JPH04112830A - Preparation of liquid composition for cleaning enteric canal - Google Patents
Preparation of liquid composition for cleaning enteric canalInfo
- Publication number
- JPH04112830A JPH04112830A JP23123790A JP23123790A JPH04112830A JP H04112830 A JPH04112830 A JP H04112830A JP 23123790 A JP23123790 A JP 23123790A JP 23123790 A JP23123790 A JP 23123790A JP H04112830 A JPH04112830 A JP H04112830A
- Authority
- JP
- Japan
- Prior art keywords
- electrolyte
- polyethylene glycol
- granules
- composition
- spraying
- 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.)
- Pending
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 31
- 239000007788 liquid Substances 0.000 title claims abstract description 18
- 238000004140 cleaning Methods 0.000 title description 4
- 238000002360 preparation method Methods 0.000 title description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 18
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 18
- 239000003792 electrolyte Substances 0.000 claims abstract description 17
- 238000004519 manufacturing process Methods 0.000 claims abstract description 13
- 238000005507 spraying Methods 0.000 claims abstract description 6
- 238000002156 mixing Methods 0.000 claims abstract description 4
- 230000000968 intestinal effect Effects 0.000 claims description 14
- 239000008187 granular material Substances 0.000 abstract description 18
- 239000002245 particle Substances 0.000 abstract description 17
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 abstract description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract description 8
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 abstract description 6
- 235000002639 sodium chloride Nutrition 0.000 abstract description 5
- 239000001103 potassium chloride Substances 0.000 abstract description 4
- 235000011164 potassium chloride Nutrition 0.000 abstract description 4
- 239000011780 sodium chloride Substances 0.000 abstract description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 4
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 abstract description 3
- 150000007524 organic acids Chemical class 0.000 abstract description 3
- 235000017557 sodium bicarbonate Nutrition 0.000 abstract description 3
- 229910000030 sodium bicarbonate Inorganic materials 0.000 abstract description 3
- 229910052938 sodium sulfate Inorganic materials 0.000 abstract description 3
- 235000011152 sodium sulphate Nutrition 0.000 abstract description 3
- 238000004806 packaging method and process Methods 0.000 abstract description 2
- 238000002844 melting Methods 0.000 abstract 2
- 230000008018 melting Effects 0.000 abstract 2
- 239000007832 Na2SO4 Substances 0.000 abstract 1
- 238000010438 heat treatment Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 238000000034 method Methods 0.000 description 10
- 238000012360 testing method Methods 0.000 description 10
- 239000000243 solution Substances 0.000 description 9
- 239000006185 dispersion Substances 0.000 description 6
- 239000007921 spray Substances 0.000 description 6
- 238000001816 cooling Methods 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 5
- 238000011049 filling Methods 0.000 description 5
- 238000005469 granulation Methods 0.000 description 4
- 230000003179 granulation Effects 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000007710 freezing Methods 0.000 description 3
- 230000008014 freezing Effects 0.000 description 3
- 229940057838 polyethylene glycol 4000 Drugs 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 239000008151 electrolyte solution Substances 0.000 description 2
- 238000012858 packaging process Methods 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 241000792859 Enema Species 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- NPYPAHLBTDXSSS-UHFFFAOYSA-N Potassium ion Chemical compound [K+] NPYPAHLBTDXSSS-UHFFFAOYSA-N 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 229910052788 barium Inorganic materials 0.000 description 1
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium atom Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 description 1
- 238000002052 colonoscopy Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000007920 enema Substances 0.000 description 1
- 229940095399 enema Drugs 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 239000011261 inert gas Substances 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
- 229910001414 potassium ion Inorganic materials 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 229920003002 synthetic resin Polymers 0.000 description 1
- 239000000057 synthetic resin Substances 0.000 description 1
Abstract
Description
【発明の詳細な説明】 （１）産業上の利用分野 本発明は、腸管洗浄液用組成物の製造法に関する。[Detailed description of the invention] (1) Industrial application fields The present invention relates to a method for producing a composition for intestinal cleansing liquid.
