JP2014224161A - Solid pharmaceutical composition - Google Patents
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- JP2014224161A JP2014224161A JP2014184016A JP2014184016A JP2014224161A JP 2014224161 A JP2014224161 A JP 2014224161A JP 2014184016 A JP2014184016 A JP 2014184016A JP 2014184016 A JP2014184016 A JP 2014184016A JP 2014224161 A JP2014224161 A JP 2014224161A
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 59
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- BWHMMNNQKKPAPP-UHFFFAOYSA-L potassium carbonate Substances [K+].[K+].[O-]C([O-])=O BWHMMNNQKKPAPP-UHFFFAOYSA-L 0.000 claims abstract description 69
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- 229910000028 potassium bicarbonate Inorganic materials 0.000 claims abstract description 65
- 239000011736 potassium bicarbonate Substances 0.000 claims abstract description 65
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 claims abstract description 65
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Abstract
Description
本発明は、固形医薬組成物に関する。さらに詳しくは、漢方エキス、炭酸水素カリウム及び／又は炭酸カリウム、ならびにデンプンを含有する固形医薬組成物であって、パウチ型包装容器に充填されている固形医薬組成物に関する。 The present invention relates to a solid pharmaceutical composition. More specifically, the present invention relates to a solid pharmaceutical composition containing a Chinese medicine extract, potassium bicarbonate and / or potassium carbonate, and starch, which is filled in a pouch-type packaging container.
炭酸水素カリウムや炭酸カリウムなどの炭酸塩は、医薬品、食品、化粧品等の多分野で古くから汎用の成分であり、制酸剤又はアシドーシス抑制剤として医薬品中に配合されたり、経口の水分補給剤の成分として用いられたりする。また、組成物をアルカリ性にしたり、アルカリ性の状態を維持したりする緩衝剤としての機能や、崩壊剤としての機能等も有するため、賦形剤として医薬品等の組成物中に配合される。例えば、特許文献１には、炭酸水素ナトリウムを配合することにより、漢方エキスの溶出性を向上させた錠剤組成物が開示されている。 Carbonates such as potassium hydrogen carbonate and potassium carbonate have long been used in many fields such as pharmaceuticals, foods, and cosmetics, and are included in pharmaceuticals as antacids or acidosis inhibitors, or oral hydration agents. Or used as a component of Moreover, since it has the function as a buffering agent which makes a composition alkaline or maintains an alkaline state, the function as a disintegrating agent, etc., it mix | blends in compositions, such as a pharmaceutical, as an excipient | filler. For example, Patent Document 1 discloses a tablet composition in which the dissolution property of a Chinese medicine extract is improved by blending sodium bicarbonate.
デンプンは、安定性や安全性に優れ、結合剤、賦形剤、崩壊剤等として、主に固形医薬組成物等の添加剤として広く使用されている。例えば、特許文献２には、薬物及び１０〜９０重量％のα化デンプンを含有する固形医薬製剤が開示されている。
Starch is excellent in stability and safety, and is widely used as a binder, excipient, disintegrant, etc., mainly as an additive for solid pharmaceutical compositions and the like. For example,
特許文献１の錠剤組成物は非発泡性であり、炭酸水素ナトリウムは崩壊補助剤としてではなく、溶出促進剤として使用されている。また、特許文献１の錠剤組成物には、漢方エキス、及び炭酸水素ナトリウム以外に、必要に応じ、適宜に賦形剤や滑沢剤等を添加できることが記載されており、その一例として、ＰＣＳ等のデンプン類が挙げられている。しかしながら、特許文献１には、漢方エキス、炭酸水素ナトリウム、及びデンプンを含有する錠剤組成物は具体的に開示されておらず、該錠剤組成物をパウチ型の包装容器に充填するとの記載もない。 The tablet composition of Patent Document 1 is non-foaming, and sodium bicarbonate is used as an elution accelerator, not as a disintegration aid. Moreover, it is described in the tablet composition of patent document 1 that an excipient | filler, a lubricant, etc. can be added suitably as needed other than a Chinese medicine extract and sodium hydrogencarbonate as an example. And the like. However, Patent Document 1 does not specifically disclose a tablet composition containing a Kampo extract, sodium hydrogen carbonate, and starch, nor does it describe filling the tablet composition into a pouch-type packaging container. .
また、特許文献２の固形医薬製剤においては、薬物及びα化デンプン以外に、添加剤を適当量含有できることが記載されており、その一例として、炭酸カルシウムが挙げられている。しかしながら、漢方エキス及びデンプンを含有する組成物はもとより、さらに炭酸水素カリウム及び／又は炭酸カリウムを含有する組成物は開示されておらず、該組成物をパウチ型の包装容器に充填するとの記載もない。
In addition, in the solid pharmaceutical preparation of
本発明者らは、固形医薬組成物の常法に従い、漢方エキス、炭酸水素カリウム、及びデンプンを含有する固形医薬組成物を得た。この固形医薬組成物をパウチ型包装容器に充填して保存したところ、驚くべきことに、該包装容器が膨らんで形状が変化するとの課題を見出した。 The present inventors obtained the solid pharmaceutical composition containing a Chinese medicine extract, potassium hydrogencarbonate, and starch according to the conventional method of a solid pharmaceutical composition. When this solid pharmaceutical composition was filled and stored in a pouch-type packaging container, it was surprisingly found that the packaging container swells and changes its shape.
本発明の課題は、漢方エキス、炭酸水素カリウム及び／又は炭酸カリウム、ならびにデンプンを含有する固形医薬組成物であって、該固形医薬組成物をパウチ型包装容器に充填した状態で保存しても、包装容器の膨張が抑制された固形医薬組成物を提供することにある。 An object of the present invention is a solid pharmaceutical composition containing a Kampo extract, potassium hydrogen carbonate and / or potassium carbonate, and starch, even if the solid pharmaceutical composition is stored in a pouch-type packaging container. An object of the present invention is to provide a solid pharmaceutical composition in which expansion of a packaging container is suppressed.
本発明者らは、上記課題を解決する為に検討を重ねた結果、漢方エキス、炭酸水素カリ及び／又は炭酸カリウムウム、ならびにデンプンを含有する固形医薬組成物であっても、漢方エキスと、炭酸水素カリウム及び／又は炭酸カリウムの重量比が特定である固形医薬組成物は、パウチ型包装容器に充填して、常温下で長期あるいは高温条件下で保存した後にも、該包装容器の膨張が抑制され、形状変化が認められないことを見出し、本発明を完成するに至った。 As a result of repeated studies to solve the above-mentioned problems, the present inventors have obtained a Kampo extract, even a solid pharmaceutical composition containing potassium herb extract, potassium bicarbonate and / or potassium carbonate, and starch, A solid pharmaceutical composition having a specific weight ratio of potassium hydrogen carbonate and / or potassium carbonate is filled in a pouch-type packaging container, and the packaging container expands even after being stored at room temperature for a long time or under a high temperature condition. It was suppressed, and it discovered that a shape change was not recognized, and came to complete this invention.
即ち、本発明は、（Ａ）漢方エキス、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウム、ならびに（Ｃ）デンプンを含有し、かつ、パウチ型包装容器に充填されてなる固形医薬組成物であって、前記（Ａ）漢方エキスの重量が（Ｂ）炭酸水素カリウム及び／又は炭酸カリウムの重量に対して３．５倍以上である、固形医薬組成物、に関する。 That is, the present invention is a solid pharmaceutical composition containing (A) Chinese medicine extract, (B) potassium bicarbonate and / or potassium carbonate, and (C) starch, and filled in a pouch-type packaging container. In addition, the present invention relates to (B) a solid pharmaceutical composition in which the weight of the Chinese medicine extract is (B) 3.5 times or more of the weight of potassium bicarbonate and / or potassium carbonate.
