JP2001139487A - Medicinal composition of nasal spray or nasal liquid medicine for pyrogenic common cold and method for producing the same - Google Patents

Medicinal composition of nasal spray or nasal liquid medicine for pyrogenic common cold and method for producing the same

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Publication number
JP2001139487A
JP2001139487A JP31900899A JP31900899A JP2001139487A JP 2001139487 A JP2001139487 A JP 2001139487A JP 31900899 A JP31900899 A JP 31900899A JP 31900899 A JP31900899 A JP 31900899A JP 2001139487 A JP2001139487 A JP 2001139487A
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JP
Japan
Prior art keywords
nasal
medicine
water
drug
solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP31900899A
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Japanese (ja)
Inventor
Bukei Kyo
武慶 許
Shukuken Ko
淑賢 耿
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Individual
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Individual
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Priority to JP31900899A priority Critical patent/JP2001139487A/en
Publication of JP2001139487A publication Critical patent/JP2001139487A/en
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

PROBLEM TO BE SOLVED: To provide safe nasal spray or nasal liquid medicine for pyrogenic common cold having high treating effect. SOLUTION: The present invention relates to a medicinal composition of nasal spray or nasal liquid medicine for pyrogenic common cold and method for producing the medicinal composition. The medicinal composition comprises Bupleurum chinese DC., Radix Isatidis Indigotica, Folium Isatidis and vitamin C. The medicine is produced by a method distilling and filtering the ingredients of the medicinal composition. The medicine is absorbed from nasal cavity into a patient body by directly spraying and dropping the medicine into the nasal cavity to provide alleviation effect of defervescence, analgesic and cold symptoms (e.g. headache, nasal congestion, cough, sore throat, sneeze, snivel and unpleasant cold symptoms of whole body). The medicine in the present invention is suitable for treatment of fever caused by various infectious diseases, particularly upper respiratory tract inflammation.

Description

【発明の詳細な説明】DETAILED DESCRIPTION OF THE INVENTION

【0001】[0001]

【発明の属する技術分野】本発明は発熱感冒噴鼻又は滴
鼻液剤の医薬組成物及びその製法に係り、該医薬組成物
は、紫胡(Bupleurum chinese D
C.)、板藍根(Radix Isatidis In
digotica)、大青葉(FoliumIsati
dis)を煎って煮た後に、含有する成分を取り出し並
びにろ過し、さらにこの薬液にビタミンCを加えて薬剤
を製造し、製造した薬剤を患者が直接鼻腔内部に噴霧或
いは滴下するのに供する、発熱感冒噴鼻又は滴鼻液剤の
医薬組成物及びその製法に関する。
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a pharmaceutical composition of a fever sensation or nasal drop and a method for producing the same, and the pharmaceutical composition comprises Bupleurum chinose D
C. ), Radix Isatidis In
digotica), large green leaves (FoliumIsati)
dis), after boiled and boiled, take out the contained components, filter, add vitamin C to this drug solution to produce a drug, and provide the manufactured drug directly to the patient by spraying or dripping into the nasal cavity. The present invention relates to a pharmaceutical composition of a fever cold nasal or nasal drop and a method for producing the same.

【0002】[0002]

【従来の技術】一般の人は感冒を非常に軽い病症と考え
ているが、実際には感冒は伝染力の非常に強いウイルス
性伝染病である。感冒と識別できるよく見られる症状と
しては、倦怠感、発熱、流涙、鼻づまり、頭痛、喉のい
がらっぽさ或いは疼痛がだる。感冒のウイルスは十分に
微小であり、体積の比較的大きい細菌しか捕捉できない
鼻道中を容易に通過して人体に進入する。且つウイルス
は迅速に増殖し、鼻と喉を侵害し、上述の感冒の症状を
引き起こし、もし処理が不当であると、肺炎や気管支炎
などの併発症を引起し、時には死に至らしめることさえ
ある。このため感冒は軽視できない常見疾病であるとい
える。西洋医学では感冒の治療として、抗生物質、ステ
ロイド、抗ヒスタミン等の薬物で感冒症状を緩和するほ
か、患者に多くの水を飲ませ、休養させる方法を採る。
一般に、西薬の薬効は迅速であるが、抗生物質のもたら
す抗薬性、ステロイドの人体に対し傷害をもたらしうる
毒性、さらには化学物質の人体器官に対する傷害はいず
れも人々の熟知するところの不良な副作用である。且つ
上述の化学薬物は発熱、感冒に対する緩和、予防効果は
理想的でなかった。また上述の感冒薬物は剤型としては
カプセル、錠剤、座薬、口服液、鼻腔への噴霧或いは滴
下剤とされるのが一般的である。感冒の治療と予防は漢
方薬では、感冒の症状を解除する薬剤、いわゆる「解
表」薬が主要な組成物とされ、その主要な機能は発汗促
進であり、風邪を発散させる効果を有している。解表薬
の機能は大きく三つに分けられる。その一つは発汗であ
り、発汗により表面に表れる風邪の症状を除去して病気
が身体の内部に進入するのを防止する。二つ目は「解
肌」と呼ばれ、風邪がすでに身体表面より深いところに
進入し、発汗しても症状を解除できないとき、身体表面
とそれより内側の部分との疎通を良好として、内側部分
の風邪を身体表面に押し出してそれを除去する。三つ目
は「透疹」と呼ばれ、身体のさらに内部に進入した風邪
を身体表面に導き、斑紋、発疹を形成させそれにより風
邪を発散させる。風邪の症状には漢方では寒と熱の別が
あり、人体には虚症と実症の別がある。ゆえに解表薬も
風邪による悪寒を除去するためのものと、風邪による熱
を除去するもの、及び体質虚弱で風邪に感応して引き起
こされた症状を改善するものの三種類がある。薬剤の形
態は通常、粉剤、湯(液)剤が主である。漢方薬は使用
して安全であり、副作用が少ないという優れた点を有し
ているが、薬の効果があらわれるのに時間がかかり、使
用上比較的不便であるという欠点も有している。解熱に
ついては、化学薬物と漢方薬で解熱するほか、氷敷やア
ルコール擦浴、氷水浣腸等の物理的降温の方法がある。
これらの方法は臨床上一定の効果を有している。しかし
少なからぬ臨床例で上述の方法を使用した後に体温が却
って上昇する傾向があった。特に、氷敷或いはアルコー
ル擦浴の物理降温の方式は、病人が高熱を有しており且
つ悪寒を感じているときには適さなかった。このため、
迅速に解熱でき、感冒症状を緩和でき、副作用がなく、
老若男女が使用できる解熱感冒製剤が開発されれば、そ
れは非常に有意義な発明であるといえる。
2. Description of the Related Art The common cold considers the common cold as a very mild disease, but in fact, the common cold is a very infectious viral infectious disease. Common symptoms that can be distinguished from the common cold include malaise, fever, lacrimation, nasal congestion, headache, throat irritation or pain. The cold virus is small enough to easily pass through the nasal passages, which can only capture relatively large volumes of bacteria, and enter the human body. And the virus multiplies quickly, invades the nose and throat, causes the aforementioned cold symptoms, and if improperly processed, can cause complications such as pneumonia and bronchitis, and can even lead to death . For this reason, it can be said that the common cold is a normal disease that cannot be neglected. In western medicine, colds are treated with drugs such as antibiotics, steroids, and antihistamines to relieve the symptoms of the cold, and to give the patient plenty of water and rest.
In general, western medicine has a rapid response, but the anti-drug properties of antibiotics, the toxicity of steroids that can cause injury to humans, and the injuries of chemicals to human organs are all poorly known to people. Side effects. In addition, the above-mentioned chemical drugs were not ideal in alleviating and preventing fever and cold. In addition, the above-mentioned common cold drugs are generally in the form of capsules, tablets, suppositories, oral liquids, sprays or drops into the nasal cavity. In the treatment and prevention of cold, in Chinese medicine, the main composition is a drug that relieves the symptoms of cold, the so-called “tablet” drug, the main function of which is to promote sweating and has the effect of releasing colds I have. The function of the drug is roughly divided into three. One is sweating, which removes the symptoms of colds that appear on the surface due to sweating and prevents the disease from entering the body. The second is called "open skin", and when a cold has already penetrated deeper into the body surface and the symptoms cannot be released even if sweating, the communication between the body surface and the inner part is considered good, and A portion of the cold is pushed to the body surface and removed. The third is called "wheal", which guides a cold that has penetrated further into the body to the surface of the body, forming mottles and rashes, thereby causing the cold to escape. Cold symptoms are classified into cold and fever in Chinese medicine, and human body is classified into illness and actual illness. Therefore, there are three types of disintegrating drugs: one for removing chills caused by a cold, one for removing heat due to a cold, and one for improving symptoms caused by a cold in response to a weak constitution. Usually, the form of the drug is mainly a powder or hot water (liquid). Although the herbal medicine is excellent in that it is safe to use and has few side effects, it also has the drawback that it takes a long time for the effect of the medicine to appear and is relatively inconvenient in use. As for the antipyretic effect, there are physical cooling methods such as icing, alcohol rubbing, ice water enema, etc., in addition to antipyretic treatment with chemical drugs and Chinese medicine.
These methods have certain clinical effects. However, in a number of clinical cases, the body temperature tended to increase after using the above method. In particular, the physical cooling method using an ice pad or an alcohol rubbing bath is not suitable when the sick person has high fever and feels chills. For this reason,
Can quickly relieve fever, relieve cold symptoms, have no side effects,
The development of an antipyretic cold preparation that can be used by men and women of all ages is a very significant invention.

