CN106063794B - Application of the Fructus Forsythiae glycoside derivates in preparation prevention or/and treatment liver injury medicament - Google Patents
Application of the Fructus Forsythiae glycoside derivates in preparation prevention or/and treatment liver injury medicament Download PDFInfo
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Abstract
The invention discloses a kind of new opplication of forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition in preparation liver protection, protect liver, anti-liver injury medicament.Test proves, forsythin, Fructus Forsythiae glycoside derivates, forsythin and the liver protection of phillygenol composition, protect liver, the effect of anti-liver injury are significant, it is quick, toxic side effect is small, is a kind of safe and efficient, stable, simple liver protection of preparation process, anti-liver injury medicament, it is easy to spread suitable for industrialized production.The present invention provides a kind of new medicament sources for protection liver, anti-liver injury.
Description
Technical field
The present invention relates to field of medicaments, be related to the drug of a kind of liver protection, anti-liver injury, in particular to a kind of Fructus Forsythiae and
Application of the Folium Forsythia extract component in liver protection, anti-liver injury medicament.
Background technique
Liver is the maximum metabolic organ of body and digestion body of gland, and the substance absorbed from gastrointestinal tract is almost intended to enter liver
It is dirty, it synthesized, decomposed, converted, stored in liver.Liver is also the important immune organ of body simultaneously.It is various to have noxa
Son and substance, such as virus, drug, ethyl alcohol, anoxic, are immunized and may act on hepatic tissue poisonous substance, and it is different can to directly result in liver cell
The damage of degree can also cause the damage, regeneration, liver fibrosis of liver cell by the activation of cytokine network, and advanced stage is then sent out
Exhibition is liver failure.It is the focus of domestic and international medical research about hepatic injury mechanism and to the research of its protective effect.
Hepatic injury is invasion of the liver by extraneous factor, so as to cause liver damage, wherein hepatic injury is divided into pathology
Property hepatic injury and chemical damage, mainly there are the livers such as virus hepatitis, cirrhosis, liver cancer in the reason of causing pathologic hepatic injury
Dirty disease；The reason of causing chemical damage mainly has chemicals poisoning, allergy, such as virus hepatitis, alcoholic liver (alcohol
Property fatty liver), organic agricultural chemicals poisoning etc..Clinically general performance is the super of AST, ALT, CHE, NO, NOS content in serum
Mark.In recent years, hepatic injury disease incidence is in apparent ascendant trend, although there are many method and drug for the treatment of, treatment level is continuous
It improves, but, the difficulty and cost for the treatment of are also being grown simultaneously, and are posed a serious threat to the health of the people.Therefore, deep
Enter to study the treatment method and drug of hepatic injury, especially good effect, drug at low cost, becomes universal in the industry
Focus of attention.The mechanism of hepatic injury is complicated, and interaction between various factors, is mutually promoted at reciprocal causation.It is main
Be related to cytochrome P-450 enzyme system, mitochondrial function, intracellular calcium overload, oxygen radical increase and neutrophil leucocyte,
Various cell factors etc. cause the damage that liver cell is different degrees of, lead to necrosis or the apoptosis of liver cell.For these different machines
System and correlation therebetween, have been observed that many drugs shield to hepatic injury in recent years, are concentrated mainly on antioxygen
Agent, membrane stabilizer, cytokine network regulator, inhibitors of apoptosis and certain Chinese medicines with hepatoprotective effect etc..It looks for
One safe, with strong points, effective therapeutic strategy and method are the hot spots that present value must be studied.
It is protease inhibitors in a kind of drug of these treatment method Importants and further investigation.Protease inhibits
Agent is tool
But the serpin that China clinically uses at this stage is ox lung extract, as heterologous protein meeting
Immunogenicity is generated, especially clinically a large amount of uses will appear allergic reaction.The metabolism raw material of hepatic tissue supplies when hepatic injury
Answering obstacle and certain synthase activities to weaken causes SOD synthesis to reduce, so that oxygen radical removing is insufficient, oxygen radical increases in blood
It is more.Super oxide anion converts the hydrogen peroxide to be formed (H2O2) and is not removed effectively, can inhibit SOD active in turn,
And oxygen radical can attack zymoprotein and change to the sensibility of hydrolase and accelerate its hydrolysis, cause SOD activity further under
Drop, causes oxygen radical to increase.Have experiments have shown that can effectively be neutralized using exogenous GSH (Redued glutathin), remove oxygen certainly
By base, mitigate liver tissue injury.
Fructus Forsythiae is the common heat-clearing and detoxifying drug of Chinese medicine, recently as to Fructus Forsythiae and its congener chemical composition analysis
Increase, the report of Fructus Forsythiae pharmacological action is also increased therewith.Fructus Forsythiae has antibacterial, antiviral, heart tonifying diuresis, liver protection decompression, town
The effects of spitting analgesia, anti-diabetic, resisiting influenza virus.Civil investigation shows that Folium Forsythia has and disappears, except constipation, preventing cold, drop blood
The effects of rouge, blood pressure lowering.In addition to this, Fructus Forsythiae can also be used in food fresh keeping, remove the effects of peculiar smell, water and soil conservation.
Forsythin (phillyrin)
Phillygenol ((+)-phillygenin)
Fructus Forsythiae tradition is with fruit medicine, comprehensive to learn in recent years to the result of study of forsythia, the leaf of congener
The chemical component of son and fruit has good consistency, and effective component such as forsythin, Forsythingenin, olive in Folium Forsythia
The content in leaf such as acid is higher than fruit.In order to develop and use this natural resources, inventor to the forsythin in Folium Forsythia into
It has gone a large amount of research, has had studied the industrial preparation process of forsythin, and experimental study is carried out to its pharmacological action, be Fructus Forsythiae
The comprehensive development and utilization of resource provides scientific basis.
