JP3047143B2 - Composition for intestinal lavage and intestinal lavage - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an intestinal washing solution and a composition for intestinal washing solution for preparing the intestinal washing solution by dissolving in water.

[0002]

2. Description of the Related Art Cleansing of the intestinal tract by washing it is necessary to ensure the accuracy of diagnosis in an enema x-ray examination and colonoscopy, and to prevent postoperative infections in intestinal resection and the like. It is an indispensable pre-treatment in order to do so. In recent years, the frequency and importance of intestinal lavage has been increasing in medical treatment due to an increase in colon disease.

In the past, intestinal lavage was generally performed by intestinal washing, but it had a problem in that the lavage fluid was sufficiently drained, and dilution of the contrast agent made it difficult to diagnose microscopic lesions. There was a problem. Then, a report of a pretreatment method without intestinal washing by Brown [Brown, GR: Univ. Michiga
n M Bull 27: 225-230, 1961] Since then, various methods of cleaning the intestinal tract with a large amount of water taken orally have been developed.

In the method according to Brown, a large amount of water is ingested on the day before the examination, and then a salt laxative that inhibits water absorption from the intestinal tract is administered, and the peristaltic movement of the intestinal tract is enhanced by the contact laxative to reduce intestinal contents. It is characterized by being washed away at once.

[0005] However, due to the difficulty of cleaning the right hemicolon with the method of Brown and concerns over the adverse effects that large amounts of water intake can have on patients with heart failure or renal impairment, the saline based method was subsequently used. Large dose of the aqueous electrolyte solution obtained (J. Hewitt, et al., Lancet, 2: 337 (1973), and a mannitol-added electrolyte solution (Minervini, S. et al., Gu
t, 20: A452, 1979], but the former caused a considerable amount of water absorption, while the latter was caused by an intraoperative intestinal explosion caused by hydrogen or methane gas generated by the decomposition of mannitol by intestinal bacteria. , Not commonly used.

[0006] Thereafter, an oral intestinal lavage solution containing polyethylene glycol and an electrolyte as main components (hereinafter referred to as "PEG solution") has been developed and spread [Davis, GR et a.
l., Gastroenterology, 78, 991-995, 1980]. PEG
Although the cleaning effect by the liquid is high, it is necessary to take a large amount (about 2 L or more) of the cleaning liquid so that it can be easily taken in order to be widely used.

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

Therefore, recently, an isotonic solution of magnesium citrate has been tried as an intestinal washing solution having an effect equal to or more than that of the PEG solution. Magnesium citrate is hardly absorbed from the intestinal tract, and by orally administering 1800 to 2700 mL of a solution dissolved in water so as to be isotonic with the body fluid, the absorption of water substantially to the body fluid side and 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 better than that of the PEG solution without dehydration of the PEG solution [Basic and Clinical, Vol. 24, No. 14, No. 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 does not easily cause nausea after taking the same.

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

However, fluctuations in the electrolyte balance in the body, which are considered to be caused by severe diarrhea inevitably caused by taking the drug, have been found as a side effect of the isotonic solution of magnesium citrate, and the function of the heart, lungs, kidneys, etc. There is a potential danger for use in patients who have problems with electrolyte metabolism due to disorders or the like.

Fluctuations in the electrolyte balance due to the isotonic solution of magnesium citrate are mainly caused by reduction of potassium ion and chloride ion. For the purpose of preventing this, it has been attempted to take potassium chloride tablets at the same time with some results. Was. On the other hand, it has been found that direct addition of potassium chloride to an isotonic solution of magnesium citrate results in a “bad taste” that cannot be directly performed. Taking with tablets is done separately. Such a method is not only complicated, but also potentially involves the possibility of occurrence of side effects due to, for example, forgetting to take the potassium chloride tablet, and requires some improvement.

[0012]

SUMMARY OF THE INVENTION Under such circumstances, the present invention has an excellent cleaning effect equivalent to that of an isotonic solution of magnesium citrate, prevents side effects on the electrolyte balance of a patient, and has a taste An object of the present invention is to provide an intestinal washing solution and a composition for the intestinal washing solution which are easy to take in the following points.

[0013]

As a result of studying various compositions based on magnesium citrate, the present inventor has found that magnesium citrate is mainly composed of sodium citrate, potassium hydroxide, and, if desired, sucrose and other components. It has been found that an aqueous solution isotonic with a bodily fluid containing a sugar having a sweet taste in a certain ratio meets the above object, and the present invention has been completed.