【0003】[0003]

【発明が解決しようとする課題】本発明は漢方と西洋の
感冒薬を混合し、高い解熱効果をあげることのできる解
熱漢方薬を提供することを主要な課題とし、それは、植
物薬を主要な有効成分とし、鼻噴剤として使用されて迅
速に解熱、感冒症状の緩和を行う薬液とされる。本発明
による薬剤は、人体の生理、器官の特徴を利用し、鼻腔
粘膜に投薬することで、薬物が胃腸のpH値或いは酵素
により破壊されるのを防止し、直接鼻腔粘膜より吸収さ
れるため、薬剤の口服により肝臓が過度の作用を受けて
破壊されることがなく、薬物の肝臓に対する毒性及び副
作用を減少できる。且つ剤型に関しては、噴霧剤或いは
滴下剤とされ飲み込むことのできない或いは困難な患者
や児童に特に便利である。
SUMMARY OF THE INVENTION The main object of the present invention is to provide an antipyretic herbal medicine which can provide a high antipyretic effect by mixing a Chinese medicine and a Western common cold medicine. As a component, it is used as a nasal propellant to quickly relieve fever and relieve cold symptoms. The drug according to the present invention utilizes the characteristics of human body physiology and organs and is administered to the nasal mucosa to prevent the drug from being destroyed by the gastrointestinal pH value or enzymes and to be absorbed directly from the nasal mucosa. In addition, the liver is not damaged by excessive action due to oral administration of the drug, and the toxicity and side effects of the drug on the liver can be reduced. In addition, the dosage form is particularly convenient for patients or children who cannot be swallowed or who have difficulty in swallowing because they are in the form of sprays or drops.

【0004】[0004]

【課題を解決するための手段】請求項1の発明は、患者
の鼻腔粘膜にスプレー或いは滴入し吸収させる発熱感冒
噴鼻又は滴鼻液剤の医薬組成物であり、250〜300
gの紫胡(Bupleurum chinese D
C.)、120〜144gの板藍根(Radix Is
atidis Indigotica)、120〜14
4gの大青葉(Folium Isatidis)、1
0〜12gのビタミンCで組成されたことを特徴とす
る、発熱感冒噴鼻又は滴鼻液剤の医薬組成物としてい
る。請求項2の発明は、発熱感冒噴鼻又は滴鼻液剤の製
造方法であって、以下のaからfのステップ、即ち、 a.250〜300gの紫胡を1倍量の水に2時間浸漬
し、さらに4倍量の水を加えて水煮し、蒸留法により揮
発油2〜2.4mlを抽出する。さらにろ過して薬液1
000ml〜1200mlを得て、さらに揮発油、ろ過
薬液及び薬残さをそれぞれ容器に暫時保存するステッ
プ、 b.120〜144gの板藍根、120〜144gの大
青葉にそれぞれ7倍量の水を加えて一時間煎煮し、並び
にろ過し、ろ過液を容器に暫時保存するステップ、 c.上記aとbのステップで抽出或いはろ過後に残った
薬の残さを混合後、さらに薬の残さを混合後の5倍量の
水を加えて1時間煎煮し、その後、4倍量の水を加えて
40分間煎煮し、さらにろ過して得たろ過液を合併する
ステップ、 d.以上により得た三つのろ過液を合併し、並びに1m
lの薬液が1gの生薬に相当するまで濃縮し、さらにこ
れを放置冷却し、95%のエタノールを加えてアルコー
ル含有量70%とするステップ、 e.さらに2ml〜2.4mlの揮発油及び10〜12
gのビタミンCを溶解後に薬液中に加え、混合、ろ過後
に分装するステップ、以上のステップを具えたことを特
徴とする、発熱感冒噴鼻又は滴鼻液剤の製造方法として
いる。
The invention of claim 1 is a pharmaceutical composition of a fever sensation nasal or instilled nasal solution which is sprayed or instilled into a nasal mucosa of a patient and absorbed.
g of Purple hu (Bupleurum chinese D)
C. ), 120-144 g of Radix Is
atidis Indigotica), 120-14
4 g of large green leaves (Folium Isatidis), 1
It is a pharmaceutical composition of a fever sensation nasal or nasal drop, characterized by being composed of 0 to 12 g of vitamin C. The invention of claim 2 is a method for producing a fever sensation or nasal drop, which comprises the following steps a to f, namely: a. 250 to 300 g of purple husk is immersed in 1 volume of water for 2 hours, and 4 volumes of water are further added and boiled in water, and 2 to 2.4 ml of volatile oil is extracted by a distillation method. Filter further and liquid 1
Obtaining from 000 ml to 1200 ml, and further temporarily storing the volatile oil, the filtered chemical solution and the drug residue in containers, respectively; b. 120-144 g of indigo root and 120-144 g of large green leaves were each added with 7 times the amount of water, decocted for 1 hour, and filtered, and the filtrate was temporarily stored in a container; c. After mixing the residue of the medicine remaining after the extraction or filtration in the above steps a and b, add 5 times the amount of water after mixing the residue of the medicine, and incubate for 1 hour, then add 4 times the amount of water. Incubating for 40 minutes in addition and combining the filtrate obtained by further filtration, d. Combine the three filtrates obtained above and 1m
concentrating until 1 liter of the drug solution corresponds to 1 g of crude drug, further allowing to cool, and adding 95% ethanol to make the alcohol content 70%, e. 2 to 2.4 ml of volatile oil and 10 to 12
g. Dissolving vitamin C in a drug solution after dissolving, mixing and filtering, and dispensing the solution. The method comprises the steps of:

【0005】[0005]

【発明の実施の形態】図1に示されるのは本発明の製造
フローチャートである。そのうちの医薬組成物は、25
0〜300gの紫胡(Bupleurum chine
se DC.)、120〜144gの板藍根(Radi
x Isatidis Indigotica)、12
0〜144gの大青葉(Folium Isatidi
s)及び10〜12gのビタミンCで組成されている。
上述の各医薬組成物の含む化学成分及び薬理方面及び機
能及び主要な治療効果について以下に説明する。
FIG. 1 is a manufacturing flowchart of the present invention. The pharmaceutical composition of which is 25
0 to 300 g of purple hugo (Bupleurum chine)
se DC. ), 120-144 g of radish (Radi)
x Isatidis Indigotica), 12
0-144 g of large green leaves (Folium Isatidi)
s) and 10-12 g of vitamin C.
The chemical components, pharmacological aspects, functions, and main therapeutic effects of each of the above-mentioned pharmaceutical compositions are described below.