本発明の固形医薬組成物は、漢方エキス、炭酸水素カリウム及び／又は炭酸カリウム、ならびに、デンプンを含有するものであるが、パウチ型包装容器に充填した状態で保存されても、該包装容器の膨張が抑制され、形状変化が少ないという効果を奏するものである。 The solid pharmaceutical composition of the present invention contains a Chinese medicine extract, potassium hydrogen carbonate and / or potassium carbonate, and starch, and even if stored in a packed state in a pouch-type packaging container, Expansion is suppressed and there exists an effect that a shape change is few.
本発明の固形医薬組成物（単に、本発明の医薬組成物ともいう）は、（Ａ）漢方エキス、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウム、ならびに（Ｃ）デンプンを含有し、かつ、パウチ型包装容器に充填されるものであって、前記（Ａ）漢方エキスの重量が（Ｂ）炭酸水素カリウム及び／又は炭酸カリウムの重量に対して３．５倍以上であることに大きな特徴を有する。 The solid pharmaceutical composition of the present invention (also simply referred to as the pharmaceutical composition of the present invention) contains (A) Chinese medicine extract, (B) potassium bicarbonate and / or potassium carbonate, and (C) starch, and The pouch-type packaging container is filled with a feature that the weight of the (A) Chinese medicine extract is 3.5 times or more of the weight of (B) potassium bicarbonate and / or potassium carbonate. Have.
パウチ型包装容器とは、一般的に、合成樹脂やアルミ箔を積層加工したフィルムで出来ており、空気や水分、光を遮断して、内容物を密閉保存することができる容器である。例えば、ジッパー式パウチ型包装容器は、ジッパーによって開閉自在な取出口を有することから、サプリメント等の包装容器として好適である。しかしながら、容器内外の空気圧によって形状が変化するために、例えば、通常雰囲気下では容器内の空気圧を大気圧と同じに保つ必要がある。 A pouch-type packaging container is generally made of a film obtained by laminating a synthetic resin or aluminum foil, and is a container capable of hermetically storing contents by blocking air, moisture and light. For example, a zipper-type pouch-type packaging container is suitable as a packaging container for supplements and the like because it has an outlet that can be opened and closed by a zipper. However, since the shape changes depending on the air pressure inside and outside the container, it is necessary to keep the air pressure inside the container the same as the atmospheric pressure in a normal atmosphere, for example.
一方、医薬品の一般的な添加剤として知られている炭酸水素塩及び／又は炭酸塩は、水や酸との接触等により炭酸ガス（ＣＯ２）を発生するという特性を有する。このＣＯ２発生（発泡ともいう）を利用して、錠剤や顆粒剤等の固形医薬組成物の崩壊特性を向上させる技術が使用されている。炭酸水素塩及び／又は炭酸塩を含有する製剤において、ＣＯ２発生は、水等の溶媒や生体内分泌物（唾液、胃液等）に接触することで誘発される。 On the other hand, hydrogen carbonate and / or carbonate known as a general additive for pharmaceuticals has a characteristic of generating carbon dioxide (CO 2 ) by contact with water or acid. A technique for improving the disintegration characteristics of solid pharmaceutical compositions such as tablets and granules by using this CO 2 generation (also referred to as foaming) has been used. In a preparation containing hydrogen carbonate and / or carbonate, CO 2 generation is induced by contact with a solvent such as water or an endocrine secretion (saliva, gastric juice, etc.).
しかし、漢方エキス、炭酸水素カリウム、及びデンプンの混合末を、通常雰囲気下で、パウチ型包装容器に充填して保存したところ、該包装容器が膨らんで形状が変化してしまうことが確認された。この現象は、漢方エキス、炭酸水素カリウム、及びデンプンを組み合わせた場合に認められ、同じ炭酸水素塩である炭酸水素ナトリウムや、デンプンに代えてその他の添加剤を用いた例では確認されなかった。このように特定の成分を配合した場合にのみ、前記現象が生じる詳細な理由については不明であるが、炭酸水素カリウム及び／又は炭酸カリウムは、漢方エキスとデンプンの共存下では、分解が促進されてＣＯ２を発生するものの、炭酸水素カリウム及び／又は炭酸カリウム重量の３．５倍量以上の漢方エキスが存在することにより、該分解が抑制されて、前記現象の発生が抑制されると推定される。 However, when the mixed powder of Kampo extract, potassium bicarbonate, and starch was filled and stored in a pouch-type packaging container under a normal atmosphere, it was confirmed that the packaging container would swell and change its shape. . This phenomenon was observed when a Chinese medicine extract, potassium bicarbonate, and starch were combined, and was not confirmed in examples using sodium bicarbonate, which is the same bicarbonate, or other additives in place of starch. The detailed reason why the above phenomenon occurs only when specific components are blended in this way is not clear, but potassium bicarbonate and / or potassium carbonate is promoted to decompose in the presence of Kampo extract and starch. although generating a CO 2 Te, estimated by potassium hydrogen carbonate and / or potassium carbonate by weight 3.5 times or more Kampo extract is present, the decomposition is suppressed, and occurrence of the phenomenon can be suppressed Is done.
本発明における（Ａ）漢方エキスとしては、医薬上、薬理学的に又は生理学的に許容されるものであればよく、構成する生薬の組合せやその配合比率についても特に制限されないが、例えば、「一般用漢方処方の手引き」〔厚生省薬務局監修、日本製薬団体連合会漢方専門委員会編、薬業時報社（現じほう社）発行〕に記載されている漢方処方のエキスを用いることが出来る。漢方エキスは、漢方処方を原料として含むものであり、具体的には、水やエタノールなど公知の溶媒を用いて抽出したものが例示される。漢方処方の具体例としては、防風通聖散、安中散、安中散加茯苓、胃風湯、胃苓湯、茵チン蒿湯、茵チン五苓散、温経湯、温清飲、温胆湯、延年半夏湯、黄耆建中湯、黄ゴン湯、応鐘散、黄連阿膠湯、黄連解毒湯、黄連湯、乙字湯、乙字湯去大黄、化食養脾湯、カッ香正気散、葛根黄連黄ゴン湯、葛根紅花湯、葛根湯、葛根湯加川キュウ辛夷、加味温胆湯、加味帰脾湯、加味解毒湯、加味逍遙散、加味逍遙散加川キュウ地黄、加味平胃散、乾姜人参半夏丸、甘草瀉心湯、甘草湯、甘麦大棗湯、帰耆建中湯、桔梗湯、帰脾湯、キュウ帰膠艾湯、キュウ帰調血飲、キュウ帰調血飲第一加減、響声破笛丸、杏蘇散、苦参湯、駆風解毒散、荊芥連翹湯、鶏肝丸、桂枝湯、桂枝加黄耆湯、桂枝加葛根湯、桂枝加厚朴杏仁湯、桂枝加芍薬生姜人参湯、桂枝加芍薬大黄湯、桂枝加芍薬湯、桂枝加朮附湯、桂枝加竜骨牡蛎湯、桂枝加苓朮附湯、桂枝人参湯、桂枝茯苓丸、桂枝茯苓丸料加ヨク苡仁、啓脾湯、荊防敗毒散、桂麻各半湯、鶏鳴散加茯苓、堅中湯、甲字湯、香砂平胃散、香砂養胃湯、香砂六君子湯、香蘇散、厚朴生姜半夏人参甘草湯、五虎湯、牛膝散、五積散、牛車腎気丸、呉茱萸湯、五物解毒散、五淋散、五苓散、柴陥湯、柴胡加竜骨牡蛎湯、柴胡桂枝乾姜湯、柴胡桂枝湯、柴胡清肝湯、柴芍六君子湯、柴朴湯、柴苓湯、左突膏、三黄散、三黄瀉心湯、酸棗仁湯、三物黄ゴン湯、滋陰降火湯、滋陰至宝湯、紫雲膏、四逆散、四君子湯、滋血潤腸湯、七物降下湯、柿蒂湯、四物湯、炙甘草湯、芍薬甘草湯、鷓鴣菜湯、蛇床子湯、十全大補湯、十味敗毒湯、潤腸湯、蒸眼一方、生姜瀉心湯、小建中湯、小柴胡湯、小柴胡湯加桔梗石膏、小承気湯、小青竜湯、小青竜湯加杏仁石膏、小青龍湯加石膏、椒梅湯、小半夏加茯苓湯、消風散、升麻葛根湯、逍遙散、四苓湯、辛夷清肺湯、秦キュウ姜活湯、秦キュウ防風湯、参蘇飲、神秘湯、参苓白朮散、清肌安蛔湯、清湿化痰湯、清暑益気湯、清上ケン痛湯、清上防風湯、清心蓮子飲、清肺湯、折衝飲、川キュウ茶調散、千金鶏鳴散、銭氏白朮散、疎経活血湯、蘇子降気湯、大黄甘草湯、大黄牡丹皮湯、大建中湯、大柴胡湯、大柴胡湯去大黄、大半夏湯、竹茹温胆湯、治打撲一方、治頭瘡一方、治頭瘡一方去大黄、中黄膏、調胃承気湯、丁香柿蒂湯、釣藤散、猪苓湯、猪苓湯合四物湯、通導散、桃核承気湯、当帰飲子、当帰建中湯、当帰散、当帰四逆湯、当帰四逆加呉茱萸生姜湯、当帰芍薬散、当帰湯、当帰貝母苦参丸、独活葛根湯、独活湯、二朮湯、二陳湯、女神散、人参養栄湯、人参湯、排膿散、排膿湯、麦門冬湯、八味地黄丸、半夏厚朴湯、半夏瀉心湯、半夏白朮天麻湯、白虎湯、白虎加桂枝湯、白虎加人参湯、不換金正気散、茯苓飲、茯苓飲加半夏、茯苓飲合半夏厚朴湯、茯苓沢瀉湯、伏竜肝湯、分消湯、平胃散、防已黄耆湯、防已茯苓湯、補気健中湯、補中益気湯、補肺湯、麻黄湯、麻黄附子細辛湯、麻杏甘石湯、麻杏ヨク甘湯、麻子仁丸、揚柏散、ヨク苡仁湯、抑肝散、抑肝散加陳皮半夏、立効散、六君子湯、竜胆瀉肝湯、苓姜朮甘湯、苓桂甘棗湯、苓桂朮甘湯、六味丸等が例示される。 