CN103211873A - Medicinal composition for treating hepatic fibrosis and preparation method thereof - Google Patents
Medicinal composition for treating hepatic fibrosis and preparation method thereof Download PDFInfo
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Abstract
本发明公开一种具有清热利湿、保肝抗纤功效，用于抗肝纤维化治疗的中药，以质量份计，各组分的配比为：地钱3～30，火炭母3～30。药理研究表明，该药具有保肝降酶、抗肝纤维化的作用；临床上用于治疗肝纤维化。The invention discloses a traditional Chinese medicine which has the functions of clearing away heat and promoting dampness, protecting the liver and resisting fibrosis, and is used for the treatment of liver fibrosis. The ratio of each component is as follows: 3-30 parts by mass, and 3-30 parts by weight. . Pharmacological studies have shown that the drug has the effects of protecting the liver, reducing enzymes, and resisting liver fibrosis; it is clinically used to treat liver fibrosis.
Description
技术领域technical field
本发明涉及一种用于治疗肝纤维化的中成药，及其生产方法。The invention relates to a Chinese patent medicine for treating liver fibrosis and a production method thereof.
背景技术Background technique
肝纤维化俗称肝硬化，是指由各种致病因子所致肝内结缔组织异常增生，导致肝内弥漫性细胞外基质过度沉淀的病理过程。它不是一个独立的疾病，许多慢性肝脏疾病均可引起肝纤维化。在我国，多由饮酒、病毒性肝炎、不良生活习惯而诱发肝纤维化，每年保有病例数超过3000万人。Liver fibrosis, commonly known as liver cirrhosis, refers to the pathological process of abnormal proliferation of connective tissue in the liver caused by various pathogenic factors, leading to excessive precipitation of diffuse extracellular matrix in the liver. It is not an independent disease, and many chronic liver diseases can cause liver fibrosis. In my country, liver fibrosis is mostly induced by drinking, viral hepatitis, and bad living habits, and the number of cases exceeds 30 million every year.
苔藓类地钱科地钱属植物地钱Marchantia polymorpha L.，以全草入药，四季可采，洗净，鲜用或晒干用。又名地浮萍、一团云等，是广西民间习用药材，具有清热，拔毒，生肌功效，外用治烧烫伤，骨折，毒蛇咬伤，疮痈肿毒，臁疮，癣。The moss species Marchantia polymorpha L. of the genus Marchantia is used as medicine with the whole plant, which can be harvested in four seasons, washed, fresh or dried. Also known as Duckweed, Yituanyun, etc., it is a traditional medicinal material in Guangxi. It has the effects of clearing away heat, pulling out toxins, and promoting muscle growth.
蓼科蓼属植物火炭母Polygunum chinense L.，又名清饭藤、火炭藤、赤地利、川七、翅地利、火炭星、火炭藤、白饭草、白饭藤、信饭藤，以全草入药，四季可采，洗净晒干或鲜用，是广西民间习用药材。火炭母酸、甘，寒，归肝、脾经，具有清热解毒，利湿消滞，凉血止痒，明目退翳功效，用于痢疾，肠炎，消化不良，肝炎，感冒，扁桃体炎，咽喉炎，白喉，百日咳，角膜云翳，霉菌性阴道炎，白带，乳腺炎，疖肿，小儿脓疱疮，湿疹，毒蛇咬伤。Polygunum chinense L., a plant belonging to the genus Polygonaceae, is also known as Qingfanteng, Fotanteng, Chidili, Chuanqi, Chidili, Fotanxing, Fotanteng, Rice Grass, Ricevine, and Xinfanteng. The whole plant is used as medicine , which can be collected in four seasons, washed and dried or used fresh, is a traditional folk medicinal material in Guangxi. Fo charcoal is acidic, sweet and cold, and returns to the liver and spleen meridian. It has the functions of clearing away heat and detoxification, promoting dampness and eliminating stagnation, cooling blood and relieving itching, improving eyesight and reducing nebula. It is used for dysentery, enteritis, indigestion, hepatitis, cold, tonsillitis, Pharyngitis, diphtheria, whooping cough, corneal clouding, fungal vaginitis, leucorrhea, mastitis, boils, impetigo in children, eczema, snake bites.
