JP2021017444A - Pharmaceutical composition containing olopatadine and caffeine - Google Patents
Pharmaceutical composition containing olopatadine and caffeine Download PDFInfo
- Publication number
- JP2021017444A JP2021017444A JP2020122750A JP2020122750A JP2021017444A JP 2021017444 A JP2021017444 A JP 2021017444A JP 2020122750 A JP2020122750 A JP 2020122750A JP 2020122750 A JP2020122750 A JP 2020122750A JP 2021017444 A JP2021017444 A JP 2021017444A
- Authority
- JP
- Japan
- Prior art keywords
- hydrochloride
- pharmaceutical composition
- caffeine
- olopatadine
- salt
- 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
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- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 title claims abstract description 56
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 42
- 229960001948 caffeine Drugs 0.000 title claims abstract description 34
- 229960004114 olopatadine Drugs 0.000 title claims abstract description 27
- JBIMVDZLSHOPLA-LSCVHKIXSA-N olopatadine Chemical compound C1OC2=CC=C(CC(O)=O)C=C2C(=C/CCN(C)C)\C2=CC=CC=C21 JBIMVDZLSHOPLA-LSCVHKIXSA-N 0.000 title claims abstract description 27
- LPHGQDQBBGAPDZ-UHFFFAOYSA-N Isocaffeine Natural products CN1C(=O)N(C)C(=O)C2=C1N(C)C=N2 LPHGQDQBBGAPDZ-UHFFFAOYSA-N 0.000 title claims abstract description 22
- VJEONQKOZGKCAK-UHFFFAOYSA-N caffeine Natural products CN1C(=O)N(C)C(=O)C2=C1C=CN2C VJEONQKOZGKCAK-UHFFFAOYSA-N 0.000 title claims abstract description 22
- 150000003839 salts Chemical class 0.000 claims abstract description 44
- KWGRBVOPPLSCSI-WPRPVWTQSA-N (-)-ephedrine Chemical compound CN[C@@H](C)[C@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WPRPVWTQSA-N 0.000 claims abstract description 24
- 229960001802 phenylephrine Drugs 0.000 claims abstract description 16
- SONNWYBIRXJNDC-VIFPVBQESA-N phenylephrine Chemical compound CNC[C@H](O)C1=CC=CC(O)=C1 SONNWYBIRXJNDC-VIFPVBQESA-N 0.000 claims abstract description 16
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- HVRLZEKDTUEKQH-NOILCQHBSA-N Olopatadine hydrochloride Chemical compound Cl.C1OC2=CC=C(CC(O)=O)C=C2C(=C/CCN(C)C)\C2=CC=CC=C21 HVRLZEKDTUEKQH-NOILCQHBSA-N 0.000 claims description 17
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Abstract
Description
本発明は、総合感冒薬又は鼻炎用薬として用いることができる抗炎症作用に優れた医薬組成物に関する。 The present invention relates to a pharmaceutical composition having an excellent anti-inflammatory effect that can be used as a common cold medicine or a drug for rhinitis.
総合感冒薬とは、かぜの諸症状、例えば、鼻水、鼻づまり、発熱、のどの痛み、せき、たん、くしゃみ、悪寒、頭痛、関節の痛み、筋肉の痛み等の緩和を目的として使用される医薬品の総称である。総合感冒薬にはこれらの症状を緩和するために解熱鎮痛成分、抗ヒスタミン成分、鎮咳成分等、多様な成分が配合されている。 Common cold medicine is used for the purpose of relieving various cold symptoms such as runny nose, stuffy nose, fever, sore throat, cough, tan, sneezing, chills, headache, joint pain, muscle pain, etc. It is a general term for medicines. Common cold medicine contains various ingredients such as antipyretic analgesic ingredient, antihistamine ingredient, and antitussive ingredient to alleviate these symptoms.
鼻炎用薬とは、急性鼻炎、アレルギー性鼻炎又は副鼻腔炎による諸症状、例えば、鼻水、鼻づまり、くしゃみ等の緩和を目的として使用される医薬品の総称である。鼻炎用薬には、これらの症状を緩和するために、抗ヒスタミン成分や抗炎症成分等、多様な成分が配合されている。 Rhinitis medicine is a general term for medicines used for the purpose of alleviating various symptoms caused by acute rhinitis, allergic rhinitis or sinusitis, such as runny nose, nasal congestion and sneezing. In order to alleviate these symptoms, rhinitis drugs contain various components such as antihistamine components and anti-inflammatory components.
オロパタジン塩酸塩は、選択的抗ヒスタミンH1受容体拮抗作用を主作用とし、さらに化学伝達物質(ロイコトリエン、トロンボキサン、PAF等)の産生・遊離抑制作用を有し、神経伝達物質タキキニン遊離抑制作用を有し、本邦では、アレルギー性鼻炎、蕁麻疹、皮膚疾患に伴う掻痒の効能・効果が認められている(例えば、非特許文献1参照)。 Olopatadine hydrochloride mainly has a selective antihistamine H1 receptor antagonism, and also has an inhibitory effect on the production and release of chemical mediators (leukotriene, thromboxane, PAF, etc.), and an inhibitory effect on the release of the neurotransmitter tachykinin. In Japan, the efficacy and effect of pruritus associated with allergic rhinitis, urticaria, and skin diseases have been recognized (see, for example, Non-Patent Document 1).
カフェインは、中枢作用としては興奮作用、末梢作用としては心筋収縮力増強作用、血管拡張作用、平滑筋弛緩作用、利尿作用を有し、眠気、倦怠感、血管拡張性又は脳圧亢進性頭痛に適応される(非特許文献2)。 Caffeine has excitatory action as a central action, myocardial contractile force enhancing action, vasodilatory action, smooth muscle relaxing action, and diuretic action as peripheral actions, and drowsiness, malaise, vasodilatory or intracranial pressure-enhancing headache. (Non-Patent Document 2).
現在、オロパタジン又はその塩を配合した総合感冒薬は販売されていないが、オロパタジン塩酸塩または抗コリン剤及びカフェインを配合した錠剤(特許文献1参照)等が知られている。 Currently, a common cold treatment drug containing olopatadine or a salt thereof is not on the market, but tablets containing olopatadine hydrochloride or an anticholinergic agent and caffeine (see Patent Document 1) and the like are known.
本発明の課題は、オロパタジン又はその塩と、カフェインとを含有し、優れた抗炎症作用を有する医薬組成物を提供することである。 An object of the present invention is to provide a pharmaceutical composition containing olopatadine or a salt thereof and caffeine and having an excellent anti-inflammatory effect.
本発明者らは、上記課題を解決するために鋭意検討した結果、オロパタジン又はその塩と、カフェインとの組み合わせに、エフェドリン又はその誘導体又はそれらの塩、及びフェニレフリン又はその塩から選ばれる1種又は2種以上を配合することにより、抗炎症作用を大幅に増強できることを見出し、本発明を完成させた。 As a result of diligent studies to solve the above problems, the present inventors have made one selected from ephedrine or a derivative thereof or a salt thereof, and phenylephrine or a salt thereof in combination with olopatadine or a salt thereof and caffeine. Alternatively, they have found that the anti-inflammatory effect can be significantly enhanced by blending two or more kinds, and have completed the present invention.
すなわち、本発明は下記に関する。
[1] (a)オロパタジン又はその塩;
(b)カフェイン;及び
(c)エフェドリン又はその誘導体又はそれらの塩、及びフェニレフリン又はその塩から選ばれる1種又は2種以上;
を含有する医薬組成物。
[2] オロパタジン又はその塩が、オロパタジン塩酸塩である、[1]に記載の医薬組成物。
[3] カフェインが、無水カフェイン又はカフェイン水和物である、[1]又は[2]に記載の医薬組成物。
[4] エフェドリン又はその誘導体が、メチルエフェドリンである、[1]から[3]のいずれか一に記載の医薬組成物。
[5] エフェドリン又はその誘導体又はそれらの塩が、メチルエフェドリン塩酸塩である[1]から[4]のいずれか一に記載の医薬組成物。
[6] フェニレフリン又はその塩が、フェニレフリン塩酸塩である、[1]から[5]のいずれか一に記載の医薬組成物。
[7] 抗炎症用である、[1]から[6]のいずれか一に記載の医薬組成物。
[8] 鼻炎の予防又は治療用である、[1]から[6]のいずれか一に記載の医薬組成物。
[9] かぜの諸症状の緩和のための、[1]から[6]のいずれか一に記載の医薬組成物。
[10] オロパタジン又はその塩の成人への一日分の投与量が1mg〜20mgであり、カフェインの成人への一日分の投与量が1mg〜1000mgである、[1]から[9]のいずれか一に記載の医薬組成物。
That is, the present invention relates to the following.
[1] (a) Olopatadine or a salt thereof;
(B) Caffeine; and (c) Ephedrine or a derivative thereof or a salt thereof, and one or more selected from phenylephrine or a salt thereof;
A pharmaceutical composition containing.
[2] The pharmaceutical composition according to [1], wherein olopatadine or a salt thereof is olopatadine hydrochloride.
[3] The pharmaceutical composition according to [1] or [2], wherein the caffeine is anhydrous caffeine or caffeine hydrate.
[4] The pharmaceutical composition according to any one of [1] to [3], wherein ephedrine or a derivative thereof is methylephedrine.
[5] The pharmaceutical composition according to any one of [1] to [4], wherein ephedrine or a derivative thereof or a salt thereof is methylephedrine hydrochloride.
[6] The pharmaceutical composition according to any one of [1] to [5], wherein phenylephrine or a salt thereof is phenylephrine hydrochloride.
[7] The pharmaceutical composition according to any one of [1] to [6], which is for anti-inflammatory use.
[8] The pharmaceutical composition according to any one of [1] to [6], which is used for the prevention or treatment of rhinitis.
[9] The pharmaceutical composition according to any one of [1] to [6] for alleviating various symptoms of cold.
[10] The daily dose of olopatadine or a salt thereof to an adult is 1 mg to 20 mg, and the daily dose of caffeine to an adult is 1 mg to 1000 mg, [1] to [9]. The pharmaceutical composition according to any one of.
本発明によれば、抗炎症作用に優れた医薬組成物を提供することができる。 According to the present invention, it is possible to provide a pharmaceutical composition having an excellent anti-inflammatory effect.
本発明の実施の形態について以下に説明する。
本発明の医薬組成物は、
(a)オロパタジン又はその塩;
(b)カフェイン;及び
(c)エフェドリン又はその誘導体又はそれらの塩、及びフェニレフリン又はその塩から選ばれる1種又は2種以上、
を含有する医薬組成物である。
Embodiments of the present invention will be described below.
The pharmaceutical composition of the present invention
(A) Olopatadine or a salt thereof;
(B) Caffeine; and (c) Ephedrine or a derivative thereof or a salt thereof, and one or more selected from phenylephrine or a salt thereof,
Is a pharmaceutical composition containing.
本発明において、「オロパタジン又はその塩」は、例えば、オロパタジン、オロパタジン塩酸塩等が挙げられる。これらは公知の化合物であり、公知の方法により製造できるほか、市販のものを用いることができる。 In the present invention, examples of the "olopatadine or a salt thereof" include olopatadine and olopatadine hydrochloride. These are known compounds and can be produced by known methods, or commercially available compounds can be used.
本発明において、「オロパタジン又はその塩」の含有量は特に限定されず、服用者の性別、年齢、症状等に応じて、適宜検討して決定すればよい。例えば、オロパタジン又はその塩が、オロパタジン塩酸塩の場合は、1日量として(好ましくは成人に対して)、通常1mg〜20mgであり、好ましくは5mg〜10mgであり、最も好ましくは10mgである。 In the present invention, the content of "olopatadine or a salt thereof" is not particularly limited, and may be appropriately examined and determined according to the sex, age, symptom, etc. of the user. For example, when olopatadine or a salt thereof is olopatadine hydrochloride, the daily dose (preferably for adults) is usually 1 mg to 20 mg, preferably 5 mg to 10 mg, and most preferably 10 mg.
