JP3535120B2 - Soft capsule - Google Patents
Soft capsuleInfo
- Publication number
- JP3535120B2 JP3535120B2 JP2001249523A JP2001249523A JP3535120B2 JP 3535120 B2 JP3535120 B2 JP 3535120B2 JP 2001249523 A JP2001249523 A JP 2001249523A JP 2001249523 A JP2001249523 A JP 2001249523A JP 3535120 B2 JP3535120 B2 JP 3535120B2
- Authority
- JP
- Japan
- Prior art keywords
- capsule
- filling
- gelatin
- soft
- soft capsule
- 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.)
- Expired - Lifetime
Links
- 239000007901 soft capsule Substances 0.000 title claims description 18
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 15
- 102000008186 Collagen Human genes 0.000 claims description 11
- 108010035532 Collagen Proteins 0.000 claims description 11
- 229920001436 collagen Polymers 0.000 claims description 11
- 238000002360 preparation method Methods 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 description 28
- 238000011049 filling Methods 0.000 description 15
- 239000000203 mixture Substances 0.000 description 15
- 108010010803 Gelatin Proteins 0.000 description 10
- 239000008273 gelatin Substances 0.000 description 10
- 229920000159 gelatin Polymers 0.000 description 10
- 235000019322 gelatine Nutrition 0.000 description 10
- 235000011852 gelatine desserts Nutrition 0.000 description 10
- 239000000126 substance Substances 0.000 description 10
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 230000006866 deterioration Effects 0.000 description 4
- 102000004196 processed proteins & peptides Human genes 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 229920001184 polypeptide Polymers 0.000 description 3
- 150000001413 amino acids Chemical class 0.000 description 2
- 125000003277 amino group Chemical group 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 235000011187 glycerol Nutrition 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 235000019198 oils Nutrition 0.000 description 2
- IKHGUXGNUITLKF-XPULMUKRSA-N acetaldehyde Chemical compound [14CH]([14CH3])=O IKHGUXGNUITLKF-XPULMUKRSA-N 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 150000001299 aldehydes Chemical class 0.000 description 1
- -1 amino compound Chemical class 0.000 description 1
- 239000010630 cinnamon oil Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000010643 fennel seed oil Substances 0.000 description 1
- 235000021323 fish oil Nutrition 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 230000036962 time dependent Effects 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Description
【０００１】[0001]
【発明の属する技術分野】軟カプセル剤は、現在、医薬
品、食品、化粧品、医薬部外品等、幅広い分野で応用さ
れている。本発明は、経時的にカプセル皮膜の不溶化
（溶解性の劣化）が起こり難い軟カプセル剤に関する。BACKGROUND OF THE INVENTION Soft capsules are currently applied in a wide range of fields such as pharmaceuticals, foods, cosmetics and quasi drugs. The present invention, over time insolubilized (solubility of deterioration) of the capsule shell regarding the occurs hardly soft capsules.
【０００２】[0002]
【従来の技術】軟カプセル剤の皮膜は通常、主に基剤の
ゼラチンと可塑剤のグリセリンとからなっている。ゼラ
チンはアミノ基を有しており、カプセル充填用組成物に
アミノ基と反応し易い物質（以下不溶化要因物質とい
う）を含んでいる場合、不溶化要因物質とゼラチンとの
反応により、経時的にカプセル皮膜の不溶化現象を引き
起こすことが知られている。不溶化要因物質の例として
はタラ油等の魚油、アセトアルデヒド等のアルデヒド
類、及びケイヒ油、ウイキョウ油等の精油類等が知られ
ている。2. Description of the Related Art The film of a soft capsule is usually composed mainly of gelatin as a base and glycerin as a plasticizer. Gelatin has an amino group, and when the composition for capsule filling contains a substance that easily reacts with the amino group (hereinafter referred to as insolubilizing factor substance), the capsule may be changed over time due to the reaction between the insolubilizing factor substance and gelatin. It is known to cause the insolubilization phenomenon of the film. Known examples of the insolubilizing substance are fish oil such as cod oil, aldehydes such as acetaldehyde, and essential oils such as cinnamon oil and fennel oil.
【０００３】従来の技術においては、この経時的なカプ
セル皮膜の不溶化現象を改善する方法として、カプセル
皮膜へアミノ酸、クエン酸、ポリペプチド等を添加する
ことが提案されている（例えば特開昭51-101118号公
報、特開昭58-62120号公報参照）。In the prior art, it has been proposed to add amino acids, citric acid, polypeptides and the like to the capsule film as a method for improving the insolubilization phenomenon of the capsule film over time (for example, JP-A-51). -101118, JP-A-58-62120).
