WO2020050182A1 - Composition liquide pour encapsulation et formulation encapsulée - Google Patents

Composition liquide pour encapsulation et formulation encapsulée 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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WO
WIPO (PCT)
Prior art keywords
oil
liquid composition
capsule
filling
hardly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2019/034257
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English (en)
Japanese (ja)
Inventor
朋之 橋本
光昭 小野
義孝 長谷川
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KAMATA Co Ltd
Original Assignee
KAMATA Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by KAMATA Co Ltd filed Critical KAMATA Co Ltd
Priority to JP2019568264A priority Critical patent/JPWO2020050182A1/ja
Publication of WO2020050182A1 publication Critical patent/WO2020050182A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • 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 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Medicinal Preparation (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

L'invention concerne une composition liquide pour encapsulation et une formulation encapsulée qui, même si l'on n'utilise pas ou si l'on n'utilise qu'une quantité réduite de cire d'abeille ou d'ester d'acide gras de glycérine, sont capables de permettre l'obtention d'une dispersion aussi stable que les produits classiques qui utilisent de la cire d'abeille ou de l'ester d'acide gras de glycérine en tant que stabilisateur de dispersion, du fait de l'utilisation d'huile de tournesol en tant que stabilisateur de dispersion pour disperser un composant peu soluble dans l'huile ; et qui sont aptes à contenir un composant peu soluble dans l'huile, qui peut être une poudre ou un extrait, à une concentration élevée.
PCT/JP2019/034257 2018-09-06 2019-08-30 Composition liquide pour encapsulation et formulation encapsulée Ceased WO2020050182A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2019568264A JPWO2020050182A1 (ja) 2018-09-06 2019-08-30 カプセル充填用液状組成物及びカプセル剤

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JP2018166737 2018-09-06
JP2018-166737 2018-09-06

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WO2020050182A1 true WO2020050182A1 (fr) 2020-03-12

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06253738A (ja) * 1993-03-05 1994-09-13 Fuji Oil Co Ltd 離型油組成物
JPH09118894A (ja) * 1991-06-27 1997-05-06 Sandoz Ag 医薬組成物
JP2017048129A (ja) * 2015-08-31 2017-03-09 小林製薬株式会社 ソフトカプセル剤およびその製造方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5405242B2 (ja) * 2009-09-07 2014-02-05 理研ビタミン株式会社 ソフトカプセル充填用液状組成物

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09118894A (ja) * 1991-06-27 1997-05-06 Sandoz Ag 医薬組成物
JPH06253738A (ja) * 1993-03-05 1994-09-13 Fuji Oil Co Ltd 離型油組成物
JP2017048129A (ja) * 2015-08-31 2017-03-09 小林製薬株式会社 ソフトカプセル剤およびその製造方法

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
"Non-official translation: EPL Capsules 250mg", ALFRESA PHARMA CORPORATION, 2007 *
21 November 2019 (2019-11-21), Retrieved from the Internet <URL:https://www.kobayashi.co.jp/seihin/bberry/index.html> *
AMAZON, 14 November 2007 (2007-11-14), Retrieved from the Internet <URL:URL:https://www.amazon.co.jp/%E5%B0%8F%E6%9E%97%E8%A3%BD%E8%96%AC%E3%81%AE%E6%A0%84%E9%A4%8A%E8%A3%9C%E5%8A%A9%E9%A3%9F%E5%93%81-%E3%83%96%E3%83%AB%E3%83%BC%E3%83%99%E3%83%AA%E3%83%BC-%E7%B4%8430%E6%97%A5%E5%88%86-30%E7%B2%92/dp/B0015I2K6I/ref=sr_1_5?hvadid=336347048157&hvdev=c&jp-ad-ap=0&keywords=%E5%B0%8F%E6%9E%97%E8%A3%BD%E8%96%AC%E3%83%96%E3%83%AB%E3%83%BC%E3%83%99%E3%83%AA%E3%83%BC&qid=1574297968&sr=8-5> *
AMAZON, 2 April 2014 (2014-04-02), Retrieved from the Internet <URL:https://www.amazon.co.jp/dp/B00JFISN9Saaxitk=KOzMqoKOXPazbOqoBe3biw&pd_rd_i=B00JFISN9S&pf_rd_p=1b1511df-b525-4a74-b79c-c8395c81af7d&hsa_cr_id=5234945680703&sb-ci-n=asinImage&sb-ci-v=https%3A%2%2Fm.media-amazon.com%2Fimages%2FI%2F31G71UBpCtL.jpg&sb-ci-a=B00JFISN9S> [retrieved on 20191121] *

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