在现有文献中，尚未见有以地钱和火炭母入药组方的报道。据发明人所知，这2味药仅在民间有所应用，或者在临床上，医生开具临时处方时用到。In the existing literature, there has not been any report of using Diqian and Fotanmu as medicinal prescriptions. As far as the inventor knows, these 2 herbs are only used among the people, or clinically, they are used when doctors issue temporary prescriptions.
发明内容Contents of the invention
本发明的处方由2味药材组成，均为广西民间草药，分别为地钱、火炭母。本发明的目的是提供一种具有清热利湿、保肝抗纤功效的中药制剂，用于治疗肝纤维化；本发明的另一个目的是提供该药物组合的制备方法。The prescription of the present invention is made up of 2 kinds of medicinal materials, all are folk herbal medicines in Guangxi, and are respectively Radix Diana and Fotanmu. The object of the present invention is to provide a traditional Chinese medicine preparation with functions of clearing away heat and dampness, protecting the liver and resisting fibrosis, which is used for treating liver fibrosis; another object of the present invention is to provide a preparation method of the drug combination.
本发明的药物组合由以下组分(质量份)组成：地钱3～30，火炭母3～30。The medicine combination of the present invention is composed of the following components (parts by mass): 3-30 parts of Radix Diana, 3-30 parts of Fotanmu.
本发明优选的组合是：地钱10，火炭母12。The preferred combination of the present invention is: ground money 10, fire charcoal mother 12.
为了将上述药物组合制备为中成药，可通过如下方法完成：①地钱用70％乙醇回流提取；②火炭母水煮，水煮液浓缩，醇沉，取上清液；③将醇沉上清液与地钱醇提液合并；④浓缩至稠膏，烤成干膏；⑤干膏打成细粉；⑥加入辅料，制成所需剂型，如片剂、丸剂、胶囊等；⑦亦可直接将步骤④中的稠膏，加适量水和糖，制成口服液。In order to prepare the above-mentioned drug combination into a Chinese patent medicine, it can be completed by the following methods: ①The ground money is refluxed with 70% ethanol to extract; The supernatant liquid is combined with the ground money alcohol extract; ④Concentrate to a thick paste, baked into a dry paste; ⑤The dry paste is beaten into a fine powder; ⑥Add auxiliary materials to make the required dosage form, such as tablets, pills, capsules, etc.; ⑦Also The thick paste in step ④ can be directly added with appropriate amount of water and sugar to make oral liquid.
与现有技术相比，本发明的显著进步表现为：Compared with prior art, remarkable progress of the present invention is shown as:
1.首次采用地钱和火炭母组成中药处方。1. For the first time, the traditional Chinese medicine prescription is composed of ground money and fotan mother.
2.首次发现由地钱和火炭母制成的药物，具有抗肝纤维化作用，可用于肝纤维化的临床治疗。2. For the first time, it was discovered that the medicine made from Diantha and Fotanmu has anti-hepatic fibrosis effect and can be used for clinical treatment of liver fibrosis.
具体实施方式Detailed ways
下列实施例子用于举例说明本发明，并不是对本发明保护范围的任何限制。The following examples are used to illustrate the present invention, but not to limit the protection scope of the present invention.
实施例一Embodiment one
处方：地钱1000g，火炭母1200g。Prescription: ground money 1000g, fotan mother 1200g.
(1)地钱用70％乙醇回流提取，第一次15倍量(v/w)，2小时；第二次8倍量(v/w)，1小时；合并2次醇提液，滤过，备用。(1) Radix chinensis is extracted with 70% ethanol under reflux, 15 times the amount (v/w) for the first time, 2 hours; 8 times the amount (v/w) for the second time, 1 hour; combine 2 times of alcohol extracts, filter Yes, spare.
(2)火炭母用水提取，第一次12倍量(v/w)，2小时；第二次8倍量(v/w)，1小时；合并两次水提液，过滤，减压浓缩至比重1.10～1.20(80℃)，加入2倍量的95％乙醇作醇沉处理，静置72小时，滤取上清液。(2) Extract with water, 12 times the amount (v/w) for the first time, 2 hours; 8 times the amount (v/w) for the second time, 1 hour; combine the two water extracts, filter, and concentrate under reduced pressure To a specific gravity of 1.10-1.20 (80°C), add 2 times the amount of 95% ethanol for alcohol precipitation treatment, let stand for 72 hours, and filter the supernatant.
