JP2596764B2 - Intestinal cleansing liquid - Google Patents
Intestinal cleansing liquidInfo
- Publication number
- JP2596764B2 JP2596764B2 JP62292996A JP29299687A JP2596764B2 JP 2596764 B2 JP2596764 B2 JP 2596764B2 JP 62292996 A JP62292996 A JP 62292996A JP 29299687 A JP29299687 A JP 29299687A JP 2596764 B2 JP2596764 B2 JP 2596764B2
- Authority
- JP
- Japan
- Prior art keywords
- polyethylene glycol
- intestinal
- mmol
- solution
- intestinal lavage
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Description
【発明の詳細な説明】 （１）産業上の利用分野 本発明は、腸管洗浄液剤に係わり、さらに詳しくは、
加熱滅菌や防腐剤の添加をしないで長期に亘って変質す
ることなく安全に使用することができる腸管洗浄液剤に
関する。DETAILED DESCRIPTION OF THE INVENTION (1) Industrial application field The present invention relates to an intestinal lavage solution.
The present invention relates to an intestinal cleansing solution that can be used safely without deterioration over a long period of time without heat sterilization or addition of a preservative.
（２）従来の技術 大腸及び直腸の検査又は手術、或いは痔疾の手術等の
前処置法として、従来よりブラウン（Brown）変法や電
解質洗浄法が用いられてきた。(2) Prior Art Conventionally, a modified Brown method or an electrolyte washing method has been used as a pretreatment method for examination or surgery of the large intestine and rectum, or surgery for hemorrhoids.
これらの処理法は、患者にとって苦痛であるばかりで
なく多大の費用を要し、しかも効果の点で問題のある方
法であった。特に電解質洗浄法は、等張の電解質のみを
含む大量の水を摂取するため腎疾患や心臓疾患或いは高
血圧症の患者には全く使用できなかった。These treatments are not only painful for the patient, but also costly and problematic in terms of effectiveness. In particular, the electrolyte washing method consumes a large amount of water containing only an isotonic electrolyte and cannot be used at all for patients with renal disease, heart disease or hypertension.
1980年にデイビス（Davis）らによって、非分泌性、
非吸収性で前記のような疾患を有する患者にも使用でき
る安全性の高い、また効果の面でも優れた全腸管洗浄法
が報告された（ガストロエンテロロジー（Gastroentero
logy），78,991（1980））。In 1980, Davis et al.
A total intestinal lavage method which is non-absorbable and can be used for patients with the above-mentioned diseases, has high safety and is also excellent in terms of efficacy (Gastroentero (Gastroentero)
logy), 78 , 991 (1980)).
この洗浄法は、ポリエチレングリコール4000（米国で
はポリエチレングリコール3350であるが同一物性品）23
6.0gと電解質として硫酸ナトリウム22.74g、塩化カリウ
ム2.97g、塩化ナトリウム5.86g及び炭酸水素ナトリウム
6.74gを４の水に溶解したものを服用することによっ
て為し遂げられる。This washing method uses polyethylene glycol 4000 (polyethylene glycol 3350 in the United States, but of the same physical properties).
6.0 g and 22.74 g sodium sulfate, 2.97 g potassium chloride, 5.86 g sodium chloride and sodium bicarbonate as electrolyte
Achieved by taking 6.74 g dissolved in 4 water.
この洗浄法用に提供する製剤としては、固形製剤より
も使用の際の適宜から既に水に溶かした内用液剤の方が
好ましい。しかしながら内用液剤は、一般に無菌化製剤
としなければ長期に亘って変質質することなく安全に使
用することができない。As a preparation to be provided for this washing method, a liquid preparation for internal use which has already been dissolved in water is more preferable than a solid preparation, as appropriate from the point of use. However, the liquid preparation for internal use cannot be safely used without deteriorating over a long period of time unless a sterilized preparation is generally used.
医薬品の微生物（細菌や真菌等）による汚染と感染に
関する検討は注射剤について多く行われているが、経口
投与製剤については少ない。しかし感染を引き起こすに
充分な菌量については若干の報告がある。それによる
と、1g当たり103〜104個の生菌を含有している食品など
を摂取した場合に消化管感染を引き起こすと報告されて
いる。また内用液剤についての生菌数は1ml当たり1000
個未満でなければならないと規定されている（薬務公
報、昭和51年６月21日）。しかしこの菌数は患者の症状
によって異なり一概に規定することができない。すなわ
ち、これ以下であれば常に安全というものではなく、無
菌状態若しくはそれに近い状態で生菌の増殖が抑制され
ていることが望ましい。Investigations on contamination and infection of pharmaceuticals by microorganisms (such as bacteria and fungi) have been conducted on injections, but not on oral preparations. However, there are some reports on the amount of bacteria sufficient to cause infection. According to the report, it is reported that ingestion of foods containing 10 3 to 10 4 viable bacteria per gram causes digestive tract infection. The number of viable bacteria for internal solutions is 1000 per ml.
