JP2023072015A - Loxoprofen-containing expectorant pharmaceutical composition - Google Patents
Loxoprofen-containing expectorant pharmaceutical composition Download PDFInfo
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- JP2023072015A JP2023072015A JP2023038234A JP2023038234A JP2023072015A JP 2023072015 A JP2023072015 A JP 2023072015A JP 2023038234 A JP2023038234 A JP 2023038234A JP 2023038234 A JP2023038234 A JP 2023038234A JP 2023072015 A JP2023072015 A JP 2023072015A
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- JP
- Japan
- Prior art keywords
- hydrochloride
- expectorant
- loxoprofen
- pharmaceutical composition
- daily dose
- 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.)
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- 230000003419 expectorant effect Effects 0.000 title claims abstract description 83
- 239000003172 expectorant agent Substances 0.000 title claims abstract description 78
- 229960002373 loxoprofen Drugs 0.000 title claims abstract description 63
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 45
- YMBXTVYHTMGZDW-UHFFFAOYSA-N loxoprofen Chemical compound C1=CC(C(C(O)=O)C)=CC=C1CC1C(=O)CCC1 YMBXTVYHTMGZDW-UHFFFAOYSA-N 0.000 title 1
- BAZQYVYVKYOAGO-UHFFFAOYSA-M loxoprofen sodium hydrate Chemical compound O.O.[Na+].C1=CC(C(C([O-])=O)C)=CC=C1CC1C(=O)CCC1 BAZQYVYVKYOAGO-UHFFFAOYSA-M 0.000 claims abstract description 58
- 150000003839 salts Chemical class 0.000 claims abstract description 54
- -1 loxoprofen sodium anhydride Chemical class 0.000 claims abstract description 16
- HSRJKNPTNIJEKV-UHFFFAOYSA-N Guaifenesin Chemical compound COC1=CC=CC=C1OCC(O)CO HSRJKNPTNIJEKV-UHFFFAOYSA-N 0.000 claims description 15
- 229960002146 guaifenesin Drugs 0.000 claims description 15
- NTCYWJCEOILKNG-ROLPUNSJSA-N [(1r,2s)-1-hydroxy-1-phenylpropan-2-yl]-dimethylazanium;chloride Chemical compound Cl.CN(C)[C@@H](C)[C@H](O)C1=CC=CC=C1 NTCYWJCEOILKNG-ROLPUNSJSA-N 0.000 claims description 10
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Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
本発明は、ロキソプロフェン又はその塩を含有する去痰医薬組成物に関する。 The present invention relates to an expectorant pharmaceutical composition containing loxoprofen or a salt thereof.
ロキソプロフェンナトリウムは、非ステロイド性消炎鎮痛剤（ＮＳＡＩＤ）の一種であり、関節リウマチ、変形性関節症、腰痛症、肩関節周囲炎、頸肩腕症候群、歯痛、急性上気道炎、手術後・外傷後・抜歯後等の消炎・鎮痛・解熱に有効なものとして知られている（非特許文献１）。 Loxoprofen sodium is a type of non-steroidal anti-inflammatory analgesic (NSAID) and is used for rheumatoid arthritis, osteoarthritis, low back pain, shoulder periarthritis, cervico-omo-brachial syndrome, toothache, acute upper respiratory tract inflammation, after surgery and after trauma.・It is known to be effective for anti-inflammatory, pain relief, and antipyretic after tooth extraction (Non-Patent Document 1).
我が国においては、近年、セルフメディケーションを一層促進すべく、ロキソプロフェンナトリウム単味成分の「解熱鎮痛薬」がスイッチＯＴＣ医薬品として上市された。セルフメディケーションの促進は、医療費抑制の観点からも、今後より一層注目されていくと考えられている。 In recent years, in order to further promote self-medication in Japan, an “antipyretic analgesic” consisting of loxoprofen sodium alone has been marketed as a switch OTC drug. The promotion of self-medication is expected to attract more attention in the future, also from the viewpoint of curbing medical expenses.
ところで、ＯＴＣ医薬品は、いわゆる一般の人が、薬剤師等から提供された適切な情報に基づいて、自らの判断・責任で購入・使用する医薬品である。そのため、ＯＴＣ医薬品には副作用の心配が少ないことが求められる。例えば、ロキソプロフェンナトリウムは、イブプロフェン等の他のＮＳＡＩＤに比べ、副作用としての消化管障害が生じにくいとされているが、ロキソプロフェンに消化管障害の虞が全くないというわけではなく、ロキソプロフェンに起因する消化管障害を軽減させる方策も種々検討されている（特許文献１～５等）。 By the way, OTC drugs are drugs that the general public purchases and uses on their own judgment and responsibility based on appropriate information provided by pharmacists and the like. Therefore, OTC drugs are required to have less side effects. For example, loxoprofen sodium is less likely to cause gastrointestinal disorders as a side effect than other NSAIDs such as ibuprofen. Various measures for reducing tube failure have also been studied (Patent Documents 1 to 5, etc.).
また、ロキソプロフェンナトリウムを含有する配合剤をＯＴＣ医薬品とするために種々の検討がなされ、去痰成分等との組み合わせが知られている。例えば、アンブロキソール又はブロムヘキシンを組み合わせた咳嗽症状の除去・軽減組成物（特許文献６）や杯細胞過形成抑制医薬組成物（特許文献７）、エフェドリン類を組み合わせたくしゃみ抑制用医薬（特許文献８）や杯細胞過形成抑制医薬組成物（特許文献９）等が知られている。 In addition, various studies have been made to make combination drugs containing loxoprofen sodium into OTC drugs, and combinations with expectorant components and the like are known. For example, a composition for removing or alleviating cough symptoms combined with ambroxol or bromhexine (Patent Document 6), a pharmaceutical composition for suppressing goblet cell hyperplasia (Patent Document 7), a medicine for suppressing sneezing combined with ephedrine (Patent Document 8) and a pharmaceutical composition for suppressing goblet cell hyperplasia (Patent Document 9).
上記のような背景の下、ＯＴＣ医薬品を指向した開発をするにあたり、ロキソプロフェン又はその塩の副作用軽減等も視野に入れつつ本発明者が種々の検討していたところ、ロキソプロフェン又はその塩を、１日量としてロキソプロフェンナトリウム無水物換算で１８０ｍｇとともに、１日最大分量の去痰成分を併用した場合であっても、去痰作用について改善の余地があることが判明した。
したがって、本発明の課題は、ロキソプロフェン又はその塩を含有し、優れた去痰作用を示す去痰医薬組成物を提供することにある。
Under the above background, in developing OTC drugs, the present inventors have conducted various studies with a view to reducing the side effects of loxoprofen or its salts, and have found that loxoprofen or its salts are It was found that there is room for improvement in the expectorant action even when the daily dose of 180 mg in terms of loxoprofen sodium anhydrate is used in combination with the maximum daily dose of an expectorant component.
Accordingly, an object of the present invention is to provide an expectorant pharmaceutical composition containing loxoprofen or a salt thereof and exhibiting excellent expectorant action.
