JP2016074658A - Antidiarrheic chinese medicine preparation - Google Patents
Antidiarrheic chinese medicine preparation Download PDFInfo
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- JP2016074658A JP2016074658A JP2015197280A JP2015197280A JP2016074658A JP 2016074658 A JP2016074658 A JP 2016074658A JP 2015197280 A JP2015197280 A JP 2015197280A JP 2015197280 A JP2015197280 A JP 2015197280A JP 2016074658 A JP2016074658 A JP 2016074658A
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Abstract
Description
本発明は、止瀉用の漢方製剤に関する。より具体的には、本発明は、柴胡桂枝湯エキスの止瀉作用を向上させた止瀉用の漢方製剤に関する。 The present invention relates to a Chinese medicine formulation for antipruritics. More specifically, the present invention relates to a Chinese medicine formulation for antipruritic that has improved the antipruritic action of Saiko Keisaito extract.
漢方薬は、数千年にも及ぶ歴史がある東洋医学に基づいて、処方されている多成分系の薬剤である。現在使用されている漢方薬は、長年の治療経験によって効能が確認され、副作用が少ない処方が受け継がれており、西洋医学的にもその有効性が認められているものも多く存在している。 Herbal medicine is a multi-component drug that is prescribed based on Oriental medicine with a history of thousands of years. The herbal medicines currently used have been confirmed to have efficacy by many years of treatment experience, and prescriptions with few side effects have been inherited, and there are many that have been recognized as effective in Western medicine.
漢方薬の中でも、柴胡桂枝湯は、腹痛を伴う胃腸炎、神経痛、胆石、肝機能障害、膵臓炎、てんかん、関節痛等に効果があることが知られており、そのエキスはこれらの症状の改善に利用されている。また、柴胡桂枝湯には、止瀉作用もあり、そのエキスは下痢の治療にも有効であることが知られている。 Among herbal medicines, Saikoukei-eda is known to be effective for gastroenteritis with abdominal pain, neuralgia, gallstones, liver dysfunction, pancreatitis, epilepsy, joint pain, etc., and its extract improves these symptoms. Has been used. In addition, Saikoukei-edu has an antipruritic action, and its extract is known to be effective in treating diarrhea.
しかしながら、柴胡桂枝湯が有する止瀉作用は、比較的緩和であり、強い効き目を期待できるものではない。そのため、止瀉作用を期待して柴胡桂枝湯エキスを服用する場合には、必ずしも満足できる効能が得られないのが現状である。 However, the antipruritic effect of Saikoukei-edu is relatively mild and cannot be expected to have a strong effect. Therefore, in the current situation, satisfactory efficacy is not always obtained when taking an extract of saikokusaito in anticipation of antipruritic action.
一方、従来、柴胡桂枝湯エキスを含む漢方製剤の製剤化技術については報告されている例はあるものの（特許文献１及び２）、柴胡桂枝湯エキスの止瀉作用を向上させる製剤化技術については報告されていない。 On the other hand, although there have been reports on the formulation of traditional Chinese medicine formulations containing Saikoukei-edu extract (Patent Documents 1 and 2), the formulation technology for improving the antipruritic action of Saikoukei-edu extract has been reported. Not reported.
本発明の目的は、柴胡桂枝湯エキスが有する止瀉作用を向上させる製剤技術を提供することである。 The objective of this invention is providing the formulation technique which improves the antipruritic action which Saikoukei-edu extract has.
本発明者は、前記課題を解決すべく鋭意検討を行ったところ、痛止め剤には、副作用として下痢が知られているにも拘わらず、柴胡桂枝湯エキスと併用すると、当該柴胡桂枝湯の止瀉作用を向上させ得ることを見出した。本発明は、かかる知見に基づいて更に検討を重ねることにより、完成したものである。 The present inventor has intensively studied to solve the above-mentioned problems, and although the painkiller is known to have diarrhea as a side effect, when used in combination with the extract of saicho keisaito, It has been found that the antipruritic action can be improved. The present invention has been completed by further studies based on such knowledge.
即ち、本発明は、下記に掲げる態様の止瀉用の漢方製剤を提供する。
項１． (A)柴胡桂枝湯エキス及び(B)痛止め剤を含有することを特徴とする、止瀉用の漢方製剤。
項２． 前記(A)柴胡桂枝湯エキス（原生薬換算量）１００重量部当たり、前記(B)痛止め剤を０．５〜５０重量部含む、項１に記載の止瀉用の漢方製剤。
項３． 経口投与によって投与される、項１又は２に記載の止瀉用の漢方製剤。
項４． 固形状製剤である、項１〜３のいずれかに記載の止瀉用の漢方製剤。
That is, this invention provides the Chinese medicine formulation for antipruritics of the aspect hung up below.
Item 1. A Kampo preparation for antipruritics, comprising (A) Saikoukei-edo extract and (B) an anti-pain agent.
Item 2. Item 2. The Chinese medicine formulation for antipruritics according to Item 1, comprising 0.5 to 50 parts by weight of the above-mentioned (B) painkiller per 100 parts by weight of the above-mentioned (A) Saikoukei-edu extract (raw drug substance equivalent).
Item 3. Item 3. A Chinese medicine preparation for antipruritics according to Item 1 or 2, which is administered by oral administration.
Item 4. Item 4. A Chinese medicine preparation for antipruritics according to any one of Items 1 to 3, which is a solid preparation.
本発明の漢方製剤によれば、柴胡桂枝湯の止瀉作用が飛躍的に向上しており、下痢を効果的に治療することができる。 According to the Kampo preparation of the present invention, the antipruritic action of Saikoukei-edu has been dramatically improved, and diarrhea can be effectively treated.
１．止瀉用の漢方製剤
本発明の止瀉用の漢方製剤は、(A)柴胡桂枝湯エキス、及び(B)痛止め剤を含有することを特徴とする。以下、本発明の漢方製剤について詳述する。
1. Chinese medicine formulation for antipruritic Chinese medicine formulation for antidiarrheal of the present invention is characterized in that it contains (A) Saikoukei-edo extract and (B) painkiller. Hereinafter, the Chinese medicine preparation of the present invention will be described in detail.
