WO2021095696A1 - 抗がん剤曝露防止方法 - Google Patents

抗がん剤曝露防止方法 Download PDF

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WO2021095696A1
WO2021095696A1 PCT/JP2020/041778 JP2020041778W WO2021095696A1 WO 2021095696 A1 WO2021095696 A1 WO 2021095696A1 JP 2020041778 W JP2020041778 W JP 2020041778W WO 2021095696 A1 WO2021095696 A1 WO 2021095696A1
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solution
hypochlorous acid
aqueous solution
acid aqueous
test
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French (fr)
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智栄子 山下
勇一 中島
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プログレス株式会社
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Priority to CN202080078466.7A priority Critical patent/CN114728189A/zh
Priority to KR1020227016126A priority patent/KR20220084109A/ko
Priority to JP2021556088A priority patent/JPWO2021095696A1/ja
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    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62D—CHEMICAL MEANS FOR EXTINGUISHING FIRES OR FOR COMBATING OR PROTECTING AGAINST HARMFUL CHEMICAL AGENTS; CHEMICAL MATERIALS FOR USE IN BREATHING APPARATUS
    • A62D3/00—Processes for making harmful chemical substances harmless or less harmful, by effecting a chemical change in the substances
    • A62D3/30—Processes for making harmful chemical substances harmless or less harmful, by effecting a chemical change in the substances by reacting with chemical agents
    • A62D3/38—Processes for making harmful chemical substances harmless or less harmful, by effecting a chemical change in the substances by reacting with chemical agents by oxidation; by combustion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/20—Elemental chlorine; Inorganic compounds releasing chlorine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L9/00—Disinfection, sterilisation or deodorisation of air
    • A61L9/01—Deodorant compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L9/00—Disinfection, sterilisation or deodorisation of air
    • A61L9/14—Disinfection, sterilisation or deodorisation of air using sprayed or atomised substances including air-liquid contact processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/02—Antidotes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2101/00—Chemical composition of materials used in disinfecting, sterilising or deodorising
    • A61L2101/02—Inorganic materials
    • A61L2101/06—Inorganic materials containing halogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2209/00—Aspects relating to disinfection, sterilisation or deodorisation of air
    • A61L2209/10—Apparatus features
    • A61L2209/13—Dispensing or storing means for active compounds
    • A61L2209/132—Piezo or ultrasonic elements for dispensing

Definitions

  • the present invention is a method for preventing exposure to an anticancer agent, particularly any of cyclophosphamide, 6-mercaptopurine, cisplatin, bendamstin, gemcitabine, oxaliplatin, vincristine, doxorubicin, fluorouracil, and paclitaxel among anticancer agents. It relates to an anticancer drug exposure prevention method for detoxifying.
  • An anticancer drug is a preparation that suppresses the growth of cancer cells and ultimately suppresses or kills the growth of the cancer cells. Its mechanism of action includes invasion of target cancer cells, inhibition of DNA replication and synthesis of the cells, inhibition of microtubule formation (inhibition of cell division), inhibition of intracellular metabolism or regulation of nutrient supply blood flow, etc. cause. Therefore, while anticancer drugs act on cancerous cells and cause cell death such as apoptosis, they are also highly toxic to normal cells. Therefore, care must be taken when handling anticancer drugs.
  • Non-Patent Document 1 In the guideline (Non-Patent Document 1) prepared for exposure countermeasures in cancer drug therapy, it is strongly recommended to take exposure countermeasures at the time of transportation / storage of the prepared drug solution and at the time of administration control.
  • a waterproof apron, double gloves, and a mask containing activated charcoal are worn.
  • the anti-cancer drug preparation work is performed in an environment that reduces drug scattering, such as a biological safety cabinet that does not allow the aerosol generated during preparation to flow out, and a closed preparation device.
  • the invention according to Patent Document 1 absorbs urine containing a highly toxic drug such as an anticancer drug, adsorbs the drug in the urine, and is secondary in a hospital such as a patient, a medical worker, a hospital staff, etc.
  • a hospital such as a patient, a medical worker, a hospital staff, etc.
