WO2020137694A1 - Capsule - Google Patents

Capsule Download PDF

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Publication number
WO2020137694A1
WO2020137694A1 PCT/JP2019/049391 JP2019049391W WO2020137694A1 WO 2020137694 A1 WO2020137694 A1 WO 2020137694A1 JP 2019049391 W JP2019049391 W JP 2019049391W WO 2020137694 A1 WO2020137694 A1 WO 2020137694A1
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WO
WIPO (PCT)
Prior art keywords
oil
gelatin
mass
content
film
Prior art date
Application number
PCT/JP2019/049391
Other languages
French (fr)
Japanese (ja)
Inventor
一宏 鳥井
涼太 要田
忠杜 渋谷
美優 岡野
Original Assignee
小林製薬株式会社
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Publication of WO2020137694A1 publication Critical patent/WO2020137694A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L5/00—Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate

Definitions

  • the present invention relates to capsules.
  • Gelatin is not toxic to the human body, is inexpensive, and has excellent jelly-forming ability and thickening properties. For this reason, gelatin is widely used as a component of capsules in the fields of medicine, foods, etc. Among them, gelatin derived from cattle is widely used as a component of capsules.
  • Patent Document 1 As a means for suppressing the insolubilization of the film, for example, a method is known in which inositol phosphate is mixed with gelatin to prepare a film composition, and the composition is used as a film of a capsule (Patent Document 1). 1). Although such a method is conventionally known, it is important to further provide a new means capable of suppressing the insolubilization of the film.
  • the present invention aims to provide a new means capable of suppressing the insolubilization of a film containing gelatin.
  • the present inventors have conducted intensive studies in view of the above-mentioned problems, and, as compared with the case where mint oil, parsley seed oil, or menthol oil is used in combination with cow-derived gelatin, these components are used in combination with pig-derived or fish-derived gelatin. In this case, it was found that insolubilization of gelatin can be effectively suppressed.
  • the present invention has been completed as a result of further studies based on the findings, and is as follows.
  • Item 1 The content containing at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil is encapsulated in a film containing at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin. Capsule characterized in that Item 2.
  • Item 2. The capsule according to Item 1, wherein the content further contains a fatty acid triglyceride, and the content contains mint oil at 28 parts by mass or less based on 100 parts by mass of the fatty acid triglyceride.
  • Item 3. Item 3.
  • Item 4. The capsule according to any one of Items 1 to 3, wherein the content further contains a fatty acid triglyceride, and the content contains menthon oil in an amount of 28 parts by mass or less based on 100 parts by mass of the fatty acid triglyceride.
  • a content containing at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil, and a group consisting of pig-derived gelatin and fish-derived gelatin A method for suppressing insolubilization of a coating, which comprises combining with a coating containing at least one selected from the following.
  • the capsule and method of the present invention it is possible to suppress the insolubilization of the film containing at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin.
  • the content containing at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil contains at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin.
  • a capsule characterized by being encapsulated in a film is provided.
  • the contents contain at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil.
  • Mint oil is an essential oil obtained by refining the above-ground parts of peppermint by steam distillation, and CAS No. Also known as 8006-90-4. Mint oil is commercially available, and is commercially available as, for example, light-weight white oil (manufactured by Nagaoka Jitsugyo Co., Ltd.), Japanese Pharmacopoeia peppermint oil (manufactured by Ogawa Fragrance Co., Ltd.) and the like.
  • the content of peppermint oil in the contents is not limited, but is preferably 0.2 to 22% by mass, more preferably 0.5 to 20% by mass, and further preferably 1 to 10% by mass.
  • Parsley seed oil is an essential oil obtained from the seeds of parsley. Also known as 8000-68-8. Parsley seed oil is commercially available, for example, as parsley seed oil (manufactured by Koei Kogyo Co., Ltd.) and the like.
  • the content of parsley seed oil in the contents is not limited, but is preferably 0.05 to 22% by mass, more preferably 0.1 to 10% by mass, and further preferably 0.15 to 5% by mass. ..
  • Mentone oil is obtained by debraining the essential oil obtained by steam-distilling a plant belonging to the genus Mint and separating it into decerebrated oil and crude brain.
  • Mentone oil is commercially available, and is commercially available, for example, as Mentone oil (manufactured by Nagaoka Jitsugyo Co., Ltd.).
  • Mentone oil is commercially available, and is commercially available, for example, as Mentone oil (manufactured by Nagaoka Jitsugyo Co., Ltd.).
  • menthol oil contains mentone as a main component
  • the mint oil contains menthol as a main component.
  • the content of menthol oil in the contents is not limited, but is preferably 1 to 22% by mass, more preferably 3 to 18% by mass, and further preferably 5 to 15% by mass.
  • the content of the present invention contains at least two kinds selected from the group consisting of mint oil, parsley seed oil and menthol oil
  • the content of mint oil, parsley is preferably 0.2 to 30% by mass, more preferably 5 to 25% by mass, further preferably 10 to 20% by mass. It is illustrated.
  • the content of the present invention is not limited to this, but preferably further contains a fatty acid triglyceride.
  • Fatty acid triglyceride is a compound having a structure in which three fatty acids are ester-bonded to one glycerol.
  • the fatty acid ester-bonded to glycerol may be a saturated fatty acid or an unsaturated fatty acid, and may be a straight chain fatty acid or a branched chain fatty acid.
  • the number of carbon atoms of the fatty acid is not limited, but fatty acids having preferably 8 to 22 carbon atoms, more preferably 10 to 21 carbon atoms, and further preferably 12 to 20 carbon atoms are exemplified.
  • fatty acid caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidic acid, behenic acid, lignoceric acid, etc. It is illustrated.
  • the three fatty acids bound to one glycerol may be the same, only two may be the same, or different from each other.
  • the fatty acid triglyceride may be used alone or in combination of two or more.
  • Fatty acid triglycerides include, for example, sunflower oil, safflower oil, rapeseed oil, olive oil, cottonseed oil, soybean oil, sesame oil, corn oil, peanut oil, vegetable oils such as grape oil and palm oil, animal oils such as lard, fish oil and beef tallow. Contains a lot. Therefore, these vegetable oils, animal oils and the like may be used for the contents. These may be used alone or in combination of two or more.
  • the present invention is not limited, but the peppermint oil is preferably 28 parts by mass or less, more preferably 100 parts by mass of the fatty acid triglyceride in the content.
  • the amount is, for example, 0.5 to 27 parts by mass, more preferably 0.5 to 20 parts by mass, and particularly preferably 1 to 12 parts by mass.
  • the present invention is not limited, but the content of parsley seed oil is not more than 28 parts by mass, more preferably 0, based on 100 parts by mass of the fatty acid triglyceride. 1 to 27 parts by mass, more preferably 0.2 to 15 parts by mass, particularly preferably 0.2 to 12 parts by mass.
  • the present invention is not limited, but the content of menthon oil is 28 parts by mass or less, more preferably 1 to 100 parts by mass of the fatty acid triglyceride. 27 parts by mass, more preferably 1 to 20 parts by mass, particularly preferably 5 to 20 parts by mass.
  • the content of the fatty acid triglyceride in the content is not limited, but is preferably 60 to 99.95% by mass, more preferably 70 to 99.9% by mass, and further preferably 75 to 99.8% by mass.
  • the content of fatty acid triglyceride in the content is not limited, but is preferably 60 to 99.9 mass%, more preferably 65 to 99.5.
  • the amount is, for example, 70 to 99% by mass, and more preferably 70 to 99% by mass.
  • the content of fatty acid triglyceride in the content is not limited, but is preferably 65 to 99.95% by mass, more preferably 70 to 99.95% by mass.
  • the amount is, for example, 9% by mass, more preferably 75 to 99.8% by mass.
  • the content of fatty acid triglyceride in the content is not limited, but is preferably 65 to 99% by mass, more preferably 70 to 97% by mass, and further It is preferably 75 to 95% by mass.
  • the contents further contain any component such as a pharmaceutically acceptable component, a cosmetically acceptable component, and an edible component as long as the effects of the present invention are not impaired.
