JP2005154301A - Soft capsule - Google Patents

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JP2005154301A
JP2005154301A JP2003391915A JP2003391915A JP2005154301A JP 2005154301 A JP2005154301 A JP 2005154301A JP 2003391915 A JP2003391915 A JP 2003391915A JP 2003391915 A JP2003391915 A JP 2003391915A JP 2005154301 A JP2005154301 A JP 2005154301A
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capsule
contents
carnitine
coating film
soft
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Izumi Kamata
泉 鎌田
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Kamata KK
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Kamata KK
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Abstract

<P>PROBLEM TO BE SOLVED: To obtain a soft capsule that has a moderately soft coating film of capsule with smooth surface, keeps protecting action of contents and easiness to swallow for a long period of time and is obtained by wrapping contents of L-carnitine of main component in a gelatin-coating film. <P>SOLUTION: The soft capsule is obtained by wrapping contents comprising 100 parts wt. of L-carnitine and 7.5-35 parts wt. of purified water in a capsule coating film consisting essentially of gelatin. Water absorption of the capsule coating film by L-carnitine is controlled and neither hardening nor cracking of capsule coating film occurs. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

この発明は、体内脂肪の燃焼を助け、ダイエット効果があるといわれるL−カルニチンを主成分とする内容物を、ゼラチン皮膜で包んだソフトカプセルに関する。   The present invention relates to a soft capsule in which a content mainly composed of L-carnitine, which is said to help burn fat in the body and have a diet effect, is wrapped with a gelatin film.

従来から、医薬製剤や健康食品製剤として、飲みやすいソフトカプセルが種々知られている。たとえば、特許文献1には、ゼラチンを用いたソフトカプセルが、錠剤に比べて内容成分の安定性、内容成分量の均一性、更には内容成分の味および臭いの面で優れており、健康食品等の産業分野において汎用されていること、ソフトカプセルの外皮膜はゼラチンを主材としており、水に易溶であることから、内容物は親油性のものが好ましく、ソフトカプセルは多くの場合、内容物が親油性物質の場合に用いられてきたこと、水溶性ビタミンのような非油溶性物質をソフトカプセル化する場合には、食用油等の油性液体に分散させ油性懸濁液としてソフトカプセル化するのが常法であること、が記載されている。   Conventionally, various soft capsules that are easy to drink are known as pharmaceutical preparations and health food preparations. For example, in Patent Document 1, soft capsules using gelatin are superior to tablets in terms of stability of content components, uniformity of content components content, and taste and smell of content components, such as health foods. In general, the outer skin of soft capsules is mainly made of gelatin and is easily soluble in water, so the contents are preferably lipophilic and the soft capsules are often It has been used in the case of lipophilic substances, and when non-oil-soluble substances such as water-soluble vitamins are softly encapsulated, it is usually dispersed in an oily liquid such as edible oil and softly encapsulated as an oily suspension. It is stated that it is a law.

特開2002−291419号公報(明細書段落番号0002、0004参照)JP 2002-291419 A (see paragraph numbers 0002 and 0004 of the specification)

ゼラチンを用いたソフトカプセルのカプセル皮膜は、適度の柔らかさと表面の滑らかさがあって内容物を緻密に保護するので、内容成分の安定性、内容成分量の均一性を長期間保持し、内容成分の味および臭いを抑え、飲みやすくなるのである。   Soft capsule capsule film using gelatin has moderate softness and surface smoothness and protects the contents precisely, so the stability of the contents and the uniformity of the contents are maintained for a long time. It suppresses the taste and smell and makes it easier to drink.

しかし、主成分がL−カルニチンの内容物のソフトカプセルを製造すると、製造当初は通常のソフトカプセルの内容物保護作用が発揮され、飲みやすさも良好であるが、数カ月で経時変化が起こり、カプセル皮膜が乾燥して、ひび割れを生じ、内容物保護作用も飲みやすさも失われてしまう。この経時変化は、内容物のL−カルニチンがカプセル皮膜の水分を吸収するために起こるものと思われる。   However, when a soft capsule having the main component L-carnitine is produced, the protective action of the normal soft capsule is demonstrated at the beginning of production, and the ease of drinking is good, but the change over time occurs in several months, It dries and cracks, losing its content protection and ease of drinking. This change with time seems to occur because the content of L-carnitine absorbs moisture from the capsule film.

このため、主成分がL−カルニチンの内容物のソフトカプセルを商品化することができなかった。   For this reason, the soft capsule of the content whose main component is L-carnitine could not be commercialized.

