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WO2016208582A1 - Composition de soin buccal pour patients atteints de cancer - Google Patents

Composition de soin buccal pour patients atteints de cancer Download PDF

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Publication number
WO2016208582A1
WO2016208582A1 PCT/JP2016/068400 JP2016068400W WO2016208582A1 WO 2016208582 A1 WO2016208582 A1 WO 2016208582A1 JP 2016068400 W JP2016068400 W JP 2016068400W WO 2016208582 A1 WO2016208582 A1 WO 2016208582A1
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Prior art keywords
oral
oral care
present
composition
care composition
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Ceased
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English (en)
Japanese (ja)
Inventor
浩平 宮野
正雄 高見
慶司 廣田
公子 牧野
弘 寺田
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Meiji Co Ltd
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Meiji Co Ltd
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Priority to JP2017524923A priority Critical patent/JP6779871B2/ja
Publication of WO2016208582A1 publication Critical patent/WO2016208582A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

Definitions

  • the present invention relates to an oral care composition for cancer patients.
  • Cancer treatment varies depending on the organ affected by the cancer and the stage of the cancer, but there are mainly three types of surgery, radiation therapy and chemotherapy.
  • endocrine therapy and immunotherapy for special tumors. Etc. are known.
  • a plurality of treatment methods may be combined, for example, with a focus on surgical therapy, and chemotherapy or radiation therapy may be combined before and after surgery.
  • Non-patent Document 1 When cancer is affected, nausea, decreased appetite, anemia, bone marrow suppression, etc. are caused as the cancer progresses, and this is accompanied by infections in the oral cavity (dental infections, oral candidiasis, herpes, etc.) ) And oral mucositis. In addition, as a side effect of cancer treatment, adverse events (oral mucositis, oral infection, dry mouth, etc.) occur in the oral cavity in any of surgical treatment, radiation therapy, and chemotherapy. % Is known to develop oral mucositis. Therefore, not only in Japan but also in other countries around the world, we are working on the development of therapeutic agents and preventive agents for oral complications including oral mucositis in cancer patients (Non-patent Document 1).
  • moisturizers that contain antibacterial substances and moisturizers that do not contain antibacterial substances. These oral moisturizers are effective in preventing dry mouth and oral infections that occur at the same time as oral mucositis. On the other hand, when targeting cancer patients, the oral environment deteriorates and severe oral intima There is concern about the possibility of causing a flame.
  • Non-patent Document 2 aqueous catechin solution
  • Patent Document 1 An oral care composition containing catechin and gelled with xanthan gum, which is a moisturizing agent, has been developed (Patent Document 1).
  • this composition for oral care is used for the adjustment of the normal oral flora, and in Patent Document 1, it is used for oral complications in cancer patients, particularly oral mucositis in cancer treated patients. There is no disclosure about.
  • the present inventors have now used oral care compositions comprising tea extract, thickening polysaccharides and humectants to reproduce oral mucositis in the oral cavity of cancer patients.
  • the present inventors succeeded in suppressing ulcer onset during ulcer onset and promoting ulcer repair during ulcer repair. That is, it has been found that by using the composition for oral care of the present invention, the onset of oral complications can be prevented and inflammation of oral complications can be reduced.
  • the present invention is based on these findings.
  • the present invention is for oral care for preventing the onset of oral complications and treating, improving, reducing and / or alleviating oral inflammation (symptoms) while improving QOL in cancer treated patients. It is an object to provide a composition.
  • a composition for oral care for cancer patients comprising a tea extract, a thickening polysaccharide and a humectant.
  • a tea extract for preventing, treating, ameliorating, reducing and / or alleviating oral complications of cancer patients who receive at least one treatment selected from surgical therapy, radiation therapy and chemotherapy
  • the composition for oral care as described.
  • the composition for oral care according to (2) above, wherein the oral complication is caused by radiation therapy or chemotherapy.
  • the composition for oral care of the present invention can maintain the tea catechin concentration in the oral cavity for a long time, can prevent the onset of oral complications, and treat inflammation (symptoms) of oral complications, Can be improved, reduced and / or alleviated. Moreover, since the composition for oral care of this invention contains a thickening polysaccharide and can be ingested (administered) locally, it suppresses the irritation
  • FIG. 3 shows the transition of the average ulcer area in the ulcer onset period (6th to 11th days after the first anticancer drug administration) in the oral mucositis model mouse.
  • A Catechin concentration (mg / L) released at each time (every 2 hours).
  • B Catechin concentration released over time (mg / L).
  • the oral care composition of the present invention comprises a tea extract, a thickening polysaccharide and a humectant as active ingredients, and is used (administered) to cancer patients.
  • the composition for oral care of the present invention is a selective antibacterial action capable of adjusting the normal microbial flora, oxidative stress (reactive oxygen) generated in the oral mucosa of cancer patients given by free radicals generated by chemotherapy or radiotherapy Therefore, oral complications of cancer patients can be efficiently prevented, treated, improved, reduced and / or alleviated.
  • cancer patient means a patient suffering from cancer.
  • cancer includes cancer (carcinoma), sarcoma, leukemia / malignant lymphoma, and the like, which are also called malignant tumors or malignant neoplasms.
  • the “cancer patient” is preferably a cancer patient who receives treatment for cancer, more preferably at least one treatment selected from surgical therapy, radiation therapy and chemotherapy, A cancer patient, more preferably a cancer patient who receives at least one treatment selected from radiation therapy and chemotherapy.