【0006】1.紫胡(Bupleurum chin
ese DC.) 化学成分:紫胡の根は0.15%の揮発油を含む。この
揮発油は吉草酸(pentanoic acid)、ヘ
キサン酸(hexanoic acid)、エナント酸
(heptanoic acid)、2−エナント酸
(2−heptanoicacid)、カプリル酸(o
ctanoic acid)、2−カプリル酸(2−o
ctanoic acid)、ノニル酸(nonano
ic acid)、2−ノニル酸(2−nonanoi
c acid)、フェノール(phenol)、ο−メ
トキシフェノール(ο−methoxypheno
l)、γ−ヘプタラクトン(γ−heptalacto
ne)、γ−オクタラクトン(γ−octalacto
ne)、γ−デカラクトン(γ−decalacton
e)、ちょうじ油(eugenol)、γ−アンデカラ
クトン(γ−undecalactone)、クレゾー
ル(cresol)、エチルフェノール(ethylp
henol)、チモール(thymol)、メソイアラ
クトン(messoia lactone)、バニリン
アセテート(vanillin acetate)、2
−メチルサイクロペンタノン(2−methylcyc
lopentanone)、リモネン(limonen
e)、ミルセン(myrcene)、カルバクロン(c
arvacrone)、カルベオール(carveo
l)、プレゴン(pulegone)、ミルテノール
(myrtenol)、α−テルピネオール(α−te
rpineol)、リナロオール(linaloo
l)、ゲラニオール(geraniol)、n−トリデ
カン(n−tridecane)、(E)−ゲラニルア
セトン((E)−geranyl acetone)、
α−クベベン(α−cubebene)、δ−カジネン
(δ−cadinene)、フムレン(humulen
e)、カリオフィレン(caryophyllen
e)、ロンギフォレン(longifolene)、ノ
オトカトン(nootkatone)、ヘキサデカン酸
(hexadecanoic acid)、ヘキサヒド
ロファルネシルアセトン(hexahydrofarn
esyl acetone)、サイコサポニン(sai
kosaponin)a、c、d、s1 、アドニトール
(adonitol)、α−スピナステロール(α−s
pinasterol)、多糖類を含む。紫胡の茎葉部
はフラボン類成分を含む。即ち、カエルンプフェロール
(kaernpferol)、カエルンプフェロール−
7−ラムノサイド(kaernpferol−7−rh
amnoside)、カエルンプフェロール−3−O−
α−L−アラビノピラノサイド−7−O−α−L−ラム
ノピラノサイド(KAERNPFEROL−3−O−α
−L−arabinopyranoside−7−O−
α−L−rhamnopyranoside)を含む。 薬理方面:鎮痛作用を有する。即ち、マウスの尾の電撃
実験及び酢酸皮下注射のいずれにおいてもサイコサポニ
ン(saikosaponin)はあきらかな鎮痛作用
を有した。マウスの尾の電撃実験によると、サイコサポ
ニン478mg/kg(1/4LD50)が痛みの遮断
効果が著しく高かった。サイコサポニンaとシロップ状
残留物を体重1kg当たり50mg或いは100mg腹
腔注射した場合、いずれもマウスの腹腔への酢酸注射に
より引き起こすねじり反応を抑制できた。また圧迫によ
り引き起こした疼痛に対してシロップ状残留物は明らか
な鎮痛作用を有した。また、すでにサイコサポニンが筋
肉の緊張を弛緩させ鎮痛作用を発揮することが認められ
ている。咳鎮静作用を有する。即ち、サイコサポニンa
は比較的強い咳鎮静作用を有し、機械刺激により咳を発
生させる方法により証明されている。モルモットの腹腔
にサイコサポニン咳鎮静のED50は9.1mg/kg
であり、その効果はリン酸コデイン7.6mg/kgに
近い。サイコサポニンaの咳鎮静作用と剤量には関係が
あり、モルモット腹腔注射100−200mg/kgの
咳鎮静作用が最も明らかであった。 機能と治療:紫胡は解表による解熱、疲れた肝臓を労
り、肝臓の働きを滑らかとし、身体に生気を漲らせる。
そして、感冒による発熱、寒けをなくし、胸部の不快感
をなくし、苦みの感覚やのどの渇き、頭痛、めまい、月
経不純、虚脱症状及び脱肛、子宮下垂、胃下垂に治療効
果がある。
[0006] 1. Purple hu (Bupleurum chin)
es DC. ) Chemical composition: Purple root contains 0.15% volatile oil. This volatile oil is composed of valeric acid (pentanoic acid), hexanoic acid (hexanoic acid), enanthic acid (heptanoic acid), 2-enanthic acid (2-heptanoic acid), caprylic acid (o
ctanoic acid), 2-caprylic acid (2-o
ctanic acid), nonylic acid (nonanoic acid)
ic acid), 2-nonyl acid (2-nonanoi)
acid), phenol (phenol), o-methoxyphenol (o-methyoxypheno)
l), γ-heptalactone (γ-heptalacto)
ne), γ-octalactone (γ-octalacto)
ne), γ-decalacton
e), fuji oil (eugenol), γ-undecalactone, cresol, ethylphenol (ethylp)
henol), thymol (thymol), mesosia lactone, vanillin acetate, 2
-Methylcyclopentanone (2-methylcyc
lopenenone), limonen
e), myrcene, carvaclone (c)
arvacrone, carveol
1), pulegone, myrtenol, α-terpineol (α-te)
rpineol), linalool
1), geraniol, n-tridecane, (E) -geranylacetone ((E) -geranylacetone),
α-Cubebene, δ-cadinene, humulen
e), caryophyllen
e), longifolene, longkatone, hexadecanoic acid, hexahydrofarnesylacetone (hexahydrofarn)
esyl acetone, saikosaponin (sai)
kosaponin) a, c, d, s 1 , adonitol, a-spinasterol (α-s)
pinasterol), including polysaccharides. The foliage of purple sesame contains flavones. That is, kaernpferol, kaernpferol-
7-rhamnoside (kaernpferol-7-rh)
amnoside), caerumpferol-3-O-
α-L-arabinopyranoside-7-O-α-L-rhamnopyranoside (KAERNPFEROL-3-O-α
-L-arabinopyranoside-7-O-
α-L-rhamnopyranoside). Pharmacological: Has an analgesic effect. That is, saikosaponin had a clear analgesic effect in both the lightning experiment of the mouse tail and the subcutaneous injection of acetic acid. According to a lightning experiment on the tail of mice, 478 mg / kg of saikosaponin (1/4 LD50) had a remarkably high pain-blocking effect. When saikosaponin a and syrup-like residue were injected intraperitoneally at 50 mg or 100 mg per kg of body weight, the torsional reaction caused by injecting acetic acid into the abdominal cavity of each mouse could be suppressed. The syrupy residue had a clear analgesic effect on the pain caused by the compression. Also, it has been already recognized that saikosaponin relaxes muscle tone and exerts an analgesic effect. Has a cough sedative effect. That is, saikosaponin a
Have a relatively strong cough sedative effect and have been demonstrated by a method of generating cough by mechanical stimulation. ED50 of sedative saikosaponin cough in guinea pig 9.1 mg / kg
And its effect is close to codeine phosphate 7.6 mg / kg. There is a relationship between the cough sedation effect of saikosaponin a and the dosage, and the cough sedation effect of 100-200 mg / kg guinea pig intraperitoneal injection was most apparent. Function and treatment: Shihu relieves fever by digestion, works on the tired liver, smoothes the function of the liver, and brings the body to life.
It also eliminates fever and cold caused by the common cold, eliminates discomfort in the chest, and has a therapeutic effect on sensation of bitterness, thirst, headache, dizziness, menstrual imperfection, collapse symptoms and anal prolapse, ptosis, ptosis.