本発明において、「カフェイン」は、カフェイン水和物、無水カフェイン、安息香酸ナトリウムカフェイン及びクエン酸カフェイン等が挙げられる。これらは公知の物質であり、公知の方法により製造できるほか、市販のものを用いることができる。 In the present invention, "caffeine" includes caffeine hydrate, anhydrous caffeine, sodium benzoate caffeine, caffeine citrate and the like. These are known substances, which can be produced by a known method, or commercially available substances can be used.
本発明において、「カフェイン」の含有量は特に限定されず、服用者の性別、年齢、症状等に応じて、適宜検討して決定すればよい。例えば、カフェインが、無水カフェインの場合は、1日量として(好ましくは成人に対して)、通常1mg〜1000mgであり、好ましくは75mg〜600mgであり、より好ましくは150mg〜300mgである 。 In the present invention, the content of "caffeine" is not particularly limited, and may be appropriately examined and determined according to the sex, age, symptom, etc. of the user. For example, when caffeine is anhydrous caffeine, the daily dose (preferably for adults) is usually 1 mg to 1000 mg, preferably 75 mg to 600 mg, and more preferably 150 mg to 300 mg.
本発明において、「エフェドリン又はその誘導体又はそれらの塩」は、例えば、プソイドエフェドリン塩酸塩、プソイドエフェドリン硫酸塩、dl−メチルエフェドリン塩酸塩、dl−メチルエフェドリンサッカリン塩等が挙げられる。これらは公知の物質であり、公知の方法により製造できるほか、市販のものを用いることができる。 In the present invention, "ephedrine or a derivative thereof or a salt thereof" includes, for example, pseudoephedrine hydrochloride, pseudoephedrine sulfate, dl-methylephedrine hydrochloride, dl-methylephedrine saccharin salt and the like. These are known substances, which can be produced by a known method, or commercially available substances can be used.
本発明において、「エフェドリン又はその誘導体又はそれらの塩」の含有量は特に限定されず、服用者の性別、年齢、症状等に応じて、適宜検討して決定すればよい。例えばエフェドリン又はその誘導体又はそれらの塩が、dl−メチルエフェドリン塩酸塩の場合は、1日量として(好ましくは成人に対して)、通常1mg〜300mgであり、好ましくは10mg〜250mgであり、より好ましくは25mg〜200mgである。 In the present invention, the content of "ephedrine or a derivative thereof or a salt thereof" is not particularly limited, and may be appropriately examined and determined according to the sex, age, symptom, etc. of the user. For example, when ephedrine or a derivative thereof or a salt thereof is dl-methylephedrine hydrochloride, the daily dose (preferably for adults) is usually 1 mg to 300 mg, preferably 10 mg to 250 mg, and more. It is preferably 25 mg to 200 mg.
本発明において、「フェニレフリン又はその塩」は、例えば、フェニレフリン、フェニレフリン塩酸塩等が挙げられる。これらは公知の化合物であり、公知の方法により製造できるほか、市販のものを用いることができる。 In the present invention, examples of the "phenylephrine or a salt thereof" include phenylephrine, phenylephrine hydrochloride and the like. These are known compounds and can be produced by known methods, or commercially available compounds can be used.
本発明において、「フェニレフリン又はその塩」の含有量は特に限定されず、服用者の性別、年齢、症状等に応じて、適宜検討して決定すればよい。例えば、フェニレフリン又はその塩が、フェニレフリン塩酸塩の場合は、1日量として(好ましくは成人に対して)、通常1mg〜50mgであり、好ましくは5mg〜30mgであり、より好ましくは10mg〜30mgである。 In the present invention, the content of "phenylephrine or a salt thereof" is not particularly limited, and may be appropriately examined and determined according to the sex, age, symptom, etc. of the user. For example, when phenylephrine or a salt thereof is phenylephrine hydrochloride, the daily dose (preferably for adults) is usually 1 mg to 50 mg, preferably 5 mg to 30 mg, and more preferably 10 mg to 30 mg. is there.
本発明においては、上記した成分に加えて、効果を損なわない範囲で、通常総合感冒薬又は鼻炎用薬に使用されているその他の成分を必要に応じて配合することができる。例えば、一般用医薬品製造販売承認基準に記載されている成分等を配合することができる。具体的には、解熱鎮痛剤、抗ヒスタミン剤、血管収縮剤、鎮咳剤、ノスカピン類、気管支拡張剤、去痰剤、抗コリン剤、抗炎症剤、ビタミン類、胃粘膜保護剤、生薬類、催眠鎮静剤、及び漢方処方等から選ばれる1種又は2種以上の成分を配合することができる。 In the present invention, in addition to the above-mentioned ingredients, other ingredients usually used for a common cold medicine or a rhinitis medicine can be blended as necessary without impairing the effect. For example, an ingredient or the like described in the over-the-counter drug manufacturing and marketing approval standard can be blended. Specifically, antipyretic analgesics, antihistamines, vasoconstrictors, antitussives, noscapines, bronchodilators, expectorants, anticholinergic agents, anti-inflammatory agents, vitamins, gastric mucosa protectants, crude drugs, hypnotic sedatives, And one or more kinds of ingredients selected from Chinese herbal formulas and the like can be blended.
解熱鎮痛剤としては、例えば、アスピリン、アスピリンアルミニウム、アセトアミノフェン、エテンザミド、サザピリン、サリチルアミド、ラクチルフェネチジン、イブプロフェン、イソプロピルアンチピリン、ロキソプロフェンナトリウム水和物、プラノプフェン、ジクロフェナクナトリウム、メフェナム酸、インドメタシンファルネシル、アセメタシン、エトドラク、ナプロキセン、メロキシカム、セレコキシブ、及びチアラミド塩酸塩等から選ばれる1種又は2種以上の成分を配合することができる。 Examples of antipyretic analgesics include aspirin, aspirin aluminum, acetaminophen, etodolac, sazapyrin, salicylamide, lactylphenetidine, ibuprofen, isopropylantipyrine, loxoprofen sodium hydrate, planopphene, diclofenac sodium, mefenamic acid, indomethacinfarnesyl, One or more components selected from aspirin, etodolac, naproxen, meloxicam, selecoxib, thialamide hydrochloride and the like can be blended.
抗ヒスタミン剤としては、例えば、塩酸イソチペンジル、塩酸ジフェテロール、塩酸トリペレナミン、塩酸トンジルアミン、塩酸フェネタジン、塩酸メトジラジン、dl−クロルフェニラミンマレイン酸塩、d−クロルフェニラミンマレイン酸塩、ジフェニルジスルホン酸カルビノキサミン、ジフェニルピラリン塩酸塩、ジフェニルピラリンテオクル酸塩、ジフェンヒドラミン塩酸塩、ジフェンヒドラミンサリチル酸塩、酒石酸アリメマジン、タンニン酸ジフェンヒドラミン、トリプロリジン塩酸塩水和物、ナパジシル酸メブヒドロリン、プロメタジンメチレン二サリチル酸塩、マレイン酸カルビノキサミン、リン酸ジフェテロール、クレマスチンフマル酸塩、メキタジン、ケトチフェンフマル酸塩、プロメタジン塩酸塩、エピナスチン塩酸塩、エメダスチンフマル酸塩、フェキソフェナジン、アゼラスチン塩酸塩、及びセチリジン塩酸塩等から選ばれる1種又は2種以上の成分を配合することができる。 Examples of the antihistamine agent include isotipendyl hydrochloride, dipheterol hydrochloride, tryperenamine hydrochloride, tonzilamine hydrochloride, phenetazine hydrochloride, metodilazine hydrochloride, dl-chlorpheniramine maleate, d-chlorpheniramine maleate, diphenyldisulfonate carbinoxamine, diphenylpyraline hydrochloride. Salt, diphenylpyraline theocrate, diphenhydramine hydrochloride, diphenhydramine salicylate, alimemazine tartrate, diphenhydramine tannate, triprolysine hydrochloride hydrate, mebhydrolin napadisylate, promethazine methylene disalicylate, carbinoxamine maleate, dipheterol phosphate, cremastine One or more components selected from fumarate, mequitazine, ketotiphen fumarate, promethazine hydrochloride, epinastine hydrochloride, emedastin fumarate, hexofenazine, azelastin hydrochloride, cetirizine hydrochloride and the like. Can be blended.
血管収縮剤としては、メトキシフェナミン塩酸塩等から選ばれる1種又は2種以上の成分を配合することができる。 As the vasoconstrictor, one or more components selected from methoxyphenamine hydrochloride and the like can be blended.
鎮咳剤としては、例えば、塩酸アロクラミド、クロペラスチン塩酸塩、クロペラスチンフェンジゾ酸塩、コデインリン酸塩水和物、ジヒドロコデインリン酸塩、デキストロメトルファン臭化水素酸塩水和物、デキストロメトルファン・フェノールフタリン塩、クエン酸チペピジン、チペピジンヒベンズ酸塩、ジブナートナトリウム、ペントキシベリンクエン酸塩、ジメモルファンリン酸塩、エプラジノン塩酸塩、ペントキシベリンクエン酸塩、ベンプロペリンリン酸塩、及びクロフェダノール塩酸塩等から選ばれる1種又は2種以上の成分を配合することができる。 Antitussives include, for example, allocramide hydrochloride, cloperastine hydrochloride, cloperastine fendizoate, codeine phosphate hydrate, dihydrocodein phosphate, dextrometholphan hydrobromide hydrate, dextrometholphan phenolphthal. Phosphate, Tipepidin Citrate, Tipepidin Hibenzate, Dibunato Sodium, Pentoxiberincate, Dimemorphan Phosphate, Epradinone Hydrochloride, Pentoxiberinnate, Benproperin Phosphate, and Crofeda One kind or two or more kinds of components selected from nol hydrochloride and the like can be blended.
ノスカピン類としては、例えば、ノスカピン、及びノスカピン塩酸塩水和物等から選ばれる1種又は2種以上の成分を配合することができる。 As the noscapines, for example, one or more components selected from noscapine, noscapine hydrochloride hydrate and the like can be blended.
気管支拡張剤としては、例えば、アミノフィリン、ジプロフィリン、テオフィリン 、プロキシフィリン、トリメトキノール塩酸塩、フェニルプロパノールアミン塩酸塩、メトキシフェナミン塩酸塩、及びイソプレナリン塩酸塩等から選ばれる1種又は2種以上の成分を配合することができる。 As the bronchodilator, for example, one or more selected from aminophylline, diprophylline, theophylline, proxyphylline, trimetokinol hydrochloride, phenylpropanolamine hydrochloride, methoxyphenamine hydrochloride, isoprenaline hydrochloride and the like. Ingredients can be blended.
去痰剤としては、例えば、グアイフェネシン、グアヤコールスルホン酸カリウム、クレゾールスルホン酸カリウム、ブロムヘキシン塩酸塩、l−カルボシステイン、l−エチルシステイン塩酸塩、l−メチルシステイン塩酸塩、アンブロキソール塩酸塩、塩化アンモニウム、l−メントール、アンモニア・ウイキョウ精、桜皮エキス、メチルシステイン塩酸塩、及びフドステイン等から選ばれる1種又は2種以上の成分を配合することができる。 Examples of sputum salts include guayphenesin, potassium guayacol sulfonate, potassium cresol sulfonate, bromhexine hydrochloride, l-carbocysteine, l-ethylcysteine hydrochloride, l-methylcysteine hydrochloride, ambroxol hydrochloride, and ammonium chloride. , L-menthol, ammonia / uikyosei, cherry bark extract, methylcysteine hydrochloride, fudostain and the like can be blended with one or more components.