  • “Surgery” refers to a surgical operation for cancer occurring in the upper gastrointestinal tract and respiratory organs as well as in the oral cavity, head and neck region.
  • patients who have undergone head and neck surgery, including the oral cavity have defects in tissues related to mastication and swallowing functions, and those who have undergone upper gastrointestinal and respiratory surgery are fed parentally. Ingestion tends to cause infections in the oral cavity and oral mucositis.
  • Radiotherapy refers to local therapy that irradiates cancer cells with radiation. Radiation therapy affects not only cancer cells but also normal cells around them. Generally, in radiation therapy, when the oral cavity, head and neck region enters the radiation field, an adverse reaction (oral adverse event) always occurs in the oral cavity, and mainly oral mucositis due to active oxygen occurs and is irreversible. Severe dry mouth due to atrophy of the salivary glands.
  • irradiation dose 60 to 70 Gy, which is used in combination with surgery and chemotherapy.
  • the irradiation dose 10 Gy or more (after the first week)
  • saliva thickening is often observed
  • the irradiation dose is 20 Gy or more (after the second week)
  • the oral mucosa is reddish, and some Mucous membranes have peeling ulcers, and taste changes are often seen.
  • the irradiation dose is 30 Gy or more (after 3 weeks) ulcer formation is promoted and the amount of saliva secretion decreases.
  • the irradiation dose is 50 Gy or more (after the 5th week)
  • the formation of ulcers further progresses and the intake of food is often difficult
  • the irradiation dose is 60 Gy or more (after the 6th week) It becomes a symptom of severe oral mucositis and often reaches the peak of oral mucositis and dry mouth at the end of irradiation. Symptoms of oral mucositis often go away in 1 to 2 months.
  • “Chemotherapy” refers to the administration of anticancer drugs to suppress cancer cell growth and destroy cancer cells.
  • anticancer agents include antimetabolites, alkylating agents, anticancer antibiotics, microtubule agonists, platinum preparations (platinum preparations), topoisomerase inhibitors, taxane preparations, and molecular target drugs. It is done.
  • anticancer agents with high incidence of oral mucositis antimetabolites such as 5-FU, methotrexate, TS-1, capecitabine, cytarabine, gemcitabine, hydroxyurea, alkylating agents such as busulfan, melphalan,
  • anticancer antibiotics for example, bleomycin, daunorubicin, doxorubicin, actinomycin D, microtubule agonists, platinum preparations (platinum preparations), for example cisplatin, carboplatin, topoisomerase inhibitors, for example irinotecan
  • etoposide and taxane preparations include paclitaxel and docetaxel, and examples of molecular targeted drugs include everolimus and temsirolimus.
  • chemotherapy In general, chemotherapy often reduces the function of not only cancer cells but also normal cells that are actively proliferating, especially bone marrow cells and other cell groups related to immunity. It is easy to produce. In addition, in chemotherapy, active oxygen is generated in the oral mucosa by an anticancer agent, and oral mucositis due to active oxygen is likely to occur.
  • the oral care composition of the present invention is preferably used to prevent, treat, ameliorate, reduce and / or alleviate oral complications in cancer patients who are treated for cancer, more preferably surgery.
  • prevention means preventing the onset of oral complications and mildly suppressing the onset of oral complications. Specifically, it acts on the pathogenesis of oral complications in advance. Prevent the onset of such diseases, acquire the function of oral complications more than normal or remission in advance, and reduce the physiological damage of the lesions caused after the onset of the disease, etc. means.
  • oral complications such as oral mucositis and oral cavity such as oral mucositis, dental caries, periodontal disease and candidiasis are prevented, treated, improved, reduced and / or alleviated. Infectious diseases, dry mouth due to salivary gland dysfunction, and the like, including those with bleeding and pain, preferably oral mucositis.
  • the “oral complication” may be one type of symptom alone or a combination of two or more types of symptoms among these oral complications.
  • oral complications are preferably those caused as side effects by radiation therapy or chemotherapy, more preferably those caused by chemotherapy, more preferably antimetabolite administration therapy, particularly Preferably, it is caused by 5-FU administration therapy.
  • Oral mucositis is also called mucositis or stomatitis, and forms symptoms such as redness and ulceration in the mucous membrane and is accompanied by intense pain.
  • oral mucositis is 40-70% of cancer patients who receive chemotherapy, 80% of patients with hematopoietic stem cell transplantation who receive large doses of anticancer drugs and whole body irradiation, radiation glands in the head and neck It is said to occur in 100% of cancer patients receiving therapy.
  • oral mucositis since it is difficult to take a meal orally with pain, the state of the whole body is weakened, resulting in serious side effects that affect the willingness to continue treatment and the willingness to fight.
  • oral mucositis active oxygen is generated in the oropharyngeal mucosa due to radiation, an anticancer agent, etc., and active oxygen stays in the oral mucosa for a long time to cause oral mucositis.
  • oral mucositis develops 7 to 10 days after the start of administration of an anticancer drug. Often subsides in about 2 weeks after onset, but may continue for more than a month.
  • radiation therapy when the irradiation dose is 20 Gy or more, the oral mucosa is reddish and some mucous membranes are peeled and ulcers are observed.
  • the irradiation dose is 30 Gy or more, the formation of ulcers is promoted and the irradiation dose is 60 Gy or more. Then, it becomes a symptom of severe oral mucositis and often reaches the peak of oral mucositis at the end of irradiation. In many cases, symptoms subside after 1 to 2 months from the end of irradiation.