【0007】2.板藍根(Radix Isatidi
s Indigotica) 板藍根の根部は、インジゴチン(indigotin,
indigo)、インジルビン(indirubi
n)、β−シトステロール(β−sitostero
l)、多種のアミノ酸、シニグリ−n(sinigri
−n)、インドキシル−β−グルコサイド(indox
yl−β−glucoside)、トリプタンンスリン
(tryptanthrine)、1−チオシアノ−2
−ヒドロキシ−3−ブテン(thiocyano−2−
hydroxy−3−butene)、エピゴイトリン
(epigoitrin)、アデノシン(adenos
ine)、パルミチン酸(palmitic aci
d)、蔗糖(sucrose)、及び12%アミノ酸の
蛋白多糖。 薬理方面:抗細菌、ウイルス作用を有する。体外試験で
は、100%板藍根水煮液は黄金色ブドウ球菌、表皮ブ
ドウ球菌に対して菌抑制作用を有した。50%組織細胞
感染量(TCID50)を使用した感染シングルセルV
ero−E6に対する板藍根注射抗ウイルス実験による
と、1:100の板藍根はウイルス殺傷作用を有した。
板藍根抽出物はウイルスの感染を抑制すると共に増殖を
抑制する作用を有する。免疫に対する調節作用として、
板藍根多糖 25mg/kg、50mg/kg、100
mg/kg腹腔注射が、マウスのDNCB(ジニトロク
ロルベンゼン)の遅発型変態反応を増強し、体内リンパ
細胞の転化を誘導し脾細胞を増強する自然殺傷細胞(N
K)の活性を明らかに増強した。50mg/kgの板藍
根多糖の腹腔注射は著しくマウスの免疫機能を促進し、
正常マウス脾臓重量の増加、白細胞総数及びリンパ細胞
数の増加、抗体形成細胞機能を増強した。 機能と治療効果:解熱、解毒、血液の熱を除去し喉をな
めらかにする。板藍根は、熱を冷まし解毒し、血液の熱
を冷まして斑紋を消す。高熱による熱、頭痛、喉の渇
き、流行性耳下腺炎、体表の化膿性感染、結膜炎、吐
血、昏睡、頭顔面感染等に治療効果がある。
[0007] 2. Radix Isatidi
s Indigotica The root of the indigo root is indigotin,
indigo), indirubin (indirubi)
n), β-sitosterol (β-sitostero)
l), various amino acids, sinigli-n (sinigri-n)
-N), indoxyl-β-glucoside (indox)
yl-β-glucoside, tryptanthrine, 1-thiocyano-2
-Hydroxy-3-butene (thiocyano-2-
hydroxy-3-butene), epigoitrin, adenosine (adenos)
ine), palmitic acid (palmic acid)
d), sucrose, and a 12% amino acid protein polysaccharide. Pharmacology: Has antibacterial and viral effects. In the in vitro test, the 100% blanched root boiled liquid had an inhibitory effect on golden staphylococci and epidermidis staphylococci. Infected single cell V using 50% tissue cell infectious dose (TCID50)
According to the anti-virus experiment for indigo root injection against ero-E6, 1: 100 indigo root had virus killing effect.
The indigo root extract has an effect of suppressing virus infection and suppressing growth. As a regulatory effect on immunity,
Itai root polysaccharide 25mg / kg, 50mg / kg, 100
Intraperitoneal injection of mg / kg enhances the late onset metamorphosis of DNCB (dinitrochlorobenzene) in mice, induces the conversion of in vivo lymphocytes and enhances spleen cells.
The activity of K) was clearly enhanced. Intraperitoneal injection of 50 mg / kg lantern polysaccharide significantly promotes the immune function of mice,
It increased normal mouse spleen weight, increased total number of white cells and lymphocytes, and enhanced antibody-forming cell function. Function and therapeutic effect: Antipyretic, detoxifying, removing heat of blood and smoothing throat. It cools the heat and detoxifies it, cools the heat of the blood and removes the spots. It has a therapeutic effect on fever due to high fever, headache, thirst, epidemic parotitis, purulent infection of the body surface, conjunctivitis, bloody bleeding, coma, craniofacial infection, etc.

【0008】3.大青葉(Folium Isatid
is) 化学成分:その葉中にインジゴチン(indigoti
n,indigo)、イサタンB(isatan
B)、インジルビン(indirubin)を含む。さ
らに、鉄、チタン、コバルト、亜鉛、銅及びニッケル、
セレン、クロム、砒素等の無機元素を含む。イサタンB
は水に溶けてインジゴとD−キシロ−5-ヘクスロフラノ
ソニックアシド(D−xyloj−5−hexulof
uranosonicacid)に変化可能である。 薬理方面:抗病原微生物作用を有する。大葉青煎剤体外
試験によると黄金色ブドウ球菌、甲型連鎖球菌、脳膜炎
雙球菌、肺炎連鎖球菌、傷寒桿菌、大腸桿菌、流行桿
菌、白喉桿菌及び痢疾桿菌のいずれに対しても一定の抑
制作用を有していた。大青葉は乙型脳炎ウイルス、流行
性耳下腺炎ウイルス、流感ウイルス等にも抑制作用を有
した。このほか、大青葉はさらにレプストピラ殺菌作用
を有する。 機能と治療効果:解熱、解毒、病原による熱の除去、発
疹の治療作用を有する。大葉青は、風邪による頭痛、喉
の渇き、高熱、意識不明、熱による血液の侵入による斑
紋、喉の痛み、黄疸、赤痢、カルブンケル、フレグモー
ネに治療効果がある。
[0008] 3. Ooba (Folium Isid)
is) Chemical component: indigotin in its leaves
n, indigo), Isatan B (isatan)
B), including indirubin. In addition, iron, titanium, cobalt, zinc, copper and nickel,
Contains inorganic elements such as selenium, chromium, and arsenic. Isatan B
Is dissolved in water and indigo and D-xylo-5-hexulofanosonic acidide (D-xyloj-5-hexulof)
uranosonic acid). Pharmacological: has antipathogenic microbial activity. According to in vitro tests of green leaf decoction, it has a certain inhibitory effect on all of Staphylococcus aureus, Streptococcus cerevisiae, Streptococcus pneumoniae, Streptococcus pneumoniae, Streptococcus pneumoniae, Bacillus bacillus, Colonic bacillus, Epidemic bacillus, White throat bacillus and Diarrhea bacillus Had. Great green leaves also had an inhibitory effect on type B encephalitis virus, epidemic parotitis virus, flu virus and the like. In addition, large green leaves also have a leptospiral bactericidal action. Function and therapeutic effect: It has antipyretic, detoxifying, pathogenic heat removal, and rash treatment. Ooba blue has a therapeutic effect on headache, thirst, high fever, unconsciousness due to a cold, mottle due to invasion of blood due to heat, sore throat, jaundice, dysentery, carbunkel, and fregmone.

