CN105078956A - Application of forsythin aglycone in preparing medicine for preventing or treating liver injury or liver failure - Google Patents
Application of forsythin aglycone in preparing medicine for preventing or treating liver injury or liver failure Download PDFInfo
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Abstract
The invention claims the protection for an application of forsythin aglycone in preparing a medicine for preventing or treating liver injury or liver failure, belonging to the field of medicines. The forsythin aglycone is a traditional Chinese medicine monomer extracted from the traditional Chinese medicine fructus forsythiae; the animal experiment shows that the forsythin aglycone has good treatment effects for liver injury caused by acetaminophen, liver injury caused by antineoplastic drug cis-platinum, acute and chronic liver injury caused by carbon tetrachloride, liver injury caused by D- galactosamine, and liver failure caused by D-galactosamine and lipopolysaccharide, and is obviously superior to fructus forsythiae extract and forsythin in treating liver injury and liver failure; the forsythin aglycone is definite in function and curative effect in treating liver injury and liver failure, low in side effect, and wide in medical treatment application prospect.
Description
Technical field
The invention belongs to field of medicaments, relate to a kind of medical usage of Fructus Forsythiae aglycon, be specifically related to the medical usage of Fructus Forsythiae aglycon in preparation prevention or treatment hepatic injury or liver failure medicine.
Background technology
Liver, as most important removing toxic substances organ, is the important target spot of many medicines, xenobiotics.Hepatic injury is the pathological changes result of various hepatic disease, be the generation of multiple major Liver disease, development and initiating link and the common pathway finally moving towards liver failure, wherein the various hepatic injury such as chemical liver injury, immunologic liver injury and physical property hepatic injury is the serious at present multiple commonly encountered diseases of China.The pathogenesis of hepatic injury is very complicated, is coefficient result on multifactor, stage construction, Mutiple Targets, causes primarily of factors such as medicine, ethanol, biology, virus, environment.Hepatic injury caused by various harmful factor can show as hepatic necrosis, fatty liver, cholestasis, hepatic fibrosis, liver cirrhosis and hepatocarcinoma etc.China is the popular more serious country of hepatopathy, and the whole world has more than 100 ten thousand patients to die from hepatopathy every year, and wherein 1/3 in China.
Chemical liver injury is the hepatic injury caused by chemical Hepatoxic substance, in continuous ascendant trend.These chemical substances comprise chemical toxicant in environment and some drugs.All there are some to the virose material of liver in the Nature and human industry's production process, be called " hepatotropic poison ", these poisonous substances are general susceptible in crowd, incubation period is short; the process of pathological changes is directly related with the dosage of infection, can cause liver hepatic necrosis in various degree, fat distortion, liver cirrhosis and hepatocarcinoma.Now confirm, often contact hepatotoxicity material can cause acute or chronic hepatic injury.Some industrial organic solvent, as carbon tetrachloride, dimethyl sulfoxide, diethylnitrosamine, sym-tetrachloroethane etc. all have serious detrimental effect to hepatocyte.It is reported have nearly thousand kinds of Western medicine that hepatic injury can be caused at present.Along with the continuous increase of medicament categories, the incidence rate of medicamentous liver lesion is also in corresponding rising.Drug induced hepatic injury accounts for the 10%-15% of whole adverse effect, and China's drug induced hepatitis accounts for 10% of acute hepatitis inpatient.
Hepatic injury is the basis of liver failure (liverfailure, LF), and serious or lasting hepatic injury causes liver failure the most at last.Liver failure patient nature case fatality rate is high, and different regions are reported in 10%-90%.Liver failure is clinical common severe liver disease syndrome, it is the major Liver infringement that many factors causes, cause the function generation serious hindrances such as its synthesis, removing toxic substances, excretion and biological conversion or lose compensatory, one group of clinical syndrome that to occur with disturbances of blood coagulation and yellow cellulitis, hepatic encephalopathy, ascites etc. be main manifestations.
Along with the develop rapidly of medical sci-tech, although the medicine for the treatment of hepatic injury has studied report a lot, some researchs have shown, the medicine of some anti-liver injury also inevitably can produce bio-toxicity, causes danger to life, moreover targeting administration is not strong yet.A global severe problem is still at present to the control of hepatic injury.Given this, research and development have the liver injury medicament of good therapeutical effect is very urgent and necessity.
Fructus Forsythiae, has another name called yerbadetajo seed (" property of medicine opinion "), sticks up son (" Newly Revised Canon of Materia Medica ") greatly, is the dry fruit of Oleaceae plants Fructus Forsythiae Forsythiasuspense (Thunb.Vahl).Bitter in the mouth is slightly cold, and returns lung, the heart, small intestine meridian, has effect of heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, cure mainly carbuncle, acute mastitis, erysipelas, anemopyretic cold, damp disease from the beginning of, high hot excessive thirst, coma send out speckle, pyretic stranguria urine retention.The complex chemical composition of Fructus Forsythiae is various, wherein mainly phenethanol and glycosides, C
6-C
2natural alcohol, lignanoid, also have flavone, pentacyclic triterpene, alkaloid etc. in addition.
Fructus Forsythiae aglycon (phillygenin) is the Lignanoids compounds monomer extracted from Oleaceae plants Fructus Forsythiae.1977, the people such as NishibeSansei are separated and obtain phillyrin phillyrin, phillygenin Fructus Forsythiae aglycon, (+)-pinoresinol dextrorotation pinoresinol (NISHIBEIS, CHIBAM, HISADAS.StudiesontheChineseCrudeDrug " ForsythiaeFructus " I.ConstituentsofForsythiaeFruitsontheMarket [J] .YakugakuZassh, i1977,97 (10): 1134-1137.).Pharmacological experiment study shows that Fructus Forsythiae aglycon has multiple pharmacologically active.
