JP6528588B2 - Solid preparation - Google Patents
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- JP6528588B2 JP6528588B2 JP2015155157A JP2015155157A JP6528588B2 JP 6528588 B2 JP6528588 B2 JP 6528588B2 JP 2015155157 A JP2015155157 A JP 2015155157A JP 2015155157 A JP2015155157 A JP 2015155157A JP 6528588 B2 JP6528588 B2 JP 6528588B2
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Description
本発明は、グルコサミン類を配合した固形製剤に関する。 The present invention relates to a solid preparation containing glucosamines.
グルコサミン類は主にカニやエビ等が有するキチン質を分解することにより精製されるアミノ糖であり、変形性関節炎等の鎮痛作用及び症状の改善 、美肌効果、血流改善効果等が得られることが報告されており、かかる効果が期待される医薬品や食品等における成分としての需要が急増している。 Glucosamines are amino sugars that are purified by degrading chitin mainly contained in crabs and shrimps, etc., and analgesia such as osteoarthritis and improvement of skin condition, blood flow improvement and the like can be obtained Have been reported, and the demand as an ingredient in pharmaceuticals and foods etc. for which such effects are expected is rapidly increasing.
グルコサミン類、特にグルコサミン塩酸塩は独特の呈味があるため、固形製剤として提供する場合、独特の呈味をマスキングした製剤であることが好まれる（特許文献１を参照）。しかしながら、グルコサミンを酸味料であるクエン酸等の有機酸及び賦形剤である糖アルコールと共に配合した場合、保存中に黄褐色に変色してしまい、製品の品質を維持できないという課題があった。 Since glucosamines, in particular glucosamine hydrochloride, have unique taste, when provided as a solid preparation, it is preferred that the preparation has a unique taste masking (see Patent Document 1). However, when glucosamine is compounded with an organic acid such as citric acid which is an acidulant and a sugar alcohol which is an excipient, it has a problem of being discolored to yellowish brown during storage, and the quality of the product can not be maintained.
本発明は、グルコサミン類、有機酸、糖アルコールの同時配合により生じる経時的変色を抑制可能な固形製剤を提供することを課題とする。 An object of the present invention is to provide a solid preparation capable of suppressing temporal discoloration caused by simultaneous blending of glucosamines, an organic acid and a sugar alcohol.
本発明者らは、上記課題を解決すべく鋭意検討した結果、グルコサミン類、有機酸及び糖アルコールの処方に有機酸カルシウムを付加し、ここで、糖アルコールを還元パラチノース、エリスリトール又はマルチトールとし、且つ有機酸カルシウムをクエン酸カルシウム又はグルコン酸カルシウムとした固形製剤とすることで、保存中の経時的変色が抑制されることがわかった。 As a result of intensive studies to solve the above problems, the present inventors add calcium of an organic acid to a formulation of glucosamines, an organic acid and a sugar alcohol, wherein the sugar alcohol is reduced palatinose, erythritol or maltitol. Moreover, it was found that, by setting the calcium salt of organic acid as calcium citrate or calcium gluconate as a solid preparation, discoloration over time during storage is suppressed.
かかる知見により得られた本発明の態様は次のとおりである。
（１）（ａ）グルコサミン類、（ｂ）有機酸、（ｃ）還元パラチノース、エリスリトール又はマルチトール及び（ｄ）クエン酸カルシウム又はグルコン酸カルシウムを含有する固形製剤。
（２）有機酸がクエン酸である、（１）に記載の固形製剤。
（３）散剤の形態である、（１）又は（２）に記載の固形製剤。
The aspect of this invention obtained by this knowledge is as follows.
A solid preparation comprising (1) (a) glucosamines, (b) organic acid, (c) reduced palatinose, erythritol or maltitol and (d) calcium citrate or calcium gluconate.
(2) The solid preparation according to (1), wherein the organic acid is citric acid.
(3) The solid preparation according to (1) or (2), which is in the form of a powder.
