JPS6163618A - Cathartic - Google Patents

Cathartic

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Publication number
JPS6163618A
JPS6163618A JP59184931A JP18493184A JPS6163618A JP S6163618 A JPS6163618 A JP S6163618A JP 59184931 A JP59184931 A JP 59184931A JP 18493184 A JP18493184 A JP 18493184A JP S6163618 A JPS6163618 A JP S6163618A
Authority
JP
Japan
Prior art keywords
lactose
lactic acid
cathartic
laxative
mesh
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
JP59184931A
Other languages
Japanese (ja)
Other versions
JPH0368010B2 (en
Inventor
Akira Yamauchi
昌 山内
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to JP59184931A priority Critical patent/JPS6163618A/en
Publication of JPS6163618A publication Critical patent/JPS6163618A/en
Publication of JPH0368010B2 publication Critical patent/JPH0368010B2/ja
Granted legal-status Critical Current

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

PURPOSE:A cathartic to evacuate efficiently the bowels by a carbonic acid gas of lactose decomposition product without causing side effects, comprising lactose with specific particle diameters and a mold such as lactic acid bacteria, etc. to mulfiply by the use of lactose as a nutrition source. CONSTITUTION:A cathartic comprising lactose having particle diameters capable of passing through at least 150-250mum mesh as a main agent, and a mold (e.g., lactic acid bacteria, Lactobacillus bifidus, etc.) to multiply by the use of lactose as a nutrition source. The cathartic uses about 20-50g lactose as an amount for one dose, it is dissolved in about 200cc water or warm water, and processed into preferably at least 1.5-10.7CS viscosity. In an existing cathartic, undissolved lactose is deposited in the stomach, and causes side effects such as nausea, vomiting feeling, but the cathartic has the fittest particle diameters determined from solubility of lactose, good circulation from the stomach to the intestine, and can evolve efficiently a carbonic acid gas, etc. by fermentation in the intestine.

Description

【発明の詳細な説明】 本発明は乳糖を主剤とし、乳酸菌類、ヴィフィズス菌類
、酵母類等乳糖を栄養源として増殖する菌類とを共存さ
せてなる下剤に係り、更に詳しくは、少なくとも150
〜250μmメツシュを通過可能な粒径からなる乳糖を
主剤とし、これと乳酸菌を共存させてなる下剤を適宜服
用することによって、腸内で該乳糖成分を分解させると
ともに、この乳糖分解物である乳酸、酢酸或は炭酸ガス
等の固壁刺激作用を利用して排便等を促進させるように
した下剤に関するものである。
DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a laxative containing lactose as a main ingredient and coexisting with fungi that grow using lactose as a nutrient source, such as lactic acid bacteria, vifidobacteria, and yeast.
By appropriately taking a laxative containing lactose with a particle size that can pass through a mesh of ~250 μm and coexisting with lactic acid bacteria, the lactose component is decomposed in the intestines, and the lactose decomposition product, lactic acid. This invention relates to a laxative that promotes defecation by utilizing the solid wall stimulating effect of acetic acid or carbon dioxide gas.

一般に下剤は、その薬効成分が腸壁に接して、もしくは
、Jlll&に吸収されて生化学的反応によって腸の神
経を刺激することで腸のダ勤を促進して排便を促すもの
であることから、下剤服用によって腹痛を起したり、又
、長期の服用によっては習慣性となって腸の神経が麻痺
して次第に下剤服用量を増量しなければ効果がでなくな
り、ひいては更に神経刺激性の強い下剤を必要として便
秘の慢性化を一層助長して重度の便秘症となったり、薬
効の副作用による服用者への悪影響が懸念される状況に
あった。
In general, laxatives have medicinal ingredients that come into contact with the intestinal wall or are absorbed by the intestinal wall and stimulate the intestinal nerves through a biochemical reaction, promoting intestinal function and promoting defecation. Taking laxatives can cause abdominal pain, and long-term use can become habit-forming and paralyze the nerves in the intestines, resulting in the laxatives becoming ineffective unless the dosage is gradually increased. There were concerns that the need for laxatives could further exacerbate chronic constipation, resulting in severe constipation, and that side effects of the medicine could have an adverse effect on users.

又、近来肉食が普及し、植物性繊維の不足のため、慢性
の便秘患者が増え、腸に内蔵する宿便が種々の疾病、癌
でさえもその原因と目されるに至り、このため長期服用
しても副作用の発生しない下剤又は排便促進剤が求めら
れていた。
In addition, with the recent spread of meat-eating and the lack of vegetable fiber, the number of patients with chronic constipation has increased, and fecal impaction in the intestines has come to be seen as the cause of various diseases and even cancer. There was a need for a laxative or a defecation stimulant that would not cause any side effects.

そこで、本発明者は、先に特開昭58−8018号公報
(特願昭56−106684号)に記載されているよう
に、乳糖を主体とし、これに乳酸菌、その他の菌類又は
薬品及び補助的添加物を加えた粉末の一定量を水分とと
もに、空腹時に服用することにより便秘を治療し、併わ
して宿便を取って病状を回復させる下剤を提案した。
Therefore, as previously described in Japanese Unexamined Patent Publication No. 58-8018 (Japanese Patent Application No. 56-106684), the present inventor has developed a method that uses lactose as the main ingredient, and adds lactic acid bacteria, other fungi, or drugs and supplements. He proposed a laxative that treats constipation by taking a certain amount of powder containing certain additives along with water on an empty stomach, and also removes fecal impaction and cures the patient's condition.

