JP2003221327A - Chewable agent containing branched amino acids - Google Patents
Chewable agent containing branched amino acidsInfo
- Publication number
- JP2003221327A JP2003221327A JP2002016480A JP2002016480A JP2003221327A JP 2003221327 A JP2003221327 A JP 2003221327A JP 2002016480 A JP2002016480 A JP 2002016480A JP 2002016480 A JP2002016480 A JP 2002016480A JP 2003221327 A JP2003221327 A JP 2003221327A
- Authority
- JP
- Japan
- Prior art keywords
- chewable
- valine
- leucine
- isoleucine
- chewable agent
- 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
- 239000003795 chemical substances by application Substances 0.000 title claims abstract description 28
- 150000001413 amino acids Chemical class 0.000 title abstract 2
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 claims abstract description 18
- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims abstract description 18
- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims abstract description 18
- ROHFNLRQFUQHCH-UHFFFAOYSA-N Leucine Natural products CC(C)CC(N)C(O)=O ROHFNLRQFUQHCH-UHFFFAOYSA-N 0.000 claims abstract description 18
- KZSNJWFQEVHDMF-UHFFFAOYSA-N Valine Natural products CC(C)C(N)C(O)=O KZSNJWFQEVHDMF-UHFFFAOYSA-N 0.000 claims abstract description 18
- 229960000310 isoleucine Drugs 0.000 claims abstract description 18
- AGPKZVBTJJNPAG-UHFFFAOYSA-N isoleucine Natural products CCC(C)C(N)C(O)=O AGPKZVBTJJNPAG-UHFFFAOYSA-N 0.000 claims abstract description 18
- 239000004474 valine Substances 0.000 claims abstract description 18
- 239000004480 active ingredient Substances 0.000 claims abstract description 12
- 150000002681 magnesium compounds Chemical class 0.000 claims abstract description 11
- 150000005693 branched-chain amino acids Chemical class 0.000 claims description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
- 239000000454 talc Substances 0.000 claims description 6
- 229910052623 talc Inorganic materials 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 5
- JAUGGEIKQIHSMF-UHFFFAOYSA-N dialuminum;dimagnesium;dioxido(oxo)silane;oxygen(2-);hydrate Chemical compound O.[O-2].[O-2].[Mg+2].[Mg+2].[Al+3].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O.[O-][Si]([O-])=O JAUGGEIKQIHSMF-UHFFFAOYSA-N 0.000 claims description 3
- 229940057106 isoleucine / leucine / valine Drugs 0.000 claims description 2
- 238000003860 storage Methods 0.000 abstract description 10
- 229940024606 amino acid Drugs 0.000 abstract 1
- 239000008187 granular material Substances 0.000 description 13
- 239000002245 particle Substances 0.000 description 11
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 8
- 238000000034 method Methods 0.000 description 7
- 239000007910 chewable tablet Substances 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 229940079593 drug Drugs 0.000 description 5
- 239000000796 flavoring agent Substances 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 229960004543 anhydrous citric acid Drugs 0.000 description 4
- 235000019634 flavors Nutrition 0.000 description 4
- 238000003756 stirring Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- NOOLISFMXDJSKH-KXUCPTDWSA-N (-)-Menthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O NOOLISFMXDJSKH-KXUCPTDWSA-N 0.000 description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 3
- 239000004386 Erythritol Substances 0.000 description 3
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 description 3
- 229930195725 Mannitol Natural products 0.000 description 3
- 229940068682 chewable tablet Drugs 0.000 description 3
- 235000019414 erythritol Nutrition 0.000 description 3
- 229940009714 erythritol Drugs 0.000 description 3
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 description 3
- 238000000855 fermentation Methods 0.000 description 3
- 230000004151 fermentation Effects 0.000 description 3
- 235000003599 food sweetener Nutrition 0.000 description 3
- 239000000594 mannitol Substances 0.000 description 3
- 235000010355 mannitol Nutrition 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000007873 sieving Methods 0.000 description 3
- 239000003765 sweetening agent Substances 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 1
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 description 1
- 108010011485 Aspartame Proteins 0.000 description 1
- 235000005979 Citrus limon Nutrition 0.000 description 1
- 244000131522 Citrus pyriformis Species 0.000 description 1
- 240000000560 Citrus x paradisi Species 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
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 1
- BIVBRWYINDPWKA-VLQRKCJKSA-L Glycyrrhizinate dipotassium Chemical compound [K+].[K+].O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C([O-])=O)[C@@H]1O[C@H](C([O-])=O)[C@@H](O)[C@H](O)[C@H]1O BIVBRWYINDPWKA-VLQRKCJKSA-L 0.000 description 1
- 101000777301 Homo sapiens Uteroglobin Proteins 0.000 description 1
- ILRKKHJEINIICQ-OOFFSTKBSA-N Monoammonium glycyrrhizinate Chemical compound N.O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O ILRKKHJEINIICQ-OOFFSTKBSA-N 0.000 description 1
- WINXNKPZLFISPD-UHFFFAOYSA-M Saccharin sodium Chemical compound [Na+].C1=CC=C2C(=O)[N-]S(=O)(=O)C2=C1 WINXNKPZLFISPD-UHFFFAOYSA-M 0.000 description 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 1
- 102100031083 Uteroglobin Human genes 0.000 description 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 1
- KPQJOKRSYYJJEL-VLQRKCJKSA-K [Na+].[Na+].CC1(C)[C@H](CC[C@@]2(C)[C@H]1CC[C@]1(C)[C@@H]2C(=O)C=C2[C@@H]3C[C@](C)(CC[C@]3(C)CC[C@@]12C)C([O-])=O)O[C@H]1O[C@@H]([C@@H](O)[C@H](O)[C@H]1O[C@@H]1O[C@@H]([C@@H](O)[C@H](O)[C@H]1O)C([O-])=O)C([O-])=O Chemical compound [Na+].[Na+].CC1(C)[C@H](CC[C@@]2(C)[C@H]1CC[C@]1(C)[C@@H]2C(=O)C=C2[C@@H]3C[C@](C)(CC[C@]3(C)CC[C@@]12C)C([O-])=O)O[C@H]1O[C@@H]([C@@H](O)[C@H](O)[C@H]1O[C@@H]1O[C@@H]([C@@H](O)[C@H](O)[C@H]1O)C([O-])=O)C([O-])=O KPQJOKRSYYJJEL-VLQRKCJKSA-K 0.000 description 1
- 239000000619 acesulfame-K Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000000605 aspartame Substances 0.000 description 1
- 235000010357 aspartame Nutrition 0.000 description 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 1
- 229960003438 aspartame Drugs 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 239000008370 chocolate flavor Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- SPPIIOPGDLITJE-VLQRKCJKSA-N diazanium;(2s,3s,4s,5r,6s)-6-[[(3s,4ar,6ar,6bs,8as,11s,12ar,14ar,14bs)-11-carboxylato-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1h-picen-3-yl]oxy]-5-[(2r,3r,4s,5s,6s)-6-carboxy-3,4,5-trihydroxyoxan-2-yl]oxy-3,4-dihy Chemical compound N.N.O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O SPPIIOPGDLITJE-VLQRKCJKSA-N 0.000 description 1
- 229940101029 dipotassium glycyrrhizinate Drugs 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 229960004949 glycyrrhizic acid Drugs 0.000 description 1
- 235000019410 glycyrrhizin Nutrition 0.000 description 1
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 description 1
- 238000009775 high-speed stirring Methods 0.000 description 1
- NFLGAXVYCFJBMK-UHFFFAOYSA-N isomenthone Natural products CC(C)C1CCC(C)CC1=O NFLGAXVYCFJBMK-UHFFFAOYSA-N 0.000 description 1
- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical compound CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 229960001855 mannitol Drugs 0.000 description 1
- 229940041616 menthol Drugs 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000007968 orange flavor Substances 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000008177 pharmaceutical agent Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 235000019204 saccharin Nutrition 0.000 description 1
- 229940081974 saccharin Drugs 0.000 description 1
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000010189 synthetic method Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 229940074410 trehalose Drugs 0.000 description 1
- CCXAYLQLOLXXKE-DWJAGBRCSA-K trisodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4s,5s,6s)-2-[[(3s,4ar,6ar,6bs,8as,11s,12ar,14ar,14bs)-11-carboxylato-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1h-picen-3-yl]oxy]-6-carboxylato-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-t Chemical compound [Na+].[Na+].[Na+].O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C([O-])=O)C([O-])=O)[C@@H]1O[C@H](C([O-])=O)[C@@H](O)[C@H](O)[C@H]1O CCXAYLQLOLXXKE-DWJAGBRCSA-K 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Gastroenterology & Hepatology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、イソロイシン、ロ
イシン及びバリンの３種の分岐鎖アミノ酸を有効成分と
する、取扱い時及び保存時の安定性に優れた医薬用のチ
ュアブル剤に関する。TECHNICAL FIELD The present invention relates to a chewable pharmaceutical agent containing three branched chain amino acids of isoleucine, leucine and valine as an active ingredient and having excellent stability during handling and storage.
【０００２】[0002]
【従来の技術】イソロイシン、ロイシン及びバリンから
なる３種の分岐鎖アミノ酸を有効成分として含む医薬用
製剤は肝疾患に有効な治療薬であり、現在市販されてい
る製剤は顆粒剤が主体である。しかし、上記３種の分岐
鎖アミノ酸粒子を有効成分とする顆粒剤の場合、その１
回服用量が約５ｇと一般の製剤と比較して著しく多く、
服用しにくいという難点があった。2. Description of the Related Art Pharmaceutical preparations containing three types of branched chain amino acids consisting of isoleucine, leucine and valine as active ingredients are effective therapeutic agents for liver diseases, and currently marketed preparations are mainly granules. . However, in the case of granules containing the above-mentioned three kinds of branched chain amino acid particles as an active ingredient,
The dose is about 5g, which is remarkably large compared to general preparations.
It was difficult to take.
【０００３】一般的に、１回服用量が多い固形薬品用の
剤形としては、口中で噛むか又は溶かして服用されるチ
ュアブル剤が好ましい剤形といえる。しかし、チュアブ
ル剤の場合、口中で速やかに崩壊する性質と、製造工程
や流通過程での衝撃によって崩壊しない強度を有すると
いう性質の相反する性質を兼ね備えることが要求される
と同時に、薬品単独又は薬品と添加剤が酸素、水分、温
度等に起因する劣化・褐変現象等を起こすことがないと
いう保存時における安定性を備えていることも要求され
ている。Generally, as a dosage form for a solid drug having a large single dose, a chewable drug to be taken by chewing or dissolving in the mouth can be said to be a preferable dosage form. However, in the case of chewable agents, it is required to have both the property of rapidly disintegrating in the mouth and the property of having the strength of not disintegrating by impact in the manufacturing process or distribution process, and at the same time, the drug alone or the drug. It is also required that the additives have stability during storage such that deterioration and browning phenomenon caused by oxygen, water, temperature, etc. do not occur.
【０００４】[0004]
【発明が解決しようとする課題】本発明の課題は、特に
保存時に着色しない保存安定性の良好なイソロイシン、
ロイシン及びバリンの３種の分岐鎖アミノ酸を有効成分
とするチュアブル剤を提供することである。DISCLOSURE OF THE INVENTION An object of the present invention is to provide isoleucine having good storage stability, which is not colored especially during storage.
It is intended to provide a chewable agent containing three types of branched chain amino acids of leucine and valine as active ingredients.
【０００５】[0005]
【課題を解決するための手段】上記課題を解決するため
に、本発明者らは鋭意検討を重ねた結果、イソロイシ
ン、ロイシン及びバリンの３種の分岐鎖アミノ酸を含有
するチュアブル剤の場合には、マグネシウム化合物を含
有せしめると、保存時においても着色しない保存安定性
の良好な分岐鎖アミノ酸含有チュアブル剤を調製できる
ことを見出し、本発明を完成するに至った。本発明は、
以下の各発明を包含する。In order to solve the above problems, the inventors of the present invention have conducted extensive studies, and as a result, in the case of a chewable agent containing three branched chain amino acids of isoleucine, leucine and valine, It was found that a chewable agent containing a branched chain amino acid containing a magnesium compound and having good storage stability without coloring even during storage can be prepared, and the present invention has been completed. The present invention is
The following inventions are included.
【０００６】（１）イソロイシン、ロイシン及びバリン
の３種の分岐鎖アミノ酸を有効成分として含有し、かつ
マグネシウム化合物を含有することを特徴とするチュア
ブル剤。(1) A chewable agent containing isoleucine, leucine, and valine, which are three types of branched chain amino acids as active ingredients, and a magnesium compound.
【０００７】（２）前記マグネシウム化合物が、ステア
リン酸マグネシウム、タルク、メタケイ酸アルミン酸マ
グネシウムから選ばれる１種以上である（１）項記載の
チュアブル剤。(2) The chewable agent according to item (1), wherein the magnesium compound is at least one selected from magnesium stearate, talc, and magnesium aluminometasilicate.
【０００８】（３）前記チュアブル剤中のマグネシウム
化合物の含量が０．０５〜１０質量％であることを特徴
とする（１）項又は（２）項に記載のチュアブル剤。(3) The chewable agent according to item (1) or (2), wherein the content of the magnesium compound in the chewable agent is 0.05 to 10% by mass.
【０００９】（４）前記チュアブル剤中のマグネシウム
化合物の含量が０．１〜５質量％であることを特徴とす
る（１）又は（２）項のいずれか１項に記載のチュアブ
ル剤。(4) The chewable agent according to any one of items (1) and (2), wherein the content of the magnesium compound in the chewable agent is 0.1 to 5% by mass.
【００１０】（５）イソロイシン、ロイシン及びバリン
の質量比が、イソロイシン／ロイシン／バリン＝１／
１．９〜２．２／１．１〜１．３である（１）〜（４）
項のいずれか１項に記載のチュアブル剤。(5) The mass ratio of isoleucine, leucine and valine is isoleucine / leucine / valine = 1 /
1.9 to 2.2 / 1.1 to 1.3 (1) to (4)
The chewable agent according to any one of items.
【００１１】（６）前記チュアブル剤に、服用性を改善
するために甘味剤、酸味剤、メントール等から選ばれる
１種以上の矯味・矯臭剤を含有することを特徴とする
（１）〜（５）項のいずれか１項に記載のチュアブル
剤。(6) The chewable agent contains one or more flavoring / flavoring agents selected from sweeteners, sour agents, menthol and the like in order to improve ingestability. The chewable agent according to any one of 5).
【００１２】[0012]
【発明の実施の形態】本発明のチュアブル剤は、イソロ
イシン、ロイシン及びバリンからなる３種の分岐鎖アミ
ノ酸を有効成分として製造されているチュアブル剤であ
る。本発明のチュアブル剤におけるイソロイシン、ロイ
シン及びバリンの配合割合は、質量比でイソロイシン／
ロイシン／バリン＝１／１．９〜２．２／１．１〜１．
３であることが好ましい。BEST MODE FOR CARRYING OUT THE INVENTION The chewable agent of the present invention is a chewable agent produced by using three kinds of branched chain amino acids consisting of isoleucine, leucine and valine as an active ingredient. The compounding ratio of isoleucine, leucine and valine in the chewable drug of the present invention is isoleucine / mass ratio.
Leucine / valine = 1 / 1.9 to 2.2 / 1.1 to 1.
It is preferably 3.
【００１３】本発明のチュアブル剤における有効成分の
一つであるイソロイシンとしては、一般的に発酵法で製
造されている粒度が１ｍｍ以下の粒子で、日本薬局方の
規格を満たすものが使用されるが、その粒度に特に制約
はない。As isoleucine, which is one of the active ingredients in the chewable composition of the present invention, particles which are generally produced by a fermentation method and have a particle size of 1 mm or less and which satisfy the standards of the Japanese Pharmacopoeia are used. However, there is no particular restriction on the granularity.
【００１４】また、有効成分の一つであるロイシンとし
ては、一般的に発酵法又は抽出法で製造されている粒度
が１ｍｍ以下の粒子で、日本薬局方の規格を満たすもの
が使用されるが、その粒度に特に制約はない。As leucine, which is one of the active ingredients, particles which are generally produced by a fermentation method or an extraction method and have a particle size of 1 mm or less and which meet the standards of the Japanese Pharmacopoeia are used. , There is no particular restriction on the granularity.
【００１５】また、有効成分の一つであるバリンとして
は、一般的に発酵法もしくは合成法で製造されている粒
度が１ｍｍ以下の粒子で、日本薬局方の規格を満たすも
のが使用されるが、その粒度に特に制約はない。As valine, which is one of the active ingredients, particles which are generally produced by a fermentation method or a synthetic method and have a particle size of 1 mm or less and which meet the standards of the Japanese Pharmacopoeia are used. , There is no particular restriction on the granularity.
【００１６】本発明の医薬用チュアブル製剤において使
用されるマグネシウム化合物は、日本薬局方あるいは医
薬品添加物規格等の規格を満たすものであり、好ましく
は、ステアリン酸マグネシウム、タルク、メタケイ酸ア
ルミン酸マグネシウムの中から１つ以上選択される。マ
グネシウム化合物は、チュアブル剤中０．０５〜１０質
量％、好ましくは０．１〜５質量％となる添加量で配合
される。The magnesium compound used in the medicinal chewable preparation of the present invention satisfies the standards such as the Japanese Pharmacopoeia or the standards for pharmaceutical additives, and is preferably magnesium stearate, talc or magnesium aluminometasilicate. One or more are selected from the inside. The magnesium compound is added in an amount of 0.05 to 10% by mass, preferably 0.1 to 5% by mass in the chewable agent.
【００１７】本発明の医薬用チュアブル剤には、各種の
矯味・矯臭物質を配合することができる。そのような物
質としては、各種フレーバー物質、各種甘味剤を用いる
ことができる。フレーバー物質としては、例えば、レモ
ンフレーバー、オレンジフレーバー、グレープフルーツ
フレーバー、チョコレートフレーバー、ｄｌ−メントー
ル、ｌ−メントール等が挙げられる。Various taste-masking substances may be added to the medicinal chewable agent of the present invention. As such substances, various flavor substances and various sweeteners can be used. Flavor substances include, for example, lemon flavor, orange flavor, grapefruit flavor, chocolate flavor, dl-menthol, 1-menthol and the like.
【００１８】甘味剤としては、例えば、アスパルテー
ム、サッカリン、サッカリンナトリウム、グリチルリチ
ン酸、グリチルリチン酸モノアンモニウム、グリチルリ
チン酸二アンモニウム、グリチルリチン酸二カリウム、
グリチルリチン酸二ナトリウム、グリチルリチン酸三ナ
トリウム、アセスルファムＫ、マンニトール、エリスリ
トール、ソルビトール、キシリトール、トレハロース等
が使用される。Examples of the sweetener include aspartame, saccharin, sodium saccharin, glycyrrhizinic acid, monoammonium glycyrrhizinate, diammonium glycyrrhizinate, dipotassium glycyrrhizinate,
Disodium glycyrrhizinate, trisodium glycyrrhizinate, acesulfame K, mannitol, erythritol, sorbitol, xylitol, trehalose and the like are used.
【００１９】本発明のチュアブル剤の造粒方法として
は、通常行われている湿式法、乾式法等の製造方法を適
用することができ、造粒用の機器としては、高速攪拌造
粒機、流動層造粒機、プラネタリーミキサー、乾式圧扁
造粒機、破砕造粒機、押し出し造粒機、転動造粒機、噴
霧乾燥造粒機、コーティング造粒機等が使用される。As the granulating method of the chewable agent of the present invention, a commonly used manufacturing method such as a wet method or a dry method can be applied, and a high speed stirring granulator or A fluidized bed granulator, a planetary mixer, a dry pressing granulator, a crushing granulator, an extrusion granulator, a tumbling granulator, a spray drying granulator, a coating granulator, etc. are used.
【００２０】[0020]
【実施例】以下、本発明の具体例を実施例として示す
が、本発明はこれらによって限定されるものではない。EXAMPLES Hereinafter, specific examples of the present invention will be shown as examples, but the present invention is not limited thereto.
【００２１】参考例
ロイシン４７６．０ｇ、バリン２３８．０ｇ、イソロイ
シン２８６．０ｇ、マンニトール３７５．９ｇを秤量
後、攪拌型混合機（深江工業社製１０Ｊ）に投入し、ア
ジテータ回転数３００ｒｐｍ、チョッパー回転数３６０
０ｒｐｍで混合した。別に、無水クエン酸１２５．５ｇ
を水約１５０．０ｇに溶解させた液を添加し、十分混合
した。これを流動層造粒機（フロイント産業社製ＦＬＯ
−５）で乾燥させ、さらに整粒機（岡田精工社製ＮＤ−
１０）に加え、スクリーンサイズ８５０μｍ、回転数２
０００ｒｐｍで整粒してチュアブル用顆粒を製造した。
この顆粒を打錠機（畑鐵工所社製ＨＴ−ＡＰ６ＳＳ−I
I）で０．５トンで打錠してチュアブル錠を製造した。Reference Example Leucine 476.0 g, valine 238.0 g, isoleucine 286.0 g, and mannitol 375.9 g were weighed and put into a stirring mixer (Fukae Kogyo Co., Ltd. 10J), and agitator rotation speed 300 rpm, chopper rotation. Number 360
Mixed at 0 rpm. Separately, 125.5 g of anhydrous citric acid
Was dissolved in about 150.0 g of water and mixed well. This is a fluidized bed granulator (FLO manufactured by Freund Sangyo).
-5), and further sieving machine (ND-made by Okada Seiko Co., Ltd.)
10), screen size 850 μm, rotation speed 2
The particles were sized at 000 rpm to produce chewable granules.
A tableting machine (HT-AP6SS-I manufactured by Hatakko Co., Ltd.)
A chewable tablet was produced by tableting at 0.5 ton in step I).
【００２２】実施例１
ロイシン４７６．０ｇ、バリン２３８．０ｇ、イソロイ
シン２８６．０ｇ、マンニトール３７５．７ｇを秤量
後、攪拌型混合機（深江工業社製１０Ｊ）に投入し、ア
ジテータ回転数３００ｒｐｍ、チョッパー回転数３６０
０ｒｐｍで混合した。別に、無水クエン酸１２５．７ｇ
を水約１５０．０ｇに溶解させた液を添加し、十分混合
した。これを流動層造粒機（フロイント産業社ＦＬＯ−
５）で乾燥し、さらに整粒機（岡田精工社製ＮＤ−１
０）に加え、スクリーンサイズ８５０μｍ、回転数２０
００ｒｐｍで整粒した。この粒状物１２４３．０ｇにタ
ルク３９．７ｇ、ステアリン酸マグネシウム６．６ｇを
加えて混合し、チュアブル用顆粒を製造した。この顆粒
を打錠機（畑鐵工所、ＨＴ−ＡＰ６ＳＳ−II）で０．５
トンで打錠してチュアブル錠を製造した。Example 1 476.0 g of leucine, 238.0 g of valine, 286.0 g of isoleucine, and 375.7 g of mannitol were weighed and put into a stirring mixer (10J manufactured by Fukae Kogyo Co., Ltd.), agitator rotation speed 300 rpm, chopper. Rotation speed 360
Mixed at 0 rpm. Separately, 125.7 g of anhydrous citric acid
Was dissolved in about 150.0 g of water and mixed well. This is a fluidized bed granulator (FLO-
5), and further sieving machine (ND-1 manufactured by Okada Seiko Co., Ltd.)
0), screen size 850 μm, rotation speed 20
The particles were sized at 00 rpm. To 1243.0 g of this granular material, 39.7 g of talc and 6.6 g of magnesium stearate were added and mixed to produce chewable granules. 0.5 of the granules with a tableting machine (HT-AP6SS-II)
A chewable tablet was produced by tableting with tons.
【００２３】実施例２
ロイシン４７６．０ｇ、バリン２３８．０ｇ、イソロイ
シン２８６．０ｇ、エリスリトール３７５．０ｇを秤量
後、攪拌型混合機（深江工業社製１０Ｊ）に投入し、ア
ジテータ回転数３００ｒｐｍ、チョッパー回転数３６０
０ｒｐｍで混合した。別に、無水クエン酸３７．５ｇを
水約１５０．０ｇに溶解させた液を添加し、十分混合し
た。これを流動層造粒機（フロイント産業社製ＦＬＯ−
５）で乾燥し、さらに整粒機（岡田精工社製ＮＤ−１
０）に加え、スクリーンサイズ８５０μｍ、回転数２０
００ｒｐｍで整粒した。この粒状物１２４７．５ｇにタ
ルク３９．７ｇ、ステアリン酸マグネシウム１３．２ｇ
を加えて混合し、チュアブル用顆粒を製造した。この顆
粒を打錠機（畑鐵工所社製ＨＴ−ＡＰ６ＳＳ−II）で
０．７トンで打錠しチュアブル錠を製造した。Example 2 476.0 g of leucine, 238.0 g of valine, 286.0 g of isoleucine, and 375.0 g of erythritol were weighed and then put into a stirring mixer (10J manufactured by Fukae Kogyo Co., Ltd.), agitator rotation speed 300 rpm, chopper. Rotation speed 360
Mixed at 0 rpm. Separately, a solution prepared by dissolving 37.5 g of anhydrous citric acid in about 150.0 g of water was added and mixed well. This is a fluidized bed granulator (FLO-
5), and further sieving machine (ND-1 manufactured by Okada Seiko Co., Ltd.)
0), screen size 850 μm, rotation speed 20
The particles were sized at 00 rpm. This granule 1247.5g is mixed with talc 39.7g, magnesium stearate 13.2g
Was added and mixed to produce chewable granules. The granules were tableted with a tableting machine (HT-AP6SS-II manufactured by Hata Works Co., Ltd.) at 0.7 tons to produce chewable tablets.
【００２４】実施例３
ロイシン４７６．０ｇ、バリン２３８．０ｇ、イソロイ
シン２８６．０ｇ、エリスリトール３７５．０ｇを秤量
後、攪拌型混合機（深江工業社製１０Ｊ）に投入し、ア
ジテータ回転数３００ｒｐｍ、チョッパー回転数３６０
０ｒｐｍで混合した。別に、無水クエン酸３７．８ｇを
水約１５０．０ｇに溶解させた液を添加し、十分混合し
た。この粒状物を流動層造粒機（フロイント産業社製Ｆ
ＬＯ−５）で乾燥し、さらに整粒機（岡田精工社製ＮＤ
−１０）に加え、スクリーンサイズ８５０μｍ、回転数
２０００ｒｐｍで整粒した。この粒状物１２４３．４ｇ
にタルク３９．７ｇを加えて混合し、チュアブル用顆粒
を製造した。この顆粒を打錠機（畑鐵工所社製ＨＴ−Ａ
ＰＳＳ−II）で０．７トンで打錠しチュアブル錠を製造
した。Example 3 476.0 g of leucine, 238.0 g of valine, 286.0 g of isoleucine, and 375.0 g of erythritol were weighed, and then charged into a stirring mixer (10J manufactured by Fukae Kogyo Co., Ltd.), agitator rotation speed 300 rpm, chopper. Rotation speed 360
Mixed at 0 rpm. Separately, a solution prepared by dissolving 37.8 g of anhydrous citric acid in about 150.0 g of water was added and mixed well. This granular material is a fluidized bed granulator (Freund Industrial Co. F
Dry with LO-5), and further granulate (ND by Okada Seiko Co., Ltd.
In addition to -10), the particle size was adjusted with a screen size of 850 μm and a rotation speed of 2000 rpm. This granule 1243.4g
Then, 39.7 g of talc was added and mixed to produce chewable granules. A tableting machine (HT-A manufactured by Hatakko Co., Ltd.)
PSS-II) was used for tableting at 0.7 tons to produce chewable tablets.
【００２５】試験例
前記各実施例及び参考例で得られた各種チュアブル錠を
アルミラミネートに充填し、４０℃、１ヶ月及び６０
℃、２週間放置後、肉眼によりチュアブル錠の色調を観
察した。Test Example Various chewable tablets obtained in each of the above Examples and Reference Examples were filled in an aluminum laminate, and the temperature was 40 ° C. for 1 month and 60 minutes.
After left at ℃ for 2 weeks, the color tone of the chewable tablet was visually observed.
【００２６】[0026]
【表１】 [Table 1]
【００２７】[0027]
【発明の効果】本発明により製造される分岐鎖アミノ酸
含有チュアブル剤は、長期の保存時にも着色することが
ないため、保存安定性が良好で、また、口中での崩壊性
も良好であり、医薬用途に有用である。EFFECTS OF THE INVENTION The chewable agent containing a branched chain amino acid produced by the present invention does not become colored even during long-term storage, and thus has good storage stability and good disintegration in the mouth. It is useful for pharmaceutical applications.
───────────────────────────────────────────────────── フロントページの続き (72)発明者 矢吹 昭 神奈川県川崎市川崎区鈴木町１番１号 味 の素株式会社医薬研究所内 Ｆターム(参考） 4C076 AA36 AA49 BB22 CC16 DD27B DD28B DD38 DD41B DD67 4C206 AA01 FA53 MA02 MA05 MA55 MA77 NA10 ZA75 ─────────────────────────────────────────────────── ─── Continued front page (72) Inventor Akira Yabuki No. 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa Prefecture Nomoto Pharmaceutical Research Institute F term (reference) 4C076 AA36 AA49 BB22 CC16 DD27B DD28B DD38 DD41B DD67 4C206 AA01 FA53 MA02 MA05 MA55 MA77 NA10 ZA75
Claims (4)
種の分岐鎖アミノ酸を有効成分として含有し、かつマグ
ネシウム化合物を含有することを特徴とするチュアブル
剤。1. Three of isoleucine, leucine and valine.
A chewable agent comprising a branched chain amino acid as an active ingredient and a magnesium compound.