本発明により、グルコサミン、糖アルコール及び有機酸を含有し、且つ保存中の経時的変色が抑制された固形製剤を提供することが可能となった。 According to the present invention, it has become possible to provide a solid preparation which contains glucosamine, a sugar alcohol and an organic acid and in which the discoloration over time during storage is suppressed.
「グルコサミン類」は、本発明において由来・製法等について特に制限はなく、天然物から精製して得られるもののみならず合成品をも利用することができ、市販のグルコサミン類もまた利用され得る。グルコサミン類としては、グルコサミン、その塩、又はそれらの誘導体のいずれも使用することもできる。グルコサミンの塩としては、硫酸塩、塩酸塩をはじめとする無機酸のほか、酢酸塩、クエン酸塩などの有機酸塩も使用することができるが、これらの中でも特に塩酸塩はクエン酸と糖アルコールとの同時配合により経時的変色を呈しやすい。また、グルコサミンの誘導体としては、Ｄ−グルコサミン、Ｎ−アセチルグルコサミン等の誘導体を使用することができる。これらのグルコサミン類は、１種類のみが用いられても良いし、２種類以上が組み合わせて用いられても良い。一般にグルコサミン類の有効量は、健康成人で一日あたり０．５〜１．５ｇとされている。本願発明の固形製剤において、グルコサミンは、１０〜９０重量％含有されることが好ましく、２０〜８０重量％がより好ましく、４０〜８０重量％が特に好ましい。 In the present invention, “glucosamines” are not particularly limited as to origin and production method, etc., and not only products obtained by purification from natural products but also synthetic products can be used, and commercially available glucosamines can also be used. . As glucosamines, either glucosamine, its salt, or derivatives thereof can also be used. As salts of glucosamine, inorganic acids such as sulfates and hydrochlorides, and organic acid salts such as acetates and citrates can also be used. Of these, especially hydrochlorides are citric acid and sugar It is easy to exhibit discoloration over time due to simultaneous blending with alcohol. Moreover, as a derivative of glucosamine, derivatives such as D-glucosamine, N-acetylglucosamine and the like can be used. Only one type of these glucosamines may be used, or two or more types may be used in combination. In general, the effective amount of glucosamines is 0.5 to 1.5 g per day for healthy adults. In the solid preparation of the present invention, glucosamine is preferably contained in an amount of 10 to 90% by weight, more preferably 20 to 80% by weight, and particularly preferably 40 to 80% by weight.
グルコサミン類含有固形製剤の製造にあたって、賦形剤として還元パラチノース、エリスリトール、マルチトール、ソルビトール、トレハロース等の糖アルコールを使用すると、いずれの糖アルコールを使用してもグルコサミン類及び有機酸との配合により保存中に黄褐色に変色してしまい，製品の品質を維持できない。本発明はクエン酸カルシウム又はグルコン酸カルシウムをさらに配合することにより上記課題を解決するものであるが、クエン酸カルシウムによる変色抑制効果は還元パラチノース又はエリスリトールを賦形剤として使用した固形製剤で強く認められ、マルチトールを賦形剤として使用した固形製剤では弱い変色抑制効果が認められた。そして意外にも、ソルビトール、トレハロース等の他の糖アルコールを賦形剤として使用した場合にはクエン酸カルシウムによる変色抑制効果が認められなかった。ここで本願発明の固形製剤において賦形剤として使用する糖アルコールとしては、還元パラチノース、エリスリトール又はマルチトールが好ましく、より好ましくは還元パラチノース又はエリスリトールであり、それぞれ固形製剤中に、５〜９０重量％含有されることが好ましく、５〜７５重量％がより好ましく、２０〜４０重量％が特に好ましい。 When sugar alcohols such as reduced palatinose, erythritol, maltitol, sorbitol and trehalose are used as excipients in the preparation of glucosamines-containing solid preparations, it is possible to mix them with glucosamines and organic acids regardless of which sugar alcohol is used. It turns yellowish brown during storage and the product quality can not be maintained. The present invention solves the above-mentioned problems by further blending calcium citrate or calcium gluconate, but the discoloration inhibitory effect by calcium citrate is strongly recognized in the solid preparation using reduced palatinose or erythritol as an excipient. In the solid preparation using maltitol as an excipient, a weak discoloration inhibitory effect was observed. And surprisingly, when other sugar alcohols such as sorbitol and trehalose were used as an excipient, no discoloration inhibitory effect by calcium citrate was observed. The sugar alcohol used as an excipient in the solid preparation of the present invention is preferably reduced palatinose, erythritol or maltitol, more preferably reduced palatinose or erythritol, each in an amount of 5 to 90% by weight in the solid preparation. It is preferable to contain, 5 to 75 weight% is more preferable, and 20 to 40 weight% is especially preferable.