(A)柴胡桂枝湯エキス
本発明の止瀉用の漢方製剤は、柴胡桂枝湯エキスを含有する。柴胡桂枝湯は、柴胡、半夏、桂枝又は桂皮、芍薬、黄ごん、大棗、人参、甘草、及び生姜からなる混合生薬である。
(A) Saikou Keishito extract The traditional Chinese medicine preparation for antipruritics of the present invention contains Saikoukei Edyu extract. Saiko Keisaito is a mixed herbal medicine consisting of Saiko, Hanatsu, Keishi or cinnamon, glaze, yellow rice, daikon, carrot, licorice, and ginger.
本発明において、柴胡桂枝湯に含まれる各生薬の混合比については、特に制限されないが、通常、柴胡５重量部、半夏４重量部、桂皮３重量部、芍薬３重量部、黄ごん２重量部、大棗２重量部、人参２重量部、甘草２重量部、及び生姜１重量部が挙げられる。 In the present invention, the mixing ratio of each herbal medicine contained in Saikoukei-edu is not particularly limited, but usually 5 parts by weight of Saiko, 4 parts by weight of summer, 3 parts by weight of cinnamon, 3 parts by weight of glaze, yellow rice 2 parts by weight, 2 parts by weight of potato, 2 parts by weight of carrot, 2 parts by weight of licorice, and 1 part by weight of ginger.
柴胡桂枝湯エキスは、柴胡桂枝湯処方に従った生薬を抽出処理することにより得られる浸出液を濃縮したもので、通常、乾燥エキス及び軟エキスの２種類がある。柴胡桂枝湯の抽出処理に使用される抽出溶媒としては、特に制限されないが、例えば、水；エタノール、アセトン、エーテル等の有機溶剤；これらの混合液が挙げられる。柴胡桂枝湯の抽出条件としては、特に制限されないが、例えば、柴胡桂枝湯に含まれる生薬の総重量（乾燥重量換算）に対して、５〜３５倍量程度の抽出溶媒を加え、冷浸（１５〜２５℃程度）、温浸（３５〜４５℃程度）又はパーコレーション法（室温１〜３０℃程度）法に準じて浸出させる方法などが挙げられる。抽出処理によって得られた柴胡桂枝湯抽出液について、濾過等により固形分を除去し、必要に応じて、濃縮処理や乾燥処理に供することによって柴胡桂枝湯エキスが得られる。 Saiko Keishito extract is a concentrate obtained by extracting a herbal medicine obtained by extracting a herbal medicine according to the Saikou Keishito prescription, and there are usually two types, a dry extract and a soft extract. Although it does not restrict | limit especially as an extraction solvent used for the extraction process of saikokuedo, For example, Water; Organic solvents, such as ethanol, acetone, ether; These liquid mixture is mentioned. The extraction conditions for Saikoukei-edu are not particularly limited. For example, the extraction solvent is added in an amount of about 5 to 35 times the total weight (in terms of dry weight) of the herbal medicine contained in Saikoukei-edu, followed by cooling ( 15-25 degreeC), digestion (about 35-45 degreeC), or the method of leaching according to the percolation method (room temperature 1-30 degreeC) method etc. are mentioned. About the saikoketsudo extract obtained by the extraction process, the solid content is removed by filtration or the like, and if necessary, it is subjected to a concentrating process or a drying process to obtain a saikokushido extract.
本発明で使用される柴胡桂枝湯エキスは、乾燥エキス末又は軟エキスのいずれであってもよい。 The Saikoukei-edu extract used in the present invention may be either a dry extract powder or a soft extract.
柴胡桂枝湯エキスは、商品名「柴胡桂枝湯エキス−Ａ」（日本粉末薬品株式会社）、柴胡桂枝湯乾燥エキス−Ｆ」（アルプス薬品工業株式会社）等として市販されており、本発明ではこれらの市販品を使用してもよい。 Saiko Keisaito extract is marketed under the trade name "Saiko Keishiyu Extract-A" (Nippon Powder Pharmaceutical Co., Ltd.), Saiko Keisho Hot Dry Extract-F "(Alps Yakuhin Kogyo Co., Ltd.), etc. in the present invention. Commercial products may be used.
本発明の止瀉用の漢方製剤において、柴胡桂枝湯エキスの含有量については、剤型等に応じて、後述する投与量を充足できるように適宜設定すればよいが、通常０．１〜９８重量％、好ましくは０．５〜９５重量％、更に好ましくは１〜９０重量％が挙げられる。 In the traditional Chinese medicine preparation for antipruritics of the present invention, the content of Saikoukei-edu extract may be appropriately set according to the dosage form and the like so as to satisfy the dose described later, but usually 0.1 to 98. % By weight, preferably 0.5 to 95% by weight, more preferably 1 to 90% by weight.
(B)痛止め剤
本発明の止瀉用の漢方製剤では、前記柴胡桂枝湯エキスと共に、痛止め剤を含有する。このように、前記柴胡桂枝湯エキスと共に痛止め剤を組み合わせて使用することによって、柴胡桂枝湯エキスの止瀉作用を向上させることが可能になる。
(B) Painkiller The Chinese medicine formulation for antipruritics of the present invention contains a painkiller along with the Saikoukeiedo extract. Thus, it becomes possible to improve the antipruritic action of the saikokushi-to extract by using a combination of painkillers with the saikokuji-to extract.
