WO2020050182A1 - Liquid composition for encapsulation and encapsulated formulation - Google Patents

Liquid composition for encapsulation and encapsulated formulation Download PDF

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Publication number
WO2020050182A1
WO2020050182A1 PCT/JP2019/034257 JP2019034257W WO2020050182A1 WO 2020050182 A1 WO2020050182 A1 WO 2020050182A1 JP 2019034257 W JP2019034257 W JP 2019034257W WO 2020050182 A1 WO2020050182 A1 WO 2020050182A1
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Prior art keywords
oil
liquid composition
capsule
filling
hardly
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PCT/JP2019/034257
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French (fr)
Japanese (ja)
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朋之 橋本
光昭 小野
義孝 長谷川
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株式会社カマタ
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Priority to JP2019568264A priority Critical patent/JPWO2020050182A1/en
Publication of WO2020050182A1 publication Critical patent/WO2020050182A1/en

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    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate

Definitions

  • the present invention relates to a liquid composition for filling capsules and capsules.
  • Capsules containing hardly oil-soluble or powdery components are generally produced by filling a dispersion prepared by dispersing components in edible oils and fats into capsules made of gelatin and non-animal-derived materials. .
  • beeswax and glycerin fatty acid esters have been conventionally used as dispersants for stably dispersing the components in edible oils and fats (Patent Document 1).
  • the liquid composition for filling the capsule is subjected to a high-speed pulverizer such as a homojetter and a high-speed stirrer.
  • a high-speed pulverizer such as a homojetter and a high-speed stirrer.
  • Patent Document 4 the method of producing an emulsified stock solution having a higher dispersion stability by treating
  • Patent Document 5 the number of carbon atoms in the constituent fatty acids and the ratio of use are limited.
  • a first object of the present invention is to use a beeswax or a glycerin fatty acid ester without using a beeswax or a glycerin fatty acid ester, and to have a dispersion stability of a hardly oil-soluble component equivalent to that of a conventional formulation using a beeswax or a glycerin fatty acid ester.
  • An object of the present invention is to provide a dispersion composition for filling capsules and capsules.
  • a second object of the present invention is to provide a liquid composition for capsule filling and a capsule composition which can contain powders and extracts at a high concentration as oil-insoluble components without using beeswax or glycerin fatty acid ester at all. To provide an agent.
  • the present inventor has conducted intensive studies to solve the above problems, and as a result, by using a transesterified oil containing sunflower seed oil as a dispersion stabilizer for dispersing the hardly oil-soluble component, beeswax and glycerin fatty acid esters.
  • the present inventors have found that even if they are not used at all or their usage is reduced, the hardly oil-soluble components in edible fats and oils are stably dispersed, and the present invention has been completed based on the findings.
  • the present inventors use a sunflower seed oil in place of beeswax and glycerin fatty acid ester, thereby enabling a liquid composition for capsule filling capable of containing powders and extracts at a high concentration as a hardly oil-soluble component. And a capsule can be provided.
  • the liquid composition for filling a capsule of the present invention is a liquid composition for filling a capsule obtained by dispersing a hardly oil-soluble component in edible oil and fat, and an ester as a dispersion stabilizer for dispersing the hardly oil-soluble component. It is characterized by containing exchanged fats and oils.
  • the transesterified fat may be sunflower seed oil.
  • the sunflower seed oil accounts for 1 to 30% by mass, preferably 1 to 20% by mass, and more preferably 2 to 10% by mass, based on 100% by mass of the liquid composition for filling capsules.
  • the capsule of the present invention is characterized by containing a capsule filling liquid composition containing the above-mentioned sunflower seed oil.
  • the liquid composition for filling a capsule of the present invention is a liquid composition for filling a capsule obtained by dispersing a hardly oil-soluble component in an edible oil or fat, and a transesterified fat or oil as a dispersion stabilizer for dispersing the hardly oil-soluble component.
  • a liquid composition for filling a capsule obtained by dispersing a hardly oil-soluble component in an edible oil or fat, and a transesterified fat or oil as a dispersion stabilizer for dispersing the hardly oil-soluble component. was constituted.
  • the capsule of the present invention also has the effect that the use of sunflower seed oil as a dispersion stabilizer makes it possible to contain a high concentration of powders and extracts as hardly oil-soluble components.
  • Edible oils and fats used in the present embodiment include, for example, rice oil, corn oil, canola oil, olive oil, rice bran oil, soybean oil, soybean squeezed oil, safflower oil, sesame oil, palm oil, palm kernel oil, coconut oil
  • Vegetable oils such as sunflower oil, cottonseed oil, rapeseed oil, rapeseed white oil, grape seed oil, perilla oil, animal fats such as beef tallow, lard, fish oil, milk fat or lard, medium chain fatty acid triglyceride (MCT), etc. No.
  • These edible fats and oils can be used alone or in any combination of two or more.
  • the hardly oil-soluble component used in the present embodiment is composed of a substance having low lipophilicity, and constitutes an effective component of the liquid composition for filling capsules of the present embodiment.
  • the hardly oil-soluble component in the present embodiment refers to a substance in the form of a powder, which does not dissolve within 30 minutes when 1 g of the powder is added to 100 g of edible fat and oil and mixed at 20 ° C. I do.
  • Such hardly oil-soluble components include vitamins (particularly water-soluble vitamins such as ascorbic acid, vitamins B 1 , B 2 , B 6 and B 12 ), nutritional supplements such as citric acid, hyaluronic acid and calcium powder.
  • vitamins particularly water-soluble vitamins such as ascorbic acid, vitamins B 1 , B 2 , B 6 and B 12
  • nutritional supplements such as citric acid, hyaluronic acid and calcium powder.
  • Ingredients Royal jelly extract powder (powder, FD powder) Propolis skid powder, blueberry extract powder, agaric extract powder, shark cartilage extract powder, turmeric powder, ginkgo leaf extract powder, gymnema extract powder, other animal and plant powder and extract powder, lactose
  • health food ingredients such as oligosaccharides, chitosan and dietary fiber, or medicinal ingredients such as crude drug extract powder, Chinese herbs, and pharmaceutical compositions.
  • the sunflower seed oil used as a dispersion stabilizer in the present embodiment has a melting point of 55 to 70 ° C, is free of pesticides, contains saturated fatty acids, but does not contain trans fatty acids.
  • the transesterification fats other than sunflower seed oil used in the present embodiment have a melting point of 55 to 70 ° C., and the content of trans fatty acid is not particularly limited, but is, for example, usually less than 10%, preferably less than 5%. , More preferably less than 0.3%.
  • the transesterified oil used in the present embodiment is, other than sunflower seed oil, for example, rice oil, corn oil, canola oil, olive oil, rice bran oil, soybean oil, soybean white squeezed oil, safflower oil, sesame oil, cottonseed oil, rapeseed oil. , Vegetable oils such as rapeseed white oil, grape seed oil, perilla oil, etc., animal oils such as fish oil, and transesterified oils such as medium chain fatty acid triglycerin (MCT).
  • MCT medium chain fatty acid triglycerin
  • sunflower seed oil as a dispersion stabilizer used in the present embodiment may be used in combination with a dispersion stabilizer such as beeswax or glycerin fatty acid ester, which is a conventionally used food additive, to obtain dispersion stability. It is possible to reduce the amount of food additives used.
  • the liquid composition for filling capsules in the present embodiment is produced by uniformly dispersing the edible oil and fat, the hardly oil-soluble component, and the transesterified oil and fat such as sunflower seed oil while mixing and stirring.
  • transesterified fats such as edible fats and sunflower seed oils are uniformly mixed and stirred by heating to about 50 to 90 ° C., for example, and then cooled to about 30 to 60 ° C.
  • the oil-insoluble component is further added, and the mixture is uniformly mixed and stirred.
  • the apparatus for mixing and stirring is not particularly limited.
  • a high-speed stirrer such as a biomixer or a homojetter, or a medium- or low-speed stirrer such as a high-speed pulverizer or a propeller can be used.
  • the content of the edible oil / fat in 100% by mass of the liquid composition for filling capsules of the present embodiment is not particularly limited, but is, for example, usually 20 to 95% by mass, preferably 25 to 90% by mass, more preferably 30% by mass. 8080% by mass. If the content of the edible oil in the present embodiment is within the above range, the hardly oil-soluble component can be sufficiently dispersed in the edible oil, and the hardly oil-soluble component and the powdery component in the edible oil and fat can be dispersed. Good dispersion stability. In order to obtain a composition in which the hardly oil-soluble component is dispersed at a high concentration in the edible oil and fat, the content of the edible oil and fat in 100% by mass of the capsule filling liquid composition is desirably 60% by mass or less.
