

The invention relates to a compound vitamin composition for injection, which comprises water soluble vitamins and fat soluble vitamins, wherein the water soluble vitamins and the fat soluble vitamins comprise, but not limited to, vitamin B, vitamin C, vitamins A, D, E and K, and pharmaceutically acceptable medicinal compositions prepared by mixing auxiliaries. In a preparation method, according to the method of the invention, the auxiliaries of specific sorts and in specific percentage are added into the various vitamins which are taken as raw materials, and then a nutritive preparation for intravenous injection is developed. The compound vitamin composition for injection can be used for maintaining nutrition for patients.

Description

A kind of composite vitamin for injection composition and method of making the same

Technical field

The present invention relates to a kind of is the composition for injection of main medicinal ingredient with multivitamin, can be used for the supply of patient's vitamin and keeping of nutrition.Belong to medical technical field.

Background technology

Vitamin is to participate in metabolic essential material on physiology, is the important composition composition of coenzyme in the body enzyme system, and during vitamin deficiency, some enzyme imbalance causes obstacle takes place on the substance metabolism in the human body, even gives rise to diseases.

Vitamin is extended familys, the present known kind more than 20 that just has, it is different with other nutrients such as protein, fat, sugar, and vitamin is a class low molecular compound, 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, exists jointly with lipid in food, also absorbs relevantly with lipid when intestinal absorption, and it is low to drain efficient, thus during Excessive Intake, can accumulate in vivo, the generation illeffects, even poison.Water soluble vitamins comprises vitamin B group (B1, B2, B6, B12, pp etc.) and vitamin C.The characteristics of water soluble vitamins: 1. water-soluble, be insoluble to fat and organic solvent: 2. from urine, excrete easily, and discharge the efficient height, so eat in a large number generally can not produce and accumulate and toxic action: 3. the overwhelming majority participates in various enzyme system work with coenzyme or prothetic group form, all plays epochmaking effect in many links of intermediate supersession; 4. its endotrophic level majority all can reflect in blood and urine.

Summary of the invention

Composite vitamin for injection compositions of the present invention and the tangible difference of other vitamin products are to replace the vitamin vitamin D2 with vitamin D3.

The structural formula of vitamin D is as follows:

Vitamin D2 has similar structure to vitamin D3, also quite similar (the Anthony W.Norman and Helen L.Henry of its dissolubility and stability, chapter 2 Vitamin D, Handbook of Vitamins 4th, CRC press, 2007,47), and from physiologically active, the activity of vitamin D2 has only 25～30% (the Armas L.A.G. of D3, Hollis B.W., andHeaney R.P., Vitamin D2 is much less effective than vitamin D3 in humans.J.Clin.Endocrinol.Metab., 89,5387,2004.)

So, in this patent, vitamin D2 is replaced with vitamin D3 in order better to replenish the vitamin of needed by human body. for the better effect of explanation vitamin D3, we have carried out following experiment:

9 of male Beagle dogs, the internal hemorrhage treatment, earlier with sugar, aminoacid, wherein be loaded with liquid electrolyte treatment five days, then be divided into three groups at random, the A group adds with multivitamin injection (containing vitamin D3), the B group adds with multivitamin injection (containing vitamin D2), and the C group continues the initial mode treatment.Continuously 4 weeks of treatment, observe and respectively organize the dog recovery situation, detect and respectively organize the blood vitamine concentration.The result shows: 3 dog internal hemorrhage situations of A group are all significantly taken a turn for the better, and show no obvious abnormalities symptom.3 dog idols of B group have ill symptomses such as vomiting, and slighter, there is a change for the better for internal hemorrhage after 4 weeks, but do not have the effect of A group remarkable.3 dogs of C group are with symptoms of emesis is above a week indirectly, and 2 numbers of elements are dead in the future, and 1 brain is badly damaged.The blood vitamine concentration detects and shows: A group vitamin B1, B2, B6, C, D3 folic acid, pantothenic acid and experiment begin not have obvious minimizing or increase, and vitamin B12, A, E, D2 descend to some extent.B group vitamin D3 reduces bigger, and vitamin D2 does not have obvious minimizing, and other vitamin amount and A group are quite.C organizes various vitamin and reduces bigger.

Above-mentioned experiment showed, with vitamin D3 replaced vitamin D2, can effectively strengthen the effect of multivitamin injection, replenishes the necessary for human body vitamin better.

The specific embodiment

Come composite vitamin for injection compositions of the present invention done further specifying by following example, but be not limited in following example.

3 13 kinds of compound vitamin lyophilized powders of embodiment

Preparation method:

1. fatsoluble vitamin dissolving

1) get the tween 80 of recipe quantity, heating in water bath to 50 ℃ also constantly stirs, and feeds carbon dioxide above tween 80, vitamin A (cetylate) successively, vitamin E, vitamin K, vitamin D3, heating in water bath to 50 a ℃ stirring makes molten entirely, and constantly stirs, insulation.

2) get the synthermal water for injection of 500ml, feed carbon dioxide from the bottom, keep temperature, behind the 5min, slowly add in the tween medicinal liquid, and constantly be stirred to and obtain clear solutions.