Research shows that: forsythin, forsythin glucuronic acid derivative, forsythin and phillygenol composition can reduce liver
The abnormal raising of mice serum and liver ALT, AST is damaged, the activity of SOD, CHE are improved, increases the content of GSH, TP, ALB,
Reduce MDA generation, adjust the metabolism of TBIL, show forsythin remove free radical, improve liver in terms of have one
Fixed effect prompts Forsythia suspense leaves tea to have certain protective effect to hepatic injury caused by carbon tetrachloride.Prove that forsythin has guarantor really
Protect liver function.
The present inventor is by a large amount of modern scientific research, using advanced separating and purifying technology from Fructus Forsythiae and Folium Forsythia
Its effective component forsythin for treating liver protection, anti-liver injury is extracted, and has been synthetically prepared Fructus Forsythiae glycoside derivates after further study.
A kind of drug of high-efficiency low-toxicity can be provided for liver protection, anti-liver injury patient.
Summary of the invention
The purpose of the present invention is being directed to existing liver protection, liver-protecting medicine existing technological deficiency in application process, provide
Forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition (i.e. forsythin/phillygenol) have the property of anti-liver injury
Energy and effect, and forsythin, Fructus Forsythiae glycoside derivates, forsythin/phillygenol prevention are provided, alleviate or/and treat hepatic injury
New opplication, purposes are preparing the new opplication in the drug for treating, improving hepatic injury.
To achieve the above object, one aspect of the present invention provides a kind of forsythin, Fructus Forsythiae glycoside derivates, forsythin and Fructus Forsythiae rouge
Application of the promotor composition in preparation prevention or/and treatment liver injury medicament.
During screening has the active skull cap components for the treatment of liver protection, protect liver, anti-liver injury effect, inventor's discovery
In the chemical component of Fructus Forsythiae forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition have strong inhibition liver protection,
The effect of anti-liver injury.
Wherein, the drug can connect by forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition and pharmaceutically
The carrier composition received.
In particular, the Fructus Forsythiae glycoside derivates select phillygenol glucuronic acid derivative.
In particular, the Fructus Forsythiae glycoside derivates include 33- hydroxyl-phillygenol glucuronide (33-Hydroxy
Phillygenin-8-O- β-D-glucuronide), 9- hydroxyl-phillygenol glucuronide (9-Hydroxy
Phillygenin-8-O- β-D-glucuronide), 33,34- methylene dioxy-phillygenol glucuronide (33,34-
Methylenedioxy phillygenin-8-O- β-D-glucuronide), phillygenol glucuronic acid methyl ester ((2R,
3R,4R,5S)-methyl 6-(5-((1R,4S)-4-(3,4-dimethoxyphenyl)hexahydrofuro[3,4-c]
furan-1-yl)-2-methoxyph enoxy)-3,4,5-trihydroxyte tra hydro-2H-pyran-2-
Carboxylate), phillygenol Sodium Glucuronate (sodium (2R, 3R, 4R, 5S) -6- (5- ((1R, 4S) -4- (3,4-
dimethoxyphenyl)hexahydrofuro[3,4-c]furan-1-yl)-2-methoxyphenoxy)-3,4,5-tri
Hydroxytetrahydro-2H-pyran-2-carboxylate), phillygenol glucuronic acid potassium (potassium (2R,
3R,4R,5S)-6-(5-((1R,4S)-4- (3,4-dimethoxyphenyl)hexahydrofuro[3,4-c]furan-1-
Yl) -2-methoxyphenoxy) -3,4,5-tri hydroxytetrahydro-2H-pyran-2-carboxylate), even
Stick up rouge element glucuronic acid ((2R, 3R, 4R, 5S) -6- (5- ((1R, 4S) -4- (3,4-dimethoxyphenyl)
hexahydrofuro[3,4-c]furan-1-yl)-2-methoxyphenoxy)-3,4,5-trihydroxytetrahydro-
2H- pyran-2-carboxylic acid)；Preferably 33- hydroxyl-phillygenol glucuronide, 9- hydroxyl-Fructus Forsythiae rouge
Plain glucuronide, 33,34- methylene dioxy-phillygenol glucuronide, phillygenol glucuronic acid methyl ester,
Phillygenol Sodium Glucuronate or phillygenol glucuronic acid potassium.
In particular, in the forsythin and phillygenol composition the weight of forsythin and phillygenol be 2~
98:2~98；Preferably 2-10:90-98；Further preferably 80:20 or 20:80, further preferably 90:10 or 10:90,
It is still more preferably 98:2 or 2:98；Much further preferably from 98:2.
Wherein, content >=1% of the forsythin, Fructus Forsythiae glycoside derivates, preferably >=30%, further preferably >=
60%, it is still more preferably >=80%, then be still more preferably >=98%；Forsythin and phillygenol composition levels >=
1%, it is still more preferably >=80% further preferably >=60% preferably >=30%, then be still more preferably >=
98%.
In particular, the forsythin, forsythin derivative content are 1%~98%；Preferably 30~80%；Fructus Forsythiae
Glycosides and phillygenol composition levels are 1%~98%；Preferably 30~80%.
Wherein, the hepatic injury is pathologic hepatic injury and chemical damage.
