JP6697234B2 - Soft capsule and method for producing the same - Google Patents
Soft capsule and method for producing the same Download PDFInfo
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- JP6697234B2 JP6697234B2 JP2015170883A JP2015170883A JP6697234B2 JP 6697234 B2 JP6697234 B2 JP 6697234B2 JP 2015170883 A JP2015170883 A JP 2015170883A JP 2015170883 A JP2015170883 A JP 2015170883A JP 6697234 B2 JP6697234 B2 JP 6697234B2
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- Prior art keywords
- soft capsule
- liquid
- wood
- content liquid
- content
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Description
本発明は、ソフトカプセル剤およびその製造方法に関する。 The present invention relates to a soft capsule and a method for producing the same.
ソフトカプセルは油脂や油溶性ビタミン等、非水溶性の成分をゼラチン等の皮膜で封入した製剤であって、有効成分の摂取に好適であるため、医薬品や食品に使用されている。このようなソフトカプセルには、有効成分として天然物由来の成分を配合する場合、抽出エキスを液状または粉末状で配合する(特許文献1)。しかしながら、有効成分が特定されていない場合には、抽出条件を適切に決定することができず、十分な有効性のある抽出エキスが得られないとの問題がある。 Soft capsules are preparations in which water-insoluble components such as fats and oils and oil-soluble vitamins are enclosed in a film such as gelatin, and are suitable for ingestion of active ingredients, and are therefore used in medicines and foods. When a natural product-derived ingredient is added as an active ingredient to such a soft capsule, the extract is added in liquid or powder form (Patent Document 1). However, when the active ingredient is not specified, there is a problem that the extraction conditions cannot be properly determined and an extract having sufficient effectiveness cannot be obtained.
抽出エキスの乾燥粉末といった天然物から溶媒を用いて抽出し濃縮、乾燥を行って製した粉末原料については、錠剤等の固形製剤に製されて摂取に用いられることが多い。昨今、使用者の嗜好性の高まりから、ソフトカプセルとしての態様も望まれている。その際、ソフトカプセルの大きな特性である良好な外観が重視される。このような粉末原料をソフトカプセルに充填しようとした場合、当該粉末原料がカプセルの接合面に挟み込まれることがあり、粉末原料と共に充填した液状成分が外部に漏れ出す(以下、「液漏れ」ということがある。)等の問題が生じる。従来、これに対してカプセル皮膜の厚みを厚くする、粉末原料の平均粒子径を前記皮膜の厚みより小さくする等の対応がとられてきた。 A powder raw material produced by extracting a natural product such as a dry powder of an extract with a solvent, concentrating and drying the extract is often used as a solid preparation such as a tablet for ingestion. Nowadays, a soft capsule is also desired because of increasing user's preference. At that time, good appearance, which is a major characteristic of the soft capsule, is emphasized. When attempting to fill such a powder raw material into a soft capsule, the powder raw material may be sandwiched between the joint surfaces of the capsule, and the liquid component filled with the powder raw material leaks to the outside (hereinafter referred to as “liquid leakage”). There is a problem such as). Conventionally, measures have been taken to increase the thickness of the capsule coating, reduce the average particle diameter of the powder raw material to be smaller than the thickness of the coating, and the like.
一方、有効成分が特定されていない場合、有効成分を含有する天然物等をそのまま摂取することが望ましい。この場合、当該天然物をソフトカプセルに製して摂取するために、当該天然物そのものを粉砕して粉末状とする必要がある。しかしながら、天然物のうち、木のような強固な繊維質を有するものを粉砕した原料を充填しようとすると、皮膜の厚みの増大や粉砕物の平均粒子径を皮膜の厚みより小さくする(皮膜の厚みの1/2以下程度)だけでは、液漏れを回避できないとの問題が生じた。それに加えて、製剤工程で熱が発生する等の問題が発生した。 On the other hand, when the active ingredient is not specified, it is desirable to take a natural product or the like containing the active ingredient as it is. In this case, in order to manufacture the natural product into a soft capsule and ingest it, it is necessary to grind the natural product itself into a powder. However, when a raw material obtained by crushing a natural product having a strong fibrous substance such as wood is attempted to be filled, the thickness of the film is increased and the average particle size of the pulverized product is made smaller than the thickness of the film. There was a problem that the liquid leakage could not be avoided only with (about 1/2 the thickness or less). In addition, problems such as heat generation during the formulation process have occurred.
本発明は、木の粉砕物を含有する内容液を有する液漏れの頻度が低く抑制されたソフトカプセル剤を提供すること、さらには内容液の整粒工程において、発熱がなく、安定性の高いソフトカプセル剤を作製する製造方法を提供することを目的とする。 The present invention provides a soft capsule having a content liquid containing a pulverized product of wood, in which the frequency of liquid leakage is suppressed to a low level, and further, in the sizing step of the content liquid, there is no heat generation and a highly stable soft capsule. It aims at providing the manufacturing method which produces an agent.
