WO2014036808A1 - Plant beneficial to liver and use thereof - Google Patents

Plant beneficial to liver and use thereof Download PDF

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Publication number
WO2014036808A1
WO2014036808A1 PCT/CN2013/001041 CN2013001041W WO2014036808A1 WO 2014036808 A1 WO2014036808 A1 WO 2014036808A1 CN 2013001041 W CN2013001041 W CN 2013001041W WO 2014036808 A1 WO2014036808 A1 WO 2014036808A1
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liver
yigancao
extract
hepatitis
pieces
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PCT/CN2013/001041
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张莘
张义飞
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北京健旭康技术有限公司
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Publication of WO2014036808A1 publication Critical patent/WO2014036808A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine

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  • the invention relates to a processing technology of a wild plant "Yigancao" with beneficial liver function and the use in food, health food, natural medicine, veterinary health care product and veterinary medicine, in particular, fresh and dry liver Vegetable whole grass, deep processing and extract preparation method, Yigan vegetable deep processing product, Yigan vegetable extract, effective chemical composition of Yigancai, use of Yigancao in preparation of liver-protecting health care products, and preparation of hepatitis in Yigancai Applications of therapeutic drugs ('. and a class of natural drugs) and applications of animal liver products (eg, prevention of duckling viral hepatitis and toxic hepatitis). Background technique
  • the liver is one of the important organs in the body. It is subjected to a large amount of biochemical chemistry every day. It is a T. work of the factory. It is very easy to fatigue and suffer from the processing of a large amount of foods and other foreign substances absorbed by the digestive tract. damage. Liver damage is a disease that seriously harms people's health. China currently has more than 100 million people living with hepatitis B virus and tens of millions of hepatitis C virus carriers. About tens of millions of them will be converted into chronic hepatitis, cirrhosis, liver cancer, and people who die every year due to liver disease. There are hundreds of thousands of people. In recent years, toxic liver damage caused by alcohol, drugs and various harmful factors has also increased.
  • liver disease in China every year is as high as tens of billions of yuan, which puts a heavy burden on economic and social development, especially the physical and mental health of patients. Therefore, maintaining the health of the liver has become the goal pursued by people. Food and medicine are important factors affecting liver function, so it is urgent to develop foods, health foods and new medicines that are good for liver health.
  • Yigancai is a cruciferous herb. Its Chinese name is - . Moon Blue (Beijing Flora) and ". Yuelan (Liao Shi' Flora The origin of Yigancai is in Northeast China and North China. There are no research reports on the consumption or medicinal Yigancai in many areas such as Beijing where Yigancai is grown. According to the Agricultural Plant Variety Nomenclature issued by the Ministry of Agriculture. 3 ⁇ 4 ⁇ (Organization of the Ministry of Agriculture of the People's Republic of China, 2012, No. 2, since April 15, 2012), we believe that Yigancai is a new resource for edible and medicinal new varieties of agricultural plants. "Liver" is the name we found after the plant has a good liver function.
  • the present invention provides a new use of Yigancai, namely, new J and V in the preparation of hepatitis therapeutic drugs, health foods and animal liver products.
  • Another object of the present invention is to provide a medicament for treating hepatitis. Still another aspect of the present invention is to provide a health food for hepatitis adjuvant therapy.
  • the object of the present invention is also to provide a beneficial liver preparation, a health care and a therapeutic effect, and a preparation method thereof.
  • the inventor conducted a large number of deep processing studies on the whole process and various parts of Yigancai according to the processing method of agricultural products, including Yigancao porridge, Yigancao soup, Yigancai juice (fresh juicing), dried Yigancai, Instant Yigancao, Yigancai wine, Yigancai pickled products, Yigancai decoction pieces, etc.
  • the corresponding products can be harvested at various stages of the growth of the beneficial liver.
  • Yigan can be eaten directly or directly in its dry plants.
  • the inventor refers to the 2003 Guidelines for the Technical Guidance of Drug Research, the Chinese Medicine and Natural Substance (National Food and Drug Administration, 2003), the Guiding Principles for Preclinical Research of New Drugs (National Food and Drug Administration, 1993) and Health Food Function.
  • the evaluation method of the evaluation (Ministry of Health 2003), the drug evaluation method for hepatitis treatment, and the health food evaluation method, the extract preparation, the pharmaceutical dosage form preparation, the animal pharmacology and the pathological study of the beneficial liver.
