JP2007051125A - Extract blended agent - Google Patents
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Abstract
Description
本発明は、カン黄草と、石蓮花、マリアアザミから抽出されたそれぞれの抽出物を主に配合してなる抽出物配合剤に関する。 TECHNICAL FIELD The present invention relates to an extract compounding agent mainly comprising kang yellow grass, each extract extracted from a stone lotus flower, and thistle.
従来から、種々の植物由来の抽出物を配合してなり、肝疾患等に対して顕著な治癒効果を奏する配合剤として、例えば、特許文献１〜４に記載されたものが知られている。特許文献１には、いんちん蓬（河原蓬）、桑黄、霊芝（万年茸）、山査子、遠志（糸姫萩）、鶏腸草（つゆくさ）、アロエ、複盆子（徳利苺の実）、川弓、桂皮、くこ子、白じゅつ（おけらの根）、山しゅゆ、霍香（排草香）、梅の実、五加皮、黄精、白伏苓、何首烏（つるどくだみ）、魚星草、浦公英（たんぽぽ）を混合してなる肝臓保護用健康食品組成物が記載され、特許文献２には、マロニエの果実、セイヨウキズタの葉、スギナの葉又は全草、トウキンセンカの花、マンネンロウの葉、フキタンポポの花の１種又は２種以上の抽出物を有効成分とする抗変異原性剤が記載され、特許文献３には、カン黄草の根から抽出されるサポニンを有効成分とする肝疾患治療薬が記載され、特許文献４には、荷花掌（石蓮花）またはこれの抽出溶媒による抽出成分を含有してなる純天然血糖値降下剤が記載されている。 Conventionally, for example, those described in Patent Documents 1 to 4 are known as compounding agents that are obtained by blending various plant-derived extracts and have a remarkable healing effect on liver diseases and the like. Patent Document 1 includes Inchin-an (Kawara Kaoru), Mulberry Huang, Ganoderma (Perennial moth), Yamasuko, Toshi (Itohime Kaoru), Chicken Intestinal (Tsukukusa), Aloe, Duobonko Fruit), river bow, cinnamon bark, wolfberry, white jutsu (okera root), mountain shyuyu, tsuka (herbaceous incense), plum seed, goka rind, yellow spirit, white swordfish, tsurundokumi, fish A health food composition for liver protection comprising a mixture of star grass and dandelion is described, and Patent Document 2 discloses a fruit of Maronier, a leaf of a horse chestnut, a leaf of cedar or whole plant, a flower of Tokinsenka In addition, an antimutagenic agent containing one or more extracts of mannenrou leaves and cypress poppy flowers as an active ingredient is described, and Patent Document 3 discloses saponin extracted from roots of corn yellow grass as an active ingredient. Patent Document 4 describes a treatment for liver disease, which is described in Patent Document 4 as a flower palm (stone lotus flower) or an extract solution thereof. It describes a pure natural blood glucose lowering agent comprising an extract component by.
しかしながら、特許文献１〜４のそれぞれのものは、天然植物由来の抽出物を主成分として構成されるため服用による副作用を少なくできるものの、脂肪肝の予防と治療及び動脈粥状硬化症の防止に関しては十分な効果を備えていなかった。このため、服用による副作用が無いことはもちろんのこと、肝臓の保護と心臓や脳等における血管疾病に対してより有効な薬剤の開発が強く要望されていた。 However, each of Patent Documents 1 to 4 is composed mainly of an extract derived from a natural plant, so that side effects caused by taking can be reduced. However, regarding prevention and treatment of fatty liver and prevention of atherosclerosis Did not have enough effect. For this reason, there has been a strong demand for the development of more effective drugs for protecting the liver and vascular diseases in the heart, brain, etc., as well as having no side effects due to administration.
そこで、本発明は上記課題を鑑み、特に脂肪肝の予防と治療効果を備えるとともに動脈粥状硬化症を防止して肝臓の保護と血管疾病を予防でき、服用による副作用の無い天然植物由来の抽出物を配合してなる抽出物配合剤の提供を課題とする。 Thus, in view of the above problems, the present invention has an effect of preventing and treating fatty liver in particular, and can prevent arteriosclerosis to prevent liver protection and vascular disease, and is derived from natural plants without side effects due to administration. An object of the present invention is to provide an extract compounding agent obtained by blending products.
上記課題を解決するため、請求項１の発明に係る抽出物配合剤は、少なくともカン黄草及び石蓮花から抽出されたそれぞれの抽出物を所定の配合重量比で配合して構成される。
ここで、カン黄草は、日本において、沼、河原、水田跡などの湿地に生えるいわゆる雑草として、タコノアシの和名で知られており、ベンケイソウ科またはユキノシタ科タコノアシ属に属するものである。また石蓮花は、景天科に属し、景天科石蓮花属（中国植物誌第３４巻第１分冊第６３頁）石蓮花種又は荷花掌とも呼ばれる（河北植物誌第１巻第５７５〜５７６頁；Ｈｏｒｔ．ｅｘ Ｂａ−ｋｅｒ．ｉｎ Ｓａｕｎｄ．Ｒｅｆｕｇ．Ｂｏｔ．１：ｓｕｂ Ｔ．６１．１８６３−Ｃｏｔｙｌｅｄｏｎ ｇｌａｕｃａ Ｂａｋｅｒ）。
In order to solve the above-mentioned problems, the extract compounding agent according to the invention of claim 1 is configured by blending at least a respective extract extracted from corn yellow grass and stone lotus flowers at a predetermined blending weight ratio.
