CN102240299A - Improved intravenously dripped multi-vitamin injection - Google Patents

Abstract

The invention relates to an improved intravenously dripped multi-vitamin injection. The injection can be mixed with high-calorie parenteral nutrients to be dissolved and adjusted to have isotonicity and isostension and then can be administrated through peripheral intravenous drip, wherein the intravenously dripping time is 6 to 12 hours; and dripping is performed at constant speed and for one time per day.

Description

But the multivitamin injection of the intravenous drip of improvement

Technical field

But the present invention is a kind of multivitamin injection that passes through the intravenous drip of improvement, belongs to medical technical field.

Background technology

Nutrition is body growth growth, repair tissue, generation resistance, keeps the material base of normal physiological function, and it is biological normal growth, active source, is patient's conditio sune qua non that rehabilitates.When health of people, all kinds of nutrients are kept poised state naturally.Often phenomenons such as nutrition Deficiency of Intake or increase in demand occur when body is ill and cause malnutrition.Although medical development is very fast in recent years, worldwide, inpatient's malnutrition problem is a ubiquitous problem always.Domestic investigation of clinical epidemiology show the inpatient that there is a 30%-70% in China when being admitted to hospital or the while in hospital have existing malnutrition.External inpatient's malnutrition incidence rate also has more latest report (being respectively 44% and 50% as the U.S. and Dutch patients of general surgery department malnutrition incidence rate).An investigation according to the outer enteral nutrition research center of BJ Union Hospital's intestinal shows: the underfed incidence rate of the gastrointestinal surgery patient of general hospital is 30-40%, and other has 20% patient to have the hidden danger of secondary malnutrition.Patient's ICU malnutrition is up to 70-80%.In addition, also deposit malnutrition in various degree among the patient that department of pediatrics, internal medicine, gynecological patient department of neurology etc. can not be taken food, numerous clinical experiences show: most patients all is among the underfed risk.Malnutrition can cause more complication, thereby mortality rate is increased after taking place, and convalescence prolongs, and hospital stay prolongs, and clinical cost increases, and has increased the weight of the burden of society, hospital and family.In time give rational nutritional support, can improve patient's nutriture, reduce complication, reduce mortality rate, shorten convalescence and hospital stay.As seen the clinical nutrition support is very important and necessary.

2003 Canadian 13 kinds of vitamin injections of Sabex company (Infuvite Adult) in U.S.'s approval listing; This project is declared by domestic existing many enterprises at present, comprises injection and congruent freeze-dried powder.These product are the medication of vein vitimin supplement, are used in through enteral nutritional support and absorb insufficient patient, comprise surgical operation, extensively burn, fracture and other wounds the patient of severe infections disease and stupor.Can with the parenteral nutrition thing mixed dissolutions such as carbohydrate, lipid, aminoacid, electrolyte and trace element of determining the compatibility and stability after carry out drop and use.The serious nutritional status that can be used for recurring changes the situation of metabolic emergency reaction of lower body and histotrophic nutrition shortage.This product can provide the intake of essential vitamin to keep body normal reaction and reparation, and this product should just not brought into use when human body is deficient in vitamin simultaneously.

13 kinds of vitamin powder pins of another injection go on the market in Japan, this medicine is identical with 13 kinds of vitamin injection indications of U.S.'s listing, but composition is different, suitable increase the consumption of vitamin D2 and vitamin K, adjusted the content of other vitamin, make its effect more comprehensive effectively, but this powder pin need be used high calorie of parenteral nutrition thing mixed dissolution, be adjusted to etc. ooze, behind the isostension, by the central vein dropleting medicine-feeding, so just limit its clinical practice greatly, reduced patient's toleration and compliance.

Summary of the invention

But the present invention is a kind of multivitamin injection of intravenous drip by improvement, this injection can with high calorie of parenteral nutrition thing mixed dissolution, be adjusted to etc. ooze, behind the isostension, by the peripheral vein dropleting medicine-feeding.The time of intravenous drip is 6-12 hour, at the uniform velocity instils, and 1 time on the 1st, can suitably increase and decrease according to concrete age of patient, symptom.The parenteral nutrition thing comprises: carbohydrate, lipid, aminoacid, electrolyte and the trace element etc. of having determined the compatibility and stability.

