JP2012120769A - Device and method for tablet administered as suspension - Google Patents

Device and method for tablet administered as suspension Download PDF

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JP2012120769A
JP2012120769A JP2010275530A JP2010275530A JP2012120769A JP 2012120769 A JP2012120769 A JP 2012120769A JP 2010275530 A JP2010275530 A JP 2010275530A JP 2010275530 A JP2010275530 A JP 2010275530A JP 2012120769 A JP2012120769 A JP 2012120769A
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syringe
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Nobuyuki Wakui
宣行 湧井
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Abstract

PROBLEM TO BE SOLVED: To administer a suspended drug obtained by crushing a tablet in a closed system and suspending the crushed tablet in the closed system, to a patient in the closed system.SOLUTION: A device for tablet administered as a suspension includes: a tablet crushing syringe for crushing the tablet; a water supplying syringe for supplying water; and a T-shaped stopcock for connecting the tablet crushing syringe and the water supplying syringe. The tablet crushing syringe internally includes pins for crushing the tablet. The T-shaped stopcock includes three connecting ends internally having flow passages, and a sliding valve body for selecting and connecting two of the flow passages of the three connecting ends at a junction base portion of the three connecting ends. The end of the tablet crushing syringe and the end of the water supplying syringe are each connected to any of the connecting ends of the T-shaped stopcock.

Description

本発明は、錠剤を水に懸濁させて懸濁薬液を形成し、該懸濁薬液を患者に投与する錠剤懸濁投与装置、及びこの装置を使用して該懸濁薬液を形成し、該懸濁薬液を患者に投与する錠剤懸濁投与方法に関するものである。   The present invention comprises a tablet suspension administration device for suspending a tablet in water to form a suspension drug solution, and administering the suspension drug solution to a patient, and using this device to form the suspension drug solution, The present invention relates to a tablet suspension administration method for administering a suspension drug solution to a patient.

近年、わが国は本格的な高齢化社会に直面し、薬剤を経管チューブで患者に投与する経鼻胃管、胃瘻投与など、薬剤の経管投与を必要とする老年者数が増加の一途をたどっている。   In recent years, Japan has faced a full-fledged aging society, and the number of elderly people who require tube administration of drugs, such as nasogastric tube and gastrostoma administration, where drugs are administered to patients via tube tubes, is increasing. I'm following.

投与する薬剤が錠剤の場合での経鼻胃管、胃瘻投与では、錠剤を粉砕して粉砕散とし、これを白湯に溶かして投与する粉砕法、および錠剤を投与直前に約55℃の温湯に入れ、崩壊懸濁化する、倉田式簡易懸濁法の二方法が用いられている。   In the case of nasogastric tube or gastrostoma administration when the drug to be administered is tablet, the tablet is pulverized into pulverized powder, and this is dissolved in white water and administered, and the tablet is heated to about 55 ° C. just before administration. Two methods, the Kurata-type simple suspension method, are used to disintegrate and suspend them.

簡易懸濁法は粉砕法に比し、主薬の安定性、薬剤投与の確実性などの面で優れた投与法であり、現在は、簡易懸濁法による錠剤懸濁液を患者に経管投与する方法が一般的となっている。   The simple suspension method is superior to the pulverization method in terms of the stability of the active ingredient and the certainty of drug administration. Currently, the tablet suspension by the simple suspension method is administered to patients by tube. The method of doing is becoming common.

しかし、熱に不安定な一部の抗癌剤などでは、現在もなお、錠剤を粉砕して粉砕散とし、これを白湯に溶かす粉砕法が用いられている。   However, some anti-cancer agents that are unstable to heat still use a pulverization method in which tablets are crushed into pulverized powder and dissolved in white water.

今日、癌化学療法に用いられている抗癌剤の多くは、変異原性や染色体異常の遺伝毒性、発癌性、胎児奇形性など、様々な危険因子を保持している。現在、内服抗癌剤の経管投与においては、粉砕法では調剤者および投与者(看護師、介護者)が、簡易懸濁法では投与者が、常に、飛散吸引などによる被曝の危険性にさらされている。   Many anticancer drugs used in cancer chemotherapy today have various risk factors such as mutagenicity, genotoxicity of chromosomal abnormalities, carcinogenicity, and fetal malformation. Currently, in tube administration of oral anticancer drugs, the pulverization method and the administration (nurse, caregiver) are always exposed to the risk of exposure by the scattered suspension method. ing.

実際の抗癌剤被曝の現状として、調剤者、看護師の尿から、微量ではあるが抗癌剤が検出され、また病院薬局のドアノブや調剤台など、直接抗癌剤に触れることない箇所からの検出も報告されている。   As the actual situation of exposure to anticancer drugs, a small amount of anticancer drug is detected from the urine of dispensers and nurses, and detection is also reported from places where the anticancer drug is not directly touched, such as door knobs and dispensing tables of hospital pharmacies. Yes.

従って、現在、粉砕調剤に関わる薬剤師だけでなく、抗癌剤投与に関わる全ての投与者(看護師、介護者など)に関して、抗癌剤被曝の危険性が懸念されている。   Therefore, at present, there is a concern about the risk of exposure to anticancer drugs not only for pharmacists involved in pulverized dispensing but also for all administration persons (nurses, caregivers, etc.) involved in administration of anticancer drugs.

また、抗癌剤の一つであるシクロフォスファミド(CPA)は常温で揮発するため、粉砕調剤および投与時に飛散した薬剤吸引による被曝だけでなく、経管投与後のチューブ、懸濁投与後の残液や使用器具および患者の尿などからの揮発により、患者が関わる全ての施設(病院、在宅、介護施設など)で抗癌剤汚染の危険性が懸念される。   In addition, cyclophosphamide (CPA), which is one of the anticancer agents, volatilizes at room temperature, so that not only exposure due to pulverized preparation and drug suction scattered during administration, but also tube after tube administration, residual after suspension administration. Due to volatilization from liquids, equipment used, and patient's urine, there is a concern about the risk of anti-cancer drug contamination in all facilities (hospital, home, care facility, etc.) involving the patient.

世界保健機構(WHO)の一部門であるInternational Agency for Research on Cancer(IARC)は、CPAの発癌性に対して、最も危険度の高いグループ1に分類し、医薬品を含む化学物質の人体への被曝と発癌性に関するデータを編集し、危険度を分類している。   The International Agency for Research on Cancer (IARC), a division of the World Health Organization (WHO), classifies CPA carcinogenicity as the most dangerous group 1 and applies chemicals, including pharmaceuticals, to the human body. Data on exposure and carcinogenicity are compiled to classify risk levels.

この報告でCPAは、アスベストと同等に分類している。事実、抗癌剤取扱い医療従事者の尿からCPAの検出報告もあり、また、CPA以外の抗癌剤検出の事例が多数報告されている。   In this report, CPA is classified as equivalent to asbestos. In fact, there are reports of detection of CPA from the urine of medical staff handling anticancer drugs, and many cases of detection of anticancer drugs other than CPA have been reported.

現在、注射剤での抗癌剤については、世界的に抗悪性腫瘍薬の注射剤の取扱いに関するガイドラインが作成され、日本でも、従来の「抗悪性腫瘍剤の院内取扱い指針」の改訂版として、日本病院薬剤師会監修のもと、2006 年に「抗がん剤調製マニュアル」が出版されるなど、抗癌剤の注射剤を取り扱う医療従事者への注意喚起がなされている。   Currently, guidelines for the treatment of injections of antineoplastic drugs have been created worldwide for anticancer drugs as injections. In Japan, a revised version of the "In-Hospital Handling Guidelines for Anti-neoplastic Agents" has been published in Japan Hospital. Under the supervision of the Pharmacists Association, the “Anticancer Drug Preparation Manual” was published in 2006, and alerts have been made to healthcare professionals who handle injections of anticancer drugs.

日本病院薬剤師会監修の「抗がん剤調製マニュアル」では、安全キャビネット内での調製が指定されており、さらに調製者のキャップ、マスク、ゴーグル、ガウン、およびグローブ着用などの被曝防止策が求められている。   The “Preparation Manual for Anticancer Drugs” supervised by the Japan Hospital Pharmacists Association specifies preparation in a safety cabinet and requires measures to prevent exposure such as wearing the cap, mask, goggles, gown, and gloves of the preparer. It has been.