Here, Kang yellow grass is known in Japan as the so-called weed that grows in swamps such as swamps, rivers, and paddy fields in Japan, and belongs to the genus Pleurotusaceae or Tachynoaceae. Also, the stone lotus belongs to the Jingtian department, and is also called the Jianten departmental stone lotus genus (Chinese botanical magazine Vol. 34, 1st volume, p. 63). Page; Hort.ex Ba-ker.in Saund.Refug.Bot.1: sub T.61.1863-Cotyldon Glauca Baker).
請求項２の発明に係る抽出物配合剤は、マリアアザミから抽出された抽出物を所定の配合重量比で配合して構成される。
ここで、マリアアザミは、おおあざみとも呼ばれ、キク科に属する植物である。
The extract compounding agent according to the invention of claim 2 is configured by blending an extract extracted from Maria thistle at a predetermined blending weight ratio.
Here, Maria thistle is a plant belonging to the family Asteraceae, also called Ozami.
請求項３の発明に係る抽出物配合剤は、それぞれの抽出物の配合重量比が、カン黄草：石蓮花：マリアアザミ＝６：１：３であるように構成される。 The extract compounding agent according to the invention of claim 3 is configured such that the compounding weight ratio of each extract is Kang yellow grass: stone lotus: Maria thistle = 6: 1: 3.
請求項１〜３の発明によれば、服用による副作用が無く、脂肪肝の予防と治療について有効な効果を備えるとともに、動脈粥状硬化症を防止して、肝臓の保護と心臓や脳等における血管疾病の予防ができる。 According to the first to third aspects of the invention, there are no side effects due to taking, and there is an effective effect on the prevention and treatment of fatty liver, and atherosclerosis is prevented, and the liver is protected and in the heart, brain, etc. Can prevent vascular diseases.
以下、本発明に係る抽出物配合剤の実施の一形態を説明する。本抽出物配合剤は、カン黄草（Penthorum Chinense Pursh、略称：Ｐ）抽出エキス及び石蓮花（Echevaria glauca、略称：Ｅ）抽出エキスを配合してなる純天然植物健康食品である。以下、略称から本抽出物配合剤をＰＥとする。 Hereinafter, an embodiment of the extract compounding agent according to the present invention will be described. This extract compounding agent is a pure natural plant health food obtained by blending an extract of corn yellow grass (Penthorum Chinense Pursh (abbreviation: P)) and an extract of stone lotus (Echevaria glauca (abbreviation: E)). Hereinafter, the present extract compounding agent is referred to as PE from an abbreviation.
１．資料と方法
１−１．臨床試験対象資料：
２００２年９月から２００３年９月までの肝臓疾患患者である６０例を臨床試験対象資料とし、この６０例を任意に治療組と対照組との２組に分ける。ここで、治療組は、３２例であり、男２８例、女４例、平均年齢（４１．５±９）才、病歴２〜３年である。また対照組は、２８例であり、男２２例、女６例、平均年齢（４９．５±１０）才、病歴２〜２５年である。
患者の臨床症状は、主に４８例（８０．０％）がだるさ、３３例（５５．０％）が肝部の具合が悪い、２８例（４６．６％）が肝部疼痛、２２例（３６．６％）がお腹が張っている等である。
1. Material and method 1-1. Data for clinical trials:
Sixty patients who are liver disease patients from September 2002 to September 2003 are used as clinical study target materials, and these 60 cases are arbitrarily divided into two groups, a treatment group and a control group. Here, there are 32 treatment groups, 28 males, 4 females, an average age (41.5 ± 9), and a medical history of 2 to 3 years. The control group is 28 cases, 22 males, 6 females, average age (49.5 ± 10) years, and medical history 2-25 years.
The clinical symptoms of patients were mainly 48 cases (80.0%), 33 cases (55.0%) had poor liver condition, 28 cases (46.6%) had liver pain, 22 cases (36.6%) are hungry.
参考文献１，２を参照し、脂肪肝の臨床指標を関連させて、下記判断基準（１）（２）を制定する。ここで、参考文献１は「張其勝，袁孟彪．脂肪肝の診断進展．実用内科雑誌，1993，13(1)：40．」であり、参考文献２は「曾民徳．脂肪肝．中華消化雑誌，1999，19(3)：120．」である。
判断基準（１）：超音波スキャン検査：
肝前後部のエコーに差異があり、near fieldエコー密集が強調され、far fieldエコーが減衰する。肝臓内のパイプ構造は、特に静脈が細くなってぼやけた場合は、肝臓が軽度腫脹あるいは中等度腫脹である。
判断基準（２）：ＣＴ検査：
肝臓の密度は、普通、脾臓、腎臓と肝臓内血管の密度より低い。肝臓／脾臓ＣＴ値＜０．８５。肝臓内血管影がはっきり示され、その形態、方向はすべて異常がない。
超音波スキャン検査、ＣＴ検査のいずれか一つであっても、確実な診断ができる。すべての病例は急性肝炎、慢性肝炎の患者を含まない。
With reference to References 1 and 2, the following criteria (1) and (2) are established in relation to clinical indicators of fatty liver. Here, Reference 1 is “Zhang Sokatsu, 袁孟彪. Diagnosis Progression of Fatty Liver. Journal of Practical Internal Medicine, 1993, 13 (1): 40.” Reference Reference 2 is “Song Minde. Fatty Liver. Chinese Digestion Journal. 1999, 19 (3): 120. "
Judgment criteria (1): Ultrasonic scan inspection:
There is a difference in echoes in the front and back of the liver, near field echo congestion is emphasized, and far field echoes are attenuated. The pipe structure in the liver is mildly or moderately swollen, especially if the veins are thin and blurred.