そこで、本発明者は、鋭意検討した結果、ロキソプロフェン又はその塩を、１日量として、ロキソプロフェンナトリウム無水物換算で６０ｍｇ超１２０ｍｇ以下の用量と、去痰成分とを併用した場合には、意外にも、ロキソプロフェン又はその塩を、１日量としてロキソプロフェンナトリウム無水物換算で１８０ｍｇの用量と去痰成分を１日最大分量で併用した場合よりも優れた去痰作用が得られることを見出し、本発明を完成した。
また、ロキソプロフェン又はその塩を、１回量として、ロキソプロフェンナトリウム無水物換算で６０ｍｇの用量と、去痰成分を、１回量として、１日最大分量の１／６以上１／３以下の用量とを併用し、１日２回服用すると、良好な去痰作用が得られることを見出し、本発明を完成した。
また、ロキソプロフェン又はその塩と去痰成分の組み合わせを１日に２回服用した場合に、優れた去痰作用が得られることを見出し、本発明を完成した。
Therefore, as a result of intensive studies, the present inventors found that when loxoprofen or a salt thereof is used in a daily dose of more than 60 mg but not more than 120 mg in terms of loxoprofen sodium anhydrate, and an expectorant component is used in combination, unexpectedly, , loxoprofen or a salt thereof, and a daily dose of 180 mg in terms of loxoprofen sodium anhydrate, combined with the maximum daily dose of an expectorant component, have found that a superior expectorant action can be obtained, thereby completing the present invention. .
In addition, loxoprofen or a salt thereof at a dose of 60 mg in terms of loxoprofen sodium anhydrate as a single dose, and an expectorant component at a dose of 1/6 or more and 1/3 or less of the maximum daily dose as a single dose. The inventors have found that a good expectorant action can be obtained by taking them twice a day, and completed the present invention.
In addition, the present inventors have found that a combination of loxoprofen or a salt thereof and an expectorant component taken twice a day provides an excellent expectorant effect, and completed the present invention.
すなわち、本発明は、（１）（Ａ）ロキソプロフェン又はその塩を、１日量として、ロキソプロフェンナトリウム無水物換算で６０ｍｇ超１２０ｍｇ以下と、（Ｂ）去痰成分とを含有する医薬組成物（以下、去痰医薬組成物（１）ともいう）を提供するものである。 That is, the present invention provides (1) a pharmaceutical composition containing (A) loxoprofen or a salt thereof in a daily dose of more than 60 mg but not more than 120 mg in terms of loxoprofen sodium anhydrate, and (B) an expectorant component (hereinafter referred to as An expectorant pharmaceutical composition (1) is provided.
また、本発明は、（２）１日２回服用するものであって、ロキソプロフェン又はその塩を、１回量として、ロキソプロフェンナトリウム無水物換算で６０ｍｇと、去痰成分を、１回量として、１日最大分量の１／６以上１／３以下含有する医薬組成物（以下、去痰医薬組成物（２）ともいう）を提供するものである。 In addition, the present invention (2) is to be taken twice a day, and the amount of loxoprofen or a salt thereof is 60 mg in terms of loxoprofen sodium anhydride, and the expectorant component is 1 A pharmaceutical composition containing ⅙ or more and ⅓ or less of the maximum daily dose (hereinafter also referred to as an expectorant pharmaceutical composition (2)) is provided.
更に、本発明は、（３）ロキソプロフェン又はその塩と去痰成分とを含有し、１日に２回服用するものである医薬組成物（以下、去痰医薬組成物（３）ともいう）を提供するものである。 Furthermore, the present invention provides (3) a pharmaceutical composition containing loxoprofen or a salt thereof and an expectorant component and taken twice a day (hereinafter also referred to as an expectorant pharmaceutical composition (3)). It is a thing.
更に、本発明は、（４）ロキソプロフェン又はその塩を有効成分とし、去痰成分を含む医薬組成物中、１日量として、ロキソプロフェンナトリウム無水物換算で６０ｍｇ超１２０ｍｇ以下の含有量で使用される、去痰作用改善剤を提供するものである。 Furthermore, the present invention provides (4) a pharmaceutical composition containing loxoprofen or a salt thereof as an active ingredient and containing an expectorant component at a daily dose of more than 60 mg and not more than 120 mg in terms of loxoprofen sodium anhydrate. To provide an expectorant action improving agent.
本発明の去痰医薬組成物は優れた去痰効果を示す。 The expectorant pharmaceutical composition of the present invention exhibits excellent expectorant effect.
まず、上記去痰医薬組成物（１）について詳細に説明する。
（ロキソプロフェン又はその塩）
本発明において、「ロキソプロフェン又はその塩」には、ロキソプロフェンそのもののほか、ロキソプロフェンの薬学上許容される塩、さらにはロキソプロフェンやその薬学上許容される塩と水やアルコール等との溶媒和物も含まれる。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。本発明において、ロキソプロフェン又はその塩としては、ロキソプロフェンナトリウム水和物（化学名： Monosodium 2-[4-[(2-oxocyclopentyl)methyl]phenyl]propanoate dihydrate）が好ましい。
First, the expectorant pharmaceutical composition (1) will be described in detail.
(Loxoprofen or its salt)
In the present invention, "loxoprofen or a salt thereof" includes loxoprofen itself, a pharmaceutically acceptable salt of loxoprofen, and a solvate of loxoprofen or a pharmaceutically acceptable salt thereof with water, alcohol, or the like. be These are known compounds and can be produced by known methods, or commercially available ones can be used. In the present invention, loxoprofen or a salt thereof is preferably loxoprofen sodium hydrate (chemical name: Monosodium 2-[4-[(2-oxocyclopentyl)methyl]phenyl]propanoate dihydrate).
本発明の去痰医薬組成物（１）におけるロキソプロフェン又はその塩の含有量は、１日量（１日の服用量）として、ロキソプロフェンナトリウム無水物換算で６０ｍｇ超１２０ｍｇ以下であり、好ましくは１２０ｍｇである。
また、１回量（１回の服用量）として、ロキソプロフェン又はその塩を、ロキソプロフェンナトリウム無水物換算で６０ｍｇ含有するものが好ましい。
The content of loxoprofen or a salt thereof in the expectorant pharmaceutical composition (1) of the present invention is more than 60 mg and not more than 120 mg, preferably 120 mg, in terms of loxoprofen sodium anhydrous as a daily dose (daily dose). .
Moreover, as a single dose (one dose), one containing 60 mg of loxoprofen or a salt thereof in terms of loxoprofen sodium anhydride is preferable.
