TW201620523A - Composition containing vitamin b6 - Google Patents

Composition containing vitamin b6 Download PDF

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TW201620523A
TW201620523A TW104109236A TW104109236A TW201620523A TW 201620523 A TW201620523 A TW 201620523A TW 104109236 A TW104109236 A TW 104109236A TW 104109236 A TW104109236 A TW 104109236A TW 201620523 A TW201620523 A TW 201620523A
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vitamin
composition
chlorophyll
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TWI686199B (en
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Keiko Fukuda
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Kobayashi Pharma
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract

To provide a composition containing a vitamin B6 compound in which the stability of the vitamin B6 compound to light is improved, and a method by which a vitamin B6 compound in a composition containing the vitamin B6 compound and a plant extract is stabilized against light. A composition contains at least one compound selected from the group consisting of vitamin B6 and salts thereof and further contains a plant extract, the composition having a chlorophyll content less than 0.15 ppm.

Description

含維他命B6之組合物 Composition containing vitamin B6

本發明係關於一種含有選自由維他命B6及該等之鹽所組成之群中之至少一種化合物(以下,將其總稱為「維他命B6化合物」)、以及植物萃取物之組合物。又,本發明係關於一種含有維他命B6化合物及植物萃取物之組合物中之維他命B6化合物之光穩定化方法。 The present invention relates to a composition comprising at least one compound selected from the group consisting of vitamin B6 and the salts (hereinafter collectively referred to as "vitamin B6 compound"), and a plant extract. Further, the present invention relates to a method for stabilizing a vitamin B6 compound in a composition comprising a vitamin B6 compound and a plant extract.

作為維他命B6,有吡哆醇、吡哆醛及吡哆胺。維他命B6於活體內作為胺基酸脫羧酶及胺基轉移酶之輔酶,係與蛋白質之代謝相關之成分,為了肉體疲勞、眼疲勞、妊娠時之營養補充,廣泛用於醫藥品、生髮劑、健康食品等。 As vitamin B6, there are pyridoxine, pyridoxal and pyridoxamine. Vitamin B6 is a coenzyme of amino acid decarboxylase and aminotransferase in vivo. It is a component related to protein metabolism. It is widely used in medicines, hair restorers, for physical fatigue, eye fatigue, and nutritional supplements during pregnancy. Healthy food, etc.

維他命B6若暴露於光,則經時地分解,故而必須遮光保存。因此,先前研究有各種使維他命B6穩定化之組合物。例如已知有調配有黃素腺嘌呤二核苷酸、吡哆醇及特定之抗氧化劑之滴眼劑(專利文獻1)、調配有鹽酸吡哆醇及氯化小蘖鹼之滴眼劑(專利文獻2)、調配有維他命B6、羥甲唑啉或其鹽、及硼酸緩衝劑之滴眼劑(專利文獻3)。 If the vitamin B6 is exposed to light, it will decompose over time, so it must be stored in a light-shielded manner. Therefore, previous studies have various compositions that stabilize vitamin B6. For example, eye drops formulated with flavin adenine dinucleotide, pyridoxine and specific antioxidants (Patent Document 1), eye drops formulated with pyridoxine hydrochloride and berberine chloride are known ( Patent Document 2), an eye drop containing vitamin B6, oxymetazoline or a salt thereof, and a boric acid buffer (Patent Document 3).

另一方面,為了將含有對光不穩定之藥理活性物質之製劑穩定地保持,使用遮光材料(褐色容器、鋁容器等)作為收容製劑之包裝材料,或採用於容器混入或塗裝紫外線吸收劑之遮光方法,或採用於流通過程中將填充有製劑之容器收納於紙箱等遮光方法。 On the other hand, in order to stably hold a preparation containing a pharmacologically active substance which is unstable to light, a light-shielding material (a brown container, an aluminum container, etc.) is used as a packaging material for containing the preparation, or a container is used for mixing or coating the ultraviolet absorbent. The light-shielding method, or a light-shielding method in which a container filled with a preparation is stored in a paper box during circulation.

然而,關於藉由無法使用容器或包裝材料之製造步驟所得之製品,有效成分變得容易因光而分解。又,例如生髮劑就在1~數月內 長期每天連續地使用之製品特性而言,考慮使用者之方便性,採用可確認使用量或剩餘量之透明或半透明之容器。因此,對該等製品係於暗處保管,或於紙箱內保管,努力維持有效成分之光穩定性。又,關於塗佈有紫外線吸收劑之容器,可某種程度地維持容器之透明性,但另一方面,存在並不能完全遮光而有效成分之光穩定性不充分,或容器之製造費用升高等問題。又,此種藉由包裝材料之遮光方法亦存在無法擔保製造步驟中之光穩定性之問題。又,製品開封後,可能有使用者不使用遮光性紙箱之情況,故而先前之遮光方法未必可稱為有效之方法。進而,根據製品不同,僅於遮光下使用製劑並不現實,將製劑自容器取出而用於頭皮、皮膚、黏膜等應用部位。因此,存在有效成分暴露於光,有效成分容易於應用部位分解之問題。 However, with respect to the product obtained by the manufacturing step in which the container or the packaging material cannot be used, the active ingredient is easily decomposed by light. Also, for example, hair tonics are within 1 to several months. For the characteristics of the product to be used continuously for a long period of time, a transparent or translucent container which can confirm the amount of use or the remaining amount is used in consideration of the convenience of the user. Therefore, these products are stored in a dark place or stored in a carton, and efforts are made to maintain the photostability of the active ingredient. Further, the container coated with the ultraviolet absorber can maintain the transparency of the container to some extent, but on the other hand, it is not completely shielded from light, the light stability of the active ingredient is insufficient, or the manufacturing cost of the container is increased. problem. Moreover, such a light-shielding method by a packaging material also has a problem that the stability of light in the manufacturing step cannot be guaranteed. Moreover, after the product is unsealed, there may be cases where the user does not use the light-shielding carton, and thus the previous shading method may not be called an effective method. Further, depending on the product, it is not practical to use the preparation only under light-shielding, and the preparation is taken out from the container and used for application sites such as scalp, skin, and mucous membrane. Therefore, there is a problem that the active ingredient is exposed to light, and the active ingredient is easily decomposed at the application site.

因此,於各種製劑及製品中,為了充分地活用維他命B6之優異之作用,要求不限制維他命B6之調配量及應用對象而提高維他命B6對光之穩定性。 Therefore, in order to fully utilize the excellent effect of vitamin B6 in various preparations and products, it is required to increase the stability of vitamin B6 to light without limiting the amount of vitamin B6 and the application target.

[先前技術文獻] [Previous Technical Literature] [專利文獻] [Patent Literature]

[專利文獻1]日本專利特開平8-104636號公報 [Patent Document 1] Japanese Patent Laid-Open No. Hei 8-104636

[專利文獻2]日本專利特開2001-48780號公報 [Patent Document 2] Japanese Patent Laid-Open Publication No. 2001-48780

[專利文獻3]日本專利特開2006-151969號公報 [Patent Document 3] Japanese Patent Laid-Open Publication No. 2006-151969

本發明之目的在於提供一種維他命B6化合物對光之穩定性得到提高之含維他命B6化合物之組合物。 It is an object of the present invention to provide a composition comprising a vitamin B6 compound having improved stability of light to a vitamin B6 compound.

又,本發明之目的在於提供一種含有維他命B6化合物及植物萃取物之組合物中之維他命B6化合物之光穩定化方法。 Further, it is an object of the present invention to provide a method for stabilizing a vitamin B6 compound in a composition comprising a vitamin B6 compound and a plant extract.

本發明者為了解決上述課題而反覆進行各種研究,結果發現:植物萃取物中所含之葉綠素使維他命B6之光穩定性降低。先前,葉綠素係作為參與植物、藍藻、藻類等之光合作用之物質為人所知,但並不知曉會因共調配葉綠素而對維他命B6等其他成分之光穩定性產生影響。 The present inventors have conducted various studies in order to solve the above problems, and as a result, it has been found that chlorophyll contained in a plant extract lowers the light stability of vitamin B6. Previously, chlorophyll was known as a substance involved in photosynthesis of plants, cyanobacteria, algae, etc., but it was not known that it would affect the photostability of other components such as vitamin B6 due to co-regulation of chlorophyll.

本發明係基於該等見解而努力研究,發現對維他命B6化合物之光穩定性產生影響之葉綠素之濃度為0.15ppm以上,從而完成者,且包含下述實施態樣。 The present invention has been diligently studied based on these findings, and has found that the concentration of chlorophyll which affects the photostability of the vitamin B6 compound is 0.15 ppm or more, and is completed, and includes the following embodiments.

項1.一種組合物,其特徵在於:其係含有選自由維他命B6及該等之鹽所組成之群中之至少一種化合物、以及植物萃取物者,且該組合物中之葉綠素之含量未達0.15ppm。 Item 1. A composition comprising at least one compound selected from the group consisting of vitamin B6 and a salt thereof, and a plant extract, and the chlorophyll content in the composition is less than 0.15 ppm.

項2.如上述項1記載之組合物,其中上述植物萃取物係含有選自由維他命B6及該等之鹽所組成之群中之至少一種化合物者,且上述化合物係內含於該植物萃取物者、或內含於該植物萃取物者與選自由外來性之維他命B6及該等之鹽所組成之群中之至少一種化合物之混合物。 The composition according to the above item 1, wherein the plant extract contains at least one compound selected from the group consisting of vitamin B6 and a salt thereof, and the compound is contained in the plant extract. Or a mixture of the plant extract and at least one compound selected from the group consisting of exogenous vitamin B6 and the salts thereof.

項3.如上述項1記載之組合物,其中上述植物萃取物係不含選自由維他命B6及該等之鹽所組成之群中之至少一種化合物者,且上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物係另外添加於組合物者。 The composition according to the above item 1, wherein the plant extract contains no at least one compound selected from the group consisting of vitamin B6 and the salts, and the above is selected from the group consisting of vitamin B6 and the like. At least one compound selected from the group consisting of salts is additionally added to the composition.

項4.如上述項1至3中任一項記載之組合物,其中上述葉綠素為選自由葉綠素a及葉綠素b所組成之群中之至少一種葉綠素。 The composition according to any one of items 1 to 3, wherein the chlorophyll is at least one chlorophyll selected from the group consisting of chlorophyll a and chlorophyll b.

項5.如上述項1至4中任一項記載之組合物,其中上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物為鹽酸吡哆醇。 The composition according to any one of the above items 1 to 4, wherein the at least one compound selected from the group consisting of vitamin B6 and the salts is pyridoxine hydrochloride.

項6.如上述項1至5中任一項記載之組合物,其中上述植物萃取物係自綠色植物之植物體萃取之萃取物。 The composition of any one of the above items 1 to 5, wherein the plant extract is an extract extracted from a plant of a green plant.

項7.如上述項1至6中任一項記載之組合物,其係生髮劑、滴眼劑、滴鼻劑、洗眼劑、洗鼻劑或隱形眼鏡用劑。 The composition according to any one of items 1 to 6, which is a hair growth agent, an eye drop, a nasal drop, an eye wash, a nasal wash or a contact lens.

項8.一種光穩定化方法,其特徵在於:其係含有選自由維他命B6及該等之鹽所組成之群中之至少一種化合物、以及植物萃取物的組合物中之上述化合物之光穩定化方法,且 將該組合物中之葉綠素之含量設為未達0.15ppm。 Item 8. A method for photostabilizing, characterized in that it comprises light stabilization of a compound selected from the group consisting of at least one compound selected from the group consisting of vitamin B6 and salts thereof, and a composition of a plant extract. Method, and The content of chlorophyll in the composition was set to be less than 0.15 ppm.

本發明之含有維他命B6化合物之組合物提高了維他命B6化合物對光之穩定性。 The composition of the present invention containing a vitamin B6 compound enhances the stability of the vitamin B6 compound to light.

又,若使用本發明之方法,則可提高含有維他命B6化合物及植物萃取物之組合物中之維他命B6化合物對光之穩定性。 Further, by using the method of the present invention, the stability of the vitamin B6 compound in the composition containing the vitamin B6 compound and the plant extract can be improved.

本發明之組合物之特徵在於含有維他命B6化合物及植物萃取物,且該組合物中之葉綠素之含量未達0.15ppm。 The composition of the present invention is characterized by containing a vitamin B6 compound and a plant extract, and the chlorophyll content in the composition is less than 0.15 ppm.