Judgment criteria (2): CT examination:
The density of the liver is usually lower than the density of blood vessels in the spleen, kidneys and liver. Liver / spleen CT value <0.85. Intrahepatic vascular shadow is clearly shown, and there is no abnormality in the form and direction.
A reliable diagnosis can be made by any one of an ultrasonic scan inspection and a CT inspection. All cases do not include patients with acute or chronic hepatitis.
１−２．治療方法：
治療組及び対照組の二つの組の患者とも、石蓮花カプセル（石蓮花抽出エキス５００ｍｇ／粒）を２粒／回、毎日２回服用し、ビタミンＢ6を３０ｍｇ／回、毎日３回服用する。さらに、治療組には、カン黄草抽出エキスを６ｇ／回、毎日３回服用する。この場合、治療組が一日当たりに服用する抽出物配合剤の配合重量比は、カン黄草：石蓮花＝６：１となる。ここで、カン黄草粉末中カン黄草エキスの含有量は三分の一、石蓮花１カプセル中石蓮花エキスの含有量は２５０ｍｇであるとする。また３ヶ月を一つの治療サイクルとする。尚、治療期間中は、全患者が他の血中脂肪降下治療薬の使用を中止し、そして飲食制限と禁酒に注意する。
1-2. Method of treatment:
The two patients in the treatment group and the control group take stone lotus capsules (Ishiren flower extract 500 mg / grain) twice a day, twice daily, and vitamin B 6 30 mg / times, three times daily. . In addition, the treatment group is to take corn yellow grass extract 6g / dose 3 times daily. In this case, the compounding weight ratio of the extract compounding agent taken by the treatment group per day is Kang yellow grass: Shiren flower = 6: 1. Here, it is assumed that the content of the corn yellow extract in the corn yellow powder is one third, and the content of the stone lotus extract in 1 lotus flower is 250 mg. Three months is one treatment cycle. During the treatment period, all patients will stop using other blood lipid lowering medications and beware of eating and drinking restrictions and alcohol prohibition.
１−３．観察指標：
臨床症状及び徴候、治療前後にはそれぞれ血清グルタミン酸ピルビン酸トランスアミナーゼ（ＡＬＴ）、グルタミン酸オキサル酢酸トランスアミナーゼ（ＡＳＴ）、トリグリセライド（ＴＧ）、総コレステロール（ＴＣ）を一回検査し、治療前後にはぞれぞれ超音波スキャンを一回検査し、積分法を採用して評価する。表１は、検査評価点数表を示す。
1-3. Observation index:
Serum glutamate pyruvate transaminase (ALT), glutamate oxalacetate transaminase (AST), triglyceride (TG), and total cholesterol (TC) were tested once before and after treatment, and before and after treatment. The ultrasonic scan is inspected once and evaluated using the integration method. Table 1 shows an inspection evaluation score table.
表１．肝臓超音波スキャン積分の検査評価点数表
１−４．治療効果の評定基準：
ＡＬＴ、ＡＳＴの測定値に合わせて、超音波スキャン積分と症状を総合確認し、治癒（全てが正常になる）、好転、変化なしを判定する。症状及び徴候が消失し、ＡＬＴ、ＡＳＴが正常、超音波スキャン積分は検査した肝臓形態及び実質エコーが正常なので、治癒が認められる。症状、徴候が明らかに好転し、ＡＬＴ、ＡＳＴが正常或いは明らかに改善し、超音波スキャン積分は少なくとも三つの項目の指標があって、各項目が＞１点降下なので、好転が認められる。好転の判断基準に達していないものは無効である。
1-4. Criteria for evaluating therapeutic effects:
In accordance with the measured values of ALT and AST, the ultrasonic scan integration and the symptom are comprehensively checked, and the cure (all becomes normal), improvement, and no change are determined. Symptoms and signs disappear, ALT and AST are normal, and ultrasound scan integration is normal because the examined liver morphology and parenchymal echo are normal. Symptoms and signs are clearly improved, ALT and AST are normal or clearly improved, and ultrasonic scan integration has at least three index values, and each item has a drop of> 1 point. Those that do not meet the criteria for improvement are invalid.
１−５．統計学の処理方法：
資料性質により、それぞれt検査、ｘ2検査を採用し、結果はｘ(アッパーバー)±ｓで表す。
1-5. Statistics processing method:
Depending on the nature of the material, t test and x 2 test are adopted, respectively, and the result is expressed as x (upper bar) ± s.
