CN106176787B - The application and drug of forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition in preparation anticancer or anti-tumor drug - Google Patents
The application and drug of forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition in preparation anticancer or anti-tumor drug Download PDFInfo
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- CN106176787B CN106176787B CN201510398806.5A CN201510398806A CN106176787B CN 106176787 B CN106176787 B CN 106176787B CN 201510398806 A CN201510398806 A CN 201510398806A CN 106176787 B CN106176787 B CN 106176787B
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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 prevention or/and tumor.Test proves, forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition are antitumor, inhibit cancer/tumour significant in efficacy, it is quick, toxic side effect is small, is a kind of safe and efficient, stable, preparation process simply treats anti-tumor drug, it is easy to spread suitable for industrialized production.The present invention provides a kind of new medicament sources to prevent and treat tumour and its complication.
Description
Technical field
The present invention relates to field of medicaments, are related to a kind of drug or health food for treating tumour, in particular to a kind of Chinese medicine
The application of Fructus Forsythiae and Folium Forsythia extract component in alleviation or/and tumor or health food.
Background technique
Tumour is body h and E carcinogenic factor in a manner of cooperateing with, and causes hereditary material DNA damage, mutation, together
When inactivated with multiple oncogene activations and tumor suppressor gene, make the continuous hyperplasia of normal cell, conversion and the new life formed
Object.It is a kind of systemic disease characterized by local cells paraplasm.It is different according to the extent of injury of the tumour to human body,
It is divided into two major classes: benign tumour and malignant tumour.Malignant cell can spread to surrounding wetting or even diffusion transfer is arrived
Other organ-tissues continue hyperplasia at double, cause greatly to threaten human life.
With aging of population and ecological environment, living-pattern preservation, it is contemplated that in the following 20-30, the whole world is pernicious
The disease incidence of tumour, the death rate have the tendency that rising year by year.According to statistics, in most suitable operation (35-60 years old), tumour is each
It ranks first in the kind cause of the death.In some countries that infectious disease is controlled, cardiovascular and cerebrovascular diseases and malignant tumour oneself account for dead original respectively
First of cause and second.The harm of tumour is self-evident, it to pain caused by patient, to family's bring it is spiritual and
Financial burden, the influence caused by social productive forces are difficult to estimate, and malignant tumour becomes the disease for seriously endangering human life.
At present modern medicine to the treatment of tumour be still with operative treatment cooperation Radiotherapy chemotherapy based on, though operation can remove
Primary lesion, but cannot fundamentally prevent the regeneration and breeding of tumour cell, and this exactly tumor recurrence and transfer in the future
Root, though chemotherapy and radiation can kill cancer cell, cannot make a choice to body cancer target cell identification, to a large amount of normal
Histocyte equally has toxic action, often causes the side reactions such as bone marrow suppression, immunologic hypofunction, not outer there are also stomach to react
With liver, kidney, impairment of cardiac function, patient is made to be difficult to adhere to treating, and the drug resistance that chemotherapeutics occurs over the course for the treatment of
Have become one of the problem in current clinical treatment.Therefore, it is necessary to seek the small treatment method of good effect, toxic side effect and medicine
Object.Chinese medicine is just becoming the hot spot of anti-tumor drug research with its medicine source the advantages that extensive, cheap, applicating history is long.
Domestic and international research experience shows the new drug for getting a good chance of becoming treating cancer from natural lead compound,
And the hit rate of natural products pharmacological screening is higher than synthesis compound.The targeted for being found to be new drug of natural lead compound
It closes object and provides tactic pattern, from natural structure activity, the activity through structural modification, the synthesis of analog and system is ground
Study carefully, the correlation of total junction structure and active (toxicity), is that research is natural in the world as the basis of design new drug target compound
The main thought of active constituent and method river.And China's medicinal plant abundant is that development structure is novel, acts on unique anticancer
New drug provides unique source.And in the complex treatment of tumour, traditional Chinese medicine is also that China has distinctive traditional means,
The antitumor action of traditional Chinese medicine has also had been to be concerned by more and more people, and the anti-tumor drug therefrom found efficiently, less toxic becomes
The hot spot of tumor research.From cellular level, the research of the effective substance of Chinese medicine and its compound is verified and disclosed to molecular level
Just become the important trend studied now.
