TWI430807B - Gastrointestinal composition for synergistically increasing peristalsis of digestive tract - Google Patents
Gastrointestinal composition for synergistically increasing peristalsis of digestive tract Download PDFInfo
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- TWI430807B TWI430807B TW095116012A TW95116012A TWI430807B TW I430807 B TWI430807 B TW I430807B TW 095116012 A TW095116012 A TW 095116012A TW 95116012 A TW95116012 A TW 95116012A TW I430807 B TWI430807 B TW I430807B
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- drug composition
- atractylodes
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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Description
本發明係關於含有維生素U(MMSC)以及蒼朮之效果顯著增強之胃腸藥組成物。The present invention relates to a gastrointestinal drug composition which is substantially enhanced in the effect of vitamin U (MMSC) and atractylodes.
一般所謂胃腸藥係顯示緩和飲食過度、胃灼熱、胃脹、胃痛、噁心、嘔吐等症狀之作用,為了維持胃腸之健康狀態或恢復其健康狀態而廣泛地被使用之醫藥品,其中,可細分為消化藥、健胃藥、制酸藥、複合胃腸藥、胃腸鎮痛鎮痙攣藥等。Generally, the gastrointestinal drug system exhibits the effects of alleviating symptoms such as overeating, heartburn, bloating, stomach pain, nausea, vomiting, etc., and is widely used in order to maintain the health of the gastrointestinal tract or restore its health. For digestive medicine, stomach medicine, antacid medicine, compound gastrointestinal medicine, gastrointestinal analgesic and antispasmodic drugs.
維生素U(MMSC)係具有修復惡化之胃黏膜的作用,而廣泛地利用作為胃腸藥,特別是複合胃腸藥之成分。再者,蒼朮為北蒼朮(Atractylodes lancea De Candolle)或山蒼朮(Atractylodes chinensis Koidzumi)之根莖,自古而來被認為係草藥(herb medicine),主要可利用作為健胃消化藥或止瀉整腸藥等(非專利文獻1)。然而,配合兩者之醫藥組成物,特別是胃腸藥係,至目前為止並不存在。Vitamin U (MMSC) has the effect of repairing a worsening gastric mucosa and is widely used as a component of gastrointestinal drugs, particularly compound gastrointestinal drugs. Furthermore, Atractylodes lancea De Candolle or the root of Atractylodes chinensis Koidzumi has been considered herbal medicine since ancient times and can be used mainly as a stomach digestive or antidiarrheal intestine medicine. Etc. (Non-Patent Document 1). However, the pharmaceutical compositions of the two, especially the gastrointestinal tract, have not existed until now.
(非專利文獻1)第14改正版日本藥局方解說書,2001年,D-674至677頁(Non-Patent Document 1) The 14th revision of the Japanese Pharmacy Bureau's Fang Jieshu, 2001, D-674 to 677 pages
本發明之目的係提供,與以往之胃腸藥比較,其有效性顯著增高之新穎胃腸藥組成物。It is an object of the present invention to provide a novel gastrointestinal drug composition which is significantly more effective than conventional gastrointestinal drugs.
本發明者組合使用已知作為胃黏膜修復劑之維生素U(MMSC),與已知作為健胃消化藥或止瀉整腸藥之蒼朮時,顯示顯著之消化管運動賦活之作用,結果發現,作為飽嗝、想吐、噁心或甚至嘔吐之抑制,或胸壓迫感、胃脹、消化不良、胃部.腹部膨脹感或食欲不振的緩解等之胃腸藥之效果係飛躍性地增高,而完成本發明。The inventors used a combination of vitamin U (MMSC), which is known as a gastric mucosa repairing agent, and a known activating technique for digestive tract movement, which is known as a stomach digestive or antidiarrheal intestine, and found that it has a significant effect on the movement of the digestive tract. As a fullness, vomiting, nausea or even vomiting, or chest pressure, bloating, indigestion, stomach. The effect of the gastrointestinal drug such as the abdomen swelling or the relief of loss of appetite is drastically increased, and the present invention has been completed.
亦即,本發明係提供含有MMSC以及蒼朮之胃腸藥組成物。此外,本發明係關於,為了緩解飽嗝、想吐、噁心或甚至嘔吐之抑制、或胸壓迫感、胃脹、消化不良、胃部.腹部膨脹感或甚至食欲不振種種之含有MMSC以及蒼朮之胃腸藥組成物。That is, the present invention provides a composition for gastrointestinal medicine containing MMSC and Atractylodes lancea. In addition, the present invention relates to alleviating satiety, vomiting, nausea or even vomiting, or chest compression, bloating, indigestion, and stomach. Abdominal swelling or even loss of appetite contains MMSC and Atractylodes gastrointestinal composition.