２．試験結果
２−１．臨床症状の変化：
治療組は、だるさ、肝部の具合が悪い、肝部疼痛、お腹が張っているなど症状の改善について、有効率がそれぞれ９５．０％、８５．０％、８８．２％、８４．８％であり、対照組は、５４．２％、３６．８％、４０．４％、５５．８％である。即ち、臨床症状の改善については、治療組が対照組より明らかに優れている（Ｐ＜０．０１、有意差が非常に顕著である）。
2. Test result 2-1. Changes in clinical symptoms:
In the treatment group, the effective rate was 95.0%, 85.0%, 88.2%, 84.8 for improvement of symptoms such as dullness, poorness of the liver, liver pain, and stomach upset, respectively. The control set is 54.2%, 36.8%, 40.4%, 55.8%. That is, the treatment group is clearly superior to the control group in improving clinical symptoms (P <0.01, significant difference is very significant).
２−２．二つの組の治療前後ＡＬＴ、ＡＳＴ、ＴＧ、ＴＣ変化：
結果を表２に示す。
2-2. ALT, AST, TG, TC changes before and after two sets of treatment:
The results are shown in Table 2.
表２．二つの組の治療前後ＡＬＴ、ＡＳＴ、ＴＧ、ＴＣ変化
２−３．超音波スキャン積分の変化：
二つの組の患者は、治療前後の積分の効果が異なる。治療組は治療後の積分が（５．５±１．８）、治療前（８．８±２．２）と比べ、明らかに下がった（Ｐ＜０．０１）。対照組も下がっているが、治療前が８．０±２．５、治療後が７．８±１．２になっており、統計学上の有意差が無い。治療組と対照組との間には、治療前後のＡＬＴ、ＡＳＴの有意差が認められる。ＴＣ、ＴＧで見れば治療組と対照組との間に有意差が無いが、治療組の治療前後に有意差が認められる。両組とも治療前後を比較すれば、有意差がある（Ｐ＜０．０５）。
2-3. Changes in ultrasound scan integration:
The two sets of patients differ in the effect of integration before and after treatment. In the treatment group, the integration after treatment (5.5 ± 1.8) was clearly lower (P <0.01) than before treatment (8.8 ± 2.2). Although the control group also decreased, it was 8.0 ± 2.5 before treatment and 7.8 ± 1.2 after treatment, and there was no statistically significant difference. There is a significant difference between ALT and AST before and after treatment between the treatment group and the control group. In terms of TC and TG, there is no significant difference between the treatment group and the control group, but a significant difference is observed before and after treatment of the treatment group. There is a significant difference between both groups before and after treatment (P <0.05).
２−４．両組の全体治療効果の比較：
結果を表３に示す。
正確には治療過程の中で明らかな毒副作用と胃腸における異常が見られない。
2-4. Comparison of overall treatment effects between the two groups:
The results are shown in Table 3.
Exactly, no obvious toxic side effects and gastrointestinal abnormalities are seen in the course of treatment.
表３．両組の全体治療効果の比較
３．試験結果考察
脂肪肝とは、多種要素によって引き起こされた肝臓脂肪の変性である。現在、発病メカニズムについて、まだ完全に判っていないが、摂取した遊離脂肪酸が多くなること、肝臓合成遊離脂肪酸及び炭水化物合成ＴＧの増加、肝臓内脂肪酸β酸化の減少、極めて低い密度脂肪合成と分泌の減少、肝臓内ＴＧ輸送障害などの諸要素が、脂肪肝の形成と関連する可能性がある。また、リポイド過酸化損傷も重要な発病要素である可能性がある。そのため、治療の上で脂肪の摂取を減少し、血脂を下げ、肝臓を保護し、肝臓自身の機能の回復を促すことは、脂肪肝を治療するための有効な方法となるはずである。
石蓮花カプセルは、石蓮花抽出エキスを主な成分とする血中脂肪を調節できる純天然植物である。日本の臨床により、血中脂肪降下の効果が明示されており、顕著な毒副作用がないことが実証されている（東方医学誌１４巻第４号別冊）。
カン黄草エキスは、肝臓を保護し、酵素と黄疸を下げ、脾臓の機能強化、繊維化の抑制に対して、顕著な作用がある。また臨床により、カン黄草エキスには、酵素と黄疸を下げる治療に関して、甘利欣（注：中国で市販されている有名新薬）と大体同じ効果を備えているとされている。また、慢性肝臓病を改善して、臨床症状とその徴候を大きく改善し、お腹が張っているなどを緩和する治療に関しては、甘利欣より明らかに優れる。
3. Consideration of test results Fatty liver is a degeneration of liver fat caused by various factors. At present, the pathogenesis mechanism is not completely understood. However, the intake of free fatty acids increases, the increase of liver synthetic free fatty acids and carbohydrate synthesis TG, the decrease of intrahepatic fatty acid β oxidation, the extremely low density of fat synthesis and secretion. Factors such as reduction and impaired intrahepatic TG transport may be associated with fatty liver formation. Lipoid peroxidative damage can also be an important pathogenic factor. Therefore, therapeutically reducing fat intake, lowering blood fat, protecting the liver, and promoting the recovery of the liver's own function should be an effective method for treating fatty liver.
