JP2013100256A - Nasal drop including azulene sodium sulfonate as main agent - Google Patents
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本発明は、アレルギー性鼻炎、急性・慢性鼻炎及び急性・慢性副鼻腔炎に使用する点鼻薬に係り、特に鼻に噴霧して使用するアズレンスルホン酸ナトリウムを主剤とする点鼻薬に関する。 The present invention relates to nasal drops used for allergic rhinitis, acute / chronic rhinitis, and acute / chronic sinusitis, and more particularly to nasal drops containing sodium azulenesulfonate as a main ingredient used by spraying on the nose.
従来からアレルギー性鼻炎、急性・慢性鼻炎、及び急性・慢性副鼻腔炎などに使用される点鼻薬には、ケミカルメディエーター遊離抑制薬、ケミカルメディエーター受容体括抗薬、鼻噴霧用ステロイド薬、血管収縮薬などがある。鼻腔、副鼻腔に直接薬剤を噴霧するステロイド薬は、現在のアレルギー性鼻炎の治療薬として症状改善効果の高い薬剤の一つである。 Conventional nasal drops used for allergic rhinitis, acute / chronic rhinitis, and acute / chronic sinusitis include chemical mediator release inhibitors, chemical mediator receptor antagonists, nasal steroids, vasoconstriction There are medicines. Steroids that spray drugs directly into the nasal cavity and paranasal sinuses are one of the drugs that are highly effective in improving symptoms as a treatment for allergic rhinitis.
アレルギー性鼻炎の薬物治療には噴霧式の点鼻薬が多用されている。鼻噴霧用ステロイド点鼻薬の作用は抗炎症作用がある。この種の点鼻薬は、微量でも効果は強いことが特徴である。またこの点鼻薬は、鼻腔又は副鼻腔の局所で吸収されにくく、吸収されてもすぐ分解されやすいため、１年以上の長期間の連用でも全身的副作用は出現しにくいなどの特徴がある。 Spray nasal sprays are frequently used for drug treatment of allergic rhinitis. The effect of nasal spray nasal sprays is anti-inflammatory. This type of nasal spray is characterized by a strong effect even in trace amounts. In addition, this nasal spray is difficult to be absorbed locally in the nasal cavity or sinuses, and is easily decomposed even if it is absorbed, so that systemic side effects are unlikely to occur even after prolonged use for one year or longer.
このような点鼻薬は、その薬液を鼻粘膜へ広く散布することにより十分な薬効を得ることができる。使用に際して、例えば水溶性の噴霧用の点鼻薬では、もともと鼻閉がある際には注意が必要であり、また鼻腔内に鼻汁がある際にもよく鼻をかんでから使用する。次に、点鼻薬は最初に数回空打ちして、薬液が確実に噴霧状に出ることを確認する。そこで、一方の鼻孔を指で塞ぎ、他方の鼻孔にノズルの先を鼻中隔に向けないように容器を押して鼻腔内に広く薬液を散布する。 Such a nasal spray can obtain a sufficient medicinal effect by widely spreading the drug solution to the nasal mucosa. In use, for example, water-soluble nasal drops for spraying require caution when there is a nasal congestion from the beginning. Next, the nasal spray is first blown several times to confirm that the liquid medicine is surely sprayed. Therefore, one nostril is closed with a finger, and the container is pushed so that the tip of the nozzle is not directed to the nasal septum in the other nostril, and the drug solution is widely spread in the nasal cavity.
なお、治療に際して鼻粘膜浮腫が強い場合には鼻腔通気を改善するために点鼻用血管収縮薬を使用することも有効である。鼻噴霧用ステロイド薬を鼻粘膜全体へ十分散布することを目的として、鼻噴霧用ステロイド薬使用１０〜３０分前に点鼻用血管収縮薬を使用することがある。１〜２週間を目途として使用し、鼻噴霧用ステロイド薬の効果発現とともに休薬する。漫然とした点鼻用血管収縮薬の使用は、薬剤性鼻炎の原因となるので避けなければいけないとされている。 When nasal mucosal edema is strong during treatment, it is also effective to use a nasal vasoconstrictor to improve nasal passage. A nasal vasoconstrictor may be used 10 to 30 minutes before the use of the nasal spray steroid for the purpose of sufficiently spreading the nasal spray steroid to the entire nasal mucosa. Use 1-2 weeks as a target, and withdraw the effect of nasal spray steroids. The use of vague nasal vasoconstrictors is thought to be avoided because it causes drug-induced rhinitis.
このような鼻炎やアレルギー性過敏症の症状の予防、治療及び緩和に使用される薬剤に関する技術について、例えば特許文献１の特開平１１−２４６４１６号公報「点鼻用添加剤及び点鼻薬」に、保湿効果をもたらし、鼻孔中の粘膜の乾燥を防ぎ、鼻孔を外気から保護することにより、鼻炎やアレルギー性過敏症を予防し、またこれらの症状を治療又は緩和することができる点鼻用添加剤及び点鼻薬が提案されている。 For techniques relating to drugs used for the prevention, treatment and alleviation of symptoms of such rhinitis and allergic hypersensitivity, for example, in JP-A-11-246416 “Additives for nasal drops and nasal drops” of Patent Document 1, A nasal additive that provides a moisturizing effect, prevents mucous membranes in the nostrils, protects the nostrils from the open air, prevents rhinitis and allergic hypersensitivity, and treats or alleviates these symptoms And nasal drops have been proposed.
本発明の発明者は、噴霧式の点鼻薬としてアズレンズルホン酸ナトリウムに着目した。アズレンスルホン酸ナトリウムは、主に用時水または微温湯に溶解する含嗽用顆粒剤として、あるいは歯肉と頬粘膜の間に挿入する徐放錠として咽頭炎、扁桃炎、口内炎、口腔創傷などに使用されている。しかし、アズレンスルホン酸ナトリウムの用時溶解型の剤形は含嗽後口腔内全体に広がるが、唾液の分泌や舌の動きによって抗炎症作用を持つアズレンスルホン酸ナトリウムが口腔粘膜面から短時間に洗い流される可能性がある。 The inventors of the present invention have focused on azulensulphonate sodium as a spray-type nasal spray. Sodium azulene sulfonate is mainly used for pharyngitis, tonsillitis, stomatitis, oral wounds, etc. as granule for gargle dissolving in water or lukewarm water at the time of use or as sustained release tablet inserted between gingiva and buccal mucosa ing. However, the dosage form of sodium azulene sulfonate spreads throughout the mouth after gargle, but sodium azulene sulfonate, which has anti-inflammatory action, is washed away from the oral mucosa surface in a short time due to saliva secretion and tongue movement. There is a possibility.
一方、アズレンスルホン酸ナトリウムの徐放錠では、長時間の持続的な効果が得られるが唾液との接触に乏しい口腔内の狭隘部には効果が少ない可能性がある。アズレンスルホン酸ナトリウムは剤形での使用に適していない。そこで、この両者の長所を合わせ持つ製剤として、アズレンスルホン酸ナトリウムの水溶液に各種増粘剤を添加した合嗽液が提案されている。この増粘剤を添加したアズレンスルホン酸ナトリウムの口腔内滞留性の向上と、増粘剤自体による炎症面の保護効果が期待されている。 On the other hand, the sustained-release tablet of sodium azulene sulfonate provides a long-lasting effect, but may be less effective in the narrow part of the oral cavity where contact with saliva is poor. Sodium azulene sulfonate is not suitable for use in dosage forms. Therefore, as a preparation having the advantages of both, a combined solution obtained by adding various thickeners to an aqueous solution of sodium azulenesulfonate has been proposed. It is expected that sodium azulene sulfonate to which this thickener is added improves the retention in the oral cavity and protects the inflammatory surface by the thickener itself.
本発明の発明者は、このような合嗽液として咽頭炎、扁桃炎、口内炎、口腔創傷など薬効を有するアズレンスルホン酸ナトリウムは、アレルギー性鼻炎、急性・慢性鼻炎、及び急性・慢性副鼻腔炎にも薬効を有することは至当であると考えた。そこで、アズレンスルホン酸ナトリウムの水溶液を点鼻薬に使用することに着目した。 The inventor of the present invention uses sodium azulenesulfonate having medicinal effects such as pharyngitis, tonsillitis, stomatitis, oral wound as such a combination liquid, allergic rhinitis, acute / chronic rhinitis, and acute / chronic sinusitis. I thought it was appropriate to have medicinal properties. Therefore, attention was paid to the use of an aqueous solution of sodium azulenesulfonate as a nasal spray.
