JP5463011B2 - Nutritional supplement for dialysis patients - Google Patents

Description

  The present invention relates to a nutritional supplement for dialysis patients. More particularly, the present invention relates to a nutritional supplement for dialysis patients comprising vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, vitamin C and vitamin E.

  The kidneys have the function of excreting waste products as urine and maintaining the water in the living body by adjusting the concentration and amount of urine. When kidney function falls, it becomes impossible to excrete waste products in the living body. A state in which the renal function is reduced to 30% or less of normal is called renal failure. Further, when the renal function progresses to less than 10%, dialysis treatment (artificial dialysis) becomes necessary.

  Many dialysis patients use vitamins in the form of health foods, supplements, and OTC drugs in order to reduce gastrointestinal disorders and skin itchiness peculiar to dialysis patients. In patients with renal failure, there are vitamins that need to be replenished for strict diet therapy, loss of appetite, and removal by dialysis.

  On the other hand, in the case of dialysis patients, substances whose excretion route is the kidney or substances metabolized by the kidney may be excessively consumed even at a normal intake amount. Furthermore, in patients with nephrotic syndrome, protein-bound vitamins may be excreted, and certain drugs may interfere with vitamin absorption, metabolism, and excretion.

  Vitamins and vitamin multi-supplements currently sold as ethical drugs, OTC drugs, and foods contain vitamin A harmful to kidney failure, unwanted vitamin D, and excess vitamin C that causes anti-oxalicemia May have. On the other hand, vitamin B6 and folic acid that tend to be deficient due to renal failure are often insufficient. It has been reported that those who take water-soluble multivitamins in dialysis patients have a better life prognosis than non-takers (Non-patent Documents 1 and 2), and we think that multivitamin supplements suitable for the pathology of dialysis patients are necessary. (Non-Patent Document 3).

Domrosese U. et al: J. Org. Clin. Nephrol. 67: 221-229, 2007 Fissell RB, et al: Am. J. et al. Kidney Dis. 44: 293-299, 2004 Hirata Juno, Fujita Minori Hen (Author): Renal failure and health foods / supplements / OTC drugs, Nanedo, 2006

  Various products are already on the market for multivitamin supplements as nutritional supplements for dialysis patients. However, it could not be said that it was well suited to dialysis patients in terms of formulation components and content.

  An object of the present invention is to provide a novel nutritional supplement for dialysis patients. In particular, an object is to provide a nutritional supplement for dialysis patients containing vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, vitamin C and vitamin E as essential components.

The present inventors have conducted multifaceted studies on the ingredients of the nutritional supplement, and have succeeded in developing an optimal vitamin-containing nutritional supplement for dialysis patients.
As is well known, vitamins are necessary for humans to live, and are substances that smooth the body's nutrients and adjust the body. Although the necessary amount is very small, it cannot be biosynthesized in the body or it is not sufficient, but it must be taken from outside (for example, food). Insufficient intake causes various deficiency symptoms, so an appropriate amount must always be ingested. However, excessive consumption causes a problem.
Especially in patients with renal failure, it is easy to fall into vitamin intake due to anorexia, the protein that binds to vitamins increases, and in patients with nephrotic syndrome, protein-bound vitamins are excreted, or vitamins are absorbed by the combination of certain drugs・ Metabolism and excretion may be disturbed. There have been many reports of excess or deficiency of certain vitamins in patients with renal failure, but the reports vary and do not necessarily lead to certain conclusions. .
We have various vitamins that need to be supplied to dialysis patients, which need not be supplied, and what amount of supply should be supplied. In order to establish the optimal vitamin-containing dietary supplement composition for dialysis patients.

  In one aspect, the present invention provides a nutritional supplement for dialysis patients comprising vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, vitamin C and vitamin E.

  In another aspect, the present invention provides a nutritional supplement for dialysis patients comprising only vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, vitamin C and vitamin E as essential vitamin components. .

  In yet another aspect, the present invention provides vitamin B1 1.2-2.7 mg, vitamin B2 1.44-3.24 mg, vitamin B6 8-18 mg, vitamin B12 2.4-5 per tablet. .4 μg, niacin 16-36 mg, pantothenic acid 4-9 mg, folic acid 800-1800 μg, vitamin C 48-108 mg and vitamin E 12-22.5 μg, preferably about 1.5 mg vitamin B1 per tablet About 1.8 mg vitamin B2, about 10 mg vitamin B6, about 3 μg vitamin B12, about 20 mg niacin, about 5 mg pantothenic acid, about 1000 μg folic acid, about 60 mg vitamin C and about 15 μg vitamin E; Provide nutritional supplements for dialysis patients.

