JPH05306221A - Composition useful as washing liquid for intestinal canal and the washing liquid for intestinal canal - Google Patents

Abstract

PURPOSE:To obtain a washing liquid for intestinal canals having effects and easy drinkability comparable to those of a magnesium citrate isotonic aqueous solution without causing the fluctuation in electrolytic balance of patients. CONSTITUTION:The objective washing liquid for intestinal canals is characterized as an aqueous solution comprising 32.3 to 35.7g magnesium citrate based on 900ml and further sodium chloride, potassium hydroxide and saccharides at concentrations so as to finally provide 290-310mOsm/l osmotic pressure. Furthermore, the objective powdery composition useful as the washing liquid for the intestinal canals is dissolved in water so as to produce the aqueous solution.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an intestinal lavage fluid and a composition for intestinal lavage fluid which is dissolved in water to prepare the intestinal lavage fluid.

[0002]

2. Description of the Related Art Cleaning of the intestinal tract is necessary to ensure the accuracy of diagnosis in enema X-ray examination and colonoscopy, and to prevent postoperative infections in enterectomy. This is also an indispensable pretreatment. In recent years, with the increase in colorectal diseases, intestinal lavage is becoming more and more important in medical practice.

In the intestinal tract lavage, a method of performing an intestinal lavage was generally used in old days, but it has a drawback in that the lavage fluid is sufficiently discharged, and it is difficult to diagnose a microscopic lesion by diluting the contrast medium. There was a problem. After that, Brown reported a pretreatment method without intestinal washing [Brown, GR: Univ. Michiga
n M Bull 27: 225-230, 1961] since then, various methods for cleaning the intestinal tract with a large amount of water taken orally have been developed.

In the method by Brown, a large amount of water was ingested on the day before the test, and then a salt laxative that inhibits water absorption from the intestinal tract was administered, and the peristaltic movement of the intestinal tract was enhanced by a contact laxative to intestinal contents. The feature is to wash away all at once.

However, because of the difficulty of clearing the right hemicolon by the method of Brown and the fear that a large amount of water intake may have an adverse effect on patients with heart failure and renal failure, a saline-based method was used thereafter. Mass dose of the above-mentioned electrolyte aqueous solution [J. Hewitt, et al., Lancet, 2: 337 (1973)] and mannitol-added electrolyte solution [Minervini, S. et al., Gu
t, 20: A452, 1979] was proposed, but the former causes a considerable amount of water absorption, and the latter causes an intraoperative intestinal explosion accident due to hydrogen or methane gas generated by decomposition of mannitol by intestinal bacteria. , Not commonly used.

After that, an oral intestinal lavage solution (hereinafter referred to as "PEG solution") containing polyethylene glycol and an electrolyte as main components was developed and is becoming popular [Davis, GR et a.
L., Gastroenterology, 78, 991-995, 1980]. PEG
Although the cleaning effect by the liquid is high, since a large amount (about 2 L or more) of cleaning liquid is also taken, it is necessary to be easy to take for widespread use.

However, the PEG solution has a considerable difficulty in taste when it is taken in a large amount, and causes pain to patients such as difficulty in taking it and nausea after taking it. There is.

Therefore, in recent years, it has been attempted to take an isotonic solution of magnesium citrate as an intestinal lavage solution having an effect equal to or higher than that of the PEG solution. Magnesium citrate is hardly absorbed from the intestinal tract, but by orally administering 1800 to 2700 mL of a solution dissolved in water so as to be isotonic with the body fluid, it is substantially absorbed from the body fluid side or from the body fluid side. It has been reported that the intestinal tract can be washed in a short time and with an excellent effect equal to or higher than that of the PEG solution without being dehydrated (basic and clinical, Vol. 24, No. 14, 246- 365 (1990)]. Moreover, the magnesium citrate solution is far superior to the PEG solution in terms of taste, and therefore is easy to take and is less likely to cause nausea after taking [the same], and is therefore a preferred washing solution for general use.

In the present specification, "magnesium citrate" means magnesium monohydrogen citrate pentahydrate (Mg
_{HC 6 H 5 O 7 · 5H} 2 O) refers to.

However, a change in the electrolyte balance in the body, which is considered to be caused by severe diarrhea inevitably caused by taking the drug, has been found as a side effect of isotonic solution of magnesium citrate, and functions of the heart, lungs, kidneys, etc. There is a potential danger when used in patients with electrolyte metabolism problems due to disorders, etc. [Same as above].

The change in the electrolyte balance due to the isotonic solution of magnesium citrate is mainly a decrease in potassium ion and chloride ion, and in order to prevent this, simultaneous administration of potassium chloride tablets has been tried and some results have been achieved. It was On the other hand, when potassium chloride is directly added to an isotonic solution of magnesium citrate, it becomes “a bad taste”, and it has been proved that direct addition cannot be practically performed (the same). It is taken separately from the tablets. Such a method is not only complicated, but it potentially involves the possibility of side effects due to forgetfulness of taking potassium chloride tablets, etc., and requires some improvement.

[0012]

Under the circumstances, the present invention has an excellent cleaning effect equivalent to that of magnesium citrate isotonic solution, prevents side effects on the electrolyte balance of the patient, and has a taste sensation. In view of the above, it is an object of the present invention to provide an intestinal lavage fluid that is easy to take and a composition for the intestinal lavage fluid.