アズレンスルホン酸ナトリウム水溶液は、抗炎症作用を有するので、くしゃみ、鼻水、鼻づまり、眼のかゆみ、涙目などの症状がみられるアレルギー性鼻炎に適している。このアレルギー性鼻炎は、外部環境中の原因物質に対して体の免疫システムが反応することによって引き起こされるとされている。しかし、アズレンスルホン酸ナトリウム水溶液の単体では、鼻水、鼻づまり、鼻汁がのどに回る後鼻漏、せき、微熱などの症状が出るウイルス性鼻炎に対しては、薬効が少なかった。
また、慢性鼻炎の１種で、鼻の粘膜が薄く硬くなり、鼻腔が広がって乾燥が進みやすい症状が出る萎縮性鼻炎にも薬効が少なかった。
Azulene sodium sulfonate aqueous solution has an anti-inflammatory action, and is therefore suitable for allergic rhinitis in which symptoms such as sneezing, runny nose, nasal congestion, itchy eyes and tears are observed. This allergic rhinitis is said to be caused by the body's immune system reacting to causative substances in the external environment. However, the sodium azulene sulfonate aqueous solution alone was less effective against viral rhinitis in which symptoms such as runny nose, nasal congestion, nasal discharge and nasal discharge, coughing, and slight fever occurred.
It was also a kind of chronic rhinitis, and it had little medicinal effect on atrophic rhinitis in which the mucous membrane of the nose became thin and hard, and the nasal cavity spread and the symptoms of easy drying progressed.
また、点鼻薬は、口腔内に入れる含嗽薬とは異なり、下向きに穴が形成されている鼻腔に噴霧するものであるために、アズレンスルホン酸ナトリウムの薬剤の滞留性が口腔内と比べると極端に低下する。即ち、薬液を鼻腔に噴霧してもすぐに滴下しやすいという問題を有していた。 In addition, nasal drops are sprayed into the nasal cavity where holes are formed downward, unlike gargles that are placed in the oral cavity, so the retention of sodium azulene sulfonate drugs is extreme compared to the oral cavity. To drop. That is, there is a problem that even if the chemical solution is sprayed on the nasal cavity, it is easy to be dripped immediately.
なお、アズレンスルホン酸ナトリウムなどの薬剤の濃度を高め、薬効を高める方法も考えられるが、鼻腔内の粘膜へ直接刺激性の高い薬剤を噴霧することは治療に適さないという問題を有していた。また、粘性が高い薬液は噴霧が困難であり、かつ鼻腔内で均一に散布しづらいという問題を有していた。 Although it is possible to increase the concentration of a drug such as sodium azulene sulfonate and increase the drug efficacy, spraying a highly irritating drug directly on the mucous membrane in the nasal cavity has the problem that it is not suitable for treatment. . In addition, a highly viscous chemical solution has a problem that it is difficult to spray and it is difficult to spray uniformly in the nasal cavity.
本発明は、かかる問題点を解決するために創案されたものである。すなわち、本発明の目的は、主剤に添加物を配合することで、従来は口腔用の含嗽薬に主に使用されていたアズレンスルホン酸ナトリウムの水溶液を噴霧式で鼻腔、副鼻腔の治療、予防に使用できるようにしたアズレンスルホン酸ナトリウムを主剤とする点鼻薬を提供することにある。 The present invention has been developed to solve such problems. That is, the object of the present invention is to treat and prevent nasal cavity and sinuses by spraying an aqueous solution of sodium azulene sulfonate, which has been used mainly for oral mouth rinses, by adding an additive to the main agent. It is an object of the present invention to provide a nasal spray containing sodium azulenesulfonate as a main ingredient.
本発明は、薬液を鼻腔内に直接噴霧する鼻噴霧用の点鼻薬であって、水１ミリリットル中にアズレンスルホン酸ナトリウムの水和物２０ｍｇ〜６０ｍｇを溶解して主剤とし、該主剤に添加物として抗アレルギーの薬効を有する漢方薬と抗炎症作用を有する漢方薬を配合した、ことを特徴とする。 The present invention is a nasal spray for nasal spray in which a chemical solution is sprayed directly into the nasal cavity, and 20 mg to 60 mg of sodium azulenesulfonate hydrate is dissolved in 1 ml of water to form a main agent, and an additive to the main agent It is characterized by blending a Chinese medicine having an antiallergic effect and a Chinese medicine having an anti-inflammatory action.
前記抗アレルギーの薬効を有する漢方薬としては柴胡を配合した。
前記抗炎症作用を有する漢方薬としては石膏を配合した。
本発明の点鼻薬は、例えば、水１ミリリットル中に、アズレンスルホン酸ナトリウムの水和物２０ｍｇ〜６０ｍｇと、前記抗アレルギーの薬効を有する漢方薬２０ｍｇ〜１００ｍｇと、前記抗炎症作用を有する漢方薬５ｍｇ〜５０ｍｇとを溶解したものである。
As a traditional Chinese medicine having an antiallergic medicinal effect, saiko was blended.
Gypsum was blended as the Chinese medicine having anti-inflammatory action.
The nasal drops of the present invention are, for example, 20 mg to 60 mg of sodium azulene sulfonate hydrate, 20 mg to 100 mg of the above-mentioned antiallergic medicinal medicine, and 5 mg of the above-mentioned Chinese medicine having the anti-inflammatory action in 1 ml of water. 50 mg is dissolved.
上記の本発明では、アズレンスルホン酸ナトリウム水和物の抗炎症作用等により、１日数回の鼻腔・副鼻腔への噴霧により、アレルギー性鼻炎の治療効果がある。更に、アレルギー性鼻炎以外に、急性・慢性鼻炎、急性・慢性副鼻腔炎の治療及び予防効果がある。本発明のアズレンスルホン酸ナトリウムは微量でも効果は強く、連用によって改善率は上昇する。更に点鼻後直ちに症状の改善、消失等の効果がみられる。
なお、アズレンスルホン酸ナトリウムは、鼻腔、副鼻腔のような局所で吸収されにくく、吸収されてもすぐ分解されるため、１年以上の連用でも全身的副作用は出現しにくいので安全性が高い。
アズレンスルホン酸ナトリウムの抗酸化作用により、患部の消毒ができるため、治療はもとより感染の予防も可能である。
In the present invention described above, there is an effect of treating allergic rhinitis by spraying the nasal cavity and sinuses several times a day due to the anti-inflammatory action of sodium azulenesulfonate hydrate and the like. Furthermore, in addition to allergic rhinitis, it has therapeutic and preventive effects on acute / chronic rhinitis and acute / chronic sinusitis. The effect of the sodium azulene sulfonate of the present invention is strong even with a small amount, and the improvement rate increases with continuous use. Furthermore, immediately after nasal nose, effects such as improvement and disappearance of symptoms are observed.
In addition, since azulene sulfonate sodium is hard to be absorbed locally, such as a nasal cavity and a paranasal sinus, and is immediately decomposed even if it is absorbed, systemic side effects hardly occur even after continuous use for one year or more, and is highly safe.
The affected area can be sterilized by the antioxidant action of sodium azulenesulfonate, so that infection can be prevented as well as treatment.
紫胡と石膏の添加により、紫胡の抗アレルギー作用と解熱鎮痛作用及び石膏の抗炎症作用といった異なる作用機序により、それぞれ単独で用いた場合より相補的相乗効果で、消炎解熱鎮痛作用の強化が得られる。
更に紫胡には免疫増強作用もあるため、アレルギーを含む炎症性疾患の治療及び予防になる。
Addition of purple hu and gypsum enhances anti-pyretic antipyretic analgesic action with complementary synergistic effects by using different action mechanisms such as anti-allergic action and antipyretic analgesic action of gypsum and anti-inflammatory action of gypsum. Is obtained.
Furthermore, since purple hu also has an immune enhancing action, it can treat and prevent inflammatory diseases including allergies.
このアズレンスルホン酸ナトリウムに紫胡と石膏を配合した点鼻薬では、紫胡の抗アレルギー作用、石膏の抗炎症作用といった異なる作用機序による相補的相乗効果で、それぞれ単独で用いた場合より抗アレルギー作用の強化が得られる。 Nasal pills containing purple hu and gypsum combined with sodium azulene sulfonate have complementary synergistic effects due to different mechanisms of action such as anti-allergic action of purple hu and anti-inflammatory action of gypsum. Strengthening of action is obtained.
また、石膏には排泄作用があるため、鼻腔・副鼻腔の炎症産物の排泄がなされ、治癒を早めることができる。 In addition, since gypsum has an excretory action, inflammation products in the nasal cavity and sinuses are excreted, and healing can be accelerated.