  • the content of the hardly oil-soluble component in 100% by mass of the liquid composition for capsule filling in the present embodiment is not particularly limited, but is, for example, usually 1 to 70% by mass, preferably about 3 to 60% by mass, more preferably It is 10 to 50% by mass.
  • the content of the hardly oil-soluble component exceeds 70% by mass, the hardly oil-soluble component cannot be sufficiently dispersed in the edible fat or oil, or the dispersion stability of the hardly oil-soluble component in the edible fat or oil decreases. In addition, the separation of the hardly oil-soluble component is likely to occur.
  • the content of the hardly oil-soluble component is less than 1% by mass, the content of the active ingredient in the capsule according to the present embodiment becomes too small, and the effect such as the physiological activity may not be sufficiently exhibited. There is.
  • the content of the hardly oil-soluble component in 100% by mass of the capsule-filling liquid composition is 40% by mass or more. desirable.
  • the content of sunflower seed oil in 100% by mass of the liquid composition for capsule filling in the present embodiment is not particularly limited, but is, for example, usually 1 to 30% by mass, preferably 1 to 20% by mass, more preferably 2 to 20% by mass. 10% by mass.
  • the content of sunflower seed oil is less than 1% by mass, the dispersion stability of the hardly oil-soluble component in the edible oil and fat is reduced, and the components are easily separated.
  • ⁇ ⁇ ⁇ Soft capsules can be manufactured by wrapping the thus obtained liquid composition for filling capsules with a film mainly composed of gelatin and non-animal-derived materials according to a conventional method.
  • a capsule can be produced by a method in which a fixed amount of a liquid composition for filling a capsule is filled as a content between two gelatin sheets and punched out.
  • a sunflower seed oil or a dispersion stabilizer made of beeswax and glycerin fatty acid ester in a ratio of 1: 1 was added to the vegetable oil, and the mixture was heated to 80 ° C. and stirred and dissolved.
  • the dissolved solution was naturally cooled to 60 ° C., and corn starch and riboflavin were added thereto, and the mixture was further mixed and stirred with a stirrer for 10 minutes.
  • the obtained dispersion was cooled to room temperature and subjected to vacuum defoaming treatment to obtain a liquid composition for filling capsules.
  • the dispersion stability of corn starch and riboflavin was obtained, separation was suppressed, and it was determined from a test whether or not they were equivalent. Preparation of the test solution was performed based on the prescription of Table 1.
  • any of the liquid compositions for filling capsules of Samples 1 to 3 have the same dispersion stability as those using beeswax or glycerin fatty acid ester, even though beeswax or glycerin fatty acid ester is not used. Was done.
  • transesterified oils and fats having different plant species were added to the vegetable oil and stirred and dissolved at the same temperature as in Example 1. Then, corn starch and riboflavin were added thereto, and the same mixing and stirring as in Example 1 was performed.
  • Example 2 The same evaluation as in Example 1 was performed for adjusting the obtained dispersion and confirming the dispersion stability. Further, adjustment of the test solution was performed based on the prescription in Table 3.
  • rapeseed extremely hardened oil, refined palm kernel oil, and coconut oil were used as food oils having viscosity other than transesterified oils and fats, and the transesterified oils and fats were evaluated.
  • each of the liquid compositions for filling capsules (samples 4 to 6 and comparative examples 4 to 6) prepared by the above-described method were placed in a stainless steel cup (300 ml), and the viscosity at a liquid temperature of 25 ° C. was measured using a viscometer (model: RVDV-I +; measured using BROOK (FIELD, rotor No. 7) and shown in Table 4.
  • any of the liquid compositions for filling capsules of Samples 4 to 6 had the same dispersion stability as that observed in the sunflower seed oil of Sample 1 in Example 1. This suggests that not only sunflower seed oil but also transesterified oils of different plant species origin have the same dispersion stability as those using beeswax or glycerin fatty acid esters.
  • Comparative Examples 5 and 6 the conventional food-derived fats and oils do not exhibit sufficient dispersion stability.
  • Comparative Example 4 even if dispersion stability is obtained, there is a concern that the opportunity to take saturated fatty acids increases.
  • Example 1 instead of using solely the sunflower seed oil used in Example 1 for the vegetable oil, various transesterified fats and oils of sunflower seed oil, MCT butter, perilla butter, and grape seed butter, or beeswax, or sunflower seed oil, MCT butter, perilla butter A mixture of various transesterified fats and oils of grape seed butter and glycerin fatty acid ester in a ratio of 1: 1 or 7: 3 was prepared, stirred and dissolved at the same temperature as in Example 1, and corn starch Riboflavin was added, and the same mixing and stirring as in Example 1 was performed.
  • Example 2 The same evaluation as in Example 1 was performed for adjusting the obtained dispersion and confirming the dispersion stability. The adjustment of the test solution was performed based on the formulation shown in Table 5.
  • any of the liquid compositions for filling capsules of Samples 7 to 22 had the same dispersion stability as that observed in the sunflower seed oil of Sample 1 in Example 1. This means that it is also possible to obtain dispersion stability by using in combination with the conventionally used food additives such as beeswax and glycerin fatty acid esters, thereby reducing the amount of food additives used. It is also possible.
  • Example 4 shows that by using sunflower seed oil instead of beeswax and glycerin fatty acid ester as a dispersion stabilizer, it is possible to disperse the hardly oil-soluble component in edible fats and oils at a high concentration. .
  • samples 1 and 2 and comparative examples 1 and 2 are described, but these are different from the above.
  • the fourth embodiment will be described.
  • Example 4 medium-chain fatty acid triglyceride (MCT) and DHA-containing purified fish oil were used as oils and fats, respectively, sunflower seed oil or beeswax was added as a dispersion stabilizer, and the mixture was heated to 80 ° C and stirred and dissolved. The dissolved solution was naturally cooled to 60 ° C., to which bilberry extract powder (bulk specific gravity 0.75 g / ml) was added, and the mixture was further mixed and stirred for 10 minutes with a stirrer.
  • MCT medium-chain fatty acid triglyceride
  • DHA-containing purified fish oil were used as oils and fats, respectively.
  • sunflower seed oil or beeswax was added as a dispersion stabilizer
  • the obtained dispersion was cooled to room temperature, subjected to vacuum defoaming treatment, to obtain a liquid composition for filling capsules (the dispersion at this stage is hereinafter referred to as an internal solution), and soft-encapsulated by a rotary soft capsule manufacturing machine. An oval capsule was obtained.
  • the purified fish oil containing medium-chain fatty acid triglyceride (MCT) and DHA differs in the proportion of long-chain fatty acids contained in the constituent fats and oils, so that the amount of bilberry extract powder that can be contained most in each fat and oil differs. Therefore, the amount of bilberry extract powder that could be contained in each of the edible oils and fats was determined, and the amount was compared with sunflower seed oil or beeswax.
  • Table 7 The results of the confirmation and test of the properties obtained from the liquid composition for filling capsules obtained in each test section and the capsules filled with the liquid composition for filling capsules are shown in Table 7 below.
  • the composition of the fat used as the medium-chain fatty acid triglyceride (MCT) is, for comparison with Patent Document 5, the ratio of the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms to the constituent fatty acids of the fat and oil. Is 98% by mass or more and the ratio of fatty acid having 8 carbon atoms is 66% by mass or more.
  • DHA-containing purified fish oil was selected as an edible oil and fat as an oil and fat that hardly disperses a hardly oil-soluble component having a low specific gravity at a high concentration.
  • liquid composition for filling capsules of the present embodiment powders and extracts as the hardly oil-soluble component are suspended at a very high content compared with the conventional one, with good dispersion stability,
  • the present invention is not limited to this, and the capsule composition may be filled in the seamless capsule or hard capsule film.
  • the base material of the capsule coating is not particularly limited, and in addition to those based on gelatin, the capsule coating of the present invention can be filled into a capsule coating using various proposed non-gelatin bases including the present applicant.
  • a liquid composition can be filled.

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Abstract

Provided are a liquid composition for encapsulation and an encapsulated formulation: that even without using beeswax or glycerin fatty acid ester, or with a reduced amount thereof, are able to demonstrate the same level of dispersion stability as conventional products that use beeswax or glycerin fatty acid ester as a dispersion stabilizer, as a result of using sunflower seed oil as a dispersion stabilizer for dispersing poorly oil-soluble component; and that are able to contain a poorly oil-soluble component, which may be a powder or an extract, at a high concentration.

Description

カプセル充填用液状組成物及びカプセル剤Liquid composition for filling capsules and capsules
 本発明は、カプセル充填用液状組成物及びカプセル剤に関する。 The present invention relates to a liquid composition for filling capsules and capsules.
