SK17398A3 - High-molecular nutritive mixtures determined in the treatment of malnutrition of various etiology - Google Patents

Abstract

nutritional mixture It contains protein laktosérovú. at it fits casein or soy, valine, leucine, isoleucine, enzyme hydrolyzate starch, sucrose, stabilized oil safflower continuous dyeing or stabilized oil soya or sunflower, eventually oil containing triacylgly- Ceroli fatty acids with 6 until 12 carbon alkyl, chloride sodium and potassium glycerophosphate calcium oxide magnesium and zinc, molybdate ammonium sulphate iron, iodide potassium acetate copper and manganese, dichromate potassium retinol acid ascorbic acid, ergocalciferol, tocopherol acetate, dichloride thiamine, RI boflavín. chloride pyridoxolia. nicotine amide, acid folic D-biotin, pantonenan calcium kyanokobala- min. phylloquinone, inositol acid citric acid. mixture can a flat flavored suitable aromatic substances and serving on the nutritional support and treatment malnutrition different etiology

Description

Nutritional mixtures of high molecular type intended for the treatment of malnutrition states of different etiology.

Technical field

The invention relates to powdered nutritional compositions of a high molecular weight type which are intended for the treatment of malnutrition of various etiologies.

BACKGROUND OF THE INVENTION

A large proportion of hospitalized patients are in a state of moderate or severe protein malnutrition, foreign literature reports about 25-50%. Malnutrition is a major contributor to the failure of properly selected surgical and conservative treatment. Protein malnutrition also affects changes in other substances, such as reduced availability of changes in levels of minerals and trace elements; between catabolism and protein anabolism, carbohydrate metabolism, and nutritional optimization expenditure. (Sur. Gyn Obst. 141, 1857, p.512, Bisreian, BR et al .: Therapeutic Index of Nutritional Depletion in Hospitalized Patients, Clin Nutr. 4, Spec Suppl., 1985, p. 133, Vinnars, E. et. al .: Postoperative nutrition, Crit.Care Med., 23, (3) 1855, pp. 436-449, Bower, RH et al .: Earla enteral administration of a formula (Impact) supplemented with arginine, nucleotides, and fish oil in intensive line unit patients: the result of a multicenter, prospective, radomized clinical trial, Biol. Neonate, 51, 1987, p.286, Gali, DG et al .: Effect of Parental and Enteral Nutrition on Postnatal Development of Small Intensinate and pancreas in the rabbit, Time Pharm. Six, 128, 1989, pp. 1537-1741, Zydák, Z. et al .: Enteral Nutrition in Clinical Practice, Pathophysiological Basis of Effective Use of Enteral Nutrition, JPEN, 11, (1) , 1987, p.14, Popp, MB et al .: Energy expediture and mater activity in rats receving total parenteral nutrition).

This requirement is virtually impossible to accomplish by two basic delivery routes - the enteral, physiological, and parenteral routes. Parenteral nutrition is precisely indicated in patients unable to feed nutrients physiologically. If at least a portion of the gastrointestinal tract is functional, it is preferable to select the enteral nutritional route by probe or stoma. In total parenteral nutrition, there is hypoplasia of the intestinal mucosa and a reduction in the secretion and function of the enzymes of the gastrointestinal tract, which makes it difficult to later switch to a normal diet. (Pharmacoter. Reports 28.3.1982, p.199 Doberský P .: Parenteral Nutrition Yesterday Adnes, Pharmacoter. Reports 28.3.1982, p.235, Zadák Z .: Treatment of Advanced Malnutrition by Parenteral Nutrition. Pharmacoter. Reports 28, 3. 1982, p.227, rye, KA et al.: Internal versus Parenteral Feeding, Effects on Septic Morbidity After Blunt and Penetraating Abdominal Trauma, Ann. Surg., 216, 1992, 172-183, Moore, FA et al .: Early Enteral Feeding, compared with parenteral, reduced postporative septic complications).