本発明では、アズレンスルホン酸ナトリウムの主剤に、紫胡と石膏という漢方薬の配合剤を点鼻することにより、鼻腔及び副鼻腔のアレルギー性鼻炎を含み、また感染性疾患を含む炎症性疾患に対して、全く新しい作用機序による治療効果おび予防効果を発揮できる。 In the present invention, a combination of Chinese acupunctures called purple hu and gypsum is added to the main ingredient of sodium azulene sulfonate, so that allergic rhinitis in the nasal cavity and sinuses is included, and inflammatory diseases including infectious diseases are treated. Thus, the therapeutic effect and the preventive effect can be exhibited by a completely new mechanism of action.
本発明は、薬液を鼻腔内に直接噴霧する鼻噴霧用の点鼻薬であって、アズレンスルホン酸ナトリウムの水溶液を主剤とし、この主剤に添加物として抗アレルギーと抗炎症作用の薬効を有する漢方薬を配合したアズレンスルホン酸ナトリウムを主剤とする点鼻薬用である。 The present invention is a nasal spray for nasal spray that sprays a drug solution directly into the nasal cavity, comprising an aqueous solution of sodium azulene sulfonate as an active ingredient, and an additive to the main agent as a herbal medicine having anti-allergic and anti-inflammatory effects. It is for nasal drops containing sodium azulenesulfonate as a main ingredient.
以下、本発明の実施例を説明する。
〈アズレンスルホン酸ナトリウムを主剤とする点鼻薬〉
アズレンスルホン酸ナトリウムを主剤とする点鼻薬は、水１ミリリットルにアズレンスルホン酸ナトリウムの水和物を、1回の噴霧量が多い場合として０．５ｍｇ〜３．０ｍｇを、1回の噴霧量が少ない場合として２０ｍｇ〜６０ｍｇを溶解した水溶液を主剤とし、この主剤に添加物として抗アレルギーの薬効を有する漢方薬と抗炎症作用の薬効を有する漢方薬を配合することが望ましい。アズレンスルホン酸ナトリウムは濃青色の昇華性の高い結晶である。粘膜の炎症を鎮静化する作用がある。また、アズレンスルホン酸ナトリウムは抗酸化作用により消毒作用があり、抗炎症作用、抗酸化作用を利用し単独でも治療薬として用いられている。
Examples of the present invention will be described below.
<Nasal drops containing sodium azulenesulfonate as the main ingredient>
Nasal drops containing sodium azulene sulfonate as the main ingredient, hydrate of sodium azulene sulfonate in 1 ml of water, 0.5 mg to 3.0 mg as a single spray amount, In the case of a small amount, it is desirable to use an aqueous solution in which 20 mg to 60 mg is dissolved as a main agent, and to this main agent as an additive, a Chinese medicine having an antiallergic effect and a Chinese medicine having an antiinflammatory effect. Sodium azulene sulfonate is a deep blue crystal with high sublimability. It has an action to soothe mucous membrane inflammation. Further, sodium azulene sulfonate has a disinfecting action due to an antioxidant action, and is used alone as a therapeutic agent by utilizing an anti-inflammatory action and an antioxidant action.
このアズレンスルホン酸ナトリウムの水溶液を主剤に、抗アレルギーの薬効を有する漢方薬として 柴胡（サイコ）を配合した。この添加物の紫胡（サイコ）は、セリ科のミシマサイコ又はその変種の根であり、サポニンを含有する。この紫胡（サイコ）の薬理作用としては、サポニン分画は中枢抑制、鎮痛、鎮咳、解熱、抗炎症、ストレス性潰瘍抑制、利尿作用を有する。また、サイコゲニンＡは中枢抑制、鎮痛、鎮咳、解熱、抗炎症の作用を有する。メタノール可溶分画は鎮痛、抗潰瘍の作用を有する。 This aqueous solution of sodium azulene sulfonate was used as the main ingredient, and Shibahu was added as a Chinese medicine with antiallergic medicinal properties. This additive, purple hu (Psycho), is the root of the ciraceae Mishima Psycho or its variants and contains saponins. As for the pharmacological action of Shihu, saponin fraction has central inhibition, analgesia, antitussive, antipyretic, anti-inflammatory, stress ulcer inhibition, diuretic action. Psychogenin A has central suppressive, analgesic, antitussive, antipyretic and anti-inflammatory effects. The methanol soluble fraction has analgesic and antiulcer actions.
紫胡（サイコ）は、リンパ球のリンパ球機能調節作用が本質的な作用である。紫胡（サイコ）の作用はステロイドホルモンの作用に類似しているが、ステロイドホルモンではないため、極めて安全性が高い。紫胡（サイコ）は、抗アレルギー作用及び免疫増強作用を有し、解熱薬、解毒薬、鎮痛薬、消炎薬、抗アレルギー薬として使用する。 Shihu has an essential effect of regulating lymphocyte function of lymphocytes. Although the action of Shihu is similar to that of steroid hormones, it is very safe because it is not a steroid hormone. Shihu has anti-allergic and immune-enhancing effects and is used as an antipyretic, antidote, analgesic, anti-inflammatory, and anti-allergic agent.
添加物としての紫胡（サイコ）は、例えば水で数十分煮出して薬液を生成する。この柴胡（サイコ）の配合割合は、アズレンスルホン酸ナトリウムの主剤に、１〜１０ｗ％の添加が適していた。 As an additive, purple hu-hu (psycho) is boiled with water, for example, several tens of minutes to produce a chemical solution. As for the blending ratio of this saiko, the addition of 1 to 10% by weight was suitable for the main ingredient of sodium azulene sulfonate.
更に、本発明の点鼻薬に添加物として石膏（硫酸カルシウムＣａＳＯ４・２Ｈ２Ｏ)を配合した。この石膏（ＣａＳＯ４・２Ｈ２Ｏ)は清熱瀉下薬の代表的なものであり、熱をとり潤す生薬で体液の保持、解熱、排泄物の排泄作用を有する。この石膏の主な作用は、抗炎症作用と排泄作用である。抗アレルギー作用もあるとされている。この石膏の配合割合は、アズレンスルホン酸ナトリウムの主剤に、０．４〜５ｗ％の添加が適していた。 Furthermore, gypsum (calcium sulfate CaSO 4 .2H 2 O) was added as an additive to the nasal drops of the present invention. This gypsum (CaSO 4 · 2H 2 O) is a representative of a hot fever laxative, and is a herbal medicine that takes heat and moisturizes it, retains bodily fluids, releases fever, and excretes excreta. The main action of this gypsum is anti-inflammatory action and excretion action. It is also said to have antiallergic effects. As for the mixing ratio of this gypsum, addition of 0.4 to 5% by weight was suitable for the main ingredient of sodium azulenesulfonate.
なお、アズレンスルホン酸ナトリウムは鼻腔、副鼻腔のような局所で吸収されにくく、吸収されてもすぐ分解されるため、1年以上の連用でも全身的副作用は出現しにくい。アズレンスルホン酸ナトリウムの抗酸化作用により、患部の消毒ができるため、治療はもとより感染の予防ができる。 It should be noted that sodium azulene sulfonate is not easily absorbed locally such as in the nasal cavity and sinuses, and is decomposed immediately after absorption, so that systemic side effects are unlikely to occur even after continuous use for more than one year. Because the affected area can be disinfected by the antioxidant action of sodium azulene sulfonate, treatment can be prevented as well as treatment.
本発明の点鼻薬は、紫胡の抗アレルギー作用と解熱鎮痛作用、及び石膏の抗炎症作用といった異なる作用機序により、それぞれ単独で用いた場合より相補的相乗効果で、消炎解熱鎮痛作用の強化が得られる。このように紫胡には免疫増強作用もあるため、アレルギーを含む炎症性疾患の治療及び予防になる。 The nasal drops of the present invention enhance anti-inflammatory and antipyretic analgesic effects by complementary synergistic effects when used alone, due to different mechanisms such as anti-allergic and antipyretic analgesic effects of Shihu and anti-inflammatory effects of gypsum. Is obtained. As described above, purple hu also has an immune enhancing action, so that it can treat and prevent inflammatory diseases including allergies.
