Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1995-12-20
1998-03-17
Jordan, Kimberly
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514 78, 514167, 514251, 514276, 514458, 514474, 514554, A61K 3170, A61K 31685, A61K 3159, A61K 31525, A61K 3151, A61K 31355, A61K 3134, A61K 31205
Patent
active
057286817
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/JP95/00778, filed Apr. 20, 1995.
TECHNICAL FIELD
This invention relates to infusion preparations which comprise a fat emulsion, sugars, amino acids, electrolytes and vitamins, and to a container filled with infusion liquids for use in making said infusion preparations and infusion liquids. More specifically, the invention relates to (1) an infusion preparation comprising a fat emulsion, sugars and specific vitamins, (2) an infusion preparation comprising amino acids, electrolytes and other vitamins, (3) a container filled with infusion preparations in which infusion preparations (1) and (2) are contained in respective compartments, and (4) an infusion preparation prepared by mixing infusion liquids contained in the respective compartments.
BACKGROUND ART
Intravenous infusion is carried out for the purpose of supplying nutrients to maintain a patient's life when oral or nasal feeding is impossible or insufficient and when the digestion and absorption functions of the patient are in a poor state even if such a feeding means can be carried out, or when the passage of food through the digestive tract makes the patient's condition or disease more serious. Examples of commercially available infusion preparations include sugar intravenous infusion which contains reducing sugars and the like, amino acid intravenous infusion which contains essential amino acids and the like, electrolyte infusion liquid which contains electrolytes and the like, a fat emulsion which contains a plant oil and the like, and a vitamin mixture. These infusion preparations are appropriately selected depending on the condition of the patient and are mixed upon use. However, mixing these preparations at the time of their use requires complex handling and, above all things, raises the problem of microbial contamination. With the aim of overcoming such problems, various infusion preparations, in which some of the aforementioned infusion liquids are mixed in advance, have been proposed. Infusion preparations which contain sugars, amino acids, electrolytes and a fat emulsion, all essential nutrients, are especially useful from a clinical point of view.
However, since these sugar infusion liquids, amino acid infusion liquids, electrolyte infusion liquids and fat emulsions are different from one another in terms of the conditions for their stable existence, various problems arise when they are mixed, and the mixture becomes useless in many cases.
For example, because of its unstable nature, a fat emulsion is apt to form bulky fat particles and to cause phase separation (creaming) when mixed with other infusion liquids. In particular, divalent cations contained in an electrolyte infusion liquid cause aggregation and disintegration of fat emulsion particles.
In the case of an electrolyte infusion liquid, since it contains calcium and phosphoric acid as essential components to maintain the balance of electrolytes, it is apt to form calcium phosphate by the reaction of calcium with phosphoric acid and therefore to generate turbidity and precipitation. In order to prevent the formation of turbidity and precipitation, such an electrolyte infusion liquid is usually adjusted to a low pH value (less than 5). When such an electrolyte infusion liquid is mixed with an amino acid infusion liquid, the pH of the mixture increases to the amino acid pH value because of the strong buffer action of amino acids, thus requiring a large quantity of acidic materials (for example, hydrochloric acid, acetic acid and the like) to keep the pH value at a low level. However, acidic materials can be used only in a limited amount because a large quantity of acid spoils the balance of the infusion components. As a consequence, the pH value of the mixture of electrolyte and amino acid infusion liquids cannot be lowered to a satisfactory level, thus resulting in the generation of turbidity and precipitation at the time of heat sterilization of the mixture.
In addition, when a mixture of an amino acid infusion liquid with a sugar infusion liqu
REFERENCES:
Remington's Pharmaceutical Sciences, 18th ed., 1990, pp. 1570-1580.
Abe Shun-ichi
Ii Shigeo
Kido Takae
Kodaira Hideto
Munechika Koji
Jordan Kimberly
The Green Cross Corporation
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