CN106474194A - Combination of two kinds of plant amedica and application thereof - Google Patents

Combination of two kinds of plant amedica and application thereof Download PDF

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CN106474194A
CN106474194A CN201611164160.5A CN201611164160A CN106474194A CN 106474194 A CN106474194 A CN 106474194A CN 201611164160 A CN201611164160 A CN 201611164160A CN 106474194 A CN106474194 A CN 106474194A
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compositionss
ethanol
hour
present
times amount
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袁宁生
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Ningbo Shanghai Pharmaceutical Technology Co Ltd
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Ningbo Shanghai Pharmaceutical Technology Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Abstract

A kind of combination of two kinds of plant amedica, takes 0.5 part～5 parts of Herba Silybi mariani, 0.2 part～3 parts of Radix Stephaniae Japonicae by weight, plus 50v/v%～80v/v% alcohol reflux 2 times, wherein, it is for the 1st time 10 times amount 50v/v%～80v/v% ethanol, 1～4 hour, it is for 2nd time 8 times amount 50v/v%～80v/v% ethanol, 1～4 hour, after filtration, merge 2 filtrates, to no alcohol taste, when continuing to be evaporated to 50 DEG C ± 5 DEG C, relative density is 1.20～1.34 to decompression recycling ethanol, obtains final product.Animal experiments prove that, the present composition can improve blood glucose and glycolated hemoglobin, there is the DEVELOPMENT PROSPECT of medicine.

Description

Combination of two kinds of plant amedica and application thereof
Technical field
The present invention relates to a kind of compositionss taking from plant, more particularly, to one kind extracts from Herba Silybi mariani and Radix Stephaniae Japonicae matches 5 compositionss, and its application in producing prevention and treatment diabetic composition.
Background technology
Diabetes (Diabetes Mellitus, DM) are a kind of because internal insulin is absolute or relative deficiency is led to A series of clinical syndromes.This disease also can cause some complication in development process, such as：Hypoglycemia (Hypoglycemia), ketoacidosiss (Ketoacidosis), non-ketone hyperosmolar coma (Nonketotic Hyperosmolar Coma), cardiovascular disease, chronic renal failure, retinopathy, neuropathy and microangiopathies etc..Sugar The conventional medicine of urine disease treatment mainly has three major types：Biological medicament class, such as：Insulin (Insulin)；Chemical drugs, such as：Sulfonylurea (Sulfonylurea), biguanideses (Biguanide), glitazone (Glitazone) and Chinese patent medicine class.It is limited to still not have at present More ripe insulin non-injection administration technology, it is using based on still injecting, and injection process there is also security risks. Though chemical classes medicine has stronger hypoglycemic activity, big to toxic and side effects such as liver, kidneys, it is also easy to lead to cardiovascular complication Increase.Additionally, also having some medicines, such as：GLUCAGON LIKE PEPTIDE (Glucagon-like peptide 1, GLP-1), fat Be acylated GLUCAGON LIKE PEPTIDE (NN2211, Novo Nordisk), Exendin-4 () and poly- second two Amylin Exendin-4 (Chinese invention patent application 00809516.7) that alcohol is modified etc., though can effective control blood glucose, fall after long term administration Low-saccharification Hb H bA1c numerical value and improve β islet cell function, but because the also same purpose of these molecules is in nervus centraliss Receptor, so after administration, the symptom of vomiting and dizziness is more difficult avoiding, and administering mode is still based on injecting.Another kind of DPPIV enzyme Inhibitor, though can be administered orally, fermentoid big in organism is all produced inhibitory action by it, thus body fat can be made to be distributed Change, and the actual effect being administered is also relatively poor.