Fructus Forsythiae is that Chinese medicine clinic commonly uses one of conventional medicament, is widely used, and dosage is huge, it reduces swelling with heat-clearing " removing toxic substances "
" function of removing free radical, is clinically often made formula with other Chinese herbal medicines to dissipating bind, is used for all kinds of oncotherapies.In recent years it grinds
Study carefully discovery, Fructus Forsythiae water extract has inhibited proliferation to gastric cancer, liver cancer, intestinal cancer, esophageal cancer cell, still, wherein specific living
Property ingredient it is unclear, inventor passes through arduous exploration, and preparation is extracted wherein active monomer compound forsythin, and through chemistry
Synthesis, is prepared for corresponding derivative, has carried out a series of pharmacology activity research, and discovery forsythin, connects Fructus Forsythiae glycoside derivates
Sticking up glycosides and phillygenol composition has inhibition tumor carcinoma cells proliferation, and enhancing immune function of human body activity is opened for tumor patient
Warded off new treatment by way of.
Forsythin (phillyrin)
Phillygenol ((+)-phillygenin)
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 tumour is extracted, and has been synthetically prepared Fructus Forsythiae glycoside derivates after further study.It can be cancer
Disease, tumor patient provide a kind of drug of high-efficiency low-toxicity.
Summary of the invention
Primary and foremost purpose of the invention is for skill present in existing anticancer or anti-tumor drug or health care product application process
Art is asked, forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition (forsythin/phillygenol) anticancer or anti-are provided
The performance and function of tumour, for alleviate or/and treating cancer, tumour, and provide forsythin, Fructus Forsythiae glycoside derivates, forsythin/
The new pharmaceutical usage of phillygenol, the i.e. new opplication in the drug or health food for the treatment of, conditioning and alleviation tumour.
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 anticancer or anti-tumor drug or health care product.For prevention or/and treating cancer or tumour.
During screening has the active skull cap components of anti-disease or antitumor action, inventor has found the chemistry of Fructus Forsythiae
Forsythin, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition have the work of strong inhibition cancer or tumour in ingredient
With.
Wherein, the drug or health care product are by forsythin, Fructus Forsythiae glycoside derivates or forsythin/phillygenol composition and medicine
Acceptable carrier composition on.
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-methoxyphenoxy)-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-
Trihydroxytetrahydro-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-trihydroxytetrahydro-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, purity >=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/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/phillygenol composition levels are 1%~98%；Preferably 30~80%.
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 a kind of anticancer or anti-tumor drug or health care product, the drug or health care product contain company
Stick up glycosides, Fructus Forsythiae glycoside derivates or forsythin and phillygenol composition.The drug or health care product are for prevention or/and treating cancer
Or tumour.
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
Plain glucuronide, 33,34- methylene dioxy-phillygenol glucuronide, phillygenol glucuronic acid methyl ester,
Phillygenol Sodium Glucuronate, phillygenol glucuronic acid potassium, phillygenol glucuronic acid；Preferably 33- hydroxyl-company
Stick up rouge element glucuronide, 9- hydroxyl-phillygenol glucuronide, 33,34- methylene dioxy-phillygenol grape
Glycuronide, 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%；The composition of forsythin and phillygenol contains
Amount >=1%, is still more preferably >=80%, then be still more preferably further preferably >=60% preferably >=30%
>=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 or health care product is 0.01-10:100, preferably 0.1~10:100, further preferably 1~10:100.
