JP3214116B2 - Intraoperative infusion preparation - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to an intraoperative infusion preparation.
More specifically, the present invention is useful as an intraoperative infusion preparation that can effectively correct the electrolyte balance in the perioperative period, and relates to an electrolyte infusion preparation containing specific amounts of electrolytes and carbohydrates.

[0002]

2. Description of the Related Art In perioperative infusions, a large amount of lactated Ringer's solution (ie,
Ringer's solution containing lactate as an alkalizing agent) is used. However, various problems have been pointed out regarding the use of a large amount of Ringer's lactate solution. First, Sh
Theory of Third Space formation theory proposed by ires GT et al.
Based on (ANN. CLIN.RES. (FINLAND), 1977, 9/3 (144-150)), the use of large amounts of Ringer's lactate solution causes sodium to accumulate and leads to edema of interstitial cells, especially for pulmonary function. It is pointed out that there is a danger of adverse effects such as a decrease in the amount. Also,
It is impossible to completely suppress the secretion of antidiuretic hormones and aldosterone even by administering a large amount of electrolytes during surgery,
As a result, it has been pointed out that the discharge of free water from the kidney is restricted, and sodium is stored in the body.

[0003]

In view of the above,
It would be desirable for an appropriate intraoperative infusion formulation to correct electrolyte balance to provide adequate hydration commensurate with metabolic rate and minimal electrolyte supplementation to compensate for extracorporeal losses. An object of the present invention is to provide an intraoperative infusion preparation which can effectively correct the electrolyte balance and is pharmaceutically stable.

[0004]

Means for Solving the Problems An intraoperative infusion preparation of the present invention made to overcome the above problems contains an electrolyte and a carbohydrate in the following ranges, and contains sodium 56.0 to 84.0 mEq / l. Potassium 3.2-4.8 mEq / l Calcium 2.4-3.6 mEq / l Kroll 41.6-62.4 mEq / l Acetic acid 20.0-30.0 mEq / l Carbohydrate 2.0- The pH is adjusted to 4.0 to 6.0 with 3.0 w / v% hydrochloric acid. In particular, the intraoperative infusion preparation of the present invention is characterized by having a lower sodium content than conventional Ringer's solution.

[0005] In the intraoperative infusion preparation of the present invention, sodium chloride, sodium acetate, or the like is used as a source of sodium, potassium chloride or the like is used as a source of potassium, calcium chloride is used as a source of calcium, and chloride is used as a source of chlor. Sodium, potassium chloride, calcium chloride and the like can be used. They can also be used as hydrates.

The intraoperative infusion preparation of the present invention uses acetic acid as an alkalizing agent. Lactic acid and the like can also be used as an alkalizing agent, but lactic acid is mainly metabolized in the liver, so lactic acidosis may occur due to a decrease in lactic acid metabolism in the liver at the time of severe liver disease or bleeding shock. Not preferred. On the other hand, acetic acid has an advantage that it can be administered even to patients with severe liver disease or bleeding shock because acetic acid is efficiently metabolized not only in the liver but also in muscles throughout the body. Acetic acid can be used in any form of free acid, salt (for example, sodium salt), and hydrate.

The carbohydrate used in the intraoperative infusion preparation of the present invention includes, for example, glucose, fructose, maltose,
Sorbitol, xylitol, glycerin and the like are exemplified, and glucose, which is the safest sugar source, is suitably used. Various effects such as an osmotic pressure adjusting effect can be expected by incorporating a saccharide. The pH of the intraoperative infusion preparation of the present invention is adjusted to 4.0 to 6.0 with hydrochloric acid. Therefore, problems such as vascular pain and phlebitis can be avoided even in the case of rapid mass administration.