In particular, the liver diseases such as the pathologic hepatic injury selection virus hepatitis, cirrhosis, liver cancer；Such as first,
Second, third, fourth, penta, hepatic injury caused by hepatic injury and liver cancer etc. caused by five kinds of virus hepatitis, such as: liver fibrosis, liver are hard
Change, necrosis of liver cells etc. can all cause dysfunction of liver.It is wherein the most typical with hepatic injury caused by heavy type hepatitis, often occur big
Block or sub- bulk necrosis of liver tissue, bleeding, hepatorenal syndrome are major causes of death.
In particular, the chemical damage is liver diseases caused by chemicals poisoning, allergy, such as viral liver
Inflammation, the poisoning of alcoholic liver (alcoholic fatty liver), organic agricultural chemicals etc..
Chemical damage: causing mainly due to chemicals poisoning, allergy etc., for example drug hepatitis, alcoholic liver, has
Machine pesticide poisoning etc. can all cause hepatic injury dysfunction of liver.But it is most common with Drug and alcoholic liver damage, and in continuous
Ascendant trend.
Wherein, the hepatic injury selects acute liver damage, acute radiation hepatic injury.
In particular, the hepatic injury is chemical damage, hepatic radiation-induced injury, drug induced hepatic injury.
Wherein, the hepatic injury is hepatic injury caused by chemical agent, hepatic injury caused by radioactive ray irradiation.
In particular, the hepatic injury is phosphorus, trinitrotoluene, carbon tetrachloride (CCl4), chloronaphthalene, methacrylaldehyde, arsenic, mercury, antimony,
Hepatic injury caused by aniline, chloroform, moaning hydrogen, dimethylformamide, dinitrophenol dinitrophenolate, acetaldehyde, organic phosphorus, acrylonitrile, lead etc., it is excellent
It is selected as CCl4, hepatic injury, further preferably CCl caused by alcohol4Caused by hepatic injury；The drug induced hepatic injury is acute
Drug-induced liver disease, chronic drug hepatopathy.
In particular, pharmaceutically acceptable carrier is usually approved by sanitarian for this purpose and as the non-of medicament
Active constituent.Compilation in relation to pharmaceutically acceptable carrier can be in " handbook of pharmaceutical excipients " (Handbook of
Pharmaceutical excipients, second edition are edited by A.Wade and P.J.Weller； American
Pharmaceutical Association is published, Washington and The Pharmaceutical Press,
London, 1994) it etc. is found in reference books.
Especially, the carrier includes excipient, such as starch, water；Lubricant, such as magnesium stearate；Disintegrating agent, such as
Microcrystalline cellulose etc.；Filler, such as lactose；Binder, such as pregelatinized starch, dextrin；Sweetener；Antioxidant；Anti-corrosion
Agent, corrigent, fragrance etc.；
Wherein, the drug exists with tablet, capsule, pill, powder, granule, syrup form.
In particular, the forsythin, forsythin derivative content >=1%, preferably >=30%, further preferably >=
60%, it is still more preferably >=80%, then be still more preferably >=98%；Forsythin and phillygenol composition levels >=
1%, it is still more preferably >=80% further preferably >=60% preferably >=30%, then be still more preferably >=
98%.
Another aspect of the present invention provides one kind and contains forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition
For preventing or/and treating the drug of liver damage disease.
Wherein, the Fructus Forsythiae glycoside derivates select phillygenol glucuronic acid derivative.
In particular, the Fructus Forsythiae glycoside derivates include 33- hydroxyl-phillygenol glucuronide, 9- hydroxyl-Fructus Forsythiae
Rouge element glucuronide, 33,34- methylene dioxy-phillygenol glucuronide, phillygenol glucuronic acid first
Ester, phillygenol Sodium Glucuronate, phillygenol glucuronic acid potassium, phillygenol glucuronic acid；Preferably 33- hydroxyl
Base-phillygenol glucuronide, 9- hydroxyl-phillygenol glucuronide, 33,34- methylene dioxy-phillygenol
Glucuronide, phillygenol glucuronic acid methyl ester, phillygenol Sodium Glucuronate or phillygenol glucuronic acid
Potassium.
Wherein, the forsythin and the weight of forsythin and phillygenol in phillygenol composition are 2~98:
2~98；Preferably 2-10:90-98；Further preferably 80:20 or 20:80, further preferably 90:10 or 10:90, more into
One step is preferably 98:2 or 2:98；Much further preferably from 98:2.
In particular, content >=1% of the forsythin, Fructus Forsythiae glycoside derivates, preferably >=30%, further preferably
>=60%, it is still more preferably >=80%, then be still more preferably >=98%；Forsythin and phillygenol composition levels
>=1%, it is still more preferably >=80% further preferably >=60% preferably >=30%, then be still more preferably >=
98%.
Especially, content >=1% of the forsythin, Fructus Forsythiae glycoside derivates, preferably 1%~98%；Preferably 30
~80%, it is still more preferably 60%；Forsythin and phillygenol composition levels >=1%, preferably 1%~98%；It is excellent
30~80% are selected as, is still more preferably 60%.
In particular, the weight and the medicine of the forsythin, Fructus Forsythiae glycoside derivates or forsythin and phillygenol composition
The ratio between total weight of object is 0.01-10:100, preferably 0.1~10:100, further preferably 1~10:100.