  In yet another aspect, the present invention provides a nutritional supplement for dialysis patients as described above in the form of chewable tablets.

  Since the composition of the present invention contains an appropriate amount of vitamin that is apt to be deficient in dialysis patients, it can be used for the purpose of improving the nutritional status of dialysis patients, in particular vitamin status. Moreover, administration in the form of chewable tablets is suitable for administration to dialysis patients who are restricted in water intake.

Definitions of Terms Terms used herein have the meanings commonly understood by those of ordinary skill in the art unless otherwise indicated.

  Nutritional supplements, also called supplements, mean dietary supplements taken to supplement nutrients that cannot be consumed in the diet.

  A dialysis patient nutritional supplement means a nutritional supplement that a dialysis patient takes for the purpose of improving nutritional status, particularly vitamin status.

  The nutritional supplement for dialysis patients of the present invention contains vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, vitamin C and vitamin E. In addition to these essential vitamin components, conventional additives such as sweeteners, flavors and excipients may be included.

  The nutritional supplement for dialysis patients of the present invention is 1.2 to 2.7 mg of vitamin B1 per day, 1.44 to 3.24 mg of vitamin B2, 8 to 18 mg of vitamin B6, 2.4 to 2.4 of vitamin B12. 5.4 μg, niacin 16-36 mg, pantothenic acid 4-9 mg, folic acid 800-1800 μg, vitamin C 48-108 mg and vitamin E 12-22.5 μg, preferably about 1 vitamin B1 per day .5 mg, vitamin B2 about 1.8 mg, vitamin B6 about 10 mg, vitamin B12 about 3 μg, niacin about 20 mg, pantothenic acid about 5 mg, folic acid about 1000 μg, vitamin C about 60 mg and vitamin E about 15 μg Having a dosage form suitable for administration. For convenience, it is preferable to contain the above amount in one tablet.

  In addition to the above vitamin components, other vitamins can be added as appropriate, but preferably only the above components are used. For example, when vitamin A is administered to patients with renal failure, it has been reported that hypercalcemia, skin symptoms, hair loss and the like have occurred, and therefore it is preferable to avoid the formulation. In the case of renal failure patients, since the activation by the kidney is reduced, the effect of vitamin D is not recognized, so the necessity of blending it is not recognized. Vitamin K is usually considered to be sufficient to be derived from food and synthesized by intestinal bacteria, except for special cases such as poor nutritional intake and antibacterial patients even in patients with renal failure. There is no need to administer. Since biotin is excreted in the urine, it is not deficient in patients with renal failure, and there are many reports that the serum biotin concentration is higher than that in healthy individuals, so there is no need to take it in particular with a nutritional supplement.

On the other hand, the compounding amount of the vitamin component per tablet corresponds to the daily dose. That is, as a result of examining each vitamin component in detail, a necessary and sufficient dose is determined, and the above-mentioned blending amount is adopted based on the determined dose. For example, vitamin E has an antioxidant effect and therefore plays an important role for patients with renal failure under oxidative stress, and its administration has been considered to reduce the risk of coronary vascular disorders. Therefore, in the past, it was normal to make the dose higher than the recommended intake (15 μg / day) for healthy individuals, but in recent years, the vitamin E high dose group has a higher mortality rate. Reports are also being made. Therefore, as a result of the study, the present inventors have confirmed that the above recommended intake for healthy individuals is sufficient for patients with renal failure. With the nutritional supplement of the present invention, 12 to 22.5 μg / day, particularly about A blending amount corresponding to 15 μg / day is employed. Vitamin C also needs to be supplemented because patients with renal failure suffer from deficiency of vitamin C due to oxidative stress, but about 1000 mg / day recommended for many conventional nutritional supplements. Therefore, the nutritional supplement of the present invention employs a much smaller amount of 48 to 108 mg / day, particularly about 60 mg / day.

