JP2018127450A - 経口組成物 - Google Patents
経口組成物 Download PDFInfo
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- JP2018127450A JP2018127450A JP2018020527A JP2018020527A JP2018127450A JP 2018127450 A JP2018127450 A JP 2018127450A JP 2018020527 A JP2018020527 A JP 2018020527A JP 2018020527 A JP2018020527 A JP 2018020527A JP 2018127450 A JP2018127450 A JP 2018127450A
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Abstract
Description
[1]
(A)胃腸薬系生薬及び/又は胃腸消炎修復成分と、
(B)非イオン性界面活性剤と、
(C)疎水性基剤とを含有する経口組成物;
[2]
前記胃腸薬系生薬が、コウボク、ソウジュツ、チンピ、ウイキョウ、ケイヒ、ウコン、ダイオウ、オウバク、オウレン、オンジ、ゲンノショウコ、ジュウヤク、センブリ、ヨクイニン及びベラドンナからなる群より選択される少なくとも1種である、[1]に記載の経口組成物;
[3]
前記胃腸消炎修復成分が、テプレノン、レバミピド、アルジオキサ、アズレンスルホン酸、ロキソプロフェン、トリメブチン、ピレンゼピン、スクラルファート及びそれらの塩からなる群より選択される少なくとも1種である、[1]に記載の経口組成物;
[4]
前記(C)疎水性基剤が、油脂類及び/又はロウ類である、[1]〜[3]のいずれかに記載の経口組成物;
[5]
液状経口組成物である、[1]〜[4]のいずれかに記載の経口組成物;
[6]
[1]〜[5]のいずれかに記載の経口組成物が、カプセル皮膜に充填されているカプセル剤;
[7]
速溶解性及び/又は速放出性である、[1]〜[6]に記載の経口組成物;
[8]
(A)胃腸薬系生薬及び/又は胃腸消炎修復成分と、
(B)非イオン性界面活性剤と、
(C)疎水性基剤とを経口組成物に共存させることを含む、カプセル皮膜に対する液なじみ改善作用を上記経口組成物に付与する方法;
等を提供するものである。
(B)非イオン性界面活性剤と、
(C)疎水性基剤とを経口組成物に共存させることを特徴とする固形製剤の製造方法を提供することも可能である。
本発明の経口組成物は、
(A)胃腸薬系生薬及び/又は胃腸消炎修復成分と、
(B)非イオン性界面活性剤と、
(C)疎水性基剤とを含有する。
本明細書において、胃腸薬系生薬とは、胃腸の不調を改善する機能又は胃腸の健康を増進する機能を有する生薬をいう。胃腸薬系生薬は、このような機能を有する生薬であれば限定はされない。
本発明の経口組成物における(B)非イオン性界面活性剤は、後述する(C)成分と共存することによって、経口組成物のカプセル皮膜に対する液なじみを低下させるという課題を生じる。一方、(B)成分は、(A)成分及び(C)成分と共存することによって、経口組成物のカプセル皮膜に対する液なじみを改善することができる成分である。
本発明の経口組成物における(C)疎水性基剤は、(A)成分と共存することによって、経口組成物のカプセル皮膜に対する液なじみを低下させるという課題を生じる。また、
(C)疎水性基剤は、(B)成分と共存することによっても、経口組成物のカプセル皮膜に対する液なじみを低下させ得る。一方、(C)成分は、(A)成分及び(B)成分と共存することによって、経口組成物のカプセル皮膜に対する液なじみを改善することができる成分である。また、(A)成分、(B)成分及び(C)成分が経口組成物において共存することによって、水に対する分散性を改善することができる。本発明は水に対する高い分散性を示すことにより、体内で経口組成物から有効成分が素早く溶解し(速溶解効果)、及び/又は素早く放出される(速放出効果)。そのため、体内での薬物吸収性が改善され、(A)成分の薬理作用に基づいて治療効果や健康増進効果が期待される疾病、症状、状態に対して効果の高い経口組成物を提供することが可能となる。