Chinese invention patent application 93100485.3 discloses a kind of health buckwheat foodstuff, with Radix Et Rhizoma Fagopyri Tatarici powder as base material, auxiliary With soybean protein powder, then add the Chinese herbal medicine natural component such as Fructus Lycii, Radix Ginseng, the Rhizoma Anemarrhenae, activated calcium, its formulation weight percentage composition For：Radix Et Rhizoma Fagopyri Tatarici flour 60-80%, soybean protein powder 15-30%, lycium barbarum polysaccharide 0.5-2.5%, zhimusaponin 0.2-0.5%, people Gracilis polysaccharide 0.5-1.5%, activated calcium 1.2-4.3%.The food of composition has therapeutical effect to diabetes.This health food is with buckwheat Based on wheat, the diet of diabeticss can be played a role, but the effect in terms for the treatment of needs further to be tested card Real.
Chinese invention patent ZL95116521.6 discloses a kind of tonic hypoglycemic capsule and preparation method thereof, using Radix Rehmanniae Preparata, The Radix Astragali, Fructus Lycii, Radix Salviae Miltiorrhizae, Cortex Phellodendri, the Rhizoma Anemarrhenae and Cortex Cinnamomi etc. 20 taste crude drug, through special processing and processing.This Jiangtang capsule Make after being pulverized by Chinese crude drug, the content of cellulose due to containing is many, and the absorption of sugar can be slowed down, add Radix Aconiti Lateralis Preparata and Cortex Cinnamomi two medicine Make medicine hypoglycemic effect more notable after material, be that the emphasis of this invention is located.
Chinese invention patent application 99126988.8 discloses a kind of capsule for lowering sugar of diabetes, with the Radix Rehmanniae, Radix Trichosanthis, The medical materials such as Radix Scrophulariae, the Rhizoma Anemarrhenae, Cortex Phellodendri, Rhizoma Coptidis, Cornu Cervi Pantotrichum, BIANGUI, Rhizoma Dioscoreae, Gypsum Fibrosum and dry Amylum Nelumbinis Rhizomatis are key component, and treatment is by diabetes Disappear on causing, in disappear, under disappear and the disease such as polyphagia polyuria.
Chinese invention patent application 02107203.5 discloses a kind of Chinese traditional compound medicine treating type 2 diabetes mellitus, with Pueraria lobota Root, Radix Trichosanthis, Rhizoma Atractylodis, Radix Scrophulariae, Radix Astragali, Rhizoma Dioscoreae, Gypsum Fibrosum, Cortex Cinnamomi, RADIX ACONITILATERALIS PREPARATA, Ramulus Euonymi, Eupolyphaga Seu Steleophaga, Herba Taxilli, Bombyx bombycis, The natural Chinese medicines such as stir-baked SQUAMA MANITIS, Hirudo, Sanguis Draxonis, Rhizoma Smilacis Chinensiss, the Rhizoma Anemarrhenae, Herb Gynostemmae Pentaphylli, the Radix Rehmanniae, Radix Ophiopogonis, Radix Paeoniae Rubra, Cortex Lycii, Radix et Rhizoma Rhei (processed) are Raw material, is made by the operation such as pulverizing, decocting, dry, sterilize, for the treatment of type ii diabetes and its complication.
Chinese invention patent application 200310110332.7 disclose a kind of medicine treating diabetes ginseng stilbene Rhizoma Dioscoreae cream and Its preparation method, by " monarch " medicine：Rhizoma Dioscoreae and Radix Ginseng；" minister " medicine：Solenognathus, Hippocampus, Resina Ferulae, Olibanum, Myrrha, Flos Carthami, Cortex Cinnamomi, treasure Pearl, artificial Moschuss, Radix Trichosanthis, Cortex Phellodendri, the Radix Astragali, Folium mangiferae and Folium Psidii Guajavae；And " making " medicine：The common compatibility of the medical materials such as Borneolum Syntheticum and Become.By broken section of mixing of the medical materials such as Rhizoma Dioscoreae, Radix Ginseng, Radix Trichosanthis, Cortex Phellodendri, the Radix Astragali, Folium mangiferae and Folium Psidii Guajavae, it is soaked in Oleum Sesami In, through heating after three days, filter, add Plumbum preparatium in oil strain, then stir evenly, receive cream；Ointment is added in cold water, is stirred continuously, Water is changed in extruding；Cream slow fire of getting it filled melts, and adds Margarita layer powder, Borneolum Syntheticum powder, artificial Moschuss, Solenognathus, Hippocampus, Resina Ferulae, Olibanum, does not have The fine powder of the medical materials such as medicine, Flos Carthami and Cortex Cinnamomi, stirs evenly, and is split on non-woven fabrics and makes plaster.Obtained ointment supplementing QI and nourishing YIN, life Quenching the thirst in Tianjin, has functions that to treat type ii diabetes.