しかし、多数の患者の一部には、前記下剤服用後に胃の
膨溝感やむかつきゃ嘔吐感をもよおしたりする者が出現
することが判った。
However, it has been found that some patients experience a feeling of gastric distension, nausea, or even vomiting after taking the laxative.

このため、前記事例を精密に調査してみると、対象患者
の多くは、胃下垂又は胃弱等の持病があり、且つ、前記
下剤を服用後の胃内部を検査すると、乳糖が未溶解の状
態で胃の底部に沈積しており、この乳糖が経過時間とと
もに発酵を始め、この作用に伴いむかつきゃ嘔吐感を覚
えさせるものと察知されるに至った。
Therefore, upon careful investigation of the above cases, it was found that many of the target patients had chronic illnesses such as gastric ptosis or weak stomach, and when the inside of the stomach was examined after taking the laxatives, lactose was found to be undissolved. It has been found that this lactose is deposited at the bottom of the stomach and begins to ferment over time, causing a feeling of nausea and vomiting.

特に、重症の胃下垂や胃弱患者の場合にはこの症状が顕
著に現われ、更に該患者の体質はいゎゆる無力体質であ
るので、胃腸のダ動作用も弱く、1、Yって腸内に貯ま
るカスの1j1出作用も弱いので、長時間むかつきゃ嘔
吐感に悩まされることになるのである。
This symptom is especially noticeable in patients with severe gastroptosis or weak stomach, and since these patients have a weak constitution, their gastrointestinal function is also weak, and 1, Y accumulates in the intestines. The 1j1 production effect of dregs is also weak, so if you feel queasy for a long time, you will suffer from vomiting.

本発明は、このような現況に鑑み鋭意研究の結果上記従
来の難点を解決したものであって、その要旨とするとこ
ろは、少なくとも 150〜250μmメツシュを通過
可能な粒澤からなる乳糖を主剤とし、これと乳酸菌数、
ヴィフィズス菌類、酵母類等、乳糖を栄養源として増殖
する菌類とを共存させたことにある。
In view of the current situation, the present invention has solved the above-mentioned conventional difficulties as a result of intensive research.The gist of the present invention is to use lactose as the main ingredient, which consists of granules that can pass through a mesh of at least 150 to 250 μm. , this and the number of lactic acid bacteria,
This is due to the coexistence of fungi such as Vifidobacteria and yeast that grow using lactose as a nutritional source.

即ち、下剤を構成する乳糖を150〜250μmメツシ
ュを通過できる粒径とするとともに、水の存在下では該
粒径の乳糖を未溶解物を含む懸濁状態の液体として調合
し、且つ、適量の乳酸菌汐、ヴィフィズス菌類、酵母類
等、乳糖を栄養源として増殖する菌類と共存させ、この
溶液を服用した患者の腸内において、前記乳糖残留微粒
子を除々に溶解させるとともに、該溶解後の発酵による
炭酸ガス等の発生を効率的に行なわせるようにしたちの
である。
That is, the lactose constituting the laxative is made to have a particle size that can pass through a mesh of 150 to 250 μm, and in the presence of water, the lactose of this particle size is prepared as a suspended liquid containing undissolved matter, and an appropriate amount of lactose is prepared. The solution is made to coexist with bacteria such as lactic acid bacteria, vifidobacteria, and yeasts that grow using lactose as a nutritional source, and in the intestines of patients who take this solution, the residual lactose particles are gradually dissolved, and fermentation occurs after the dissolution. This allows carbon dioxide gas to be generated efficiently.

なお、この溶液は、使用に際し、少なくとも一定の粘度
をもたせ、この粘性により該溶液中の薬効成分を腸内で
一定時間作用させるようにすることが望ましい。
When this solution is used, it is desirable that it has at least a certain viscosity, and this viscosity allows the medicinal ingredients in the solution to act in the intestines for a certain period of time.

以下、本発明を具体的に説明すると、本発明に係る下剤
は、基本的には、乳糖を主体とし、この乳糖に乳酸菌類
、ヴィフィズス菌類、酵母類等、乳糖を栄養源として増
殖する菌類とを共存させて服用後の発酵の際に発生する
炭酸ガスを主として利用し、且つ、この炭酸ガスのもつ
物理的圧力と、該炭酸ガス発生期の腸壁刺激作用を活用
する下剤を作成するものであり°、従って、その主成分
である乳糖及び乳酸菌の1回服用時の配合量が治療効果
を左右する重要な要件となる。
To explain the present invention in detail below, the laxative according to the present invention basically contains lactose, and in this lactose, fungi such as lactic acid bacteria, vifidobacteria, and yeasts that grow using lactose as a nutritional source are combined. A laxative that primarily utilizes the carbon dioxide gas generated during fermentation after ingestion, and utilizes the physical pressure of this carbon dioxide gas and the intestinal wall stimulating effect during the carbon dioxide generation period. Therefore, the amount of its main ingredients, lactose and lactic acid bacteria, in a single dose is an important factor that determines the therapeutic effect.

