JP6292938B2 - ソフトカプセル皮膜及びソフトカプセル - Google Patents
ソフトカプセル皮膜及びソフトカプセル Download PDFInfo
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- JP6292938B2 JP6292938B2 JP2014066728A JP2014066728A JP6292938B2 JP 6292938 B2 JP6292938 B2 JP 6292938B2 JP 2014066728 A JP2014066728 A JP 2014066728A JP 2014066728 A JP2014066728 A JP 2014066728A JP 6292938 B2 JP6292938 B2 JP 6292938B2
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- soft capsule
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- capsule film
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- 239000007901 soft capsule Substances 0.000 title claims description 88
- 229920002472 Starch Polymers 0.000 claims description 49
- 235000019698 starch Nutrition 0.000 claims description 48
- 239000008107 starch Substances 0.000 claims description 47
- 239000000679 carrageenan Substances 0.000 claims description 37
- 235000010418 carrageenan Nutrition 0.000 claims description 37
- 229920001525 carrageenan Polymers 0.000 claims description 37
- 229940113118 carrageenan Drugs 0.000 claims description 37
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims description 37
- PYMYPHUHKUWMLA-UHFFFAOYSA-N 2,3,4,5-tetrahydroxypentanal Chemical compound OCC(O)C(O)C(O)C=O PYMYPHUHKUWMLA-UHFFFAOYSA-N 0.000 claims description 36
- AEQDJSLRWYMAQI-UHFFFAOYSA-N 2,3,9,10-tetramethoxy-6,8,13,13a-tetrahydro-5H-isoquinolino[2,1-b]isoquinoline Chemical compound C1CN2CC(C(=C(OC)C=C3)OC)=C3CC2C2=C1C=C(OC)C(OC)=C2 AEQDJSLRWYMAQI-UHFFFAOYSA-N 0.000 claims description 25
- 239000000176 sodium gluconate Substances 0.000 claims description 25
- 235000012207 sodium gluconate Nutrition 0.000 claims description 25
- 229940005574 sodium gluconate Drugs 0.000 claims description 25
- 108010010803 Gelatin Proteins 0.000 claims description 16
- 239000008273 gelatin Substances 0.000 claims description 16
- 229920000159 gelatin Polymers 0.000 claims description 16
- 235000019322 gelatine Nutrition 0.000 claims description 16
- 235000011852 gelatine desserts Nutrition 0.000 claims description 16
- 230000032050 esterification Effects 0.000 claims description 11
- 238000005886 esterification reaction Methods 0.000 claims description 11
- 150000003839 salts Chemical class 0.000 claims description 11
- HLCFGWHYROZGBI-JJKGCWMISA-M Potassium gluconate Chemical compound [K+].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O HLCFGWHYROZGBI-JJKGCWMISA-M 0.000 claims description 10
- 239000004224 potassium gluconate Substances 0.000 claims description 10
- 235000013926 potassium gluconate Nutrition 0.000 claims description 10
- 229960003189 potassium gluconate Drugs 0.000 claims description 10
- RGHNJXZEOKUKBD-SQOUGZDYSA-M D-gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O RGHNJXZEOKUKBD-SQOUGZDYSA-M 0.000 claims description 9
- 229940050410 gluconate Drugs 0.000 claims description 9
- 230000009435 amidation Effects 0.000 claims description 8
- 238000007112 amidation reaction Methods 0.000 claims description 8
- 229920002261 Corn starch Polymers 0.000 claims description 7
- 239000008120 corn starch Substances 0.000 claims description 7
- 230000000704 physical effect Effects 0.000 description 29
- 238000000576 coating method Methods 0.000 description 27
- 239000007788 liquid Substances 0.000 description 25
- 239000011248 coating agent Substances 0.000 description 24
- 239000000203 mixture Substances 0.000 description 17
- 239000000243 solution Substances 0.000 description 10
- 238000012360 testing method Methods 0.000 description 10
- 238000011156 evaluation Methods 0.000 description 9
- 238000000034 method Methods 0.000 description 8
- AEMOLEFTQBMNLQ-YMDCURPLSA-N D-galactopyranuronic acid Chemical compound OC1O[C@H](C(O)=O)[C@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-YMDCURPLSA-N 0.000 description 5
- IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 description 5
- 210000004051 gastric juice Anatomy 0.000 description 5
- 239000001814 pectin Substances 0.000 description 5
- 235000010987 pectin Nutrition 0.000 description 5
- 229920001277 pectin Polymers 0.000 description 5
- 210000002784 stomach Anatomy 0.000 description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
- 150000004676 glycans Chemical class 0.000 description 3
- 229920001282 polysaccharide Polymers 0.000 description 3
- 239000005017 polysaccharide Substances 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 241000283690 Bos taurus Species 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 108010025899 gelatin film Proteins 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 235000011187 glycerol Nutrition 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 229910021645 metal ion Inorganic materials 0.000 description 2
- 150000004702 methyl esters Chemical class 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 239000003002 pH adjusting agent Substances 0.000 description 2
- 239000004014 plasticizer Substances 0.000 description 2
- 239000013076 target substance Substances 0.000 description 2
- 239000012085 test solution Substances 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- OCUCCJIRFHNWBP-IYEMJOQQSA-L Copper gluconate Chemical compound [Cu+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O OCUCCJIRFHNWBP-IYEMJOQQSA-L 0.000 description 1
- 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
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 229920001800 Shellac Polymers 0.000 description 1
- 244000061456 Solanum tuberosum Species 0.000 description 1
- 235000002595 Solanum tuberosum Nutrition 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- 208000018756 Variant Creutzfeldt-Jakob disease Diseases 0.000 description 1
- 229920002494 Zein Polymers 0.000 description 1
- WHMDKBIGKVEYHS-IYEMJOQQSA-L Zinc gluconate Chemical compound [Zn+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O WHMDKBIGKVEYHS-IYEMJOQQSA-L 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 125000003368 amide group Chemical group 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 208000005881 bovine spongiform encephalopathy Diseases 0.000 description 1
- 229960005069 calcium Drugs 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000004227 calcium gluconate Substances 0.000 description 1
- 235000013927 calcium gluconate Nutrition 0.000 description 1
- 229960004494 calcium gluconate Drugs 0.000 description 1
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 150000003841 chloride salts Chemical class 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 229940108925 copper gluconate Drugs 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 235000015872 dietary supplement Nutrition 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 239000005417 food ingredient Substances 0.000 description 1
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 238000001879 gelation Methods 0.000 description 1
- 235000013402 health food Nutrition 0.000 description 1
- 238000007654 immersion Methods 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 229940091250 magnesium supplement Drugs 0.000 description 1
- 239000000845 maltitol Substances 0.000 description 1
- 235000010449 maltitol Nutrition 0.000 description 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 description 1
- 229940035436 maltitol Drugs 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 235000011837 pasties Nutrition 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 230000000379 polymerizing effect Effects 0.000 description 1
- 229960003975 potassium Drugs 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000001508 potassium citrate Substances 0.000 description 1