  • a pharmaceutically acceptable component such as a pharmaceutically acceptable component, a cosmetically acceptable component, and an edible component as long as the effects of the present invention are not impaired.
  • an edible component is preferable.
  • the form of the content is not limited, and may be solid (powder, granule, etc.), semi-solid (gel (jelly), cream, paste, etc.), liquid or the like.
  • the form of the contents is preferably semi-solid or liquid.
  • the content may be produced according to the procedure for producing the content contained in a conventionally known capsule, for example, at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil, and if necessary.
  • a fatty acid triglyceride and, if necessary, the above optional components may be appropriately mixed and prepared.
  • the film contains at least one selected from the group consisting of gelatin derived from swine and gelatin derived from fish.
  • the swine-derived gelatin and fish-derived gelatin may be any gelatin that has been conventionally used in the fields of foods, pharmaceuticals, quasi-drugs, and the like, and edible gelatin is preferable.
  • the gelatin is a chemically modified gelatin such as acid- and/or alkali-treated gelatin, acylated gelatin, etc., which is made from pig or fish skin, bone, tendon, ligament, scale, etc., and hydrolysis of gelatin. Examples include gelatin such as things. These gelatins may be used alone or in combination of two or more.
  • Pig-derived gelatin and fish-derived gelatin are commercially available, and are commercially available from, for example, Nippi Co., Ltd., Nitta Gelatin Co., Ltd., Zerais Co., Rousselott, Weishhardt, etc.
  • Pork-derived gelatin and fish-derived gelatin are not limited as long as they are present, but the jelly strength (Bloom value) of the gelatin may be appropriately selected and used.
  • the jelly strength of gelatin is preferably in the range of 50 to 350 g, more preferably 80 to 300 g.
  • the jelly strength of gelatin is measured according to JIS K-6503 (2001). Specifically, the surface of the jelly prepared by cooling a 6.67 mass% gelatin aqueous solution at 10° C. for 17 hours is 2 minutes.
  • the jelly strength is defined as the load (g) required to push down by 4 mm with a 1 inch (12.7 mm) diameter plunger.
  • the content of at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin in the coating is not limited, but the total amount of at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin is The content is preferably 15 to 85% by mass, more preferably 20 to 80% by mass, and further preferably 25 to 75% by mass.
  • a group consisting of peppermint oil, parsley seed oil and menthol oil based on 100 parts by mass of at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin.
  • the total amount of at least one selected from the group is preferably 1 to 50 parts by mass, more preferably 3 to 45 parts by mass, further preferably 5 to 35 parts by mass.
  • the film may further contain any component such as a pharmaceutically acceptable component, a cosmetically acceptable component, and an edible component, if necessary, as long as the effect of the present invention is not impaired. Good.
  • a pharmaceutically acceptable component such as a pharmaceutically acceptable component, a cosmetically acceptable component, and an edible component, if necessary, as long as the effect of the present invention is not impaired.
  • an edible component is preferable.
  • the coating does not contain bovine-derived gelatin.
  • a plasticizer will be described as an example of the optional component.
  • Glycerin as a plasticizer; glycols such as propylene glycol and polyethylene glycol; sucrose, fructose, sorbitol, mannitol, corn syrup, etc. Liquid saccharides; crystalline cellulose, low-substituted hydroxypropyl cellulose, water-insoluble cellulose such as ethyl cellulose, and the like. Any of these may be used alone or in combination of two or more.
  • the content of the plasticizer in the film is not limited, but is preferably 1 to 45% by mass, more preferably 5 to 35% by mass, and further preferably 10 to 30% by mass.
  • the film may be produced according to a conventionally known procedure for producing a film used for capsules, and for example, at least one selected from the group consisting of swine-derived gelatin and fish-derived gelatin and, if necessary, the above-mentioned optional components. May be appropriately mixed and prepared.
  • the capsule contains the above-mentioned contents in the above-mentioned film.
  • the capsule may be produced according to a conventionally known procedure for producing a capsule, for example, at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil, and if necessary, a fatty acid triglyceride, and further if necessary.
  • the content prepared by appropriately mixing the above-mentioned arbitrary components is appropriately mixed with at least one selected from the group consisting of swine-derived gelatin and fish-derived gelatin and, if necessary, the above-mentioned arbitrary components. It can be produced by encapsulating the prepared film (capsule).
  • the capsule of the present invention may be produced by encapsulating the content in the film according to a conventionally known procedure for producing a capsule, such as filling the content in the film or encapsulating the content with the film.
  • the capsule of the present invention may be a soft capsule or a hard capsule.
  • examples of the shape of the capsule include an oval (football) type, an oblong (oblong ellipse) type, a round (spherical) type, a tear type, a triangle, and the like. It is preferably not limited as long as it can be taken.
  • the major axis is preferably 6 to 20 mm
  • the minor axis is 4 to 15 mm
  • the minor axis is 4 to 10 mm.
  • the capsule of the present invention may be used orally or parenterally, preferably orally.
  • the mode of use of the capsule is not limited and may be appropriately set according to the purpose. Illustrating the case of oral use as the mode of use, food compositions (including beverages, foods with health claims (foods for specified health uses, foods with nutritional function, foods with functional claims, supplements, etc.), health supplements, diseases (Including foods for personal use), pharmaceutical compositions, quasi-drug compositions, feed compositions, and food compositions, pharmaceutical compositions, quasi-drug compositions, additives for feed, etc. You can The capsule of the present invention may be swallowed promptly, or may be swallowed for a certain period of time in the oral cavity and then swallowed.
  • the subject to whom the capsule of the present invention is applied is not limited, and examples thereof include humans and non-human mammals.
  • mammals other than humans include animals such as guinea pigs, rabbits, dogs, cats, monkeys, and chimpanzees.
  • the capsule of the present invention by using at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil, it is possible to effectively insolubilize a film containing pig-derived gelatin or fish-derived gelatin. Can be suppressed.
  • the present invention also provides a content and a capsule having a film containing the content, the content containing at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil, and pork.
  • a method for suppressing the insolubilization of a film is provided, which is characterized by combining with a film containing at least one selected from the group consisting of gelatin derived from fish and gelatin derived from fish.
  • at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil, at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin, contents, film, capsules, etc. Will be described in the same manner as described above.
  • the method uses a content containing at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil, at least 1 selected from the group consisting of swine-derived gelatin and fish-derived gelatin. It can be said that it can be carried out by encapsulating in a film containing seeds.
  • the present invention as described above, it is possible to suppress the insolubilization of the film containing at least one selected from the group consisting of swine-derived gelatin and fish-derived gelatin. Allows for proper release.
  • Test example Preparation of contents and film Mint oil and fatty acid triglyceride were mixed as contents according to the composition of the following Table 1 to obtain transparent liquids (Examples 1 to 6 and Comparative Examples 1 to 3). Transparent liquids were obtained according to the compositions shown in Table 2 below (Examples 7 to 12 and Comparative Examples 4 to 6) in the same manner as described above except that menthol oil was used instead of peppermint oil. Transparent liquids were obtained according to the compositions shown in Table 3 below (Examples 13 to 18 and Comparative Examples 7 to 9) except that parsley seed oil was used instead of peppermint oil. Transparent liquids were obtained according to the compositions of the following Table 4 in the same manner as above except that mint flavor or lemon flavor was used instead of peppermint oil (Comparative Examples 10 to 15). No solid matter was visually observed in any of the obtained liquids.
  • Mint oil is the trade name of light-weight white oil (made by Nagaoka Jitsugyo Co., Ltd.), menton oil is the trade name of Menton oil 95% (made by Nagaoka Jitsugyo Co., Ltd.), and parsley seed oil is the trade name of parsley seed oil (Koei Kogyo Co., Ltd.).
  • Mint) mint flavor is trade name Spearmint oil (Takasago International Co., Ltd.)
  • lemon flavor is trade name Lemon Oil (Ogawa Fragrance Co., Ltd.)
  • fatty acid triglyceride is trade name J Sunflower White Oil (J-Oil Co., Ltd.) Mills) was used.
  • Sunflower oil generally contains about 95 to 100% by mass of fatty acid triglyceride, and contains fatty acid triglyceride containing oleic acid and linoleic acid as main constituent fatty acids.