抗コリン剤としては、例えば、ベラドンナ又はその抽出物(ベラドンナ総アルカロイド等)、ヨウ化イソプロパミド等の成分を配合することができる。本発明の医薬組成物は、ベラドンナ又はその抽出物(ベラドンナ総アルカロイド等)を含んでいてよく、ベラドンナ又はその抽出物(ベラドンナ総アルカロイド等)を含まなくてもよい。 As the anticholinergic agent, for example, components such as belladonna or an extract thereof (belladonna total alkaloid, etc.), isopropamide iodide, and the like can be blended. The pharmaceutical composition of the present invention may contain belladonna or an extract thereof (belladonna total alkaloid, etc.), and may not contain belladonna or an extract thereof (belladonna total alkaloid, etc.).
抗炎症剤としては、セラペプターゼ、ブロメライン、セミアルカリプロティナーゼ、プロナーゼ、セアプローゼ、プロクターゼ、グリチルリチン酸及びその塩類、トラネキサム酸、及びリゾチーム塩酸塩等から選ばれる1種又は2種以上の成分を配合することができる。本発明の医薬組成物は、トラネキサム酸を含んでいてよく、トラネキサム酸を含まなくてもよい。 As the anti-inflammatory agent, one or more components selected from serrapeptase, bromelain, semi-alkali proteinase, pronase, seaprose, proctase, glycyrrhizinic acid and its salts, tranexamic acid, lysozyme hydrochloride and the like may be blended. it can. The pharmaceutical composition of the present invention may contain tranexamic acid and may not contain tranexamic acid.
ビタミン類としては、例えば、チアミン、チアミン塩化物塩酸塩、チアミン硝化物、ジセチアミン塩酸塩、セトチアミン塩酸塩、フルスルチアミン、フルスルチアミン塩酸塩、オクトチアミン、シコチアミン、チアミンジスルフィド、ビスイブチアミン、ビスベンチアミン、プロスルチアミン、及びベンフォチアミン等のビタミンB1及びその誘導体並びにそれらの塩類、リボフラビン、リボフラビンリン酸エステル、リボフラビン酪酸エステル、及びリン酸リボフラビンナトリウム等のビタミンB2及びその誘導体並びにそれらの塩類、パントテン酸、パンテノール、パンテチン、パントテン酸カルシウム、及びパントテン酸ナトリウム等のビタミンB5及びその誘導体並びにそれらの塩類、ピリドキシン塩酸塩、及びピリドキサールリン酸エステル等のビタミンB6及びその誘導体並びにそれらの塩類、シアノコバラミン、及びメコバラミン等のビタミンB12及びその誘導体並びにそれらの塩類、アスコルビン酸、アスコルビン酸ナトリウム、及びアスコルビン酸カルシウム等のビタミンC及びその誘導体並びにそれらの塩類、及びヘスペリジン及びその誘導体並びにそれらの塩類等から選ばれる1種又は2種以上の成分を配合することができる。 Examples of vitamins include thiamine, thiamine chloride hydrochloride, thiamine nitrate, disetiamine hydrochloride, setothiamine hydrochloride, flusultiamine, flusultiamine hydrochloride, octothiamine, sicothamine, thiamine disulfide, bisibuchiamine, bis. Vitamin B1 and its derivatives such as bentiamine, prosulthiamine, and benfothiamine and their salts, riboflavin, riboflavin phosphate, riboflavin butyrate, and vitamin B2 such as riboflavin sodium phosphate and their salts. Vitamin B5 and its derivatives such as pantothenic acid, pantenol, pantetin, calcium pantothenate, and sodium pantothenate and their salts, pyridoxin hydrochloride, and vitamin B6 such as pyridoxal phosphate ester and their derivatives, and their salts. From vitamin B12 and its derivatives such as cyanocobalamine and mecobalamine and their salts, vitamin C and its derivatives such as ascorbic acid, sodium ascorbate, and calcium ascorbate and their salts, and hesperidin and its derivatives and their salts and the like. One or more selected ingredients can be blended.
胃粘膜保護剤としては、グリシン、ケイ酸マグネシウム、合成ケイ酸アルミニウム、 合成ヒドロタルサイト、酸化マグネシウム、ジヒドロキシアルミニウムアルノアセテート(アルミニウムグリシネート)、水酸化アルミニウムゲル、乾燥水酸化アルミニウムゲル、水酸化アルミニウム・炭酸水素ナトリウムの共沈生成物、水酸化アルミニウム・炭酸マグネシウム混合乾燥ゲル、水酸化アルミニウム・炭酸マグネシウム・炭酸カルシウムの共沈物、水酸化マグネシウム・ 硫酸アルミニウムカリウムの共沈生成物、炭酸マグネシウム、メタケイ酸アルミン酸マグネシウム、アルジオキサ、銅クロロフィリンナトリウム、銅クロロフィリンカリウム、メチルメチオニンスルホニウムクロリド、スクラルファート、セトラキサート塩酸塩、ソファルコン、ゲファルナート、テプレノン、及びレバミピド等から選ばれる1種又は2種以上の成分を配合することができる。 Gastric mucosa protective agents include glycine, magnesium silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, dihydroxyaluminum arnoacetate (aluminum glycinate), aluminum hydroxide gel, dry aluminum hydroxide gel, aluminum hydroxide.・ Co-precipitated product of sodium hydrogen carbonate, mixed dry gel of aluminum hydroxide and magnesium carbonate, co-precipitated product of aluminum hydroxide, magnesium carbonate and calcium carbonate, co-precipitated product of magnesium hydroxide and potassium aluminum sulfate, magnesium carbonate, Contains one or more ingredients selected from magnesium aluminometasilicate, aldioxa, sodium copper chlorophyllin, potassium copper chlorophyllin, methylmethionine sulfonium chloride, scralfate, setraxate hydrochloride, sofalcone, gefarnate, teprenone, levamipide, etc. can do.
生薬類としては、マオウ、ナンテンジツ、オウヒ、オンジ、カンゾウ、キキョウ、シャゼンシ、シャゼンソウ、セキサン(石蒜)、セネガ、バイモ、ウイキョウ、オウバク、オウレン、ガジュツ、カミツレ、ケイヒ、ゲンチアナ、ゴオウ、獣胆(ユウタン含む)、シャジン、ショウキョウ、ソウジュツ、チョウジ、チンピ、ビャクジュツ、ジリュウ、チクセツニンジン、ニンジン、アカメガシワ、アセンヤク、インヨウカク、エンゴサク、オウゴン、オウセイ、カノコソウ、カロニン、キョウニン、クコシ、クコヨウ、ケイガイ、ケツメイシ、ゲンノショウコ、 コウブシ、ゴミシ、サイシン、サンショウ、シオン、ジコッピ、シャクヤク、ジャコウ、シンイ、センキュウ、ゼンコ、センブリ、ソウハクヒ、ソヨウ、タイサン、トウキ、トコン、バクモンドウ、ハンゲ、バンコウカ、ハンピ、ビャクシ、ブクリョウ、ボタンピ、ボレイ、ロクジョウ等の生薬及びこれらの抽出物(エキス、チンキ、乾燥エキス等)等から選ばれる1種又は2種以上の成分を配合することができる。 Herbal medicines include Maou, Nantenjitsu, Ohi, Onji, Kanzo, Kikyo, Shazenshi, Shazensou, Sexan (Swertia japonica), Senega, Baimo, Fennel, Oubaku, Ouren, Gajutsu, Kamitsure, Keihi, Gentiana, Goou, Beast. (Including Yutan), Shajin, Geranium, Sojutsu, Chouji, Chinpi, Byakujutsu, Jiryu, Chikusetsu carrot, Carrot, Akamega wrinkle, Asenyaku, Inyoukaku, Engosaku, Ogon, Osei, Kanokosou, Karonin, Kyounin, Kukoshi , Geranium thunbergii, Kobushi, Garbage, Saishin, Sansho, Zion, Jikoppi, Shakuyaku, Jakou, Shini, Senkyu, Zenko, Swertia japonica, Souhakuhi, Soyo, Taisan, Touki, Tokon, Bakumondou, Hange, Bankouka, Hanpi, Byakushi, Bukuryo One or more kinds of ingredients selected from crude drugs such as botanical, volley, and geranium thunbergii and extracts thereof (extracts, tinctures, dried extracts, etc.) can be blended.
催眠鎮静剤としては、ブロムワレリル尿素、及びアリルイソプロピルアセチル尿素等から選ばれる1種又は2種以上の成分を配合することができる。 As the hypnotic sedative, one or more components selected from bromvalerylurea, allylisopropylacetylurea and the like can be blended.
漢方処方としては、葛根湯、葛根湯加桔梗、桂枝湯、香蘇散、柴胡桂枝湯、小柴胡湯、小青竜湯、麦門冬湯、半夏厚朴湯、麻黄湯等から選ばれる1種又は2種以上の成分を配合することができる。 One type of Chinese medicine prescription selected from Kakkonto, Kakkonto Kakikyo, Keishito, Kasosan, Shosaikoto, Shosaikoto, Shoseiryuto, Bakumondoto, Hangekobokuto, Maoto, etc. Alternatively, two or more kinds of components can be blended.
さらに、本発明の医薬組成物には、本発明の効果を損なわない範囲で、製剤を製造するために必要な医薬品添加物を配合することができる。例えば、医薬品添加物は、薬食審査発1204第1号(薬事行政法令)、医薬品添加物辞典2007(日本医薬品添加剤協会編集、薬事日報社)、及び第8版食品添加物公定書(日本食品添加物協会)等に記載されているものを配合することができる。具体的には、賦形剤、結合剤、崩壊剤、崩壊補助剤、流動化剤、滑沢剤、可塑剤、コーティング剤、糖衣剤、光沢化剤、溶剤、pH調節剤、着色剤、矯味剤、甘味剤、香料、着香剤・香料等から選ばれる1種又は2種以上の成分を配合することができる。 Further, the pharmaceutical composition of the present invention may contain pharmaceutical additives necessary for producing a preparation as long as the effects of the present invention are not impaired. For example, for pharmaceutical additives, 1204 No. 1 (Pharmaceutical Administration Law) issued by Pharmaceutical and Food Examination, Pharmaceutical Additives Dictionary 2007 (edited by Japan Pharmaceutical Additives Association, Yakuji Nippo Co., Ltd.), and 8th Edition Food Additives Official Code (Japan) Those described in the Food Additives Association) etc. can be blended. Specifically, excipients, binders, disintegrants, disintegrant aids, fluidizers, lubricants, plasticizers, coating agents, sugar coating agents, brighteners, solvents, pH regulators, colorants, and flavors. One or more kinds of ingredients selected from agents, sweeteners, fragrances, flavoring agents, fragrances and the like can be blended.