【0009】4.ビタミンC 化学成分:主要な成分は葡萄糖である。 薬理方面:ろ過性ウイルスに対する抑制作用を有する。 機能と治療:インフルエンザを予防し、抵抗力を増強
し、インフルエンザ症状、即ち発熱、寒け、疲労、ひど
い咳、痰、鼻づまり、頭痛、関節痛等の症状を緩和す
る。インフルエンザ感染は、肺炎、気管支炎、扁桃炎等
を引き起こす。インフルエンザはろ過性ウイルスにより
引き起こされる。
4. Vitamin C Chemical composition: The main ingredient is glucose. Pharmacological direction: has an inhibitory effect on filterable viruses. Function and treatment: Prevents flu, enhances resistance and relieves flu symptoms such as fever, cold, fatigue, severe cough, sputum, nasal congestion, headache, joint pain, etc. Influenza infection causes pneumonia, bronchitis, tonsillitis and the like. Influenza is caused by a filterable virus.

【0010】本発明の製造過程は以下のステップを含
む。第1ステップにおいて、250〜300gの紫胡を
1倍量の水に2時間浸漬し、さらに4倍量の水を加えて
水煮し、水蒸気蒸留法により揮発油2−2.4mlを抽
出する。さらにろ過して薬液1000ml−1200m
lを得る。さらに揮発油、ろ過薬液及び薬残さをそれぞ
れ容器に暫時保存する。第2ステップにおいて、120
〜144gの板藍根、120〜144gの大青葉にそれ
ぞれ7倍量の水を加えて一時間煎じ、並びにろ過し、ろ
過液を容器に暫時保存する。第3ステップにおいて、第
1ステップと第2ステップで抽出或いはろ過後に残った
薬の残さを混合後、さらに薬の残さを混合後の5倍量の
水を加えて1時間煎じ、その後、4倍量の水を加えて4
0分間煎じ、さらにろ過して得たろ過液を合併する。第
4ステップにおいて、以上により得た三つのろ過液を合
併し、並びに1mlの薬液が1gの生薬に相当するまで
濃縮する。さらにこれを放置冷却し、95%のエタノー
ルを加えてアルコール含有量70%とする。第5ステッ
プにおいて、さらに以上によりエタノールを加えた後の
薬液を24時間静かに置き、ろ過し、エタノールを回収
し1mlに生薬1gを含むようにする。第6ステップに
おいて、さらに2ml〜2.4mlの揮発油と10〜1
2gのビタミンCを溶解後に薬液中に加え、混合、ろ過
後に、分装する。
The manufacturing process of the present invention includes the following steps. In the first step, 250-300 g of purple husk is immersed in 1 volume of water for 2 hours, and 4 volumes of water is further added and boiled in water, and 2-2.4 ml of volatile oil is extracted by steam distillation. . After further filtration, the drug solution is 1000ml-1200m
1 is obtained. Further, the volatile oil, the filtered chemical solution, and the drug residue are each temporarily stored in a container. In the second step, 120
To 144 g of indigo root and 120 to 144 g of large green leaves, 7 times the amount of water is added, decocted for 1 hour, filtered, and the filtrate is temporarily stored in a container. In the third step, after mixing the residue of the medicine left after extraction or filtration in the first step and the second step, add the remaining amount of the medicine, add 5 times the amount of water after mixing, incubate for 1 hour, and then quadruple Add the amount of water and add 4
Decant for 0 minutes and combine the filtrates obtained by filtration. In a fourth step, the three filtrates obtained above are combined and concentrated until 1 ml of drug solution corresponds to 1 g of crude drug. It is then left to cool and 95% ethanol is added to bring the alcohol content to 70%. In the fifth step, the drug solution after the addition of ethanol is gently placed for 24 hours, filtered, and the ethanol is collected so that 1 ml contains 1 g of crude drug. In the sixth step, another 2 ml to 2.4 ml of volatile oil and 10 to 1
After dissolving 2 g of vitamin C, the solution is added, mixed, filtered, and then dispensed.