  • Pig-derived gelatin is trade name KKSC (jelly strength described by the manufacturer (the same applies below) 250-280 g)
  • fish-derived gelatin is trade name SCG-230L (jelly strength 230-270 g)
  • beef-derived gelatin is trade name #250 ( Jelly strength of 235 to 265 g (all manufactured by Nitta Gelatin Co., Ltd.) was used.
  • the jelly strength is a value measured according to JIS K-6503 (2001). Specifically, the surface of a jelly prepared by cooling a 6.67 mass% gelatin aqueous solution at 10° C. for 17 hours is used. The load (g) was required to push down by 4 mm with a 1/2 inch (12.7 mm) diameter plunger.
  • peppermint oil, menthol oil, and parsley seed oil are excellent in suppressing the insolubilization of the film containing pig-derived gelatin and fish-derived gelatin.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
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Abstract

[Problem] The purpose of the present invention is to provide a novel means capable of suppressing insolubilization of a coating that includes gelatin. [Solution] Provided is a capsule characterized in that an ingredient that comprises at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthone oil is contained in a coating that comprises at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin.

Description

カプセル剤Capsule
　本発明はカプセル剤に関する。 The present invention relates to capsules.
　ゼラチンは、人体に対して毒性がなく安価であり、ゼリー形成能、増粘性等に優れている。このため、ゼラチンはカプセル剤の成分として医薬や食品等の分野におい広く使用されており、なかでも牛由来のゼラチンがカプセル剤の成分として汎用されている。 Gelatin is not toxic to the human body, is inexpensive, and has excellent jelly-forming ability and thickening properties. For this reason, gelatin is widely used as a component of capsules in the fields of medicine, foods, etc. Among them, gelatin derived from cattle is widely used as a component of capsules.
　しかし、ゼラチンをカプセル剤の皮膜として使用する場合、カプセルに充填された内容物との架橋反応等により、皮膜の溶解性が経時的に低下しやすい傾向がある。このような溶解性の低下は皮膜の不溶化をもたらし、例えば、有効成分が適切に放出されない等の不都合をもたらす。このため、皮膜の不溶化は、カプセル剤において品質低下等の深刻な問題につながる。 However, when gelatin is used as a capsule film, the solubility of the film tends to decrease over time due to a crosslinking reaction with the contents filled in the capsule. Such a decrease in solubility leads to insolubilization of the coating film, which causes inconveniences, for example, that the active ingredient is not appropriately released. Therefore, the insolubilization of the film leads to serious problems such as quality deterioration in the capsule.
　これまでに、皮膜の不溶化を抑制する手段として、例えば、イノシトールリン酸をゼラチンに配合して皮膜用組成物を作製し、これをカプセル剤の皮膜として使用する方法が知られている（特許文献１）。このような方法が従来知られているものの、皮膜の不溶化を抑制できる新たな手段を更に提供することは重要である。 As a means for suppressing the insolubilization of the film, for example, a method is known in which inositol phosphate is mixed with gelatin to prepare a film composition, and the composition is used as a film of a capsule (Patent Document 1). 1). Although such a method is conventionally known, it is important to further provide a new means capable of suppressing the insolubilization of the film.
特開２００６－３２８０３８号公報JP, 2006-328038, A
　本発明は、ゼラチンを含む皮膜の不溶化を抑制できる新たな手段を提供することを目的とする。 The present invention aims to provide a new means capable of suppressing the insolubilization of a film containing gelatin.
　本発明者らは、前記課題に鑑み鋭意検討を行ったところ、ハッカ油、パセリ種子油またはメントン油を牛由来ゼラチンと併用した場合よりも、これらの成分を豚由来または魚由来のゼラチンと併用した場合において、ゼラチンの不溶化を効果的に抑制できることを見出した。本発明は該知見に基づき更に検討を重ねた結果完成されたものであり、次に掲げるものである。 The present inventors have conducted intensive studies in view of the above-mentioned problems, and, as compared with the case where mint oil, parsley seed oil, or menthol oil is used in combination with cow-derived gelatin, these components are used in combination with pig-derived or fish-derived gelatin. In this case, it was found that insolubilization of gelatin can be effectively suppressed. The present invention has been completed as a result of further studies based on the findings, and is as follows.
項１．ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を含有する内容物が、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜に内包されていることを特徴とする、カプセル剤。
項２．内容物が更に脂肪酸トリグリセリドを含有し、該内容物中、該脂肪酸トリグリセリド１００質量部に対して、ハッカ油を２８質量部以下で含有する、項１に記載のカプセル剤。
項３．内容物が更に脂肪酸トリグリセリドを含有し、該内容物中、該脂肪酸トリグリセリド１００質量部に対して、パセリ種子油を２８質量部以下で含有する、項１または２に記載のカプセル剤。
項４．内容物が更に脂肪酸トリグリセリドを含有し、該内容物中、該脂肪酸トリグリセリド１００質量部に対して、メントン油を２８質量部以下で含有する、項１～３のいずれかに記載のカプセル剤。
項５．ソフトカプセル剤である、項１～４のいずれかに記載のカプセル剤。
項６．内容物及びこれを内包する皮膜を有するカプセル剤において、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を含有する内容物と、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜とを組み合わせることを特徴とする、該皮膜の不溶化抑制方法。 Item 1. The content containing at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil is encapsulated in a film containing at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin. Capsule characterized in that
Item 2. Item 2. The capsule according to Item 1, wherein the content further contains a fatty acid triglyceride, and the content contains mint oil at 28 parts by mass or less based on 100 parts by mass of the fatty acid triglyceride.
Item 3. Item 3. The capsule according to Item 1 or 2, wherein the content further contains a fatty acid triglyceride, and the content contains parsley seed oil in an amount of 28 parts by mass or less based on 100 parts by mass of the fatty acid triglyceride.
Item 4. Item 4. The capsule according to any one of Items 1 to 3, wherein the content further contains a fatty acid triglyceride, and the content contains menthon oil in an amount of 28 parts by mass or less based on 100 parts by mass of the fatty acid triglyceride.
Item 5. Item 5. The capsule according to any one of Items 1 to 4, which is a soft capsule.
Item 6. In a capsule having a content and a film containing the content, a content containing at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil, and a group consisting of pig-derived gelatin and fish-derived gelatin A method for suppressing insolubilization of a coating, which comprises combining with a coating containing at least one selected from the following.
　本発明のカプセル剤や方法によれば、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜の不溶化を抑制することができる。 According to the capsule and method of the present invention, it is possible to suppress the insolubilization of the film containing at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin.
　本発明は、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を含有する内容物が、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜に内包されていることを特徴とする、カプセル剤を提供する。 In the present invention, the content containing at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil contains at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin. Provided is a capsule characterized by being encapsulated in a film.
内容物
　本発明のカプセル剤において、内容物は、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を含有する。 Contents In the capsule of the present invention, the contents contain at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil.
　ハッカ油は、ハッカの地上部を水蒸気蒸留により精製して得られる精油であり、ＣＡＳ　Ｎｏ．８００６－９０－４としても知られている。ハッカ油は商業的に入手可能であり、例えば薄荷白油（長岡実業株式会社製）、日本薬局方ハッカ油（小川香料株式会社製）等として市販されている。 Mint oil is an essential oil obtained by refining the above-ground parts of peppermint by steam distillation, and CAS No. Also known as 8006-90-4. Mint oil is commercially available, and is commercially available as, for example, light-weight white oil (manufactured by Nagaoka Jitsugyo Co., Ltd.), Japanese Pharmacopoeia peppermint oil (manufactured by Ogawa Fragrance Co., Ltd.) and the like.
　内容物中、ハッカ油の含有量は制限されないが、好ましくは０．２～２２質量％、より好ましくは０．５～２０質量％、更に好ましくは１～１０質量％が例示される。 The content of peppermint oil in the contents is not limited, but is preferably 0.2 to 22% by mass, more preferably 0.5 to 20% by mass, and further preferably 1 to 10% by mass.