一方、抗癌剤内服薬の粉砕調剤、懸濁液調製では、注射剤の調製と同様の危険性があるにもかかわらず、日本薬剤師会編集の「第12 改訂調剤指針」では、「調剤者は通常のマスク、帽子の着用に加え、薬剤が直接皮膚に付着しないよう手袋で防御する」という記載のみであり、被曝防止の詳細な方策、指針を示していないのが現状である。   On the other hand, in the preparation of pulverized preparations and suspensions of anticancer drugs, there is a risk similar to the preparation of injections. In addition to wearing masks and hats, it is only a statement that “protect gloves with gloves to prevent chemicals from directly attaching to the skin”, and there are no detailed measures or guidelines for preventing exposure.

CPAは乳癌治療の多剤併用療法として、注射剤、内服薬として用いられるが、注射剤による治療が困難な場合や、一部の化学療法のレジメン(CMF療法など)では、経口内服薬(エンドキサン錠:登録商標)によるCPAの連日投与が必要とされる。   CPA is used as a multi-drug combination therapy for breast cancer treatment. It is used as an injection or internal medicine. However, when treatment with an injection is difficult or in some chemotherapy regimens (such as CMF therapy), oral medicine (Endoxan tablets: Daily administration of CPA by registered trademark is required.

しかし、嚥下障害がある癌患者では、粉砕調剤などでの投与法が必要であるが、現在のところ、調剤者、投与者(看護師、介護者など)が安全に調製し投与する方法は開発されておらず、CPAを代表とする危険薬剤での、投与関係者への早急な被曝回避対策が求められる。   However, for cancer patients with dysphagia, administration methods such as pulverized preparation are necessary, but at present, a method for safe preparation and administration by dispensers and administra- tors (nurses, caregivers, etc.) has been developed. There is a need for immediate exposure avoidance measures for those involved in administration with dangerous drugs represented by CPA.

特開2008−264504号公報JP 2008-264504 A

倉田なおみ著、藤島一郎監修「内服薬経管投与ハンドブック 第2版 簡易懸濁法可能医薬品一覧」株式会社じほう 2006年Naomi Kurata, supervised by Ichiro Fujishima “Handbook of Oral Drug Tube Administration Second Edition: List of Drugs Available for Simple Suspension Method” Jiho Co., Ltd. 2006 北田 光一、加藤 裕久、濱 敏弘、中山 季昭、杉浦 伸一著、日本病院薬剤師会監修「抗がん薬調製マニュアル 第2版 抗悪性腫瘍剤の院内取扱い指針」株式会社じほう 2009年Koichi Kitada, Hirohisa Kato, Toshihiro Tsuji, Kiyoaki Nakayama, Shinichi Sugiura, “Hospital Handling Guidelines for Anticancer Drug Preparations 2nd Edition”, Jiho Co., Ltd.

本発明が解決しようとする課題は、錠剤の破砕及び懸濁液化、懸濁薬液の投与の一連の操作において、閉鎖系で錠剤の破砕と懸濁液化、懸濁薬液の投与ができない点である。   The problem to be solved by the present invention is that in a series of operations of tablet crushing and suspension, and suspension drug solution administration, tablet crushing and suspension, suspension drug solution administration cannot be performed in a closed system. .

本発明は、医療従事者が危険な薬剤によって被曝しないように、錠剤を閉鎖系内で破砕し、この破砕した錠剤を閉鎖系内で懸濁液化し、得られた懸濁薬液を閉鎖系で患者に投与することを最も主要な特徴とする。   In the present invention, tablets are crushed in a closed system, and the crushed tablets are suspended in a closed system so that medical personnel are not exposed to dangerous drugs. The most important feature is administration to patients.

すなわち、本発明に係る錠剤懸濁投与装置は、錠剤を破砕するための錠剤破砕用シリンジと、水を供給するための水供給用シリンジと、該錠剤破砕用シリンジと該水供給用シリンジを連結する三方活栓とを備え、該錠剤破砕用シリンジは内部に錠剤破砕用のピンを備え、該三方活栓は内部に各々流路を有する3本の連結端部と、該3本の連結端部の合流基部において該3本の連結端部の各流路の2本を選択して連通させる摺動弁体とを備え、該錠剤破砕用シリンジの先端部と該水供給用シリンジの先端部は該三方活栓のいずれかの連結端部に連結されていることを特徴とする。   That is, the tablet suspension administration device according to the present invention connects a tablet crushing syringe for crushing a tablet, a water supply syringe for supplying water, the tablet crushing syringe, and the water supply syringe. The tablet crushing syringe has a tablet crushing pin inside the three-way cock, and the three-way cock has three connection ends each having a flow path therein, and the three connection ends. A sliding valve body that selects and communicates two of the flow paths at the three connecting end portions at the confluence base, and the distal end portion of the tablet crushing syringe and the distal end portion of the water supply syringe are It is connected to any connecting end of the three-way stopcock.

ここで、前記錠剤破砕用シリンジ及び前記水供給用シリンジは透光性の材料で形成してもよいし、遮光性の材料で形成してもよい。錠剤破砕用シリンジ及び前記水供給用シリンジを遮光性の材料で形成した場合は、光に不安定な薬剤でも、遮光下で懸濁液化することができるので、薬効を低下させることなく薬剤を患者に投与することができる。   Here, the tablet crushing syringe and the water supply syringe may be formed of a light-transmitting material or a light-shielding material. When the tablet crushing syringe and the water supply syringe are formed of a light-shielding material, even a drug that is unstable to light can be suspended in the light-shielded state, so that the drug can be administered to the patient without reducing the drug efficacy. Can be administered.

また、本発明に係る薬剤投与方法は、水供給用シリンジ内に水を入れ、錠剤破砕用シリンジ内に錠剤を入れ、該錠剤破砕用シリンジで錠剤を破砕し、該錠剤破砕用シリンジと該水供給用シリンジを三方活栓を介して連結させた状態で、該三方活栓の該錠剤破砕用シリンジと該水供給用シリンジの間を連通させ、該錠剤破砕用シリンジと該水供給用シリンジとの間で水と錠剤を行き来させて水と錠剤を攪乱させ、この攪乱で得られた水と錠剤からなる錠剤懸濁液を該三方活栓を介して患者に投与することを特徴とする。   In addition, the method for administering a medicine according to the present invention is to put water in a syringe for water supply, put the tablet in a tablet crushing syringe, crush the tablet with the tablet crushing syringe, and crush the tablet crushing syringe and the water. In a state where the supply syringe is connected via a three-way stopcock, the tablet crushing syringe and the water supply syringe of the three-way stopcock are communicated with each other, and between the tablet crushing syringe and the water supply syringe Then, water and tablets are moved back and forth to disturb the water and tablets, and a tablet suspension comprising water and tablets obtained by this disturbance is administered to the patient via the three-way cock.

ここで、前記錠剤懸濁液を前記水供給用シリンジに移し、前記三方活栓の前記錠剤破砕用シリンジの側の経路を閉じ、該水供給用シリンジ内の該錠剤懸濁液を該三方活栓を介して患者に投与してもよい。また、患者にセットした薬剤投入用チューブ又は栄養剤供給用チューブを介して前記錠剤懸濁液を前記三方活栓から患者に投与してもよい。   Here, the tablet suspension is transferred to the water supply syringe, the path on the side of the tablet crushing syringe of the three-way stopcock is closed, and the tablet suspension in the water supply syringe is connected to the three-way stopcock. To the patient. Further, the tablet suspension may be administered to the patient from the three-way stopcock through a drug input tube or a nutrient supply tube set in the patient.

また、本発明に係る別の錠剤懸濁投与装置は、錠剤を破砕するための錠剤破砕用シリンジと、水を供給するための水供給用シリンジと、該錠剤破砕用シリンジと該水供給用シリンジを連結する三方活栓と、洗浄水を供給するための洗浄水供給用シリンジと、該三方活栓と該洗浄水供給用シリンジを連結する第2三方活栓とを備え、該錠剤破砕用シリンジは内部に錠剤破砕用のピンを備え、該三方活栓及び該第2三方活栓は内部に各々流路を有する3本の連結端部と、該3本の連結端部の合流基部において該3本の連結端部の各流路の2本を選択して連通させる摺動弁体とを備え、該錠剤破砕用シリンジの先端部と該水供給用シリンジの先端部は該三方活栓のいずれかの連結端部に連結され、該第2三方活栓のいずれかの連結端部は該三方活栓の未連結の連結端部に連結され、該洗浄水供給用シリンジの先端部は該第2三方活栓の未連結の連結端部に連結されていることを特徴とする。   Another tablet suspension administration apparatus according to the present invention includes a tablet crushing syringe for crushing a tablet, a water supply syringe for supplying water, the tablet crushing syringe, and the water supply syringe. A three-way stopcock that connects the three-way stopcock, a cleaning water supply syringe for supplying cleaning water, and a second three-way stopcock that connects the three-way stopcock and the cleaning water supply syringe. The three-way stopcock and the second three-way stopcock have pins for crushing the tablet, the three connection ends having flow paths therein, and the three connection ends at the merging base of the three connection ends. A sliding valve element that selects and communicates two of each of the flow paths, and the distal end portion of the tablet crushing syringe and the distal end portion of the water supply syringe are connected end portions of any of the three-way stopcocks Connected to either end of the second three-way stopcock is the three-way stopcock Connected to the connecting end of the unconnected, the tip of the cleaning water supply syringe is characterized in that it is connected to the connecting end of the unligated the second three-way stopcock.