この観点から、先ず本発明に係る下剤成分の主体となる
乳糖について説明すると、実際の服用に際しては乳糖溶
解用の水又は温湯が必要であり、又、服用者の味覚、嗜
好、もしくは栄養バランス上の要望等に応じてケール末
、グルコマンナン、クロレラ乾燥米、黒糖、各種ビタミ
ン類等を選択的に配合して服用されるものであごとから
、その決用量は必ずしも特定し難い面があるが、少なく
とも下剤として治療効果をあげるためには、一定量以上
の乳糖を摂取する必要があり、これは通常成人の場合約
20〜50gの範囲内で選択的に用いるのが望ましいも
のとなる。
From this point of view, first of all, we will explain about lactose, which is the main component of the laxative component according to the present invention.Water or warm water is required to dissolve the lactose when actually taking it, and it also depends on the taste, preference, or nutritional balance of the user. It is taken by selectively combining kale powder, glucomannan, chlorella dried rice, brown sugar, various vitamins, etc. in response to the requests of people, and it is difficult to determine the exact amount from the mouth. In order to have a therapeutic effect, at least as a laxative, it is necessary to ingest a certain amount of lactose, and it is usually desirable for adults to use this selectively within a range of about 20 to 50 g.

ところが、乳糖は、その性質から水への溶解度が低く、
例えば150〜250ccの水(コツプ1杯程度0水)
中に下剤として必要とされる乳糖20〜50gを添加し
て溶解させようとしても、完全に溶解させることが困難
である。
However, due to its nature, lactose has low solubility in water.
For example, 150 to 250 cc of water (about 1 cup of water)
Even if 20 to 50 g of lactose, which is required as a laxative, is added and attempted to be dissolved therein, it is difficult to dissolve it completely.

このため、熱湯を用いて乳糖を溶解することも考えられ
るが、一方、本発明においては、その構成要件の−っで
ある乳酸菌の生菌等の配合物等を有効に作用させること
も治療上大切なことであるので、前記高温処理によって
該生菌等を死滅させることは好ましくなく、更に、完全
に溶解させた乳糖の水溶液は、強い甘味を呈し、長間の
服用には不適となるものである。
For this reason, it is conceivable to dissolve lactose using boiling water, but on the other hand, in the present invention, it is also therapeutically effective to use a mixture such as live lactic acid bacteria, which is one of the constituent elements. As this is an important point, it is not preferable to kill the viable bacteria by the high temperature treatment, and furthermore, a completely dissolved aqueous solution of lactose has a strong sweet taste, making it unsuitable for long-term administration. It is.

そこで本発明者は、乳糖成分を主剤とした下剤を多様な
病態からなる多くの患者に適応可能とさせるために、服
用後の乳糖成分の腸内における作用態様等を考慮して、
先ず乳糖の粒径と水に対する溶解度との関係等を調べて
、次の通り最適粒径範囲を決定した。
Therefore, in order to make laxatives based on lactose components applicable to many patients with various pathological conditions, the present inventor took into consideration the mode of action of lactose components in the intestines after taking them,
First, the relationship between the particle size of lactose and its solubility in water was investigated, and the optimum particle size range was determined as follows.

即ち、100.150.200.250.300μmメ
ツシュを各々通過可能な粒径とした乳糖の粉末を各50
g採取し、これを水温25℃及び40℃の水200cc
中にそれぞれ投入して充分攪拌後1分間静置し、その上
澄液を移し取り、残留した乳糖分を乾燥後秤量した。こ
の結果を表1に示す。
That is, 50 lactose powders each having a particle size that can pass through a mesh of 100, 150, 200, 250, and 300 μm are
g was collected and added to 200cc of water at temperatures of 25°C and 40°C.
After stirring thoroughly, the mixture was allowed to stand for 1 minute, the supernatant liquid was transferred, and the remaining lactose was dried and weighed. The results are shown in Table 1.

表  1 この結果からみると、乳糖粉末の粒径は大きい捏水に対
する溶解が少なく、残留乳糖量は多くなり、又、微細な
捏水に対する溶解がよく、従って残留乳糖量は微細な程
少なくなるが、本発明の主旨である懸濁状態の溶液をも
って治療を行なう下剤においては、残留乳糖量が前記実
験の際約50%以上、或は約5%以下の状態では、本発
明に係る下剤として適した懸濁状態とはなり雅いので、
これから本発明においては、少なくとも乳糖粉末粒径は
、150〜250μmメツシュ通過分を対象とするもの
である。
Table 1 From these results, the larger the particle size of the lactose powder is, the less it dissolves in large amounts of water and the amount of residual lactose increases, and the better it dissolves in finer portions of water, so the finer the particle size, the less the amount of residual lactose. However, in the case of the purgative which is treated with a suspended solution, which is the gist of the present invention, when the amount of residual lactose was about 50% or more or about 5% or less at the time of the above experiment, the laxative according to the present invention Since the appropriate suspension state is elegant,
From now on, in the present invention, at least the particle size of the lactose powder is intended to be that which passes through a mesh of 150 to 250 μm.

なお、この粒径範囲はゑ密には130〜270μmメツ
シュ通過分をも使用可能とするものであるが、患者の病
態や、服用後の作用等によっても各々異なり、極めて複
雑な人体内部のからみ合いもあるので、その粒径範囲は
必ずしも限定し難いことから、本発明においては、一般
的に考えられる下剤服用患者を基準として、その最適な
作用、効果を挙げられる範囲、即ち150〜250μm
メツシュ通過分を提示するものである。
Note that this particle size range allows the use of particles that pass through a mesh of 130 to 270 μm, but each differs depending on the patient's medical condition and the effects after taking the drug. Therefore, in the present invention, the particle size range is 150 to 250 μm, which is the range in which the optimal action and effect can be achieved, based on patients who are generally considered to be taking laxatives.
This shows the amount that passes through the mesh.