(1)組合物(1) Composition (1-1)維他命B6化合物(1-1) Vitamin B6 compound

所謂維他命B6化合物,意指維他命B6或其鹽。此處,作為維他命B6,例如可列舉:吡哆醇、吡哆醛、及吡哆胺。又,作為該等之鹽,可列舉:鹽酸鹽、硫酸鹽、硝酸鹽、氫溴酸鹽、磷酸鹽等,但並無特別限制。作為維他命B6化合物,就眼疲勞改善效果優異之方面而言,較佳為鹽酸吡哆醇。該等維他命B6化合物可單獨使用一種,又,亦可將兩種以上任意組合而使用。 The so-called vitamin B6 compound means vitamin B6 or a salt thereof. Here, examples of the vitamin B6 include pyridoxine, pyridoxal, and pyridoxamine. Further, examples of the salt include a hydrochloride, a sulfate, a nitrate, a hydrobromide, a phosphate, and the like, but are not particularly limited. As the vitamin B6 compound, pyridoxine hydrochloride is preferred in terms of excellent eye fatigue improvement effect. These vitamin B6 compounds may be used singly or in combination of two or more.

該維他命B6化合物並不特別限制其來源。例如,可為由合成產生者,又,亦可為源自植物等天然物者。再者,維他命B6化合物可 於商業上獲取。 The vitamin B6 compound is not particularly limited in its source. For example, it may be produced by a synthetic product, or may be a natural product derived from a plant or the like. Furthermore, vitamin B6 compounds are available. Obtained commercially.

本發明之組合物中所含之維他命B6化合物可為同時調配於組合物之植物萃取物中所含之內含性之維他命B6化合物,又,亦可為與植物萃取物分開另外添加於本發明之組合物者(外來性維他命B6化合物),進而,亦可為該等兩者(內含性+外來性維他命B6化合物)。 The vitamin B6 compound contained in the composition of the present invention may be an intrinsic vitamin B6 compound contained in the plant extract of the composition, or may be additionally added to the present invention separately from the plant extract. The composition (exogenous vitamin B6 compound) may further be both (inclusive + exogenous vitamin B6 compound).

本發明之組合物中之維他命B6化合物之比率只要為可獲得維他命B6化合物之作用效果之比率,則並無特別限制。此處,作為維他命B6化合物之作用效果,可列舉:幫助來自蛋白質之能量產生與皮膚或黏膜之健康維持、脂溢性皮膚炎或濕疹、痤瘡、皮膚粗糙等皮膚病之改善、皮膚細胞活化作用、頭屑或搔癢之改善、由紫外線導致之紅斑之改善、抗過敏作用、肉體疲勞改善、眼疲勞改善等作用。因此,其調配量係根據本發明之組合物之用途(例如,生髮劑及化妝料等皮膚用製劑、滴眼劑、滴鼻劑、洗眼劑、洗鼻劑或隱形眼鏡用劑)而適當製備。作為維他命B6化合物之通常之比率,通常為0.0001~1重量%左右,較佳為0.02~0.5重量%左右,尤佳為0.05~0.2重量%左右,於生髮劑之情形時,可例示通常為0.02~0.5重量%左右,較佳為0.05~0.2重量%左右;於化妝料之情形時,可例示通常為0.0001~5重量%左右,較佳為0.05~0.2重量%左右;於滴眼藥或滴鼻藥之情形時,可例示通常為0.005~0.2重量%左右,較佳為0.01~0.1重量%左右;於洗眼劑或洗鼻藥之情形時,可例示通常為0.0005~0.02重量%左右,較佳為0.001~0.01重量%左右;於隱形眼鏡用劑之情形時,可例示通常為0.0005~1重量%左右,較佳為0.001~0.01重量%左右。 The ratio of the vitamin B6 compound in the composition of the present invention is not particularly limited as long as it is a ratio at which the action of the vitamin B6 compound can be obtained. Here, as the action effect of the vitamin B6 compound, it can be mentioned that it helps the energy production from the protein and the health maintenance of the skin or mucous membrane, seborrheic dermatitis or eczema, acne, rough skin and other skin diseases, skin cell activation. Effects, improvement of dandruff or itching, improvement of erythema caused by ultraviolet rays, anti-allergic effect, improvement of physical fatigue, improvement of eye fatigue, etc. Therefore, the blending amount thereof is suitably prepared according to the use of the composition of the present invention (for example, a dermatological preparation such as a hair restorer and a cosmetic, an eye drop, a nasal drop, an eye wash, a nasal wash or a contact lens). . The usual ratio of the vitamin B6 compound is usually about 0.0001 to 1% by weight, preferably about 0.02 to 0.5% by weight, particularly preferably about 0.05 to 0.2% by weight, and in the case of a hair tonic, it is usually 0.02. ~0.5% by weight or so, preferably about 0.05 to 0.2% by weight; in the case of a cosmetic, it is usually about 0.0001 to 5% by weight, preferably about 0.05 to 0.2% by weight; in eye drops or drops In the case of a nasal medicine, it is usually about 0.005 to 0.2% by weight, preferably about 0.01 to 0.1% by weight. In the case of an eye wash or a nasal wash, it is usually about 0.0005 to 0.02% by weight. It is preferably about 0.001 to 0.01% by weight; in the case of a contact lens agent, it is usually about 0.0005 to 1% by weight, preferably about 0.001 to 0.01% by weight.

(1-2)葉綠素(1-2) Chlorophyll

本發明之組合物之特徵在於:葉綠素之含量未達0.15ppm。 The composition of the present invention is characterized in that the content of chlorophyll is less than 0.15 ppm.

葉綠素亦稱為綠色素(chlorophyll),係植物中所含之卟啉系色素,且係與光合作用相關之化學物質。 Chlorophyll, also known as chlorophyll, is a porphyrin-based pigment contained in plants and is a chemical substance related to photosynthesis.

作為植物中所含之葉綠素,主要有葉綠素a及b。 As the chlorophyll contained in plants, there are mainly chlorophyll a and b.

因此,組合物中所含之葉綠素之量於包含複數種葉綠素之情形時,意指其總量,於僅包含任一者之情形時,意指該調配之葉綠素之量。 Therefore, when the amount of chlorophyll contained in the composition is in the case of a plurality of chlorophyll, it means the total amount thereof, and when it contains only one of them, it means the amount of the chlorophyll to be formulated.

組合物中之葉綠素之含量較佳為未達0.1ppm左右,尤佳為未達0.05ppm左右。又,於本發明之組合物中,可於不損害本發明之效果之範圍內含有葉綠素,可含有葉綠素0.001ppm左右。 The content of chlorophyll in the composition is preferably less than about 0.1 ppm, and particularly preferably less than about 0.05 ppm. Further, in the composition of the present invention, chlorophyll may be contained in a range which does not impair the effects of the present invention, and chlorophyll may be contained in an amount of about 0.001 ppm.

(1-3)植物萃取物及其製備方法(1-3) Plant extract and preparation method thereof

本發明作為對象之植物萃取物包括:不含維他命B6化合物者(不含維他命B6化合物之植物萃取物)、及含有維他命B6化合物者(含維他命B6化合物之植物萃取物)之兩者。 The plant extracts to which the present invention is directed include both those which do not contain a vitamin B6 compound (a plant extract which does not contain a vitamin B6 compound), and those which contain a vitamin B6 compound (a plant extract containing a vitamin B6 compound).

再者,所謂本發明作為對象之植物萃取物,係如下所述般於將植物體浸出至萃取溶劑(水、乙醇等)中後,使液體濃縮所獲得者(軟萃取物或乾燥萃取物),並不指自植物體所萃取之化學物質(單離物)本身。 In addition, the plant extract to be used in the present invention is obtained by leaching a plant body into an extraction solvent (water, ethanol, etc.) as described below, and concentrating the liquid (soft extract or dried extract). Does not refer to the chemical substance (isolated) itself extracted from the plant body.

就顯著發揮本發明之效果之觀點而言,作為植物萃取物,較佳為自綠色植物之植物體所萃取之植物萃取物。概括而言,綠色植物係特徵在於藉由具有與光合作用相關之葉綠素(葉綠素a及/或b),而具有典型之綠色之營養體的系統群。 From the viewpoint of remarkably exerting the effects of the present invention, the plant extract is preferably a plant extract extracted from a plant of a green plant. In summary, a green plant line is characterized by a system of vegetatives with typical green vegetatives by having chlorophyll (chlorophyll a and/or b) associated with photosynthesis.

作為植物,具體而言,可較佳地列舉:蘆薈、明日葉、兒茶、甘茶、七葉膽、蜀葵、銀杏、蕁麻、五彩蘇(Coleus scutellarioides Benth)、紫錐花、大花紫薇、短柄野芝麻、西洋菜、橄欖、柿、巴西棕櫚樹、桐樹、熊笹草、金黃洋甘菊、鐵線蓮、桑樹、白桑、溫州蜜柑、酸橙、益母草、生薑、牡丹、當藥、大棗、酸橙、柚子、魚腥草、薄荷、延命草、甘草、甜菊、苦參、月桃、紫檀、紅茶、蛇麻草、香蜂草、歐洲槲寄生、貫葉連翹、一串紅、欵冬蒲公英、木賊、 萬年草、蓍、睡菜、白樺、山金車、洋甘菊、百里香、錦葵、小麥、苦蔘根、黃芩、紫根、紅花、丁香、甘蔗、聚合草、肥皂草、紫蘇、椴樹、金銀花、歐洲常春藤、歐洲山楂、西洋薄荷、鼠尾草、茶樹、雷公根、甜茶、洋芹、青稞、金縷梅、藥用牆草、番石榴、絲瓜、枇杷、葡萄、山毛櫸、海蘿、馬郁蘭、七葉樹、大葉月橘、蜂花、黃香草木樨、桃、豆芽、桉樹、人蔘、亞洲蔘、常春藤、胡桃、菩提樹、迷迭香、五月艾、羅布麻、萵苣、茴香、木瓜、老鸛草、艾葉、小燭樹、雞血藤、旱芹、大蒜、五葉木通、三葉木通等。該等植物均為綠色植物。 Specific examples of the plant include: aloe vera, tomorrow's leaves, catechu tea, sweet tea, esculenta, hollyhock, ginkgo, ramie, Coleus scutellarioides Benth, echinacea, large flower crape, short Wild sesame, watercress, olive, persimmon, brasil palm tree, tung tree, bear sedge, golden chamomile, clematis, mulberry, white mulberry, mandarin orange, lime, motherwort, ginger, peony, medicine, large Jujube, lime, grapefruit, houttuynia, mint, marguerite, licorice, stevia, sophora, moon peach, red sandalwood, black tea, hop, lemon balm, European mistletoe, St. John's wort, a bunch of red, red Winter dandelion, wood thief, Wannian grass, alfalfa, sleeping vegetables, white birch, arnica, chamomile, thyme, mallow, wheat, bitter root, scutellaria, purple root, safflower, clove, sugar cane, polymer grass, saponaria, perilla, eucalyptus, honeysuckle , European ivy, European hawthorn, western mint, sage, tea tree, Leigonggen, sweet tea, parsley, barley, witch hazel, medicinal wall grass, guava, loofah, alfalfa, grape, beech, hail, Marjoram, horse chestnut, big leaf moon orange, bee flower, yellow vanilla hibiscus, peach, bean sprout, eucalyptus, aphid, Asian cockroach, ivy, walnut, linden, rosemary, May AI, apocynum, lettuce, fennel , papaya, geranium, wormwood, candelilla, spatholobus, celery, garlic, lobelia, and shamrock. These plants are all green plants.

上述植物體中,較佳為由選自由蘆薈、甘茶、桐樹、桑樹、白桑、大棗、及魚腥草所組成之群中之至少一種植物萃取之植物萃取物。 Among the above plant bodies, a plant extract extracted from at least one plant selected from the group consisting of aloe vera, sweet tea, tung tree, mulberry tree, white mulberry, jujube, and houttuynia cordata is preferred.

植物萃取物中,作為含有維他命B6化合物之植物萃取物,較佳為自選自由明日葉、聚合草、洋芹、萵苣、旱芹及大蒜所組成之群中之至少一種植物之葉或莖萃取之植物萃取物。 In the plant extract, the plant extract containing the vitamin B6 compound is preferably extracted from leaves or stems of at least one plant selected from the group consisting of tomorrow leaves, polymer grass, parsley, lettuce, celery and garlic. Plant extracts.

