JPH0312890B2 - - Google Patents

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Publication number
JPH0312890B2
JPH0312890B2 JP14868480A JP14868480A JPH0312890B2 JP H0312890 B2 JPH0312890 B2 JP H0312890B2 JP 14868480 A JP14868480 A JP 14868480A JP 14868480 A JP14868480 A JP 14868480A JP H0312890 B2 JPH0312890 B2 JP H0312890B2
Authority
JP
Japan
Prior art keywords
weight
kinematic viscosity
maintenance
centistokes
emulsion
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
Application number
JP14868480A
Other languages
Japanese (ja)
Other versions
JPS5775642A (en
Inventor
Koji Inoe
Nobukatsu Sato
Takashi Tamura
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.)
Maruishi Pharmaceutical Co Ltd
Original Assignee
Maruishi Pharmaceutical 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 Maruishi Pharmaceutical Co Ltd filed Critical Maruishi Pharmaceutical Co Ltd
Priority to JP14868480A priority Critical patent/JPS5775642A/en
Publication of JPS5775642A publication Critical patent/JPS5775642A/en
Publication of JPH0312890B2 publication Critical patent/JPH0312890B2/ja
Granted legal-status Critical Current

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  • Colloid Chemistry (AREA)
  • Preventing Corrosion Or Incrustation Of Metals (AREA)

Description

【発明の詳細な説明】[Detailed description of the invention]