本發明之胃腸藥組成物係,各別單獨使用MMSC或蒼朮所無法得到之依據其協同性地增高消化管運動賦活作用,MMSC所具有之飽嗝、想吐、噁心或甚至嘔吐之抑制,或胸壓迫感、胃脹、消化不良、胃部.腹部膨脹感或食欲不振之緩解等效果顯著提高。The gastrointestinal drug composition of the present invention, which can not be obtained by using MMSC or Atractylodes alone, can synergistically increase the activity of digestive tract movement, MMSC has fullness, vomiting, nausea or even vomiting inhibition, or chest Pressure, bloating, indigestion, stomach. The effects of abdominal swelling or loss of appetite are significantly improved.
MMSC係1959年開始販賣之醫藥品,主要作為胃黏膜修復劑,或於慢性肝疾病之肝機能改善之用。然而,有關於藉由合併使用MMSC與蒼朮而顯示顯著之消化管運動賦活作用,結果,飽嗝、想吐、噁心或甚至嘔吐之抑制效果,或胸壓迫感、胃脹、消化不良、胃部.腹部膨脹感或食欲不振之緩解效果,比起單獨使用MMSC時明顯增高的情形,至今尚無推論及報告。MMSC is a pharmaceutical product that began to be sold in 1959, mainly as a gastric mucosal repair agent, or as a liver function improvement for chronic liver disease. However, there is a significant effect on the digestive tract movement by combining the use of MMSC with Atractylodes, and the result is a suppressive effect of satiety, vomiting, nausea or even vomiting, or chest compression, bloating, indigestion, and stomach. The mitigation effect of abdominal swelling or loss of appetite is not inferred and reported until the case of significantly increased MMSC alone.
此外,至於蒼朮之亢進消化管運動之機能雖已為人所知(非專利文獻1),但有關於與MMSC併用而致使其機能協同性地增強,結果,作為含有MMSC與蒼朮之胃腸組成物之效果係協同性地增高之情形,至今亦無推論及報告。In addition, although the function of the movement of the digestive tract into the atractylodes of Atractylodes is known (Non-Patent Document 1), it is synergistically enhanced by the use of MMSC in combination with it, and as a result, it is a gastrointestinal composition containing MMSC and Atractylodes The effect is synergistically increased, and there is no inference and report so far.
本發明係提供一種胃腸藥組成物,藉由以往未曾組合使用之MMSC與蒼朮之併用,而具有當各別單獨使用時無法達成的協同性地增高之效果。The present invention provides a gastrointestinal drug composition which has synergistically enhanced effects which cannot be achieved when used alone, by the combination of MMSC and Atractylodes, which have not been used in the past.
本發明之胃腸藥組成物係,如以下之實施例所示,具有以腸管輸送率表示之消化管運動賦活化作用。其效果係比起MMSC、蒼朮分別單獨使用時所確認效果的合計,更顯著地增高,得到協同性地賦活化消化管運動。The gastrointestinal drug composition of the present invention, as shown in the following examples, has a digestive tract movement activation function expressed by intestinal tube delivery rate. The effect is more remarkable than the sum of the effects confirmed when MMSC and Atractylodes are used alone, and synergistically activates the movement of the digestive tract.
本發明雖不為以下之推論所限定者,本發明係依據消化管運動協同性地賦活化,腸管內容物滯留的原因所引起之飽嗝、想吐、噁心或甚至嘔吐、胸壓迫感、胃脹、消化不良、胃部.腹部膨脹感或食欲不振等症狀,特別是,飲酒過量或飲食過量產生之症狀緩解效果,比起單獨使用MMSC或蒼朮時,觀察到顯著地改善。此外,因消化管運動協同性地賦活化作用,緩解腸管內部滯留物,而能更強力促成消化促進作用。The present invention is not limited by the following inferences, and the present invention is based on the synergistic activation of the digestive tract movement, the fullness of the intestinal tube contents, vomiting, nausea or even vomiting, chest compression, bloating caused by the retention of intestinal contents. Indigestion, stomach. Symptoms such as abdominal swelling or loss of appetite, especially the symptoms of palliative remission caused by excessive drinking or overeating, were significantly improved compared to MMSC or Atractylodes alone. In addition, due to the synergistic activation of the digestive tract movement, the internal retention of the intestinal tract is relieved, and the digestive promoting effect can be more strongly promoted.