Wherein, the forsythin/phillygenol composition with the monomer composition of forsythin and phillygenol or uses solvent
The phillygenol that heating extraction method is prepared-forsythin extract composition or phillygenol and forsythin and cyclodextrin or
The derivative of cyclodextrin is composed phillygenol-forsythin-cyclodextrin composite.
In particular, phillygenol-the forsythin-cyclodextrin composite selection phillygenol and forsythin and α-, β-or
Mixture made of gamma-cyclodextrin or derivatives thereof mixes or phillygenol and forsythin and α-, β-or gamma-cyclodextrin or
The compound that its derivative is formed through physics, chemical method processing.
Wherein, in the phillygenol-forsythin-cyclodextrin composite forsythin and phillygenol weight and cyclodextrin or
The weight ratio of the derivative of cyclodextrin is 1:1-50.
In particular, the cyclodextrin is α-or β-, gamma-cyclodextrin；The cyclodextrine derivatives be ethoxy-cyclodextrin,
2,6- dimethyl-cyclodextrin, 2,3,6- trimethyl-cyclodextrin, 2,6- diethyl-cyclodextrin, 2,3,6- triethyl group-cyclodextrin,
Beta-cyclodextrin that maltosyl-cyclodextrin or sulphur butyl ether beta-cyclodextrin, p-methyl benzene sulfonic chloride (p-TsCl) replace, 6- take
β-CD p-methyl benzenesulfonic acid the ester (beta-cyclodextrin -6-OTs) in generation, 2- oxygen hydroxypropyl-β-cyclodextrin, 2- it is mono-substituted to methyl
Benzene sulfonate (beta-cyclodextrin -2-OTs), beta-cyclodextrin p-methyl benzenesulfonic acid ester (Tosyl- β-CD), the star of beta-cyclodextrin are big
Molecule PCL- (Tos) 7- β-CD.
In particular, further including Notogineng Extract, Rhizoma Curcumae extract, licorice, shrubby sophora extract, mattress in the drug
Old extract, white peony root extract, angelica extract, ginseng extract, Astragalus Root P.E, vitamin C and its derivative or dimension life
Plain E and its derivative.
Compared with prior art, the present invention has following obvious advantage:
1, the present invention has excavated newly known compound forsythin, Fructus Forsythiae glycoside derivates, forsythin/phillygenol composition
Medical value, be used for liver protection, protect liver, anti-liver injury, and can prepare liver protection, protect liver, anti-liver injury drug, to be
A new field has been opened up in the application of Fructus Forsythiae and Folium Forsythia medicinal material.
2, campaign research of the invention has shown that forsythin and Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition
Have effects that significant liver protection, protect liver, anti-liver injury.
3, forsythin of the invention, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition pharmacological action are strong, for protecting
The effect of liver, protect liver, anti-liver injury, is significant, quick, toxic side effect is small, safety is good, can take for a long time, has good
Prospect in medicine.
4, products material abundance of the invention, inexpensive, clinical use is safe, preparation process is simple, can be made into various
Dosage form, and dosing is small, it is easy to use therefore easy to spread.
5, forsythin, Fructus Forsythiae glycoside derivates or the forsythin and phillygenol composition of single component had both can be used in the present invention
Active constituent prepare liver protection, protect liver, anti-liver injury drug, and forsythin, Fructus Forsythiae glycoside derivates or forsythin/Fructus Forsythiae can be used
Rouge promotor composition and other active constituents (such as with Notogineng Extract, Rhizoma Curcumae extract, licorice, shrubby sophora extract, mattress
Old extract, white peony root extract, angelica extract, ginseng extract, Astragalus Root P.E, vitamin C and its derivative or dimension life
Plain E and its derivative.) common prescription, preparation treatment liver protection, anti-liver injury compound medicine.
Specific embodiment
The beneficial effect of formula of the present invention is further described below by specific embodiment, these embodiment packets
The pharmacodynamics test of the capsule of forsythin and Fructus Forsythiae glycoside derivates of the invention, tablet, soft capsule is included.These embodiments are only
Be it is exemplary, it is not intended to limit the scope of the present invention in any way.It will be understood by those skilled in the art that without departing from
Under formula thinking of the invention, scope of use can with the details and forms of the technical scheme of the invention are modified or replaced, but
These modifications and replacement are fallen within the protection scope of the present invention.
Heretofore described Fructus Forsythiae glycoside derivates 33- hydroxyl-phillygenol glucuronide, 9- hydroxyl-phillygenol
Glucuronide, 33,34- methylene dioxy-phillygenol glucuronide and patent application (application number:
201510319303.4 priority number: 201510164294.6) Fructus Forsythiae glycoside derivates described in is identical；Phillygenol glucose
Aldehydic acid methyl esters, phillygenol Sodium Glucuronate, phillygenol glucuronic acid potassium, phillygenol glucuronic acid and patent Shen
Please (application number: 201510320579.4, priority number: 201410825547.5) identical in.
1 forsythin tablet of embodiment
1, prepare raw material according to the following ratio
2, particle after mixing by forsythin and starch, is made, talcum powder is added and magnesium stearate is pressed after mixing
It is made 10000.
2 forsythin capsule of embodiment
1, prepare raw material according to the following ratio
Forsythin (purity 60%) 200g
Starch 1000g
2, forsythin and starch is encapsulated after mixing, it is made 10000.
3 forsythin capsule of embodiment
1, prepare raw material according to the following ratio
Forsythin (purity 98%) 500g
Starch 1000g
2, forsythin and starch is encapsulated after mixing, it is made 10000.