It is stipulated that the number must be less than one (Pharmaceutical Gazette, June 21, 1976). However, this bacterial count varies depending on the patient's condition and cannot be defined unconditionally. In other words, if it is less than this, it is not always safe, and it is desirable that the growth of viable bacteria be suppressed in a sterile state or a state close thereto.
無菌化した内用液剤を製造するためには、一般に薬液
調製後適当な容器に充填密閉して加熱滅菌を施すか、加
熱滅菌を行いながら滅菌容器に充填密閉するか、防腐剤
と製剤工程の無菌化を組み合わせ充填密閉するなどの方
法がとられている。In order to manufacture a sterilized liquid medicine for internal use, it is generally necessary to fill and seal in an appropriate container and heat sterilize it after preparing a chemical solution, or to fill and seal in a sterilized container while performing heat sterilization, or to use a preservative and a preparation process. Methods such as combining sterilization, filling and sealing are used.
上記全腸管洗浄液の場合、熱に不安定な炭酸水素ナト
リウムが含まれているため加熱による滅菌方法は採用で
きず、また、防腐剤の添加も腸管洗浄液の目的に照らし
好ましくない。In the case of the whole intestinal lavage solution, a sterilization method by heating cannot be adopted because of containing heat-labile sodium bicarbonate, and addition of a preservative is not preferable in view of the purpose of the intestinal lavage solution.
したがって従来は、ポリエチレングリコール4000の水
に対する溶解速度が遅いため使用時の水溶液調製に時間
を要する不便があるにも拘らず、固形製剤が提供されて
いた。Therefore, conventionally, a solid preparation has been provided in spite of the fact that the dissolution rate of polyethylene glycol 4000 in water is slow, so that it takes time to prepare an aqueous solution at the time of use.
（３）発明が解決しようとする問題点 本発明の目的は、加熱滅菌せず防腐剤を添加しない
で、長期に亘って変質することなく安全に使用できる腸
管洗浄液剤を提供することにある。(3) Problems to be Solved by the Invention It is an object of the present invention to provide an intestinal cleansing liquid that can be safely used without heat-sterilization and without the addition of a preservative, without any deterioration over a long period of time.
（４）問題点を解決するための手段 本発明者らは前述の問題点を解決するため、先ず、前
記デイビス（Davis）らの全腸管洗浄液に一般的な混入
菌であるセラチア（Serratia）、シュードモナス（Psud
omonus）、スタフィロコッカス・エピデルミディス（St
aphylococcus epidermidis）及びカンジダ・アルビカン
ス（Candida albicans）をそれぞれ15〜20個/mlとなる
ように接種し繁殖につき調べた。室温においてはいずれ
も速やかに増殖し、経口的接種が危険とされている前記
規定値1000個/mlに数日以内に達することが判った。こ
の検討をさらに進める段階で、驚くべきことに、デイビ
ス（Davis）らの全腸管洗浄液の濃度よりも２倍以上の
濃度、すなわちポリエチレングリコール4000の濃度で表
現すれば11.8（W/V）％以上とすることによって、室温
においても全く微生物が増殖しないことを見出し本発明
を完成するに至った。(4) Means for Solving the Problems In order to solve the above-mentioned problems, the present inventors firstly tried Serratia, which is a common contaminating bacterium in the whole intestinal lavage solution of Davis et al. Pseudomonas (Psud
omonus), Staphylococcus epidermidis (St
aphylococcus epidermidis) and Candida albicans (Candida albicans) were each inoculated at a concentration of 15 to 20 cells / ml and examined for reproduction. It was found that all grew rapidly at room temperature and reached the above-mentioned specified value of 1000 cells / ml within several days, which was considered dangerous for oral inoculation. As we proceed with this study further, it is surprising that, surprisingly, the concentration of the total intestinal lavage fluid of Davis et al. As a result, the present inventors have found that microorganisms do not grow at all even at room temperature, and have completed the present invention.
本発明は、ポリエチレングリコール4000並びに電解質
の相対的量の範囲が ポリエチレングリコール4000 53〜65g 硫酸ナトリウム 35〜44mmol 塩化カリウム ９〜11mmol 塩化ナトリウム 23〜28mmol 炭酸水素ナトリウム 18〜23mmol であるように水に溶解し、前記ポリエチレングリコール
4000の濃度を11.8（W/V）％以上としたことを特徴とす
る腸管洗浄液剤を提供するものである。The present invention dissolves in water so that the relative range of polyethylene glycol 4000 and electrolyte is polyethylene glycol 4000 53-65 g sodium sulfate 35-44 mmol potassium chloride 9-11 mmol sodium chloride 23-28 mmol sodium bicarbonate 18-23 mmol And the polyethylene glycol
It is intended to provide an intestinal lavage solution, wherein the concentration of 4,000 is 11.8 (W / V)% or more.