本発明者らは、木の粉砕物を含有する内容液を有するソフトカプセル剤の液漏れについて検討したところ、ソフトカプセル剤の液漏れは木の粉砕物の平均粒子径に大きく影響すること、また、平均粒子径が80μm以下であれば、液漏れの発生頻度が低いソフトカプセル剤を提供することができ、さらには、内容液の整粒工程において発熱が抑制されることを見出し、本発明を完成した。 The present inventors have examined the leakage of soft capsules having a content liquid containing crushed wood, liquid leakage of the soft capsule has a large effect on the average particle size of the crushed wood, the average When the particle size is 80 μm or less, a soft capsule having a low frequency of liquid leakage can be provided, and further, heat generation is suppressed in the step of sizing the content liquid, and the present invention has been completed.
すなわち、本発明は、木の粉砕物を含有する内容液を有するソフトカプセル剤に関する。 That is, the present invention relates to a soft capsule having a content liquid containing a pulverized product of wood.
木の粉砕物の平均粒子径が80μm以下であることが好ましい。 It is preferable that the average particle size of the pulverized wood is 80 μm or less.
木の粉砕物の含有量が、内容液中に20重量%以下であることが好ましい。 The content of the pulverized wood is preferably 20% by weight or less in the content liquid.
また、本発明は、内容液の整粒工程を含むことを特徴とする前記ソフトカプセル剤の製造方法に関する。 The present invention also relates to the method for producing a soft capsule, which comprises a step of sizing the content liquid.
本発明のソフトカプセル剤は、木の粉砕物を含有する内容液を有するため、有効成分が知られていない場合であっても、ソフトカプセル化することができる。また、木の粉砕物の平均粒子径が80μm以下であるので、得られたソフトカプセルの内容物の液漏れの頻度が低く抑制されており、製剤性に優れている。さらに、ソフトカプセルの作製時の内容液の整粒工程において、発熱を抑制することができ、安定なソフトカプセル剤を提供することができる。 Since the soft capsule of the present invention has a content liquid containing a pulverized product of wood, it can be soft-encapsulated even when the active ingredient is unknown. Moreover, since the average particle diameter of the pulverized wood is 80 μm or less, the frequency of liquid leakage of the contents of the obtained soft capsules is suppressed to be low, and the formulation properties are excellent. Furthermore, heat generation can be suppressed in the step of sizing the content liquid during production of the soft capsule, and a stable soft capsule can be provided.
本発明のソフトカプセル剤は、木の粉砕物を含有する内容液を有する。ここで、ソフトカプセル剤とは、非水溶性の液体や粉末含有液体をゼラチン等の皮膜で封入した製剤であり、外観に優れる点で、健康食品に多用されるものである。 The soft capsule of the present invention has a content liquid containing a pulverized product of wood. Here, the soft capsule is a preparation in which a water-insoluble liquid or a powder-containing liquid is enclosed with a film such as gelatin, and is often used in health foods because of its excellent appearance.
木とは、「木本植物」と呼ばれ、硬い幹をもち、耐性芽が地面より高いところにあって、二次肥大成長するものである。木の種類は特に限定されず、たとえばメグスリノキ、トネリコ、インドボダイジュ、キハダ、ヤマザクラ、アカキナノキ、クスノハガシワ、アカメガシワ、クスノキ、センダン、メギ、ホウノキ、クヌギ、タラノキ、トチュウ、ニガキ、ヨウバイヒ等が挙げられる。 A tree is called a "woody plant", and has a hard trunk and has resistant buds higher than the ground, and undergoes secondary hypertrophic growth. The type of tree is not particularly limited, and examples thereof include Megsuri, ash, ash, Indian bodice, yellowfin, yamazakura, red quince, camphor tree, red megalois, camphor tree, sardines, barberry, honoki, kunugi, aralia, eucommia, lacquer tree, euglena and the like.
木の粉砕物に使用する部位は特に限定されず、たとえば茎や枝を構成する木部、樹皮などが挙げられる。 The part used for the pulverized product of wood is not particularly limited, and examples thereof include xylem, bark, and the like constituting stems and branches.