ChenCC etc. have studied Fructus Forsythiae aglycon that extraction and isolation from Fructus Forsythiae obtains to LDL oxidation inhibitory action, result shows, the antioxidation potential of Fructus Forsythiae aglycon is stronger than matched group (probucol), it is 7.9 times of probucol, and have after effect, after administration 3h, still retain the inhibit activities (ChenCC of 71%, ChenHY, ShiaoMS, eta1.Inhibitionoflowdensitylipoproteinoxidationbytetrahy drofurofuranlignansfromForsythiasuspenseandMagnoliacoco [J] .PlantaMed, 1999, 65:709).Hair prestige have studied phillyrin, Fructus Forsythiae aglycon, table pinoresinol to the growth inhibited effect of human stomach cancer cell line SGC7901 by MTT colorimetry, found that Fructus Forsythiae aglycon and the growth of table pinoresinol to human stomach cancer cell line SGC7901 have certain inhibitory action, and the inhibitory action of phillyrin not obvious (hair prestige. the research [D] of Fructus Forsythiae chemical composition and anti-tumor activity thereof. Wuhan: Hubei College Of Traditional Chinese Medicine, 2009).Chinese patent application CN101537046A discloses a kind of preparation method of Fructus Forsythiae aglycon, and discloses blood fat reducing and the antioxidant activity of Fructus Forsythiae aglycon.
Summary of the invention
The invention provides the medicine of a kind of new prevention or treatment hepatic injury or liver failure, this medicine with Fructus Forsythiae aglycon for active constituents of medicine.Fructus Forsythiae aglycon is a kind of Chinese medicine monomer extracted from Fructus Forsythiae, prior art shows that it has multiple therapeutic activity, therefore the present invention relates to a kind of new medical usage of Fructus Forsythiae aglycon, i.e. the purposes of Fructus Forsythiae aglycon in preparation prevention or treatment hepatic injury or liver failure medicine.
Chemical Hepatoxic substance comprises chemical toxicant in environment and medicine, now confirms, often contact hepatotoxicity material can cause acute or chronic hepatic injury.In course of liver damage, liver plasma membrane structural deterioration, permeability of cell membrane increases, and in hepatocyte, serum glutamic pyruvic transminase effusion hepatocyte enters in blood circulation, serum glutamic oxalacetic transaminase activity raises, and therefore the mensuration of serum AST and ALT is the sensitivity monitoring index reflecting hepatic injury.
The purposes of Fructus Forsythiae aglycon of the present invention in preparation prevention or treatment hepatic injury or liver failure medicine, wherein said hepatic injury is chemical liver injury, the hepatic injury namely caused by chemical Hepatoxic substance.Test examples display of the present invention, the hepatic injury that Fructus Forsythiae aglycon causes for multi-medicament or other chemical substances all has good therapeutic effect, significantly can reduce ALT and AST of liver injury model.Fructus Forsythiae aglycon is all significantly better than phillyrin or Fructus Forsythiae extract when being used for the treatment of above-mentioned liver damage animal model in reduction animal ALT and AST value.Therefore described Fructus Forsythiae aglycon is for chemical liver injury or hepatic failure patients are that its most important feature is exactly significantly to reduce ALT and the AST value of patient clinically.
Preferably, described chemical liver injury is drug induced hepatic injury or drug induced hepatitis.Drug induced hepatic injury or drug induced hepatitis refer to the liver injury because medicine and/or its metabolite cause.The patient not having the healthy person of hepatitis history in the past or originally just had serious disease can be occurred in, the liver injury that occurrence degree is different after using certain medicine, all claim medicine liver.Its clinical symptoms can have uncomfortable liver area, abdominal distention, loss of appetite, feels sick, weak etc., modally the earliest in lab testing increases for serum transaminase, and also jaundice can occur, hemobilirubin increases, and other still have blood alkali phosphatase, and glutamyl transpeptidase increases.Test examples of the present invention display, in the hepatic injury that Fructus Forsythiae aglycon acetaminophen causes or hepatitis model and the hepatic injury caused by antitumor drug cisplatin or hepatitis model, transaminase raises and has good therapeutic effect.
Preferably, the hepatic injury of described chemical liver injury caused by organic solvent or the toxic hepatitis caused by organic solvent, toxic hepatitis is hepatitis caused by chemical toxicant (as phosphorus, arsenic, carbon tetrachloride etc.), medicine or biotoxin or caused hepatic lesions.Toxic hepatitis can be divided into acute and chronic toxic hepatitis two class by the time of contact poison with amount, common with chronic person.Acute toxic hepatitis morbidity is hurried, and normal absence of prodrome, generally occurred symptom at poisoning 24 ~ 48 hours.Test examples of the present invention display, the chronic hepatic injury that the acute liver damage that Fructus Forsythiae aglycon causes carbon tetrachloride or acute toxic hepatitis and carbon tetrachloride cause or chronic toxic hepatitis all have good therapeutic effect.
Fructus Forsythiae aglycon is also applied in the treatment of liver failure by the present inventor, animal experiment shows, Fructus Forsythiae aglycon combines lipopolysaccharide-induced Mouse Liver exhaustion model for D-Gal all good therapeutic effect, it significantly can not only reduce AST and ALT of liver failure mice, and the survival rate of liver failure mice can be increased substantially, it is all significantly better than phillyrin or Fructus Forsythiae extract in the improvement of These parameters.
