JPH01132527A - Intestine washing solution - Google Patents

Intestine washing solution

Info

Publication number
JPH01132527A
JPH01132527A JP62292996A JP29299687A JPH01132527A JP H01132527 A JPH01132527 A JP H01132527A JP 62292996 A JP62292996 A JP 62292996A JP 29299687 A JP29299687 A JP 29299687A JP H01132527 A JPH01132527 A JP H01132527A
Authority
JP
Japan
Prior art keywords
polyethylene glycol
concentration
water
washing solution
solution
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.)
Granted
Application number
JP62292996A
Other languages
Japanese (ja)
Other versions
JP2596764B2 (en
Inventor
Hideya Yaginuma
柳沼 英哉
Makoto Sato
誠 佐藤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MORISHITA SEIYAKU KK
Morishita Pharmaceuticals Co Ltd
Original Assignee
MORISHITA SEIYAKU KK
Morishita Pharmaceuticals Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by MORISHITA SEIYAKU KK, Morishita Pharmaceuticals Co Ltd filed Critical MORISHITA SEIYAKU KK
Priority to JP62292996A priority Critical patent/JP2596764B2/en
Publication of JPH01132527A publication Critical patent/JPH01132527A/en
Application granted granted Critical
Publication of JP2596764B2 publication Critical patent/JP2596764B2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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

【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 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)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 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.

これらの処置法は、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 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.

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存する患者にも使
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−(Gas
troenLer。
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)、ユ、991 (1980))。1ogy), Yu, 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−物
性品)236.0gと電解質として硫酸ナトリウム22
.74g、塩化カリウム2.97g。
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.

塩化ナトリウム5.86g及び炭酸水素ナトリウム6.
74gを42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。
5.86 g of sodium chloride and sodium bicarbonate6.
This can be accomplished by taking 74g dissolved in 42g of 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
使用の際の便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 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.

医薬品の微生物(細菌や頁面等)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lae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)、シかしこの菌
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。
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.

無菌化した内用液剤を製造するためには、−1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 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.

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 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.

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, 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)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 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)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
入直であるセラチア(Serratia)、シュードモ
ナス(Psudo■onus) 、スタフィロコッカス
・チビデルミディス(Staphylococcus 
epidermidis)及びカンジダ・アルビカンス
(Candida albicans)をそれぞれ15
〜20個/Idとなるように接種し繁殖につき調べた。
(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.

室温においてはいずれも速やかに増殖し、経口的摂取が
危険とされている前記規定値1000個/d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。
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.

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400053〜65g硫酸ナト
リウム       36〜44m+mol塩化カリウ
ム         9〜111IIlol塩化ナトリ
ウム        23〜28mmol炭酸水素ナト
リウム     18〜23s+ol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 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.

本発明腸管洗浄液において、ポリエチレングリ:I−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 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.

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 cleansing 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(至)のメンブランフィルタ−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 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.

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

実施例1 ポリエチレングリコール4000118g硫酸ナトリウ
ム        11.4g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11とした0次いで
0.22μ−のミリポアフィルタ−(ミリボア社製)で
濾過し、予め滅菌処理した500W1のガラス瓶に充填
、密閉した。
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.

実施例2〜7 ポリエチレングリコール4000240g硫酸ナトリウ
ム        22.8g塩化カリウム     
   3.00g塩化ナトリウム       5.9
0g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500−
の容器に充填し密閉した。
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.

(余  白) (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(D
avis)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/rn1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。
(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.

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 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)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 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.