  • the whole grass or part of Yigancai can be made into pieces of natural medicine.
  • Harvesting of beneficial liver vegetables can be carried out all year round.
  • Harvesting the characteristics of the pieces produced in Ding Cut the same grass into small pieces, net, and dry.
  • Yigancao seed pieces are net and dry.
  • the Yigancao Pieces can be used directly or directly after eating the dried pieces.
  • the preparation method of Yigancao extract is as follows: You can take 1000g of Yigancao decoction pieces or appropriate amount of fresh whole grass, crush, wash 3 ⁇ 4 times, add water for three times, each time for 15 minutes, combine decoction, filter After that, the filtrate is concentrated and thickened, and after drying, a fine powder is obtained. This product is brown granules; sweet and sweet.
  • Yigancao extract When it is treated with Yigancao extract, it can be administered orally in the form of powder, granules, tablets, capsules, pills and liquid medicaments; it can also be in the form of injections, suppositories, transdermal preparations, sprays, etc. Administered enterally.
  • An effective agent for the extract of yoghurt is prepared by mixing with a suitable pharmaceutical blend such as an excipient, a binder, a penetrant, a lubricant or the like.
  • the dose of the beneficial liver extract varies depending on the condition of the patient, the route of administration, the age of the patient, and the body S.
  • the dose is usually from 500 to 1000 mg per day for adults, preferably 800 mg per day.
  • the same principle applies to health food use.
  • the beneficial liver treatment effect of Yigancai is first discovered both domestically and internationally.
  • Yigancao can be used as a natural medicine for the treatment of hepatitis B, for the treatment of cirrhosis, for the treatment of toxic hepatitis such as alcoholic hepatitis and carbon tetrachloride.
  • toxic hepatitis such as alcoholic hepatitis and carbon tetrachloride.
  • the Yigancao pieces used in the examples were made by us. Different parts such as whole liver grass or seeds are used. We have established the seasons for harvesting different parts of the beneficial liver and the operating standards for the production of the medicinal herbs in different parts. Simply put, the main game in autumn is to harvest the stems and leaves. Spring harvesting Whole grass including roots and pods. Harvest seeds in summer. After washing the stems and roots, cut into small pieces of 2 cm and dry. The seed pieces are made through a dry and net selection process.
  • the extract of the beneficial liver obtained by the preparation method of the second embodiment is dissolved in water, and can be directly formulated into a U solution.
  • the extract of the beneficial liver obtained by the preparation method of the second embodiment can be combined with a drug such as licorice extract and astragalus extract to prepare a compound for treating hepatitis.
  • a drug such as licorice extract and astragalus extract
  • the experimental animals were adult healthy male CD-I mice. During the test period, I'Hj provided a sufficient amount of tap water and ordinary feed. Grouping and Processing of Animals Mice were randomized by body weight. In the observation of the efficacy of toxic hepatitis, it was administered for 3 consecutive days, once a day. On the fourth day, blood was taken and the liver of the animal was collected. The liver function enzyme alanine transferase (ALT) was measured in the serum, and the degree of liver pathological changes was observed. The administration time of the evaluation of '. methyl nitrosamine cirrhosis treatment was 2 months, and then the degree of fibrosis in the liver tissue (hydroxyproline) was measured. Hepatitis B efficacy evaluation using fine Cell evaluation method. Experimental data is expressed as mean ⁇ standard deviation. The results of the experiment were analyzed by ANOVA and t-test using the EXCEL statistical software. The difference of the group I'Hj was considered to be significant at p ⁇ 0.05.
  • the dose in the seed extract was 181 ⁇ 88**. Note: #Compared with the control group, p ⁇ 0.05. '
  • * is compared with the model group p ⁇ 0.01.

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Abstract

A use of Oiychophragmus violaceus for preparing a plant productbeneficial to livers of the human and animals. Various plant products beneficial to the livers are prepared with the whole herb or a part (root, stem and leaf, sprout and seedling, flower and seed) of Oiychophragmus violaceus as a raw material, and through washing, drying, or further water decoction and extraction. Dosage forms of the products comprise health food, Chinese herbal pieces and injections, granule, tablets, capsules, pills, powder and the like. The products can treat liver cirrhosis, virus B hepatitis, alcoholic hepatitis and toxic hepatitis caused by carbon tetrachloride.