本発明はポリブテンおよび/または流動パラフ
インの脂肪酸石鹸による安定な乳化液をもつて主
として金属製の医療器具の保守を行うことに関す
る。 医療用器具、例えば金属製の小物、特に手術用
の鉗子や剪刀類は、使用直前に滅菌消毒を行い、
無菌状態で使用に供するのであるが、使用後は洗
浄して乾燥させ、錆などを生じないよう且つ器具
の関節部(box−lock)が平滑に動くように保存
するのが一般であり、この操作を保守と呼んでい
る。 従来、この保守操作としては流動パラフインや
シリコン樹脂を器具表面に直接塗布または噴霧す
るか、あるいは器具の関節部に注油することが行
われていた。 しかし、これらの方法によるときは、付着して
いた耐熱性の細菌芽胞が流動パラフイン等の層に
より隠ぺいされて滅菌時の湿熱に曝露されること
なく生き残るとか、関節部に注油された流動パラ
フイン等がそのまま加熱されて酸敗、変質して関
節部の動きを悪くする等の欠点が生じやすく、こ
とに超音波洗浄器の普及に伴い、この欠点が目立
つようになつている。 本発明は、これらの欠点を回避する目的で提案
されたものである。 本発明の主薬の一つであるポリブテンとは、イ
ソブチレンを主体とし、一部n−ブテンが反応し
た共重合物質で、透明、無毒な液状ポリマーで下
記構造式で表わされる: このポリブテンは食品添加物公定書にも収載さ
れており、チユーインガム用の添加物としても認
められているが、本発明で好適に使用されるポリ
ブテンとしては、種々実験の結果、平均分子量
200〜500、動粘度5〜150センチストークス(以
下cSTで表わす。)(100〓)のものが選ばれる。
この規格外のポリブテンでは前述した欠点が生じ
ることがある。 本発明の主薬の他の一つである流動パラフイン
は日本薬局方にも収載されている物質であるが、
本発明で好適に利用できるのは、実験の結果、比
重0.825〜0.850で動粘度40〜90cST(100〓)のも
のが選ばれ、この規格外の品ではポリブテンと同
様に前述の欠点が表われる傾向がみられる。 乳化剤としての脂肪酸石鹸としては炭素数12〜
20すなわちラウリン酸よりアラキン酸までの石鹸
類が利用でき、実用上はこれら脂肪酸とトリエタ
ノールアミン類とを溶媒中に共存させることによ
る好適に代用できる。 前記脂肪酸を石鹸としかつ、組成物を中性ない
し弱アルカリ性にするためのアルカリ剤、例えば
有機のモノ、ジ、トリ−エタノールアミン類が用
いられ、また、乳化液安定剤の非イオン界面活性
剤、例えばポリエチレングリコール(200〜1000)
−モノまたはジオレアートの使用が必要である。 本発明乳化液組成物の各成分の配合比は、大体
次記で示される: 主薬 15〜35重量% 脂肪酸 3〜5重量% 有機アルカリ剤 2〜5重量% 安定化剤 2〜3重量 水を加えて100重量%とする。 前記配合において、主薬濃度が規定範囲に達し
なければ乳化液として塗布した場合油分が連続し
た薄膜を形成せず、規定範囲をオーバーすると粘
度が高くなつて関節部に浸透しないほか、油分が
過剰のため器具がべとつく等の不都合が見られ
る。脂肪酸、有機アルカリ剤および安定剤の配合
量は、適切な主薬濃度をもつた安定なエマルジヨ
ンを形成し、かつ液性をPH7〜10とするのに過不
足のない範囲である。 かくして得られた本発明乳化液組成物は、比重
0.9〜1.0、動粘度9〜15cST(100〓)でPH7〜10
の値を示す。 本発明乳化液組成物をもつて保守操作を施した
医療器具は、これを滅菌消毒した場合に、従来し
ばしばみられた関節部における注油分が白濁する
とか、器具表面における伸展が不充分で均等に分
散せずにしみとなつて残るとか、ベトツキの原因
となるとかなどの現象が起こることがない。 本発明乳化液組成物による保守操作は、例えば
手術器具などの鋼製小物を本乳化液に充分浸漬し
た後に取り出して乾燥するか、または乾燥せずに
濡れたまま滅菌バツグに納め、高圧蒸気滅菌を行
うことが推奨される。 かかる保守操作により、主薬の油分は微粒子状
に乳化分散されているので器具表面に均等に付着
し、また関節部の小空隙にも深達し、滅菌時に水
分を揮散し、かつ油分は薄膜状に安定に塗布され
る。この際の油膜の厚さは0.1μ程度と計算され
る。 かくして、本発明乳化液組成物を利用した保守
操作により、従来斯界において色々と欠点がある
ことが知られておりながら、ある程度止むをえず
行われていた流動パラフインやシリコン樹脂の直
接塗布や注油による保守操作を避けることがで
き、発錆を完全に防ぎ、しかも外科手術用剪刀な
どの関節部の微妙な作動が要求されていた点を維
持することが可能になつたのである。更に、従来
操作のように器具一つ一つを手に取り、油分を塗
布、注油したり、またこれを拭き取つたりする時
間と手間を省き、多数の器具を一括浸漬させて保
守目的が達成できるようになつた点に医家の省力
にも資することが大きいという利点も有する。 以下に実施例をもつて、本発明乳化液組成物の
製造の態様を示す: 実施例 1 平均分子量300、動粘度21cST(100〓)のポリ
ブテンの30重量%、トリエタノールアミン2.2重
量%、オレイン酸5重量%およびポリエチレング
リコール400ジオレアート2重量%を混合し、激
しくかき混ぜながら精製水60.8重量%を加えると
安定な乳化液を得ることができる。 この乳化液は比重0.94、動粘度9cST(室温)、
PH8.5を示す。 実施例 2 比重0.83、動粘度55cST(100〓)の液状パラフ
イン18重量%に対し、トリエタノールアミン4.5
重量%、ポリエチレングリコール600モノオレア
ート2重量%、ポリエチレン400ジオレアート2
重量%およびオレイン酸3重量%をとり、激しく
かき混ぜながら精製水70.5重量%を加えるとき、
安定な乳化液が得られる。比重0.97、動粘度
15cST(室温)でPH8.8を示す。 実施例 3 平均分子量300で動粘度21cST(100〓)のポリ
ブテン10重量%と比重0.83で動粘度55cST(100
〓)の液状パラフイン15重量%の混合物に対し、
トリエタノールアミン3重量%、オレイン酸4重
量%およびポリエチレン−400ジステアレート3
重量%を加え、激しくかき混ぜながら精製水65重
量%を加え、安定な乳化液を製する。この乳化液
は比重0.95、動粘度10cST(室温)でPH8.2で示す。 医療器具の従来知られた保守(潤滑、防錆)剤
との比較における本発明乳化液組成物の菌隠ぺい
(非貯留)性試験の成績を次記に示す: 試験方法 パチルス、ステアロテルモフイルス、スポーレ
(B.stearothermophilus sport)を使用菌とし、
ステンレス、ペニシリンダーの1区画(キヤリヤ
ー)につき菌を平均5.5×103付着させ、米国薬局
方ビオロジカル、インデイケーター試験法に準
じ、1回9個ずつ3回試験を行つた。滅菌温度
121℃である。
The present invention relates to the maintenance of primarily metallic medical instruments with stable emulsions of fatty acid soaps of polybutene and/or liquid paraffin. Medical instruments, such as small metal objects, especially surgical forceps and scissors, should be sterilized and disinfected immediately before use.