賦形剤としては、アメ粉、アルファー化デンプン、イソマルト、カカオ脂、加水分解デンプン乾燥物、カラメル、カルメロース、カルメロースカルシウム、カルメロースナトリウム、含水二酸化ケイ素、含水無結晶酸化ケイ素、乾燥水酸化アルミニウムゲル、乾燥バレイショデンプン、カンゾウ末、乾燥硫酸マグネシウム、カンテン、カンテン末、寒梅粉、キシリトール、クロスカルメロースナトリウム、クロスポビドン、ケイ酸アルミン酸マグネシウム、ケイ酸カルシウム、ケイ酸マグネシウム、軽質無水ケイ酸、ケイ酸カルシウム、ケイ酸マグネシウム、軽質無水ケイ酸、ケイヒ末、結晶セルロース、結晶セルロース・カルメロースナトリウム、結晶セルロース(微粒子)、結晶セルロース(粒)、合成ケイ酸アルミニウム、合成ケイ酸アルミニウム・ヒドロキシプロピルスターチ・結晶セルロース、合成ヒドロタルサイト、コムギデンプン、米粉、コメデンプン、β―シクロデキストリン、重質無水ケイ酸、水酸化アルミナマグネシウム、水酸化アルミニウムゲル、水酸化アルミニウム・炭酸水素ナトリウム共沈物、水酸化アルミニウム・炭酸マグネシウム・炭酸カルシウム共沈物、水酸化マグネシウム、D−ソルビトール、タルク、炭酸カルシウム、炭酸マグネシウム、沈降炭酸カルシウム、低置換度カルボキシメチルスターチナトリウム、低置換度ヒドロキシプロピルセルロース、デンプングリコール酸ナトリウム、トウモロコシデンプン、トウモロコシデンプン造粒物、トレハロース水和物、二酸化ケイ素、乳糖水和物、乳糖造粒物、ノンパレル、白糖、バレイショデンプン、微結晶セルロース、ヒドロキシプロピルスターチ、ヒドロキシプロピルセルロース、ヒプロメロース(2208)、ヒプロメロース(2906)、ヒプロメロース(2910)、ヒプロメロースフタル酸エステル(200731型)、ヒプロメロースフタル酸エステル(220824型)、微粒二酸化ケイ素、部分アルファー化デンプン、プルラン、粉糖、粉末還元麦芽糖水アメ、粉末セルロース、粉末セルロース(平均重合度:800〜1100)、ポビドン(K25)、ポビドン(K30)、ポビドン(K90)、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレン硬化ヒマシ油60、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール、ポリスチレンスルホン酸ナトリウム、ポリソルベート80、ポリビニルアセタールジエチルアセトアセテート、ポリビニルアルコール・ジエチレングリコール混合物、マルチトール、マルトース水和物、D−マンニトール、D−マンニトール・クロスポビドン・D−ソルビトール・含水二酸化ケイ素混合物、無水ケイ酸水和物、無水乳糖、無水リン酸水素カルシウム、無水リン酸水素カルシウム造粒物、メタクリル酸コポリマーLD、メタケイ酸アルミン酸マグネシウム、メチルアクリレート・メタクリル酸コポリマー、メチルアクリレート・メチルメタクリレート、メチルセルロース、リン酸水素カルシウム水和物、リン酸水素カルシウム造粒物、リン酸水素ナトリウム水和物、リン酸二水素カリウム、リン酸二水素カルシウム水和物、リン酸二水素ナトリウム、及びエリスリトール等から選ばれる1種又は2種以上の成分を配合することができる。 Examines include candy flour, pregelatinized starch, isomalt, cacao butter, dried hydrolyzed starch, caramel, carmellose, carmellose calcium, carmellose sodium, hydrous silicon dioxide, water-containing non-crystalline silicon oxide, and dry aluminum hydroxide. Gel, dried potato starch, citrus powder, dried magnesium sulfate, canten, canten powder, cold plum flour, xylitol, croscarmellose sodium, crospovidone, magnesium silicate aluminate, calcium silicate, magnesium silicate, light anhydrous silicic acid, Calcium silicate, magnesium silicate, light anhydrous silicate, starch starch, crystalline cellulose, crystalline cellulose / carmellose sodium, crystalline cellulose (fine particles), crystalline cellulose (grains), synthetic aluminum silicate, synthetic aluminum silicate / hydroxypropyl silicate Starch / crystalline cellulose, synthetic hydrotalcite, wheat starch, rice flour, rice starch, β-cyclodextrin, heavy anhydrous silicic acid, alumina magnesium hydroxide, aluminum hydroxide gel, aluminum hydroxide / sodium hydrogen carbonate co-precipitate, Aluminum hydroxide / magnesium carbonate / calcium carbonate co-precipitate, magnesium hydroxide, D-sorbitol, talc, calcium carbonate, magnesium carbonate, precipitated calcium carbonate, low-substituted carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, starch glycol Sodium acid, corn starch, corn starch granules, trehalose hydrate, silicon dioxide, lactose hydrate, lactose granules, non-parel, sucrose, potato starch, microcrystalline cellulose, hydroxypropyl starch, hydroxypropyl cellulose, hypromerose (2208), Hypromellose (2906), Hypromellose (2910), Hypromellose Phthrate (Type 200331), Hypromellose Phthrate (Type 220824), Fine Silicon Dioxide, Partially Pregelatinized Starch, Pulran, Powdered Sugar, Powdered reduced starch sugar water candy, powdered cellulose, powdered cellulose (average degree of polymerization: 800 to 1100), povidone (K25), povidone (K30), povidone (K90), polyoxyethylene hydrogenated castor oil, polyoxyethylene cured castor oil 60 , Polyoxyethylene (105) Polyoxypropylene (5) Glycol, Polyoxyethylene (160) Polyoxypropylene (30) Glyco Cole, sodium polystyrene sulfonate, polysorbate 80, polyvinyl acetal diethyl acetoacetate, polyvinyl alcohol / diethylene glycol mixture, martitol, maltose hydrate, D-mannitol, D-mannitol / crospovidone / D-sorbitol / hydrous silicon dioxide mixture, Anhydrous silicate hydrate, anhydrous lactose, anhydrous calcium hydrogen phosphate granules, anhydrous calcium hydrogen phosphate granules, methacrylic acid copolymer LD, magnesium aluminometasilicate, methyl acrylate / methacrylic acid copolymer, methyl acrylate / methyl methacrylate, methyl cellulose , Calcium hydrogen phosphate hydrate, calcium hydrogen phosphate granules, sodium hydrogen phosphate hydrate, potassium dihydrogen phosphate, calcium dihydrogen phosphate hydrate, sodium dihydrogen phosphate, erythritol, etc. One or more selected ingredients can be blended.
結合剤としては、例えば、アラビアゴム、アラビアゴム末、カンテン、カンテン末、寒梅粉、結晶セルロース、コポリビドン、ゼラチン、セラック、低置換度ヒドロキシプロピルセルロース、トウモロコシデンプン、ヒドロキシエチルセルロース、ヒドロキシエチルメチルセルロース、ヒドロキシプロピルスターチ、ヒドロキシプロピルセルロース、ビニルピロリドン・酢酸ビニル共重合体、ヒプロメロース(2208)、ヒプロメロース(2906)、ヒプロメロース(2910)、ヒプロメロース酢酸エステルコハク酸エステル、ヒプロメロースフタル酸エステル(200731型)、ヒプロメロースフタル酸エステル(220824型)、フマル酸・ステアリン酸・ポリビニルアセタールジエチルアミノアセテート・ヒドロキシプロピルセルロース2910混合物、プルラン、ポビドン(K25)、ポビドン(K30)、ポビドン(K90)、ポリビニルアルコール(完全ケン化物)、ポリビニルアルコール(部分ケン化物)、ポリビニルアルコール・ポリエチレングリコール・グラフトポリマー、メタクリル酸コポリマーL、メタクリル酸コポリマーLD、メタクリル酸コポリマーS、メタクリル酸ブチル・メタクリル酸メチルコポリマー、メタケイ酸アルミン酸マグネシウム、及びメチルセルロース等から選ばれる1種又は2種以上の成分を配合することができる。 Examples of the binder include arabic rubber, arabic rubber powder, canten, canten powder, cold plum flour, crystalline cellulose, copolyvidone, gelatin, cellac, low-substituted hydroxypropyl cellulose, corn starch, hydroxyethyl cellulose, hydroxyethyl methyl cellulose, and hydroxypropyl. Starch, hydroxypropyl cellulose, vinylpyrrolidone / vinyl acetate copolymer, hypromellose (2208), hypromellose (2906), hypromellose (2910), hypromellose acetate succinate, hypromellose phthalate (type 200731), hyprome Loin phthalate (type 220824), fumaric acid, stearic acid, polyvinyl acetal diethylaminoacetate, hydroxypropyl cellulose 2910 mixture, purulan, povidone (K25), povidone (K30), povidone (K90), polyvinyl alcohol (completely saponified product) , Polyvinyl alcohol (partially saponified), polyvinyl alcohol / polyethylene glycol / graft polymer, methacrylic acid copolymer L, methacrylic acid copolymer LD, methacrylic acid copolymer S, butyl methacrylate / methyl methacrylate copolymer, magnesium aluminometasilicate, and methyl cellulose. One kind or two or more kinds of ingredients selected from the above can be blended.
崩壊剤としては、例えば、アルファー化デンプン、カルメロース、カルメロースカルシウム、カルメロースナトリウム、クロスカルメロースナトリウム、クロスポピドン、低置換度カルボキシメチルスターチナトリウム、低置換度ヒドロキシプロピルセルロース、デンプングリコール酸ナトリウム、バレイショデンプン、ヒドロキシプロピルスターチ、及び部分アルファー化デンプン等から選ばれる1種又は2種以上の成分を配合することができる。 Examples of the disintegrant include pregelatinized starch, carmellose, carmellose calcium, carmellose sodium, croscarmellose sodium, crospopidone, low-substituted carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, sodium starch glycolate, and potato. One or more components selected from starch, hydroxypropyl starch, partially pregelatinized starch and the like can be blended.
崩壊補助剤としては、例えば、カルメロース、カルメロースカルシウム、カルメロースナトリウム、クロスカルメロースナトリウム、軽質無水ケイ酸、結晶セルロース、デンプングリコール酸ナトリウム、及びヒドロキシプロピルスターチ等から選ばれる1種又は2種以上の成分を配合することができる。 As the disintegration aid, one or more selected from, for example, carmellose, carmellose calcium, carmellose sodium, croscarmellose sodium, light anhydrous silicic acid, crystalline cellulose, sodium starch glycolate, hydroxypropyl starch and the like. Ingredients can be blended.
流動化剤としては、例えば、含水二酸化ケイ素、軽質無水ケイ酸、結晶セルロース、合成ケイ酸アルミニウム、重質無水ケイ酸、水酸化アルミナマグネシウム、第三リン酸カルシウム、タルク、トウモロシデンプン、メタケイ酸アルミン酸マグネシウム、及びリン酸水素カルシウム造粒物等から選ばれる1種又は2種以上の成分を配合することができる。 Examples of the fluidizing agent include hydrous silicon dioxide, light anhydrous silicic acid, crystalline cellulose, synthetic aluminum silicate, heavy anhydrous silicic acid, magnesium hydroxide aluminate, calcium tertiary phosphate, talc, corn starch, and aluminate metasilicate. One or more components selected from magnesium, calcium hydrogen phosphate granules, and the like can be blended.
滑沢剤としては、例えば、含水二酸化ケイ素、含水無晶形酸化ケイ素、グリセリン脂肪酸エステル、ケイ酸マグネシウム、軽質無水ケイ酸、硬化油、重質無水ケイ酸、ショ糖脂肪酸エステル、ステアリルアルコール、ステアリン酸、ステアリン酸亜鉛、ステアリン酸アルミニウム、ステアリン酸カルシウム、ステアリン酸ポリオキシル40、ステアリン酸マグネシウム、ダイズ硬化油、タルク、フマル酸ステアリルナトリウム、ミツロウ、無水ケイ酸水和物、メタケイ酸アルミン酸マグネシウム、及びモノステアリン酸グリセリン等から選ばれる1種又は2種以上の成分を配合することができる。 Examples of the lubricant include hydrous silicon dioxide, hydrous amorphous silicon oxide, glycerin fatty acid ester, magnesium silicate, light anhydrous silicic acid, hardened oil, heavy anhydrous silicic acid, sucrose fatty acid ester, stearyl alcohol, and stearic acid. , Zinc stearate, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, hardened soybean oil, talc, sodium stearyl fumarate, beeswax, silicate anhydride, magnesium aluminometasilicate, and monostearate. One or more components selected from glycerin acid acid and the like can be blended.