Description

一种具有益肝作用的植物及其应用 技术领域  Plant with beneficial liver function and application thereof
本发明涉及一种具有益肝作用的野生植物 "益肝菜"的加工技术以及在食品、 保健食品、 天然药物、 兽用保健品和兽药中的用途, 具体地说, 是新鲜和干燥益肝菜全草、 深加工和提取物制备方法、 益肝菜深 加工产品、 益肝菜提取物、 益肝菜有效化学成分、 益肝菜在制备保肝功效保健品中的用途、 益肝菜在制备 肝炎的治疗药物 ( '.类和一类天然药物) 中的应用以及动物益肝制品的应用 (如防治雏鸭病毒性肝炎和中 毒性肝炎)。 背景技术  The invention relates to a processing technology of a wild plant "Yigancao" with beneficial liver function and the use in food, health food, natural medicine, veterinary health care product and veterinary medicine, in particular, fresh and dry liver Vegetable whole grass, deep processing and extract preparation method, Yigan vegetable deep processing product, Yigan vegetable extract, effective chemical composition of Yigancai, use of Yigancao in preparation of liver-protecting health care products, and preparation of hepatitis in Yigancai Applications of therapeutic drugs ('. and a class of natural drugs) and applications of animal liver products (eg, prevention of duckling viral hepatitis and toxic hepatitis). Background technique
肝脏是机体内重要的器官之一, 每天承受着大量的生物化学丁.厂的加 T.工作, 对大量的经消化道吸 收的食物和其它外来物质进行代谢的处理加工, 非常容易疲劳和受到损伤。 肝脏损伤是严重危害人民健康 的病种。 我国目前有超过一亿人的乙肝病毒终身携带者、 数千万丙型肝炎病毒的携带者, 其中约数千万人 会转变成慢性肝炎、 肝硬化、 肝癌, 每年因肝病而死亡的人约有数十万人。 近年来由嗜酒、 药物和各种有 害因素而引起的中毒性肝脏损伤也日趋增多。 中国每年用丁 ·治疗肝病的费用高达数百亿元人民币, 对经济 和社会发展特别是患者的身心健康造成了很大的负担, 所以保持肝脏的健康成为人们追求的目标。 食物和 药物是影响肝脏功能的重要闵素, 所以开发有益于肝脏健康的食品、 保健食品和新药就非常迫切。  The liver is one of the important organs in the body. It is subjected to a large amount of biochemical chemistry every day. It is a T. work of the factory. It is very easy to fatigue and suffer from the processing of a large amount of foods and other foreign substances absorbed by the digestive tract. damage. Liver damage is a disease that seriously harms people's health. China currently has more than 100 million people living with hepatitis B virus and tens of millions of hepatitis C virus carriers. About tens of millions of them will be converted into chronic hepatitis, cirrhosis, liver cancer, and people who die every year due to liver disease. There are hundreds of thousands of people. In recent years, toxic liver damage caused by alcohol, drugs and various harmful factors has also increased. The cost of treating liver disease in China every year is as high as tens of billions of yuan, which puts a heavy burden on economic and social development, especially the physical and mental health of patients. Therefore, maintaining the health of the liver has become the goal pursued by people. Food and medicine are important factors affecting liver function, so it is urgent to develop foods, health foods and new medicines that are good for liver health.
益肝菜 ( Oryc hmgm νίο! D O. E. Sc lz : 益肝菜是一种十字花科草本植物。 它的中文名 为- .月蓝 (北京植物志) 和」 .月兰 (辽十 '植物志)。 益肝菜原产地在中国东北及华北地区。 在北京等许多 生长益肝菜的地区都没有食用或药用益肝菜的 惯和研究报告。 根据农业部发布的 《农业植物品种命名规 ¾》 (巾华人民共和国农业部令, 2012年筇 2号, 自 2012年 4月 15 ϋ起施行), 我们认为益肝菜属于一种 新资源食用和药用的农业植物新品种。 "益肝菜" 是我们发现了这个植物具有良好的益肝作用后而起的名 '† -。  Yiyin (Oryc hmgm νίο! D OE Sc lz : Yigancai is a cruciferous herb. Its Chinese name is - . Moon Blue (Beijing Flora) and ". Yuelan (Liao Shi' Flora The origin of Yigancai is in Northeast China and North China. There are no research reports on the consumption or medicinal Yigancai in many areas such as Beijing where Yigancai is grown. According to the Agricultural Plant Variety Nomenclature issued by the Ministry of Agriculture. 3⁄4》 (Organization of the Ministry of Agriculture of the People's Republic of China, 2012, No. 2, since April 15, 2012), we believe that Yigancai is a new resource for edible and medicinal new varieties of agricultural plants. "Liver" is the name we found after the plant has a good liver function.
