CN106727647A - 一种治疗脂肪肝的药物 - Google Patents
一种治疗脂肪肝的药物 Download PDFInfo
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- CN106727647A CN106727647A CN201611208100.9A CN201611208100A CN106727647A CN 106727647 A CN106727647 A CN 106727647A CN 201611208100 A CN201611208100 A CN 201611208100A CN 106727647 A CN106727647 A CN 106727647A
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- medicine
- fatty liver
- treatment
- glucurolactone
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- 239000003814 drug Substances 0.000 title claims abstract description 55
- 231100000240 steatosis hepatitis Toxicity 0.000 title claims abstract description 53
- 208000004930 Fatty Liver Diseases 0.000 title claims abstract description 52
- 206010019708 Hepatic steatosis Diseases 0.000 title claims abstract description 52
- 208000010706 fatty liver disease Diseases 0.000 title claims abstract description 52
- GGHMUJBZYLPWFD-UHFFFAOYSA-N patchoulialcohol Chemical compound C1CC2(C)C3(O)CCC(C)C2CC1C3(C)C GGHMUJBZYLPWFD-UHFFFAOYSA-N 0.000 claims abstract description 38
- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 claims abstract description 36
- TUSDEZXZIZRFGC-UHFFFAOYSA-N 1-O-galloyl-3,6-(R)-HHDP-beta-D-glucose Natural products OC1C(O2)COC(=O)C3=CC(O)=C(O)C(O)=C3C3=C(O)C(O)=C(O)C=C3C(=O)OC1C(O)C2OC(=O)C1=CC(O)=C(O)C(O)=C1 TUSDEZXZIZRFGC-UHFFFAOYSA-N 0.000 claims abstract description 19
- 229920002786 Corilagin Polymers 0.000 claims abstract description 19
- UYUXSRADSPPKRZ-SKNVOMKLSA-N D-glucurono-6,3-lactone Chemical compound O=C[C@H](O)[C@H]1OC(=O)[C@@H](O)[C@H]1O UYUXSRADSPPKRZ-SKNVOMKLSA-N 0.000 claims abstract description 19
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- TUSDEZXZIZRFGC-XIGLUPEJSA-N corilagin Chemical compound O([C@H]1[C@H](O)[C@H]2OC(=O)C3=CC(O)=C(O)C(O)=C3C3=C(O)C(O)=C(O)C=C3C(=O)OC[C@@H](O1)[C@H]2O)C(=O)C1=CC(O)=C(O)C(O)=C1 TUSDEZXZIZRFGC-XIGLUPEJSA-N 0.000 claims abstract description 19
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A—HUMAN NECESSITIES
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- 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