  • the invention according to Patent Document 2 reduces the possibility that a medical worker accidentally touches a drug solution when handling an infusion bag, and provides a bag body capable of safely and easily administering a drug solution.
  • the invention according to Patent Document 3 includes more effective leakage prevention measures and leakage prevention measures from pharmaceutical preparation instruments and pharmaceutical administration instruments, which may cause adverse health effects if leaked, and a plurality of pharmaceuticals.
  • the invention according to Patent Document 4 exerts a sufficient effect on adsorption and retention of highly toxic drugs such as anticancer agents, and further improves the safety of medical staff in a medical environment. I will provide a.
  • the invention according to Patent Document 5 is to provide an infusion tube set and a method of using the infusion tube set, which effectively reduces the risk of exposure to dangerous chemicals such as anticancer agents.
  • Patent Documents 1 to 5 the effect of reducing the exposure is limited to the prevention of leakage from the equipment, and in fact, the environmental pollution cannot be completely prevented.
  • the above guideline P66 calls attention to "minimize the scattering to the surroundings during excretion. For example, men and women if possible. Both use Western-style toilets, and men sit in a sitting position when urinating. Close the lid of the water-washing toilet and then flush. " Rinse the spilled area with detergent (for cleaning) and repeat “rinse with water” multiple times. Alternatively, if there is a drug that inactivates the anticancer drug, wipe it off, soak it in paper or cloth, wipe it off, and finally wipe it dry. As the drug, sodium hypochlorite solution, sodium hydroxide, etc. are mentioned, and in particular, 5.25% sodium hypochlorite is effective as a part of the anticancer drug. It has been confirmed that.
  • JP-A-2018-126316 Japanese Unexamined Patent Publication No. 2018-12223 Japanese Patent No. 6117973 Japanese Patent No. 6092445 Japanese Unexamined Patent Publication No. 2014-217555
  • sodium hypochlorite which is said to be effective in neutralizing anticancer agents, is a so-called commercially available liquid chlorine bleach, but it contains an alkaline agent and is an acidic detergent. It is dangerous because chlorine gas is generated when mixed with, and the label says "Danger of mixing".
  • Alkaline agents are used to prevent the decomposition of sodium hypochlorite in the container, but since they are strongly alkaline, they must be used with rubber gloves.
  • the present invention provides a method for detoxifying an anticancer agent, particularly an alkylating agent, by using a safe hypochlorous acid aqueous solution that does not affect the human body even when sprayed into a space. Is to provide. That is, the present invention is used for the purpose of preventing exposure to anticancer agents by spraying an aqueous solution of hypochlorous acid developed by the applicant.
  • the present invention sprays an aqueous hypochlorite solution onto the object to be treated or toward the space where the object to be treated exists, so that at least cyclophosphamide among the anticancer agents, 6 -It is a method for preventing exposure to an anticancer drug that detoxifies any of mercaptopurine, cisplatin, bendamstin, gemcitabine, oxaliplatin, vincristine, doxorubicin, fluorouracil, and paclitaxel.
  • the hypochlorous acid aqueous solution is contained and sprayed by a sprayer that atomizes the hypochlorous acid aqueous solution into a gas or mist.
  • the spraying may be performed by an ultrasonic spraying device containing an aqueous hypochlorous acid solution.
  • the pH of the hypochlorous acid aqueous solution is preferably 5.5 to 7.0.
  • the present invention is characterized in that paclitaxel is detoxified by spraying an aqueous hypochlorous acid solution toward the object to be treated and leaving it to stand for 24 hours.
  • the method of using the anti-cancer agent neutralizing agent according to the present invention it is possible to safely and efficiently prevent exposure to the anti-cancer agent by spraying the hypochlorous acid aqueous solution.
  • the inventor of the present application has invented a method and an apparatus for producing a slightly acidic hypochlorous acid aqueous solution capable of maintaining a constant pH value in the range of 5.5 to 7.0 for a long period of time (Patent No. 6553955). ).
  • the present invention proposes a method of using a neutralizing agent that safely and efficiently prevents exposure to an anticancer drug by spraying the hypochlorous acid aqueous solution produced by the above-mentioned production method into a space. Please understand that it is done.