(3)将火炭母醇沉上清液与地钱醇提液合并，减压浓缩至稠膏。稠膏移入托盘，80～100℃烤成干膏。(3) Combine the supernatant of the ethanol precipitation of Fotan mother and the ethanol extract, and concentrate under reduced pressure to a thick paste. The thick paste is transferred to the tray, and baked at 80-100°C to form a dry paste.
(4)干膏打成细粉，全部过80目筛。(4) The dry paste is ground into a fine powder, and all of them are passed through an 80-mesh sieve.
(5)加入适量淀粉，以85％乙醇水溶液制粒，压成900片。(5) Add appropriate amount of starch, granulate with 85% ethanol aqueous solution, and press into 900 tablets.
(6)用法用量：每日3次，每次3片。(6) Usage and dosage: 3 times a day, 3 tablets each time.
实施例二Embodiment two
处方：地钱1000g，火炭母1000g。Prescription: ground money 1000g, fotan mother 1000g.
(1)地钱用75％乙醇回流提取，第一次12倍量(v/w)，1小时；第二次8倍量(v/w)，1小时；第三次8倍量(v/w)，1小时；合并3次醇提液，滤过，备用。(1) Radix chinensis is extracted with 75% ethanol backflow, 12 times of amount (v/w) for the first time, 1 hour; 8 times of amount (v/w) for the second time, 1 hour; 8 times of amount (v/w) for the third time /w), 1 hour; 3 times of alcohol extracts were combined, filtered, and set aside.
(2)火炭母用水提取，第一次15倍量(v/w)，1.5小时；第二次10倍量(v/w)，1小时；合并两次水提液，过滤，减压浓缩至比重1.10～1.20(80℃)，加入2.5倍量的95％乙醇作醇沉处理，静置60小时，滤取上清液。(2) Extract with water, 15 times the amount (v/w) for the first time, 1.5 hours; 10 times the amount (v/w) for the second time, 1 hour; combine the two water extracts, filter, and concentrate under reduced pressure To a specific gravity of 1.10-1.20 (80°C), add 2.5 times the amount of 95% ethanol for alcohol precipitation treatment, let stand for 60 hours, and filter the supernatant.
(3)将火炭母醇沉上清液与地钱醇提液合并，减压浓缩至稠膏。稠膏移入托盘，80～100℃烤成干膏。(3) Combine the supernatant of the ethanol precipitation of Fotan mother and the ethanol extract, and concentrate under reduced pressure to a thick paste. The thick paste is transferred to the tray, and baked at 80-100°C to form a dry paste.
(4)干膏打成细粉，全部过80目筛。(4) The dry paste is ground into a fine powder, and all of them are passed through an 80-mesh sieve.
(5)加入适量淀粉，以蜂蜜作粘合剂，泛丸，得900丸。(5) Add an appropriate amount of starch, use honey as a binder, and make pills to obtain 900 pills.
(6)用法用量：每日3次，每次3丸。(6) Usage and dosage: 3 times a day, 3 pills each time.
实施例三Embodiment three
处方：地钱1000g，火炭母1500g。Prescription: ground money 1000g, fotan mother 1500g.
(1)地钱用65％乙醇回流提取，第一次15倍量(v/w)，1小时；第二次8倍量(v/w)，1小时；第三次8倍量(v/w)，1小时；合并3次醇提液，滤过，备用。(1) Radix chinensis is extracted with 65% ethanol backflow, 15 times of amount (v/w) for the first time, 1 hour; 8 times of amount (v/w) for the second time, 1 hour; 8 times of amount (v/w) for the third time /w), 1 hour; 3 times of alcohol extracts were combined, filtered, and set aside.
(2)火炭母用水提取，第一次15倍量(v/w)，1.5小时；第二次10倍量(v/w)，1小时；合并两次水提液，过滤，减压浓缩至比重1.10～1.20(80℃)，加入2倍量的95％乙醇作醇沉处理，静置96小时，滤取上清液。(2) Extract with water, 15 times the amount (v/w) for the first time, 1.5 hours; 10 times the amount (v/w) for the second time, 1 hour; combine the two water extracts, filter, and concentrate under reduced pressure To a specific gravity of 1.10-1.20 (80°C), add 2 times the amount of 95% ethanol for alcohol precipitation treatment, let stand for 96 hours, and filter the supernatant.