（去痰成分）
本発明において、去痰成分は、去痰作用を示すものであれば特に限定されるものではないが、例えば、チペピジン又はその塩、メチルエフェドリン又はその塩、グアヤコールスルホン酸又はその塩、グアイフェネシン又はその塩、リゾチーム又はその塩、アルキルシステイン又はその塩、ブロムヘキシン又はその塩、アンブロキソール又はその塩が挙げられ、１種以上を単独で用いても２種以上を組み合わせて用いてもよい。
これらの中でも、チペピジン又はその塩、メチルエフェドリン又はその塩、グアヤコールスルホン酸又はその塩、グアイフェネシン又はその塩、リゾチーム又はその塩、ブロムヘキシン又はその塩、アンブロキソール又はその塩が好ましい。
(expectoration ingredient)
In the present invention, the expectorant component is not particularly limited as long as it exhibits expectorant action, but examples include tipepidine or its salts, methylephedrine or its salts, guaiacolsulfonic acid or its salts, guaifenesin or its salts, Lysozyme or its salts, alkylcysteine or its salts, bromhexine or its salts, ambroxol or its salts may be mentioned, and one or more thereof may be used alone or two or more thereof may be used in combination.
Among these, tipepidine or its salts, methylephedrine or its salts, guaiacolsulfonic acid or its salts, guaifenesin or its salts, lysozyme or its salts, bromhexine or its salts, and ambroxol or its salts are preferable.
また、去痰成分の具体例としては、チペピジンクエン酸塩、チペピジンヒベンズ酸塩、メチルエフェドリン塩酸塩（例えば、ｌ－メチルエフェドリン塩酸塩、ｄｌ－メチルエフェドリン塩酸塩等）、メチルエフェドリンサッカリン塩（例えば、ｌ－メチルエフェドリンサッカリン塩、ｄｌ－メチルエフェドリンサッカリン塩等）、グアヤコールスルホン酸カリウム、グアイフェネシン、リゾチーム塩酸塩、メチルシステイン塩酸塩、エチルシステイン塩酸塩、ブロムヘキシン塩酸塩、アンブロキソール塩酸塩が挙げられる。
これらの中でも、チペピジンクエン酸塩、チペピジンヒベンズ酸塩、メチルエフェドリン塩酸塩、メチルエフェドリンサッカリン塩、グアヤコールスルホン酸カリウム、グアイフェネシン、リゾチーム塩酸塩、メチルシステイン塩酸塩、エチルシステイン塩酸塩が好ましく、チペピジンクエン酸塩、チペピジンヒベンズ酸塩、メチルエフェドリン塩酸塩、グアイフェネシン、リゾチーム塩酸塩、ブロムヘキシン塩酸塩、アンブロキソール塩酸塩がより好ましく、メチルエフェドリン塩酸塩、グアイフェネシン、ブロムヘキシン塩酸塩、アンブロキソール塩酸塩が特に好ましい。
上述の成分は、いずれも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。
Specific examples of expectorant components include tipepidine citrate, tipepidine hibenzate, methylephedrine hydrochloride (e.g., l-methylephedrine hydrochloride, dl-methylephedrine hydrochloride, etc.), methylephedrine saccharin salt (e.g., l-methylephedrine saccharin salt, dl-methylephedrine saccharin salt, etc.), potassium guaiacolsulfonate, guaifenesin, lysozyme hydrochloride, methylcysteine hydrochloride, ethylcysteine hydrochloride, bromhexine hydrochloride, ambroxol hydrochloride.
Among these, tipepidine citrate, tipepidine hibenzate, methylephedrine hydrochloride, methylephedrine saccharin salt, potassium guaiacolsulfonate, guaifenesin, lysozyme hydrochloride, methylcysteine hydrochloride, and ethylcysteine hydrochloride are preferable, and tipepidine citrate. salt, tipepidine hibenzate, methylephedrine hydrochloride, guaifenesin, lysozyme hydrochloride, bromhexine hydrochloride, ambroxol hydrochloride are more preferred, and methylephedrine hydrochloride, guaifenesin, bromhexine hydrochloride, ambroxol hydrochloride are particularly preferred. .
All of the above components are known compounds, can be produced by known methods, and can be commercially available.
また、本発明の去痰医薬組成物（１）における去痰成分の含有量は、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が、服薬コンプライアンス、去痰作用の観点から、１日量として、１日最大分量の１／３以上２／３以下が好ましく、２／３がより好ましい。斯様な１日量とすることによって、１日あたりの去痰成分の服用量が１日最大分量よりも少ないにも拘わらず、優れた去痰効果が得られる。
ここで、１日最大分量とは、１日量として医薬組成物中に配合することが可能な最大の分量として知られるものをいい、去痰成分を２種以上含む場合は、各１日最大分量の合計量である。例えば、チペピジンクエン酸塩の１日最大分量は７５ｍｇであり、チペピジンヒベンズ酸塩の１日最大分量は６０ｍｇであり、メチルエフェドリン塩酸塩の１日最大分量は６０ｍｇであり、メチルエフェドリンサッカリン塩の１日最大分量は６０ｍｇであり、グアヤコールスルホン酸カリウムの１日最大分量は２５０ｍｇであり、グアイフェネシンの１日最大分量は２５０ｍｇであり、リゾチーム塩酸塩の１日最大分量は９０ｍｇ（力価）であり、メチルシステイン塩酸塩の１日最大分量は３００ｍｇであり、エチルシステイン塩酸塩の１日最大分量は３００ｍｇであり、ブロムヘキシン塩酸塩の１日最大分量は１２ｍｇであり、アンブロキソール塩酸塩の１日最大分量は４５ｍｇである。
In addition, the content of the expectorant component in the expectorant pharmaceutical composition (1) of the present invention may be appropriately determined according to the gender, age, symptoms, etc. of the user. Therefore, the daily dose is preferably 1/3 or more and 2/3 or less, more preferably 2/3 of the maximum daily dose. With such a daily dose, an excellent expectorant effect can be obtained even though the dose of the expectorant ingredient per day is less than the maximum daily dose.
Here, the maximum daily dose refers to what is known as the maximum dose that can be incorporated in a pharmaceutical composition as a daily dose. is the total amount of For example, the maximum daily dose for tipepidine citrate is 75 mg, the maximum daily dose for tipepidine hibenzate is 60 mg, the maximum daily dose for methylephedrine hydrochloride is 60 mg, and the maximum daily dose for methylephedrine saccharin is 1 The maximum daily dose is 60 mg, the maximum daily dose of potassium guaiacol sulfonate is 250 mg, the maximum daily dose of guaifenesin is 250 mg, the maximum daily dose of lysozyme hydrochloride is 90 mg (potency), The maximum daily dose of methylcysteine hydrochloride is 300 mg, the maximum daily dose of ethylcysteine hydrochloride is 300 mg, the maximum daily dose of bromhexine hydrochloride is 12 mg, and the maximum daily dose of ambroxol hydrochloride is 300 mg. The quantity is 45 mg.
また、１回量として、去痰成分を１日最大分量の１／６以上１／３以下含有するものが好ましく、１／３含有するものがより好ましい。 In addition, as a single dose, one containing 1/6 or more and 1/3 or less, more preferably 1/3 of the maximum daily dose of expectorant components is preferred.