  • “Dry mouth” is also called xerostomia (dry mouth), and refers to symptoms accompanied by abnormal dryness in the oral cavity due to a decrease in salivary secretion.
  • the decrease in the amount of saliva secretion causes a decrease in the self-cleaning action in the oral cavity, the wet state in the oral cavity, the mucosal protective action in the oral cavity, and the like, which directly and indirectly cause other oral complications.
  • salivary gland atrophy is caused by radiation therapy of cancer patients who receive radiation therapy in the head and neck, causing irreversible and difficult to dry mouth, resulting in infections in the oral cavity and oral cavity Susceptible to mucositis.
  • Oral infection refers to an infection caused by pathogenic microorganisms in the oral cavity.
  • pathogenic microorganisms for example, caries-causing bacteria (Actinomyces naeslundii and Streptococcus mutans ⁇ ⁇ ⁇ ⁇ ⁇ ), periodontal disease-causing bacteria (Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Prevotella intermedia and Fusobacterium nucleatum), Candida ⁇ albicans, methicillin-resistant Staphylococcus aureus (MRSA), and other causative agents of opportunistic infections. Oral infections are likely to occur if the balance of the normal bacterial flora in the oral cavity, such as a decrease in immunity, is lost.
  • the “tea extract” typically refers to a mixture extracted from tea and contains tea polyphenols, and preferably contains catechins at a high concentration.
  • the “tea extract” may be a catechin obtained by purifying a specific polyphenol such as catechin, a synthesized catechin, or a commercially available tea extract.
  • examples of the tea extract include Sanphenon BG-5 (Taiyo Kagaku), Sunphenon BG-3 (Taiyo Kagaku), and Camellia Extract 30S (Taiyo Kagaku).
  • “Catechin” includes epi-forms, non-epi-forms, hydroxy forms, gallate esters, and the like.
  • catechin for example, epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECg), epigallocatechin gallate (EGCg), catechin (C), gallocatechin (GC), catechin gallate (Cg) , Gallocatechin (GC) and the like.
  • catechin may be a single kind of these catechins or a combination of two or more kinds (mixtures), but is easily available. And, since it has a good flavor, a mixture of catechins is preferable.
  • the content of the tea extract is not particularly limited as long as the bitterness derived from polyphenols such as catechin is less affected and the selective antibacterial effect and active oxygen removal effect are exhibited.
  • the content of catechin is 0.05% by weight or more, for example, the selective antibacterial effect and the active oxygen removal effect are sufficiently expected, preferably 0.05 to 1% by weight, more preferably 0.05 to 0.8% by weight, more preferably 0.05 to 0.6% by weight, further preferably 0.05 to 0.5% by weight, particularly preferably 0.1 to 0.4% by weight. .
  • “Selective antibacterial effect” refers to an effective amount of catechin, specifically, caries-causing bacteria (at least one of Actinomyces naeslundii and Streptococcus mutans ⁇ ), periodontal disease-causing bacteria (Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, At least one of the causative bacteria of opportunistic infections such as Prevotella intermedia and Fusobacterium nucleatum, Candida albicans, and methicillin-resistant Staphylococcus aureus (MRSA), but has high antibacterial activity It means that it does not affect the normal flora. Therefore, if the composition for oral care of the present invention is used, the hygiene condition in the oral cavity can always be adjusted satisfactorily without breaking the balance of the normal bacterial flora in the oral cavity.
  • caries-causing bacteria at least one of Actinomyces naeslundii and Streptococcus
  • Removing effect of active oxygen means removing or suppressing oxidative stress (reactive oxygen) generated in the oral mucosa of cancer patients given by anti-cancer drugs or free radicals generated by radiation associated with chemotherapy or radiation therapy Means that.
  • the “thickening polysaccharide” is not particularly limited as long as it can be administered into the oral cavity, in particular, can be locally administered to the inflamed area, and can exhibit retention and sustained release in the oral cavity.
  • the thickening polysaccharide for example, xanthan gum, agar, agarose, agaropectin, amylopectin, isolikenan, laminaran, lichenan, glucan, levan, fructan, galactan, mannan, xylan, arabinan, pentozan, alginic acid, pectic acid, fucoidan, pectin , Locust bean gum, guar gum, tara gum, gum arabic and the like.
  • the “thickening polysaccharide” may be a single type of these thickening polysaccharides or a combination (mixture) of two or more types. Further, since it has a moisturizing action, xanthan gum and guar gum are preferable, and further, oxidation of tea catechin can be suppressed, and xanthan gum is more preferable.
  • the content of the thickening polysaccharide is not particularly limited as long as the effects of retention and sustained release such as catechin are exhibited in the oral cavity.
  • the xanthan gum content is, for example, 1% by weight or more
  • the effect of retention and sustained release of polyphenols such as catechin in the oral cavity is sufficiently expected, preferably 1 to 8% by weight, more preferably Is 2 to 7% by weight, more preferably 2.5 to 5.5% by weight.
  • the “humectant” is not particularly limited as long as it is a substance having a moisturizing action.
  • examples of the humectant include carrageenan, hyaluronic acid, glycerin, propylene glycol, polyethylene glycol, sorbit liquid, and carboxymethyl cellulose.
  • the “humectant” may be a single type of these humectants or a combination (mixture) of two or more types. A mixture of glycerin and propylene glycol is preferable because it effectively improves and maintains the wet state.