Wherein, the forsythin/phillygenol composition is added with forsythin and phillygenol monomer composition or using solvent
The phillygenol that thermal extraction method is prepared-forsythin extracts composition or phillygenol and forsythin and cyclodextrin or ring
The derivative of dextrin 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,
Maltosyl-cyclodextrin or sulphur butyl ether beta-cyclodextrin, the beta-cyclodextrin of p-methyl benzene sulfonic chloride (p-TsCl) substitution, 6- substitutions
β-CD p-methyl benzenesulfonic acid ester (beta-cyclodextrin -6-OTs), 2- oxygen hydroxypropyl-β-cyclodextrin, 2- it is mono-substituted to methylbenzene
Sulphonic acid ester (beta-cyclodextrin -2-OTs), beta-cyclodextrin p-methyl benzenesulfonic acid ester (Tosyl- β-CD), beta-cyclodextrin star divide greatly
Sub- PCL- (Tos) 7- β-CD.
In particular, further including sophorae subprostratae radix extract, xanthium sibiricum, Sculellaria barbata extraction in the drug or health care product
Object, shrubby sophora extract, dandelion extract, Honegsukle flower P.E, Ginger P.E, Semen Vitis viniferae extract, pomegranate seed extract,
Vitamin C and its derivative or vitamin E and its derivative.
Compared with prior art, the present invention has following obvious advantage:
1, the present invention has excavated new medical value to compound forsythin, phillygenol, is used for preventing, treating cancer
Disease or tumour, and can be used for being prepared into anticancer or anti-tumor drug or health food, to be Fructus Forsythiae and Folium Forsythia medicinal material
Using having opened up a new field.
2, campaign research of the invention has shown that forsythin, Fructus Forsythiae glycoside derivates, forsythin/phillygenol composition tool
There is the effect of significant inhibition, alleviation, treating cancer, tumour.
3, forsythin of the invention, Fructus Forsythiae glycoside derivates, forsythin and phillygenol composition pharmacological action are strong, for pre-
The effect of anti-, conditioning and treating cancer or tumour, is significant, quick, toxic side effect is small, safety is good, can take for a long time, has
There is 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.
6, forsythin, forsythin derivatives active ingredient, forsythin and phillygenol composition system had both can be used in the present invention
The standby drug for preventing and treating cancer, tumour, but can be used forsythin, Fructus Forsythiae glycoside derivates and other active constituents (such as with
Sophorae subprostratae radix extract, xanthium sibiricum, Herba Scutellariae Barbatae extract, shrubby sophora extract, dandelion extract, Honegsukle flower P.E,
Ginger P.E, Semen Vitis viniferae extract, pomegranate seed extract, vitamin C and its derivative or vitamin E and its derivative.) altogether
The compound medicine of same prescription, preparation prevention or/and treating cancer, tumour.
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 forsythin of the invention, the capsule of Fructus Forsythiae glycoside derivates, 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, sophorae subprostratae radix extract, vitamin C and starch are pelletized after mixing, talcum powder and tristearin is added
Sour magnesium is pressed into 10000 after mixing.
5 forsythin capsule of embodiment
1, prepare raw material according to the following ratio
2, forsythin, Honegsukle flower P.E, 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, shrubby sophora extract, 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, xanthium sibiricum, Herba Scutellariae Barbatae extract are taken, dextrose syrup is added after being dissolved with ethyl alcohol, adds
Ionized water to 100ml to get.
8 Fructus Forsythiae glucoside oral liquid of embodiment
1, prepare raw material according to the following ratio
2, forsythin, xanthium sibiricum, Semen Vitis viniferae extract are taken, dextrose syrup is added after being dissolved with ethyl alcohol, adds
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, after mixing by 33- hydroxyl-phillygenol glucuronide, Herba Scutellariae Barbatae extract, vitamin C and starch
Granulation 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, shrubby sophora 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, dandelion extract, vitamin C and cane sugar powder is uniformly mixed
It is packed after particle is made, 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, shrubby sophora extract, Honegsukle flower P.E are taken, after being dissolved with ethyl alcohol
Be added 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, after mixing by 9- hydroxyl-phillygenol glucuronide, Herba Scutellariae Barbatae extract, vitamin C and starch
Granulation 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, shrubby sophora 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, dandelion extract, vitamin C and cane sugar powder is uniformly mixed
It is packed after particle is made, is made 10000 bags.