2. get the water for injection 2000ml of prepared fresh, feed carbon dioxide, 30min from the bottom.Add the recipe quantity vitamin C, regulate pH value to 4.3, add the recipe quantity vitamin B2 successively with 2M NaOH, nicotiamide, Dexpanthenol, vitamin B1, vitamin B6 stirs and makes dissolving fully.

3. mix

1) gets 2 solution and slowly add in 1, and fully stir 10min, to obtaining clear solutions.

2) medicinal liquid is placed room temperature, regulates pH value between 4.5-5.5 with NaOH solution and hydrochloric acid solution.

4. standardize solution, packing, lyophilization

1) above-mentioned solution is added water for injection, be settled to 3000ml.

2) in hundred grades of clean districts of knot, filter with 0.22 μ m duplicature, after the assay was approved, the brown cillin bottle of packing, every bottle of 3ml, half moulding plug, lyophilization charges into nitrogen, and aluminium-plastic cap is rolled in tamponade.

Freezing curve is seen accompanying drawing 1.

24 kinds of fatsoluble vitamin injections of embodiment lyophilized powder

Preparation technology:

1. get the tween 80 of recipe quantity, heating in water bath to 50 ℃ also constantly stirring feeds carbon dioxide above tween 80, vitamin A (cetylate) successively, vitamin E, vitamin K, vitamin D3, heating in water bath to 50 a ℃ stirring makes molten entirely, and constantly stirs, insulation.

2. get the synthermal water for injection of 500ml, feed carbon dioxide from the bottom, keep temperature, behind the 5min, slowly add in the tween medicinal liquid, and constantly be stirred to and obtain clear solutions.

3. above-mentioned solution is added water for injection, be settled to 3000ml.

4. in hundred grades of clean districts of knot, filter with 0.22 μ m duplicature, after the assay was approved, the brown cillin bottle of packing, every bottle of 3ml,

Description of drawings

Fig. 1 is an injection multivitamin freezing curve sketch map.

Claims

1. a composite vitamin for injection compositions is characterized in that, is to be active component with vitamin A, B, C, D, E, K, mixes the Pharmaceutical composition of formation with suitable pharmaceutic adjuvant.

2. the described composition for injection of claim 1 is characterized in that, described vitamin A includes but not limited to its cetylate, acetate.Consumption is unit dose 350IU～35000IU, and vitamin C includes but not limited to its sodium salt, and consumption is unit dose 12.5mg～1.25g.Vitamin D includes but not limited to D2, D3, and preferred vitamin D2, consumption are unit dose 20IU～2000IU, and vitamin K includes but not limited to K1, K2, K3.Consumption is unit dose 15ug～1.5mg.

3. the described composition for injection of claim 1 is characterized in that, described vitamin B includes but not limited to B1, B2, B3, B5, B6, B7, B9, B12.Wherein B1 includes but not limited to thiamine hydrochloride, thiamine mononitrate, single phosphothiaminum, phosphorylated thiamine ester, triphosphoric acid thiamine ester, preferred phosphorylated thiamine ester; B2 includes but not limited to riboflavin sodium phosphate; B3 includes but not limited to nicotinic acid, nicotiamide; B5 includes but not limited to pantothenic acid, pantothenylol and optical isomer thereof; B6 includes but not limited to Pyridoxine Hydrochloride, benadon, hydrochloric acid Vitamin B6, Pyridoxamine hydrochloride; B7 includes but not limited to biotin and optical isomer thereof; B9 includes but not limited to folic acid; B12 includes but not limited to cobalamin; Its consumption is respectively B1:0.5-10mg; B2:0.5-10mg; B3 (nicotiamide): 10-100mg; B5 (pantothenic acid): 5-50mg; B6:0.5-10mg; B7 (biotin): 10-200mcg; B9:0.1-0.5mg; B12:0.5-10mcg.

4. the described composition for injection of claim 1 is characterized in that, described suitable pharmaceutic adjuvant comprises pharmaceutical carrier, pH regulator agent, buffer salt, solubilizing agent.

5. the described composition for injection of claim 4 is characterized in that, described buffer salt includes but not limited to L-histidine-L-histidine hydrochloride, citric acid-sodium citrate, glycine-glycine hydrochloride, preferred L-histidine-L-histidine hydrochloride.

6. the described composition for injection of claim 4, it is characterized in that, described pH regulator agent is the water solublity regulator, can be hydrochloric acid, in potassium acetate, sodium acetate, Ammonium Acetate, natrium carbonicum calcinatum, meglumine, sal soda, sodium bicarbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, phosphate, sodium hydrogen phosphate, dipotassium hydrogen phosphate, sodium bitartrate, potassium hydrogen tartrate, sodium potassium tartrate tetrahydrate, triethanolamine, potassium metaphosphate, Kurrol's salt, the Polymeric sodium metaphosphate. one or more, preferred hydrochloric acid and sodium hydroxide.

7. the described composition for injection of claim 4 is characterized in that, described solubilizing agent includes but not limited to the poly yamanashi esters surfactant, as Tween 80, phospholipid, and as phosphatidylcholine, PHOSPHATIDYL ETHANOLAMINE, phosphatidyl glycerol, Phosphatidylserine etc.The cithrol class, as polyglycol distearate, one or more in the poloxamer.

8. the described composition for injection of claim 1 is mainly used in the supply of patient's vitamin and keeping of nutrition.