The (A) Kampo extract in the present invention may be any pharmaceutically, pharmacologically or physiologically acceptable, and there are no particular restrictions on the combination of herbal medicines and the blending ratio thereof. Extracts of Kampo prescriptions described in “Guide to general-use Kampo prescriptions” (supervised by the Ministry of Health and Welfare, Pharmacy Bureau, edited by the Japan Pharmaceutical Association, Kampo Special Committee, published by Yakuho Jihosha (currently Jihosha)) can be used. . The Kampo extract contains a Kampo prescription as a raw material, and specific examples include those extracted using a known solvent such as water and ethanol. Specific examples of Kampo prescriptions include Fufutsu Seiki, Anchu-san, Annaka-san, Ganfu-to, Gabuchi-yu, Sakai Chin-to, Sakai Chin Go-san, Unkei-to, Warm-and-drink, Hot-boiled hot water, Ennenhan summer hot water, Huanglong Jianchu hot water, Huang-gon hot water, Okansan, Hokuren Aji hot water, Huangren detoxifying hot water, Houren hot water, Otsuji hot water, Otsuji hot water leaving Daihyo, Kayaku no Splenic hot water, Kasuka Sankisan, Kakkon Houren Huang-Gon, Kakkon Hongka-yu, Kakkon-yu, Kakone-yu Kagawa Spicy Hot Spring, Kami Hot-boiled Hot Spring, Kami Kaitou-yu, Kami Detoxing Hot Water, Kami-Sanyu, Kami-San Kagawa Kyu Ji-Huang, Kamiheigasakusan, Inui-Ginseng Hanatsumaru, Liquorice Hot Spring, Licorice Hot Spring, Sweet Barley Hot Spring, Kikai Kenchu Hot Spring, Kikyo Hot Spring, Kisui Hot Spring, Kyu Ki-Gai Hot Spring, Kyu Kisei Blood Drink, Kyu Home First adjustment of blood-drinking, Hibiki-fu-Fuemaru, Anzu-san, Nana-san, Kaifu-to-doku-san, Kureren-yu, Chicken liver-maru, Katsue-yu, Keishika-kao-yu, Keishika-kakatsu-yu , Katsueka Atsu Park Anjinyu, Katsueka Ginseng Ginseng Hot Spring, Katsueda Shakuyaku Daioyu, Keishika Kayakuyu, Katsueka Kayutsuyu, Katsueka Dragon Bone Oysteryu, Keishika Katsukiyuyu, Keishijinjin-yu, Keishi Karasuma, Keishi Karasuma Yokajin , Keisyu-to, Tsumugi detoxification powder, Katsura-han Hanyu, Chicken narcissus hot water, Kenchu-yu, Ko-ji-yu, Kosa-hiragashira-san, Kosa-no-yaku-to, Kosa-Rokukimiko-to, Kosa-san , Kopak Ginger Hanatsu Ginseng Amakusa-yu, Gotora-yu, Gyu-Kyo-san, Gokan-san, Ushizura-Ken-maru, Kureyu-yu, Gomono-detox-san, Gojo-san, Gojo-san, Goka-san Keel oyster bath, Saiko katsushi dry bath, Saiko katsushi hot water, Saiko Seiki liver bath, Saiko rikkunshiyu, Sabak hot water, Sakai hot water, left plaster, Sankosan, Sankoshinshin hot water, Suijin hot water, Three Monogon Gon-yu, Shi-in Furu-yu, Shi-in Zouho-yu, Shiun-gyo, Shikaku-san, Shikinko-yu, Shige-Jun-yu, Shichi-jyu-sen-yu, Tsuku-yu, Yotsumono-yu, Tsuga-kanzo-to, Glaze Licorice hot water, beef hot spring, snake bed child hot water, Juzen Daiyu hot water, Jumi-detoxicated hot water, Jun-in hot water, steamed eye, ginger heart hot water, small Nakayu, Shosaikoyu, Shosaikoyu Kyokyo-gypsum, Kojoki-yu, Shosei-ryu, Shosei-ryu-ka-anjin-gypsum, Shosei-ryu-ka-gypsum, Ume-yu, Shohanka-ka-yu, Shoufu-san Hakone, Yusan, Shijonawate, Karin Kiyoku-yu, Sakai Kyu Kou Hot Spring, Sakai Kyu Fengyu, Sansou Drinking, Mystic Hot Spring, Sanraku Hakuensan, Kiyohisa Antoyu, Kiyozuka Tokuyu , Kiyotaka Kouki, Kiyokami Ken-to, Kiyokami Fudo-yu, Seishin Renko Drinking, Kiyo-no-yu, Negoti Drinking, Kawa Kyu-cha-san, Senkin-Chicken-san, Qianji Haku-san Kogeki-to, Dai-kokanzo-yu, Dai-ko peony-skin-yu, Daikenchu-yu, Dai-saiko-yu, Dai-saiko-yu-de-dai-o-ko, most summer bath, bamboo-boiled hot-boiled hot water, bruise one, juniper one, head Azalea Daiochi, Chuo-Otsuka, Toki-gaki-to, Choko-san, Choto-san, Tsuga-to, Tsuyu-yu Gomono-yu, Tsutsu-san, Toukoku-jo-ki-to, Toki Dinko , Tokikenchu, Tokisan, Toki Yotsukato, Toki Shikaka-Gyu Gyoyu, Toki Seiyaku, Toki-yu, Tokaikai Mother Nansen-maru, Tokiwa Kakkon-yu, Tokiwa-yu, Futaba-yu, Ni-Cen-yu, Megami-san, Ninjin-yoei-yu, Ginseng-yu, Dyu-yu-san, Dyu-yu-yu, Bakumon-toyu , Hachimoji Huangmaru, Semi-Summer Koboku-yu, Semi-Summer Hot Spring, Semi-Summer Hakuto Tenma-yu, Shira-Tou-Yu, Shira-Tora Kakei-Edo, Shira-Tora Ginseng-yu, Insane Kim San-San, Sake-drinking, Sake-drinking, Summer Drinking half-summer Koboku hot water, Serizawa hot spring, Fushiryo liver hot water, Bakuryo hot water, Hiragasakusan, Hakusen Houyu, Hakuhoyu hot water, Akiken Kenchu hot water, Hochuekki hot water, Hyukan hot water, Mao Hot water, Mao-bushi spicy hot water, Mao Amami-yu, Mao Yoku-ma-yu, Asako Jinmaru, Yodo-san, Yoku-jin-to, Yokukansan, Yokukansan, Yakukansan-ka-summer, Ritsu-san Illustrative examples include hot water, ryokyokubuto, tsukuyame-yu, tsukutsu-kyo kanto-yu, tsukutsu-ke tsutsu-yu, rikmi-maru, and the like.