  • At least cyclophosphamide, 6-mercaptopurine, cisplatin, and vincristine among anticancer agents are sprayed by spraying an aqueous hypochlorite solution onto the object to be treated or toward the space where the object to be treated exists.
  • Gemcitabine, oxaliplatin, vincristine, doxorubicin, fluorouracil, paclitaxel which is an anticancer drug exposure prevention method for detoxifying any of them.
  • the hypochlorous acid aqueous solution is contained and sprayed by a sprayer that atomizes the hypochlorous acid aqueous solution into a gas or mist.
  • the pH of the hypochlorous acid aqueous solution is preferably 5.5 to 7.0.
  • the alkylating agent is any of ifosfamide, cyclophosphamide, dacarbazine, temozolomide, nimustine, busulfan, procarbazine, melphalan, and ranimustine.
  • Alkylating agents are typical agents of cytotoxic anticancer agents. Alkylating agents attach a mass of atoms called an alkyl group to the DNA of a cancer cell and bind two spirally twisted DNAs in an abnormal manner, making it impossible to copy the DNA. If the cancer cells continue to divide and proliferate with the alkylating group bound, the DNA will be torn and the cancer cells will die.
  • cyclophosphamide is one of the most commonly used anticancer drugs, and is used as a central drug such as CAV therapy for small cell lung cancer and CHOP therapy for malignant lymphoma, or it can be used alone. is there.
  • the method for producing an aqueous hypochlorite solution of the present invention is as follows: a) a first step of supplying raw water to a storage tank, and b) supplying an acidic aqueous solution while stirring the raw water in the storage tank to prepare the raw water and the acidic aqueous solution. A second step of producing a mixed aqueous solution, and c) a third step of supplying sodium hypochlorite while stirring the mixed aqueous solution in the storage tank to generate a hypochlorite aqueous solution after the second step.
  • the hypochlorous acid aqueous solution produced in the above step has a pH value of a constant value in the range of 5.5 to 7.0, preferably a constant value in the range of 6.0 to 7.0, more preferably. It is controlled to 7.0. That is, since the pH value of the hypochlorous acid aqueous solution is almost the same as the pH value of human skin, it can be evaluated that the influence on the human body is extremely small and the safety is excellent.
  • FIG. 1 is a diagram showing a state in which the hypochlorous acid aqueous solution 1 is sprayed toward the toilet bowl.
  • the sprayer 10 contains the hypochlorous acid aqueous solution 1 and sprays it toward the toilet bowl by operating the handle.
  • the atomizer 10 a commercially available atomizer can be used. It is also possible to use the hypochlorous acid aqueous solution 1 by spraying it into the space where the object to be treated exists, or after treating the non-processed object or toward the space.
  • Example 2 will be described in detail.
  • the applicant of the present application has conducted an anticancer drug decomposition performance confirmation test on the hypochlorous acid aqueous solution according to the present application, and this will be described.
  • LC / MS / MS was adopted as the test method.
  • the stock solution (20 mL) is prepared by adding 5 mL of physiological saline to 100 mg of cyclophosphamide, accurately weighing 1 mL of the stock solution, and adding purified water to make exactly 20 mL. .. Further, 5 mL of this solution was accurately weighed, and purified water was added to make exactly 50 mL, which was used as a test substance solution (100 ⁇ g / mL).
  • a sample solution (decomposition solution A) is prepared by adding 1 mL of the above-mentioned test substance solution to 9 mL of the hypochlorous acid aqueous solution used in the present application and shaking the mixture. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • a sample solution (decomposition solution B) is prepared by adding 1 mL of the above-mentioned test substance solution to 9 mL of 10-fold diluted strong alkaline electrolyzed water (PW-No.135) and shaking. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • a solution diluted 10 times is used assuming general cleaning.
  • 1 mL of the above-mentioned test substance solution is added to 9 mL of purified water and shaken to obtain a sample solution. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • Each decomposition solution prepared as described above was measured using LC / MS / MS. Then, the decomposition solution A and the decomposition solution B were compared with the control solution, and the decomposition effects of each were confirmed.
  • an ultrasonic spray device 20 is provided on the floor of the space.
  • the ultrasonic spray device neutralizes a small amount of anticancer agent remaining in the space by accommodating the hypochlorous acid aqueous solution 1 in the tank and discharging the hypochlorous acid aqueous solution 1 into a mist into a space.