痛止め剤とは、痛みを伝える痛覚伝導路の少なくとも１カ所において、痛覚の伝導を遮断することによって、大脳皮質の知覚領の感受性を低下し痛みを抑える薬物である。本発明で使用される痛止め剤の種類については、特に制限されないが、例えば、アセトアミノフェン、イブプロフェン、ロキソプロフェン、アスピリン、アスピリンアルミニウム、ジクロフェナク、エテンザミド、サザピリン、サリチルアミド、ラクチルフェネチジン、サリチル酸、アミノピリン、アンチピリン、イソプロピルアンチピリン、ラクチルフェネジン、トルフェナム酸、メフェナム酸、オキシフェンブタゾン、クロフェゾン、スルピリン、フェニルブタゾン、メタミゾール、クロフェゾン、ナプロキセン、ケトプロフェン、インドメタシン、スルピリン、アセメタシン、トルメチンの解熱消炎鎮痛薬等が挙げられる。また、これらの化合物は、塩の形態をとり得る場合には、塩の形態で使用されてもよい。このような塩については、薬学的に許容されることを限度として、特に制限されないが、例えば、ロキソプロフェン、ジクロフェナク、サリチル酸、トルメチン等の場合であれば、ナトリウム塩、カリウム塩等のアルカリ金属塩、好ましくはナトリウム塩が挙げられる。また、これらの化合物は、無水物の形態であってもよく、また水和物の形態であってもよい。 An analgesic is a drug that reduces pain sensitivity by reducing the sensitivity of the sensory area of the cerebral cortex by blocking the conduction of pain at least in one pain conduction pathway that transmits pain. The type of painkiller used in the present invention is not particularly limited. , Antipyrine, isopropylantipyrine, lactylphenidine, tolfenamic acid, mefenamic acid, oxyphenbutazone, clofesone, sulpyrine, phenylbutazone, metamizole, clofesone, naproxen, ketoprofen, indomethacin, sulpyrine, acemetacin, tolmetine antipyretic analgesic Etc. In addition, these compounds may be used in the form of a salt if they can take the form of a salt. Such a salt is not particularly limited as long as it is pharmaceutically acceptable. For example, in the case of loxoprofen, diclofenac, salicylic acid, tolmetin, and the like, an alkali metal salt such as a sodium salt or a potassium salt, A sodium salt is preferable. In addition, these compounds may be in the form of anhydrides or hydrates.
これらの痛止め剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These painkillers may be used alone or in combination of two or more.
これらの痛止め剤の中でも、柴胡桂枝湯エキスの止瀉作用をより一層効果的に向上させるという観点から、好ましくはアセトアミノフェン、ロキソプロフェン、イブプロフェン、及びこれらの塩、更に好ましくはアセトアミノフェン、ロキソプロフェンナトリウム水和物、及びイブプロフェンが挙げられる。 Among these pain relievers, from the viewpoint of further effectively improving the antipruritic action of Saikoukei-edu extract, preferably acetaminophen, loxoprofen, ibuprofen, and salts thereof, more preferably acetaminophen, Examples include loxoprofen sodium hydrate and ibuprofen.
本発明の止瀉用の漢方製剤において、柴胡桂枝湯エキスと痛止め剤の比率は、通常、柴胡桂枝湯エキスの原生薬換算量１００重量部当たり、痛止め剤を０．５〜５０重量部となるように設定すればよい。柴胡桂枝湯エキスの止瀉作用をより一層効果的に向上させるという観点から、柴胡桂枝湯エキスと痛止め剤の比率として、柴胡桂枝湯エキスの原生薬換算量１００重量部当たり、痛止め剤が好ましくは０．５〜４０重量部、更に好ましくは１．０〜４０重量部が挙げられる。 In the traditional Chinese medicine formulation for antipruritics of the present invention, the ratio of Saikoukei-edu extract to the pain relieving agent is usually 0.5 to 50 parts by weight of the pain relieving agent per 100 parts by weight of the active ingredient of saikokei-edu extract. Should be set to be. From the viewpoint of further effectively improving the antipruritic action of the saikokushi-to extract, the ratio of the saikokushi-to extract to the painkiller is as follows. Preferably 0.5-40 weight part, More preferably, 1.0-40 weight part is mentioned.
本発明の止瀉用の漢方製剤において、痛止め剤の含有量については、使用する痛止め剤の種類、剤型等に応じて、前述する柴胡桂枝湯エキスと痛止め剤の比率を充足できるように適宜設定すればよいが、通常０．０１〜９５重量％、好ましくは０．０５〜９０重量％、更に好ましくは０．０５〜８０重量％、特に好ましくは０．０５〜７０重量％が挙げられる。 In the antipruritic traditional Chinese medicine preparation of the present invention, the content of the pain relieving agent can satisfy the ratio of the above-mentioned Saikoukei-edu extract and the pain relieving agent according to the type, dosage form, etc. of the pain relieving agent used. However, it is usually 0.01 to 95% by weight, preferably 0.05 to 90% by weight, more preferably 0.05 to 80% by weight, particularly preferably 0.05 to 70% by weight. Can be mentioned.
その他の含有成分
本発明の止瀉用の漢方製剤には、前記柴胡桂枝湯エキス及び痛止め剤以外に、必要に応じて、他の薬理成分を含んでいてもよい。このような薬理成分の種類については、特に制限されないが、例えば、制酸剤、健胃剤、消化剤、整腸剤、鎮痙剤、粘膜修復剤、抗炎症剤、収れん剤、鎮吐剤、鎮咳剤、去痰剤、消炎酵素剤、鎮静催眠剤、抗ヒスタミン剤、カフェイン類、強心利尿剤、抗菌剤、血管収縮剤、血管拡張剤、局所麻酔剤、生薬、生薬エキス末、ビタミン類、メントール類等が挙げられる。これらの薬理成分は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの薬理成分の含有量については、使用する薬理成分の種類や止瀉用の漢方製剤の剤型等に応じて適宜設定すればよい。
Other ingredients The Chinese medicine preparation for antipruritics according to the present invention may contain other pharmacological ingredients as required in addition to the Saikoukei-edu extract and the painkiller. The type of such pharmacological component is not particularly limited, but for example, antacids, gastric agents, digestive agents, intestinal agents, antispasmodic agents, mucosal repair agents, anti-inflammatory agents, astringents, antiemetics, antitussives, expectorants, antiphlogistics Enzymes, sedative hypnotics, antihistamines, caffeine, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal medicines, herbal extract powders, vitamins, menthols and the like. These pharmacological components may be used alone or in combination of two or more. Moreover, what is necessary is just to set suitably about content of these pharmacological components according to the kind of pharmacological component to be used, the dosage form of the Chinese medicine formulation for antipruritics, etc.
