JPH02180815A - Soft capsule agent - Google Patents
Soft capsule agentInfo
- Publication number
- JPH02180815A JPH02180815A JP89789A JP89789A JPH02180815A JP H02180815 A JPH02180815 A JP H02180815A JP 89789 A JP89789 A JP 89789A JP 89789 A JP89789 A JP 89789A JP H02180815 A JPH02180815 A JP H02180815A
- Authority
- JP
- Japan
- Prior art keywords
- cellulose
- water
- soft capsule
- inorganic acid
- gelatin
- 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.)
- Granted
Links
- 239000007901 soft capsule Substances 0.000 title claims abstract description 25
- 239000003795 chemical substances by application Substances 0.000 title abstract 3
- 239000001913 cellulose Substances 0.000 claims abstract description 15
- 229920002678 cellulose Polymers 0.000 claims abstract description 15
- -1 inorganic acid salt Chemical class 0.000 claims abstract description 12
- 229910052784 alkaline earth metal Inorganic materials 0.000 claims abstract description 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 8
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 4
- BVKZGUZCCUSVTD-UHFFFAOYSA-N carbonic acid Chemical group OC(O)=O BVKZGUZCCUSVTD-UHFFFAOYSA-N 0.000 claims description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 abstract description 17
- 108010010803 Gelatin Proteins 0.000 abstract description 9
- 239000008273 gelatin Substances 0.000 abstract description 9
- 229920000159 gelatin Polymers 0.000 abstract description 9
- 235000019322 gelatine Nutrition 0.000 abstract description 9
- 235000011852 gelatine desserts Nutrition 0.000 abstract description 9
- 239000002775 capsule Substances 0.000 abstract description 8
- 239000011248 coating agent Substances 0.000 abstract description 8
- 239000007788 liquid Substances 0.000 abstract description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 5
- 229940095079 dicalcium phosphate anhydrous Drugs 0.000 abstract description 4
- 238000011049 filling Methods 0.000 abstract description 4
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 abstract description 3
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 abstract description 3
- 238000000576 coating method Methods 0.000 abstract description 3
- 235000019700 dicalcium phosphate Nutrition 0.000 abstract description 3
- 238000002156 mixing Methods 0.000 abstract description 3
- 239000008213 purified water Substances 0.000 abstract description 3
- ZAKOWWREFLAJOT-CEFNRUSXSA-N D-alpha-tocopherylacetate Chemical compound CC(=O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-CEFNRUSXSA-N 0.000 abstract description 2
- 239000001856 Ethyl cellulose Substances 0.000 abstract description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 abstract description 2
- YYRMJZQKEFZXMX-UHFFFAOYSA-L calcium bis(dihydrogenphosphate) Chemical compound [Ca+2].OP(O)([O-])=O.OP(O)([O-])=O YYRMJZQKEFZXMX-UHFFFAOYSA-L 0.000 abstract description 2
- 235000019325 ethyl cellulose Nutrition 0.000 abstract description 2
- 229920001249 ethyl cellulose Polymers 0.000 abstract description 2
- 238000010438 heat treatment Methods 0.000 abstract description 2
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 abstract description 2
- 239000001095 magnesium carbonate Substances 0.000 abstract description 2
- 229910000021 magnesium carbonate Inorganic materials 0.000 abstract description 2
- 235000019691 monocalcium phosphate Nutrition 0.000 abstract description 2
- 239000008159 sesame oil Substances 0.000 abstract description 2
- 235000011803 sesame oil Nutrition 0.000 abstract description 2
- 238000003756 stirring Methods 0.000 abstract description 2
- 229940042585 tocopherol acetate Drugs 0.000 abstract description 2
- 229910019142 PO4 Inorganic materials 0.000 abstract 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 abstract 2
- 239000010452 phosphate Substances 0.000 abstract 2
- 229910000019 calcium carbonate Inorganic materials 0.000 abstract 1
- 235000010216 calcium carbonate Nutrition 0.000 abstract 1
- 229910000389 calcium phosphate Inorganic materials 0.000 abstract 1
- 235000014380 magnesium carbonate Nutrition 0.000 abstract 1
- 150000007522 mineralic acids Chemical class 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 235000011187 glycerol Nutrition 0.000 description 7
- 230000000052 comparative effect Effects 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 229920001800 Shellac Polymers 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 239000007963 capsule composition Substances 0.000 description 1
- 239000004203 carnauba wax Substances 0.000 description 1
- 235000013869 carnauba wax Nutrition 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000012812 general test Methods 0.000 description 1
- 229960001708 magnesium carbonate Drugs 0.000 description 1
- 229910000150 monocalcium phosphate Inorganic materials 0.000 description 1
- 229940088417 precipitated calcium carbonate Drugs 0.000 description 1
- 239000004208 shellac Substances 0.000 description 1
- 235000013874 shellac Nutrition 0.000 description 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 1
- 229940113147 shellac Drugs 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 238000009849 vacuum degassing Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
【発明の詳細な説明】
〔産業上の利用分野〕
本発明は新規な軟カプセル剤、更に詳細には、吸湿又は
加熱等によりカプセル同士が付着することのない軟カプ
セル剤に関する。DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a novel soft capsule, and more particularly to a soft capsule in which capsules do not stick to each other due to moisture absorption, heating, or the like.