另外, 益肝菜在保健食品和药用方面都没有应用, 本发明这是发现了益肝菜在食用、 食品、 保健食 品和药品中的新用途、 加工方法以及含有的有效成分等。 发明内容  In addition, Yigancao has no application in health foods and medicinal purposes. The present invention finds new uses, processing methods, and active ingredients contained in edible foods, foods, and foods. Summary of the invention
本发明的 的是提供益肝菜的新用途, 即在制备肝炎治疗药物、 保健食品和动物益肝产品中的新 J、V 用。  The present invention provides a new use of Yigancai, namely, new J and V in the preparation of hepatitis therapeutic drugs, health foods and animal liver products.
本发明的另一目的是提供一种肝炎治疗的药物。 本发明的再一个 的是提供一种肝炎辅助治疗的保健食品。 Another object of the present invention is to provide a medicament for treating hepatitis. Still another aspect of the present invention is to provide a health food for hepatitis adjuvant therapy.
本发明的目的还包括提供制备方便、 保健和治疗效果好的益肝菜提取物及其制备方法。 发明人按照农产品的加工方法对益肝菜全草和各部位都进行了大量的深加工研究, 包括益肝菜粥、 益肝菜汤、 益肝菜青汁 (新鲜搾汁)、 干燥益肝菜、 即食益肝菜、 益肝菜酒、 益肝菜腌制品、 益肝菜饮片 等。 在益肝菜生长的各个阶段都可以收割制成对应的产品。  The object of the present invention is also to provide a beneficial liver preparation, a health care and a therapeutic effect, and a preparation method thereof. The inventor conducted a large number of deep processing studies on the whole process and various parts of Yigancai according to the processing method of agricultural products, including Yigancao porridge, Yigancao soup, Yigancai juice (fresh juicing), dried Yigancai, Instant Yigancao, Yigancai wine, Yigancai pickled products, Yigancai decoction pieces, etc. The corresponding products can be harvested at various stages of the growth of the beneficial liver.
益肝菜可以直接食用, 也可以直接食用其干燥植物。  Yigan can be eaten directly or directly in its dry plants.
发明人参照《2003年度药物研究技术指导原则一中药、天然物分册》 (国家食品药品监督管理局 2003 年)、 《新药临床前研究指导原则》(国家药监局 1993年)和 《保健食品功能学评价程序》 (卫生部 2003年) 等的肝炎治疗的药物评价方法以及保健食品评价方法, 对益肝菜进行了提取物制备、 药物剂型制备、 动物 药理和病理研究。  The inventor refers to the 2003 Guidelines for the Technical Guidance of Drug Research, the Chinese Medicine and Natural Substance (National Food and Drug Administration, 2003), the Guiding Principles for Preclinical Research of New Drugs (National Food and Drug Administration, 1993) and Health Food Function. The evaluation method of the evaluation (Ministry of Health 2003), the drug evaluation method for hepatitis treatment, and the health food evaluation method, the extract preparation, the pharmaceutical dosage form preparation, the animal pharmacology and the pathological study of the beneficial liver.
发明人发现益肝菜的各个部位都有益肝的作用, 这些部位是植物的花、 种子、 叶、 茎、 根以及芽苗。 益肝菜全草或部位可以制成天然药物的饮片。 一年四季都可以对益肝菜进行收割。 收割 其饮片制作的特 征在丁: 切制仝草为小段、 净制、 干燥。 益肝菜种子饮片为净制和干燥。 益肝菜饮片可以直接鲜用, 也可 以直接食用其干燥后的饮片。  The inventors found that various parts of the beneficial liver are beneficial to the liver, which are the flowers, seeds, leaves, stems, roots and sprouts of the plants. The whole grass or part of Yigancai can be made into pieces of natural medicine. Harvesting of beneficial liver vegetables can be carried out all year round. Harvesting the characteristics of the pieces produced in Ding: Cut the same grass into small pieces, net, and dry. Yigancao seed pieces are net and dry. The Yigancao Pieces can be used directly or directly after eating the dried pieces.