この発明は、上記問題点を解決するためになされたものであり、その目的とするところは、カプセル皮膜の適度な柔らかさ、表面の滑らかさ、および内容物保護作用を長期間維持できる、L−カルニチンを主成分とする内容物をゼラチン皮膜で包み込んだソフトカプセルを提供しようとするものである。   The present invention has been made to solve the above-mentioned problems, and the object of the present invention is to maintain the moderate softness of the capsule film, the smoothness of the surface, and the content protecting action for a long period of time. -To provide a soft capsule in which a content mainly composed of carnitine is wrapped with a gelatin film.

この発明は、L−カルニチン100重量部に対して、精製水7.5〜35重量部を含む内容物を、ゼラチンを主成分とするカプセル皮膜で包み込むことにより、上記目的を達成している。   The present invention achieves the above object by enclosing a content containing 7.5 to 35 parts by weight of purified water with 100 parts by weight of L-carnitine in a capsule film mainly composed of gelatin.

この発明によれば、吸水性の大きいL−カルニチンが内容物内の精製水を吸収し、これにより、L−カルニチンのカプセル皮膜水分吸収は抑制されて、カプセル皮膜の乾燥、割れ発生を防止する。精製水が7.5重量部未満だとカプセル皮膜水分吸収が起こり始め、35重量部を超えると逆に内容物の水分がカプセル皮膜に浸潤してカプセル皮膜が軟化したり溶け出したりする。   According to the present invention, L-carnitine having a large water absorption absorbs purified water in the contents, thereby suppressing the absorption of moisture in the capsule film of L-carnitine and preventing the capsule film from drying and cracking. . When the purified water is less than 7.5 parts by weight, moisture absorption of the capsule film starts to occur, and when it exceeds 35 parts by weight, the moisture of the contents infiltrates into the capsule film and the capsule film softens or dissolves.

この発明によれば、長期間にわたってカプセル皮膜が乾燥したり、ひび割れしたりすることがなく、内容物保護作用と飲みやすさを維持できるL−カルニチンのソフトカプセルを得ることができる。   According to the present invention, it is possible to obtain a soft capsule of L-carnitine that can maintain the content protecting action and ease of drinking without the capsule film being dried or cracked over a long period of time.

以下、この発明に係る実施形態について説明する。   Embodiments according to the present invention will be described below.

表1の組成の原料を調合し、精製水、増粘剤のミツロウと粉体のL−カルニチン、CO−Q10、ビタミンB1、ビタミンEを、グリセリン脂肪酸エステルでサフラワ油に乳化させて内容物に仕上げた。   Prepare ingredients of the composition shown in Table 1 and emulsify purified water, thickening beeswax and powdered L-carnitine, CO-Q10, vitamin B1, and vitamin E in saffron oil with glycerin fatty acid ester into the contents. Finished.

Figure 2005154301
Figure 2005154301

この表1の組成の内容物と、常法により精製水85重量部、グリセリン45重量部にゼラチン100重量部を加えて調整したカプセル皮膜とを常法により周知のソフトカプセル成型機に供給し、内容物をカプセル皮膜で包み込んでソフトカプセルに成型し、乾燥して仕上げた。   The contents of the composition of Table 1 and a capsule film prepared by adding 100 parts by weight of gelatin to 85 parts by weight of purified water and 45 parts by weight of glycerin by a conventional method are supplied to a known soft capsule molding machine by a conventional method. The product was wrapped in a capsule film, molded into a soft capsule, and dried to finish.

表2の組成の原料を調合し、実施例1と同様にして、内容物に仕上げ、この表2の組成の内容物で、ソフトカプセルを仕上げた。   Raw materials having the composition shown in Table 2 were prepared, and the contents were finished in the same manner as in Example 1. Soft capsules were finished with the contents having the composition shown in Table 2.

Figure 2005154301
Figure 2005154301

表3の組成の原料を調合し、実施例1と同様にして、内容物に仕上げ、この表3の組成の内容物で、ソフトカプセルを仕上げた。   Raw materials having the composition shown in Table 3 were prepared, and the contents were finished in the same manner as in Example 1. Soft capsules were finished with the contents having the composition shown in Table 3.

Figure 2005154301
Figure 2005154301

上記サフラワ油は、他の汎用される食用油、たとえば、パーム油、小麦胚芽油、大豆油、菜種油等に代えることができる。   The safflower oil can be replaced with other widely used edible oils such as palm oil, wheat germ oil, soybean oil, rapeseed oil and the like.

次に、この発明の構成成分量を確定するために、比較例のカプセルを製造した。   Next, in order to determine the amount of the component of the present invention, a capsule of a comparative example was manufactured.

比較例1として、表4の組成の原料を調合し、実施例1と同様にして、内容物に仕上げ、この表4の組成の内容物で、ソフトカプセルを仕上げた。   As Comparative Example 1, raw materials having the composition shown in Table 4 were prepared, and the contents were finished in the same manner as in Example 1. Soft capsules were finished with the contents having the composition shown in Table 4.

