JP2013100270A - Galenical extract-containing liquid composition - Google Patents
Galenical extract-containing liquid composition Download PDFInfo
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- JP2013100270A JP2013100270A JP2012226466A JP2012226466A JP2013100270A JP 2013100270 A JP2013100270 A JP 2013100270A JP 2012226466 A JP2012226466 A JP 2012226466A JP 2012226466 A JP2012226466 A JP 2012226466A JP 2013100270 A JP2013100270 A JP 2013100270A
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- 239000000203 mixture Substances 0.000 title claims abstract description 37
- 239000000284 extract Substances 0.000 title claims abstract description 31
- 239000002244 precipitate Substances 0.000 claims abstract description 33
- 239000000341 volatile oil Substances 0.000 claims abstract description 26
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- 230000015572 biosynthetic process Effects 0.000 claims abstract description 24
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Abstract
Description
本発明は、生薬エキスを含有する液体組成物に関する。さらに詳しくは、生薬エキスを含有し、長期間保存した場合に沈殿や浮遊物の生成が抑制された液体組成物に関し、医薬品、指定医薬部外品及び食品の分野に応用できる。 The present invention relates to a liquid composition containing a herbal extract. More specifically, the present invention relates to a liquid composition containing a herbal extract and in which the formation of precipitates and suspended solids is suppressed when stored for a long period of time, and can be applied to the fields of pharmaceuticals, designated quasi drugs and foods.
生薬は動植物の薬用とする部分、細胞内容物、分泌物、抽出物又は鉱物などである。生薬は特有の効能、効果を有しており、医薬品、指定医薬部外品及び食品の成分・有効成分として利用されてきた。そして、生薬中の成分を抽出した生薬エキスは、医薬品、指定医薬部外品及び食品の分野に属する各種飲料に配合されているが、生薬エキスをそのまま各種飲料に配合した場合、経時的に沈殿や浮遊物が生成するという課題があった。飲料中の生薬エキスに起因する沈殿や浮遊物は、商品価値を低下させるばかりでなく、沈殿や浮遊物の中に薬効成分が含まれていた場合、十分な薬効を発揮できない可能性があるため好ましくない。 Herbal medicines are medicinal parts of animals and plants, cell contents, secretions, extracts or minerals. Herbal medicines have specific effects and effects, and have been used as components and active ingredients of pharmaceuticals, designated quasi drugs and foods. The herbal extracts from which the ingredients in the herbal medicine are extracted are blended in various beverages belonging to the fields of pharmaceuticals, designated quasi-drugs and foods. There was a problem of generating floating substances. Precipitates and suspended solids resulting from crude drug extracts in beverages not only reduce the commercial value, but if the precipitate or suspended matter contains medicinal ingredients, it may not be able to exert its full medicinal properties. It is not preferable.
そこで、生薬エキスを飲料に配合する場合において、経時的な沈殿や浮遊物の生成を抑制するために種々の方法が提案されてきた。例えば、アルギン酸プロピレングリコールエステルを配合したサポニン含有生薬を有効成分とする内服液剤の沈殿抑制方法（特許文献１参照）、ポリオキシエチレン硬化ヒマシ油誘導体及びポリビニルピロリドンを配合した生薬浸出成分を含む水性液剤の生薬成分析出防止方法（特許文献２参照）である。 Therefore, various methods have been proposed in order to suppress the formation of precipitates and suspended matters over time in the case of blending herbal extracts into beverages. For example, an aqueous liquid preparation containing a crude drug leaching component containing a saponin-containing herbal medicine blended with alginate propylene glycol ester as an active ingredient (see Patent Document 1), a polyoxyethylene hydrogenated castor oil derivative and polyvinylpyrrolidone This is a herbal medicine component precipitation prevention method (see Patent Document 2).
しかしながら、これらの方法は、飲料としての服用性や防腐性等の観点から好ましいとされる酸性域での長期保存安定性に課題があり、酸性域においても生薬エキスに起因する沈殿や浮遊物の生成が十分に抑制された飲料は、未だに提供されていないというのが実状であった。 However, these methods have a problem in long-term storage stability in the acidic range, which is preferable from the viewpoint of ingestion as a beverage, antiseptic properties, and the like. The actual situation is that beverages whose production is sufficiently suppressed have not yet been provided.