21 9- hydroxyl of embodiment-phillygenol glucuronic acid glucoside oral liquid
1, prepare raw material according to the following ratio
Full side finally adds deionized water to 100ml.
2,9- hydroxyl-phillygenol glucuronide, shrubby sophora extract, Honegsukle flower P.E are taken, after being dissolved with ethyl alcohol
Be added 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, by 33,34- methylene dioxy-phillygenol glucuronide, Herba Scutellariae Barbatae extract, vitamin C and starch
It pelletizes after mixing, is pressed into 10000 after talcum powder and magnesium stearate mixing is added.
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, shrubby sophora 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, dandelion extract, vitamin C and sucrose
Powder be uniformly mixed particle is made after pack, 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, dandelion extract, vitamin C and sucrose
Powder be uniformly mixed particle is made after pack, 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, shrubby sophora extract, Honegsukle flower P.E is taken, is used
Ethyl 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 shrubby sophora 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 Semen Vitis viniferae extract, shrubby sophora extract powder, then with it is micro-
Particle pack is made in crystalline 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, Semen Vitis viniferae extract, Honegsukle flower P.E powder
Uniformly, then it is 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 Herba Scutellariae Barbatae extract powder, then be uniformly mixed with starch
After be made particle, 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 (dandelion, ginger) powder, then with
Particle pack is made in microcrystalline 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 mixed with said extracted object (Sculellaria barbata, grapestone, the achene of Siberian cocklebur) powder
Uniformly, then it is encapsulated after mixing with starch, it is made 10000.
1 forsythin of test example, Fructus Forsythiae glycoside derivates, forsythin/phillygenol composition anti-mouse S180 sarcoma test
1 experimental material
1.1 experimental animals and transplantable tumor strain
Kunming mice is provided by Guangdong Medical Lab Animal Center, credit number: SCXK2013-005；
S180 sarcoma tumor strain is purchased from Guangdong Medical Lab Animal Center.
1.2 drug
Forsythin (content > 98%), white powder, Dalian Fu Sheng natural drug development corporation, Ltd. production, through efficient liquid
Two kinds of detector UV detector of phase chromatography and the measurement of evaporative light scattering detector area normalization method, purity 99.5%,
And with Chinese pharmaceutical biological product assay forsythin reference substance calibration and confirm that its content is 99.5%.Lot number:
20130303。
33- hydroxyl-phillygenol glucuronide (Fructus Forsythiae glycoside derivates A, content > 98%), white powder, Dalian
The production of Fu Sheng natural drug development corporation, Ltd., lot number: 20130301.Through two kinds of detector UV detector of high performance liquid chromatography
It is measured with evaporative light scattering detector area normalization method, purity 98.5%.
9- hydroxyl-phillygenol glucuronide (Fructus Forsythiae glycoside derivates B, content > 98%), white powder, Dalian are rich
Raw natural drug development corporation, Ltd. production, lot number: 20130302.Through two kinds of detector UV detector of high performance liquid chromatography and
The measurement of evaporative light scattering detector area normalization method, purity 99.2%.
33,34- methylene dioxies-phillygenol glucuronide (Fructus Forsythiae glycoside derivates C, content > 98%), white
Powder, the production of Dalian Fu Sheng natural drug development corporation, Ltd., lot number: 20130301.Through two kinds of detectors of high performance liquid chromatography
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: cyclophosphamide (lot number: 20130105, Hengrui Medicine Co., Ltd., Jiangsu Prov.).For clinic at
People's equivalent dose (is calculated) administration by adult's 60kg weight, required suspension is made into distilled water, the medical fluid prepared, which is deposited, to be kept away
It is spare in 4 DEG C of refrigerators of light.