木の粉砕物の平均粒子径は特に限定されないが、木の粉砕物は、樹皮等の強固な繊維質を持つものを原料としており、粉砕しても繊維質の影響により、長径と短径が生じてしまうことになるため、好ましくは80μm以下、より好ましくは40μm以下である。下限は特に限定されないが、20μm以上であることが好ましい。80μmを超えると、液漏れを生じる頻度が多くなる傾向があり、20μm未満では、粉砕工程が煩雑になる傾向がある。木の粉砕方法は特に限定されないが、衝突粉砕、圧縮粉砕、せん断力による粉砕、摩擦力による粉砕、これらを組み合わせた粉砕などの方法が挙げられ、必要に応じて篩にかけることもできる。ここで、本発明において平均粒子径とは、レーザー回析式粒度分布測定装置で測定した値である。 The average particle size of the crushed wood is not particularly limited, but the crushed wood is made of a material having a strong fibrous material such as bark. Therefore, it is preferably 80 μm or less, more preferably 40 μm or less. The lower limit is not particularly limited, but is preferably 20 μm or more. If it exceeds 80 μm, the frequency of liquid leakage tends to increase, and if it is less than 20 μm, the crushing process tends to be complicated. The method for crushing the tree is not particularly limited, and examples thereof include collision crushing, compression crushing, crushing by shearing force, crushing by frictional force, crushing combining these, and the like, and sieving may be performed if necessary. Here, in the present invention, the average particle size is a value measured by a laser diffraction type particle size distribution measuring device.
木の粉砕物の含有量は特に限定されないが、内容液中に好ましくは20重量%以下、より好ましくは19重量%以下、更に好ましくは14重量%以下である。下限は特に限定されないが、好ましくは1重量%以上、より好ましくは3重量%以上である。1重量%未満では、成分によっては充分な有効性が得られなくなる傾向となり、20重量%を超えると、製剤性が悪くなったり、整粒工程で発熱が生じる傾向がある。 The content of the pulverized wood is not particularly limited, but is preferably 20% by weight or less, more preferably 19% by weight or less, further preferably 14% by weight or less in the content liquid. The lower limit is not particularly limited, but is preferably 1% by weight or more, more preferably 3% by weight or more. If it is less than 1% by weight, sufficient effectiveness tends to be not obtained depending on the components, and if it exceeds 20% by weight, the formulation property tends to deteriorate and heat generation in the sizing step tends to occur.
内容液には、木の粉砕物以外に、必要に応じて油性基剤が含まれていても良い。油性基剤としては、食品または医薬品に使用できるものであることを限度として特に制限されないが、例えば、ワックス、植物油、動物油、高級脂肪酸等が挙げられる。 The content liquid may contain an oily base, if necessary, in addition to the pulverized product of wood. The oily base is not particularly limited as long as it can be used in foods or pharmaceuticals, and examples thereof include wax, vegetable oil, animal oil, and higher fatty acid.
ワックスとしては、たとえばミツロウ、カルナウバロウ、キャンデリラロウ、コメヌカロウ、モクロウ、サトウキビロウ、パームロウ等が挙げられる。これらのワックスは、単独で用いてもよいし、2種以上を併用してもよい。 As the wax, for example, beeswax, carnauba wax, candelilla wax, rice bran wax, wax, sugarcane wax, palm wax and the like can be mentioned. These waxes may be used alone or in combination of two or more.
植物油としては、たとえばサフラワー油、オリーブ油、小麦胚芽油、こめ油、大豆油、つばき油、とうもろこし油、なたね油、ひまわり油、綿実油、落花生油、ホホバ油、アボカド油、ウイキョウ油、チョウジ油、ハッカ油、ユーカリ油、レモン油、等が挙げられる。これらの植物油は、単独で用いてもよいし、2種以上を併用してもよい。 Examples of vegetable oils include safflower oil, olive oil, wheat germ oil, rice oil, soybean oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, peanut oil, jojoba oil, avocado oil, fennel oil, clove oil, peppermint. Oil, eucalyptus oil, lemon oil, etc. are mentioned. These vegetable oils may be used alone or in combination of two or more.
動物油としては、具体的には、ラード、魚油、スクワラン、牛脂等が挙げられる。これらの動物油は、単独で用いてもよいし、2種以上を併用してもよい。 Specific examples of animal oils include lard, fish oil, squalane, beef tallow, and the like. These animal oils may be used alone or in combination of two or more kinds.
高級脂肪酸としては、例えば、炭素数8〜22の脂肪酸が挙げられ、具体的には、ドコサヘキサエン酸、エイコサペンタエン酸、ステアリン酸、ラウリン酸、ミリスチン酸、パルミチン酸、セバシン酸、オレイン酸等が挙げられる。これらの高級脂肪酸は、単独で用いてもよいし、2種以上を併用してもよい。 Examples of the higher fatty acid include fatty acids having 8 to 22 carbon atoms, and specific examples include docosahexaenoic acid, eicosapentaenoic acid, stearic acid, lauric acid, myristic acid, palmitic acid, sebacic acid, oleic acid and the like. Be done. These higher fatty acids may be used alone or in combination of two or more.
これらの油性基剤は、単独で用いてもよいし、2種以上を併用してもよい。これらの油性基剤の中でも、植物油及びワックスが好ましい。 These oily bases may be used alone or in combination of two or more. Among these oily bases, vegetable oils and waxes are preferable.