本発明は、生薬エキスを含有する液体組成物において、服用性や防腐性等の観点から好ましいとされる酸性域においても、長期間保存した場合に、生薬エキスに起因する沈殿や浮遊物の生成が十分に抑制された液体組成物を提供することを目的とする。 The present invention is a liquid composition containing a herbal extract, and when it is stored for a long period of time, even in an acidic range that is preferable from the viewpoints of ingestion and preservability, the formation of precipitates and floating substances caused by the herbal extract An object of the present invention is to provide a liquid composition in which is sufficiently suppressed.
本発明者らは、上記課題を解決すべく鋭意検討した結果、生薬エキスに１種以上の精油及びポリビニルアルコールを配合することにより、酸性域においても生薬エキスに起因する沈殿や浮遊物の生成が抑制され、長期間保存しても安定な生薬エキス含有液体組成物を提供できることを見出した。 As a result of intensive studies to solve the above-mentioned problems, the present inventors have formulated one or more kinds of essential oils and polyvinyl alcohol into the crude drug extract, so that precipitates and suspended matter caused by the crude drug extract can be generated even in the acidic region. It was found that a herbal extract-containing liquid composition that is suppressed and stable even after long-term storage can be provided.
かかる知見に基づく本発明の態様は次のとおりである。
（１）精油、ポリビニルアルコール及び生薬エキスを含有することを特徴とする液体組成物。
（２）（ａ）オクタノール／水分配係数（ＬｏｇＰｏｗ）が３．３以下である成分を５０質量％以上含有する精油、（ｂ）けん化度が７０mol％以上で平均重合度が５００〜４５００であるポリビニルアルコール、並びに（ｃ）ｐＨ３．２のクエン酸水溶液に３．０質量％を配合し、９０℃で２時間加熱したときに、目視によって沈殿や浮遊物の生成が確認される生薬エキス、を含有することを特徴とする液体組成物。
（３）生薬エキスの１質量部に対して、精油が０．００１質量部以上及びポリビニルアルコールが０．０２質量部以上である前記（１）又は（２）に記載の液体組成物。
（４）生薬エキスがニンジン、カンゾウ、チンピ、ショウキョウ、コウジン、シゴカ、タイソウ、サイコ及びインヨウカクからなる群より選択される１種もしくは２種以上のエキスである前記（１）〜（３）のいずれかに記載の液体組成物。
（５）精油がチョウジ油、ケイヒ油、ハッカ油及びシソ油からなる群より選択される１種もしくは２種以上である前記（１）〜（３）のいずれかに記載の液体組成物。
（６）ｐＨが２．０〜７．０の飲料である前記（１）〜（５）のいずれかに記載の液体組成物。
Aspects of the present invention based on such findings are as follows.
(1) A liquid composition comprising essential oil, polyvinyl alcohol and a herbal extract.
(2) (a) Essential oil containing 50% by mass or more of a component having an octanol / water partition coefficient (LogPow) of 3.3 or less, (b) A saponification degree of 70 mol% or more and an average polymerization degree of 500 to 4500 Polyvinyl alcohol, and (c) a herbal medicine extract in which 3.0% by mass is added to a citric acid aqueous solution of pH 3.2 and the formation of precipitates and suspended solids is visually confirmed when heated at 90 ° C. for 2 hours. A liquid composition containing the liquid composition.
(3) The liquid composition according to (1) or (2), wherein the essential oil is 0.001 part by mass or more and the polyvinyl alcohol is 0.02 part by mass or more with respect to 1 part by mass of the herbal extract.
(4) The above (1) to (3), wherein the herbal extract is one or more extracts selected from the group consisting of carrot, licorice, chimpi, ginger, kojin, shigoka, taisou, psychiatric and indigo. A liquid composition according to any one of the above.
(5) The liquid composition according to any one of (1) to (3), wherein the essential oil is one or more selected from the group consisting of clove oil, cinnamon oil, mint oil and perilla oil.
(6) The liquid composition according to any one of (1) to (5), which is a beverage having a pH of 2.0 to 7.0.