本発明腸管洗浄液において、ポリエチレングリコール
4000の濃度が11.8（W/V）％以上であれば、微生物増殖
抑制効果が得られ特に問題はないが、好適にはその３〜
５倍の濃度である。In the intestinal washing solution of the present invention, polyethylene glycol
If the concentration of 4000 is 11.8 (W / V)% or more, there is no particular problem because the effect of suppressing the growth of microorganisms can be obtained.
Five times the concentration.
本発明の腸管洗浄液剤は、次のようにして製造するこ
とができる。The intestinal lavage solution of the present invention can be produced as follows.
上記相対的範囲内にある各成分量を、ポリエチレング
リコール4000の濃度を指標として11.8（W/V）％以上と
なるように精製水に溶解し、次いで孔径が0.22〜0.45μ
ｍのメンブランフィルターで無菌的に濾過すればよい。
この溶液は、前述の通りの滅菌処理を施さないが、容器
は予め滅菌処理したものを使用し充填後密閉することが
望ましい。容器としては、水分透過性とガズ透過性がな
いか殆どないものであれば何れでもよく、例えばガラス
瓶、合成樹脂製瓶、合成樹脂製バッグ、液体用アルミラ
ミネートバッグ、液体用紙容器等が挙げられる。The amount of each component within the above relative range is dissolved in purified water so that the concentration of polyethylene glycol 4000 becomes 11.8 (W / V)% or more, and then the pore size is 0.22 to 0.45 μm.
What is necessary is just to filter aseptically with a membrane filter of m.
Although this solution is not subjected to the sterilization treatment as described above, it is desirable to use a container which has been sterilized in advance and seal it after filling. The container may be any as long as it has no or little moisture permeability and gas permeability, and examples thereof include a glass bottle, a synthetic resin bottle, a synthetic resin bag, a liquid aluminum laminate bag, and a liquid paper container. .
本発明腸管洗浄液剤の使用に際しては、水道水若しく
は精製水で希釈し、前記デイビス（Davis）らの全腸管
洗浄液と同じ濃度とすればよい。When using the intestinal cleansing solution of the present invention, it may be diluted with tap water or purified water to the same concentration as the whole intestinal cleansing solution of Davis et al.
（５）実施例 以下に実施例を挙げて本発明を具体的に説明する。(5) Example Hereinafter, the present invention will be specifically described with reference to examples.
実施例１ ポリエチレングリコール4000 118 ｇ 硫酸ナトリウム 11.4 g 塩化カリウム 1.49g 塩化ナトリウム 2.93g 炭酸水素ナトリウム 3.37g 以上の各成分量を精製水に溶解し、全量を１とし
た。次いで0.22μｍのミリポアフィルター（ミリポア社
製）で濾過し、予め滅菌処理した500mlのガラス瓶に充
填、密閉した。Example 1 Polyethylene glycol 4000 118 g Sodium sulfate 11.4 g Potassium chloride 1.49 g Sodium chloride 2.93 g Sodium bicarbonate 3.37 g The above components were dissolved in purified water to make a total amount of 1. Then, the mixture was filtered through a 0.22 μm Millipore filter (manufactured by Millipore), filled into a 500 ml glass bottle previously sterilized, and sealed.
実施例２〜７ ポリエチレングリコール4000 240 ｇ 硫酸ナトリウム 22.8 g 塩化カリウム 3.00g 塩化ナトリウム 5.90g 炭酸水素ナトリウム 6.74g 以上の各成分量を精製水に下表の容量となるように溶
解し、以下実施例１と同様に処理して、予め滅菌処理し
た500mlの容器に充填し密閉した。Examples 2 to 7 Polyethylene glycol 4000 240 g Sodium sulfate 22.8 g Potassium chloride 3.00 g Sodium chloride 5.90 g Sodium bicarbonate 6.74 g Each of the above components was dissolved in purified water to a volume shown in the following table. The same treatment as in No. 1 was performed, and the mixture was filled in a 500 ml container previously sterilized and sealed.