本発明の止瀉用の漢方製剤には、所望の剤型に調製するために、必要に応じて、薬学的に許容される基剤や添加剤等が含まれていてもよい。このような基剤及び添加剤としては、例えば、賦形剤、結合剤、崩壊剤、滑沢剤、等張化剤、可塑剤、分散剤、乳化剤、溶解補助剤、湿潤化剤、安定化剤、懸濁化剤、粘着剤、コーティング剤、光沢化剤、水、油脂類、ロウ類、炭化水素類、脂肪酸類、高級アルコール類、エステル類、水溶性高分子、界面活性剤、金属石鹸、低級アルコール類、多価アルコール、ｐＨ調整剤、緩衝剤、酸化防止剤、紫外線防止剤、防腐剤、矯味剤、香料、粉体、増粘剤、色素、キレート剤等が挙げられる。これらの基剤や添加剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの基剤や添加剤の含有量については、使用する添加成分の種類や止瀉用の漢方製剤の剤型等に応じて適宜設定すればよい。 In order to prepare a desired dosage form, the traditional Chinese medicine preparation for antipruritics of the present invention may contain a pharmaceutically acceptable base or additive as necessary. Examples of such bases and additives include excipients, binders, disintegrants, lubricants, isotonic agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, and stabilization. Agent, suspending agent, adhesive, coating agent, brightening agent, water, fats and oils, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymer, surfactant, metal soap , Lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV inhibitors, preservatives, flavoring agents, fragrances, powders, thickeners, dyes, chelating agents, and the like. These bases and additives may be used individually by 1 type, and may be used in combination of 2 or more type. Moreover, what is necessary is just to set suitably about content of these bases and additives according to the kind of additive component to be used, the dosage form of the Chinese medicine formulation for antipruritics, etc.
投与形態・剤型・用途
本発明の止瀉用の漢方製剤の投与形態としては、経口投与（内服）又は経腸投与が挙げられるが、好ましくは経口投与である。
Administration Form / Dosage Form / Use Examples of administration forms of the antipruritic Chinese medicine preparation of the present invention include oral administration (internal use) and enteral administration, preferably oral administration.
本発明の止瀉用の漢方製剤の剤型については、前記投与形態に適用可能であることを限度として特に制限されず、固形状、半固形状、又は液体状のいずれであってもよい。具体的には、本発明の止瀉用の漢方製剤の剤型として、錠剤、丸剤、カプセル剤（軟カプセル剤、硬カプセル剤）、散剤、顆粒剤（ドライシロップを含む）等の固体状製剤；ゼリー剤等の半固形状製剤；液剤、懸濁剤、シロップ剤等の液体状製剤が挙げられ、これらの剤型の中でも、含有成分の安定性や携帯性等の観点から、好ましくは固形状製剤が挙げられる。 The dosage form of the antipruritic Chinese medicine preparation of the present invention is not particularly limited as long as it can be applied to the administration form, and may be any of solid, semi-solid, or liquid. Specifically, solid dosage forms such as tablets, pills, capsules (soft capsules, hard capsules), powders, granules (including dry syrup), etc. Semi-solid preparations such as jelly preparations; liquid preparations such as liquid preparations, suspensions, syrup preparations and the like. Among these dosage forms, from the viewpoints of stability of components and portability, Shaped formulations are mentioned.
本発明の止瀉用の漢方製剤を前記剤型に調製するには、柴胡桂枝湯エキス、痛止め剤、並びに必要に応じて添加される薬理成分、基剤、及び添加剤を用いて、医薬分野で採用されている通常の製剤化手法に従って製剤化すればよい。 To prepare the antipruritic Chinese medicine preparation of the present invention into the above-mentioned dosage form, using saikokushito extract, painkiller, and optionally added pharmacological ingredients, bases, and additives, What is necessary is just to formulate according to the normal formulation method employ | adopted by the field | area.
本発明の止瀉用の漢方製剤は、下痢症状を緩和又は治癒させる目的で使用される。本発明の止瀉用の漢方製剤の投与量については、使用する痛止め剤の種類、剤型、患者の年齢、下痢症状の程度等に応じて適宜設定されるが、例えば、１日当たりの投与量として、前記、柴胡桂枝湯エキスの原生薬換算量で２４００〜２４０００ｍｇ、好ましくは４８００〜１２０００ｍｇになる量が挙げられる。 The antipruritic Chinese medicine preparation of the present invention is used for the purpose of alleviating or curing diarrhea symptoms. The dosage of the anti-pruritic Chinese medicine preparation of the present invention is appropriately set according to the type of painkiller used, the dosage form, the age of the patient, the degree of diarrhea, etc., for example, administration per day The amount is 2400 to 24000 mg, preferably 4800 to 12000 mg, in terms of the above-mentioned raw drug equivalent of Saikoukei-edu extract.
２．医薬組成物
前述するように、痛止め剤には、副作用として下痢が知られているにも拘わらず、柴胡桂枝湯エキスと併用すると、柴胡桂枝湯エキスの止瀉作用を向上させることができる。また、柴胡桂枝湯エキスには、止瀉作用の他、かぜの諸症状、胃腸炎、神経症等を緩和する作用があることが知られている。更に、痛止め剤には、鎮痛作用だけでなく消炎作用や解熱作用があり、消化不良や食べ過ぎ飲みすぎによる胃腸の不快感；精神的なストレスによる胃腸の痛み；腸感染症などによる胃腸の痛み；筋肉の炎症；偏頭痛；及び腹痛、吐気、食欲不振、のどの痛み、悪寒、発熱、頭痛、関節の痛み、筋肉の痛み等のかぜの諸症状等を緩和することもできる。そのため、柴胡桂枝湯エキス及び痛止め剤の併用は、消化不良、ストレス性胃炎、腸感染症、筋肉痛、偏頭痛、神経症、かぜに伴う諸症状等の緩和を目的とした医薬組成物において、優れた止瀉作用という付加的効果を備えさせることができる。
2. Pharmaceutical Composition As described above, although antidiarrheal agents are known to have diarrhea as a side effect, the antipruritic action of Saikou Keishito extract can be improved when used in combination with Saikou Keishito extract. In addition to antipruritic action, Saikoukei-edu extract is known to have the action of alleviating various symptoms of cold, gastroenteritis, neurosis and the like. In addition, analgesics have anti-inflammatory and antipyretic effects as well as analgesic effects, gastrointestinal discomfort due to indigestion and overdose, gastrointestinal pain due to mental stress, gastrointestinal pain due to intestinal infections, etc. Pain; muscle inflammation; migraine; and abdominal pain, nausea, loss of appetite, sore throat, chills, fever, headache, joint pain, muscle pain, and other cold symptoms. Therefore, the combination of Saikoukei-edu extract and painkillers is used in pharmaceutical compositions aimed at alleviating dyspepsia, stress gastritis, intestinal infections, myalgia, migraine, neurosis, symptoms associated with colds, etc. , It can be provided with an additional effect of excellent anti-pasting action.