In medical usage described above, Fructus Forsythiae aglycon can be prepared into suitable pharmaceutical dosage form oral administration or drug administration by injection, and its applicable object can be people or other Homoiotherms.When applicable object is behaved, the consumption of Fructus Forsythiae aglycon is preferably 0.001mg/kgd ~ 50mg/kgd, more preferably 0.01mg/kgd ~ 10mg/kgd.The administration time of medicine of the present invention's prevention or treatment hepatic injury or liver failure and administration number of times are needed to the concrete diagnostic result according to the state of an illness and determine, and this is within the technical scope of those skilled in the art's grasp.Such as, to be applied on the person to the therapeutic scheme of mice prevention or treatment hepatic injury or liver failure, medicine used can be converted by the effective dose of this medicine to mice to the effective dose of people, and this is apparent for the person of ordinary skill of the art.
In medical usage described above, Fructus Forsythiae aglycon can be prepared into suitable pharmaceutical preparation to facilitate medication according to the animal state of an illness and agents area, as Fructus Forsythiae aglycon can be developed to the use that oral formulations, sublingual administration preparation or ejection preparation facilitate patient, wherein said oral formulations can be tablet, capsule or microemulsion formulation, is preferably tablet; Described sublingual administration preparation is containing Fructus Forsythiae aglycon and is suitable for the pharmaceutical preparation of sublingual administration, is preferably its sublingual lozenge; Described ejection preparation can be its injection, injection microemulsion etc., is preferably injection.When Fructus Forsythiae aglycon is prepared into injection, medicine acceptable carrier can be water for injection, sodium chloride, sodium citrate, citric acid, glycerol, ethanol, propylene glycol etc.Fructus Forsythiae aglycon injection described above can also add suitable additives according to the character of medicine, as osmotic pressure regulator, pH value regulator, solubilizing agent, the agent for the treatment of oxygen, antibacterial, emulsifying agent, suspending agent etc., wherein said solubilizing agent is any one or two kinds in PEG400, tween 80.
The preparation method of said medicine preparation all can adopt those skilled in the art to prepare this kind of dosage form routine use preparation method and obtain.In said medicine preparation, the content containing Fructus Forsythiae aglycon in each preparation unit is 0.001mg ~ 50mg.
Compared with prior art, advantage of the present invention is:
1, Fructus Forsythiae aglycon of the present invention has the effect of significant prevention or treatment hepatic injury or liver failure.The embodiment of the present invention shows the treatment that Fructus Forsythiae aglycon of the present invention can be used in the hepatic injury that acetaminophen causes, for the treatment of the hepatic injury that antitumor drug cisplatin causes, for the treatment of the acute liver damage that carbon tetrachloride causes, for the treatment of the chronic hepatic injury that carbon tetrachloride causes, for the treatment of the hepatic injury that D-Gal causes, for the treatment of the hepatic injury that concanavalin A, Con A causes, and be used for the treatment of the liver failure that D-Gal and lipopolysaccharide cause.Embodiments of the invention show the therapeutic effect of Fructus Forsythiae aglycon of the present invention to above-mentioned disease and are better than Fructus Forsythiae extract and phillyrin.
2, Fructus Forsythiae aglycon of the present invention is from Chinese medicine Fructus Forsythiae, extract the natural Chinese medicine monomer obtained, it is low to human body toxic and side effects, drug safety and the compliance of patient can be significantly improved, and then significantly improve therapeutic effect and the quality of life of patients with liver deficiency.
Detailed description of the invention
In order to make those skilled in the art fully understand the present invention, further illustrate the present invention below by way of specific embodiment, but those skilled in the art should know, the embodiment of the present invention does not also limit the present invention in any way.
Embodiment 1 Fructus Forsythiae aglycon injection
Preparation technology: by the propylene glycol of recipe quantity and ethanol mix homogeneously, add Fructus Forsythiae aglycon, stirring and dissolving, adds 0.9% sodium chloride solution of recipe quantity, stirs, add 0.5% needle-use activated carbon, stirs, and de-charcoal, to obtain final product.
Embodiment 2 Fructus Forsythiae aglycon injection
Preparation technology: the PEG-400 to recipe quantity adds Fructus Forsythiae aglycon, stirring and dissolving, adds 0.9% sodium chloride solution to 10L, stirs, add 0.5% needle-use activated carbon, stirs, and de-charcoal, to obtain final product.
Embodiment 3 Fructus Forsythiae aglycon injection
Preparation technology: by the ethanol of recipe quantity and tween 80 mix homogeneously, add Fructus Forsythiae aglycon, stirring and dissolving, add water for injection to 10L, stir, add 0.5% needle-use activated carbon, stirs, and de-charcoal, to obtain final product.
Embodiment 4 Fructus Forsythiae aglycon injection
Fructus Forsythiae aglycon 0.01g
Ethanol 3.3L
Water for injection adds to 10L
Preparation technology: the ethanol of recipe quantity is added Fructus Forsythiae aglycon, stirring and dissolving, adds water for injection to 10L, stirs, and adds 0.5% needle-use activated carbon, stirs, and de-charcoal, to obtain final product.
The preparation of embodiment 5 tablet
Preparation technology: by Fructus Forsythiae aglycon and microcrystalline cellulose excipients, carboxymethyl starch sodium mix homogeneously, add appropriate starch slurry soft material, then crosses 16 mesh sieves and granulates.Wet granular is 60 DEG C of dryings, and dry granule crosses 20 mesh sieve granulate, sifts out the fine powder in dry granular, mixes with magnesium stearate, and then mixes with dry granule, tabletting, and every agreement that contracts a film or TV play to an actor or actress 200mg, to obtain final product.