（２）従来の技術
腸管の洗浄は、大腸内視鏡検査や二重造影バリウム注腸
検査において重要な前処置である。洗浄液としては電解
質組成液（ＢＥＳ：Ｂａ１ａｎｃｅｄ ＥｌｅＣｔｒ
Ｏｌｙｔｅ ５ｏｌｕｔｉ。(2) Conventional Technique Cleaning of the intestinal tract is an important pretreatment for colonoscopy and double-contrast barium enema examination. As a cleaning solution, an electrolyte composition solution (BES: Ba1anced EleCtr
Olyte 5oluti.
ｎ）、特殊組成電解質液（商品名、ゴライトリー（Ｇｏ
ｌｙｔｅｌｙ））及び特殊組成電解質液の改良液（ＷＯ
８７１０Ｏ７５４）が提案されている。また、従来の腸
管洗浄液用組成物は服用しずらく９体内の電解質バラン
スに悪影響を及ぼすことが予想されるなどいくつかの欠
点を有していたが、これらの欠点を克服する腸管洗浄液
が特開平２−２５４２４号に開示されている。n), special composition electrolyte solution (product name, Golightly)
lytely) and improved solution of special composition electrolyte solution (WO
8710O754) has been proposed. In addition, conventional intestinal cleansing liquid compositions had several drawbacks, such as being difficult to take and expected to have a negative effect on the electrolyte balance in the body, but a special intestinal cleansing liquid that overcomes these drawbacks has been developed. It is disclosed in JP-A No. 2-25424.
腸管洗浄液の製造については既に洗浄液成分を至適な粒
度に粉砕して混合する方法が特開平１１３５３１９号に
開示されている。Regarding the production of intestinal cleansing liquid, Japanese Patent Application Laid-Open No. 1135319 has already disclosed a method in which cleansing liquid components are pulverized to an optimum particle size and mixed.
しかし、前述の製造法は製造工程数が多いうえ組成物の
流動性は悪い。そこで、各成分を粉砕し混合する方法に
代わる腸管洗浄液用組成物の製造法の開発が望まれてい
る。However, the above-mentioned manufacturing method requires a large number of manufacturing steps and the fluidity of the composition is poor. Therefore, it is desired to develop a method for producing a composition for intestinal cleansing solution, which is an alternative to the method of grinding and mixing each component.
（３）発明が解決しようとする課題
各種の腸管洗浄液用組成物の中で、ポリエチレングリコ
ールと電解質を含む組成物を製造するに当たり、ポリエ
チレングリコールと電解質を均質化する工程が必要であ
る。この際、ポリエチレングリコールが組成中の約８５
％を占め、他の組成物に比べ極端に含有量が高いこと、
またポリエチレングリコールと電解質の比重差が大きく
、均一に混合することが難しい。(3) Problems to be Solved by the Invention In producing a composition containing polyethylene glycol and an electrolyte among various intestinal cleansing liquid compositions, a step of homogenizing the polyethylene glycol and the electrolyte is necessary. At this time, polyethylene glycol is about 85% of the composition.
%, and the content is extremely high compared to other compositions,
Furthermore, the difference in specific gravity between polyethylene glycol and electrolyte is large, making it difficult to mix them uniformly.
一般にこの様な場合の解決策として、滑沢側等の添加が
有効であるが、腸管洗浄という目的を考えると水に溶解
しない成分を添加することは好ましくない。また、既に
特開平１−１３５３１９号に開示されている粉砕によっ
て各成分の粒子径を調整する方法では粉砕、篩分けの工
程を目的の粒子径が得られるまで繰り返さなければなら
ず、これがコストアップの原因となっている。Generally, as a solution to such cases, adding a lubricant or the like is effective, but considering the purpose of intestinal cleansing, it is not preferable to add components that are not soluble in water. Furthermore, in the method of adjusting the particle size of each component by crushing, which has already been disclosed in JP-A-1-135319, the process of crushing and sieving must be repeated until the desired particle size is obtained, which increases costs. It is the cause of
さらに、ポリエチレングリコールの粉砕はポリエチレン
グリコールの凝固点が低いために、通常用いられる粉砕
機で粉砕すると溶融してしまう。Furthermore, since polyethylene glycol has a low freezing point, it will melt if it is crushed with a commonly used crusher.