4 forsythin tablet of embodiment
1, prepare raw material according to the following ratio
2, forsythin, licorice, vitamin C and starch are pelletized after mixing, talcum powder and stearic acid is added
Magnesium is pressed into 10000 after mixing.
5 forsythin capsule of embodiment
1, prepare raw material according to the following ratio
2, forsythin, capillary extract, vitamin C and starch is encapsulated after mixing, it is made 10000.
6 forsythin granule of embodiment
1, prepare raw material according to the following ratio
2, forsythin, radix paeoniae alba extraction, vitamin C and cane sugar powder are uniformly mixed after particle is made and are packed, be made 10000
Bag.
7 Fructus Forsythiae glucoside oral liquid of embodiment
1, prepare raw material according to the following ratio
2, forsythin, shrubby sophora extract, capillary extract are taken, dextrose syrup is added after being dissolved with ethyl alcohol, finally plus is gone
Ionized water to 100ml to get.
9 33- hydroxyl of embodiment-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
33- hydroxyl-phillygenol glucuronide (purity 60%) 200g
Starch 1000g
2,33- hydroxyl-phillygenol glucuronide and starch is encapsulated after mixing, it is made 10000.
10 33- hydroxyl of embodiment-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
33- hydroxyl-phillygenol glucuronide (purity 98%) 500g
Starch 1000g
2,33- hydroxyl-phillygenol glucuronide and starch is encapsulated after mixing, it is made 10000.
11 33- hydroxyl of embodiment-phillygenol glucuronide tablet
1, prepare raw material according to the following ratio
2,33- hydroxyl-phillygenol glucuronide, licorice, vitamin C and starch is made after mixing
Grain is pressed into 10000 after talcum powder and magnesium stearate mixing is added.
12 33- hydroxyl of embodiment-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
2,33- hydroxyl-phillygenol glucuronide, capillary extract, vitamin C and starch is filled after mixing
Capsule is made 10000.
13 33- hydroxyl of embodiment-phillygenol glucuronide granule
1, prepare raw material according to the following ratio
2,33- hydroxyl-phillygenol glucuronide, radix paeoniae alba extraction, vitamin C and cane sugar powder are uniformly mixed system
At packing after particle, it is made 10000 bags.
14 33- hydroxyl of embodiment-phillygenol glucuronic acid glucoside oral liquid
1, prepare raw material according to the following ratio
2,33- hydroxyl-phillygenol glucuronide, capillary extract, shrubby sophora extract are taken, is added after being dissolved with ethyl alcohol
Enter dextrose syrup, finally plus deionized water to 100ml to get.
15 9- hydroxyl of embodiment-phillygenol glucuronide tablet
1, prepare raw material according to the following ratio
2, after mixing by 9- hydroxyl-phillygenol glucuronide and starch, be made particle, be added talcum powder and
Magnesium stearate is pressed into 10000 after mixing.
16 9- hydroxyl of embodiment-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
9- hydroxyl-phillygenol glucuronide (purity 97%) 200g
Starch 1000g
2,9- hydroxyl-phillygenol glucuronide and starch is encapsulated after mixing, it is made 10000.
17 9- hydroxyl of embodiment-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
9- hydroxyl-phillygenol glucuronide (purity 98%) 500g
Starch 1000g
2,9- hydroxyl-phillygenol glucuronide and starch is encapsulated after mixing, it is made 10000.
18 9- hydroxyl of embodiment-phillygenol glucuronide tablet
1, prepare raw material according to the following ratio
2,9- hydroxyl-phillygenol glucuronide, licorice, vitamin C and starch is made after mixing
Grain is pressed into 10000 after talcum powder and magnesium stearate mixing is added.
19 9- hydroxyl of embodiment-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
2,9- hydroxyl-phillygenol glucuronide, capillary extract, vitamin C and starch is filled after mixing
Capsule is made 10000.
20 9- hydroxyl of embodiment-phillygenol glucuronide granule
1, prepare raw material according to the following ratio
2,9- hydroxyl-phillygenol glucuronide, radix paeoniae alba extraction, vitamin C and cane sugar powder are uniformly mixed system
At packing after particle, it is made 10000 bags.
21 9- hydroxyl of embodiment-phillygenol glucuronic acid glucoside oral liquid
1, prepare raw material according to the following ratio
2,9- hydroxyl-phillygenol glucuronide, capillary extract, shrubby sophora extract are taken, is added after being dissolved with ethyl alcohol
Enter dextrose syrup, finally plus deionized water to 100ml to get.
Embodiment 22 33,34- methylene dioxy-phillygenol glucuronide tablet
1, prepare raw material according to the following ratio
2, after mixing by 33,34- methylene dioxy-phillygenol glucuronide and starch, particle is made, adds
Enter talcum powder and magnesium stearate and is pressed into 10000 after mixing.
Embodiment 23 33,34- methylene dioxy-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
33,34- methylene dioxies-phillygenol glucuronide (purity 97%) 200g
Starch 1000g
2,33,34- methylene dioxy-phillygenol glucuronide and starch is encapsulated after mixing, it is made
10000.
Embodiment 24 33,34- methylene dioxy-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
33,34- methylene dioxies-phillygenol glucuronide (purity 98%) 500g
Starch 1000g
2,33,34- methylene dioxy-phillygenol glucuronide and starch is encapsulated after mixing, it is made
10000.
Embodiment 25 33,34- methylene dioxy-phillygenol glucuronide tablet
1, prepare raw material according to the following ratio
2,33,34- methylene dioxy-phillygenol glucuronide, licorice, vitamin C and starch is mixed
Granulation after closing uniformly, addition talcum powder and magnesium stearate are pressed into 10000 after mixing.