Thus, the nutritional trend in patients in whom parenteral nutrition is indicated is, as quickly as possible, a combination with enteral nutrition and a gradual transition to the enteral nutritional support pathway, less burdensome to the patient and less at risk of secondary infection. Enteral nutrition can be applied to a greater amount of nutrients in a better balanced ratio, without overloading the patient with fluids. The steady-state relationship between parenteral and enteral nutrition is, according to US statistics, 1: 1.2 in favor of enteral nutrition, of course, depending on the type and nature of the disease. (Arch. Biochem. Biophis. 72, 1957, p. 396, Greenctein, JP et al .: Quantitative nutritional studies with wather-soluble chemically defined diets. I. Growth, reproduction and lactation in rats, JPEN, 9, (6) 732, Murray, DP et al., Survey: Use of clear and full liquid diets with or without commercially produced formulas, JPEN, 9, 1985, p. 317, Salvin, JL et al .: Bowel function on healthy Men consuming liquid diets with and without dietary fiber, Kidney Int, 39, 1991, 831-835, Boliga, R. et al .: Effects of reduced renal function and dietary protein on muscle protein synthesis)

Pharmaceutically prepared or evaluated dietetics serve for the combination of parenteral and enteral nutrition, or for single enteral nutrition by intragastric to intrajejunal polyunsaturated fatty on the modulation of the probe, or by direct ostomy. These are calibrated, chemically or biochemically defined, drugs subject to drug prescription (JPEN 15, (5), 1991, 517-520, Vanbordolle, M .: Action of enterally administered ornithine-alpha-ketoglutarate on protein breakdown in skeletal muscle and liver of the burned rat, JPEN 15/4, 1991, 450-453, Frendstrom, SB et al .: Determination of the Fiber Contour of Enteral Feedins Nutrition 6, 1990, 24-44, Konsella, JE et al., Dietary acids and eicosanoids, potential effects of inflammatory and immune cells, an overview, JPEN 15, (4), 1991,

376-383, Schroeder, D. et al .: Effect of Immediate Postoperative Enteral Nutrition on Body Composition).

Depending on the purpose of use, pharmaceutical enteral nutrition is divided into two main groups: enteral nutritional and enteric medicinal products, which take advantage of the fact that some nutritional substrates (glutamine, arginine, nucleotides, w-3 unsaturated fatty acids and others) have a marked pharmacological effect on organ function (Crit. Čare Med., 23, (3) 1995, pp. 436-449, Bower, RH et al .: Early Enteral Administration of Formula (Impact) Supplemented with Arginine, Nucleotides, and Fish Oil in Intensive Line) J., Carol, L., et al .: The Relationship between Enteral Formulation Contamination and Lenght of Enteral Delivery Set Usage, Canad. Physiol Pharmacol., 66, 1988, pp. 985-992, Thomson ABR et al: Dietary Effects of β-3-Fatty Acids on Intestinal Transport Function, Ann Inter Med 116, 1992, 821-826,

Ziegler, T.R. et al .: Clinical and metabolic efficacy of glutamine supplemented parenteral nutrition after bone morrow transplantation and randomized, double-blind, controlled study).

Nutritional enteral diets are designed to meet the nutritional needs of the body. These preparations contain nutritional substrates, vitamins and trace elements in amounts and ratios, optimally to provide metabolic functions of increased ratios of nutrients and other biological components. (N.Engl.J.Med. 328, 1993, 1444-1495, Stammpfer, MJ et al., Nutritional Needs in Patient or Under which are Normal): Vitamin E Consumption and the Risk of Coronary Heart Disease in Women, Canad. J. Phisiol. Pharmacol., 66, 1988, pp. 855-922, Thompson, ABR et al .: Dietary Effects of W-3-Fatty Acids on Intrastinal Transport Function, Int. Med., 37, 1991, pp. 29-36 , Zadák et al. Changes in plasma lipids, lipoproteins and utilization of energy substrates in continuous enteral nutrition containing 50% MCT (Preciten MCT 50).

SUMMARY OF THE INVENTION

A large number of hospitalized patients (25% to 50%) are in a state of moderate or severe malnutrition, which in turn is responsible for the possible failure of a properly selected conservative or surgical treatment. In order to balance the relationship between nutrient intake and expenditure and energy, it is necessary to optimize the nutrition of patients, which can be done parenterally or enterally.