一方、前記乳糖と共存させる乳酸菌としては、例えば、
ヴィフィズス菌等の乳酸菌或は乳酸菌を含有している納
豆菌類、酵母類等の発酵後の培養基をそのまま乾燥して
生菌、芽胞、酵母の全てを含む半乾燥物又は乾燥粉末を
つくり、これを乳酸菌発酵素として用いたり、或は、納
豆菌類や酵母類を含まない乳酸菌類の生菌、芽胞、培養
基のl挿又は2種以上を選択的に乳酸菌発酵素として使
用するものである。
On the other hand, examples of the lactic acid bacteria to coexist with lactose include:
The culture medium after fermentation of lactic acid bacteria such as Vifidobacterium or natto bacteria containing lactic acid bacteria, yeast, etc. is dried as it is to make a semi-dry product or dry powder containing all of live bacteria, spores, and yeast. It is used as a lactic acid bacterium enzyme, or alternatively, one or more types of live bacteria, spores, and culture media of lactic acid bacteria that do not contain natto fungi or yeast are selectively used as a lactic acid bacterium enzyme.

前記成分からなる発酵素は、組成的には生菌、芽胞、酵
素、培養基に分けることができるが、生菌は商品として
流通中に仮死状態となるが、芽胞、酵素は乾燥状態に耐
えることができるものであり、又、下剤として服用に際
しては、服用者の胃から ′小腸に入って発酵素が溶解
されるにつれ、先ず酵素が作用を開始し、続いて生菌が
よみがえり、やがて芽胞が吸水して芽生え、増殖を始め
ることになるものと考えられる。
The enzymes made up of the above components can be classified into live bacteria, spores, enzymes, and culture media.Live bacteria enter a state of suspended animation during distribution as a product, but spores and enzymes can withstand dry conditions. Moreover, when taken as a laxative, it enters the small intestine from the stomach of the user and as the enzyme is dissolved, the enzyme first begins to act, followed by the revival of viable bacteria, and eventually spores. It is thought that they absorb water, sprout, and begin to multiply.

なお、培養基は、商品流通中には外気との保護作用を行
ない、服用後は細菌類のなじみのある栄産素としても働
くものと思われる。
The culture medium is thought to act as a protective agent against the outside air during product distribution, and after consumption, it also acts as a trophic factor that is familiar to bacteria.

このような、下剤の構成成分として速効のある発酵素は
多い程よいが、これは定量的に働くので、下痢作用をも
たらす程度に服用することは先ず困難であり、生菌、芽
胞が大半の働きをするものと考えられることから、1回
の服用量中の発酵素は数g、例えば1〜5g位で充分で
ある。
As a component of laxatives, it is better to have as many fast-acting enzymes as possible, but since they act quantitatively, it is difficult to take enough to produce a diarrheal effect, and live bacteria and spores account for most of the action. Therefore, several grams of the enzyme, for example 1 to 5 grams, per dose is sufficient.

ちなみに、微生物、例えば乳酸菌1個は、1液で約1億
個にも増えるものではあるが、胃液中を通過して腸内に
到着して増殖しはじめるまでに相当な消耗を考えねばな
らず、効果の信頼性のためタ  1 に発酵素1g中に生菌又は芽胞を10〜10個を含有し
たものを使用することが望ましく、又、乳酸菌の種類と
しては、 Lactobacillus、  Ac1d
ophilus、L、Bulgaricus等を選択的
に用いればよい。
By the way, one microorganism, such as lactic acid bacteria, can grow to about 100 million in one liquid, but it must be considered that a considerable amount of wastage is required for the microorganisms to pass through the gastric fluid, reach the intestines, and begin to multiply. For the reliability of the effect, it is desirable to use one containing 10 to 10 live bacteria or spores in 1 g of enzyme, and the types of lactic acid bacteria include Lactobacillus, Ac1d.
Ophilus, L., Bulgaricus, etc. may be selectively used.

しかして、前記のように、本発明に係る下剤は、少なく
とも150〜250μmメツシュを通過可能な粒径から
なる乳糖を主剤として、これを懸濁状態の溶液とし、且
つ、この溶液中に乳酸菌数、ヴィフィズス菌類、酵母類
等、乳糖を栄養源として増殖する菌類とを共存させて構
成させるものであるから、この成分を服用者の胃から腸
内に送り込めば、該乳糖分解物が腸内壁に対して刺激作
用を起し、排便を促すとともに、腸内に粘着した宿便等
をも取除き、腸内を清浄になし得るものとなるが、前記
のように、多様な病態からなる患者を対象とする場合、
この内の特定患者に対しては更にその効力が発現できる
ように工夫する必要があり、このため、該配合成分服用
後の患者に対する作用態様等を考慮した特有な性状付加
を行うものである。
Therefore, as mentioned above, the laxative of the present invention has lactose as a main ingredient having a particle size that can pass through a mesh of at least 150 to 250 μm, and has a suspension of this as a solution, and the number of lactic acid bacteria in this solution. , Vifidobacteria, yeast, and other fungi that grow using lactose as a nutritional source coexist, so if this ingredient is delivered from the stomach of the user into the intestine, the lactose decomposition product will be absorbed into the intestinal lining. In addition to stimulating defecation, it also removes fecal impaction stuck in the intestines and cleanses the intestines. If applicable,
It is necessary to devise ways to further develop the efficacy for specific patients, and for this reason, unique properties are added that take into account the mode of action on patients after taking the compounded ingredients.

即ち、前記本発明に係る下剤を服用後、該薬効成分が服
用者の腸内において、前記治療効果を発揮するには、少
なくとも懸濁状の該成分が、腸内て一定時間滞留し、発
酵等の反応を持続することが望ましく、このため本発明
においては、該薬効成分に一定の粘度を与えることによ
り、この目的を達成させるものである。
That is, after taking the laxative according to the present invention, in order for the medicinal ingredient to exert the therapeutic effect in the intestine of the user, at least the suspended component must remain in the intestine for a certain period of time and undergo fermentation. It is desirable to sustain such reactions, and therefore, in the present invention, this objective is achieved by imparting a certain viscosity to the medicinal ingredient.