Embodiment 26 33,34- methylene dioxy-phillygenol glucuronide capsule
1, prepare raw material according to the following ratio
2,33,34- methylene dioxy-phillygenol glucuronide, capillary extract, vitamin C and starch is mixed
It is encapsulated after closing uniformly, it is made 10000.
Embodiment 27 33,34- methylene dioxy-phillygenol glucuronide granule
1, prepare raw material according to the following ratio
2, by 33,34- methylene dioxy-phillygenol glucuronide, radix paeoniae alba extraction, vitamin C and cane sugar powder
It is uniformly mixed after particle is made and packs, be made 10000 bags.
Embodiment 28 33,34- methylene dioxy-phillygenol glucuronide granule
1, prepare raw material according to the following ratio
2, by 33,34- methylene dioxy-phillygenol glucuronide, radix paeoniae alba extraction, vitamin C and cane sugar powder
It is uniformly mixed after particle is made and packs, be made 10000 bags.
Embodiment 29 33,34- methylene dioxy-phillygenol glucuronic acid glucoside oral liquid
1, prepare raw material according to the following ratio
2,33,34- methylene dioxy-phillygenol glucuronide, capillary extract, shrubby sophora extract is taken, second is used
Alcohol dissolution after dextrose syrup is added, finally plus deionized water to 100ml to get.
30 forsythin of embodiment and the preparation of phillygenol composition tablet
1, forsythin/phillygenol composition tablet is prepared according to the following ratio:
2, forsythin 490g, phillygenol 10g and starch are taken after mixing, particle is made, talcum powder and tristearin is added
Sour magnesium is pressed into 10000 after mixing.
31 forsythins of embodiment/phillygenol composition granule preparation
1, forsythin/phillygenol composition granule is prepared according to the following ratio:
Forsythin/phillygenol composition (the two weight ratio is 98:2) 100g
Microcrystalline cellulose 10000g
2, forsythin 98g, phillygenol 2g and microcrystalline cellulose are taken after mixing, particle pack is made, is made 10000
Bag.
32 forsythins of embodiment/phillygenol composition capsule preparation
1, forsythin/phillygenol composition capsule is prepared according to the following ratio:
Forsythin/phillygenol composition (the two weight ratio is 98:2) 250g
Starch 2500g
2, it takes forsythin 245g, phillygenol 5g and starch encapsulated after mixing, is made 10000.
Embodiment 33-36 forsythin/phillygenol composition capsule preparation
In embodiment 33-36, forsythin/phillygenol composition difference according to the form below weight ratio and starch are after mixing
It is encapsulated, 10000 capsules are respectively made.
Embodiment: 37-40 forsythin/phillygenol composition granule preparation
In embodiment 37-30, forsythin/phillygenol composition difference according to the form below weight ratio is mixed with microcrystalline cellulose
After uniformly, particle pack is made, is made 10000 bags.
41 forsythins of embodiment/phillygenol composition tablet preparation
1, forsythin/phillygenol composition tablet is prepared according to the following ratio:
2, forsythin 490g is weighed, phillygenol 10g is uniformly mixed with capillary extract powder, then is uniformly mixed with starch
After be made particle, talcum powder is added and magnesium stearate is pressed into 10000 after mixing.
42 forsythins of embodiment/phillygenol composition granule preparation
1, forsythin/phillygenol composition granule is prepared according to the following ratio:
2, forsythin 245g, phillygenol 5g is taken to be uniformly mixed with Notogineng Extract, capillary extract powder, then with crystallite
Particle pack is made in cellulose after mixing, is made 10000 bags.
43 forsythins of embodiment/phillygenol composition capsule preparation
1, forsythin/phillygenol composition capsule is prepared according to the following ratio:
2, forsythin 245g, phillygenol 5g are mixed with shrubby sophora extract, ginseng extract, shrubby sophora extract powder
It is even then encapsulated after mixing with starch, it is made 10000.
44 forsythins of embodiment/phillygenol composition tablet preparation
1, forsythin/phillygenol composition tablet is prepared according to the following ratio:
2, forsythin 490g, phillygenol 10g is taken to be uniformly mixed with licorice powder, then after mixing with starch
Particle is made, talcum powder is added and magnesium stearate is pressed after mixing, is made 10000.
45 forsythins of embodiment/phillygenol composition granule preparation
1, forsythin/phillygenol composition granule is prepared according to the following ratio:
2, forsythin 900g, phillygenol 100g is taken to be uniformly mixed with said extracted object (Radix Paeoniae Alba, Radix Angelicae Sinensis) powder, then with it is micro-
Particle pack is made in crystalline cellulose after mixing, is made 10000 bags.
46 forsythins of embodiment/phillygenol composition capsule preparation
1, forsythin/phillygenol composition capsule is prepared according to the following ratio:
2, forsythin 1880g, phillygenol 120g are uniformly mixed with said extracted object (Radix Glycyrrhizae, Radix Notoginseng, Radix Astragali) powder, then
It is encapsulated after mixing with starch, it is made 10000.
The reality of 1 forsythin of test example, Fructus Forsythiae glycoside derivates, forsythin and the anti-acute liver injury of rats of phillygenol composition
Test research
1, experimental material
1.1 animal
SD rat (cures dynamic word the 000158th), half male and half female, 180~220g of weight, by Guangdong Province's Experimental Animal Center
It provides.