これらの漢方エキスは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。これらの漢方エキスの中でも、甘草、芍薬、川きゅう、及び当帰からなる群より選ばれる１以上の生薬を含有する漢方処方を原料として含むエキス、即ち、前記漢方処方から抽出されたエキスが好適例として挙げられる。さらに好適な例として、防風通聖散エキス、温経湯エキスが挙げられる。 These Chinese medicine extracts may be used alone or in combination of two or more. Among these Kampo extracts, an extract containing as a raw material a Kampo prescription containing at least one herbal medicine selected from the group consisting of licorice, glaze, Kawakyu, and Toki, that is, an extract extracted from the Kampo prescription is suitable. Take as an example. Further preferred examples include Fukatsutsu Seisaku extract and Unkeiyu extract.
上記「一般用漢方処方の手引き」には、漢方エキスを構成する生薬の組合せやその配合量が記載されているが、構成する生薬やその配合比率を適宜変更して得られる漢方エキスであっても、本発明に使用することができる。例えば、防風通聖散エキスは、防風１．２重量部、黄ごん２．０重量部、大黄１．５重量部、芒硝１．５重量部、麻黄１．２重量部、石膏２〜３重量部、白朮２．０重量部、荊芥１．２重量部、連翹１．２重量部、桔梗２．０重量部、山梔子１．２重量部、芍薬１．２重量部、当帰１．２重量部、川きゅう１．２重量部、薄荷１．２重量部、滑石３〜５重量部、生姜１．２重量部、及び甘草２．０重量部からなる混合原料の抽出物として知られているが、黄ごんを含まないもの、白朮を含まないもの、配合比率を適宜変更したもの等であってもよい。また、温経湯エキスは、半夏３〜５重量部、麦門冬３〜１０重量部、当帰２〜３重量部、川きゅう２.０重量部、芍薬２.０重量部、人参２.０重量部、桂枝２．０重量部、阿膠２.０重量部、牡丹皮２.０重量部、甘草２.０重量部、乾生姜１.０重量部(生姜1〜２重量部)、及び呉茱萸1〜３重量部からなる混合原料の抽出物として知られているが、各生薬の配合比率を適宜変更したもの等であってもよい。 The above-mentioned “Guide for general-purpose Kampo prescription” describes the combination of herbal medicines constituting the Kampo extract and the blending amount thereof, but is a Kampo extract obtained by appropriately changing the constituting herbal medicine and its blending ratio. Can also be used in the present invention. For example, the windproof tsushosan extract is 1.2 parts by weight of windproof, 2.0 parts by weight of yellow rice, 1.5 parts by weight of large yellow, 1.5 parts by weight of mirabilite, 1.2 parts by weight of hemp, 2-3 gypsum. Parts by weight, white birch 2.0 parts by weight, firewood 1.2 parts by weight, ream 1.2 parts by weight, bellflower 2.0 parts by weight, yam 1.2 parts by weight, glaze 1.2 parts by weight, Toki 1.2 Known as an extract of mixed raw materials consisting of parts by weight, 1.2 parts by weight of river cucumber, 1.2 parts by weight of light load, 3-5 parts by weight of talc, 1.2 parts by weight of ginger, and 2.0 parts by weight of licorice However, it may be one that does not contain yellow rice, one that does not contain white rice cake, one in which the blending ratio is appropriately changed, and the like. In addition, Onkeito extract is 3 to 5 parts by weight in the summer, 3 to 10 parts by weight in the winter, 2 to 3 parts by weight, 2.0 parts by weight of Kawakyu, 2.0 parts by weight of glaze, 2 ginseng. 0.0 parts by weight, 2.0 parts by weight of katsura, 2.0 parts by weight of glue, 2.0 parts by weight of peony skin, 2.0 parts by weight of licorice, 1.0 part by weight of dried ginger (1 to 2 parts by weight of ginger) Although it is known as an extract of a mixed raw material consisting of 1 to 3 parts by weight of Kure Koji, it may be one obtained by appropriately changing the blending ratio of each herbal medicine.
また、本発明の医薬組成物は、炭酸水素カリウム（ＫＨＣＯ３）及び炭酸カリウム（Ｋ２ＣＯ３）の少なくとも１種を含有する。本発明における、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウムは、本発明の医薬組成物が水等の溶媒や生体分泌物（唾液や胃液等）と接触することにより分解して、ＣＯ２を発生（発泡）し崩壊性を向上させる。炭酸水素カリウム及び／又は炭酸カリウムとしては、市販品を用いることができ、例えば、日本薬局方、European Pharmacopeia、United States Pharmacopeia等に適合するものが使用される。また、好適な市販品としては、旭硝子社製、東亜合成化学工業社製、東京応化社製、林純薬工業社製等が挙げられる。
The pharmaceutical compositions of the present invention contains at least one potassium bicarbonate (KHCO 3) and
（Ｃ）デンプンとしては、バレイショデンプン、コメデンプン、トウモロコシデンプン、コムギデンプン、デキストラン等、当該分野で公知のデンプンを用いることができるが、なかでもバレイショデンプンが好ましい。デンプンは、公知の方法に従って調製してもよく、市販品を用いてもよい。好適な市販品としては、日澱化学社製、丸石製薬社製、松谷化学社製社製、日本食品加工社製等が挙げられる。 (C) As starch, potato starch, rice starch, corn starch, wheat starch, dextran, etc. can use well-known starch in the said field | area, Among these, potato starch is preferable. Starch may be prepared according to a known method, or a commercially available product may be used. Suitable commercial products include those manufactured by Nissho Chemical Co., Ltd., Maruishi Pharmaceutical Co., Ltd., Matsutani Chemical Co., Ltd., and Nippon Food Processing Co., Ltd.