2, experimental method
2.1 groupings and administration
Sl80 sarcoma 7 days well-grown ascitic type mouse of inoculation are taken, ascites are extracted under sterile working, with the life of sterilizing
Salt water dilution is managed, adjusting cell number is 2 × 106A/0.2mL, is placed in ice water and saves.
Healthy kunming mice 210 (half male and half female), 6-8W age, weight 18-22g, under experiment condition after precuring 1 week, with
Machine takes out 10 and is only used as blank control group, remaining 200, every left hind armpit inoculates S180 tumor cell suspension
0.2mL, inoculation are weighed afterwards for 24 hours, are randomly divided into 20 groups: lotus knurl control group, positive drug control group, the high, medium and low dosage of forsythin
Group, the high, medium and low dosage group of Fructus Forsythiae glycoside derivates A, the high, medium and low dosage group of Fructus Forsythiae glycoside derivates B；Fructus Forsythiae glycoside derivates C high,
In, low dose group；Forsythin/high, medium and low the dosage group of phillygenol composition A；Forsythin/phillygenol composition B high, in,
Low dose group.In grouping the same day start gastric infusion, basic, normal, high three groups of forsythin give respectively forsythin (36mg/kg,
72mg/kg, 144mg/kg；Fructus Forsythiae glycoside derivates A low, middle and high dose groups give Fructus Forsythiae glycoside derivates A 36mg/kg respectively,
72mg/kg, 144mg/kg；Fructus Forsythiae glycoside derivates B low, middle and high dose groups give Fructus Forsythiae glycoside derivates B 36mg/kg respectively,
72mg/kg, 144mg/kg；Fructus Forsythiae glycoside derivates C low, middle and high dose groups give Fructus Forsythiae glycoside derivates C 36mg/kg respectively,
72mg/kg, 144mg/kg；Forsythin/phillygenol composition A low, middle and high dose groups give forsythin/phillygenol respectively
Composition A 36mg/kg, 72mg/kg, 144mg/kg；Forsythin/phillygenol composition B low, middle and high dose groups are given respectively
Forsythin/phillygenol composition B 36mg/kg, 72mg/kg, 144mg/kg；Positive controls give cyclophosphamide 45mg/kg；
Normal group, model group is to same amount of normal saline, stomach-filling, and 1 time/d.
After modeling medication, observe the feed of every group of mouse, drinking-water, hair color variation, activity condition, to the reaction of stimulation, have
Situations such as without diarrhea, syntexis, death, and record at any time.21d is discontinued after gastric infusion, and next day cervical dislocation is put to death mouse and claimed
Weight, completely strips left hind subcutaneous tumor tissue, and the nonneoplastic tissues such as removal blood stains, fat claim knurl weight with electronic balance, press
Formula calculates tumour inhibiting rate:
Tumour inhibiting rate=(control group average knurl weight-medication group average knurl weight)/control group average knurl weight × 100%
2.2 data are with mean ± standard deviationIt indicates, measurement data comparison among groups are carried out with SPASS13.0 statistical software
One-way analysis of variance is with significant difference with P < 0.05.
3, experimental result
Animal ordinary circumstance is observed after 3.1 medications
Each group mouse survives after medication, and blank control group mouse feed, drinking-water situation are normal, and activity flexibly, reacts spirit
It is quick, hair luster, no diarrhea, thin situation.In comparison, forsythin, Fructus Forsythiae glycoside derivates, forsythin/phillygenol are respectively given
Medicine group mouse ordinary circumstance is taken second place；The feed of positive controls mouse is poor, and drinking-water is few, and slowly, it is more blunt to react for activity, depilation,
Hair color is matt, there is diarrhea, thin；Lotus knurl control group is more secondary, it is seen that mouse feed is seldom, seldom movable, slow in reacting, hair color
It is withered, it is thin obvious.