 難油溶性や粉末状の成分を含有するカプセル剤は、一般に、成分を食用油脂中に分散して調製した分散液を、ゼラチン及び非動物由来原料を皮膜とするカプセルに充填して製造される。その際、成分を食用油脂中に安定に分散させるための分散剤として、従来ミツロウやグリセリン脂肪酸エステルが使用されている(特許文献1)。 Capsules containing hardly oil-soluble or powdery components are generally produced by filling a dispersion prepared by dispersing components in edible oils and fats into capsules made of gelatin and non-animal-derived materials. . At this time, beeswax and glycerin fatty acid esters have been conventionally used as dispersants for stably dispersing the components in edible oils and fats (Patent Document 1).
 ミツロウやグリセリン脂肪酸エステルは、食品添加物であることから、食品添加物の摂取を控えたい利用者から、食品添加物ではない分散安定剤が求められている。食品添加物を使用せずに成分を食用油脂中に安定に分散させる食品素材として、従来、ナタネ硬化油、パーム核油、ココナッツオイルなどが提案されている(特許文献2および3)。しかしながら、上記技術では、ミツロウやグリセリン脂肪酸エステルを使用した従来品に比べて、例えば成分の分散安定性やトランス脂肪酸摂取の可能性の面と飽和脂肪酸の摂取の機会を増やす面で難があり、必ずしも満足できるものではない。 Since beeswax and glycerin fatty acid esters are food additives, users who want to refrain from ingesting food additives have demanded dispersion stabilizers that are not food additives. Conventionally, rapeseed hardened oil, palm kernel oil, coconut oil and the like have been proposed as food materials for stably dispersing components in edible fats and oils without using food additives (Patent Documents 2 and 3). However, in the above technology, compared to conventional products using beeswax and glycerin fatty acid esters, for example, there are difficulties in terms of the dispersion stability of components and the possibility of ingesting trans fatty acids and the opportunity to increase the intake of saturated fatty acids, Not always satisfactory.
 また、粉末およびエキス類を高濃度に含有したカプセルの製造のためには、カプセル充填用液状組成物の作成の際に、カプセル充填用液状組成物をホモジェッターなどの高速粉砕機および高速攪拌機で処理し、分散安定性をより向上させた乳化原液を製造する方法(特許文献4)や食用油脂の構成について、構成脂肪酸に占める炭素数の指定や使用の割合を制限する(特許文献5)ことにより難油溶性成分を高濃度に含有するカプセル剤を製造する方法が提供されている。 In addition, for the production of capsules containing powders and extracts at a high concentration, during the preparation of the liquid composition for filling the capsule, the liquid composition for filling the capsule is subjected to a high-speed pulverizer such as a homojetter and a high-speed stirrer. Regarding the method of producing an emulsified stock solution having a higher dispersion stability by treating (Patent Document 4) and the constitution of edible fats and oils, the number of carbon atoms in the constituent fatty acids and the ratio of use are limited (Patent Document 5). Provides a method for producing a capsule containing a hardly oil-soluble component at a high concentration.
 しかしながら、難油溶性成分として粉末およびエキス類を高濃度に含有する際に、素材を著しく物理的および化学的に変質させないことや、食用油脂の選択の幅に制限がかかることは、望まれない場合もあることから、従来のカプセル剤では必ずしも満足できるものとは言えない。 However, when powders and extracts are contained at a high concentration as the hardly oil-soluble component, it is not desired that the material is not significantly physically and chemically deteriorated and that the range of selection of edible fats and oils is restricted. In some cases, conventional capsules are not always satisfactory.
特開2009-242334号公報JP 2009-242334 A 特開昭61-151127号公報JP-A-61-151127 特開平4-320666号公報JP-A-4-320666 特開2000-083599号公報Japanese Patent Application Laid-Open No. 2000-083599 特開2012-144450号公報JP 2012-144450 A
 そこで、本発明の第1の目的は、ミツロウやグリセリン脂肪酸エステルを使用せずあるいはなるべく使用せず、かつミツロウやグリセリン脂肪酸エステルを使用した従来処方と同等の難油溶性成分の分散安定性を有するカプセル充填用分散液組成物及びカプセル剤を提供することにある。 Therefore, a first object of the present invention is to use a beeswax or a glycerin fatty acid ester without using a beeswax or a glycerin fatty acid ester, and to have a dispersion stability of a hardly oil-soluble component equivalent to that of a conventional formulation using a beeswax or a glycerin fatty acid ester. An object of the present invention is to provide a dispersion composition for filling capsules and capsules.
 また、本発明の第2の目的は、ミツロウやグリセリン脂肪酸エステルを全く使用しなくても難油溶性成分として粉末およびエキス類を高濃度に含有することが可能なカプセル充填用液状組成物及びカプセル剤を提供することにある。 A second object of the present invention is to provide a liquid composition for capsule filling and a capsule composition which can contain powders and extracts at a high concentration as oil-insoluble components without using beeswax or glycerin fatty acid ester at all. To provide an agent.
 本発明者は、上記課題を解決するために鋭意検討した結果、難油溶性成分を分散させるための分散安定剤としてヒマワリ種子油を含むエステル交換油脂を使用することにより、ミツロウやグリセリン脂肪酸エステルを全く使用しないあるいはこれらの使用量を軽減したとしても食用油脂中の難油溶性成分が安定に分散することを見出し、その知見に基づいて本発明を完成した。 The present inventor has conducted intensive studies to solve the above problems, and as a result, by using a transesterified oil containing sunflower seed oil as a dispersion stabilizer for dispersing the hardly oil-soluble component, beeswax and glycerin fatty acid esters. The present inventors have found that even if they are not used at all or their usage is reduced, the hardly oil-soluble components in edible fats and oils are stably dispersed, and the present invention has been completed based on the findings.
 さらに、本発明者らは、ミツロウやグリセリン脂肪酸エステルの代わりにヒマワリ種子油を使用することにより、難油溶性成分として粉末およびエキス類を高濃度に含有することが可能なカプセル充填用液状組成物及びカプセル剤を提供することができることを見出した。 Furthermore, the present inventors use a sunflower seed oil in place of beeswax and glycerin fatty acid ester, thereby enabling a liquid composition for capsule filling capable of containing powders and extracts at a high concentration as a hardly oil-soluble component. And a capsule can be provided.
 すなわち、本発明のカプセル充填用液状組成物は、食用油脂中に難油溶性成分を分散せしめたカプセル充填用液状組成物であって、前記難油溶性成分を分散させるための分散安定剤としてエステル交換油脂を含有することを特徴とする。 That is, the liquid composition for filling a capsule of the present invention is a liquid composition for filling a capsule obtained by dispersing a hardly oil-soluble component in edible oil and fat, and an ester as a dispersion stabilizer for dispersing the hardly oil-soluble component. It is characterized by containing exchanged fats and oils.
 また、前記エステル交換油脂は、ヒマワリ種子油であってもよい。 The transesterified fat may be sunflower seed oil.
 また、前記ヒマワリ種子油は、前記カプセル充填用液状組成物100質量%中、1~30質量%、好ましくは1~20質量%、より好ましくは2~10質量%である。 The sunflower seed oil accounts for 1 to 30% by mass, preferably 1 to 20% by mass, and more preferably 2 to 10% by mass, based on 100% by mass of the liquid composition for filling capsules.
 また、本発明のカプセル剤は、前述のヒマワリ種子油を含有したカプセル充填用液状組成物を含有することを特徴とする。 カ プ セ ル Further, the capsule of the present invention is characterized by containing a capsule filling liquid composition containing the above-mentioned sunflower seed oil.
 本発明のカプセル充填用液状組成物は、食用油脂中に難油溶性成分を分散せしめたカプセル充填用液状組成物であって、前記難油溶性成分を分散させるための分散安定剤としてエステル交換油脂を含有するように構成した。これにより、ミツロウやグリセリン脂肪酸エステルなどを使用しなくても、ミツロウやグリセリン脂肪酸エステルを使用した従来品と同等の難油溶性成分の分散安定性を有することができるといった効果を有する。 The liquid composition for filling a capsule of the present invention is a liquid composition for filling a capsule obtained by dispersing a hardly oil-soluble component in an edible oil or fat, and a transesterified fat or oil as a dispersion stabilizer for dispersing the hardly oil-soluble component. Was constituted. Thereby, even if beeswax or glycerin fatty acid ester is not used, there is an effect that the same oil-soluble component dispersion stability as a conventional product using beeswax or glycerin fatty acid ester can be obtained.
 また、本発明のカプセル剤は、分散安定剤としてヒマワリ種子油を使用したことにより、難油溶性成分として粉末およびエキス類を高濃度に含有することができるといった効果を有する。 The capsule of the present invention also has the effect that the use of sunflower seed oil as a dispersion stabilizer makes it possible to contain a high concentration of powders and extracts as hardly oil-soluble components.