For enteral nutrition of malnutrition patients, a nutritional composition can be used to treat malnutrition conditions of various etiologies, based on high molecular weight substances with precise chemical and microbiological parameters according to the invention, which comprises the necessary components in the following proportions:

21,260 until 22,490 % wt 0,001 until 1,670% materials. 0,001 until 2,220% materials. 0, 001 until 1,920% materials. 21,740 until 22,400 % wt 43,480 until 53,630 % wt 0,350 until 0.370% materials.

0,001 in until 4,350 % materials. 0,340 until 0,360 % materials.

dried serum, soy or casein L-valine protein concentrate

L-leucine

L-isoleucine sucrose enzyme hydrolyzate starch stabilized oil ingested dyeing, soy or sunflower natural neutral oil based on sodium caprylic capric acid triacylglycerol

0,580 until 0 610% by weight. potassium chloride 0,980 until 1 030% by weight. calcium glycerophosphate.2H ₂ O 0,590 until 0 061% wt. of magnesium oxide 11,090 until 11 , 740.10-3% wt. sulfate železnatého.7H ₂ O 0,039 until 0 041.10-3% wt. potassium iodide 1,400 until 1 480.10-3% by weight. copper acetate. H ₂ O 3,900 until 4. 130.10-3% by weight. acetate mangánatého.4H ₂ O 1,480 until 1 570.10-3% by weight. zinc oxide 0,210 until 0 220.10-3% by weight. potassium dichromate 0,049 until 0 051.10-3% wt. molybdate amónneho.4H ₂ O 24,660 until 26 , 280.10-3% wt. ascorbic acid 0,970 until 1 030.10-3% by weight. retinol 0,001 until about, 002.10-3% wt. ergocalciferol 5,840 until 6. 170.10-3% wt. tocopherol acetate 0,270 until about, 290.10-3% by weight. thiaminium dichloride 0,270 until 0 290.10-3% by weight. 5-riboflavin phosphoric acid sodium salt 0,530 until about, 570.10-3% by weight. pyridoxolia chloride 0,130 until 0 140.10-3% by weight. D-biotin 4,560 until 4. 830.10-3% by weight. nicotinamide 0,029 until 0 031.10-3% wt. folic acid 2,930 until 3 100.10-3% by weight. calcium pantothenate 0,001 until about, 002.10-3% wt. kyanokoba1tamínu 0,270 until 0 290.10-3% by weight. phylloquinone 26,700 until 28 i, 260.10-3% by weight. inositol 0,480 until 0 510% wt. citric acid

The nutritional composition of the invention is prepared by weighing and sieving the individual components. These are combined with separately prepared triturations of vitamins and trace elements in a homogenizer with stirrer. The stabilized oil phase with lipophilic vitamins and optionally the flavoring is placed in the homogenizer by injection. The homogenized mixture is filled into special foil bags, preferably under a protective nitrogen atmosphere, in a microbiologically safe environment and sealed with a hot weld. The production is practically waste-free, ecologically advantageous, but it is demanding on the accuracy of the weighing and hygienic conditions, in order to maintain the microbiological safety of the final product.

For the nutritional compositions of the invention, safety of administration has been demonstrated in long-term pharmacological long-term pharmacological testing. In clinical tolerance trials, the endpoints during the nutritional composition administration were within the reference range of normal values, and pathological values at baseline were adjusted towards normal. The nutritional status of the patients was balanced, in most cases there was an improvement.

Production technology guarantees two years of stability without loss of biological value and chemical identity of the contained substances, which has been proven in certain cases.

The nutritional composition according to the invention serves for the dietary treatment of malnutrition states of different etiology, with the possibility of continuous evaluation of patients. The powder mixture is prepared after use with a suitable liquid and immediately after mixing it is drunk by probe or stoma, bolus or continuously by mixing in or applied by gravity or using a peristaltic pump.