Knurl weight is transplanted between 3.2 each groups and tumour inhibiting rate is shown in Table 1.
Knurl weight and tumour inhibiting rate are transplanted between 1 each group of table
Test result shows that medication group transplanting knurl weight significantly lower than lotus knurl control group, shows that forsythin, forsythin are derivative
Object, forsythin/phillygenol composition all have the effect of colonization resistance mouse S 180 sarcoma, forsythin, Fructus Forsythiae glycoside derivates,
The tumour inhibiting rate of forsythin/phillygenol composition high dose is above positive drug group, and forsythin/phillygenol A, Fructus Forsythiae
Glycosides/phillygenol B high dose group inhibitory rate absolutely proves the two in forsythin and phillygenol composition to 50% or more
With synergistic function, the effect of inhibiting tumour, is improved, with preferable antitumaous effect.
The research of the anti-nude mice MGC gastric cancer of 2 forsythin of test example, Fructus Forsythiae glycoside derivates, forsythin/phillygenol composition
1 experimental material
1.1 experimental animals and transplantable tumor strain
Nude mouse is provided, credit number: SCXK2013-006 by Experimental Animal Centers such as Guangdong Province's medicine；
MGC human stomach cancer cell line is purchased from Guangdong Medical Lab Animal Center.
1.2 drug
Forsythin (content > 98%), white powder, Dalian Fu Sheng natural drug development corporation, Ltd. production, through efficient liquid
Two kinds of detector UV detector of phase chromatography and the measurement of evaporative light scattering detector area normalization method, purity 99.5%,
And with Chinese pharmaceutical biological product assay forsythin reference substance calibration and confirm that its content is 99.5%.Lot number:
20130303。
33- hydroxyl-phillygenol glucuronide (Fructus Forsythiae glycoside derivates A, content > 98%), white powder, Dalian
The production of Fu Sheng natural drug development corporation, Ltd., lot number: 20130301.Through two kinds of detector UV detector of high performance liquid chromatography
It is measured with evaporative light scattering detector area normalization method, purity 98.5%.
9- hydroxyl-phillygenol glucuronide (Fructus Forsythiae glycoside derivates B, content > 98%), white powder, Dalian are rich
Raw natural drug development corporation, Ltd. production, lot number: 20130302.Through two kinds of detector UV detector of high performance liquid chromatography and
The measurement of evaporative light scattering detector area normalization method, purity 99.2%.
33,34- methylene dioxies-phillygenol glucuronide (Fructus Forsythiae glycoside derivates C, content > 98%), white
Powder, the production of Dalian Fu Sheng natural drug development corporation, Ltd., lot number: 20130301.Through two kinds of detectors of high performance liquid chromatography
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.
Forsythin (content > 98%), white powder, Dalian Fu Sheng natural drug development corporation, Ltd. production, through efficient liquid
Two kinds of detector UV detector of phase chromatography and the measurement of evaporative light scattering detector area normalization method, purity 99.5%,
And with Chinese pharmaceutical biological product assay forsythin reference substance calibration and confirm that its content is 99.5%.Lot number:
20130303。
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: cyclophosphamide (lot number: 20130105, Hengrui Medicine Co., Ltd., Jiangsu Prov.).For clinic at
People's equivalent dose (is calculated) administration by adult's 60kg weight, required suspension is made into distilled water, the medical fluid prepared, which is deposited, to be kept away
It is spare in 4 DEG C of refrigerators of light.