【０００４】[0004]
【発明が解決しようとする課題】軟カプセル剤は、経口
使用の場合、胃内で速やかに崩壊することが望まれるた
め、経時的に発生する不溶化現象を改善する方法が要望
されてきた。しかし、従来の改善策であるカプセル皮膜
へのアミノ酸、クエン酸、ポリペプチド等の添加は、そ
の効果を十分にあげるための添加量を増やそうとする
と、製造時の困難性が増大したり、製造後のカプセル自
体の品質が悪くなったり（例えば添加物の析出、強度の
低下、カプセル同士の付着等）する。そのため、必ずし
も十分な効果を得られていないという欠点があった。The soft capsules are desired to be rapidly disintegrated in the stomach when used orally. Therefore, there has been a demand for a method of improving the insolubilization phenomenon which occurs over time. However, the addition of amino acids, citric acid, polypeptides, etc. to the capsule film, which is a conventional improvement measure, increases the difficulty in production or increases the production amount if an attempt is made to increase the addition amount to sufficiently enhance the effect. After that, the quality of the capsule itself may be deteriorated (for example, precipitation of additives, decrease in strength, adhesion between capsules, etc.). Therefore, there is a drawback that a sufficient effect is not always obtained.
【０００５】本発明の課題は、軟カプセル剤において、
製造時の困難性やカプセル自体の品質の劣化を伴うこと
なく、カプセル皮膜の不溶化現象を防ぐことにある。An object of the present invention, Oite soft capsules,
The purpose is to prevent the insolubilization phenomenon of the capsule film without causing difficulty during production and deterioration of the quality of the capsule itself.
【０００６】[0006]
【課題を解決するための手段】コラーゲンペプチドをカ
プセル充填用組成物中に配合させることにより、不溶化
要因物質がカプセル皮膜基剤であるゼラチンとの反応よ
りも先に充填用組成物中のアミノ化合物と反応すると考
えられる。[Means for Solving the Problems] By incorporating a collagen peptide into a capsule filling composition, the amino compound in the filling composition is added before the reaction of the insolubilizing substance with gelatin, which is the capsule film base. It is thought to react with.
【０００７】コラーゲンペプチドはゼラチンの加水分解
物であり、一般的に分子量が500から10000の物質であ
る。コラーゲンペプチドは、他の一般的な名称としてポ
リペプチド、ペプタイドゼラチン、水溶性ゼラチン、加
水分解コラーゲン、加水分解ゼラチンと呼ばれているも
のである。[0007] Collagen peptide is a hydrolyzate of gelatin and generally has a molecular weight of 500 to 10,000. Collagen peptides are known as other general names such as polypeptide, peptide gelatin, water-soluble gelatin, hydrolyzed collagen, and hydrolyzed gelatin.
【０００８】尚、コラーゲンペプチドの配合量は、本発
明において特に制約はないが、5重量％よりも少ないと
当該物質の効果が殆ど現れず、50重量％を越えると今度
はカプセル充填が困難となり、他の成分を配合する余地
もなくなってしまうので好ましくない。The content of the collagen peptide is not particularly limited in the present invention, but if it is less than 5% by weight, the effect of the substance hardly appears, and if it exceeds 50% by weight, capsule filling becomes difficult this time. However, it is not preferable because there is no room to mix other components.
【０００９】[0009]
【作用】カプセル充填用組成物中にコラーゲンペプチド
を配合することにより、以下の現象が起こると考えられ
る。[Function] It is considered that the following phenomenon occurs by incorporating the collagen peptide in the composition for filling capsules.
【００１０】不溶化要因物質がカプセル皮膜基剤である
ゼラチンよりも先にカプセル充填用組成物に配合したコ
ラーゲンペプチドと反応し、ゼラチンと不溶化因子物質
との反応を抑制する。結果として、当該軟カプセルにお
いて経時的に起こるカプセル皮膜の不溶化現象を改善す
ることができる。[0010] copolymers of insolubilizing factor substance is formulated into capsules fill composition prior to gelatin capsules film base
Reacts with the Lagen peptide and suppresses the reaction between gelatin and the insolubilizing factor substance. As a result, the insolubilization phenomenon of the capsule coating that occurs over time in the soft capsule can be improved.
【００１１】[0011]
【発明の実施の形態】本発明に基づき、実際に軟カプセ
ル剤を製造した。本実施形態では、「不溶化要因物質」
としてタラ油を使用した。BEST MODE FOR CARRYING OUT THE INVENTION Based on the present invention, soft capsules were actually produced. In the present embodiment, the “insolubilization factor substance”
And use the cod oil as.
【００１２】カプセル充填用組成物処方を比較例１、実
施例１、２、３、４で表１の如くにした。The formulation of the composition for filling capsules was as shown in Table 1 in Comparative Example 1, Examples 1, 2, 3, and 4.
【００１３】[0013]
【表１】 [Table 1]
【００１４】比較例、実施例１、２、３、４のそれぞれ
のカプセル充填用組成物において軟カプセル充填の適性
をみるため粘度を測定し表２を得た。In order to check the suitability of filling soft capsules in the capsule filling compositions of Comparative Examples, Examples 1, 2, 3 and 4, the viscosity was measured and Table 2 was obtained.