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- A—HUMAN NECESSITIES
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- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
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Abstract
本发明公开了一种治疗脂肪肝的药物,所述治疗脂肪肝的药物,按照重量份的主要原料为:L‑谷氨酰胺8‑20份、D‑色氨酸0.2‑0.6份、百秋李醇4‑8份、老鹳草素0.2‑0.7份、葡醛内酯10‑20份、柯里拉京3‑7份、槲皮素0.9‑1.5份、丹参素钠0.2‑0.5份、对甲氧基肉桂酸乙酯4‑6份、水飞蓟素1‑3份。本发明药物显著改善脂肪肝患者症状和体症,可明显调节血脂代谢作用,具有疗效好,疗程短,价格低,基本无毒副作用等特点,在治疗脂肪肝方面具有推广应用的价值。
Description
技术领域
本发明涉及一种医药制备领域,具体是一种治疗脂肪肝的药物。
背景技术
正常情况下脂肪占肝脏总重量的3%~5%。当脂肪含量超过肝脏重量的1/10或组织学上肝细胞半数以上脂肪性变时即为脂肪肝。其发病机制至今尚未完全明确,一般认为肝细胞合成三酰甘油及分泌极低密度脂蛋白之间的不平衡是形成脂肪肝的主要原因,而这种不平衡是由于肝细胞脂肪合成增加或氧化减少所致。随着生活习惯和饮食结构的改变,保健意识的增强,检测手段的进步,脂肪肝的发病率和检出率逐渐增多,已成为一个严重危害人类身体健康的常见隐患,某些地区脂肪肝已成为仅次于病毒性肝炎的第二大肝病。据欧美学者统计,脂肪肝发病率在一般人群占10%~24%,在肥胖者中占57.5%~74%。在我国,据北京、上海、南京、杭州、江苏连云港等地区的部分调查结果,发病率在5.2%~11.4%之间不等,其中男性高于女性,发病年龄有越来越小的趋势。值得重视的是,有研究发现在非酒精性脂肪肝(NAFL)肝纤维化的发生率高达25%。其中1.5%~8.0%的患者可进展为肝硬变,而导致一系列严重并发症,被认为是隐源性肝硬变的常见病因。因此,脂肪肝防治越来越引起人们的重视。目前西药治疗脂肪肝或存在不同程度的毒性,或降脂效果不理想且停药后常会反弹影响疗效,故对于脂肪肝这样一种慢性疾病,在控制其发展及肝脏的纤维化方面受到限制。脂肪肝中医无此病名,多归属于“积聚”“肥气”等范畴,属肝脾之病,正如《内经》所云:“肝之积,日肥气”。认为该病是由于长期嗜食肥甘厚味,饮酒过度或久卧久坐,体丰痰盈,或七情内伤,调摄失当,使脾失运化,肝失疏泄,机体代谢紊乱,水谷不能化生精微,聚而为湿为痰,瘀阻肝络而形成该病。中医药治疗脂肪肝疗效平稳、有多向调节的优势,近年来对中药汤剂治疗脂肪肝的研究较多。迄今为止,对于脂肪肝的治疗,在中医和西医方面均未找到完全满意的治疗方案。
脂肪肝的发病机制至今尚未完全明确,一般认为肝细胞合成三酰甘油及分泌低密度脂蛋白之间的不平衡是形成脂肪肝的主要原因。因此,急需研发一种适合疗效好、速度快、价格低、无毒副作用的西药组合物。
发明内容
本发明的目的在于提供一种治疗脂肪肝的药物,以解决上述背景技术中提出的问题。
为实现上述目的,本发明提供如下技术方案:
一种治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺8-20份、D-色氨酸0.2-0.6份、百秋李醇4-8份、老鹳草素0.2-0.7份、葡醛内酯10-20份、柯里拉京3-7份、槲皮素0.9-1.5份、丹参素钠0.2-0.5份、对甲氧基肉桂酸乙酯4-6份、水飞蓟素1-3份。
作为本发明进一步的方案:所述治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺11-16份、D-色氨酸0.4-0.5份、百秋李醇5-7份、老鹳草素0.3-0.6份、葡醛内酯12-17份、柯里拉京4-6份、槲皮素1.2-1.4份、丹参素钠0.2-0.5份、对甲氧基肉桂酸乙酯4-6份、水飞蓟素1-3份。
作为本发明进一步的方案:所述治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺14份、D-色氨酸0.5份、百秋李醇6份、老鹳草素0.5份、葡醛内酯15份、柯里拉京5份、槲皮素1.3份、丹参素钠0.4份、对甲氧基肉桂酸乙酯5份、水飞蓟素2份。
一种治疗脂肪肝的药物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取L-谷氨酰胺、D-色氨酸、百秋李醇、老鹳草素、葡醛内酯、柯里拉京、槲皮素、丹参素钠、对甲氧基肉桂酸乙酯、水飞蓟素,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4-8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在10℃,包装即得治疗脂肪肝的药物。