 以下、本発明を実施するための形態について説明する。 Hereinafter, embodiments for carrying out the present invention will be described.
 本実施形態で用いられる食用油脂としては、例えば、コメ油、コーン油、キャノーラ油、オリーブ油、米ぬか油、大豆油、大豆白絞油、サフラワー油、ゴマ油、パーム油、パーム核油、ヤシ油、ヒマワリ油、綿実油、菜種油、菜種白絞油、グレープシード油、シソ油等の植物性油脂、牛脂、豚脂、魚油、乳脂又はラード等の動物性油脂、中鎖脂肪酸トリグリセリド(MCT)等が挙げられる。これら食用油脂は、1種又は2種以上を任意に組み合わせて用いることができる。 Edible oils and fats used in the present embodiment include, for example, rice oil, corn oil, canola oil, olive oil, rice bran oil, soybean oil, soybean squeezed oil, safflower oil, sesame oil, palm oil, palm kernel oil, coconut oil Vegetable oils such as sunflower oil, cottonseed oil, rapeseed oil, rapeseed white oil, grape seed oil, perilla oil, animal fats such as beef tallow, lard, fish oil, milk fat or lard, medium chain fatty acid triglyceride (MCT), etc. No. These edible fats and oils can be used alone or in any combination of two or more.
 本実施形態で用いられる難油溶性成分は、親油性の低い物質から構成され、本実施形態のカプセル充填用液状組成物の有効性分を構成するものである。具体的には、本実施形態における難油溶性成分とは、粉末の形態であって、食用油脂100gに該粉末1gを入れ20℃で混合したとき、30分以内に溶解しない物質を指すものとする。 難 The hardly oil-soluble component used in the present embodiment is composed of a substance having low lipophilicity, and constitutes an effective component of the liquid composition for filling capsules of the present embodiment. Specifically, the hardly oil-soluble component in the present embodiment refers to a substance in the form of a powder, which does not dissolve within 30 minutes when 1 g of the powder is added to 100 g of edible fat and oil and mixed at 20 ° C. I do.
 このような難油溶性成分としては、例えば、ビタミン類(特にアスコルビン酸、ビタミンB、B、B、B12などの水溶性ビタミン)、クエン酸、ヒアルロン酸、カルシウムパウダーなどの栄養補助成分、ローヤルゼリーエキス末(粉末、FD末)プロポリスキス末、ブルーベリーエキス末、アガリスクエキス末、サメ軟骨抽出エキス末、ウコン末、イチョウ葉エキス末、ギムネマエキス末、その他の動植物粉末及びエキス末、乳糖、オリゴ糖、キトサン、食物繊維などの健康食品成分、或いは生薬エキス末、漢方、医薬組成物などの薬効成分が挙げられる。 Examples of such hardly oil-soluble components include vitamins (particularly water-soluble vitamins such as ascorbic acid, vitamins B 1 , B 2 , B 6 and B 12 ), nutritional supplements such as citric acid, hyaluronic acid and calcium powder. Ingredients, Royal jelly extract powder (powder, FD powder) Propolis skid powder, blueberry extract powder, agaric extract powder, shark cartilage extract powder, turmeric powder, ginkgo leaf extract powder, gymnema extract powder, other animal and plant powder and extract powder, lactose And health food ingredients such as oligosaccharides, chitosan and dietary fiber, or medicinal ingredients such as crude drug extract powder, Chinese herbs, and pharmaceutical compositions.
 本実施形態において分散安定剤として用いられるヒマワリ種子油は、融点55~70℃、農薬フリー、飽和脂肪酸を含むもののトランス脂肪酸は含まない。なお、本実施形態で用いられるヒマワリ種子油以外のエステル交換油脂の融点は、55~70℃、また、トランス脂肪酸含有量は、特に限定されないが、例えば、通常10%未満、好ましくは5%未満、より好ましくは0.3%未満である。 ヒ The sunflower seed oil used as a dispersion stabilizer in the present embodiment has a melting point of 55 to 70 ° C, is free of pesticides, contains saturated fatty acids, but does not contain trans fatty acids. The transesterification fats other than sunflower seed oil used in the present embodiment have a melting point of 55 to 70 ° C., and the content of trans fatty acid is not particularly limited, but is, for example, usually less than 10%, preferably less than 5%. , More preferably less than 0.3%.
 本実施形態で用いられるエステル交換油脂は、ヒマワリ種子油の他、例えば、コメ油、コーン油、キャノーラ油、オリーブ油、米ぬか油、大豆油、大豆白絞油、サフラワー油、ゴマ油、綿実油、菜種油、菜種白絞油、グレープシード油、シソ油、等の植物性油脂、魚油、等の動物性油脂、中鎖脂肪酸トリグリセリン(MCT)などのエステル交換油脂で代替えすることができる。 The transesterified oil used in the present embodiment is, other than sunflower seed oil, for example, rice oil, corn oil, canola oil, olive oil, rice bran oil, soybean oil, soybean white squeezed oil, safflower oil, sesame oil, cottonseed oil, rapeseed oil. , Vegetable oils such as rapeseed white oil, grape seed oil, perilla oil, etc., animal oils such as fish oil, and transesterified oils such as medium chain fatty acid triglycerin (MCT).
 なお、本実施形態で用いられる分散安定剤としてのヒマワリ種子油は、従来使用されている食品添加物であるミツロウやグリセリン脂肪酸エステル等の分散安定剤と組合せて使用し分散安定性を得ることも可能であり、これにより食品添加物の使用量を低減することも可能である。 Incidentally, sunflower seed oil as a dispersion stabilizer used in the present embodiment may be used in combination with a dispersion stabilizer such as beeswax or glycerin fatty acid ester, which is a conventionally used food additive, to obtain dispersion stability. It is possible to reduce the amount of food additives used.
 本実施形態におけるカプセル充填用液状組成物は、上記食用油脂、難油溶性成分、ヒマワリ種子油等のエステル交換油脂を混合・撹拌しながら、均一に分散させることにより製造される。具体的には、例えば、食用油脂、ヒマワリ種子油等のエステル交換油脂を、例えば、約50~90℃に加熱して均一に混合・撹拌した後、これを例えば約30~60℃に冷却し、更に難油溶成分を加えて均一に混合・撹拌して製造される。混合・撹拌するための装置に特に制限はないが、例えば、バイオミキサー、ホモジェッター等の高速攪拌機または高速粉砕機やプロペラ等の中速・低速攪拌機を用いることができる。 The liquid composition for filling capsules in the present embodiment is produced by uniformly dispersing the edible oil and fat, the hardly oil-soluble component, and the transesterified oil and fat such as sunflower seed oil while mixing and stirring. Specifically, for example, transesterified fats such as edible fats and sunflower seed oils are uniformly mixed and stirred by heating to about 50 to 90 ° C., for example, and then cooled to about 30 to 60 ° C. In addition, the oil-insoluble component is further added, and the mixture is uniformly mixed and stirred. The apparatus for mixing and stirring is not particularly limited. For example, a high-speed stirrer such as a biomixer or a homojetter, or a medium- or low-speed stirrer such as a high-speed pulverizer or a propeller can be used.
 本実施形態のカプセル充填用液状組成物100質量%中の食用油脂の含有量は、特に制限されていないが、例えば、通常20~95質量%、好ましくは25~90質量%、より好ましくは30~80質量%である。本実施形態において食用油脂の含有量が上記範囲内であれば、難油溶性成分を食用油中に十分に分散されることができるとともに、食用油脂中における難油溶性成分や粉末状の成分の分散安定性が良好である。なお、食用油脂中に難油溶性成分を高濃度に分散せしめた組成物とするためには、カプセル充填用液状組成物100質量%中の食用油脂の含有量は、60質量%以下が望ましい。 The content of the edible oil / fat in 100% by mass of the liquid composition for filling capsules of the present embodiment is not particularly limited, but is, for example, usually 20 to 95% by mass, preferably 25 to 90% by mass, more preferably 30% by mass. 8080% by mass. If the content of the edible oil in the present embodiment is within the above range, the hardly oil-soluble component can be sufficiently dispersed in the edible oil, and the hardly oil-soluble component and the powdery component in the edible oil and fat can be dispersed. Good dispersion stability. In order to obtain a composition in which the hardly oil-soluble component is dispersed at a high concentration in the edible oil and fat, the content of the edible oil and fat in 100% by mass of the capsule filling liquid composition is desirably 60% by mass or less.