本発明において、経口組成物は、本発明の効果が十分に奏される限りにおいて、他の成分(生理活性成分)を含有してもよい。
抗ヒスタミン成分(例えば、イソチペンジル塩酸塩、イプロヘプチン塩酸塩、ジフェテロール塩酸塩、ジフェニルピラリン塩酸塩、ジフェンヒドラミン塩酸塩、トリプロリジン塩酸塩水和物、トリペレナミン塩酸塩、トンジルアミン塩酸塩、プロメタジン塩酸塩、メトジラジン塩酸塩、ジフェンヒドラミンサリチル酸塩、ジフェニルジスルホン酸カルビノキサミン、アリメマジン酒石酸塩、ジフェンヒドラミンタンニン酸塩、ジフェニルピラリンテオクル酸塩、カルビノキサミンマレイン酸塩、クロルフェニラミンマレイン酸塩、プロメタジンメチレンジサリチル酸塩)、
副交感神経遮断成分(例えば、アトロピン、スコポラミン、ベラドンナ総アルカロイド、ヨウ化イソプロパミド、ダツラエキス、ロートエキスなど)、
交感神経興奮成分(例えばメチルエフェドリン、プソイドエフェドリン、フェニレフリン、フェニルプロパノールアミン、エフェドリン、エチレフリン、メトキサミン、ミドドリン、メトキシフェナミン又はそれらの塩など)、
消炎酵素類(例えば、リゾチーム、セラペプターゼ、ブロメライン、プロナーゼ、リパーゼAP6など)、生薬、及び生薬由来成分(例えば、ショウキョウ、カンゾウ、ニンジン、マオウ、ケイガイ、サイシン、ナンテンジツ、オウヒ、ビャクシ、ゼンコ、キキョウ、シャゼンシ、ゴオウ、ガジュツ、ビャクジュツ、ゲンチアナ、チクセツニンジン、チョウジ、セネガ、シャゼンソウ、シャジンなど)、
グリチルリチン酸類(例えば、グリチルリチン酸又はその塩など)、
キサンチン誘導体(例えば、安息香酸ナトリウムカフェイン、カフェイン水和物、無水カフェイン等のカフェイン、テオフィリン、アミノフィリン、テオブロミン、ジプロフェイリン、プロキシフィリン、ペントキシフィリンなど)、
解熱鎮痛薬成分(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、サリチル酸ナトリウム、ラクチルフェネチジン、イブプロフェン、ケトプロフェン、チアラミド、アルミノプロフェンなど)、
ロイコトリエン拮抗成分(モンテルカスト、プランルカスト、ザフィルルカストなど)
鎮咳薬成分(例えば、アクロラミド、クロペラスチン、ペントキシベリン(カルベタペンタン)、チペピジン、ジブナート、デキストロメトルファン、コデイン、ジヒドロコデイン、ノスカピンなど)、
去痰薬(例えば、グアヤコールスルホン酸カリウム、グアイフェネシンなど)、
粘膜修復成分(例えば、銅クロロフィリンナトリウムなど)、
ビタミン類(例えば、ビタミンA類[例えば、レチナール、レチノール、レチノイン酸、カロチン、デヒドロレチナール、リコピンなど]、ビタミンB類[例えば、チアミン、チアミンジスルフィド、ジセチアミン、オクトチアミン、シコチアミン、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、フルスルチアミン、リボフラビン、フラビンアデニンジヌクレオチド、ピリドキシン、ピリドキサール、ヒドロキソコバラミン、シアノコバラミン、メチルコバラミン、デオキシアデノコバラミン、葉酸、テトラヒドロ葉酸、ジヒドロ葉酸、ニコチン酸、ニコチン酸アミド、ニコチニルアルコール、パントテン酸、パンテノール、ビオチン、コリン、イノシトールなど]、ビタミンC類[例えば、アスコルビン酸、エリソルビン酸、又はその誘導体など]、ビタミンD類[例えば、エルゴカルシフェロール、コレカルシフェロール、ヒドロキシコレカルシフェロール、ジヒドロキシコレカルシフェロール、ジヒドロタキステロールなど]、ビタミンE類[例えば、トコフェロール及びその誘導体、ユビキノン誘導体など]、その他のビタミン類[例えば、ヘスペリジン、カルニチン、フェルラ酸、γ−オリザノール、オロチン酸、ルチン、エリオシトリンなど]など)及び