作为本发明进一步的方案:具体步骤中混合6min。
与现有技术相比,本发明的有益效果是:
本发明药物显著改善脂肪肝患者症状和体症,可明显调节血脂代谢作用,具有疗效好,疗程短,价格低,基本无毒副作用等特点,在治疗脂肪肝方面具有推广应用的价值。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺8份、D-色氨酸0.2份、百秋李醇4份、老鹳草素0.2份、葡醛内酯10份、柯里拉京3份、槲皮素0.9份、
丹参素钠0.2份、对甲氧基肉桂酸乙酯4份、水飞蓟素1份。
一种治疗脂肪肝的药物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取L-谷氨酰胺、D-色氨酸、百秋李醇、老鹳草素、葡醛内酯、柯里拉京、槲皮素、丹参素钠、对甲氧基肉桂酸乙酯、水飞蓟素,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4min,控制RSD≤5%,混合后压片并低温干燥,温度控制在10℃,包装即得治疗脂肪肝的药物。
实施例2
一种治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺11份、D-色氨酸0.4份、百秋李醇5份、老鹳草素0.3份、葡醛内酯12份、柯里拉京4份、槲皮素1.2份、丹参素钠0.2份、对甲氧基肉桂酸乙酯4份、水飞蓟素1份。
一种治疗脂肪肝的药物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取L-谷氨酰胺、D-色氨酸、百秋李醇、老鹳草素、葡醛内酯、柯里拉京、槲皮素、丹参素钠、对甲氧基肉桂酸乙酯、水飞蓟素,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4min,控制RSD≤5%,混合后压片并低温干燥,温度控制在10℃,包装即得治疗脂肪肝的药物。
实施例3
一种治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺14份、D-色氨酸0.5份、百秋李醇6份、老鹳草素0.5份、葡醛内酯15份、柯里拉京5份、槲皮素1.3份、丹参素钠0.4份、对甲氧基肉桂酸乙酯5份、水飞蓟素2份。
一种治疗脂肪肝的药物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取L-谷氨酰胺、D-色氨酸、百秋李醇、老鹳草素、葡醛内酯、柯里拉京、槲皮素、丹参素钠、对甲氧基肉桂酸乙酯、水飞蓟素,过筛,机械混匀后添加超纯水,放置制药混合机中,混合6min,控制RSD≤5%,混合后压片并低温干燥,温度控制在10℃,包装即得治疗脂肪肝的药物。
实施例4
一种治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺16份、D-色氨酸0.5份、百秋李醇7份、老鹳草素0.6份、葡醛内酯17份、柯里拉京6份、槲皮素1.4份、丹参素钠0.5份、对甲氧基肉桂酸乙酯6份、水飞蓟素3份。
一种治疗脂肪肝的药物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取L-谷氨酰胺、D-色氨酸、百秋李醇、老鹳草素、葡醛内酯、柯里拉京、槲皮素、丹参素钠、对甲氧基肉桂酸乙酯、水飞蓟素,过筛,机械混匀后添加超纯水,放置制药混合机中,混合8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在10℃,包装即得治疗脂肪肝的药物。
实施例5
一种治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺20份、D-色氨酸0.6份、百秋李醇8份、老鹳草素0.7份、葡醛内酯20份、柯里拉京7份、槲皮素1.5份、丹参素钠0.5份、对甲氧基肉桂酸乙酯6份、水飞蓟素3份。
一种治疗脂肪肝的药物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取L-谷氨酰胺、D-色氨酸、百秋李醇、老鹳草素、葡醛内酯、柯里拉京、槲皮素、丹参素钠、对甲氧基肉桂酸乙酯、水飞蓟素,过筛,机械混匀后添加超纯水,放置制药混合机中,混合8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在10℃,包装即得治疗脂肪肝的药物。
药理学实验
1、急性毒性试验