油性基剤の含有量については、特に制限されないが、例えば40〜98重量%、好ましくは45〜98重量%、更に好ましくは50〜98重量%が挙げられる。 The content of the oily base is not particularly limited, but is, for example, 40 to 98% by weight, preferably 45 to 98% by weight, and more preferably 50 to 98% by weight.
内容液には、木の粉砕物以外に、必要に応じて界面活性剤が含まれていても良い。特に、当該内容液に前記油性基剤を含有させる場合には、木の粉砕物の分散性等の観点から、界面活性剤を含んでいることが好ましい。 The content liquid may contain a surfactant, if necessary, in addition to the pulverized product of wood. In particular, when the oily base is contained in the content liquid, it is preferable to contain a surfactant from the viewpoint of dispersibility of the pulverized wood.
界面活性剤としては、食品又は医薬品に使用できるものであることを限度として特に制限されないが、例えば、ポリオキシエチレンラウリルエーテル硫酸ナトリウム、ラウリル硫酸ナトリウム、ミリスチル硫酸ナトリウム、N−ラウロイルザルコシン酸ナトリウム、N−ミリストリルザルコシン酸ナトリウム、ドデシルベンゼンスルホン酸ナトリウム、水素添加ココナッツ脂肪酸モノグリセリドモノ硫酸ナトリウム、ラウリルスルホ酢酸ナトリウム、α−オレフィンスルホン酸ナトリウム、N−パルミトイルグルタルミン酸ナトリウム、N−メチル−N−アシルタウリンナトリウム等の陰イオン性界面活性剤;グリセリン脂肪酸エステル、ショ糖脂肪酸エステル、マルトース脂肪酸エステル、マルチトール脂肪酸エステル、ラクトール脂肪酸エステル、ソルビタン脂肪酸エステル、ポリオキシエチレンソルビタンモノステアレート、ポリオキシエチレン高級アルコールエーテル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンポリオキシプロピレン共重合体、ポリオキシエチレンポリオキシプロピレン脂肪酸エステル、レシチン等の非イオン性界面活性剤;ヤシ油脂肪酸アミドプロピルベタイン、ラウリルジメチルアミノ酢酸ベタイン、ラウリルジメチルアミンオキシド、2-アルキル−N−カルボキシメチル−N−ヒドロキシエチルイミダゾリウムベタイン、N−ラウリルジアミノエチルグリシン、N−ミリスチルジアミノエチルグリシン、N−アルキル−1−ヒドロキシエチルイミダゾリンベタインナトリウム等両性界面活性剤;塩化ラウリルトリメチルアンモニウム、塩化ステアリルトリメチルアンモニウム、塩化ベンゼトニウム、塩化ベンザルコニウム、塩化ステアリルジメチルベンジルアンモニウム等の陽イオン性界面活性剤が挙げられる。これらの界面活性剤の中でも、好ましくは非イオン性界面活性剤、更に好ましくはグリセリン脂肪酸エステル、ショ糖脂肪酸エステル、レシチンが挙げられる。 The surfactant is not particularly limited as long as it can be used in foods or pharmaceuticals, for example, sodium polyoxyethylene lauryl ether sulfate, sodium lauryl sulfate, sodium myristyl sulfate, sodium N-lauroyl sarcosinate, Sodium N-myristol sarcosinate, sodium dodecylbenzene sulfonate, hydrogenated coconut fatty acid monoglyceride sodium monosulfate, sodium lauryl sulfoacetate, sodium α-olefin sulfonate, sodium N-palmitoyl glutamate, N-methyl-N- Anionic surfactants such as sodium acyltaurine; glycerin fatty acid ester, sucrose fatty acid ester, maltose fatty acid ester, maltitol fatty acid ester, lactol fatty acid Stell, sorbitan fatty acid ester, polyoxyethylene sorbitan monostearate, polyoxyethylene higher alcohol ether, polyoxyethylene hydrogenated castor oil, polyoxyethylene polyoxypropylene copolymer, polyoxyethylene polyoxypropylene fatty acid ester, lecithin, etc. Nonionic surfactant; coconut oil fatty acid amide propyl betaine, lauryl dimethyl amino acetic acid betaine, lauryl dimethyl amine oxide, 2-alkyl-N-carboxymethyl-N-hydroxyethyl imidazolium betaine, N-lauryl diaminoethyl glycine, N Amphoteric surfactants such as -myristyldiaminoethylglycine, N-alkyl-1-hydroxyethylimidazoline betaine sodium; lauryltrimethylammonium chloride, Stearyl trimethyl ammonium, benzethonium chloride, benzalkonium chloride, cationic surfactants such as chloride stearyl dimethyl benzyl ammonium. Among these surfactants, nonionic surfactants are preferable, and glycerin fatty acid ester, sucrose fatty acid ester, and lecithin are more preferable.