The stone lotus capsule is a pure natural plant that can regulate blood fat, which is mainly composed of stone lotus extract. Japanese clinics have demonstrated the effect of lowering blood fat, and it has been demonstrated that there are no significant toxic side effects (Touhou Medical Journal Vol. 14, No. 4).
Kang yellow grass extract has significant effects on protecting the liver, lowering enzymes and jaundice, strengthening spleen function and suppressing fibrosis. In addition, it has been clinically reported that Kang Yong Extract has almost the same effect as Amari Koji (a famous new drug marketed in China) in terms of enzyme and jaundice reduction treatment. In addition, it is clearly superior to Amari in terms of treatment to improve chronic liver disease, greatly improve clinical symptoms and signs, and relieve stomach upset.
本願の発明者は、脂肪肝の臨床治療で初めてカン黄草と石蓮花との抽出物を配合使用することによって、このＰＥが顕著に血中脂肪を下げるばかりではなく、臨床症状の改善、肝臓機能の回復をでき、肝臓超音波スキャン積分状況の改善の上で、治療組が対照組より明らかに優れることを確認した。また、肝臓を改善し肝臓自身機能の回復機能を促すカン黄草エキスと、良好な血中脂肪降下作用を備えた石蓮花カプセルとを、脂肪肝の臨床治療に配合使用することに関して、明らかな相乗効果があり、脂肪肝を治療するための有効な方法であり、推進、応用に値することを示した。 The inventor of the present application not only significantly reduces blood fat but also improves clinical symptoms, liver by using a combination of an extract of corn yellow grass and stone lotus flower for the first time in clinical treatment of fatty liver. It was confirmed that the treatment group was clearly superior to the control group in restoring the function and improving the liver ultrasound scan integration status. In addition, it is clear that Kang Yong Extract that improves the liver and promotes the recovery of the liver's own function, and the stone lotus capsule with good blood fat lowering action are combined in clinical treatment of fatty liver. It has a synergistic effect and is an effective method for treating fatty liver, and it is worthy of promotion and application.
次に、本発明に係る抽出物配合剤の他の実施の一形態を説明する。本抽出物配合剤は、前述のカン黄草抽出エキス及び石蓮花抽出エキスに、マリアアザミ（Silybum marianum（Ｌ）、略称：Ｓ）抽出エキスを所定の配合重量比で配合してなる純天然植物健康食品である。以下、略称から本抽出物配合剤をＰＥＳとする。 Next, another embodiment of the extract compounding agent according to the present invention will be described. This extract compounding agent is a pure natural plant obtained by blending the above extract of citrus yellow grass and Ishiren flower extract with the extract of Maria thistle (Silybum marianum (L), abbreviation: S) at a predetermined blending weight ratio. It is a health food. Hereinafter, this extract compounding agent is referred to as PES from an abbreviation.
１．ＰＥＳの配合方法
１−１．ＰＥＳの配合：
先ず、６０ｇの乾燥したカン黄草抽出エキス粉末、１０ｇの乾燥した石蓮花抽出エキス粉末、３０ｇの乾燥したマリアアザミ抽出エキス粉末を取り、混合してから粉砕機に入れて１００メッシュまで粉砕してＰＥＳを作る。この場合、それぞれの抽出物の配合重量比は、カン黄草：石蓮花：マリアアザミ＝６：１：３である。尚、カン黄草抽出エキスは、特願２００５−２３２０８３号公報等に記載された公知の製造方法によって抽出された抽出物を乾燥粉末化したものである。また、石蓮花抽出エキス粉末は、特許第３０９７９９７号公報等に記載された公知の抽出溶媒によって抽出された抽出物を乾燥粉末化したものである。また、マリアアザミ抽出エキス粉末は、アルコール抽出等、公知の抽出方法によって抽出された抽出物を乾燥粉末化したものである。
1. Formulation method of PES 1-1. PES formulation:
First, take 60 g of dried citrus yellow extract powder, 10 g of dried stone lotus extract powder, and 30 g of dried thistle extract powder, mix them, put them into a pulverizer and grind them to 100 mesh. Make PES. In this case, the compounding weight ratio of each extract is Kang yellow grass: Ishiren flower: Maria thistle = 6: 1: 3. Incidentally, the corn yellow extract is a dry powder of an extract extracted by a known production method described in Japanese Patent Application No. 2005-232083. The stone lotus extract powder is a powder obtained by drying an extract extracted with a known extraction solvent described in Japanese Patent No. 3097997. Further, Maria thistle extract powder is a dry powder of an extract extracted by a known extraction method such as alcohol extraction.