【0011】以上により製造された噴鼻又は滴鼻液剤
は、その解熱作用、毒理研究の実験結果及び方法は以下
のとおりである。 一.解熱作用方面: 実験材料: 1.生薬2gを含む噴鼻又は滴鼻液剤。臨床投薬量は子
児の体重各10kgに対して2滴(約0.1ml)とし
て10分内に滴下完了し、10回連用する。累計投薬量
は体重1kg当たり生薬約0.2g、実験前に噴鼻又は
滴鼻液剤を希釈して必要な薬物濃度となす。 2.アナルジン(Analgin)注射液、武漢製薬会
社生産,バッチナンバー9511.04,規格0.5g
/2ml、臨床嬰幼児用20%溶液を滴鼻し、毎回各鼻
孔側より1〜2滴を滴下する。毎回の最大投薬量は約4
0mgとし、嬰幼児の平均体重を10kgとして計算
し、体重1kg当たりの投薬量を約4mgとする。実験
前にアナルジン注射液を希釈し、必要な薬物濃度とな
す。 3.タイリノル解熱口服滴液(TYLENOL CHI
LDREN’S P.S.LIQUID,アメリカのジ
ョンソン社製造,バッチ番号SGM199,毎瓶15m
l),0.8ml当たり80mgのアセトアミノフェン
(Acetaminophen)を含むものを、臨床で
は年齢或いは体重に応じて投薬し、各体重1kgあたり
一回に約0.12ml投薬し、即ちアセトアミノフェン
12mlを与える。 4.生理食塩水(河南省平頂山市製薬会社生産、バッチ
番号9512301)。5.10%新鮮ビール酵母懸濁
液(The mingling ferment li
quid for fresh beer)。新鮮ビー
ル酵母懸濁液をろ過し、残さを生理食塩水で反復洗浄
し、遠心分離機にかけた後、上澄み液を除去し、0.5
%カルボキシメチルセルロースと配合し10%の濃度と
する。 6.体重170〜210gのウイスター(Wista
r)ラット(河南医科大学実験動物センター提供) 方法と結果:室温20〜25℃の条件下で進行し、雄の
体重170〜210gのウイスターラットに対して、実
験前に肛門で基礎体温を三回測定し、体温波動<=0.
3℃のラットに10%のビール酵母懸濁液10ml/k
gを注射し、注射4時間後に再度体温測定し、体温が1
℃以上上昇したものを選び、且つ体温上昇が近いラット
50匹に対して実験を進行する。ラットを均等に5組に
分け、即ち、高剤量噴鼻又は滴鼻グループ、低剤量噴鼻
グループ、アナルジン(Analgin)投与グルー
プ、タイリノール解熱口服滴液投与グループ、及び空白
対照グループとする。図2に示されるように、噴鼻又は
滴鼻液剤の、ビール酵母により発熱させたラットの体温
への影響(℃,X±SD)を各グループ10匹に対して
調べた。各実験グループのいずれにも滴鼻式に投薬し、
毎回0.14ml/kgで10分以内に滴下完了し、1
0分毎に一回投薬し、連続10回投薬し総投薬量は体重
に対して1.4ml/kgとなるようにした。二つの噴
鼻又は滴鼻液剤グループに、それぞれ希釈後に二組の濃
度とした噴鼻又は滴鼻液剤を与え、総投薬量は、高剤量
グループで生薬2.4g/kg相当、低剤量グループで
生薬1.2g/kgとした。アナルジンを希釈後にアナ
ルジン投与グループに投与し、アナルジンの累計容量は
0.08g/kgとし、タイリノール解熱口服滴液投与
グループに、タイリノール解熱口服滴液を、総投薬量
0.14g/kgを以て投与した。空白対照グループ
に、生理食塩水を同量投与した。0.5、1、2、4時
間後に体温を測定した。実験結果は図2に示されるとお
りである。実験結果から、噴鼻又は滴鼻液剤、タイリノ
ール解熱口服滴液、アナルジン注射液滴鼻投薬のそれぞ
れが異なった程度の解熱作用を有し、空白参照グループ
と比較すると、顕著性と非顕著性の違いがあり、三種類
の試験薬物のなかでアナルジンの解熱効果が比較的弱
く、投薬後2時間でやっと顕著な解熱作用(P<0.0
5)が表れた。噴鼻液高剤量グループとタイリノール解
熱口服滴液は比較的強い解熱作用を有し、空白参照グル
ープと比較すると、投薬0.5、1、2、4時間後のい
ずれにも非常に顕著な解熱作用を有し、解熱過程全体か
らみると、タイリノール解熱口服滴液は即効効果が比較
的良好であり、噴鼻又は滴鼻液剤は作用の持続時間が比
較的長かった。
The nasal or nasal drops prepared as described above have the following experimental results and methods for their antipyretic and toxicological studies. one. Antipyretic effect: Experimental materials: Nasal or nasal drops containing 2 g of crude drug. The clinical dosage is 2 drops (approximately 0.1 ml) for each 10 kg of the infant's body weight, which is completed within 10 minutes, and repeated 10 times. The cumulative dose is about 0.2 g of crude drug per kg of body weight, and the nasal or nasal solution is diluted to the required drug concentration before the experiment. 2. Analgin injection solution, produced by Wuhan Pharmaceutical Company, batch number 9511.04, standard 0.5g
/ 2 ml, 20% solution for clinical infants is dropped and nosed, and 1-2 drops are dropped from each nostril side each time. The maximum dosage for each is about 4
0 mg and the average weight of the infant is calculated as 10 kg, and the dosage per kg of the weight is set at about 4 mg. The analdine injection solution is diluted to the required drug concentration before the experiment. 3. TYLINOL CHI
LDREN'S P.L. S. LIQUID, manufactured by Johnson, USA, batch number SGM199, each bottle 15m
l) A drug containing 80 mg of acetaminophen per 0.8 ml is clinically dosed according to age or body weight, and is dosed at about 0.12 ml at a time per kg of body weight, ie, 12 ml of acetaminophen. give. 4. Physiological saline (produced by Pingdingshan City Pharmaceutical Company, Henan Province, batch number 9512301). 5. 10% fresh beer yeast suspension (The mingling fermenti
(quid for fresh beer). The fresh brewer's yeast suspension was filtered, the residue was repeatedly washed with saline, centrifuged, and the supernatant was removed.
% Carboxymethylcellulose to give a concentration of 10%. 6. Wistar weighing 170-210 g (Wista
r) Rats (Courtesy of Experimental Animal Center, Henan Medical University) Methods and results: Wistar rats that proceed under conditions of room temperature of 20 to 25 ° C. and weigh 170 to 210 g of males were subjected to three anal basal body temperatures before the experiment. Measurement, body temperature wave <= 0.
10% brewer's yeast suspension 10ml / k in rats at 3 ° C
g, and 4 hours after the injection, the body temperature was measured again.
The experiment is carried out on 50 rats whose temperature has risen by at least 0 ° C., and whose body temperature rise is close. The rats are divided equally into five groups: a high dose nasal or drip nasal group, a low dose nasal nasal group, an analgin administration group, a tylinol antipyretic oral administration drop administration group, and a blank control group. . As shown in FIG. 2, the effects of the nasal spray or nasal drops on the body temperature of rats exothermic with brewer's yeast (° C., X ± SD) were examined for each group of 10 rats. Dosing nasal to each of the experimental groups,
Dropping was completed within 10 minutes at 0.14 ml / kg each time.
A single dose was administered every 0 minutes, and 10 consecutive doses were made so that the total dose was 1.4 ml / kg of body weight. Two groups of nasal or nasal drops were given two sets of nasal or nasal drops after dilution, respectively, and the total dosage was 2.4 g / kg crude drug in the high dose group, low Herbal composition was 1.2 g / kg. Analgin was diluted and administered to the analdine administration group, the cumulative volume of analdine was set to 0.08 g / kg, and the tylinol antipyretic oral dose was administered to the group administered the tylinol antipyretic oral solution at a total dosage of 0.14 g / kg. Was administered. A blank control group received the same volume of saline. Body temperature was measured after 0.5, 1, 2, and 4 hours. The experimental results are as shown in FIG. Experimental results show that nasal or nasal drops, Tylinol antipyretic oral drops, and analdine nasal drops had different degrees of antipyretic activity, and were significantly or less pronounced when compared to the blank reference group. The analgesic effect of analdine was relatively weak among the three test drugs, and only 2 hours after administration, a significant antipyretic effect (P <0.02) was observed.
5) appeared. The nasal fluid high dose group and the Tylinol antipyretic oral solution have a relatively strong antipyretic effect, and are very remarkable at 0.5, 1, 2, and 4 hours after administration as compared to the blank reference group. In view of the whole antipyretic process, Tylinol antipyretic oral liquid had a relatively good immediate effect, and the nasal or nasal solution had a relatively long duration of action.