そこで、粉砕装置内を冷却するなど特殊な条件設定が必
要である。しかもポリエチレングリコールの粉砕物は粒
子径が不定形で、付着性があるため流動性が悪く、分包
工程で充填バラツキを生し易い。Therefore, it is necessary to set special conditions such as cooling the inside of the crushing device. Moreover, the pulverized polyethylene glycol has an irregular particle size and has poor fluidity due to its adhesive properties, and tends to cause filling variations in the packaging process.
組成物の流動性と同様に問題になるのがポリエチレング
リコールの溶解性である。各成分の均一性を高めるため
に非常に細かいポリエチレングリコールを用いた場合は
溶解時に凝集し薬液調製時間が長くなる。従って、本発
明は流動性、溶解性及び均一性に優れた腸管洗浄液用組
成物を製造することを目的とする。Similar to the fluidity of the composition, the solubility of polyethylene glycol is a problem. If very fine polyethylene glycol is used to improve the uniformity of each component, it will aggregate during dissolution, prolonging the preparation time of the drug solution. Therefore, an object of the present invention is to produce a composition for intestinal cleansing liquid having excellent fluidity, solubility, and uniformity.
（４）課題を解決するための手段
本発明者らは、上記の問題点を克服するために種々検討
を行った結果、ポリエチレングリコールの凝固点が低い
ことを利用して、ポリエチレングリコールを溶融させた
状態で電解質を均一に混合し噴霧すると、各成分が均一
に混合された球形の造粒物が得られることを見いだした
。また、この造粒物の流動性及び溶解性を調べた結果、
特開平１−１３５３１９号に開示されている各成分の粉
砕品を混合する方法に比べ優れていることが判明した。(4) Means for Solving the Problems The present inventors conducted various studies to overcome the above problems, and as a result, they melted polyethylene glycol by taking advantage of its low freezing point. It has been found that if the electrolyte is uniformly mixed and sprayed under the condition, spherical granules in which each component is uniformly mixed can be obtained. In addition, as a result of examining the fluidity and solubility of this granule,
It has been found that this method is superior to the method disclosed in JP-A-1-135319, in which pulverized products of each component are mixed.
それらの知見に基づいて初期の目的を達成する本願発明
を完成することができた。Based on these findings, we were able to complete the present invention which achieves the initial objective.
すなわち、本発明はポリエチレングリコールを溶融させ
た状態で電解質を均一に混合し噴霧することを特徴とす
る腸管洗浄液用組成物の製造法である。That is, the present invention is a method for producing a composition for intestinal cleansing liquid, which is characterized by uniformly mixing and spraying an electrolyte in a state in which polyethylene glycol is melted.
本発明の製造法は、例えばポリエチレングリコールと電
解質が相対的に下記の範囲に含まれる腸管洗浄液用組成
物の製造に利用でき、好ましい実施態様を示せば次の通
りである。The production method of the present invention can be used, for example, to produce a composition for intestinal cleansing liquid in which polyethylene glycol and electrolyte are contained in the following relative ranges, and preferred embodiments are as follows.