本発明の点鼻薬は、アズレンスルホン酸ナトリウムに紫胡と石膏を配合したので、それぞれの薬剤の持つ抗炎症作用等をそれぞれ単独で用いた場合より相補的、相乗的に強化できる。特に漢方薬と西洋薬では作用機序が全く異なるため、これらの配合は真に相加相乗的となる。また、紫胡の抗アレルギー作用、石膏の抗炎症作用といった異なる作用機序による相補的相乗効果で、それぞれ単独で用いた場合より抗アレルギー作用の強化が得られる。
また、石膏には排泄作用があるため、鼻腔・副鼻腔の炎症産物の排泄がなされ、治癒を早めることができる。
Since the nasal drops of the present invention are formulated with sodium azulene sulfonate and purple hu and gypsum, the anti-inflammatory action and the like of each drug can be complementarily and synergistically enhanced when used alone. In particular, since the mechanism of action is completely different between Chinese and Western medicines, these formulations are truly additively synergistic. In addition, the complementary synergistic effects by different mechanisms such as the anti-allergic effect of purple hu and the anti-inflammatory effect of gypsum can enhance the anti-allergic effect compared to the case where each is used alone.
In addition, since gypsum has an excretory action, inflammation products in the nasal cavity and sinuses are excreted, and healing can be accelerated.
本発明の点鼻薬は、紫胡と石膏とアズレンスルホン酸ナトリウムという漢方薬と西洋薬の配合剤を点鼻することにより、鼻腔及び副鼻腔のアレルギー性鼻炎を含み、また感染性疾患を含む炎症性疾患に対して今まで考えられなかった、全く新しい作用機序による治療効果おび予防効果を発揮する。 The nasal drops of the present invention include allergic rhinitis of the nasal cavity and sinuses by instilling a combination of Chinese medicine and Western medicine called purple pepper, gypsum and sodium azulenesulfonate, and inflammatory including infectious diseases It exhibits therapeutic and preventive effects by a completely new mechanism of action that has never been considered for diseases.
本発明の発明者は、紫胡（サイコ）、石膏以外の漢方薬の添加物について薬効があるものを検討してみた。点鼻薬を処方する年代に応じて薬効が相違するので、小児、青年、中高年の場合に分けて検証してみた。
（１）小児の場合
鼻アレルギーの子供には、本発明の点鼻薬に葛根湯（カッコントウ）を添加したものを使用した。良好な薬効を得ることができた。この葛根湯には排膿作用があり、異物を排出する作用があるからと推測される。そこで、添加物は紫胡（サイコ）に代えて葛根湯（カッコントウ）を配合することも可能である。
なお、慢性副鼻腔炎に使う場合は、葛根湯と葛根湯加朮附湯（カツコントウカジュツブトウ）では、葛根湯の方が却って薬効が良いことがある。葛根湯は排膿作用が強いので排膿口が閉鎖されている場合は葛根湯は適さなかった。
The inventor of the present invention has studied what has medicinal properties as additives for Chinese medicines other than purple and plaster. Since the efficacy of nasal drops differs depending on the age of prescription, we examined it separately for children, adolescents, and middle-aged and older people.
(1) In the case of children For children with nasal allergies, nasal drops of the present invention to which kakkonto was added were used. Good medicinal effects could be obtained. This Kakkonto has a draining effect and is presumed to have a function of discharging foreign matter. Therefore, as an additive, kakkonto can be blended instead of saiko.
In addition, when using it for chronic sinusitis, Kakkonto and Kakkontokatsutsutou may be more effective than Kakkonto. Since Kakkonto has a strong drainage effect, Kakkonto was not suitable when the drainage opening was closed.
（２）青年の場合
青年には、本発明の点鼻薬に柴胡剤（小柴胡湯（ショウサイコトウ）、四逆散（シギャクサン））や柴胡を含む刑芥連勉湯（ケイガイレンギョウトウ）などを添加したものを使用した。特に四逆散には芍薬（シャクヤク）、枳実（キョジツ）が含まれていて排膿散の作用があるので，鼻疾患に有用であった。
(2) In the case of adolescents For adolescents, the nasal drops of the present invention include saihu (Shosaikouto, Shigyakusan) and punishment that includes saihorenkyoto. What added tow etc. was used. In particular, Shigyakusan is useful for nasal diseases because it contains peony and kojitsu and has the effect of drainage.
（３）中高年の場合
中高年には、葛根湯は適さなかった。本発明の点鼻薬に辛夷清肺湯（シンイセイハイトウ）か補中益気湯（ホチュウエッキトウ）、黄耆連中湯（オウギケンチュウトウ），十全大輔湯（ジュウゼンタイホトウ）などを添加したものを使用した。
鼻に「熱をもつ感じ」で鼻づまりがひどく、後鼻漏があるものは、辛夷清肺湯（シンイセイハイトウ）を添加したものを使用した。
(3) In the case of middle-aged and elderly people Kakkon-to was not suitable for middle-aged and elderly people. To the nasal sprays of the present invention, add Seisei Seito-to, Hochuekki-to, Hoyukenchu-to, Juzentai-to We used what we did.
For the nose that had a sensation of heat and had severe nasal congestion and posterior rhinorrhea, the one added with Shinsei Seito was used.
〈漢方薬以外に配合する添加物〉
本発明の点鼻薬には、漢方薬、石膏以外にも次のような添加物を配合することができる。これらは、増粘剤、抗酸化剤、分散剤、安定化剤又は香料などを目的とする。例えば、エデト酸ナトリウム、ベンザルコニウム塩化物、等張化剤、グリセリン、メントール、エタノール、ｐＨ調節剤、等張化剤、香料、カルボキシビニルポリマー、アルギニン、セルロース、ＣＭＣ−Ｎａ、プロピレングリコール、ポリソルベート、クエン酸、Ｄ−ソルビトール、ポリビニルアルコール、シリコーン樹脂、リン酸二水素、塩化ナトリウム、フェニルエチルアルコール、ベンジルアルコール、ホウ酸、ホウ砂、炭酸水素ナトリウムなどがある。
これらの添加物は、点鼻薬の主な治療目的に応じて選択し、その配合量が決められる。または成人用、小児用の別に応じても選択され、その配合量が決められる。
<Additives to be blended in addition to herbal medicine>
In addition to herbal medicine and gypsum, the following additives can be added to the nasal spray of the present invention. These are intended for thickeners, antioxidants, dispersants, stabilizers or perfumes. For example, sodium edetate, benzalkonium chloride, tonicity agent, glycerin, menthol, ethanol, pH adjusting agent, tonicity agent, fragrance, carboxyvinyl polymer, arginine, cellulose, CMC-Na, propylene glycol, polysorbate , Citric acid, D-sorbitol, polyvinyl alcohol, silicone resin, dihydrogen phosphate, sodium chloride, phenylethyl alcohol, benzyl alcohol, boric acid, borax, sodium bicarbonate and the like.
These additives are selected according to the main therapeutic purpose of the nasal spray, and the amount of the additive is determined. Or it can be selected depending on whether it is for adults or for children, and the amount to be blended is determined.
〈漢方薬以外に配合する併用薬〉
更に、本発明の点鼻薬には、漢方薬、石膏、添加物以外にも次のような併用薬を配合することができる。例えば、ケミカルメディエーター遊離抑制薬、抗ヒスタミン薬、抗ロイコトリエン薬、抗プロスタグランジンＤ２・トロンボキサンＡ２薬、Ｔｈ２サイトカイン阻害薬、ステロイド薬、血管収縮薬などがある。
これらの併用薬についても添加物と同様に、点鼻薬の主な治療目的、成人用、小児用の別に応じても選択され、その配合量が決められる。
<Concomitant medications other than Chinese medicine>
Furthermore, in addition to herbal medicine, gypsum and additives, the following nasal drugs can be blended with the nasal drops of the present invention. Examples include chemical mediator release inhibitors, antihistamines, anti-leukotrienes, anti-prostaglandin D2 / thromboxane A2, Th2 cytokine inhibitors, steroids, and vasoconstrictors.
These concomitant drugs are selected according to the main therapeutic purpose of nasal drops, for adults, and for children, as well as additives, and the amount of the combination is determined.
〈本発明の点鼻薬の使用方法〉
このような配合からなる本発明の点鼻薬は、鼻腔・副鼻腔の鼻粘膜へ広く散布されることで十分な薬効を得ることができる。例えば、鼻腔・副鼻腔内に鼻閉がある場合には使用に注意が必要である。また、鼻腔内に鼻汁がある際にはよく鼻をかんでおく必要がある。
<Method of using nasal drops of the present invention>
The nasal spray of the present invention composed of such a composition can obtain a sufficient medicinal effect by being widely applied to the nasal mucosa of the nasal cavity and sinuses. For example, if there is a nasal obstruction in the nasal cavity or paranasal sinuses, it is necessary to be careful in use. In addition, when there is nasal discharge in the nasal cavity, it is necessary to keep your nose in your mouth.