  • the power of ultrasonic waves can be used to make the particle size of the mist of the spray into ultrafine particles of about 4 to 5 micrometers, and to gently and efficiently spray every corner of the space.
  • hypochlorous acid aqueous solution 1 is made from safe components, there is no effect on health even if the sprayed mist is inhaled.
  • continuous operation is performed for about 10 to 20 minutes, and the hypochlorous acid aqueous solution 1 is spread throughout the space. Once the hypochlorous acid aqueous solution 1 is distributed in the space, the effect of neutralizing the drug is maintained by additional spraying.
  • Example 3 the applicant of the present application conducted a solution concentration measurement test with the implementation of spraying by the ultrasonic spraying device 20 containing the hypochlorous acid aqueous solution 1, and this will be described.
  • the test was conducted from July 19 to 26, 2019 at Shionogi Pharma Co., Ltd. (2-5-1 Mishima, Settsu City, Osaka Prefecture).
  • LC / MS / MS was adopted as the test method, and the measured value (ng / mL) and the detected amount ( ⁇ g) were confirmed with respect to cyclophosphamide as the target drug. Apply 100 ⁇ g of cyclophosphamide to each of 10 10 cm ⁇ 10 cm sampling sheets and allow them to dry completely.
  • Example 4 will be described in detail.
  • the applicant of the present application has conducted another anticancer drug decomposition performance confirmation test on the hypochlorous acid aqueous solution according to the present application, and this will be described.
  • LC / MS / MS was adopted as the test method.
  • the stock solution (20 mL) was prepared by adding 5 mL of physiological saline to 100 mg each of 6-mercaptopurine and cisplatin, and 1 mL of the stock solution was accurately weighed, and purified water was added to make it accurate. 20 mL. Further, 5 mL of this solution was accurately weighed, and purified water was added to make exactly 50 mL, which was used as a test substance solution (100 ⁇ g / mL).
  • a sample solution (decomposition solution A) is prepared by adding 1 mL of the above-mentioned test substance solution to 9 mL of the hypochlorous acid aqueous solution used in the present application and shaking the mixture. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • a control solution 1 mL of the above-mentioned test substance solution is added to 9 mL of purified water and shaken to obtain a sample solution. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • the decomposition solution A and purified water prepared in the above manner were measured using LC / MS / MS, and the decomposition solution A was compared with the purified water as the control solution to confirm the decomposition effect of each test substance.
  • Table 3 shows the test results for 6-mercaptopurine and Table 4 shows the test results for cisplatin.
  • the average decomposition rates of the decomposition liquid A were 95% and 99.2%, respectively, for 6-mercaptopurine and cisplatin.
  • Test Survey content Anti-cancer drug decomposition performance confirmation test Test reception number: JF19-M010, M012 Test location: Shionogi Pharma Co., Ltd.
  • Test date January 9-February 12, 2020
  • Test method LC / MS / MS Specimen: 6-mercaptopurine, cisplatin decomposition solution A: Hypochlorous acid aqueous solution used in the present application As a result, it was proved that the aqueous hypochlorous acid solution used in Example 1 decomposed 95% and 99.2% on average with respect to 6-mercaptopurine and cisplatin, respectively.
  • Example 5 will be described in detail.
  • the applicant of the present application has conducted another anticancer drug decomposition performance confirmation test on the hypochlorous acid aqueous solution according to the present application, and this will be described.
  • LC / MS / MS was adopted as the test method.
  • 100 mg each of bendamustine, gemcitabine, oxaliplatin, vincristine, doxorubicin, and fluorouracil was dissolved in 5 mL of physiological saline to make a stock solution (20 mL), and 1 mL of the stock solution was accurately weighed. Add purified water to make exactly 20 mL.
  • a sample solution (decomposition solution A) is prepared by adding 1 mL of the above-mentioned test substance solution to 9 mL of the hypochlorous acid aqueous solution used in the present application and shaking the mixture. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • a control solution 1 mL of the above-mentioned test substance solution is added to 9 mL of purified water and shaken to obtain a sample solution. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • the decomposition solution A and purified water prepared in the above manner were measured using LC / MS / MS, and the decomposition solution A was compared with the purified water as the control solution to confirm the decomposition effect of each test substance.