Figure 2005154301
Figure 2005154301

比較例2として、表5の組成の原料を調合し、実施例1と同様にして、内容物に仕上げ、この表5の組成の内容物で、ソフトカプセルを仕上げた。   As Comparative Example 2, raw materials having the composition shown in Table 5 were prepared, and the contents were finished in the same manner as in Example 1. Soft capsules were finished with the contents having the composition shown in Table 5.

Figure 2005154301
Figure 2005154301

上記の実施例1〜3と比較例1、2について、カプセル皮膜の経時変化の有無を、以下の試験により確認して品質評価を行った。   About said Examples 1-3 and Comparative Examples 1 and 2, the presence or absence of the time-dependent change of a capsule membrane | film | coat was confirmed by the following tests, and quality evaluation was performed.

先ず、各実施例および各比較例のサンプル100カプセルを透明ガラス12号規格瓶に入れて密栓して、実施例1〜3の入った瓶各2、比較例1、2の入った瓶各2、計10瓶を準備した。   First, sample 100 capsules of each example and each comparative example were put in a transparent glass No. 12 standard bottle and sealed, and each bottle containing Examples 1 to 3 and each bottle containing Comparative Examples 1 and 2 were each 2 A total of 10 bottles were prepared.

次に、実施例1〜3、比較例1、2の入った5種類の瓶各1個を40℃で保存し、残りの5種類の瓶を室温保存して、それぞれのカプセルの外観を目視により観察した。   Next, each of the five bottles containing Examples 1 to 3 and Comparative Examples 1 and 2 was stored at 40 ° C., the remaining five bottles were stored at room temperature, and the appearance of each capsule was visually observed. Was observed.

評価試験の結果は、表6および表7に示す。表6、表7において、○は、経時変化が認められず、カプセル皮膜が、適度に柔らかく、表面が滑らかで、内容物保護作用と飲みやすさを維持できていると認められたもの、△は、カプセル皮膜に軟化が認められたもの、または、カプセル皮膜表面が乾燥し、やや皮膜の硬化が認められたもの、×は、カプセル皮膜が乾燥して割れを生じ、内容物保護作用と飲みやすさが失われたと認められたもの、または、カプセル皮膜が著しく軟化したものである。   The results of the evaluation test are shown in Table 6 and Table 7. In Tables 6 and 7, ◯ indicates that no change over time was observed, the capsule film was found to be moderately soft, smooth in surface, and capable of maintaining the content protecting action and ease of drinking, Δ Indicates that the capsule film has been softened, or the capsule film surface has been dried, and the film has been slightly cured, and × indicates that the capsule film has dried and cracked, protecting the contents and It is recognized that the ease has been lost, or the capsule film has been significantly softened.

Figure 2005154301
Figure 2005154301

Figure 2005154301
Figure 2005154301

Claims (1)

L−カルニチン100重量部に対して、精製水7.5〜35重量部を含む内容物を、ゼラチンを主成分とするカプセル皮膜で包み込んだことを特徴とするソフトカプセル。   A soft capsule characterized in that a content containing 7.5 to 35 parts by weight of purified water with respect to 100 parts by weight of L-carnitine is wrapped in a capsule film mainly composed of gelatin.
JP2003391915A 2003-11-21 2003-11-21 Soft capsule Withdrawn JP2005154301A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009507817A (en) * 2005-09-09 2009-02-26 ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー Liquid filled delivery system, preferably HPMC capsules filled with glycerol
US8623433B1 (en) * 2011-01-07 2014-01-07 Innovitamin Organics, Llc Safflower oil emulsion as dietary supplement and preparation thereof
JP2015024979A (en) * 2013-07-29 2015-02-05 三生医薬株式会社 Capsule formulation

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009507817A (en) * 2005-09-09 2009-02-26 ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー Liquid filled delivery system, preferably HPMC capsules filled with glycerol
US8795720B2 (en) 2005-09-09 2014-08-05 Capsugel Belgium Nv Liquid filled delivery system
US8623433B1 (en) * 2011-01-07 2014-01-07 Innovitamin Organics, Llc Safflower oil emulsion as dietary supplement and preparation thereof
US9968121B1 (en) 2011-01-07 2018-05-15 Innovitamin Organics, Llc Safflower oil emulsion as dietary supplement and preparation thereof
US10426749B2 (en) 2011-01-07 2019-10-01 Innovitamin Organics, Llc Safflower oil emulsion as dietary supplement and preparation thereof
JP2015024979A (en) * 2013-07-29 2015-02-05 三生医薬株式会社 Capsule formulation

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