また、本発明の去痰医薬組成物（１）としては、服薬コンプライアンス、去痰作用の観点から、上記１日量を、１日２回に分けて服用するものが好ましく、１日２回に分けて、食前、食間、食後、就寝前等に服用するものがより好ましく、１日２回に分けて食後に服用するものがさらに好ましい。 In addition, as the expectorant pharmaceutical composition (1) of the present invention, the above daily dose is preferably divided into two times a day from the viewpoint of compliance and expectorant action, and is divided into two times a day. , before meals, between meals, after meals, before bedtime, etc., and more preferably after meals in two divided doses per day.
また、本発明は、（２）１日２回服用するものであって、ロキソプロフェン又はその塩を、１回量として、ロキソプロフェンナトリウム無水物換算で６０ｍｇと、去痰成分を、１回量として、１日最大分量の１／６以上１／３以下含有する医薬組成物、（３）ロキソプロフェン又はその塩と去痰成分とを含有し、１日に２回服用するものである医薬組成物をも提供するものである。これら医薬組成物に含まれるロキソプロフェン又はその塩や去痰成分としては上記と同様のものが好ましい。 In addition, the present invention (2) is to be taken twice a day, and the amount of loxoprofen or a salt thereof is 60 mg in terms of loxoprofen sodium anhydride, and the expectorant component is 1 (3) A pharmaceutical composition containing loxoprofen or a salt thereof and an expectorant component and to be taken twice a day is also provided. It is a thing. Loxoprofen or a salt thereof and an expectorant component contained in these pharmaceutical compositions are preferably the same as those described above.
本発明の去痰医薬組成物（２）におけるロキソプロフェン又はその塩の含有量は、１回量として、ロキソプロフェンナトリウム無水物換算で６０ｍｇである。
また、１日量として、ロキソプロフェン又はその塩を、ロキソプロフェンナトリウム無水物換算で６０ｍｇ超１２０ｍｇ以下含有するものが好ましく、１２０ｍｇ含有するものがより好ましい。
また、本発明の去痰医薬組成物（２）における去痰成分の含有量は、１回量として、１日最大分量の１／６以上１／３以下であり、好ましくは１／３である。
また、服薬コンプライアンス、去痰作用の観点から、１日量として、１日最大分量の１／３以上２／３以下が好ましく、２／３がより好ましい。斯様な１日量とすることによって、１日あたりの去痰成分の服用量が１日最大分量よりも少ないにも拘わらず、優れた去痰効果が得られる。
また、本発明の去痰医薬組成物（２）は、上記１回量を、１日２回服用するものであり、服薬コンプライアンス、去痰作用の観点から、１日に２回、食前、食間、食後、就寝前等に服用するものが好ましく、１日２回食後に服用するものがより好ましい。
The content of loxoprofen or a salt thereof in the expectorant pharmaceutical composition (2) of the present invention is 60 mg in terms of loxoprofen sodium anhydrate per dose.
In addition, the daily dose of loxoprofen or a salt thereof preferably contains more than 60 mg but not more than 120 mg, more preferably 120 mg, in terms of loxoprofen sodium anhydrate.
In addition, the content of the expectorant component in the expectorant pharmaceutical composition (2) of the present invention is 1/6 or more and 1/3 or less, preferably 1/3, of the maximum daily dose as a single dose.
From the viewpoint of drug compliance and expectorant action, the daily dose is preferably 1/3 or more and 2/3 or less, more preferably 2/3 of the maximum daily dose. With such a daily dose, an excellent expectorant effect can be obtained even though the dose of the expectorant ingredient per day is less than the maximum daily dose.
In addition, the expectorant pharmaceutical composition (2) of the present invention is to be taken twice a day in the above-mentioned single dose, and from the viewpoint of compliance and expectorant action, twice a day , preferably before going to bed, and more preferably twice a day after meals.
本発明の去痰医薬組成物（３）におけるロキソプロフェン又はその塩の含有量は、１日量として、ロキソプロフェンナトリウム無水物換算で６０ｍｇ超１２０ｍｇ以下が好ましく、より好ましくは１２０ｍｇである。
また、１回量（１回の服用量）として、ロキソプロフェン又はその塩を、ロキソプロフェンナトリウム無水物換算で６０ｍｇ含有するものが好ましい。
また、本発明の去痰医薬組成物（３）における去痰成分の含有量は、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が、服薬コンプライアンス、去痰作用の観点から、１日量として、１日最大分量の１／３以上２／３以下が好ましく、２／３がより好ましい。斯様な１日量とすることによって、１日あたりの去痰成分の服用量が１日最大分量よりも少ないにも拘わらず、優れた去痰効果が得られる。
また、１回量として、去痰成分を１日最大分量の１／６以上１／３以下含有するものが好ましく、１／３含有するものがより好ましい。
また、本発明の去痰医薬組成物（３）は、１日に２回服用するものであるが、１日２回、食前、食間、食後、就寝前等に服用するものが好ましく、１日２回食後に服用するものがより好ましい。
The content of loxoprofen or a salt thereof in the expectorant pharmaceutical composition (3) of the present invention is preferably more than 60 mg and not more than 120 mg, more preferably 120 mg, in terms of loxoprofen sodium anhydrate per day.
Moreover, as a single dose (one dose), one containing 60 mg of loxoprofen or a salt thereof in terms of loxoprofen sodium anhydride is preferable.
In addition, the content of the expectorant component in the expectorant pharmaceutical composition (3) of the present invention may be appropriately determined according to the sex, age, symptoms, etc. of the user. Therefore, the daily dose is preferably 1/3 or more and 2/3 or less, more preferably 2/3 of the maximum daily dose. With such a daily dose, an excellent expectorant effect can be obtained even though the dose of the expectorant ingredient per day is less than the maximum daily dose.
In addition, as a single dose, one containing 1/6 or more and 1/3 or less, more preferably 1/3 of the maximum daily dose of expectorant components is preferred.
The expectorant pharmaceutical composition (3) of the present invention is taken twice a day, preferably twice a day, before meals, between meals, after meals, before bedtime, etc. It is more preferable to take the medicine after each meal.
また、上記去痰医薬組成物（１）～（３）中のロキソプロフェン又はその塩の含有量としては、組成物全量に対し、１質量％以上が好ましく、３質量％以上がより好ましく、５質量％以上がさらに好ましく、また、５０質量％以下が好ましく、３５質量％以下がより好ましく、２０質量％以下がさらに好ましく、１５質量％以下がさらに好ましく、１０質量％以下がさらに好ましい。 In addition, the content of loxoprofen or a salt thereof in the expectorant pharmaceutical compositions (1) to (3) is preferably 1% by mass or more, more preferably 3% by mass or more, and 5% by mass, based on the total amount of the composition. 50% by mass or less is more preferable, 35% by mass or less is more preferable, 20% by mass or less is even more preferable, 15% by mass or less is even more preferable, and 10% by mass or less is even more preferable.