詳述するならば、前記薬効成分に、一定の粘度を付与さ
せると、服用後、該成分が懸濁状態のまま胃の底部に沈
積することなく急速に胃から腸へ送られて腸内て溶解す
る間の持続時間が、該設定粘度に応じて延長、或は短縮
されるので、この粘度設定操作により薬効成分の腸内て
の滞留時間や溶出速度をコントロールし、多様な病態の
患者に各々適応できる治療を行なうことを可能とするも
のである。
To be more specific, if the medicinal ingredients are given a certain viscosity, after taking the drug, the ingredients will not remain suspended at the bottom of the stomach, but will be rapidly transported from the stomach to the intestines. The duration of dissolution is extended or shortened depending on the set viscosity, so by setting the viscosity, the retention time and elution rate of the medicinal ingredient in the intestine can be controlled, making it suitable for patients with various pathological conditions. This makes it possible to perform treatments that are applicable to each patient.

このため、前記乳糖を主剤とした本発明に係る下剤成分
を対象に、種々な条件設定を行ない、これに対する付加
粘度について検討を行った。
For this reason, various conditions were set for the laxative component according to the present invention, which uses lactose as a main ingredient, and the added viscosity thereof was investigated.

先ず、−主条件で本発明の主剤となる乳糖懸濁溶液を調
整するとともに数種に分割し、この各溶液に粘度付加剤
としてアルギン酸ソーダを使用し、且つ、このアルギン
酸ソーダ量を変化させることにより供試溶液を作成した
First, - adjust the lactose suspension solution that is the main ingredient of the present invention under the main conditions and divide it into several types, use sodium alginate as a viscosity additive in each solution, and change the amount of sodium alginate. A test solution was prepared.

即ち、水温40℃に保持した200ccの温湯を収容し
たビーカー内に、乳糖(200μmメツシュを通過可能
な粒径のもの)を50gと、この乳糖量に対し、下表(
表2)の通り各々添加量を変化させたアルギン酸ソーダ
を添加して充分攪拌した後、1分間放置して、ビーカー
上部の懸濁液を別の容器に移し取り、この一部を分取し
て該溶液の粘度を測定し、且つ、前記ビーカー内の残留
液を乾燥してその残渣を秤量し、残留乳糖量を調べた。
That is, in a beaker containing 200 cc of hot water maintained at a water temperature of 40°C, 50 g of lactose (with a particle size that can pass through a 200 μm mesh) is added, and for this amount of lactose, the following table (
After adding sodium alginate in varying amounts as shown in Table 2) and stirring thoroughly, leave it for 1 minute, transfer the suspension at the top of the beaker to another container, and collect a portion of it. The viscosity of the solution was measured, and the remaining liquid in the beaker was dried and the residue was weighed to determine the amount of residual lactose.

この結果を表2に示す。The results are shown in Table 2.

表  2 表2の結果からも判るように、粘度付加剤となるアルギ
ン酸ソーダの添加量が増えるに従い、その溶液の粘度は
高くなるが、反面、乳糖残留量は減少していく傾向があ
る。
Table 2 As can be seen from the results in Table 2, as the amount of sodium alginate added as a viscosity additive increases, the viscosity of the solution increases, but on the other hand, the amount of residual lactose tends to decrease.

これは、アルギン酸ソーダの添加に伴って、乳糖の溶解
度積が変化するものと考えられ、この作用から、前記乳
糖成分とアルギン酸ソーダ量とを相互に適宜コントロー
ルすることにより、前記多様な患者に適合させることの
できる下剤の調合が可「1シであることがわかる。
This is thought to be due to the solubility product of lactose changing with the addition of sodium alginate, and based on this effect, it is possible to suit the various patients by controlling the lactose component and the amount of sodium alginate as appropriate. It turns out that there is only one laxative preparation that can be used to cure the disease.

そして、懸濁状の溶液として、未溶解の乳糖分を残留さ
せる該溶液に対する付加粘度は、残留乳糖量を参酌し、
表2のように1.5〜10.7C5の範囲に設定すれば
よいことが判明した。
Then, the additional viscosity of the solution that leaves undissolved lactose as a suspended solution is determined by taking into consideration the amount of residual lactose,
As shown in Table 2, it has been found that it is sufficient to set the temperature in the range of 1.5 to 10.7C5.

更に、これらの実験結果を基に、実使用時の効果を確認
するため、従来から治療を受けている患者のうち、特に
下剤飲用後、胃の膨満感、嘔吐感、胃痛等の不快感を訴
える32名をモニターとして下記組成の下剤を投与し、
その服用後4時間絶食させた後の治療状況を調べてみた
Furthermore, based on these experimental results, in order to confirm the effectiveness in actual use, we conducted a study on patients receiving conventional treatment who experience discomfort such as stomach bloating, vomiting, and stomach pain, especially after taking laxatives. A laxative with the following composition was administered to 32 complaining patients as monitors.
We investigated the treatment status after the patient was fasted for 4 hours after taking the drug.

