JPH01132527A - Intestine washing solution - Google Patents

Abstract

PURPOSE:To obtain a safe intestine washing solution useful in examination of intestinum crassum and operation, requiring no heat sterilization, containing no antiseptic, having no change in quality for a long period of time, by dissolving polyethylene glycol 4,000 and specific amounts of electrolytic components in water into a specific concentration of polyethylene glycol 4,000. CONSTITUTION:Relative amounts of polyethylene glycol 4,000 and electrolytes are dissolved in water to give 53-65g polyethylene 4,000, 36-44mmol sodium sulfate, 9-11mmol KCl, 23-28mmol NaCl and 18-23mmol NaHCO3 and the concentration of the polyethylene glycol 4,000 is made >=11.8(W/V)%. Further preferably concentration of the polyethylene glycol 4,000 is 3-5 times the concentration. The intestine washing solution is packed into a container having no gas permeability or almost no gas permeability such as glass bottle or synthetic resin bottle.

Description

Detailed Description of the Invention (1) Industrial Application Field The present invention relates to an intestinal cleansing liquid, and more specifically, it can be used safely for a long period of time without deterioration in quality without heat sterilization or addition of preservatives. The present invention relates to an intestinal cleansing solution that can be used to cleanse the intestines.

(2) Prior Art As a pretreatment method for examination or surgery of the large intestine and rectum, or surgery for hemorrhoids, a modified Brown method and an electrolyte washing method have been used in the past.

These treatment methods are not only painful for patients, but also expensive and have problems in terms of effectiveness. In particular, the electrolyte washing method could not be used at all for patients with renal disease, heart disease, or hypertension because it requires ingesting large amounts of water containing only isotonic electrolytes.

In 1980, Davis et al. reported a non-secretory, non-absorptive whole-intestinal cleansing method that was highly safe and effective even for patients with the above-mentioned diseases. (Gastroenterology (Gas)
troenLer.

1ogy), Yu, 991 (1980)).

This cleaning method uses 236.0 g of polyethylene glycol 4000 (polyethylene glycol 3350 in the United States, which has the same physical properties) and 22 g of sodium sulfate as an electrolyte.
．． 74g, potassium chloride 2.97g.

5.86 g of sodium chloride and sodium bicarbonate6.
This can be accomplished by taking 74g dissolved in 42g of water.

As a preparation for this cleaning method, it is preferable to use an oral liquid preparation already dissolved in water for convenience of use than a solid preparation.However, oral liquid preparations generally do not last long unless they are sterilized. It cannot be used safely without deterioration in quality.

Many studies on contamination and infection by microorganisms (bacteria, pages, etc.) of pharmaceuticals have been conducted for injectables, but there are few reports on oral preparations, although there are some reports on the amount of bacteria sufficient to cause infection. according to it,
It has been reported that ingesting foods containing 103 to 104 live bacteria per gram can cause gastrointestinal infections. In addition, it is stipulated that the number of viable bacteria for internal liquid preparations must be less than 1,000 per lae (Pharmacy Bulletin, June 21, 1976); however, this number varies depending on the patient's symptoms, and there is no general rule. cannot be specified. That is, it is not always safe if it is less than this, and it is desirable that the growth of viable bacteria be suppressed in a sterile state or a state close to it.

In order to produce a sterilized internal solution, first, after preparing the medicinal solution, fill it into a suitable container and seal it and heat sterilize it, or fill it in a sterile container while heat sterilizing it and seal it, or add preservatives and preparations. Methods such as filling and sealing are being used in combination with sterilization of the process.

In the case of the above-mentioned whole intestinal tract cleansing solution, sterilization by heating cannot be used because it contains sodium bicarbonate, which is unstable to heat, and addition of preservatives is also undesirable in view of the purpose of the intestinal tract cleansing solution.

Therefore, in the past, solid preparations have been provided despite the inconvenience that it takes time to prepare an aqueous solution during use due to the slow dissolution rate of polyethylene glycol 4000 in water.

(3) Problems to be Solved by the Invention The purpose of the present invention is to provide a
To provide an intestinal cleansing liquid that can be used safely for a long period of time without deteriorating in quality.

(4) Means for Solving the Problems In order to solve the above-mentioned problems, the present inventors first tried to use Serratia, which is a common contaminant in the whole intestinal cleansing solution of Davis et al. Pseudomonas, Staphylococcus tibidermidis
15 each of C. epidermidis and Candida albicans.
The cells were inoculated at ~20 cells/Id and their reproduction was examined.