本発明の去痰医薬組成物（１）～（３）中の去痰成分の含有量としては、組成物全量に対し、０．１質量％以上が好ましく、０．５質量％以上がより好ましく、１質量％以上がさらに好ましく、また、６０質量％以下が好ましく、５０質量％以下がより好ましく、３０質量％以下がさらに好ましく、２５質量％以下がさらに好ましく、２０質量％以下がさらに好ましい。
また、本発明の去痰医薬組成物（１）～（３）中の（Ａ）ロキソプロフェン又はその塩と（Ｂ）去痰成分との質量比率〔（Ａ）／（Ｂ）〕は、好ましくは０．５以上、より好ましくは０．６以上、さらに好ましくは０．７５以上であり、また、好ましくは２０以下、より好ましくは１５以下である。
The content of expectorant components in the expectorant pharmaceutical compositions (1) to (3) of the present invention is preferably 0.1% by mass or more, more preferably 0.5% by mass or more, based on the total amount of the composition. It is more preferably 60% by mass or less, more preferably 50% by mass or less, even more preferably 30% by mass or less, still more preferably 25% by mass or less, and even more preferably 20% by mass or less.
In the expectorant pharmaceutical compositions (1) to (3) of the present invention, the mass ratio [(A)/(B)] of (A) loxoprofen or a salt thereof and (B) an expectorant component is preferably 0. It is 5 or more, more preferably 0.6 or more, still more preferably 0.75 or more, and preferably 20 or less, more preferably 15 or less.
そして、上記本発明の去痰医薬組成物（１）～（３）は、例えば、第十六改正日本薬局方 製剤総則等に記載の公知の方法により製造することができる。また、剤形は、特に限定されるものではなく、固形状、半固形状、液状のいずれの形状でもよい。具体的には例えば、錠剤（口腔内崩壊錠、チュアブル錠、発泡錠、分散錠、溶解錠も含む）、カプセル剤（硬カプセル剤、軟カプセル剤）、丸剤、顆粒剤、細粒剤、散剤、ドライシロップ剤、ゼリー剤、シロップ剤、ドリンク剤などにすることができる。 The expectorant pharmaceutical compositions (1) to (3) of the present invention can be produced, for example, by known methods described in the Japanese Pharmacopoeia, 16th Edition, General Rules for Pharmaceutical Preparations. Moreover, the dosage form is not particularly limited, and may be solid, semi-solid, or liquid. Specifically, for example, tablets (including orally disintegrating tablets, chewable tablets, effervescent tablets, dispersible tablets, dissolving tablets), capsules (hard capsules, soft capsules), pills, granules, fine granules, It can be made into powder, dry syrup, jelly, syrup, drink, and the like.
また、本発明の去痰医薬組成物（１）～（３）としては、服用の簡便性や薬物服用量の管理等の点で、固形製剤が好ましく、錠剤、カプセル剤、丸剤、顆粒剤、細粒剤、散剤及びドライシロップ剤からなる群より選ばれる固形製剤がより好ましい。 In addition, the expectorant pharmaceutical compositions (1) to (3) of the present invention are preferably solid preparations, such as tablets, capsules, pills, granules, from the viewpoint of ease of administration and control of drug dosage. Solid formulations selected from the group consisting of fine granules, powders and dry syrups are more preferred.
本発明の去痰医薬組成物は、その１日量を１日につき２回に分けて食前、食間、食後、就寝前等に服用することができ、１日につき２回に分けて食後に服用するのが好ましい。また、その１回量を１日に２回、食前、食間、食後、就寝前等に服用することができ、１日２回食後に服用するのが好ましい。 The daily dose of the expectorant pharmaceutical composition of the present invention can be divided into two doses per day before meals, between meals, after meals, before bedtime, etc., and can be taken in two doses per day after meals. is preferred. In addition, the dose can be taken twice a day, before meals, between meals, after meals, before bedtime, etc., and preferably twice a day after meals.
本発明の去痰医薬組成物（１）～（３）には、医薬成分として、さらに成分（Ａ）及び（Ｂ）以外の薬物、例えば、抗ヒスタミン剤、鎮咳剤、カフェイン類、解熱鎮痛剤、ノスカピン類、気管支拡張剤、催眠鎮静剤、ビタミン類、抗炎症剤、胃粘膜保護剤、抗コリン剤、生薬類、漢方処方、キサンチン系成分等からなる群より選ばれる１種又は２種以上を含んでいてもよい。 The expectorant pharmaceutical compositions (1) to (3) of the present invention may contain, as pharmaceutical ingredients, drugs other than ingredients (A) and (B), such as antihistamines, antitussives, caffeines, antipyretic analgesics, and noscapines. , bronchodilators, hypnotic sedatives, vitamins, anti-inflammatory agents, gastric mucosa protective agents, anticholinergic agents, herbal medicines, Chinese herbal formulations, xanthine-based ingredients, etc. You can
抗ヒスタミン剤としては、例えば、アゼラスチン塩酸塩、アリメマジン酒石酸塩、イソチペンジル塩酸塩、イプロヘプチン塩酸塩、エバスチン、エピナスチン塩酸塩、エメダスチンフマル酸塩、オキサトミド、オロパタジン塩酸塩、カルビノキサミンジフェニルジスルホン酸塩、カルビノキサミンマレイン酸塩、クレマスチンフマル酸塩、ｄ－クロルフェニラミンマレイン酸塩、ｄｌ－クロルフェニラミンマレイン酸塩、ケトチフェンフマル酸塩、ジフェテロール塩酸塩、ジフェテロールリン酸塩、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、ジフェンヒドラミンタンニン酸塩、シプロへプタジン塩酸塩水和物、セチリジン塩酸塩、トリプロリジン塩酸塩、トリペレナミン塩酸塩、トンジルアミン塩酸塩、フェキソフェナジン、フェネタジン塩酸塩、プロメタジン塩酸塩、プロメタジンメチレン二サリチル酸塩、ベポタスチンベシル酸塩、ホモクロルシクリジン塩酸塩、メキタジン、メトジラジン塩酸塩、メブヒドロリンナパジシル酸塩、ロラタジン等が挙げられる。
本発明の去痰医薬組成物（１）～（３）中の（Ａ）ロキソプロフェン又はその塩と（Ｃ）抗ヒスタミン剤との質量比率〔（Ａ）／（Ｃ）〕は、好ましくは１０以上、より好ましくは２０以上であり、また、好ましくは２００以下、より好ましくは１５０以下である。
Antihistamines include, for example, azelastine hydrochloride, alimemazine tartrate, isothipendyl hydrochloride, iproheptine hydrochloride, ebastine, epinastine hydrochloride, emedastine fumarate, oxatomide, olopatadine hydrochloride, carbinoxamindiphenyldisulfonate, carbi noxamine maleate, clemastine fumarate, d-chlorpheniramine maleate, dl-chlorpheniramine maleate, ketotifen fumarate, difererol hydrochloride, difererol phosphate, diphenylpyraline hydrochloride, Diphenylpyraline teocrate, diphenhydramine hydrochloride, diphenhydramine salicylate, diphenhydramine tannate, cyproheptadine hydrochloride hydrate, cetirizine hydrochloride, triprolidine hydrochloride, tripelennamine hydrochloride, tondylamine hydrochloride, fexofenadine, phenetazine Hydrochloride, promethazine hydrochloride, promethazine methylene disalicylate, bepotastine besilate, homochlorcyclidine hydrochloride, mequitazine, methdilazine hydrochloride, mebhydroline napadisilate, loratadine and the like.