Embodiment 6 Fructus Forsythiae aglycon sublingual lozenge
Preparation technology: said components is dried, pulverize and sieve and mix direct compression after pretreatment and obtain.
Embodiment 7 Fructus Forsythiae aglycon sublingual lozenge
Preparation technology: principal agent and each adjunct ingredient are dried, pulverizes and sieves pretreatment, principal agent and sugar, lactose, sodium carboxymethyl cellulose are mixed, using pure water as binding agent, the material of mixing is prepared soft material, cross 20 mesh sieves granulate and at 60 DEG C the dry granule of dry preparation, magnesium stearate is joined above-mentioned dry granule always to mix, tabletting and get final product.
Embodiment 8 microemulsion concentrate
Preparation technology: take recipe quantity medium chain length fatty acid triglyceride, Polyoxyethylene castor oil EL-40,1,2-propylene glycol, dehydrated alcohol, stir after mixing, then add Fructus Forsythiae aglycon to dissolve, also can ultrasonic Treatment with accelerate dissolution, must concentrated solution be clarified, be Fructus Forsythiae aglycon microemulsion concentrate.Above-mentioned microemulsion concentrate can dilute further for injection or oral.
Embodiment 9 microemulsion concentrate
Preparation technology: stir after taking recipe quantity PEG-2-stearate, tween 20,1-hexanol, PEG3350 mixing, then add Fructus Forsythiae aglycon to dissolve, also can ultrasonic Treatment with accelerate dissolution, obtain clarification concentrated solution, be Fructus Forsythiae aglycon microemulsion concentrate.Above-mentioned microemulsion concentrate can need to carry out dilution further for patient's drug administration by injection or oral administration according to medication.
Embodiment 10 Fructus Forsythiae aglycon causes the experimentation of Liver Damage in Rats or hepatitis model to acetaminophen
In course of liver damage, liver plasma membrane structural deterioration, permeability of cell membrane increases, serum glutamic pyruvic transminase (glutamicpyruvictransminase in hepatocyte, ALT) hepatocyte of can overflowing enters in blood circulation, serum glutamic oxalacetic transaminase (glutamicoxaloacetictransaminase, AST) activity raises the damage of prompting cell mitochondrial, therefore the mensuration of serum AST and ALT is the sensitivity monitoring index reflecting hepatic injury.
1. animal grouping and administration
Healthy SD rat, cleaning grade, 80, female, body weight (180 ± 20) g, rat is divided into 8 groups at random by body weight, often organize 10, be respectively Normal group, model control group, Radix Glycyrrhizae group, Fructus Forsythiae extract group (preparation technology prepares Fructus Forsythiae extract according to patent application CN101085043B embodiment 2), phillyrin group is (according to " Chemistry for Chinese Traditional Medicine " the 188th page, Shanghai science tech publishing house, within 1987, publish, self-control phillyrin, purity is greater than 97%), Fructus Forsythiae aglycon low dose group, dosage group in Fructus Forsythiae aglycon, Fructus Forsythiae aglycon high dose group.Each group gives following medicine respectively:
Normal group: isopyknic normal saline, subcutaneous injection
Model control group: isopyknic normal saline, subcutaneous injection
Radix Glycyrrhizae group: 25mg/kg diammonium glycyrrhizinate injection, intravenous injection
Fructus Forsythiae extract group: 60mg/kg Fructus Forsythiae extract, gastric infusion
Phillyrin group: 60mg/kg phillyrin, gastric infusion
Fructus Forsythiae aglycon low dose group: 0.1mg/kg Fructus Forsythiae aglycon, subcutaneous injection
Dosage group in Fructus Forsythiae aglycon: 0.5mg/kg Fructus Forsythiae aglycon, subcutaneous injection
Fructus Forsythiae aglycon high dose group: 2.5mg/kg Fructus Forsythiae aglycon, subcutaneous injection
According to dosage daily once, continuous 7d, 1h after last administration, except Normal group, all the other respectively organize equal lumbar injection acetaminophen sterile saline solution 1g/kg modeling.Rat Fast can't help water 24h, extracts rat eye and gets blood, for measuring Biochemical Indices In Serum; Take out liver to prepare liver tissue homogenate's regulating liver-QI histopathological examination.
2. experimental technique and date processing
The mensuration of 2.1 Serum ALT and AST
After rat modeling, water 24h is can't help in fasting, and extract rat eye and get blood, leave standstill 1h, 3000r/min, centrifugal 15min gets serum, and the stand-by automatic biochemistry analyzer of cold preservation 4 DEG C surveys ALT, AST.
2.2 data statisticss and analysis
Data with
represent, adopt SPSS15.0 software to carry out variance analysis.
3. result and discussion
As seen from the results in Table 1:
(1) compared with Normal group, model control group rat blood serum ALT, AST all significantly raise.After each administration group process rat, all can reduce rat blood serum ALT, AST, compared with matched group, there is significant difference.
(2) each dosage group of Fructus Forsythiae aglycon can significantly reduce rat blood serum ALT, AST, compared with Fructus Forsythiae extract group, pole significance (P<0.01) difference, shows that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than Fructus Forsythiae extract.The each dosage group of Fructus Forsythiae aglycon can significantly reduce rat blood serum ALT, AST, compared with phillyrin group, there is significance (P<0.05) or pole significance (P<0.01) difference, show that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than phillyrin.
Table 1 Fructus Forsythiae aglycon on acetaminophen cause Liver Damage in Rats impact
Compared with Normal group,
$p<0.05,
$$p<0.01;
Compared with model control group,
#p<0.05,
##p<0.01;
Compared with Fructus Forsythiae extract group,
Ω<0.05,
Ω Ωp<0.01;
Compared with phillyrin group,
aMP.AMp.Ampp<0.05,
aMP.AMp.Amp &p<0.01.