ポリエチレングリコール １０〜１５０ｇに対し
有機酸のナトリウム塩 Ｏ〜６０ｍｍｏｌ有機
酸のカリウム塩 ０〜１２１１１１１０１塩
化ナトリウム ７〜６０ｍ１Ｉｌｏｌ塩
化カリウム Ｏ〜１２ＩＩＩｌｏｌ
硫酸ナトリウム Ｏ〜４４ｍｍｏｌ炭
酸水素ナトリウム Ｏ〜２３＋＋ｍｏｌ（但
し、カリウムイオンとして２〜１２’ｍＥｑ）まず、ポ
リエチレングリコールの処方量を秤取して溶解タンクに
投入し、このタンクを６０°Ｃ〜１００℃付近まで加温
する。常温で固体のポリエチレングリコールの凝固点は
５３℃〜５７℃であるため、ポリエチレングリコールは
溶融して液体となる。この溶液に各電解質をそれぞれ処
方量秤取して添加し、撹拌機を用いて分散させる。通常
、分散液中の電解質の粒度は、１００μｍ以下で、好ま
しくは５０μｍ以下である。また、電解質の比率は、通
常１０〜５０％の範囲が適当であるが、好ましくは１０
〜２０％である。 分散終了後、定量ポンプを用いて噴
霧装置に分散液を供給する。For 10-150 g of polyethylene glycol Sodium salt of organic acid O-60 mmol Potassium salt of organic acid 0-121111101 Sodium chloride 7-60 ml Ilol Potassium chloride O-12 IIIlol
Sodium sulfate O ~ 44 mmol Sodium hydrogen carbonate O ~ 23++ mol (however, 2 ~ 12'mEq as potassium ion) First, the prescribed amount of polyethylene glycol is weighed and put into a dissolution tank, and this tank is heated at 60°C to 100°C. Warm up to the vicinity. Since polyethylene glycol, which is solid at room temperature, has a freezing point of 53°C to 57°C, polyethylene glycol melts and becomes liquid. A prescribed amount of each electrolyte is added to this solution by weighing, and dispersed using a stirrer. Typically, the particle size of the electrolyte in the dispersion is less than 100 μm, preferably less than 50 μm. In addition, the ratio of electrolyte is usually appropriate in the range of 10 to 50%, but preferably 10%.
~20%. After dispersion is completed, the dispersion liquid is supplied to the spray device using a metering pump.
この噴霧装置には回転ディスク式とスプレー式の２種類
があるがどちらを使用してもよい。室内の温度は分散液
が固形化する温度であれば何れでもよいが、通常−３０
°Ｃ〜３０°Ｃの範囲が好ましい。There are two types of spraying devices: a rotating disk type and a spray type, and either of these can be used. The room temperature may be any temperature at which the dispersion solidifies, but it is usually -30°C.
A range of 0.degree. C. to 30.degree. C. is preferred.
また、室内を窒素等の不活性ガスで置換してもよく、ど
ちらでも対応できる噴霧冷却造粒装置が望ましい。噴霧
された分散液は、表面張力により球形となって落下し冷
却されて各成分が均一に混合された球形の造粒物を得る
ことができる。Further, the interior of the room may be replaced with an inert gas such as nitrogen, and a spray cooling granulation device that can handle either of these is desirable. The sprayed dispersion becomes spherical and falls due to surface tension, and is cooled to obtain spherical granules in which each component is uniformly mixed.
この噴霧冷却造粒における造粒物の粒子径は、５００
ａｍ以上が５％以下で、７５〜５００μｍが９５％以上
、７５μｍ以下が５％以下に調製することが好ましい。The particle size of the granules in this spray cooling granulation is 500
It is preferable to adjust the thickness to 5% or less for am or more, 95% or more for 75 to 500 μm, and 5% or less for 75 μm or less.
また、造粒物の平均粒子径は通常１００〜３００μｍで
、流動性、付着性及び溶解性を考慮すると好ましくは２
５０〜３００μｍである。In addition, the average particle diameter of the granules is usually 100 to 300 μm, and preferably 2 μm in consideration of fluidity, adhesion, and solubility.
It is 50 to 300 μm.
上記のごとく得られた組成物を常法に従って一回使用量
を分包し、臨床に供することができる。The composition obtained as described above can be packaged in single-use doses according to a conventional method and used clinically.
分包に適用することのできる容器もしくは袋は水分透過
性及びガス透過性が無いものであれば、何れも使用でき
る。容器としては、ガラス容器、合成樹脂容器、金属容
器等が使用でき、袋としては、例えば、アルミニウムと
ラミネートした多層フィルム製のものが好適に使用でき
る。Any container or bag that can be used for sachets may be used as long as it is not permeable to water or gas. As the container, a glass container, a synthetic resin container, a metal container, etc. can be used, and as the bag, for example, a bag made of a multilayer film laminated with aluminum can be suitably used.