「有機酸」とは、炭素原子を有する酸性物質を意味し、例えばクエン酸、リンゴ酸、酒石酸、アスコルビン酸、コハク酸、フマル酸、酢酸等が挙げられるが、好ましくはクエン酸である。「クエン酸」は、例えばデンプンあるいは糖の発酵等により製造されるヒドロキシ酸の一つである。ここで有機酸は、固形製剤中に、１〜４０重量％含有されることが好ましく、３〜３０重量％がより好ましく、５〜２０重量％が特に好ましい。 The "organic acid" means an acidic substance having a carbon atom, and examples thereof include citric acid, malic acid, tartaric acid, ascorbic acid, succinic acid, fumaric acid, acetic acid and the like, with preference given to citric acid. "Citrate" is one of the hydroxy acids produced, for example, by fermentation of starch or sugar. Here, the organic acid is preferably contained in the solid preparation in an amount of 1 to 40% by weight, more preferably 3 to 30% by weight, and particularly preferably 5 to 20% by weight.
「クエン酸カルシウム」は、例えば果汁を得た柑橘類の残渣にpH調整・熱処理等を加えることで製造される有機酸カルシウムの一つである。ここでクエン酸カルシウムは、固形製剤中に、０．１〜５重量％含有されることが好ましく、０．３〜５重量％がより好ましく、０．５〜５重量％が特に好ましい。また、クエン酸カルシウムは、グルコサミン類１重量部に対して、０．００３〜０．５重量部含有されることが好ましく、０．００３〜０．２５重量部がより好ましく、０．０１〜０．１重量部が特に好ましい。 "Calcium citrate" is one of the organic acid calciums manufactured by adding pH adjustment, heat processing, etc. to the residue of the citrus obtained from fruit juice, for example. Here, calcium citrate is preferably contained in a solid preparation in an amount of 0.1 to 5% by weight, more preferably 0.3 to 5% by weight, and particularly preferably 0.5 to 5% by weight. In addition, calcium citrate is preferably contained in an amount of 0.003 to 0.5 parts by weight, more preferably 0.003 to 0.25 parts by weight, with respect to 1 part by weight of glucosamines, and 0.01 to 0 .1 part by weight is particularly preferred.
「グルコン酸カルシウム」は、例えばグルコン酸を炭酸カルシウムで中和して製造される有機酸カルシウムの一つである。ここでグルコン酸カルシウムは、固形製剤中に、０．１〜２０質量％含有されることが好ましく、５〜２０質量％がより好ましく、９．６〜２０質量％が特に好ましい。また、グルコン酸カルシウムは、グルコサミン類１質量部に対して、０．０１〜１．５質量部含有されることが好ましく、０．０７〜１質量部がより好ましく、０．１５〜０．５質量部が特に好ましい。 "Calcium gluconate" is one of the organic acid calciums produced, for example, by neutralizing gluconic acid with calcium carbonate. Here, calcium gluconate is preferably contained in a solid preparation in an amount of 0.1 to 20% by mass, more preferably 5 to 20% by mass, and particularly preferably 9.6 to 20% by mass. Further, calcium gluconate is preferably contained in an amount of 0.01 to 1.5 parts by mass, more preferably 0.07 to 1 parts by mass, per 1 part by mass of glucosamines. Parts by weight are particularly preferred.
「固形製剤」には、グルコサミン、有機酸、糖アルコール及び有機酸カルシウムを配合する他、本発明の効果を損なわない範囲で、賦形剤、滑沢剤、結合剤、崩壊剤、流動化剤、分散剤、着色剤、矯味剤等を適宜に配合することができる。 Glucosamine, an organic acid, a sugar alcohol and an organic acid calcium are blended in the "solid preparation", and an excipient, a lubricant, a binder, a disintegrant and a fluidizing agent as long as the effects of the present invention are not impaired. Dispersants, coloring agents, flavoring agents and the like can be appropriately blended.
本発明の「固形製剤」とは、例えば、医薬品、医薬部外品、食品などに幅広く利用することができる固形製剤（例えば、医薬製剤、医薬部外品製剤、または特定保健用食品、栄養機能食品、特別用途食品、機能性食品、健康補助食品（サプリメント）、もしくは食品用製剤など）であり得る。 The “solid preparation” of the present invention is, for example, a solid preparation which can be widely used for medicines, quasi-drugs, foods, etc. (eg, pharmaceutical preparations, quasi-drug preparations, food for specified health use, nutritional function It may be a food, a special purpose food, a functional food, a health supplement (supplement), a food preparation or the like.
さらに本発明の固形製剤の用途は特に制限されず、例えば、内服用、外用、または注射用などであり得る。しかし好ましくは、本発明の製剤は内服用固形製剤である。内服用固形製剤の場合、本発明の固形製剤は、固形製剤としてそのまま摂取することも可能であり、また、摂取直前に水等に溶かして飲む態様としての使用も可能である。 Furthermore, the application of the solid preparation of the present invention is not particularly limited, and may be, for example, internal administration, external use, or injection. However, preferably, the formulation of the invention is a solid formulation for internal use. In the case of a solid preparation for internal use, the solid preparation of the present invention can also be taken as it is as a solid preparation, and can also be used as an aspect of dissolving it in water etc. immediately before taking it.
本発明の固形製剤の剤形は特に制限されず、通常使用され得る任意の剤形をとることができる。例えば、錠剤（素錠、糖衣錠、口腔内速崩壊錠、咀嚼可能錠、発泡錠、トローチ剤、ドロップ剤、フィルムコーティング錠などを含む）、丸剤、顆粒剤、細粒剤、散剤、硬カプセル剤、軟カプセル剤、ドライシロップ剤であり、より好ましくは錠剤、顆粒剤、細粒剤、散剤である。例えば、摂取直前に水等に溶かして飲む態様の場合は、特に散剤が好ましい。本発明の固形製剤は、当該技術分野における慣用の方法をそのまま又は適宜応用して製造することができる。 The dosage form of the solid preparation of the present invention is not particularly limited, and any dosage form which can be usually used can be taken. For example, tablets (including uncoated tablets, sugar-coated tablets, intraoral fast disintegrating tablets, chewable tablets, effervescent tablets, lozenges, drops, film-coated tablets, etc.), pills, granules, fine granules, powders, hard capsules Agents, soft capsules, dry syrups, more preferably tablets, granules, fine granules, powders. For example, in the case of a mode in which it is dissolved in water or the like and consumed immediately before ingestion, a powder is particularly preferable. The solid preparation of the present invention can be produced by applying a conventional method in the art as it is or by appropriately applying it.
以下に、比較例、実施例及び試験例を挙げ、本発明をさらに詳細に説明する。 Hereinafter, the present invention will be described in more detail by way of comparative examples, examples and test examples.
試験例１
表１及び２記載の成分を秤量・混合し、実施例１〜３並びに比較例１〜１２の混合粉体を調整し、５０℃の恒温槽にて１８日間加温した後、粉体の外観変色を評価した。外観変色評価試験は、下記「外観評価基準」に従い２名のパネラーにより実施した。その評価の平均値を表１及び２に示す。尚、実施例１〜３、比較例９〜１１のクエン酸及びクエン酸カルシウムは、それぞれを９５：５の割合で含む原料、クエン酸ＣＩ（メーカー：磐田化学工業）を使用し本試験を実施した。
Test Example 1
The components described in Tables 1 and 2 are weighed and mixed, the mixed powders of Examples 1 to 3 and Comparative Examples 1 to 12 are prepared, and after heated for 18 days in a thermostat at 50 ° C., the appearance of the powders Color change was evaluated. The appearance discoloration evaluation test was implemented by two panelists according to the following "appearance evaluation criteria". The average value of the evaluation is shown in Tables 1 and 2. In addition, the citric acid and calcium citrate of Examples 1 to 3 and Comparative Examples 9 to 11 were each used as a raw material containing 95: 5 ratio, and this test was carried out using citric acid CI (manufacturer: Shibata Chemical Industry) did.
外観評価基準
４：著しい変化を認める
３：明らかな変化を認める
２：変化を認めるが許容できる
１：わずかに変化を認める
０：変化なし
Appearance Evaluation criteria 4: Mark significant change 3: Mark obvious change 2: Mark change but acceptable 1: Mark slight change 0: No change
表１及び２より、クエン酸カルシウムを含まない処方である比較例１〜８ではいずれの糖アルコールの組み合わせにおいても保存後の変色が認められた。クエン酸カルシウムを含む処方である比較例９〜１１においても保存後の変色が確認されたが、クエン酸カルシウムを含みつつ、糖アルコールとして還元パラチノース及びエリスリトールを選択した処方においては保存後の変色の抑制が確認された。また、グルコサミン塩酸塩の代わりにN-アセチルグルコサミンを配合した処方においても同様に、クエン酸カルシウムを含まない処方である比較例１２では保存後の変色が確認され、クエン酸カルシウムを含む処方である実施例３ではその変色の抑制が確認された。 From Tables 1 and 2, in Comparative Examples 1 to 8 in which calcium citrate was not contained, discoloration after storage was observed in any of the combinations of sugar alcohols. Discoloration after storage was also confirmed in Comparative Examples 9 to 11 which are formulations containing calcium citrate, but in formulations where reduced palatinose and erythritol were selected as sugar alcohols while containing calcium citrate, discoloration after storage was observed Suppression was confirmed. Further, also in the formulation in which N-acetylglucosamine is blended instead of glucosamine hydrochloride, similarly, the discoloration after storage is confirmed in Comparative Example 12 which is a formulation not containing calcium citrate, and is a formulation containing calcium citrate. In Example 3, the suppression of the color change was confirmed.
試験例２
表３記載の成分を秤量・混合し、実施例４並びに比較例１３〜１５の混合粉体を調製し、５０℃の恒温槽にて７日間加温した後、粉体の外観変色を評価した。外観変色評価試験は、試験例１と同様に、下記「外観評価基準」に従い２名のパネラーにより実施した。その評価の平均値を表３に示す。尚、クエン酸ナトリウム、乳酸カルシウム、グルコン酸カルシウムはそれぞれクエン酸と事前にアルコールで造粒・乾燥した後、他の成分と混合し、本試験を実施した。
Test example 2
The components described in Table 3 were weighed and mixed, mixed powders of Example 4 and Comparative Examples 13 to 15 were prepared, and after warming for 7 days in a thermostat of 50 ° C., appearance discoloration of the powder was evaluated. . The appearance discoloration evaluation test was carried out by two panelists according to the following "appearance evaluation criteria" in the same manner as in Test Example 1. The average value of the evaluation is shown in Table 3. Sodium citrate, calcium lactate and calcium gluconate were respectively granulated and dried with citric acid and alcohol in advance, and then mixed with other components to carry out this test.