本発明により、酸性域においても、生薬エキスに起因する沈殿や浮遊物の生成が抑制され、長期間保存しても安定な生薬エキス含有液体組成物を提供することが可能となった。 According to the present invention, it is possible to provide a herbal extract-containing liquid composition that is stable even when stored for a long period of time.
本発明の生薬とは、植物、動物、鉱物等の天然の存在する素材の全部又は一部をそのまま又は加工処理し、薬用に供するものをいい、例えば、インヨウカク、ウコン、エンメイソウ、オウギ、カンゾウ、キキョウ、コウジン、サイコ、シゴカ、シャクヤク、ショウキョウ、タイソウ、チンピ、トウキ、トシシ、ニンジン、ハンゲ、ブクリョウ等、日本薬局方等の公定書収載品又はその他の汎用生薬等を包含するものである。 The herbal medicine of the present invention refers to those that are used for medicinal purposes, as they are, or after processing all or part of naturally occurring raw materials such as plants, animals, minerals, etc., for example, indigo, turmeric, enamel, ogi, licorice, It includes officially listed products such as Japanese pharmacopoeia or other general herbal medicines such as Kyoku, Kojin, Psycho, Shigoka, Peonies, Pepper, Taiso, Chimpi, Toki, Toshishi, Carrot, Hange, Bukuryo.
本発明の生薬エキスとしては、かかる生薬の１種又は２種以上から公知の方法により抽出された抽出物が挙げられる。抽出方法は特に限定されるものではなく、一般的に公知の方法で抽出されたエキス、例えば日本薬局方に示された方法等により製造された流エキス、軟エキス、乾燥エキス、チンキ等が該当する。 The crude drug extract of the present invention includes an extract extracted from one or more of these crude drugs by a known method. The extraction method is not particularly limited, and generally includes extracts extracted by known methods, such as flow extract, soft extract, dry extract, tincture, etc. produced by the method shown in the Japanese Pharmacopoeia. To do.
生薬エキスは、ｐＨが低い酸性域ほど沈殿や浮遊物が生成しやすく、経時的に沈殿や浮遊物の生成が生じる生薬エキスの簡易な見極め法として、ｐＨ３．２のクエン酸水溶液に３．０質量％を配合し（溶解させて）、９０℃で２時間加熱した場合に、目視によって沈殿や浮遊物の生成が確認されることが挙げられる。 The crude drug extract is more likely to precipitate or float in the acidic region where the pH is lower, and as a simple method of identifying a crude drug extract in which precipitation or float is generated over time, the crude drug extract is added to an aqueous citric acid solution of pH 3.2. When mass% is blended (dissolved) and heated at 90 ° C. for 2 hours, the formation of precipitates and suspended matters can be confirmed by visual observation.
そして、そのような沈殿や浮遊物の生成抑制という観点からは、ニンジン、カンゾウ、チンピ、ショウキョウ、コウジン、シゴカ、タイソウ、サイコ及びインヨウカクからなる群より選択される１種もしくは２種以上を含む生薬エキスが好ましく、ニンジン、カンゾウ、ショウキョウ及びチンピからなる群より選択される１種もしくは２種を含む生薬エキスがより好ましい。中でも、ニンジンエキスは最も沈殿や浮遊物が生成しやすく、本発明を用いる意義が大きい。 From the viewpoint of suppressing the formation of such precipitates and suspended solids, it includes one or more selected from the group consisting of carrots, licorice, chimpi, ginger, kojin, shigoka, taisou, psycho and indigo. Herbal extracts are preferred, and herbal extracts containing one or two selected from the group consisting of carrot, licorice, ginger and chimpi are more preferred. Among them, the carrot extract is most likely to produce precipitates and suspended matters, and is significant for using the present invention.
生薬エキスの含有（配合）量は、液体組成物を液剤として提供する場合、液剤全体の０．００１〜５．０質量％である。 When the liquid composition is provided as a liquid preparation, the content (formulation) of the crude drug extract is 0.001 to 5.0 mass% of the whole liquid preparation.
本発明の精油とは、種々の植物の花、つぼみ、葉、枝、幹、根などから得られる揮発性の油のことであり、例えば、チョウジ油、ケイヒ油、ハッカ油、シソ油、トウヒ油、ウイキョウ油が挙げられる。 The essential oil of the present invention is a volatile oil obtained from flowers, buds, leaves, branches, trunks, roots, and the like of various plants. For example, clove oil, cinnamon oil, mint oil, perilla oil, spruce And oil and fennel oil.
かかる精油のうち、液体組成物中の生薬エキスに起因する沈殿や浮遊物の生成を抑制するという観点から、オクタノール／水分配係数（ＬｏｇＰｏｗ）が３．３以下、好ましくは１．５〜３．３である成分を５０質量％以上含有する精油が好ましい。具体的には、チョウジ油、ケイヒ油、ハッカ油及びシソ油からなる群より選択される１種もしくは２種以上を含む精油が好ましく、チョウジ油及びケイヒ油からなる群より選択される１種もしくは２種を含む精油がより好ましい。 Among such essential oils, from the viewpoint of suppressing the formation of precipitates and suspended solids due to the herbal extract in the liquid composition, the octanol / water partition coefficient (LogPow) is 3.3 or less, preferably 1.5 to 3. An essential oil containing 50% by mass or more of the component 3 is preferable. Specifically, an essential oil containing one or more selected from the group consisting of clove oil, cinnamon oil, mint oil and perilla oil is preferred, and one or more essential oils selected from the group consisting of clove oil and cinnamon oil The essential oil containing 2 types is more preferable.
なお、チョウジ油はオクタノール／水分配係数（ＬｏｇＰｏｗ）が２．３であるオイゲノールを７０〜９０質量％含有し、ケイヒ油はＬｏｇＰｏｗが１．９であるケイヒアルデヒドを７５〜９０質量％含有し、ハッカ油はＬｏｇＰｏｗが２．５であるｌ−メントールを７０〜９０質量％含有し、シソ油はＬｏｇＰｏｗが２．６であるぺリラアルデヒドを５５質量％含有するが、ウイキョウ油はＬｏｇＰｏｗが３．５であるアネトールを５０〜６０質量％、他にＬｏｇＰｏｗが４．６であるリモネンを含有するため、ＬｏｇＰｏｗが３．３以下である成分を５０質量％以上含有することはない。 In addition, clove oil contains 70 to 90% by mass of eugenol having an octanol / water partition coefficient (LogPow) of 2.3, and cinnamon oil contains 75 to 90% by mass of cinnamaldehyde having a LogPow of 1.9, Mentha oil contains 70-90% by mass of 1-menthol having a LogPow of 2.5, and perilla oil contains 55% by mass of perylaldehyde having a LogPow of 2.6, whereas fennel oil has a LogPow of 3. 5 contains 50 to 60% by mass of anethole, and limonene having a LogPow of 4.6, so that a component having a LogPow of 3.3 or less does not contain 50% by mass or more.
精油の含有（配合）量は、生薬エキスに起因する沈殿や浮遊物の生成を抑制しうる量であれば特に限定はないが、生薬エキスの１質量部に対して０．００１質量部以上であり、０．００３質量部以上が好ましい。 The content (formulation) of the essential oil is not particularly limited as long as it is an amount that can suppress the formation of precipitates and suspended matters due to the herbal extract, but 0.001 part by mass or more with respect to 1 part by mass of the herbal extract. Yes, 0.003 parts by mass or more is preferable.
本発明のポリビニルアルコールとは、ポリ酢酸ビニルをけん化して得られた重合物である。ポリビニルアルコールのけん化度は通常７０mol％以上であり、８０mol％以上が好ましく、８５mol％以上がより好ましい。ポリビニルアルコールの平均重合度は通常５００以上４５００以下であり，５００以上３０００以下が好ましい。 The polyvinyl alcohol of the present invention is a polymer obtained by saponifying polyvinyl acetate. The saponification degree of polyvinyl alcohol is usually 70 mol% or more, preferably 80 mol% or more, and more preferably 85 mol% or more. The average degree of polymerization of polyvinyl alcohol is usually 500 or more and 4500 or less, and preferably 500 or more and 3000 or less.
ポリビニルアルコールの含有（配合）量は、精油と共に生薬エキスに起因する沈殿や浮遊物の生成を抑制しうる量であれば特に限定はないが、生薬エキスの１質量部に対して０．０２質量部以上であり、０．１質量部以上が好ましい。 The content (formulation) of polyvinyl alcohol is not particularly limited as long as it is an amount that can suppress the formation of precipitates and suspended matters caused by the herbal extract together with the essential oil, but is 0.02 mass relative to 1 part by mass of the herbal extract. Part or more, preferably 0.1 part by weight or more.
本発明の液体組成物はいずれのｐＨでも安定であるが、〔水性〕飲料として提供する場合、服用性や防腐性等の観点から、酸性域における生薬エキスに起因する沈殿や浮遊物の生成を抑制することに大きな意義がある。よって、〔水性〕飲料とする場合のｐＨとしては、ｐＨ２．０〜７．０が好ましく、ｐＨ２．０〜６．０がより好ましい。そして、ｐＨの調整には、可食性の酸を用いることができ、具体的には、クエン酸、リンゴ酸、酒石酸、フマル酸、乳酸、コハク酸、アスコルビン酸などの有機酸及びそれらの塩類、塩酸、リン酸などの無機酸及びそれらの塩類などが挙げられる。これらのｐＨ調整剤は１種を用いるだけでなく、２種以上を組み合わせて用いてもよい。 The liquid composition of the present invention is stable at any pH, but when it is provided as an [aqueous] beverage, from the viewpoint of ingestion and preservability, the formation of precipitates and suspended matters due to the herbal extract in the acidic region There is great significance in suppressing it. Therefore, the pH in the case of an [aqueous] beverage is preferably pH 2.0 to 7.0, more preferably pH 2.0 to 6.0. An edible acid can be used to adjust the pH. Specifically, citric acid, malic acid, tartaric acid, fumaric acid, lactic acid, succinic acid, ascorbic acid and other organic acids and their salts, Examples thereof include inorganic acids such as hydrochloric acid and phosphoric acid, and salts thereof. These pH adjusters may be used alone or in combination of two or more.
本発明の生薬エキス含有液体組成物を調製する方法は、通常、生薬エキス、精油、ポリビニルアルコールを含む各成分を適量の精製水で溶解した後、ｐＨを調整し、更に精製水を加えて容量調整し、必要に応じて濾過、滅菌処理を施す方法が挙げられる。また、生薬エキス、精油、ポリビニルアルコールを秤量して精製水を加え、超音波やホモジナイザー等により分散させた後、その他の成分を溶解し、ｐＨを調整し、更に精製水を加えて容量調整し、必要に応じて濾過、滅菌処理を施す方法も挙げられる。 The method for preparing the herbal extract-containing liquid composition of the present invention is usually prepared by dissolving each component including herbal extracts, essential oils, and polyvinyl alcohol with an appropriate amount of purified water, adjusting the pH, and further adding purified water. The method of adjusting and performing filtration and a sterilization process as needed is mentioned. Also, weigh herbal extracts, essential oils, polyvinyl alcohol, add purified water, disperse with ultrasonic waves or homogenizer, etc., dissolve other components, adjust pH, and add purified water to adjust the volume. A method of performing filtration and sterilization treatment as necessary is also mentioned.
本発明の生薬エキス含有液体組成物は、内服液剤、ドリンク剤等の医薬品及び指定医薬部外品の他、栄養機能食品、特定保健用食品等の食品領域における各種飲料として提供される。 The crude drug extract-containing liquid composition of the present invention is provided as various beverages in food areas such as nutritional functional foods and foods for specified health use, in addition to pharmaceuticals such as internal liquids and drinks and designated quasi drugs.
その際、水、アルコール、ビタミン及びその塩類、ミネラル、アミノ酸又はその塩類、カフェイン、コンドロイチン硫酸ナトリウム、甘味剤、矯味剤、界面活性剤、溶解補助剤、保存剤、抗酸化剤、着色剤、香料等の飲食品または製剤に一般に使用される成分等を、本発明の効果を損なわない範囲で適宜に配合することができる。 In that case, water, alcohol, vitamins and salts thereof, minerals, amino acids or salts thereof, caffeine, sodium chondroitin sulfate, sweetener, flavoring agent, surfactant, solubilizer, preservative, antioxidant, colorant, Ingredients generally used in foods and beverages such as fragrances or preparations can be appropriately blended as long as the effects of the present invention are not impaired.
なお、生薬エキスに起因する沈殿や浮遊物の評価は、後述する試験例のように５０℃において２ヶ月間または６５℃において２週間保存し、液体組成物中の沈殿や浮遊物を目視により評価することによって行われる。 In addition, as for the evaluation of the precipitate and floating substance resulting from the crude drug extract, it is stored at 50 ° C. for 2 months or at 65 ° C. for 2 weeks, and the precipitation or floating substance in the liquid composition is evaluated visually. Is done by doing.
以下に、実施例、比較例及び試験例を挙げ、本発明をさらに詳細に説明する。
なお、実施例で使用したポリビニルアルコールは変性していないものであり、けん化度は８６．０〜９０．０mol％、平均重合度は９００〜１１００である。
Hereinafter, the present invention will be described in more detail with reference to Examples, Comparative Examples and Test Examples.
The polyvinyl alcohol used in the examples is unmodified, has a saponification degree of 86.0-90.0 mol%, and an average polymerization degree of 900-1100.
実施例１〜７及び比較例１〜１０
表１に示す処方に従い、生薬エキス、精油、ポリビニルアルコールを秤量して精製水を加え、超音波を照射して分散させた後、その他の成分を溶解した後、ｐＨを２．０または３．２に調整し、更に精製水を加えて全量を１００ｍＬとした。これらをガラス瓶に充填してキャップを施し殺菌後、内服液剤を調製し、実施例１〜７及び比較例１〜１０とした。なお、ニンジンエキス１３０ｍｇは原生薬換算で９１０ｍｇに相当する。
Examples 1-7 and Comparative Examples 1-10
According to the formulation shown in Table 1, weighed herbal extracts, essential oils and polyvinyl alcohol, added purified water, dispersed by irradiating with ultrasonic waves, dissolved other components, and then adjusted the pH to 2.0 or 3. 2 and further purified water was added to make up a total volume of 100 mL. These were filled in a glass bottle, capped and sterilized, and then an internal liquid preparation was prepared to be Examples 1 to 7 and Comparative Examples 1 to 10. In addition, 130 mg of carrot extract is equivalent to 910 mg in terms of bulk drug.
これらの液剤を５０℃の恒温槽にて２ヶ月間保存後、液剤中の沈殿及び浮遊物を目視により評価した。表中の「◎」は沈殿や浮遊物の生成が認められなかったことを示し、「○」は僅かに沈殿や浮遊物の生成が認められたが商品性上は問題無いことを示し、「×」は沈殿又は浮遊物の生成が認められたことを示す。 These solutions were stored in a thermostat at 50 ° C. for 2 months, and then the precipitates and suspended matters in the solution were visually evaluated. "◎" in the table indicates that no precipitation or suspended matter was observed, and "○" indicates that a slight amount of precipitation or suspended matter was observed, but there was no problem in terms of commercial properties. “X” indicates that the formation of precipitate or suspended matter was observed.
表１より、実施例１の液剤は、チョウジ油及びポリビニルアルコールを配合することにより、ニンジンエキスに起因する沈殿及び浮遊物の生成が抑制されることが確認された。また、実施例１の液剤には、調製直後は勿論のこと、５０℃で２ヶ月保存した場合であっても、商品性の上で問題となるような沈殿や浮遊物の生成は認められなかった。 From Table 1, it was confirmed that the liquid preparation of Example 1 suppresses the formation of precipitates and suspended matters due to the carrot extract by adding clove oil and polyvinyl alcohol. In addition, in the liquid preparation of Example 1, not only immediately after preparation, but also when stored at 50 ° C. for 2 months, the formation of precipitates and suspended matters that cause a problem in terms of merchantability was not observed. It was.
一方、比較例１〜３の液剤は、チョウジ油及びポリビニルアルコールを配合しておらず、比較例４〜８の液剤は、ポリビニルアルコールを配合していないが、これらの液剤では、ニンジンエキスに起因する沈殿や浮遊物の生成を抑制することができず、商品性という観点からも問題があった。 On the other hand, the liquid preparations of Comparative Examples 1 to 3 do not contain clove oil and polyvinyl alcohol, and the liquid preparations of Comparative Examples 4 to 8 do not contain polyvinyl alcohol, but these liquid preparations are caused by carrot extract. It was impossible to suppress the formation of precipitates and suspended solids, and there was a problem from the viewpoint of merchantability.
また、上表１より、実施例２〜７の液剤は、チョウジ油、ケイヒ油及びポリビニルアルコールを配合することにより、ｐＨ２．０及びｐＨ３．２の条件でニンジンエキスに起因する沈殿及び浮遊物の生成が抑制されることが確認された。また、実施例２〜７の液剤は、調製直後は勿論のこと、５０℃で２ヶ月保存した場合であっても、商品性の上で問題となるような沈殿や浮遊物の生成は認められなかった。 From Table 1 above, the liquids of Examples 2 to 7 were prepared by adding clove oil, cinnamon oil, and polyvinyl alcohol, so that precipitates and suspended matters caused by carrot extract under the conditions of pH 2.0 and pH 3.2 were obtained. It was confirmed that generation was suppressed. In addition, the liquid preparations of Examples 2 to 7 were observed immediately after preparation, and even when stored at 50 ° C. for 2 months, formation of precipitates and suspended matters that would cause problems in terms of merchantability was observed. There wasn't.
一方、比較例９の液剤はウイキョウ油を配合しているが、ニンジンエキスに起因する沈殿や浮遊物の生成を抑制することができず、商品性という観点からも問題があった。どのような精油でも沈殿や浮遊物の発生を抑制できるわけではないことが分かった。また、比較例１０の液剤は、チョウジ油及びケイヒ油を配合しておらず、ニンジンエキスに起因する沈殿や浮遊物の生成を抑制することができず、商品性という観点からも問題があった。 On the other hand, although the liquid agent of the comparative example 9 mix | blended fennel oil, the production | generation of the precipitation resulting from a carrot extract and a suspended | floating matter cannot be suppressed and there also existed a problem also from a viewpoint of commercial property. It was found that not all essential oils can suppress the occurrence of precipitation and suspended matter. In addition, the liquid preparation of Comparative Example 10 does not contain clove oil and cinnamon oil, and can not suppress the formation of precipitates and suspended matters due to the carrot extract, which has a problem from the viewpoint of merchantability. .
実施例８〜１２及び比較例１１〜１６
表２に示す処方に従い、生薬エキス、精油、ポリビニルアルコールを秤量して精製水を加え、超音波を照射して分散させた後、その他の成分を溶解した後、ｐＨを３．２に調整し、更に精製水を加えて全量を１００ｍＬとした。これらをガラス瓶に充填してキャップを施し殺菌後、内服液剤を調製し、実施例８〜１２及び比較例１１〜１６とした。なお、カンゾウエキス５０ｍｇは原生薬換算で２００ｍｇ、ショウキョウエキス５．５６ｍｇは原生薬換算で５０ｍｇ、チンピエキス４００ｍｇは原生薬換算で２０００ｍｇに相当する。
Examples 8-12 and Comparative Examples 11-16
According to the formulation shown in Table 2, weighed herbal extracts, essential oils and polyvinyl alcohol, added purified water, dispersed by irradiating with ultrasonic waves, dissolved other components, then adjusted the pH to 3.2. Further, purified water was added to make up a total volume of 100 mL. These were filled into glass bottles, capped and sterilized, and then internal liquid preparations were prepared, and Examples 8 to 12 and Comparative Examples 11 to 16 were obtained. In addition, 50 mg of licorice extract is equivalent to 200 mg in terms of the drug substance, 5.56 mg of ginger extract is equivalent to 50 mg in terms of the drug substance, and 400 mg of the chimp extract is equivalent to 2000 mg in terms of the drug substance.