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 saccharides at a concentration at which the osmotic pressure finally becomes 290 to 310 mOsm / L. An intestinal lavage solution characterized by being an aqueous solution comprising: Preferred amounts of each component for achieving such an osmotic pressure are, for example, 4.8 to 5.4 mmol of sodium chloride, 8.5 to 9.3 mmol of potassium hydroxide, and 10.
7 to 2.1 g.

Further, the present invention contains magnesium citrate, and the magnesium citrate is contained in an amount of 32.3 to 35.7 g.
4.8-5.4 mmol of sodium chloride, 8.5-9.3 mmol of potassium hydroxide and 10.7 saccharides
A composition for an intestinal lavage solution for use as an aqueous solution having an osmotic pressure of 290 to 310 mOsm / L, which is dissolved in water and further containing 2.1 to 2.1 g.

In the above, saccharides include saccharides having a sweet taste, such as sucrose, maltose, glucose, fructose, invert sugar and the like. Most conveniently, sucrose is used.

By dissolving, for example, 50 g of such a composition in water to make a total amount of 900 mL, an intestinal washing solution having an intended osmotic pressure in the range 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 it is safe and intact as an intestinal washing solution without causing any absorption of water from the intestinal tract to the body fluid or dehydration from the body fluid. The osmotic pressure range that can be used effectively. As a result, the intestinal washing solution of the present invention is equivalent to the existing isotonic solution of magnesium citrate in the intestinal washing effect.

Further, according to the intestinal lavage solution of the present invention, it is possible to prevent fluctuations in the electrolyte balance of a patient as observed in the existing isotonic solution of magnesium citrate. For this reason, the intestinal lavage fluid of the present invention can be used safely even in patients with problems in electrolyte metabolism due to impairment of heart, lungs, kidneys, etc., as in a conventional magnesium citrate isotonic solution, There is no need to take potassium chloride tablets or the like separately.

Furthermore, despite the presence of potassium ions and the like to prevent fluctuations in the electrolyte balance of the patient, the generation of “unsatisfactory taste” can be prevented. Provided is an intestinal lavage solution that is excellent in taste and easy to take like the isotonic solution of magnesium acid.

The production of the composition for intestinal lavage of the present invention can be carried out, for example, as follows. That is, first, magnesium carbonate is dispersed in water, citric acid is added and dissolved therein, and a predetermined amount of an aqueous solution of potassium hydroxide and sodium chloride is added to the solution, followed by stirring, and then drying and pulverizing the solution. 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, by dispensing an amount necessary to make it isotonic with body fluids in a package indicating a certain amount of water (for example, 900 mL) to be used for dissolving, a formulation convenient for dissolving and using at the time of use can be obtained. it can.

Next, a typical 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 (JP product) in 480 L of purified water, citric acid (JP product)
Gradually add 184.0 kg and warm to a nearly clear liquid. After cooling, add purified water to make 640 L. To this solution, 21.0 kg of citric acid is added and dissolved, and a solution in which 4.0 kg of potassium hydroxide and 2.4 kg of sodium chloride are previously dissolved in water is added and mixed. The mixed solution is dried and powdered to obtain 290 kg of a dried product. 102.8 kg of sucrose is added to the obtained powder and mixed with a mixer to obtain a uniform mixture to obtain a composition for intestinal washings. This is filled with 50 g (for 900 mL) of each package by an automatic filling machine. A solution prepared by dissolving 50 g of this preparation in water to make 900 mL has an osmotic pressure of about 300 mOsm / L, and impairs the taste of the current isotonic solution of magnesium citrate despite the presence of potassium ions, chloride ions, etc. No, that is, it maintained the same excellent taste, and was confirmed to be suitable for inevitable large-dose administration as an intestinal lavage fluid.

Claims (2)

(57) [Claims] 1. A method according to claim 1, wherein the solution contains 32.3 to 35.7 g of magnesium citrate per 900 mL, and further contains sodium chloride,
An intestinal washing solution comprising an aqueous solution containing potassium hydroxide and a saccharide at a concentration at which the osmotic pressure finally becomes 290 to 310 mOsm / L. 2. Magnesium citrate is contained, and 4.8 to 5.4 mmol of sodium chloride, 8.5 to 9.3 mmol of potassium hydroxide and 10.7 g of saccharide per 32.3 to 35.7 g of the magnesium citrate. To 2.1
g for use as an aqueous solution having an osmotic pressure of 290 to 310 mOsm / L by dissolving in water, further comprising g.