そこで、本発明の他の一態様として、(A)柴胡桂枝湯エキス、及び(B)痛止め剤を含有することを特徴とする医薬組成物を提供する。以下、本発明の医薬組成物について詳述する。
(A)柴胡桂枝湯エキス
本発明の医薬組成物は、柴胡桂枝湯エキスを含有する。柴胡桂枝湯は、柴胡、半夏、桂枝又は桂皮、芍薬、黄ごん、大棗、人参、甘草、及び生姜からなる混合生薬である。
Therefore, as another embodiment of the present invention, there is provided a pharmaceutical composition characterized by containing (A) an extract of saikokusaito and (B) an painkiller. Hereinafter, the pharmaceutical composition of the present invention will be described in detail.
(A) Saiko Keiedo Extract The pharmaceutical composition of the present invention contains an extract of Saiko Keiedo. Saiko Keisaito is a mixed herbal medicine consisting of Saiko, Hanatsu, Keishi or cinnamon, glaze, yellow rice, daikon, carrot, licorice, and ginger.
本発明において、柴胡桂枝湯に含まれる各生薬の混合比については、特に制限されないが、通常、柴胡５重量部、半夏４重量部、桂枝３重量部、芍薬３重量部、黄ごん２重量部、大棗２重量部、人参２重量部、甘草２重量部、及び生姜１重量部が挙げられる。 In the present invention, the mixing ratio of each herbal medicine contained in Saikou Keishiyu is not particularly limited, but usually 5 parts by weight of Saiko, 4 parts by weight of summer, 3 parts by weight of Katsushi, 3 parts by weight of glaze, yellow 2 parts by weight, 2 parts by weight of potato, 2 parts by weight of carrot, 2 parts by weight of licorice, and 1 part by weight of ginger.
柴胡桂枝湯エキスは、柴胡桂枝湯処方に従った生薬を抽出処理することにより得られる浸出液を濃縮したもので、通常、乾燥エキス及び軟エキスの２種類がある。柴胡桂枝湯の抽出処理に使用される抽出溶媒としては、特に制限されないが、例えば、水；エタノール、アセトン、エーテル等の有機溶剤；これらの混合液が挙げられる。柴胡桂枝湯の抽出条件としては、特に制限されないが、例えば、柴胡桂枝湯に含まれる生薬の総重量（乾燥重量換算）に対して、５〜３５倍量程度の抽出溶媒を加え、冷浸（１５〜２５℃程度）、温浸（３５〜４５℃程度）又はパーコレーション法（室温１〜３０℃程度）法に準じて浸出させる方法などが挙げられる。抽出処理によって得られた柴胡桂枝湯抽出液について、濾過等により固形分を除去し、必要に応じて、濃縮処理や乾燥処理に供することによって柴胡桂枝湯エキスが得られる。 Saiko Keishito extract is a concentrate obtained by extracting a herbal medicine obtained by extracting a herbal medicine according to the Saikou Keishito prescription, and there are usually two types, a dry extract and a soft extract. Although it does not restrict | limit especially as an extraction solvent used for the extraction process of saikokuedo, For example, Water; Organic solvents, such as ethanol, acetone, ether; These liquid mixture is mentioned. The extraction conditions for Saikoukei-edu are not particularly limited. For example, the extraction solvent is added in an amount of about 5 to 35 times the total weight (in terms of dry weight) of the herbal medicine contained in Saikoukei-edu, followed by cooling ( 15-25 degreeC), digestion (about 35-45 degreeC), or the method of leaching according to the percolation method (room temperature 1-30 degreeC) method etc. are mentioned. About the saikoketsudo extract obtained by the extraction process, the solid content is removed by filtration or the like, and if necessary, it is subjected to a concentrating process or a drying process to obtain a saikokushido extract.
本発明で使用される柴胡桂枝湯エキスは、乾燥エキス末又は軟エキスのいずれであってもよい。 The Saikoukei-edu extract used in the present invention may be either a dry extract powder or a soft extract.
柴胡桂枝湯エキスは、商品名「柴胡桂枝湯エキス−Ａ」（日本粉末薬品株式会社）、柴胡桂枝湯乾燥エキス−Ｆ」（アルプス薬品工業株式会社）等として市販されており、本発明ではこれらの市販品を使用してもよい。 Saiko Keisaito extract is marketed under the trade name "Saiko Keishiyu Extract-A" (Nippon Powder Pharmaceutical Co., Ltd.), Saiko Keisho Hot Dry Extract-F "(Alps Yakuhin Kogyo Co., Ltd.), etc. in the present invention. Commercial products may be used.
本発明の医薬組成物において、柴胡桂枝湯エキスの含有量については、剤型、用途等に応じて、後述する投与量を充足できるように適宜設定すればよいが、通常０．１〜９８重量％、好ましくは０．５〜９５重量％、更に好ましくは１〜９０重量％が挙げられる。 In the pharmaceutical composition of the present invention, the content of Saikoukei-edu extract may be appropriately set depending on the dosage form, application, etc. so that the dose described later can be satisfied, but usually 0.1 to 98 wt. %, Preferably 0.5 to 95% by weight, more preferably 1 to 90% by weight.
(B)痛止め剤
本発明の医薬組成物では、前記柴胡桂枝湯エキスと共に、痛止め剤を含有する。このように、前記柴胡桂枝湯エキスと共に痛止め剤を組み合わせて使用することによって、柴胡桂枝湯エキスの止瀉作用を向上させるだけでなく、痛止め剤による効能（消化不良や食べ過ぎ飲みすぎによる胃腸の不快症状、精神的なストレスによる胃腸の痛み、腸感染症などによる胃腸の痛み、筋肉の炎症、偏頭痛、及びかぜの諸症状の緩和等）を備えさせることが可能になる。
(B) Painkiller The pharmaceutical composition of the present invention contains a painkiller along with the Saikoukei-edu extract. Thus, by using a combination of painkillers together with the above-mentioned Saikoukei-edu extract, not only improves the antipruritic action of the Saikoukei-edu extract, but also the efficacy of the painkillers (due to indigestion and excessive eating too much Gastrointestinal discomfort, gastrointestinal pain due to mental stress, gastrointestinal pain due to intestinal infection, muscle inflammation, migraine, relief of various symptoms of cold, etc.).