The preferred composition range of the intraoperative infusion preparation of the present invention is as follows. Sodium 56.0-84.0, preferably 63.0-77.0 mEq / l potassium 3.2-4.8, preferably 3.6-4.4 、 calcium 2.4-3.6, preferably 2.7-3.3 〃 chlor 41.6-62.4, preferably 46.8-57.2 〃 acetic acid 20.0-30.0 , Preferably 22.5-27.5 〃 glucose 2.0-3.0, preferably 2.2-2.8 w / v%

The intraoperative infusion preparation of the present invention can be prepared by various methods. For example, each component is weighed, dissolved in a corresponding amount of water for injection, and then adjusted to pH 4.0 using hydrochloric acid. It can be prepared by adjusting the pH to 6.0, preferably 4.5 to 5.5. The intraoperative infusion preparation of the present invention can be heat-sterilized. In the heat sterilization, for example, the infusion solution can be obtained in a glass container or a plastic (eg, polypropylene, polyethylene, ethylene-vinyl acetate copolymer, polyvinyl chloride, etc.) container (for example, , Bags, bottles, etc.), sealed, and then subjected to a sterilization step. The sterilization step can be performed according to a conventional method, for example, a method such as high-pressure steam sterilization, hot water immersion sterilization, or hot water shower sterilization. The intraoperative infusion preparation of the present invention is administered to a patient parenterally, alone or, if necessary, mixed with other infusions, drugs and the like.

[0010]

EXAMPLES The present invention will be described in more detail with reference to the following Examples, but it should not be construed that the invention is limited thereto. Example 1 Glucose 25.00 g, sodium chloride 2.63 g, potassium chloride 0.30 g, calcium chloride 0.22 g, anhydrous sodium acetate 2.05 g in 900 ml of water for injection at normal temperature
g was added sequentially and dissolved. After adjusting the pH to 5.0 with 1N hydrochloric acid, water for injection was further added to make the total volume 1000 ml. Filtration was performed using a 0.45 μm membrane filter, and 250 ml was dispensed into 500 ml PP bags (soft bags made of polypropylene). 3 at 115 ° C
Hot water static sterilization was performed for 0 minutes to obtain an intraoperative infusion preparation. The composition of each component in 1 liter of the above preparation is shown below. Sodium 70.0 mEq / l Potassium 4.0 カ ル シ ウ ム Calcium 3.0 〃 Kroll 52.0 酢 酸 Acetic acid 25.0 〃 Glucose 25.0 g Accelerated preservation test (40 ° C for 6 months) and long-term stability of this intraoperative infusion preparation As a result of the test (at room temperature for 2 years), no decrease in pH or coloration occurred, no formation of precipitates was observed, and it was found that this intraoperative infusion preparation was extremely stable.

[0011]

EFFECT OF THE INVENTION The intraoperative infusion preparation of the present invention has a low sodium content so that it does not cause edema of the interstitium due to sodium storage in the body, and acetic acid used as an alkalizing agent is only liver. Rather, it has properties such as efficient metabolism and utilization in muscles of the whole body, so that it is useful as an intraoperative infusion preparation for correcting electrolyte balance. In particular, it has the advantage that a large amount of rapid infusion can be performed even for patients with liver failure and circulatory failure.
In addition, since the composition is stable, long-term storage is possible. Furthermore, since it contains a carbohydrate, it is possible to perform infusion while injecting appropriate nutrition.

──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Takashi Imagawa 2- 25-1, Otani Otani, Hirakata City Inside the Central Research Laboratory, Midori Cross Corporation (72) Inventor Kazumasa Yokoyama 2- 25-1, Otani Otani, Hirakata City (72) Inventor Ryu Ogawa 3-2-1-707 Machiya, Arakawa-ku, Tokyo (56) References JP-A-57-91911 (JP, A) JP-A-2-108619 (JP) , A) (58) Field surveyed (Int. Cl. ⁷ , DB name) A61K 9/08, 31/19 A61K 31/70, 33/14

Claims (1)

(57) [Claims] An electrolyte and a saccharide are contained in the following range, and sodium 56.0 to 84.0 mEq / l potassium 3.2 to 4.8 mEq / l calcium 2.4 to 3.6 mEq / l Kroll 41.6-62.4 mEq / l Acetic acid 20.0-30.0 mEq / l Carbohydrate 2.0-3.0 w / v% The pH is adjusted to 4.0-6.0 with hydrochloric acid. An intraoperative infusion preparation, characterized in that: