JP2023015409A - Oral gelatinous composition - Google Patents
Oral gelatinous composition Download PDFInfo
- Publication number
- JP2023015409A JP2023015409A JP2022194427A JP2022194427A JP2023015409A JP 2023015409 A JP2023015409 A JP 2023015409A JP 2022194427 A JP2022194427 A JP 2022194427A JP 2022194427 A JP2022194427 A JP 2022194427A JP 2023015409 A JP2023015409 A JP 2023015409A
- Authority
- JP
- Japan
- Prior art keywords
- gel composition
- oral
- oral gel
- vitamin
- present
- 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
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- 235000012141 vanillin Nutrition 0.000 description 1
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- 239000011719 vitamin A Substances 0.000 description 1
- NCYCYZXNIZJOKI-UHFFFAOYSA-N vitamin A aldehyde Natural products O=CC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C NCYCYZXNIZJOKI-UHFFFAOYSA-N 0.000 description 1
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- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
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- 239000011653 vitamin D2 Substances 0.000 description 1
- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 description 1
- 235000005282 vitamin D3 Nutrition 0.000 description 1
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- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 1
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- 239000011709 vitamin E Substances 0.000 description 1
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- 229940011671 vitamin b6 Drugs 0.000 description 1
- 229940021056 vitamin d3 Drugs 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 229960002675 xylitol Drugs 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
- 239000009538 yokuinin Substances 0.000 description 1
- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
本発明は、ビタミンB1類を含有する経口ゲル状組成物に関する。 TECHNICAL FIELD The present invention relates to an oral gel composition containing vitamin B1 .
ビタミンB1類は、生体に対する様々な有用性を有することが知られており、経口摂取される医薬品、医薬部外品及び食品等において広く用いられている。
ビタミンB1類を十分量で摂取可能にする形態としては、主に錠剤や飲料などの形態が好適に採用されているが、近年、流動性のある粘稠なゲル状の経口製剤もその形態として採用される場合が増加している。
このようなゲル状製剤が採用される背景には、特に先進国における高齢者の増加に伴う嚥下障害者の増加に関連して、投与若しくは摂取及び嚥下が容易である形態が消費者に好まれていることや、短時間で簡便に摂取が可能でありながら、空腹感を軽減できる形態が好まれていること等の理由が存在していると考えられる。
Vitamin B1 is known to have various usefulness to the living body, and is widely used in orally ingested pharmaceuticals, quasi - drugs, foods, and the like.
Forms such as tablets and beverages are mainly suitably used as forms that allow vitamin B1 to be taken in sufficient amounts. are increasingly being adopted as
In the background of the adoption of such gel formulations, forms that are easy to administer or ingest and swallow are preferred by consumers, especially in relation to the increase in dysphagia accompanying the increase in the elderly population in developed countries. It is thought that there are reasons for this, such as the fact that it is easy to take in a short period of time and that the form that can reduce hunger is preferred.
ビタミンB1類を含有する経口ゲル状製剤に近い公知技術としては、0.01~0.5重量%のビタミンB1類、及び0.5~30重量%のコンドロイチン硫酸塩を含有する経口ゼリー剤(特許文献1)が挙げられるが、該経口ゼリー剤は、流動性の無い成形したゲル状の製剤であり、液状または流動性のある粘稠なゲル状の製剤ではない。 Oral jelly containing 0.01 to 0.5% by weight of vitamin B1 and 0.5 to 30% by weight of chondroitin sulfate as a known technology close to oral gel preparations containing vitamin B1 (Patent Document 1), but the oral jelly is a non-flowing molded gel-like preparation, not a liquid or fluid viscous gel-like preparation.
本発明者らの検討によれば、ビタミンB1類を安定に含有する経口ゲル状組成物(本明細書において「ゲル状組成物」とは、固体であるゲル組成物ではなく、流動性のある粘稠な液体組成物をいう)の実現、及びゲル状形態が安定なビタミンB1類を含有する経口ゲル状組成物の実現はそれぞれ困難であり、ビタミンB1類を安定に含有し、尚且つゲル状形態も安定な経口ゲル状組成物の実現は更に困難である。 According to the studies of the present inventors, an oral gel composition stably containing vitamin B1 (the term "gel composition" in this specification means not a solid gel composition but a fluid It is difficult to realize a certain viscous liquid composition) and to realize an oral gel composition containing vitamin B 1s in a stable gel form, stably containing vitamin B 1s , Moreover, it is even more difficult to realize an oral gel composition with a stable gel form.
従い、本発明においては、ビタミンB1類を安定に含有し、且つゲル状形態も安定な経口ゲル状組成物の提供を目的とする。 Accordingly, it is an object of the present invention to provide an oral gel composition that stably contains vitamin B1 and has a stable gel form.
本発明者らは、鋭意検討の結果、ビタミンB1類、及びゼリー強度が700~1500g/cm2の範囲内にある粘稠剤を含有し、且つpHが2.8~3.8の範囲内である経口ゲル状組成物によって、前記した課題が解決できることを見出し、本発明を完成するに至った。 As a result of intensive studies, the present inventors have found that it contains vitamin B1 and a thickening agent with a jelly strength in the range of 700 to 1500 g/cm 2 and a pH in the range of 2.8 to 3.8. The inventors have found that the above-described problems can be solved by the oral gel composition, and have completed the present invention.
すなわち、本発明は、以下の態様を含む。
[1] ビタミンB1類、及びゼリー強度が700~1500g/cm2の範囲内にある粘稠剤を含有し、pHが2.8~3.8の範囲内である経口ゲル状組成物。
[2] ビタミンB1類が、チアミン塩酸塩、チアミン硝酸塩、ビスチアミン硝酸塩、チアミンジスルフィド、チアミンジセチル硫酸エステル塩、ジセチアミン塩酸塩、フルスルチアミン、フルスルチアミン塩酸塩、オクトチアミン、シコチアミン、ビスイブチアミン、ビスベンチアミン、プロスルチアミン、及びベンフォチアミンからなる群より選択され
る1種以上である、上記[1]に記載の経口ゲル状組成物。
[3] 粘稠剤が寒天である、上記[1]又は[2]に記載の経口ゲル状組成物。
[4] 寒天の還元糖含量が0.02重量%~0.05重量%である、上記[3]に記載の経口ゲル状組成物。
[5] 硬さが0.08~0.35Nの範囲内である、上記[1]~[4]いずれか一項に記載の経口ゲル状組成物。
[6] 医薬品または医薬部外品として用いられる、上記[1]~[5]いずれか一項に記載の経口ゲル状組成物。
[7] パウチタイプの容器に包装されている、上記[1]~[6]いずれか一項に記載の経口ゲル状組成物。
That is, the present invention includes the following aspects.
[1] An oral gel composition containing vitamin B1 and a thickening agent having a jelly strength in the range of 700 to 1500 g/cm 2 and a pH in the range of 2.8 to 3.8.
[2] Vitamin B 1 type is thiamine hydrochloride, thiamine nitrate, bisthiamine nitrate, thiamine disulfide, thiamine dicetyl sulfate, dicetiamine hydrochloride, fursultiamine, fursultiamine hydrochloride, octotiamine, sicotiamine, bisive The oral gel composition according to [1] above, which is at least one selected from the group consisting of thiamine, bisbentiamine, prosultiamine, and benfotiamine.
[3] The oral gel composition according to [1] or [2] above, wherein the thickening agent is agar.
[4] The oral gel composition according to [3] above, wherein the reducing sugar content of the agar is 0.02% by weight to 0.05% by weight.
[5] The oral gel composition according to any one of [1] to [4] above, which has a hardness in the range of 0.08 to 0.35N.
[6] The oral gel composition according to any one of [1] to [5] above, which is used as a drug or quasi-drug.
[7] The oral gel composition according to any one of [1] to [6] above, which is packaged in a pouch-type container.
本発明によれば、ビタミンB1類を安定に含有し、且つゲル状形態も安定な経口ゲル状組成物が提供される。 ADVANTAGE OF THE INVENTION According to this invention, the oral gel composition which contains vitamin B1 class stably and whose gel form is also stable is provided.
用語
本明細書中、用語「ゲル状組成物」とは、固体であるゲル組成物と区別して、流動性のある粘稠な液体組成物を意味する。
本明細書中、用語「粘稠剤」とは、当業者が通常理解する通り、液体の粘性を高めるために混入する添加物の総称で、水性液体(例:水、水溶液、水分散液)に溶解または分散して当該水性液体を高粘度化(粘稠化)させる物質を意味する。
Terms In the present specification, the term "gel composition" means a fluid and viscous liquid composition to distinguish it from a solid gel composition.
As used herein, the term "viscosifier" is a general term for additives mixed in to increase the viscosity of a liquid, as is commonly understood by those skilled in the art, and is an aqueous liquid (e.g., water, aqueous solution, aqueous dispersion). Means a substance that dissolves or disperses in to increase the viscosity (viscosity) of the aqueous liquid.
本明細書中、用語「ゼリー強度(jelly strength)」は、寒天に関する技術分野の慣用に従い、粘稠剤の一性質を表す。念のために記載するに過ぎないが、当該用語は、ゲルの一性質を表す用語「ゲル強度(gel strength)」とは区別して用いられる。 本明細書中、粘稠剤の「ゼリー強度」は、本発明に用いられる粘稠剤の種類によらず共通して、寒天についてのJIS K 8263:2015に記載の測定方法で決定されるゼリー強度である。すなわち、粘稠剤の「ゼリー強度」とは、水に粘稠剤を1.5wt%の濃度で溶解させて作製したゲルの強度である。ここで水としては、精製水を用いる。 As used herein, the term "jelly strength" refers to a property of a thickening agent, according to the art convention for agar. As a reminder, the term is used in distinction from the term "gel strength," which describes one property of gels. As used herein, the "jelly strength" of a thickening agent is common regardless of the type of thickening agent used in the present invention, and is commonly determined by the measurement method described in JIS K 8263: 2015 for agar. strength. That is, the "jelly strength" of a thickening agent is the strength of a gel prepared by dissolving the thickening agent in water at a concentration of 1.5 wt%. Here, purified water is used as water.
本明細書中の記号及び略号は、特に限定のない限り、本発明が属する技術分野において通常用いられる意味に理解される。
本明細書中に記載されている工程、処理、又は操作は、特に限定されない限り、室温で実施される。本明細書中、室温は、10~35℃の範囲内の温度を意味する。
The symbols and abbreviations in this specification are understood to have meanings commonly used in the technical field to which the present invention belongs, unless otherwise specified.
Unless otherwise specified, any step, treatment or operation described herein is performed at room temperature. As used herein, room temperature means a temperature within the range of 10-35°C.
経口ゲル状組成物
本発明の経口ゲル状組成物は、ビタミンB1類、及びゼリー強度が700~1500g/cm2の範囲内にある粘稠剤を含有する。
以下、本発明の経口ゲル状組成物に含有する成分、及び含有してもよい成分について説明する。
Oral Gel Composition The oral gel composition of the present invention contains vitamin B1 and a thickening agent having a jelly strength within the range of 700 to 1500 g/cm 2 .
Components contained in the oral gel composition of the present invention and components that may be contained are described below.
・ビタミンB
1
類
本発明において用いられるビタミンB1類の例は、チアミン、ビスチアミン、チアミンジスルフィド、ジセチアミン、フルスルチアミン、オクトチアミン、シコチアミン、ビスイブチアミン、ビスベンチアミン、プロスルチアミン、及びベンフォチアミン、並びにそれらの塩、溶媒和物(例:水和物)、並びに塩の溶媒和物(例:水和物)を包含する。当該塩の例は、塩酸塩、硝酸塩、及びセチル硫酸塩を包含する。
・Vitamin B 1 type
Examples of vitamin B1s used in the present invention are thiamine, bisthiamine, thiamine disulfide, dicetiamine, fursultiamine, octotiamine, sicotiamine, bisivetiamine, bisbentiamine, prosultiamine, and benfotiamine, and their salts, solvates (eg hydrates), and solvates (eg hydrates) of salts. Examples of such salts include hydrochloride, nitrate, and cetyl sulfate.
当該ビタミンB1類は、好適に、チアミン塩酸塩、チアミン硝酸塩、ビスチアミン硝酸
塩、チアミンジスルフィド、チアミンジセチル硫酸エステル塩、ジセチアミン塩酸塩、フルスルチアミン、フルスルチアミン塩酸塩、オクトチアミン、シコチアミン、ビスイブチアミン、ビスベンチアミン、プロスルチアミン、及びベンフォチアミンからなる群より選択される1種以上であることができる。
本発明において特に好適に用いられるビタミンB1類は、フルスルチアミン又はその塩酸塩である。
The vitamin B1 is preferably thiamine hydrochloride, thiamine nitrate, bisthiamine nitrate, thiamine disulfide, thiamine dicetyl sulfate, disetiamine hydrochloride, fursultiamine, fursultiamine hydrochloride, octotiamine, sicotiamine, bis It can be one or more selected from the group consisting of ibtiamine, bisbentiamine, prosultiamine, and benfotiamine.
A vitamin B1 group particularly suitably used in the present invention is fursultiamine or its hydrochloride.
本発明の経口ゲル状組成物におけるビタミンB1類の配合量は、組成物全体に対して、約0.00005~0.5w/v%、好ましくは約0.0002~0.25w/v%、より好ましくは約0.0005~0.05w/v%、さらに好ましくは約0.001~0.03w/v%である。 The amount of vitamin B1 in the oral gel composition of the present invention is about 0.00005 to 0.5 w/v%, preferably about 0.0002 to 0.25 w/v%, based on the total composition. , more preferably about 0.0005 to 0.05 w/v%, more preferably about 0.001 to 0.03 w/v%.
・ビタミンB
1
類以外の有効成分
本発明の経口ゲル状組成物においては、本発明の効果を阻害しない限り、ビタミンB1類以外の有効成分、例えばビタミンB1類以外のビタミン類、アミノ酸類等をはじめとする、医薬品、医薬部外品、保健機能食品(例:機能性表示食品、栄養機能食品、特定保健用食品)、又は一般食品(例:栄養補助食品、健康補助食品、栄養調整食品)等において用いられる、その他の有効成分の一種以上をさらに含有してもよい。
・Active ingredients other than vitamin B1
In the oral gel composition of the present invention, pharmaceuticals and pharmaceuticals including active ingredients other than vitamin B1 , such as vitamins other than vitamin B1 , amino acids, etc., as long as they do not inhibit the effects of the present invention Others used in quasi-products, foods with health claims (e.g., foods with function claims, foods with nutrient function claims, foods for specified health uses), or general foods (e.g., nutritional supplements, health supplements, nutritionally balanced foods), etc. It may further contain one or more active ingredients.
前記ビタミンB1類以外のビタミン類の例は、ビタミンA類(例:レチノール、レチノイン酸、レチナール、レチノール酢酸エステル、レチノールパルミチン酸エステル、ビタミンA油、肝油、強肝油)、ビタミンB2類[例:リボフラビン、リボフラビン誘導体(例:リボフラビンリン酸エステル、リボフラビン酢酸エステル、リボフラビン酪酸エステル等のリボフラビンエステル;フラビンアデニンジヌクレオチドナトリウム等)及びその塩(例:リボフラビンリン酸エステルナトリウム)]、ビタミンB6類[例:ピリドキシン、ピリドキサミン、ピリドキサール、それらの誘導体(例:ピリドキシンリン酸エステル、ピリドキサールリン酸エステル水和物、ピリドキサミンリン酸エステル、ピリドキシンパルミチン酸エステル)及びその塩(例:ピリドキシン塩酸塩、ピリドキサール塩酸塩、ピリドキサミン二塩酸塩)]、ビタミンB12類(例:コバラミン、シアノコバラミン、メチルコバラミン、アデノシルコバラミン、ヒドロキソコバラミン、ヒドロキソコバラミン塩酸塩、ヒドロキソコバラミン酢酸塩)、ビタミンC類(例:アスコルビン酸、アスコルビン酸リン酸エステルマグネシウム、アスコルビン酸ナトリウム、アスコルビン酸カルシウム、酢酸トコフェロールアスコルビン酸エステル)、ビタミンD類(例:エルゴカルシフェロール、コレカルシフェロール)、ビタミンE類(例:コハク酸d-α-トコフェロール、コハク酸dl-α-トコフェロール、コハク酸dl-α-トコフェロールカルシウム、コハク酸d-α-トコフェロールカルシウム、コハク酸トコフェロールカルシウム、酢酸d-α-トコフェロール、酢酸dl-α-トコフェロール、d-α-トコフェロール、dl-α-トコフェロール)、ナイアシン類(例:ニコチン酸、ニコチン酸アミド)、パントテン酸類(例:パンテノール、パントテン酸カルシウム、パントテン酸ナトリウム)、及びその他のビタミン類(例:ビタミンK類、ビオチン、葉酸、γ-オリザノール)、並びにそれらの組合せを包含する。 Examples of vitamins other than vitamin B1 are vitamin A (e.g., retinol, retinoic acid, retinal, retinol acetate, retinol palmitate, vitamin A oil, cod liver oil, strong cod liver oil), vitamin B2 [ Examples: riboflavin, riboflavin derivatives (e.g. riboflavin esters such as riboflavin phosphate, riboflavin acetate, riboflavin butyrate; flavin adenine dinucleotide sodium, etc.) and salts thereof (e.g. riboflavin sodium phosphate)], vitamin B6 class [e.g. pyridoxine, pyridoxamine, pyridoxal, their derivatives (e.g. pyridoxine phosphate, pyridoxal phosphate hydrate, pyridoxamine phosphate, pyridoxine palmitate) and their salts (e.g. pyridoxine hydrochloride , pyridoxal hydrochloride, pyridoxamine dihydrochloride)], vitamin B12 group (e.g. cobalamin, cyanocobalamin, methylcobalamin, adenosylcobalamin, hydroxocobalamin, hydroxocobalamin hydrochloride, hydroxocobalamin acetate), vitamin C group (e.g.: Ascorbic acid, magnesium ascorbate phosphate, sodium ascorbate, calcium ascorbate, tocopheryl acetate ascorbate), vitamin Ds (e.g. ergocalciferol, cholecalciferol), vitamins E (e.g. d-succinate) α-Tocopherol, dl-α-tocopherol succinate, dl-α-tocopherol calcium succinate, d-α-tocopherol calcium succinate, calcium tocopherol succinate, d-α-tocopherol acetate, dl-α-tocopherol acetate, d -α-tocopherol, dl-α-tocopherol), niacins (e.g. nicotinic acid, nicotinamide), pantothenic acids (e.g. panthenol, calcium pantothenate, sodium pantothenate), and other vitamins (e.g. vitamin Ks, biotin, folic acid, gamma-oryzanol), and combinations thereof.
前記アミノ酸類の例は、アスパラギン酸(例:L-アスパラギン酸、L-アスパラギン酸カリウム、L-アスパラギン酸ナトリウム、L-アスパラギン酸マグネシウム、アスパラギン酸カリウム・マグネシウム等量混合物)、グルタミン酸(例:L-グルタミン酸)、アルギニン(例:L-アルギニン、L-アルギニン塩酸塩)、トリプトファン(例:L-トリプトファン)、リシン(例:L-リシン塩酸塩、L-リシン酢酸塩)、グリシン、ロイシン(例:L-ロイシン)、イソロイシン(例:L-イソロイシン)、トレオニン(例:L-トレオニン)、システイン(例:L-システイン、L-システイン塩酸塩、L-システイン塩酸塩水和物)、バリン(例:L-バリン)、ヒスチジン(例:L-ヒスチジ
ン、L-ヒスチジン塩酸塩、L-ヒスチジン塩酸塩水和物)、及びメチオニン(例:DL-メチオニン)、並びにそれらの組合せを包含する。
Examples of the amino acids include aspartic acid (e.g. L-aspartic acid, potassium L-aspartate, sodium L-aspartate, magnesium L-aspartate, potassium/magnesium aspartate equivalent mixture), glutamic acid (e.g. L -glutamic acid), arginine (e.g. L-arginine, L-arginine hydrochloride), tryptophan (e.g. L-tryptophan), lysine (e.g. L-lysine hydrochloride, L-lysine acetate), glycine, leucine (e.g. : L-leucine), isoleucine (e.g. L-isoleucine), threonine (e.g. L-threonine), cysteine (e.g. L-cysteine, L-cysteine hydrochloride, L-cysteine hydrochloride hydrate), valine (e.g. : L-valine), histidine (eg, L-histidine, L-histidine hydrochloride, L-histidine hydrochloride hydrate), and methionine (eg, DL-methionine), and combinations thereof.
前記その他の有効成分の他の例は、タウリン(アミノエチルスルホン酸)、ウルソデスオキシコール酸、塩化カルニチン、オロチン酸、オロチン酸コリン、ガンマ-オリザノール、クエン酸カルシウム、グリセリン酸カルシウム、グルコン酸カルシウム、ジクロロ酢酸ジイソプロピルアミン、炭酸カルシウム、沈降炭酸カルシウム、乳酸カルシウム、リン酸水素カルシウム、無水リン酸水素カルシウム、クエン酸鉄アンモニウム、フマル酸第一鉄、グルクロノラクトン、グルクロン酸、グルクロン酸アミド、カフェイン、無水カフェイン、コンドロイチン硫酸ナトリウム、イノシトール、グリチルリチン酸、グリチルリチン酸ナトリウム、グルコン酸ナトリウム、重酒石酸コリン、炭酸マグネシウム、チオクト酸、チオクト酸アミド、デヒドロコール酸、パンテチン、ヨークレシチン、ルチン、及び生薬(例:アセンヤク、ウイキョウ、エゾウコギ、オウセイ、加工ダイサン、ガラナ、カンゾウ、クコシ、ケイヒ、コウジン、サフラン、サンザシ、サンヤク、シャクヤク、シュクシャ、ショウキョウ、ジョテイシ、セイヨウサンザシ、タイソウ、チョウジ、チンピ、トウキ、トシシ、トチュウ、ニクジュヨウ、ニンジン、ニンニク、ブクリョウ、ムイラブアマ、モッコウ、ヤクチ、ヨクイニン、リュウガンニク、ロクジョウ、カイバ、ニクジュヨウ、ハゲキテン、オウギ、ビャクジュツ、ローヤルゼリー)、並びにそれらの組合せを包含する。 Other examples of the other active ingredients include taurine (aminoethylsulfonic acid), ursodesoxycholic acid, carnitine chloride, orotic acid, choline orotate, gamma-oryzanol, calcium citrate, calcium glycerate, calcium gluconate, Diisopropylamine dichloroacetate, calcium carbonate, precipitated calcium carbonate, calcium lactate, calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate, ferric ammonium citrate, ferrous fumarate, glucuronolactone, glucuronic acid, glucuronic acid amide, caffeine , anhydrous caffeine, sodium chondroitin sulfate, inositol, glycyrrhizic acid, sodium glycyrrhizinate, sodium gluconate, choline bitartrate, magnesium carbonate, thioctic acid, thioctic acid amide, dehydrocholic acid, pantethine, yoke lecithin, rutin, and crude drugs ( Examples: Asan yak, fennel, eleuthero, oleifera, processed daisan, guarana, licorice, Chinese wolfberry, cinnamon bark, red ginseng, saffron, hawthorn, sanyak, peony, syukusha, ginger, jotei, hawthorn, taisou, clove, chimp, radish, toshishi , Eucommia, Citrus, Carrot, Garlic, Bukuryo, Muirabuama, Mokkou, Yakuchi, Yokuinin, Longanniku, Rokujyo, Kaiba, Citrus, Bald Tentacle, Astragalus, Byakujutsu, Royal Jelly), and combinations thereof.
これらビタミンB1類以外の有効成分の量は、その種類、及び目的等に応じて、適宜設定される。 The amount of these active ingredients other than vitamin B1 is appropriately set according to the type, purpose, and the like.
・粘稠剤
本発明者らは鋭意検討の結果、「粘稠剤」のゼリー強度が700g/cm2未満では、耐酸性が悪いので、ビタミンB1類が安定な低pH領域では、ゲル状組成物の経時的な離水の増加や、硬さの低下などにつながってしまうことを見出した。
また、「粘稠剤」のゼリー強度が1500g/cm2を超えると、使用濃度(ゲル状組成物における粘稠剤の配合量)が減るため、所望の物性にならず、やはりゲル状組成物の経時的な離水の増加などにつながってしまうことを見出した。
従って、本発明の経口ゲル状組成物において用いられる「粘稠剤」のゼリー強度は、700~1500g/cm2の範囲内であり、好ましくは900~1200g/cm2の範囲内、より好ましくは950~1150g/cm2の範囲である。
・Thickening agent
As a result of intensive studies, the present inventors found that when the jelly strength of the "viscosity agent" is less than 700 g/cm 2 , the acid resistance is poor. It was found that it leads to a significant increase in water separation and a decrease in hardness.
In addition, when the jelly strength of the "viscosity agent" exceeds 1500 g/cm 2 , the use concentration (the amount of the viscosity agent in the gel composition) is reduced, so that the desired physical properties are not obtained, and the gel composition is also not produced. It was found that it leads to an increase in syneresis over time.
Therefore, the jelly strength of the “viscous agent” used in the oral gel composition of the present invention is within the range of 700-1500 g/cm 2 , preferably within the range of 900-1200 g/cm 2 , more preferably It ranges from 950 to 1150 g/cm 2 .
本発明の経口ゲル状組成物における「粘稠剤」として、好ましくは「寒天(カンテンを粉末としたカンテン末を含む)」である。
本明細書中、寒天は、通常理解される通り、テングサ属の海藻、オゴノリ属の海藻、及びオバクサ属の海藻からなる群より選択される一種以上の海藻から得られる多糖類である。
The "viscosity agent" in the oral gel composition of the present invention is preferably "agar (including powdered agar powder)".
As used herein, agar is a polysaccharide obtained from one or more seaweeds selected from the group consisting of seaweeds belonging to the genus Agaricus, seaweeds belonging to the genus Gracilaria, and seaweeds belonging to the genus Magnolia.
本発明においては、700~1500g/cm2の範囲内のゼリー強度を有する寒天である限り、様々な寒天を好適に使用し得る。
このような寒天は、商業的に入手可能であり、具体例としては、カンテン末 PS-8
8(製品名、伊那食品工業)、カンテン末 T-1(製品名、伊那食品工業)などが挙げ
られる。
Various agars can be suitably used in the present invention as long as they have a jelly strength within the range of 700 to 1500 g/cm 2 .
Such agars are commercially available, and specific examples include agar powder PS-8
8 (product name, Ina Food Industry), agar powder T-1 (product name, Ina Food Industry), and the like.
寒天は、ガラクトースとアンヒドロガラクトースが繋がった高分子構造で、分子末端の糖は還元糖(reducing sugar)として存在しており、還元糖としての活性を示す。還元糖とは、塩基性溶液中でアルデヒド基又はケトン基を形成する糖のことで、酸化剤によって酸化されてアルドン酸、アルダル酸を与える。還元糖には、例えば、グルコース、フルク
トース、グリセルアルデヒド等の全ての単糖、ラクトース、アラビノース、マルトース等のマルトース型二糖・オリゴ糖が含まれる。
本発明者らは鋭意検討の結果、ビタミンB1類の安定性の観点から、寒天の還元糖含量は0.02重量%以上であることが望ましいこと、さらに糖の褐変反応によって褐色に変化するのを防止する観点から、寒天の還元糖含量は0.05重量%以下であることが望ましいことを見出した。
従い、本発明で用いられる寒天としては、還元糖含量が0.02重量%~0.05重量%の寒天が好適に使用される。
なお、寒天中の還元糖含量は、Park-Johnson法(例、糖質の科学(下)第368頁)などの
公知の方法により、測定することができる。
Agar has a macromolecular structure in which galactose and anhydrogalactose are linked, and the sugar at the end of the molecule exists as a reducing sugar, exhibiting activity as a reducing sugar. A reducing sugar is a sugar that forms an aldehyde group or a ketone group in basic solution and is oxidized by an oxidizing agent to give aldonic acid or aldaric acid. Reducing sugars include, for example, all monosaccharides such as glucose, fructose and glyceraldehyde, and maltose-type disaccharides and oligosaccharides such as lactose, arabinose and maltose.
As a result of intensive studies by the present inventors, from the viewpoint of the stability of vitamin B1 , it is desirable that the content of reducing sugars in agar is 0.02% by weight or more. From the viewpoint of preventing this, it has been found that the reducing sugar content of agar is desirably 0.05% by weight or less.
Therefore, the agar used in the present invention preferably has a reducing sugar content of 0.02% to 0.05% by weight.
The reducing sugar content in agar can be measured by a known method such as the Park-Johnson method (eg, Science of Carbohydrates (2), p. 368).
本発明の経口ゲル状組成物における粘稠剤の配合量は、組成物全体に対して、好ましくは0.008~85w/w%、より好ましくは0.03~40w/w%、更に好ましくは0.08~8w/w%である。 The content of the thickening agent in the oral gel composition of the present invention is preferably 0.008 to 85 w/w%, more preferably 0.03 to 40 w/w%, still more preferably 0.08 to 8 w/w%.
本発明の経口ゲル状組成物では、さらに粘度を上げることを目的として、必要に応じて、前記した寒天に加えて、キサンタンガム(伊那食品工業、ウルトラキサンタン)、グァーガム(伊那食品工業、グァーガム)などを含有してもよい。
本発明の経口ゲル状組成物における寒天と、キサンタンガム及び/又はグァーガムの質量比は、寒天1質量部に対して、0.01~10質量部が好ましく、0.1~2質量部がより好ましい。
For the purpose of further increasing the viscosity of the oral gel composition of the present invention, xanthan gum (Ina Food Industry Co., Ltd., Ultraxanthan), guar gum (Ina Food Industry Co., Ltd., Guar Gum), etc. may be added in addition to the agar described above, if necessary. may contain.
The mass ratio of agar to xanthan gum and/or guar gum in the oral gel composition of the present invention is preferably 0.01 to 10 parts by mass, more preferably 0.1 to 2 parts by mass, per 1 part by mass of agar. .
・粘稠剤以外の添加成分
本発明の経口ゲル状組成物においては、本発明の効果を阻害しない限り、前記成分に加えて、他の成分、例えば、一般的に経口ゲル状組成物に添加可能な成分(例:甘味剤、矯味剤、防腐剤、保存剤、着香剤、芳香剤、清涼化剤、界面活性剤、可溶化剤、乳化剤、溶剤、pH調節剤、緩衝剤、懸濁剤、着色剤、安定化剤、消泡剤、溶解補助剤、苦味マスキング剤)の一種以上を含有してもよい。
・Additional ingredients other than thickening agents
In the oral gel composition of the present invention, in addition to the above components, other components, such as components that can generally be added to oral gel compositions (e.g., sweetener , flavoring agents, preservatives, preservatives, flavoring agents, fragrances, cooling agents, surfactants, solubilizers, emulsifiers, solvents, pH adjusters, buffering agents, suspending agents, coloring agents, stabilizers , antifoaming agent, solubilizing agent, bitterness masking agent).
甘味剤の例は、糖類(例:ブドウ糖、ガラクトース、果糖、ショ糖、乳糖、麦芽糖、異性化糖、液糖、転化型液糖、トレハロース)、多糖類(例:オリゴ糖、デンプン)、糖アルコール類(例:エリスリトール、キシリトール、マルチトール、ソルビトール、還元麦芽糖水飴、粉末還元麦芽糖水飴)、高甘味度甘味料(例:アセスルファムカリウム)及び非糖質甘味料(例:スクラロース、ステビア抽出物、サッカリン、アスパルテーム)、並びにそれらの組合せを包含する。
矯味剤の例は、クエン酸又はその水和物、クエン酸ナトリウム、リンゴ酸(例:DL-リンゴ酸)等の酸味剤、及び果汁、並びにそれらの組合せを包含する。
防腐剤又は保存剤の例は、安息香酸、安息香酸ナトリウム、ソルビン酸ナトリウム、及びパラベン類(例:パラオキシ安息香酸エチル、パラオキシ安息香酸ブチル、パラオキシ安息香酸プロピル)、並びにそれらの組合せを包含する。
着香剤、芳香剤又は清涼化剤の例は、オレンジ油、メントール、バニリン及びその誘導体(例:エチルバニリン)、及び各種香料(例:ストロベリーフレーバー、チェリーフレーバー、オレンジフレーバー、グレープフルーツフレーバー、アップルフレーバー、レモンフレーバー、グレープフレーバー、コーヒーフレーバー、ブラックティーフレーバー、ビターフレーバー、ハーブミントフレーバー、チョコレートフレーバー、薬味酒フレーバー)、並びにそれらの組合せを包含する。
界面活性剤の例は、ショ糖脂肪酸エステル、プロピレングリコール、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール(ポロクサマー188)、ポリオキシエチレン硬化ヒマシ油類(例:ポリオキシエチレン硬化ヒマシ油60)、ポリソルベート20、及びポリソルベート80、並びにそれらの組合せを包含する。
可溶化剤の例は、精製大豆レシチン、大豆レシチン、ダイズ油、中鎖脂肪酸トリグリセリド、マクロゴール4000、マクロゴール6000、流動パラフィン、ショ糖脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油類、及びポリソルベート80、並びにそれらの組合せを包含する。
乳化剤の例は、ショ糖脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油類、ポリソルベート20、ポリソルベート80、精製大豆レシチン、大豆レシチン、中鎖脂肪酸トリグリセリド、及び流動パラフィン、並びにそれらの組合せを包含する。
溶剤の例は、水(例:精製水)、エタノール、プロピレングリコール、オリーブ油、ゴマ油、ヒマシ油、ダイズ油、及び流動パラフィンを包含する。
pH調節剤又は緩衝剤の例は、リン酸、乳酸、酢酸、炭酸及びそれらの塩、塩酸、水酸化ナトリウム、水酸化カリウム、クエン酸緩衝液(0.2M)、及び炭酸水素ナトリウム、並びにそれらの組合せを包含する。
懸濁剤の例は、アラビアゴム、結晶セルロース、ビーガム、キサンタンガム、グァーガム、ゼラチン、メトロース及びその塩、カルメロース及びその塩、並びにそれらの組合せを包含する。
着色剤の例は、カラメル、β-カロチン、及び各種食用色素(例:食用黄色1号、食用赤色2号)、並びにそれらの組合せを包含する。
安定化剤の例は、シリコーン樹脂、グリセリン、エデト酸の塩、塩化ナトリウム、及びピロ亜硫酸の塩、並びにそれらの組合せを包含する。
消泡剤の例は、シリコーン樹脂、シリコーン油、エタノール、グリセリン脂肪酸エステル、ジメチルポリシロキサン、ショ糖脂肪酸エステル、ステアリル酸ポリオキシル、ソスルビタン脂肪酸エステル、トリオレイン酸ソルビタン、及びポリソルベート80、並びにそれらの組合せを包含する。
溶解補助剤の例は、プロピレングリコール、シクロデキストリン、及びアルギニン、並びにそれらの組合せを包含する。
苦味マスキング剤の例は、フォスファチジル類[例:BMI-60(製品名、花王)]を包含する。
Examples of sweeteners include sugars (e.g. glucose, galactose, fructose, sucrose, lactose, maltose, isomerized sugar, liquid sugar, invert liquid sugar, trehalose), polysaccharides (e.g. oligosaccharides, starch), sugars Alcohols (e.g. erythritol, xylitol, maltitol, sorbitol, hydrogenated maltose starch syrup, powdered hydrogenated maltose starch syrup), high intensity sweeteners (e.g. acesulfame potassium) and non-sugar sweeteners (e.g. sucralose, stevia extract, saccharin, aspartame), and combinations thereof.
Examples of flavoring agents include acidulants such as citric acid or its hydrates, sodium citrate, malic acid (eg, DL-malic acid), and fruit juices, and combinations thereof.
Examples of preservatives or preservatives include benzoic acid, sodium benzoate, sodium sorbate, and parabens (eg, ethyl parahydroxybenzoate, butyl parahydroxybenzoate, propyl parahydroxybenzoate), and combinations thereof.
Examples of flavoring agents, fragrances or cooling agents are orange oil, menthol, vanillin and its derivatives (e.g. ethyl vanillin), and various flavors (e.g. strawberry flavor, cherry flavor, orange flavor, grapefruit flavor, apple flavor). , lemon flavor, grape flavor, coffee flavor, black tea flavor, bitter flavor, herbal mint flavor, chocolate flavor, spice flavor), and combinations thereof.
Examples of surfactants include sucrose fatty acid esters, propylene glycol, polyoxyethylene (160) polyoxypropylene (30) glycol (poloxamer 188), polyoxyethylene hydrogenated castor oils (e.g. polyoxyethylene hydrogenated castor oil 60 ), polysorbate 20, and polysorbate 80, and combinations thereof.
Examples of solubilizers include refined soybean lecithin, soybean lecithin, soybean oil, medium-chain triglycerides, macrogol 4000, macrogol 6000, liquid paraffin, sucrose fatty acid esters, polyoxyethylene hydrogenated castor oils, and polysorbate 80, as well as combinations thereof.
Examples of emulsifying agents include sucrose fatty acid esters, polyoxyethylene hydrogenated castor oils, polysorbate 20, polysorbate 80, refined soy lecithin, soy lecithin, medium chain triglycerides, and liquid paraffin, and combinations thereof.
Examples of solvents include water (eg, purified water), ethanol, propylene glycol, olive oil, sesame oil, castor oil, soybean oil, and liquid paraffin.
Examples of pH adjusters or buffers are phosphoric acid, lactic acid, acetic acid, carbonic acid and their salts, hydrochloric acid, sodium hydroxide, potassium hydroxide, citrate buffer (0.2M), and sodium bicarbonate, and includes combinations of
Examples of suspending agents include gum arabic, microcrystalline cellulose, veegum, xanthan gum, guar gum, gelatin, metolose and its salts, carmellose and its salts, and combinations thereof.
Examples of coloring agents include caramel, beta-carotene, and various food colorings (eg, Food Yellow No. 1, Food Red No. 2), and combinations thereof.
Examples of stabilizers include silicone resins, glycerin, salts of edetic acid, sodium chloride, and salts of pyrosulfite, and combinations thereof.
Examples of antifoam agents include silicone resins, silicone oils, ethanol, glycerin fatty acid esters, dimethylpolysiloxane, sucrose fatty acid esters, polyoxyl stearate, sosulbitan fatty acid esters, sorbitan trioleate, and polysorbate 80, and combinations thereof. contain.
Examples of solubilizing agents include propylene glycol, cyclodextrin, and arginine, and combinations thereof.
Examples of bitterness-masking agents include phosphatidyls [eg, BMI-60 (product name, Kao Corporation)].
これらの粘稠剤以外の添加成分の量は、その種類、及び目的等に応じて、適宜設定される。 The amount of additive components other than these thickening agents is appropriately set according to the type, purpose, and the like.
経口ゲル状組成物のpH
本発明者らは、ビタミンB1類(例、フルスルチアミン又はその塩酸塩)を安定に含有し、尚且つゲル状形態を安定に保持する経口ゲル状組成物を提供するためには、該組成物のpHの上限を3.8以下、より好ましくは3.6以下、さらに好ましくは3.5以下とすることを見出した。また、該組成物のpHの下限を2.8以上、より好ましくは3.1以上、さらに好ましくは3.3以上とすることを見出した。
即ち、本発明の経口ゲル状組成物におけるpHは、2.8~3.8の範囲内、より好ましくは3.1~3.6の範囲内、さらに好ましくは3.3~3.5の範囲内である。
pH of oral gel composition
In order to provide an oral gel composition that stably contains vitamin B1 (e.g., fursultiamine or its hydrochloride) and that stably retains the gel form, the present inventors We have found that the upper limit of the pH of the composition is 3.8 or less, more preferably 3.6 or less, and even more preferably 3.5 or less. Also, the inventors have found that the lower limit of the pH of the composition is 2.8 or higher, more preferably 3.1 or higher, and still more preferably 3.3 or higher.
That is, the pH of the oral gel composition of the present invention is within the range of 2.8 to 3.8, more preferably within the range of 3.1 to 3.6, and further preferably within the range of 3.3 to 3.5. Within range.
pHの調整は、例えば、上記したpH調節剤又は緩衝剤の使用により行えばよい。
本発明における経口ゲル状組成物のpHを測定するにあたっては、当該組成物を市販の食品用ミキサーを用いて微細化し、均質な溶液とした上で、日局・一般試験法に記載のpH測定法に従い、試験を実施すればよい。
The pH may be adjusted, for example, by using a pH adjusting agent or buffer as described above.
In measuring the pH of the oral gel composition in the present invention, the composition is pulverized using a commercially available food mixer to make a homogeneous solution, and the pH is measured according to the general test method of the Japanese Pharmacopoeia. The test should be conducted in accordance with the law.
経口ゲル状組成物の形態
本発明の経口ゲル状組成物は、例えば、第十七改正日本薬局方の製剤総則に規定される経口液剤、すなわち『経口投与する、液状又は流動性のある粘稠なゲル状の製剤』として好適に用いることができる。
製剤が、ゲル等の固形製剤ではなく、液状又は流動性のある粘稠なゲル状の製剤である
ことは、技術常識に照らして判断される。
Form of oral gel composition It can be suitably used as a "gel-like preparation".
It is determined in light of common general technical knowledge that the formulation is not a solid formulation such as a gel, but a liquid or fluid viscous gel formulation.
ゲル状組成物の粘稠さは、ゲル状組成物の硬さによって示すことができ、硬さが大きいゲル状組成物は、粘稠性が高いということができる。
本発明の経口ゲル状組成物は、例えば、後記の試験方法によって測定される硬さが、好ましくは0.05N以上、より好ましくは0.08N以上、更に好ましくは0.10N以上である。このような硬さを有することにより、本発明の経口ゲル状組成物は、誤嚥を防止できるし、投与又は摂取も容易である。
本発明の経口ゲル状組成物は、当該硬さが、好ましくは0.50N以下、より好ましくは0.35N以下、更に好ましくは0.30N以下である。このような硬さを有することにより、本発明の経口ゲル状組成物は、投与又は摂取が容易である。
本発明の経口ゲル状組成物は、当該硬さが、好ましくは0.05~0.50Nの範囲内、より好ましくは0.08~0.35Nの範囲内、更に好ましくは0.10~0.30Nの範囲内ある。
The consistency of the gel composition can be indicated by the hardness of the gel composition, and it can be said that a gel composition having a high hardness has a high viscosity.
The oral gel composition of the present invention preferably has a hardness of, for example, 0.05 N or more, more preferably 0.08 N or more, and even more preferably 0.10 N or more, as measured by the test method described below. By having such hardness, the oral gel composition of the present invention can prevent aspiration and can be easily administered or ingested.
The hardness of the oral gel composition of the present invention is preferably 0.50N or less, more preferably 0.35N or less, still more preferably 0.30N or less. By having such hardness, the oral gel composition of the present invention is easy to administer or ingest.
The hardness of the oral gel composition of the present invention is preferably in the range of 0.05 to 0.50N, more preferably in the range of 0.08 to 0.35N, still more preferably 0.10 to 0.35N. .30N range.
本発明の経口ゲル状組成物は、経口投与、又は経口摂取される。
本発明の経口ゲル状組成物は、医薬品、医薬部外品、保健機能食品(例:機能性表示食品、栄養機能食品、特定保健用食品)、又は一般食品(例:栄養補助食品、健康補助食品、栄養調整食品)等として用いることができる。
The oral gel composition of the present invention is orally administered or orally ingested.
The oral gel composition of the present invention can be used as a drug, quasi-drug, food with health claims (e.g. food with functional claims, food with nutrient function claims, food for specified health use), or general food (e.g. dietary supplement, health supplement). food, nutritious food) and the like.
本発明の経口ゲル状組成物は、そのゲル状形態が高い安定性を有する。
本発明において、ゲル状形態が高い安定性を有することとは、物性的には、
(1)苛酷な条件下(例:高温、及び/又は長期間)での保存後も、離水が抑制されていること、及び/又は
(2)苛酷な条件下(例:高温、及び/又は長期間)での保存後も、その硬さの低下が抑制されていること、を意味する。
また、官能的には、ゲル状組成物の食感が維持されていることを意味する。
The oral gel composition of the present invention has high stability in its gel form.
In the present invention, the fact that the gel form has high stability means that, physically,
(1) Syneresis is suppressed even after storage under severe conditions (e.g., high temperature and / or long term), and / or (2) Harsh conditions (e.g., high temperature and / or It means that the decrease in hardness is suppressed even after storage for a long period of time.
Moreover, functionally, it means that the texture of the gel composition is maintained.
ここで、ゲル状組成物の離水量の測定、及び離水率の算出は、次の測定方法により、実施される。
<ゲル状組成物の離水の測定方法>
当該測定方法では、ふるいとして、目開き2mmのメッシュ[第十七改正日本薬局方、ふるい番号8.6号(2000μm)]、且つ直径200mmのふるいを使用する。
試験されるゲル状組成物を容器に入れて所定の保存条件に曝露した後、容器の内容物の全量を、ふるい下を敷いたふるい上に入れ、その質量を測定し、該質量をA(g)とする。次に、前記ふるいを45度傾けて1分間保持した後、当該ふるいから前記ふるい下に落ちた液体(離水)の質量を測定して、これをB(g)とし、次式により離水率を算出する。
離水率(%)=B(g)/A(g)×100
Here, the measurement of the amount of syneresis of the gel composition and the calculation of the syneresis rate are carried out by the following measuring methods.
<Method for measuring syneresis of gel composition>
In this measurement method, a mesh with an opening of 2 mm [Japanese Pharmacopoeia 17th Edition, Sieve No. 8.6 (2000 μm)] and a diameter of 200 mm is used as a sieve.
After placing the gel composition to be tested in a container and exposing it to predetermined storage conditions, the total amount of the contents of the container was placed on a sieve with a sieve underlay, the mass was measured, and the mass was A ( g). Next, after tilting the sieve at 45 degrees and holding it for 1 minute, the mass of the liquid (water syneresis) that fell from the sieve under the sieve was measured, and this was B (g). calculate.
Separation rate (%) = B (g) / A (g) x 100
本発明の経口ゲル状組成物において、ゲル状形態の高い安定性は、苛酷な条件下(例:高温、及び/又は長期間)の保存後においても、ゲル状組成物の適当な硬さが維持されている。 In the oral gel composition of the present invention, the high stability of the gel form is due to the appropriate hardness of the gel composition even after storage under severe conditions (e.g., high temperature and/or long term). maintained.
本発明の経口ゲル状組成物は、好ましくは、冷蔵庫内で(すなわち、約4℃で)8週間保存した場合の硬さに対する、50℃で同期間保存した場合の硬さの比(本明細書中、これを「硬さの残存率」と称する場合がある。当該硬さの残存率は、この定義から理解される通り、100%を超える場合がある。)が、好ましくは65%以上、より好ましくは70%以上、更に好ましくは80%以上である。 The oral gel composition of the present invention preferably has a ratio of firmness when stored in a refrigerator (i.e. at about 4°C) for 8 weeks to firmness when stored at 50°C for the same period (herein In the book, this may be referred to as the "remaining rate of hardness".As understood from this definition, the residual rate of hardness may exceed 100%.), but is preferably 65% or more. , more preferably 70% or more, and still more preferably 80% or more.
本発明の経口ゲル状組成物の硬さの測定については、前記ゲル状組成物の離水の測定方法で、ふるいに残ったゲル状組成物を試料として使用して、次の測定方法により、実施される。
<ゲル状組成物の硬さの試験方法>
当該試験には、材料試験機として、直線運動により物質の圧縮応力を測定することが可能な材料試験機 EZ-SX(製品名、島津製作所)(ロードセル:50N、試験治具:ユニバー
サルデザインフード試験セット、ソフトウェア : TRAPEZIUM X テクスチャー、恒温装置
: 冷熱恒温器)、又はその同等品を使用する。
試料を容器(直径40mm、高さ20mm)に高さ15mmまで充填し、前記材料試験機を用いて、樹脂性の円形プランジャー(直径20mm、高さ8mm)により、圧縮速度10mm/秒、及びクリアランス5mmの条件で2回圧縮し、その時の圧縮応力を測定する。測定は、20±2℃で行う。
2回の圧縮における圧縮応力の最大値を、試料の硬さとする。
The hardness of the oral gel composition of the present invention is measured by the following measurement method using the gel composition remaining on the sieve as a sample in the method for measuring syneresis of the gel composition. be done.
<Method for testing hardness of gel composition>
For this test, a material testing machine EZ-SX (product name, Shimadzu Corporation) capable of measuring the compressive stress of a substance by linear motion (load cell: 50 N, test jig: universal design hood test set, software: TRAPEZIUM X texture, constant temperature device: cold and hot constant temperature chamber), or equivalent.
The sample is filled into a container (diameter 40 mm, height 20 mm) to a height of 15 mm, and using the material testing machine, a resin circular plunger (diameter 20 mm, height 8 mm) is compressed at a compression rate of 10 mm / sec, and It is compressed twice under the condition of a clearance of 5 mm, and the compressive stress at that time is measured. Measurements are made at 20±2°C.
The maximum value of compressive stress in two compressions is taken as the hardness of the sample.
当該試験における試料としては、前記ゲル状組成物の離水の測定方法で、ふるいに残ったゲル状組成物を使用して実施する。
従って、ふるいにゲル状組成物が残らない場合は、当該硬さを測定できないが、当業者が通常理解する通り、ふるいにゲル状組成物が残らない場合、その硬さは、ふるいに残ったゲル状組成物の硬さよりも低いことが合理的に推定される。
As a sample in the test, the gel composition remaining on the sieve by the method for measuring syneresis of the gel composition is used.
Therefore, if no gel composition remains on the sieve, the hardness cannot be measured. It is reasonably estimated to be lower than the hardness of the gel composition.
本発明において、ゲル状組成物の硬さの高い安定性は、苛酷な条件下(例:高温、及び/又は長期間)での保存後も、当該組成物の食感が維持されている。
当該組成物の食感は、前記離水の抑制、及び前記硬さの維持と、密接に関連する。
In the present invention, the high hardness stability of the gel composition means that the texture of the composition is maintained even after storage under severe conditions (eg, high temperature and/or long term).
The texture of the composition is closely related to the suppression of syneresis and the maintenance of hardness.
経口ゲル状組成物の製造方法
本発明の経口ゲル状組成物は、公知の経口ゲル状組成物の製造方法を採用して製造すればよく、具体的には、例えば、
(1)前記粘稠剤及び水(例:精製水)を混合した後、加熱して、前記粘稠剤を溶解させる工程、
(2)前記粘稠剤及び水以外の成分を前記工程(1)で得られた液体と混合して液状組成物を得る工程、を含む製造方法により、製造できる。
前記粘稠剤及び水以外の成分は、適宜、前記工程(1)で得られた液体と混合する前に、予め混合されていてもよい。
Method for Producing Oral Gel Composition The oral gel composition of the present invention may be produced by adopting a known method for producing an oral gel composition.
(1) a step of mixing the thickening agent and water (e.g., purified water) and then heating to dissolve the thickening agent;
(2) It can be produced by a production method including a step of mixing ingredients other than the thickening agent and water with the liquid obtained in step (1) to obtain a liquid composition.
The ingredients other than the thickening agent and water may optionally be premixed prior to mixing with the liquid obtained in step (1).
経口ゲル状組成物の包装
本発明の経口ゲル状組成物には、経口投与又は経口摂取されるゲル状組成物に通常採用される包装が施される。当該包装は、その形態に応じて、慣用の方法により実施すればよい。
特に、本発明の経口ゲル状組成物は、苛酷な条件下でも、ゲル状形態が高い安定性を有し、且つビタミンB1類を安定に含有できるので、包装工程の条件の制限も小さい。
従って、本発明の経口ゲル状組成物には容易且つ好適に様々な包装方法を採用できる。
Packaging of Oral Gel Composition The oral gel composition of the present invention is packaged in a packaging that is commonly employed for gel compositions that are orally administered or ingested. The packaging may be carried out by a conventional method depending on the form.
In particular, the oral gel composition of the present invention has high stability in gel form even under severe conditions and can stably contain vitamin B1 , so that there is little restriction on the conditions of the packaging process.
Therefore, various packaging methods can be easily and suitably adopted for the oral gel composition of the present invention.
経口ゲル状組成物の包装は、例えば、前記経口ゲル状組成物の製造方法で得られた液状組成物を容器に充填することにより、実施できる。
このような包装の好適な例として、パウチタイプの容器による包装が挙げられる。
The oral gel composition can be packaged, for example, by filling a container with the liquid composition obtained by the method for producing the oral gel composition.
Preferable examples of such packaging include pouch-type container packaging.
前記パウチタイプの容器としては、汎用されているものを使用でき、例えば、アルミ箔、及び樹脂フィルム(例:ポリエチレンテレフタレート、ナイロン、及びポリエチレン、並びにこれらの組合せ)が積層されているフィルム素材から形成された容器を使用できる。
前記パウチタイプの容器は、レトルト殺菌可能な容器、すなわちレトルトパウチ容器である。
前記パウチタイプの容器は、スタンディング袋型、ガゼット袋型、又は三方袋型等の任意のタイプである。
前記パウチタイプの容器は、好適にスパウトを備えている。これによれば、簡便に、経口投与又は経口摂取できる。
1個のパウチタイプの容器に封入されている本発明の経口ゲル状組成物は、例えば、80mL~300mLの範囲内である。
As the pouch-type container, a commonly used one can be used, for example, formed from a film material in which aluminum foil and resin film (e.g., polyethylene terephthalate, nylon, polyethylene, and combinations thereof) are laminated. You can use a pre-made container.
Said pouch-type container is a retort-sterilizable container, ie a retort pouch container.
The pouch-type container is of any type, such as a standing bag type, a gusset bag type, or a three-sided bag type.
Said pouch-type container is preferably provided with a spout. According to this, oral administration or oral intake can be easily performed.
The oral gel composition of the present invention enclosed in one pouch-type container is, for example, within the range of 80 mL to 300 mL.
前記の説明から理解される通り、パウチタイプの容器に包装されている、本発明の経口ゲル状組成物もまた提供する。
特に、本発明の経口ゲル状組成物は、苛酷な条件下でも、ゲル状形態が高い安定性を有し、且つビタミンB1類を安定に含有できるので、包装工程の条件の制限も小さく、容易且つ好適にパウチタイプの容器に包装される。
Also provided is an oral gel composition of the present invention packaged in a pouch-type container, as understood from the foregoing description.
In particular, the oral gel composition of the present invention has high stability in gel form even under severe conditions and can stably contain vitamin B1 , so that the conditions for the packaging process are less limited. Easily and conveniently packaged in pouch-type containers.
これから理解される通り、本発明は、本発明の経口ゲル状組成物、及び当該経口ゲル状組成物を内封するパウチタイプの容器を備えるバック製剤(パウチ製剤、又はパウチ型製剤)もまた提供する。 As will be understood from this, the present invention also provides an oral gel composition of the present invention and a bag formulation (pouch formulation or pouch-type formulation) comprising a pouch-type container enclosing the oral gel composition. do.
当該バック製剤は、好適には、液体を実質的に含有しない。
具体的には、当該パウチ製剤、パウチ型製剤、又はバック製剤においては、その内容物全体にする液体の量が、好ましくは10質量%以下、より好ましくは5質量%以下、更に好ましくは3質量%以下である。
The bag formulation is preferably substantially free of liquids.
Specifically, in the pouch formulation, pouch-type formulation, or bag formulation, the amount of liquid in the entire contents is preferably 10% by mass or less, more preferably 5% by mass or less, and still more preferably 3% by mass. % or less.
以下、実施例によって本発明をさらに詳細に説明するが、本発明はこれに限定されるものではない。実施例中、特に記載が無い限り、「%」は「w/w%」を意味する。 EXAMPLES The present invention will be described in more detail below with reference to Examples, but the present invention is not limited thereto. In the examples, "%" means "w/w %" unless otherwise specified.
以下の材料を用いて、経口ゲル状組成物を調整した。なお、ゼリー強度は、前記に記載したJIS K 8263:2015に従って測定した値である。
[材料]
・粘稠剤としての寒天:
カンテン末 PS-88(製品名、伊那食品工業)
(ゼリー強度:950~1150g/cm2)
カンテン末 PS-6 (製品名、伊那食品工業)
(ゼリー強度:600~ 660g/cm2)
・フルスルチアミン塩酸塩(以下、TTFDともいう)
・クエン酸緩衝液 0.2M
An oral gel composition was prepared using the following materials. The jelly strength is a value measured according to JIS K 8263:2015 described above.
[material]
- Agar as a thickening agent:
Agar end PS-88 (product name, Ina Food Industry)
(Jelly strength: 950-1150 g/cm 2 )
Agar end PS-6 (product name, Ina Food Industry)
(Jelly strength: 600-660 g/cm 2 )
・ Fursultiamine hydrochloride (hereinafter also referred to as TTFD)
・Citrate buffer 0.2M
1袋当たりの量として、1.5mgのフルスルチアミン塩酸塩(TTFD)と、pH2.8、3.1、3.4、3.8の50mLのクエン酸緩衝液(0.2M)、及び粘稠剤として300mgの寒天[カンテン末 PS-88(実施例1)、カンテン末 PS-6(比較例1)]を加熱および撹拌混合し、TTFDおよび寒天を溶解させ、精製水を加えて100mLにした。
得られた溶液を口栓付きアルミパウチに充填し、pH2.8、3.1、3.4、及び3.8の各ゲル状組成物を得た。
1.5 mg fursultiamine hydrochloride (TTFD) and 50 mL citrate buffer (0.2 M) at pH 2.8, 3.1, 3.4, 3.8, and 300 mg of agar as a thickener [agar end PS-88 (Example 1), agar end PS-6 (Comparative Example 1)] was heated and stirred to dissolve TTFD and agar, and purified water was added to make 100 mL. made it
Aluminum pouches with spouts were filled with the obtained solutions to obtain gel compositions of pH 2.8, 3.1, 3.4 and 3.8.
試験例(保存試験)
[1]フルスルチアミン塩酸塩(TTFD)の安定性
実施例1として製造した、pH2.8、3.1、3.4、及び3.8の各ゲル状組成物
を、それぞれ50℃で、8週間保存した。
50℃、8週間保存後のTTFD量を測定し、その残存率(製造直後の初期含量と比較した残存率)を算出した。当該残存率(%)を表1に示した。
Test example (preservation test)
[1] Stability of fursultiamine hydrochloride (TTFD) Each gel composition of pH 2.8, 3.1, 3.4, and 3.8 produced as Example 1 was heated at 50°C, Stored for 8 weeks.
The amount of TTFD after storage at 50°C for 8 weeks was measured, and its residual rate (residual rate compared with the initial content immediately after production) was calculated. The residual rate (%) is shown in Table 1.
表1の結果より、50℃で8週間の苛酷な条件での保存において、TTFD量はいずれのpHでも高い割合で残存し、特にpH3.1~3.4の範囲においては、より高い割合(80%以上)で残存した。 From the results in Table 1, in storage under severe conditions at 50 ° C. for 8 weeks, the amount of TTFD remained in a high proportion at any pH, and in particular in the pH range of 3.1 to 3.4, a higher proportion ( 80% or more) remained.
[2]ゲル状組成物の離水
各ゲル状組成物を、50℃および4℃(対照)で8週間保存後、後述する測定方法により、離水量を測定した後、離水率を算出し、これから[(50℃で8週間保存後の離水率)-(4℃で8週間保存後の離水率)]の差を算出した。
当該離水率の差を表2に示した。
[2] Separation of Gel Composition Each gel composition was stored at 50° C. and 4° C. (control) for 8 weeks. The difference of [(water syneresis after storage at 50° C. for 8 weeks)−(water syneresis after storage at 4° C. for 8 weeks)] was calculated.
Table 2 shows the difference in the separation rate.