外観評価基準
４：著しい変化を認める
３：明らかな変化を認める
２：変化を認めるが許容できる
１：わずかに変化を認める
０：変化なし
Appearance Evaluation criteria 4: Mark significant change 3: Mark obvious change 2: Mark change but acceptable 1: Mark slight change 0: No change
表３より、クエン酸ナトリウム及び乳酸カルシウムを含む比較例１４及び１５では共に保存後の変色が認められた。一方、グルコン酸カルシウムを配合した実施例４においては保存後の変色の抑制が確認された。 From Table 3, in Comparative Examples 14 and 15 containing sodium citrate and calcium lactate, discoloration after storage was observed. On the other hand, in Example 4 in which calcium gluconate was blended, suppression of discoloration after storage was confirmed.
試験例３
表４記載の成分を秤量・混合し、実施例５並びに比較例１６及び１７の混合粉体を調整し、５０℃の恒温槽にて７日間加温した後、粉体の外観変色を評価した。外観変色評価試験は、下記「外観評価基準」に従い２名のパネラーにより実施した。その評価の平均値を表４に示す。尚、実施例５、比較例１７のクエン酸及びクエン酸カルシウムは、それぞれを９５：５の割合で含む原料、クエン酸ＣＩ（メーカー：磐田化学工業）を使用し本試験を実施した。
Test Example 3
The components described in Table 4 were weighed and mixed, the mixed powder of Example 5 and Comparative Examples 16 and 17 was prepared, and after warming for 7 days in a thermostat of 50 ° C., the appearance discoloration of the powder was evaluated. . The appearance discoloration evaluation test was implemented by two panelists according to the following "appearance evaluation criteria". The average value of the evaluation is shown in Table 4. In addition, the citric acid and the calcium citrate of Example 5 and Comparative Example 17 implemented this test using the raw material and citric acid CI (Manufacturer: Shibata Chemical Industry) which contain each in the ratio of 95: 5.
外観評価基準
４：著しい変化を認める
３：明らかな変化を認める
２：変化を認めるが許容できる
１：わずかに変化を認める
０：変化なし
Appearance Evaluation criteria 4: Mark significant change 3: Mark obvious change 2: Mark change but acceptable 1: Mark slight change 0: No change
表４より、クエン酸カルシウムを含まない比較例１６では保存後の変色が認められた。また、クエン酸カルシウムを含みつつ、糖アルコールとしてソルビトールを含む比較例１７においても保存後の変色が確認された。一方で、クエン酸カルシウムを含みつつ、糖アルコールとしてマルチトールを含む実施例５においては保存後の変色の抑制が確認された。 From Table 4, in Comparative Example 16 in which calcium citrate was not contained, discoloration after storage was observed. Moreover, the discoloration after storage was also confirmed in Comparative Example 17 in which sorbitol is contained as a sugar alcohol while containing calcium citrate. On the other hand, in Example 5 containing maltitol as a sugar alcohol while containing calcium citrate, suppression of discoloration after storage was confirmed.
以上により、グルコサミン類，有機酸，糖アルコール及び有機酸カルシウムを含有し、ここで、糖アルコールを還元パラチノース、エリスリトール又はマルチトールとし、且つ有機酸カルシウムをクエン酸カルシウム又はグルコン酸カルシウムとすることにより，保存中の経時的変色が抑制された固形製剤を提供できることが確認された。 Thus, by containing glucosamines, organic acids, sugar alcohols and calcium organic acids, wherein the sugar alcohol is reduced palatinose, erythritol or maltitol, and the organic acid calcium is calcium citrate or calcium gluconate. Thus, it was confirmed that it was possible to provide a solid preparation in which discoloration with time was suppressed during storage.
本発明により、グルコサミン類独特の呈味を抑えつつ，製品の品質も確保したグルコサミン類含有固形製剤を提供することが可能となった。よって、医薬品や食品等の関連産業の発達が期待される。 According to the present invention, it has become possible to provide a solid preparation containing glucosamines in which the product quality is secured while suppressing the characteristic taste of glucosamines. Therefore, development of related industries such as medicines and food is expected.
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