Herba Silybi mariani is the dry mature fruit of feverfew Herba Silybi mariani (Silybummarianum (L.) Gaertn.), function Cure mainly as heat-clearing and toxic substances removing, depressed liver-energy dispersing and function of gallbladder promoting, be conventionally used to dampness-heat in the liver and gallbladder, hypochondriac pain, jaundice etc..People also not yet recognize it to prevention What treats the pharmacological action of diabetes.
Radix Stephaniae Japonicae is the dried root of menispermaceous plantss Radix Stephaniae Japonicae Stephania sinica Diels.There is heat clearing away Removing toxic substances, eliminating stasis to stop pain effect, for upper respiratory tract infection, pharyngolaryngitis, stomachache, acute gastroenteritis, bacillary dysentery, malaria, wind Wet pain, trauma pain etc.；Traumatic injury, venom, sore swollen toxin etc. are controlled in external.People also not yet recognize it to prevention What treats the pharmacological action of diabetes.
Content of the invention
It is an object of the present invention to provide a kind of compositionss, will be compatible to Herba Silybi mariani and Radix Stephaniae Japonicae, there is improvement Blood glucose and the pharmacological action of glycolated hemoglobin.
Further object is that providing a kind of compositionss, the extract of Herba Silybi mariani and Radix Stephaniae Japonicae has improvement Blood glucose and the pharmacological action of glycolated hemoglobin.
It is yet a further object of the present invention to provide a kind of compositionss, its with silymarin and rotundine as active component, There is the pharmacological action improving blood glucose and glycolated hemoglobin.
A further object of the present invention is to provide a kind of compositionss, will be compatible to Herba Silybi mariani and Radix Stephaniae Japonicae, and its carries Thing isoreactivity composition is taken to make medicine, food and health product, for the prevention and treatment of diabetes.
A further object of the present invention is to provide a kind of compositionss, its with will be compatible to Herba Silybi mariani and Radix Stephaniae Japonicae, and Its extract isoreactivity composition, also combined with the other materials prevention and treatment for diabetes.
" silymarin " alleged by the present invention refers to extract gained skin from planting of the medicinal plants of Compositae Herba Silybi mariani seed A kind of flavanolignan class compound, in yellow powder, bitter in the mouth.Main active component has silibinin (Silybin), different water Four kinds of isomerisms such as winged Ji guest (Isosilybin), Silychristin (Silychristin) and silidianin (Silydianin) Body, wherein silibinin (CAS No.：22888-70-6) content is more than 50%.Its off-white color crystalline powder, odorless, taste are micro- Bitterness, have draw moist.It is dissolved in acetone, be slightly soluble in methanol, ethanol, be insoluble in chloroform, water insoluble.Additionally, also include it being become Hydrate etc..
" rotundine " alleged by the present invention is CAS No.：The compound of 10097-84-4, white or yellowish crystallization； Odorless, tasteless；Meet light and be heated and easily turn yellow.Chloroform dissolves, slightly molten in ethanol or ether, insoluble in water；In dilute sulfuric acid In readily soluble.Fusing point is 141 DEG C～144 DEG C.Additionally, also including pharmaceutically acceptable salt formed by it, such as：But it is not limited only to salt Hydrochlorate and sulfate etc..