於製備本發明之組合物時,於使用不含維他命B6化合物之植物萃取物之情形時,該植物萃取物係與上述維他命B6化合物組合而使用。即,於該情形時,本發明之組合物含有不含維他命B6化合物之植物萃取物與外來性之維他命B6化合物。另一方面,於製備本發明之組合物時,於使用含有維他命B6化合物之植物萃取物之情形時,該含維他命B6化合物之植物萃取物可不另外添加上述維他命B6化合物而直接使用,又,亦可與維他命B6化合物組合而使用。即,於該情形時,本發明之組合物含有含維他命B6化合物之植物萃取物(包含內含性之維他命B6化合物、不包含外來性之維他命B6化合物)、或含有含維他命B6化合物之植物萃取物與外來性之維他命B6化合物。 In the case of preparing the composition of the present invention, in the case of using a plant extract containing no vitamin B6 compound, the plant extract is used in combination with the above-mentioned vitamin B6 compound. That is, in this case, the composition of the present invention contains a plant extract containing no vitamin B6 compound and a vitamin B6 compound which is exogenous. On the other hand, in the case of preparing the composition of the present invention, when a plant extract containing a vitamin B6 compound is used, the plant extract containing the vitamin B6 compound can be directly used without additionally adding the above vitamin B6 compound, and It can be used in combination with a vitamin B6 compound. That is, in this case, the composition of the present invention contains a plant extract containing a vitamin B6 compound (including an inclusive vitamin B6 compound, does not contain an exogenous vitamin B6 compound), or a plant extract containing a vitamin B6-containing compound. And exotic vitamin B6 compounds.

調配於本發明之組合物中之植物萃取物之比率只要為可獲得植 物萃取物之作用效果之比率,則並無特別限制。此處,作為植物萃取物之作用效果,根據植物之種類而不同,可列舉保濕效果。因此,其調配量係根據本發明之組合物之用途(例如,生髮劑及化妝料等皮膚用製劑、滴眼劑、滴鼻劑、洗眼劑、洗鼻劑或隱形眼鏡用劑)而適當製備。 The ratio of the plant extract formulated in the composition of the present invention is as long as it is available The ratio of the effect of the extract of the substance is not particularly limited. Here, the effect of the plant extract varies depending on the type of the plant, and a moisturizing effect can be cited. Therefore, the blending amount thereof is suitably prepared according to the use of the composition of the present invention (for example, a dermatological preparation such as a hair restorer and a cosmetic, an eye drop, a nasal drop, an eye wash, a nasal wash or a contact lens). .

作為植物萃取物之通常之比率,例如可列舉:以乾燥物重量換算計通常為0.00001~5重量%左右,較佳為0.0001~1重量%左右,尤佳為0.005~0.1重量%左右,於生髮劑之情形時,可列舉通常為0.00001~5重量%左右,較佳為0.0001~1重量%左右;於滴眼劑或滴鼻劑之情形時,可列舉通常為0.00001~1重量%左右,較佳為0.0001~0.1重量%左右;於洗眼劑或洗鼻劑之情形時,可列舉通常為0.00001~1重量%左右,較佳為0.0001~0.1重量%左右;於隱形眼鏡用劑之情形時,可列舉通常為0.00001~1重量%左右,較佳為0.0001~0.1重量%左右。 The usual ratio of the plant extract is, for example, about 0.00001 to 5% by weight, preferably 0.0001 to 1% by weight, and particularly preferably about 0.005 to 0.1% by weight, based on the weight of the dried product. In the case of a dose, it is usually about 0.00001 to 5% by weight, preferably about 0.0001 to 1% by weight. In the case of an eye drop or a nasal drop, it is usually about 0.00001 to 1% by weight. Preferably, it is about 0.0001 to 0.1% by weight; in the case of an eye wash or a nasal wash, it is usually about 0.00001 to 1% by weight, preferably about 0.0001 to 0.1% by weight; in the case of a contact lens agent, It is usually about 0.00001 to 1% by weight, preferably about 0.0001 to 0.1% by weight.

再者,於使用含維他命B6化合物之植物萃取物作為植物萃取物之情形時,較佳為考慮組合物中之維他命B6化合物之比率(下限與上限),調整上述植物萃取物之調配比率。 Further, in the case of using a plant extract containing a vitamin B6 compound as a plant extract, it is preferred to adjust the ratio of the vitamin B6 compound in the composition (lower limit and upper limit) to adjust the blending ratio of the above plant extract.

植物萃取物之原料可直接使用植物之整體,亦可使用植物之一部分。 The raw material of the plant extract can be directly used as a whole of the plant, and a part of the plant can also be used.

通常,葉綠素主要包含於植物之葉或莖,故而就充分發揮本發明之效果之觀點而言,植物萃取物較佳為自包含葉或莖之植物體整體萃取之植物萃取物,更佳為自葉及/或莖萃取之植物萃取物。 In general, chlorophyll is mainly contained in the leaves or stems of the plant, and therefore, the plant extract is preferably a plant extract extracted from a whole plant body containing leaves or stems, and more preferably from the viewpoint of exerting the effects of the present invention. Leaf and/or stem extract plant extract.

以下,將植物之全部及一部分總稱為「植物體」。 Hereinafter, all or part of the plant will be collectively referred to as "plant body".

於萃取中,可使用植物體(植物之全部或例如葉、莖、根等一部分)為生之狀態者(未乾燥物)、乾燥者(乾燥物)、或冷凍者(冷凍物)。又,亦可使用將植物體之未乾燥物、乾燥物或冷凍物粉碎成適當之大 小而粉末化者。 In the extraction, a plant body (all of the plants or a part such as leaves, stems, roots, etc.) can be used as a raw state (undried matter), a dryer (dried matter), or a freezer (frozen). In addition, it is also possible to pulverize the undried, dried or frozen material of the plant body into a suitable large size. Small and powdered.

作為製作植物之萃取物之方法,可列舉:將萃取步驟及分離步驟組合之方法、於上述方法中進而組合區分步驟之方法等,但並不限定於該等。 Examples of the method for producing the extract of the plant include a method in which the extraction step and the separation step are combined, a method in which the separation step is further combined in the above method, and the like, but the method is not limited thereto.

萃取步驟係使用萃取溶劑,自植物體提取作為萃取物所必需之成分之步驟,萃取方法或萃取條件並無特別限定。 The extraction step is a step of extracting a component necessary for the extract from the plant body using an extraction solvent, and the extraction method or extraction conditions are not particularly limited.

萃取溶劑之種類並無特別限定,可列舉:水、有機溶劑及該等之混合溶劑。作為上述水,可列舉:冷水、常溫水、溫水、熱水及水蒸氣等所有溫度下之水,又,亦可進行殺菌處理、離子交換處理、滲透壓調整或緩衝化。作為有機溶劑,較佳為親水性有機溶劑,例如可使用:碳數1~5之一元醇(乙醇、甲醇、丙醇、異丙醇等)、碳數2~5之多元醇(甘油、異丙二醇、丙二醇及1,3-丁二醇等)、酯(乙酸甲酯等)、酮(丙酮等)等。該等親水性有機溶劑可僅使用一種,亦可併用兩種以上。於本發明中,就安全性及有效成分之萃取效率之方面而言,較佳為使用選自由水、乙醇、1,3-丁二醇及該等之混合液所組成之群中之至少一種萃取溶劑。 The type of the extraction solvent is not particularly limited, and examples thereof include water, an organic solvent, and a mixed solvent thereof. Examples of the water include water at all temperatures such as cold water, normal temperature water, warm water, hot water, and water vapor, and may be subjected to sterilization treatment, ion exchange treatment, osmotic pressure adjustment, or buffering. The organic solvent is preferably a hydrophilic organic solvent, and for example, a carbon number of 1 to 5 monohydric alcohol (ethanol, methanol, propanol, isopropanol, etc.) or a polyhydric alcohol having 2 to 5 carbon atoms (glycerol or different) can be used. Examples of propylene glycol, propylene glycol, and 1,3-butylene glycol, esters (such as methyl acetate), and ketones (such as acetone). These hydrophilic organic solvents may be used alone or in combination of two or more. In the present invention, in terms of safety and extraction efficiency of the active ingredient, it is preferred to use at least one selected from the group consisting of water, ethanol, 1,3-butylene glycol, and a mixture thereof. Extraction solvent.

於使用水及1,3-丁二醇之混合液作為萃取溶劑之情形時,混合液中之1,3-丁二醇之含有率較佳為0.1~70重量%左右,更佳為5~60重量%左右,進而較佳為10~50重量%左右。 When a mixed solution of water and 1,3-butanediol is used as the extraction solvent, the content of 1,3-butanediol in the mixed solution is preferably about 0.1 to 70% by weight, more preferably 5~. It is about 60% by weight, and more preferably about 10 to 50% by weight.

於使用水及乙醇之混合液作為萃取溶劑之情形時,混合液中之乙醇之含有率較佳為0.1~99.5重量%左右,更佳為5~95重量%左右,進而較佳為50~95重量%左右,最佳為60~90重量%左右。 When a mixed solution of water and ethanol is used as the extraction solvent, the content of ethanol in the mixed solution is preferably from about 0.1 to 99.5% by weight, more preferably from about 5 to 95% by weight, still more preferably from 50 to 95. The weight is about 60% to about 90% by weight.

作為萃取方法,可列舉:浸漬萃取、攪拌萃取、回流萃取、振盪萃取及超音波萃取,作為萃取條件,可列舉:室溫萃取、加熱萃取(亦稱為加溫萃取)、加壓萃取、超臨界萃取等,較佳為室溫或加熱萃取。萃取時間並無特別限定。又,亦可進行pH值調整。上述萃取操 作可為1次,亦可藉由反覆複數次將進行萃取操作後所獲得之萃取殘渣再次萃取而進行萃取操作。進而,亦可於萃取步驟之前後,視需要進行過濾等處理。 Examples of the extraction method include dip extraction, stirring extraction, reflux extraction, shaking extraction, and ultrasonic extraction. As extraction conditions, room temperature extraction, heat extraction (also referred to as warm extraction), pressure extraction, and super extraction are mentioned. Critical extraction, etc., preferably at room temperature or by heating. The extraction time is not particularly limited. Also, pH adjustment can be performed. The above extraction operation The extraction may be carried out once, and the extraction residue obtained after the extraction operation may be re-extracted to perform the extraction operation. Further, it is also possible to perform a treatment such as filtration after the extraction step.

分離步驟係自上述所獲得之萃取物中將作為萃取殘渣之不溶物與萃取液分離之固液方法,例如可列舉:離心分離、壓濾、過濾(加壓、常壓)、層析法等藉由使用吸附劑、吸收劑之萃取分離等之方法。自萃取液所分取之萃取物可直接使用,亦可進而藉由區分等而純化。 The separation step is a solid-liquid method in which the insoluble matter of the extraction residue is separated from the extract from the extract obtained above, and examples thereof include centrifugal separation, pressure filtration, filtration (pressurization, atmospheric pressure), chromatography, and the like. A method of extracting and separating by using an adsorbent or an absorbent. The extract obtained from the extract can be used as it is, or can be further purified by differentiation or the like.

區分步驟係自上述所獲得之萃取物將必需之成分區分而進行純化及濃縮之方法。作為區分步驟中所使用之方法,可列舉:使用活性碳、陰離子交換樹脂、陽離子交換樹脂、矽膠、吸附芳香族化合物之聚苯乙烯系樹脂等作為載體之層析法、透析、分子篩、減壓濃縮、冷凍乾燥等方法,但並不限定於該等。進而,亦可於本步驟後,視需要進行藉由離心分離等將上清液回收之步驟。 The distinguishing step is a method of purifying and concentrating the essential components from the extract obtained above. Examples of the method used in the discrimination step include chromatography using a living carbon, an anion exchange resin, a cation exchange resin, a silicone resin, a polystyrene resin adsorbing an aromatic compound, or the like as a carrier, dialysis, molecular sieve, and decompression. Methods such as concentration, freeze drying, etc., but are not limited thereto. Further, after this step, the step of recovering the supernatant by centrifugation or the like may be carried out as needed.

再者,亦可於上述各步驟之前後,視需要進行過濾等處理。過濾可使用紗布或濾片、市售之過濾器等。又,視需要可實施滅菌處理等。 Further, it is also possible to perform filtration or the like as needed before and after the above steps. For the filtration, gauze or a filter, a commercially available filter, or the like can be used. Further, sterilization treatment or the like can be performed as needed.

藉由上述方法所獲得之植物萃取物可直接以液狀形態使用,亦可藉由噴霧乾燥、真空乾燥、冷凍乾燥等乾燥步驟而粉末化。 The plant extract obtained by the above method may be used as it is in a liquid form, or may be powdered by a drying step such as spray drying, vacuum drying or freeze drying.

如上所述,本發明之組合物之特徵在於葉綠素之含量未達0.15ppm。該葉綠素通常係源自植物萃取物,故而較佳為於製備植物萃取物時,進行將葉綠素去除或減量之處理。作為該處理,可列舉:使用各種萃取溶劑(水、乙醇、1,3-丁二醇、該等之混合液等)之萃取方法、使用載體(活性碳等)之區分方法、使用離心分離或壓濾、過濾之萃取分離法等。 As described above, the composition of the present invention is characterized in that the content of chlorophyll is less than 0.15 ppm. The chlorophyll is usually derived from a plant extract, and therefore it is preferred to carry out the treatment of removing or reducing chlorophyll when preparing the plant extract. Examples of the treatment include an extraction method using various extraction solvents (water, ethanol, 1,3-butylene glycol, a mixed solution thereof, etc.), a method of distinguishing using a carrier (activated carbon or the like), and using centrifugal separation or Filter separation, filtration and separation methods.

又,植物萃取物中所含之葉綠素之含量可藉由使用分光光度計 之吸光光度法、高效液相層析法、萃取單離法、衍生物變換法等而測定。 Moreover, the content of chlorophyll contained in the plant extract can be obtained by using a spectrophotometer It is measured by an absorptiometry method, a high performance liquid chromatography method, an extraction separation method, a derivative conversion method, or the like.

(1-4)其他成分(1-4) Other ingredients

本發明之組合物亦可進而視需要於不損害維他命B6化合物及植物萃取物之藥理作用及穩定性之範圍內,進而含有於該領域通常所使用之其他成分。然而,與已說明之含有成分重複之情形並不在此列。作為此種其他成分,例如可列舉:溶劑、充血去除成分、眼調節成分、消炎成分、收斂成分、抗組織胺成分、抗過敏成分、維他命類、胺基酸類、抗菌成分、殺菌成分、糖類、多糖類及其衍生物、纖維素及其衍生物、水溶性高分子、局部麻醉成分、類固醇成分、青光眼治療成分、及白內障治療成分等。作為本發明中較佳之其他成分,例如可列舉如下者。 The composition of the present invention may, if necessary, be included in the range which does not impair the pharmacological action and stability of the vitamin B6 compound and the plant extract, and further contains other ingredients which are generally used in the field. However, the case of repeating the ingredients contained therein is not listed here. Examples of such other components include a solvent, a hyperemia-removing component, an eye-regulating component, an anti-inflammatory component, astringent component, an antihistamine component, an antiallergic component, a vitamin, an amino acid, an antibacterial component, a bactericidal component, and a saccharide. Polysaccharides and derivatives thereof, cellulose and derivatives thereof, water-soluble polymers, local anesthetic components, steroid components, glaucoma therapeutic components, and cataract treatment components. As other preferable components in the present invention, for example, the following may be mentioned.

溶劑:作為溶劑,例如可列舉水、醇類、醚、或該等之混合物。作為醇類,例如可列舉:選自由多元醇及低級醇所組成之群中之至少一種。 Solvent: As the solvent, for example, water, an alcohol, an ether, or a mixture thereof may be mentioned. The alcohol may, for example, be at least one selected from the group consisting of a polyol and a lower alcohol.

作為多元醇,可列舉:1,2-丙二醇、甘油、雙甘油、三甘油、乙二醇、二乙二醇、三乙二醇、聚乙二醇、1,3-丙二醇、二丙二醇、三丙二醇、丁二醇、二丁二醇、戊二醇、戊三醇、己二醇、環己三醇、季戊四醇、三羥甲基丙烷、山梨糖醇及甘露醇等。作為低級醇,可列舉:甲醇、乙醇、丙醇、異丙醇、丁醇、異丁醇、戊醇、異戊醇等。其中,就安全性與維他命B6化合物及植物萃取物之穩定性之方面而言,作為醇類,較佳為丙二醇、甘油、乙醇等。 Examples of the polyhydric alcohol include 1,2-propanediol, glycerin, diglycerin, triglycerin, ethylene glycol, diethylene glycol, triethylene glycol, polyethylene glycol, 1,3-propanediol, dipropylene glycol, and trisole. Propylene glycol, butanediol, dibutylene glycol, pentanediol, pentanetriol, hexanediol, cyclohexanetriol, pentaerythritol, trimethylolpropane, sorbitol, and mannitol. Examples of the lower alcohol include methanol, ethanol, propanol, isopropanol, butanol, isobutanol, pentanol, and isoamyl alcohol. Among them, as the alcohol, propylene glycol, glycerin, ethanol, and the like are preferable as the alcohol in terms of safety and stability of the vitamin B6 compound and the plant extract.

本發明之組合物中之醇類之合計含有比率亦取決於多元醇或低級醇之種類,較佳為40重量%左右以下,更佳為30重量%左右以下,進而較佳為20重量%左右以下,但並無特別限制。 The total content ratio of the alcohols in the composition of the present invention depends on the type of the polyol or the lower alcohol, preferably about 40% by weight or less, more preferably about 30% by weight or less, and still more preferably about 20% by weight. The following, but there are no special restrictions.

充血去除成分:例如可列舉α-腎上腺素促效劑,具體而言,可列 舉腎上腺素、鹽酸腎上腺素、鹽酸麻黃素、鹽酸羥甲唑啉、鹽酸四氫唑啉、硝酸四氫唑啉、鹽酸萘甲唑啉、硝酸萘甲唑啉、鹽酸脫羥腎上腺素、鹽酸甲基麻黃素、重酒石酸腎上腺素等。該等可為d體、l體或dl體中之任一者。 Congestion-removing component: for example, an α-adrenergic agonist can be cited, specifically, it can be listed Epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, oxymetazoline hydrochloride, tetrahydrozoline hydrochloride, tetrahydrozoline nitrate, naphazoline hydrochloride, naphazoline nitrate, phenylephrine hydrochloride, hydrochloric acid Methyl ephedrine, heavy tartaric acid and adrenaline. These may be any of d, l or dl.

眼肌調節劑成分:例如可列舉具有與乙醯膽鹼類似之活性中心之抗膽鹼酯酶劑,具體而言,可列舉甲基硫酸新斯的格明等四級銨化合物及該等之藥理學上容許之鹽類等。 The eye muscle regulator component: for example, an anticholinergic ester agent having an active center similar to acetylcholine, and specific examples thereof include a quaternary ammonium compound such as gemmin of methyl sulphate and such a quaternary ammonium compound. Pharmacologically acceptable salts and the like.

消炎劑成分或收斂劑成分:例如可列舉硫酸鋅、乳酸鋅、尿囊素、ε-胺基己酸、吲哚美辛、氯化溶菌酶、硝酸銀、普拉洛芬、甘草酸二鉀、雙氯芬酸鈉、溴芬酸鈉、氯化小蘖鹼、硫酸小蘖鹼、水楊酸甲酯等。 Anti-inflammatory agent component or astringent component: for example, zinc sulfate, zinc lactate, allantoin, ε-aminohexanoic acid, indomethacin, chlorinated lysozyme, silver nitrate, pranoprofen, dipotassium glycyrrhizinate, Diclofenac sodium, bromfenac sodium, berberine chloride, berberine sulfate, methyl salicylate, and the like.

維他命類:例如可含有選自由維他命A類、維他命B類(除上述維他命B6化合物以外)、維他命C類、維他命D類、維他命E類、及其他維他命類所組成之群中之至少一種維他命類。作為維他命A類,例如可列舉:視網醛、視網醇、視網酸、胡蘿蔔素、脫氫視網醛、茄紅素及其藥理學上容許之鹽類等。作為維他命B類,例如可列舉:硫胺、二硫硫胺、基世甲命、奧托硫胺、賽可硫胺、雙異丁硫胺、雙苯醯硫胺、丙舒硫胺、苯磷硫胺、呋喃硫胺、核黃素、黃素腺嘌呤二核苷酸、羥鈷銨、氰鈷胺、甲鈷胺、deoxyadeno鈷胺、葉酸、四氫葉酸、二氫葉酸、菸鹼酸、菸鹼醯胺、菸醇、泛酸、泛醇、生物素、膽鹼、肌醇及其藥理學上容許之該等之鹽類。作為維他命C類,例如可列舉:抗壞血酸及其衍生物、異抗壞血酸及其衍生物及其藥理學上容許之鹽類等。作為維他命D類,例如可列舉:麥角鈣化固醇、膽鈣化固醇、羥基膽鈣化固醇、二羥基膽鈣化固醇、二氫速固醇及其藥理學容許之鹽類等。作為維他命E類,例如可列舉:生育酚及其衍生物、泛醌衍生物及其藥理學上容許之鹽類等。作為其他維他命類,例如可列 舉:肉鹼、阿魏酸、γ-谷醇、乳清酸、芸香苷、聖草次苷、橙皮苷及其藥理學上容許之鹽類等。 Vitamins: for example, may contain at least one vitamin selected from the group consisting of vitamin A, vitamin B (other than the above vitamin B6 compound), vitamin C, vitamin D, vitamin E, and other vitamins. . Examples of the vitamin A include, for example, retinol, retinol, retinoid, carotenes, dehydroformaldehyde, lycopene, and pharmacologically acceptable salts thereof. Examples of the vitamin B can be exemplified by thiamine, dithiothiamine, thiophene, otoxuramine, seletonamide, bisisobutyl thiamine, bisphenyl sulfonamide, propyl thiamine, and benzene. Phosphine thiamine, furan thiamine, riboflavin, flavin adenine dinucleotide, hydrocobalamin, cyanocobalamin, mecobalamin, deoxyadeno cobalamin, folic acid, tetrahydrofolate, dihydrofolate, nicotinic acid Nicotinamide, nicotinol, pantothenic acid, panthenol, biotin, choline, inositol and their pharmacologically acceptable salts. Examples of the vitamin C class include ascorbic acid and derivatives thereof, erythorbic acid and derivatives thereof, and pharmacologically acceptable salts thereof. Examples of the vitamin D class include ergot calciferol, cholecalciferol, hydroxycholecalciferol, dihydroxycholecalciferol, dihydrocohol, and pharmacologically acceptable salts thereof. Examples of the vitamin E class include tocopherol and its derivatives, ubiquinone derivatives, and pharmacologically acceptable salts thereof. As other vitamins, for example, For example: carnitine, ferulic acid, γ-glutol, orotic acid, rutin, eriocitrin, hesperidin and its pharmacologically acceptable salts.

胺基酸類:例如可列舉胺基乙基磺酸(牛磺酸)、麩胺酸、肌酐、麩胺酸鈉、軟骨素硫酸鈉等。該等可為d體、l體或dl體中之任一種。 Examples of the amino acid: aminoethyl sulfonic acid (taurine), glutamic acid, creatinine, sodium glutamate, and sodium chondroitin can be mentioned. These may be any of d, l or dl.

抗菌劑成分或殺菌劑成分:例如可列舉硫酸胺基脫氧康黴素、硫酸康黴素、硫酸建它黴素、硫酸西索黴素、硫酸鏈黴素、妥布黴素、硫酸小諾黴素、烷基聚胺基乙基甘胺酸、氯黴素、鹽酸四環素、鹽酸羥四環素、氧氟沙星、諾氟沙星、左旋氧氟沙星、鹽酸洛美沙星、磺苄西林鈉、鹽酸頭孢甲肟、苄基青黴素鉀、硫酸小蘖鹼、氯化小蘖鹼、黏菌素甲磺酸鈉、紅黴素、乳糖酸紅黴素、吉他黴素、螺旋黴素、硫酸新黴素、硫酸多黏菌素、地貝卡星、阿米卡星、硫酸阿米卡星、阿昔洛韋、碘脫氧胞苷(Iodo deoxycytidine)、碘苷、環胞苷、阿糖胞苷、三氟胸苷、溴脫氧尿苷、聚乙烯醇碘、碘、雙性黴素B、異康唑、益康唑、克黴唑、制黴素、鏈黴菌素、氟胞嘧啶、咪康唑等。 Antibacterial agent component or fungicide component: for example, amine-based deoxycorticillin sulfate, kampomycin sulfate, stabalamycin sulfate, sisosine sulfate, streptomycin sulfate, tobramycin, and scleromycin sulfate , alkyl polyaminoethylglycine, chloramphenicol, tetracycline hydrochloride, hydroxytetracycline hydrochloride, ofloxacin, norfloxacin, levofloxacin, lomefloxacin hydrochloride, sulfacillin sodium, Cefmenoxime hydrochloride, benzylpenicillin potassium, berberine sulfate, berberine chloride, colistin sodium, erythromycin, erythromycin lactobionate, guitarmycin, spiramycin, neomycin sulfate , polymyxin sulfate, dibekacin, amikacin, amikacin sulfate, acyclovir, Iodo deoxycytidine, iodine, cyclocytidine, cytarabine, Trifluorothymidine, bromodeoxyuridine, polyvinyl alcohol iodine, iodine, amphotericin B, isoconazole, econazole, clotrimazole, mycin, streptavidin, flucytosine, miconazole Wait.

糖類:例如可列舉單糖類、二糖類,具體而言,可列舉葡萄糖、海藻糖、乳糖、果糖等。 Examples of the saccharide include monosaccharides and disaccharides, and specific examples thereof include glucose, trehalose, lactose, and fructose.

多糖類或其衍生物:例如可列舉玻尿酸鈉、軟骨素硫酸鈉等。 Examples of the polysaccharide or a derivative thereof include sodium hyaluronate, sodium chondroitin sulfate, and the like.

纖維素或其衍生物或該等之鹽:例如可列舉羧甲基纖維素鈉、羥乙基纖維素、羥丙基甲基纖維素、甲基纖維素等。 Examples of the cellulose or a derivative thereof or the salt thereof include sodium carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, and methylcellulose.

上述以外之水溶性高分子:例如可列舉聚乙烯醇(完全或部分皂化物)、聚乙烯吡咯啶酮、糊精、聚乙二醇等。 Examples of the water-soluble polymer other than the above include polyvinyl alcohol (complete or partial saponified product), polyvinylpyrrolidone, dextrin, and polyethylene glycol.

局部麻醉藥成分:例如可列舉利多卡因、奧布卡因、狄布卡因、普魯卡因、胺基苯甲酸乙酯、美普卡因、及該等之鹽等。 Local anesthetic components: for example, lidocaine, oxybuprocaine, dibucaine, procaine, ethyl urethane, mepivain, and the like can be mentioned.

類固醇成分:例如可列舉氫化可體松、潑尼松龍、及該等之鹽等。 Examples of the steroid component include hydrocortisone, prednisolone, and the like.

青光眼治療成分:例如可列舉左旋布諾洛爾、噻嗎洛爾、及該等之鹽等。 The glaucoma therapeutic component: for example, levobnorolol, timolol, and the like can be mentioned.

白內障治療成分:例如可列舉吡諾克辛等。 Cataract treatment component: for example, pirenoxine or the like can be cited.

組合物中之該等成分之含有比率係根據製劑之種類、及含有成分之種類等而適當決定。例如相對於製劑整體為0.0001~50重量%左右,較佳為0.0001~25重量%左右,更佳為0.001~10重量%左右。 The content ratio of the components in the composition is appropriately determined depending on the type of the preparation, the type of the component to be contained, and the like. For example, it is about 0.0001 to 50% by weight, preferably about 0.0001 to 25% by weight, and more preferably about 0.001 to 10% by weight, based on the total amount of the preparation.

又,於本發明之水性液劑中,可視需要於不損害維他命B6化合物及植物萃取物之藥理作用及穩定性之範圍內,進而含有於該領域通常所使用之添加劑。然而,與已說明之含有成分重複之情形並不在此列。作為此種成分,例如可列舉:防腐劑、殺菌劑或抗菌劑、增黏劑、助溶劑或溶解助劑、pH值調節劑、等張劑、香料、清涼劑、螯合劑、緩衝劑、穩定劑、及基材等。作為本發明中較佳之添加物,例如可列舉如下之添加物。 Further, in the aqueous liquid preparation of the present invention, it is possible to contain an additive which is generally used in the field, without damaging the pharmacological action and stability of the vitamin B6 compound and the plant extract. However, the case of repeating the ingredients contained therein is not listed here. Examples of such a component include preservatives, bactericides or antibacterial agents, tackifiers, solubilizers or dissolution aids, pH adjusters, isotonic agents, perfumes, cooling agents, chelating agents, buffers, and stabilization. Agents, substrates, and the like. As a preferable additive in the present invention, for example, the following additives can be mentioned.

防腐劑、殺菌劑或抗菌劑:例如可列舉鹽酸烷基二胺基乙基甘胺酸、苯甲酸鈉、乙醇、氯丁醇、己二烯酸、己二烯酸鉀、脫氫乙酸鈉、對羥苯甲酸甲酯、對羥苯甲酸乙酯、對羥苯甲酸丙酯、對羥苯甲酸丁酯、硫酸羥基喹啉、苯乙醇、苄醇、雙胍化合物、利凡諾等。 Preservatives, bactericides or antibacterial agents: for example, alkyldiamine ethylglycine hydrochloride, sodium benzoate, ethanol, chlorobutanol, hexadienoic acid, potassium hexadienoate, sodium dehydroacetate, methylparaben, Ethyl p-hydroxybenzoate, propyl paraben, butyl paraben, hydroxyquinoline, phenylethyl alcohol, benzyl alcohol, biguanide, rivanol and the like.

增黏劑:例如可列舉羧甲基纖維素鈉、葡聚糖、聚乙二醇、羧基乙烯基聚合物、羥乙基纖維素、羥丙基甲基纖維素、甲基纖維素、聚乙烯醇(完全、或部分皂化物)、聚乙烯吡咯啶酮、聚乙二醇、軟骨素硫酸鈉等。 Tackifier: Examples thereof include sodium carboxymethylcellulose, dextran, polyethylene glycol, carboxyvinyl polymer, hydroxyethyl cellulose, hydroxypropylmethylcellulose, methylcellulose, and polyethylene. Alcohol (complete or partially saponified), polyvinylpyrrolidone, polyethylene glycol, sodium chondroitin, and the like.

助溶劑或溶解助劑:例如可列舉烷基二胺基乙基甘胺酸等甘胺酸型兩性界面活性劑、烷基醚羧酸鹽、十四烯磺酸鈉等磺酸鹽、月桂基硫酸鈉等烷基硫酸鹽、N-椰油醯基甲基牛磺酸鈉等N-醯基牛磺酸鹽、POE(polyoxyethylene,聚氧乙烯)(10)月桂醚磷酸鈉等POE烷基醚磷酸及其鹽、月桂醯基甲基丙胺酸鈉等N-醯基胺基酸鹽、POE(3)月桂 醚硫酸鈉等POE烷基醚硫酸鹽、α-烯烴磺酸鹽等陰離子界面活性劑等。具體而言,有聚氧乙烯氫化蓖麻油60、聚氧乙烯(20)山梨糖醇酐單月桂酸酯、聚氧乙烯(20)山梨糖醇酐單油酸酯、聚氧乙烯(20)山梨糖醇酐三硬脂酸酯、聚氧乙烯(20)山梨糖醇酐油酸酯、硬脂酸聚烴氧(40)酯、蔗糖硬脂酸酯、單硬脂酸十甘油酯、月桂基葡糖苷、聚乙二醇4000。再者,括號內之數字表示加成莫耳數。 Examples of the cosolvent or the dissolution aid include a glycine type amphoteric surfactant such as an alkyldiaminoethylglycine, a sulfonate such as an alkyl ether carboxylate or a tetradecenesulfonate, and a lauryl group. Alkyl sulfate such as sodium sulfate, N-mercapto taurate such as N-cocoylmethyltaurate, POE alkyl ether such as POE (polyoxyethylene) (10) sodium lauryl ether phosphate N-decylamino acid salt such as phosphoric acid and its salt, sodium lauryl methyl propylamine, POE (3) laurel An anionic surfactant such as POE alkyl ether sulfate or α-olefin sulfonate such as sodium ether sulfate. Specifically, there are polyoxyethylene hydrogenated castor oil 60, polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (20) Yamanashi Sugar anhydride tristearate, polyoxyethylene (20) sorbitan oleate, polyoxyl (40) ester of stearic acid, sucrose stearate, decaglyceryl monostearate, lauryl Glucoside, polyethylene glycol 4000. Furthermore, the numbers in parentheses indicate the addition of moles.

作為陽離子性界面活性劑,例如可列舉:四級銨化合物及雙胍系化合物等。作為四級銨化合物,可列舉:氯化鯨蠟基吡啶鎓水合物、地喹氯銨、苄索氯銨、氯化苄烷銨、氯化烷基二甲基銨、氯化烷基三甲基銨、甲基苄索氯銨、氯化月桂醯膽胺基甲醯基甲基吡啶鎓等。又,作為雙胍系化合物,例如可列舉:氯已定或其鹽,較佳可列舉氯已定葡萄糖酸鹽、鹽酸氯已定等。 Examples of the cationic surfactant include a quaternary ammonium compound and a biguanide compound. Examples of the quaternary ammonium compound include cetylpyridinium chloride hydrate, decaquinium chloride, benzethonium chloride, benzalkonium chloride, alkyldimethylammonium chloride, and alkyltrimethyl chloride. Alkyl ammonium, methyl benzethonium chloride, lauric acid, cholestylmethylmercaptomethylpyridinium or the like. Further, examples of the biguanide compound include chlorhexidine or a salt thereof, and preferably chlorhexidine gluconate or chlorhexidine hydrochloride.

pH值調整劑:例如可列舉鹽酸、胺基乙基磺酸、ε-胺基己酸、乙酸、氫氧化鈉、碳酸氫鈉、碳酸鈉、三乙醇胺、單乙醇胺等。 Examples of the pH adjuster include hydrochloric acid, aminoethylsulfonic acid, ε-aminohexanoic acid, acetic acid, sodium hydroxide, sodium hydrogencarbonate, sodium carbonate, triethanolamine, monoethanolamine, and the like.

等張劑:例如可列舉亞硫酸氫鈉、亞硫酸鈉、氯化鉀、氯化鈣、氯化鈉、氯化鎂、乙酸鉀、乙酸鈉、碳酸氫鈉、碳酸鈉、硫代硫酸鈉、硫酸鎂、甘油、丙二醇等。 Isotonic agents: for example, sodium hydrogen sulfite, sodium sulfite, potassium chloride, calcium chloride, sodium chloride, magnesium chloride, potassium acetate, sodium acetate, sodium hydrogencarbonate, sodium carbonate, sodium thiosulfate, magnesium sulfate, glycerin , propylene glycol and the like.

香料或清涼劑:例如可列舉萜烯類(具體而言為大茴香腦、丁香油酚、樟腦、香葉草醇、桉醚、冰片、薄荷腦、檸檬烯、龍腦等;該等可為d體、l體或dl體中之任一種)精油(具體而言,為茴香油、冰薄荷油、桂皮油、綠薄荷油、薄荷水、薄荷油、西洋薄荷油、香柑油、桉樹油、玫瑰油等)等。 Perfume or cooling agent: for example, terpenes (specifically, aniseed brain, eugenol, camphor, geranyl alcohol, decyl ether, borneol, menthol, limonene, borneol, etc.; these may be d Any of the body, body or dl body) (specifically, fennel oil, ice mint oil, cinnamon oil, spearmint oil, peppermint water, peppermint oil, peppermint oil, citrus oil, eucalyptus oil, Rose oil, etc.).

螯合劑:例如可列舉抗壞血酸、乙二胺四乙酸四鈉、乙二胺四乙酸鈉、檸檬酸等。 Examples of the chelating agent include ascorbic acid, tetrasodium ethylenediaminetetraacetate, sodium ethylenediaminetetraacetate, citric acid, and the like.

緩衝劑:例如可列舉檸檬酸、檸檬酸鈉、乙酸、乙酸鉀、乙酸鈉、碳酸氫鈉、碳酸鈉、硼酸、硼砂等。 Examples of the buffer: citric acid, sodium citrate, acetic acid, potassium acetate, sodium acetate, sodium hydrogencarbonate, sodium carbonate, boric acid, borax, and the like.

穩定劑:例如可列舉環糊精、二丁基羥基甲苯、胺基丁三醇、生育酚、焦亞硫酸鈉、單乙醇胺、單硬脂酸鋁等。 Stabilizers: for example, cyclodextrin, dibutylhydroxytoluene, tromethamine, tocopherol, sodium metabisulfite, monoethanolamine, aluminum monostearate, and the like can be mentioned.

基劑:例如可列舉辛基十二烷醇、橄欖油、芝麻油、氧化鈦、溴化鉀、大豆油、山茶油、玉米油、菜籽油、石蠟、蓖麻油、樹脂基質、花生油、羊毛脂、凡士林等。 Base: for example, octyldodecanol, olive oil, sesame oil, titanium oxide, potassium bromide, soybean oil, camellia oil, corn oil, rapeseed oil, paraffin wax, castor oil, resin matrix, peanut oil, lanolin Vaseline and so on.

(1-6)組合物之滲透壓及pH值(1-6) osmotic pressure and pH of the composition

本發明之組合物可視需要調節為活體容許之範圍內之滲透壓比。相對於生理鹽水之滲透壓比通常為0.3~4左右,較佳為0.5~2左右,更佳為0.5~1.4左右。除上述pH值調整劑以外,滲透壓比之調節亦可適當使用緩衝劑、等張劑、及鹽類等而進行。 The composition of the present invention can be adjusted to an osmotic pressure ratio within a range acceptable to the living body as needed. The osmotic pressure ratio with respect to physiological saline is usually about 0.3 to 4, preferably about 0.5 to 2, more preferably about 0.5 to 1.4. In addition to the above pH adjusting agent, the adjustment of the osmotic pressure ratio can be carried out by appropriately using a buffering agent, an isotonic agent, a salt or the like.

本發明之組合物例如於下述內服用液劑中,通常就服用感及有效成分之穩定性之方面而言,若pH值為2~10則較佳,若pH值為4~9則更佳,若pH值為6~8則進而較佳。於外皮用組合物中,通常就對皮膚之低刺激性、使用感之良好度及有效成分之穩定性之方面而言,若pH值為3~10則較佳,若pH值為3~9則更佳,若pH值為4~8則進而較佳。 The composition of the present invention is, for example, in the following liquid dosage form, and it is usually preferred if the pH is 2 to 10, and the pH is 4 to 9 in terms of the stability of the administration and the stability of the active ingredient. Preferably, if the pH is 6-8, it is further preferred. In the composition for outer skin, it is usually preferred that the pH is from 3 to 10, and the pH is from 3 to 9 in terms of low irritation to the skin, good feeling of use, and stability of the active ingredient. More preferably, the pH is preferably from 4 to 8.

尤其是於滴眼劑、滴鼻劑、洗眼劑、洗鼻劑、隱形眼鏡用劑等黏膜應用組合物之情形時,通常就對黏膜之低刺激性及有效成分之穩定性之方面而言,若pH值為5~9.5則較佳,若pH值為5.5~9則更佳,若pH值為6~8則進而較佳。 In particular, in the case of an application for a mucosa such as an eye drop, a nasal drop, an eye wash, a nasal wash, or a contact lens, it is usually in terms of low irritation of the mucosa and stability of the active ingredient. If the pH is 5 to 9.5, it is preferably, and if the pH is 5.5 to 9, it is more preferable, and if the pH is 6 to 8, it is further preferable.

(1-7)組合物之製造方法(1-7) Method for producing composition

維他命B6化合物於水之含量較多之組合物中容易變得不穩定,容易光分解。因此,於本發明之含有維他命B6化合物之組合物為含有水之組合物(含水組合物)之情形時,可有效地提高維他命B6化合物對光之穩定性。 The vitamin B6 compound tends to become unstable in a composition containing a large amount of water, and is easily decomposed by light. Therefore, when the composition containing the vitamin B6 compound of the present invention is a composition containing water (aqueous composition), the stability of the vitamin B6 compound to light can be effectively improved.

於本發明之組合物含有水之情形時,組合物中之水之含量較佳 為5重量%左右以上,更佳為20重量%左右以上,進而較佳為50重量%左右以上,尤佳為70重量%以上。又,作為上限,可列舉99.9重量%左右以下,較佳為99重量%左右以下,進而較佳為95重量%左右以下。 When the composition of the present invention contains water, the content of water in the composition is preferably It is about 5% by weight or more, more preferably about 20% by weight or more, further preferably about 50% by weight or more, and particularly preferably 70% by weight or more. Further, the upper limit is about 99.9% by weight or less, preferably about 99% by weight or less, and more preferably about 95% by weight or less.

本發明之組合物可藉由根據其用途(生髮劑及化妝料等皮膚用製劑、滴眼劑、滴鼻劑、洗眼劑、洗鼻劑、隱形眼鏡用劑等),利用公知之操作並調配上述各成分進行混合而製造。再者,各成分之調配順序並無特別限制。 The composition of the present invention can be handled and prepared by a known method according to the use thereof (skin preparations such as hair restorer and cosmetic, eye drop, nasal drops, eye wash, nasal wash, contact lens, etc.). Each of the above components is produced by mixing. Furthermore, the order in which the components are formulated is not particularly limited.

例如,於生髮劑、外用鎮痛劑或化妝料等皮膚用製劑及滴眼劑或洗眼劑等眼科用製劑之情形時,可藉由首先將各成分混合後,進而視需要進行過濾滅菌處理,最後向容器填充而製備。更具體而言,於組合物為生髮劑之情形時,可藉由使用蒸餾水或純化水及添加劑,使維他命B6化合物、植物萃取物等成分溶解,調整為特定之滲透壓及pH值,於無菌環境下進行過濾滅菌處理,並無菌填充至已洗淨滅菌之容器而製造。 For example, in the case of a dermatological preparation such as a hair growth agent, a topical analgesic or a cosmetic, or an ophthalmic preparation such as an eye drop or an eye wash, the components may be first mixed, and then subjected to filtration sterilization treatment as needed. Prepared by filling the container. More specifically, when the composition is a hair growth agent, the components such as vitamin B6 compound and plant extract can be dissolved by using distilled water or purified water and additives, and adjusted to a specific osmotic pressure and pH value, and sterilized. It is manufactured by filtration sterilization in an environment and aseptically filled into a container which has been washed and sterilized.

(1-8)組合物之用途(1-8) Use of the composition

本發明之組合物可根據目的例如以內服或外用之形態使用,可作為各種用途之局部投予製劑而提供。 The composition of the present invention can be used, for example, in the form of internal or external use depending on the purpose, and can be provided as a topical preparation for various uses.

作為內服形態,例如可製成:錠劑、丸劑、膠囊劑(軟膠囊劑、硬膠囊劑)、散劑(粉末劑)及顆粒劑(包含乾糖漿)等各種固形製劑、或內服用液劑(包含液劑、懸濁劑、糖漿劑、凝膠劑)等液狀製劑等劑型。 As an internal form, for example, various solid preparations such as tablets, pills, capsules (soft capsules, hard capsules), powders (powders), and granules (including dry syrup), or internal liquid preparations can be prepared ( A dosage form such as a liquid preparation containing a liquid preparation, a suspension, a syrup, or a gelling agent.

作為外用形態,例如若為皮膚用製劑,則可製成液劑(洗劑、懸濁液劑、乳液劑、氣溶膠劑)、軟膏劑、乳霜劑、凝膠劑(gel agent)、貼附劑等劑型。又,若為眼科用製劑,則並不限於治療用製劑,亦可作為隱形眼鏡用劑等非治療用製劑而利用。作為眼科用製劑之具體 例,例如可列舉:滴眼藥(亦稱為滴眼劑,包括亦可於佩戴隱形眼鏡時使用之滴眼藥)、洗眼藥(亦稱為洗眼劑,包括亦可於佩戴隱形眼鏡時使用之洗眼藥)、隱形眼鏡配戴液、及隱形眼鏡用劑(洗淨液、保存液、沖洗液、消毒液、及多功能護理液(Multi-Purpose Solution)等)等。再者,本說明書中,所謂隱形眼鏡,意指硬質隱形眼鏡(亦包含透氧性硬質隱形眼鏡)、及軟質隱形眼鏡等所有類型之隱形眼鏡。 The external form can be prepared, for example, as a skin preparation (a lotion, a suspension, an emulsion, an aerosol), an ointment, a cream, a gel agent, or a paste. Attachment and other dosage forms. In addition, the ophthalmic preparation is not limited to the therapeutic preparation, and may be used as a non-therapeutic preparation such as a contact lens. Specific as an ophthalmic preparation For example, eye drops (also known as eye drops, including eye drops which can also be used when wearing contact lenses), eye washes (also known as eye washes, including use when wearing contact lenses) Eyewashing agents, contact lens wearing solutions, and contact lens agents (washing liquid, preservation solution, rinse solution, disinfectant, and Multi-Purpose Solution). Further, in the present specification, the term "contact lens" means all types of contact lenses such as a hard contact lens (including an oxygen-permeable rigid contact lens) and a soft contact lens.

本發明之組合物由於維他命B6化合物對光之穩定性提高,故而較佳為應用於先前維他命B6化合物對光之穩定性較低成為問題之製劑。作為維他命B6化合物對光之穩定性較低尤其成為問題之製劑,例如可列舉:內服用液劑、作為液劑之皮膚用製劑、洗眼劑、隱形眼鏡用劑等含有水之組合物(含水組合物)。其原因在於:於含有水之組合物中,維他命B6化合物容易變得不穩定,容易光分解。 Since the composition of the present invention has improved stability against light due to the vitamin B6 compound, it is preferably applied to a preparation in which the stability of the former vitamin B6 compound to light is low. A preparation containing water, such as a liquid preparation, a skin preparation for a liquid preparation, an eye wash, and a contact lens, may be mentioned as a preparation which is particularly problematic for the low stability of the light of the vitamin B6 compound (aqueous composition) ()). The reason for this is that in a composition containing water, the vitamin B6 compound tends to become unstable and is easily decomposed by light.

本發明之組合物由於維他命B6化合物對光之穩定性較高,故而亦可用作以供複數次投予之形態包裝,且使用者連續使用之多次劑量之水性液劑、例如滴眼藥(滴眼劑)、洗眼藥(洗眼劑)、洗鼻藥(洗鼻劑)、口腔用藥(口腔咽藥、及含漱用藥等)、滴耳藥、滴鼻藥(滴鼻劑)、隱形眼鏡用劑、液狀內服藥(液狀胃腸藥、液狀感冒藥等)、皮膚外用藥(生髮劑、外用鎮痛劑、外用鎮癢劑等)、化妝料(化妝水、乳液、美容液等)等。 Since the vitamin B6 compound has high stability to light, the composition of the present invention can also be used as a multi-aqueous aqueous solution, such as an eye drop, which is packaged in a form for multiple administrations and continuously used by the user. (eye drops), eye wash (eye wash), nasal wash (nasal wash), oral medication (oral pharyngeal, and sputum-containing medication), ear drops, nasal drops (nasal drops), invisible Glasses, liquid internal medicine (liquid gastrointestinal medicine, liquid cold medicine, etc.), external skin medication (hair growth agent, topical analgesic, topical itch, etc.), cosmetics (lotion, lotion, beauty lotion, etc.) )Wait.

本發明之組合物於作為特定之製劑使用之情形時,可不依賴於容器及包裝材料之設計,而提高維他命B6化合物對光之穩定性。作為將本發明之組合物包裝之容器,並無特別限定,例如就亦有欲掌握眼科用製劑等填充之組合物之內容量或剩餘量之情形等而言,可較佳地列舉包含聚乙烯、聚丙烯等烯烴系樹脂或聚對苯二甲酸乙二酯等聚酯系樹脂等之具有透光性之容器。 When the composition of the present invention is used as a specific preparation, the stability of the vitamin B6 compound to light can be improved without depending on the design of the container and the packaging material. The container for packaging the composition of the present invention is not particularly limited. For example, in order to grasp the content or the remaining amount of the composition filled with an ophthalmic preparation, etc., it is preferable to include polyethylene. A container having translucency such as an olefin resin such as polypropylene or a polyester resin such as polyethylene terephthalate.

於填充至透明或半透明之容器之情形時,先前,維他命B6化合 物容易暴露於光下,將含有植物萃取物與維他命B6之組合物製成填充於透明或半透明之容器之製品會降低維他命B6化合物對光之穩定性,故而非常困難。然而,由於本發明之組合物提高維他命B6類對光之穩定性,故而即便採用透明或半透明之容器作為將組合物包裝之容器,亦可發揮作為本發明之組合物之效果,可將組合物穩定地保持。作為透明或半透明之容器,可見光區域之透過率通常為10%以上,較佳為30%以上,更佳為50%以上,進而較佳為70%以上,尤佳為80%以上。又,關於該透過率之上限,為99%以下,但並不特別要求上限。 In the case of filling into a transparent or translucent container, previously, vitamin B6 combination The article is easily exposed to light, and the composition containing the plant extract and the vitamin B6 is filled into a transparent or translucent container to reduce the stability of the vitamin B6 compound to light, which is very difficult. However, since the composition of the present invention enhances the stability of the vitamin B6 to light, even if a transparent or translucent container is used as the container for packaging the composition, the effect of the composition of the present invention can be exerted, and the combination can be achieved. The material is kept steadily. As the transparent or translucent container, the transmittance in the visible light region is usually 10% or more, preferably 30% or more, more preferably 50% or more, further preferably 70% or more, and particularly preferably 80% or more. Further, the upper limit of the transmittance is 99% or less, but the upper limit is not particularly required.

(2)維他命B6化合物之光穩定化方法(2) Photo-stabilization method of vitamin B6 compound

本發明之光穩定化方法之特徵在於:其係含有維他命B6化合物及植物萃取物之組合物中之上述化合物之光穩定化方法,且將該組合物中之葉綠素之含量設為未達0.15ppm。 The light stabilizing method of the present invention is characterized in that it is a photostabilizing method of the above compound in a composition containing a vitamin B6 compound and a plant extract, and the content of the chlorophyll in the composition is set to less than 0.15 ppm. .

組合物中所含之維他命B6化合物及植物萃取物之含量可採用上述組合物之項目中記載之含量。 The content of the vitamin B6 compound and the plant extract contained in the composition may be the content described in the item of the above composition.

本發明之光穩定化方法可藉由於含有維他命B6化合物及植物萃取物之組合物中,使該組合物中之葉綠素之含量未達0.15ppm,而提高該組合物中之維他命B6化合物對光之穩定性。組合物中之葉綠素之含量較佳為未達0.1ppm左右,尤佳為未達0.05ppm左右。 The light stabilizing method of the present invention can improve the vitamin B6 compound in the composition by the composition containing the vitamin B6 compound and the plant extract, so that the content of the chlorophyll in the composition is less than 0.15 ppm. stability. The content of chlorophyll in the composition is preferably less than about 0.1 ppm, and particularly preferably less than about 0.05 ppm.

關於組合物中之其他成分、及添加物等之說明係如於上述組合物之項目中所說明般。 Descriptions of other ingredients, additives, and the like in the composition are as described in the items of the above composition.

[實施例] [Examples]

以下,藉由實施例更明確地說明本發明。然而,本發明並不受該實施例任何限定。 Hereinafter, the present invention will be more specifically described by way of examples. However, the invention is not limited by the examples.

(1)組合物之製備(1) Preparation of the composition

使用蘆薈(蘆薈之種類:木立蘆薈)作為植物體,製備植物萃取 物。 Preparation of plant extracts using aloe vera (aloe vera: Aloe vera) as a plant Things.

蘆薈之乙醇萃取物係藉由將生蘆薈細細切碎後,進行乾燥而使其粉末化,於該乾燥物總量中添加約10倍量之乙醇水溶液(80重量%乙醇,80%EtOH),於70~90℃下萃取2~3小時而獲得(蘆薈EtOH萃取物)。其後,添加活性碳而將葉綠素去除,藉此獲得蘆薈之活性碳處理萃取物(蘆薈EtOH萃取物(活性碳處理後))。又,蘆薈之1,3-丁二醇萃取物係藉由將生蘆薈細細切碎後進行乾燥,於該乾燥物總量中添加約30倍量之40重量%1,3-丁二醇水溶液,於室溫下萃取5~7晝夜而獲得(蘆薈BG(butylene glycol,丁二醇)萃取物)。 The ethanol extract of aloe vera is pulverized by finely chopping raw aloe vera, and about 10 times the amount of ethanol aqueous solution (80% by weight of ethanol, 80% EtOH) is added to the total amount of the dried product. It is extracted at 70-90 ° C for 2 to 3 hours to obtain (Aloe EtOH extract). Thereafter, activated carbon was added to remove chlorophyll, thereby obtaining an activated carbon treatment extract of aloe (aloe EtOH extract (after activated carbon treatment)). Further, the 1,3-butanediol extract of aloe vera is dried by finely chopping raw aloe vera, and about 30 times by weight of 1,3-butanediol is added to the total amount of the dried product. The aqueous solution was extracted at room temperature for 5-7 days to obtain (aloe BG (butylene glycol) extract).

蘆薈萃取物之固形物成分之含量係如下所述。 The content of the solid component of the aloe extract is as follows.

蘆薈之80%EtOH萃取物(表中之蘆薈EtOH萃取物):2.5重量%(乾燥物重量) 80% EtOH extract of aloe vera (Aloe EtOH extract in the table): 2.5% by weight (dry weight)

蘆薈之1,3-丁二醇萃取物(表中之蘆薈BG萃取物):1重量%(乾燥物重量) Aloe 1,3-butanediol extract (Aloe BG extract in the table): 1% by weight (dry weight)

蘆薈之80%EtOH萃取及活性碳處理後之萃取物(表中之蘆薈EtOH萃取物(活性碳處理後)):1重量%(乾燥物重量) 80% EtOH extraction of aloe vera and extract after activated carbon treatment (aloe extract from the table (after activated carbon treatment)): 1% by weight (dry weight)

使用上述蘆薈萃取物,以表1所示之組成,將各成分溶解於純化水,將總量設為100g,製備組合物之試驗液。 Using the above aloe extract, the components shown in Table 1 were dissolved in purified water, and the total amount was set to 100 g to prepare a test liquid of the composition.

於上述所製備之各蘆薈萃取物(蘆薈EtOH萃取物、蘆薈BG萃取物及蘆薈EtOH萃取物(活性碳處理後))中,確認含有作為蘆薈之含有成分之蘆薈素及蘆薈寧。因此,該等蘆薈萃取物係含有蘆薈之有效成分之適當之植物萃取物。 Among the aloe extracts (Aloe EtOH extract, Aloe BG extract and Aloe EtOH extract (after activated carbon treatment)) prepared above, it was confirmed that aloe and aloe were contained as a component of aloe. Accordingly, the aloe extracts are suitable plant extracts containing the active ingredients of aloe vera.

為了調整試驗液之pH值,使用檸檬酸及檸檬酸鈉。將試驗液之pH值設為pH值5.5。 In order to adjust the pH of the test solution, citric acid and sodium citrate were used. The pH of the test solution was set to pH 5.5.

鹽酸吡哆醇(維他命B6)係與蘆薈萃取物(植物萃取物)分開另行追加者。 Pyridoxine hydrochloride (vitamin B6) is added separately from aloe extract (plant extract).

試驗液中之葉綠素(Chlorophyll)之含量係藉由使用分光光度計之吸光光度法,按以下之程序測定。取試樣4g,添加鹼性碳酸鈣0.1g並添加水5mL與丙酮40mL後,放至超音波洗淨器,進行離心分離。將該步驟重複2次。於上清液中添加二乙醚50mL與水40mL,混合後靜置,將水層去除,將此操作重複3次。進而,利用無水硫酸鈉進行脫水過濾,利用二乙醚定容為100mL。對其使用分光光度計(日立製作所製造,型號U-2000),於測定波長660nm及642.5nm下測定,根據以下之式求值。 The content of chlorophyll (Chlorophyll) in the test solution was determined by the spectrophotometry using a spectrophotometer according to the following procedure. 4 g of the sample was taken, 0.1 g of basic calcium carbonate was added, and 5 mL of water and 40 mL of acetone were added, and the mixture was placed in an ultrasonic cleaner and centrifuged. This step was repeated 2 times. 50 mL of diethyl ether and 40 mL of water were added to the supernatant, and the mixture was allowed to stand, and the aqueous layer was removed, and this operation was repeated 3 times. Further, it was subjected to dehydration filtration using anhydrous sodium sulfate, and made up to 100 mL with diethyl ether. This was measured using a spectrophotometer (manufactured by Hitachi, Ltd., model U-2000) at measurement wavelengths of 660 nm and 642.5 nm, and was evaluated according to the following formula.

總葉綠素(mg/100g)=(7.12E660+16.8E642.5)×V×100/1000 Total chlorophyll (mg / 100g) = (7.12E 660 + 16.8E 642.5) × V × 100/1000

葉綠素a(mg/100g)=(9.93E660-0.777E642.5)×V×100/1000 Chlorophyll a (mg / 100g) = ( 9.93E 660 -0.777E 642.5) × V × 100/1000

葉綠素b(mg/100g)=總葉綠素(mg/100g)-葉綠素b(mg/100g) Chlorophyll b (mg/100g) = total chlorophyll (mg/100g) - chlorophyll b (mg/100g)

所謂E660、E642.5,係指660nm、642.5nm下之吸光度,W係指樣品採集量(g)、V係指醚定容量(mL)。 The so-called E 660, E 642.5, refers to 660nm, the absorbance at 642.5nm, W refers to the amount of collected sample (g), V refers ether constant volume (mL).

表中,EtOH表示乙醇,BG表示1,3-丁二醇。 In the table, EtOH represents ethanol and BG represents 1,3-butanediol.

(2)組合物中之維他命B6類之光穩定性評價(2) Light stability evaluation of vitamin B6 in the composition 光穩定性之試驗方法Test method for light stability

將各試驗液分別填充100mL或200mL至透明玻璃瓶(容量200mL),將該等作為受檢樣品。作為螢光燈試驗機,使用growth chamber(三洋電機,MLR-351),對受檢樣品於15℃下連續54小時照射10,000勒克司/小時之光,暴露於54萬勒克司‧hr之光。該光照射量係參照「大阪府LED照明機器開發推進計劃策定事業」報告書(大阪府),以一般家庭之約6個月間之平均照射量為基礎而設定。 Each test solution was filled with 100 mL or 200 mL to a clear glass bottle (capacity: 200 mL), and these were used as test samples. As a fluorescent lamp tester, a growth chamber (Sanyo Electric, MLR-351) was used, and the test sample was irradiated with 10,000 lux/hr of light at 15 ° C for 54 hours, and exposed to light of 540,000 lux. This light exposure amount is set based on the "Osaka Prefecture LED Lighting Equipment Development Promotion Planning Policy" (Osaka Prefecture), based on the average exposure of the general family for about 6 months.

藉由高效液相層析法測定光照射前與光照射後之受檢樣品中之鹽酸吡哆醇濃度。由所測定之受檢樣品之鹽酸吡哆醇濃度,根據下述式,算出光照射後之鹽酸吡哆醇之殘存率(%)。 The concentration of pyridoxine hydrochloride in the test sample before and after light irradiation was measured by high performance liquid chromatography. From the pyridoxine hydrochloride concentration of the sample to be measured, the residual ratio (%) of pyridoxine hydrochloride after light irradiation was calculated according to the following formula.

殘存率(%)=100×光照射後之鹽酸吡哆醇濃度(重量%) /光照射前之鹽酸吡哆醇濃度(重量%) Residual rate (%) = 100 × pyridoxine hydrochloride concentration after light irradiation (% by weight) /pyridinium hydrochloride concentration before light irradiation (% by weight)

(3)試驗結果(3) Test results

將光穩定性之試驗結果示於表1及2。 The test results of the photostability are shown in Tables 1 and 2.

含有鹽酸吡哆醇(維他命B6化合物)及蘆薈萃取物(植物萃取物)且葉綠素a(葉綠素)之含量未達0.15ppm之實施例1~3於光穩定性試驗後,鹽酸吡哆醇之殘存率較高。具體而言,於實施例1~3中,鹽酸吡 哆醇之殘存率為90%以上。 Examples 1 to 3 containing pyridoxine hydrochloride (vitamin B6 compound) and aloe extract (plant extract) and chlorophyll a (chlorophyll) content of less than 0.15 ppm after photostability test, residual pyridoxine hydrochloride The rate is higher. Specifically, in Examples 1 to 3, pyridinium hydrochloride The residual rate of sterol is 90% or more.

