WO2009000150A1 - Utilisation de la sanchinoside dans le traitement de la septicémie - Google Patents

Utilisation de la sanchinoside dans le traitement de la septicémie Download PDF

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Publication number
WO2009000150A1
WO2009000150A1 PCT/CN2008/001170 CN2008001170W WO2009000150A1 WO 2009000150 A1 WO2009000150 A1 WO 2009000150A1 CN 2008001170 W CN2008001170 W CN 2008001170W WO 2009000150 A1 WO2009000150 A1 WO 2009000150A1
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Prior art keywords
notoginsenoside
lps
use according
panax notoginseng
sepsis
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PCT/CN2008/001170
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English (en)
Chinese (zh)
Inventor
Jingyan Han
Jiying Yang
Kai Sun
Chuanshe Wang
Yuying Liu
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Tianjin Tasly Pharmaceutical Co. Ltd.
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Publication of WO2009000150A1 publication Critical patent/WO2009000150A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • 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
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

Definitions

  • the invention relates to new uses of traditional Chinese medicine products, in particular to the application of Panax notoginseng saponins in the treatment and/or prevention of sepsis. Background technique
  • Panax notoginseng (Burk. ) FH Chen, PN ) is the root of the traditional Chinese medicine Sanqi after air drying.
  • Panax notoginseng saponins also known as: notoginsenosides
  • Panax notoginseng saponins are the main active ingredients of Panax notoginseng, including one or two or more saponins contained in traditional Chinese medicine Panax notoginseng, and the total saponins of Panax notoginseng include the traditional Chinese medicine Panax notoginseng
  • Various saponins which are widely used clinically to treat cardiovascular diseases and liver dysfunction.
  • Panax notoginseng has been listed in the National Pharmacopoeia, and there are corresponding preparation products listed, such as: Xuesaitong for injection.
  • Chinese patent CN200410058111.4 describes a preparation method of Panax notoginseng saponins: extracting water from Sanqi, concentrating the extract, precipitating with ethanol, removing the ethanol in the supernatant, dissolving in water, and using the macroporous resin HPD400 for column After chromatographic treatment, the impurities are removed by water elution, and then eluted with 90% ethanol until the active ingredient is completely eluted, and the alcohol eluate is recovered and dried.
  • the human immune response can be divided into two types: non-specific immune response and specific immune response. The latter can be divided into cellular immunity and humoral immunity. When the body's immune function declines, it can't fully exert its phagocytosis and kill bacteria. Even if the amount of invading bacteria is small and the pathogenicity is not strong, it can cause sepsis.
  • Primary inflammation The primary inflammation caused by various pathogens is related to its distribution in the human body. Primary inflammation is characterized by localized redness, swelling, heat, pain, and dysfunction.
  • Symptoms of Toxemia The onset is more rapid. Frequent chills, high fever, and fever are mostly relaxation heat and/or intermittent heat. They can also be caused by heat retention, irregular heat and bimodal fever. The latter are caused by sepsis of Gram-negative bacilli. Fever is accompanied by varying degrees of symptoms of toxemia such as headache, nausea, vomiting, bloating, abdominal pain, general discomfort, and muscle and joint pain.
  • Rash Seen in some patients, the most common defects are distributed in the trunk, limbs, conjunctiva, oral mucosa, etc., not many.
  • Joint symptoms may have large joint redness, swelling, heat, pain and limited mobility, and even complicated with joint fluid, empyema, more common in Gram-positive cocci, meningococcal, Alcaligenes and other sepsis in.
  • Infectious shock About 1/5 ⁇ 1/3 of patients with sepsis, manifested as irritability, rapid pulse rate, cold limbs, skin spots, decreased urine output and decreased blood pressure, etc. Caused by severe toxemia.
  • LPS lipopolysaccharide
  • ROS reactive oxygen species
  • IL-6 interleukin-6
  • Prime-gamma (INF- ⁇ LPS-induced microcirculatory disorders play a key role in organ dysfunction in sepsis, during which white blood cells rotate along the vascular endothelium and adhere to the vascular endothelium, which produces hydrogen peroxide and Mast cell degranulation is a key step in the literature.