なお、鼻粘膜浮腫が強い場合には鼻腔通気を改善するために点鼻用血管収縮薬を使用することも有効である。本発明の点鼻薬を鼻粘膜全体へ十分散布すべく、この点鼻薬の使用１０〜３０分前に点鼻用血管収縮薬を使用することが望ましい。 When nasal mucosal edema is strong, it is also effective to use a nasal vasoconstrictor to improve nasal ventilation. In order to sufficiently spread the nasal spray of the present invention over the nasal mucosa, it is desirable to use a nasal vasoconstrictor 10 to 30 minutes before the use of the nasal spray.
〈各症例における、本発明の点鼻薬Ａ使用による症状の経過〉
点鼻薬Ａを使用した複数の人の症状の経過を説明する。
点鼻薬Ａは、アズレンスルホン酸ナトリウムの主剤（水１ミリリットルにアズレンスルホン酸ナトリウムの水和物０．５ｍｇ〜３．０ｍｇを溶解）に添加物として柴胡（サイコ）と石膏（ＣａＳＯ４)を配合した点鼻薬（アズレンスルホン酸ナトリウムの主剤にそれぞれ、１〜１０ｗ％、１〜５ｗ％の添加）であり、1日に1回、１ｍｌの噴霧を行った。
（１）慢性副鼻腔炎（３５歳 女性）
５年間も慢性副鼻腔炎の症状があり、難しい場所に膿ができるので頭痛、顔面痛、体調不良で治療中の人が、点鼻薬Ａを1日1回、１ｍｌ噴霧使用したところ、１ヶ月で諸症状が回復した。
（２）急性鼻炎（１０歳 男性）
急性鼻炎の症状がある人に、点鼻薬Ａを1日1回、１ｍｌ噴霧使用したところ、１週間以内に消失した。
（３）アレルギー性鼻炎（１０代から６０代の男女多数）
アレルギー性鼻炎の症状のある人に、点鼻薬Ａを1日1回、１ｍｌ噴霧使用したところ、アレルギー症状の改善が見られた。
<Symptom progress of nasal spray A of the present invention in each case>
The course of symptoms of a plurality of people using nasal spray A will be described.
Nasal Drops A consists of sodium azulene sulfonate, the main agent (dissolving 0.5 mg to 3.0 mg of azulene sulfonate hydrate in 1 ml of water) as additives, with saiko and gypsum (CaSO 4 ). It was a blended nasal spray (addition of 1 to 10 w% and 1 to 5 w% to the main component of sodium azulenesulfonate, respectively), and 1 ml was sprayed once a day.
(1) Chronic sinusitis (35 years old female)
A person who is suffering from chronic sinusitis for 5 years and has pus in difficult places, and who is being treated with headache, facial pain, poor physical condition, and 1 ml of nasal spray A once a day, 1 month The symptoms recovered.
(2) Acute rhinitis (10 years old male)
A person who had symptoms of acute rhinitis used nasal spray A once a day as a 1 ml spray and disappeared within one week.
(3) Allergic rhinitis (many men and women in their teens to 60s)
When a person with allergic rhinitis symptoms used 1 ml of nasal spray A once a day, improvement of allergic symptoms was observed.
〈各症例における、本発明の点鼻薬Ｂ使用による症状の経過〉
点鼻薬Ｂを使用した複数の人の症状の経過を説明する。
点鼻薬Ｂは、水１ミリリットルにアズレンスルホン酸ナトリウムの水和物２０ｍｇ〜６０ｍｇを溶解したアズレンスルホン酸ナトリウムの主剤に、添加物として柴胡（サイコ）２０ｍｇ〜１００ｍｇと石膏（ＣａＳＯ４) ５ｍｇ〜５０ｍｇを配合した点鼻薬であり、１日数回、０．１ｍｌ／1回の噴霧を行った。
（１）急性鼻炎（生後３か月 男性）
前日から鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回１噴霧左右の鼻腔に１日２回点鼻した。点鼻開始後、直ちに症状が改善してゆき、３日で治癒を確認した。
（２）急性鼻炎（２歳 女性）
前日から鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回１噴霧左右の鼻腔に１日２回点鼻した。点鼻開始後、直ちに症状が改善してゆき、５日で治癒を確認した。
（３）急性鼻炎（１２歳 男性）
前々日から鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日２回点鼻した。点鼻開始後、直ちに症状が改善してゆき、４日で治癒を確認した。
（４）急性鼻炎（２５歳 女性）
前日から鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日２回点鼻した。点鼻開始後、直ちに症状が改善してゆき、３日で治癒を確認した。
（５）急性鼻炎（５４歳 男性）
当日から鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日２回点鼻した。点鼻開始後、直ちに症状が改善してゆき、４日で治癒を確認した。
（６）急性鼻炎（７８歳 女性）
前々日から鼻汁、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日２回点鼻した。点鼻開始後、直ちに症状が改善してゆき、７日で治癒を確認した。
<In each case, symptom progress by use of nasal spray B of the present invention>
The course of the symptoms of a plurality of people using nasal spray B will be described.
Nasal spray B is composed of sodium azulene sulfonate in which 20 mg to 60 mg of hydrate of sodium azulene sulfonate is dissolved in 1 ml of water, and 20 mg to 100 mg of saiko (Psycho) and 5 mg to gypsum (CaSO 4 ) as additives. A nasal spray containing 50 mg, sprayed 0.1 ml / time several times a day.
(1) Acute rhinitis (3 months old male)
The patient had symptoms of nasal discharge and nasal congestion from the previous day, and nasal spray B was sprayed once in the right and left nasal cavities twice a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 3 days.
(2) Acute rhinitis (2 years old female)
The patient had symptoms of nasal discharge and nasal congestion from the previous day, and nasal spray B was sprayed once in the right and left nasal cavities twice a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 5 days.
(3) Acute rhinitis (12 years old male)
Symptoms of nasal discharge and nasal congestion were observed two days before, and nasal spray B was sprayed once twice into the left and right nasal cavities twice a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 4 days.
(4) Acute rhinitis (25 years old female)
The patient had symptoms of nasal discharge and nasal congestion from the previous day, and nasal spray B was sprayed once twice into the left and right nasal cavities twice a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 3 days.
(5) Acute rhinitis (54 years old male)
From that day, she had symptoms of nasal discharge and nasal congestion, and nasal spray B was sprayed once twice into the left and right nasal cavities twice a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 4 days.
(6) Acute rhinitis (78 years old female)
The patient had symptoms of nasal discharge, nasal congestion, and sneezing the day before the last day, and nasal spray B was sprayed once twice into the left and right nasal cavities twice a day. Immediately after the start of instillation, symptoms improved and healing was confirmed in 7 days.
（７）急性副鼻腔炎（３歳 男性）
前日から膿性鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回１噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、６日で治癒を確認した。
（８）急性副鼻腔炎（８歳 男性）
前日から膿性鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、６日で治癒を確認した。
（９）急性副鼻腔炎（１４歳 女性）
一週間前から膿性鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、７日で治癒を確認した。
（１０）急性副鼻腔炎（３７歳 男性）
３日前から膿性鼻汁、鼻閉、頭重感の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、１０日で治癒を確認した。
（１１）急性副鼻腔炎（６２歳 女性）
当日から膿性鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、６日で治癒を確認した。
(7) Acute sinusitis (3 years old male)
The patient had symptoms of purulent nasal discharge and nasal congestion from the previous day, and nasal spray B was sprayed once to the right and left nasal cavities four times a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 6 days.
(8) Acute sinusitis (8 years old male)
From the previous day, there was a symptom of purulent nasal discharge and nasal congestion, and nasal spray B was sprayed once twice into the right and left nasal cavities four times a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 6 days.
(9) Acute sinusitis (14 years old female)
Symptoms of purulent nasal discharge and nasal congestion occurred from one week before, and nasal spray B was sprayed once twice into the right and left nasal cavities four times a day. Immediately after the start of instillation, symptoms improved and healing was confirmed in 7 days.
(10) Acute sinusitis (37 years old male)
Symptoms of purulent nasal discharge, nasal congestion, and head sensation were observed from 3 days before, and nasal spray B was sprayed 2 times on the right and left nasal cavities 4 times a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 10 days.
(11) Acute sinusitis (62 years old female)
From that day, there was a symptom of purulent nasal discharge and nasal congestion, and nasal spray B was sprayed once in the right and left nasal cavities four times a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed in 6 days.