粘膜保護成分(例えば、アミノ酢酸、乾燥水酸化アルミニウムゲル、ジヒドロキシアルミニウム・アミノ酢酸塩などのアルミニウム系粘膜保護剤;メタケイ酸アルミン酸マグネシウム、ケイ酸アルミニウム、ヒドロタルサイト、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・炭酸カルシウム・炭酸マグネシウムの共沈生成物、炭酸マグネシウム、酸化マグネシウム、水酸化マグネシウム、ケイ酸マグネシウム、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などのマグネシウム系粘膜保護剤、炭酸水素ナトリウム、沈降炭酸カルシウムなど)、などが挙げられる。
本発明において、経口組成物は、本発明の効果が十分に奏される限りにおいて、軟カプセル剤等に通常用いられる添加剤を含有してもよい。
本発明の経口組成物は、当業者に公知の方法に従って、固形製剤として種々の剤形に調製することができる。固形製剤の形状や大きさには特に限定はなく、例えば内服剤としては、錠剤[口腔内崩壊錠、チュアブル錠(咀嚼可能錠)、発泡錠、分散錠、溶解錠、フィルムコーティング錠、素錠及び糖衣錠等を含む]、カプセル剤[硬カプセル剤及び軟カプセル剤等を含む]、顆粒剤[発泡顆粒剤を含む]、散剤、粉末剤、細粒剤、丸剤、口腔用錠剤[トローチ剤、舌下錠、バッカル錠、付着錠及びガム剤等を含む]、フィルム剤、ドライシロップ剤、ゼリー剤、口腔用半固形剤、製菓剤[キャンディー(飴)、グミ剤及びヌガー剤等を含む]などの固形製剤が挙げられる。これらの固形製剤のなかでも、本発明の効果をより顕著に発揮させる観点から、本発明の経口組成物は、不快な呈味や臭いを有する成分が口内で効果的にマスキングされ服用しやすい観点から、カプセル剤に用いることが好ましく、軟カプセル剤に用いることがより好ましい。
本発明の別の実施態様において、(A)胃腸薬系生薬及び/又は胃腸消炎修復成分と、(B)非イオン性界面活性剤と、(C)疎水性基剤とを共存させることを特徴とする固形製剤の製造方法を提供することができる。(A)成分の種類や量、(B)成分の種類や量、(C)成分の種類や量は、上記の[経口組成物]の記載と同様である。また、固形製剤の種類等は、上記の[剤形]の記載と同様である。
本発明はまた、(A)胃腸薬系生薬及び/又は胃腸消炎修復成分と、(B)非イオン性界面活性剤と、(C)疎水性基剤とを経口組成物に共存させることにより、カプセル皮膜に対する液なじみ改善作用を該経口組成物に付与する方法に関する。(A)成分の種類や量、(B)成分の種類や量、(C)成分の種類や量は、上記の[経口組成物]の場合と同様である。本明細書において、カプセル皮膜に対する液なじみとは、カプセル皮膜と、充填される内容物との接触面における濡れをいう。カプセル皮膜に対する液なじみの指標としては、例えば、カプセル皮膜上に滴下した液滴の濡れを動的接触角(前進角)の大きさで表すことができる。動的接触角が大きい程流動する液体の濡れが低く、液なじみが低い。動的接触角が小さいほど、カプセル皮膜と接して流動する液体の濡れが高く、液なじみが高いことになる。このような「カプセル皮膜に対する液なじみ」が向上すると、カプセル皮膜に内容物を充填する工程を高度に制御することが可能となり、例えば、充填内容物の偏り、泡かみ、液漏れが生じにくいとの効果を奏する。