  • the main clinical treatments for sepsis include volume recovery, catecholamine use and antibiotic compensation. These methods can increase the survival rate of patients with sepsis, but clinically lead to elevated blood glucose. And blood pressure and blood calcium decline, and bleeding occurs. Clinical studies suggest that anti-TNF- ⁇ treatment may be helpful in the treatment of sepsis.
  • the present invention provides a novel therapeutic use of notoginsenoside, ⁇ :
  • the present invention provides the use of panax notoginseng in the preparation of a medicament for the treatment and/or prevention of sepsis.
  • the notoginsenosides described in the present invention may be panax notoginseng saponins.
  • the panax notoginseng saponins described in the present invention preferably meet the following criteria: loss on drying 5%;
  • the notoginsenoside of the present invention may also be a pharmaceutical composition containing notoginsenoside.
  • the pharmaceutical composition containing notoginsenoside is based on panax notoginsenoside as a pharmaceutically active ingredient, and a pharmaceutically acceptable carrier, wherein the weight percentage of notoginsenoside in the composition is 0.1 to 99.9%, and the rest It is a pharmaceutically acceptable carrier.
  • the sepsis is an acute systemic infection caused by pathogenic bacteria or conditional pathogens invading into the blood circulation to produce toxins and other metabolites.
  • the notoginsenoside can treat and/or alleviate microcirculatory disorders caused by sepsis caused by a systemic inflammatory response caused by excessive release of LPS.
  • the notoginsenoside can reduce the number of white blood cells induced by LPS to adhere to the wall of the small vein.
  • the notoginsenoside inhibits LPS-induced degranulation of mast cells.
  • the notoginsenoside inhibits an increase in LPS-induced blood plasma IL-6 and INF- ⁇ concentrations.
  • the notoginsenoside inhibits an increase in LPS-induced neutrophil CD1 lb expression.
  • the Panax notoginseng saponin according to the present invention may be Panax notoginseng saponins, and the main components thereof are ginsenoside Rb, Rg, notoginsenoside Rl, R2, R3 o
  • the notoginsenosides according to the present invention may be commercially available or may be commercially available. It can be prepared according to the prior art and meets the medicinal standards. For example, it can be the following standard Panax notoginseng supplied by Yunnan Ruibao Natural Pigment Co., Ltd. - Appearance: Light yellow amorphous powder
  • the medicament of the present invention is a pharmaceutical composition prepared by using the above-mentioned notoginsenoside as a pharmaceutically active ingredient.
  • the pharmaceutical composition of the present invention may contain a pharmaceutically acceptable carrier as needed, wherein the notoginsenoside is used as a pharmaceutically active ingredient, and the weight percentage in the preparation may be 0.1 to 99.9%, and the rest is a pharmaceutically acceptable carrier.
  • the pharmaceutical composition of the present invention is present in unit dosage form, which means a unit of the preparation, such as each tablet, each capsule, each vial of oral solution, granules per bag, each injection, and the like.
  • the pharmaceutical composition of the present invention may be in any pharmaceutically acceptable dosage form, including tablets (for example, sugar-coated tablets, film-coated tablets and enteric coated tablets), capsules (for example, hard capsules, soft capsules), orally.
  • tablets for example, sugar-coated tablets, film-coated tablets and enteric coated tablets
  • capsules for example, hard capsules, soft capsules
  • the pharmaceutical composition of the present invention may contain conventional excipients such as a binder, a filler, a diluent, a tablet, a lubricant, a disintegrant, a coloring agent, a flavoring agent, and a moisturizing agent.
  • a binder such as a binder, a filler, a diluent, a tablet, a lubricant, a disintegrant, a coloring agent, a flavoring agent, and a moisturizing agent.
  • Suitable fillers include cellulose, mannitol, lactose and other similar fillers.
  • Suitable disintegrants include starch, polyvinylpyrrolidone and starch derivatives such as sodium starch glycolate.
  • Suitable lubricants include, for example, magnesium stearate.
  • Suitable humectants include sodium decyl sulfate.