本發明所使用之MMSC係可利用米澤濱理藥品工業公司所市售之物,或者亦可遵循日本專利特公昭36-13209號公報所記載之方法合成使用。或者,關於蒼朮,亦可使用作為草藥成分廣泛流通所使用之物。The MMSC used in the present invention can be used as a product commercially available from Yonezawa Hama Pharmaceutical Co., Ltd., or can be synthesized and used in accordance with the method described in Japanese Patent Publication No. Sho 36-13209. Alternatively, as for atractylodes, it is also possible to use it as a widely used herbal ingredient.
MMSC與蒼朮之調配比與二者之協同作用,以重量比為MMSC:蒼朮(原草藥換算)9份:8份至3份:500份,特別是1份:2份至1份:5份時,特別能夠強力發揮由併用所致之協同性效果。再者,MMSC與蒼朮的組成物中的調配量亦可,由其各別作為胃腸藥組成物可調配量之範圍,各別決定滿足前述調配比之量來使用。The ratio of MMSC to Atractylodes and the synergistic effect of the two, the weight ratio of MMSC: Atractylodes (original herbal conversion) 9: 8 to 3: 500, especially 1: 2 to 1: 5 In particular, it is possible to strongly exert synergistic effects due to the combination. Furthermore, the blending amount of the composition of MMSC and Atractylodes can also be used as the range of the gastrointestinal drug composition arbitrarily adjusted, and each of them is determined to satisfy the aforementioned blending ratio.
此外,本發明之胃腸藥組成物係,於MMSC與蒼朮之外,亦可使用含有醫藥上容許之載體或其他之醫藥成分、賦形劑、結合劑、崩解劑、光滑劑、著色劑、矯味劑等,作為醫藥組成物形態。In addition, the gastrointestinal drug composition of the present invention may be used in addition to MMSC and Atractylodes sinensis, or may contain a pharmaceutically acceptable carrier or other pharmaceutical ingredients, excipients, binding agents, disintegrating agents, smoothing agents, coloring agents, A flavoring agent or the like is used as a pharmaceutical composition.
作為賦形劑係可舉出,乳糖、澱粉、結晶纖維素、蔗糖、甘露醇、輕質無水矽酸等。作為結合劑可舉出,羥基丙基甲基纖維素、羥基丙基纖維素、明膠、α-化澱粉、聚乙烯基四氫吡咯酮、聚乙烯基醇、茁黴多糖等。作為崩解劑可舉出,羧甲基纖維素、羧甲基纖維素鈣、交互羧甲基纖維素鈉、交互聚乙烯啶酮、玉米澱粉、低取代度羥基丙基纖維素等。作為光滑劑可舉出,硬脂酸鎂、滑石等。作為著色劑可舉出,焦油色素、二氧化三鐡等。作為矯味劑可舉出,甜菊、阿斯巴甜(Aspartame)、香料等。Examples of the excipient include lactose, starch, crystalline cellulose, sucrose, mannitol, and light anhydrous citric acid. Examples of the binding agent include hydroxypropylmethylcellulose, hydroxypropylcellulose, gelatin, α-starch, polyvinyltetrahydropyrrolidone, polyvinyl alcohol, and pupa polysaccharide. Examples of the disintegrator include carboxymethylcellulose, carboxymethylcellulose calcium, interactive sodium carboxymethylcellulose, cross-vinyl ketone, corn starch, and low-substituted hydroxypropylcellulose. Examples of the smoothing agent include magnesium stearate and talc. Examples of the colorant include tar dye, ruthenium trioxide, and the like. Examples of the flavoring agent include stevia, aspartame, and flavor.
本發明之胃腸藥組成物係,依其目的,可使用製造為散劑、顆粒劑、錠劑、可咀嚼錠劑、覆膜劑、糖衣錠、飲料劑、軟膠囊、硬膠囊、果凍等劑型。特別是,較佳使用製造為散劑、顆粒劑、錠劑、覆膜劑。The gastrointestinal drug composition of the present invention may be used in the form of a powder, a granule, a troche, a chewable tablet, a filming agent, a sugar-coated tablet, a drink, a soft capsule, a hard capsule, or a jelly, depending on the purpose. In particular, it is preferably used as a powder, a granule, a tablet, or a film-coating agent.
此外,含有MMSC與蒼朮之胃腸組成物對人之投藥量,取決劑型、疾病之程度、病人之年齡等因素,通常對成人MMSC基本上每日投予30至3000 mg左右,特別是每日投予100至225 mg,配合所需之投予量,可決定蒼朮之投予量。In addition, the dosage of the gastrointestinal composition containing MMSC and Atractylodes to humans depends on factors such as the dosage form, the degree of the disease, the age of the patient, etc., and the adult MMSC is usually administered with a daily dose of about 30 to 3000 mg, especially daily. A dose of 100 to 225 mg, in combination with the required dosage, can determine the amount of atractylodes.