Although instruments are used in aseptic conditions, they are generally washed and dried after use and stored to prevent rust and to ensure that the box-locks of the instruments move smoothly. The operation is called maintenance. Traditionally, this maintenance has involved applying or spraying liquid paraffin or silicone resin directly onto the instrument surface, or lubricating the joints of the instrument. However, when using these methods, the attached heat-resistant bacterial spores are hidden by a layer of liquid paraffin, etc., and survive without being exposed to the moist heat during sterilization, or the liquid paraffin, etc. lubricated in the joint area. When heated as it is, it tends to become rancid and change in quality, resulting in problems such as poor movement of joints, and this problem is becoming more noticeable as ultrasonic cleaners become more widespread. The present invention has been proposed to avoid these drawbacks. Polybutene, which is one of the main ingredients of the present invention, is a copolymer material mainly composed of isobutylene and partially reacted with n-butene, and is a transparent, non-toxic liquid polymer represented by the following structural formula: This polybutene is also listed in the Japan Food Additives Official Standards and is also recognized as an additive for chewing gum. However, as a result of various experiments, the average molecular weight of the polybutene suitably used in the present invention was
200 to 500, and a kinematic viscosity of 5 to 150 centistokes (hereinafter expressed as cST) (100〓) is selected.
This substandard polybutene may cause the drawbacks mentioned above. Liquid paraffin, which is another main drug of the present invention, is a substance listed in the Japanese Pharmacopoeia.
As a result of experiments, it was determined that a product suitable for use in the present invention has a specific gravity of 0.825 to 0.850 and a kinematic viscosity of 40 to 90 cST (100〓); products that do not meet this standard exhibit the aforementioned drawbacks similar to polybutene. There is a trend. The fatty acid soap used as an emulsifier has 12 or more carbon atoms.
In other words, soaps ranging from lauric acid to arachidic acid can be used, and in practice, these fatty acids and triethanolamines can be suitably substituted by coexisting in a solvent. Alkaline agents such as organic mono-, di-, and tri-ethanolamines are used to use the fatty acids as soap and to make the composition neutral to weakly alkaline, and nonionic surfactants as emulsion stabilizers are used. , e.g. polyethylene glycol (200-1000)
- Requires the use of mono- or dioleate. The blending ratio of each component of the emulsion composition of the present invention is roughly shown as follows: Main ingredient: 15-35% by weight Fatty acid: 3-5% by weight Organic alkaline agent: 2-5% by weight Stabilizer: 2-3% by weight Water In addition, it shall be 100% by weight. In the above formulation, if the concentration of the active ingredient does not reach the specified range, the oil will not form a continuous thin film when applied as an emulsion, and if it exceeds the specified range, the viscosity will become high and it will not penetrate into the joints, and the oil will not penetrate into the joint area. This causes inconveniences such as the utensils becoming sticky. The blending amounts of the fatty acid, organic alkali agent, and stabilizer are within a range that is just enough to form a stable emulsion with an appropriate concentration of the active ingredient and to have a liquid pH of 7 to 10. The emulsion composition of the present invention thus obtained has a specific gravity of
0.9~1.0, kinematic viscosity 9~15cST (100〓), PH7~10
