JP2940249B2 - Infusion preparation - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an infusion preparation, and more particularly to an infusion preparation comprising a fat emulsion and a reducing sugar.

[0002]

2. Description of the Related Art Conventionally, in the maintenance of a patient's life, oral nutrition and tube feeding have been impossible or inadequate, or even if they are possible, the digestive and absorptive function of the patient is reduced. In cases where the condition is extremely poor or the passage of food through the digestive tract leads to an exacerbation of the underlying disease, an infusion is administered intravenously for nutritional supplementation. As such infusion preparations, sugar infusions containing reducing sugars and the like, amino acid infusions containing essential amino acids and the like, electrolyte infusions containing minerals, fat emulsions containing vegetable oil emulsions and the like, and mixed vitamin preparations are commercially available. These infusion preparations are appropriately mixed at the time of use according to the symptoms of the patient and the like.

[0003]

As described above, various infusion preparations are mixed at the time of use, but mixing at the time of use of the infusion preparation is a cumbersome operation for the worker, and above all, mixing is difficult. There is a problem of bacterial contamination. From such problems, infusion preparations in which a fat emulsion and a reducing sugar are previously mixed have been studied.However, fat emulsions and reducing sugars are unstable, and infusion preparations in which a reducing emulsion is combined with a fat emulsion are known. Not. The present invention has been made to solve the above-mentioned problems of the prior art, and an object of the present invention is to provide an infusion preparation in which a reducing emulsion is added to a fat emulsion.

[0004]

The infusion preparation of the present invention is an infusion preparation comprising a fat emulsion obtained by emulsifying an oil or fat with a phospholipid and a reducing sugar, wherein the oil or fat is 0.1 to 30 W / V%, It contains 0.01 to 10 W / V% of lipid and 5 to 60 W / V% of reducing sugar.

In the present invention having the above-mentioned structure, various types of fat emulsions used for infusion can be used as the fat emulsion. For example, fats and oils are emulsified with phospholipids to reduce the average particle size of fat particles to 1 μm. Hereinafter, an oil-in-water type fat emulsion emulsified to preferably 0.5 μm or less, more preferably 0.3 μm or less, may be mentioned. More specifically, after adding fats and oils and phospholipids to water (preferably water for injection), stirring to prepare a crude emulsion, and then emulsifying the crude emulsion by a conventional method such as a high-pressure emulsification method. To prepare a fat emulsion. When the above emulsification is carried out by a high-pressure emulsification method, the emulsification is carried out, for example, by passing the coarse emulsion approximately 5 to 50 times under conditions of approximately ²⁰ to 700 kg / cm ² using an emulsifier such as a Menton-Gaulin homogenizer.

As the above fats and oils, any fats and oils can be used as long as they are edible oils.
Cottonseed oil, safflower oil, corn oil, coconut oil, perilla oil, sesame oil, etc.), fish oil (eg, cod liver oil, etc.), medium chain fatty acid triglycerides [eg, Panassate (trade name),
ODO (trade name) etc. and chemically synthesized triglycerides [eg, chemically defined such as 2-linoleoyl-1,3-dioctanoylglycerol (8L8), 2-linoleoyl-1,3-didecanoyylglycerol (10L10) and the like] triglyceride
s] is preferably used. In addition, any phospholipid can be used as long as it is a phospholipid used in pharmaceutical preparations.For example, selected from egg yolk phospholipids, hydrogenated egg yolk phospholipids, soybean phospholipids, and hydrogenated soybean phospholipids. One or two
More than one phospholipid is preferably used. Particularly preferred is a fat emulsion in which soybean oil is used as the oil and fat and egg yolk phospholipid is used as the phospholipid, and the average particle diameter of the fat particles is adjusted to 0.3 μm or less.

[0007] Examples of the reducing sugar as another component of the infusion preparation of the present invention include glucose, fructose, maltose and the like. These reducing sugars may be used as a mixture of two or more kinds. Further, a mixture of these reducing sugars and sorbitol, xylitol and / or glycerin may be used. The addition of the reducing sugar and a mixture of the reducing sugar and sorbitol (hereinafter, these are collectively referred to as saccharides) may be performed after preparing the fat emulsion or may be performed when preparing the fat emulsion.

The infusion preparation of the present invention is mainly composed of the above-mentioned components. The composition is preferably 0.1 to 30 W / V% of fats and oils (hereinafter, unless otherwise specified,% indicates W / V%), preferably Is about 1 to 20%, more preferably about 2 to 10%, phospholipid 0.
01-10%, preferably about 0.05-5%, more preferably 0.1
About 1%, reducing sugar 5-60%, preferably about 7-40%, more preferably about 10-30%, and water required to make the total amount 100.

The infusion preparation of the present invention may contain a pH buffer or a coloring inhibitor in order to prevent a decrease in pH and coloration during sterilization and storage. The addition amounts of these pH buffers and coloring inhibitors are usually about 1% or less, respectively. Further, vitamins (for example, vitamin A, vitamin B, vitamin C, vitamin D, vitamin E,
Vitamin Ks) may be added. These various additives may be added to the coarse emulsion or may be added to the emulsified fat emulsion.