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 239000004208 shellac Substances 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
- 235000013874 shellac Nutrition 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 229940083542 sodium Drugs 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 description 1
- 229940048086 sodium pyrophosphate Drugs 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 235000019818 tetrasodium diphosphate Nutrition 0.000 description 1
- 239000001577 tetrasodium phosphonato phosphate Substances 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 235000015870 tripotassium citrate Nutrition 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
- 235000019263 trisodium citrate Nutrition 0.000 description 1
- 229940038773 trisodium citrate Drugs 0.000 description 1
- 239000005019 zein Substances 0.000 description 1
- 229940093612 zein Drugs 0.000 description 1
- 235000011478 zinc gluconate Nutrition 0.000 description 1
- 239000011670 zinc gluconate Substances 0.000 description 1
- 229960000306 zinc gluconate Drugs 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Description
ロータリーダイ式でソフトカプセルを成形することを想定して、皮膜液をガラス板に流延した後、乾燥させてゲル化した皮膜を常温で剥がす試験を行った。皮膜が切れない、皮膜が脆くなく適度な柔軟性を有する、皮膜が粘着せずガラス板から剥がれ易い場合を、「ソフトカプセル皮膜として適した物性」を有すると評価して「○」で表示し、そうでない場合を不適であると評価して「×」で表示した。評価結果を表2に示す。
日本薬局方に規定された崩壊試験法に則り、第一液及び第二液を使用して行った。ここで、第一液は耐胃液性を評価するためのpH1.2の試験液であり、試験液中でソフトカプセル皮膜を所定時間上下運動させ、その後の観察においてソフトカプセル皮膜が残存しているか否かを確認した。また、第二液は耐腸液性を評価するためのpH6.8の試験液であり、試験液中でソフトカプセル皮膜を所定時間上下運動させ、その後の観察において、ソフトカプセル皮膜が残存しているか否かを確認した。評価は、ソフトカプセル皮膜が、第一液による崩壊試験において残存し、第二液による崩壊試験において崩壊する場合に腸溶性を有するものとして「○」で表示し、それ以外の場合、つまり第一液による崩壊試験において崩壊する場合、及び、第一液による崩壊試験において残存するが、第二液による崩壊試験においても残存する場合は「×」と表示した。なお、第一液による崩壊試験において崩壊する場合は、第二液による試験は行わなかった。
Claims (2)
- ロータリーダイ式成形品であるソフトカプセルの皮膜であって、
塩の存在下で湿式加熱処理されたもち種トウモロコシ澱粉である湿式加熱処理澱粉と、
グルコン酸ナトリウム及びグルコン酸カリウムの何れかであり、前記湿式加熱処理澱粉100重量部に対して5.0重量部〜5.5重量部のグルコン酸塩と、
前記湿式加熱処理澱粉100重量部に対して40重量部〜45重量部のイオタカラギーナンと、
エステル化度が26%〜27%、且つ、アミド化度が20%〜22%であり、イオタカラギーナンに対する質量比が2:1〜1.8:1の低メトキシルペクチンと、を含有し、
ゼラチンを含有しないものであり、
腸溶性を示す
ことを特徴とするソフトカプセル皮膜。 - 請求項1に記載のソフトカプセル皮膜に内容物が充填されている
ことを特徴とするソフトカプセル。
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JP2014066728A JP6292938B2 (ja) | 2014-03-27 | 2014-03-27 | ソフトカプセル皮膜及びソフトカプセル |
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JP2014066728A JP6292938B2 (ja) | 2014-03-27 | 2014-03-27 | ソフトカプセル皮膜及びソフトカプセル |
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JP2015189684A JP2015189684A (ja) | 2015-11-02 |
JP6292938B2 true JP6292938B2 (ja) | 2018-03-14 |
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Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2016052699A1 (ja) * | 2014-10-03 | 2016-04-07 | 富士カプセル株式会社 | 軟カプセル皮膜 |
AR115269A1 (es) | 2018-03-15 | 2020-12-16 | Scherer Technologies Llc R P | Cápsulas de gelatina blanda entéricas |
US10813887B2 (en) | 2018-04-18 | 2020-10-27 | Dah Feng Capsule Industry Co., Ltd | Acid resistant capsule shell composition |
JP7411990B2 (ja) | 2019-12-24 | 2024-01-12 | 中日本カプセル 株式会社 | ソフトカプセル皮膜、ソフトカプセル、及び、ソフトカプセルの製造方法 |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS61151127A (ja) * | 1984-12-25 | 1986-07-09 | Meiji Milk Prod Co Ltd | ビフイズス菌含有ソフトカプセルの製造方法 |
JPH0427352A (ja) * | 1990-05-22 | 1992-01-30 | Fuji Capsule Kk | 健康食品用腸溶性軟カプセル |
KR100379674B1 (ko) * | 2000-03-06 | 2003-04-10 | 주식회사 서흥캅셀 | 펙틴과 글리세린의 배합용액을 이용한 셀룰로오스 캅셀 및그의 제조방법 |
JP4252619B1 (ja) * | 2008-08-25 | 2009-04-08 | 中日本カプセル 株式会社 | 腸溶性ソフトカプセルの製造方法及び腸溶性ソフトカプセル |
JP4797211B2 (ja) * | 2009-02-05 | 2011-10-19 | キャタレント・ジャパン株式会社 | ソフトカプセル用フィルム形成組成物 |
JP5334727B2 (ja) * | 2009-07-28 | 2013-11-06 | 中日本カプセル 株式会社 | ソフトカプセルの製造方法 |
JP2014015431A (ja) * | 2012-07-10 | 2014-01-30 | Nakanihon Capsule Co Ltd | ソフトカプセル皮膜及びソフトカプセル |
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