これらの界面活性剤は、単独で用いてもよいし、2種以上を併用してもよい。 These surfactants may be used alone or in combination of two or more.
界面活性剤の含有量については、特に制限されないが、1〜10重量%、好ましくは2〜9重量%、更に好ましくは2〜8重量%である。 The content of the surfactant is not particularly limited, but is 1 to 10% by weight, preferably 2 to 9% by weight, more preferably 2 to 8% by weight.
内容液には、木の粉砕物、油性基剤、界面活性剤の他に、本発明の目的を損なわない範囲で、他の成分を含有していてもよい。他の成分としては、たとえばブルーベリー、ラズベリー、クランベリー、ゴジベリー、マキベリー、リンゴ、ビワ、ブドウ、イチゴ、アボガド、ニセアカシア、コケモモ、ヤマモモ、カシス、イチョウバなどの抽出エキス(濃縮・粉末化したものを含む);ビタミンB1、ビタミンB2、ビタミンB6(ビリドキシン塩酸塩)、ビタミンB12(シアノコバラミン)、ビタミンC、ビタミンA、ビタミンD、ビタミンE(トコフェロール酢酸エステル)、ビタミンK、ナイアシン、パントテン酸、葉酸、ビオチン、リコペン等のビタミン類;カルシウム、イオウ、マグネシウム、亜鉛、セレン、鉄等のミネラル類;大豆タンパク、卵白粉末、乳清タンパク等のタンパク質;グリシン、アラニン、アルギニン、アスパラギン酸、シスチン、フェニルアラニン、タウリン、トリプトファン等のアミノ酸;ショ糖、果糖、乳糖、水アメ、果糖ブドウ糖液糖、スクラロース、ソーマチン、アスパルテーム、アセスルファムK、オリゴ糖(例えば、マルトオリゴ糖、イソマルトオリゴ糖、ガラクトオリゴ糖、イヌロオリゴ糖、フラクトオリゴ糖、キシロオリゴ糖)、ポリデキストロース、デキストリン、難消化性デキストリン、還元難消化性デキストリン等の甘味料;リノール酸、γ−リノレン酸、α−リノレン酸等の脂肪酸類;アガリクス、シイタケ、レイシ、ヤマブシタケ等のキノコ類又はそのエキス;食物繊維、ローヤルゼリー、プロポリス、ハチミツ、コンドロイチン硫酸、グルコサミン、セラミド、ヒアルロン酸、大豆イソフラボン、エクオール、カロテン類(αカロテン、βカロテン、γカロテン、σカロテン、リコペン)、キサントフィル類(ルテイン、ゼアキサンチン、フコキサンチン)、アントシアニン、タンニン、ゲニポシド酸、クルクミン等のその他機能性素材等が挙げられる。 The content liquid may contain other components in addition to the pulverized product of wood, the oily base, and the surfactant as long as the object of the present invention is not impaired. Other ingredients include, for example, blueberry, raspberry, cranberry, goji berry, maqui berry, apple, loquat, grape, strawberry, avocado, black locust, cowberry, bayberry, black currant, ginkgo biloba, etc. (including concentrated and powdered extracts). Vitamin B1, vitamin B2, vitamin B6 (viridoxine hydrochloride), vitamin B12 (cyanocobalamin), vitamin C, vitamin A, vitamin D, vitamin E (tocopherol acetate), vitamin K, niacin, pantothenic acid, folic acid, biotin, Lycopene and other vitamins; Calcium, sulfur, magnesium, zinc, selenium, iron and other minerals; soy protein, egg white powder, whey protein and other proteins; glycine, alanine, arginine, aspartic acid, cystine, fe Amino acids such as lualanine, taurine, and tryptophan; sucrose, fructose, lactose, starch syrup, fructose corn syrup, sucralose, thaumatin, aspartame, acesulfame K, oligosaccharides (eg, maltooligosaccharides, isomaltooligosaccharides, galactooligosaccharides, inulooligosaccharides) , Fructooligosaccharides, xylooligosaccharides), polydextrose, dextrin, indigestible dextrin, reduced indigestible dextrin, and other sweeteners; linoleic acid, γ-linolenic acid, α-linolenic acid, and other fatty acids; agaricus, shiitake mushrooms, and litchi , Mushrooms such as edible mushrooms and their extracts; dietary fiber, royal jelly, propolis, honey, chondroitin sulfate, glucosamine, ceramide, hyaluronic acid, soy isoflavone, equol, carotene (α-carotene, β-carotene) , Γ-carotene, σ-carotene, lycopene), xanthophylls (lutein, zeaxanthin, fucoxanthin), anthocyanins, tannins, geniposide acid, curcumin, and other functional materials.