ここで、前記錠剤破砕用シリンジ及び前記水供給用シリンジは透光性の材料で形成してもよいし、遮光性の材料で形成してもよい。錠剤破砕用シリンジ及び前記水供給用シリンジを遮光性の材料で形成した場合は、光に不安定な薬剤でも、遮光下で懸濁液化することができるので、薬効を低下させることなく薬剤を患者に投与することができる。   Here, the tablet crushing syringe and the water supply syringe may be formed of a light-transmitting material or a light-shielding material. When the tablet crushing syringe and the water supply syringe are formed of a light-shielding material, even a drug that is unstable to light can be suspended in the light-shielded state, so that the drug can be administered to the patient without reducing the drug efficacy. Can be administered.

また、本発明に係る別の薬剤投与方法は、水供給用シリンジ内に水を入れ、洗浄水供給用シリンジ内に水を入れ、錠剤破砕用シリンジ内に錠剤を入れ、該錠剤破砕用シリンジで錠剤を破砕し、該錠剤破砕用シリンジと該水供給用シリンジを三方活栓を介して連結させた状態で、該三方活栓の該錠剤破砕用シリンジと該水供給用シリンジの間を連通させ、該錠剤破砕用シリンジと該水供給用シリンジとの間で水と錠剤を行き来させて水と錠剤を攪乱させ、この攪乱で得られた水と錠剤からなる錠剤懸濁液を該三方活栓及び第2三方活栓を介して患者に投与し、該第2三方活栓から患者に至る該錠剤懸濁液の投与経路に洗浄水供給用シリンジ内の水を該第2三方活栓を介して送給することを特徴とする。   Another method for administering a drug according to the present invention is to put water in a syringe for supplying water, put water in a syringe for supplying washing water, put a tablet in a syringe for crushing tablets, and use the syringe for crushing tablets. The tablet is crushed, and the tablet crushing syringe and the water supply syringe are connected via a three-way stopcock, and the tablet crushing syringe and the water supply syringe of the three-way stopcock are communicated with each other. Water and tablets are moved back and forth between the tablet crushing syringe and the water supply syringe to disturb the water and the tablet, and the tablet suspension comprising the water and the tablet obtained by this disturbance is transferred to the three-way stopcock and the second stopcock. Administering to the patient via the three-way stopcock, and feeding the water in the washing water supply syringe to the administration route of the tablet suspension from the second three-way stopcock to the patient via the second three-way stopcock Features.

ここで、前記錠剤懸濁液を前記水供給用シリンジに移し、前記三方活栓の前記錠剤破砕用シリンジの側の経路を閉じ、該水供給用シリンジ内の該錠剤懸濁液を前記三方活栓及び前記第2三方活栓を介して患者に投与してもよい。   Here, the tablet suspension is transferred to the water supply syringe, the path on the side of the tablet crushing syringe of the three-way stopcock is closed, and the tablet suspension in the water supply syringe is transferred to the three-way stopcock and The patient may be administered via the second three-way stopcock.

また、患者にセットした薬剤投入用チューブ又は栄養剤供給用チューブを介して前記錠剤懸濁液を前記第2三方活栓から患者に投与してもよい。   Further, the tablet suspension may be administered to the patient from the second three-way stopcock through a drug input tube or a nutrient supply tube set in the patient.

本発明は、錠剤粉砕用シリンジ内という閉鎖系内で錠剤を破砕することができ、また錠剤粉砕用シリンジと水供給用シリンジとこれらを連結する三方活栓という閉鎖系内で、破砕された錠剤と水(温湯)とを混合することができるので、薬剤が外部に暴露されることがなく、薬剤が抗癌剤などの細胞毒性、二次発癌性がある危険薬剤の場合でも医療従事者が薬剤に被曝する心配がなく、医療従事者を医療業務に安全に従事させることができるという効果がある。   The present invention is capable of crushing tablets in a closed system called a tablet crushing syringe, and crushing tablets in a closed system called a tablet crushing syringe, a water supply syringe and a three-way stopcock connecting them. Because it can be mixed with water (hot water), the drug is not exposed to the outside, and medical personnel are exposed to the drug even if the drug is a cytotoxic or secondary carcinogenic drug such as an anticancer drug. There is an effect that the medical staff can be safely engaged in the medical work without worrying to do so.

また、本発明は、三方活栓を切り替えることにより、錠剤懸濁液を三方活栓から経管チューブという閉鎖系を介して患者に投与することができるので、薬剤が外部に暴露されることがなく、薬剤が抗癌剤などの細胞毒性、二次発癌性がある危険薬剤の場合でも医療従事者が薬剤に被曝する心配がなく、医療従事者を医療業務に安全に従事させることができるという効果がある。   Moreover, since the present invention can administer the tablet suspension from the three-way stopcock to the patient through a closed tube tube tube by switching the three-way stopcock, the drug is not exposed to the outside, Even if the drug is a dangerous drug having cytotoxicity or secondary carcinogenicity such as an anticancer drug, there is no worry that the medical worker is exposed to the drug, and the medical worker can be safely engaged in medical work.

また、本発明は、三方活栓を介して洗浄用シリンジを連結しているので、錠剤懸濁液を投与した経管チューブ内を患者にセットした閉鎖系の状態で洗浄することができ、この錠剤懸濁投与装置を患者から外したときに薬剤が外部に暴露されることがなく、薬剤が抗癌剤などの細胞毒性、二次発癌性がある危険薬剤の場合でも医療従事者が薬剤に被曝する心配がなく、医療従事者を医療業務に安全に従事させることができるという効果がある。   In addition, since the present invention is connected to a syringe for washing via a three-way stopcock, the inside of a tube tube to which a tablet suspension is administered can be washed in a closed system set in a patient. When the suspension administration device is removed from the patient, the drug is not exposed to the outside, and even if the drug is a dangerous drug that has cytotoxicity or secondary carcinogenicity such as an anticancer drug, the health care worker may be exposed to the drug. There is an effect that the medical staff can be safely engaged in medical work.

また、本発明は、抗癌剤などの細胞毒性、二次発癌性がある危険薬剤の使用でも、閉鎖系の状態で経管チューブ内や三方活栓内を洗浄することができるので、経管チューブや三方活栓を安全に取外すことができ、医療施設だけでなく在宅介護でも、使用済み器具を安全に廃棄することができるという効果がある。   In addition, the present invention can clean the inside of a tube tube or a three-way stopcock in a closed system state even with the use of a dangerous drug having cytotoxicity or secondary carcinogenicity such as an anticancer agent. The stopcock can be removed safely, and there is an effect that used instruments can be safely discarded not only in medical facilities but also at home care.

また、本発明は、錠剤を錠剤破砕用シリンジという閉鎖空間内で破砕し、破砕された錠剤と水を三方活栓で連結された錠剤破砕用シリンジと水供給用シリンジという閉鎖系内で混合するので、異物の混入や細菌による汚染のない、きれいな清潔な状態の錠剤懸濁液を作ることができ、従って、きれいな清潔な状態の錠剤懸濁液を患者に投与することができるという効果がある。   In the present invention, the tablet is crushed in a closed space called a tablet crushing syringe, and the crushed tablet and water are mixed in a closed system called a tablet crushing syringe connected with a three-way stopcock and a water supply syringe. Therefore, it is possible to produce a clean and clean tablet suspension free from contamination by foreign substances and bacteria, and therefore, it is possible to administer a clean and clean tablet suspension to a patient.