（６）試験例 実施例１の方法と同様にして調製した前記デイビス
（Davis）らの全腸管洗浄液と実施例２の腸管洗浄液剤
に、常法に従って培養したセラチア（Serratia）及びシ
ュードモナス（Psudomonus）をそれぞれ15〜20個/ml接
種した。室温に放置して経時的に菌数を測定し、得られ
た結果を第１図に示した。 (6) Test Example Serratia and Pseudomonus (Psudomonus) cultured in the same manner as in Example 1 with the whole intestinal lavage solution of Davis et al. And the intestinal lavage solution of Example 2 according to a conventional method. Was inoculated at 15 to 20 cells / ml. After standing at room temperature, the number of bacteria was measured over time, and the obtained results are shown in FIG.
この図から、デイビス（Davis）らの全腸管洗浄液中
では顕著な菌の増殖が認められ、実施例２の腸管洗浄液
剤中ではむしろ減少傾向にあることがわかる。From this figure, it can be seen that remarkable growth of bacteria was observed in the whole intestinal lavage solution of Davis et al., And it was rather decreased in the intestinal lavage solution of Example 2.
（７）発明の効果 本発明の腸管洗浄液剤は、長期間に亘って変質するこ
となく安全に使用でき、また使用にあたり、単に希釈す
るだけで所定濃度の液剤が調製できる。(7) Effects of the Invention The intestinal lavage solution of the present invention can be used safely without deterioration over a long period of time, and upon use, a solution having a predetermined concentration can be prepared by simply diluting.
第１図は、デイビス（Davis）らの全腸管洗浄液中及び
実施例２の腸管洗浄液剤中での菌の経時的増殖変化を示
す。FIG. 1 shows the time course of bacterial growth in the whole intestinal lavage solution of Davis et al. And in the intestinal lavage solution of Example 2.
Claims (2)
の相対的量の範囲が ポリエチレングリコール4000 53〜65g 硫酸ナトリウム 35〜44mmol 塩化カリウム ９〜11mmol 塩化ナトリウム 23〜28mmol 炭酸水素ナトリウム 18〜23mmol であるように水に溶解し、前記ポリエチレングリコール
4000の濃度を11.8（W/V）％以上としたことを特徴とす
る腸管洗浄液剤。1. The water so that the relative range of polyethylene glycol 4000 and the electrolyte is polyethylene glycol 4000 53-65 g sodium sulfate 35-44 mmol potassium chloride 9-11 mmol sodium chloride 23-28 mmol sodium bicarbonate 18-23 mmol. Dissolve the polyethylene glycol
An intestinal irrigant, wherein the concentration of 4,000 is 11.8 (W / V)% or more.
容器に充填されたことを特徴とする特許請求の範囲第１
項記載の腸管洗浄液剤。2. The container according to claim 1, wherein the container is filled with little or no moisture permeability and gas permeability.
The intestinal lavage solution according to the above item.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62292996A JP2596764B2 (en) | 1987-11-18 | 1987-11-18 | Intestinal cleansing liquid |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62292996A JP2596764B2 (en) | 1987-11-18 | 1987-11-18 | Intestinal cleansing liquid |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH01132527A JPH01132527A (en) | 1989-05-25 |
| JP2596764B2 true JP2596764B2 (en) | 1997-04-02 |
Family
ID=17789125
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP62292996A Expired - Lifetime JP2596764B2 (en) | 1987-11-18 | 1987-11-18 | Intestinal cleansing liquid |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2596764B2 (en) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH04198126A (en) * | 1990-11-28 | 1992-07-17 | Otsuka Pharmaceut Factory Inc | Solution for cleaning intestine |
| JP5041642B2 (en) * | 2001-08-30 | 2012-10-03 | 日本製薬株式会社 | Composition for oral intestinal lavage and filling preparation for oral intestinal lavage |
| US6946149B2 (en) * | 2002-04-30 | 2005-09-20 | Braintree Laboratories, Inc. | Salt solution for colon cleansing |
| JP4572185B2 (en) | 2006-08-28 | 2010-10-27 | ミヤリサン製薬株式会社 | Gastrointestinal cleansing aid containing butyric acid bacteria and / or lactic acid bacteria |
| GB0913295D0 (en) | 2009-07-30 | 2009-09-02 | Norgine Bv | Improvements in and relating to pharmaceutical compositions |
| TWI535461B (en) | 2011-03-11 | 2016-06-01 | 諾金私人有限公司 | Colon cleansing solutions,compositions for preparing the solutions,kits comprising the compositions or solutions,and methods for preparing the solutions |
| EP3473248B1 (en) | 2012-09-11 | 2022-01-05 | Norgine BV | Compositions comprising polyethylene glycol and alkali metal or alkaline earth metal sulphates for use as colon cleansing compositions |
| WO2019239963A1 (en) * | 2018-06-11 | 2019-12-19 | Ea Pharma Co., Ltd. | Pharmaceutical composition for treating chronic constipation |
-
1987
- 1987-11-18 JP JP62292996A patent/JP2596764B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPH01132527A (en) | 1989-05-25 |
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