（１２）慢性副鼻腔炎（１０歳 男性）
３カ月前から膿性鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、２８日で治癒を確認した。
（１３）慢性副鼻腔炎（２８歳 女性）
６カ月前から膿性鼻汁、鼻閉及び頭重感の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、４９日で治癒を確認した。
（１４）慢性副鼻腔炎（４９歳 男性）
２カ月前から膿性鼻汁、鼻閉、異臭の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、４９日で治癒を確認した。特に異臭については７日で消失した。
（１５）慢性副鼻腔炎（７２歳 男性）
数年来の膿性鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、６３日で治癒を確認した。
（１６）慢性副鼻腔炎（４６歳 女性）
６カ月前から膿性鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、４２日で治癒を確認した。
（１７）慢性副鼻腔炎（１０歳 男性）
３カ月前から膿性鼻汁、鼻閉の症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始後、直ちに症状が改善してゆき、２８日で治癒を確認した。
(12) Chronic sinusitis (10 years old male)
Symptoms of purulent nasal discharge and nasal congestion were observed from 3 months before, and nasal spray B was sprayed once in the right and left nasal cavities four times a day. Immediately after the start of instillation, symptoms improved and healing was confirmed on the 28th.
(13) Chronic sinusitis (28 years old female)
Symptoms of purulent nasal discharge, nasal congestion and head sensation were observed from 6 months ago, and nasal drops B were sprayed once in the right and left nasal cavities four times a day. Immediately after the start of instillation, symptoms improved and healing was confirmed in 49 days.
(14) Chronic sinusitis (49-year-old male)
Symptoms of purulent nasal discharge, nasal congestion and nasty smell were observed from 2 months ago, and nasal spray B was sprayed once in the right and left nasal cavities four times a day. Immediately after the start of instillation, symptoms improved and healing was confirmed in 49 days. In particular, the off-flavor disappeared in 7 days.
(15) Chronic sinusitis (72 years old male)
Symptoms of purulent nasal discharge and nasal congestion for several years have been observed, and nasal spray B was sprayed once twice into the left and right nasal cavities four times a day. Immediately after the start of instillation, symptoms improved immediately, and healing was confirmed at 63 days.
(16) Chronic sinusitis (46 years old female)
Symptoms of purulent nasal discharge and nasal congestion occurred from 6 months ago, and nasal spray B was sprayed once twice into the right and left nasal cavities four times a day. Immediately after the start of nasal nose, symptoms improved and healing was confirmed in 42 days.
(17) Chronic sinusitis (10 years old male)
Symptoms of purulent nasal discharge and nasal congestion were observed from 3 months before, and nasal spray B was sprayed once in the right and left nasal cavities four times a day. Immediately after the start of instillation, symptoms improved and healing was confirmed on the 28th.
（１８）アレルギー性鼻炎（軽症）（２歳 女性）
３日前から鼻汁、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回１噴霧左右の鼻腔に１日２回点鼻した。点鼻後、直ちに症状が消失した。
（１９）アレルギー性鼻炎（軽症）（７歳 女性）
通年性に鼻汁、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日２回点鼻した。点鼻後、症状が軽減するも尚コントロールできないため、ベボタスチンベジル酸塩を内服させた。これにより症状が消失した。点鼻、内服を続行している。
（２０）アレルギー性鼻炎（軽症）（１５歳 男性）
４日前から鼻汁、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日２回点鼻した。点鼻後、直ちに症状が消失した。
（２１）アレルギー性鼻炎（軽症）（４２歳 男性）
通年制に鼻汁、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日２回点鼻した。点鼻後、直ちに症状が消失した。点鼻薬Ｂをやめるとアレルギー症状がでるため、継続して点鼻している。
（２２）アレルギー性鼻炎（軽症）（６１歳 女性）
通年制に鼻汁、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日２回点鼻した。点鼻後、直ちに症状が消失した。点鼻薬Ｂをやめるとアレルギー症状がでるため、継続して点鼻している。
(18) Allergic rhinitis (mild) (2 years old female)
Symptoms of nasal discharge, nasal congestion and sneezing were observed from 3 days before, and nasal spray B was sprayed once in the right and left nasal cavities twice a day. The symptoms disappeared immediately after nasal drop.
(19) Allergic rhinitis (mild) (7 years old female)
Perennial symptoms were nasal discharge, nasal congestion, and sneezing, and nasal spray B was sprayed once twice into the right and left nasal cavities twice a day. After nasal nose, symptoms were alleviated but still uncontrollable, so bevostatin besylate was taken. As a result, the symptoms disappeared. Continue nasal and internal use.
(20) Allergic rhinitis (mild) (15 years old male)
Symptoms of nasal discharge, nasal congestion, and sneezing were observed from 4 days before, and nasal spray B was sprayed once twice into the right and left nasal cavities twice a day. The symptoms disappeared immediately after nasal drop.
(21) Allergic rhinitis (mild) (42 years old male)
There were symptoms of nasal discharge, nasal congestion, and sneezing in the full year system, and nasal spray B was sprayed once twice into the right and left nasal cavities twice a day. The symptoms disappeared immediately after nasal drop. Stopping Nasal Drug B causes allergic symptoms, so she continues to nasalize.
(22) Allergic rhinitis (mild) (61 years old female)
There were symptoms of nasal discharge, nasal congestion, and sneezing in the full year system, and nasal spray B was sprayed once twice into the right and left nasal cavities twice a day. The symptoms disappeared immediately after nasal drop. Stopping Nasal Drug B causes allergic symptoms, so she continues to nasalize.
（２３）アレルギー性鼻炎（中等症）（２歳 男性）
１０日前から鼻汁、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回１噴霧左右の鼻腔に１日４回点鼻した。点鼻後、直ちに症状が消失した。
（２４）アレルギー性鼻炎（中等症）（１４歳 男性）
７日前から鼻汁、鼻閉、くしゃみの症状があり、点鼻薬Ｂを２回２噴霧左右の鼻腔に１日４回点鼻した。点鼻後、直ちに症状が消失した。
（２５）アレルギー性鼻炎（中等症）（３３歳 女性）
通年性に鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻後、症状が軽減するも尚コントロールできないため、ベボタスチンベジル酸塩を内服させた。これにより症状が消失した。点鼻、内服を続行している。
（２６）アレルギー性鼻炎（中等症）（４６歳 男性）
通年性に鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻後、直ちに症状が消失した。点鼻を続行している。
（２７）アレルギー性鼻炎（中等症）（６６歳 女性）
３日前から鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日４回点鼻した。点鼻後、直ちに症状が消失した。
(23) Allergic rhinitis (moderate) (2 years old male)
Symptoms of nasal discharge, nasal congestion and sneezing occurred 10 days ago, and nasal spray B was sprayed once in the right and left nasal cavities four times a day. The symptoms disappeared immediately after nasal drop.
(24) Allergic rhinitis (moderate) (14 years old male)
Symptoms of nasal discharge, nasal congestion and sneezing were observed from 7 days before, and nasal spray B was sprayed twice in the right and left nasal cavities four times a day. The symptoms disappeared immediately after nasal drop.
(25) Allergic rhinitis (moderate) (33 years old female)
There were symptoms of nasal discharge, nasal congestion, and sneezing throughout the year, and nasal spray B was sprayed once in the right and left nasal cavities four times a day. After nasal nose, symptoms were alleviated but still uncontrollable, so bevostatin besylate was taken. As a result, the symptoms disappeared. Continue nasal and internal use.
(26) Allergic rhinitis (moderate) (46 years old male)
There were symptoms of nasal discharge, nasal congestion, and sneezing throughout the year, and nasal spray B was sprayed once in the right and left nasal cavities four times a day. The symptoms disappeared immediately after nasal drop. Continue nasal nose.
(27) Allergic rhinitis (moderate) (66 years old female)
Symptoms of nasal discharge, nasal congestion, and sneezing were observed from 3 days before, and nasal spray B was sprayed 2 times on the right and left nasal cavities 4 times a day. The symptoms disappeared immediately after nasal drop.