It was found that all of them proliferated rapidly at room temperature and reached the specified value of 1000 cells/d, which is considered dangerous for oral ingestion, within a few days. As we proceeded further with this study, we surprisingly found that the concentration of polyethylene glycol 4000 was more than twice that of the whole intestinal lavage solution of Davis et al.
The present inventors discovered that microorganisms do not proliferate at all even at room temperature by setting the concentration to 8 (W/V)% or more, leading to the completion of the present invention.

The present invention can be dissolved in water such that the relative amounts of polyethylene glycol 4000 as well as electrolytes range from 3 to 65 g of polyethylene glycol 400,005 g of sodium sulfate, 36 to 44 m+mol, of potassium chloride, of 9 to 111 IIlol, of sodium chloride, 23 to 28 mmol, of sodium bicarbonate, of 18 to 23 s+ol. , the concentration of the polyethylene glycol 4000 was set to 11. The present invention provides an intestinal cleansing solution characterized by having a concentration of 8 (W/V)% or more.

In the intestinal cleansing solution of the present invention, the concentration of polyethylene glycol 4000 is 11. If it is 8 (W/V)% or more, the effect of inhibiting microbial growth can be obtained and there is no particular problem, but
The concentration is preferably 3 to 5 times that amount.

The intestinal cleansing solution of the present invention can be produced as follows.

The amount of each component within the above relative range is 11.8 (w/v) using the concentration of polyethylene glycol 4000 as an index.
% or more in purified water, and then the pore size is 0.
This solution should be aseptically filtered through a membrane filter with a diameter of 22 to 0.45μ (maximum). Although this solution is not sterilized as described above, the container should be sterilized in advance and sealed after filling. It is desirable that the container has no or almost no moisture permeability and gas permeability, such as glass bottles, synthetic resin bottles, synthetic resin bags, aluminum laminate bags for liquids, and paper containers for liquids. etc.

When using the intestinal tract cleansing solution of the present invention, it may be diluted with tap water or purified water to give the same concentration as the whole intestinal tract cleansing solution of Davis et al.

(5) Examples The present invention will be specifically explained below with reference to Examples.

Example 1 Polyethylene glycol 4000 118g Sodium sulfate 11.4g Potassium chloride
1.49g sodium chloride 2.
93g Sodium bicarbonate 3.37g or more of each ingredient was dissolved in purified water, the total volume was adjusted to 11, and filtered through a 0 then 0.22μ Millipore filter (manufactured by Millipore) and pre-sterilized in a 500W1 glass bottle. It was filled and sealed.

Examples 2-7 Polyethylene glycol 4000240g Sodium sulfate 22.8g Potassium chloride
3.00g Sodium chloride 5.9
0g Sodium hydrogen carbonate 6.74g or more of each component was dissolved in purified water to the volume shown in the table below, and treated in the same manner as in Example 1 to pre-sterilize 500-
The container was filled and sealed.

(Margin) (6) Test Example The Davis (D) prepared in the same manner as in Example 1.
Avis et al.'s whole intestinal tract cleansing solution and the intestinal tract cleansing solution preparation of Example 2 were used to culture Serratia in accordance with a conventional method.
) and Pseudomonas were each inoculated at 15 to 20 cells/rn1. The number of bacteria was measured over time after being left at room temperature, and the results are shown in FIG.

From this figure, it can be seen that significant bacterial growth was observed in the whole intestinal tract cleansing solution of Davis et al., and on the contrary, there was a tendency to decrease in the intestinal tract cleansing solution of Example 2.

(7) Effects of the Invention The intestinal cleansing solution of the present invention can be safely used over a long period of time without deteriorating in quality, and a solution with a predetermined concentration can be prepared by simply diluting it.

[Brief explanation of the drawing]

FIG. 1 shows changes in the growth of bacteria over time in the whole intestinal tract washing solution of Davis et al. and in the intestinal tract washing solution of Example 2. Patent applicant Morishita Pharmaceutical Co., Ltd.

Claims (2)

[Claims] (1) Polyethylene glycol 4000 and electrolyte are dissolved in water such that the relative amounts range from 3 to 65 g, sodium sulfate, 36 to 44 mmol, potassium chloride, 9 to 11 mmol, sodium chloride, 23 to 28 mmol, sodium hydrogen carbonate, 18 to 23 mmol, An intestinal cleansing liquid preparation, characterized in that the concentration of the polyethylene glycol 4000 is 11.8 (w/v)% or more. (2) The intestinal cleansing liquid preparation according to claim 1, which is filled in a container having no or almost no water permeability and gas permeability.