痛止め剤とは、痛みを伝える痛覚伝導路の少なくとも１カ所において、痛覚の伝導を遮断することによって、大脳皮質の知覚領の感受性を低下し痛みを抑える薬物である。本発明で使用される痛止め剤の種類については、特に制限されないが、例えば、アセトアミノフェン、イブプロフェン、ロキソプロフェン、アスピリン、アスピリンアルミニウム、ジクロフェナク、エテンザミド、サザピリン、サリチルアミド、ラクチルフェネチジン、サリチル酸、アミノピリン、アンチピリン、イソプロピルアンチピリン、ラクチルフェネジン、トルフェナム酸、メフェナム酸、オキシフェンブタゾン、クロフェゾン、スルピリン、フェニルブタゾン、メタミゾール、クロフェゾン、ナプロキセン、ケトプロフェン、インドメタシン、スルピリン、アセメタシン、トルメチン等の解熱消炎鎮痛薬が挙げられる。また、これらの化合物は、塩の形態をとり得る場合には、塩の形態で使用されてもよい。このような塩については、薬学的に許容されることを限度として、特に制限されないが、例えば、ロキソプロフェン、ジクロフェナク、サリチル酸、トルメチン等の場合であれば、ナトリウム塩、カリウム塩等のアルカリ金属塩、好ましくはナトリウム塩が挙げられる。また、これらの化合物は、無水物の形態であってもよく、また水和物の形態であってもよい。 An analgesic is a drug that reduces pain sensitivity by reducing the sensitivity of the sensory area of the cerebral cortex by blocking the conduction of pain at least in one pain conduction pathway that transmits pain. The type of painkiller used in the present invention is not particularly limited. , Antipyrine, isopropylantipyrine, lactylphenidine, tolfenamic acid, mefenamic acid, oxyphenbutazone, clofesone, sulpyrine, phenylbutazone, metamizole, clofezone, naproxen, ketoprofen, indomethacin, sulpyrine, acemetacin, tolmethine, etc. Medicines. In addition, these compounds may be used in the form of a salt if they can take the form of a salt. Such a salt is not particularly limited as long as it is pharmaceutically acceptable. For example, in the case of loxoprofen, diclofenac, salicylic acid, tolmetin, and the like, an alkali metal salt such as a sodium salt or a potassium salt, A sodium salt is preferable. In addition, these compounds may be in the form of anhydrides or hydrates.
これらの痛止め剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These painkillers may be used alone or in combination of two or more.
これらの痛止め剤の中でも、柴胡桂枝湯エキスの止瀉作用をより一層効果的に向上させて、胃腸炎、神経症、かぜ等に伴う胃腸の不快症状（下痢等）を効果的に緩和させるという観点から、好ましくはアセトアミノフェン、ロキソプロフェン、イブプロフェン、及びこれらの塩、更に好ましくはアセトアミノフェン、ロキソプロフェンナトリウム水和物、及びイブプロフェンが挙げられる。 Among these anti-pain agents, the antipruritic action of Saikoukei-edu extract is further effectively improved to effectively relieve gastrointestinal discomfort (diarrhea, etc.) associated with gastroenteritis, neurosis, colds, etc. In view of the above, acetaminophen, loxoprofen, ibuprofen, and salts thereof are preferable, and acetaminophen, loxoprofen sodium hydrate, and ibuprofen are more preferable.
本発明の医薬組成物において、柴胡桂枝湯エキスと痛止め剤の比率は、通常、柴胡桂枝湯エキスの原生薬換算量算１００重量部当たり、痛止め剤を０．５〜５０重量部となるように設定すればよい。柴胡桂枝湯エキスの止瀉作用をより一層効果的に向上させて、胃腸炎、神経症、かぜ等に伴う胃腸の不快症状（下痢等）を効果的に緩和させるという観点から、柴胡桂枝湯エキスと痛止め剤の比率として、柴胡桂枝湯エキスと痛止め剤の比率として、柴胡桂枝湯エキスの乾燥重量換算１００重量部当たり、痛止め剤が好ましくは０．５〜４０重量部、更に好ましくは１．０〜４０重量部が挙げられる。 In the pharmaceutical composition of the present invention, the ratio of Saikoukei-edu extract to the pain relieving agent is usually 0.5 to 50 parts by weight of the pain relieving agent per 100 parts by weight in terms of the raw drug equivalent of the saikokei-edu extract. It should be set as follows. From the viewpoint of effectively improving the antipruritic action of Saikou Keishito extract and effectively relieving gastrointestinal discomfort (diarrhea, etc.) associated with gastroenteritis, neurosis, colds, etc. As a ratio of the painkillers extract and the painkiller, the amount of the painkillers is preferably 0.5 to 40 parts by weight, more preferably 100 parts by weight in terms of dry weight in terms of the dry weight of the peppers. 1.0-40 weight part is mentioned.
本発明の医薬組成物において、痛止め剤の含有量については、使用する痛止め剤の種類、剤型等に応じて、前述する柴胡桂枝湯エキスと痛止め剤の比率を充足できるように適宜設定すればよいが、通常０．０１〜９５重量％、好ましくは０．０５〜９０重量％、更に好ましくは０．０５〜８０重量％、特に好ましくは０．０５〜７０重量％が挙げられる。 In the pharmaceutical composition of the present invention, the content of the pain relieving agent is appropriately determined so as to satisfy the above-mentioned ratio of Saikoukei-edu extract and the pain relieving agent depending on the type, dosage form, etc. of the pain relieving agent to be used. What is necessary is just to set, but 0.01-95 weight% normally, Preferably it is 0.05-90 weight%, More preferably, it is 0.05-80 weight%, Most preferably, 0.05-70 weight% is mentioned.