また、本発明は、錠剤破砕用シリンジと水供給用シリンジを三方活栓を介して連結しているので、破砕した錠剤と水を錠剤破砕用シリンジと水供給用シリンジとの間で行き来させ、破砕した錠剤と水とを強制的に攪乱させ、錠剤懸濁液を短時間に容易に作ることができ、そして、錠剤懸濁液を患者に直ちに投与することができるという効果がある。   In the present invention, since the tablet crushing syringe and the water supply syringe are connected via a three-way stopcock, the crushed tablet and water are moved back and forth between the tablet crushing syringe and the water supply syringe. The tablet suspension and water are forcibly disturbed, and the tablet suspension can be easily made in a short time, and the tablet suspension can be immediately administered to the patient.

また、本発明は、三方活栓を切り替えることにより、錠剤懸濁液を三方活栓から経管チューブを介して患者に投与することができるので、錠剤懸濁液を患者に容易に投与することができるという効果がある。   In addition, the present invention can easily administer the tablet suspension to the patient because the tablet suspension can be administered from the three-way stopcock to the patient via the tube by switching the three-way stopcock. There is an effect.

また、本発明は、三方活栓を連結させることにより、複数薬剤をそれぞれ別の系で、薬剤の配合変化なしに投与することができるという効果がある。   In addition, the present invention has an effect that, by connecting the three-way stopcocks, a plurality of drugs can be administered in different systems without changing the composition of the drugs.

図1は本発明の実施例1に係る錠剤懸濁投与装置の説明図である。FIG. 1 is an explanatory diagram of a tablet suspension administration device according to Example 1 of the present invention. 図2は錠剤破砕用シリンジの説明図である。FIG. 2 is an explanatory diagram of a tablet crushing syringe. 図3は水供給用シリンジの説明図である。FIG. 3 is an explanatory diagram of a water supply syringe. 図4は三方活栓の説明図である。FIG. 4 is an explanatory view of a three-way cock. 図5は実施例1の装置を用いた錠剤懸濁投与方法の手順を示す工程図である。FIG. 5 is a process diagram showing the procedure of the tablet suspension administration method using the apparatus of Example 1. 図6は本発明の実施例2に係る錠剤懸濁投与装置の説明図である。FIG. 6 is an explanatory diagram of a tablet suspension administration device according to Example 2 of the present invention. 図7は洗浄水供給用シリンジの説明図である。FIG. 7 is an explanatory view of a washing water supply syringe. 図8は実施例2の装置を用いた錠剤懸濁投与方法の手順を示す工程図である。FIG. 8 is a process chart showing the procedure of the tablet suspension administration method using the apparatus of Example 2. 液体クロマトグラフ / タンデム質量分析装置(LC/MS/MS)でパッシブサンプラー中のシクロホスファミドを分析した結果を示すグラフである。It is a graph which shows the result of having analyzed the cyclophosphamide in a passive sampler with a liquid chromatograph / tandem mass spectrometer (LC / MS / MS).

錠剤を閉鎖系内で破砕し、この破砕した錠剤を閉鎖系内で懸濁液化し、得られた懸濁薬液を閉鎖系で患者に投与するという目的を、簡単な装置で、面倒な操作をすることなく実現した。   A simple device is used for the purpose of pulverizing tablets in a closed system, suspending the crushed tablets in a closed system, and administering the obtained suspension drug solution to the patient in a closed system. Realized without.

図1は本発明の実施例1に係る錠剤懸濁投与装置の説明図である。同図において、10は錠剤破砕用シリンジ、12は水供給用シリンジであり、錠剤破砕用シリンジ10と水供給用シリンジ12は三方活栓14を介して相互に連結されている。そして、三方活栓14の未連結の連結端部には接続用チューブ16が連結されている。   FIG. 1 is an explanatory diagram of a tablet suspension administration device according to Example 1 of the present invention. In the figure, 10 is a tablet crushing syringe, 12 is a water supply syringe, and the tablet crushing syringe 10 and the water supply syringe 12 are connected to each other via a three-way cock 14. A connecting tube 16 is connected to the unconnected connecting end of the three-way cock 14.

図2は錠剤破砕用シリンジの説明図である。同図に示すように、錠剤破砕用シリンジ10は、略円筒状の外筒10aと、外筒10a内に摺動可能に挿入された略円柱状のガスケット10bと、ガスケット10bの後部に連結され、ガスケット10bを前後に移動操作するプランジャ10cとからなる。   FIG. 2 is an explanatory diagram of a tablet crushing syringe. As shown in the figure, the tablet crushing syringe 10 is connected to a substantially cylindrical outer cylinder 10a, a substantially cylindrical gasket 10b slidably inserted into the outer cylinder 10a, and a rear portion of the gasket 10b. The plunger 10c moves the gasket 10b back and forth.

錠剤破砕用シリンジ10の外筒10aは一般的には透光性のプラスチック材料で形成されているが、遮光性のプラスチック材料で形成されていてもよい。錠剤破砕用シリンジ10の外筒10aの先端側には注射針を嵌合させるための先端部10fが突出形成されている。先端部10fは中心に貫通孔が形成され、先端側に向けて細くなるようにテーパーが付いている略円筒体からなる。   The outer cylinder 10a of the tablet crushing syringe 10 is generally formed of a light-transmitting plastic material, but may be formed of a light-shielding plastic material. A distal end portion 10f for fitting an injection needle is formed on the distal end side of the outer cylinder 10a of the tablet crushing syringe 10 so as to protrude. The distal end portion 10f is formed of a substantially cylindrical body having a through hole formed in the center and tapered toward the distal end side.

錠剤破砕用シリンジ10の外筒10aの先端側の内部には錠剤破砕用のピン10dが内側に向けて突出するように設けられている。また、錠剤破砕用シリンジ10のガスケット10bの先端側には錠剤を乗せるための凹部10eが形成されている。   A tablet crushing pin 10d is provided inside the outer cylinder 10a of the tablet crushing syringe 10 so as to protrude inward. Moreover, the recessed part 10e for putting a tablet is formed in the front end side of the gasket 10b of the syringe 10 for tablet crushing.

図3は水供給用シリンジの説明図である。水供給用シリンジ12は、同図に示すように、略円筒状の外筒12aと、外筒12a内に摺動可能に挿入された略円柱状のガスケット12bと、ガスケット12bの後部に連結され、ガスケット12bを前後に移動操作するプランジャ12cとからなる。   FIG. 3 is an explanatory diagram of a water supply syringe. As shown in the figure, the water supply syringe 12 is connected to a substantially cylindrical outer cylinder 12a, a substantially cylindrical gasket 12b slidably inserted into the outer cylinder 12a, and a rear portion of the gasket 12b. And a plunger 12c for moving the gasket 12b back and forth.

水供給用シリンジ12の外筒12aは一般的には透光性のプラスチック材料で形成されているが、遮光性のプラスチック材料で形成されていてもよい。水供給用シリンジ12の外筒12aの先端側には注射針を嵌合させるためのテーパー状の先端部12dが突出形成されている。先端部12dは中心に貫通孔が形成され、先端側に向けて細くなるようにテーパーが付いている略円筒体からなる。   The outer cylinder 12a of the water supply syringe 12 is generally formed of a light-transmitting plastic material, but may be formed of a light-blocking plastic material. A tapered distal end portion 12d for fitting the injection needle is formed on the distal end side of the outer cylinder 12a of the water supply syringe 12 so as to protrude. The distal end portion 12d is formed of a substantially cylindrical body having a through-hole formed at the center and tapered toward the distal end side.

図4は三方活栓の説明図である。三方活栓14は一般に市販されているものであり、3本の筒状の連結端部14aを備えている。連結端部14aは、一方の側が各々開放状態にあり、他方の側が相互に連結した状態になっている。3本の連結端部14aの相互に連結合流している部分には摺動弁体が回転可能に設けられ、摺動弁体にはコック14bが一体的に設けられている。摺動弁体はコック14bの下に隠れていて見えない。   FIG. 4 is an explanatory view of a three-way cock. The three-way stopcock 14 is generally commercially available and includes three cylindrical connection ends 14a. As for the connection end part 14a, one side is in an open state, respectively, and the other side is in a connected state. A sliding valve body is rotatably provided at a portion of the three connecting end portions 14a that are connected to each other, and a cock 14b is integrally provided on the sliding valve body. The sliding valve body is hidden under the cock 14b and cannot be seen.