（従来の技術および課題）
軟カプセル剤は、−ａに、ゼラチンにグリセリン、ソル
ビトール等の可ｍ剤を配合して調製した皮膜中に有効成
分を充填して製造される。(Prior Art and Problems) Soft capsules are manufactured by filling active ingredients into a film prepared by blending -a with gelatin and a mulcholizer such as glycerin or sorbitol.
カプセル皮膜の硬度は、主として、配合されるグリセリ
ンの量及び水分含量によって決まり、グリセリン及び水
分の含量が多い程カプセル皮膜は柔らかくなる。そして
、使用者は、柔らかい軟カプセル剤を好む傾向にある。The hardness of the capsule film is determined mainly by the amount of glycerin and water content, and the higher the content of glycerin and water, the softer the capsule film becomes. And users tend to prefer soft capsules.
このため、カプセル皮膜のグリセリンの量を多くするこ
とが行われているが、軟カプセル剤は、硬いものでも、
高温又は多湿下に保存するとカプセル同士が付着するこ
とを避けられなかったが、グリセリン量をふやすとその
付着傾向は益々増大し、甚しい場合には皮膜が溶解して
しまうという欠点があった。For this reason, attempts have been made to increase the amount of glycerin in the capsule film, but soft capsules, even hard ones,
When stored at high temperatures or high humidity, it was unavoidable that the capsules would stick to each other, but as the amount of glycerin was increased, the tendency to stick to each other would further increase, and in severe cases, the film would dissolve.
従来、これを解決する方法として、セラック、カルナウ
バロウ等を表面にコーティングして吸湿を防止する方法
がとられているが、未だ充分に満足でき、るものではな
かった。Conventionally, methods to solve this problem include coating the surface with shellac, carnauba wax, etc. to prevent moisture absorption, but these methods have not yet been fully satisfactory.
（０！題を解決するための手段）
斯かる実状において、本発明者は鋭意研究を行った結果
、カプセル皮膜中に水不溶性のセルロースもしくはその
誘導体又は水不溶性の無機酸塩を配合すれば、上記問題
点を解決できることを見出し、本発明を完成した。(Means for Solving Problem 0!) Under such circumstances, the present inventor has conducted extensive research and found that if water-insoluble cellulose or its derivatives or water-insoluble inorganic acid salts are blended into the capsule film, The inventors have discovered that the above problems can be solved and have completed the present invention.
すなわち、本発明は、水不溶性のセルロースもしくはそ
の誘導体または／および水不溶性の無機酸塩を含有する
皮膜によって被覆された軟カプセル剤を提供するもので
ある。That is, the present invention provides a soft capsule coated with a film containing water-insoluble cellulose or a derivative thereof and/or a water-insoluble inorganic acid salt.
本発明で使用される水不溶性のセルロース又はその誘導
体としては結晶セルロース、エチルセルロース等が挙げ
られる。また水不溶性の無機酸塩としては、第一リン酸
、第二リン酸、炭酸のアルカリ土類金属塩が挙げられ、
特に第一リン酸カルシウム、第二リン酸カルシウム、沈
降炭酸カルシウム、炭酸マグネシウム等が好ましい、こ
れらのセルロース、セルロース誘導体及び無機酸塩はゼ
ラチン１ｏｏｚＥｋ部に対し３〜５０！ｉ量部、特に５
〜３５！ｉ量部を配合するのが好ましい、この配合量が
これより少ないと本発明の目的が達成されず、またこれ
を超えて配合すると成型性に問題がある。Examples of the water-insoluble cellulose or its derivatives used in the present invention include crystalline cellulose and ethyl cellulose. Examples of water-insoluble inorganic acid salts include primary phosphoric acid, secondary phosphoric acid, and alkaline earth metal salts of carbonic acid.