　パセリ種子油は、パセリの種子から得られる精油であり、ＣＡＳ　Ｎｏ．８０００－６８－８としても知られている。パセリ種子油は商業的に入手可能であり、例えば、パセリ種子油（香栄興業株式会社製）等として市販されている。 Parsley seed oil is an essential oil obtained from the seeds of parsley. Also known as 8000-68-8. Parsley seed oil is commercially available, for example, as parsley seed oil (manufactured by Koei Kogyo Co., Ltd.) and the like.
　内容物中、パセリ種子油の含有量は制限されないが、好ましくは０．０５～２２質量％、より好ましくは０．１～１０質量％、更に好ましくは０．１５～５質量％が例示される。 The content of parsley seed oil in the contents is not limited, but is preferably 0.05 to 22% by mass, more preferably 0.1 to 10% by mass, and further preferably 0.15 to 5% by mass. ..
　メントン油は、ハッカ属に属する植物を水蒸気蒸留して得た精油を脱脳油と粗脳に分離し、ここで分離した脱脳油から得られる。メントン油は商業的に入手可能であり、例えばメントン油（長岡実業株式会社製）等として市販されている。従来知られている通り、メントン油はメントンを主成分として含有し、前記ハッカ油はメントールを主成分として含有する。 Mentone oil is obtained by debraining the essential oil obtained by steam-distilling a plant belonging to the genus Mint and separating it into decerebrated oil and crude brain. Mentone oil is commercially available, and is commercially available, for example, as Mentone oil (manufactured by Nagaoka Jitsugyo Co., Ltd.). As is conventionally known, menthol oil contains mentone as a main component, and the mint oil contains menthol as a main component.
　内容物中、メントン油の含有量は制限されないが、好ましくは１～２２質量％、より好ましくは３～１８質量％、更に好ましくは５～１５質量％が例示される。 The content of menthol oil in the contents is not limited, but is preferably 1 to 22% by mass, more preferably 3 to 18% by mass, and further preferably 5 to 15% by mass.
　また、本発明を制限するものではないが、本発明の内容物がハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも２種を含有する場合、内容物中、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも２種の含有量は総量で、好ましくは０．２～３０質量％、より好ましくは５～２５質量％、更に好ましくは１０～２０質量％が例示される。 Although not limiting the present invention, when the content of the present invention contains at least two kinds selected from the group consisting of mint oil, parsley seed oil and menthol oil, the content of mint oil, parsley The content of at least two kinds selected from the group consisting of seed oil and menthol oil is preferably 0.2 to 30% by mass, more preferably 5 to 25% by mass, further preferably 10 to 20% by mass. It is illustrated.
　本発明の内容物は、この限りにおいて制限されないが、好ましくは更に脂肪酸トリグリセリドを含有する。 The content of the present invention is not limited to this, but preferably further contains a fatty acid triglyceride.
　脂肪酸トリグリセリドは、１つのグリセロールに３つの脂肪酸がエステル結合した構造を有する化合物である。グリセロールにエステル結合する脂肪酸は、飽和脂肪酸であっても不飽和脂肪酸であってもよく、また、直鎖脂肪酸であっても分岐鎖脂肪酸であってもよい。該脂肪酸の炭素数も制限されないが、好ましくは炭素数８～２２、より好ましくは炭素数１０～２１、更に好ましくは１２～２０の脂肪酸が例示される。この限りにおいて制限されないが、脂肪酸として、カプリル酸、カプリン酸、ラウリン酸、ミリスチン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、オレイン酸、リノール酸、リノレン酸、アラキジン酸、ベヘン酸、リグノセリン酸等が例示される。１つのグリセロールに結合する３つの脂肪酸は、それぞれ同じであってもよく、２種のみが同じであってもよく、互いに異なってもよい。脂肪酸トリグリセリドは、１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。 Fatty acid triglyceride is a compound having a structure in which three fatty acids are ester-bonded to one glycerol. The fatty acid ester-bonded to glycerol may be a saturated fatty acid or an unsaturated fatty acid, and may be a straight chain fatty acid or a branched chain fatty acid. The number of carbon atoms of the fatty acid is not limited, but fatty acids having preferably 8 to 22 carbon atoms, more preferably 10 to 21 carbon atoms, and further preferably 12 to 20 carbon atoms are exemplified. Not limited to this, as the fatty acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidic acid, behenic acid, lignoceric acid, etc. It is illustrated. The three fatty acids bound to one glycerol may be the same, only two may be the same, or different from each other. The fatty acid triglyceride may be used alone or in combination of two or more.
　脂肪酸トリグリセリドは、例えば、ヒマワリ油、サフラワー油、菜種油、オリーブ油、綿実油、大豆油、ゴマ油、トウモロコシ油、落花生油、ブドウ油、ヤシ油等の植物油、ラード、魚油、牛脂等の動物油等にも多く含有されている。このため、内容物にはこれらの植物油、動物油等を用いてもよい。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。 Fatty acid triglycerides include, for example, sunflower oil, safflower oil, rapeseed oil, olive oil, cottonseed oil, soybean oil, sesame oil, corn oil, peanut oil, vegetable oils such as grape oil and palm oil, animal oils such as lard, fish oil and beef tallow. Contains a lot. Therefore, these vegetable oils, animal oils and the like may be used for the contents. These may be used alone or in combination of two or more.
　本発明の内容物が脂肪酸トリグリセリドを含有する場合、本発明を制限するものではないが、内容物中、該脂肪酸トリグリセリド１００質量部に対して、ハッカ油が好ましくは２８質量部以下、より好ましくは０．５～２７質量部、更に好ましくは０．５～２０質量部、特に好ましくは１～１２質量部が例示される。 When the content of the present invention contains a fatty acid triglyceride, the present invention is not limited, but the peppermint oil is preferably 28 parts by mass or less, more preferably 100 parts by mass of the fatty acid triglyceride in the content. The amount is, for example, 0.5 to 27 parts by mass, more preferably 0.5 to 20 parts by mass, and particularly preferably 1 to 12 parts by mass.
　本発明の内容物が脂肪酸トリグリセリドを含有する場合、本発明を制限するものではないが、内容物中、該脂肪酸トリグリセリド１００質量部に対して、パセリ種子油が２８質量部以下、より好ましくは０．１～２７質量部、更に好ましくは０．２～１５質量部、特に好ましくは０．２～１２質量部が例示される。 When the content of the present invention contains a fatty acid triglyceride, the present invention is not limited, but the content of parsley seed oil is not more than 28 parts by mass, more preferably 0, based on 100 parts by mass of the fatty acid triglyceride. 1 to 27 parts by mass, more preferably 0.2 to 15 parts by mass, particularly preferably 0.2 to 12 parts by mass.
　本発明の内容物が脂肪酸トリグリセリドを含有する場合、本発明を制限するものではないが、内容物中、該脂肪酸トリグリセリド１００質量部に対して、メントン油が２８質量部以下、より好ましくは１～２７質量部、更に好ましくは１～２０質量部、特に好ましくは５～２０質量部が例示される。 When the content of the present invention contains fatty acid triglyceride, the present invention is not limited, but the content of menthon oil is 28 parts by mass or less, more preferably 1 to 100 parts by mass of the fatty acid triglyceride. 27 parts by mass, more preferably 1 to 20 parts by mass, particularly preferably 5 to 20 parts by mass.
　内容物中、脂肪酸トリグリセリドの含有量は制限されないが、好ましくは６０～９９．９５質量％、より好ましくは７０～９９．９質量％、更に好ましくは７５～９９．８質量％が例示される。 The content of the fatty acid triglyceride in the content is not limited, but is preferably 60 to 99.95% by mass, more preferably 70 to 99.9% by mass, and further preferably 75 to 99.8% by mass.
　この限りにおいて制限されないが、内容物がハッカ油を含有する場合、該内容物中、脂肪酸トリグリセリドの含有量は制限されないが、好ましくは６０～９９．９質量％、より好ましくは６５～９９．５質量％、更に好ましくは７０～９９質量％が例示される。 Although not limited thereto, when the content contains peppermint oil, the content of fatty acid triglyceride in the content is not limited, but is preferably 60 to 99.9 mass%, more preferably 65 to 99.5. The amount is, for example, 70 to 99% by mass, and more preferably 70 to 99% by mass.