さらに、内容液には、必要に応じて、その他の基剤や添加剤等が含まれていてもよい。このような基剤及び添加剤としては、食品や医薬品に使用可能なものであれば特に制限されないが、たとえば、水溶性高分子、乳化剤、防腐剤、酸味剤、香料、色素、キレート剤等が挙げられる。これらの成分は、単独で用いてもよいし、2種以上を併用しても良い。これらの基剤、添加剤の含有量については、使用する成分の種類等に応じて適宜設定される。 Further, the content liquid may contain other bases, additives, etc., if necessary. Such bases and additives are not particularly limited as long as they can be used in foods and pharmaceuticals, for example, water-soluble polymers, emulsifiers, preservatives, acidulants, fragrances, dyes, chelating agents and the like. Can be mentioned. These components may be used alone or in combination of two or more. The contents of these bases and additives are appropriately set according to the types of components used and the like.
前記内容液を封入する皮膜は、ソフトカプセル剤として一般的に使用可能なものであれば特に限定されず、たとえばゼラチンを基剤とし、任意成分として可塑剤、水等を含有する。また、皮膜の厚みは、本発明の効果が得られる限度において特に限定されないが、例えば、240〜400μmが挙げられる。 The film for enclosing the content liquid is not particularly limited as long as it can be generally used as a soft capsule, and for example, it is based on gelatin and contains a plasticizer, water and the like as optional components. The thickness of the film is not particularly limited as long as the effect of the present invention can be obtained, but is, for example, 240 to 400 μm.
原料のゼラチンとしては特に限定されず、例えば酸処理ゼラチン、アルカリ処理ゼラチン、両性処理ゼラチン、化学修飾ゼラチン等、一般のカプセル剤に使用されている公知のゼラチンが挙げられる。これらは単独で用いてもよいし、2種以上を併用してもよい。 The starting gelatin is not particularly limited, and examples thereof include known gelatin used in general capsules such as acid-treated gelatin, alkali-treated gelatin, amphoteric-treated gelatin, and chemically modified gelatin. These may be used alone or in combination of two or more.
可塑剤としては、ゼラチンの可塑化を促し、かつ食品・医薬品用途に応用可能なものであればよい。例えば、グリセリン、ソルビトール、プロピレングリコール等が挙げられる。これらは単独で用いてもよいし、2種以上を併用してもよい。 Any plasticizer may be used as long as it promotes plasticization of gelatin and can be applied to foods and pharmaceuticals. For example, glycerin, sorbitol, propylene glycol and the like can be mentioned. These may be used alone or in combination of two or more.
また、本発明のソフトカプセル剤の製造方法は、内容液の整粒工程を含むことを特徴とする。整粒工程の後に、ソフトカプセル剤の被膜の形成工程を含む。 The method for producing a soft capsule of the present invention is characterized by including a step of sizing the content liquid. After the sizing step, a step of forming a film of the soft capsule is included.
整粒工程は、内溶液のすりつぶし工程であり、木の粉砕物と他の内容物を均一に混合する工程である。整粒するための装置としては特に限定されず、たとえばマイコロイダー、コロイドミル、マスコロイダー等が挙げられる。分散方法としては、たとえば粉砕機に、木の粉砕物以外の成分を混合したものを投入し、粉砕物を徐々に添加する方法が挙げられる。分散時の温度は特に限定されず、通常は室温で行われる。分散時間は好ましくは15〜120分、より好ましくは30〜120分である。 The sizing step is a step of smashing the inner solution, and is a step of uniformly mixing the pulverized product of wood and other contents. The apparatus for controlling the particle size is not particularly limited, and examples thereof include mycoloider, colloid mill, mass colloider and the like. Examples of the dispersing method include a method in which a crusher is charged with a mixture of components other than the crushed product of wood and the crushed product is gradually added. The temperature at the time of dispersion is not particularly limited and is usually room temperature. The dispersion time is preferably 15 to 120 minutes, more preferably 30 to 120 minutes.
木の粉砕物や、その他の成分については前述したものをそのまま利用できる。 As for the crushed wood and other components, those mentioned above can be used as they are.
皮膜による内容液の封入方法としては、周知のソフトカプセル剤の製造方法であれば特に限定されず、たとえばロータリー式ソフトカプセル化法や、シームレスカプセル化法等が適用可能である。ロータリー式ソフトカプセル化法では、例えば、ロータリー式ソフトカプセル充填機を用い、カプセル皮膜用内容液を薄膜状に加工し、これを左右両側からロール金型に供給し、所定形状に打ち抜く直前に内容液を圧入し、成形及び乾燥することで、ソフトカプセル剤を製造することができる。 The method for enclosing the content liquid by the film is not particularly limited as long as it is a known method for manufacturing a soft capsule, and, for example, a rotary soft encapsulation method, a seamless encapsulation method, or the like can be applied. In the rotary type soft encapsulation method, for example, a rotary type soft capsule filling machine is used to process the content liquid for the capsule coating into a thin film, which is supplied to the roll die from both left and right sides, and the content liquid is immediately before punching into a predetermined shape. A soft capsule can be produced by press-fitting, molding and drying.