益肝菜提取物的制备方法是: 可以取^种部位的益肝菜饮片 1000g或适量新鲜全草, 粉碎, 水洗 3〜 4次, 加水煎煮三次, 每次 15分钟, 合并煎液, 滤过, 滤液浓缩稠膏, 继续干燥后, 制细粉, 即得。 本品 为棕色的颗粒; 味淡甜。  The preparation method of Yigancao extract is as follows: You can take 1000g of Yigancao decoction pieces or appropriate amount of fresh whole grass, crush, wash 3~4 times, add water for three times, each time for 15 minutes, combine decoction, filter After that, the filtrate is concentrated and thickened, and after drying, a fine powder is obtained. This product is brown granules; sweet and sweet.
发明人发现, 以益肝菜提取物进行口服给药和注射给药, 都有明显的效果, 血清肝脏生化功能指标 和病理指标都有明显的改善。  The inventors found that oral administration and injection administration of Yigancao extract have obvious effects, and serum liver biochemical function indexes and pathological indexes are significantly improved.
以益肝菜提取物进行治疗时, 它可以以粉剂、 颗粒剂、 片剂、 胶囊、 丸剂和液体药剂等形式口服给 药; 也可以以注射液、 栓剂、 经皮制剂、 喷雾剂等形式非经肠给药。 益肝菜提取物的有效药剂, 是通过与 适 _¾的药用掺混物, 如赋形剂、 粘合剂、 渗透剂、 润滑剂等混合而配制成的。  When it is treated with Yigancao extract, it can be administered orally in the form of powder, granules, tablets, capsules, pills and liquid medicaments; it can also be in the form of injections, suppositories, transdermal preparations, sprays, etc. Administered enterally. An effective agent for the extract of yoghurt is prepared by mixing with a suitable pharmaceutical blend such as an excipient, a binder, a penetrant, a lubricant or the like.
益肝菜提取物剂量随患者的病情、 给药途径、 患者的年龄和体 S而改变。 在口服给药情况下, 剂量 通常为成年人 500~1000mg天, 优选为 800mg/天。 在保健食品 用方面也是同样的原则。  The dose of the beneficial liver extract varies depending on the condition of the patient, the route of administration, the age of the patient, and the body S. In the case of oral administration, the dose is usually from 500 to 1000 mg per day for adults, preferably 800 mg per day. The same principle applies to health food use.
本发明的优点足: 益肝菜的益肝治疗作用在国内和国际上都是首次发现。 益肝菜可以作为治疗乙型 肝炎、 治疗肝硬化、 治疗酒精中毒性肝炎和四氯化碳等中毒性肝炎的天然药物。 目前国际上还没有乙型肝 炎和肝硬化以及酒精中¾性肝炎的公认天然药物。  Advantages of the invention: The beneficial liver treatment effect of Yigancai is first discovered both domestically and internationally. Yigancao can be used as a natural medicine for the treatment of hepatitis B, for the treatment of cirrhosis, for the treatment of toxic hepatitis such as alcoholic hepatitis and carbon tetrachloride. There are currently no internationally recognized natural medicines for hepatitis B and cirrhosis and 3⁄4 hepatitis in alcohol.
另外, 益肝菜制备方法比较简 ., 植物生长特点研究的也比较透彻, 有了一定规模的种植基地, 所 以材料的来源和经济性都有保障。 天然产物的市场认同性比较高, 市场的接受度高, 市场前景良好。 具体实施方式 In addition, the preparation method of Yigancao is relatively simple. The research on plant growth characteristics is also relatively thorough. With a certain scale of planting base, the source and economy of the materials are guaranteed. The market identity of natural products is relatively high, the market acceptance is high, and the market prospects are good. detailed description
下面提供的实施例用丁进一步阐明本发明, 而不构成对本发明范围的限制。 实施例 1. 材料  The invention is further illustrated by the following examples, which are not intended to limit the scope of the invention. Example 1. Material
实施例所用益肝菜饮片我们自制。 使用的是益肝菜全草或种子等不同部位。 我们制订了不同益肝菜 部位收获的季节时间以及不同部位药材饮片的制作的操作标准。 简单地说, 秋季主耍收获茎叶。 春季收获 包括根部和果荚的全草。 夏季收获种子。 茎叶和根部在洗净之后, 切成 2cm的小段, 干燥。 种子的饮片制 作耍经过千燥和净选工序。  The Yigancao pieces used in the examples were made by ourselves. Different parts such as whole liver grass or seeds are used. We have established the seasons for harvesting different parts of the beneficial liver and the operating standards for the production of the medicinal herbs in different parts. Simply put, the main game in autumn is to harvest the stems and leaves. Spring harvesting Whole grass including roots and pods. Harvest seeds in summer. After washing the stems and roots, cut into small pieces of 2 cm and dry. The seed pieces are made through a dry and net selection process.