  • the content of the moisturizing agent is not particularly limited as long as the effect of retention of active ingredients such as catechin, sustained release, and moisturizing effect is exhibited in the oral cavity.
  • the retention of active ingredients such as catechin, sustained release and moisturizing effects are It is sufficiently expected, preferably 5 to 40% by weight, more preferably 10 to 30% by weight, still more preferably 15 to 25% by weight.
  • the oral care composition of the present invention comprises catechin, xanthan gum, glycerin and propylene glycol, and the content of catechin is 0.05% by weight or more, preferably 0.05.
  • the content of catechin is 1% by weight or more, preferably 1 to 8% by weight, more preferably 2 to 7% by weight, still more preferably 2.5 to 5.5% by weight.
  • the glycerin content is, for example, 5% by weight or more, preferably 5 to 40% by weight, more preferably 10 to 30% by weight, still more preferably 15 to 25% by weight.
  • the content of the glycol 1% by weight or more, preferably 1 to 25 wt%, more preferably from 2.5 to 20 wt%, more preferably 5 to 15 wt%.
  • the oral care composition of the present invention comprises catechin, xanthan gum and propylene glycol, the catechin content is 0.05 to 1 wt%, and the xanthan gum content is 1 to 8% by weight, glycerin content is 5 to 40% by weight, and propylene glycol content is 1 to 25% by weight.
  • the oral care composition of the present invention comprises catechin, xanthan gum and propylene glycol, the catechin content is 0.05 to 1% by weight, and the xanthan gum content is 2%.
  • the glycerin content is 15 to 25% by weight, and the propylene glycol content is 5 to 15% by weight.
  • the oral care composition of the present invention may preferably contain an antioxidant and a preservative in addition to the above active ingredients from the viewpoint of long-term storage.
  • the “antioxidant” is not particularly limited as long as it is a substance having an antioxidant action.
  • examples of the antioxidant include erythorbic acid, ascorbic acid, tocopheric acid, tocopherol acetate, cyclodextrin, and salts or derivatives thereof.
  • the “antioxidant” may be a single type of these antioxidants or a combination (mixture) of two or more types. From the viewpoint of preservation, erythorbic acid and / or sodium erythorbate is preferably a single substance or a mixture thereof.
  • the “antioxidant” those for usual food addition can be used as they are.
  • the content of the antioxidant is not particularly limited as long as the antioxidant effect in long-term storage is exhibited.
  • the content of erythorbic acid and / or sodium erythorbate alone or as a mixture is, for example, 0.01% by weight or more, the antioxidant effect in long-term storage is sufficiently expected, preferably 0.01 to It is 1.0% by weight, more preferably 0.02 to 0.5% by weight, still more preferably 0.05 to 0.1% by weight.
  • the “preservative” is not particularly limited as long as it is a substance having an antiseptic action.
  • examples of the preservative include cetylpyridinium chloride, ethyl paraoxybenzoate, methyl paraoxybenzoate, propyl paraoxybenzoate, phenoxyethanol, isopropylmethylphenol, alkyldiaminoethylglycine hydrochloride, sodium benzoate, and potassium sorbate.
  • the “preservative” may be a single kind of these preservatives, or may be a combination of two or more kinds (mixtures).
  • methyl paraoxybenzoate propyl paraoxybenzoate, phenoxyethanol, isopropylmethylphenol and / or alkyldiaminoethylglycine hydrochloride.
  • a conventional food additive can be used as it is.
  • the content of the preservative is not particularly limited as long as the antiseptic effect and the miscellaneous taste suppressing effect during long-term storage are exhibited.
  • the content of methyl paraoxybenzoate and / or propyl paraoxybenzoate alone or as a mixture is, for example, 0.01% by weight or more, the antiseptic effect and the miscellaneous taste suppressing effect in long-term storage are sufficiently expected.
  • the content is preferably 0.01 to 1.0% by weight, more preferably 0.04 to 0.5% by weight, and still more preferably 0.05 to 0.1% by weight.
  • the antiseptic effect and the miscellaneous taste suppressing effect in long-term storage are sufficiently expected, preferably 0.1 to 1.5% by weight, more preferably It is 0.3 to 1.3% by weight, more preferably 0.5 to 1.0% by weight.
  • the content of isopropylmethylphenol is, for example, 0.0025% by weight or more, the antiseptic effect and the miscellaneous taste suppressing effect in long-term storage are sufficiently expected, preferably 0.0025 to 0.1% by weight, The amount is preferably 0.005 to 0.09% by weight, more preferably 0.01 to 0.08% by weight.
  • the content of alkyldiaminoethylglycine hydrochloride is, for example, 0.03% by weight or more, the antiseptic effect and the miscellaneous taste suppressing effect in long-term storage are sufficiently expected, and preferably 0.03 to 0.8 % By weight, more preferably 0.05 to 0.4% by weight, still more preferably 0.1 to 0.2% by weight.
  • the oral care composition of the present invention is a general oral cavity within the range that does not impair the effects of the present invention and the retention and sustained release properties of the present invention. It may contain general additives used in care compositions and foods.
  • the content of xylitol is, for example, 0.02% by weight or more, the improvement of the effect of the present invention is sufficiently expected, preferably 0.02 to 4% by weight, more preferably 0.3 to 4% by weight. It is 3% by weight, more preferably 0.5 to 2% by weight.
  • the manufacturing method and manufacturing process of a general composition for oral care can be applied.
