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WO2008040187A1 - Utilisation d'astilbine dans la préparation d'un médicament pour le traitement ou la prévention de l'insuffisance rénale aiguë ou chronique, de la fibrose rénale et de la néphropathie diabétique - Google Patents

Utilisation d'astilbine dans la préparation d'un médicament pour le traitement ou la prévention de l'insuffisance rénale aiguë ou chronique, de la fibrose rénale et de la néphropathie diabétique Download PDF

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Publication number
WO2008040187A1
WO2008040187A1 PCT/CN2007/002818 CN2007002818W WO2008040187A1 WO 2008040187 A1 WO2008040187 A1 WO 2008040187A1 CN 2007002818 W CN2007002818 W CN 2007002818W WO 2008040187 A1 WO2008040187 A1 WO 2008040187A1
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WO
WIPO (PCT)
Prior art keywords
astilbin
group
weight
parts
renal failure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2007/002818
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English (en)
Chinese (zh)
Inventor
Wanglin Jiang
Xidian Yue
Jingwei Tian
Guisheng Li
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shandong Luye Natural Drug Research and Development Co Ltd
Original Assignee
Shandong Luye Natural Drug Research and Development Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shandong Luye Natural Drug Research and Development Co Ltd filed Critical Shandong Luye Natural Drug Research and Development Co Ltd
Publication of WO2008040187A1 publication Critical patent/WO2008040187A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K31/33—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 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys

Definitions

  • astilbin in the preparation of medicine for treating or preventing acute and chronic renal failure, renal fibrosis and diabetic nephropathy
  • the present invention relates to the use of astilbin in the manufacture of a medicament for the treatment or prevention of acute and chronic renal failure and renal fibrosis.
  • Astilbin has anti-myocardial ischemia, immune regulation, anti-inflammatory, analgesic and other pharmacological effects [Shao Chunhong, Xinhua, Zhou Chengming et al. Protective effect of saponin on myocardial ischemia in rats. Journal of Xinjiang Medical University, 2000, 23 ( 3): 205-207.; Gao Sihai, Pan Tiecheng. Extraction of astilbin and its protective effect on myocardial ischemia-reperfusion injury. Chinese Journal of Practical Traditional Chinese and Western Medicine, 2003, 3: 1693-1694].
  • the present inventors have invented the application of astilbin in the preparation of a medicament for treating or preventing acute and chronic renal failure, renal fibrosis and diabetic nephropathy through a large number of experimental studies. Summary of the invention:
  • the present invention provides the use of astilbin in the preparation of a medicament for treating or preventing acute and chronic renal failure, renal fibrosis and diabetic nephropathy.
  • the present invention provides the use of astilbin in the preparation of a medicament for treating or preventing acute renal failure.
  • the present invention provides the use of astilbin in the preparation of a medicament for treating or preventing chronic renal failure.
  • the present invention provides the use of astilbin in the preparation of a medicament for treating or preventing renal fibrosis.
  • the present invention provides the use of astilbin in the preparation of a medicament for treating or preventing diabetic nephropathy.
  • the present invention provides a pharmaceutical composition for acute and chronic renal failure, renal fibrosis, and diabetic nephropathy using astilbin as an active ingredient.
  • the aspirin provided by the present invention is used for the acute and chronic renal failure, renal fibrosis and diabetic nephropathy, and the dosage range thereof is 10 mg ⁇ : 1000 mg/day/person; preferably 10 ⁇ 500 mg/day/ For humans, the dosage range for oral administration is 10 mg ⁇ ; 1000 mg/day/person; preferably 10 to 500 mg/day/person.
  • the astilbin may be prepared according to the literature (Li Yuqi, Li Yulian, Zhang Kejin et al. Separation and structural identification of saponin. Chinese Journal of Pharmaceutical Sciences, 1999, 15 (1): 42-44.), preferably according to the method disclosed.
  • the astilbinin pharmaceutical composition provided by the present invention may be added in the form of an injection, a tablet, a pill, a granule, a capsule, a syrup or the like according to the needs of the preparation, and is preferably a lyophilized powder needle and a capsule.
  • the various dosage forms provided by the present invention can be prepared by a conventional method of pharmacy.
  • the present inventors conducted the following tests to confirm the use of astilbin for the treatment or prevention of acute and chronic renal failure, renal fibrosis and diabetic nephropathy, but the pharmacological action is not limited thereto.
  • Figure 1 shows a pathological section (H&E staining) of the effect of astragaloside on adenine-induced chronic renal failure in rats.
  • Figure 2 shows a pathological section (Masson staining) of the effect of astragaloside on adenine-induced chronic renal failure in rats. detailed description:
  • the diameter of the dripper is 5. 0/6. 0mm
  • the dropping speed is 60 drops/min
  • the coolant is dimethyl silicone oil
  • the temperature of the cooling liquid is 10 ⁇
  • the weight of the dropping pills is 60 mg
  • the dropping is made. 1000 pills, remove the cooling liquid on the surface of the dropping pills, that is.
  • Astilbin 10.0 g add water for injection to 1000 ml 60 ° C to dissolve, and then filter the microporous membrane to make 1000 injections.
  • Test 1 Effect of astilbin on acute renal failure in rats
  • Astilbin is prepared according to Preparation Example 1, Preparation Example 3, Preparation Example 6;
  • Jia Qianglong (Belgium Pharmacia, Belgium specification: 300mg/branch, batch number: 040706), is a positive control drug
  • Creatinine and Urea Nitrogen Kit (Beijing Zhongsheng Technology Co., Ltd., batch number: 050606), as a test kit; Experimental animals: SPF Sprague Dawley rats, weighing 150 g-200 g, provided by Shandong Luye Pharmaceutical Co., Ltd. Experimental Animal Center The animal certificate number is: SYXK (Lu) 20030020.
  • Rats were randomly divided into normal group, model group, methylprednisolone (12 mg/kg) group, astilbin IV 1 mg/kg group, and astilbin IV 5 rag/kg group.
  • the normal group and the model group were administered with normal saline by gavage, and the other administration groups were administered by intragastric administration or intravenous administration according to the dosage and manner of administration. Each group was administered continuously for 2 days.
  • the glycerol solution was formulated into 50% (V/V). Except the normal group, the rats in each group were banned from water. After 16 hours, the glycerol solution was intramuscularly injected with 1 mL/100 g, and then each group was administered once again.
  • Test 2 Effect of astilbin on chronic renal failure in rats induced by adenine
  • Astilbin is prepared according to Preparation Example 1, Preparation Example 4 and Preparation Example 6;
  • Glutathione (Shandong Green Leaf Pharmaceutical Co., Ltd., Specification: 300mg/piece, batch number: 040706), for Positive control drug;
  • Creatinine and Urea Nitrogen Kit (Beijing Zhongsheng Technology Co., Ltd., batch number: 050606), as a test kit; Experimental animals: SPF Sprague Dawley rats, weighing 150 g-200 g, provided by Shandong Luye Pharmaceutical Co., Ltd. Experimental Animal Center The animal certificate number is: SYXK (Lu) 20030020.
  • mice were divided into normal group, model group, glutathione intravenous injection (150 mg/kg) group, astilbin intravenous injection 1 mg/kg group, astilbin intravenous injection 5 mg/kg group, astilbin intravenous injection
  • 50 mg/kg of astilbin was given intravenously, 100 mg/kg of astilbin, 100 mg/kg of astilbin, 1 mg/kg of astilbin, and 5 mg/kg of astilbin.
  • astilbin was intragastrically administered in the 50 mg/kg group, and astilbin was administered to the 100 mg/kg group, with 10 rats in each group.
  • the administration was started after the 8th day of modeling, and the normal group and the model group were administered with normal saline by gavage, and the other administration groups were administered by intragastric administration or intravenous administration according to the dosage and manner of administration.
  • Blood was taken from the eyelids after 14 days of continuous administration.
  • Serum creatinine and urea nitrogen (creatinine and urea nitrogen kit were used to measure creatinine and urea nitrogen), and the experimental animals were sacrificed for pathological section.
  • H&E staining and Masson staining were used to observe the pathological changes of renal tissue. The degree of fibrosis. The data is indicated by the SD, and the T-test is performed between the groups. See Table 2 for the results of the measurements.
  • Astilbin gavage group 5 1.67 ⁇ 0.28** 31.47 ⁇ 5.60"
  • Astilbin is prepared according to Preparation Example 2, Preparation Example 5, Preparation Example 6;