DETAILED DESCRIPTION OF THE INVENTION

Example 1

Weigh, stitch the ingredients according to the following and recipes:

are mixed individually dried serum protein concentrate sucrose enzyme starch hydrolyzate oil ingested dye stabilized sodium chloride potassium chloride calcium glycerophosphate.H ₂ 0 magnesium oxide ferrous sulfate.7H ₂ O potassium copper iodide. H ₂ 0 manganese acetate.4 ₂ H0 zinc oxide

15.520 g 16.350 g 39.150 g

0,256 g 0,250 g 0,420 g 0,712 g 0,043 g 8,100 mg 0,027 mg 1,020 mg 2,850 mg 1,080 mg

potassium dichromate 0.153 mg ammonium molybdate.4 ₂ H0 0.037 mg ascorbic acid 18,000 mg retinol 0.711 mg ergokarciferol 0.002 mg tocopherol acetate 4,260 mg thiaminium dichloride 0.200 mg 5-riboflavin phosphoric acid sodium salt 0.200 mg pyridoxolium chloride 0.390 mg nicotinamide 3,330 mg folic acid 0.019 mg calcium pantothenate 2,140 mg D-biotin 0.098 mg cyanocobalamine 0.001 mg filochinón 0.200 mg inositol 19,500 mg citric acid 350,000 mg

In this way, 73 g of a nutritional composition according to the invention with an energy value of 1220 kJ (292 kcal) are prepared.

Example 2

The procedure is as in Example 1 except that the same amount of casein protein is used instead of serum protein.

Example 3

The procedure is as in Example 1 except that the same amount of soy protein is used instead of serum protein.

Example 4

The procedure is as in Example 1 except that the same amount of stabilized soybean oil is used instead of the stabilized oil used by the dye

Example 5

The procedure is as in Example 1 except that the same amount of stabilized sunflower oil is used instead of the stabilized oil used by the dye.

Example 6 If necessary, to increase the supply of fat-replaced energy, the nutritional composition can be enriched by the addition of an oil with medium chain triglycerides of fatty acids. Their metabolism and mode of transport allows maximum utilization of this energy also in pathologically altered fat metabolism and dysfunction of transport metabolisms. The mixture is prepared by weighing, sieving and mixing the ingredients according to the following recipe:

dried serum, soya concentrate

or casein protein 15,520 g sucrose 17,000 g starch enzyme hydrolyzate 35,000 g stabilized oil used for dyeing, soya or sunflower 0,256 g natural neutral oil based on triacylglycerol of caprylic capric acid 3,000 g sodium chloride 0,250 g Potassium chloride 0,420 g Calcium glycerophosphate.H ₂ 0 0,712 g magnesium oxide 0,043 g ferrous sulphate.7H ₂ 0 8,100 mg Potassium iodide 0,027 mg copper acetate. H ₂ 0 1,020 mg acetate mangánatý.4H ₂ O 2,850 mg zinc oxide 1,080 mg potassium dichromate 0,153 mg molybdate amónny.4H ₂ O 0,037 mg ascorbic acid 18,000 mg retinol 0, 711 mg ergokarciferol 0,002 mg tocopherol acetate 4,260 mg thiaminium dichloride 0,200 mg 5-riboflavin phosphoric acid sodium salt 0,200 mg pyridoxolium chloride 0,390 mg

nicotinamide 3,330 mg folic acid 0,019 mg calcium pantothenate 2,140 mg D-biotin 0,098 mg cyanocobalamine 0,001 mg filochinón 0,200 mg inositol 19,500 mg citric acid 350,000 mg

Example 7

If it is necessary to increase the intake of nitrogen substances, the nutritional mixture can be enriched by adding branched amino acids according to the following recipe:

dried serum, soya concentrate

or casein protein 15.520 g L-valine 1,150 g L-leucine 1,500 g L-isoleucine 1,130 g sucrose 15,000 g starch enzyme hydrolyzate 30,000 g stabilized oil used for dyeing, sunflower or soybean 0.256 g natural neutral oil based on triacylglycerol of capry1-capric acid 3,000 g sodium chloride 0,250 g Potassium chloride 0.420 g calcium glycerophosphate.2H ₂ O 0.712 g magnesium oxide 0.043 g ferrous sulphate.7H ₂ O 8,100 mg Potassium iodide 0,027 mg copper acetate. H ₂ 0 1,020 mg acetate mangánatý.4H ₂ O 2,850 mg zinc oxide 1,080 mg potassium dichromate 0.153 mg molybdate amónny.4H ₂ O 0.037 mg ascorbic acid 18,000 mg lip inolacetate 0.711 mg ergokarciferol 0.012 mg