その他の含有成分
本発明の医薬組成物には、前記柴胡桂枝湯エキス及び痛止め剤以外に、必要に応じて、他の薬理成分を含んでいてもよい。このような薬理成分の種類については、特に制限されないが、例えば、制酸剤、健胃剤、消化剤、整腸剤、鎮痙剤、粘膜修復剤、抗炎症剤、収れん剤、鎮吐剤、鎮咳剤、去痰剤、消炎酵素剤、鎮静催眠剤、抗ヒスタミン剤、カフェイン類、強心利尿剤、抗菌剤、血管収縮剤、血管拡張剤、局所麻酔剤、生薬、生薬エキス末、ビタミン類、メントール類等が挙げられる。これらの薬理成分は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの薬理成分の含有量については、使用する薬理成分の種類や医薬組成物の剤型等に応じて適宜設定すればよい。
Other components The pharmaceutical composition of the present invention may contain other pharmacological components, if necessary, in addition to the above-mentioned Saikoukei-edu extract and painkiller. The type of such pharmacological component is not particularly limited, but for example, antacids, gastric agents, digestive agents, intestinal agents, antispasmodic agents, mucosal repair agents, anti-inflammatory agents, astringents, antiemetics, antitussives, expectorants, antiphlogistics Enzymes, sedative hypnotics, antihistamines, caffeine, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal medicines, herbal extract powders, vitamins, menthols and the like. These pharmacological components may be used alone or in combination of two or more. Moreover, what is necessary is just to set suitably about content of these pharmacological components according to the kind of pharmacological component to be used, the dosage form of a pharmaceutical composition, etc.
本発明の医薬組成物には、所望の剤型に調製するために、必要に応じて、薬学的に許容される基剤や添加剤等が含まれていてもよい。このような基剤及び添加剤としては、例えば、賦形剤、結合剤、崩壊剤、滑沢剤、等張化剤、可塑剤、分散剤、乳化剤、溶解補助剤、湿潤化剤、安定化剤、懸濁化剤、粘着剤、コーティング剤、光沢化剤、水、油脂類、ロウ類、炭化水素類、脂肪酸類、高級アルコール類、エステル類、水溶性高分子、界面活性剤、金属石鹸、低級アルコール類、多価アルコール、ｐＨ調整剤、緩衝剤、酸化防止剤、紫外線防止剤、防腐剤、矯味剤、香料、粉体、増粘剤、色素、キレート剤、等が挙げられる。これらの基剤や添加剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの基剤や添加剤の含有量については、使用する添加成分の種類や医薬組成物の剤型等に応じて適宜設定すればよい。 The pharmaceutical composition of the present invention may contain a pharmaceutically acceptable base or additive as necessary in order to prepare a desired dosage form. Examples of such bases and additives include excipients, binders, disintegrants, lubricants, isotonic agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, and stabilization. Agent, suspending agent, adhesive, coating agent, brightening agent, water, fats and oils, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymer, surfactant, metal soap , Lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV inhibitors, preservatives, corrigents, fragrances, powders, thickeners, dyes, chelating agents, and the like. These bases and additives may be used individually by 1 type, and may be used in combination of 2 or more type. Moreover, what is necessary is just to set suitably about content of these bases and additives according to the kind of additive component to be used, the dosage form of a pharmaceutical composition, etc.
投与形態・剤型・用途
本発明の医薬組成物の投与形態としては、経口投与（内服）又は経腸投与が挙げられるが、好ましくは経口投与である。
Administration form / dosage form / use Examples of administration form of the pharmaceutical composition of the present invention include oral administration (internal use) and enteral administration, preferably oral administration.
本発明の医薬組成物の剤型については、前記投与形態に適用可能であることを限度として特に制限されず、固形状、半形体状、又は液状のいずれであってもよい。具体的には、本発明の医薬組成物の剤型として、錠剤、丸剤、カプセル剤（軟カプセル剤、硬カプセル剤）、散剤、顆粒剤（ドライシロップを含む）等の固形状製剤；ゼリー剤等の半固形状製剤；液剤、懸濁剤、シロップ剤等の液状製剤が挙げられる。これらの剤型の中でも、含有成分の安定性や携帯性等の観点から、好ましくは固形状製剤が挙げられる。 The dosage form of the pharmaceutical composition of the present invention is not particularly limited as long as it can be applied to the administration form, and may be any of solid, half-form, or liquid. Specifically, as a dosage form of the pharmaceutical composition of the present invention, solid preparations such as tablets, pills, capsules (soft capsules, hard capsules), powders, granules (including dry syrup); Semi-solid preparations such as liquid preparations, liquid preparations such as liquids, suspensions, and syrups. Among these dosage forms, a solid preparation is preferable from the viewpoints of stability of components and portability.
本発明の医薬組成物を前記剤型に調製するには、柴胡桂枝湯エキス、痛止め剤、並びに必要に応じて添加される薬理成分、基剤、及び添加剤を用いて、医薬分野で採用されている通常の製剤化手法に従って製剤化すればよい。 In order to prepare the pharmaceutical composition of the present invention in the above-mentioned dosage form, it is employed in the pharmaceutical field by using Saikoukei-edu extract, an analgesic agent, and pharmacological ingredients, bases, and additives that are added as necessary. What is necessary is just to formulate according to the usual formulation method currently used.
本発明の医薬組成物は、柴胡桂枝湯エキス及び痛止め剤を含有しているので、これらの薬効に基づいて、下痢、腹痛、吐気、食欲不振、のどの痛み、悪寒、発熱、頭痛、関節の痛み、筋肉の痛み等の胃腸炎、神経症、かぜ等の諸症状緩和目的で使用することができる。特に、本発明の医薬組成物では、柴胡桂枝湯エキスによる止瀉作用が向上し、胃腸の不快症状を効果的に緩和できることを鑑みれば、胃腸炎、胃腸の不快症状を伴う神経症、胃腸の不快症状を伴うかぜの諸症状の緩和の目的で好適に使用でき、とりわけ下痢を伴う胃腸炎、下痢を伴う神経症、下痢を伴うかぜの諸症状の緩和の緩目的で特に好適に使用できる。 Since the pharmaceutical composition of the present invention contains Saikoukei-edu extract and an analgesic, based on these medicinal effects, diarrhea, abdominal pain, nausea, anorexia, sore throat, chills, fever, headache, joints It can be used for the purpose of alleviating various symptoms such as gastroenteritis such as pain in the stomach and muscles, neurosis and cold. In particular, in the pharmaceutical composition of the present invention, in view of the improvement of antipruritic action by Saikoukei-edu extract and effective relief of gastrointestinal discomfort, gastroenteritis, neurosis with gastrointestinal discomfort, gastrointestinal It can be preferably used for the purpose of alleviating the symptoms of cold accompanied by unpleasant symptoms, and particularly preferably for the purpose of alleviating the symptoms of gastroenteritis accompanied by diarrhea, neurosis accompanied by diarrhea, and cold symptoms accompanied by diarrhea.