以下、実施例に基づいて本発明を具体的に説明するが、本発明はこれらのみに限定されるものではない。 Hereinafter, the present invention will be specifically described based on Examples, but the present invention is not limited thereto.
以下、実施例および参考例で使用した配合成分について、まとめて説明する。
メグスリノキ粉砕物1:株式会社栃本天海堂製メグスリノキAcer nikooense Maxim.(Aceraceae)の木部の粉砕物、平均粒子径:76μm
メグスリノキ粉砕物2:株式会社栃本天海堂製メグスリノキAcer nikooense Maxim.(Aceraceae)の木部の粉砕物、平均粒子径:30μm
たまねぎ粉砕物:こだま食品株式会社製、可食部である鱗茎の粉砕物、平均粒子径:100μm
ミツロウ:横関油脂工業株式会社製「精製ミツロウTS」
グリセリン脂肪酸エステル:理研ビタミン株式会社製「ポエムS−100」
サフラワー油:日清オイリオグループ株式会社製「サフラワー白絞油」
Hereinafter, the compounding components used in Examples and Reference Examples will be collectively described.
Grinded megusurinoki 1: Tochimoto Tenkaido Co., Ltd. megusurinoki Acer nikooense Maxim. (Aceraceae) wood pulverized product, average particle size: 76 μm
Megusurinoki crushed product 2: manufactured by Tochimoto Tenkaido Co., Ltd. (Aceraceae) wood pulverized product, average particle size: 30 μm
Onion crushed product: Kodama Foods Co., Ltd., crushed edible bulb, average particle size: 100 μm
Beeswax: "Purified beeswax TS" manufactured by Yokozeki Yushi Kogyo Co., Ltd.
Glycerin fatty acid ester: "Poem S-100" manufactured by Riken Vitamin Co., Ltd.
Safflower oil: "Safflower white squeezing oil" manufactured by Nisshin Oillio Group Co., Ltd.
(平均粒子径の測定条件)
分散溶媒としてサフラワー油を用い、各種粉砕物を適切な散乱強度が得られる濃度に希釈して調整し、レーザー回析式粒度分布測定装置(株式会社島津製作所製「SALD−2200」)を使用し、30秒間測定した。
(Measurement condition of average particle size)
Using safflower oil as a dispersion solvent, various pulverized products are diluted and adjusted to a concentration at which an appropriate scattering intensity is obtained, and a laser diffraction particle size distribution analyzer (“SALD-2200” manufactured by Shimadzu Corporation) is used. Then, it was measured for 30 seconds.
実施例1〜4および参考例1
マイコロイダーを用いて、表1に記載したミツロウ、グリセリン脂肪酸エステル、サフラワー油を表1に示した配合割合で室温において混合した。表1に記載した粉砕物を表1に示した配合割合で徐々に添加し、粉砕物が内容液中に分散した内容液を作製した。
Examples 1 to 4 and Reference Example 1
Using Mycoloider, beeswax, glycerin fatty acid ester, and safflower oil described in Table 1 were mixed at a mixing ratio shown in Table 1 at room temperature. The pulverized products shown in Table 1 were gradually added at the blending ratio shown in Table 1 to prepare a content liquid in which the pulverized products were dispersed in the content liquid.
<液漏れ抑制効果>
得られた内容液(1カプセルあたり300mg)を用い、カプセル皮膜(1カプセルあたりゼラチン100mgおよびグリセリン50mg含有)で被包したソフトカプセル剤(皮膜の厚み:約320μm)を計5000粒、常法に従って作製し、内容液の液漏れ抑制効果を下記基準により評価した。その結果を表1に示す。
判定基準
○:目視で1粒も液漏れが認められない
×:目視で1粒以上液漏れが認められる
<Liquid leakage suppression effect>
Using the obtained content liquid (300 mg per capsule), a total of 5000 soft capsules (coating thickness: about 320 μm) encapsulated with a capsule film (containing 100 mg gelatin and 50 mg glycerin per capsule) were prepared in accordance with a conventional method. Then, the liquid leakage suppression effect of the content liquid was evaluated according to the following criteria. The results are shown in Table 1.