tocopherol acetate thiaminium dichloride 5-riboflavin phosphoric acid sodium salt 4,260 mg 0.200 mg 0.200 mg pyridoxolium chloride 0.390 mg D-biotin 0.098 mg nicotinamide 3,330 mg folic acid 0.019 mg calcium pantothenate 2,140 mg cyanocobalamine 0.001 mg filochinón 0.200 mg inositol 19,500 mg citric acid 350,000 mg

Addition of valine, leucine and isoleucine at the doses specified by the formula will allow them to increase their proportion in the starting protein to pharmacodynamic levels at which their effect on the pathologically altered spectrum of other amino acids and on the incipient proteosynthesis is applied.

The homogenized mixtures mentioned in Examples 1 to 7 can preferably be flavored with food flavorings. The use of flavoring with banana, orange, qrapefruit, strawberry, nut, caramel, nougat, chocolate, crocodile and vanilla aroma has been verified.

The natural neutral oil used, miglyol 812, is caprylic capric acid triacylglycerol of molecular weight 520, which, according to analysis, contains 3% by weight of caproic acid, 50 to 65% by weight. caprylic acid, 30 to 45 wt.%. capric acid and not more than 5% by weight. lauric acid.

Industrial usability

The novel composition of the present invention serves to nutritionally support and treat malnutrition conditions of various etiologies, which has been proven in practice.

Claims (1)

PATENT CLAIMS A nutritional blend of etiology, solved by microbiological and containing: for the treatment of malnutrition conditions based on high molecular weight substances with precise chemical parameters, 21,260 until 22,490 % wt. 0,001 until 1,670% materials. 0, 001 until 2,220% materials. 0,001 until 1, 920% materials. 21,740 until 22,400 % wt. 43,480 until 53,630 % wt. 0,350 until 0.370% materials. 0.001 to 4.350% by weight. 0,340 until 0.360% by weight 0,580 until 0.610% by weight 0,980 until 1.030 wt.% • 0,590 until 0.061 wt% 11,090 until 11,740.10-3% materials. 0,039 in until 0,041.10-3% materials. 1,400 until 1,480.10-3% materials. 3,900 until 4,130.10-3% materials. 1,480 until 1,570.10-3% materials. 0,210 until 0,220.10-3% materials. 0,049 in until 0,051.10-3% materials. 24,660 until 26,280.10-3% materials. 0,970 until 1,030.10-3% materials. 0,001 until 0,002.10-3% materials. 5,840 until 6,170.10-3% materials. 0,270 until 0,290.10-3% materials. 0,270 until 0,290.10-3% materials. dried serum, soy or casein L-valine protein concentrate L-leucine L-isoleucine enzymatic hydrolysis of starch, sucrose fixed oil continuous dyeing safflower, soybean or sunflower oil, natural based neutral triglycerides of caprylic-capric chloride, potassium chloride, glycerophosphate vápenatého.2H ₂ O MgO ₂ železnatého.7H sulfate potassium iodide of copper acetate. H ₂ 0 manganese acetate.4H ₂ 0 zinc oxide potassium dichromate ammonium molybdate.4H ₂ O ascorbic acid retinol acetate ergocalciferol tocopherol acetate thiammonium dichloride sodium salt of 5-riboflavin phosphoric acid 0,530 until 0,570.10-3% materials. 0,130 until 0,140.10-3% materials. 4,560 until 4,830.10-3% materials. 0,029 until 0,031.10-3% materials. 2,930 until 3,100.10-3% materials. 0,001 until 0,002.10-3% materials. 0,270 until 0,290.10-3% materials. 26,700 until 28,260.10-3% by weight 0,480 until 0.510% by weight. pyridoxolia chloride D-biotin nicotinamide calcium pantothenate cyanocobaltamine phylloquinone citric acid inosity