其它的药品、 试剂和实验动物, 都能方便地市购。  Other drugs, reagents, and laboratory animals are readily available commercially.
¾施例 2. 制备方法例 3⁄4 Example 2. Example of preparation method
取益肝菜仝草的饮片 1000g, 粉碎, 水洗 3次, 加水 2500ml煎煮, 共三次, 每次 20分钟, 合并煎 液, 滤过, 滤液浓缩成相对密度为 1.18的稠膏, 继续减压浓缩至干, 得棕色粉末 51g。 实施例 3. 制剂实施例,  Take 1000g of lettuce and liver grass, smash, wash 3 times, add 2500ml of water to cook, three times each time, 20 minutes each time, combine the decoction, filter, concentrate the filtrate into a thick paste with a relative density of 1.18, continue to decompress Concentrated to dryness to give a brown powder of 51 g. Example 3. Formulation Example,
( 1 )取 lkg实施例 2的制备方法获得各个植物部位的益肝菜提取物, 粉碎并过 100目筛, 进入适量 淀粉混匀, 制各颗粒剂, 整粒后进行分装, 每袋 2g。  (1) taking the preparation method of the lkg Example 2 to obtain the extract of the beneficial liver of each plant part, pulverizing and passing through a 100 mesh sieve, and mixing into a proper amount of starch to prepare each granule, and then granulating the whole granules, 2 g per bag .
(2) 取¾施例 2的制备方法获得的益肝菜提取物 1000g, 羟乙基纤维素 10g, 压片制成片剂。 (2) 1000 g of the extract of Yigancai obtained by the preparation method of Example 2, 10 g of hydroxyethylcellulose, and tableted into tablets.
( 3 )实施例 2的制备方法获得的益肝菜提取物溶 Γ生理盐水或等渗葡萄糖液, 经过滤过后按需耍使 用配制的注射液。 (3) The extract of the beneficial liver obtained by the preparation method of Example 2 is dissolved in physiological saline or isotonic glucose solution, and after filtration, the prepared injection solution is used as needed.
(4 ) 实施例 2的制备方法获得的益肝菜提取物溶于水, 可以直接配制成 U服液。  (4) The extract of the beneficial liver obtained by the preparation method of the second embodiment is dissolved in water, and can be directly formulated into a U solution.
( 5 )实施例 2的制备方法获得的益肝菜提取物可以和甘草提取物、 黄芪提取物等药物配合制成复方 合剂用于治疗肝炎。 实施例 4. 药效实验  (5) The extract of the beneficial liver obtained by the preparation method of the second embodiment can be combined with a drug such as licorice extract and astragalus extract to prepare a compound for treating hepatitis. Example 4. Pharmacodynamic experiment
( 1 ) 评价方法 (1) Evaluation method
益肝菜及其提取物治疗肝炎的药效研究部分  Study on the efficacy of Yigancai and its extracts in the treatment of hepatitis
实验动物为成年健康雄性 CD-I小鼠。试验期 I'Hj提供足量的自来水及普通饲料。动物的分组与处理将 小鼠按体重随机分组。 在中毒性肝炎的疗效观察中为连续 3天给药, 每天一次。 第四天取血和留取动物肝 脏, 测定血清中的肝功酶丙氨酸转移酶(ALT), 观察肝脏病理变化程度。 进行. '.甲基亚硝胺肝硬化治疗的 评价时的给药时间为 2个月, 之后测定肝脏组织内的纤维化程度指标 (羟脯氨酸)。 乙肝药效评价采用细 胞评价方法。 实验数据以均数士标准差表示。 应用 EXCEL统计软件对实验结果采用方差分析、 t检验等方 法分析处理, p<0.05认为组 I'Hj差异具有显著性。 The experimental animals were adult healthy male CD-I mice. During the test period, I'Hj provided a sufficient amount of tap water and ordinary feed. Grouping and Processing of Animals Mice were randomized by body weight. In the observation of the efficacy of toxic hepatitis, it was administered for 3 consecutive days, once a day. On the fourth day, blood was taken and the liver of the animal was collected. The liver function enzyme alanine transferase (ALT) was measured in the serum, and the degree of liver pathological changes was observed. The administration time of the evaluation of '. methyl nitrosamine cirrhosis treatment was 2 months, and then the degree of fibrosis in the liver tissue (hydroxyproline) was measured. Hepatitis B efficacy evaluation using fine Cell evaluation method. Experimental data is expressed as mean ± standard deviation. The results of the experiment were analyzed by ANOVA and t-test using the EXCEL statistical software. The difference of the group I'Hj was considered to be significant at p<0.05.