The mass ratio [(A)/(C)] of (A) loxoprofen or a salt thereof and (C) an antihistamine in the expectorant pharmaceutical compositions (1) to (3) of the present invention is preferably 10 or more, more preferably is 20 or more, preferably 200 or less, more preferably 150 or less.
鎮咳剤としては、例えば、アロクラミド塩酸塩、エプラジノン塩酸塩、カルベタペンタンクエン酸塩、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、コデインリン酸塩水和物、ジヒドロコデイン、ジヒドロコデインリン酸塩、ジブナートナトリウム、ジメモルファンリン酸塩、デキストロメトルファン、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等が挙げられる。
本発明の去痰医薬組成物（１）～（３）中の（Ａ）ロキソプロフェン又はその塩と（Ｄ）鎮咳剤との質量比率〔（Ａ）／（Ｄ）〕は、好ましくは１以上、より好ましくは３以上であり、また、好ましくは１５以下、より好ましくは１２以下である。
Antitussives include, for example, aloclamide hydrochloride, eprazinone hydrochloride, carbetapentancitrate, cloperastine hydrochloride, cloperastine fendizoate, codeine, codeine phosphate hydrate, dihydrocodeine, dihydrocodeine phosphate, dib sodium nate, dimemorphan phosphate, dextromethorphan, dextromethorphan hydrobromide hydrate, dextromethorphan phenolphthalate and the like.
The mass ratio [(A)/(D)] of (A) loxoprofen or a salt thereof and (D) an antitussive in the expectorant pharmaceutical compositions (1) to (3) of the present invention is preferably 1 or more, more preferably is 3 or more, preferably 15 or less, more preferably 12 or less.
カフェイン類としては、例えば、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、クエン酸カフェイン等が挙げられる。
本発明の去痰医薬組成物（１）～（３）中の（Ａ）ロキソプロフェン又はその塩と（Ｅ）カフェイン類との質量比率〔（Ａ）／（Ｅ）〕は、好ましくは１以上、より好ましくは２以上であり、また、好ましくは１０以下、より好ましくは５以下である。
Examples of caffeine include caffeine hydrate, anhydrous caffeine, sodium caffeine benzoate, and caffeine citrate.
The mass ratio [(A)/(E)] of (A) loxoprofen or a salt thereof and (E) caffeine in the expectorant pharmaceutical compositions (1) to (3) of the present invention is preferably 1 or more, It is more preferably 2 or more, preferably 10 or less, and more preferably 5 or less.
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、イブプロフェン、エテンザミド、サザピリン、サリチルアミド、サリチル酸ナトリウム、チアラミド塩酸塩、ラクチルフェネチジン等が挙げられる。 Examples of antipyretic analgesics include aspirin, aspirin aluminum, acetaminophen, ibuprofen, ethenzamide, sazapyrin, salicylamide, sodium salicylate, tiaramide hydrochloride, lactylphenetidine and the like.
ノスカピン類としては、例えば、ノスカピン塩酸塩、ノスカピン等が挙げられる。 Examples of noscapines include noscapine hydrochloride and noscapine.
気管支拡張剤としては、例えば、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、フェニレフリン塩酸塩、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、メトキシフェナミン塩酸塩等が挙げられる。 Bronchodilators include, for example, trimetoquinol hydrochloride, phenylpropanolamine hydrochloride, phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, methoxyphenamine hydrochloride and the like.
催眠鎮静剤としては、例えば、アリルイソプロピルアセチル尿素やブロムワレリル尿素等が挙げられる。 Hypnotic sedatives include, for example, allylisopropylacetylurea, bromvalerylurea, and the like.
ビタミン類としては、例えば、ビタミンＢ1、ビタミンＢ2、ビタミンＢ5、ビタミンＢ6、ビタミンＢ12、ビタミンＣ、ヘスペリジン及びその誘導体並びにそれらの塩類等（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、ベンフォチアミン、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、リン酸リボフラビンナトリウム、パンテノール、パンテチン、パントテン酸ナトリウム、ピリドキシン塩酸塩、ピリドキサールリン酸エステル、シアノコバラミン、メコバラミン、アスコルビン酸、アスコルビン酸ナトリウム、アスコルビン酸カルシウム、ヘスペリジン等）が挙げられる。 Examples of vitamins include vitamin B 1 , vitamin B 2 , vitamin B 5 , vitamin B 6 , vitamin B 12 , vitamin C, hesperidin and derivatives thereof, and salts thereof (e.g., thiamine, thiamine chloride hydrochloride, Thiamine nitrate, dicetiamine hydrochloride, cetotiamine hydrochloride, fursultiamine, fursultiamine hydrochloride, octotiamine, cicotiamine, thiamine disulfide, bisivtiamine, bisbentiamine, prosultiamine, benfotiamine, riboflavin, riboflavinlin acid ester, riboflavin butyrate, riboflavin sodium phosphate, panthenol, pantethine, sodium pantothenate, pyridoxine hydrochloride, pyridoxal phosphate, cyanocobalamin, mecobalamin, ascorbic acid, sodium ascorbate, calcium ascorbate, hesperidin, etc.). be done.
抗炎症剤としては、例えば、グリチルリチン酸及びその誘導体並びにそれらの塩類（例えば、グリチルリチン酸二カリウム、グリチルリチン酸モノアンモニウム等）、セアプローゼ、セミアルカリプロティナーゼ、セラペプターゼ、プロクターゼ、プロナーゼ、ブロメライン、トラネキサム酸等が挙げられる。 Examples of anti-inflammatory agents include glycyrrhizic acid, derivatives thereof, and salts thereof (e.g., dipotassium glycyrrhizinate, monoammonium glycyrrhizinate, etc.), seaprose, semi-alkaline proteinase, serrapeptase, procase, pronase, bromelain, tranexamic acid, and the like. mentioned.
胃粘膜保護剤としては、例えば、ゲファルナート、セトラキサート塩酸塩、ソファルコン、テプレノン、メチルメチオニンスルホニウムクロリド等が挙げられる。 Gastric mucosa protective agents include, for example, gefarnate, cetraxate hydrochloride, sofalcon, teprenone, methylmethionine sulfonium chloride and the like.