indicates the value of When a medical device that has been subjected to maintenance using the emulsion composition of the present invention is sterilized, the lubricant in the joints may become cloudy, as has often been the case in the past, or the device surface may not spread properly or evenly. No phenomena such as not dispersing and remaining as stains or causing stickiness occur. Maintenance operations using the emulsion composition of the present invention include, for example, immersing small steel items such as surgical instruments in the emulsion and then taking them out and drying them, or placing them in a sterilization bag while wet without drying them and sterilizing them with high-pressure steam. It is recommended that you do this. Through this maintenance operation, the oil content of the main drug is emulsified and dispersed in the form of fine particles, so it adheres evenly to the instrument surface, penetrates deep into the small spaces of the joints, evaporates water during sterilization, and leaves the oil content in the form of a thin film. It is applied stably. The thickness of the oil film in this case is calculated to be about 0.1μ. Thus, maintenance operations using the emulsion composition of the present invention eliminate the direct application of liquid paraffin or silicone resin and lubrication, which have been unavoidably performed to some extent, although they are known to have various drawbacks in the art. This made it possible to avoid maintenance operations, completely prevent rusting, and maintain the delicate operation of joints such as surgical scissors. Furthermore, the time and effort required to pick up each instrument one by one, apply oil, lubricate, and wipe them off as required in conventional operations can be eliminated, and many instruments can be immersed at once for maintenance purposes. It also has the advantage that it greatly contributes to saving the labor of doctors. The embodiment of the production of the emulsion composition of the present invention is shown below with Examples: Example 1 30% by weight of polybutene with an average molecular weight of 300 and a kinematic viscosity of 21 cST (100〓), 2.2% by weight of triethanolamine, and olein. A stable emulsion can be obtained by mixing 5% by weight of acid and 2% by weight of polyethylene glycol 400 dioleate and adding 60.8% by weight of purified water while stirring vigorously. This emulsion has a specific gravity of 0.94, a kinematic viscosity of 9 cST (room temperature),
Indicates PH8.5. Example 2 18% by weight of liquid paraffin with a specific gravity of 0.83 and a kinematic viscosity of 55cST (100〓) was mixed with 4.5% of triethanolamine.
Weight%, polyethylene glycol 600 monooleate 2%, polyethylene 400 dioleate 2
When taking % by weight and 3% by weight of oleic acid and adding 70.5% by weight of purified water while stirring vigorously,
A stable emulsion can be obtained. Specific gravity 0.97, kinematic viscosity
Shows PH8.8 at 15cST (room temperature). Example 3 10% by weight of polybutene with an average molecular weight of 300 and a kinematic viscosity of 21 cST (100〓) and a kinematic viscosity of 55 cST (100
〓) For a mixture of 15% by weight of liquid paraffin,
3% by weight of triethanolamine, 4% by weight of oleic acid and 3% by weight of polyethylene-400 distearate
% by weight, and add 65% by weight of purified water while stirring vigorously to make a stable emulsion. This emulsion has a specific gravity of 0.95, a kinematic viscosity of 10 cST (room temperature), and a pH of 8.2. The results of the bacteria hiding (non-storage) property test of the emulsion composition of the present invention in comparison with conventionally known maintenance (lubrication, rust prevention) agents for medical instruments are shown below: Test method Patillus, stearothermophilus , using B. stearothermophilus sport as the bacteria,
An average of 5.5 x 10 3 bacteria was attached to each compartment (carrier) of a stainless steel penicylinder, and the test was conducted three times with nine pieces each according to the US Pharmacopoeia Biological Indicator Test Method. sterilization temperature
It is 121℃.