  • the oral care composition of the present invention is preferably a tea extract (tea catechin), a thickening polysaccharide, xanthan gum, humectants, glycerin and propylene glycol, antioxidants, sodium erythorbate, preservatives , Ethyl paraben and propyl paraben, xylitol, and a fragrance.
  • the oral care composition of the present invention has a predetermined viscosity, and the viscosity measured with a B-type viscometer (measurement temperature: 20 to 25 ° C., shear rate corresponding to a rotation speed of 12 rpm) is, for example, 5 to If it is 1,000 Pa ⁇ s, it is easy to adjust the retention and sustained release of an active ingredient such as catechin in the oral cavity, and therefore, preferably 10 to 500 Pa ⁇ s, more preferably 20 to 400 Pa ⁇ s, The pressure is preferably 30 to 300 Pa ⁇ s.
  • composition for oral care of the present invention has a predetermined light transmittance, and preferably has a light transmittance of a wavelength of 800 nm, for example, if it is 2% or more, the appearance is good. It is 2 to 95%, more preferably 5 to 90%, still more preferably 10 to 80%.
  • the oral care composition of the present invention has a predetermined form, and as a specific form, gel, liquid, foam, cream, ointment, etc. can be applied, and saliva is used in the oral cavity, A film, a tablet, or the like may be applied as long as it is dissolved in water or the like and has a predetermined viscosity.
  • the oral care composition of the present invention preferably has good handling properties such as actual administration (ingestion) and application, and retention and release of active ingredients such as catechin in the oral cavity. Since it is easy to adjust the properties, it is preferably a gel, and since it can be easily used with one hand, it is more preferably a sprayable gel.
  • composition for oral care of this invention may distribute
  • composition for oral care of the present invention can be used as a pharmaceutical, a quasi-drug, or a cosmetic, preferably an oral cosmetic, as it is or in combination with other components.
  • the oral care composition of the present invention is labeled with an indication that it is effective in treating oral complications in cancer patients, preferably cancer patients. Indices may be attached to indicate that they are effective in preventing, treating, improving, reducing and / or alleviating oral complications. And according to another aspect of the present invention, preferably the one with indication indicating that it is effective in the treatment of oral complications in a cancer patient, preferably receiving cancer treatment, preferably In addition, a sign indicating that the treatment is effective in preventing, treating, ameliorating, reducing and / or alleviating oral complications in a cancer patient may be given.
  • the present invention is effective in the treatment of oral complications in cancer patients who receive at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy.
  • Prevention, treatment, amelioration, and / or prevention of oral complications in cancer patients who have at least one treatment selected from surgical therapy, radiation therapy, or chemotherapy, with an indication that it is present Or the display which shows that it is effective in relaxation may be attached
  • the indication of the present invention is not particularly limited as long as it is given in relation to the composition for oral care, and for example, the oral care is applied to a container, packaging material or package insert containing the composition for oral care. It may be provided with a display / advertisement etc. for which the composition is effective.
  • the display of the present invention is a display in which the oral care composition is effective for storage media such as flyers, brochures, pops, catalogs, posters, posters, books, DVDs, advertisements on electronic bulletin boards, the Internet, etc. -An advertisement etc. may be attached.
  • the oral care composition of the present invention is a containerized oral care composition.
  • the container-packed oral care composition of the present invention is a form in which an oral care composition comprising a tea extract, a thickening polysaccharide and a humectant is applied as a gel, liquid, foam, cream, ointment, etc.
  • an oral care composition comprising a tea extract, a thickening polysaccharide and a humectant is applied as a gel, liquid, foam, cream, ointment, etc.
  • it can be obtained by filling the oral care composition of the present invention into a container.
  • the container used in the container-packed oral care composition of the present invention is not particularly limited, and for example, glass, plastic, PET bottle, paper pack, or metal (for example, aluminum, steel) may be used.
  • the container-packed oral care composition is preferable because it does not come into contact with air and thus has an antioxidant function.
  • the container-packed oral care composition of the present invention is 1 to 120 times, more preferably 1 to 90 times, still more preferably 1 to 80 times, still more preferably 1 to 60 times.
  • a gel it is a type of 1 to 100 ml, more preferably 1 to 90 ml, still more preferably 1 to 80 ml, still more preferably 1 to 60 ml.
  • the container-packed oral care composition of the present invention may be a single-use individual package.
  • the oral care composition of the present invention comprises oral complications of cancer patients, preferably comprising tea extract, thickening polysaccharide and humectant as active ingredients. It may be a composition for preventing, treating, improving, reducing and / or alleviating oral mucositis.
  • the composition of the present invention prevents, treats, ameliorates or reduces oral complications in cancer patients, preferably oral mucositis, receiving at least one treatment selected from surgical therapy, radiation therapy and chemotherapy.
  • / or a palliative composition and more preferably, prevention, treatment, amelioration of oral complications in cancer patients, preferably oral mucositis, receiving at least one treatment selected from radiation therapy and chemotherapy, A mitigating and / or mitigating composition.
  • the composition for oral care of the present invention comprises, as an active ingredient, surgical treatment, radiation therapy and cancer therapy comprising a tea extract, a thickening polysaccharide and a humectant.