抗コリン薬としては、例えば、オキシフェンサイクリミン塩酸塩、ジサイクロミン塩酸塩、メチキセン塩酸塩、スコポラミン臭化水素酸塩、ダツラエキス、チペピジウム臭化物、メチルアトロピン臭化物、メチルアニソトロピン臭化物、メチルスコポラミン臭化物、メチル－ｌ－ヒヨスチアミン臭化物、メチルベナクチジウム臭化物、ピレンゼピン塩酸塩、ブチルスコポラミン臭化物、ベラドンナアルカロイド、ベラドンナエキス、ベラドンナ総アルカロイド、ヨウ化イソプロパミド、ヨウ化ジフェニルピペリジノメチルジオキソラン、ロートエキス、ロート根、ロート根総アルカロイドクエン酸塩等が挙げられる。 Anticholinergics include, for example, oxyphencyclamine hydrochloride, dicyclomine hydrochloride, methixene hydrochloride, scopolamine hydrobromide, Datura extract, tipepidium bromide, methylatropine bromide, methylanisotropine bromide, methylscopolamine bromide, methyl- l-hyoscyamine bromide, methylbenactidium bromide, pirenzepine hydrochloride, butylscopolamine bromide, belladonna alkaloids, belladonna extract, belladonna total alkaloids, isopropamide iodide, diphenylpiperidinomethyldioxolane iodide, roth extract, roth root, roth roth root total alkaloid citrate and the like.
生薬類としては、例えば、アカメガシワ（赤芽柏）、アセンヤク（阿仙薬）、インヨウカク（淫羊霍）、ウイキョウ(茴香)、エンゴサク（延胡索）、オウゴン（黄岑）、オウセイ（黄精）、オウバク(黄柏)、オウヒ(桜皮)、オウレン(黄連)、オンジ(遠志)、ガジュツ（我朮）、カノコソウ（鹿子草）、カミツレ、カロニン（か楼仁）、キキョウ(桔梗)、キョウニン（杏仁）、クコシ（枸杞子）、クコヨウ（枸杞葉）、ケイガイ（荊芥）、ケイヒ(桂皮)、ケツメイシ（決明子）、ゲンチアナ、ゲンノショウコ（現証拠）、コウブシ（香附子）、ゴオウ(牛黄)、ゴミシ（五味子）、サイシン（細辛）、サンショウ（山椒）、シオン（紫苑）、ジコッピ（地骨皮）、シャクヤク（芍薬）、ジャコウ（麝香）、シャジン (沙参)、シャゼンシ(車前子)、シャゼンソウ(車前草)、獣胆(ユウタン(熊胆)を含む)、ショウキョウ(生姜)、ジリュウ（地竜）、シンイ（辛夷）、セキサン（石蒜）、セネガ、センキュウ（川きゅう）、ゼンコ（前胡）、センブリ（千振）、ソウジュツ(蒼朮)、ソウハクヒ（桑白皮）、ソヨウ（蘇葉）、タイサン（大蒜）、チクセツニンジン(竹節人参)、チョウジ(丁子)、チンピ(陳皮)、トウキ（当帰）、トコン（吐根）、ナンテンジツ（南天実）、ニンジン(人参)、バイモ(貝母)、バクモンドウ（麦門冬）、ハンゲ（半夏）、バンコウカ（番紅花）、ハンピ（反鼻）、ビャクシ（白し）、ビャクジュツ(白朮)、ブクリョウ（茯苓）、ボタンピ（牡丹皮）、ロクジョウ（鹿茸）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）等が挙げられる。 Herbal medicines include Akamegashiwa (Akamegashiwa), Asenyaku (Asenyaku), Inyo-kaku (Lady), Fennel, Corydalis, Scutellaria japonicum, Ousei, and Phellodendron. , Ouhi (cherry bark), Japanese coptis (huangren), Onji (toshi), zedoary (Gajutsu), valerian (garden), chamomile, caronin (karoin), bellflower (bellflower), kyonin (apricot kernel), wolfberry (Kumiko), Kukoyou (Kukouyou), Keigai (Kingai), Cinnamon (cinnamon bark), Ketsumeishi (decision), Gentiana, Gennoshoko (current evidence), Kobushi (Kobushi), Goou (beef yellow), Gomishi (Gomiso), Saishin (spicy), Sansho (Japanese pepper), Shion (Shion), Jikoppi (root skin), Peony (peony), Musk (Musk), Shajin (Sansan), Shazenshi (shazen), Shazensou (shazensou) ), Beast bile (including Yutan (bear bile)), Ginger (ginger), Jiryu (earth dragon), Shini (spicy), Sekisan (stone garlic), Senega, Senkyu (river), Zenko (Maehu) , Senburi, Sojutsu, Souhakuhi, Soyou, Taisan, Chikusetsu Carrot, Clove, Chimpi, Touki return), tokon (root), nantenjitsu (nantenjitsu), carrot (carrot), baimo (shellfish mother), bakumondou (wheat gate winter), hange (half summer), bankouka (safflower), hampi (anti-nose) , Byakushi, Byakujutsu, Bukuryo, Botanpi, Rokujo, and extracts thereof (extracts, tinctures, dried extracts, etc.).
漢方処方としては、例えば、ケイシトウ（桂枝湯）、コウソサン（香蘇散）、サイコケイシトウ（柴胡桂枝湯）、ショウサイコトウ（小柴胡湯）、バクモンドウトウ（麦門冬湯）、ハンゲコウボクトウ（半夏厚朴湯）等が挙げられる。 Kampo prescriptions include, for example, Keishito (Keishito), Kososan (Kousosan), Saiko Keishito (Saikokeishito), Shosaikoto (Shosaikoto), Bakumondoto (Bakumondoto), Hange Koubokutou (Hangekobokuto) and the like can be mentioned.
キサンチン系成分としては、例えば、アミノフィリン、ジプロフィリン、テオフィリン、プロキシフィリン等が挙げられる。 Examples of xanthine-based components include aminophylline, diprophylline, theophylline, proxyphylline, and the like.
そして、本発明の去痰医薬組成物は、去痰成分の含有量が少ないのにもかかわらず、優れた去痰作用を発揮し、副作用の心配が少なく安全性が高い。
また、本発明の去痰医薬組成物は、ＮＳＡＩＤの一種であるロキソプロフェン又はその塩と去痰成分を含有するため、かぜの諸症状（たん）の緩和や「たん」の効能又は効果を有する、総合感冒薬（かぜ薬）や去痰薬として有用である。
In addition, the expectorant pharmaceutical composition of the present invention exhibits excellent expectorant action despite the low content of expectorant components, and is highly safe with little concern about side effects.
In addition, since the expectorant pharmaceutical composition of the present invention contains loxoprofen or a salt thereof, which is a type of NSAID, and an expectorant component, it is effective for alleviating cold symptoms (phlegm) and having the efficacy or effect of "phlegm". It is useful as a medicine (cold remedy) and an expectorant.
以下に実施例を挙げて本発明を詳細に説明するが、本発明はこれら実施例に何ら限定されるものではない。 EXAMPLES The present invention will be described in detail with reference to Examples below, but the present invention is not limited to these Examples.