  • Table 5 shows bendamustine, gemcitabine, and oxaliplatin
  • Table 6 shows vincristine, doxorubicin, and fluoracil
  • the average decomposition rates of the decomposition liquid A are 100% and 99.5%, respectively. , 99.8%, 100%, 99.9%, 100%.
  • Test Survey content Anti-cancer drug decomposition performance confirmation test
  • Test reception number JF20-G003, H002, H003, K011, K012, J008
  • Test location Shionogi Pharma Co., Ltd. (2-5-1 Mishima, Settsu City, Osaka Prefecture)
  • Test date August 27-31, 2020 (Bendamustine) September 9th-September 14th, 2020 (Gemcitabine) August 28-September 1, 2020 (oxaliplatin) October 22-27, 2020 (Vincristine) October 23-27, 2020 (doxorubicin) September 28-October 5, 2020 (Fluorouracil)
  • Test method LC / MS / MS Specimen: Bendamustine, gemcitabine, oxaliplatin, vincristine, doxorubicin, fluoracil decomposition solution
  • A Hypochlorous acid aqueous solution used in the present application As a result, the hypochlorous acid aqueous solution used in Example 1
  • Example 6 will be described in detail.
  • the applicant of the present application has conducted an anticancer drug decomposition performance confirmation test on paclitaxel with respect to the hypochlorous acid aqueous solution according to the present application, and this will be described.
  • LC / MS / MS was adopted as the test method.
  • a stock solution (20 mL) is prepared by adding 5 mL of physiological saline to 100 mg of paclitaxel, and 1 mL of the stock solution is accurately weighed, and purified water is added to make exactly 20 mL. Further, 5 mL of this solution was accurately weighed, and purified water was added to make exactly 50 mL, which was used as a test substance solution (100 ⁇ g / mL).
  • a sample solution (decomposition solution A) is prepared by adding 1 mL of the above-mentioned test substance solution to 9 mL of the hypochlorous acid aqueous solution used in the present application and shaking the mixture. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • As a control solution 1 mL of the above-mentioned test substance solution is added to 9 mL of purified water and shaken to obtain a sample solution. This solution is measured immediately after preparation, and this operation is repeated 3 times.
  • Each decomposition solution prepared as described above was measured using LC / MS / MS.
  • the decomposition solution A was compared with the control solution, and the decomposition effect of the decomposition solution A was confirmed.
  • Table 7 below shows the results of immediate measurement
  • Table 8 shows the test results after 24 hours.
  • the average decomposition rate of the decomposition liquid A was 1.3% for paclitaxel, as shown in Table 6. That is, no decomposing effect of the decomposing solution A was observed on paclitaxel.
  • the concentration of paclitaxel was measured 10 times higher than that of the decomposition solution A carried out on February 12, 2020, and the amount of paclitaxel detected was measured after 24 hours had passed.
  • the average decomposition rate of the decomposition liquid A was 99.1%.
  • Test Survey content Anti-cancer drug decomposition performance confirmation test
  • Test location Shionogi Pharma Co., Ltd. (2-5-1 Mishima, Settsu City, Osaka Prefecture)
  • Test date February 12, 2020 and October 2 to 13, 2020
  • Test method LC / MS / MS Specimen: Paclitaxel decomposition solution A: Hypochlorous acid aqueous solution used in the present application As a result, it was proved that the hypochlorous acid aqueous solution used in Example 6 decomposes 99.1% of paclitaxel after a certain period of time after increasing the concentration, although it is difficult to decompose paclitaxel immediately.
  • the method for preventing exposure to anti-cancer agents it is possible to safely and efficiently prevent exposure to anti-cancer agents by spraying an aqueous hypochlorite solution, so that only medical facilities such as hospitals can be prevented.
  • it can be widely applied to the prevention of anti-cancer drug exposure in facilities for the elderly, living spaces and toilets of residences, and animal hospitals.

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PCT/JP2020/041778 2019-11-11 2020-11-09 抗がん剤曝露防止方法 WO2021095696A1 (ja)

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