2, experimental method
2.1 groupings and administration
The eugonic internal MGC gastric cancer for passing for 2 generations is taken under aseptic condition, is prepared into about 2 × 10 with homogenate method7/ ml is thin
Born of the same parents' suspension takes nude mouse 200, and underwent operative is in injection cell suspension 0.05ml in the greater curvature muscle layer of nude mouse, after inoculation for 24 hours
Weighing, is randomly divided into 20 groups: lotus knurl control group, positive drug control group, the high, medium and low dosage group of forsythin, Fructus Forsythiae glycoside derivates A
High, medium and low dosage group, 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；Fructus Forsythiae
Glycosides/high, medium and low the dosage group of phillygenol composition A；Forsythin/high, medium and low the dosage group of phillygenol composition B.In grouping
The same day starts gastric infusion,
Basic, normal, high three groups of forsythin give forsythin (36mg/kg, 72mg/kg, 144mg/kg respectively；Forsythin spreads out
Biological A low, middle and high dose groups give Fructus Forsythiae glycoside derivates A 36mg/kg, 72mg/kg, 144mg/kg respectively；Forsythin is derivative
Object B low, middle and high dose groups give Fructus Forsythiae glycoside derivates B 36mg/kg, 72mg/kg, 144mg/kg respectively；Fructus Forsythiae glycoside derivates C
Low, middle and high dose groups give Fructus Forsythiae glycoside derivates C 36mg/kg, 72mg/kg, 144mg/kg respectively；Forsythin/phillygenol
Composition A low, middle and high dose groups give forsythin/phillygenol composition A 36mg/kg, 72mg/kg, 144mg/kg respectively；
Forsythin/phillygenol composition B low, middle and high dose groups give forsythin/phillygenol composition B 36mg/kg respectively,
72mg/kg, 144mg/kg；Positive controls give cyclophosphamide 45mg/kg；Model group is to same amount of normal saline, stomach-filling, and 1 time/d.
21d is discontinued after gastric infusion, and lotus knurl host's increase in life span is calculated according to the following formula:
Increase in life span %=administration group the average survival time day/control group the average survival time day × 100%
2.2 data are with mean ± standard deviationIt indicates, measurement data comparison among groups are carried out with SPASS13.0 statistical software
One-way analysis of variance is with significant difference with P < 0.05.
3, experimental result
Lotus knurl host life of forsythin, Fructus Forsythiae glycoside derivates, forsythin/the phillygenol composition to nude mice MGC gastric cancer
Rate elongation test result is shown in Table 2.
2 forsythin of table, Fructus Forsythiae glycoside derivates, forsythin/phillygenol extend lotus knurl host's life of nude mice MGC gastric cancer
Rate
The experimental results showed that extend lotus knurl naked for forsythin, Fructus Forsythiae glycoside derivates, forsythin/phillygenol composition
The life cycle of mouse illustrates that forsythin, Fructus Forsythiae glycoside derivates, forsythin/phillygenol composition have one to the treatment of tumour
Fixed meaning.
Lotus knurl of forsythin, Fructus Forsythiae glycoside derivates, forsythin/phillygenol composition high dose to nude mice MGC gastric cancer
Host's increase in life span is above positive drug group；Forsythin/phillygenol A, forsythin/middle and high dosage group of phillygenol B
It is higher to lotus knurl host's increase in life span of nude mice MGC gastric cancer, absolutely prove that the two has in forsythin and phillygenol composition
The effect of having synergistic function, inhibiting cancer, improves, with preferable antitumaous effect.
Claims (4)
1. Fructus Forsythiae glycoside derivates are as sole active agent in preparation for answering in anticancer or anti-tumor drug or health care product
With, wherein the Fructus Forsythiae glycoside derivates select 33- hydroxyl-phillygenol glucuronide, 9- hydroxyl-phillygenol grape
Glycuronide, 33,34- methylene dioxy-phillygenol glucuronide.
2. application according to claim 1, it is characterized in that the drug is by Fructus Forsythiae glycoside derivates and pharmaceutically acceptable
Carrier composition.
3. application according to claim 1 or 2, it is characterized in that the drug is with tablet, capsule, pill, powder, particle
Agent, syrup, solution form exist.
4. application according to claim 1 or 2, it is characterized in that the weight of the Fructus Forsythiae glycoside derivates and the drug or guarantor
The ratio between the total weight of strong product is 0.01-10:100.
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