可塑剤としては、クエン酸トリエチル、グリセリン、グリセリン脂肪酸エステル、中鎖脂肪酸トリグリセリド、トリアセチン、濃グリセリン、ヒマシ油、プロピレングリコール、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリソルベート80、マクロゴール400、マクロゴール600、マクロゴール1500、マクロゴール4000、マクロゴール6000、マクロゴール6000NF、モノステアリン酸グリセリン、リノール酸イソプロピル、及び流動パラフィン等から選ばれる1種又は2種以上の成分を配合することができる。 Plastic agents include triethyl citrate, glycerin, glycerin fatty acid ester, medium chain fatty acid triglyceride, triacetin, concentrated glycerin, castor oil, propylene glycol, polyoxyethylene (105) polyoxypropylene (5) glycol, polysorbate 80, macrogol. Mixing one or more components selected from 400, macrogol 600, macrogol 1500, macrogol 4000, macrogol 6000, macrogol 6000NF, glycerin monostearate, isopropyl linoleate, liquid paraffin, and the like. Can be done.
コーティング剤としては、アクリル酸エチル・メタクリル酸メチルコポリマー分散液、アセチルグリセリン脂肪酸エステル、アミノアルキルメタクリレートコポリマーE、アラビアゴム、アラビアゴム末、アンモニオアルキルメタクリレートコポリマー、エチルセルロース、エチルセルロース水分散液、オクチルデシルトリグリセリド、オパドライOY−6950、オパドライOY−L−28900、オパドライOY−LS−20291、オパドライOY−LS−23016、オパドライOY−S−7135、オパドライOY−S−8471、オパドライOY−S−9607、オパドライOY−S−22829、オパドライOY−S−22835、オパドライOY−S−22961、オパドライOY−S−28924、オパドライYS−1−7003白、オパドライYS−1−12524−A、オパドライYS−1−14762−A、オパドライYS−1−15585−A、オパドライYS−1−19025A、オパドライYS−2−19114−A、オパドライIIイエロー、オパドライクリアー(YS−2−19114−A)、オパドライIIグレイ85F17659、オパドライ白03K280000、オパドライピンク(02F34337)、オパドライIIピンク、オパドライIIピンク85F97191、オパドライIIブルー(85G20427)、オパドライIIベージュ85F17438、オパドライホワイト(15B180002)、オパドライホワイトOY−LS−28914、オパドライホワイトYS−1−18177−A、オパドライホワイト(YS−1−18202−A)、オパドライIIホワイト(33G28523)、オパドライIIホワイト(85F28751)、オパドライIIホワイト(OY−LS−28914)、オパドライIIライトブルー(85G20426)、オパドライIIライトベージュ85F17498、オパドライIIレッド(32K15441)、カルナウバロウ、カルメロースカルシウム、カルメロースナトリウム、含水二酸化ケイ素、乾燥水酸化アルミニウムゲル、乾燥メタクリル酸コポリマーLD、クエン酸トリエチル、グリセリン、グリセリン脂肪酸エステル、ケイ酸マグネシウム、軽質無水ケイ酸、軽質無水ケイ酸含有ヒドロキシプロピルセルロース、結晶セルロース、合成ケイ酸アルミニウム、合成ヒドロタルサイト、酸化チタン、酸化マグネシウム、ジメチルアミノエチルメタアクリレート・メチルメタアクリレートコポリマー、ショ糖脂肪酸エステル、水酸化アルミニウムゲル、ステアリルアルコール、ステアリン酸、ステアリン酸アルミニウム、ステアリン酸カルシウム、ステアリン酸ポリオキシル40、ステアリン酸マグネシウム、精製ゼラチン、精製セラック、精製白糖、ゼラチン、セラック、D−ソルビトール、D−ソルビトール液、タルク、炭酸カルシウム、炭酸マグネシウム、沈降炭酸カルシウム、低置換度ヒドロキシプロピルセルロース、濃グリセリン、白色セラック、白糖、パラフィン、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース2910・酸化チタン・マクロゴール混合物、ヒプロメロース(2208)、ヒプロメロース(2906)、ヒプロメロース(2910)、ヒプロメロース酢酸エステルコハク酸エステル、ヒプロメロースフタル酸エステル(200731型)、ヒプロメロースフタル酸エステル(220824型)、フマル酸・ステアリン酸・ポリビニルアセタールジエチルアミノアセテート・ヒドロキシプロピルメチルセルロース2910混合物、プルラン、プレミックス添加剤Opadry White、ベントナイト、ポリオキシエチレン硬化ヒマシ油40、ポリオキシエチレン硬化ヒマシ油60、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール、ポリスチレンスルホン酸ナトリウム、ポリソルベート80、ポリビニルアセタールジエチルアセトアセテート、ポリビニルアルコール(部分ケン化物)、マクロゴール300、マクロゴール400、マクロゴール600、マクロゴール1500、マクロゴール1540、マクロゴール4000、マクロゴール6000、マクロゴール6000EP、マクロゴール20000、マクロゴール35000、D−マンニトール、無水クエン酸、無水ケイ酸水和物、無水フタル酸、無水リン酸水素カルシウム、メタクリル酸コポリマーL、メタクリル酸コポリマーLD、メタクリル酸コポリマーS、メタケイ酸アルミン酸マグネシウム、メチルメタクリレート・メタアクリル酸・メチルメタアクリレートコポリマー、モノステアリン酸アルミニウム、モノステアリン酸グリセリン、モノステアリン酸ソルビタン、モノラウリン酸ソルビタン、硫酸カルシウム、及びDL−リンゴ酸等から選ばれる1種又は2種以上の成分を配合することができる。 As a coating agent, ethyl acrylate / methyl methacrylate copolymer dispersion, acetylglycerin fatty acid ester, aminoalkyl methacrylate copolymer E, arabic rubber, arabic rubber powder, ammonioalkyl methacrylate copolymer, ethyl cellulose, ethyl cellulose aqueous dispersion, octyldecyltriglyceride. , Opadry OY-6950, Opadry OY-L-28900, Opadry OY-LS-20291, Opadry OY-LS-23016, Opadry OY-S-7135, Opadry OY-S-8471, Opadry OY-S-9607, Opadry OY -S-22829, Opadry OY-S-22835, Opadry OY-S-22961, Opadry OY-S-28924, Opadry YS-1-7003 White, Opadry YS-1-122524-A, Opadry YS-1-14762- A, Opadry YS-1-15585-A, Opadry YS-1-19025A, Opadry YS-2-19114-A, Opadry II Yellow, Opadry Clear (YS-2-19114-A), Opadry II Gray 85F17659, Opadry White 03K280000, Opadry Pink (02F34337), Opadry II Pink, Opadry II Pink 85F97191, Opadry II Blue (85G20427), Opadry II Beige 85F17438, Opadry White (15B180002), Opadry White OY-LS-28914, Opadry White YS-1-1877-A, Opadry White (YS-1-18202-A), Opadry II White (33G28523), Opadry II White (85F28751), Opadry II White (OY-LS-28914), Opadry II Light Blue (85G20426), Opadry II Light Beige 85F17498, Opadry II Red (32K15441), Carnauba Row, Carmellose Calcium, Carmellose Sodium, Hydrous Silicon Dioxide, Dry Aluminum Hydroxide Gel, Dry Methacrylate Copolymer LD, Triethyl Citrate, Glycerin, Glycerin Fatty acid ester, magnesium silicate, light anhydrous silicic acid, hydroxypropyl cellulose containing light anhydrous silicic acid, crystalline cellulose, synthetic aluminum silicate, synthetic hydrotalcite, titanium oxide, magnesium oxide , Dimethylaminoethyl methacrylate / methyl methacrylate copolymer, sucrose fatty acid ester, aluminum hydroxide gel, stearyl alcohol, stearic acid, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, purified gelatin, purified cellac , Purified sucrose, gelatin, cellac, D-sorbitol, D-sorbitol solution, talc, calcium carbonate, magnesium carbonate, precipitated calcium carbonate, low substitution hydroxypropyl cellulose, concentrated glycerin, white cellac, sucrose, paraffin, hydroxypropyl cellulose, Hydroxypropyl methylcellulose 2910 / titanium oxide / macrogol mixture, hypromellose (2208), hypromellose (2906), hypromellose (2910), hypromellose acetate succinate, hypromellose phthalic acid ester (type 200731), hypromellose phthalic acid Ester (type 220824), fumaric acid / stearic acid / polyvinyl acetal diethylaminoacetate / hydroxypropylmethylcellulose 2910 mixture, purulan, premix additive Opadry White, bentonite, polyoxyethylene hydrogenated castor oil 40, polyoxyethylene hydrogenated castor oil 60, Polyoxyethylene (105) polyoxypropylene (5) glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, sodium polystyrene sulfonate, polysolvate 80, polyvinyl acetal diethyl acetoacetate, polyvinyl alcohol (partially saponified), Macrogol 300, macrogol 400, macrogol 600, macrogol 1500, macrogol 1540, macrogol 4000, macrogol 6000, macrogol 6000EP, macrogol 20000, macrogol 35000, D-mannitol, stearic acid anhydride, kei anhydride Acid hydrate, phthalic anhydride, calcium hydrogen phosphate anhydride, methacrylic acid copolymer L, methacrylic acid copolymer LD, methacrylic acid copolymer S, magnesium aluminometasilicate, methyl methacrylate / methacrylic acid / methyl methacrylate copolymer, monostearic acid Aluminum acetate, glycerin monostearate, sorbitan monostearate, sorbitan monolaurate, calcium sulfate, And one or more components selected from DL-malic acid and the like can be blended.
糖衣剤としては、アラビアゴム、アラビアゴム末、エチルセルロース、カルナウバロウ、カルメロースナトリウム、結晶セルロース、酸化チタン、ステアリン酸、ステアリン酸ポリオキシル40、精製ゼラチン、精製セラック、精製白糖、ゼラチン、セラック、タルク、沈降炭酸カルシウム、白色セラック、白糖、ヒドロキシプロピルセルロース、ヒプロメロース(2208)、ヒプロメロース(2910)、プルラン、ポビドン(K25)、ポビドン(K30)、ポビドン(K90)、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリビニルアルコール(部分ケン化物)、マクロゴール1500、マクロゴール4000、マクロゴール6000、及びD−マンニトール等から選ばれる1種又は2種以上の成分を配合することができる。 As sugar coating agents, arabic rubber, arabic rubber powder, ethyl cellulose, carnauba wax, carmellose sodium, crystalline cellulose, titanium oxide, stearic acid, polyoxyl stearate 40, purified gelatin, purified cellac, purified sucrose, gelatin, cellac, talc, sedimentation. Calcium carbonate, white cellac, sucrose, hydroxypropyl cellulose, hypromellose (2208), hypromellose (2910), purulan, povidone (K25), povidone (K30), povidone (K90), polyoxyethylene (105) polyoxypropylene (5) ) Glycol, polyvinyl alcohol (partially saponified product), macrogol 1500, macrogol 4000, macrogol 6000, D-mannitol and the like can be blended with one or more components.
光沢化剤としては、カルナウバロウ、精製セラック、マクロゴール400、マクロゴール1500、マクロゴール4000、マクロゴール6000、及びミツロウ等から選ばれる1種又は2種以上の成分を配合することができる。 As the brightener, one or more components selected from carnauba wax, purified shellac, macrogol 400, macrogol 1500, macrogol 4000, macrogol 6000, beeswax and the like can be blended.