Compositionss alleged by the present invention, also include the various excipient substances being adapted with contained compound or compositionss, with It is formed with the dosage form beneficial to administration (drug delivery), such as：But it is not limited only to aqueous solution injection, injectable powder, pill, dissipate Agent, tablet, patch, suppository, Emulsion, cream, gel, granule, capsule, aerosol, spray, powder spray, slow releasing agent With controlled release agent etc..These pharmaceutic adjuvants both can be conventional use of in various preparations, such as：But it is not limited only to isotonic agent, buffering Liquid, correctivess, excipient, filler, binding agent, disintegrating agent and lubricant etc.；Can also be to be adapted with described material And select use, such as：Emulsifying agent, solubilizing agent, antibacterial, analgesic and antioxidant etc., this kind of adjuvant can effectively improve combination The rate of release of the stability of compound contained by thing and dissolubility or change compound and absorption rate etc., thus improve variousization Compound metabolism in vivo, and then the administering effect of enhancing composition.Further, it is also possible to for realizing specific administration purpose Or mode, such as：Sustained-release administration, controlled release drug administration and pulsatile administration etc., and the adjuvant using, such as：But it is not limited only to gelatin, white egg In vain, shitosan, polyethers and polyester-based polymer material, such as：But it is not limited only to, Polyethylene Glycol, polyurethane, Merlon and its altogether Polymers etc..Mainly being presented with of alleged " being conducive to being administered "：But be not limited only to improve therapeutic effect, improve bioavailability, Reduce toxic and side effects and improve patient's compliance etc..
In aqueous solution injection, adjuvant generally comprises isotonic agent and buffer, and necessary emulsifying agent is (such as： Tweeen-80, Pluronic and Poloxamer etc.), solubilizing agent and antibacterial etc..Additionally, also including containing pharmaceutically acceptable Other pharmaceutic adjuvants, such as：Antioxidant, pH adjusting agent and analgesic etc..
Adjuvant for producing oral liquid generally comprises solvent, and necessary correctivess, antibacterial, emulsifying agent With coloring agent etc..
Adjuvant for producing tablet generally comprises filler (such as：Starch, Icing Sugar, dextrin, Lactose, amylum pregelatinisatum, micro- Crystalline cellulose, calcium sulfate, calcium hydrogen phosphate and Mannitol etc.), binding agent (such as：Ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl Base cellulose, methylcellulose, ethyl cellulose, hydroxypropyl methyl cellulose, gelatin solution, sucrose solution and polyvinyl pyrrole The aqueous solution of alkanone or alcoholic solution etc.), disintegrating agent (such as：Dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crosslinking Polyvinylpyrrolidone and cross-linking sodium carboxymethyl cellulose) and lubricant is (such as：Magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenation Vegetable oil, Polyethylene Glycol 4,000, Polyethylene Glycol 6,000 and magnesium laurylsulfate etc.) etc..
Adjuvant for producing Emulsion is generally water, oil (such as：Fatty acid), emulsifying agent, and necessary preservative and rectify Taste agent etc..
Adjuvant for preparing granular agent is similar with tablet, but granulation process is different.As needed, the granule being obtained Load capsule after mixing with fluidizer and obtain final product capsule.
" organism ", " animal " or " patient " alleged by the present invention refers to people, wild animal and domestic animal (Livestock). Wild animal is the animal under naturalness without domestication.Domestic animal be to provide for food source and artificial breeding dynamic Thing, such as：But it is not limited only to Canis familiaris L., cat, Mus, rat, hamster, pig, rabbit, milch cow, Babalus bubalis L., bull, sheep, goat, goose and chicken etc..Give Give " patient " or " organism " prioritizing selection mammal for the treatment of, especially people.
" prevention " alleged by the present invention refers to before the disease do not assert by clinical criteria, various for prevent disease occur Development means or measure, include medical science, method physically or chemically, with stop and reduction disease various symptoms generation or Development.