(2 ) 评价结果: 表 1 益肝菜企草提取物和各部位提取物抗四氯化碳中毒性肝炎的作用 提取物分类 ALT (2) Evaluation results: Table 1 Effect of extracts of Yigancao grass and extracts from various parts on carbon tetrachloride poisoning hepatitis Extract classification ALT
(植物 g/kg) (1U L)  (plant g/kg) (1U L)
对照组 35士 20  Control group 35 people 20
四氯化碳肝炎组 2680±778#* Carbon tetrachloride hepatitis group 2680±778 # *
仝草提取物低剂量 2375±1089  Same grass extract low dose 2375±1089
全草提取物中剂 ¾ 661±659**  Whole herb extract 3⁄4 661±659**
全草提取物高剂量 102±63**  Whole grass extract high dose 102±63**
根提取物中剂量 532±269**  Root extract dose 532±269**
茎叶提取物中剂量 898±5 S5i8**  Stem and leaf extract dose 898±5 S5i8**
花提取物中剂 fi 1665±1126* oo  Flower extract agent fi 1665±1126* oo
种子提取物中剂量 181±88** 注: #与对照组比较 p < 0.05。 ' |=*与模型组比较 p < 0.01。 The dose in the seed extract was 181±88**. Note: #Compared with the control group, p < 0.05. ' |=* is compared with the model group p < 0.01.
表 2 益肝菜全草种子抗酒精的小鼠中毒性肝炎作用 益肝菜种子提取物 ALT Table 2 Yigancao whole grass seeds anti-alcoholic mice toxic hepatitis effect Yigancao seed extract ALT
(植物 g/kg) (IU/L)  (plant g/kg) (IU/L)
对照绗 50±15  Control 绗 50±15
酒精肝炎组 101±60  Alcohol hepatitis group 101±60
低剂量 47±12*  Low dose 47±12*
中剂量 50±20*  Medium dose 50±20*
高剂 *  High dose *
注: #与对照组比较 p < 0.05。 *与模型组比较 p < 0.05。 益肝菜种子提取物治疗二甲基亚硝胺肝硬化的作用 益肝菜种子提取物 羟脯氨酸 Note: #Compared with the control group, p < 0.05. *Compared with the model group p < 0.05. Effect of Yigancao Seed Extract on Dimethylnitrosamine Liver Cirrhosis Yigancao Seed Extract Hydroxyproline
(植物 g/kg) (mg g) 对照组 0.10±0.04 肝硬化组 0.23±0.07#* 低剂量 0.20±0.56 中剂量 0.18±0.05* 高齐 !j暈 0.15±0.02** 注: ##与对照组比较 p < 0.01。 * , **与模型组比较 p < 0.05, p < 0.01。 表 4 益肝菜种子提取物抗乙型肝炎的病毒抑制作用的细胞学 益肝菜种子提取物 (plant g/kg) (mg g) control group 0.10±0.04 cirrhosis group 0.23±0.07 # * low dose 0.20±0.56 medium dose 0.18±0.05* high Qi! j halo 0.15±0.02** Note: ##与对照Group comparison p < 0.01. * , ** compared with the model group p < 0.05, p < 0.01. Table 4 Cytopathic Yigancao Seed Extract of Yigancao Seed Extract against Virus Inhibition of Hepatitis B
浓度 (mmol ) HBsAg  Concentration (mmol) HBsAg
空 对照 2.284±0.194  Empty control 2.284±0.194
低浓度 1.407±0.578* 中浓度 1.331±0.393** 中浓度 1.106±0.245** 高浓度 0.678±0.026** 与空 Ci对照 (细胞) 比较, *p<0.05 , **p<0.01  Low concentration 1.407±0.578* medium concentration 1.331±0.393** medium concentration 1.106±0.245** high concentration 0.678±0.026** compared with empty Ci control (cell), *p<0.05, **p<0.01

Claims

权 利 要 求 书 Claim
1. 用丁 ·制备具有对人类和动物益肝作用的植物产品, 其特征在于含有益肝菜全鲜草或部位的提取物。1. Use Ding to prepare a plant product having a beneficial effect on humans and animals, characterized by an extract containing whole grass or parts of Yigancai.