１−２．中投与量のＰＥＳ溶液：
ＰＥＳを１３．３４ｇ取り、２５５ｍｌ、０．５％ＣＭＣＮａ溶液に溶解させ、７０℃の条件下で十分に撹拌しながら２０分間加熱して、濃度が０．０５２ｇ／ｍｌの中投与量のＰＥＳ溶液を作る。
１−３．高投与量のＰＥＳ溶液：
ＰＥＳを２６．５２ｇ取り、２５５ｍｌ、０．５％ＣＭＣＮａ溶液に溶解させ、７０℃の条件下で十分に撹拌しながら２０分間加熱して、濃度が０．１０４ｇ／ｍｌの高投与量のＰＥＳ溶液を作る。
１−４．低投与量のＰＥＳ溶液：
ＰＥＳを４．４９ｇ取り、２５５ｍｌ、０．５％ＣＭＣＮａ溶液に溶解させ、７０℃の条件下で十分に撹拌しながら２０分間加熱して、濃度が０．０１７６ｇ／ｍｌの低投与量のＰＥＳ溶液を作る。
1-2. Medium dose PES solution:
Take 13.34 g of PES, dissolve in 255 ml, 0.5% CMCNa solution, heat for 20 minutes with sufficient agitation at 70 ° C., medium concentration PES solution with a concentration of 0.052 g / ml make.
1-3. High dose PES solution:
Take 26.52g of PES, dissolve in 255ml, 0.5% CMCNa solution and heat for 20 minutes under agitation at 70 ° C, high dosage PES solution with a concentration of 0.104g / ml make.
1-4. Low dose PES solution:
4.49 g of PES was taken, dissolved in 255 ml, 0.5% CMCNa solution, heated for 20 minutes with sufficient stirring at 70 ° C., and a low dose PES solution with a concentration of 0.0176 g / ml make.
２．動物試験
２−１：次に、動物試験の材料と方法を説明する。
2. Animal test 2-1: Next, materials and methods of animal test will be described.
２−１−１．試験用ラットの準備：
中国医学科学院実験動物研究所から提供された４１匹のＷｉｓｔａｒ系雄性ラットを、ランダムに、正常組、病理組、高投与組、中投与組、低投与組の５組の試験用ラットとして分ける。ここで、４１匹のラット平均体重は１８５．８４±１１．４ｇである。
正常組の５匹にはトウモロコシ粉末だけを投与し、そのほかの３６匹には、表４に示す配合した脂肪肝飼料（低蛋白、高脂肪、高コレステロール飼料）を投与しながら、四塩化炭素と植物油の混合液（４０％ＣＣｌ４、６０％大豆油）０．５ｍｌ／１００ｇを皮下注射する。これを一週間に２回、三週間続ける。
病理組の９匹には、脂肪過剰血症脂肪肝を生成させ治療薬剤は何も投与しない。投与組（高投与組、中投与組、低投与組）の各９匹には、脂肪過剰血症脂肪肝を生成させ対応するＰＥＳ溶液を投与する。
2-1-1. Preparation of test rats:
Forty-one Wistar male rats provided by the Institute of Experimental Animals of the Chinese Academy of Medical Sciences are randomly divided into five groups of test rats: normal group, pathological group, high-dose group, medium-dose group, and low-dose group. Here, the average weight of 41 rats is 185.84 ± 11.4 g.
The normal group of 5 animals was given only corn powder, and the other 36 animals were administered fatty liver diet (low protein, high fat, high cholesterol diet) as shown in Table 4, while carbon tetrachloride and A mixture of vegetable oils (40% CCl4, 60% soybean oil) 0.5 ml / 100 g is injected subcutaneously. Continue this twice a week for three weeks.
Nine animals in the pathology group produce hyperlipidemic fatty liver and receive no therapeutic agent. Nine animals in each of the administration groups (high administration group, medium administration group, and low administration group) generate hyperlipidemic fatty liver and administer the corresponding PES solution.
２−１−２．治療方法：
正常組の５匹以外の上述の試験用ラットは下記の4組に分けられる。
（１）病理組 ：治療薬剤を何も投与しない。
（２）高投与組：ＰＥＳ原材料０．１０４ｇ／１８６ｇ、５６２ｍｇ／ｋｇ
（３）中投与組：ＰＥＳ原材料０．０５２ｇ／１８６ｇ、２８１ｍｇ／ｋｇ
（４）低投与組：ＰＥＳ原材料０．０１７６ｇ／１８６ｇ、９５ｍｇ／ｋｇ
2-1-2. Method of treatment:
The above test rats other than the normal group of 5 animals are divided into the following 4 groups.
(1) Pathology group: No therapeutic drug is administered.
(2) High dose group: PES raw materials 0.104 g / 186 g, 562 mg / kg
(3) Medium administration group: PES raw materials 0.052 g / 186 g, 281 mg / kg
(4) Low administration group: PES raw materials 0.0176 g / 186 g, 95 mg / kg
２−１−３．データの処理：
分散分析統計ソフトでｔ検査と分散分析統計を行う。統計結果を表７に示す。
2-1-3. Data processing:
Perform t-test and analysis of variance statistics with analysis of variance statistics software The statistical results are shown in Table 7.