・下剤組成(処方) ■乳糖(100μInメツシユ)47g乳酸菌、その他
を含む発酵素   38玄米胚芽米         
  2g水                  20
0cc■乳糖(150μmメツシュ1 )      
47g乳酸菌、その他を含む発酵素   3g玄米胚芽
米            2g水         
         200cc■乳糖(200μmメツ
シュ)47g 乳酸菌、その他を含む発酵素   3g玄米胚芽米  
         28水             
     200cc■乳糖(2001tmメツシュ)
47g・アルギン酸ソーダ       0.025g
乳wi菌、その他を含む発酵素   3g玄米胚芽米 
          2g水            
      200cc■乳糖(250μmメツシュ)
478 乳酸菌、その他を含む発酵素   3g玄米胚芽米  
         2g水             
     200cc■乳糖(300μmメツシュ)4
7g 乳酸菌、その他を含む発酵素   3g  −玄米胚芽
米           2g水          
        200ccこの結果を表3にて示す。
・Laxative composition (prescription) ■Lactose (100 μIn mesh) 47g Lactobacillus and other enzymes containing 38 brown rice germ rice
2g water 20
0cc■Lactose (150μm mesh 1)
47g Enzyme containing lactic acid bacteria and others 3g brown rice germ rice 2g water
200cc■ Lactose (200μm mesh) 47g Enzyme containing lactic acid bacteria and others 3g Brown rice germ rice
28 water
200cc ■ Lactose (2001tm Metshu)
47g・Sodium alginate 0.025g
3g of brown rice germ rice containing milk bacteria and others
2g water
200cc ■ Lactose (250μm mesh)
478 Enzyme containing lactic acid bacteria and others 3g brown rice germ rice
2g water
200cc ■ Lactose (300μm mesh) 4
7g Enzyme containing lactic acid bacteria and others 3g - Brown rice germ rice 2g water
200cc The results are shown in Table 3.

表  3 即ち、表3における不適合作用の有無の項は、下剤服用
後、胃の膨溝感、嘔吐感、むかつき、胃痛等の不快感を
覚えたモニター自身の報告をもとに作成し、又、効果の
強弱の項は、服用後2時間以内に排便があった人を強と
し、同様に4時間以後の人を中とし、全く無かった人を
弱として作成したものである。
Table 3 In other words, the section on the presence or absence of incompatible effects in Table 3 was created based on the monitors' own reports of discomfort such as stomach distension, vomiting, nausea, and stomach pain after taking laxatives. In terms of the strength of the effect, those who had a bowel movement within 2 hours after taking the drug were classified as strong, those who had a bowel movement after 4 hours were similarly classified as medium, and those who had no effect at all were classified as weak.

なお、表3の結果からは、乳糖100μmメツシュ程度
のものは粒度が荒すぎ、又、300μmメツシュのもの
は、粒度が細か過ぎることにより不適合作用が大きく、
乳糖150〜250μmメツシュのものが不適合作用が
小さく、且つ、効果も大きくなっている。
Furthermore, from the results in Table 3, it can be seen that the particle size of lactose with a 100 μm mesh is too coarse, and that the particle size of the 300 μm mesh is too fine, resulting in a large incompatibility effect.
The one with a lactose mesh of 150 to 250 μm has less incompatibility and has a greater effect.

特に乳糖200μmメツシュのものは最も効果が大きく
、更にこれに粘度付加剤を適量加えたときは、その効果
は一段と増強されることが判る。
In particular, the lactose 200 μm mesh has the greatest effect, and when an appropriate amount of a viscosity additive is added thereto, the effect is further enhanced.

この作用は、服用時の乳糖の粒径、即ち、200μmメ
ツシュ通過可能な粒径程度の乳糖懸濁液、或はそれに適
量の粘度付加剤を加えたものは、胃から腸へと送られる
際の流通性が非常に良く、従って、胃の中を不溶解の乳
糖微粉末を懸濁させたまま急速に通過し、胃中での不都
合な作用をなくし、且つ、その粒径により腸内での溶解
等に伴う発酵作用を効果的になさしめることによるもの
と考えられる。
This effect is due to the particle size of lactose when taken, that is, a lactose suspension with a particle size that can pass through a 200 μm mesh, or a suspension containing an appropriate amount of viscosity additive, when sent from the stomach to the intestines. It has very good distribution properties, and therefore, it rapidly passes through the stomach as a suspension of insoluble lactose fine powder, eliminating any undesirable effects in the stomach, and due to its particle size, it passes through the intestine. This is thought to be due to the fact that the fermentation effect accompanying the dissolution etc. of

又、前記モニターが、服用の際、乳糖の粒径が150μ
mメツシュ以下のものでは、舌の上に粒状物が残る傾向
があり好ましくなく、この点150μmメツシュ以上、
特に200μmメツシュ、或は250μm■メツシュ前
後の粒径のものは、その感覚が全く起らなかったと述べ
ていることからも、乳糖の粒径は15G〜250μmの
範囲が最良と思われる。
In addition, the monitor indicates that the particle size of lactose is 150μ when taking the drug.
A mesh of 150 μm or more tends to leave particulate matter on the tongue, which is undesirable.
In particular, it is said that the particle size of 200 μm mesh or around 250 μm mesh did not cause this sensation at all, so it seems that the best lactose particle size is in the range of 15G to 250 μm.

なお、前述の実験において、各処方品の粘度は、乳糖、
乳酸菌糸では各々1 、5C5に設定し、アルギン酸ソ
ーダを添加したものは2.0C5に設定したが、この粘
度の設定については、前記乳糖、乳酸菌系の成分だけて
はその性状から制限があり、一定値以上の高粘度とする
には粘度付加剤、例えは、アルギン酸ソーダを添加する
必要がある。
In addition, in the above experiment, the viscosity of each formulation was determined by lactose,
The viscosity was set at 1 and 5C5 for lactic acid mycelia, and 2.0C5 for those with sodium alginate added, but there is a limit to the setting of this viscosity due to the properties of the lactose and lactic acid bacteria components. In order to increase the viscosity above a certain value, it is necessary to add a viscosity additive, for example, sodium alginate.