（５）作用
本発明により調製した造粒物は球形であることから流動
性が良く付着性が少ないため製造工程におけるハンドリ
ングが優れている。その結果、製造工程の自動化が容易
となり、また分包工程における充填バラツキが減少する
。(5) Effect Since the granulated material prepared according to the present invention is spherical, it has good fluidity and little adhesion, so it is easy to handle in the manufacturing process. As a result, the manufacturing process can be easily automated, and filling variations in the packaging process can be reduced.
また驚くべきことに本発明の方法により得られた造粒物
は粒度分布がロフト間変動により変化しても速やかに溶
解する特徴を持つことから、製品の粒度を厳しく管理す
る必要がなく篩下工程を簡略化できる。Surprisingly, the granules obtained by the method of the present invention have the characteristic of quickly dissolving even if the particle size distribution changes due to fluctuations between lofts, so there is no need to strictly control the particle size of the product The process can be simplified.
（６）実施例
実施例１
予め、硫酸ナトリウム２．９ｋｇ、塩化ナトリウム０．
７５ｋｇ、塩化カリウム０．３８ｋｇ。(6) Examples Example 1 2.9 kg of sodium sulfate and 0.0 kg of sodium chloride were prepared in advance.
75 kg, potassium chloride 0.38 kg.
炭酸水素ナトリウム０．８ｋｇをそれぞれ秤取して、ロ
ッキングミキサー（愛知電機株式会社製）にて混合した
。この混合物をハンマータイプの粉砕機パルペライザ−
（細川ミクロン株式会社製ニスクリーン径０．５ｍｍ）
を用いて室温下にて粉砕した。この時、粉砕物の粒度分
布は２０μｍ〜７４ρｍで平均粒子径は約４０μｍであ
った。次に、ポリエチレングリコール４０００を３０ｋ
ｇ秤取し、溶解用タンクに投入後、約８０゛ｃに加温し
てポリエチレングリコール４０００を溶融させ、この中
に、粉砕した電解質混合物を添加し、撹拌機を用いて分
散させた。この分散液をポンプを用いて噴霧冷却造粒装
置（大川原化工機株式会社製）に供給し噴霧冷却造粒を
行なった結果、造粒物２７ｋｇを得た。噴霧装置は回転
ディスク式を使用し、回転数は４０００ｒｐｍで、室内
の温度は約５°Ｃであった。0.8 kg of sodium hydrogen carbonate was weighed out and mixed using a rocking mixer (manufactured by Aichi Denki Co., Ltd.). This mixture is passed through a hammer type pulverizer.
(Niclean diameter 0.5mm manufactured by Hosokawa Micron Co., Ltd.)
The mixture was pulverized at room temperature. At this time, the particle size distribution of the pulverized product was 20 μm to 74 μm, and the average particle diameter was about 40 μm. Next, add 30k of polyethylene glycol 4000.
After weighing and putting it into a dissolution tank, it was heated to about 80°C to melt polyethylene glycol 4000, and the pulverized electrolyte mixture was added thereto and dispersed using a stirrer. This dispersion liquid was supplied to a spray cooling granulation device (manufactured by Okawara Kakoki Co., Ltd.) using a pump and spray cooling granulation was performed, resulting in 27 kg of granules. A rotating disk type spraying device was used, the rotation speed was 4000 rpm, and the room temperature was about 5°C.
この造粒物をパウダーテスター（細川ミクロン株式会社
製）及びシーブシェイ力−（飯田製作所型）で測定し、
次の結果を得た。The granules were measured with a powder tester (manufactured by Hosokawa Micron Co., Ltd.) and a sieve shear force (Iida Seisakusho type),
I got the following results.