  • Composition for preventing, treating, ameliorating, reducing and / or alleviating oral complications as a side effect caused by at least one treatment selected from chemotherapy, preferably oral mucositis, more preferably radiation of cancer patients A composition for preventing, treating, ameliorating, reducing and / or alleviating oral complications as a side effect caused by at least one treatment selected from therapy and chemotherapy, preferably oral mucositis, more preferably for cancer patients
  • Prevention of oral complications as a side effect caused by chemotherapy preferably antimetabolite administration, more preferably 5-FU administration
  • preferably oral mucositis, Care, improvement, and alleviation and / or alleviating composition preferably oral mucositis, Care, improvement, and alleviation and / or alleviating composition.
  • the composition for oral care of the present invention When the composition for oral care of the present invention is used, the selective antibacterial action of the composition, the action of removing oxidative stress generated in the oral mucosa of cancer patients, and the moisturizing action The patient's oral complications can be effectively prevented, treated, ameliorated, reduced and / or alleviated. And, by using the composition for oral care of the present invention, preferably, the onset of oral complications in cancer patients can be efficiently prevented, and at the same time, oral complications can be treated, improved, reduced and / or Can be relaxed.
  • the oral care composition of the present invention is used to treat, ameliorate, reduce and / or reduce the oral complication of the cancer patient. At the same time, the inflammatory condition can be suppressed.
  • a method for treating oral complications comprising administering the oral care composition of the present invention to a cancer patient, preventing oral complications, Treatment, amelioration, alleviation and / or alleviation methods are provided.
  • a method for treating oral complications preferably comprising administering to a cancer patient, receiving treatment for cancer, Methods of prevention, treatment, amelioration, reduction and / or alleviation are provided.
  • the oral cavity comprising administering to a cancer patient who receives at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy.
  • the oral care composition of the present invention is applied to cancer patients before cancer treatment is performed.
  • a method of administering to a cancer patient more preferably a method of administering the oral care composition of the present invention to a cancer patient before cancer chemotherapy or radiation therapy is performed on the cancer patient. It is.
  • the method for treating oral complications according to the present invention preferably excludes medical practice for humans.
  • the medical practice for humans means an act of taking (administering) pharmaceuticals to humans, which requires prescription by a doctor or the like.
  • the treatment method of the present invention can be performed according to the contents described in the present specification for the oral care composition of the present invention.
  • oral care composition of the present invention a wide range of administration (ingestion) methods such as oral administration such as eating and drinking, topical administration such as application to the oral cavity, and toothpaste, depending on the use state and use scene.
  • oral administration such as eating and drinking
  • topical administration such as application to the oral cavity
  • toothpaste depending on the use state and use scene.
  • oral care composition of the present invention is orally administered by eating or drinking, as an effective dose for preventing, treating, improving, reducing and / or alleviating oral complications of cancer patients, Based on catechin, it is preferably equivalent to 10 to 100 mg.
  • the oral care composition of the present invention is locally administered by application to the oral cavity or the like, the administration is effective for preventing, treating, improving, reducing and / or alleviating oral complications in cancer patients.
  • the catechin concentration in the oral cavity is preferably 1 to 100 ⁇ g / cm 2 per unit time (1 hour).
  • catechin is used as an effective dose for preventing, treating, improving, reducing and / or alleviating oral complications in cancer patients.
  • 1 g is used as a single dose, at least twice a day, preferably at least 3 times a day, more preferably at least 4 times, and even more preferably 1
  • the frequency is 6 times or more per day (see Example 2 in the Examples).
  • the oral care composition of the present invention applies a wide range of administration (intake) periods such as when feeling dry, feeling pain, after normal meals or before going to bed, depending on the state of use and scene of use. be able to.
  • the use of the oral care composition of the present invention for the treatment of oral complications in cancer patients, and the prevention and treatment of oral complications in cancer patients.
  • the use of the oral care composition of the present invention for improvement, reduction and / or alleviation.
  • the use of the oral care composition of the present invention for the treatment of oral complications in cancer patients, preferably receiving treatment for cancer.
  • the use of the oral care composition of the present invention for the prevention, treatment, amelioration, reduction and / or alleviation of oral complications in cancer patients who are treated for cancer.
  • the oral care composition of the present invention for the treatment of oral complications in cancer patients who receive at least one treatment selected from surgical therapy, radiation therapy, chemotherapy.
  • Prevention, treatment, amelioration, and / or reduction of oral complications in cancer patients provided that the use of the oral care composition of the present invention is provided and receives at least one treatment selected from surgical therapy, radiation therapy, chemotherapy.
  • Or use of the oral care composition of the present invention for relief is provided.
  • the use of the oral care composition of the present invention in the manufacture of a medicament for the treatment of oral complications in cancer patients, and oral complications in cancer patients.
  • the use of the oral care composition of the present invention in the manufacture of a medicament for the prevention, treatment, amelioration, alleviation and / or alleviation.
  • the oral care composition of the present invention in the manufacture of a medicament for the treatment of oral complications in a cancer patient who is treated for cancer.
  • an agent for the treatment of oral complications in a cancer patient that receives at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy
  • the use of the oral care composition of the present invention in the manufacture of an oral complication prevents or treats or improves oral complications in cancer patients who receive at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy
  • the use of the oral care composition of the present invention in the manufacture of a cosmetic product for the treatment of oral complications in cancer patients, and oral complications in cancer patients.
  • the use of the oral care composition of the present invention in the manufacture of a cosmetic product for prevention, treatment, amelioration, alleviation and / or alleviation.
  • the oral care composition of the present invention in the manufacture of a cosmetic product for the treatment of oral complications in a cancer patient who is treated for cancer.