(3)将火炭母醇沉上清液与地钱醇提液合并，减压浓缩至稠膏。稠膏移入托盘，80～100℃烤成干膏。(3) Combine the supernatant of the ethanol precipitation of Fotan mother and the ethanol extract, and concentrate under reduced pressure to a thick paste. The thick paste is transferred to the tray, and baked at 80-100°C to form a dry paste.
(4)干膏打成细粉，全部过80目筛。(4) The dry paste is ground into a fine powder, and all of them are passed through an 80-mesh sieve.
(5)加入适量淀粉，制粒。(5) Add appropriate amount of starch and granulate.
(6)颗粒装入胶囊，得600粒。(6) The granules are packed into capsules to obtain 600 granules.
(7)用法用量：每日3次，每次2粒。(7) Usage and dosage: 3 times a day, 2 capsules each time.
实施例四Embodiment four
处方：地钱1000g，火炭母1200g。Prescription: ground money 1000g, fotan mother 1200g.
(1)地钱用70％乙醇回流提取，第一次15倍量(v/w)，2小时；第二次8倍量(v/w)，1小时；合并2次醇提液，滤过，备用。(1) Radix chinensis is extracted with 70% ethanol under reflux, 15 times the amount (v/w) for the first time, 2 hours; 8 times the amount (v/w) for the second time, 1 hour; combine 2 times of alcohol extracts, filter Yes, spare.
(2)火炭母用水提取，第一次12倍量(v/w)，2小时；第二次8倍量(v/w)，1小时；合并两次水提液，过滤，减压浓缩至比重1.10～1.20(80℃)，加入2倍量的95％乙醇作醇沉处理，静置96小时，滤取上清液。(2) Extract with water, 12 times the amount (v/w) for the first time, 2 hours; 8 times the amount (v/w) for the second time, 1 hour; combine the two water extracts, filter, and concentrate under reduced pressure To a specific gravity of 1.10-1.20 (80°C), add 2 times the amount of 95% ethanol for alcohol precipitation treatment, let stand for 96 hours, and filter the supernatant.
(3)将火炭母醇沉上清液与地钱醇提液合并，减压浓缩至稠膏。(3) Combine the supernatant of the ethanol precipitation of Fotan mother and the ethanol extract, and concentrate under reduced pressure to a thick paste.
(4)稠膏用少量水加热化开，加入1800g白砂糖，加热溶解，然后继续加水，定容至3000ml，充分混匀，得口服液。(4) Heat the thick ointment with a small amount of water to dissolve, add 1800g of white granulated sugar, heat to dissolve, then continue to add water, set the volume to 3000ml, and mix well to obtain an oral liquid.
(5)用法用量：每日3次，每次10ml。(5) Usage and dosage: 3 times a day, 10ml each time.
药理学实验Pharmacological experiment
取上述实施例一中所得的片剂(为了方便描述，记作″地母片″)进行以下药理学实验。The tablet obtained in the above-mentioned Example 1 (referred to as "Dimu Tablet" for convenience of description) was used for the following pharmacological experiments.
(1)对CCl4所致急性肝损伤模型的保护作用：(1) Protective effect on the acute liver injury model caused by CCl4 :
取小鼠60只，随机分为正常对照组(蒸馏水20ml/kg)、CCl4模型对照组(蒸馏水，20ml/kg)、联苯双酯对照组(0.1g/kg)，地母片大中小剂量组(1.2，0.6，0.3g/kg)。小鼠每天灌胃(ig)给药1次，连续15d。末次给药1h后，除正常对照组外，各ip1％CCl4花生油溶液10ml/kg。20h后从小鼠眼眶静脉丛取血，2500rpm/min离心20min，分离血清，测定血清中丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)的活性，结果见表1。联苯双酯组和地母片大剂量组明显降低ALT、AST的活性(p＜0.01)，中剂量次之(p＜0.05)，小剂量组也有降低的趋势，但不明显(p＞0.05)。Get 60 mice and randomly divide them into normal control group (distilled water 20ml/kg), CCl 4 model control group (distilled water, 20ml/kg), bifendate control group (0.1g/kg), Dimu Tablets large, medium and small Dosage groups (1.2, 0.6, 0.3 g/kg). Mice were administered intragastrically (ig) once a day for 15 consecutive days. One hour after the last administration, except for the normal control group, each ip 1% CCl 4 peanut oil solution 10ml/kg. After 20 hours, blood was taken from the orbital venous plexus of the mice, centrifuged at 2500rpm/min for 20min, and the serum was separated to determine the activities of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the serum. The results are shown in Table 1. The bifendate group and the Dimu tablet high-dose group significantly reduced the activity of ALT and AST (p<0.01), followed by the middle dose (p<0.05), and the low-dose group also had a tendency to decrease, but not significantly (p>0.05 ).