溶剤としては、イソプロパノール、エタノール、グリセリン、1,3−ブチレングリコール、プロピレングリコール、及びマクロゴールなどから選ばれる1種又は2種以上の成分を配合することができる。 As the solvent, one or more components selected from isopropanol, ethanol, glycerin, 1,3-butylene glycol, propylene glycol, macrogol and the like can be blended.
pH調節剤としては、塩酸、酢酸、りん酸、乳酸、クエン酸、コハク酸、酒石酸、炭酸水素ナトリウム、炭酸ナトリウム、水酸化ナトリウム、水酸化カリウム、及びトリエタノールアミン等から選ばれる1種又は2種以上の成分を配合することができる。 As the pH adjuster, one or 2 selected from hydrochloric acid, acetic acid, phosphoric acid, lactic acid, citric acid, succinic acid, tartaric acid, sodium hydrogen carbonate, sodium carbonate, sodium hydroxide, potassium hydroxide, triethanolamine and the like. More than seeds can be blended.
着色剤としては、黄酸化鉄、黄色5号プレミックス、褐色酸化鉄、カーボンブラック、カラメル、β―カロテン、カンゾウエキス、黒酸化鉄、酸化チタン、三二酸化鉄、三二酸化鉄・グリセリン懸濁液、食用青色1号、食用青色2号アルミニウムレーキ、食用黄色4号、食用黄色4号アルミニウムレーキ、食用黄色5号、食用赤色2号、食用赤色3号、食用赤色102号、銅クロロフィリンナトリウム、銅クロロフィル、リボフラビン、リボフラビン酪酸エステル、リボフラビンリン酸エステルナトリウム、緑茶末、及びローズ油等から選ばれる1種又は2種以上の成分を配合することができる。 Coloring agents include yellow iron oxide, yellow No. 5 premix, brown iron oxide, carbon black, caramel, β-carotene, kanzo extract, black iron oxide, titanium oxide, iron sesquioxide, iron sesquioxide / glycerin suspension. , Edible Blue No. 1, Edible Blue No. 2 Aluminum Lake, Edible Yellow No. 4, Edible Yellow No. 4 Aluminum Lake, Edible Yellow No. 5, Edible Red No. 2, Edible Red No. 3, Edible Red No. 102, Copper Chlorophyllin Sodium, Copper One or more components selected from chlorophyll, riboflavin, riboflavin butyrate, sodium riboflavin phosphate, green tea powder, rose oil and the like can be blended.
矯味剤としては、エリスリトール、塩化ナトリウム、オウバク末、オウヒエキス、オウレン、オウレン末、オノニス根乾燥エキス、オレンジ、オレンジ油、カカオ末、果糖、カラメル、カンゾウ、カンゾウエキス、カンゾウ粗エキス、カンゾウ末、キシリトール、クエン酸カルシウム、クエン酸水和物、クエン酸ナトリウム水和物、L−グルタミン酸、L−グルタミン酸L−アルギニン、L−グルタミン酸塩酸塩、L−グルタミン酸ナトリウム、グレープフルーツエキス、黒砂糖、ケイヒチンキ、ケイヒ末、ケイヒ油、コンブ末、サッカリン、サッカリンナトリウム水和物、サフラン、サフランチンキ、サンショウチンキ、サンショウ末、酒石酸、D−酒石酸、酒石酸水素カリウム、DL−酒石酸ナトリウム、ショウキョウチンキ、ショウキョウ末、スクラロース、ステビアエキス、ステビア抽出精製物、精製カンゾウエキス末、精製白糖、センブリ、ソヨウ末、D−ソルビトール、タイソウ末、タウリン、タラクサシ根・草乾燥エキス、タンニン酸、チョウジチンキ、チョウジ油、チンピチンキ、トウガラシ、トウガラシチンキ、トウガラシ末、トウヒチンキ、トウヒ末、トレハロース水和物、ニガキ末、梅肉エキス、白糖、フラクトオリゴ糖、粉糖、ペパーミントパウダー、マルトース水和物、D−マンニトール、dl−メントール、l−メントール、メントールパウダー、リュウノウ、リュウノウ末、緑茶末、DL−リンゴ酸、DL−リンゴ酸ナトリウム、レモン油、及びローズ油等から選ばれる1種又は2種以上の成分を配合することができる。 As a flavoring agent, erythritol, sodium chloride, powdered pearl oyster, powdered pearl oyster extract, auren, powdered aulen powder, dried ononis root extract, orange, orange oil, cocoa powder, fructose, caramel, citrus fruit, citrus extract, crude citrus extract, powdered citrus fruit, xylitol. , Calcium citrate, citrate hydrate, sodium citrate hydrate, L-glutamic acid, L-arginine L-glutamate, L-glutamate, sodium L-glutamate, grapefruit extract, brown sugar, keihi tincture, keihi powder , Keihi oil, konbu powder, saccharin, saccharin sodium hydrate, saffron, saffron tincture, sansho tincture, sansho powder, tartaric acid, D-tartaric acid, potassium hydrogen tartrate, DL-sodium tartrate, gypsum tincture, ginger powder, Sclarose, Stevia extract, Stevia extract purified product, Purified citrus extract powder, Purified sucrose, Senburi, Soyo powder, D-sorbitol, Taiso powder, Taurine, Tarakusashi root / grass dried extract, Tannic acid, Choji tincture, Chouji oil, Chimpitinki, Togarashi, Togarashi tincture, Togarashi powder, Tohi tincture, Tohi powder, Trehalose hydrate, Nigaki powder, Plum extract, Sucrose, Fracto-oligosaccharide, Powdered sugar, Peppermint powder, Martose hydrate, D-mannitol, dl-menthol, l -Mentor, menthol powder, ryuno, ryuno powder, green tea powder, DL-tartaric acid, DL-sodium malate, lemon oil, rose oil and the like can be blended with one or more components selected.
甘味剤としては、アスパルテーム、アセスルファムカリウム、アマチャ、アマチャ末、還元麦芽糖水アメ、カンゾウ、カンゾウエキス、カンゾウ末、キシリトール、グリチルリチン酸二カリウム、グリチルリチン酸二ナトリウム、グリチルリチン酸モノアンモニウム、グリチルリチン酸モノカリウム、サッカリン、サッカリンナトリウム水和物、スクラロース、ステビアエキス、ステビア抽出精製物、精製白糖、精製白糖球状顆粒、白糖、粉末還元麦芽糖水アメ、マルチトール、D−マンニトール、及びエリスリトール等から選ばれる1種又は2種以上の成分を配合することができる。 Sweeteners include aspartame, acesulfam potassium, amacha, amacha powder, reduced granulated sugar candy, saccharin, saccharin extract, saccharin powder, xylitol, dipotassium glycyrrhizinate, disodium glycyrrhizinate, monoammonium glycyrrhizinate, monopotassium glycyrrhizinate, One or 2 selected from saccharin, saccharin sodium hydrate, sucralose, stevia extract, stevia extract purified product, purified sucrose, purified sucrose spherical granules, sucrose, powdered reduced granulated sugar water candy, martitol, D-mannitol, erythritol, etc. More than seeds can be blended.
香料としては、オレンジフレーバー、オレンジフレーバーパウダーSH−1171−A、オレンジミクロンH−800092、ガラナエキス、香料(スイートオレンジ)、香料(ストロベリー)、香料(レモン)、黒糖フレーバー、ストロベリーエッセンス、ストロベリーフレーバーB86173、チェリーフレーバー181612、デントミント1148J、バナナパウダーフレーバー、ピーチエッセンス、ヒノキ6E−84211、ブラックカレントフレーバー290012SYM、フルーツエッセンス、ペパーミントNAEFCOPO551957685、ペパーミントミクロンH−81550、ミックスフレーバーパウダー、メロンパウダーフレーバー、l−メントール、及びメントールL163592SYM等から選ばれる1種又は2種以上の成分を配合することができる。 As fragrances, orange flavor, orange flavor powder SH-1171-A, orange micron H-800092, galana extract, fragrance (sweet orange), fragrance (strawberry), fragrance (lemon), brown sugar flavor, strawberry essence, strawberry flavor B86173 , Cherry Flavor 181612, Dent Mint 1148J, Banana Powder Flavor, Peach Essence, Hinoki 6E-84211, Black Current Flavor 290012SYM, Fruit Essence, Peppermint NAEFCOPO551957685, Peppermint Micron H-81550, Mixed Flavor Powder, Melon Powder Flavor, And one or more components selected from Mentor L163592SYM and the like can be blended.
着香剤・香料としては、ウイキョウ末、ウイキョウ油、エチルバニリン、オレンジ、オレンジエキス、オレンジエッセンス、オレンジ油、カミツレ油、カラメル、カンゾウ末、d−カンフル、dl−カンフル、ケイヒ末、ケイヒ油、シトロネラー油、シュガーフレーバー、スペアミント油、チェリーフレーバー、チョウジ油、チリフレーバー、トウヒチンキ、トウヒ油、パインオイル、ハッカ油、バニラフレーバー、バニリン、ビターエッセンス、ビタベース、ヒマラヤスギ油、フルーツフレーバー、フレーバーG1、ヘスペリジンペパーミントエッセンス、ベルガモット油、ベルモットフレーバー、d−ボルネオール、dl−ボルネオール、マッチャ、ミックスフレーバー、ミントフレーバー、dl−メントール、l−メントール、ユーカリ油、ラベンダー油、リュウノウ、リュウノウ末、レモンパウダー、レモン油、ローズ水、ローズ油、ロート油、及びローマカミツレ油等から選ばれる1種又は2種以上の成分を配合することができる。 As flavoring agents and fragrances, uikyo powder, uikyo oil, ethyl vanillin, orange, orange extract, orange essence, orange oil, chamomile oil, caramel, kanzo powder, d-campul, dl-campul, keihi powder, keihi oil, Citronella oil, sugar flavor, spare mint oil, cherry flavor, chow oil, chili flavor, tohi tincture, touhi oil, pine oil, peppermint oil, vanilla flavor, vanillin, bitter essence, bita base, Himalayan cedar oil, fruit flavor, flavor G1, hesperidin Peppermint essence, bergamot oil, velmot flavor, d-bornole, dl-bornole, matcha, mixed flavor, mint flavor, dl-menthol, l-menthol, eucalyptus oil, lavender oil, ryunou, ryunou powder, lemon powder, lemon oil, One or more components selected from rose water, rose oil, funnel oil, Roman chamomile oil and the like can be blended.
本発明の医薬組成物の剤形としては、特に限定されるべきものではなく、例えば、カプセル剤、丸剤、顆粒剤、細粒剤、散剤、錠剤、液剤、シロップ剤、ゼリー剤、トローチ剤等の経口投与製剤や外用液剤、軟膏剤、クリーム剤、ゲルクリーム剤、パップ剤、経皮吸収型製剤、貼付剤、リニメント剤、ローション剤、坐剤、点眼剤、点鼻剤等の非経口投与製剤が挙げられる。好ましくは経口投与製剤、点鼻剤又は点眼剤であり、より好ましくは経口投与製剤であり、カプセル剤、丸剤、顆粒剤、細粒剤、散剤、錠剤等の固形製剤がさらに好ましい。なお、これらの固形製剤は、必要に応じて公知の方法により、糖衣やフィルムコーティング等により被覆されていても良い。 The dosage form of the pharmaceutical composition of the present invention is not particularly limited, and is, for example, a capsule, a pill, a granule, a fine granule, a powder, a tablet, a liquid, a syrup, a jelly, or a troche. Orally administered preparations such as, external liquid preparations, ointments, creams, gel creams, poultices, transdermal preparations, patches, liniments, lotions, suppositories, eye drops, nasal drops, etc. Dosage forms include. It is preferably an orally administered preparation, a nasal drop or an eye drop, more preferably an orally administered preparation, and a solid preparation such as a capsule, a pill, a granule, a fine granule, a powder, or a tablet is further preferable. If necessary, these solid preparations may be coated with a sugar coating, a film coating, or the like by a known method.