  • a cosmetic for the treatment of oral complications in a cancer patient receiving at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy.
  • the use of the oral care composition of the present invention in the manufacture of an oral complication prevents or treats or improves oral complications in cancer patients who receive at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy.
  • tea extract preferably a tea extract, an increase in the manufacture of an oral care composition for the treatment of oral complications in a cancer patient who is treated for cancer.
  • an oral care composition for the prevention, treatment, amelioration, alleviation and / or alleviation of oral complications in cancer patients provided with the use of mucopolysaccharides and humectants
  • Use of tea extract, thickening polysaccharides and humectants is provided.
  • the oral cavity for the treatment of oral complications in cancer patients that receives at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy.
  • Oral mergers in cancer patients who are provided with the use of tea extract, thickening polysaccharides and humectants in the manufacture of care compositions and receive at least one treatment selected from surgical therapy, radiation therapy, chemotherapy
  • Use of tea extract, thickening polysaccharides and humectants in the manufacture of an oral care composition for prevention, treatment, amelioration, alleviation and / or alleviation of diseases is provided.
  • a tea extract for the treatment of oral complications in a cancer patient.
  • tea extract for the prevention, treatment, amelioration, reduction and / or alleviation of oral complications.
  • a tea extract, a thickening polysaccharide and a pharmaceutical in the manufacture of a medicament for the treatment of oral complications in a cancer patient who is treated for cancer Tea extract, thickening polysaccharide in the manufacture of a medicament for the prevention, treatment, amelioration, mitigation and / or alleviation of oral complications in cancer patients who are provided with the use of humectants and who are treated for cancer And the use of humectants.
  • an agent for the treatment of oral complications in a cancer patient that receives at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy
  • Prevention of oral complications in cancer patients provided the use of tea extract, thickening polysaccharides and humectants in the manufacture of and receiving at least one treatment selected from surgical therapy, radiation therapy, chemotherapy,
  • tea extract, thickening polysaccharides and humectants in the manufacture of a medicament for treatment, amelioration, alleviation and / or alleviation.
  • a tea extract for the treatment of oral complications in a cancer patient, in a cancer patient.
  • tea extracts for the prevention, treatment, amelioration, reduction and / or alleviation of oral complications.
  • tea extract, thickening polysaccharide and in the manufacture of cosmetics for the treatment of oral complications in cancer patients who are treated for cancer Tea extract thickening polysaccharide in the manufacture of cosmetics for the prevention, treatment, amelioration, reduction and / or alleviation of oral complications in cancer patients who are provided with the use of moisturizers and who are treated for cancer And the use of humectants.
  • a cosmetic for the treatment of oral complications in a cancer patient receiving at least one treatment selected from surgical therapy, radiation therapy, and chemotherapy.
  • tea extract thickening polysaccharides and humectants in the manufacture of and receiving at least one treatment selected from surgical therapy, radiation therapy, chemotherapy.
  • tea extracts thickening polysaccharides and humectants in the manufacture of cosmetics for treatment, improvement, reduction and / or alleviation.
  • Example 1 Evaluation test of anti-ulcer effect using oral mucositis model mouse After anticancer drug was administered to mice and the function of cell groups related to immunity such as bone marrow cells was reduced, acetic acid was submucous into oral mucosa Oral mucositis model mice were prepared by an experimental system that artificially develops ulcers and the antiulcer effects of various preparations were evaluated.
  • Oral sonde needle with glass syringe (capacity: 0.25 ml, needle diameter: 20G, diameter of blunt; 2.25 mm, length: 2.5 cm, curvilinear) (SouthPointe Surgical Supply, CoralsSprings, FL , USA Co., Ltd.), 30 mg each of the oral care composition of the present invention or a commercially available moisturizing agent in the oral mucosa of an oral mucositis model mouse under non-anaesthesia twice a day (at 10 o'clock and 18 o'clock) Administration). At this time, there were 6 mice in each group (oral mucositis model mice administered with various preparations). In addition, in order to evaluate the preventive effect of the onset of ulcers, application of various preparations was started 7 days before the first anticancer drug administration (day 7 of the study). Continued until day 16 after administration.
  • the ulcer area developed in the oral cavity of each group of mice was determined at predetermined intervals from the day after the administration day of the acetic acid solution (20%) (study day 6) (measurement date: tests 6, 8, and 11). , 13, 16).
  • the major axis and minor axis were measured with a ruler to determine the ulcer area.
  • the ulcer area was also determined in mice not receiving various preparations (untreated group).
  • the average value (average ulcer area) of the ulcer area of each group and the untreated group was calculated, and the average ulcer area of each group and the untreated group was compared to evaluate the anti-ulcer effect. Specifically, in the ulcer onset period (days 6 to 11 of the study), the ulcer onset suppression effect (ulcer prevention effect) was evaluated, and in the ulcer repair stage (day 12 to 16 of the study) The effect of promoting (treatment effect of ulcer) was evaluated. Each result is shown in FIG. 1 and FIG.
  • the average ulcer area of the administration group of the oral care composition of the present invention was smaller than the average ulcer area of the untreated group. That is, it was confirmed that the composition for oral care of the present invention has an effect of suppressing the onset of ulcer (preventive effect of ulcer). This is because, when the oral care composition of the present invention is applied to the oral cavity before administration of the anticancer agent, antibacterial effects such as oral bacteria on the oral mucosa are caused by the anti-bacterial active ingredient catechin. It is presumed that both functions of the removal effect of “active oxygen derived from cancer drugs” were exerted, and the onset of ulcer due to acetic acid was suppressed.