このため、乳糖を主剤とする下剤において、最も効果的
な粘度付加剤添加範囲をG!へてみた。
For this reason, G! I tried it.

下剤組成(処方)としては、前記表3に示した処方を基
本とし、粘度付加剤であるアルギン酸ソーダ量を表4に
記載のように各々変化させて添加し試料とした。
The laxative composition (prescription) was based on the recipe shown in Table 3 above, and the amount of sodium alginate as a viscosity additive was varied as shown in Table 4 to prepare samples.

・基本処方 乳糖(200μmメツシュ)47g 乳酸菌、その曲を含む発酵素   3g玄米胚芽米  
         2g・アルキン酸ソーダ里 アルギン酸ソーダ   0.010〜0.500g水 
                   200ccこ
の結果を表4に示す。
・Basic prescription lactose (200μm mesh) 47g lactic acid bacteria, enzyme containing the song 3g brown rice germ rice
2g Sodium alginate 0.010-0.500g Water
200cc The results are shown in Table 4.

即ち、本実験は、従来から治療を受けている患者35名
をモニターとして採用し、前記基本処方に、アルギン酸
ソーダを各々変化させて添加した試料を朝食前の空腹時
に服用させ、服用後4時間絶食させた後の効果を調べた
ものである。
That is, in this experiment, 35 patients who had been receiving conventional treatment were employed as monitors, and they were asked to take samples prepared by adding various amounts of sodium alginate to the basic prescription on an empty stomach before breakfast, and for 4 hours after taking the drug. This study investigated the effects after fasting.

なお、表4における効果の強弱の判定は、服用後2時間
以内に排便があった人を強とし、同様に4時間以後を中
とし、全くなかった人を弱としている。
In Table 4, the strength of the effect was determined as strong for those who had a bowel movement within 2 hours after taking the drug, moderate for after 4 hours, and weak for those who had no bowel movements at all.

この結果からみると、懸濁状態からなる乳糖を主剤とし
てなる溶液下では、アルギン酸ソーダ量を0.010〜
0.250gの範囲で添加すると、顕著な効果を発揮す
るが、一定量以上、例えば0.400g以上とした場合
は次第に効果が弱くなっている。
Based on these results, in a suspension solution containing lactose as the main ingredient, the amount of sodium alginate should be 0.010 to 0.010.
When added in an amount of 0.250 g, a remarkable effect is exhibited, but when the amount is more than a certain amount, for example, 0.400 g or more, the effect gradually becomes weaker.

この理由としては、該i8液中の粘度が高い程、服用後
、人体内の消化液等の粘性体と混合して更に薬効成分の
溶解が遅くなり、これに伴い主剤の乳糖に共存させた乳
酸菌角、ヴイフイズス菌類、酵I3類等、乳糖を栄養源
として増殖する菌類等が作用されにくくなるとともに、
乳糖の分解物である乳酸、酢酸、炭酸ガス等の発生が遅
くなることによるものと推察できる。
The reason for this is that the higher the viscosity of the i8 liquid, the more it mixes with viscous substances such as digestive juices in the human body after taking it, and the more the medicinal ingredients dissolve, the slower the dissolution of the medicinal ingredients. Fungi that proliferate using lactose as a nutritional source, such as Lactobacillus horni, Vifidus fungi, and I3, are less likely to be affected, and
It can be inferred that this is because the generation of lactic acid, acetic acid, carbon dioxide gas, etc., which are decomposition products of lactose, is delayed.

従って、前記本発明に係る下剤において、その粒径を、
少くとも150〜250μmメツシュ通過可能としてな
る乳糖の一回服用量を約20〜50gとし、これに乳酸
菌その他玄米胚芽米等を約1〜5gを共存させるととも
に、200cc前後の水又は温湯に溶解させた場合の該
溶液の粘度範囲は、少なくとも1.5〜lO,7cs程
度が最適となるといえるものである。
Therefore, in the laxative according to the present invention, the particle size is
A single dose of lactose that can pass through a mesh of at least 150 to 250 μm is about 20 to 50 g, and about 1 to 5 g of lactic acid bacteria, brown rice germ, etc. are coexisting therein, and the lactose is dissolved in about 200 cc of water or hot water. In this case, the optimum viscosity range of the solution can be said to be at least about 1.5 to 10.7 cs.

以上のように、本発明の下剤は少なくとも150〜25
0μmメツシュを通過可能な粒径からなる乳糖を主剤と
し、これと乳酸菌類、ヴィフィズス菌類、酵母類等、乳
糖を栄養源として増殖する菌類とを共存させてなるもの
であるから、治療患者が一定量の該下剤を水分とともに
服用すると、患者の腸内において、乳糖等の微粒子が溶
解するとともに分解し、この分解反応によって発生する
炭酸カス等によって効果的に治療を行なうものとなり、
従って、腹痛や慢性化等の副作用を何ら伴うことなく多
様な病態の患者の便秘や宿便を取除く治療用として適用
できるものとなるのである。
As mentioned above, the laxative of the present invention has at least 150 to 25
The main ingredient is lactose, which has a particle size that can pass through a 0 μm mesh, and it is made by coexisting with fungi such as lactic acid bacteria, vifidobacteria, and yeasts, which grow using lactose as a nutritional source. When a certain amount of the laxative is taken with water, fine particles such as lactose are dissolved and decomposed in the patient's intestine, and the carbon dioxide scum generated by this decomposition reaction effectively provides treatment.
Therefore, it can be applied to treat constipation and fecal impaction in patients with various pathological conditions without any side effects such as abdominal pain or chronicity.