1.2 drug
Forsythin, white powder, the production of Dalian Fu Sheng natural drug development corporation, Ltd. are examined through two kinds of high performance liquid chromatography
Survey device UV detector and evaporative light scattering detector area normalization method measurement, purity 99.5%, and with China drug
It is 99.5% that its content is demarcated and confirmed to biological products assay forsythin reference substance.Lot number: 20130303.
33- hydroxyl-phillygenol glucuronide (Fructus Forsythiae glycoside derivates A), (content > 98%), white powder, greatly
The production of Lian Fusheng natural drug development corporation, Ltd., lot number: 20130301.Through two kinds of detector ultraviolet detections of high performance liquid chromatography
Device and the measurement of evaporative light scattering detector area normalization method, purity 98.5%.
9- hydroxyl-phillygenol glucuronide (Fructus Forsythiae glycoside derivates B), (content > 98%), white powder, Dalian
The production of Fu Sheng natural drug development corporation, Ltd., lot number: 20130302.Through two kinds of detector UV detector of high performance liquid chromatography
It is measured with evaporative light scattering detector area normalization method, purity 99.2%.
33,34- methylene dioxies-phillygenol glucuronide (Fructus Forsythiae glycoside derivates C), (content > 98%) is white
Color powder, the production of Dalian Fu Sheng natural drug development corporation, Ltd., lot number: 20130301.It is detected through two kinds of high performance liquid chromatography
Device UV detector and the measurement of evaporative light scattering detector area normalization method, purity 98.7%.
Forsythin/phillygenol composition A, forsythin (content > 98%), white powder, the raw natural drug of Dalian richness are opened
Send out Co., Ltd's production, lot number: 20130303；Phillygenol (content > 98%), white powder, the raw natural drug of Dalian richness are opened
Send out Co., Ltd's production, lot number: 20130301；The weight ratio of forsythin and phillygenol is 98:2.
Forsythin/phillygenol composition B, forsythin (content > 98%), white powder, the raw natural drug of Dalian richness are opened
Send out Co., Ltd's production, lot number: 20130303；Phillygenol (content > 98%), white powder, the raw natural drug of Dalian richness are opened
Send out Co., Ltd's production, lot number: 20130301；The weight ratio of forsythin and phillygenol is 90:10.
Test the basic, normal, high dosage of medication is respectively clinical adult equivalent dose (calculating by adult's 60kg weight) 2
Times, 4 times and 8 times, the suspension of required concentration is made into distilled water, the medical fluid prepared deposit be protected from light it is spare in 4 DEG C of refrigerators.
Positive control drug: bifendate (lot number: 100401, Shandong Plain pharmaceutical factory).It (is pressed for clinical adult equivalent dose
Adult 60kg weight calculates) administration, required suspension is made into distilled water, the medical fluid prepared deposit be protected from light it is standby in 4 DEG C of refrigerators
With.
2, experimental method
2.1 groupings and administration
SD rat 176, half male and half female is randomly divided into 22 groups by gender and weight precuring 1 week under experiment condition: every
Group 8.Normal group, model group, positive drug control group, phillygenol group, the high, medium and low dosage group of forsythin, forsythin spread out
The biological high, medium and low dosage group of A, the high, medium and low dosage group of Fructus Forsythiae glycoside derivates B；The high, medium and low dosage group of Fructus Forsythiae glycoside derivates C；
Forsythin/high, medium and low the dosage group of phillygenol composition A；Forsythin/high, medium and low the dosage group of phillygenol composition B.Sun
Property control group give bifendate (45mg/kg), phillygenol group gives phillygenol (144mg/kg), forsythin three groups difference
It gives forsythin low dose group (36mg/kg), middle dosage (72mg/kg) group, high dose group (144mg/kg), Fructus Forsythiae glycoside derivates
A low dose group (36mg/kg), middle dosage (72mg/kg) group, high dose group (144mg/kg), Fructus Forsythiae glycoside derivates B low dosage
Group (36mg/kg), middle dosage (72mg/kg) group, high dose group (144mg/kg), Fructus Forsythiae glycoside derivates C low dose group (36mg/
Kg), middle dosage (72mg/kg) group, high dose group (144mg/kg), forsythin/phillygenol composition A low dose group
(36mg/kg), middle dosage (72mg/kg) group, high dose group (144mg/kg), forsythin/phillygenol composition B low dose group
(36mg/kg), middle dosage (72mg/kg) group, high dose group (144mg/kg), Normal group, model group give normal salt
Water, stomach-filling, 1 time/d, continuous 9d, in the 2nd, 5,8 day (totally 3 times) of administration, model group, forsythin group, Fructus Forsythiae glycoside derivates group,
10%CCl is injected intraperitoneally by 2ml/kg weight in forsythin/phillygenol group, positive drug control group, phillygenol group4Salad
Oil solution modeling.10th day, i.e., last dose for 24 hours after, abdominal aortic blood takes liver, thymus gland, weighing, calculate organ coefficient,
Put to death animal.
2.2 detection project
Blood sample carries out Biochemical Indexes immediately, measures ATL, AST in serum, T-BIL content.
2.3 pathological observation
Same position hepatic tissue is taken, 10% neutral formalin is fixed, and HE dyeing observation hepatic tissue pathology changes.By hepar damnification
It is divided into 4 grades: 0 grades (one), hepatic tissue structure is normal, without obvious denaturation, necrosis and cell infiltration；1 grade (+), lobuli hepatis structure
It is still complete, it is seen that apparent muddy, swelling, the change of balloon sample or steatosis are dispersed in spotty necrosis；2 grades (++), lobuli hepatis structure
It is unclear, it is seen that apparent focal necrosis is with cell infiltration；3 grades (+++), lobuli hepatis structure is unclear, it is seen that apparent sheet is bad
Dead companion's cell infiltration.