２−１−４．投与と分析：
ＰＥＳを蒸留水で溶解させ、各組のラットに毎日１ｍｌ投与する。各治療組のラットにＰＥＳを投与しながら脂肪肝になる飼料を投与し続ける。病理組にも脂肪肝になる飼料を投与し続ける。三週間投与した後、全部の試験用ラットを死亡させて血液を取り、無菌状態で血清を分離させる。北京大学医院の全自動生物化学分析器で、グルタミン酸ピルビン酸トランスアミナーゼ（ＡＬＴ）、トリグリセライド（ＴＧ）、コレステロール（ＴＣ）、高密度リポプロテイン（ＨＤＬ−ｃ）、低密度リポプロテイン（ＬＤＬ）、超低密度リポプロテイン（ＶＬＤＬ）などの生物化学指標を測定し、ＰＥＳによる脂肪過剰血症脂肪肝の治療効果を検討する。
2-1-4. Administration and analysis:
PES is dissolved in distilled water and 1 ml daily is administered to each set of rats. Continue to administer diets that become fatty liver while administering PES to rats in each treatment group. Continue to administer diets that cause fatty liver to the pathological group. After three weeks of administration, all test rats are killed and blood is collected and serum is separated in a sterile manner. Fully automated biochemical analyzer at Peking University Clinic with glutamate pyruvate transaminase (ALT), triglyceride (TG), cholesterol (TC), high density lipoprotein (HDL-c), low density lipoprotein (LDL), ultra low Biochemical indicators such as density lipoprotein (VLDL) are measured, and the therapeutic effect of hyperlipidemic fatty liver by PES is examined.
表４．脂肪肝飼料の配合割合
２−２：次に、動物試験の結果を示す。
２−２−１．試験結果：
正常組と比べて、病理組のラットのＡＬＴ、ＴＧ、ＴＣ、ＬＤＬ、ＶＬＤＬなどは明らかに高くなり（ｐ＜0.0001）、ＨＤＬ−ｃは明らかに低くなり、ＨＤＬ−ｃ／ＴＣも明らかに低くなる。治療が終わるとき、病理組と比べて、各投与組のラットのＡＬＴ、ＴＧ、ＴＣ、ＬＤＬ、ＶＬＤＬなどは明らかに低くなり（ｐ＜0.05〜0.01）、ＨＤＬ−ｃとＨＤＬ−ｃ／ＴＣは大幅に高くなる。
2-2: Next, the results of animal tests are shown.
2-2-1. Test results:
Compared with the normal group, ALT, TG, TC, LDL, VLDL, etc. of rats in the pathological group are clearly higher (p <0.0001), HDL-c is clearly lower, and HDL-c / TC is also clearly lower. Become. At the end of treatment, ALT, TG, TC, LDL, VLDL, etc. of the rats in each treatment group are clearly lower (p <0.05-0.01) compared to the pathological group, and HDL-c and HDL-c / TC are Significantly higher.
２−２−２．脂肪肝の生成過程における試験用マウスの体重変化：
表５．体重変化
Table 5. Weight change
２−２−３．飼料の摂取量：
表６．飼料の摂取量
Table 6. Feed intake
２−２−４．生物化学指標：
表７．ＰＥＳによる脂肪過剰血症脂肪肝ラットを治療した後、ラットのＡＬＴおよび血中脂肪の変化ｘ(アッパーバー)±ｓ
Table 7. After treatment of hyperlipidemic fatty liver rats with PES, changes in rat ALT and blood fat x (upper bar) ± s
３．試験結果考察
３−１．四塩化炭素と植物油の混合液によってラットが急性肝毒性になり、全部体重は減少した。しかし、正常組のラットの体重は６．１ｇ増加した（表５参照）。
３−２．四塩化炭素と植物油の混合液によってラットが急性肝毒性になり、飼料の摂取量も急に低下した。あるラットは二日間何も食べず、体重が急に減少した（表６参照）。
３−３．投与組のＨＤＬ−ｃ／ＴＣ割合は病理組より高くなり、ＰＥＳは肝臓に対して顕著的な保護作用があることを明示している。ＨＤＬ−ｃ／ＴＣ割合は心脳動脈アテローム硬化予防の重要指標であり、ＨＤＬ−ｃ／ＴＣの割合が大きいほど、心脳血管疾病の発生率は低いものである。
３−４．投与組のＡＬＴ、ＴＧ、ＴＣ、ＨＤＬ−ｃ、ＬＤＬ、ＶＬＤＬなどの生物化学指標は、病理組より明らかに低くなった。それは投与組の肝臓機能が正常になり、脂肪肝も治ることを明示している。よって、投与組には、病理組と比べて、各生物化学指標に関し非常に顕著な差が生じている。
３−５．投与組と正常組の間には、顕著な差がないことが認められた（ｐ＞0.05）。
３−６．投与組では、投与量と改善効果については、顕著な対応関係がないことを明示している。すなわち、投与量が一定量になったら、その改善効果も最高になったとの判断が可能となる。投与量を多くすれば、効果が良くなるとは言えないことが認められた。
３−７．臨床推薦使用量は、０．０９５ｇ／ｋｇ×６０ｋｇ×１／２＝２．８５ｇ／日／人、即ち、一人当たりの毎日の使用量は１．５〜３ｇが適当であることが分かった。
3. Test result consideration 3-1. A mixture of carbon tetrachloride and vegetable oil resulted in acute hepatotoxicity in rats, all of which lost weight. However, the weight of the normal group of rats increased by 6.1 g (see Table 5).
3-2. The mixture of carbon tetrachloride and vegetable oil resulted in acute hepatotoxicity in rats, and food intake suddenly decreased. One rat ate nothing for two days and suddenly lost weight (see Table 6).