平均粒子径 ２５０μｍ
粒度分布 ５００μｍ以上 １．２％７５〜５０
０μｍ９８．７％
７５μｍ以下 ０．１％
次に、この造粒物を自動分包機（名古屋東陽機械製作所
製）を用いて、ラミネート（ポリエステル、ポリエチレ
ン、アルミニウムの多層ラミネート）袋に１３７ｇずつ
充填することによって腸管洗浄液２ｆ用分包品を得た。Average particle diameter 250μm Particle size distribution 500μm or more 1.2%75-50
0μm98.7% 75μm or less 0.1% Next, each 137g of this granulated material is filled into a laminate (multilayer laminate of polyester, polyethylene, and aluminum) bag using an automatic packaging machine (manufactured by Nagoya Toyo Kikai Seisakusho). A packaged product for intestinal cleansing liquid 2f was obtained.
なお、１包の充填量は必要に応じて変えることができ、
例えば１！用として６８．７ｇ、３２用として２０６ｇ
、４１用として２７５ｇとしてもよい。In addition, the filling amount of one package can be changed as necessary.
For example 1! 68.7g for 32, 206g for 32
, 275g for 41.
実施例２
予め、塩化ナトリウム０．４７ｋｇ、塩化カリウムＱ、
３０ｋｇ、クエン酸ナトリウム４．１１ｋｇをそれぞれ
秤取して、ロッキングミキサー（愛知電機株式会社製）
にて混合した。この混合物をハンマータイプの粉砕機パ
ルペライザ−（細川ミクロン株式会社製ニスクリーン径
０． ５ｍｍ）を用いて室温下にて粉砕した。Example 2 In advance, 0.47 kg of sodium chloride, potassium chloride Q,
Weigh out 30 kg and 4.11 kg of sodium citrate, and place them in a rocking mixer (manufactured by Aichi Denki Co., Ltd.).
Mixed at . This mixture was pulverized at room temperature using a hammer type pulverizer (Niclean, diameter 0.5 mm, manufactured by Hosokawa Micron Co., Ltd.).
次に、ポリエチレングリコール４０００を２９゜９５ｋ
ｇ秤取し、以下実施例１と同様な方法で造粒物２７ｋｇ
を得た。Next, add polyethylene glycol 4000 to 29°95k.
Weighed out 27 kg of granulated material in the same manner as in Example 1.
I got it.
比較例
比較試験に°用いるため表１に示した成分の腸管洗浄液
用組成物を特開平１−１３５３１９号に開示されている
方法により調製した。Comparative Example A composition for intestinal cleansing liquid having the components shown in Table 1 was prepared for use in a comparative test by the method disclosed in JP-A-1-135319.
（余白）
表１ 組成（ｇ）
表２ 含量測定結果
（７）試験例
試験例１
実施例１で製造した造粒物６８．６ｇ （ｌｆｆｉの洗
浄液を調製できる量）を５回秤取しそれぞれ含量試験を
行った。（表２）
（余白）
試験の結果、実施例１で調製した造粒物中の各成分が均
一に分散している結果を得た。(Margin) Table 1 Composition (g) Table 2 Content measurement results (7) Test example Test example 1 68.6 g of the granulated material produced in Example 1 (an amount that can prepare the cleaning solution for lffi) was weighed 5 times, and each A content test was conducted. (Table 2) (Margin) The test results showed that each component in the granules prepared in Example 1 was uniformly dispersed.
試験例２
実施例１で製造した造粒物と参考例で調製した組成物の
安定性試験を行ったところ、２５°Ｃ及び４０°Ｃ相対
湿度７５％の保存条件に各６ケ月においたところ双方と
も含量、外観等の品質変化は認められず安定であった。Test Example 2 A stability test was conducted on the granules produced in Example 1 and the composition prepared in Reference Example, and they were stored at 25°C and 40°C with a relative humidity of 75% for 6 months each. Both were stable with no changes in quality such as content or appearance.
試験例３
実施例１で得た分包品と、参考例で調製した組成物の分
包品の重量バラツキを比較した。（表裏３ 分包品の充
填バラツキ
表４ 溶解時間
試験の結果、本発明で調製した造粒物は特開平１−１３
５３１９号に開示されている組成物に比べ充填バラツキ
が小さく流動性が優れている。Test Example 3 The weight variations of the packaged product obtained in Example 1 and the packaged product of the composition prepared in Reference Example were compared. (Front and back 3 Filling variation of sachets Table 4 As a result of the dissolution time test, the granules prepared according to the present invention were
Compared to the composition disclosed in No. 5319, the filling variation is small and the fluidity is excellent.