【0012】二.噴鼻又は滴鼻液剤の毒理研究方面: 実験材料: 1.噴鼻又は滴鼻液剤、毎mlに生薬2g或いは4gを
含む噴鼻又は滴鼻液剤を用意する。臨床において毎ml
に生薬2gを含む噴鼻又は滴鼻液剤を、子供に、体重1
0kg当たり2滴(即ち約0.1ml)を、10分以内
に滴下投与完了する。10分ごとに一回投与し、体重1
kg当たり約0.2gの投薬量となるよう連続投薬す
る。 2.河南医科大学実験動物センターより提供されたウイ
スターラット、体重180〜220gを雄雌兼用する。 方法と結果: 1.急性毒性試験:健康なラット(体重180〜220
g)を選び、ランダムに三つのグループに分け、それぞ
れ噴鼻又は滴鼻液剤高剤量グループ、低剤量グループ、
空白対照グループに分ける。各グループ10匹で雌雄半
分ずつとする。20〜25℃の室温条件下で、噴鼻又は
滴鼻液剤高剤量グループに、1ml当たり4gの生薬を
含む噴鼻又は滴鼻液剤を投与し、低剤量グループに1m
l当たり2gの生薬を含む噴鼻又は滴鼻液剤を投与し、
空白対照グループに生理食塩水を投与する。毎回0.1
ml/kg、10分内に投与完成し、10分ごとに一回
投与し、連続10回投与する。その後、8時間あけて、
その後に上述の投与過程を重複して行い、一日の総投薬
量を累計し、噴鼻又は滴鼻液剤高剤量グループは生薬8
g/kg相当、低剤量グループは4g/kg相当に相当
するようにする。投薬後室温下で飼育し、7日間連続観
察する。投薬後のラットの飲水、食餌、活動、体重、毛
づやなどにはいずれも異常がなかった。詳細な状況は以
下の表1に示されるとおりである。7日後のラットを解
剖し、心臓、肝臓、脾臓、肺、腎臓、胃、腸、脳、鼻、
喉、気管、支気管等の組織器官にもいずれも異常は見ら
れなかった。ゆえに噴鼻又は滴鼻液剤のラットに対する
8g/kgの投薬量は、急性毒性反応を引き起こさない
ことが分かった。この投薬量は臨床用量の約40倍であ
る。
[0012] 2. Toxicological research on nasal or nasal solutions: Experimental materials: A nasal or dripping nasal solution, a nasal or dripping nasal solution containing 2 g or 4 g of crude drug per ml is prepared. Every ml in the clinic
A nasal or nasal solution containing 2 g of crude drug to a child, weighing 1
Two drops per 0 kg (ie, about 0.1 ml) are completed in less than 10 minutes. Dosing once every 10 minutes, weight 1
Continuous dosing to give a dosage of about 0.2 g per kg. 2. Wistar rats provided by the Laboratory Animal Center of Henan Medical University, weighing 180-220 g, are used for both male and female. Methods and results: Acute toxicity test: Healthy rats (body weight 180-220)
g), randomly divided into three groups, nasal or nasal drops high dose group, low dose group,
Divide into blank control groups. There are 10 males and 10 males in each group. Under the condition of room temperature of 20 to 25 ° C., the nasal or nasal solution high-dose group was administered with the nasal or nasal solution containing 4 g of crude drug per ml, and 1 m to the low-dosage group.
administering a nasal or nasal solution containing 2 g of crude drug per liter;
The blank control group receives saline. 0.1 each time
The administration is completed within 10 minutes, and the administration is performed once every 10 minutes and 10 times continuously. Then, after 8 hours,
Thereafter, the above-described administration process is repeated, and the total daily dose is accumulated.
g / kg, the low dosage group should be equivalent to 4 g / kg. After dosing, the animals are kept at room temperature and continuously observed for 7 days. There were no abnormalities in drinking water, diet, activity, body weight, hairiness, etc. of the rats after dosing. The detailed situation is as shown in Table 1 below. Seven days later, the rats were dissected, and the heart, liver, spleen, lung, kidney, stomach, intestine, brain, nose,
No abnormalities were found in any of the tissue organs such as the throat, trachea, and bronchus. Thus, a dose of 8 g / kg of nasal or nasal solutions to rats was found not to cause an acute toxic reaction. This dosage is about 40 times the clinical dose.

【表1】 2.噴鼻又は滴鼻液剤高剤の刺激性試験 健康な体重180〜220gのラット20匹を選び、噴
鼻又は滴鼻液剤投与グループと空白対照グループに分け
る。なお、各グループ10匹ずつで雌雄半々となるよう
にする。実験は室温22±2℃で進行し、実験時に、噴
鼻又は滴鼻液剤を、ゆっくりとラットの鼻腔に滴入し、
10分ごとに1回投与し、毎回、体重1kg当たり0.
1ml与え、連続10回投薬する。累計投薬量が体重1
kg当たり1ml(生薬2g含有)となるようにした。
投薬後のラットの呼吸は平穏で、呼吸頻度、リズムは正
常で、咳や喘息症状、窒息等の呼吸道不良反応はなく、
投薬24時間後にラットを解剖し、鼻、喉、気管、支気
管等の呼吸道の粘膜のいずれにも充血、紅腫などの病理
学改変は見られなかった。これから噴鼻又は滴鼻液剤が
無刺激性であることが認められた。
[Table 1] 2. Irritation test of nasal or instilled nasal solution high drug Twenty healthy rats weighing 180-220 g are selected and divided into a nasal or instilled nasal solution administration group and a blank control group. In addition, each group consists of 10 animals, so that the sex becomes half. The experiment proceeds at room temperature 22 ± 2 ° C. At the time of the experiment, a nasal or nasal solution was slowly instilled into the rat nasal cavity,
Dosing once every 10 minutes, every time 0.1 mg / kg body weight.
Give 1 ml and administer 10 consecutive times. Total dose is 1 body weight
The volume was adjusted to 1 ml (containing 2 g of crude drug) per kg.
After dosing, the rats breathe calmly, their breathing frequency and rhythm are normal, and there are no respiratory tract reactions such as cough, asthma symptoms, and suffocation.
The rats were dissected 24 hours after administration, and no pathological alterations such as hyperemia and erythema were found in any of the mucous membranes of the respiratory tract, such as the nose, throat, trachea, and bronchus. This confirmed that the nasal or nasal drops were non-irritating.

【0013】[0013]

【発明の効果】上述の本発明の噴鼻又は滴鼻液剤は良好
な解熱作用を有し、作用強度と作用時間のいずれにおい
ても周知の解熱薬であるアナルジンより優れ、タイリノ
ール解熱口服滴液作用と同等であり、且つ無刺激性で、
臨床用量40倍(8kg/kg生薬)をラットに滴鼻し
ても急性毒性反応は見られず、このことから本発明の噴
鼻又は滴鼻液剤が安全な意訳組成物であることが証明さ
れた。図3から図6は本発明の発熱感冒噴鼻又は滴鼻液
剤治療効果観察表である。この治療効果観察表は、異な
る年齢層の人の異なる感冒疾病に応じて異なる薬剤量を
患者の鼻腔内部にスプレー或いは滴入した結果を示す。
薬剤は鼻腔内部の粘膜に吸収された後に、短時間で病状
を抑え、顕著な治療効果を示した。注意すべきこととし
て、上述の紫胡(Bupleurum chinese
DC.)の代わりに狭葉紫胡(Bupleurum
Scorzonerifolium Willd)を使
用可能であり、両者の成分と薬理はほぼ同じで、且つ両
者の実験後の結果もほぼ同じであった。なお、上述の漢
方薬物の薬理と成分については、中国国家中医薬管理局
編集委員会が上海科学技術出版社に委託し1998年1
月出版、発行した「中華本草乙書(上下刊)」を参照で
きる。
The nasal or instilled nasal solution of the present invention described above has a good antipyretic effect, and is superior to the well-known antipyretic analdine in both action intensity and action time. Equivalent to action and non-irritating,
No acute toxic reaction was observed even when the rat was instilled with a clinical dose of 40 times (8 kg / kg crude drug) in the nose, which proved that the nasal or nasal solution of the present invention was a safe paraphrase composition. Was. FIG. 3 to FIG. 6 are observation tables of the therapeutic effects of the fever sensation or nasal drop of the present invention. This therapeutic effect observation table shows the results of spraying or instilling different amounts of a drug into the nasal cavity of a patient according to different cold diseases of people of different ages.
After the drug was absorbed into the mucous membrane inside the nasal cavity, it suppressed the disease state in a short time and showed a remarkable therapeutic effect. It should be noted that the above-mentioned purple huhu (Bupleurum chinese)
DC. ) Instead of narrow leaf purple hu
Scorzonerifolia Will) could be used, the components and pharmacology of both were almost the same, and the results after both experiments were almost the same. The pharmacology and ingredients of the above-mentioned Kampo medicines were commissioned to the Shanghai Science and Technology Publishing Company by the Editorial Committee of the State Chinese Pharmaceutical Management Agency in January 1998.
You can refer to “Chinese book book” (published and published by Tsuki).

【図面の簡単な説明】[Brief description of the drawings]

【図1】本発明の発熱感冒噴鼻又は滴鼻液剤の医薬組成
物の製造フローチャートである。
FIG. 1 is a production flowchart of a pharmaceutical composition of a fever sensation or nasal drops according to the present invention.

【図2】本発明の噴鼻又は滴鼻液剤のビール酵母で発熱
させたマウスの体温に対する影響(℃,X±SD)表示
図である。
FIG. 2 is a diagram showing the effects (° C., X ± SD) on body temperature of mice heated by brewer's yeast with the nasal or dripping nasal solution of the present invention.