3-3. The HDL-c / TC ratio of the administration group is higher than that of the pathology group, demonstrating that PES has a significant protective effect on the liver. The HDL-c / TC ratio is an important index for preventing cardio-cerebral artery atherosclerosis, and the greater the ratio of HDL-c / TC, the lower the incidence of cardiovascular disease.
3-4. The biochemical indicators such as ALT, TG, TC, HDL-c, LDL, and VLDL in the administration group were clearly lower than those in the pathology group. It shows that the liver function of the administration group is normal and that fatty liver is cured. Therefore, there is a very significant difference in the administration group regarding each biochemical index compared to the pathology group.
3-5. There was no significant difference between the treated and normal groups (p> 0.05).
3-6. The administration group clearly shows that there is no significant correspondence between the dose and the improvement effect. That is, when the dose reaches a certain level, it can be determined that the improvement effect is maximized. It was found that increasing the dose does not improve the effect.
3-7. The recommended clinical use amount was 0.095 g / kg × 60 kg × 1/2 = 2.85 g / day / person, that is, the daily use amount per person was found to be 1.5 to 3 g.
尚、本発明は上記実施形態に限定されるものではなく、以下列挙するように、本発明の趣旨を逸脱しない範囲で各部の形状並びに構成を適宜に変更して実施することも可能である。
（１）本抽出物配合剤は、カン黄草、石蓮花及びマリアアザミの３種の抽出物を配合して構成することが望ましいが、少なくともカン黄草及び石蓮花から抽出した２種の抽出物を配合して構成しても同様の効果を得ることが可能となる。
（２）ＰＥＳは、カン黄草：石蓮花：マリアアザミ＝６：１：３の配合重量比で配合することが望ましいが、これに限らず、少なくともカン黄草の抽出物１０〜９０重量％（＝ｕ重量％）、石蓮花の抽出物１〜５０重量％（＝ｖ重量％）、及びマリアアザミの抽出物ｗ重量％（＝１００−（ｕ＋ｖ））の範囲の配合重量比を組み合わせて構成できる。この場合も同様の効果を得ることが可能である。
（３）本抽出物配合剤は、マリアアザミに替えて、他の天然植物等の抽出物や有効成分を配合して構成しても良い。
（４）本抽出物配合剤は、カン黄草、石蓮花及びマリアアザミの３種だけでなく、他の天然植物等の有効成分をさらに追加配合して構成しても良い。
In addition, this invention is not limited to the said embodiment, As it enumerates below, it is also possible to implement by changing suitably the shape and structure of each part in the range which does not deviate from the meaning of this invention.
(1) The present extract compounding agent is preferably composed by blending three kinds of extracts of Kang yellow grass, stone lotus flower and Maria thistle, but at least two kinds of extraction extracted from Kang yellow grass and stone lotus flower The same effect can be obtained even if the product is mixed.
(2) PES is desirably blended at a blending weight ratio of Kang yellow grass: Ishiren flower: Maria thistle = 6: 1: 3, but is not limited to this, and at least 10 to 90% by weight of Kang yellow extract (= U wt%), stone lotus flower extract 1-50 wt% (= v wt%), and Maria Thistle extract w wt% (= 100− (u + v)) Can be configured. In this case, the same effect can be obtained.
(3) The present extract compounding agent may be constituted by blending extracts and active ingredients of other natural plants in place of Maria Thistle.
(4) The present extract compounding agent may be constituted by further adding an active ingredient such as other natural plants as well as three kinds of kang yellow grass, stone lotus and maria thistle.
Claims (3)
ことを特徴とする抽出物配合剤。 Each extract extracted from at least corn yellow grass and stone lotus flower is blended at a predetermined blending weight ratio, and is effective at least for the treatment of fatty liver.
An extract compounding agent characterized by that.
請求項１に記載の抽出物配合剤。 An extract extracted from Maria Thistle is blended at a predetermined blending weight ratio,
The extract compounding agent according to claim 1.
カン黄草：石蓮花：マリアアザミ＝６：１：３
である、
請求項２に記載の抽出物配合剤。
The blended weight ratio of each extract is
Kang Yellow Grass: Stone Lotus: Maria Thistle = 6: 1: 3
Is,
The extract compounding agent according to claim 2.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510124233 CN1977872A (en) | 2005-11-29 | 2005-11-29 | Function of PES for preventing and treating hyper lipidemia and fat liver |
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| KR101352591B1 (en) * | 2012-03-22 | 2014-01-22 | 임실생약영농조합법인 | Composition for improving blood circulationthistle extract |
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| KR100863524B1 (en) * | 2007-12-28 | 2008-10-15 | 주식회사 뉴젝스 | Composition for preventing and treating metabolic diseases comprising the extract of lysimachiae foenum-graeci herba |
| CN105535826A (en) * | 2015-12-29 | 2016-05-04 | 上海珍岛信息技术有限公司 | Pharmaceutical composition for treating cat fatty liver and preparation method thereof |
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| KR101352591B1 (en) * | 2012-03-22 | 2014-01-22 | 임실생약영농조합법인 | Composition for improving blood circulationthistle extract |
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