  • Glutathione (Shandong Green Leaf Pharmaceutical Co., Ltd., Specification: 300mg/branch, batch number: 040706), is a positive control drug;
  • Creatinine and Urea Nitrogen Kit (Beijing Zhongsheng Technology Co., Ltd., batch number: 050606), as a test kit; Experimental animals: SPF Sprague Dawley rats, weighing 150 g-200 g, provided by Shandong Luye Pharmaceutical Co., Ltd. Experimental Animal Center The animal certificate number is: SYXK (Lu) 20030020.
  • Intravenous injection of glycoside 150mg/kg
  • intravenous injection of astilbin in the 1 mg/kg group intravenous injection of astilbin
  • intravenous injection of astilbin In the 5 mg/kg group, the 4 mg/kg group of astilbin was given intravenously, the 50 mg/kg group of astilbin was given intravenously, the 100 mg/kg group of astilbin was given intravenously, and the img/kg group was administered with astilbin.
  • astilbin was intragastrically administered in the 25 mg/kg group, astilbin was administered to the 50 mg/kg group, and astilbin was administered to the 100 mg/kg group.
  • the normal group and the model group were administered with normal saline by gavage, and the other administration groups were administered by intragastric administration or intravenous administration according to the dosage and manner of administration.
  • Rats were continuously administered for 4 weeks and 8 weeks, and blood was taken from the ocular frame. Serum creatinine and urea nitrogen were measured.
  • Ten experimental animals were sacrificed in each group for 4 weeks. The remaining experimental animals were sacrificed at the end of the 8 weeks of the experiment. , H&E staining, Masson staining to observe the pathological changes of renal tissue and the degree of fibrosis. Observe the pathological changes of kidney tissue. Data were expressed in terms of SD and T-test was performed between groups. See Table 3 and Table 4 for the test results.
  • the results of pathological examination showed that the glomeruli had different degrees of compensatory hypertrophy, mesangial cell proliferation, mesangial matrix increased, glomerular capillary loops were lobulated, part of the kidneys under the light microscope of the 8th week of administration.
  • the small balloon cavity disappears, the capillary wall thickens, the renal tubules swell and expand, the protein is deposited in the lumen, some of the tubules are atrophied, the interstitial inflammatory cells infiltrate, and the fibrous tissue proliferate.
  • the above changes were also observed in the administration groups of astilbin. However, the degree of lesions is mild, and the degree of lesions decreases with increasing dose.
  • Astilbin is prepared according to Preparation Example 2 and Preparation Example 3, Preparation Example 6;
  • Experimental animals SPF grade Sprague Dawley rats, weighing 220 g-250 g, provided by Shandong Luye Pharmaceutical Co., Ltd. Experimental Animal Center, animal certification number: SYXK (Lu) 20030020.
  • Luo Tingxin produced by Beijing Novartis Pharmaceutical Co., Ltd., batch number: 040306; positive control drug group; hydroxyproline kit, Nanjing Jianfei Biological Company, batch number: 050906, as test kit.
  • chloral hydrate 350 rag/kg, ip
  • the operation area was disinfected with iodine and 75% alcohol.
  • the flank incision was made to cut the skin, muscle and abdominal wall layer by layer.
  • the left ureter was exposed and separated, 4-0 silk ligature was ligated and the ureter was blocked, sutured layer by layer, and penicillin was intramuscularly injected.
  • Rats in the sham operation group (10 rats) underwent only left ureteral separation surgery.
  • Rats with successful model were randomly divided into 12 groups: model group, Luotingxin (4 mg/kg) group, astilbin IV 1 mg/kg group, and astilbin IV 5 mg/kg group.
  • astilbin was intragastrically administered in the 25 mg/kg group
  • astilbin was administered intragastrically in the 50 mg/kg group
  • astilbin was administered intragastrically in the 100 mg/kg group, with 10 rats in each group.
  • the pseudo-surgical group and the model group were administered with normal saline by gavage, and the other administration groups were administered orally or intravenously according to the dosage and manner of administration.
  • each group of animals was sacrificed after anesthesia with 10% chloral hydrate.
  • the left kidney was left after repeated lavage with saline, and the kidney tissue was fixed with 4% paraformaldehyde buffer.
  • An appropriate amount of kidney tissue was excised, and hydroxyproline was determined according to the hydroxyproline kit assay. Data were expressed as soil SD and T-test was performed between groups. The test results are shown in Table 5.
  • Test 5 Effect of astilbin on rats with diabetic nephropathy
  • Astilbin is prepared according to Preparation Example 1, Preparation Example 4, Preparation Example 6;
  • Benazepril produced by Beijing Novartis Pharmaceutical Co., Ltd., batch number: 040306; positive control drug; streptozotocin (Sigma), for diabetes model
  • Blood glucose determination kit (Beijing Zhongsheng Reagent Co., Ltd. batch number: 060503); creatinine and urea nitrogen test kit (Beijing Zhongsheng Technology Co., Ltd., batch number: 060606); as test kit;
  • Experimental animals SPF grade Sprague Dawley rats, weighing 220 g-250 g, provided by Shandong Luye Pharmaceutical Co., Ltd. Experimental Animal Center, animal certification number: SYXK (Lu) 20030020.
  • the normal group and the model group were administered with normal saline by gavage, and the other administration groups were administered by intragastric administration or intravenous administration according to the dosage and manner of administration.
  • Pathological examination revealed that the glomerular basement membrane was normal in the normal control group, no widening was observed, and the foot processes were arranged neatly.
  • the model control group the glomerular basement membrane was significantly broadened, the foot processes were disordered, fused, and the mesangial cells and the matrix were mildly segmental hyperplasia.
  • the administration group of astilbin was lighter than the model group, and the dose was increased. The pathology is gradually reduced.
  • the invention proves that the asparagusin has a pharmacologically significant effect in treating or preventing acute and chronic renal failure, renal fibrosis and diabetic nephropathy through a large number of experiments, and provides a possibility for obtaining a new drug for treating various kidney diseases, suitable for Industrial applications.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Urology & Nephrology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention porte sur l'utilisation de l'astilbine pour la préparation d'un médicament destiné au traitement ou à la prévention de l'insuffisance rénale aiguë ou chronique, la fibrose rénale et la néphropathie diabétique, ainsi que sur la composition pharmaceutique correspondante, et permet ainsi d'obtenir un nouveau médicament pour le traitement de maladies rénales multiples.
PCT/CN2007/002818 2006-09-27 2007-09-25 Utilisation d'astilbine dans la préparation d'un médicament pour le traitement ou la prévention de l'insuffisance rénale aiguë ou chronique, de la fibrose rénale et de la néphropathie diabétique Ceased WO2008040187A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN200610069223.9 2006-09-27
CN2006100692239A CN101152200B (zh) 2006-09-27 2006-09-27 落新妇苷在制备治疗或预防急慢性肾功能衰竭及肾纤维化的药物中的应用