  • the solid oral composition can be prepared by a conventional method such as mixing, filling, tableting or the like. Repeated mixing allows the active ingredient to be distributed throughout the composition containing a substantial amount of filler.
  • the oral liquid preparation may be in the form of, for example, an aqueous or oily suspension, solution, emulsion, syrup or elixir, or may be a dry product which may be formulated with water or other suitable carrier before use.
  • Such liquid preparations may contain conventional additives such as suspending agents such as sorbitol, syrup, methylcellulose, gelatin, hydroxyethylcellulose, carboxymethylcellulose, aluminum stearate gel or hydrogenated edible fat; An emulsifier such as lecithin, sorbitan monooleate or gum arabic; a non-aqueous carrier (which may include edible oils), such as almond oil, fractionated coconut oil, An oily ester such as a glyceride, propylene glycol or ethanol; a preservative such as p-hydroxybenzyl or propylparaben or sorbic acid, and if desired, may contain a conventional flavoring or coloring agent.
  • suspending agents such as sorbitol, syrup, methylcellulose, gelatin, hydroxyethylcellulose, carboxymethylcellulose, aluminum stearate gel or hydrogenated edible fat
  • An emulsifier such as lecithin, sorbitan monooleate or gum arabic
  • the liquid unit dosage form prepared contains the active ingredient of the invention and a sterile vehicle.
  • the compound can be suspended or dissolved depending on the carrier and concentration.
  • the solution is usually prepared by dissolving the active ingredient in a carrier, sterilizing it by filtration before filling it into a suitable vial or ampoule, and then sealing. Excipients such as a local anesthetic, preservative and buffer may also be dissolved in such a carrier.
  • the composition can be frozen after filling the vial and the water removed under vacuum.
  • the pharmaceutical composition of the present invention may optionally be added to a suitable pharmaceutically acceptable carrier when prepared as a medicament, the pharmaceutically acceptable carrier being selected from the group consisting of: mannitol, sorbitol, sodium metabisulfite, sodium hydrogen sulfite , sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin C, disodium EDTA, calcium EDTA, monovalent alkali metal carbonate, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid , sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and Derivatives, alginate, gelatin, polyvinylpyrrolidone, glycerin
  • the dosage can be determined according to the condition of the patient, and can be taken three times a day, 1 ⁇ 20 doses per time.
  • the "agent" can be such as a bag, a granule, a tablet, etc., each dose.
  • the active ingredient of the drug, notoginsenoside is from 1 to 1000 mg.
  • the therapeutic use of the present invention is demonstrated by the following experiment. The results show that after 30 minutes after LPS injection, post-treatment with Panax notoginseng saponins can significantly reduce the number of white blood cells adhering to the wall of the small vein and reduce the number of degranulated mast cells.
  • LPS is derived from the Escherichia coli O55:B5 plasma type obtained from Sigma (St Louis, MO), and Panax notoginseng is supplied by Tianjin Tianshili Group (Tianjin, China). Both are soluble in the saline solution.
  • SD rats Male sprague-dawley (SD) rats, weighing between 200 and 250 grams, were provided by the Animal Center of Peking University Medical School. SD rats were fasted for 12 hours before the test.
  • the test animals were anesthetized with urethane (1.25 mg/kg body weight, i.m.).
  • control group after 10 minutes of basal observation, the left jugular vein and the left femoral vein were placed, and then saline was injected for 60 minutes.
  • the test animals received the same treatment as the control group, except that the LPS solution (2 mg/kg/hr) was continuously injected through the left femoral vein for 60 minutes without a 10-minute basic observation.
  • LPS solution (2 mg/kg/hr) was continuously injected through the left femoral vein, and continuous injection of Panax notoginseng saponin solution through the left jugular vein was started 20 minutes after the injection of LPS solution. (5mg/kg/hr) until the end of the observation.
  • the abdominal cavity was incision using a median incision (incision 2 to 3 cm long).
  • the ileocecal portion of the mesentery (10 to 15 cm from the tail of the mesentery) was carefully separated, and the mesentery was removed from the abdominal cavity and laid flat on a transparent plastic table.