The infusion preparation of the present invention can be prepared by various methods. For example, a predetermined amount of saccharides and, if necessary, various additives such as a coloring inhibitor and a pH buffer are added to the fat emulsion. A method of mixing and mixing; in preparing a fat emulsion, a predetermined amount of saccharide is added to a roughly emulsified liquid and emulsified to obtain a fat emulsion, and if necessary, various additives such as a coloring inhibitor and a pH buffering agent are added. Method of adding and mixing agents; a method of mixing predetermined amounts of fats and oils and saccharides into an emulsion using phospholipids, and then adding and mixing various additives such as a coloring inhibitor and a pH buffer as needed. Can be prepared.
The liquid properties of the infusion preparation of the present invention usually have a pH of 5.
It is adjusted to about 0 to 8.0, preferably about 5.5 to 7.0.

The infusion preparation of the present invention can be heat-sterilized. For example, in the heat sterilization, the infusion solution is in a glass container or a plastic (eg, polypropylene, polyethylene, ethylene-vinyl acetate copolymer, polyvinyl chloride, etc.) container. (Eg, bags, bottles, etc.) and then replaced with an inert gas (eg, nitrogen gas, helium gas, etc.)
After sealing, it is performed by subjecting it to a sterilization step. The sterilization step can be performed according to a conventional method, for example, by a method such as high-pressure steam sterilization, hot water immersion sterilization, or hot water shower sterilization. When a plastic container is used, sterilization is preferably performed in an atmosphere substantially free of oxygen.

The infusion preparation of the present invention is intravenously administered to a patient as it is or diluted with water, or alone or, if necessary, mixed with another amino acid infusion, electrolyte infusion or the like. Furthermore, it can be used for administration in oral or enteral administration forms.

[0013]

EXAMPLES Hereinafter, the present invention will be described in more detail with reference to Examples, but the present invention is not limited to these Examples. Example 1 An appropriate amount of water was added to 60 g of soybean oil and 7.2 g of egg yolk phospholipid, and the mixture was stirred with a homomixer. Water was added to 1000 ml to obtain a crude emulsion. The coarse emulsion was emulsified with a Manton-Gaulin homogenizer (manufactured by Gorin, Model 15M-8TA) to obtain an emulsion. 250 g of glucose was added to 500 ml of the obtained emulsion,
Water was added to make the total volume 1000 ml, and the pH was adjusted to 6 to prepare an infusion preparation. Table 1 shows the composition of the obtained infusion preparation. This formulation was dispensed into a 50 ml glass container, replaced with nitrogen gas, stoppered, and then subjected to high-pressure steam sterilization at 115 ° C. for 30 minutes. The properties, pH and average particle size of the emulsion before and after sterilization were compared. Table 2 shows the results.

[0014]

[0015]

As shown in Table 2, although the pH was slightly lowered by sterilization, the preparation maintained a stable emulsified state.

Example 2 Infusion preparations shown in Table 3 below were prepared in the same manner as in Example 1. Subsequently, high-pressure steam sterilization was performed in the same manner as in Example 1. All the preparations after sterilization maintained a good emulsified state.

[0018]

As described above, the infusion preparation of the present invention is an infusion preparation in which a reducing emulsion is blended with a fat emulsion, and can be used without an operation of mixing a reducing emulsion with a fat emulsion. This has the effect of simplifying the operation and preventing bacterial contamination during mixing.

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁶ Identification code FI A61K 31/70 A61K 31/70 (72) Inventor Ryoichiro Murashima 2-25-1, Shodai Otani, Hirakata City Midori Cross Research Center In-house (72) Inventor Shunichi Abe 2- 25-1, Inui Otani, Hirakata City Midori Cross Central Research Institute, Inc. (72) Inventor Kazumasa Yokoyama 2, 25-1, Invitation Otani Hirakata City Midori Cross Central Research Institute In-house (56) References JP-A-58-79528 (JP, A) JP-A-62-29511 (JP, A) New drugs and clinical trials, Vol. 32, No. 12, issued December 1983, No. 146- Page 153 (58) Fields investigated (Int. Cl. ⁶ , DB name) A61K 38/00 A61K 9/107 A61K 31/045 A61K 31/23 A61K 31/70 CA (STN) MEDLINE (STN)

Claims (3)

(57) [Claims] 1. An infusion preparation comprising a fat emulsion obtained by emulsifying fats and oils with a phospholipid and a reducing sugar, wherein the fats and oils are mixed at a concentration of 0.1%.
1 ~ 30W / V%, phospholipid 0.01 ~ 10W / V%, and reducing sugar 5 ~
An infusion preparation characterized by containing 60 W / V%. 2. The oil or fat selected from vegetable oils, fish oils, medium chain fatty acid triglycerides and chemically synthesized triglycerides.
Is a species or two or more, or phospholipids egg yolk phospholipids, hydrogenated egg yolk phospholipids, one or more selected or found soybean phospholipid and hydrogenated soybean phospholipid <br/> lipids, reduced The sugar is one or more reducing sugars selected from glucose, fructose and maltose, or a mixture of the reducing sugars with one or more selected from sorbitol, xylitol and glycerin. Infusion preparations. 3. One to two or more fats and oils selected from vegetable oil, fish oil, medium-chain fatty acid triglyceride and chemically synthesized triglyceride in an amount of 1 to 20 W / V%, egg yolk phospholipid, hydrogenated egg yolk phospholipid, soybean phospholipid and hydrogenated soybean phospholipid lipid
Pressurized et chosen one or more phospholipids 0.05~5W / V
%, Glucose, one or more reducing sugars selected from fructose and maltose, or the reducing sugar and sorbitol,
The infusion preparation according to claim 2, comprising 7 to 40 W / V% of a mixture with one or more selected from xylitol and glycerin.