【図面の簡単な説明】[Brief explanation of the drawing]

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。 特許出願人  森下製薬株式会社
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)

【特許請求の範囲】[Claims] (1)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400053〜65g硫酸ナト
リウム36〜44mmol 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) 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)水分透過性とガス透過性がないか殆どない容器に
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 intestinal cleansing liquid preparation according to claim 1, which is filled in a container having no or almost no water permeability and gas permeability.
JP62292996A 1987-11-18 1987-11-18 Intestinal cleansing liquid Expired - Lifetime JP2596764B2 (en)

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 true JPH01132527A (en) 1989-05-25
JP2596764B2 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)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04198126A (en) * 1990-11-28 1992-07-17 Otsuka Pharmaceut Factory Inc Solution for cleaning intestine
JP2003073260A (en) * 2001-08-30 2003-03-12 Nihon Pharmaceutical Co Ltd Composition for oral enterolavage liquid and packed preparation for the oral enterolavage liquid
EP1499331A2 (en) * 2002-04-30 2005-01-26 Braintree Laboratories, Inc. Salt solution for colon cleansing
WO2008026444A1 (en) 2006-08-28 2008-03-06 Miyarisan Pharmaceutical Co., Ltd. Aid for irrigating gastrointestinal tract comprising butyric acid bacteria and/or lactic acid bacteria
WO2011012866A1 (en) 2009-07-30 2011-02-03 Norgine Bv Solutions comprising polyethylene glycol and electrolytes
US8999313B2 (en) 2012-09-11 2015-04-07 Norgine Bv Compositions
US9592252B2 (en) 2011-03-11 2017-03-14 Norgine Bv Colonoscopy—preparation
JP2020045332A (en) * 2018-06-11 2020-03-26 Eaファーマ株式会社 Pharmaceutical composition for treating chronic constipation

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04198126A (en) * 1990-11-28 1992-07-17 Otsuka Pharmaceut Factory Inc Solution for cleaning intestine
JP2003073260A (en) * 2001-08-30 2003-03-12 Nihon Pharmaceutical Co Ltd Composition for oral enterolavage liquid and packed preparation for the oral enterolavage liquid
EP1499331A2 (en) * 2002-04-30 2005-01-26 Braintree Laboratories, Inc. Salt solution for colon cleansing
EP1499331A4 (en) * 2002-04-30 2007-04-18 Braintree Lab Salt solution for colon cleansing
US8597639B2 (en) 2006-08-28 2013-12-03 Miyarisan Pharmaceutical Co., Ltd. Adjunctive agent for lavaging the alimentary canal comprising butyric acid bacterium and/or lactic acid bacterium
WO2008026444A1 (en) 2006-08-28 2008-03-06 Miyarisan Pharmaceutical Co., Ltd. Aid for irrigating gastrointestinal tract comprising butyric acid bacteria and/or lactic acid bacteria
WO2011012866A1 (en) 2009-07-30 2011-02-03 Norgine Bv Solutions comprising polyethylene glycol and electrolytes
US9468686B2 (en) 2009-07-30 2016-10-18 Norgine Bv Solutions comprising polyethylene glycol and electrolytes
US10646512B2 (en) 2011-03-11 2020-05-12 Norgine Bv Colonoscopy - preparation
US11529368B2 (en) 2011-03-11 2022-12-20 Norgine Bv Colonoscopy—preparation
US9592252B2 (en) 2011-03-11 2017-03-14 Norgine Bv Colonoscopy—preparation
US10792306B2 (en) 2011-03-11 2020-10-06 Norgine Bv Colonoscopy—preparation
US10780112B2 (en) 2011-03-11 2020-09-22 Norgine Bv Colonoscopy-preparation
US9326969B2 (en) 2012-09-11 2016-05-03 Norgine Bv Compositions
US10016504B2 (en) 2012-09-11 2018-07-10 Norgine Bv Compositions
US9707297B2 (en) 2012-09-11 2017-07-18 Norgine Bv Compositions
US10918723B2 (en) 2012-09-11 2021-02-16 Norgine Bv Colon cleansing compositions and methods of use
US8999313B2 (en) 2012-09-11 2015-04-07 Norgine Bv Compositions
JP2020045332A (en) * 2018-06-11 2020-03-26 Eaファーマ株式会社 Pharmaceutical composition for treating chronic constipation

Also Published As

Publication number Publication date
JP2596764B2 (en) 1997-04-02

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