本発明の固形医薬組成物における（Ａ）漢方エキスの含有量は、該組成物の総量１００重量％に対して、３０〜９０重量％が好ましく、５０〜９０重量％がより好ましく、６０〜９０重量％がさらに好ましい。 The content of the Chinese medicine extract (A) in the solid pharmaceutical composition of the present invention is preferably 30 to 90% by weight, more preferably 50 to 90% by weight, and more preferably 60 to 90% with respect to 100% by weight of the total amount of the composition. More preferred is weight percent.
本発明の固形医薬組成物における（Ｂ）炭酸水素カリウム及び／又は炭酸カリウムの含有量は、該組成物の総量１００重量％に対して、１〜２０重量％が好ましく、２〜１５重量％がより好ましく、３〜１０重量％がさらに好ましい。なお、本明細書において、炭酸水素カリウム及び／又は炭酸カリウムの、含有量又は重量とは、本発明の医薬組成物に含有される炭酸水素カリウム及び炭酸カリウムの合計重量のことを意味する。 The content of (B) potassium hydrogen carbonate and / or potassium carbonate in the solid pharmaceutical composition of the present invention is preferably 1 to 20% by weight, and 2 to 15% by weight with respect to 100% by weight of the total amount of the composition. More preferred is 3 to 10% by weight. In the present specification, the content or weight of potassium bicarbonate and / or potassium carbonate means the total weight of potassium bicarbonate and potassium carbonate contained in the pharmaceutical composition of the present invention.
本発明の固形医薬組成物における（Ｃ）デンプンの含有量は、該組成物の総量１００重量％に対して、３〜４５重量％が好ましく、４〜４０重量％がより好ましく、５〜３５重量％がさらに好ましい。 The content of (C) starch in the solid pharmaceutical composition of the present invention is preferably from 3 to 45% by weight, more preferably from 4 to 40% by weight, more preferably from 5 to 35% by weight based on 100% by weight of the total amount of the composition. % Is more preferable.
本発明の固形医薬組成物において、（Ａ）漢方エキスの重量は、パウチ型包装容器の膨張抑制の観点から、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウムの重量に対して３．５倍以上、好ましくは３．７倍以上、より好ましくは４．０倍以上、さらに好ましくは４．５倍以上、さらに好ましくは５．０倍以上である。また、崩壊性の観点から、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウムの重量に対して、好ましくは２０倍以下、より好ましくは１５倍以下である。従って、（Ａ）漢方エキスの重量は、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウムの重量に対して、３．５倍以上であり、３．５〜２０倍が好ましく、３．７〜２０倍がより好ましく、４.０〜２０倍がさらに好ましく、４.５〜２０倍がさらに好ましく、５.０〜１５倍がさらに好ましい。 In the solid pharmaceutical composition of the present invention, the weight of (A) Chinese medicine extract is 3.5 times or more with respect to the weight of (B) potassium bicarbonate and / or potassium carbonate from the viewpoint of suppressing expansion of the pouch-type packaging container. The ratio is preferably 3.7 times or more, more preferably 4.0 times or more, further preferably 4.5 times or more, and further preferably 5.0 times or more. Moreover, from a disintegrating viewpoint, it is 20 times or less with respect to the weight of (B) potassium hydrogencarbonate and / or potassium carbonate, More preferably, it is 15 times or less. Therefore, the weight of (A) Chinese medicine extract is 3.5 times or more, preferably 3.5 to 20 times, preferably 3.7 to 20 times the weight of (B) potassium bicarbonate and / or potassium carbonate. Is more preferable, 4.0 to 20 times is more preferable, 4.5 to 20 times is further preferable, and 5.0 to 15 times is more preferable.
また、本発明の固形医薬組成物において、（Ｃ）デンプンの重量は、漢方エキス製剤化の観点から、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウムの重量に対して、好ましくは０．５〜２０倍、より好ましくは１．０〜１０倍である。 In the solid pharmaceutical composition of the present invention, the weight of (C) starch is preferably 0.5 to the weight of (B) potassium bicarbonate and / or potassium carbonate, from the viewpoint of formulating Kampo extract. 20 times, more preferably 1.0 to 10 times.
本発明の固形医薬組成物は、上記成分以外に、賦形剤、結合剤、崩壊剤、滑沢剤、甘味剤、矯味剤、防腐剤、キレート剤、抗酸化剤、清涼化剤、コーティング剤、安定化剤、流動化剤、粘稠剤、溶解補助剤、増粘剤、緩衝剤、香料、着色剤、吸着剤、湿潤剤、防湿剤、帯電防止剤、可塑剤、消泡剤、界面活性剤等の添加剤を含有することができる。添加剤の例としては、乳糖、白糖等の糖類；結晶セルロース、ヒドロキシプロピルセルロース等のセルロース類；メタケイ酸アルミン酸マグネシウム、ステアリン酸マグネシウム、夕ルク、酸化チタン等の無機物質が挙げられる。 In addition to the above components, the solid pharmaceutical composition of the present invention comprises excipients, binders, disintegrants, lubricants, sweeteners, corrigents, preservatives, chelating agents, antioxidants, cooling agents, and coating agents. , Stabilizer, Fluidizer, Thickener, Solubilizer, Thickener, Buffer, Fragrance, Colorant, Adsorbent, Wetting Agent, Dehumidifier, Antistatic Agent, Plasticizer, Defoamer, Interface Additives such as activators can be included. Examples of additives include saccharides such as lactose and sucrose; celluloses such as crystalline cellulose and hydroxypropyl cellulose; and inorganic substances such as magnesium aluminate metasilicate, magnesium stearate, evening liqueur, and titanium oxide.
本発明の固形医薬組成物は、（Ａ）漢方エキス、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウム、ならびに（Ｃ）デンプンを含有し、かつ、漢方エキスと、炭酸水素カリウム及び／又は炭酸カリウムの重量比が前記割合である固形製剤であって、該固形製剤をパウチ型包装容器に充填しているのであれば特に限定はなく、当業者に公知の方法に従って、調製することができる。また、固形医薬組成物の形状や大きさも特に限定はなく錠剤、又は、散剤、顆粒剤、細粒剤等の造粒物が例示される。なお、錠剤や造粒物は、公知の方法に従って、コーティング処理がされてもよい。 The solid pharmaceutical composition of the present invention comprises (A) Chinese medicine extract, (B) potassium hydrogen carbonate and / or potassium carbonate, and (C) starch, and contains the Chinese medicine extract, potassium hydrogen carbonate and / or potassium carbonate. There is no particular limitation as long as the weight ratio is a solid preparation having the above-mentioned ratio, and the solid preparation is filled in a pouch-type packaging container, it can be prepared according to methods known to those skilled in the art. Further, the shape and size of the solid pharmaceutical composition are not particularly limited, and examples thereof include tablets, or granulated products such as powders, granules, and fine granules. In addition, a tablet and granulated material may be coated according to a known method.
