Main > VITAMINS > Ascorbic Acid. Vitamin C > Delivery. > Solution. > Patent Assignee. > Japan. W

Product Japan. W

PATENT NUMBER This data is not available for free
PATENT GRANT DATE July 4, 2000
PATENT TITLE Stable vitamin C preparation

PATENT ABSTRACT This invention relates to a stable vitamin C preparation and a method for stabilizing vitamin C preparation. According to the invention, the vitamin C preparation stable for a long period of time can be obtain, since the preparation contains magnesium ions which have the effect of stabilizing vitamin C
PATENT INVENTORS This data is not available for free
PATENT ASSIGNEE This data is not available for free
PATENT FILE DATE October 28, 1998
PATENT CT FILE DATE September 18, 1996
PATENT CT NUMBER This data is not available for free
PATENT CT PUB NUMBER This data is not available for free
PATENT CT PUB DATE March 27, 1997
PATENT FOREIGN APPLICATION PRIORITY DATA This data is not available for free
PATENT CLAIMS What is claimed is:

1. A stable vitamin C infusion preparation composed of a vitamin C preparation blended with an electrolyte infusion solution containing magnesium ions.

2. The stable vitamin C infusion preparation of claim 1, wherein magnesium ions are contained by 14 parts by weight or more in 100 parts by weight of vitamin C.

3. The stable vitamin C infusion preparation of claim 1 or 2, wherein magnesium ions are blended as an electrolyte infusion solution at magnesium ion concentration of 1.5 to 5.0 mEq/liter.

4. The stable vitamin C infusion preparation of claim 3, wherein magnesium ions are blended as an electrolyte infusion solution at magnesium ion concentration of 15 to 35 mEq/liter and further containing at least one component selected from the group consisting of amino acids, sugars and fats.

5. A stabilizing method for a vitamin C infusion preparation comprising blending an electrolyte infusion solution containing magnesium ions with a vitamin C preparation
PATENT DESCRIPTION 1. Technical Field

The present invention relates to a stable vitamin C preparation which is used in the field of medicine and the like.

2. Prior Art

Recently, in maintenance of patient's life, total parenteral nutrition is employed for nutritional supplement in patients unable to take nutrition orally or enterally, or insufficient in oral intake, or, if possible, in patients extremely poor in the digestion and absorption functions or patients whose underlying diseases may be aggravated by passing of the food through the digestive tract. Such treatment is often accompanied by vitamin preparations containing various vitamins necessary for man.

Many vitamins are, however, unstable per se, and addition of vitamins to an infusion preparation is done immediately before administration to the patients in consideration of the stability of the preparation after addition. Above all, vitamin C (ascorbic acid) is known to be easily decomposed in the presence of oxygen, water, or metal ions such as copper ion or iron ion. From such viewpoint, the stabilization of vitamin C in a vitamin C preparation is an important problem in pharmaceutical technology.

The present inventors attempted various investigations about stabilization of vitamin C in an aqueous solution, and discovered that vitamin C is stabilized in the presence of magnesium ions, which has led to the completion of the invention.

DISCLOSURE OF THE INVENTION

The invention provides a stable vitamin C preparation composed of a vitamin C preparation blended with magnesium ions. In this vitamin C preparation, magnesium ions are preferably contained by 14 parts by weight or more in 100 parts by weight of vitamin C. The vitamin C preparation can be an infusion preparation containing vitamin C. In this case, the vitamin C preparation can be one blended magnesium ions as an electrolyte infusion solution containing magnesium ions, and one blended an electrolyte infusion solution at magnesium ion concentration of 1.5 to 5.0 mEq/liter. Moreover, the vitamin C preparation can be one blended an electrolyte infusion solution containing magnesium ions at magnesium ion concentration of 15 to 35 mEq/liter and further containing at least one component selected from the group consisting of amino acids, sugars and fats.

The invention also relates to a stabilizing method of vitamin C preparation by blending magnesium ions with the vitamin C preparation, and magnesium ions may be blended as an electrolyte infusion solution containing magnesium ions.