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WO2008040187A1 true WO2008040187A1 (fr) 2008-04-10

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CN (1) CN101152200B (fr)
WO (1) WO2008040187A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2372898C1 (ru) * 2008-09-29 2009-11-20 Государственное образовательное учреждение высшего профессионального образования "Северо-Осетинская государственная медицинская академия" Федерального агентства по здравоохранению и социальному развитию Способ лечения нефроангиопатии при аллоксановом диабете у экспериментальных животных

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CN101638424A (zh) * 2008-07-28 2010-02-03 山东绿叶天然药物研究开发有限公司 落新妇苷衍生物及其制备方法
CN103768082B (zh) * 2012-10-18 2016-06-15 滨州医学院 落新妇苷在制备治疗或预防糖尿病合并中风药物中的应用
CN104107185A (zh) * 2013-04-18 2014-10-22 滨州医学院 落新妇苷在治疗或预防肺纤维化的药物中的应用
CN104208086B (zh) * 2013-06-04 2017-05-24 广州中医药大学第二附属医院 落新妇苷或其同系物在制备治疗银屑病药物中的应用
CN108567941B (zh) * 2018-07-18 2021-05-07 衢州市人民医院 土茯苓提取物在制备用于预防和/或治疗顺铂肾损伤的药物中的用途
CN116059247B (zh) * 2023-01-28 2025-11-28 中国人民解放军总医院第一医学中心 落新妇苷刺激间充质干细胞在制备治疗糖尿病肾病的药物中的应用
CN116159116A (zh) * 2023-03-06 2023-05-26 浙江中医药大学 土茯苓总黄酮在制备抗衰老药物中的应用
CN118304313A (zh) * 2024-03-25 2024-07-09 山东第一医科大学(山东省医学科学院) Astilbin在制备单磷酸尿苷酸化修饰酶抑制剂中的应用

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2372898C1 (ru) * 2008-09-29 2009-11-20 Государственное образовательное учреждение высшего профессионального образования "Северо-Осетинская государственная медицинская академия" Федерального агентства по здравоохранению и социальному развитию Способ лечения нефроангиопатии при аллоксановом диабете у экспериментальных животных

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CN101152200B (zh) 2011-09-14

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