以本发明实施例3制得的药物为试验,采用灌胃给药方式,在24h内连续给药3次,每次间隔6h,每次给药30mg/kg药量,每天累积药物总量达90mg药物/kg,相当于人临床用量的180倍。给药后7d内,小鼠活动、进食、排泄均正常,生长良好,毛色光亮,其平均体重均随实验时间的延长而增加。第8d处死后解剖每只小鼠,肉眼观察心、肝、脾、肺、肾、脑、胸腺、胃、肠等均未发现颜色及形态异常,未能测出半数致死量(LD50)。结果表明:本发明药物无急性毒性反应。
2、长期毒性试验
以本发明实施例3制得的药物为试验,采用灌胃给药方式,将本发明药物分为低剂量、中剂量、高剂量三组,各组的药物用量分别为5、10、15mg药物/kg/d,相当于临床剂量的10、20、30倍。灌胃给药24周后,本发明药物对动物的一般状况、血液学指标、血液生化指标均无明显的影响,系统解剖、脏器系数及组织病理学检查也未发现异常病理改变。停药2周也未见明显改变。结果表明:本发明药物在长期毒性试验中,未发现明显毒性反应和延迟毒性反应。可见,本发明药物无毒性反应,长期用药安全可靠。
3、临床试验
2015年6月到2016年6月期间,选取湖北某医疗机构200例门诊病例,其中男性121例,女性79例;治疗组100例,对照组100例,两组性别、年龄、病程等资料无显著性差异(p>0.05),具有可比性。
治疗组口服本发明实施例3制备的药物,服用量为20mg/kg,每天服用两次,治疗疗程为4周;
对照组口服多烯磷脂酰胆碱胶囊,服用量按照说明书,治疗疗程为4周。
疗效标准与治疗结果:疗效标准:痊愈:主要症状消失,肝肿大消失或回缩,肝区无明显压痛或叩击痛,肝功能正常,超声回声图及声像图正常,血脂趋于正常或明显改善,体重下降。好转:主要症状基本消失,肝肿大有所恢复,超声图像明显好转,血脂有所改善,体重有所下降。无效:症状、体征、化验、超声图像及体重无改变者。
治疗统计结果,治疗组:痊愈85例,好转4例,无效11例,不良反应0例,总有效率89.0%;对照组:痊愈42例,好转13例,无效45例,不良反应9例,总有效率55.0%。
本发明制备的药物对脂肪肝有显著治疗效果,对心、脑、肝、肾、血液的正常功能亦无明显影响,对心电图、脑血流流图有一定的改善趋势,因此,作为一个新的降脂肪肝药物,显示了一定的临床优越性。
对于本领域技术人员而言,显然本发明不限于上述示范性实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。因此,无论从哪一点来看,均应将实施例看作是示范性的,而且是非限制性的,本发明的范围由所附权利要求而不是上述说明限定,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
Claims (5)
1.一种治疗脂肪肝的药物,其特征在于,按照重量份的主要原料为:L-谷氨酰胺8-20份、D-色氨酸0.2-0.6份、百秋李醇4-8份、老鹳草素0.2-0.7份、葡醛内酯10-20份、柯里拉京3-7份、槲皮素0.9-1.5份、丹参素钠0.2-0.5份、对甲氧基肉桂酸乙酯4-6份、水飞蓟素1-3份。
2.根据权利要求1所述的治疗脂肪肝的药物,其特征在于,所述治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺11-16份、D-色氨酸0.4-0.5份、百秋李醇5-7份、老鹳草素0.3-0.6份、葡醛内酯12-17份、柯里拉京4-6份、槲皮素1.2-1.4份、丹参素钠0.2-0.5份、对甲氧基肉桂酸乙酯4-6份、水飞蓟素1-3份。
3.根据权利要求1或2所述的治疗脂肪肝的药物,其特征在于,所述治疗脂肪肝的药物,按照重量份的主要原料为:L-谷氨酰胺14份、D-色氨酸0.5份、百秋李醇6份、老鹳草素0.5份、葡醛内酯15份、柯里拉京5份、槲皮素1.3份、丹参素钠0.4份、对甲氧基肉桂酸乙酯5份、水飞蓟素2份。
4.一种如权利要求1-3任一所述的治疗脂肪肝的药物的制备方法,其特征在于,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取L-谷氨酰胺、D-色氨酸、百秋李醇、老鹳草素、葡醛内酯、柯里拉京、槲皮素、丹参素钠、对甲氧基肉桂酸乙酯、水飞蓟素,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4-8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在10℃,包装即得治疗脂肪肝的药物。
5.根据权利要求4所述的治疗脂肪肝的药物的制备方法,其特征在于,具体步骤中混合6min。
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CN117860678B (zh) * | 2024-03-13 | 2024-05-28 | 中国农业大学 | 一种治疗酒精性脂肪肝的药物组合物及其制备方法 |
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