本発明の経口組成物は、(A)成分の薬理作用に基づいて治療効果や健康増進効果が期待される疾病、症状、状態に対する治療薬、予防薬、改善剤として好適に使用される。(A)成分の薬理作用に基づく治療効果や健康増進効果としては、限定はされないが、例えば、健胃、消炎、鎮痛、鎮痙、沈静、筋弛緩、中枢抑制、胃運動促進、腸管運動抑制、抗菌、抗潰瘍、駆風、整腸、利尿、利胆、去痰、鎮嘔、鎮吐、発汗、鎮咳、消化機能亢進、解熱、収斂、駆淤血、通経、便通改善、腸内環境改善、精神安定等が挙げられる。このような効果が期待される疾病、症状、状態としては、限定はされないが、例えば、胃もたれ、腹痛、急性胃炎、慢性胃炎、慢性胃炎の急性増悪期、下痢、消化性潰瘍(胃・十二指腸潰瘍)、胃粘膜病変(びらん、出血、発赤、浮腫)、お腹の張り(腹部膨満感)、感冒(かぜ)などの上気道炎、気管支炎、湿疹(ただれ)、アレルギー性結膜炎、急性結膜炎、慢性結膜炎、角膜炎、眼瞼縁炎、咽喉炎、扁桃炎、舌炎、口内炎、口腔創傷、月経困難症、便秘、関節痛、関節炎、神経痛、神経炎、手術後・外傷(けが)後の疼痛等が挙げられる。これらの疾病、症状、状態は、別の疾病、症状、状態に対する治療、予防、改善のために使用された成分の副作用として生じたものも含む。
接触角計DM−501(協和界面科学株式会社製)を用い、同接触角計の拡張法の測定手順に従って、後述する試験例1−1〜1−13の各液状組成物の動的接触角(前進角)を測定した。
試験方法1で用いたカプセル皮膜は、以下の表1のとおりである。各試験例の表では、表1に記載のアルファベット記号(a〜d)により、カプセル皮膜の種類を表記している。
カプセル皮膜b(ロートアルガード鼻炎ソフトカプセルEX)は、ゼラチン、グリセリン及び酸化チタンを含有するゼラチン皮膜である。
カプセル皮膜c(デイトナS)は、コハク化ゼラチン、濃グリセリン、酸化チタン、黄色三二酸化鉄を含有するゼラチン皮膜である。
カプセル皮膜d(エスタック鼻炎ソフトニスキャップ)は、ゼラチン、グリセリン、青色1号等を含有するゼラチン皮膜である。
表2に示す各液状組成物を、上記の試験方法1で示した手順に従い、各試験液を調製後、すぐに動的接触角(前進角)を測定した(3つの測定値の平均)。(B)成分のうち、グリセリン脂肪酸エステルは、ポエムS-100(理研ビタミン株式会社)を用いた(以下同じ)。プロピレングリコール脂肪酸エステルは、PMS−1CV(日光ケミカルズ株式会社製)を用いた(以下同じ)。ポリソルベート80は、TO−10MV(日光ケミカルズ株式会社製)を用いた(以下同じ)。(C)成分のうち、中鎖脂肪酸トリグリセリドは、パナセート810(日油株式会社製)を用いた(以下同じ)。大豆油、オリブ油、小麦胚芽油、ツバキ油は、第十七改正日本薬局方又は医薬品添加物規格2013に収載されるそれぞれの項目を満たすものを用いた(以下同じ)。下記[式1]により、各試験液で用いた(C)成分のみからなる液に対する各試験液の液なじみ改善率を算出した。算出した結果を表2に併せて示す。
[式1]
各試験液で用いた(C)成分のみからなる液に対する液なじみ改善率(%)={1−(各試験液の動的接触角/(C)成分のみからなる液の動的接触角)}×100
表3に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。(A)成分のうち、コウボク末、ソウジュツ末又はチンピ末は、第十七改正日本薬局方又は日本薬局方外生薬規格2015に収載されるコウボク、ソウジュツ又はチンピのそれぞれの項目を満たすものを用いた(以下同じ)。算出した結果を表3に併せて示す。
表4に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。(A)成分のうち、ウイキョウ末又はケイヒ末は、第十七改正日本薬局方又は日本薬局方外生薬規格2015に収載されるウイキョウ又はケイヒのそれぞれの項目を満たすものを用いた(以下同じ)。算出した結果を表4に併せて示す。
表5に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。(A)成分のうち、ウコン末は、第十七改正日本薬局方又は日本薬局方外生薬規格2015に収載されるウコンの項目を満たすものを用いた(以下同じ)。算出した結果を表5に併せて示す。
表6に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。算出した結果を表6に併せて示す。