本発明の医薬組成物は、第17改正日本薬局方等に記載された方法に従い、上記に挙げた剤形の製剤とすることができる。例えば、本発明の医薬組成物の剤形が錠剤の場合は、日本薬局方製剤総則「錠剤」の項に準じて製造することができる。また、本発明の医薬組成物の剤形が顆粒剤の場合には、日本薬局方製剤総則「顆粒剤」の項に準じて製造することができる。なお、本発明の医薬組成物が固形製剤の場合、かかる固形製剤における、本発明で規定する成分及びその他の成分・添加物が、互いに配合禁忌等の課題により、保存安定性等に問題が生じる場合には、適宜、顆粒分け、多層化等により互いに接触しないように製剤化することができる。 The pharmaceutical composition of the present invention can be prepared in the dosage form listed above according to the method described in the 17th revised Japanese Pharmacopoeia. For example, when the dosage form of the pharmaceutical composition of the present invention is a tablet, it can be produced in accordance with the section "Tablets" in the general rules of the Japanese Pharmacopoeia. In addition, when the dosage form of the pharmaceutical composition of the present invention is a granule, it can be produced according to the section of "Granule" in the general rules of the Japanese Pharmacopoeia. When the pharmaceutical composition of the present invention is a solid preparation, the components specified in the present invention and other components / additives in the solid preparation may have problems in storage stability due to problems such as contraindications to each other. In some cases, it can be appropriately formulated so as not to come into contact with each other by granulation, multi-layering, or the like.
本発明の医薬組成物の剤形が、固形製剤の場合、SP包装、PTP包装、スティック包装、瓶包装等により一旦包装して気密保存してもよい。さらにそれらをピロー包装してもよく、それらを箱等に格納してもよい。ピロー包装に用いられる材料としては、特に限定されず、例えば、ポリプロピレンフィルム、ポリエチレンテレフタレートフィルム、ポリエチレンフィルム等の樹脂フィルムやこれらの樹脂フィルムにアルミ箔を付着させたものを用いることができる。なお、吸湿性が懸念される場合には、乾燥剤等を瓶包装内やピロー包装内に同時に保存してもよい。 When the dosage form of the pharmaceutical composition of the present invention is a solid preparation, it may be once packaged in SP packaging, PTP packaging, stick packaging, bottle packaging or the like and stored in an airtight manner. Further, they may be pillow-wrapped, or they may be stored in a box or the like. The material used for pillow packaging is not particularly limited, and for example, a resin film such as a polypropylene film, a polyethylene terephthalate film, or a polyethylene film, or a resin film to which an aluminum foil is attached can be used. If hygroscopicity is a concern, a desiccant or the like may be stored in a bottle package or a pillow package at the same time.
本発明の医薬組成物は、抗炎症用として投与することができる。抗炎症用医薬組成物が適用される疾患としては、かぜ、鼻炎、湿疹、蕁麻疹、扁桃炎、咽喉頭炎、痔疾患、口内炎、及びこれらの疾患に伴う諸症状の緩和等が挙げられる。すなわち、かぜ薬、鼻炎(アレルギー性鼻炎、副鼻腔炎など)時における点鼻薬、虫さされ、痒み止め、皮膚炎用の予防及び/又は治療薬、水虫・たむし用薬ならびに痔疾患時の痒み等の症状に対する予防及び/又は治療薬、及びのどの炎症によるのどのあれや痛み等の予防及び/又は治療薬等として使用することができる。 The pharmaceutical composition of the present invention can be administered for anti-inflammatory purposes. Diseases to which the anti-inflammatory pharmaceutical composition is applied include cold, rhinitis, eczema, urticaria, tonsillitis, throat inflammation, hemorrhoids, stomatitis, and alleviation of various symptoms associated with these diseases. That is, cold medicine, nasal drops during rhinitis (allergic rhinitis, sinusitis, etc.), insect bites, itching prevention, preventive and / or therapeutic agents for dermatitis, water bug / swelling agents, and itching during hemorrhage disease. It can be used as a prophylactic and / or therapeutic agent for symptoms such as, and as a prophylactic and / or therapeutic agent for throat and pain caused by inflammation of the throat.
本発明の医薬組成物は、かぜの諸症状(発熱、悪寒、頭痛、のどの痛み、鼻水、鼻づまり、せき、たん、関節の痛み、筋肉の痛み、くしゃみ)を緩和するために投与することができる。 The pharmaceutical composition of the present invention should be administered to relieve various cold symptoms (fever, chills, headache, sore throat, runny nose, stuffy nose, cough, tan, joint pain, muscle pain, sneezing). Can be done.
さらに本発明の医薬組成物は、鼻炎の予防又は治療のために投与することができ、特に急性鼻炎、アレルギー性鼻炎又は副鼻腔炎による諸症状(鼻水、鼻づまり、くしゃみ)の緩和のために投与することができる。 Furthermore, the pharmaceutical composition of the present invention can be administered for the prevention or treatment of rhinitis, especially for the relief of various symptoms (snot, stuffy nose, sneezing) due to acute rhinitis, allergic rhinitis or sinusitis. Can be administered.
さらに本発明の医薬組成物は、皮膚炎の予防及び/又は治療のために投与することができ、特に皮膚のかゆみ、湿疹、じんましん、皮膚炎、かぶれの予防及び/又は治療のために投与することができる。 Further, the pharmaceutical composition of the present invention can be administered for the prevention and / or treatment of dermatitis, particularly for the prevention and / or treatment of itching, eczema, urticaria, dermatitis and rash on the skin. be able to.
以下、実施例及び製造例を示すが、本発明は下記の例に制限されるものではない。 Examples and production examples will be shown below, but the present invention is not limited to the following examples.
(試験例)ラットを用いたブラジキニン‐プラスミン足浮腫に対する抗炎症試験
1−1.被験物質及び起炎用試薬
本試験において、メチルセルロースは信越化学工業(株)製のものを、オロパタジン塩酸塩(以下、オロパタジン)はTORONTO RESEARCH CHEMICALSINC社製のものを、無水カフェイン(以下、カフェイン)は株式会社静岡カフェイン工業所製のものを、フェニレフリン塩酸塩(以下、フェニレフリン)は和光純薬工業(株)製のものを、dl−メチルエフェドリン塩酸塩(以下、メチルエフェドリン)はアルプス薬品工業(株)製のものを使用した。また、ブラジキニンは和光純薬工業(株)のものを、Human Plasmin(以下、プラスミン)はHaemagtologic Technology Inc社製のものを使用した。各検体は、各被験物質を秤量し、0.5%メチルセルロース水溶液に希釈又は懸濁して調製した。
(Test example) Anti-inflammatory test for bradykinin-plasmin foot edema using rats 1-1. Test substance and reagent for inflammation In this test, methylcellulose was manufactured by Shin-Etsu Chemical Industry Co., Ltd., and olopatadine hydrochloride (hereinafter, olopatadine) was manufactured by TORONTO RESEARCH CHEMICALINC, and anhydrous caffeine (hereinafter, caffeine). ) Is manufactured by Shizuoka Caffeine Industry Co., Ltd., phenylephrine hydrochloride (hereinafter, phenylephrine) is manufactured by Wako Pure Chemical Industries, Ltd., and dl-methylephedrine hydrochloride (hereinafter, methylephedrine) is Alps Pharmaceuticals. The one manufactured by Kogyo Co., Ltd. was used. Bradykinin used was manufactured by Wako Pure Chemical Industries, Ltd., and Human Plasmin (hereinafter referred to as plasmin) used was manufactured by Haemagtologic Technology Inc. Each sample was prepared by weighing each test substance and diluting or suspending it in a 0.5% aqueous solution of methyl cellulose.
(検体)
0群:媒体(0.5%メチルセルロース) ※起炎対照群
1群:オロパタジン0.1mg/kg
2群:カフェイン150mg/kg
3群:フェニレフリン30mg/kg
4群:メチルエフェドリン110mg/kg
5群:オロパタジン0.1mg/kg+カフェイン150mg/kg
6群:オロパタジン0.1mg/kg+フェニレフリン30mg/kg
7群:オロパタジン0.1mg/kg+カフェイン150mg/kg+フェニレフリン30mg/kg
8群:オロパタジン0.1mg/kg+カフェイン150mg/kg+メチルエフェドリン110mg/kg
(Sample)
Group 0: Medium (0.5% methylcellulose) * Inflammation control group 1: Olopatadine 0.1 mg / kg
Group 2: Caffeine 150 mg / kg
Group 3: Phenylephrine 30 mg / kg
Group 4: Methylephedrine 110 mg / kg
Group 5: Olopatadine 0.1 mg / kg + caffeine 150 mg / kg
Group 6: Olopatadine 0.1 mg / kg + phenylephrine 30 mg / kg
Group 7: Olopatadine 0.1 mg / kg + caffeine 150 mg / kg + phenylephrine 30 mg / kg
Group 8: Olopatadine 0.1 mg / kg + caffeine 150 mg / kg + methylephedrine 110 mg / kg
(起炎剤)
ブラジキニン1mg及びプラスミン0.5Uを生理食塩液に溶解し20mLとした。
(Flame agent)
1 mg of bradykinin and 0.5 U of plasmin were dissolved in physiological saline to make 20 mL.
1−2.試験方法
5週齢のCrij:WI系雄性ラット(日本チャールスリバー(株))に5日間の検疫期間を設け、その後2〜4日間馴化させた。馴化後に体重測定結果を用いて群分け(1群5匹)を行い、ゾンデを用いて被験物質を経口投与した。30分後、右側後肢足蹠に、起炎剤としてブラジキニン‐プラスミン溶液0.1mlを皮下注射し、炎症を惹起させた。個体ごとに群分け前及び起炎後60分の足蹠容積を測定し、後述する数式を用いて浮腫率、曲線下面積及び抑制率を算出した。
1-2. Test method A 5-week-old Crij: WI male rat (Charles River Laboratories, Japan) was provided with a 5-day quarantine period and then acclimatized for 2 to 4 days. After acclimation, grouping was performed using the weight measurement results (5 animals per group), and the test substance was orally administered using a sonde. Thirty minutes later, 0.1 ml of a bradykinin-plasmin solution was subcutaneously injected into the plantar of the right hind limb as an inflaming agent to induce inflammation. The footpad volume before grouping and 60 minutes after the onset of inflammation was measured for each individual, and the edema rate, area under the curve, and suppression rate were calculated using the mathematical formulas described later.
1−3.足蹠容積の測定及び浮腫率、曲線下面積(AUC)及び抑制率の算出
群分け前、起炎後、15、30、45、60分に、マウス・ラット後肢足蹠浮腫容積測定装置(TK−101CMP、(有)ユニコム社製)を用いて右側後肢足蹠容積(mL)を測定した。個体ごとに群分け前の足蹠容積と各測定時間における足蹠容積の値から、以下の数式を用いて浮腫率を算出した。
1-3. Measurement of footpad volume and calculation of edema rate, area under the curve (AUC) and suppression rate Before grouping, after inflammation, 15, 30, 45, 60 minutes, mouse / rat hindlimb footpad edema volume measuring device (TK- The right hind limb footpad volume (mL) was measured using 101 CMP (manufactured by Unicom). The edema rate was calculated from the footpad volume before grouping and the footpad volume at each measurement time for each individual using the following formula.
さらに、個体ごとに、各時間の浮腫率から以下の数式を用いて曲面下面積(AUC0−1hr)を算出した。 Further, for each individual, the area under the curved surface (AUC 0-1hr ) was calculated from the edema rate at each time using the following mathematical formula.
a:起炎後15分の浮腫率
b:起炎後30分の浮腫率
c:起炎後45分の浮腫率
d:起炎後60分の浮腫率
a: Edema rate 15 minutes after onset b: Edema rate 30 minutes after onset c: Edema rate 45 minutes after onset d: Edema rate 60 minutes after onset
さらに、起炎対照群(0群)のAUC0−1hrの値と、各薬剤群(1〜8群)のAUC0−1hrの値から、以下の数式を用いて各薬剤群の抑制率を算出した。 Furthermore, the value of AUC 0-1Hr of pathogenic control group (group 0), the value of AUC 0-1Hr of each drug group (1-8 groups), using the following formula inhibition rate of each drug group Calculated.