Particularly preferred are monocalcium phosphate, dibasic calcium phosphate, precipitated calcium carbonate, magnesium carbonate, etc. The amount of these cellulose, cellulose derivatives and inorganic acid salts is 3 to 50% per 1 ozEk part of gelatin! i parts, especially 5
~35! It is preferable to mix i parts. If the amount is less than this, the object of the present invention will not be achieved, and if it is blended in an amount exceeding this, there will be problems with moldability.
本発明の軟カプセル剤は、皮膜に上記セルロース、セル
ロース誘導体又は無機酸塩を配合する以外は、自体公知
の方法によって調製される。The soft capsule of the present invention is prepared by a method known per se, except that the cellulose, cellulose derivative, or inorganic acid salt described above is incorporated into the film.
（発明の効果）
本発明の軟カプセル剤は湿気及び加熱等によフてカプセ
ル同士が付着することがないので、夏期等の高温、多湿
時においても室温で安定に保存できる。(Effects of the Invention) Since the soft capsules of the present invention do not adhere to each other due to humidity, heat, etc., they can be stored stably at room temperature even in high temperature and high humidity times such as summer.
（実施例） 次に実施例を挙げて説明する。(Example) Next, an example will be given and explained.
実施例１
（ｉ）ゼラチン１０ｋｇ、グリセリン１５ｋｇ、結晶セ
ルロース４ｋｇ及び精製水７ｋｇを８０℃で３時間加熱
攪拌してゼラチンのゾル溶液とし、真空脱気したのち、
５０℃の恒温槽に貯留して、軟カプセル皮膜剤とした。Example 1 (i) 10 kg of gelatin, 15 kg of glycerin, 4 kg of crystalline cellulose, and 7 kg of purified water were heated and stirred at 80°C for 3 hours to form a gelatin sol solution, and after vacuum degassing,
It was stored in a constant temperature bath at 50°C to prepare a soft capsule coating agent.
（１１）酢酸トコフェロール１ｋｇ及びゴマ油０．５ｋ
ｇを攪拌して均一な混合液とし、この液を内容液として
、ライナー社製ロータリー充填機を用いて常法により、
上記の軟カプセル皮膜で被包成型し、通常の乾燥工程を
経て、内容量１５０ｔｇの球形の軟カプセル剤を製造し
た。(11) Tocopherol acetate 1kg and sesame oil 0.5k
Stir g to make a homogeneous mixed liquid, and use this liquid as the content liquid using a conventional method using a Reiner rotary filling machine.
The soft capsules were encapsulated with the above-mentioned soft capsule film and subjected to a normal drying process to produce spherical soft capsules with an internal capacity of 150 tg.
実施例２゜
（ｉ）ゼラチン１０ｋｇ、グリセリン６ｋｇ％第二リン
酸カルシウム２ｋｇ及び精製水７ｋｇを８０℃で３時間
加熱攪拌してゼラチンのゾル溶液とし、真空脱気したの
ち、５０℃の恒温Ｉｆｆに貯留して、軟カプセル皮膜剤
とした。Example 2゜(i) 10 kg of gelatin, 2 kg of dibasic calcium phosphate with 6 kg of glycerin, and 7 kg of purified water were heated and stirred at 80°C for 3 hours to make a gelatin sol solution, vacuum degassed, and stored at a constant temperature of 50°C. Then, a soft capsule coating agent was prepared.
（ｉｉ ）実施例１ （ｉ）の混合液を内容液として、
ライナー社製ロータリー充填機を用いて常法により、上
記の軟カプセル皮膜で被包成型し、通常の乾燥工程を経
て、内容、１１５０Ｂの卵形の軟カプセルを製造した。(ii) Example 1 Using the mixed liquid of (i) as the content liquid,
The capsules were encapsulated with the above-mentioned soft capsule film in a conventional manner using a rotary filling machine manufactured by Reiner Co., Ltd., and then subjected to a conventional drying process to produce oval soft capsules having a content of 1150B.