【図3】本発明の発熱感冒噴鼻又は滴鼻液剤の治療効果
観察表である。
FIG. 3 is a treatment effect observation table of the fever sensation nasal drop or nasal drop of the present invention.

【図4】本発明の発熱感冒噴鼻又は滴鼻液剤の治療効果
観察表である。
FIG. 4 is a therapeutic effect observation table of the fever sensation or nasal drop of the present invention.

【図5】本発明の発熱感冒噴鼻又は滴鼻液剤の治療効果
観察表である。
FIG. 5 is a therapeutic effect observation table of the fever sensation or nasal drop of the present invention.

【図6】本発明の発熱感冒噴鼻又は滴鼻液剤の治療効果
観察表である。
FIG. 6 is a therapeutic effect observation table of the fever sensation or nasal drop of the present invention.

───────────────────────────────────────────────────── フロントページの続き (72)発明者 耿 淑賢 台湾台北市中山區南京東路2段41巷16弄2 號 Fターム(参考) 4C076 AA12 CC01 CC07 CC10 CC16 CC17 CC31 CC35 FF67 FF68 4C086 AA01 AA02 BA08 BA17 BA18 CB22 EA11 GA17 MA02 MA03 MA04 NA06 NA10 ZA05 ZA07 ZA08 ZA14 ZA62 ZA75 ZA81 ZB07 ZB09 ZB32 ZB33 ZB35 4C088 AB12 AB40 AC05 AC11 BA08 BA09 BA11 BA13 BA18 CA02 CA05 CA17 MA08 MA13 MA59 NA06 NA10 ZA05 ZA07 ZA08 ZA14 ZA62 ZA75 ZA81 ZB07 ZB09 ZB32 ZB33 ZB35  ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Geng Shu-ken, 2nd floor, 41st street, 2nd floor, Nanjing East Road, Zhongshan District, Taipei, Taiwan No.2 F No.F Reference (reference) BA17 BA18 CB22 EA11 GA17 MA02 MA03 MA04 NA06 NA10 ZA05 ZA07 ZA08 ZA14 ZA62 ZA75 ZA81 ZB07 ZB09 ZB32 ZB33 ZB35 4C088 AB12 AB40 AC05 AC11 BA08 BA09 BA11 BA13 BA18 CA02 CA05 CA17 MA08 MA13 Z05A07 Z10A05 Z10 ZB33 ZB35

Claims (2)

【特許請求の範囲】[Claims] 【請求項1】 患者の鼻腔粘膜にスプレー或いは滴入し
吸収させる発熱感冒噴鼻又は滴鼻液剤の医薬組成物であ
り、 250〜300gの紫胡(Bupleurum chi
nese DC.)、120〜144gの板藍根(Ra
dix Isatidis Indigotica)、
120〜144gの大青葉(Folium Isati
dis)、10〜12gのビタミンCで組成されたこと
を特徴とする、発熱感冒噴鼻又は滴鼻液剤の医薬組成
物。
1. A pharmaceutical composition of a fever sensation or nasal solution prepared by spraying or dropping into a nasal mucosa of a patient and absorbing the same, comprising 250 to 300 g of Bupleurum chi.
nice DC. ), 120-144 g of indigo root (Ra)
dix Isatidis Indigotica),
120-144 g of large green leaves (Folium Isati
dis), a pharmaceutical composition of a fever cold or nasal drop, characterized by comprising 10 to 12 g of vitamin C.
【請求項2】 発熱感冒噴鼻又は滴鼻液剤の製造方法で
あって、 以下のaからfのステップ、即ち、 a.250〜300gの紫胡を1倍量の水に2時間浸漬
し、さらに4倍量の水を加えて水煮し、蒸留法により揮
発油2〜2.4mlを抽出する。さらにろ過して薬液1
000ml〜1200mlを得て、さらに揮発油、ろ過
薬液及び薬残さをそれぞれ容器に暫時保存するステッ
プ、 b.120〜144gの板藍根、120〜144gの大
青葉にそれぞれ7倍量の水を加えて一時間煎煮し、並び
にろ過し、ろ過液を容器に暫時保存するステップ、 c.上記aとbのステップで抽出或いはろ過後に残った
薬の残さを混合後、さらに薬の残さを混合後の5倍量の
水を加えて1時間煎煮し、その後、4倍量の水を加えて
40分間煎煮し、さらにろ過して得たろ過液を合併する
ステップ、 d.以上により得た三つのろ過液を合併し、並びに1m
lの薬液が1gの生薬に相当するまで濃縮し、さらにこ
れを放置冷却し、95%のエタノールを加えてアルコー
ル含有量70%とするステップ、 e.さらに2ml〜2.4mlの揮発油及び10〜12
gのビタミンCを溶解後に薬液中に加え、混合、ろ過後
に分装するステップ、 以上のステップを具えたことを特徴とする、発熱感冒噴
鼻又は滴鼻液剤の製造方法。
2. A method for producing a fever sensation or nasal drop, comprising the steps a to f, namely: a. 250 to 300 g of purple husk is immersed in 1 volume of water for 2 hours, and 4 volumes of water are further added and boiled in water, and 2 to 2.4 ml of volatile oil is extracted by a distillation method. Filter further and liquid 1
Obtaining from 000 ml to 1200 ml, and further temporarily storing the volatile oil, the filtered chemical solution and the drug residue in containers, respectively; b. 120-144 g of indigo root and 120-144 g of large green leaves were each added with 7 times the amount of water, decocted for 1 hour, and filtered, and the filtrate was temporarily stored in a container; c. After mixing the residue of the medicine remaining after the extraction or filtration in the above steps a and b, add 5 times the amount of water after mixing the residue of the medicine, and incubate for 1 hour, then add 4 times the amount of water. Incubating for 40 minutes in addition and combining the filtrate obtained by further filtration, d. Combine the three filtrates obtained above and 1m
concentrating until 1 liter of the drug solution corresponds to 1 g of crude drug, further allowing to cool, and adding 95% ethanol to make the alcohol content 70%, e. 2 to 2.4 ml of volatile oil and 10 to 12
A step of adding g of vitamin C to a drug solution after dissolving, mixing and filtering, and dispensing the solution.
JP31900899A 1999-11-10 1999-11-10 Medicinal composition of nasal spray or nasal liquid medicine for pyrogenic common cold and method for producing the same Pending JP2001139487A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004084794A1 (en) * 2003-03-27 2004-10-07 Matsuura Yakugyo Co., Ltd. Galenical-extract-blended liquid medicine pack
JP2013100256A (en) * 2011-10-13 2013-05-23 Jun Tsuda Nasal drop including azulene sodium sulfonate as main agent
CN104116790A (en) * 2014-07-24 2014-10-29 李玉兰 Traditional Chinese medicine composition for treating rhinitis
CN118161553A (en) * 2024-02-28 2024-06-11 北京正元脐医药科技有限公司 Antipyretic composition, and preparation method, medicine and application thereof

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004084794A1 (en) * 2003-03-27 2004-10-07 Matsuura Yakugyo Co., Ltd. Galenical-extract-blended liquid medicine pack
JP2013100256A (en) * 2011-10-13 2013-05-23 Jun Tsuda Nasal drop including azulene sodium sulfonate as main agent
CN104116790A (en) * 2014-07-24 2014-10-29 李玉兰 Traditional Chinese medicine composition for treating rhinitis
CN118161553A (en) * 2024-02-28 2024-06-11 北京正元脐医药科技有限公司 Antipyretic composition, and preparation method, medicine and application thereof

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