三方活栓14の摺動弁体には摺動弁体の回転軸と直角な貫通孔がT字状に形成され、摺動弁体の貫通孔の端部と連結端部の貫通孔の端部とを合わせることにより、三方活栓14の流路を選択することができるようになっている。摺動弁体の貫通孔の端部と連結端部の貫通孔の端部とは、コック14bを摺動弁体とともに回転させることにより、合わせることができる。   The sliding valve body of the three-way stopcock 14 is formed with a T-shaped through hole perpendicular to the rotation axis of the sliding valve body, and the end of the through hole of the sliding valve body and the end of the through hole of the connecting end In combination, the flow path of the three-way cock 14 can be selected. The end portion of the through hole of the sliding valve body and the end portion of the through hole of the connecting end portion can be matched by rotating the cock 14b together with the sliding valve body.

三方活栓14の一の連結端部14aには錠剤破砕用シリンジ10の先端部10dが連結され、三方活栓14の別の連結端部14aには水供給用シリンジ12の先端部12dが連結されている。三方活栓14の残りの連結端部14aには接続用チューブ16が連結されている。接続用チューブ16は、患者にセットした経管チューブ(図示せず)に残りの連結端部14aを接続するためのものである。   The leading end 10d of the tablet crushing syringe 10 is connected to one connecting end 14a of the three-way stopcock 14, and the leading end 12d of the water supply syringe 12 is connected to the other connecting end 14a of the three-way stopcock 14. Yes. A connecting tube 16 is connected to the remaining connecting end 14 a of the three-way cock 14. The connection tube 16 is for connecting the remaining connecting end 14a to a transtube tube (not shown) set in the patient.

次に、この実施例1に係る錠剤懸濁投与装置の使用方法について、図5に示す工程図を参照しながら説明する。   Next, a method of using the tablet suspension administration device according to Example 1 will be described with reference to the process chart shown in FIG.

まず、三方活栓14の連結端部14aから水供給用シリンジ12を外し、予め水を入れておいたコップ内にこの水供給用シリンジ12の先端部12dを浸し、プランジャ12cを引いて水供給用シリンジ12内に水を入れ、この水供給用シリンジ12を三方活栓14の元の連結端部14aに連結する。   First, the water supply syringe 12 is removed from the connecting end 14a of the three-way stopcock 14, the tip 12d of the water supply syringe 12 is immersed in a pre-filled cup, and the plunger 12c is pulled to supply water. Water is put into the syringe 12, and the water supply syringe 12 is connected to the original connecting end 14 a of the three-way cock 14.

また、三方活栓14の連結端部から錠剤破砕用シリンジ10を外し、錠剤破砕用シリンジ10の外筒10aからガスケット10b及びプランジャ10cを抜き取り、外筒10a内に錠剤を入れ、ガスケット10b及びプランジャ10cを外筒10aに戻し、錠剤破砕用シリンジ10の先端部10fを連結端部14aに連結する。   Further, the tablet crushing syringe 10 is removed from the connecting end of the three-way cock 14, the gasket 10b and the plunger 10c are extracted from the outer cylinder 10a of the tablet crushing syringe 10, the tablet is put into the outer cylinder 10a, and the gasket 10b and the plunger 10c. Is returned to the outer cylinder 10a, and the tip portion 10f of the tablet crushing syringe 10 is connected to the connecting end portion 14a.

プランジャ10cの先端側を錠剤破砕用シリンジ10とともに上方に向け、プランジャ10cの先端側のガスケット10bの凹部10eに錠剤を乗せ、この状態でプランジャ10cを押し、錠剤破砕用のピン10dに錠剤をガスケット10bで押し付け、錠剤を破砕する。   The distal end side of the plunger 10c is directed upward together with the tablet crushing syringe 10, and the tablet is placed in the recess 10e of the gasket 10b on the distal end side of the plunger 10c. In this state, the plunger 10c is pushed, and the tablet is gasketed on the tablet crushing pin 10d. Press with 10b to break the tablet.

ここで、三方活栓14は、コック14dを摺動弁体とともに回転させ、接続用チューブ16の側が閉状態になり、錠剤破砕用シリンジ10に連結している連結端部14aと、水供給用シリンジ12に連結している連結端部14aとの間で流路が連通形成されるようにしておく。   Here, the three-way stopcock 14 rotates the cock 14d together with the sliding valve body, the connection tube 16 side is closed, and the connection end 14a connected to the tablet crushing syringe 10 and the water supply syringe. A flow path is formed so as to communicate with the connection end portion 14 a connected to the terminal 12.

次に、水供給用シリンジ12のプランジャ12cと錠剤破砕用シリンジ10のプランジャ10cを交互に押して、水と錠剤を錠剤破砕用シリンジ10と水供給用シリンジ12との間で行き来させ、破砕された錠剤とともに水を攪乱させ、破砕された錠剤を懸濁液化させ、最後に、懸濁薬液の全てを水供給用シリンジ12に移しておく。   Next, the plunger 12c of the water supply syringe 12 and the plunger 10c of the tablet crushing syringe 10 were alternately pushed, and water and tablets were moved back and forth between the tablet crushing syringe 10 and the water supply syringe 12 to be crushed. Water is disturbed together with the tablet, the crushed tablet is made into a suspension, and finally, all of the suspended drug solution is transferred to the water supply syringe 12.

次に、患者にセットされている経管チューブに接続チューブ16を接続し、三方活栓14のコック14dを摺動弁体とともに回転させ、錠剤破砕用シリンジ10が連結している連結端部14aの側を閉じ、接続用チューブ16の端部に連結している連結端部14aの側を開ける。   Next, the connecting tube 16 is connected to a transluminal tube set in the patient, the cock 14d of the three-way cock 14 is rotated together with the sliding valve body, and the connecting end 14a to which the tablet crushing syringe 10 is connected is connected. The side is closed and the side of the connecting end 14 a connected to the end of the connecting tube 16 is opened.

次に、水供給用シリンジ12のプランジャ12cを押し、三方活栓14を介して水供給用シリンジ12内の懸濁薬液を接続用チューブ16の側に送る。接続用チューブ16に送られた懸濁薬液は経管チューブを通って患者に投与される。ここで、患者にセットした経管チューブは、薬剤投入用チューブでもよいし、栄養剤供給用チューブでもよい。   Next, the plunger 12 c of the water supply syringe 12 is pushed, and the suspended chemical solution in the water supply syringe 12 is sent to the connection tube 16 side through the three-way cock 14. The suspension drug solution sent to the connecting tube 16 is administered to the patient through the tube. Here, the transtube tube set in the patient may be a drug input tube or a nutrient supply tube.

図6は本発明の実施例2に係る錠剤懸濁投与装置の説明図である。同図に示すように、この錠剤懸濁投与装置は、錠剤を破砕するための錠剤破砕用シリンジ10と、水を供給するための水供給用シリンジ12と、錠剤破砕用シリンジ10と水供給用シリンジ12を連結する三方活栓14と、洗浄水を供給するための洗浄水供給用シリンジ18と、三方活栓14と洗浄水供給用シリンジ18を連結する第2三方活栓20とを備えている。   FIG. 6 is an explanatory diagram of a tablet suspension administration device according to Example 2 of the present invention. As shown in the figure, the tablet suspension administration device includes a tablet crushing syringe 10 for crushing tablets, a water supply syringe 12 for supplying water, a tablet crushing syringe 10 and water supply. A three-way cock 14 for connecting the syringe 12, a cleaning water supply syringe 18 for supplying cleaning water, and a second three-way cock 20 for connecting the three-way cock 14 and the cleaning water supply syringe 18 are provided.

この錠剤懸濁投与装置は、実施例1に係る錠剤懸濁投与装置に第2三方活栓20を介して洗浄水供給用シリンジ18を取り付けた点だけが実施例1の錠剤懸濁投与装置と相違している。従って、実施例1の錠剤懸濁投与装置と同一部分の説明は省略し、相違点だけについて説明する。   This tablet suspension administration device is different from the tablet suspension administration device of Example 1 only in that the washing water supply syringe 18 is attached to the tablet suspension administration device according to Example 1 via the second three-way cock 20. is doing. Therefore, description of the same part as the tablet suspension administration apparatus of Example 1 is abbreviate | omitted, and only a different point is demonstrated.

図7は洗浄水供給用シリンジの説明図である。洗浄水供給用シリンジ18は、同図に示すように、略円筒状の外筒18aと、外筒18a内に摺動可能に挿入された略円柱状のガスケット18bと、ガスケット18bの後部に連結され、ガスケット18bを前後に移動操作するプランジャ18cとからなる。   FIG. 7 is an explanatory view of a washing water supply syringe. As shown in the figure, the cleaning water supply syringe 18 is connected to a substantially cylindrical outer cylinder 18a, a substantially cylindrical gasket 18b slidably inserted into the outer cylinder 18a, and a rear portion of the gasket 18b. The plunger 18c moves the gasket 18b back and forth.