比較例１
実施例１（ｉ）において、結晶セルロースを配合しない
以外は同様にして軟カプセル皮膜剤を調製し、これを用
いて実施例１（ｉｉ）と同様にして軟カプセル剤を製造
した。Comparative Example 1 A soft capsule coating agent was prepared in the same manner as in Example 1(i) except that crystalline cellulose was not blended, and using this, soft capsules were manufactured in the same manner as in Example 1(ii).
試験例１
実施例１〜２、及び比較例！で得た軟カプセル剤を、ガ
ラスビン中に密栓し、４０℃で１ケ月放置したときの結
果を第１表に、また３５℃、７５％Ｒ１＋で１ケ月放置
したときの結果を第２表に示す。Test Example 1 Examples 1 to 2 and Comparative Example! Table 1 shows the results when the soft capsules obtained were sealed in a glass bottle and left at 40°C for one month, and Table 2 shows the results when left at 35°C and 75% R1+ for one month. show.
第１表（４０℃、１ケ月）
第２表（３５℃、７５％Ｉｔ）１，１ケ月）試験例２
実施例１〜２、及び比較例１で得た軟カプセル剤をガラ
スビン中に密栓し、４０℃で１ケ月及び３ケ月放置した
後、日本薬局方、一般試験法のカプセル剤の項によって
崩壊時間を測定した。Table 1 (40°C, 1 month) Table 2 (35°C, 75% It) 1.1 months) Test Example 2 The soft capsules obtained in Examples 1 to 2 and Comparative Example 1 were placed in a glass bottle and sealed. After being left at 40° C. for 1 month and 3 months, the disintegration time was measured according to the capsule formulation section of the Japanese Pharmacopoeia, General Tests.
その結果を第３表に示す。The results are shown in Table 3.
第３表 以 上Table 3 Below Up
Claims (1)
および水不溶性の無機酸塩を含有する皮膜によって被覆
された軟カプセル剤。 ２、水不溶性の無機酸塩が、第一リン酸、第二リン酸ま
たは炭酸のアルカリ土類金属塩である請求項１記載の軟
カプセル剤。[Claims] 1. Water-insoluble cellulose or its derivatives or/
and a soft capsule coated with a film containing a water-insoluble inorganic acid salt. 2. The soft capsule according to claim 1, wherein the water-insoluble inorganic acid salt is an alkaline earth metal salt of primary phosphoric acid, secondary phosphoric acid, or carbonic acid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP64000897A JP2711703B2 (en) | 1989-01-06 | 1989-01-06 | Soft capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP64000897A JP2711703B2 (en) | 1989-01-06 | 1989-01-06 | Soft capsule |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH02180815A true JPH02180815A (en) | 1990-07-13 |
| JP2711703B2 JP2711703B2 (en) | 1998-02-10 |
Family
ID=11486473
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP64000897A Expired - Lifetime JP2711703B2 (en) | 1989-01-06 | 1989-01-06 | Soft capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2711703B2 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5742769A (en) * | 1996-05-06 | 1998-04-21 | Banyan Systems, Inc. | Directory with options for access to and display of email addresses |
| CN104068401A (en) * | 2014-06-27 | 2014-10-01 | 安徽先知缘食品有限公司 | Preparation method for natural vitamin E soft capsules |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100450471C (en) * | 2006-08-25 | 2009-01-14 | 石药集团欧意药业有限公司 | Soft capsule of atovastatine salts and prepn. method therefor |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61115019A (en) * | 1984-11-09 | 1986-06-02 | Nippi Zerachin Kogyo Kk | Gelatin capsule coating film |
-
1989
- 1989-01-06 JP JP64000897A patent/JP2711703B2/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61115019A (en) * | 1984-11-09 | 1986-06-02 | Nippi Zerachin Kogyo Kk | Gelatin capsule coating film |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5742769A (en) * | 1996-05-06 | 1998-04-21 | Banyan Systems, Inc. | Directory with options for access to and display of email addresses |
| US6108691A (en) * | 1996-05-06 | 2000-08-22 | Switchboard, Inc. | Directory with options for access to and display of email addresses |
| CN104068401A (en) * | 2014-06-27 | 2014-10-01 | 安徽先知缘食品有限公司 | Preparation method for natural vitamin E soft capsules |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2711703B2 (en) | 1998-02-10 |
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