【表】【table】

【表】 上表の結果より、従来のシリコン油や液状パラ
フインに比して、本発明組成物は菌の発育を隠ぺ
いして完全滅菌を阻害することが少ないことが実
証された。 なお、本発明乳化液組成物は毒性も低く安全無
害なものであり、その急性毒性値を示せば次の通
りである。
[Table] The results shown in the above table demonstrate that the composition of the present invention is less likely to hide the growth of bacteria and inhibit complete sterilization than conventional silicone oil or liquid paraffin. The emulsion composition of the present invention has low toxicity, is safe and harmless, and its acute toxicity values are as follows.

【表】【table】

【表】【table】

Claims (1)

【特許請求の範囲】 1 比重0.9〜1.0、動粘度9〜15センチストーク
ス(100〓)のPH7〜10の水性乳化液であつて、 ポリブデンおよび/または液状流動パラフイン
(主薬) 15〜35重量% 炭素数12〜20の脂肪酸(乳化剤)3〜5重量% 前記脂肪酸を中和しかつ液性をPH7〜10にする
ための有機アルカリ化剤 2〜5重量% 非イオン界面活性剤(安定化剤)2〜3重量% 水を加えて100重量%とする, なる組成よりなる医療器具の保守用乳化液組成
物。 2 乳化剤がオレイン酸とトリエタノールアミン
より生成した石鹸であり、有機アルカリ化剤がト
リエタノールアミンであり、安定化剤がポリエチ
レングリコール(重合度200〜1000)のオレイン
酸エステルであることを特徴とする特許請求の範
囲第1項記載の医療器具の保守用組成物。 3 主薬が平均分子量200〜500で動粘度5〜150
センチストークス(100〓)のポリブテンと比重
0.825〜0.850で動粘度40〜90センチストークス
(100〓)の流動パラフインの重量比で1対1.5の
割合の混合物であることを特徴とする特許請求の
範囲第1項または同第2項記載の医療器具の保守
用乳化液組成物。
[Scope of Claims] 1. An aqueous emulsion with a specific gravity of 0.9 to 1.0, a kinematic viscosity of 9 to 15 centistokes (100〓), and a pH of 7 to 10, comprising 15 to 35% by weight of polybdenum and/or liquid paraffin (main ingredient). Fatty acid having 12 to 20 carbon atoms (emulsifier) 3 to 5% by weight Organic alkalizing agent for neutralizing the fatty acid and making the liquid pH 7 to 10 2 to 5% by weight Nonionic surfactant (stabilizer) ) An emulsion composition for maintenance of medical instruments, comprising: 2 to 3% by weight and made up to 100% by weight by adding water. 2. The emulsifier is a soap produced from oleic acid and triethanolamine, the organic alkalizing agent is triethanolamine, and the stabilizer is an oleic acid ester of polyethylene glycol (degree of polymerization 200-1000). A composition for maintaining a medical device according to claim 1. 3 The main drug has an average molecular weight of 200 to 500 and a kinematic viscosity of 5 to 150.
Polybutene and specific gravity of centistokes (100〓)
Claim 1 or 2 is a mixture of liquid paraffin having a kinematic viscosity of 0.825 to 0.850 and a kinematic viscosity of 40 to 90 centistokes (100〓) in a weight ratio of 1:1.5. Emulsion composition for maintenance of medical equipment.
JP14868480A 1980-10-22 1980-10-22 Emuslsion composition for maintaining therapeutic instrument Granted JPS5775642A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP14868480A JPS5775642A (en) 1980-10-22 1980-10-22 Emuslsion composition for maintaining therapeutic instrument

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP14868480A JPS5775642A (en) 1980-10-22 1980-10-22 Emuslsion composition for maintaining therapeutic instrument

Publications (2)

Publication Number Publication Date
JPS5775642A JPS5775642A (en) 1982-05-12
JPH0312890B2 true JPH0312890B2 (en) 1991-02-21

Family

ID=15458281

Family Applications (1)

Application Number Title Priority Date Filing Date
JP14868480A Granted JPS5775642A (en) 1980-10-22 1980-10-22 Emuslsion composition for maintaining therapeutic instrument

Country Status (1)

Country Link
JP (1) JPS5775642A (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59186547A (en) * 1983-04-08 1984-10-23 オリンパス光学工業株式会社 Surgical incision instrument
JP5744725B2 (en) 2008-06-20 2015-07-08 スリーエム イノベイティブ プロパティズ カンパニー Medical aqueous lubricant emulsion or cleaning apparatus and method
CN106947387A (en) * 2017-03-28 2017-07-14 泉州恒卓化工机械科技有限公司 A kind of transformer insulation antirust solution

Also Published As

Publication number Publication date
JPS5775642A (en) 1982-05-12

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