表7に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。(A)成分のうち、ダイオウ末は、第十七改正日本薬局方又は日本薬局方外生薬規格2015に収載されるダイオウの項目を満たすものを用いた(以下同じ)。算出した結果を表7に併せて示す。
表8に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。(A)成分のうち、オウバク末は、第十七改正日本薬局方又は日本薬局方外生薬規格2015に収載されるオウバクの項目を満たすものを用いた(以下同じ)。算出した結果を表8に併せて示す。
表9に記載の処方に従い、各液状組成物を調製した。(A)成分のうち、ソウジュツ乾燥エキス又はコウボク乾燥エキスは、第十七改正日本薬局方又は日本薬局方外生薬規格2015に収載されるソウジュツ又はコウボクの項目を満たすものを用いた(以下同じ)。表9のソウジュツ乾燥エキスをソウジュツの原生薬換算量で表すと、1500mgであり、表9のコウボク乾燥エキスをコウボクの原生薬換算量で表すと、1000mgである。試験例1−1と同様の方法で動的接触角(前進角)を求めた。算出した結果を表9に併せて示す。
表10に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。算出した結果を表10に併せて示す。
表11に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。算出した結果を表11に併せて示す。
表12に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。算出した結果を表12に併せて示す。
表13に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。算出した結果を表13に併せて示す。
表14〜表18に記載の処方に従い、各液状組成物を調製した。試験例1−1と同様の方法で動的接触角(前進角)を求めた。(A)成分のうち、オンジエキス、ゲンノショウコ末、ジュウヤク乾燥エキス、センブリ末、ヨクイニン乾燥エキス、ベラドンナエキスは、第十七改正日本薬局方又は日本薬局方外生薬規格2015に収載されるオンジ、ゲンノショウコ末、ジュウヤク、センブリ末、ヨクイニン末又はベラドンナエキスのそれぞれの項目を満たすものを用いた(以下同じ)。表15のヨクイニン乾燥エキスをヨクイニンの原生薬換算量で表すと、比較例13−5及び実施例13−5は2000mgであり、比較例13−6及び実施例13−6は6000mgである。表16のジュウヤク乾燥エキスをジュウヤクの原生薬換算量で表すと、比較例13−11及び実施例13−11は1500mgであり、比較例13−12及び実施例13−12は15000mgである。表16の比較例13−9及び実施例13−9のオンジエキスはオンジ300mgより製したものである。表16の比較例13−10、実施例3−10−1及び実施例3−10−2のオンジエキスはオンジ3000mgより製したものである。表17のピレンゼピン塩酸塩水和物の含有量は、ピレンゼピン塩酸塩無水物としての含有量である。算出した結果を表14〜表18に併せて示す。
表19及び表20に記載の処方に従い、各液状組成物を調製した。試験管に7mLの精製水を入れ、各試験液をそれぞれ0.7gずつ滴下し、上下に10回撹拌振とうした。1分間静置した後、目視で観察した。評価基準は、「水に不溶で、水と試験液は分離している」場合に×、「水にほとんど不溶で、ほぼ透明に近く、ごくわずかに濁っている」場合に△、「試験液の一部が分散しているが、不均一である」場合に○、「試験液が均一に分散し、均一に濁っている」場合に◎、と評価した。評価結果を表19及び表20に併せて示す。