以下,本發明係依據實施例詳細說明之,然而本發明係不為此所限定。Hereinafter, the present invention is described in detail based on the examples, but the present invention is not limited thereto.
於實驗前1日起禁食之5週齡之ddY系雄鼠,經口投予懸濁液於0.5%甲基纖維素(以下稱為MC)之維生素U(1000 mg/kg,以下稱為M)、蒼朮乾燥萃取物S(300 mg/kg,原草藥換算量為3000 mg/kg,以下稱為S)及其混合物(以下稱為M+S),15分鐘後經口投予活性碳粉末懸濁液,進一步,30分鐘後,以頸椎脫臼法殺死動物,摘除由幽門至迴盲部之腸管。被試驗物質之腸管輸送功能力係由幽門之碳素粉末之移動距離除以腸管全長,以其表示腸管輸送率。The ddY male rats that were fasted for 5 weeks from the 1st day before the experiment were orally administered with a suspension of 0.5% methylcellulose (hereinafter referred to as MC) of vitamin U (1000 mg/kg, hereinafter referred to as M), Atractylodes sinensis L. extract (300 mg/kg, original herbal amount 3000 mg/kg, hereinafter referred to as S) and its mixture (hereinafter referred to as M+S), and oral administration of activated carbon powder after 15 minutes Suspension, further, 30 minutes later, the animals were sacrificed by cervical dislocation and the intestines from the pylorus to the ileocecal area were removed. The intestinal tube delivery function of the test substance is divided by the moving distance of the pyloric carbon powder by the full length of the intestinal tube, and the intestinal tube delivery rate is expressed.
試驗結果如表1所示。The test results are shown in Table 1.
腸管輸送率,於投予MC之控制組為48.5%,M組為69.0%,S組為53.0%,M+S組為76.2%。控制組之腸管輸送率為1時,M+S組腸管輸送率的比例為1.57。大於與單味組之乘積比1.55(1.42×1.09),判定其有協同性效果。由此,本發明促進消化管運動機能,其結果,明顯得知非常有用於作為飽嗝、想吐、噁心或甚至嘔吐之抑制效果,或胸壓迫感、胃脹、消化不良、胃部.腹部膨脹感或食欲不振之緩解等顯著增強之胃腸藥組成物。The intestinal tube delivery rate was 48.5% in the control group administered to MC, 69.0% in the M group, 53.0% in the S group, and 76.2% in the M+S group. When the intestinal tube delivery rate of the control group was 1, the ratio of intestinal delivery rate in the M+S group was 1.57. It is greater than the product ratio of 1.55 (1.42 × 1.09) and the synergistic effect. Thus, the present invention promotes the kinetic function of the digestive tract, and as a result, it is apparent that it is very useful as a suppressing effect of satiety, vomiting, nausea or even vomiting, or chest compression, bloating, indigestion, and stomach. A gastrointestinal drug composition that significantly enhances the swelling of the abdomen or the loss of appetite.
使用乳糖作為賦形劑,依據一般之濕式造粒法造粒含MMSC之顆粒後,依據一般方法壓縮成型,製造每1錠含有25 mg之MMSC之A錠劑。再者,同樣地製造每1錠含有25 mg之MMSC及12 mg蒼朮(原草藥換算)之B錠劑。Using Lactose as an excipient, granules containing MMSC were granulated according to a general wet granulation method, and compression-molded according to a general method to produce an A tablet containing 25 mg of MMSC per one tablet. Further, a B tablet containing 25 mg of MMSC and 12 mg of atractylodes (original herbal conversion) per one tablet was produced in the same manner.
對於胃有其訴求一定程度之腹部不安困擾之20至59歲的志願者,隨意抽樣,分成各5名之兩組,對A組給予A錠劑,對B組給予B錠劑,各別連續3日每餐後服用2錠,於服用前、中、後,不安困擾之症狀的推衍以問卷形式進行回答。結果如表2所示。For volunteers aged 20 to 59 who have a certain degree of abdominal discomfort in their stomachs, they were randomly sampled and divided into two groups of 5, and A tablets were given to group A, and B tablets were given to group B. On the 3rd, 2 tablets were taken after each meal. Before, during and after the treatment, the symptoms of restless troubles were answered in the form of a questionnaire. The results are shown in Table 2.
如表2明顯地顯示,服用本發明胃腸藥組成物之B組,確認其腹部不安困擾訴求有顯著之改善效果。As clearly shown in Table 2, the group B of the gastrointestinal drug composition of the present invention was confirmed to have a significant improvement effect on the abdominal discomfort.
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