2.試験結果
試験結果を表1に示す。
表1において、オロパタジンとカフェインとフェニレフリンを併用した7群は、各々単独投与(1〜3群)と比較して、浮腫の抑制率が著しく改善し、高い抗炎症作用が確認された。また、フェニレフリンの単独群に比べ、オロパタジンとフェニレフリンを併用した6群は、浮腫の抑制率が減弱したが、オロパタジン及びフェニレフリンにカフェインを併用した7群は、浮腫の抑制率が著しく改善し、高い抗炎症作用が確認された。 In Table 1, in the 7 groups in which olopatadine, caffeine and phenylephrine were used in combination, the suppression rate of edema was significantly improved and a high anti-inflammatory effect was confirmed as compared with the single administration (groups 1 to 3). In addition, the edema suppression rate was weakened in the 6 groups using olopatadine and phenylephrine as compared with the phenylephrine alone group, but the edema suppression rate was significantly improved in the 7 groups using olopatadine and phenylephrine combined with caffeine. A high anti-inflammatory effect was confirmed.
また、オロパタジンとカフェインとメチルエフェドリンを併用した8群の浮腫抑制率は、各々単独投与(1,2,4群)の相加効果及びオロパタジンとカフェインを併用した5群の効果を上回り、高い抗炎症作用が確認された。 In addition, the edema suppression rate of the 8 groups using olopatadine, caffeine and methylephedrine exceeded the additive effect of single administration (groups 1, 2 and 4) and the effect of the combined use of olopatadine and caffeine, respectively. A high anti-inflammatory effect was confirmed.
以下に製造例を示す。なお、数値は、製剤に含まれる成分の1日あたりの配合量を示す。
(製造例1)
下記成分を用いて、日本薬局方製剤総則「錠剤」の項に準じて製造し、錠剤とする。
オロパタジン塩酸塩 10mg
dl-メチルエフェドリン塩酸塩 60mg
無水カフェイン 60mg
結晶セルロース 適量
カルメロースカルシウム 15mg
ヒドロキシプロピルセルロース 8mg
ステアリン酸マグネシウム 微量
ヒプロメロース 35mg
マクロゴール 10mg
酸化チタン 15mg
A manufacturing example is shown below. The numerical value indicates the amount of the component contained in the preparation per day.
(Manufacturing Example 1)
Using the following ingredients, manufacture in accordance with the "Tablets" section of the Japanese Pharmacopoeia General Regulations for Preparation to make tablets.
Olopatadine hydrochloride 10 mg
dl-methylephedrine hydrochloride 60 mg
Anhydrous caffeine 60 mg
Crystalline Cellulose Appropriate amount Carmellose Calcium 15mg
Hydroxypropyl cellulose 8 mg
Magnesium stearate trace amount hypromellose 35 mg
Macrogol 10 mg
Titanium oxide 15 mg
(製剤例2)
下記成分を用いて、ステアリン酸マグネシウム以外の成分を混合した後、造粒して顆粒を製造した。さらに該顆粒にステアリン酸マグネシウムを加えて硬カプセルに封入し、カプセル剤を製造する。
プソイドエフェドリン塩酸塩 120mg
フェニレフリン塩酸塩 10mg
オロパタジン塩酸塩 10mg
無水カフェイン 100mg
トウモロコシデンプン 適量
乳糖 適量
結晶セルロース 適量
カルメロースカルシウム 15mg
ヒドロキシプロピルセルロース 9mg
ステアリン酸マグネシウム 微量
(Formulation Example 2)
Granules were produced by mixing components other than magnesium stearate using the following components and then granulating. Further, magnesium stearate is added to the granules and encapsulated in a hard capsule to produce a capsule.
Pseudoephedrine hydrochloride 120 mg
Phenylephrine hydrochloride 10 mg
Olopatadine hydrochloride 10 mg
Anhydrous caffeine 100 mg
Corn Starch Appropriate amount Lactose Appropriate amount Crystalline cellulose Appropriate amount Carmellose Calcium 15 mg
Hydroxypropyl cellulose 9 mg
Magnesium stearate trace amount
(製剤例3)
下記成分を用いて、日本薬局方製剤総則「顆粒剤」の項に準じて製造し、顆粒剤とする。
トラネキサム酸 420mg
dl-メチルエフェドリン塩酸塩 10mg
オロパタジン塩酸塩 10mg
無水カフェイン 100mg
トウモロコシデンプン 適量
D-マンニトール 適量
結晶セルロース 適量
クロスポピドン 10mg
ヒドロキシプロピルセルロース 適量
(Formulation Example 3)
Using the following ingredients, manufacture in accordance with the section "Granule" in the general rules of the Japanese Pharmacopoeia, and use it as a granule.
Tranexamic acid 420 mg
dl-Methylephedrine hydrochloride 10 mg
Olopatadine hydrochloride 10 mg
Anhydrous caffeine 100 mg
Appropriate amount of corn starch
D-mannitol Appropriate amount Crystalline cellulose Appropriate amount Crospopidone 10 mg
Hydroxypropyl cellulose suitable amount
(製造例4)
下記成分を用いて、日本薬局方製剤総則「錠剤」の項に準じて製造し、フィルムコーティング錠とする。
イブプロフェン 600mg
オロパタジン塩酸塩 10mg
ジヒドロコデインリン酸塩 24mg
dl-メチルエフェドリン塩酸塩 60mg
ブロムヘキシン塩酸塩 12mg
ベラドンナ総アルカロイド 0.3mg
無水カフェイン 60mg
ベンフォチアミン 24mg
結晶セルロース 適量
カルメロースカルシウム 20mg
ヒドロキシプロピルセルロース 15mg
ステアリン酸マグネシウム 微量
ヒプロメロース 30mg
マクロゴール 5mg
酸化チタン 10mg
カルナウバロウ 微量
(Manufacturing Example 4)
Manufactured in accordance with the "Tablets" section of the Japanese Pharmacopoeia General Regulations, using the following ingredients, and made into film-coated tablets.
Ibuprofen 600 mg
Olopatadine hydrochloride 10 mg
Dihydrocodeine Phosphate 24 mg
dl-methylephedrine hydrochloride 60 mg
Bromhexine hydrochloride 12 mg
Belladonna total alkaloids 0.3 mg
Anhydrous caffeine 60 mg
Benfotiamine 24 mg
Crystalline Cellulose Appropriate amount Carmellose Calcium 20mg
Hydroxypropyl cellulose 15 mg
Magnesium stearate trace amount hypromellose 30 mg
Macrogol 5 mg
Titanium oxide 10 mg
Carnauba wax trace amount
(製剤例5)
下記成分を用いて、ステアリン酸マグネシウム以外の成分を混合した後、造粒して顆粒を製造した。さらに該顆粒にステアリン酸マグネシウムを加えて硬カプセルに封入し、カプセル剤を製造する。
プソイドエフェドリン塩酸塩 120mg
フェニレフリン塩酸塩 10mg
オロパタジン塩酸塩 10mg
トラネキサム酸 420mg
グリチルリチン酸 45mg
無水カフェイン 100mg
ベンフォチアミン 24mg
トウモロコシデンプン 適量
乳糖 適量
結晶セルロース 適量
カルメロースカルシウム 10mg
ヒドロキシプロピルセルロース 20mg
ステアリン酸マグネシウム 微量
(Formulation Example 5)
Granules were produced by mixing components other than magnesium stearate using the following components and then granulating. Further, magnesium stearate is added to the granules and encapsulated in a hard capsule to produce a capsule.
Pseudoephedrine hydrochloride 120 mg
Phenylephrine hydrochloride 10 mg
Olopatadine hydrochloride 10 mg
Tranexamic acid 420 mg
Glycyrrhizic acid 45 mg
Anhydrous caffeine 100 mg
Benfotiamine 24 mg
Corn starch Appropriate amount Lactose Appropriate amount Crystalline cellulose Appropriate amount Carmellose calcium 10 mg
Hydroxypropyl cellulose 20 mg
Magnesium stearate trace amount
(製造例6)
下記成分を用いて、日本薬局方製剤総則「錠剤」の項に準じて製造し、フィルムコーティング錠とする。
ロキソプロフェン 180mg
トラネキサム酸 750mg
オロパタジン塩酸塩 10mg
デキストロメトルファン臭化水素酸塩水和物 48mg
dl-メチルエフェドリン塩酸塩 60mg
ブロムヘキシン塩酸塩 12mg
グリチルリチン酸 39mg
無水カフェイン 60mg
ベンフォチアミン 24mg
結晶セルロース 適量
カルメロースカルシウム 30mg
ヒドロキシプロピルセルロース 20mg
ステアリン酸マグネシウム 微量
ヒプロメロース 20mg
マクロゴール 10mg
酸化チタン 6mg
カルナウバロウ 微量
(Manufacturing Example 6)
Manufactured in accordance with the "Tablets" section of the Japanese Pharmacopoeia General Regulations, using the following ingredients, and made into film-coated tablets.
Loxoprofen 180 mg
Tranexamic acid 750 mg
Olopatadine hydrochloride 10 mg
Dextromethorphan hydrobromide hydrate 48 mg
dl-methylephedrine hydrochloride 60 mg
Bromhexine hydrochloride 12 mg
Glycyrrhizic acid 39 mg
Anhydrous caffeine 60 mg
Benfotiamine 24 mg
Crystalline Cellulose Appropriate amount Carmellose calcium 30 mg
Hydroxypropyl cellulose 20 mg
Magnesium stearate trace amount hypromellose 20 mg
Macrogol 10 mg
Titanium oxide 6 mg
Carnauba wax trace amount
(製造例7)
下記成分を用いて、日本薬局方製剤総則「錠剤」の項に準じて製造し、フィルムコーティング錠とする。
アセトアミノフェン 900mg
エテンザミド 750mg
トラネキサム酸 750mg
オロパタジン塩酸塩 10mg
ノスカピン 48mg
dl-メチルエフェドリン塩酸塩 60mg
アンブロキソール塩酸塩 12mg
無水カフェイン 60mg
ベンフォチアミン 24mg
結晶セルロース 適量
トウモロコシデンプン 適量
低置換度ヒドロキシプロピルセルロース 15mg
ポリビニルアルコール 5mg
ステアリン酸マグネシウム 適量
(Manufacturing Example 7)
Manufactured in accordance with the "Tablets" section of the Japanese Pharmacopoeia General Regulations, using the following ingredients, and made into film-coated tablets.
Acetaminophen 900 mg
Ethenzamide 750 mg
Tranexamic acid 750 mg
Olopatadine hydrochloride 10 mg
Noscapine 48 mg
dl-methylephedrine hydrochloride 60 mg
Ambroxol hydrochloride 12 mg
Anhydrous caffeine 60 mg
Benfotiamine 24 mg
Crystalline Cellulose Appropriate amount Corn starch Appropriate amount Low substitution degree Hydroxypropyl cellulose 15 mg
Polyvinyl alcohol 5 mg
Magnesium stearate suitable amount
Claims (10)
(b)カフェイン;及び
(c)エフェドリン又はその誘導体又はそれらの塩、及びフェニレフリン又はその塩から選ばれる1種又は2種以上;
を含有する医薬組成物。 (A) Olopatadine or a salt thereof;
(B) Caffeine; and (c) Ephedrine or a derivative thereof or a salt thereof, and one or more selected from phenylephrine or a salt thereof;
A pharmaceutical composition containing.
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