例えば、本発明における固形医薬組成物が造粒物である場合、漢方エキスに、炭酸水素カリウム及び／又は炭酸カリウム、ならびにデンプン、必要により、添加剤を混合することにより得られた混合物を、ローラーコンパクター等で圧縮した後、ロールグラニュレーターで粉砕して篩過する方法により調製することができる。また、本発明における固形医薬組成物が錠剤である場合、漢方エキスに、炭酸水素カリウム及び／又は炭酸カリウム、ならびにデンプン、必要により、添加剤を混合することにより得られた混合物を、そのまま、或いは前記方法に従って造粒後に、打錠機に投入して成型加工する方法により調製することができる。 For example, when the solid pharmaceutical composition according to the present invention is a granulated product, a mixture obtained by mixing potassium bicarbonate and / or potassium carbonate and starch, and, if necessary, an additive with a Kampo extract is added to a roller. After compressing with a compactor etc., it can prepare by the method of grind | pulverizing with a roll granulator and sieving. Further, when the solid pharmaceutical composition in the present invention is a tablet, a mixture obtained by mixing a Chinese medicine extract with potassium bicarbonate and / or potassium carbonate, and starch, and if necessary, an additive as it is, or After granulation according to the above-mentioned method, it can be prepared by a method of putting into a tableting machine and molding.
なお、本発明における固形医薬組成物は、パウチ型包装容器から取り出した後、そのまま口に含んで水や白湯等とともに服用することができる。また、同様にして取り出した後、水や白湯等にあらかじめ溶解又は懸濁してから服用してもよい。 In addition, after taking out from the pouch-type packaging container, the solid pharmaceutical composition in the present invention can be taken in the mouth as it is and taken with water, white water, or the like. Further, after taking out in the same manner, it may be taken after dissolving or suspending in water or white hot water beforehand.
本発明においては、かくして得られた固形医薬組成物はパウチ型包装容器に充填される。パウチ型包装容器としては、特に限定はなく、平型パウチ、スタンディング型パウチ等が例示され、ジッパーがついていてもいなくても良い。パウチの大きさ（容量）も特に限定されない。 In the present invention, the solid pharmaceutical composition thus obtained is filled in a pouch-type packaging container. The pouch-type packaging container is not particularly limited, and examples thereof include a flat pouch and a standing pouch, which may or may not have a zipper. The size (capacity) of the pouch is not particularly limited.
また、充填後、密封されるのであれば、パウチ型包装容器への充填方法、及び、パウチ型包装容器の密封方法は問わない。 Moreover, as long as it seals after filling, the filling method to a pouch type packaging container and the sealing method of a pouch type packaging container are not ask | required.
本発明の医薬組成物のパウチ型包装容器への充填量は、特に限定されない。 The filling amount of the pharmaceutical composition of the present invention into the pouch-type packaging container is not particularly limited.
また、本発明は、別の態様として、（Ａ）漢方エキス、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウム、ならびに（Ｃ）デンプンを含有する固形製剤を充填してなるパウチ型包装容器の膨張抑制方法を提供する。 Further, the present invention provides, as another aspect, an expansion of a pouch-type packaging container filled with a solid preparation containing (A) Chinese medicine extract, (B) potassium bicarbonate and / or potassium carbonate, and (C) starch. Provide a suppression method.
具体的には、（Ａ）漢方エキス、（Ｂ）炭酸水素カリウム及び／又は炭酸カリウム、ならびに（Ｃ）デンプンを含有する固形製剤をパウチ型包装容器に充填する際に、漢方エキスの重量を、炭酸水素カリウム及び／又は炭酸カリウムの重量に対して３．５倍以上、好ましくは３．５〜２０倍、より好ましくは３．７〜２０倍、さらに好ましくは４.０〜２０倍、さらに好ましくは４.５〜２０倍、さらに好ましくは５.０〜１５倍にすることで、該パウチ型包装容器を通常条件下で長期保存、又は高温条件下で保存しても、パウチ型包装容器の膨張が抑制され、形状変化が少ないものとなる。 Specifically, when filling a pouch-type packaging container with a solid preparation containing (A) Kampo extract, (B) potassium bicarbonate and / or potassium carbonate, and (C) starch, 3.5 times or more, preferably 3.5 to 20 times, more preferably 3.7 to 20 times, still more preferably 4.0 to 20 times, still more preferably with respect to the weight of potassium bicarbonate and / or potassium carbonate. Is 4.5 to 20 times, more preferably 5.0 to 15 times, so that even if the pouch-type packaging container is stored for a long time under normal conditions or under high-temperature conditions, the pouch-type packaging container Expansion is suppressed and the shape change is small.
以下、本発明を実施例に基づいて説明するが、本発明はこれらの実施例等によりなんら限定されるものではない。 EXAMPLES Hereinafter, although this invention is demonstrated based on an Example, this invention is not limited at all by these Examples.
実施例１−１〜１−６、比較例１−１〜１−４及び参考例１−１〜１−１２（防風通聖散エキス）
表１、２、又は３に示す原料粉末を混合して、実施例１−１〜１−６、比較例１−１〜１−４及び参考例１−１〜１−１２の固形医薬組成物（粉末）を得た。得られた固形医薬組成物（粉末）を、２１０ｍＬ容又は５９０ｍＬ容のパウチ型包装容器（生産日本社製、セイニチクリップラミジップＡＬ10又はセイニチクリップラミジップＡＬ14）に、通常雰囲気下（約２５℃、ＲＨ約５０％）で、充填して該容器を密封した。なお、参考例１−１〜１−６は、漢方エキス、炭酸水素カリウム、及びデンプンからなる群より選ばれるいずれか１成分、又は２成分からなる医薬組成物であり、参考例１−７〜１−１２は、炭酸水素カリウム、又はデンプンの代わりに、異なる添加剤（炭酸水素ナトリウム、乳糖等）を配合した医薬組成物である。
Examples 1-1 to 1-6, Comparative Examples 1-1 to 1-4, and Reference Examples 1-1 to 1-12 (Fengtsu Seikisan Extract)
Solid pharmaceutical compositions of Examples 1-1 to 1-6, Comparative Examples 1-1 to 1-4, and Reference Examples 1-1 to 1-12 by mixing the raw material powders shown in Tables 1, 2, or 3 (Powder) was obtained. The obtained solid pharmaceutical composition (powder) is placed in a 210 mL or 590 mL pouch-type packaging container (manufactured by Production Japan, Seinichi Clip Lam Zip AL10 or Seinichi Clip Lam Zip AL14) under a normal atmosphere (about 25 ° C., about RH). 50%) to fill and seal the container. Reference Examples 1-1 to 1-6 are pharmaceutical compositions composed of any one component or two components selected from the group consisting of Kampo extracts, potassium bicarbonate, and starch, and Reference Examples 1-7 to 1-12 is a pharmaceutical composition containing different additives (sodium bicarbonate, lactose, etc.) in place of potassium bicarbonate or starch.
なお、表３で示す各成分は以下の通りである。
乳糖：「乳糖２００Ｍ」、DMV-Fonterra Excipients社製
白糖：「グラニュー糖」、三井製糖社製
飴粉：「サンマルトミドリ」、林原商事社製
結晶セルロース：「セオラスＰＨ１０１」、旭化成ケミカルズ社製
ヒドロキシプロピルセルロース（ＨＰＣ）：「ＮＩＳＳＯ ＨＰＣ−Ｌ」、日本曹達社製
In addition, each component shown in Table 3 is as follows.
Lactose: “Lactose 200M”, DMV-Fonterra Excipients White Sucrose: “Granulated Sugar”, Mitsui Sugar Co., Ltd. “Sanmaruto Midori”, Hayashibara Corporation Crystalline Cellulose: “Theolas PH101”, Asahi Kasei Chemicals Hydro Propylcellulose (HPC): “NISSO HPC-L”, manufactured by Nippon Soda Co., Ltd.