　この限りにおいて制限されないが、内容物がパセリ種子油を含有する場合、該内容物中、脂肪酸トリグリセリドの含有量は制限されないが、好ましくは６５～９９．９５質量％、より好ましくは７０～９９．９質量％、更に好ましくは７５～９９．８質量％が例示される。 Although not limited thereto, when the content contains parsley seed oil, the content of fatty acid triglyceride in the content is not limited, but is preferably 65 to 99.95% by mass, more preferably 70 to 99.95% by mass. The amount is, for example, 9% by mass, more preferably 75 to 99.8% by mass.
　この限りにおいて制限されないが、内容物がメントン油を含有する場合、該内容物中、脂肪酸トリグリセリドの含有量は制限されないが、好ましくは６５～９９質量％、より好ましくは７０～９７質量％、更に好ましくは７５～９５質量％が例示される。 Although not limited thereto, when the content contains menthon oil, the content of fatty acid triglyceride in the content is not limited, but is preferably 65 to 99% by mass, more preferably 70 to 97% by mass, and further It is preferably 75 to 95% by mass.
　内容物には、本発明の効果を損なわない範囲で必要に応じて、薬学的に許容される成分、香粧学的に許容される成分、可食性の成分といった任意の成分を更に含有してもよい。該成分として好ましくは可食可能な成分が挙げられる。 If necessary, the contents further contain any component such as a pharmaceutically acceptable component, a cosmetically acceptable component, and an edible component as long as the effects of the present invention are not impaired. Good. As the component, an edible component is preferable.
　該任意の成分として、水、可塑剤、着色料、アミノ酸、ビタミン類、酵素、甘味料、清涼剤、香料、賦形剤、崩壊剤、流動化剤、界面活性剤、矯味剤、矯臭剤、懸濁剤、湿潤剤、乳化剤、可溶化剤、分散剤、緩衝剤、結合剤、浸透促進剤、安定剤、増量剤、防腐剤、増粘剤、ｐＨ調整剤、コーティング剤、吸収促進剤、酸化防止剤、抗炎症剤、蝋、各種有用成分等が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよく、その含有量も本発明の効果を損なわない限り適宜決定すればよい。 As the optional components, water, plasticizers, colorants, amino acids, vitamins, enzymes, sweeteners, cooling agents, flavors, excipients, disintegrating agents, superplasticizers, surfactants, flavoring agents, flavoring agents, Suspending agents, wetting agents, emulsifying agents, solubilizing agents, dispersing agents, buffers, binders, penetration enhancers, stabilizers, extenders, preservatives, thickeners, pH adjusters, coating agents, absorption enhancers, Examples include antioxidants, anti-inflammatory agents, waxes, various useful ingredients, and the like. These may be used alone or in combination of two or more, and the content thereof may be appropriately determined as long as the effect of the present invention is not impaired.
　内容物の形態は制限されず、固形状（粉末状、顆粒状等）、半固形状（ゲル状（ゼリー状）、クリーム状、ペースト状等）、液状等のいずれであってもよい。内容物の形態として、好ましくは半固形状または液状が例示される。 The form of the content is not limited, and may be solid (powder, granule, etc.), semi-solid (gel (jelly), cream, paste, etc.), liquid or the like. The form of the contents is preferably semi-solid or liquid.
　内容物は、従来公知のカプセル剤に内包される内容物の製造手順に従い製造すればよく、例えば、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種、必要に応じて脂肪酸トリグリセリド、更に必要に応じて前記任意の成分を適宜混合等して調製すればよい。 The content may be produced according to the procedure for producing the content contained in a conventionally known capsule, for example, at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil, and if necessary. A fatty acid triglyceride and, if necessary, the above optional components may be appropriately mixed and prepared.
皮膜
　また、本発明のカプセル剤において、皮膜は、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する。 Film In the capsule of the present invention, the film contains at least one selected from the group consisting of gelatin derived from swine and gelatin derived from fish.
　豚由来ゼラチンや魚由来ゼラチンは、食品、医薬品、医薬部外品等の分野において従来使用されているゼラチンであればよく、好ましくは可食性のゼラチンが例示される。この限りにおいて制限されないが、該ゼラチンとして、豚や魚の皮、骨、腱、靭帯、鱗等を原料とした、酸及び／またはアルカリ処理ゼラチン、アシル化ゼラチン等の化学修飾ゼラチン、ゼラチンの加水分解物等のゼラチンが例示される。これらのゼラチンは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。豚由来ゼラチンや魚由来ゼラチンは商業的に入手可能であり、例えば株式会社ニッピ、新田ゼラチン株式会社、ゼライス株式会社、Ｒｏｕｓｓｅｌｏｔ社、Ｗｅｉｓｈａｒｄｔ社等から市販されている。 The swine-derived gelatin and fish-derived gelatin may be any gelatin that has been conventionally used in the fields of foods, pharmaceuticals, quasi-drugs, and the like, and edible gelatin is preferable. Although not limited thereto, the gelatin is a chemically modified gelatin such as acid- and/or alkali-treated gelatin, acylated gelatin, etc., which is made from pig or fish skin, bone, tendon, ligament, scale, etc., and hydrolysis of gelatin. Examples include gelatin such as things. These gelatins may be used alone or in combination of two or more. Pig-derived gelatin and fish-derived gelatin are commercially available, and are commercially available from, for example, Nippi Co., Ltd., Nitta Gelatin Co., Ltd., Zerais Co., Rousselott, Weishhardt, etc.
　豚由来ゼラチンや魚由来ゼラチンは、この限りにおいて制限されないが、該ゼラチンのゼリー強度（ブルーム値）を適宜選択して使用してもよい。本発明を制限するものではないが、ゼラチンのゼリー強度は、好ましくは５０～３５０ｇ、より好ましくは８０～３００ｇの範囲が例示される。ゼラチンのゼリー強度はＪＩＳ　Ｋ－６５０３（２００１）に準じて測定され、具体的には、６．６７質量％のゼラチン水溶液を、１０℃で１７時間冷却して調製したゼリーの表面を２分の１インチ（１２．７ｍｍ）径のプランジャーで４ｍｍ押し下げるのに必要な荷重（ｇ）をゼリー強度とする。 Pork-derived gelatin and fish-derived gelatin are not limited as long as they are present, but the jelly strength (Bloom value) of the gelatin may be appropriately selected and used. Although not limiting the present invention, the jelly strength of gelatin is preferably in the range of 50 to 350 g, more preferably 80 to 300 g. The jelly strength of gelatin is measured according to JIS K-6503 (2001). Specifically, the surface of the jelly prepared by cooling a 6.67 mass% gelatin aqueous solution at 10° C. for 17 hours is 2 minutes. The jelly strength is defined as the load (g) required to push down by 4 mm with a 1 inch (12.7 mm) diameter plunger.
　皮膜中、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種の含有量は制限されないが、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種が総量で、皮膜中、好ましくは１５～８５質量％、より好ましくは２０～８０質量％、更に好ましくは２５～７５質量％が例示される。 The content of at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin in the coating is not limited, but the total amount of at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin is The content is preferably 15 to 85% by mass, more preferably 20 to 80% by mass, and further preferably 25 to 75% by mass.
　また、本発明を制限するものではないが、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種の総量１００質量部に対して、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種が総量で、好ましくは１～５０質量部、より好ましくは３～４５質量部、更に好ましくは５～３５質量部が例示される。 Further, although not limiting the present invention, a group consisting of peppermint oil, parsley seed oil and menthol oil based on 100 parts by mass of at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin. The total amount of at least one selected from the group is preferably 1 to 50 parts by mass, more preferably 3 to 45 parts by mass, further preferably 5 to 35 parts by mass.
　皮膜には、本発明の効果を損なわない範囲で必要に応じて、薬学的に許容される成分、香粧学的に許容される成分、可食性の成分といった任意の成分を更に含有してもよい。該成分として好ましくは可食可能な成分が挙げられる。 The film may further contain any component such as a pharmaceutically acceptable component, a cosmetically acceptable component, and an edible component, if necessary, as long as the effect of the present invention is not impaired. Good. As the component, an edible component is preferable.