" prevention diabetes " alleged by the present invention refer to be used for also not meeting " diabetes " clinic by the present composition refer to Target, continuity over time will slowly develop into the potential patient being clinically defined as " diabetes ", thus improving these The tolerance to glucose for the patient, promotes human body to glycometabolic ability, increases the sensitivity to insulin for the human body.This kind of potential Patient often suffer from " metabolic syndrome (Metabolic Syndrome) " (Annnu.Rev.Nutri., 2005,25,391- 406；Annnu.Rev.Med., 2005,56,45-62；Nat.Rev.Drug.Disc., 2006,5,295-309； Nat.Rev.Endocri., 2006,2,335-348), such as：Obesity, insulin resistance, glucose intolerance, hypertension, tremulous pulse Hardening card (antherosclerosis), dyslipidemia (dyslipidemia) (i.e. the triglyceride levels in blood are higher, High density lipoprotein is simultaneously low) etc..
" treatment " alleged by the present invention refers to the generation in order to stop and reducing disease or development, makes the development of disease course Or increase to be suppressed, contain, mitigate, improve, slow down, stop, postponing or invert, when described holding and/or medication Disease, disorderly or pathologic state various indexs include mitigating or reduce symptom or complication, or cure or eliminate disease Disease, disorderly or situation.
" treatment diabetes " alleged by the present invention refer to for the present composition to be used for the trouble that clinical diagnosises are " diabetes " Person, improves the tolerance to glucose for these patients, promotes human body to glycometabolic ability, increases the sensitivity to insulin for the human body Property.And then make being controlled in normal level after the meal of patient with fasting glucose.Due to obtaining to the ability of glucose metabolism To improve, thus slow down the various cardiovascular disease producing because of long term hyperglycemia, chronic renal failure, retinopathy, god Occurrence and development through pathological changes and microangiopathies.
" food " alleged by the present invention refers to the various compounds of present invention offer, compositionss or extract are made can Edible single compound or compositionss.The production of this kind of single compound or compositionss and manufacture should meet relevant food peace Full standard, but these food security standards must not limit the present invention.
" health product " alleged by the present invention refer to include various compounds, compositionss or the extract system that the present invention provides Become edible single compound or compositionss to impose on patient, play the purpose that disease is prevented and treated.It belongs to Food alleged by the present invention, but it produces, manufactures and sells requirement, the standards and norms that also should meet various correlations.
" medicine " alleged by the present invention refers to can be used for preventing or treats the single compound of certain disease, multiple chemical combination Compositionss, Chinese crude drug and its extract that thing is formed, or refer to the compositionss with single compound as main active or preparation (formulation), also referring to by multiple compounds is the compositionss of active component or preparation." medicine " should be interpreted to refer to root According to the legal provisions of a state, examine and grant the product of production by the administrative organization that it is set up, also refer to passing through to obtain Examination ＆ approval and grant produce during, formed containing single compound for active component all kinds of physical forms." formation " should It is interpreted as obtaining by approach such as chemosynthesis, bioconversion or purchases.
A kind of compositionss that the present invention provides, will be compatible to Herba Silybi mariani and Radix Stephaniae Japonicae, the compatibility of two kinds of compositions by weight Relation is：0.5 part～5 parts of Herba Silybi mariani, 0.2～3 part of Radix Stephaniae Japonicae.So that compositionss can play improves blood glucose and saccharifying blood The pharmacological action of Lactoferrin.
Another kind of compositionss that the present invention provides, will be compatible to Herba Silybi mariani and Radix Stephaniae Japonicae, the joining of two kinds of compositions by weight 5 relations are：1～3 part of Herba Silybi mariani, 0.2～2 part of Radix Stephaniae Japonicae.So that compositionss can play improves blood glucose and HbAle The pharmacological action of albumen.
Another kind of compositionss that the present invention provides, will be compatible to Herba Silybi mariani and Radix Stephaniae Japonicae, the joining of two kinds of compositions by weight 5 relations are：1～3 part of Herba Silybi mariani, 0.5～1 part of Radix Stephaniae Japonicae.So that compositionss can play improves blood glucose and HbAle The pharmacological action of albumen.
It has also been found that, Herba Silybi mariani and Radix Stephaniae Japonicae extract also have the pharmacology improving blood glucose and glycolated hemoglobin to make With.