洗浄水供給用シリンジ18の外筒18aは透光性のプラスチック材料で形成されている。洗浄水供給用シリンジ18の外筒18aの先端側には注射針を嵌合させるためのテーパー状の先端部18dが突出形成されている。先端部18dは中心に貫通孔が形成され、先端側に向けて細くなるようにテーパーが付いている略円筒体からなる。   The outer cylinder 18a of the washing water supply syringe 18 is formed of a light-transmitting plastic material. A tapered distal end portion 18d for fitting an injection needle is formed on the distal end side of the outer cylinder 18a of the syringe 18 for supplying cleaning water. The tip end portion 18d is formed of a substantially cylindrical body having a through-hole formed at the center and tapered toward the tip end side.

次に、この実施例2に係る錠剤懸濁投与装置の使用方法について、図8に示す工程図を参照しながら説明する。   Next, a method for using the tablet suspension administration device according to the second embodiment will be described with reference to the process chart shown in FIG.

まず、三方活栓14(以下、表現上の便宜から、第1三方活栓14という。)の連結端部14aから水供給用シリンジ12を外し、予め水を入れておいたコップ内にこの水供給用シリンジ12の先端部12dを浸し、プランジャ12cを引いて水供給用シリンジ12内に水を入れ、この水供給用シリンジ12を第1三方活栓14の元の連結端部14aに連結する。   First, the water supply syringe 12 is removed from the connecting end portion 14a of the three-way stopcock 14 (hereinafter referred to as the first three-way stopcock 14 for convenience of expression), and this water supply is provided in a previously charged cup. The tip 12 d of the syringe 12 is immersed, the plunger 12 c is pulled to put water into the water supply syringe 12, and the water supply syringe 12 is connected to the original connection end 14 a of the first three-way cock 14.

また、第1三方活栓14の連結端部から錠剤破砕用シリンジ10を外し、錠剤破砕用シリンジ10の外筒10aからガスケット10b及びプランジャ10cを抜き取り、外筒10a内に錠剤を入れ、ガスケット10b及びプランジャ10cを外筒10aに戻し、錠剤破砕用シリンジ10の先端部10fを連結端部14aに連結する。   Further, the tablet crushing syringe 10 is removed from the connecting end of the first three-way cock 14, the gasket 10b and the plunger 10c are extracted from the outer cylinder 10a of the tablet crushing syringe 10, the tablet is put in the outer cylinder 10a, and the gasket 10b and The plunger 10c is returned to the outer cylinder 10a, and the tip portion 10f of the tablet crushing syringe 10 is connected to the connecting end portion 14a.

プランジャ10cの先端側を錠剤破砕用シリンジ10とともに上方に向け、プランジャ10cの先端側のガスケット10bの凹部10eに錠剤を乗せ、この状態でプランジャ10cを押し、錠剤破砕用のピン10dに錠剤をガスケット10bで押し付け、錠剤を破砕する。   The distal end side of the plunger 10c is directed upward together with the tablet crushing syringe 10, and the tablet is placed in the recess 10e of the gasket 10b on the distal end side of the plunger 10c. In this state, the plunger 10c is pushed, and the tablet is gasketed on the tablet crushing pin 10d. Press with 10b to break the tablet.

ここで、第1三方活栓14は、コック14bを摺動弁体とともに回転させて第2三方活栓20の側を閉状態にし、錠剤破砕用シリンジ10に連結している連結端部14aと、水供給用シリンジ12に連結している連結端部14aとの間で流路が連通形成されるようにしておく。   Here, the first three-way stopcock 14 rotates the cock 14b together with the sliding valve body to close the second three-way stopcock 20 side, and connects the connection end 14a connected to the tablet crushing syringe 10 with water. A flow path is formed so as to communicate with the connection end portion 14 a connected to the supply syringe 12.

次に、水供給用シリンジ12のプランジャ12cと錠剤破砕用シリンジ10のプランジャ10cを交互に押して、水と錠剤を錠剤破砕用シリンジ10と水供給用シリンジ12との間で行き来させ、水を破砕された錠剤とともに攪乱させ、破砕された錠剤を懸濁液化させ、最後に、懸濁薬液の全てを水供給用シリンジ12に移しておく。   Next, the plunger 12c of the water supply syringe 12 and the plunger 10c of the tablet crushing syringe 10 are alternately pressed, water and tablets are moved back and forth between the tablet crushing syringe 10 and the water supply syringe 12, and the water is crushed. Then, the crushed tablet is made into a suspension, and finally, all of the suspended drug solution is transferred to the water supply syringe 12.

次に、栄養剤供給用チューブ22の途中の第3三方活栓24に第2三方活栓20を連結し、第1三方活栓14のコック14bを摺動弁体とともに回転させて錠剤破砕用シリンジ10の側を閉状態にし、第2三方活栓20の側を開状態にする。そして、第2三方活栓20のコック20bを摺動弁体とともに回転させて第3三方活栓24の側を開状態にし、洗浄水供給用シリンジ18の側を閉状態にする。そして、第3三方活栓24のコックを摺動弁体とともに回転させて栄養剤の側を閉状態にし、第2三方活栓20の側を開状態にする。   Next, the second three-way stopcock 20 is connected to the third three-way stopcock 24 in the middle of the nutrient supply tube 22, and the cock 14 b of the first three-way stopcock 14 is rotated together with the sliding valve body to The side is closed and the second three-way cock 20 side is opened. Then, the cock 20b of the second three-way cock 20 is rotated together with the sliding valve body so that the third three-way cock 24 side is opened and the cleaning water supply syringe 18 side is closed. Then, the cock of the third three-way cock 24 is rotated together with the sliding valve body so that the nutrient side is closed and the second three-way cock 20 side is opened.

次に、水供給用シリンジ12のプランジャ12cを押し、水供給用シリンジ12内の懸濁薬液を、第1三方活栓14、第2三方活栓20を介して栄養剤供給用チューブ22の第3三方活栓24に送る。懸濁薬液は第3三方活栓24を介して栄養剤供給用チューブ22に入り、栄養剤供給用チューブ22を通って患者に投与される。   Next, the plunger 12c of the water supply syringe 12 is pushed, and the suspended chemical solution in the water supply syringe 12 is transferred to the third three-way of the nutrient solution supply tube 22 through the first three-way stopcock 14 and the second three-way stopcock 20. Send to stopcock 24. The suspended drug solution enters the nutrient solution supply tube 22 via the third three-way cock 24 and is administered to the patient through the nutrient solution supply tube 22.

次に、予め水を入れておいたコップ内に洗浄水供給用シリンジ18の先端部18dを浸し、プランジャ18cを引いて洗浄水供給用シリンジ18内に水を入れ、この洗浄水供給用シリンジ18を第2三方活栓20の元の連結端部20aに連結する。そして、第2三方活栓20のコック20bを摺動弁体とともに回転させて第1三方活栓14の側を閉状態にし、洗浄水供給用シリンジ18の側を開状態にする。   Next, the tip 18d of the cleaning water supply syringe 18 is dipped in a glass in which water has been put in advance, the plunger 18c is pulled to put water into the cleaning water supply syringe 18, and the cleaning water supply syringe 18 is drawn. Is connected to the original connecting end 20 a of the second three-way cock 20. Then, the cock 20b of the second three-way cock 20 is rotated together with the sliding valve body so that the first three-way cock 14 side is closed and the cleaning water supply syringe 18 side is opened.

次に、洗浄水供給用シリンジ18のプランジャ18cを押し、第2三方活栓20を介して洗浄水供給用シリンジ18内の洗浄水を第2三方活栓20及び第3三方活栓24の側に送る。洗浄水は第2三方活栓20及び第3三方活栓24の内部を洗いながら栄養剤供給用チューブ22内に入る。   Next, the plunger 18 c of the cleaning water supply syringe 18 is pushed, and the cleaning water in the cleaning water supply syringe 18 is sent to the second three-way stopcock 20 and the third three-way stopcock 24 via the second three-way stopcock 20. The washing water enters the nutrient supply tube 22 while washing the inside of the second three-way cock 20 and the third three-way cock 24.

この状態では、第2三方活栓20及び第3三方活栓24の内部は洗浄水によって洗浄されているので、本装置を第2三方活栓20と第3三方活栓24の間で取り外しても、懸濁薬剤による被曝の心配が無い。   In this state, since the insides of the second three-way cock 20 and the third three-way cock 24 are washed with washing water, even if the apparatus is removed between the second three-way cock 20 and the third three-way cock 24, the suspension is suspended. There is no worry about exposure to drugs.