　該任意の成分として、水、可塑剤、賦形剤、崩壊剤、流動化剤、界面活性剤、滑沢剤、香料、着色料、甘味料、矯味剤、矯臭剤、懸濁剤、湿潤剤、乳化剤、可溶化剤、分散剤、緩衝剤、結合剤、浸透促進剤、安定剤、増量剤、防腐剤、増粘剤、油性基剤、ｐＨ調整剤、コーティング剤、吸収促進剤、酸化防止剤、抗炎症剤、清涼剤、アミノ酸、ビタミン類、酵素、各種有用成分等が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよく、その含有量も本発明の効果を損なわない限り適宜決定すればよい。なお、本発明を制限するものではないが、好ましくは、本発明において皮膜は牛由来のゼラチンを含まない。 As the optional component, water, a plasticizer, an excipient, a disintegrating agent, a fluidizing agent, a surfactant, a lubricant, a flavoring agent, a coloring agent, a sweetener, a flavoring agent, a flavoring agent, a suspending agent, a wetting agent. , Emulsifiers, solubilizers, dispersants, buffers, binders, penetration enhancers, stabilizers, bulking agents, preservatives, thickeners, oily bases, pH adjusters, coating agents, absorption enhancers, antioxidants Examples include agents, anti-inflammatory agents, cooling agents, amino acids, vitamins, enzymes, and various useful ingredients. These may be used alone or in combination of two or more, and the content thereof may be appropriately determined as long as the effect of the present invention is not impaired. Although not limiting the present invention, preferably, in the present invention, the coating does not contain bovine-derived gelatin.
　本発明を制限するものではないが、該任意の成分の一例として可塑剤について説明すると、可塑剤としてグリセリン；プロピレングルコールやポリエチレングリコール等のグリコール類；スクロース、フルクトース、ソルビトール、マンニトール、コーンシロップ等の液状糖類；結晶セルロース、低置換度ヒドロキシプロピルセルロース、エチルセルロース等の水不溶性セルロース等が例示される。これらはいずれも１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。また、皮膜中の可塑剤の含有量は制限されないが、好ましくは１～４５質量％、より好ましくは５～３５質量％、更に好ましくは１０～３０質量％が例示される。 Although not limiting the present invention, a plasticizer will be described as an example of the optional component. Glycerin as a plasticizer; glycols such as propylene glycol and polyethylene glycol; sucrose, fructose, sorbitol, mannitol, corn syrup, etc. Liquid saccharides; crystalline cellulose, low-substituted hydroxypropyl cellulose, water-insoluble cellulose such as ethyl cellulose, and the like. Any of these may be used alone or in combination of two or more. The content of the plasticizer in the film is not limited, but is preferably 1 to 45% by mass, more preferably 5 to 35% by mass, and further preferably 10 to 30% by mass.
　皮膜は、従来公知のカプセル剤に使用される皮膜の製造手順に従い製造すればよく、例えば、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種と必要に応じて前記任意の成分を適宜混合等して調製すればよい。 The film may be produced according to a conventionally known procedure for producing a film used for capsules, and for example, at least one selected from the group consisting of swine-derived gelatin and fish-derived gelatin and, if necessary, the above-mentioned optional components. May be appropriately mixed and prepared.
カプセル剤
　本発明においてカプセル剤は、前述の内容物が、前述の皮膜に内包されている。カプセル剤は、従来公知のカプセル剤の製造手順に従い製造すればよく、例えば、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種、必要に応じて脂肪酸トリグリセリド、更に必要に応じて前記任意の成分を適宜混合等して調製した内容物を、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種と必要に応じて前記任意の成分とを適宜混合等して調製した皮膜（カプセル）に内包することにより製造することができる。本発明のカプセル剤は、皮膜内に内容物を充填したり、皮膜で内容物を被包するなど、従来公知のカプセル剤の製造手順に従って皮膜に内容物を内包することにより製造すればよい。 Capsule In the present invention, the capsule contains the above-mentioned contents in the above-mentioned film. The capsule may be produced according to a conventionally known procedure for producing a capsule, for example, at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil, and if necessary, a fatty acid triglyceride, and further if necessary. Accordingly, the content prepared by appropriately mixing the above-mentioned arbitrary components is appropriately mixed with at least one selected from the group consisting of swine-derived gelatin and fish-derived gelatin and, if necessary, the above-mentioned arbitrary components. It can be produced by encapsulating the prepared film (capsule). The capsule of the present invention may be produced by encapsulating the content in the film according to a conventionally known procedure for producing a capsule, such as filling the content in the film or encapsulating the content with the film.
　本発明のカプセル剤は、ソフトカプセル剤であってもハードカプセル剤であってもよい。また、本発明を制限するものではないが、カプセル剤の形状としてオーバール（フットボール）型、オブロング（長楕円）型、ラウンド（球状）型、涙型、三角形等が例示され、その大きさも好ましくは服用可能な限り制限されず、例えばオーバール型の場合は、好ましくは長径６～２０ｍｍ、短径４～１５ｍｍ、より好ましくは長径６～１５ｍｍ、短径４～１０ｍｍが挙げられる。 The capsule of the present invention may be a soft capsule or a hard capsule. Although not limiting the present invention, examples of the shape of the capsule include an oval (football) type, an oblong (oblong ellipse) type, a round (spherical) type, a tear type, a triangle, and the like. It is preferably not limited as long as it can be taken. For example, in the case of an oval type, the major axis is preferably 6 to 20 mm, the minor axis is 4 to 15 mm, more preferably the major axis is 6 to 15 mm, and the minor axis is 4 to 10 mm.
　本発明のカプセル剤は経口、非経口のいずれで使用してもよく、好ましくは経口で使用される。カプセル剤の使用態様は制限されず、目的に応じて適宜設定すればよい。該使用態様として経口で使用する場合を例示すると、食品組成物（飲料を含む、保健機能食品（特定保健用食品、栄養機能食品、機能性表示食品、サプリメント等を含む）、健康補助食品、病者用食品を含む）、医薬組成物、医薬部外品組成物、飼料組成物、また、食品組成物、医薬組成物、医薬部外品組成物、飼料等への添加剤等として使用することができる。本発明のカプセル剤は、例えば、速やかに飲み込むものであってもよく、口腔内に一定時間とどめておき、その後飲み込むものであってもよい。 The capsule of the present invention may be used orally or parenterally, preferably orally. The mode of use of the capsule is not limited and may be appropriately set according to the purpose. Illustrating the case of oral use as the mode of use, food compositions (including beverages, foods with health claims (foods for specified health uses, foods with nutritional function, foods with functional claims, supplements, etc.), health supplements, diseases (Including foods for personal use), pharmaceutical compositions, quasi-drug compositions, feed compositions, and food compositions, pharmaceutical compositions, quasi-drug compositions, additives for feed, etc. You can The capsule of the present invention may be swallowed promptly, or may be swallowed for a certain period of time in the oral cavity and then swallowed.
　本発明のカプセル剤を適用（摂取、投与等）する対象者も制限されず、ヒト、ヒト以外の哺乳動物が例示される。ヒト以外の哺乳動物としては、モルモット、ウサギ、イヌ、ネコ、サル、チンパンジー等の動物が例示される。 The subject to whom the capsule of the present invention is applied (ingestion, administration, etc.) is not limited, and examples thereof include humans and non-human mammals. Examples of mammals other than humans include animals such as guinea pigs, rabbits, dogs, cats, monkeys, and chimpanzees.
　本発明のカプセル剤によれば、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を用いることにより、豚由来ゼラチンや魚由来ゼラチンを含有する皮膜の不溶化を効果的に抑制することができる。 According to the capsule of the present invention, by using at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil, it is possible to effectively insolubilize a film containing pig-derived gelatin or fish-derived gelatin. Can be suppressed.