Judgment Criteria ◯: No liquid leak was visually observed ×: One or more liquid leaks were visually observed
<篩過性>
得られた内容液300gを70メッシュの篩に入れ、必要に応じてヘラを使用し、内容液の篩過性を下記判定基準1により5段階評価した。6名の平均点を算出し、内容液の篩過性を下記判定基準2により評価した。その結果を表1に示す。
判定基準1
5:ヘラで押さえなくてもほぼ通る
4:多少ヘラで振動させれば通る
3:ヘラで振動を与えれば落ちていく
2:ヘラで押し込まないと通過しない
1:かなり通過させ難い、または通過しない
判定基準2
○:平均点が4以上、5以下
△:平均点が3以上、4未満
×:平均点が3未満
<Screenability>
300 g of the obtained content liquid was put into a 70-mesh sieve, a spatula was used if necessary, and the sieving property of the content liquid was evaluated by 5 criteria according to the following criteria 1. The average score of 6 persons was calculated, and the sieving property of the content liquid was evaluated according to the following criterion 2. The results are shown in Table 1.
Judgment standard 1
5: Almost passes without pressing with a spatula 4: Passes if vibrated with a spatula 3: Falles by vibrating with a spatula 2: Does not pass unless pushed with a spatula 1: Difficult to pass or does not pass Criteria 2
◯: Average score of 4 or more and 5 or less Δ: Average score of 3 or more and less than 4 ×: Average score of less than 3
<発熱抑制効果>
内容液の作製直後の温度を測定し、下記基準により内容液の発熱抑制効果を評価した。その結果を表1に示す。
判定基準
○:40℃未満
△:40℃以上、45℃未満
×:45℃以上
<Heat suppression effect>
The temperature immediately after preparation of the content liquid was measured, and the heat generation suppressing effect of the content liquid was evaluated according to the following criteria. The results are shown in Table 1.
Judgment criteria ○: Less than 40 ° C △: 40 ° C or more, less than 45 ° C ×: 45 ° C or more
表1より、実施例1〜2および参考例1では、各種粉砕物を6.0重量%含有する内容液を使用して、内容液の液漏れ抑制効果を評価した。平均粒子径100μmのたまねぎ粉砕物を配合した参考例1の内容液では液漏れが認められず、整粒工程で発熱が生じることはなかった。同様に、平均粒子径76μm、30μmを有するメグスリノキ粉砕物1、2を配合した実施例1、2の内容液では液漏れが認められなかった。また、メグスリノキ粉砕物1、2の含有量を10.0重量%に増大した場合にも、実施例3、4に示すように、液漏れは認められなかった。また、メグスリノキ粉砕物の平均粒子径が細かい方が、発熱抑制効果が優れていた。 From Table 1, in Examples 1 and 2 and Reference Example 1, the content liquid containing 6.0% by weight of various pulverized products was used to evaluate the liquid leakage suppression effect of the content liquid. No liquid leakage was observed in the content liquid of Reference Example 1 containing a crushed onion product having an average particle diameter of 100 μm, and heat was not generated in the sizing step. Similarly, no liquid leakage was observed in the content liquids of Examples 1 and 2 in which the Megsulinoki crushed products 1 and 2 having average particle diameters of 76 μm and 30 μm were mixed. In addition, even when the content of the crushed Megsulinokis 1 and 2 was increased to 10.0% by weight, no liquid leakage was observed as shown in Examples 3 and 4. In addition, the smaller the average particle size of the pulverized Megsuri tree was, the more excellent the heat generation suppressing effect was.
なお、篩過性と液漏れ抑制効果との間には相関関係が認められ、優れた篩過性(○)を示す内容液は優れた液漏れ抑制効果(○)を示す。 It should be noted that there is a correlation between the sieving property and the liquid leakage suppressing effect, and the content liquid showing excellent sieving property (∘) shows the excellent liquid leakage suppressing effect (∘).
処方例1〜15
表2に示す処方に従い調整した内容液(1カプセルあたり300mg)を、常法に従って、カプセル皮膜(1カプセルあたりゼラチン50mgおよびグリセリン150mg含有)で被包したソフトカプセル剤(皮膜の厚み:約320μm)を作製した。
Prescription examples 1 to 15
A soft capsule agent (coating thickness: about 320 μm) obtained by encapsulating a liquid content (300 mg per capsule) prepared according to the formulation shown in Table 2 with a capsule film (containing 50 mg gelatin and 150 mg glycerin per capsule) was prepared according to a conventional method. It was made.
得られた内容液について発熱抑制効果を評価したところ、いずれも優れた発熱抑制効果を示した。また、得られたソフトカプセル剤について液漏れ抑制効果を評価したところ、いずれも液漏れが認められなかった。 The resulting contents liquid was evaluated for heat generation suppressing effect, and all showed excellent heat generation suppressing effect. Further, when the liquid leakage suppression effect of the obtained soft capsules was evaluated, liquid leakage was not observed in any of them.
Claims (3)
Method for producing a soft capsule according to claim 1 or 2, characterized in that it comprises a liquid content of the granule sizing step.
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