The experimentation of the antagonism tumour medicine induced by cisplatin in rats hepatic injury of embodiment 11 Fructus Forsythiae aglycon or hepatitis model
1. animal grouping and administration
Healthy SD rat, cleaning grade, 60, female, body weight (180 ± 20) g, rat is divided into 6 groups at random by body weight, often organize 10, be respectively Normal group, model control group, Fructus Forsythiae extract group (preparation technology prepares Fructus Forsythiae extract according to patent application CN101085043B embodiment 2), phillyrin group (according to " Chemistry for Chinese Traditional Medicine " the 188th page, Shanghai science tech publishing house, 1987 publish, self-control phillyrin, purity is greater than 97%), Fructus Forsythiae aglycon low dose group, Fructus Forsythiae aglycon high dose group.Each group gives following medicine respectively:
Normal group: isopyknic normal saline, subcutaneous injection
Model control group: isopyknic normal saline, subcutaneous injection
Fructus Forsythiae extract group: 60mg/kg Fructus Forsythiae extract, gastric infusion
Phillyrin group: 60mg/kg phillyrin, gastric infusion
Fructus Forsythiae aglycon low dose group: 0.1mg/kg Fructus Forsythiae aglycon, subcutaneous injection
Fructus Forsythiae aglycon high dose group: 2.5mg/kg Fructus Forsythiae aglycon, subcutaneous injection
Modeling method is: rat tail vein injection cisplatin 2.0mg/kg, and every day 1 time, interval 5d after successive administration 2d, then administration 2d, 3 circulations like this, inject 6 times altogether, and drug withdrawal recovers to observe 28d.After modeling success, by above-mentioned dosage daily once, continuous 7d, after last administration, Rat Fast can't help water 24h, extracts rat eye and gets blood, for measuring Biochemical Indices In Serum; Take out liver to prepare liver tissue homogenate's regulating liver-QI histopathological examination.
2. experimental technique and date processing
The mensuration of 2.1 Serum ALT and AST
After rat modeling, water 24h is can't help in fasting, and extract rat eye and get blood, leave standstill 1h, 3000r/min, centrifugal 15min gets serum, and the stand-by automatic biochemistry analyzer of cold preservation 4 DEG C surveys ALT, AST.
2.2 data statisticss and analysis
Data with
represent, adopt SPSS15.0 software to carry out variance analysis.
3. result and discussion
As seen from the results in Table 2: (1), compared with Normal group, model control group rat blood serum ALT, AST all significantly raise.After each administration group process rat, all can reduce rat blood serum ALT, AST, compared with matched group, there is significant difference.
(2) each dosage group of Fructus Forsythiae aglycon can significantly reduce rat blood serum ALT, AST, compared with Fructus Forsythiae extract group, there is significance (P<0.05) or pole significance (P<0.01) difference, show that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than Fructus Forsythiae extract.The each dosage group of Fructus Forsythiae aglycon can significantly reduce rat blood serum ALT, AST, compared with phillyrin group, there is significance (P<0.05) or pole significance (P<0.01) difference, show that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than phillyrin.
Table 2 Fructus Forsythiae aglycon on induced by cisplatin in rats hepatic injury impact
Compared with Normal group,
$p<0.05,
$$p<0.01;
Compared with model control group,
#p<0.05,
##p<0.01;
Compared with Fructus Forsythiae extract group,
Ω<0.05,
Ω Ωp<0.01;
Compared with phillyrin group,
aMP.AMp.Ampp<0.05,
aMP.AMp.Amp &p<0.01.
Embodiment 10 and the display of the experimental result described in embodiment 11, the hepatic injury that Fructus Forsythiae aglycon causes for acetaminophen or hepatitis model and the hepatic injury caused for cisplatin or hepatitis model all have the effect reducing its serum transaminase ALT and AST, embody significant therapeutic effect.This shows that Fructus Forsythiae aglycon has positive therapeutical effect for the hepatic injury of drug-induced or drug induced hepatitis.
Embodiment 12 Fructus Forsythiae aglycon causes the experimentation of acute liver injury of rats or hepatitis model to carbon tetrachloride
1. animal grouping and administration
Healthy SD rat, cleaning grade, 60, female, body weight (180 ± 20) g, rat is divided into 6 groups at random by body weight, often organize 10, be respectively Normal group, model control group, Fructus Forsythiae extract group (preparation technology prepares Fructus Forsythiae extract according to patent application CN101085043B embodiment 2), phillyrin group (according to " Chemistry for Chinese Traditional Medicine " the 188th page, Shanghai science tech publishing house, 1987 publish, self-control phillyrin, purity is greater than 97%), Fructus Forsythiae aglycon low dose group, Fructus Forsythiae aglycon high dose group.Each group gives following medicine respectively:
Normal group: isopyknic normal saline, gastric infusion
Model control group: isopyknic normal saline, gastric infusion
Fructus Forsythiae extract group: 60mg/kg Fructus Forsythiae extract, gastric infusion
Phillyrin group: 60mg/kg phillyrin, gastric infusion
Fructus Forsythiae aglycon low dose group: 5.0mg/kg Fructus Forsythiae aglycon, gastric infusion
Fructus Forsythiae aglycon high dose group: 10.0mg/kg Fructus Forsythiae aglycon, gastric infusion
According to dosage daily once, continuous 7d, 1h after last administration, except Normal group, all the other each group all to CCl
4induced liver injury, concrete grammar is: rats by intraperitoneal injection 5%CCl
4peanut oil solution 6ml/kg.After modeling, Rat Fast can't help water 24h, gets blood after anesthesia, for measuring Biochemical Indices In Serum; Take out liver to prepare liver tissue homogenate's regulating liver-QI histopathological examination.