これらの液剤を６５℃の恒温槽に２週間保存後、液剤中の沈殿及び浮遊物を目視により評価した。表中の「◎」は沈殿や浮遊物の生成が認められなかったことを示し、「○」は僅かに沈殿や浮遊物の生成が認められたが商品性上問題無いことを示し、「×」は沈殿又は浮遊物の生成が認められたことを示す。 These solutions were stored in a constant temperature bath at 65 ° C. for 2 weeks, and then precipitates and suspended matters in the solutions were visually evaluated. “◎” in the table indicates that no precipitation or suspended matter was observed, and “○” indicates that a slight amount of precipitate or suspended matter was observed, but there was no problem in terms of merchantability. "" Indicates that precipitation or suspended matter was observed.
表２より、実施例８〜１２の液剤は、チョウジ油、ケイヒ油及びポリビニルアルコールを配合することにより、カンゾウエキス、ショウキョウエキス及びチンピエキスに起因する沈殿及び浮遊物の生成が抑制されることが確認された。また、実施例１の液剤には、調製直後は勿論のこと、６５℃で２週間保存した場合であっても、商品性の上で問題となるような沈殿や浮遊物の生成は認められず、幅広い生薬で効果を有することが分かった。 From Table 2, the liquid agents of Examples 8 to 12 can suppress the formation of precipitates and suspended matters caused by licorice extract, ginger extract and chimpan extract by blending clove oil, cinnamon oil and polyvinyl alcohol. confirmed. In addition, in the liquid preparation of Example 1, not only immediately after the preparation, but also when stored at 65 ° C. for 2 weeks, the formation of precipitates and suspended matters that cause a problem in terms of merchantability was not observed. It was found to have an effect with a wide range of crude drugs.
一方、比較例１１、１３及び１５の液剤は、チョウジ油及びケイヒ油を配合しておらず、カンゾウエキス、ショウキョウエキス及びチンピエキスに起因する沈殿や浮遊物の生成を抑制することができず、商品性という観点からも問題があった。また、比較例１２、１４及び１６の液剤は、チョウジ油、ケイヒ油及びポリビニルアルコールを配合しておらず、カンゾウエキス、ショウキョウエキス及びチンピエキスに起因する沈殿や浮遊物の生成を抑制することができず、商品性という観点からも問題があった。 On the other hand, the liquid preparations of Comparative Examples 11, 13, and 15 do not contain clove oil and cinnamon oil, and cannot suppress the formation of precipitates and suspended matters due to licorice extract, ginger extract and chimpan extract, There was also a problem in terms of merchantability. Moreover, the liquid agent of Comparative Examples 12, 14, and 16 does not contain clove oil, cinnamon oil, and polyvinyl alcohol, and suppresses the formation of precipitates and suspended solids resulting from licorice extract, ginger extract, and chimney extract. There was also a problem from the viewpoint of merchantability.
本発明により、生薬エキスを含有する液体組成物において、精油及びポリビニルアルコールを配合することにより、生薬エキスの全含有成分を含み、且つ、生薬エキスに起因する沈殿や浮遊物の生成が抑制され、服用性が良好で、長期間の保存安定性に優れた生薬エキス含有液体組成物を提供することが可能となった。これにより、商品性の高い生薬エキス含有液体組成物を液剤等として医薬品、指定医薬部外品及び食品の分野において提供することが期待される。 According to the present invention, in a liquid composition containing a herbal extract, by blending essential oil and polyvinyl alcohol, all the ingredients of the herbal extract are included, and the formation of precipitates and suspended matters due to the herbal extract is suppressed, It became possible to provide a herbal extract-containing liquid composition that has good dosing properties and excellent long-term storage stability. As a result, it is expected that a herbal extract-containing liquid composition having high commercial properties will be provided as a liquid in the fields of pharmaceuticals, designated quasi-drugs and foods.
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| JPH09315987A (en) * | 1996-05-24 | 1997-12-09 | Kureha Chem Ind Co Ltd | Utilization of awamori as antiallergic active ingredient |
| JP2000319187A (en) * | 1999-05-06 | 2000-11-21 | Medion Research Laboratories Inc | Carbon dioxide transcutaneous and transmucosal absorption composition |
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| JPH09315987A (en) * | 1996-05-24 | 1997-12-09 | Kureha Chem Ind Co Ltd | Utilization of awamori as antiallergic active ingredient |
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