  The composition containing the nutritional supplement component for dialysis patients of the present invention may be in an appropriate form that, when ingested, improves the nutritional status, particularly vitamin status, of the dialysis patient. For ingestion, in the case of dialysis patients, water is restricted, so oral intake is preferable, but is not limited thereto. For oral administration, a tablet-form preparation is swallowed as it is, chewed in the mouth, or administered sublingually. Chewable tablets that can be taken without water are particularly suitable.

  Chewable tablets are produced by directly compressing a mixture of an active ingredient and a sweetener, flavoring agent, excipient, and the like for masking the bitterness of the active ingredient. Examples of sweeteners include aspartame / L-phenylalanine compounds and thaumatin. Examples of excipients include reduced maltose starch syrup, indigestible dextrin, trehalose, erythritol, and glycerin fatty acid ester.

  The nutritional supplement for dialysis patients of the present invention may be used in combination with other appropriate compositions such as pharmaceutical compositions and supplements as necessary.

Example 1
Chewable tablets containing vitamin C, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, vitamin E and folic acid:

composition

  After pulverizing potassium gluconate and erythritol, they are put into a mixer. To this, a mixture of glycerin fatty acid ester, tricalcium phosphate and dextrin is added, and successively, a mixture of vitamin B2, vitamin B6, vitamin B12, folic acid and calcium pantothenate, vitamin B1, vitamin E-containing vegetable oil, sweetener (aspartame) , Neo Saint Marc DC) and a mixture of nicotinamide, a mixture of trehalose and fragrance, a mixture of reduced maltose starch syrup and vitamin C. The total charge is 50-320 kg and mixed until uniform.

The obtained uniform mixture is tableted under the following working conditions, and bottled every 60 tablets to obtain a product.
Tablet type: small egg, designated by the collect machine, 25-30 rotations, using a stirring feed shoe.
Average weight: 300 ± 7 mg, average hardness: 8.0 ± 3.0 kg / cm ² (actual measurement 4 kg / cm ² ), average tablet thickness: 4.8 ± 0.2 mm.

Example 2
Vitamin B1 (1.5 mg), vitamin B2 (1.8 mg), vitamin B6 (10 mg), vitamin B12 (3 μg), niacin (20 mg), pantothenic acid (5 mg), folic acid (1000 μg), vitamin C (per tablet) 60 mg) and chewable tablets containing vitamin E (15 μg):

  Vitamin B1 (150 g), Vitamin B2 (180 g), Vitamin B6 (1000 g), Vitamin B12 (0.3 g), Niacin (2000 g), Pantothenic acid (500 g), Folic acid (100 g), Vitamin C (6000 g) and Vitamin E (1.5 g) is mixed with other additives used according to the proportions described in Example 1, and the mixture is compressed to obtain 100,000 chewable tablets.

  The present invention should not be limited to the scope according to the specific embodiments described herein. Indeed, various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are intended to fall within the scope of the appended claims.

  Documents disclosed in this specification are hereby incorporated by reference in their entirety.

Claims (4)

A nutritional supplement for dialysis patients containing vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, vitamin C and vitamin E, but not biotin and other vitamin components,
Daily vitamin B1 1.2-2.7mg, vitamin B2 1.44-3.24mg, vitamin B6 8-18mg, vitamin B12 2.4-5.4μg, niacin 16-36mg, pantothene A nutritional supplement for administering 4-9 mg of acid, 800-1800 μg of folic acid, 48-108 mg of vitamin C and 12-22.5 μg of vitamin E.   Vitamin B1 1.2-2.7mg, Vitamin B2 1.44-3.24mg, Vitamin B6 8-18mg, Vitamin B12 2.4-5.4μg, Niacin 16-36mg per tablet A nutritional supplement for dialysis patients containing 4 to 9 mg of acid, 800 to 1800 μg of folic acid, 48 to 108 mg of vitamin C and 12 to 22.5 μg of vitamin E, and not containing biotin and other vitamin components. Vitamin B1 1 per tablet. 5 mg, vitamin B2 1 . 8 mg, vitamin B6 1 0 mg, vitamin B12 3 [mu] g, niacin 2 0 mg, pantothenic acid 5 mg, containing 1 5 [mu] g of folic acid and 1 000μg, vitamin C and 6 0 mg and vitamin E, nutrition claim 2 Adjuvant.   The nutritional supplement according to any one of claims 1 to 3, wherein the dosage form is a chewable tablet.