得られた医薬組成物について、以下の試験例１〜２を行って、各固形医薬組成物が充填されたパウチ型包装容器の体積変化量と性状を評価した。結果を表１〜３に示す。また、表１のデータを図１に、表２のデータを図２に、表３のデータを図３に、また、表１のデータから、漢方エキスと炭酸水素カリウムの重量比と、パウチの体積変化量の関係を示す結果を図４に示す。 About the obtained pharmaceutical composition, the following test examples 1-2 were performed, and the volume variation | change_quantity and property of the pouch-type packaging container with which each solid pharmaceutical composition was filled were evaluated. The results are shown in Tables 1-3. In addition, the data in Table 1 is shown in FIG. 1, the data in Table 2 is shown in FIG. 2, the data in Table 3 is shown in FIG. 3, and the weight ratio of Kampo extract to potassium bicarbonate is calculated from the data in Table 1. The results showing the relationship between the volume changes are shown in FIG.
試験例１〔膨らみ（体積変化）〕
各医薬組成物を、パウチ型包装容器に密封充填された状態で、５０℃の恒温槽内で１週間保存し、保存前後の包装容器毎の体積を以下の方法に従って測定し、膨らみ（体積変化）を評価する。
Test Example 1 [swelling (volume change)]
Each pharmaceutical composition is stored in a thermostatic bath at 50 ° C. for 1 week in a state where it is hermetically packed in a pouch-type packaging container, and the volume of each packaging container before and after storage is measured according to the following method to swell (change in volume) ).
具体的には、１０００ｍＬのメスシリンダーに、水５００ｍＬを量り入れた後、検体を沈め、完全に検体が沈んだ状態のメスシリンダーの目盛りを読み取って検体の体積（ｍＬ）を算出し、保存前後の検体について同様にして体積を求めることにより、差分（体積変化）を求める。
検体の体積（ｍＬ）＝（メスシリンダーの読み取り値）−５００
体積変化量（ｍＬ）＝（５０℃保存後の体積）−（５０℃保存前の体積）
Specifically, after weighing 500 mL of water into a 1000 mL graduated cylinder, submerge the sample, read the scale of the graduated cylinder with the sample completely submerged, calculate the volume (mL) of the sample, and before and after storage Similarly, the difference (volume change) is obtained by obtaining the volume in the same manner.
Sample volume (mL) = (Measuring cylinder reading) −500
Volume change (mL) = (Volume after storage at 50 ° C.) − (Volume before storage at 50 ° C.)
試験例２〔膨らみ（外観）〕
試験例１で体積を測定する際に、あわせて外観を観察し、以下の評価基準に従って、保存開始前の状態に対する膨らみ（外観）を評価する。
Test Example 2 [bulge (appearance)]
When measuring the volume in Test Example 1, the appearance is also observed, and the swelling (appearance) with respect to the state before the start of storage is evaluated according to the following evaluation criteria.
〔膨らみ（外観）の評価基準〕
◎：保存開始前より、容器は膨らんでいない
○：保存開始前より、容器はやや膨らんでいる
△：保存開始前より、容器は膨らんでいる
×：保存開始前より、容器は大きく膨らんでいる
[Evaluation criteria for swelling (appearance)]
◎: The container has not expanded since before the start of storage. ○: The container has slightly expanded since before the start of storage. △: The container has expanded since before the start of storage. ×: The container has expanded significantly before the start of storage.
表１及び２より、組成物における炭酸水素カリウム配合量が同じであっても、防風通聖散エキスと炭酸水素カリウムの重量比が１．１／１である比較例１−１や１−４は、体積変化が大きく、防風通聖散エキスと炭酸水素カリウムの重量比が、固体状態でのＣＯ２発生に影響することが示唆される。また、炭酸水素カリウム重量に対する防風通聖散エキス重量が大きくなるほど、体積変化が小さくなることが分かる。なお、パウチ型包装容器の大きさが異なるものであっても、同様の傾向が認められている。 From Tables 1 and 2, even if the amount of potassium hydrogen carbonate in the composition is the same, Comparative Examples 1-1 and 1-4 in which the weight ratio of Fufutsu Seisaku Extract and potassium hydrogen carbonate is 1.1 / 1 The volume change is large, and it is suggested that the weight ratio of Fufutsu Seisan extract and potassium hydrogen carbonate affects the CO 2 generation in the solid state. Moreover, it turns out that a volume change becomes small, so that the wind-proof Tsushosan extract weight with respect to the potassium hydrogen carbonate weight becomes large. The same tendency is recognized even if the size of the pouch-type packaging container is different.
なお、表１より、防風通聖散エキス、炭酸水素カリウム、デンプンのそれぞれ単独で封入したもの（参考例１−１〜１−３）は、５０℃保存後もパウチ型包装容器の膨らみは見られず、防風通聖散エキス、炭酸水素カリウム、デンプンのいずれか２成分を選択して組み合わせたもの（参考例１−４〜１−６）を封入しても、パウチ型包装容器の膨らみは見られなかった。また、表３より、炭酸水素カリウムの代わりに炭酸水素ナトリウムを用いた例（参考例１−７）や、デンプンの代わりにその他の添加剤等を用いた例（参考例１−８〜１−１２）では、固体状態での保存中にパウチ型包装容器の膨らみは見られず、保存中のパウチ型包装容器の膨らみは、漢方エキス、炭酸水素カリウム、デンプンの３成分を組み合わせた場合に生じる特有の現象であることが示唆される。 From Table 1, the bulge of the pouch-type packaging container was observed after the storage at 50 ° C. in the case where each of Fudotsu Seisaku Extract, potassium hydrogen carbonate, and starch was encapsulated alone (Reference Examples 1-1 to 1-3). The pouch-shaped packaging container does not swell even when encapsulated (Reference Examples 1-4 to 1-6), which is a combination of two components selected from Fufutsu Seisaku Extract, potassium bicarbonate, and starch I couldn't see it. Moreover, from Table 3, the example (reference example 1-7) which used sodium hydrogencarbonate instead of potassium hydrogencarbonate, the example which used other additives etc. instead of starch (reference examples 1-8 to 1- 12), the pouch-type packaging container does not swell during storage in the solid state, and the pouch-type packaging container during storage is swelled when the three components of Chinese medicine extract, potassium bicarbonate, and starch are combined. It is suggested that this is a unique phenomenon.
実施例２−１〜２−２、比較例２−１及び参考例２−１〜２−６（温経湯エキス）
表４に示す原料粉末を混合して、実施例２−１〜２−２、比較例２−１及び参考例２−１〜２−６の固形医薬組成物（粉末）を得た。得られた固形医薬組成物（粉末）は、２１０ｍＬ容のパウチ型包装容器（生産日本社製、セイニチクリップラミジップＡＬ10）を通常雰囲気下（約２５℃、ＲＨ約５０％）で、充填して、該容器を密封した。なお、参考例２−１〜２−６は、漢方エキス、炭酸水素カリウム、及びデンプンからなる群より選ばれるいずれか１成分、又は２成分からなる医薬組成物である。
Examples 2-1 to 2-2, Comparative Example 2-1 and Reference Examples 2-1 to 2-6 (Honkeito extract)
The raw material powders shown in Table 4 were mixed to obtain solid pharmaceutical compositions (powder) of Examples 2-1 to 2-2, Comparative Example 2-1, and Reference Examples 2-1 to 2-6. The obtained solid pharmaceutical composition (powder) is filled with a 210 mL pouch-type packaging container (manufactured by Nihon Shokuhin Co., Ltd., Seinichi Clip Lam Zip AL10) under a normal atmosphere (about 25 ° C., RH about 50%), The container was sealed. Reference Examples 2-1 to 2-6 are pharmaceutical compositions composed of any one component or two components selected from the group consisting of Kampo extract, potassium bicarbonate, and starch.