<ゲル状組成物の離水の測定方法>
当該測定方法では、ふるいとして目開き2mmのメッシュ[第十七改正日本薬局方、ふるい番号8.6号(2000μm)]、且つ直径200mmのふるいを使用した。 試験されるゲル状組成物を容器に入れて所定の保存条件に曝露した後、容器の内容物の全量を、ふるい下を敷いたふるい上に入れ、その質量を測定し、当該質量をA(g)とした。 前記ふるいを45度傾けて1分間保持した後、当該ふるいから前記ふるい下に落ちた液体(離水)の質量を測定し、これをB(g)とし、次式により離水率を算出した。
離水率(%)=B(g)/A(g)×100
<Method for measuring syneresis of gel composition>
In the measurement method, a mesh with an opening of 2 mm [Japanese Pharmacopoeia 17th Edition, Sieve No. 8.6 (2000 μm)] and a diameter of 200 mm were used as the sieve. After placing the gel composition to be tested in a container and exposing it to predetermined storage conditions, the total amount of the contents of the container is placed on a sieve with a sieve under the sieve, the mass is measured, and the mass is A ( g). After the sieve was tilted at 45 degrees and held for 1 minute, the mass of the liquid (water syneresis) that fell from the sieve to the bottom of the sieve was measured.
Separation rate (%) = B (g) / A (g) x 100
表2の結果より、本発明のゲル状組成物では、いずれのpHでも、離水が抑制され、特にpH3.1以上で離水が高度に抑制された。 From the results in Table 2, the gel composition of the present invention suppressed syneresis at any pH, and particularly at pH 3.1 or higher, syneresis was highly suppressed.
[3]ゲル状組成物の硬さ
各ゲル状組成物の保存後[50℃又は4℃(対照)で8週間保存後]の硬さを以下の方法で測定し、その比(50℃/対照)を算出し、硬さ及びその比を表3に示した。
[3] Hardness of gel composition After storage of each gel composition [after storage at 50 ° C. or 4 ° C. (control) for 8 weeks] hardness was measured by the following method, and the ratio (50 ° C./ Control) was calculated, and the hardness and its ratio are shown in Table 3.
<ゲル状組成物の硬さの試験方法>
当該試験には、材料試験機として、直線運動により物質の圧縮応力を測定することが可能な材料試験機 EZ-SX(製品名、島津製作所)(ロードセル:50N、試験治具:ユニバー
サルデザインフード試験セット、ソフトウェア : TRAPEZIUM X テクスチャー、恒温装置
: 冷熱恒温器)を使用した。
試料を容器(直径40mm、高さ20mm)に高さ15mmまで充填し、前記材料試験機を用いて、樹脂性の円形プランジャー(直径20mm、高さ8mm)により、圧縮速度10mm/秒、及びクリアランス5mmの条件で2回圧縮し、その時の圧縮応力を測定した。測定は、ゲルを20℃の恒温槽に入れ、20℃に安定させた後、20±2℃で行った。
2回の圧縮における圧縮応力の最大値を、試料の硬さとした。
<Method for testing hardness of gel composition>
For this test, a material testing machine EZ-SX (product name, Shimadzu Corporation) capable of measuring the compressive stress of a substance by linear motion (load cell: 50 N, test jig: universal design hood test Set, software: TRAPEZIUM X texture, constant temperature device: cold and hot constant temperature device) were used.
The sample is filled into a container (diameter 40 mm, height 20 mm) to a height of 15 mm, and using the material testing machine, a resin circular plunger (diameter 20 mm, height 8 mm) is compressed at a compression rate of 10 mm / sec, and It was compressed twice under the condition of a clearance of 5 mm, and the compressive stress at that time was measured. The measurement was carried out at 20±2°C after the gel was placed in a 20°C constant temperature bath and stabilized at 20°C.
The maximum value of compressive stress in two compressions was taken as the hardness of the sample.
ゲル状組成物について、保存後[50℃又は4℃(対照)で8週間保存後]の硬さを上記方法により測定し、その比(50℃で8週間保存後/対照)を算出した。
当該硬さ、及びその比を表3に示した。
表中、「ND」は、ふるい上にゲル状組成物が残らず、その硬さを測定できなかったことを表す。このことは、ゲル状組成物のゲル様の形態、特にその適度な硬さが全く、又はほとんど維持されなったことを示す。
The hardness of the gel composition after storage [after storage at 50°C or 4°C (control) for 8 weeks] was measured by the above method, and the ratio (after storage at 50°C for 8 weeks/control) was calculated.
The hardness and its ratio are shown in Table 3.
In the table, "ND" indicates that no gel composition remained on the sieve and its hardness could not be measured. This indicates that the gel-like morphology of the gel-like composition, especially its moderate hardness, was not or hardly maintained.
表3の結果より、本発明の経口ゲル状組成物では、50℃で8週間の苛酷な条件での保存において、いずれのpHにおいても、比較例のゲル状組成物に比べて、その適度な硬さが高度に維持された。特にpH3.1以上で離水が極めて高度に抑制された。
さらにpH3.1~pH3.4の範囲では、50℃で8週間の苛酷な条件での保存についても、TTFD、及びゲル状形態が、ともに高度に維持されることが示された。
From the results in Table 3, the oral gel composition of the present invention exhibited a moderate degree of stability at any pH when stored under severe conditions at 50°C for 8 weeks, compared to the gel compositions of the comparative examples. A high degree of hardness was maintained. Especially at pH 3.1 or higher, syneresis was suppressed to a very high degree.
Furthermore, in the range of pH 3.1 to pH 3.4, it was shown that both TTFD and gel-like morphology were highly maintained even after storage under severe conditions at 50°C for 8 weeks.
製剤例1
表4の処方に従い、ビタミンB1類として「フルスルチアミン塩酸塩(TTFD)」、粘稠剤として「カンテン末 PS-88(伊那食品工業)」を含有する、容器詰の経口ゲ
ル状組成物(pHは3.4に調整)を調製した。
Formulation example 1
A container-packed oral gel composition containing "Fursultiamine hydrochloride (TTFD)" as a vitamin B class 1 and "Agar powder PS-88 (Ina Food Industry)" as a thickening agent according to the formulation in Table 4. (pH adjusted to 3.4) was prepared.
製剤例1の経口ゲル状組成物について、前記の測定方法により硬さを測定した結果、0.11~0.20N(実測値は0.113N、0.162N、0.137N)であった。 The hardness of the oral gel composition of Formulation Example 1 was measured by the method described above and found to be 0.11 to 0.20N (measured values were 0.113N, 0.162N, and 0.137N).
製剤例2
表5の処方に従い、ビタ
ミンB1類として「フルスルチアミン塩酸塩」、粘稠剤として「カンテン末 T-1(伊
那食品工業)」を含有する、容器詰の経口ゲル状組成物(pHは3.1に調整)を調製した。
なお、カンテン末 T-1のゼリー強度は、約950g/cm2である。
Formulation example 2
According to the formulation in Table 5, a container - packed oral gel composition (pH is 3.1) was prepared.
The jelly strength of agar powder T-1 is about 950 g/cm 2 .
製剤例3
表6の処方に従い、ビタミンB1類として「フルスルチアミン塩酸塩」、粘稠剤として「カンテン末 S-6(伊那食品工業)」を含有する、容器詰の経口ゲル状組成物(pH
は3.1に調整)を調製した。
Formulation example 3
According to the formulation in Table 6, a packaged oral gel composition (pH
was adjusted to 3.1) was prepared.
本発明によれば、ビタミンB1類、及びゼリー強度が700~1500g/cm2の範囲内にある粘稠剤を含有し、pHを2.8~3.8の範囲内に調整することによって、ビタミンB1類を安定に含有し、且つゲル状形態も安定な経口ゲル状組成物が提供される。 According to the present invention, by containing vitamin B1 and a thickening agent having a jelly strength within the range of 700 to 1500 g/cm 2 and adjusting the pH within the range of 2.8 to 3.8 , vitamin B1 group stably, and an oral gel composition having a stable gel form is provided.
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WO1999034690A1 (en) * | 1998-01-08 | 1999-07-15 | Otsuka Foods Co., Ltd. | Gelled foods and process for producing the same |
JP2004137268A (en) * | 2002-09-27 | 2004-05-13 | Univ Shinshu | Accelerator for increasing amount of plasma |
WO2005084461A1 (en) * | 2004-03-08 | 2005-09-15 | Fuji Oil Company, Limited | Mineral-containing acidic protein drink |
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WO1999034690A1 (en) * | 1998-01-08 | 1999-07-15 | Otsuka Foods Co., Ltd. | Gelled foods and process for producing the same |
JP2004137268A (en) * | 2002-09-27 | 2004-05-13 | Univ Shinshu | Accelerator for increasing amount of plasma |
WO2005084461A1 (en) * | 2004-03-08 | 2005-09-15 | Fuji Oil Company, Limited | Mineral-containing acidic protein drink |
Non-Patent Citations (1)
Title |
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"寒天の科学|寒天のゼリー強度", INTERNET ARCHIVE: WAYBACK MACHINE[ONLINE], vol. 2016年10月4日, [2020年11月13日検索], JPN6020044463, ISSN: 0005191563 * |
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