2. experimental technique and date processing
The mensuration of 2.1 Serum ALT and AST
After rat modeling, water 24h is can't help in fasting, gets blood after anesthesia, and leave standstill 1h, 3000r/min, centrifugal 15min gets serum, and the stand-by automatic biochemistry analyzer of cold preservation 4 DEG C surveys ALT, AST.
2.2 data statisticss and analysis
Data with
represent, adopt SPSS15.0 software to carry out variance analysis.
3. result and discussion
As seen from the results in Table 3: (1), compared with Normal group, model control group rat blood serum ALT, AST all significantly raise.After each administration group process rat, all can reduce rat blood serum ALT, AST, compared with matched group, there is significant difference.
(2) each dosage group of Fructus Forsythiae aglycon can significantly reduce rat blood serum ALT, AST, compared with Fructus Forsythiae extract group, pole significance (P<0.01) difference, shows that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than Fructus Forsythiae extract.The each dosage group of Fructus Forsythiae aglycon can significantly reduce rat blood serum ALT, AST, compared with phillyrin group, has pole significance (P<0.01) difference, shows that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than phillyrin.
Table 3 Fructus Forsythiae aglycon on carbon tetrachloride cause acute liver injury of rats impact
Compared with Normal group,
$p<0.05,
$$p<0.01;
Compared with model control group,
#p<0.05,
##p<0.01;
Compared with Fructus Forsythiae extract group,
Ω<0.05,
Ω Ωp<0.01;
Compared with phillyrin group,
aMP.AMp.Ampp<0.05,
aMP.AMp.Amp &p<0.01.
Embodiment 13 Fructus Forsythiae aglycon causes the experimentation of murine chronic hepatic injury or hepatitis model to carbon tetrachloride
1. animal grouping and administration
Healthy kunming mice, cleaning grade, 60, female, body weight (18 ± 2) g, mice is divided into 6 groups at random by body weight, often organize 10, be respectively Normal group, model control group, Fructus Forsythiae extract group (preparation technology prepares Fructus Forsythiae extract according to patent application CN101085043B embodiment 2), phillyrin group (according to " Chemistry for Chinese Traditional Medicine " the 188th page, Shanghai science tech publishing house, 1987 publish, self-control phillyrin, purity is greater than 97%), Fructus Forsythiae aglycon low dose group, Fructus Forsythiae aglycon high dose group.Each group gives following medicine respectively:
Normal group: isopyknic normal saline, subcutaneous injection
Model control group: isopyknic normal saline, subcutaneous injection
Fructus Forsythiae extract group: 60mg/kg Fructus Forsythiae extract, gastric infusion
Phillyrin group: 60mg/kg phillyrin, gastric infusion
Fructus Forsythiae aglycon low dose group: 0.5mg/kg Fructus Forsythiae aglycon, subcutaneous injection
Fructus Forsythiae aglycon high dose group: 2.5mg/kg Fructus Forsythiae aglycon, subcutaneous injection
According to dosage daily once, successive administration 4 weeks.Except Normal group, all the other respectively organize mice all from the on-test, give 40%CCl
4an olive oil solution 0.05ml/ subcutaneous injection, 2 times weekly (Monday and Thursday each 1 time), totally 4 weeks.The olive oil of Normal group subcutaneous injection equivalent, number of times is identical.After last administration, water 24h (omnidistance administration terminates rear 24h) is can't help in mice fasting, plucks eyeball and gets blood, centrifuging and taking serum, for measuring Biochemical Indices In Serum; Take out liver to prepare liver tissue homogenate's regulating liver-QI histopathological examination.
2. experimental technique and date processing
The mensuration of 2.1 Serum ALT and AST
After mice modeling, water 24h is can't help in fasting, gets blood after anesthesia, and leave standstill 1h, 3000r/min, centrifugal 15min gets serum, and the stand-by automatic biochemistry analyzer of cold preservation 4 DEG C surveys ALT, AST.
2.2 data statisticss and analysis
Data with
represent, adopt SPSS15.0 software to carry out variance analysis.
3. result and discussion
As seen from the results in Table 4: (1), compared with Normal group, model control group mice serum ALT, AST all significantly raise.After each administration group process mice, all can reduce mice serum ALT, AST, compared with matched group, there is significant difference.
(2) each dosage group of Fructus Forsythiae aglycon can significantly reduce mice serum ALT, AST, compared with Fructus Forsythiae extract group, pole significance (P<0.01) difference, shows that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than Fructus Forsythiae extract.The each dosage group of Fructus Forsythiae aglycon can significantly reduce mice serum ALT, AST, compared with phillyrin group, has pole significance (P<0.01) difference, shows that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than phillyrin.
Table 4 Fructus Forsythiae aglycon on carbon tetrachloride cause murine chronic hepatic injury impact
Compared with Normal group,
$p<0.05,
$$p<0.01;
Compared with model control group,
#p<0.05,
##p<0.01;
Compared with Fructus Forsythiae extract group,
Ω<0.05,
Ω Ωp<0.01;
Compared with phillyrin group,
aMP.AMp.Ampp<0.05,
aMP.AMp.Amp &p<0.01.