得られた医薬組成物について、前記の試験例１〜２を行って、各固形医薬組成物が充填されたパウチ型包装容器の体積変化量と性状を評価した。結果を表４及び図５に示す。 About the obtained pharmaceutical composition, said Test Examples 1-2 were performed, and the volume variation | change_quantity and property of the pouch-type packaging container with which each solid pharmaceutical composition was filled were evaluated. The results are shown in Table 4 and FIG.
表４より、組成物における炭酸水素カリウム配合量が同じであっても、温経湯エキスと炭酸水素カリウムの重量比が１．２／１である比較例２−１は、体積変化が大きく、温経湯エキスと炭酸水素カリウムの重量比が、固体状態でのＣＯ２発生に影響することが示唆される。また、表１、２、４の結果より、漢方エキスの種類が異なる場合でも、漢方エキスと炭酸水素カリウムとデンプンを配合して、パウチ型包装容器に充填して保存する場合に、漢方エキスと炭酸水素カリウムの重量比によって前記容器の膨らみが調整されることが示唆される。 From Table 4, even if the amount of potassium hydrogen carbonate in the composition is the same, Comparative Example 2-1 in which the weight ratio of Onkeito extract and potassium hydrogen carbonate is 1.2 / 1 has a large volume change, It is suggested that the weight ratio of the hot water extract and potassium hydrogen carbonate affects the CO 2 generation in the solid state. In addition, from the results of Tables 1, 2, and 4, even when the type of Kampo extract is different, when the Kampo extract, potassium hydrogen carbonate and starch are blended and stored in a pouch-type packaging container, It suggests that the swelling of the container is adjusted by the weight ratio of potassium bicarbonate.
以下に処方例を挙げるが、本発明はこれらの実施例に限られるものではない。 Formulation examples are given below, but the present invention is not limited to these examples.
処方例１
下記原料をそれぞれ篩を用いて篩過し、下記配合比に基づいて秤量した後混合したものを打錠用混合末とし、これを打錠機を用いて錠剤化することにより、錠剤（１錠当たり０．４２ｇ）が製造される。
防風通聖散エキス（エキス含量８０．２重量％） ２６００重量部
炭酸水素カリウム １８０重量部
バレイショデンプン ３００重量部
結晶セルロース ５０重量部
メタケイ酸アルミン酸マグネシウム ７０重量部
ステアリン酸マグネシウム ４０重量部
合計 ３２４０重量部
Formulation Example 1
Each of the following raw materials is sieved using a sieve, weighed according to the following blending ratio, and then mixed to obtain a mixed powder for tableting. 0.42 g) is produced.
Fufutsu Seisaku Extract (extract content 80.2% by weight) 2600 parts by weight Potassium bicarbonate 180 parts by
処方例２
下記配合比の原料を使用して、上記処方例１と同様の方法で錠剤（１錠当たり０．４８ｇ）が製造される。
防風通聖散エキス（エキス含量６９．４重量％） ３０００重量部
炭酸水素カリウム ３００重量部
バレイショデンプン ４７０重量部
乳糖 ８０重量部
メタケイ酸アルミン酸マグネシウム １００重量部
ステアリン酸マグネシウム ３０重量部
ヒドロキシプロピルメチルセルロース ７０重量部
マクロゴール ９０重量部
タルク １００重量部
カルナウバロウ ３０重量部
カラメル ５０重量部
合計 ４３２０重量部
Formulation example 2
Tablets (0.48 g per tablet) are produced in the same manner as in Formulation Example 1 using the raw materials having the following blending ratio.
Fufutsu Seisaku Extract (extract content 69.4% by weight) 3000 parts by
処方例３
下記配合比の原料を使用して、上記処方例１と同様の方法で錠剤（１錠当たり０．４０ｇ）が製造される。
温経湯エキス（エキス含量７１．５重量％） ３５２０重量部
炭酸水素カリウム ２８０重量部
バレイショデンプン ３４０重量部
ラウリル硫酸ナトリウム ２００重量部
乳糖 １００重量部
メタケイ酸アルミン酸マグネシウム １００重量部
ステアリン酸マグネシウム ５０重量部
ヒドロキシプロピルメチルセルロース ８０重量部
マクロゴール ８０重量部
タルク １００重量部
カルナウバロウ ２０重量部
カラメル ５０重量部
合計 ４９２０重量部
Formulation Example 3
Tablets (0.40 g per tablet) are produced in the same manner as in Formulation Example 1 using the raw materials having the following blending ratio.
Unkeito extract (extract content: 71.5% by weight) 3520 parts by weight Potassium bicarbonate 280 parts by weight Potato starch 340 parts by weight
処方例４
下記配合比の原料を使用して、上記処方例１と同様の方法で錠剤（１錠当たり０．３８ｇ）が製造される。
温経湯エキス（エキス含量６５．６重量％） ３０００重量部
炭酸水素カリウム ４５０重量部
バレイショデンプン ６３０重量部
結晶セルロース １００重量部
乳糖 １００重量部
クロスカルメロースナトリウム １５０重量部
メタケイ酸アルミン酸マグネシウム １００重量部
ステアリン酸マグネシウム ４０重量部
合計 ４５７０重量部
Formulation Example 4
Tablets (0.38 g per tablet) are produced in the same manner as in Formulation Example 1 using the raw materials having the following blending ratio.
Unkeito extract (extract content 65.6% by weight) 3000 parts by weight Potassium bicarbonate 450 parts by weight Potato starch 630 parts by
処方例５
下記配合比の原料を使用して、上記処方例１と同様の方法で錠剤（１錠当たり０．４５ｇ）が製造される。
小青竜湯エキス（エキス含量６６．１重量％） ３０００重量部
炭酸水素カリウム ３２０重量部
バレイショデンプン ６５０重量部
結晶セルロース ２００重量部
カルメロースカルシウム １５０重量部
メタケイ酸アルミン酸マグネシウム １２０重量部
ステアリン酸マグネシウム ５０重量部
ポリオキシエチレンポリオキシプロピレングリコール ５０重量部
合計 ４５４０重量部
Formulation Example 5
Tablets (0.45 g per tablet) are produced in the same manner as in Formulation Example 1 using the raw materials having the following blending ratio.
Shoseiryu extract (extract content 66.1% by weight) 3000 parts by weight Potassium bicarbonate 320 parts by weight Potato starch 650 parts by
処方例６
下記原料をそれぞれ篩を用いて篩過し、下記配合比に基づいて秤量した後混合したものを造粒することで顆粒剤（１包１．２ｇ）が製造される。
小青竜湯エキス（エキス含量７１．０重量％） ２５００重量部
炭酸水素カリウム ２２０重量部
バレイショデンプン ４００重量部
乳糖 ２５０重量部
ヒドロキシプロピルセルロース １００重量部
ポリオキシエチレンポリオキシプロピレングリコール ５０重量部
合計 ３５２０重量部
Formulation Example 6
Each of the following raw materials is sieved using a sieve, and the mixture is weighed based on the following blending ratio and then granulated to produce a granule (1.2 g per packet).
Shoseiryu extract (extract content 71.0% by weight) 2500 parts by weight potassium hydrogen carbonate 220 parts by weight Potato starch 400 parts by
本発明の固形医薬組成物は、漢方エキスを配合したものであり、パウチ型包装容器に保存されても安定であることから、携帯性に優れ、簡便に摂取することができるため好適に用いられる。 The solid pharmaceutical composition of the present invention contains a Chinese medicine extract and is stable even when stored in a pouch-type packaging container. Therefore, the solid pharmaceutical composition is suitably used because it is highly portable and can be easily ingested. .
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| CN101199347A (en) * | 2006-12-13 | 2008-06-18 | 中国医药研究开发中心有限公司 | Pb excluding health care product and its preparation method |
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