［実施例１］錠剤
９錠あたり、ロキソプロフェンナトリウム水和物（大和薬品工業製：商品名 日本薬局方 ロキソプロフェンナトリウム水和物）２０４．３ｍｇ（ロキソプロフェンナトリウム無水物換算で１８０ｍｇ）、ｄ－クロルフェニラミンマレイン酸塩（金剛化学製：商品名Ｄ－マレイン酸クロルフェニラミン）３．５ｍｇ、ジヒドロコデインリン酸塩（塩野義製薬製：商品名 リン酸ジヒドロコデイン「シオノギ」）２４ｍｇ、ｄｌ－メチルエフェドリン塩酸塩（アルプス薬品工業製：商品名 日本薬局方 ｄｌ－塩酸メチルエフェドリン末）６０ｍｇ、グアイフェネシン（アルプス薬品工業製：商品名 日本薬局方 グアイフェネシン）２５０ｍｇ及び無水カフェイン（静岡カフェイン工業所製：商品名 無水カフェイン）４０ｍｇを含むように、これら医薬成分と、結晶セルロース、ヒドロキシプロピルセルロース、カルメロースカルシウム、無水リン酸水素カルシウム及びメタケイ酸アルミン酸マグネシウム等の製剤添加物とを混合し、精製水を用いて造粒した。得られた造粒物を乾燥し、整粒して、整粒物を得た。得られた整粒物に、ステアリン酸マグネシウムを加えて打錠して、錠剤を得た。
[Example 1] 204.3 mg of loxoprofen sodium hydrate (manufactured by Daiwa Pharmaceutical Co., Ltd.; trade name: Japanese Pharmacopoeia loxoprofen sodium hydrate) (180 mg in terms of loxoprofen sodium anhydrate) per 9 tablets, d-chlorpheniramine Maleate (manufactured by Kongo Chemical: trade name D-chlorpheniramine maleate) 3.5 mg, dihydrocodeine phosphate (manufactured by Shionogi Pharmaceutical: trade name dihydrocodeine phosphate "Shionogi") 24 mg, dl-methylephedrine hydrochloride ( Alps Pharmaceutical Co., Ltd.: product name Japanese Pharmacopoeia dl-methylephedrine hydrochloride powder) 60 mg, guaifenesin (Alps Pharmaceutical Co., Ltd.: product name Japanese Pharmacopoeia Guaifenesin) 250 mg, and anhydrous caffeine (Shizuoka Caffeine Kogyosho: product name Anhydrous Caffeine) i) These pharmaceutical ingredients were mixed with formulation additives such as crystalline cellulose, hydroxypropyl cellulose, carmellose calcium, anhydrous calcium hydrogen phosphate and magnesium aluminometasilicate so as to contain 40 mg, and purified water was used. Granulated. The obtained granules were dried and sieved to obtain a sieved product. Magnesium stearate was added to the obtained sieved product and tableted to obtain tablets.
［試験例１］去痰作用の検討
実施例１で得た錠剤を用いて、痰の症状を示す２０代～３０代の患者男女６２名を２群に分けて、症状の改善の検討を行った。
すなわち、実施例１で得た錠剤を１日に２回、１回あたり３錠を食後に服用する群と１日に３回、１回あたり３錠を食後に服用する群に分け３日間投与した。投与終了後、痰の症状の改善具合を、消失、軽減、不変、悪化の４段階に分けて評価した。症状の改善が「軽減」以上の患者の割合を表１に示した。
[Test Example 1] Examination of expectorant action Using the tablets obtained in Example 1, 62 male and female patients in their twenties to thirties exhibiting symptoms of phlegm were divided into two groups, and improvement of symptoms was examined. .
That is, the tablets obtained in Example 1 were divided into a group taking 3 tablets after meals twice a day and a group taking 3 tablets 3 times a day after meals and administered for 3 days. bottom. After the end of the administration, the degree of improvement in phlegm symptoms was evaluated by dividing it into 4 grades of disappearance, reduction, no change, and deterioration. Table 1 shows the percentage of patients whose symptom improvement was "reduced" or more.
表１から明らかなように、１日あたりの服用回数が少ない患者（１日２回投与群）のほうが、痰の症状の改善が優れていた。
一般には、症状の改善を期待して薬物を投与する際、その症状に応じた薬物を多く投与したほうが症状の改善度が高まると期待されるにも拘わらず、驚くべきことに、薬物の投与量が少ない１日２回投与群（１日に６錠服用）のほうが１日３回投与群（１日９錠服用）に比べ、痰の症状が改善された。
As is clear from Table 1, the improvement of phlegm symptoms was superior in patients who took fewer doses per day (twice-daily administration group).
In general, when a drug is administered with the expectation of improving symptoms, administration of a large amount of drug according to the symptom is expected to increase the degree of symptom improvement. The twice-daily administration group (taking 6 tablets daily) with a small dose improved phlegm symptoms compared to the thrice-daily administration group (taking 9 tablets daily).
［製造例１］
実施例１と同様にして、９錠あたりグアイフェネシン２５０ｍｇ含有するところをチペピジンクエン酸塩７５ｍｇに換えた錠剤を得た。
[Production Example 1]
In the same manner as in Example 1, 9 tablets containing 250 mg of guaifenesin were replaced with 75 mg of tipepidine citrate to obtain tablets.
［製造例２］
実施例１と同様にして、９錠あたりグアイフェネシン２５０ｍｇ含有するところをチペピジンヒベンズ酸塩６０ｍｇに換えた錠剤を得た。
[Production Example 2]
In the same manner as in Example 1, 9 tablets containing 250 mg of guaifenesin were replaced with 60 mg of tipepidine hibenzate to obtain tablets.
［製造例３］
実施例１と同様にして、９錠あたりグアイフェネシン２５０ｍｇ含有するところをリゾチーム塩酸塩９０ｍｇ（力価）に換えた錠剤を得た。
[Production Example 3]
In the same manner as in Example 1, tablets containing 250 mg of guaifenesin per 9 tablets were replaced with 90 mg (potency) of lysozyme hydrochloride.
［製造例４］
実施例１と同様にして、９錠あたりグアイフェネシン２５０ｍｇ含有するところをブロムヘキシン塩酸塩１２ｍｇに換えた錠剤を得た。
[Production Example 4]
In the same manner as in Example 1, 9 tablets containing 250 mg of guaifenesin were replaced with 12 mg of bromhexine hydrochloride to obtain tablets.
［製造例５］
実施例１と同様にして、９錠あたりグアイフェネシン２５０ｍｇ含有するところをアンブロキソール塩酸塩４５ｍｇに換えた錠剤を得た。
[Production Example 5]
In the same manner as in Example 1, 9 tablets containing 250 mg of guaifenesin were replaced with 45 mg of ambroxol hydrochloride to obtain tablets.
本発明の去痰医薬組成物は去痰成分の含有量が少ないのにもかかわらず、優れた去痰作用を発揮し、副作用の心配が少なく安全性が高いものである。 The expectorant pharmaceutical composition of the present invention exhibits an excellent expectorant action despite its low content of expectorant components, and is highly safe with little concern about side effects.
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