Embodiment 12 and the display of the experimental result described in embodiment 13, Fructus Forsythiae aglycon all has the level significantly reducing its serum transaminase ALT and AST for the murine chronic hepatic injury caused by the acute liver injury of rats caused by carbon tetrachloride or hepatitis model and carbon tetrachloride or hepatitis model, embody significant therapeutical effect.This shows, Fructus Forsythiae aglycon has positive therapeutical effect for the hepatic injury caused by organic solvent or the toxic hepatitis caused by organic solvent.
Embodiment 14 Fructus Forsythiae aglycon causes the experimentation of mouse liver injury effect to D-Gal
1. animal grouping and administration
Healthy BALB/C mice, cleaning grade, 60, female, body weight (20 ± 2) g, mice is divided into 6 groups at random by body weight, often organize 10, be respectively Normal group, model control group, Fructus Forsythiae extract group (preparation technology prepares Fructus Forsythiae extract according to patent application CN101085043B embodiment 2), phillyrin group (according to " Chemistry for Chinese Traditional Medicine " the 188th page, Shanghai science tech publishing house, 1987 publish, self-control phillyrin, purity is greater than 97%), Fructus Forsythiae aglycon low dose group, Fructus Forsythiae aglycon high dose group.Each group gives following medicine respectively:
Normal group: isopyknic normal saline, subcutaneous injection
Model control group: isopyknic normal saline, subcutaneous injection
Fructus Forsythiae extract group: 50mg/kg Fructus Forsythiae extract, gastric infusion
Phillyrin group: 50mg/kg phillyrin, gastric infusion
Fructus Forsythiae aglycon low dose group: 0.5mg/kg Fructus Forsythiae aglycon, subcutaneous injection
Fructus Forsythiae aglycon high dose group: 2.5mg/kg Fructus Forsythiae aglycon, subcutaneous injection
According to dosage every day morning dose once, continuous 3d, 1h after last day morning dose, except Normal group, all the other each group all to D-Gal induced liver injury, concrete grammar is: mouse peritoneal injection 800mg/kgD-aminogalactose, water is can't help in mice fasting, and 2 pm is administered once again.After modeling, fasting, after 24h, anesthesia gets blood, for measuring Biochemical Indices In Serum; Take out liver to prepare liver tissue homogenate's regulating liver-QI histopathological examination.
2. experimental technique and date processing
The mensuration of 2.1 Serum ALT and AST
After mice modeling, water 24h is can't help in fasting, gets blood after anesthesia, and leave standstill 1h, 3000r/min, centrifugal 15min gets serum, and the stand-by automatic biochemistry analyzer of cold preservation 4 DEG C surveys ALT, AST.
2.2 data statisticss and analysis
Data with
represent, adopt SPSS15.0 software to carry out variance analysis.
3. result and discussion
As seen from the results in Table 5:
(1) compared with Normal group, model control group mice serum ALT, AST all significantly raise.After each administration group process mice, all can reduce mice serum ALT, AST, compared with matched group, there is significant difference.
(2) each dosage group of Fructus Forsythiae aglycon can significantly reduce mice serum ALT, AST, compared with Fructus Forsythiae extract group, pole significance (P<0.01) difference, shows that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than Fructus Forsythiae extract.The each dosage group of Fructus Forsythiae aglycon can significantly reduce mice serum ALT, AST, compared with phillyrin group, has pole significance (P<0.01) difference, shows that the effect of Fructus Forsythiae aglycon treatment hepatic injury is better than phillyrin.
Table 5 Fructus Forsythiae aglycon on D-Gal cause mouse liver injury impact
Compared with Normal group,
$p<0.05,
$$p<0.01;
Compared with model control group,
#p<0.05,
##p<0.01;
Compared with Fructus Forsythiae extract group,
Ω<0.05,
Ω Ωp<0.01;
Compared with phillyrin group,
aMP.AMp.Ampp<0.05,
aMP.AMp.Amp &p<0.01.
Embodiment 16 Fructus Forsythiae aglycon combines the experimentation of lipopolysaccharide-induced chmice acute liver failure effect to D-Gal
1. animal grouping and administration
Healthy ICR mice, cleaning grade, 120, male, body weight (18 ± 2) g, mice is divided into 6 groups at random by body weight, often organize 20, be respectively Normal group, model control group, Fructus Forsythiae extract group (preparation technology prepares Fructus Forsythiae extract according to patent application CN101085043B embodiment 2), phillyrin group (according to " Chemistry for Chinese Traditional Medicine " the 188th page, Shanghai science tech publishing house, 1987 publish, self-control phillyrin, purity is greater than 97%), Fructus Forsythiae aglycon low dose group, Fructus Forsythiae aglycon high dose group.Each group gives following medicine respectively:
Normal group: isopyknic normal saline, gastric infusion
Model control group: isopyknic normal saline, gastric infusion
Fructus Forsythiae extract group: 50mg/kg Fructus Forsythiae extract, gastric infusion
Phillyrin group: 50mg/kg phillyrin, gastric infusion
Fructus Forsythiae aglycon low dose group: 4.5mg/kg Fructus Forsythiae aglycon, gastric infusion
Fructus Forsythiae aglycon high dose group: 9.0mg/kg Fructus Forsythiae aglycon, gastric infusion
Model control group and each treatment group respectively lumbar injection D-Gal (D-GAL) 600mg/kg combine lipopolysaccharide (LPS) 10 μ g/kg structure chmice acute liver failure model, 2h is in a manner described and dosed administration before modeling for each treatment group, model control group correspondingly before modeling 2h give and normal saline, Normal group all corresponding time point give and normal saline and lumbar injection.