表21〜表23に記載の処方に従い、各液状組成物を調製した。表22のピレンゼピン塩酸塩水和物の含有量は、ピレンゼピン塩酸塩無水物としての含有量である。試験管に7mLの精製水を入れ、各試験液をそれぞれ0.7gずつ滴下し、上下に10回撹拌振とうした。1分間静置した後、目視で観察した。評価基準は、「水に不溶で、水と試験液は分離している」場合に×、「水にほとんど不溶で、ほぼ透明又は不透明であり、ごくわずかに濁っている」場合に△、「試験液の一部が分散しているが、不均一である」場合に○、「試験液が均一に分散し、均一に濁っている」場合に◎、と評価した。評価結果を表21〜表23に併せて示す。
公知の技術を用いて、表24〜表30に記載される処方例について液状組成物を調製し、軟カプセル剤を製造する。表中の質量は、1日の服用量とした。
Claims (8)
- (A)胃腸薬系生薬及び/又は胃腸消炎修復成分と、
(B)非イオン性界面活性剤と、
(C)疎水性基剤とを含有する経口組成物。 - 前記胃腸薬系生薬が、コウボク、ソウジュツ、チンピ、ウイキョウ、ケイヒ、ウコン、ダイオウ、オウバク、オウレン、オンジ、ゲンノショウコ、ジュウヤク、センブリ、ヨクイニン及びベラドンナからなる群より選択される少なくとも1種である、請求項1に記載の経口組成物。
- 前記胃腸消炎修復成分が、テプレノン、レバミピド、アルジオキサ、アズレンスルホン酸、ロキソプロフェン、トリメブチン、ピレンゼピン、スクラルファート及びそれらの塩からなる群より選択される少なくとも1種である、請求項1に記載の経口組成物。
- 前記(C)疎水性基剤が、油脂類及び/又はロウ類である、請求項1〜3のいずれか1項に記載の経口組成物。
- 液状経口組成物である、請求項1〜4のいずれか1項に記載の経口組成物。
- 請求項1〜5のいずれか1項に記載の経口組成物が、カプセル皮膜に充填されているカプセル剤。
- 速溶解性及び/又は速放出性である、請求項1〜6に記載の経口組成物。
- (A)胃腸薬系生薬及び/又は胃腸消炎修復成分と、
(B)非イオン性界面活性剤と、
(C)疎水性基剤とを経口組成物に共存させることを含む、カプセル皮膜に対する液なじみ改善作用を該経口組成物に付与する方法。
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CN110623976A (zh) * | 2019-10-24 | 2019-12-31 | 无锡济民可信山禾药业股份有限公司 | 一种治疗胃及十二指肠溃疡的咀嚼片及制备方法 |
JP2021001142A (ja) * | 2019-06-21 | 2021-01-07 | 東洋カプセル株式会社 | ヒドロキシチロソール含有軟カプセル剤 |
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JP2001031565A (ja) * | 1999-07-19 | 2001-02-06 | Nisshin Flour Milling Co Ltd | ロキソプロフェンナトリウム含有カプセル製剤 |
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JP2019001749A (ja) * | 2017-06-15 | 2019-01-10 | 大峰堂薬品工業株式会社 | オンジエキス含有内服用固形医薬製剤 |
JP2021001142A (ja) * | 2019-06-21 | 2021-01-07 | 東洋カプセル株式会社 | ヒドロキシチロソール含有軟カプセル剤 |
JP7360103B2 (ja) | 2019-06-21 | 2023-10-12 | 東洋カプセル株式会社 | ヒドロキシチロソール含有軟カプセル剤 |
CN110623976A (zh) * | 2019-10-24 | 2019-12-31 | 无锡济民可信山禾药业股份有限公司 | 一种治疗胃及十二指肠溃疡的咀嚼片及制备方法 |
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