酸マグネシウム、タルク、メタケイ酸アルミン酸マグネ
シウムから選ばれる１種以上である請求項１記載のチュ
アブル剤。2. The chewable agent according to claim 1, wherein the magnesium compound is at least one selected from magnesium stearate, talc, and magnesium aluminometasilicate.
物の含量が０．０５〜１０質量％であることを特徴とす
る請求項１又は２に記載のチュアブル剤。3. The chewable agent according to claim 1, wherein the content of the magnesium compound in the chewable agent is 0.05 to 10% by mass.
量比が、イソロイシン／ロイシン／バリン＝１／１．９
〜２．２／１．１〜１．３である請求項１〜３のいずれ
か１項に記載のチュアブル剤。4. The mass ratio of isoleucine, leucine and valine is isoleucine / leucine / valine = 1 / 1.9.
It is 2.2 / 1.1-1.3, The chewable agent of any one of Claims 1-3.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2002016480A JP3341769B1 (en) | 2002-01-25 | 2002-01-25 | Chewable preparation containing branched-chain amino acid |
| PCT/JP2003/000580 WO2003063855A1 (en) | 2002-01-25 | 2003-01-23 | Chewable tablet containing branched amino acids |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2002016480A JP3341769B1 (en) | 2002-01-25 | 2002-01-25 | Chewable preparation containing branched-chain amino acid |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP3341769B1 JP3341769B1 (en) | 2002-11-05 |
| JP2003221327A true JP2003221327A (en) | 2003-08-05 |
Family
ID=19192005
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2002016480A Expired - Fee Related JP3341769B1 (en) | 2002-01-25 | 2002-01-25 | Chewable preparation containing branched-chain amino acid |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JP3341769B1 (en) |
| WO (1) | WO2003063855A1 (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004016262A1 (en) * | 2002-08-12 | 2004-02-26 | Kyowa Hakko Kogyo Co., Ltd. | Amino acid-containing chewable |
| WO2007043363A1 (en) | 2005-10-12 | 2007-04-19 | Otsuka Pharmaceutical Factory, Inc. | Composition for use in prevention of hypoglycemic condition |
| WO2008044691A1 (en) | 2006-10-10 | 2008-04-17 | Otsuka Pharmaceutical Factory, Inc. | Antidepressant agent |
| WO2011151685A1 (en) * | 2010-06-03 | 2011-12-08 | Raouf Rekik | N-acetyl-dl-leucine, neuroprotective and retinoprotective medicament |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3987593B2 (en) * | 1995-10-02 | 2007-10-10 | サンスター株式会社 | Oral composition containing sodium chloride and magnesium chloride |
-
2002
- 2002-01-25 JP JP2002016480A patent/JP3341769B1/en not_active Expired - Fee Related
-
2003
- 2003-01-23 WO PCT/JP2003/000580 patent/WO2003063855A1/en active Application Filing
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004016262A1 (en) * | 2002-08-12 | 2004-02-26 | Kyowa Hakko Kogyo Co., Ltd. | Amino acid-containing chewable |
| WO2007043363A1 (en) | 2005-10-12 | 2007-04-19 | Otsuka Pharmaceutical Factory, Inc. | Composition for use in prevention of hypoglycemic condition |
| EP1935417A4 (en) * | 2005-10-12 | 2009-06-10 | Otsuka Pharma Co Ltd | COMPOSITION FOR PREVENTING HYPOGLYKEMIC CONDITIONS |
| WO2008044691A1 (en) | 2006-10-10 | 2008-04-17 | Otsuka Pharmaceutical Factory, Inc. | Antidepressant agent |
| US9060979B2 (en) | 2006-10-10 | 2015-06-23 | Otsuka Pharmaceutical Factory, Inc. | Antidepressant |
| WO2011151685A1 (en) * | 2010-06-03 | 2011-12-08 | Raouf Rekik | N-acetyl-dl-leucine, neuroprotective and retinoprotective medicament |
| US9155719B2 (en) | 2010-06-03 | 2015-10-13 | Raouf Rekik | N-acetyl-DL-leucine, neuroprotective and retinoprotective medicament |
| RU2598339C2 (en) * | 2010-06-03 | 2016-09-20 | Рауф РЕКИК | Neuroprotective and retinoprotective agent n-acetyl-dl-leucine |
Also Published As
| Publication number | Publication date |
|---|---|
| JP3341769B1 (en) | 2002-11-05 |
| WO2003063855A1 (en) | 2003-08-07 |
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