2. experimental technique and date processing
The mensuration of 2.1 Serum ALT and AST
After mice modeling, water 6h is can't help in fasting, often organizes random selecting 10 mouse anesthesias, and eyeball is taken a blood sample, and leave standstill 1h, 3000r/min, centrifugal 15min gets serum, and the stand-by automatic biochemistry analyzer of cold preservation 4 DEG C surveys serum transaminase ALT, AST.
The statistics of 2.2 mouse survival rates
The survival rate of statistics mice 48h.
2.3 data statisticss and analysis
Data with
represent, adopt SPSS15.0 software to carry out variance analysis.
3. result and discussion
As seen from the results in Table 7: (1), compared with Normal group, model control group mice serum ALT, AST all significantly raise.After each administration group process mice, all can reduce mice serum ALT, AST, compared with matched group, there is significant difference.
(2) each dosage group of Fructus Forsythiae aglycon can significantly reduce mice serum ALT, AST, compared with Fructus Forsythiae extract group, pole significance (P<0.01) difference, shows that the effect that Fructus Forsythiae aglycon alleviates liver failure hepatic injury degree is better than Fructus Forsythiae extract.The each dosage group of Fructus Forsythiae aglycon can significantly reduce mice serum ALT, AST, compared with phillyrin group, has pole significance (P<0.01) difference, shows that the effect that Fructus Forsythiae aglycon alleviates liver failure hepatic injury degree is better than phillyrin.
Table 7 Fructus Forsythiae aglycon causes the impact of chmice acute liver failure ALT, AST on D-GAL/LPS
Compared with Normal group,
$p<0.05,
$$p<0.01;
Compared with model control group,
#p<0.05,
##p<0.01;
Compared with Fructus Forsythiae extract group,
Ω<0.05,
Ω Ωp<0.01;
Compared with phillyrin group,
aMP.AMp.Ampp<0.05,
aMP.AMp.Amp &p<0.01.
As seen from the results in Table 8: (1), compared with Normal group, model control group mouse survival rate obviously reduces.After each administration group process mice, all can improve mouse survival rate.
(2) each dosage group of Fructus Forsythiae aglycon can significantly improve mouse survival rate, and compared with phillyrin group and Fructus Forsythiae extract group, the effect that Fructus Forsythiae aglycon improves liver failure mouse survival rate is more excellent.
Table 8 Fructus Forsythiae aglycon is on the impact of liver failure mouse survival rate
Claims (10)
1. the purposes of Fructus Forsythiae aglycon in preparation prevention or treatment hepatic injury or liver failure medicine.
2. purposes as claimed in claim 1, it is characterized in that, Fructus Forsythiae aglycon can reduce AST and the ALT value of hepatic injury or hepatic failure patients.
3. purposes as claimed in claim 1, it is characterized in that, described hepatic injury is chemical liver injury, and described chemical liver injury comprises acute chemical hepatic injury and chronic chemical hepatic injury.
4. purposes as claimed in claim 3, it is characterized in that, described chemical liver injury is drug induced hepatic injury or drug induced hepatitis.
5. purposes as claimed in claim 3, is characterized in that, the hepatic injury of described chemical liver injury caused by organic solvent or the toxic hepatitis caused by organic solvent.
6. the purposes as described in as arbitrary in claim 1-5, it is characterized in that, people's dosage of described Fructus Forsythiae aglycon is 0.001mg/kgd ~ 50mg/kgd.
7. purposes as claimed in claim 5, it is characterized in that, people's dosage of described Fructus Forsythiae aglycon is 0.01mg/kgd ~ 10mg/kgd.
8. the purposes as described in as arbitrary in claim 1-5, it is characterized in that, described Fructus Forsythiae aglycon is oral formulations, sublingual administration preparation or ejection preparation.
9. purposes as claimed in claim 8, is characterized in that, in each preparation unit of the oral formulations of described Fructus Forsythiae aglycon, sublingual administration preparation or ejection preparation, the content of Fructus Forsythiae aglycon is 0.001mg ~ 50mg.
10. purposes as claimed in claim 8, it is characterized in that, described oral formulations is tablet, capsule or microemulsion formulation, and described ejection preparation is injection or injection microemulsion.
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| CN106822159A (en) * | 2017-02-27 | 2017-06-13 | 温州医科大学附属第二医院、温州医科大学附属育英儿童医院 | One kind treats the medicine of lipopolysaccharides/D amine-galactose amine induced liver injuries |
| CN113476456A (en) * | 2021-08-26 | 2021-10-08 | 山西大学 | Pharmaceutical composition rich in forsythiaside and application thereof |
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| CN105687181B (en) * | 2014-12-09 | 2021-08-31 | 山东新时代药业有限公司 | Application of phillygenin in preparation of medicine for treating viral hepatitis B |
| CN105816448B (en) * | 2015-01-07 | 2018-07-06 | 鲁南制药集团股份有限公司 | Application of the Fructus Forsythiae aglycon in prevention or treatment hepatic fibrosis medicines is prepared |
| CN105982871B (en) * | 2015-02-03 | 2019-05-31 | 山东新时代药业有限公司 | A kind of Fructus Forsythiae aglycon tablet |
| CN106063794B (en) * | 2015-04-23 | 2019-07-30 | 富力 | Application of the Fructus Forsythiae glycoside derivates in preparation prevention or/and treatment liver injury medicament |
| CN106309422B (en) * | 2015-07-11 | 2018-10-02 | 鲁南制药集团股份有限公司 | Fructus Forsythiae aglycon is preparing the purposes in treating oneself immunity hepatitis drug |
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| CN114224903A (en) * | 2021-12-30 | 2022-03-25 | 安徽中医药大学 | Application of phillyrin in preparation of fatty triglyceride lipase inhibitor |
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