 本実施形態におけるカプセル充填用液状組成物100質量%中の難油溶性成分の含有量は、特に限定されないが、例えば、通常1~70質量%、好ましくは約3~60質量%、より好ましくは10~50質量%である。難油溶性成分の含有量が70質量%を超える場合には、難油溶性成分を食用油脂中に十分に分散させることができないか、食用油脂中における難油溶性成分の分散安定性が低下し、難油溶性成分の分離が生じやすくなる。また、難油溶性成分の含有量が1質量%未満の場合には、本実施形態に係るカプセル剤中の有効成分の含量が少なくなりすぎて、生理活性などの効果が十分に発揮されなくなるおそれがある。なお、食用油脂中に難油溶性成分を高濃度に分散せしめた組成物とするためには、カプセル充填用液状組成物100質量%中の難油溶性成分の含有量は、40質量%以上が望ましい。 The content of the hardly oil-soluble component in 100% by mass of the liquid composition for capsule filling in the present embodiment is not particularly limited, but is, for example, usually 1 to 70% by mass, preferably about 3 to 60% by mass, more preferably It is 10 to 50% by mass. When the content of the hardly oil-soluble component exceeds 70% by mass, the hardly oil-soluble component cannot be sufficiently dispersed in the edible fat or oil, or the dispersion stability of the hardly oil-soluble component in the edible fat or oil decreases. In addition, the separation of the hardly oil-soluble component is likely to occur. When the content of the hardly oil-soluble component is less than 1% by mass, the content of the active ingredient in the capsule according to the present embodiment becomes too small, and the effect such as the physiological activity may not be sufficiently exhibited. There is. In addition, in order to obtain a composition in which the hardly oil-soluble component is dispersed in edible fat or oil at a high concentration, the content of the hardly oil-soluble component in 100% by mass of the capsule-filling liquid composition is 40% by mass or more. desirable.
 本実施形態におけるカプセル充填用液状組成物100質量%中のヒマワリ種子油の含有量は、特に限定されないが、例えば、通常1~30質量%、好ましくは1~20質量%、より好ましくは2~10質量%である。ヒマワリ種子油の含有量が1質量%未満の場合には、食用油脂中の難油溶性成分の分散安定性が低下して各成分の分離が生じやすくなる。 The content of sunflower seed oil in 100% by mass of the liquid composition for capsule filling in the present embodiment is not particularly limited, but is, for example, usually 1 to 30% by mass, preferably 1 to 20% by mass, more preferably 2 to 20% by mass. 10% by mass. When the content of sunflower seed oil is less than 1% by mass, the dispersion stability of the hardly oil-soluble component in the edible oil and fat is reduced, and the components are easily separated.
 このようにして得られるカプセル充填用液状組成物を、常法に従い、ゼラチン及び非動物由来原料を主成分とする皮膜で包み込むことによりソフトカプセルを製造することができる。具体的には、例えば、2枚のゼラチンシートの間に内容物としてカプセル充填用液状組成物を一定量充填して打ち抜く方法によりカプセルを製造することができる。 ソ フ ト Soft capsules can be manufactured by wrapping the thus obtained liquid composition for filling capsules with a film mainly composed of gelatin and non-animal-derived materials according to a conventional method. Specifically, for example, a capsule can be produced by a method in which a fixed amount of a liquid composition for filling a capsule is filled as a content between two gelatin sheets and punched out.
 植物油脂にヒマワリ種子油もしくはミツロウとグリセリン脂肪酸エステルを1:1とした分散安定剤を加え、80℃に加熱して撹拌・溶解した。溶解した溶液を60℃まで自然冷却し、これにトウモロコシデンプン・リボフラビンを加え攪拌機でさらに10分間混合・撹拌した。得られた分散液を室温まで冷却、真空脱泡処理をし、カプセル充填用液状組成物を得た。分散安定剤については、トウモロコシデンプンとリボフラビンの分散安定性を得て、分離を抑制し同等であるかを試験より求めた。試験液の調整は表1の処方に基づき行った。 分散 A sunflower seed oil or a dispersion stabilizer made of beeswax and glycerin fatty acid ester in a ratio of 1: 1 was added to the vegetable oil, and the mixture was heated to 80 ° C. and stirred and dissolved. The dissolved solution was naturally cooled to 60 ° C., and corn starch and riboflavin were added thereto, and the mixture was further mixed and stirred with a stirrer for 10 minutes. The obtained dispersion was cooled to room temperature and subjected to vacuum defoaming treatment to obtain a liquid composition for filling capsules. Regarding the dispersion stabilizer, the dispersion stability of corn starch and riboflavin was obtained, separation was suppressed, and it was determined from a test whether or not they were equivalent. Preparation of the test solution was performed based on the prescription of Table 1.
[表1]
Figure JPOXMLDOC01-appb-I000001
[Table 1]
Figure JPOXMLDOC01-appb-I000001
 [カプセル充填用液状組成物の評価]
 上述した方法により作製したカプセル充填用液状組成物(検体1~3および比較例1~3)の各々を遠心管(10ml、共栓付き)に10g入れ、これに遠心機(型式:H-11NA;コクサン社製)を用いて回転数2000rpmで5分間運転した時、回転数3000rpmで5分間運転したときトウモロコシデンプンとリボフラビンの分離の有無を表2に示す。
[Evaluation of Liquid Composition for Capsule Filling]
Each of the capsule-filling liquid compositions (samples 1 to 3 and comparative examples 1 to 3) prepared by the above-described method is put into a centrifugal tube (10 ml, with a stopper) with 10 g, and a centrifuge (model: H-11NA) is added thereto. Table 2 shows the presence or absence of separation of corn starch and riboflavin when operated at a rotation speed of 2000 rpm for 5 minutes using a Kokusan Co., Ltd.) and at a rotation speed of 3000 rpm for 5 minutes.
 上述した方法により作製したカプセル充填用液状組成物(検体1~3および比較例1~3)の各々をステンレスカップ(300ml)に250g入れ、液温25℃における粘度を粘度計(型式:RVDV-I+;BROOK FIELD社製、ローターNo.7)を用いて、測定し表2に示す。なお、上記の粘度計で直接に得られる単位であるセンチポアズ(cP)をSI単位であるパスカル秒(Pa・s)に換算して記載した。 250 g of each of the liquid compositions for filling capsules (samples 1 to 3 and comparative examples 1 to 3) prepared by the above-described method were placed in a stainless steel cup (300 ml), and the viscosity at a liquid temperature of 25 ° C. was measured using a viscometer (model: RVDV- I +; measured using BROOK (FIELD, rotor No. 7) and shown in Table 2. In addition, centipoise (cP) which is a unit directly obtained by the above-mentioned viscometer was converted into Pascal second (Pa · s) which is an SI unit and described.
[表2]
Figure JPOXMLDOC01-appb-I000002
[Table 2]
Figure JPOXMLDOC01-appb-I000002
 得られた分散安定性について評価方法を以下に示す。
 ○:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の分離することなく分散安定性を維持しているもの
 △:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の一部分離しているもの
 ×:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の完全に分離しているもの
The method for evaluating the obtained dispersion stability is shown below.
:: Those which maintain dispersion stability without separation of hardly oil-soluble components (corn starch and riboflavin) △: Some of hardly oil-soluble components (corn starch and riboflavin) are separated ×: Hardly oil-soluble components (Corn starch and riboflavin) completely separated
 検体1~3のいずれのカプセル充填用液状組成物は、ミツロウやグリセリン脂肪酸エステルを使用していないにも関わらず、ミツロウやグリセリン脂肪酸エステルを使用したものと同等の分散安定性を有することが示唆された。 It is suggested that any of the liquid compositions for filling capsules of Samples 1 to 3 have the same dispersion stability as those using beeswax or glycerin fatty acid ester, even though beeswax or glycerin fatty acid ester is not used. Was done.
 植物油脂に実施例1で用いたヒマワリ種子油の代わりに、植物種の起源が異なるエステル交換油脂(MCTバター、シソバター、グレープシードバター)を加え、実施例1と同様な温度で撹拌・溶解し、これに、トウモロコシデンプン・リボフラビンを加え、実施例1と同様な混合・撹拌を行った。 In place of the sunflower seed oil used in Example 1, transesterified oils and fats (MCT butter, perilla butter, grape seed butter) having different plant species were added to the vegetable oil and stirred and dissolved at the same temperature as in Example 1. Then, corn starch and riboflavin were added thereto, and the same mixing and stirring as in Example 1 was performed.