（２８）アレルギー性鼻炎（重症）（２歳 女性）
３日前から鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回１噴霧左右の鼻腔に１日６回点鼻した。点鼻後、直ちに症状が消失した。
（２９）アレルギー性鼻炎（重症）（１１歳 男性）
４日前から鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日６回点鼻した。点鼻後、直ちに症状が消失した。
（３０）アレルギー性鼻炎（重症）（２４歳 女性）
通年性に鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日６回点鼻した。点鼻後、症状が軽減するも尚コントロールできないため、ベボタスチンベジル酸塩を内服させた。これにより症状が消失した。点鼻、内服を続行している。
（３１）アレルギー性鼻炎（重症）（４０歳 女性）
７日前から鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日６回点鼻した。点鼻後、直ちに症状が消失した。
（３２）アレルギー性鼻炎（重症）（５５歳 男性）
５日前から鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日６回点鼻した。点鼻後、症状が軽減するも尚コントロールできないため、ベボタスチンベジル酸塩を内服させた。これにより症状が消失した。
（３３）アレルギー性鼻炎（重症）（５５歳 男性）
通年制に鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日６回点鼻した。点鼻後、症状が軽減するも尚コントロールできないため、ベボタスチンベジル酸塩を内服させた。これにより症状が消失した。点鼻、内服を続行している。
（３４）アレルギー性鼻炎（重症）（６７歳 女性）
通年制に鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日６回点鼻した。点鼻後、症状が軽減するも尚コントロールできないため、ベボタスチンベジル酸塩を内服させた。これにより症状が消失した。点鼻、内服を続行している。
（３５）アレルギー性鼻炎（重症）（８０歳 女性）
２日前から鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日６回点鼻した。点鼻後、直ちに症状が消失した。
（３６）アレルギー性鼻炎（重症）（８０歳 男性）
通年制に鼻汁性、鼻閉、くしゃみの症状があり、点鼻薬Ｂを１回２噴霧左右の鼻腔に１日６回点鼻した。点鼻後、症状が軽減するも尚コントロールできないため、ベボタスチンベジル酸塩を内服させた。これにより症状が消失した。点鼻、内服を続行している。
(28) Allergic rhinitis (severe) (2 years old female)
Symptoms of nasal discharge, nasal congestion and sneezing were observed from 3 days before, and nasal spray B was sprayed once in the right and left nasal cavities 6 times a day. The symptoms disappeared immediately after nasal drop.
(29) Allergic rhinitis (severe) (11 years old male)
Symptoms of nasal discharge, nasal congestion and sneezing were observed from 4 days before, and nasal spray B was sprayed twice in the right and left nasal cavities 6 times a day. The symptoms disappeared immediately after nasal drop.
(30) Allergic rhinitis (severe) (24-year-old female)
There were symptoms of nasal discharge, nasal congestion, and sneezing throughout the year, and nasal spray B was sprayed once twice into the right and left nasal cavities 6 times a day. After nasal nose, symptoms were alleviated but still uncontrollable, so bevostatin besylate was taken. As a result, the symptoms disappeared. Continue nasal and internal use.
(31) Allergic rhinitis (severe) (40-year-old female)
Symptoms of nasal discharge, nasal congestion and sneezing were observed from 7 days before, and nasal spray B was sprayed twice in the right and left nasal cavities 6 times a day. The symptoms disappeared immediately after nasal drop.
(32) Allergic rhinitis (severe) (55 years old male)
Symptoms of nasal discharge, nasal congestion and sneezing were observed from 5 days before, and nasal spray B was sprayed twice in the right and left nasal cavities 6 times a day. After nasal nose, symptoms were alleviated but still uncontrollable, so bevostatin besylate was taken. As a result, the symptoms disappeared.
(33) Allergic rhinitis (severe) (55 years old male)
There were symptoms of nasal discharge, nasal congestion and sneezing throughout the year, and nasal spray B was sprayed once twice into the right and left nasal cavities 6 times a day. After nasal nose, symptoms were alleviated but still uncontrollable, so bevostatin besylate was taken. As a result, the symptoms disappeared. Continue nasal and internal use.
(34) Allergic rhinitis (severe) (67-year-old female)
There were symptoms of nasal discharge, nasal congestion and sneezing throughout the year, and nasal spray B was sprayed once twice into the right and left nasal cavities 6 times a day. After nasal nose, symptoms were alleviated but still uncontrollable, so bevostatin besylate was taken. As a result, the symptoms disappeared. Continue nasal and internal use.
(35) Allergic rhinitis (severe) (80-year-old female)
Symptoms of nasal discharge, nasal congestion, and sneezing were observed from 2 days before, and nasal spray B was sprayed twice in the right and left nasal cavities 6 times a day. The symptoms disappeared immediately after nasal drop.
(36) Allergic rhinitis (severe) (80-year-old male)
There were symptoms of nasal discharge, nasal congestion and sneezing throughout the year, and nasal spray B was sprayed once twice into the right and left nasal cavities 6 times a day. After nasal nose, symptoms were alleviated but still uncontrollable, so bevostatin besylate was taken. As a result, the symptoms disappeared. Continue nasal and internal use.
〈点鼻薬Ａを１日１回、１ｍｌ／１回噴霧した場合の症状の改善状況〉
点鼻薬Ａはアズレンスルホン酸ナトリウムの水和物が抗炎症作用を有し、１日１回の鼻腔・副鼻腔への噴霧により、アレルギー性鼻炎の治療効果がある。更に、アレルギー性鼻炎以外に、急性・慢性鼻炎、急性・慢性副鼻腔炎の治療及び予防効果がある。本発明のアズレンスルホン酸ナトリウムは微量でも効果は強く、連用によって症状の改善率は上昇する。更に効果発現は早く、約１〜２日で効果がみられた。
<Improvement of symptoms when nasal spray A is sprayed once a day, 1 ml / 1 time>
Nasal drug A is a hydrate of sodium azulene sulfonate having an anti-inflammatory action, and has a therapeutic effect for allergic rhinitis by spraying once a day to the nasal cavity and sinuses. Furthermore, in addition to allergic rhinitis, it has therapeutic and preventive effects on acute / chronic rhinitis and acute / chronic sinusitis. The sodium azulene sulfonate of the present invention is highly effective even in a small amount, and the symptom improvement rate is increased by continuous use. Furthermore, the onset of effect was early, and the effect was observed in about 1-2 days.
〈点鼻薬Ｂを１日数回、０．１ｍｌ／１回噴霧した場合の症状の改善状況〉
（１）急性鼻炎について
０〜３歳の患者には、１回１噴霧左右の鼻腔に噴霧した。生後２ヶ月から３歳までの患者、男女３０名に、左右の鼻腔に１日２回点鼻した。その結果、３〜７日で、全員治癒した。４〜８０歳の患者、男女３０名に鞍鼻したのち１回に２噴霧左右の鼻腔に１日２回点鼻した。その結果、３〜１０日で、全員治癒した。
（２）急性副鼻腔炎
０〜３歳の患者には、１回１噴霧左右の鼻腔に噴霧した。生後２ヶ月から３歳までの患者、男女３０名に、左右の鼻腔に１日４回点鼻した。その結果、５〜１４日で、全員治癒した。４〜８０歳の患者、男女３０名に鞍鼻したのち１回に２噴霧左右の鼻腔に１日４回点鼻した。その結果、５〜１０日で、全員治癒した。
（３）慢性副鼻腔炎
４〜８０歳の患者、男女２０名鞍鼻したのち１回に２噴霧左右の鼻腔に１日４回点鼻した。点鼻開始から４日目から徐々に症状、所見が改善していった。その結果、１５〜９０日で、全員治癒した。
（４）アレルギー性鼻炎
アレルギー性鼻炎は体質なので、減感作療法が成功しない限り、治癒する疾患ではないが以下のような効果が確認された。
軽症の患者には１２０名では１〜３歳の患者には、１回１噴霧１日２回左右の鼻腔に噴霧した。４〜８０歳の患者、鞍鼻したのち１回に２噴霧１日２回左右の鼻腔に点鼻した。点鼻効果は、５分であらわれた。症状消失８０％、症状改善２０％、無効０％であった。
中等症の患者には男女１００名では、１〜３歳の患者には、１回１噴霧１日４回左右の鼻腔に噴霧した。４〜８０歳の患者、鞍鼻したのち１回に２噴霧１日４回左右の鼻腔に点鼻した。点鼻効果は、５分であらわれた。症状消失６５％、症状改善３５％、無効５％であった。症状消失しない患者には、第二世代の抗ヒスタミン薬を併用し、症状消失１００％であった。
重症の患者２０名には、１〜３歳の患者には、１回１噴霧１日６回左右の鼻腔に噴霧した。４〜８０歳の患者、鞍鼻したのち１回に２噴霧１日６回左右の鼻腔に点鼻した。点鼻効果は、５分であらわれた。症状消失５０％、症状改善４５％、無効５％であった。症状消失しない患者には、第二世代の抗ヒスタミン薬を併用し、症状消失１００％であった。なお、通常、アレルギー性鼻炎の場合、中等症、重症例においてはベボタスチンベジル酸塩のみでは、症状をコントロールできなかった。
<Improvement of symptoms when nasal spray B is sprayed several times a day, 0.1 ml / time>
(1) About acute rhinitis For patients aged 0 to 3 years, each spray was sprayed once to the right and left nasal cavities. Thirty patients, male and female, from 2 months to 3 years of age were instilled twice daily in the left and right nasal passages. As a result, all were cured in 3 to 7 days. After vaginal nose in 30 male and female patients aged 4 to 80 years, 2 sprays were sprayed once in the right and left nasal cavities twice a day. As a result, all were cured in 3 to 10 days.