　このことから、本発明はまた、内容物及びこれを内包する皮膜を有するカプセル剤において、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を含有する内容物と、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜とを組み合わせることを特徴とする、該皮膜の不溶化抑制方法を提供するといえる。該方法において、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種、内容物、皮膜、カプセル剤等については、前述と同様にして説明される。このことから、該方法は、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を含有する内容物を、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜に内包することにより実施できるといえる。 From this, the present invention also provides a content and a capsule having a film containing the content, the content containing at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil, and pork. It can be said that a method for suppressing the insolubilization of a film is provided, which is characterized by combining with a film containing at least one selected from the group consisting of gelatin derived from fish and gelatin derived from fish. In the method, at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil, at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin, contents, film, capsules, etc. Will be described in the same manner as described above. From this, the method uses a content containing at least one selected from the group consisting of peppermint oil, parsley seed oil, and menthol oil, at least 1 selected from the group consisting of swine-derived gelatin and fish-derived gelatin. It can be said that it can be carried out by encapsulating in a film containing seeds.
　本発明によれば、このように、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜の不溶化を抑制することができ、ひいてはカプセル剤に含まれる有効成分のより適切な放出を可能にする。 According to the present invention, as described above, it is possible to suppress the insolubilization of the film containing at least one selected from the group consisting of swine-derived gelatin and fish-derived gelatin. Allows for proper release.
　以下、実施例を示して本発明をより詳細に説明するが、本発明はこれらに限定されない。 Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited thereto.
試験例
内容物及び皮膜の調製
　次の表１の組成に従って、内容物として、ハッカ油と脂肪酸トリグリセリドとを混合し、透明な液体を得た（実施例１～６、比較例１～３）。ハッカ油に代えてメントン油を使用した以外は前述と同様にして、次の表２の組成に従って透明な液体を得た（実施例７～１２、比較例４～６）。ハッカ油に代えてパセリ種子油を使用した以外は前述と同様にして、次の表３の組成に従って透明な液体を得た（実施例１３～１８、比較例７～９）。ハッカ油に代えてミント香料またはレモン香料を使用した以外は前述と同様にして、次の表４の組成に従って透明な液体を得た（比較例１０～１５）。得られたいずれの液体にも固形物は目視で認められなかった。 Test example
Preparation of contents and film Mint oil and fatty acid triglyceride were mixed as contents according to the composition of the following Table 1 to obtain transparent liquids (Examples 1 to 6 and Comparative Examples 1 to 3). Transparent liquids were obtained according to the compositions shown in Table 2 below (Examples 7 to 12 and Comparative Examples 4 to 6) in the same manner as described above except that menthol oil was used instead of peppermint oil. Transparent liquids were obtained according to the compositions shown in Table 3 below (Examples 13 to 18 and Comparative Examples 7 to 9) except that parsley seed oil was used instead of peppermint oil. Transparent liquids were obtained according to the compositions of the following Table 4 in the same manner as above except that mint flavor or lemon flavor was used instead of peppermint oil (Comparative Examples 10 to 15). No solid matter was visually observed in any of the obtained liquids.
　別途、豚由来ゼラチン１０ｇ、水２０ｇ及びグリセリン４ｇを混合して、ゼラチンを加熱溶解（８０℃）し、次いで冷却（２５℃）して、冷却物を、１枚あたり１．５ｃｍ×１．５ｃｍ（重さ８０ｍｇ）のシートになるように裁断し、豚由来ゼラチンを含む皮膜片（豚ゼラチン皮膜片）を作製した。豚由来ゼラチンを魚由来ゼラチン、牛由来ゼラチンに代えた以外は同様にして、魚由来ゼラチンを含む皮膜片（魚ゼラチン皮膜片）、牛由来ゼラチンを含む皮膜片（牛ゼラチン皮膜片）を作製した。 Separately, 10 g of pork-derived gelatin, 20 g of water and 4 g of glycerin were mixed, and the gelatin was dissolved by heating (80°C), then cooled (25°C), and the cooled product was 1.5 cm x 1.5 cm per sheet. It was cut into a sheet having a weight of 80 mg to prepare a film piece containing pig-derived gelatin (pork gelatin film piece). A film piece containing fish-derived gelatin (fish gelatin film piece) and a film piece containing cow-derived gelatin (bovine gelatin film piece) were prepared in the same manner except that the pig-derived gelatin was replaced with fish-derived gelatin or bovine-derived gelatin. ..
　なお、ハッカ油は商品名薄荷白油（長岡実業株式会社製）、メントン油は商品名メントン油９５％（長岡実業株式会社製）、パセリ種子油は商品名パセリ種子油（香栄興業株式会社製）、ミント香料は商品名スペアミントオイル（高砂香料工業株式会社製）、レモン香料は商品名レモンオイル（小川香料株式会社製）、脂肪酸トリグリセリドは商品名Ｊひまわり白絞油（株式会社Ｊ－オイルミルズ社製）を使用した。なお、ひまわり油は、一般的に、脂肪酸トリグリセリドを約９５～１００質量％含有し、主な構成脂肪酸としてオレイン酸及びリノール酸を含む脂肪酸トリグリセリドを含有する。 Mint oil is the trade name of light-weight white oil (made by Nagaoka Jitsugyo Co., Ltd.), menton oil is the trade name of Menton oil 95% (made by Nagaoka Jitsugyo Co., Ltd.), and parsley seed oil is the trade name of parsley seed oil (Koei Kogyo Co., Ltd.). Mint), mint flavor is trade name Spearmint oil (Takasago International Co., Ltd.), lemon flavor is trade name Lemon Oil (Ogawa Fragrance Co., Ltd.), and fatty acid triglyceride is trade name J Sunflower White Oil (J-Oil Co., Ltd.) Mills) was used. Sunflower oil generally contains about 95 to 100% by mass of fatty acid triglyceride, and contains fatty acid triglyceride containing oleic acid and linoleic acid as main constituent fatty acids.
　豚由来ゼラチンは商品名ＫＫＳＣ（製造社により記載のゼリー強度（以下同様）２５０～２８０ｇ）、魚由来ゼラチンは商品名ＳＣＧ－２３０Ｌ（ゼリー強度２３０～２７０ｇ）、牛由来ゼラチンは商品名♯２５０（ゼリー強度２３５～２６５ｇ）（いずれも新田ゼラチン株式会社製）を使用した。ゼリー強度は、ＪＩＳ　Ｋ－６５０３（２００１）に準じて測定された値であり、具体的には、６．６７質量％のゼラチン水溶液を、１０℃で１７時間冷却して調製したゼリーの表面を２分の１インチ（１２．７ｍｍ）径のプランジャーで４ｍｍ押し下げるのに必要な荷重（ｇ）であった。 Pig-derived gelatin is trade name KKSC (jelly strength described by the manufacturer (the same applies below) 250-280 g), fish-derived gelatin is trade name SCG-230L (jelly strength 230-270 g), and beef-derived gelatin is trade name #250 ( Jelly strength of 235 to 265 g (all manufactured by Nitta Gelatin Co., Ltd.) was used. The jelly strength is a value measured according to JIS K-6503 (2001). Specifically, the surface of a jelly prepared by cooling a 6.67 mass% gelatin aqueous solution at 10° C. for 17 hours is used. The load (g) was required to push down by 4 mm with a 1/2 inch (12.7 mm) diameter plunger.
　前記内容物及び皮膜片の作製後、次の不溶化試験を行った。前述のようにして作製したゼラチン皮膜片１枚を、前述のようにして作製した各内容物４ｍＬ（５０℃）に１週間、静置で完全に浸漬した。次いで、ゼラチン皮膜片を内容物から取り出し、ヘキサンで洗浄後、ゼラチン皮膜片を６０℃の水５０ｍＬに完全に浸漬し（５０ｍＬのビーカー使用）、スターラーを用いて５分間撹拌（回転数６７０ｒｐｍ）した。次いで、静止状態で目視観察し、ゼラチン皮膜片の不溶化の評価を次のようにして行った。なお、ヘキサンで洗浄後の（水浸漬前の）ゼラチン皮膜片はいずれも、内容物に浸漬前の形状を維持していた。 After the above-mentioned contents and film pieces were prepared, the following insolubilization test was conducted. One piece of the gelatin coating film produced as described above was completely immersed in 4 mL (50° C.) of each content produced as described above for one week while still standing. Then, the gelatin film piece was taken out from the contents, washed with hexane, completely immersed in 50 mL of water at 60° C. (using a 50 mL beaker), and stirred for 5 minutes using a stirrer (rotation speed 670 rpm). .. Then, visual observation was carried out in a stationary state, and the insolubilization of the gelatin film pieces was evaluated as follows. The gelatin film pieces after washing with hexane (before immersion in water) maintained the shape before immersion in the contents.