 また、得られた分散液の調整や分散安定性の確認についても実施例1と同様な評価を行った。また、試験液の調整は、表3の処方に基づき行った。なお、比較例として、エステル交換油脂以外で粘性を有する食品油脂として、菜種極度硬化油、精製パーム核油、ココナッツオイルを供試し、併せて、エステル交換油脂の評価を行った。 {Circle around (1)} The same evaluation as in Example 1 was performed for adjusting the obtained dispersion and confirming the dispersion stability. Further, adjustment of the test solution was performed based on the prescription in Table 3. In addition, as a comparative example, rapeseed extremely hardened oil, refined palm kernel oil, and coconut oil were used as food oils having viscosity other than transesterified oils and fats, and the transesterified oils and fats were evaluated.
[表3]
Figure JPOXMLDOC01-appb-I000003
[Table 3]
Figure JPOXMLDOC01-appb-I000003
 [カプセル充填用液状組成物の評価]
 上述した方法により作製したカプセル充填用液状組成物(検体4~6および比較例4~6)の各々を遠心管(10ml、共栓付き)に10g入れ、これに遠心機(型式:H-11NA;コクサン社製)を用いて回転数2000rpmで5分間運転したとき、回転数3000rpmで5分間運転したときトウモロコシデンプンとリボフラビンの分離の有無を表4に示す。
[Evaluation of Liquid Composition for Capsule Filling]
10 g of each of the capsule-filling liquid compositions (samples 4 to 6 and comparative examples 4 to 6) prepared by the above-described method is placed in a centrifuge tube (10 ml, with a stopper), and a centrifuge (model: H-11NA) is added thereto. Table 5 shows the presence or absence of separation of corn starch and riboflavin when operated for 5 minutes at a rotation speed of 2,000 rpm using a Kokusan Co., Ltd.).
 また、上述した方法により作製したカプセル充填用液状組成物(検体4~6および比較例4~6)の各々をステンレスカップ(300ml)に250g入れ、液温25℃における粘度を粘度計(型式:RVDV-I+;BROOK FIELD社製、ローターNo.7)を用いて、測定し表4に示す。 In addition, 250 g of each of the liquid compositions for filling capsules (samples 4 to 6 and comparative examples 4 to 6) prepared by the above-described method were placed in a stainless steel cup (300 ml), and the viscosity at a liquid temperature of 25 ° C. was measured using a viscometer (model: RVDV-I +; measured using BROOK (FIELD, rotor No. 7) and shown in Table 4.
[表4]
Figure JPOXMLDOC01-appb-I000004
[Table 4]
Figure JPOXMLDOC01-appb-I000004
 得られた分散安定性について評価方法を以下に示す。
 ○:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の分離することなく分散安定性を維持しているもの
 △:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の一部分離しているもの
 ×:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の完全に分離しているもの
The method for evaluating the obtained dispersion stability is shown below.
:: Those which maintain dispersion stability without separation of hardly oil-soluble components (corn starch and riboflavin) △: Some of hardly oil-soluble components (corn starch and riboflavin) are separated ×: Hardly oil-soluble components (Corn starch and riboflavin) completely separated
 検体4~6のいずれのカプセル充填用液状組成物は、実施例1における検体1のヒマワリ種子油で認められたものと同等の分散安定性を有することが示唆された。このことは、ヒマワリ種子油に限らず、植物種の起源を異にしたエステル交換油脂においてもミツロウやグリセリン脂肪酸エステルを使用したものと同等の分散安定性を有することが示唆された。 It was suggested that any of the liquid compositions for filling capsules of Samples 4 to 6 had the same dispersion stability as that observed in the sunflower seed oil of Sample 1 in Example 1. This suggests that not only sunflower seed oil but also transesterified oils of different plant species origin have the same dispersion stability as those using beeswax or glycerin fatty acid esters.
 なお、この特性は、比較例5および6のように、従来の食品由来の油脂では、充分な分散安定性が得られない。もしくは、比較例4のように、分散安定性を得られたとしても、飽和脂肪酸を摂取する機会が増すことについて懸念が持たれるものとなる。 Note that, as in Comparative Examples 5 and 6, the conventional food-derived fats and oils do not exhibit sufficient dispersion stability. Alternatively, as in Comparative Example 4, even if dispersion stability is obtained, there is a concern that the opportunity to take saturated fatty acids increases.
 植物油脂に実施例1で用いたヒマワリ種子油単体での使用の代わりに、ヒマワリ種子油、MCTバター、シソバター、グレープシードバターの各種エステル交換油脂とミツロウ、もしくは、ヒマワリ種子油、MCTバター、シソバター、グレープシードバターの各種エステル交換油脂とグリセリン脂肪酸エステルを1:1、もしくは、7:3に混ぜたものを作成し、実施例1と同様な温度で撹拌・溶解し、これに、トウモロコシデンプン・リボフラビンを加え、実施例1と同様な混合・撹拌を行った。 Instead of using solely the sunflower seed oil used in Example 1 for the vegetable oil, various transesterified fats and oils of sunflower seed oil, MCT butter, perilla butter, and grape seed butter, or beeswax, or sunflower seed oil, MCT butter, perilla butter A mixture of various transesterified fats and oils of grape seed butter and glycerin fatty acid ester in a ratio of 1: 1 or 7: 3 was prepared, stirred and dissolved at the same temperature as in Example 1, and corn starch Riboflavin was added, and the same mixing and stirring as in Example 1 was performed.
 また、得られた分散液の調整や分散安定性の確認についても実施例1と同様な評価を行った。また、試験液の調整は、表5の処方に基づき行った。 {Circle around (1)} The same evaluation as in Example 1 was performed for adjusting the obtained dispersion and confirming the dispersion stability. The adjustment of the test solution was performed based on the formulation shown in Table 5.
[表5]
Figure JPOXMLDOC01-appb-I000005
[Table 5]
Figure JPOXMLDOC01-appb-I000005
 [カプセル充填用液状組成物の評価]
 上述した方法により作製したカプセル充填用液状組成物(検体7~22)の各々を遠心管(10ml、共栓付き)に10g入れ、これに遠心機(型式:H-11NA;コクサン社製)を用いて回転数2000rpmで5分間運転したとき、回転数3000rpmで5分間運転したときトウモロコシデンプンとリボフラビンの分離の有無を表6に示す。
[Evaluation of Liquid Composition for Capsule Filling]
10 g of each of the liquid compositions for capsule filling (samples 7 to 22) prepared by the above-described method is placed in a centrifuge tube (10 ml, with a stopper), and a centrifuge (model: H-11NA; manufactured by Kokusan) is added thereto. Table 6 shows the presence or absence of separation of corn starch and riboflavin when operated at 2000 rpm for 5 minutes and when operated at 3000 rpm for 5 minutes.
 また、上述した方法により作製したカプセル充填用液状組成物(検体7~22)の各々をステンレスカップ(300ml)に250g入れ、液温25℃における粘度を粘度計(型式:RVDV-I+;BROOK FIELD社製、ローターNo.7)を用いて、測定し表6に示す。 250 g of each of the capsule-filling liquid compositions (samples 7 to 22) prepared by the above-described method is placed in a stainless steel cup (300 ml), and the viscosity at a liquid temperature of 25 ° C. is measured with a viscometer (model: RVDV-I +; BROOK @ FIELD). The results are shown in Table 6.
[表6]
Figure JPOXMLDOC01-appb-I000006
[Table 6]
Figure JPOXMLDOC01-appb-I000006
 得られた分散安定性について評価方法を以下に示す。
 ○:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の分離することなく分散安定性を維持しているもの
 △:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の一部分離しているもの
 ×:難油溶性成分(トウモロコシデンプンおよびリボフラビン)の完全に分離しているもの
The method for evaluating the obtained dispersion stability is shown below.
:: Those that maintain dispersion stability without separation of hardly oil-soluble components (corn starch and riboflavin) △: Partly separated of hardly oil-soluble components (corn starch and riboflavin) ×: Hardly oil-soluble components (Corn starch and riboflavin) completely separated
 検体7~22のいずれのカプセル充填用液状組成物は、実施例1における検体1のヒマワリ種子油で認められたものと同等の分散安定性を有することが示唆された。このことは、従来使用されている食品添加物であるミツロウやグリセリン脂肪酸エステル等の分散安定剤と組合せて使用し分散安定性を得ることも可能であり、これにより食品添加物の使用量を低減することも可能である。 It was suggested that any of the liquid compositions for filling capsules of Samples 7 to 22 had the same dispersion stability as that observed in the sunflower seed oil of Sample 1 in Example 1. This means that it is also possible to obtain dispersion stability by using in combination with the conventionally used food additives such as beeswax and glycerin fatty acid esters, thereby reducing the amount of food additives used. It is also possible.