2.4 statistical analysis
It is examined between mean using t, pathology of hepar is changed and is handled through Ridit analytical statistics.
3, experimental result
3.1 pairs of Serum ALTs, the influence of AST, T-BIL
Model group rats, phillygenol group Serum ALT, AST, T-BIL obviously higher than normal group (P < 0.05 or P <
0.001), have a statistical significance.Forsythin, Fructus Forsythiae glycoside derivates, forsythin and each administration group of phillygenol composition can be shown
Writing reduces Serum ALT levels (P < 0.05)；Middle and high dosage group significantly reduces AST value (P < 0.0l or P < 0.05)；And middle and high dose
Amount group can reduce T-BIL to close to normal level result.It is shown in Table 1.
1 forsythin of table, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition are to rat blood serum ALT, AST, T-BIL
Influence
3.2 pathological observation
Normal group: rat normal liver tissue structure has no denaturation, necrosis, cell infiltration；Model group: leaflet knot
Structure is unclear, it is seen that hepatic tissue is multiple, diffusivity is downright bad, and cell infiltration is obvious, liver cell enlargement, steatosis；Forsythin
Low dose group: lobuli hepatis part of hepatocytes necrosis, substantially reduced compared with model group, the arrangement of liver rope is relatively neat, and liver cell part is swollen
Greatly, steatosis, with a small amount of cell infiltration；Middle dose group: lobuli hepatis structure is complete, but still has a small amount of cell enlargement, has no
Necrosis of liver cells, cell infiltration are unobvious；High dose group: liver cell has a focal necrosis, anthorisma, and cell infiltration is existing
As visible.Through Ridit method statistical disposition.It the results are shown in Table 2.
2 forsythin of table, the influence of Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition to rat liver pathological change
It was found from experimental result above:
1, forsythin, Fructus Forsythiae glycoside derivates, forsythin/phillygenol composition have liver protection, the effect of protect liver, wherein connecting
Stick up the effect of glycosides/phillygenol composition clearly, action intensity is slightly stronger than positive drug.
2, the effect of phillygenol group passivity hepatic injury, forsythin/phillygenol composition, which resists hepatic injury, has association
Same synergistic effect, forsythin/phillygenol A, forsythin/two groups of phillygenol B rat hepatopathy parameter, hepatic disease series
It is below model control group, and is lower than forsythin, Fructus Forsythiae glycoside derivates A, B, C group rat, is had through statistics comparing difference aobvious
Work property.Forsythin/phillygenol composition group rat liver lesion degree reduces significantly, similar to the effect of positive drug, and
It is better than the protective action of positive drug.Show forsythin of the invention/phillygenol composition in the mistake for preventing, treating hepatic injury
Have the function of synergy in journey, improves the curative effect of prevention and treatment hepatic injury.
Claims (8)
1.33- hydroxyl-phillygenol glucuronide or 9- hydroxyl-phillygenol glucuronide or 33,34- methylene
Application of the dioxy-phillygenol glucuronide in the drug of preparation prevention or/and treatment hepatic injury.
2. application according to claim 1, characterized in that the drug is by 33- hydroxyl-phillygenol glucuronide
It is formed with pharmaceutically acceptable carrier, or by 9- hydroxyl-phillygenol glucuronide and pharmaceutically acceptable carrier
Composition, or be made of 33,34- methylene dioxy-phillygenol glucuronide and pharmaceutically acceptable carrier.
3. application according to claim 2, characterized in that the pharmaceutically acceptable carrier is cyclodextrin.
4. application according to claim 2, characterized in that the pharmaceutically acceptable carrier is α-or β-or γ-ring
Dextrin.
5. application according to claim 1, characterized in that the drug is with tablet, capsule, pill, powder, particle
Agent, syrup, solution form exist.
6. application according to claim 1, characterized in that 33- hydroxyl-phillygenol glucuronide or 9- hydroxyl-
Phillygenol glucuronide or 33,34- methylene dioxy-phillygenol glucuronide weight and the drug
The ratio between total weight is 0.01-10:100.
7. application according to claim 6, characterized in that 33- hydroxyl-phillygenol glucuronide or 9- hydroxyl-
Phillygenol glucuronide or 33,34- methylene dioxy-phillygenol glucuronide weight and the drug
The ratio between total weight is 0.1~10:100.
8. application according to claim 7, characterized in that 33- hydroxyl-phillygenol glucuronide or 9- hydroxyl-
Phillygenol glucuronide or 33,34- methylene dioxy-phillygenol glucuronide weight and the drug
The ratio between total weight is 1~10:100.
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| CN101095691A (en) * | 2006-06-29 | 2008-01-02 | 山东绿叶天然药物研究开发有限公司 | Application of phillyrin in the preparing of medicine for treating or preventing acute and chronic liver injury and hepar fibrosis |
| CN103989668A (en) * | 2014-05-19 | 2014-08-20 | 鲁南制药集团股份有限公司 | Application of fructus forsythiae aglycone in preparing medicament for preventing or treating liver injury or liver failure |
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| CN103989668A (en) * | 2014-05-19 | 2014-08-20 | 鲁南制药集团股份有限公司 | Application of fructus forsythiae aglycone in preparing medicament for preventing or treating liver injury or liver failure |
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