(2) Acute sinusitis For patients aged 0 to 3 years, each spray was sprayed once on the right and left nasal cavities. Thirty patients, male and female, from 2 months to 3 years of age were instilled 4 times a day in the left and right nasal passages. As a result, all were cured within 5 to 14 days. After a vaginal nose to 30 patients aged 4 to 80 years, they sprayed nose four times a day in the left and right nasal cavities at two sprays. As a result, all were cured in 5 to 10 days.
(3) Chronic sinusitis Four to 80-year-old patients, 20 men and women, were vaginally nasal and then nasalized twice in the right and left nasal cavities four times a day. Symptoms and findings gradually improved from day 4 after the start of instillation. As a result, all healed in 15 to 90 days.
(4) Allergic rhinitis Since allergic rhinitis is a constitution, it is not a curable disease unless desensitization therapy is successful, but the following effects were confirmed.
120 patients with mild illness and 1 to 3 years old patients sprayed once and twice in the nasal cavity once a day. A patient aged 4 to 80 years, after vaginal nose, sprayed 2 sprays 2 times a day, and nasalized in the left and right nasal cavity. The nasal effect appeared in 5 minutes. Symptom disappearance was 80%, symptom improvement was 20%, and invalidity was 0%.
For moderate patients, 100 males and females were sprayed on the right and left nasal cavities, once per spray, four times a day for patients 1 to 3 years old. A patient aged 4 to 80 years, after vaginal nose, sprayed 2 sprays 4 times a day to the left and right nasal cavities. The nasal effect appeared in 5 minutes. Symptom disappearance 65%, symptom improvement 35%, ineffectiveness 5%. For patients who did not lose their symptoms, the second generation antihistamine was used in combination, and the symptoms disappeared 100%.
For 20 critically ill patients, 1 to 3 year old patients were sprayed once per spray 6 times a day on the left and right nasal cavities. A patient aged 4 to 80 years, after vaginal nose, sprayed 2 sprays 6 times a day to the left and right nasal cavities. The nasal effect appeared in 5 minutes. Symptom disappearance was 50%, symptom improvement was 45%, and ineffectiveness was 5%. For patients who did not lose their symptoms, the second generation antihistamine was used in combination, and the symptoms disappeared 100%. In general, in the case of allergic rhinitis, symptoms could not be controlled only with bevostatin besylate in moderate and severe cases.
点鼻薬Ｂは、アズレンスルホン酸ナトリウムの水和物の抗炎症作用等により、１日数回の鼻腔・副鼻腔への噴霧により、アレルギー性鼻炎の治療効果があった。更にまた、アレルギー性鼻炎以外に、急性・慢性鼻炎、急性・慢性副鼻腔炎の治療及び予防効果があった。本発明のアズレンスルホン酸ナトリウムは微量でも効果は強く、連用によって症状の改善率は上昇した。また、点鼻後直ちに症状の改善、消失等の効果がみられた。 Nasal spray B had a therapeutic effect on allergic rhinitis by spraying to the nasal cavity and sinuses several times a day due to the anti-inflammatory action of hydrate of sodium azulenesulfonate. Furthermore, in addition to allergic rhinitis, there was an effect of treating and preventing acute / chronic rhinitis and acute / chronic sinusitis. The sodium azulene sulfonate of the present invention is highly effective even in a trace amount, and the symptom improvement rate increased with continuous use. In addition, immediately after nasal nose, effects such as improvement and disappearance of symptoms were observed.
なお、本発明は、主剤に添加物を配合することで、従来は口腔用にしか使用されていなかったアズレンスルホン酸ナトリウムの水溶液を噴霧式で鼻腔、副鼻腔の治療に使用することができれば、上述した発明の実施の形態に限定されず、本発明の要旨を逸脱しない範囲で種々変更できることは勿論である。 In the present invention, if an additive is added to the main agent, an aqueous solution of sodium azulenesulfonate, which has been conventionally used only for the oral cavity, can be used for the treatment of nasal cavity and sinuses by spraying, Of course, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention.
本発明のアズレンスルホン酸ナトリウムを主剤とする点鼻薬は、アレルギー性鼻炎、急性・慢性鼻炎、及び急性・慢性副鼻腔炎などの治療、予防に利用することができる。
The nasal drops containing sodium azulene sulfonate of the present invention as a main ingredient can be used for treatment and prevention of allergic rhinitis, acute / chronic rhinitis, acute / chronic sinusitis and the like.
Claims (4)
水１ミリリットル中にアズレンスルホン酸ナトリウムの水和物２０ｍｇ〜６０ｍｇを溶解して主剤とし、
該主剤に添加物として抗アレルギーの薬効を有する漢方薬と抗炎症作用を有する漢方薬を配合した、ことを特徴とするアズレンスルホン酸系薬剤を主剤とする点鼻薬。 A nasal spray for nasal spray that sprays the drug solution directly into the nasal cavity,
Dissolve 20 mg to 60 mg of sodium azulene sulfonate in 1 ml of water as a main ingredient,
A nasal drop containing an azulene sulfonic acid-based drug as a main ingredient, wherein the main ingredient contains a Chinese medicine having an antiallergic effect and a Chinese medicine having an anti-inflammatory action as additives.
前記抗アレルギーの薬効を有する漢方薬２０ｍｇ〜１００ｍｇと、
前記抗炎症作用を有する漢方薬５ｍｇ〜５０ｍｇとを溶解した、ことを特徴とするアズレンスルホン酸系薬剤を主剤とする請求項１の点鼻薬。
In 1 ml of water, 20 mg to 60 mg of sodium azulene sulfonate hydrate,
20 mg to 100 mg of Chinese medicine having the antiallergic effect,
The nasal drop according to claim 1, wherein the main ingredient is an azulene sulfonic acid-based drug in which 5 to 50 mg of a Chinese medicine having an anti-inflammatory action is dissolved.
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| CN103861000A (en) * | 2014-03-10 | 2014-06-18 | 宁波大学 | External-use drug used for treating chronic nasosinusitis |
| CN104189800A (en) * | 2014-07-30 | 2014-12-10 | 严中明 | Traditional Chinese medicine composition for treating allergic rhinitis |
| CN104474253A (en) * | 2014-12-09 | 2015-04-01 | 杨佳 | Traditional Chinese medicine composition for treating chronic rhinitis |
| CN104547937A (en) * | 2015-01-16 | 2015-04-29 | 李玉 | Traditional Chinese medicine composition for treating nasosinusitis and preparation method thereof |
| CN104815235A (en) * | 2015-05-26 | 2015-08-05 | 合肥丰瑞隆生物科技有限公司 | Traditional Chinese medicine for treating rhinitis |
| CN104873872A (en) * | 2015-05-30 | 2015-09-02 | 陈爱华 | Granular formulation for treating perennial allergic rhinitis |
| CN104958583A (en) * | 2015-06-10 | 2015-10-07 | 江琴 | Medicinal composition for treating nasopharyngeal cancer, and application thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103861000A (en) * | 2014-03-10 | 2014-06-18 | 宁波大学 | External-use drug used for treating chronic nasosinusitis |
| CN104189800A (en) * | 2014-07-30 | 2014-12-10 | 严中明 | Traditional Chinese medicine composition for treating allergic rhinitis |
| CN104474253A (en) * | 2014-12-09 | 2015-04-01 | 杨佳 | Traditional Chinese medicine composition for treating chronic rhinitis |
| CN104547937A (en) * | 2015-01-16 | 2015-04-29 | 李玉 | Traditional Chinese medicine composition for treating nasosinusitis and preparation method thereof |
| CN104815235A (en) * | 2015-05-26 | 2015-08-05 | 合肥丰瑞隆生物科技有限公司 | Traditional Chinese medicine for treating rhinitis |
| CN104873872A (en) * | 2015-05-30 | 2015-09-02 | 陈爱华 | Granular formulation for treating perennial allergic rhinitis |
| CN104958583A (en) * | 2015-06-10 | 2015-10-07 | 江琴 | Medicinal composition for treating nasopharyngeal cancer, and application thereof |
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