本発明に係る錠剤懸濁投与装置を用いて、一般薬であるコートリル錠の懸濁液化を行ったところ、常温の水を用いていても、1分間で錠剤の懸濁液化ができ、患者に投与可能であった。   Using the tablet suspension administration device according to the present invention, when the suspension of the coatryl tablet, which is a general drug, was performed, the suspension of the tablet could be made in 1 minute even when using room temperature water. Administration was possible.

これに対し、簡易懸濁法ハンドブックにおけるコートリル錠の記載では、55℃の温湯20mLで錠剤の懸濁を行った場合、5分間では懸濁液化は不可、10分間で懸濁液化ができ、投与可能と記されている。   On the other hand, in the description of Courtryl tablet in the simple suspension method handbook, when the tablet is suspended with 20 mL of hot water at 55 ° C., the suspension cannot be made in 5 minutes, and the suspension can be made in 10 minutes. It is marked as possible.

従って、本発明に係る錠剤懸濁投与装置を用いた場合、お湯の用意なしで、水道水(25℃)20mL 、所要時間1分間で錠剤の破砕から懸濁液化、投与までが可能となり、従来法よりもはるかに迅速に薬剤を懸濁液化して投与することが可能であることがわかった。   Therefore, when the tablet suspension administration device according to the present invention is used, from tablet crushing to suspension and administration can be performed in 20 mL of tap water (25 ° C.) for 1 minute without preparation of hot water. It has been found that the drug can be administered in suspension much faster than the method.

また、本発明に係る錠剤懸濁投与装置を用いて錠剤の懸濁薬液を形成し、この懸濁薬液の主薬を液体クロマトグラフィー/紫外可視吸光検出器で定量分析し、主薬の回収率を求めたところ、主薬の回収率は95%〜100%であった。従って、本発明に係る錠剤懸濁投与装置を用いて錠剤の懸濁薬液を形成した場合、主薬の損失がなく、殆ど全ての薬剤を投与することが可能であることがわかった。   In addition, a tablet suspension drug solution is formed using the tablet suspension administration device according to the present invention, and the active ingredient of this suspension drug solution is quantitatively analyzed with a liquid chromatography / UV-visible light detector to determine the recovery rate of the active ingredient. As a result, the recovery rate of the main drug was 95% to 100%. Therefore, it was found that when a tablet suspension drug solution was formed using the tablet suspension administration device according to the present invention, almost all drugs could be administered without loss of the main drug.

口元に市販の高性能パッシブサンプラー(VOC-SD溶媒抽出用、シグマアルドリッチ社製)をつけ、抗癌剤のエンドキサン錠を用いて、本発明器具により錠剤の破壊から懸濁投与までの一連操作を行い、液体クロマトグラフ/タンデム質量分析装置(LC/MS/MS)でシクロホスファミドを測定した。   Attach a commercially available high-performance passive sampler (VOC-SD solvent extraction, manufactured by Sigma-Aldrich) to the mouth, and use the anticancer drug Endoxan tablet to perform a series of operations from tablet breakage to suspension administration with the present instrument, Cyclophosphamide was measured with a liquid chromatograph / tandem mass spectrometer (LC / MS / MS).

その結果、すべてのサンプル(n = 5)において、シクロホスファミドは検出限界(0.005 ng/mL)以下であり、本発明器具により錠剤の破壊から懸濁投与までの一連操作における薬剤被曝に対する安全性を確認することができた。   As a result, in all samples (n = 5), cyclophosphamide is below the detection limit (0.005 ng / mL), and the device of the present invention is safe against drug exposure in a series of operations from tablet destruction to suspension administration. I was able to confirm the sex.

また、比較例として、従来法の粉砕法によりエンドキサン錠を粉砕、懸濁液化し、投与を行う過程での被曝状況を調べた。   Further, as a comparative example, the endoxan tablet was pulverized and suspended by a conventional pulverization method, and the exposure situation during the administration process was examined.

ここでも、調剤者、投与者の口元にパッシブサンプラーをつけ、エンドキサン錠の粉砕調剤、および粉砕散の懸濁投与を行い、液体クロマトグラフ/タンデム質量分析装置(LC/MS/MS)でパッシブサンプラー(各N=5)中のシクロホスファミドを分析した。   Here too, a passive sampler is attached to the mouth of the pharmacist and the recipient, and the endoxan tablet pulverized preparation and pulverized powder suspension are administered, and the passive sampler is used with a liquid chromatograph / tandem mass spectrometer (LC / MS / MS). The cyclophosphamide in (each N = 5) was analyzed.

その結果、図9に示すように、調剤者(n = 5)、投与者(n = 5)のすべてのサンプラーから10〜100μgの範囲で抗癌剤のシクロホスファミド(CPA)が検出され、調剤者だけでなく、投与者でも抗癌剤被曝の危険性が確認された。   As a result, as shown in FIG. 9, the anti-cancer agent cyclophosphamide (CPA) was detected in the range of 10 to 100 μg from all samplers of the dispenser (n = 5) and the administration person (n = 5). The risk of exposure to anticancer drugs was confirmed not only by the patient but also by the recipient.

10 錠剤破砕用シリンジ
10a 外筒
10b ガスケット
10c プランジャ
10d ピン
10d 先端部
10e 凹部
10f 先端部
12 水供給用シリンジ
12a 外筒
12b ガスケット
12c プランジャ
12d 先端部
14 三方活栓
14a 連結端部
14b コック
16 接続用チューブ
18 洗浄水供給用シリンジ
18a 外筒
18b ガスケット
18c プランジャ
18d 先端部
20 第2三方活栓
20a 連結端部
22 栄養剤供給用チューブ
24 第3三方活栓
DESCRIPTION OF SYMBOLS 10 Tablet crushing syringe 10a Outer cylinder 10b Gasket 10c Plunger 10d Pin 10d Tip part 10e Recess 10f Tip part 12 Water supply syringe 12a Outer cylinder 12b Gasket 12c Plunger 12d Tip part 14 Three-way cock 14a Connecting end 14b Cock 16 Connecting tube 18 Washing water supply syringe 18a Outer cylinder 18b Gasket 18c Plunger 18d Tip 20 Second three-way stopcock 20a Connection end 22 Nutrient supply tube 24 Third three-way stopcock

Claims (11)