於葉綠素a之含量為0.15ppm以上之比較例1~3中,鹽酸吡哆醇之殘存率降低至85%以下。 In Comparative Examples 1 to 3 in which the content of chlorophyll a was 0.15 ppm or more, the residual ratio of pyridoxine hydrochloride was lowered to 85% or less.

即,判明藉由將含有蘆薈萃取物之組合物中之葉綠素a之濃度調整為未達0.15ppm,可提高鹽酸吡哆醇對光之穩定性。 That is, it was found that the stability of pyridoxine hydrochloride to light can be improved by adjusting the concentration of chlorophyll a in the composition containing the aloe extract to less than 0.15 ppm.

再者,於蘆薈中,通常包含葉綠素a及b,但葉綠素b之含量少於葉綠素a之含量,於任一實施例及比較例中,均未達0.05ppm。 Further, in aloe vera, chlorophyll a and b are usually contained, but the content of chlorophyll b is less than the content of chlorophyll a, and in any of the examples and comparative examples, it is less than 0.05 ppm.

藻類及藍藻亦含有葉綠素(葉綠素)。作為藻類中所含之葉綠素,有葉綠素b(一部分綠藻類)、葉綠素c(褐藻類及矽藻類)、葉綠素d(紅藻類)、葉綠素e(不等鞭毛藻類)。作為藍藻中所含之葉綠素,有葉綠素c。 Algae and cyanobacteria also contain chlorophyll (chlorophyll). As the chlorophyll contained in the algae, there are chlorophyll b (a part of green algae), chlorophyll c (hay algae and algae), chlorophyll d (red algae), and chlorophyll e (unequalile algae). As a chlorophyll contained in cyanobacteria, there is chlorophyll c.

此處,使用藻類及藍藻代替上述植物體(蘆薈),以與上述蘆薈相同之方式製備萃取物等組合物之試驗液。於該等組合物中含有鹽酸吡哆醇(維他命B6化合物)及藻類及藍藻之萃取物等,將葉綠素之含量設為未達0.15ppm。然後,亦對該等試驗液與上述植物體同樣地評價組合物中之維他命B6類之光穩定性。 Here, algae and cyanobacteria were used instead of the above-mentioned plant body (aloe), and a test liquid of a composition such as an extract was prepared in the same manner as the above aloe. The composition contains pyridoxine hydrochloride (vitamin B6 compound), an extract of algae and cyanobacteria, and the like, and the content of chlorophyll is less than 0.15 ppm. Then, the test liquids were also evaluated for the photostability of the vitamin B6 in the composition in the same manner as the above plant.

其結果為,可知關於由藻類及藍藻所製備之萃取物等之組合物,於光穩定性試驗後,鹽酸吡哆醇之殘存率亦較高。 As a result, it was found that the composition of the extract or the like prepared from algae and cyanobacteria had a high residual ratio of pyridoxine hydrochloride after the photostability test.

由該等情況判明,與植物萃取物同樣地,於含有由藻類及藍藻所製備之萃取物等之組合物中,亦可藉由將組合物中之葉綠素之濃度調整為未達0.15ppm而提高鹽酸吡哆醇對光之穩定性。 From these circumstances, it has been found that, in the same manner as the plant extract, the composition containing the extract or the like prepared from the algae and the cyanobacteria can be improved by adjusting the concentration of the chlorophyll in the composition to less than 0.15 ppm. The stability of pyridoxine hydrochloride to light.

(3)配方例(3) Formulation example 生髮劑Hair tonic

製備表3所示之組成之葉綠素之含量未達0.15ppm之生髮劑(配方例1~9)。任一生髮劑均為鹽酸吡哆醇、鹽酸吡哆醛、二鹽酸吡哆胺之穩定性優異者。 A hair restorer (Formulation Examples 1 to 9) having a chlorophyll content of the composition shown in Table 3 of less than 0.15 ppm was prepared. Any of the hair growth agents are excellent in the stability of pyridoxine hydrochloride, pyridoxal hydrochloride, and pyridoxamine dihydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

滴眼劑Eye drops

製備表4所示之組成之葉綠素之含量未達0.15ppm之滴眼劑(配方例10~18)。任一滴眼劑均為鹽酸吡哆醇之穩定性優異者。 The eye drops of the composition shown in Table 4 having a chlorophyll content of less than 0.15 ppm (Formulation Examples 10 to 18) were prepared. Any eye drop is excellent in the stability of pyridoxine hydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

滴鼻劑Nasal drops

製備表5所示之組成之葉綠素之含量未達0.15ppm之滴鼻劑(配方例19)。該滴鼻劑亦為鹽酸吡哆醇之穩定性優異者。 Nasal drops having a composition of the chlorophyll of the composition shown in Table 5 of less than 0.15 ppm (Formulation Example 19) were prepared. The nasal drops are also excellent in the stability of pyridoxine hydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

洗眼劑Eye wash

製備表6所示之組成之葉綠素之含量未達0.15ppm之洗眼劑(配方例20)。該洗眼劑亦為鹽酸吡哆醇之穩定性優異者。 An eye wash (formulation example 20) having a chlorophyll content of the composition shown in Table 6 of less than 0.15 ppm was prepared. The eye wash is also excellent in the stability of pyridoxine hydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

洗鼻劑Nasal wash

製備表7所示之組成之葉綠素之含量未達0.15ppm之洗鼻劑(配方例21)。該洗鼻劑亦為鹽酸吡哆醇之穩定性優異者。 Nasal drops having a composition of the chlorophyll of the composition shown in Table 7 of less than 0.15 ppm (Formulation Example 21) were prepared. The nasal wash is also excellent in the stability of pyridoxine hydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

隱形眼鏡用劑Contact lens agent

製備表8所示之組成之葉綠素之含量未達0.15ppm之隱形眼鏡用劑(配方例22)。該隱形眼鏡用劑亦為鹽酸吡哆醇之穩定性優異者。 A contact lens agent (Formulation Example 22) having a chlorophyll content of the composition shown in Table 8 of less than 0.15 ppm was prepared. The contact lens agent is also excellent in the stability of pyridoxine hydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

乳霜Cream

製備表9所示之組成之葉綠素之含量未達0.15ppm之乳霜(配方例23)。該乳霜亦為鹽酸吡哆醇之穩定性優異者。 A cream having a composition of the chlorophyll of the composition shown in Table 9 of less than 0.15 ppm was prepared (Formulation Example 23). The cream is also excellent in the stability of pyridoxine hydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

化妝水Lotion

製備表10所示之組成之葉綠素之含量未達0.15ppm之化妝水(配方例24)。該化妝水亦為鹽酸吡哆醇之穩定性優異者。 A lotion having a composition of the chlorophyll of the composition shown in Table 10 of less than 0.15 ppm was prepared (Formulation Example 24). The lotion is also excellent in the stability of pyridoxine hydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

美容液Beauty liquid

製備表11所示之組成之葉綠素之含量未達0.15ppm之美容液(配方例25)。該美容液亦為鹽酸吡哆醇之穩定性優異者。 A cosmetic liquid having a composition of the composition shown in Table 11 and having a chlorophyll content of less than 0.15 ppm was prepared (Formulation Example 25). The cosmetic liquid is also excellent in the stability of pyridoxine hydrochloride.

表中,各調配成分之含量之單位為重量%。 In the table, the unit of the content of each compounding component is % by weight.

飲劑Drink

製備表12所示之組成之葉綠素之含量未達0.15ppm之飲劑(配方例26)。該飲劑亦為鹽酸吡哆醇之穩定性優異者。 A drink having a composition of the composition shown in Table 12 having a chlorophyll content of less than 0.15 ppm was prepared (Formulation Example 26). The drink is also excellent in the stability of pyridoxine hydrochloride.

Claims (16)

一種組合物,其特徵在於:其係含有選自由維他命B6及該等之鹽所組成之群中之至少一種化合物、以及植物萃取物者,且該組合物中之葉綠素之含量未達0.15ppm。 A composition comprising at least one compound selected from the group consisting of vitamin B6 and the salts thereof, and a plant extract, and the chlorophyll content of the composition is less than 0.15 ppm. 如請求項1之組合物,其中上述植物萃取物係含有選自由維他命B6及該等之鹽所組成之群中之至少一種化合物者,且上述化合物係內含於該植物萃取物者、或內含於該植物萃取物者與選自由外來性之維他命B6及該等之鹽所組成之群中之至少一種化合物之混合物。 The composition of claim 1, wherein the plant extract contains at least one compound selected from the group consisting of vitamin B6 and a salt thereof, and the compound is contained in the plant extract, or A mixture of the plant extract and at least one compound selected from the group consisting of exogenous vitamin B6 and salts thereof. 如請求項1之組合物,其中上述植物萃取物係不含選自由維他命B6及該等之鹽所組成之群中之至少一種化合物者,且上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物係另外添加於組合物者。 The composition of claim 1, wherein the plant extract is free of at least one compound selected from the group consisting of vitamin B6 and a salt thereof, and the above is selected from the group consisting of vitamin B6 and the salts thereof. At least one compound of the group is additionally added to the composition. 如請求項1之組合物,其中上述葉綠素係選自由葉綠素a及葉綠素b所組成之群中之至少一種葉綠素。 The composition of claim 1, wherein the chlorophyll is selected from the group consisting of chlorophyll a and chlorophyll b. 如請求項2之組合物,其中上述葉綠素係選自由葉綠素a及葉綠素b所組成之群中之至少一種葉綠素。 The composition of claim 2, wherein the chlorophyll is selected from the group consisting of chlorophyll a and chlorophyll b. 如請求項3之組合物,其中上述葉綠素係選自由葉綠素a及葉綠素b所組成之群中之至少一種葉綠素。 The composition of claim 3, wherein the chlorophyll is selected from the group consisting of chlorophyll a and chlorophyll b. 如請求項1之組合物,其中上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物為鹽酸吡哆醇。 The composition of claim 1, wherein the at least one compound selected from the group consisting of vitamin B6 and the salts is pyridoxine hydrochloride. 如請求項2之組合物,其中上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物為鹽酸吡哆醇。 The composition of claim 2, wherein the at least one compound selected from the group consisting of vitamin B6 and the salts is pyridoxine hydrochloride. 如請求項3之組合物,其中上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物為鹽酸吡哆醇。 The composition of claim 3, wherein the at least one compound selected from the group consisting of vitamin B6 and the salts is pyridoxine hydrochloride. 如請求項4之組合物,其中上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物為鹽酸吡哆醇。 The composition of claim 4, wherein the at least one compound selected from the group consisting of vitamin B6 and the salts is pyridoxine hydrochloride. 如請求項5之組合物,其中上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物為鹽酸吡哆醇。 The composition of claim 5, wherein the at least one compound selected from the group consisting of vitamin B6 and the salts is pyridoxine hydrochloride. 如請求項6之組合物,其中上述選自由維他命B6及該等之鹽所組成之群中之至少一種化合物為鹽酸吡哆醇。 The composition of claim 6, wherein the at least one compound selected from the group consisting of vitamin B6 and the salts is pyridoxine hydrochloride. 如請求項1至12中任一項之組合物,其中上述植物萃取物係自綠色植物之植物體萃取之萃取物。 The composition of any one of claims 1 to 12, wherein the plant extract is an extract extracted from a plant of a green plant. 如請求項1至12中任一項之組合物,其係生髮劑、滴眼劑、滴鼻劑、洗眼劑、洗鼻劑或隱形眼鏡用劑。 The composition according to any one of claims 1 to 12, which is a hair growth agent, an eye drop, a nasal drop, an eye wash, a nasal wash or a contact lens. 如請求項13之組合物,其係生髮劑、滴眼劑、滴鼻劑、洗眼劑、洗鼻劑或隱形眼鏡用劑。 The composition of claim 13, which is a hair growth agent, eye drops, nasal drops, eye wash, nasal wash or contact lens. 一種光穩定化方法,其特徵在於:其係含有選自由維他命B6及該等之鹽所組成之群中之至少一種化合物、以及植物萃取物的組合物中之上述化合物之光穩定化方法,且將該組合物中之葉綠素之含量設為未達0.15ppm。 A method for stabilizing light, which comprises a method for stabilizing a compound selected from the group consisting of at least one compound selected from the group consisting of vitamin B6 and salts thereof, and a compound of the plant extract, and The content of chlorophyll in the composition was set to be less than 0.15 ppm.
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