2. 一种益肝菜饮片, 其特征在于益肝菜全草或部位均可以制成天然饮片。 其饮片制作的特征在于: 切制 企草为小段、 净制、 干燥。 益肝菜种子饮片为净制和干燥。 益肝菜的部位为根、 茎叶 (包括苗)、 花、 种莢和种子。 益肝菜饮片可以直接鲜用, 也可以直接食用其干燥后的饮片。 2. A Yigancai decoction piece, characterized in that all the grass or parts of Yigancai can be made into natural pieces. The characteristics of the preparation of the pieces are as follows: the cut grass is small, net, and dry. Yigancao seed pieces are net and dry. The parts of the beneficial liver are roots, stems and leaves (including seedlings), flowers, seed pods and seeds. Yigancao decoction pieces can be used directly or directly after eating the dried pieces.
3. 一种益肝菜提取物, 其特征在于采用如下方法制备获得, 取益肝菜各部位的饮片或新鲜全草, 净制, 粉碎, 水洗 3〜4次, 加水煎煮三次, 每次 15分钟, 合并煎液, 滤过, 滤液浓缩稠膏。 或将稠膏干燥 n , 制得细粉。  3. An extract of Yigancai, characterized in that it is prepared by the following method, taking the pieces of fresh liver or the whole whole grass, net, crushing, washing 3~4 times, boiling water three times, each time After 15 minutes, the decoction was combined, filtered, and the filtrate was concentrated. Or dry the thick paste to make a fine powder.
4. 根据权利要求 3所述的益肝菜提取物, 其特征在与提取物细粉和适 ¾的药用敷料一起可以制成口服制 剂、 注射剂、 颗粒剂、 片剂、 胶囊剂、 丸剂、 散剂等多种剂型。 也可以和其它药物或其它植物提取物 配伍绗成复方制剂。  4. The beneficial liver extract according to claim 3, which is characterized in that it can be formulated into an oral preparation, an injection, a granule, a tablet, a capsule, a pill, together with an extract fine powder and a suitable medicinal dressing. A variety of dosage forms such as powder. It can also be combined with other drugs or other plant extracts to form a compound preparation.
5. 一种用于肝炎辅助治疗的药物, 其特征在于含有权利要求 2和 3所述的益肝菜饮片或提取物。  A medicament for adjuvant therapy of hepatitis, which comprises the beneficial liver flakes or extract of claims 2 and 3.
6. 一种用于益肝的保健品, 其特征在于含有权利要求 2和 3所述的益肝菜饮片或提取物。  A health product for benefiting liver, which comprises the beneficial liver flakes or extract of claims 2 and 3.
7. 益肝菜或权利耍求 2和 3所述的益肝菜饮片或提取物在制各乙型病毒性肝炎的治疗药物以及保健品中 的应用。  7. The use of Yigancao decoction pieces or extracts described in Yigancai or the rights of 2 and 3 in the manufacture of therapeutic drugs for various hepatitis B and health care products.
8. 益肝菜或权利耍求 2和 3所述的益肝菜饮片或提取物在制备中毒性肝炎的治疗药物以及保健品中的应 用, 优选所述的巾毒性肝炎足酒精中毒性肝炎、 四氯化碳中毒性肝炎。  8. The use of Yigancao or the extracts of Yigancao or the extracts according to claims 2 and 3 for the preparation of a therapeutic drug for toxic hepatitis and a health care product, preferably the toxic hepatitis of the towel, alcoholic toxic hepatitis, Carbon tetrachloride toxic hepatitis.
9. 益肝菜或权利要求 3和 3所述的益肝菜饮片或提取物在制备肝硬化治疗药物以及保健品中的应用。  9. Use of Yigancao or the beneficial liver tablets or extracts according to claims 3 and 3 for the preparation of cirrhosis therapeutic drugs and health care products.
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