 実施例4は、分散安定剤としてミツロウやグリセリン脂肪酸エステルの代わりにヒマワリ種子油を使用することにより、食用油脂中に難油溶性成分を高濃度に分散せしめることが可能であること示すものである。なお、表中において、検体1、2及び比較例1、2と表記しているが、これらは上記のものとは別物である。以下本実施例4について説明する。 Example 4 shows that by using sunflower seed oil instead of beeswax and glycerin fatty acid ester as a dispersion stabilizer, it is possible to disperse the hardly oil-soluble component in edible fats and oils at a high concentration. . In the table, samples 1 and 2 and comparative examples 1 and 2 are described, but these are different from the above. Hereinafter, the fourth embodiment will be described.
 本実施例4においては、油脂として中鎖脂肪酸トリグリセリド(MCT)およびDHA含有精製魚油をそれぞれ用い、分散安定剤としてヒマワリ種子油もしくはミツロウを加え、80℃に加熱して撹拌・溶解した。溶解した溶液を60℃まで自然冷却し、これにビルベリーエキス末(かさ比重0.75g/ml)を加え攪拌機でさらに10分間混合・撹拌した。得られた分散液を室温まで冷却、真空脱泡処理をし、カプセル充填用液状組成物(この段階の分散液を以下、内溶液とする)を得て、ロータリー式ソフトカプセル製造機でソフトカプセル化し、オーバル型のカプセルを得た。 In Example 4, medium-chain fatty acid triglyceride (MCT) and DHA-containing purified fish oil were used as oils and fats, respectively, sunflower seed oil or beeswax was added as a dispersion stabilizer, and the mixture was heated to 80 ° C and stirred and dissolved. The dissolved solution was naturally cooled to 60 ° C., to which bilberry extract powder (bulk specific gravity 0.75 g / ml) was added, and the mixture was further mixed and stirred for 10 minutes with a stirrer. The obtained dispersion was cooled to room temperature, subjected to vacuum defoaming treatment, to obtain a liquid composition for filling capsules (the dispersion at this stage is hereinafter referred to as an internal solution), and soft-encapsulated by a rotary soft capsule manufacturing machine. An oval capsule was obtained.
 なお、中鎖脂肪酸トリグリセリド(MCT)およびDHA含有精製魚油は、構成油脂に含まれる長鎖脂肪酸の割合が異なることから、それぞれの油脂に最も多く含有できるビルベリーエキス末の量が異なる。よって、それぞれの食用油脂で含有しうるビルベリーエキス末の量を求めて、その量におけるヒマワリ種子油もしくはミツロウでの比較を行った。各試験区で得られたカプセル充填用液状組成物とカプセル充填用液状組成物を充填したカプセルで得られた性状の確認や試験の結果を下記表7に記載した。 精製 In addition, the purified fish oil containing medium-chain fatty acid triglyceride (MCT) and DHA differs in the proportion of long-chain fatty acids contained in the constituent fats and oils, so that the amount of bilberry extract powder that can be contained most in each fat and oil differs. Therefore, the amount of bilberry extract powder that could be contained in each of the edible oils and fats was determined, and the amount was compared with sunflower seed oil or beeswax. The results of the confirmation and test of the properties obtained from the liquid composition for filling capsules obtained in each test section and the capsules filled with the liquid composition for filling capsules are shown in Table 7 below.
 ここで、中鎖脂肪酸トリグリセリド(MCT)として用いた油脂の組成は、特許文献5との比較のために、油脂の構成脂肪酸に占める炭素数8の脂肪酸と炭素数10の脂肪酸との和の割合が98質量%以上であり、炭素数8の脂肪酸の割合が66質量%以上のものを選択した。また、比重の軽い難油溶性成分を高濃度に分散しにくい油脂として、DHA含有精製魚油を食用油脂として選択した。 Here, the composition of the fat used as the medium-chain fatty acid triglyceride (MCT) is, for comparison with Patent Document 5, the ratio of the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms to the constituent fatty acids of the fat and oil. Is 98% by mass or more and the ratio of fatty acid having 8 carbon atoms is 66% by mass or more. In addition, DHA-containing purified fish oil was selected as an edible oil and fat as an oil and fat that hardly disperses a hardly oil-soluble component having a low specific gravity at a high concentration.
[表7]
Figure JPOXMLDOC01-appb-I000007
[Table 7]
Figure JPOXMLDOC01-appb-I000007
 [カプセル充填用液状組成物の性状の評価]
 上述した方法により作製したカプセル充填用液状組成物(検体1、2および比較例1、2)の各々をステンレスカップ(300ml)に250g入れ、液温25℃における粘度を粘度計(型式:RVDV-I+;BROOK FIELD社製、ローターNo.7)を用いて、測定する。なお、20Pa・s以下を「良好」、50Pa・s以下を「やや硬い」、50Pa・sよりも硬い場合を「硬い」として、表7に示す。なお、「硬い」状態の場合には、充填が行えないこともある。
[Evaluation of properties of liquid composition for capsule filling]
250 g of each of the capsule-filling liquid compositions (Samples 1 and 2 and Comparative Examples 1 and 2) prepared by the above-described method is placed in a stainless steel cup (300 ml), and the viscosity at a liquid temperature of 25 ° C. is measured using a viscometer (model: RVDV- I +; measured using BROOK FIELD Co., Ltd., rotor No. 7). The results are shown in Table 7 as “good” when 20 Pa · s or less, “slightly hard” when 50 Pa · s or less, and “hard” when harder than 50 Pa · s. In the case of the "hard" state, filling may not be performed.
 [カプセル充填用液状組成物の分散安定性(遠心分離)の評価]
 上述した方法により作製したカプセル充填用液状組成物(検体1、2及び比較例1、2)の各々を遠心管(10ml、共栓付き)に10g入れ、これに遠心機(型式:H-11NA;コクサン社製)を用いて回転数2000rpmで5分間運転したときの分離の有無を表7に示す。
[Evaluation of dispersion stability (centrifugation) of liquid composition for capsule filling]
10 g of each of the liquid compositions for filling capsules (samples 1 and 2 and comparative examples 1 and 2) prepared by the above-described method were put into a centrifuge tube (10 ml, with a stopper), and a centrifuge (model: H-11NA) was added thereto. Table 7 shows the presence or absence of separation when the system was operated for 5 minutes at a rotation speed of 2000 rpm using Kokusan Co., Ltd.).
 [カプセル充填用液状組成物を充填したカプセルで得られた作業性の確認]
 上述した方法により作製したカプセル充填用液状組成物(検体1、2及び比較例1、2)の各々をロータリー式ソフトカプセル製造機でソフトカプセル化した。その際に、作業性に問題がなかった場合を「良好」、作業性に支障はあったもののソフトカプセル化をなしえた場合を「やや悪い」、ソフトカプセル化がなされなかった場合を「悪い」とし、表7に示す。
[Confirmation of workability obtained by capsule filled with liquid composition for capsule filling]
Each of the capsule-filling liquid compositions (samples 1 and 2 and comparative examples 1 and 2) produced by the above-described method was soft-encapsulated by a rotary soft capsule manufacturing machine. At that time, if there was no problem with workability, `` good '', workability was impaired but soft encapsulation was achieved `` somewhat bad '', if soft encapsulation was not made `` bad '', It is shown in Table 7.
 [カプセル充填用液状組成物を充填したカプセルで得られた分散安定性(継時変化)の確認]
 上述した方法により作製したカプセル充填用液状組成物(検体1、2及び比較例1、2)の各々をロータリー式ソフトカプセル製造機でソフトカプセル化したカプセルについて、各々のカプセルをガラス容器に100粒程度入れ、温度40℃、相対湿度75%の恒温恒湿槽に保管して、カプセル充填用液状組成物の分散安定性を1日後、3日後、7日後、1か月後、3カ月後、6カ月後に観察した。結果は、分離の有無を表7に示す。
[Confirmation of dispersion stability (change over time) obtained in capsules filled with liquid composition for capsule filling]
About 100 capsules of each of the capsule-filling liquid compositions (samples 1 and 2 and comparative examples 1 and 2) produced by the above-described method were soft-encapsulated by a rotary soft capsule manufacturing machine, and each capsule was placed in a glass container. , At a temperature of 40 ° C. and a relative humidity of 75%, and the dispersion stability of the liquid composition for capsule filling was checked for 1 day, 3 days, 7 days, 1 month, 3 months, and 6 months. Observed later. The results are shown in Table 7 for the presence or absence of separation.
 [カプセル充填用液状組成物を充填したカプセルで得られた液漏れ(製造直後)の確認]
 上述した方法により作製したカプセル充填用液状組成物(検体1、2及び比較例1、2)の各々をロータリー式ソフトカプセル製造機でソフト化カプセル化したカプセルについて、各々のカプセルの1000粒程度を室温の紙を敷いた棚に設置して、液漏れが生じるかを調査した。液漏れの有無を表7に示す。
[Confirmation of liquid leakage (immediately after production) obtained in capsules filled with the liquid composition for capsule filling]
Each of the capsule-filling liquid compositions (samples 1 and 2 and comparative examples 1 and 2) prepared by the above-described method was softened and encapsulated by a rotary soft capsule maker. It was installed on a shelf laid with a piece of paper, and it was examined whether or not liquid leakage would occur. Table 7 shows the presence or absence of liquid leakage.