In the invention, since magnesium ions having the effect of stabilizing vitamin C are blended, a vitamin C preparation stable for a long period can be obtained.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a graph showing the residual rate (%) of ascorbic acid after sterilization in Example 1.

BEST MODE FOR CARRYING OUT THE INVENTION

In the invention, the vitamin C preparation is a pharmaceutical preparation containing vitamin C as ingredient, and various forms of preparations are included, and preferably liquid and freeze-dried preparations are exemplified, and more preferably an infusion preparation containing vitamin C is exemplified. The above-mentioned vitamin C includes derivatives of vitamin C, and specific examples include, aside from ascorbic acid, palmitate ascorbate and dipalmitate ascorbate.

Contents of vitamin C to be contained in the vitamin C preparation are not particularly limited, and may be selected appropriately. For example, the daily required amount per person is presented as a recommended value in the literature, such as The Journal of Japanese Society for Parenteral and Enteral Nutrition, Vol. 13, No. 4, p. 317, 1991, and the content may be determined so that the daily required amount may be taken. More specifically, 30 to 2000 mg may be contained.

Further, the vitamin C preparation of the invention is not intended to exclude blending of other components such as vitamins (e.g. vitamin A, vitamin B1, etc.), sugars, amino acids, and electrolytes.

As magnesium ions in the invention, various magnesium salts such as magnesium sulfate, magnesium chloride, magnesium glycerophosphate, magnesium acetate, magnesium lactate and the like may be used and blended.

Contents of magnesium ions to be blended in the vitamin C preparation of the invention are not particularly limited, and may be selected from a wide range appropriately, and magnesium ions are preferably blended by an equimolar amount or more of vitamin C, and specifically magnesium ions are blended by 14 parts by weight or more in 100 parts by weight of vitamin C in the preparation.

The blending method of magnesium ions to the vitamin C preparation is not particularly limited, and an appropriate method may be employed. For example, the blending can be carried out by mixing a proper amount of the magnesium salt with an aqueous solution of vitamin C. Further, a freeze-dried preparation can be prepared by lyophilizing thus obtained solution in a conventional method.

Magnesium ions may be blended alone, but generally since magnesium ions are a part of electrolyte infusion preparation, by blending vitamin C with the electrolyte infusion preparation containing magnesium ions, a stable pre-mixed type electrolyte infusion preparation containing vitamin C may be obtained. In this case, in this infusion preparation, magnesium ions are contained by 14 parts by weight or more in 100 parts by weight of vitamin C, and blended at concentration of 1.5 to 5.0 mEq/liter, which is preferable in order that the intrinsic function of vitamin C can be exhibited, that the stabilizing effect of magnesium ions on vitamin C can be exhibited, and that the magnesium ion concentration in the plasma can be maintained. Moreover, this electrolyte infusion preparation may also contain amino acids commonly used in amino acid infusion solution, and further sugars, fats and the like. When the electrolyte infusion solution contains at least one component selected from the group consisting of amino acids, sugars and fats, magnesium ions are contained by 14 parts by weight or more in 100 parts by weight of vitamin C, and blended at concentration of 15 to 35 mEq/liter, which is preferable in order that the intrinsic function of vitamin C can be exhibited, that the stabilizing effect of magnesium ions on vitamin C can be exhibited, and that the blended amino acids, sugars or fats may be metabolized efficiently.

In the invention, when the vitamin C preparation is a liquid, its liquid properties are not particularly limited, but pH is usually in a range of about 4.0 to 8.0.

According to the invention, as described in Examples mentioned later, the stability of vitamin C is notably improved by blending magnesium ions.

Industrial Applicability

In the vitamin C preparation and stabilizing method of vitamin C preparation of the invention, magnesium ions having the stabilizing action on vitamin C are blended. Therefore, according to the invention, the hitherto unstable vitamin C, in particular, vitamin C in solution can be stabilized, and the vitamin C preparation stable for a long period is obtained
PATENT EXAMPLES This data is not available for free
PATENT PHOTOCOPY Available on request

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