試験例４
実施例１の造粒品と比較例の組成物について１３７ｇ（
ただし、平均粒子径を３００μｍ、２００μｍ、１５０
μｍ及び１００μｍに調製）をそれぞれ攪拌下２２の水
に完全に溶解するまでの時間を調べた。Test Example 4 137g (137g) of the granulated product of Example 1 and the composition of Comparative Example
However, the average particle diameter is 300 μm, 200 μm, 150 μm.
The time required for complete dissolution of 22 μm and 100 μm of water under stirring was investigated.
試験の結果、表４に示すように、本発明の造粒品は平均
粒子径１５０μｍ、および１００μｍの溶解性が優れて
いる。As shown in Table 4, the test results show that the granulated product of the present invention has an average particle size of 150 μm and excellent solubility of 100 μm.
（７）発明の効果
本発明の方法により、腸管洗浄液用組成物の各成分が均
一に混合され、また流動性に優れた造粒物を製造できる
ことから、製造工程の簡略化、自動化が計れ大幅なコス
トダウンが可能となる。さらに、使用に際し水溶液とし
て速やかに調製でき、その便益は大である。(7) Effects of the invention By the method of the invention, each component of the composition for intestinal cleansing solution can be mixed uniformly, and a granulated product with excellent fluidity can be produced, which greatly simplifies and automates the manufacturing process. It is possible to reduce costs. Furthermore, it can be quickly prepared as an aqueous solution for use, which has great benefits.
Claims (1)
質を均一に混合し噴霧することを特徴とする腸管洗浄液
用組成物の製造法。(1) A method for producing a composition for intestinal cleansing liquid, which comprises uniformly mixing and spraying an electrolyte in a molten state of polyethylene glycol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP23123790A JPH04112830A (en) | 1990-08-31 | 1990-08-31 | Preparation of liquid composition for cleaning enteric canal |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP23123790A JPH04112830A (en) | 1990-08-31 | 1990-08-31 | Preparation of liquid composition for cleaning enteric canal |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH04112830A true JPH04112830A (en) | 1992-04-14 |
Family
ID=16920471
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP23123790A Pending JPH04112830A (en) | 1990-08-31 | 1990-08-31 | Preparation of liquid composition for cleaning enteric canal |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH04112830A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| US8999313B2 (en) | 2012-09-11 | 2015-04-07 | Norgine Bv | Compositions |
| US9592252B2 (en) | 2011-03-11 | 2017-03-14 | Norgine Bv | Colonoscopy—preparation |
-
1990
- 1990-08-31 JP JP23123790A patent/JPH04112830A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| US9592252B2 (en) | 2011-03-11 | 2017-03-14 | Norgine Bv | Colonoscopy—preparation |
| US10646512B2 (en) | 2011-03-11 | 2020-05-12 | Norgine Bv | Colonoscopy - preparation |
| US10780112B2 (en) | 2011-03-11 | 2020-09-22 | Norgine Bv | Colonoscopy-preparation |
| US10792306B2 (en) | 2011-03-11 | 2020-10-06 | Norgine Bv | Colonoscopy—preparation |
| US11529368B2 (en) | 2011-03-11 | 2022-12-20 | Norgine Bv | Colonoscopy—preparation |
| US8999313B2 (en) | 2012-09-11 | 2015-04-07 | Norgine Bv | Compositions |
| US9326969B2 (en) | 2012-09-11 | 2016-05-03 | Norgine Bv | Compositions |
| US9707297B2 (en) | 2012-09-11 | 2017-07-18 | Norgine Bv | Compositions |
| US10016504B2 (en) | 2012-09-11 | 2018-07-10 | Norgine Bv | Compositions |
| US10918723B2 (en) | 2012-09-11 | 2021-02-16 | Norgine Bv | Colon cleansing compositions and methods of use |
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