錠剤を破砕するための錠剤破砕用シリンジと、水を供給するための水供給用シリンジと、該錠剤破砕用シリンジと該水供給用シリンジを連結する三方活栓とを備え、該錠剤破砕用シリンジは内部に錠剤破砕用のピンを備え、該三方活栓は内部に各々流路を有する3本の連結端部と、該3本の連結端部の合流基部において該3本の連結端部の各流路の2本を選択して連通させる摺動弁体とを備え、該錠剤破砕用シリンジの先端部と該水供給用シリンジの先端部は該三方活栓のいずれかの連結端部に連結されていることを特徴とする錠剤懸濁投与装置。   A tablet crushing syringe for crushing a tablet, a water supply syringe for supplying water, a three-way cock connecting the tablet crushing syringe and the water supply syringe, A tablet crushing pin is provided inside, and the three-way stopcock has three connecting end portions each having a flow path therein, and each flow of the three connecting end portions at a merging base portion of the three connecting end portions. A sliding valve body for selecting and communicating two of the passages, and the distal end portion of the tablet crushing syringe and the distal end portion of the water supply syringe are connected to one of the connecting end portions of the three-way stopcock A tablet suspension administration device. 前記錠剤破砕用シリンジ及び前記水供給用シリンジが遮光性の材料からなることを特徴とする請求項1に記載の錠剤懸濁投与装置。   The tablet suspension administration device according to claim 1, wherein the tablet crushing syringe and the water supply syringe are made of a light-shielding material. 水供給用シリンジ内に水を入れ、錠剤破砕用シリンジ内に錠剤を入れ、該錠剤破砕用シリンジで錠剤を破砕し、該錠剤破砕用シリンジと該水供給用シリンジを三方活栓を介して連結させた状態で、該三方活栓の該錠剤破砕用シリンジと該水供給用シリンジの間を連通させ、該錠剤破砕用シリンジと該水供給用シリンジとの間で水と錠剤を行き来させて水を錠剤とともに攪乱して錠剤を懸濁液化させることを特徴とする錠剤懸濁投与方法。   Put water in the water supply syringe, put the tablet in the tablet crushing syringe, crush the tablet with the tablet crushing syringe, and connect the tablet crushing syringe and the water supply syringe through a three-way cock. In this state, the tablet crushing syringe and the water supply syringe of the three-way cock are communicated, and water and tablets are moved back and forth between the tablet crushing syringe and the water supply syringe. And a tablet suspension administration method, wherein the tablet is suspended by suspension. 水供給用シリンジ内に水を入れ、錠剤破砕用シリンジ内に錠剤を入れ、該錠剤破砕用シリンジで錠剤を破砕し、該錠剤破砕用シリンジと該水供給用シリンジを三方活栓を介して連結させた状態で、該三方活栓の該錠剤破砕用シリンジと該水供給用シリンジの間を連通させ、該錠剤破砕用シリンジと該水供給用シリンジとの間で水と錠剤を行き来させて水を錠剤とともに攪乱して錠剤を懸濁液化させ、得られた錠剤懸濁液を該三方活栓を介して患者に投与することを特徴とする錠剤懸濁投与方法。   Put water in the water supply syringe, put the tablet in the tablet crushing syringe, crush the tablet with the tablet crushing syringe, and connect the tablet crushing syringe and the water supply syringe through a three-way cock. In this state, the tablet crushing syringe and the water supply syringe of the three-way cock are communicated, and water and tablets are moved back and forth between the tablet crushing syringe and the water supply syringe. A tablet suspension administration method comprising: disrupting the suspension together to form a tablet suspension, and administering the obtained tablet suspension to a patient via the three-way stopcock. 前記錠剤懸濁液を前記水供給用シリンジに移し、前記三方活栓の前記錠剤破砕用シリンジの側の経路を閉じ、該水供給用シリンジ内の該錠剤懸濁液を該三方活栓を介して患者に投与することを特徴とする請求項4に記載の錠剤懸濁投与方法。   The tablet suspension is transferred to the water supply syringe, the path of the three-way stopcock on the side of the tablet crushing syringe is closed, and the tablet suspension in the water supply syringe is passed through the three-way stopcock to the patient. The tablet suspension administration method according to claim 4, wherein the tablet suspension is administered. 患者にセットした薬剤投入用チューブ又は栄養剤供給用チューブを介して前記錠剤懸濁液を前記三方活栓から患者に投与することを特徴とする請求項4又は5に記載の錠剤懸濁投与方法。   The tablet suspension administration method according to claim 4 or 5, wherein the tablet suspension is administered to the patient from the three-way stopcock through a drug feeding tube or a nutrient supply tube set in the patient. 錠剤を破砕するための錠剤破砕用シリンジと、水を供給するための水供給用シリンジと、該錠剤破砕用シリンジと該水供給用シリンジを連結する三方活栓と、洗浄水を供給するための洗浄水供給用シリンジと、該三方活栓と該洗浄水供給用シリンジを連結する第2三方活栓とを備え、該錠剤破砕用シリンジは内部に錠剤破砕用のピンを備え、該三方活栓及び該第2三方活栓は内部に各々流路を有する3本の連結端部と、該3本の連結端部の合流基部において該3本の連結端部の各流路の2本を選択して連通させる摺動弁体とを備え、該錠剤破砕用シリンジの先端部と該水供給用シリンジの先端部は該三方活栓のいずれかの連結端部に連結され、該第2三方活栓のいずれかの連結端部は該三方活栓の未連結の連結端部に連結され、該洗浄水供給用シリンジの先端部は該第2三方活栓の未連結の連結端部に連結されていることを特徴とする錠剤懸濁投与装置。   Tablet crushing syringe for crushing tablets, water supply syringe for supplying water, three-way cock connecting the tablet crushing syringe and water supply syringe, and washing for supplying washing water A syringe for water supply, and a second three-way stopcock connecting the three-way stopcock and the syringe for supplying cleaning water. The tablet crushing syringe includes a pin for tablet crushing inside, and the three-way stopcock and the second stopcock The three-way stopcock has three connecting end portions each having a flow path therein, and a slide for selecting and communicating two of the three flow paths at the three connecting end portions at the joining base portion of the three connecting end portions. A distal end portion of the tablet crushing syringe and a distal end portion of the water supply syringe are connected to any connecting end portion of the three-way stopcock, and any connecting end of the second three-way stopcock is provided. Is connected to the unconnected connecting end of the three-way stopcock, and the washing water supply Tip of the syringe tablet suspended administration apparatus characterized by being connected to the connecting end of the unligated the second three-way stopcock. 前記錠剤破砕用シリンジ及び前記水供給用シリンジが遮光性の材料からなることを特徴とする請求項7に記載の錠剤懸濁投与装置。   The tablet suspension administration device according to claim 7, wherein the tablet crushing syringe and the water supply syringe are made of a light-shielding material. 水供給用シリンジ内に水を入れ、洗浄水供給用シリンジ内に水を入れ、錠剤破砕用シリンジ内に錠剤を入れ、該錠剤破砕用シリンジで錠剤を破砕し、該錠剤破砕用シリンジと該水供給用シリンジを三方活栓を介して連結させた状態で、該三方活栓の該錠剤破砕用シリンジと該水供給用シリンジの間を連通させ、該錠剤破砕用シリンジと該水供給用シリンジとの間で水と錠剤を行き来させて水を錠剤とともに攪乱して錠剤を懸濁液化させ、得られた錠剤懸濁液を該三方活栓及び第2三方活栓を介して患者に投与し、該第2三方活栓から患者に至る該錠剤懸濁液の投与経路に洗浄水供給用シリンジ内の水を該第2三方活栓を介して送給することを特徴とする錠剤懸濁投与方法。   Put water in the syringe for water supply, put water in the syringe for supply of washing water, put the tablet in the syringe for tablet crushing, crush the tablet with the syringe for crushing tablet, and crush the tablet crushing syringe and the water In a state where the supply syringe is connected via a three-way stopcock, the tablet crushing syringe and the water supply syringe of the three-way stopcock are communicated with each other, and between the tablet crushing syringe and the water supply syringe The water and the tablet are moved back and forth to disturb the water together with the tablet to make the tablet suspension, and the obtained tablet suspension is administered to the patient through the three-way stopcock and the second three-way stopcock, and the second three-way A tablet suspension administration method, wherein water in a washing water supply syringe is fed through the second three-way stopcock to an administration route of the tablet suspension from a stopcock to a patient. 前記錠剤懸濁液を前記水供給用シリンジに移し、前記三方活栓の前記錠剤破砕用シリンジの側の経路を閉じ、該水供給用シリンジ内の該錠剤懸濁液を前記三方活栓及び前記第2三方活栓を介して患者に投与することを特徴とする請求項9に記載の錠剤懸濁投与方法。   The tablet suspension is transferred to the water supply syringe, the path on the side of the tablet crushing syringe of the three-way stopcock is closed, and the tablet suspension in the water supply syringe is transferred to the three-way stopcock and the second stopcock. The tablet suspension administration method according to claim 9, wherein the tablet suspension is administered to a patient via a three-way stopcock. 患者にセットした薬剤投入用チューブ又は栄養剤供給用チューブを介して前記錠剤懸濁液を前記第2三方活栓から患者に投与することを特徴とする請求項9又は10に記載の錠剤懸濁投与方法。   The tablet suspension administration according to claim 9 or 10, wherein the tablet suspension is administered to the patient from the second three-way stopcock via a drug feeding tube or a nutrient supply tube set in the patient. Method.
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Publication number Priority date Publication date Assignee Title
EP3925592A4 (en) * 2019-02-11 2022-11-09 Vidal Lopez, Carlos Francisco Device for crushing and dissolving/suspending dangerous drugs for enteral administration

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WO2008047699A1 (en) * 2006-10-18 2008-04-24 Terumo Kabushiki Kaisha Medical apparatus
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JPH01139841U (en) * 1988-03-17 1989-09-25
JP2003325641A (en) * 2002-05-15 2003-11-18 Oohashi:Kk Tablet fragmenting device
WO2007083763A1 (en) * 2006-01-23 2007-07-26 Greenpeptide Co., Ltd. Method for production of emulsion preparation comprising physiologically active peptide, and kit for production of the preparation
WO2008047699A1 (en) * 2006-10-18 2008-04-24 Terumo Kabushiki Kaisha Medical apparatus
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3925592A4 (en) * 2019-02-11 2022-11-09 Vidal Lopez, Carlos Francisco Device for crushing and dissolving/suspending dangerous drugs for enteral administration

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