＜評価＞
◎：ゼラチン皮膜片が完全に溶解し、不溶物が全く認められなかった。
○：ゼラチン皮膜片は溶解するが、不溶物が若干（水浸漬直前のゼラチン皮膜の質量と比較して１０質量％以下の不溶物）認められた。
△：ゼラチン皮膜片は溶解するが、不溶物が多く（水浸漬直前のゼラチン皮膜の質量と比較して１０質量％より多く５０質量％以下の不溶物）認められた。
×：ゼラチン皮膜片がほとんど溶解せず、不溶物が非常に多く（水浸漬直前のゼラチン皮膜の質量と比較して５０質量％より多くの不溶物）認められた。 <Evaluation>
⊚: Gelatin film pieces were completely dissolved and no insoluble matter was observed.
◯: The gelatin film pieces were dissolved, but a small amount of insoluble matter (10% by mass or less of insoluble matter compared to the weight of the gelatin film immediately before immersion in water) was observed.
(Triangle|delta): The gelatin film piece melt|dissolved, but many insoluble matter (The insoluble matter of more than 10 mass% and 50 mass% or less compared with the mass of the gelatin film just before water immersion) was recognized.
X: Gelatin film pieces were hardly dissolved, and a large amount of insoluble matter (more than 50 mass% of insoluble matter compared to the mass of the gelatin film immediately before immersion in water) was observed.
結果
　結果を表１～４に示す。 Results The results are shown in Tables 1 to 4.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000004
　ハッカ油を用いた表１の比較例１～３に示す通り、皮膜片として牛ゼラチン皮膜片を用いた場合、皮膜片の不溶物が多量に認められた。これに対して、表１の実施例１～６に示す通り、皮膜片として豚ゼラチン皮膜片、魚ゼラチン皮膜片を用いた場合は、皮膜片の不溶物がほとんど認められなかった。これらの結果から、ハッカ油は、豚ゼラチン皮膜や魚ゼラチン皮膜の不溶化抑制に優れていることが分かった。 As shown in Comparative Examples 1 to 3 of Table 1 using mint oil, when a bovine gelatin film piece was used as a film piece, a large amount of insoluble matter in the film piece was observed. On the other hand, as shown in Examples 1 to 6 of Table 1, when the pig gelatin film piece and the fish gelatin film piece were used as the film pieces, almost no insoluble matter of the film pieces was observed. From these results, it was found that peppermint oil was excellent in suppressing the insolubilization of pig gelatin film and fish gelatin film.
　また、メントン油を用いた表２においても、比較例４～６に示す通り、皮膜片として牛ゼラチン皮膜片を用いた場合、皮膜片の不溶物が多量に認められた。これに対して、実施例７～１２に示す通り、皮膜片として豚ゼラチン皮膜片、魚ゼラチン皮膜片を用いた場合は、皮膜片の不溶物がほとんど認められなかった。これらの結果から、メントン油も、豚ゼラチン皮膜や魚ゼラチン皮膜の不溶化抑制に優れていることが分かった。 Also in Table 2 using menthol oil, as shown in Comparative Examples 4 to 6, when bovine gelatin film pieces were used as the film pieces, a large amount of insoluble matter was observed in the film pieces. On the other hand, as shown in Examples 7 to 12, when the pig gelatin film piece and the fish gelatin film piece were used as the film pieces, almost no insoluble matter of the film pieces was observed. From these results, it was found that menthol oil was also excellent in suppressing the insolubilization of pork gelatin film and fish gelatin film.
　また、パセリ種子油を用いた表３においても、比較例７～９に示す通り、皮膜片として牛ゼラチン皮膜片を用いた場合、皮膜片の不溶物が多量に認められた。これに対して、実施例１３～１８に示す通り、皮膜片として豚ゼラチン皮膜片、魚ゼラチン皮膜片を用いた場合は、皮膜片の不溶物がほとんど認められなかった。これらの結果から、パセリ種子油も、豚ゼラチン皮膜や魚ゼラチン皮膜の不溶化抑制に優れていることが分かった。 Also, in Table 3 using parsley seed oil, as shown in Comparative Examples 7 to 9, when bovine gelatin film pieces were used as the film pieces, a large amount of insoluble matter was observed in the film pieces. On the other hand, as shown in Examples 13 to 18, when the pig gelatin film piece and the fish gelatin film piece were used as the film pieces, almost no insoluble matter of the film pieces was observed. From these results, it was found that parsley seed oil is also excellent in suppressing the insolubilization of pig gelatin film and fish gelatin film.
　一方、ミント香料やレモン香料を用いた表４では、豚ゼラチン皮膜片（比較例１０及び１３）、魚ゼラチン皮膜片（実施例１１及び１４）、牛ゼラチン皮膜片（比較例１２及び１５）のいずれであっても皮膜片の不溶物が多量に確認された。 On the other hand, in Table 4 using the mint flavor and the lemon flavor, the pork gelatin film pieces (Comparative Examples 10 and 13), the fish gelatin film pieces (Examples 11 and 14), and the bovine gelatin film pieces (Comparative Examples 12 and 15) were used. In either case, a large amount of insoluble matter on the film pieces was confirmed.
　これらのことから、ハッカ油、メントン油、パセリ種子油は、豚由来ゼラチンや魚由来ゼラチンを含む皮膜の不溶化抑制に優れていることが確認された。 From these facts, it was confirmed that peppermint oil, menthol oil, and parsley seed oil are excellent in suppressing the insolubilization of the film containing pig-derived gelatin and fish-derived gelatin.

Claims (6)

  1. ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を含有する内容物が、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜に内包されていることを特徴とする、カプセル剤。 A content containing at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil is included in a film containing at least one selected from the group consisting of pig-derived gelatin and fish-derived gelatin. Capsule characterized in that
  2. 前記内容物が更に脂肪酸トリグリセリドを含有し、該内容物中、該脂肪酸トリグリセリド１００質量部に対して、ハッカ油を２８質量部以下で含有する、請求項１に記載のカプセル剤。 The capsule according to claim 1, wherein the content further contains a fatty acid triglyceride, and the content contains mint oil at 28 parts by mass or less based on 100 parts by mass of the fatty acid triglyceride.
  3. 前記内容物が更に脂肪酸トリグリセリドを含有し、該内容物中、該脂肪酸トリグリセリド１００質量部に対して、パセリ種子油を２８質量部以下で含有する、請求項１または２に記載のカプセル剤。 The capsule according to claim 1 or 2, wherein the content further contains a fatty acid triglyceride, and the content contains parsley seed oil in an amount of 28 parts by mass or less with respect to 100 parts by mass of the fatty acid triglyceride.
  4. 前記内容物が更に脂肪酸トリグリセリドを含有し、該内容物中、該脂肪酸トリグリセリド１００質量部に対して、メントン油を２８質量部以下で含有する、請求項１～３のいずれかに記載のカプセル剤。 The capsule according to any one of claims 1 to 3, wherein the content further contains a fatty acid triglyceride, and the content contains menthon oil in an amount of 28 parts by mass or less based on 100 parts by mass of the fatty acid triglyceride. ..
  5. ソフトカプセル剤である、請求項１～４のいずれかに記載のカプセル剤。 The capsule according to any one of claims 1 to 4, which is a soft capsule.
  6. 内容物及びこれを内包する皮膜を有するカプセル剤において、ハッカ油、パセリ種子油及びメントン油からなる群より選択される少なくとも１種を含有する内容物と、豚由来ゼラチン及び魚由来ゼラチンからなる群より選択される少なくとも１種を含有する皮膜とを組み合わせることを特徴とする、該皮膜の不溶化抑制方法。 In a capsule having a content and a film containing the content, a content containing at least one selected from the group consisting of peppermint oil, parsley seed oil and menthol oil, and a group consisting of pig-derived gelatin and fish-derived gelatin A method for suppressing insolubilization of a coating, which comprises combining with a coating containing at least one selected from the following.
PCT/JP2019/049391 2018-12-28 2019-12-17 Capsule WO2020137694A1 (en)

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