Described injection is freeze-dried powder, compares with the lyophilized powder that passes through the central vein administration that Japan goes on the market, and has simplified medication, is more conducive to clinical manipulation, has increased patient's toleration and compliance.Compare with 13 kinds of vitamin injections that the present U.S. goes on the market, its vitamin D3 is replaced to vitamin D2, simultaneously suitable increase the content of vitamin K, H and B12, reasonably adjusted the consumption of other vitamin, make it more meet the demand of patient, more fully improve underfed situation vitamin.Its main component and content are seen specific embodiment.

The specific embodiment

1 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 D2, 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, TPP, 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.

Embodiment 2

Different way of administration drug effect and untoward reaction contrast experiment

24 of healthy adult rabbit, male and female half and half, body weight (2.45 ± 0.40) kg.Be divided into 2 groups at random: the A group is sham operated rats (6), and the B group is total gastrectomy group (18).Through the urethane 5ml/kg of auricular vein injection (quiet notes) 20%, injection finishes in the 15min, animal is fixed after waiting to anaesthetize successfully.Cover internal organs with the normal saline gauze after A group rabbit is opened the abdominal cavity, close the abdominal cavity behind the 1h.B group rabbit row total gastrectomy (excision extension from cardia to the about 0.5cm of pylorus nearside) is left behind esophagus and the closely section capable end-to-side anastomosis of duodenum then.The B group rabbit of postoperative is divided into 3 groups more at random, and 6 every group, the B1 group does not process for model control group; B2 organizes in the auricular vein remaining needle in the outside and is used for administration, and the B3 component is inserted remaining needle and is used for administration from also free right internal jugular vein.

Equal fasting 12h (can't help water) before the rabbit art, all in the 2nd day drink of postoperative 5% G/NS, the 3rd～5 day feeding green vegetable leaf carried out the transition to the normal rabbit feed diet on the 6th day.The 2nd day venous transfusion of rabbit postoperative.A, B1 group postoperative needn't be infused, B2, B3 group by remaining needle slowly input be dissolved in 13 kinds of vitamin of high caloric injection, be adjusted to wait ooze, etc., drip velocity is in the 50ug/kgmin, every day 1 time, continuous 15 days.

4 groups of rabbit are respectively at operation day (before the art), the preceding body constitution amount of measuring of postoperative 8 feedings in the 3rd, 5,7 day morning.At once measure the stomach quality of downcutting after the operation of B group rabbit, postoperative records the body constitution amount and adds that the stomach quality is body constitution amount data on the same day.The results are shown in Table 1), can find out each group of postoperative owing to the gastrointestinal absorption obstacle from the result, body weight all descends to some extent, blank model group descends obviously, administration group (B1, B2) fall is little, and both there was no significant differences, illustrates that two kinds of different approaches give 13 kinds of vitamin therapeutic equivalences.

Table 1 is respectively organized rabbit body weight change situation

Perusal administration every day local response (color, erythema, edema, congested degree and scope) has or not general toxic reaction.Check that substantially classification is as follows: 0 minute (no significant reaction), 1 minute (mild hyperaemia), 2 minutes (mild to moderate hyperemia, swelling), 3 minutes (in to severe hyperemia, swelling), 4 minutes (, and mild to moderate necrosis being arranged), 5 minutes (, and having the severe extensively downright bad) with 3 with 3.(the results are shown in Table 2) found that two kinds of route of administration do not have obvious damage and zest to blood vessel, two groups of there was no significant differences.

After the last administration of table 2 after 24 hours, each rabbit scoring situation

Claims (5)

1. but the multivitamin injection of intravenous drip by improvement is characterized in that, this injection can with high calorie of parenteral nutrition thing mixed dissolution, be adjusted to etc. ooze, behind the isostension, by the peripheral vein dropleting medicine-feeding.

2. the described medication of claim 1 is characterized in that, the time of intravenous drip is 6-12 hour, at the uniform velocity instils 1 time on the 1st.

3. the described medication of claim 1 is characterized in that, the parenteral nutrition thing comprises: carbohydrate, lipid, aminoacid, electrolyte and the trace element etc. of having determined the compatibility and stability.

4. the described injection of claim 1 is freeze-dried powder, and composition is as follows:

Vitamin C 100g

Vitamin A 0.99g (3,300,000 IU)

Vitamin D2 10mg (400,000 IU)

Diphosphothiamine (in vitamin B1) 3g

Vitamin B2 5.08g

Vitamin B6 4g

Nicotiamide 40g

Dexpanthenol 14.04g

Vitamin E 15g (1.5 ten thousand IU)

Vitamin K1 2g

Folic acid 0.4g

Biotin 0.1g

Vitamin B12 10mg

5. the described injection of claim 1 is mainly used in through enteral nutritional support and absorbs insufficient patient.