表1对CCl4所致小鼠急性肝损伤模型ALT活性的影响(
注：经t检验，与CCl4模型对照组比较，**p＜0.01，*p＜0.05Note: After t test, compared with the CCl 4 model control group, **p<0.01, *p<0.05
(2)对大鼠实验性肝纤维化的影响(2) Effects on experimental liver fibrosis in rats
取大鼠，随机分为正常对照组(蒸馏水20ml/kg)、CCl4模型对照组(蒸馏水，20ml/kg)、CCl4+联苯双酯对照组(0.1g/kg)，CCl4+地母片大中小剂量组(1.2，0.6，0.3g/kg)。每日灌胃(ig)给药一次，连续45d；除正常对照组外，每隔3d各动物ipCCl40.3ml/100g(40％豆油溶液)，首次剂量0.5ml/100g。于末次给药24h后，断头处死动物，取肝组织测定羟脯氨酸和肝总脂含量，结果见表2、表3。同时做肝组织病理切片，染色后显微镜下观察肝的纤维化程度，与模型组进行比较。Rats were taken and randomly divided into normal control group (distilled water 20ml/kg), CCl 4 model control group (distilled water, 20ml/kg), CCl 4 + bifendate control group (0.1g/kg), CCl 4 + ground Mother tablet large, medium and small dose groups (1.2, 0.6, 0.3g/kg). Intragastric administration (ig) was administered once a day for 45 consecutive days; except for the normal control group, each animal received ipCCl 4 0.3ml/100g (40% soybean oil solution) every 3 days, and the first dose was 0.5ml/100g. 24 hours after the last administration, the animals were sacrificed by decapitation, and the liver tissue was taken to measure the content of hydroxyproline and total liver lipid. The results are shown in Table 2 and Table 3. At the same time, liver tissue pathological sections were made, and the degree of liver fibrosis was observed under a microscope after staining, and compared with the model group.
表2对大鼠肝脏组织中羟脯氨酸含量的影响(
注：经t检验，与CCl4模型对照组比较，**p＜0.01，*p＜0.05Note: After t test, compared with the CCl 4 model control group, **p<0.01, *p<0.05
表3对大鼠肝脏组织中总脂含量的影响(
汪：经t检验，与CCl4模型对照组比较，**p＜0.01，*p＜0.05Wang: By t test, compared with the CCl 4 model control group, **p<0.01, *p<0.05
表2和表3表明，联苯双酯组和地母片大剂量组均能显著降低肝组织中的羟脯氨酸含量和总脂含量(p＜0.01)，中剂量组次之(p＜0.05)。病理切片检查结果显示，联苯双酯组、地母片大、中剂量组的肝组织纤维增生明显减少，未见重度纤维化发生；地母片大剂量组的肝纤维化程度较中剂量组轻，而中剂量组较小剂量组轻，显示剂量-效应关系。Table 2 and table 3 show that the bifendate group and the Dimu tablet high-dose group all can significantly reduce the hydroxyproline content and the total lipid content in the liver tissue (p＜0.01), followed by the middle dose group (p＜0.01). 0.05). The results of pathological section examination showed that the fibrosis of the liver tissue in the bifendate group, the large-dose Dimu tablet group and the middle-dose group was significantly reduced, and no severe fibrosis occurred; Mild, while the medium dose group and the small dose group were mild, showing a dose-effect relationship.
临床应用Clinical application
本发明的药物组合，作为医生临时处方在临床上应用多年；使用过的病例表明，该药物能延缓和减轻肝的纤维化程度。The drug combination of the present invention has been used clinically for many years as a doctor's temporary prescription; used cases show that the drug can delay and alleviate the degree of liver fibrosis.
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