 [カプセル充填用液状組成物を充填したカプセルで得られた液漏れ(継時変化)の確認]
 上述した方法により作製したカプセル充填用液状組成物(検体1、2及び比較例1、2)の各々をロータリー式ソフトカプセル製造機でソフトカプセル化したカプセルについて、各々のカプセルガラス容器に100粒程度入れ、温度40℃、相対湿度75%の恒温恒湿槽に保管して、液漏れの有無を1日後、3日後、7日後、1か月後、3カ月後、6カ月後に観察した。結果は、液漏れの有無を表7に示す。
[Confirmation of liquid leakage (sequential change) obtained in capsules filled with the liquid composition for capsule filling]
About 100 capsules of each of the capsule-filling liquid compositions (Samples 1 and 2 and Comparative Examples 1 and 2) prepared by the above-described method were soft-encapsulated by a rotary soft capsule manufacturing machine, and about 100 capsules were placed in each capsule glass container. The solution was stored in a thermo-hygrostat at a temperature of 40 ° C. and a relative humidity of 75%, and the presence or absence of liquid leakage was observed one day, three days, seven days, one month, three months, and six months. The results are shown in Table 7 for the presence or absence of liquid leakage.
 [カプセル充填用液状組成物を充填したカプセルで得られたその他(継時変化)の確認]
 上記液漏れの試験と併せて、外観、臭い、色調、変形等の変化があるのかを確認した。結果は、変化の有無等について、表7に示す。
[Confirmation of Others (Change over Time) Obtained with Capsules Filled with Liquid Composition for Capsule Filling]
In addition to the above-mentioned liquid leakage test, it was confirmed whether there was a change in appearance, odor, color tone, deformation and the like. The results are shown in Table 7 regarding the presence or absence of a change.
 表7に示すように、分散安定剤としてヒマワリ種子油を使用した場合は、ミツロウを使用した場合に比べて、中鎖脂肪酸トリグリセリド(MCT)およびDHA含有精製魚油ともに、難油溶性成分として選択したビルベリーエキス末を多く含有できる。もしくは、ビルベリーエキス末含有量が同量だとしても作業性(充填性)や品質(液漏れ)が優れることが判明した。 As shown in Table 7, when sunflower seed oil was used as a dispersion stabilizer, compared with the case where beeswax was used, both medium-chain fatty acid triglyceride (MCT) and DHA-containing purified fish oil were selected as poor oil-soluble components. Can contain a lot of bilberry extract powder. Alternatively, it was found that even if the bilberry extract powder content was the same, the workability (fillability) and the quality (liquid leakage) were excellent.
 従来の既知見として、特許文献5の中で、食用油脂の構成について、構成脂肪酸に占める炭素数の指定や使用の割合を制限することで得られた中鎖脂肪酸トリグリセリド(MCT)を使用することで達成された57.1~62.5質量%のブルーベリー粉末の量とほぼ同量を充填することが可能であった。 As a conventional knowledge, in Patent Document 5, regarding the composition of edible oils and fats, use of medium-chain fatty acid triglyceride (MCT) obtained by specifying the number of carbon atoms in the constituent fatty acids and restricting the ratio of use is described. It was possible to fill almost the same amount as the amount of blueberry powder of 57.1 to 62.5% by mass achieved in the above.
 なお、特許文献5においてサフラワー油を食用油脂とした場合では、ブルーベリー粉末を50.0質量%懸濁させることが不可能であった。本試験において分散安定剤としてヒマワリ種子油を選択することで、サフラワー油のように中鎖脂肪酸トリグリセリド(MCT)より構成脂肪酸に含まれる長鎖脂肪酸の割合が多いDHA含有精製魚油を食用油脂とした場合でも50質量%を懸濁させることが可能になることからも、本実施形態のカプセル充填用液状組成物によれば、食用油脂の選択の幅に制限がかかることや特殊な機器を選択して素材を著しく物理的および化学的に変質させる懸念を抱くことなく、難油溶性成分として粉末およびエキス類を高濃度に含有するカプセル充填用液状組成物を提供できる。 In addition, when safflower oil was used as an edible fat in Patent Document 5, it was impossible to suspend 50.0% by mass of blueberry powder. By selecting sunflower seed oil as a dispersion stabilizer in this test, DHA-containing purified fish oil having a higher proportion of long-chain fatty acids contained in constituent fatty acids than medium-chain fatty acid triglyceride (MCT), such as safflower oil, is used as an edible oil and fat. According to the liquid composition for filling capsules of this embodiment, the range of choice of edible oils and fats is limited, and special equipment is selected. Thus, there can be provided a liquid composition for filling capsules containing a powder and an extract at a high concentration as a hardly oil-soluble component, without having to worry about the physical and chemical deterioration of the material significantly.
 上記のように、本実施形態のカプセル充填用液状組成物によれば、難油溶性成分としてとして粉末およびエキス類を、従来に比べて非常に高い含有率で、分散安定性よく懸濁させ、かつ、ソフトカプセル皮膜に充填性よく充填でき、かつ、カプセル化されたカプセルの品質が優れるカプセル充填用液状組成物を提供することが出来る。 As described above, according to the liquid composition for filling capsules of the present embodiment, powders and extracts as the hardly oil-soluble component are suspended at a very high content compared with the conventional one, with good dispersion stability, In addition, it is possible to provide a liquid composition for filling capsules which can be filled into the soft capsule film with good filling properties and has excellent quality of the encapsulated capsules.
 以上、本発明について好適な実施形態を挙げて説明したが、本発明は上記の実施形態に限定されるものではなく、以下に示すように、本発明の要旨を逸脱しない範囲において、種々の改良および設計の変更が可能である。 As described above, the present invention has been described with reference to the preferred embodiments. However, the present invention is not limited to the above embodiments, and various improvements can be made without departing from the gist of the present invention as described below. And design changes are possible.
 例えば、上記の実施形態では、カプセル充填用液状組成物をソフトカプセル皮膜に充填する場合を例示したが、これに限定されず、シームレスカプセルやハードカプセル皮膜に充填しても構わない。また、カプセル皮膜の基材は特に限定されず、ゼラチンを基材とするものの他、本出願人を含め種々の提案されている非ゼラチン基材を使用したカプセル皮膜に、本発明のカプセル充填用液状組成物を充填することが出来る。 For example, in the above embodiment, the case where the liquid composition for filling capsules is filled in the soft capsule film is exemplified, but the present invention is not limited to this, and the capsule composition may be filled in the seamless capsule or hard capsule film. The base material of the capsule coating is not particularly limited, and in addition to those based on gelatin, the capsule coating of the present invention can be filled into a capsule coating using various proposed non-gelatin bases including the present applicant. A liquid composition can be filled.

Claims (4)

  1.  食用油脂中に難油溶性成分を分散せしめたカプセル充填用液状組成物であって、
     前記難油溶性成分を分散させるための分散安定剤としてエステル交換油脂を含有することを特徴とするカプセル充填用液状組成物。
    A liquid composition for filling capsules in which the hardly oil-soluble component is dispersed in edible oil and fat,
    A liquid composition for filling capsules, comprising a transesterified fat as a dispersion stabilizer for dispersing the hardly oil-soluble component.
  2.  前記エステル交換油脂は、ヒマワリ種子油であることを特徴とする請求項1に記載のカプセル充填用液状組成物。 The liquid composition for filling capsules according to claim 1, wherein the transesterified fat is sunflower seed oil.
  3.  前記ヒマワリ種子油は、前記カプセル充填用液状組成物100質量%中、1~30質量%、好ましくは1~20質量%、より好ましくは2~10質量%であることを特徴とする請求項2に記載のカプセル充填用液状組成物。 3. The composition according to claim 2, wherein the sunflower seed oil accounts for 1 to 30% by mass, preferably 1 to 20% by mass, more preferably 2 to 10% by mass, based on 100% by mass of the liquid composition for filling capsules. The liquid composition for filling capsules according to the above.
  4.  請求項2あるいは3に記載のカプセル充填用液状組成物を含有することを特徴とするカプセル剤。
     
    A capsule containing the liquid composition for filling a capsule according to claim 2 or 3.
PCT/JP2019/034257 2018-09-06 2019-08-30 Liquid composition for encapsulation and encapsulated formulation WO2020050182A1 (en)

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