【００１５】[0015]
【表２】 [Table 2]
【００１６】表２における実施例４によれば、コラーゲ
ンペプチドを60％配合したカプセル充填用組成物の物性
として流動性は全くなく、軟カプセル充填の適性は認め
られなかった。According to Example 4 in Table 2, the composition of the capsule-filling composition containing 60% of collagen peptide had no fluidity and no suitability for filling the soft capsule was observed.
【００１７】軟カプセル充填の適性が可であった比較例
１、実施例１、２、３のそれぞれにおいて、実際に軟カ
プセル剤を製造した。In each of Comparative Example 1, Examples 1, 2 and 3, which were suitable for filling soft capsules, soft capsules were actually produced.
【００１８】ここで、カプセル皮膜処方を比較例１、実
施例１、２、３で共通の以下の如くとした。
ゼラチン 100重量部
グリセリン 35重量部Here, the capsule film formulation was common to Comparative Example 1 and Examples 1, 2 and 3 as follows. Gelatin 100 parts by weight Glycerin 35 parts by weight
【００１９】作製した各軟カプセル検体をガラスビンに
つめ、40℃に保存した。この場合での経時的な崩壊性を
比較し、表３を得た。Each soft capsule sample thus prepared was packed in a glass bottle and stored at 40 ° C. The time-dependent disintegration in this case was compared and Table 3 was obtained.
【００２０】[0020]
【表３】 [Table 3]
【００２１】表１、表３における実施例１によれば、コ
ラーゲンペプチドを2.0％配合したカプセル充填用組成
物を含む軟カプセル剤において、カプセル皮膜の不溶化
現象を防ぐことはできなかった。According to Example 1 in Tables 1 and 3, the insolubilization phenomenon of the capsule film could not be prevented in the soft capsule containing the capsule filling composition containing 2.0% of collagen peptide.
【００２２】表１、表３における実施例２、３によれ
ば、「不溶化要因物質」をカプセル充填用組成物に含む
軟カプセル剤においても、コラーゲンペプチドをカプセ
ル充填用組成物に配合することにより、カプセル皮膜の
不溶化現象を防ぐことができた。しかも、従来技術（カ
プセル皮膜成分に配合する方法）の欠点である、製造時
の困難性やカプセル自体の品質の劣化もなかった。According to Examples 2 and 3 in Tables 1 and 3, even in the soft capsule preparation containing the "insolubilizing factor substance" in the capsule filling composition, the collagen peptide was added to the capsule filling composition. It was possible to prevent the insolubilization phenomenon of the capsule film. Moreover, there were no drawbacks of the prior art (method of blending with the capsule film component), such as difficulty in production and deterioration of quality of the capsule itself.
【００２３】[0023]
【発明の効果】以上のように本発明によれば、軟カプセ
ル剤充填用組成物において、製造時の困難性やカプセル
自体の品質の劣化を伴うことなく、カプセル皮膜の不溶
化現象を防ぐことができる。As described above, according to the present invention, in the composition for filling a soft capsule, the insolubilization phenomenon of the capsule film can be prevented without causing difficulty during production and deterioration of the quality of the capsule itself. it can.
Claims (2)
ル剤。1. A soft capsule containing a collagen peptide.
Agent .
量％である請求項１に記載の軟カプセル剤。 2. The soft capsule preparation according to claim 1, wherein the content of the collagen peptide is 5 to 50% by weight .
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2001249523A JP3535120B2 (en) | 2001-08-20 | 2001-08-20 | Soft capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2001249523A JP3535120B2 (en) | 2001-08-20 | 2001-08-20 | Soft capsule |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2003055263A JP2003055263A (en) | 2003-02-26 |
| JP3535120B2 true JP3535120B2 (en) | 2004-06-07 |
Family
ID=19078514
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2001249523A Expired - Lifetime JP3535120B2 (en) | 2001-08-20 | 2001-08-20 | Soft capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3535120B2 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2003301654A1 (en) * | 2002-10-22 | 2004-05-13 | Dainippon Pharmaceutical Co., Ltd. | Stabilized composition |
| JP2011136927A (en) | 2009-12-28 | 2011-07-14 | Pfizer Inc | Gelatin capsule and gelatin composition for forming capsule coating film |
| WO2014118997A1 (en) * | 2013-01-30 | 2014-08-07 | 宏輝システムズ株式会社 | Novel polyhydric alcohol base soft capsule preparation |
| JP2022183114A (en) * | 2021-05-28 | 2022-12-08 | アピ株式会社 | Gelatin capsule dissolution delay inhibitor, gelatin capsule, and gelatin capsule coating |
-
2001
- 2001-08-20 JP JP2001249523A patent/JP3535120B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JP2003055263A (en) | 2003-02-26 |
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