  • the temperature and humidity of the mesentery are maintained by continuous surface perfusion of TC saline.
  • the microcirculation of the mesentery was observed using an inverted microscope (Leica, DM-IRB, Germany) using a transilluminator.
  • a TV camera (Japan, Toshiba Jk-TU53H) was mounted on the microscope, and the image was transmitted to a color display (Korea, TCL, J2118A), and the transmitted image was recorded by a DVD tape recorder (China, Malata DVR-R25).
  • the time to start injecting LPS is set to TV timer (TV timing) 0 o'clock at VTG-55B, FOR-A, Japan).
  • a single vein with no branching and no obvious curvature was selected for the following test.
  • the diameter of the small vein was between 30 and 50 ⁇ m, and the length was about 200 ⁇ m.
  • Vessel diameters were determined using Image-Pro Plus 5.0 (Media Cybernetic, USA) software for images recorded at 0, 20, 30, 40, 50, and 60 minutes after LPS injection. The vessel diameter was measured three times at the same position and then averaged.
  • SR venous wall shear rate
  • adherent white blood cells were defined as white blood cells that adhered to the ipsilateral vascular wall for more than 10 seconds. The number of adherent white blood cells was counted by randomly selecting the recorded images, and the number of adhered white blood cells was expressed as the number of adherent cells/200 ⁇ venules.
  • ⁇ 2 ⁇ 2 sensitive fluorescent probe dihydronobamine 123 (DHR, molecular probe) was added to the mesenteric surface to observe the oxidative capacity of the venular wall. Fluorescence of a wavelength of 455 mm generated by excitation with a mercury lamp (100 W) was applied to an inverted fluorescence microscope (DM-IRB, Leica, Germany ) Observe fluorescence. Fluorescence images were then recorded at 0, 20, 30, 40, 50, and 60 minutes after LPS injection using a CD recorder. Image-Pro Plus 5.0 software was used to measure the fluorescence of the intervenous wall of the small vein and the small vein. strength.
  • DHR inverted fluorescence microscope
  • the difference between the fluorescence intensity of the venular wall and the venous interstitial at 0 minutes was taken as the baseline value, and the DHR was obtained by calculating the ratio of the difference between the venous wall and venous interstitial fluorescence intensity at each time point and the baseline value. Fluorescence intensity ratio.
  • FITC-labeled bovine plasma albumin 50 mg/kg was slowly injected through the left jugular vein. After a 10-minute baseline observation, a mercury lamp (100W) was excited to produce a fluorescence of 455 mm to an inverted fluorescence microscope (DM-IRB, Leica, Germany) for fluorescence observation using a CD recorder at 0 minutes after LPS injection. Fluorescence images were recorded at 20 minutes, 30 minutes, 40 minutes, 50 minutes, and 60 minutes, and the fluorescence intensity of the venule wall and venules was measured using Image-Pro Plus 5.0 software.
  • the ratio of the fluorescence intensity of the venular wall to the venous interstitial at 0 minutes was taken as the baseline value, and the ratio of the fluorescence intensity of the venule wall to the venous interstitial at each time point was divided by the baseline value to calculate the FITC fluorescence intensity.
  • the ratio of the fluorescence intensity of the venule wall to the venule interstitial at time P 0 0, the baseline value.
  • tissue staining was performed with 0.1% toluidine blue for 1 minute and then bleached with saline.
  • the degranulated mast cells were identified as having cells that release intracellular particles into the surrounding tissue, and the number of cells in the circular field of view of the microscope microscope was counted to determine the number of such cells. There are five mesenteric windows per window for assessing the field of view along the microvasculature. The number of degranulated and non-degranulated mast cells was recorded, and then the proportion of degranulated mast cells was calculated.
  • the control group found only a small amount of adherent white blood cells during the entire 60-minute observation period. After 10 minutes of baseline observation, no adherent leukocytes were observed in the LPS and LPS + notoginsenoside groups.
  • LPS group injection of LPS for 20 minutes and LPS for 60 minutes resulted in the adhesion of a large number of white blood cells to the vessel wall.