なお、上述した本発明の説明において、下剤成分を主に
粉末として説明したが、これを顆粒状或は錠剤等に加工
して溶媒に溶解させ、懸濁状態の溶渣として服用すれば
、前記粉末状のものと同様な効果を奏することができる
ものである。
In the above description of the present invention, the laxative component was mainly explained as a powder, but if it is processed into granules or tablets, dissolved in a solvent, and taken as a suspended solution, the above-mentioned laxative components can be obtained. It can produce the same effects as the powdered version.

又、本発明の主旨の範囲内において、前記本発明の下剤
にかかる薬効成分を従来公知の下剤組成中に配合させた
り、さらに本発明の下剤における薬効成分をベースとし
た組成中に従来公知の下剤成分を添加することによって
下剤を作成し、これを適宜服用することにより治療効果
を高めることも可能である。
Furthermore, within the scope of the present invention, the medicinal ingredient of the laxative of the present invention may be incorporated into a conventionally known laxative composition, or the medicinal ingredient of the laxative of the present invention may be incorporated into a composition based on the medicinal ingredient. It is also possible to create a laxative by adding a laxative component and to enhance the therapeutic effect by taking the laxative as appropriate.

Claims (2)

【特許請求の範囲】[Claims] (1)少なくとも150〜250μmメッシュを通過可
能な粒径からなる乳糖を主剤とし、これと乳酸菌類、ヴ
ィフィズス菌類、酵母類等、乳糖を栄養源として増殖す
る菌類とを共存させてなることを特徴とする下剤。
(1) The main ingredient is lactose, which has a particle size that can pass through a mesh of at least 150 to 250 μm, and it is made by coexisting with fungi that grow using lactose as a nutritional source, such as lactic acid bacteria, vifidobacteria, and yeast. A laxative.
(2)前記乳糖の一回服用量として約20〜50gを用
いるとともに、200c前後の水又は温湯に溶解した際
、該溶液の粘度が少くとも1.5〜10.7CSになる
よう調整してなる特許請求の範囲第1項記載の下剤。
(2) Use about 20 to 50 g of the lactose as a single dose, and adjust the viscosity of the solution to at least 1.5 to 10.7 CS when dissolved in water or hot water of around 200 c. A laxative according to claim 1.
JP59184931A 1984-09-03 1984-09-03 Cathartic Granted JPS6163618A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP59184931A JPS6163618A (en) 1984-09-03 1984-09-03 Cathartic

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP59184931A JPS6163618A (en) 1984-09-03 1984-09-03 Cathartic

Publications (2)

Publication Number Publication Date
JPS6163618A true JPS6163618A (en) 1986-04-01
JPH0368010B2 JPH0368010B2 (en) 1991-10-25

Family

ID=16161848

Family Applications (1)

Application Number Title Priority Date Filing Date
JP59184931A Granted JPS6163618A (en) 1984-09-03 1984-09-03 Cathartic

Country Status (1)

Country Link
JP (1) JPS6163618A (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6363620A (en) * 1986-09-03 1988-03-22 Toa Yakuhin Kogyo Kk Mixture of three kinds of living bacteria
US20110086093A1 (en) * 1998-07-07 2011-04-14 Ritter Pharmaceuticals, Inc. Method for increasing lactose tolerance in mammals exhibiting lactose intolerance
US9226933B2 (en) 2004-07-22 2016-01-05 Ritter Pharmaceuticals, Inc. Methods and compositions for treating lactose intolerance
US9579340B2 (en) 2009-02-24 2017-02-28 Ritter Pharmaceuticals, Inc. Prebiotic formulations and methods of use
US9592248B2 (en) 2009-02-24 2017-03-14 Ritter Pharmaceuticals, Inc. Prebiotic formulations and methods of use

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS555490A (en) * 1978-05-30 1980-01-16 Gen Electric Cooling system for gas turbine
JPS588018A (en) * 1981-07-07 1983-01-18 Akira Yamauchi Cathartic

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS555490A (en) * 1978-05-30 1980-01-16 Gen Electric Cooling system for gas turbine
JPS588018A (en) * 1981-07-07 1983-01-18 Akira Yamauchi Cathartic

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6363620A (en) * 1986-09-03 1988-03-22 Toa Yakuhin Kogyo Kk Mixture of three kinds of living bacteria
US20110086093A1 (en) * 1998-07-07 2011-04-14 Ritter Pharmaceuticals, Inc. Method for increasing lactose tolerance in mammals exhibiting lactose intolerance
US9226933B2 (en) 2004-07-22 2016-01-05 Ritter Pharmaceuticals, Inc. Methods and compositions for treating lactose intolerance
US9579340B2 (en) 2009-02-24 2017-02-28 Ritter Pharmaceuticals, Inc. Prebiotic formulations and methods of use
US9592248B2 (en) 2009-02-24 2017-03-14 Ritter Pharmaceuticals, Inc. Prebiotic formulations and methods of use
US9775860B2 (en) 2009-02-24 2017-10-03 Ritter Pharmaceuticals, Inc. Prebiotic formulations and methods of use
US9808481B2 (en) 2009-02-24 2017-11-07 Ritter Pharmaceuticals, Inc. Prebiotic formulations and methods of use

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