Another kind of compositionss that the present invention provides, take 0.5 part～5 parts of Herba Silybi mariani by weight, 0.2～3 part of Radix Stephaniae Japonicae, Plus 50v/v%～80v/v% alcohol reflux 2 times, wherein, it is for the 1st time 10 times amount 50v/v%～80v/v% ethanol, 1～4 Hour, it is for the 2nd time 8 times amount 50v/v%～80v/v% ethanol, 1～4 hour, after filtration, merge 2 filtrates, recovered under reduced pressure second To no alcohol taste, when continuing to be evaporated to 50 DEG C ± 5 DEG C, relative density is 1.20～1.34 to alcohol, obtains extract.
Another kind of compositionss that the present invention provides, take 1～3 part of Herba Silybi mariani by weight, 0.2～2 part of Radix Stephaniae Japonicae, plus 50v/v%～80v/v% alcohol reflux 2 times, wherein, the 1st time is 10 times amount 50v/v%～80v/v% ethanol, and 1～4 is little When, it is for the 2nd time 8 times amount 50v/v%～80v/v% ethanol, 1～4 hour, after filtration, merge 2 filtrates, decompression recycling ethanol To no alcohol taste, when continuing to be evaporated to 50 DEG C ± 3 DEG C, relative density is 1.20～1.34, obtains extract.
Another kind of compositionss that the present invention provides, take 1～3 part of Herba Silybi mariani by weight, 0.5～1 part of Radix Stephaniae Japonicae, plus 50v/v%～80v/v% alcohol reflux 2 times, wherein, the 1st time is 10 times amount 50v/v%～80v/v% ethanol, and 1～4 is little When, it is for the 2nd time 8 times amount 50v/v%～80v/v% ethanol, 1～4 hour, after filtration, merge 2 filtrates, decompression recycling ethanol To no alcohol taste, when continuing to be evaporated to 50 DEG C ± 3 DEG C, relative density is 1.20～1.34, obtains extract.
Further study show that, silymarin and rotundine are active component, also show and improve blood glucose and HbAle The pharmacological action of albumen.
Another kind of compositionss that the present invention provides, it with silymarin and its hydrate and rotundine and its pharmaceutically can connect The salt being subject to is active component, and the compatibility relationship of two kinds of compositions by weight is：Silymarin and its hydrate 10%～90%, Luo Tong Determine and its pharmaceutically acceptable salt 10%～90%.
Another kind of compositionss that the present invention provides, it with silymarin and its hydrate and rotundine and its pharmaceutically can connect The salt being subject to is active component, and the compatibility relationship of two kinds of compositions by weight is：Silymarin and its hydrate 51%～90%, Luo Tong Determine and its pharmaceutically acceptable salt 10%～49%.
Another kind of compositionss that the present invention provides, it with silymarin and its hydrate and rotundine and its pharmaceutically can connect The salt being subject to is active component, and the compatibility relationship of two kinds of compositions by weight is：Silymarin and its hydrate 61%～90%, Luo Tong Determine and its pharmaceutically acceptable salt 10%～39%.
Another kind of compositionss that the present invention provides, it with silibinin and its hydrate and rotundine and its pharmaceutically can connect The salt being subject to is active component, and the compatibility relationship of two kinds of compositions by weight is：Silibinin and its hydrate 10%～90%, Luo Tong Determine and its pharmaceutically acceptable salt 10%～90%.
Another kind of compositionss that the present invention provides, it with silibinin and its hydrate and rotundine and its pharmaceutically can connect The salt being subject to is active component, and the compatibility relationship of two kinds of compositions by weight is：Silibinin and its hydrate 51%～90%, Luo Tong Determine and its pharmaceutically acceptable salt 10%～49%.
Another kind of compositionss that the present invention provides, it with silibinin and its hydrate and rotundine and its pharmaceutically can connect The salt being subject to is active component, and the compatibility relationship of two kinds of compositions by weight is：Silibinin and its hydrate 61%～90%, Luo Tong Determine and its pharmaceutically acceptable salt 10%～39%.