本発明の医薬組成物は、下痢症状を緩和又は治癒させる目的で使用される。本発明の医薬組成物の投与量については、使用する痛止め剤の種類、剤型、患者の年齢、用途、症状の程度等に応じて適宜設定されるが、例えば、１日当たりの投与量として、前記、柴胡桂枝湯エキスの原生薬換算量で２４００〜２４０００ｍｇ、好ましくは４８００〜１２０００ｍｇになる量が挙げられる。 The pharmaceutical composition of the present invention is used for the purpose of alleviating or curing diarrhea symptoms. The dosage of the pharmaceutical composition of the present invention is appropriately set according to the type of painkiller to be used, dosage form, patient age, application, degree of symptoms, etc., for example, as the dosage per day The amount of the above-mentioned saikokeisaito extract is 2400 to 24000 mg, preferably 4800 to 12000 mg, in terms of bulk drug substance.
以下に、実施例を挙げて、本発明を具体的に説明するが、本発明はこれらによって何ら限定されるものではない。 EXAMPLES The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.
試験例：止瀉効果の検証
１．試験液の調製
表１に示す組成の試験液を調製した。具体的には、所定量のカルボキシメチルセルロースナトリウムを添加して溶解させた水溶液に、所定量の柴胡桂枝湯エキス及び所定量の痛止め剤を添加することにより、試験液を調製した。
Test example: Verification of antipruritic effect
1. Preparation of test solution Test solutions having the compositions shown in Table 1 were prepared. Specifically, a test solution was prepared by adding a predetermined amount of Saikoukei-to extract and a predetermined amount of painkiller to an aqueous solution in which a predetermined amount of sodium carboxymethylcellulose was added and dissolved.
２．ストレス誘発下痢モデルラットに対する止瀉効果の評価方法
本試験では、ラット（SPF、Slc:SD、日本エスエルシー株式会社より入手）を用いた。6週齢で入手後、８日間の検疫・馴化期間を設け、体重推移及び一般状態に異常の認められない７週齢となったラットを試験に用いた。表１に示す各試験液を各ラットに対して５ｍｌ／ｋｇ-体重となるように、１ｍｌのディスポーザブルシリンジ（株式会社ＪＭＳ）及びディスポーザブル経口ゾンデ（有限会社フチガミ器械）を用いて経口投与し、投与60分後にラットをイソフルラン（商品名「エスカイン吸入麻酔液」、マイラン製薬株式会社製）で麻酔し、左右の上肢を含む胸部を粘着テープ（５ｃｍ×３０ｃｍを２枚使用）で包んで上半身を固定し拘束ストレスの負荷を与えた。粘着テープで固定したラットを直ちに観察用のケージに1匹ずつ入れ、その後1時間の糞便個数を測定した。本試験では、各群１０匹のラットを用いて行い、糞便個数の平均値を算出した。
2. Method for evaluating antipruritic effect on stress-induced diarrhea model rats Rats (SPF, Slc: SD, obtained from Japan SLC Co., Ltd.) were used in this test. After obtaining at 6 weeks of age, a quarantine / acclimation period of 8 days was provided, and rats that were 7 weeks of age with no abnormalities in weight transition and general condition were used in the test. Each test solution shown in Table 1 is orally administered using a 1 ml disposable syringe (JMS Co., Ltd.) and a disposable oral sonde (Fuchigami Instrument Co., Ltd.) so that each rat has a 5 ml / kg body weight. After 60 minutes, the rat was anesthetized with isoflurane (trade name “Escaine Inhalation Anesthetic Solution”, manufactured by Mylan Pharmaceutical Co., Ltd.), and the upper body was fixed by wrapping the chest including the left and right upper limbs with adhesive tape (2 pieces of 5 cm × 30 cm). The load of restraint stress was given. Rats fixed with adhesive tape were immediately placed in observation cages one by one, and then the number of stools for 1 hour was measured. In this test, 10 rats were used for each group, and the average number of feces was calculated.
３．試験結果
得られた結果を図１に示す。この結果、柴胡桂枝湯エキスを単独で投与した場合（比較例１）に比べて、柴胡桂枝湯エキスと痛止め剤を併用した場合（実施例１〜５）では、ストレス誘発下痢モデルラットにおける糞便個数が減少しており、痛止め剤には、柴胡桂枝湯エキスの止瀉作用を向上させる作用があることが明らかとなった。また、柴胡桂枝湯エキスと痛止め剤を併用した場合（実施例１〜５）において、糞便の性状も正常化していることも確認された。
3. Test results The results obtained are shown in FIG. As a result, stool in stress-induced diarrhea model rats was obtained in the case of using Saikoukei-edu extract and the painkiller in combination (Examples 1 to 5), compared with the case where Saikoukei-edu extract was administered alone (Comparative Example 1). The number has decreased, and it has been clarified that the painkillers have the effect of improving the antipruritic action of Saikoukeiedo extract. It was also confirmed that fecal properties were normalized in the case of using Saikoukei-edu extract and painkiller (Examples 1 to 5).
処方例
表２及び３に示す組成の錠剤（１錠当たり３３３ｍｇ）を常法に従って調製した。
Formulation Examples Tablets having the composition shown in Tables 2 and 3 (333 mg per tablet) were prepared according to a conventional method.
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| JPH08208465A (en) * | 1994-11-11 | 1996-08-13 | Kanebo Ltd | Therapeutic agent of cold |
| JPH09286736A (en) * | 1996-04-23 | 1997-11-04 | Taisho Pharmaceut Co Ltd | Liquid drug for internal use |
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| JPH08208465A (en) * | 1994-11-11 | 1996-08-13 | Kanebo Ltd | Therapeutic agent of cold |
| JPH09286736A (en) * | 1996-04-23 | 1997-11-04 | Taisho Pharmaceut Co Ltd | Liquid drug for internal use |
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| 星野 恵津夫: "下部消化管の機能異常を中心に 漢方薬による過敏性腸症候群の治療", PROGRESS IN MEDICINE, vol. 第１３巻，第１２号, JPN6019025692, 1993, pages 2908 - 2913, ISSN: 0004070702 * |
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