  • the average ulcer area of the group administered with the commercial moisturizer was larger than the average ulcer area of the untreated group. That is, it was confirmed that the commercially available moisturizing agent has no ulcer onset suppression effect (ulcer prevention effect) and rather has an ulcer onset promotion effect. This is because when a commercially available moisturizer is applied to the oral cavity before the administration of the anticancer agent, the moisturizing component (humectant) causes oral bacteria on the oral mucosa and other "active oxygen derived from the anticancer agent" It is inferred that the retention action was exerted and promoted damage to the oral mucosa.
  • the average ulcer area of the oral care composition administration group and the commercial moisturizing agent administration group of the present invention was smaller than that of the untreated group. That is, it was confirmed that the composition for oral care and the commercially available moisturizing agent of the present invention have an ulcer repair promoting effect (ulcer treatment effect).
  • the ulcer onset period, the ulcer repair period, and the ulcer state (the degree of ulcer) of all the combined periods are indicated by the product of the ulcer area and the number of measurement days, that is, AUC (area under the curve).
  • AUC area under the curve
  • the AUC of the oral care composition administration group of the present invention was smaller in the ulcer onset period, the ulcer repair period, and the entire period than in the untreated group AUC.
  • the AUC of the commercial moisturizer group was larger than the AUC of the untreated group, and the AUC of the commercial moisturizer group was smaller than the AUC of the untreated group in the ulcer repair period and the whole period. It was.
  • Example 2 Evaluation test of sustained release The sustained release of the oral care composition (Aurora Coat, Meiji Co., Ltd.) of the present invention was confirmed.
  • the sustained release property was evaluated by the following procedure.
  • the oral care composition was filled in 3 ml each in a 12-well plate (Falcon), and then filled in 3 ml PBS (multilayer treatment). After collecting the whole amount of the supernatant (PBS) every 2 hours after the stratification treatment (2, 4, 6, 8, 10, 12 hours after the stratification treatment) and after collecting the whole amount of the supernatant, Then, 3 ml of fresh PBS was filled (layered treatment).
  • PBS supernatant
  • the catechin release concentration per unit time (1 hour) of the oral care composition of the present invention was 27.1 ⁇ g / cm 2 / h on average in 2 hours after the multi-layer treatment.
  • the catechin release concentration per unit time (1 hour) of the oral care composition of the present invention was 2.5 ⁇ g / cm 2 / h on average in 12 hours (integration) after the multi-layer treatment. .
  • the composition for oral care of the present invention even if the catechin is a small amount (low concentration), since the catechin is gradually released over a long period of time, the antibacterial effect is effectively exhibited, It is useful in that irritation and bitterness caused by catechin are suppressed, and it can be continued comfortably.

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Abstract

La présente invention concerne une composition de soin buccal, qui empêche des complications dans la cavité buccale et, en même temps, traite, améliore, atténue et/ou soulage une inflammation (symptômes) dans la cavité buccale tout en améliorant la qualité de vie de patients atteints de cancer pendant le traitement. Plus spécifiquement, la présente invention concerne une composition de soin buccal pour des patients atteints de cancer, ladite composition comprenant un extrait de thé, un polysaccharide épaississant et un humectant.
PCT/JP2016/068400 2015-06-22 2016-06-21 Composition de soin buccal pour patients atteints de cancer Ceased WO2016208582A1 (fr)

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CN108542973A (zh) * 2018-04-03 2018-09-18 金华市飞凌生物科技有限公司 一种抑菌健齿提取物的制备方法
JP2020529475A (ja) * 2017-07-31 2020-10-08 ムコサ イノバティオンズ, エセ エレMucosa Innovations, S.L. 腫瘍処置誘導性の経口胃腸粘膜炎の予防および／または処置における使用のための組成物
WO2022074422A1 (fr) * 2020-10-05 2022-04-14 Stone Tree International Limited Agencement phytochimique et procédé associé
WO2022224464A1 (fr) * 2021-04-21 2022-10-27 順也 藤森 Composition phytochimique

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Cited By (8)

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Publication number Priority date Publication date Assignee Title
JP2020529475A (ja) * 2017-07-31 2020-10-08 ムコサ イノバティオンズ, エセ エレMucosa Innovations, S.L. 腫瘍処置誘導性の経口胃腸粘膜炎の予防および／または処置における使用のための組成物
JP7096332B2 (ja) 2017-07-31 2022-07-05 ムコサ イノバティオンズ，エセ エレ 腫瘍処置誘導性の経口胃腸粘膜炎の予防および／または処置における使用のための組成物
CN108542973A (zh) * 2018-04-03 2018-09-18 金华市飞凌生物科技有限公司 一种抑菌健齿提取物的制备方法
WO2022074422A1 (fr) * 2020-10-05 2022-04-14 Stone Tree International Limited Agencement phytochimique et procédé associé
WO2022224464A1 (fr) * 2021-04-21 2022-10-27 順也 藤森 Composition phytochimique
JP2022166793A (ja) * 2021-04-21 2022-11-02 順也 藤森 フィトケミカル組成物
CN116096366A (zh) * 2021-04-21 2023-05-09 藤森顺也 植物化学物质组合物
JP7611783B2 (ja) 2021-04-21 2025-01-10 順也 藤森 フィトケミカル組成物の製造方法

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