[0013]

As a result of studying various compositions based on magnesium citrate, the present inventor has found that magnesium citrate is the main component of which sodium chloride, potassium hydroxide, and optionally sucrose and other The present invention has been completed by finding that a body fluid containing isotonic sugar in a ratio of a certain range and an isotonic aqueous solution meet the above object.

That is, the present invention contains 32.3 to 35.7 g of magnesium citrate per 900 mL, and further contains sodium chloride, potassium hydroxide and saccharide in a concentration such that the osmotic pressure finally becomes 290 to 310 mOsm / L. The intestinal lavage fluid is an aqueous solution obtained by Preferred amounts of each component for achieving such an osmotic pressure are, for example, sodium chloride 4.8 to 5.4 mmol, potassium hydroxide 8.5 to 9.3 mmol, and sugar 10.
7 to 2.1 g.

Further, the present invention contains magnesium citrate, and the magnesium citrate 32.3 to 35.7 g
Sodium chloride 4.8 to 5.4 mmol, potassium hydroxide 8.5 to 9.3 mmol, and sugar 10.7
The composition for intestinal tract washing liquid for use as an aqueous solution having an osmotic pressure of 290 to 310 mOsm / L after being dissolved in water, further containing 0.1 to 2.1 g.

In the above, sugars include sugars having sweetness, such as sucrose, maltose, glucose, fructose and invert sugar. Most conveniently, white sugar is used.

By dissolving, for example, 50 g of such a composition in water to a total amount of 900 mL, a desired intestinal tract washing solution having an osmotic pressure of 290 to 310 mOsm / L can be easily produced.

The osmotic pressure in the range of 290 to 310 mOsmol / L is substantially isotonic with the body fluid, and is safe as an intestinal lavage fluid without causing any absorption of water from the intestinal tract to the body fluid side or dehydration from the body fluid side. It is an osmotic pressure range that can be effectively used. As a result, the intestinal lavage fluid of the present invention is equivalent in intestinal lavage effect to the current isotonic magnesium citrate solution.

Further, according to the intestinal lavage fluid of the present invention, it is possible to prevent the fluctuation of the electrolyte balance of the patient, which is observed in the current isotonic magnesium citrate solution. Therefore, the intestinal lavage fluid of the present invention can be safely used even in patients with problems in electrolyte metabolism due to functional disorders such as heart, lung, and kidney, and like conventional magnesium citrate isotonic solution, There is no need to take potassium chloride tablets etc. separately.

Further, in order to prevent a change in the electrolyte balance of the patient, the occurrence of "a bad taste that cannot be said" is prevented even though it contains potassium ions and the like. Provided is an intestinal lavage liquid which is as tasty as the isotonic liquid of magnesium acid and is easy to take.

The intestinal tract washing composition of the present invention can be produced, for example, as follows. That is, first, magnesium carbonate is dispersed in water, citric acid is added to and dissolved in this, and a predetermined amount of an aqueous solution of potassium hydroxide and sodium chloride is added and stirred, and then the solution is dried and powdered. can get. Sugars can be included in the composition, for example, by adding to the powder thus obtained.

The obtained mixed powder is packaged in an appropriate container for use. For example, a certain amount of water used for dissolution (for example, 900 mL) may be packaged in an amount corresponding to the amount necessary to make the body fluid isotonic in a labeled package, thereby making it a convenient formulation to be dissolved before use. it can.

Next, an exemplary embodiment will be described, but the present invention is not limited to the details of the embodiment.

[Example] After dispersing 86.5 kg of magnesium carbonate (JPN product) in 480 L of purified water, citric acid (JPN product)
Gradually add 184.0 kg and heat until a nearly transparent liquid is obtained. After cooling, add purified water to make 640 L. To this solution is added 21.0 kg of citric acid to dissolve it, and to this is added a solution prepared by previously dissolving 4.0 kg of potassium hydroxide and 2.4 kg of sodium chloride in water, and mixed. The mixed solution is dried and powdered to obtain 290 kg of a dried product. 102.8 kg of sucrose was added to the obtained powder and mixed with a mixer to obtain a uniform mixture, thereby obtaining a composition for intestinal lavage fluid. This is filled with 50 g (for 900 mL) per packet by an automatic filling machine. A 50 mL portion of this preparation dissolved in water to make 900 mL has an osmotic pressure of about 300 mOsm / L, and the taste of the current isotonic solution of magnesium citrate is impaired despite the presence of potassium ion, chloride ion, etc. That is, it was confirmed that it was excellent, that is, it had an excellent taste equivalent to this, and that it was suitable as an intestinal lavage liquid for inevitable large dose administration.

Claims (2)

[Claims] 1. 900 mL of magnesium citrate is contained in an amount of 32.3 to 35.7 g, and sodium chloride is further added,
An intestinal lavage fluid, which is an aqueous solution containing potassium hydroxide and saccharide in a concentration such that the osmotic pressure finally becomes 290 to 310 mOsm / L. 2. Containing magnesium citrate, and 4.8 to 5.4 mmol of sodium chloride, 8.5 to 9.3 mmol of potassium hydroxide and 10.7 saccharide per 32.3 to 35.7 g of the magnesium citrate. To 2.1
A composition for intestinal lavage fluid, which further contains g, for use as an aqueous solution having an osmotic pressure of 290 to 310 mOsm / L by being dissolved in water.