  • LPS + Panax notoginseng group the number of white blood cells adhering to the wall of the small vein was significantly increased 20 minutes after the injection of LPS, and then the post-treatment of Panax notoginseng saponins was started, resulting in a significant decrease in the number of adherent white blood cells.
  • the percentage of degranulated mast cells was 23.91 ⁇ 5.21%, which represents the spontaneous degeneration of mast cells in this test. After 60 minutes of LPS injection, the degranulated mast cells increased to 51.20 ⁇ 5.86%. Post-treatment of Panax notoginseng saponins significantly inhibited LPS-induced degranulation of mast cells, which reached 23.96 ⁇ 6.12%.
  • CDl lb and CD 18 in the control group were 27.36 ⁇ 2.33 and 44.31 ⁇ 4.09, respectively.
  • the fluorescence intensity of CDl lb and CD18 increased significantly, with values of 54.98 ⁇ 4.14 and 65.83 ⁇ 4.12, respectively.
  • Post-treatment of Panax notoginseng saponins inhibited the fluorescence intensity of CD1 lb, indicating that Panax notoginseng was used to inhibit LPS-induced increase in CD1 lb concentration in neutrophils, but had no effect on LPS-induced CD18 expression.
  • the concentrations of TNF-a, IL-6 and INF- ⁇ were 17.68 ⁇ 2.64, 22.01 ⁇ 4.60 and 1.91 ⁇ 0.1 ng/L, respectively.
  • all measured cytokines increased rapidly, reaching 252.22 ⁇ 64.10, 647.83 ⁇ 182.80 and 2.63 ⁇ 0.11 ng/L, respectively.
  • Post-treatment of Panax notoginseng significantly inhibited the production of IL-6 and INF- ⁇ , and inhibited the release of TNF- ⁇ to a certain extent, but did not reach a significant level.
  • Panax notoginseng saponin 100g, calcium sulphate 150g, microcrystalline cellulose 50g, micronized silica gel 3g, magnesium stearate 1.5g Take the above raw materials through a 100 mesh sieve; take notoginsenoside, calcium sulfate, microcrystalline cellulose, mix, Use 60% (v/v) ethanol as binder, make soft material; pass 20 mesh sieve, granulate; 60 ⁇ dry, take out, pass 30 mesh sieve, whole grain; add micro-silica gel and magnesium stearate, mix Evenly, tablet, made into 1000 pieces, that is.
  • Panax notoginseng saponin 75g, calcium sulfate 1 12g, microcrystalline cellulose 37g, micronized silica gel 2.3g, magnesium stearate l. lg Take the above raw materials through a 100 mesh sieve; take notoginsenoside, calcium sulfate, microcrystalline cellulose, Mix well, use 60% (v/v) ethanol as the binder, make soft material; pass 20 mesh sieve, granulate; 60. C dry, take out, pass 30 mesh sieve, whole grain; add appropriate amount of micro-silica gel and magnesium stearate, mix, compress, and make 1000 pieces, that is.
  • Panax notoginseng 133g, calcium sulfate 200g, microcrystalline cellulose 66g, micronized silica gel 4g, magnesium stearate 2g take the above raw materials through a 100 mesh sieve; take notoginsenoside, calcium sulfate, microcrystalline cellulose, mix, use 60 % ( v / v ) Ethanol as a binder, soft material; 20 mesh sieve, granulation; 60 ⁇ dry, taken out, passed through 30 mesh sieve, whole grain; add appropriate amount of micro-silica gel and magnesium stearate, mixed Evenly, tablet, made into 1000 pieces, that is.
  • Preparation Example 4 Capsules
  • Typical case Patient Wang xx, male, 45 years old, civil servant, with headache, nausea, vomiting, bloating, abdominal pain, general discomfort, muscle and joint pain, etc., diagnosed with sepsis, injection of Panax notoginseng saponin injection, specification O. lg / support, three times a day, three at a time. After half a month, the symptoms have improved significantly. There were no adverse reactions during the medication.

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Abstract

L'invention concerne l'utilisation de la sanchinoside dans le traitement de la septicémie. Elle concerne en particulier l'utilisation des notoginsenosides Panax dans le traitement et/ou la prévention de la septicémie.
PCT/CN2008/001170 2007-06-21 2008-06-17 Utilisation de la sanchinoside dans le traitement de la septicémie WO2009000150A1 (fr)

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CN2007101112771A CN101327235B (zh) 2007-06-21 2007-06-21 三七皂甙在制备治疗败血症的药物中的应用
CN200710111277.1 2007-06-21

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CN102048818A (zh) * 2009-11-05 2011-05-11 天津天士力制药股份有限公司 丹参总酚酸、三七总皂苷,及其配伍对微循环障碍引发的疾病的预防和治疗
CN103463191A (zh) * 2013-08-20 2013-12-25 李颖 一种细菌性败血症的口服药剂及其制备工艺

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CN116850228B (zh) * 2023-08-21 2024-02-06 广州白云山医药集团股份有限公司白云山何济公制药厂 一种田七跌打风湿软膏及其制备方法

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