The various compositionss that the present invention provides, have the pharmacological action improving blood glucose, can be used as unique or main Active component and being applied to produces medicines, food and the health product of various prevention and treatment diabetes, or a kind of or many with other Kind has the chemical substance improving diabetes or medicine gives organism in the lump.These chemical substances are such as：But it is not limited only to fine grinding Ji extract, Radix Stephaniae Japonicae extract, silymarin and rotundine etc..Alleged " giving organism in the lump " refers to that the present invention is each Kind of compound has for one or more individually or with other after compound, extract or the medicament mixed improving diabetes through single Route of administration, such as：But it is not limited only to, (Oral), nasal cavity (Nasal), (face) cheek (Buccal), transdermal are administered orally (Transdermal), pulmonary (Pulmonal), vagina (Vaginal), subcutaneous (Subcutaneous) or vein (Intravenous) give organism；Or there is for one or more chemical substance or the medicine difference improving diabetes with other Give organism through multiple route of administration.
A kind of pharmaceutical composition that the present invention provides, with the compositionss of present invention offer as active component.
Another kind of food that the present invention provides, with the compositionss of present invention offer as active component.
Another kind of health product that the present invention provides, with the compositionss of present invention offer as active component.
The beneficial effect that technical solution of the present invention is realized：
The compositionss that the present invention provides, improve blood by compatible to Herba Silybi mariani and Radix Stephaniae Japonicae so that having after both compatibilities Sugar and the pharmacological action of glycolated hemoglobin, have the DEVELOPMENT PROSPECT of medicine.
The present invention provide compositionss, will be compatible to Herba Silybi mariani and Radix Stephaniae Japonicae extract so that having after both compatibilities Improve the pharmacological action of blood glucose and glycolated hemoglobin, there is the DEVELOPMENT PROSPECT of food, health product and medicine.
The compositionss that the present invention provides, with silymarin (especially silibinin) and its hydrate and rotundine and its medicine On, acceptable salt is active component, also shows the pharmacological action improving blood glucose and glycolated hemoglobin.
Specific embodiment
Technical scheme described in detail below.The embodiment of the present invention only in order to technical scheme to be described and Unrestricted, although being described in detail to the present invention with reference to preferred embodiment, it will be understood by those within the art that, The technical scheme of invention can be modified or equivalent, without deviating from the spirit and scope of technical solution of the present invention, It all should be covered in scope of the presently claimed invention.
If the reagent used by the present invention does not clearly indicate, it is purchased from Sigma-Aldrich (Sigma- Aldrich).
Embodiment 1 Herba Silybi mariani and Radix Stephaniae Japonicae are compatible
0.5 part～5 parts of Herba Silybi mariani and 0.2～3 part of mixing of Radix Stephaniae Japonicae, obtain test sample by way of powder processed or decocting 1.
The producing of embodiment 2 Herba Silybi mariani and Radix Stephaniae Japonicae extract
Take 0.5 part～5 parts of Herba Silybi mariani by weight, 0.2～3 part of Radix Stephaniae Japonicae, plus 80% alcohol reflux 2 times, the 1st Secondary ethanol is 10 times amount, 4 hours, and the 2nd ethanol is 8 times amount, 1 hour, and double gauze filters, and merges 2 filtrates, recovered under reduced pressure To no alcohol taste, when continuing to be evaporated to 55 DEG C, relative density is 1.30 to ethanol, obtains extract, is designated as test sample 2.
The producing of embodiment 3 Herba Silybi mariani and Radix Stephaniae Japonicae extract
Take 1～3 part of Herba Silybi mariani and 0.2～2 part of Radix Stephaniae Japonicae by weight, plus 80% alcohol reflux 2 times, the 1st time Ethanol is 10 times amount, 4 hours, and the 2nd ethanol is 8 times amount, 1 hour, and double gauze filters, and merges 2 filtrates, recovered under reduced pressure second To no alcohol taste, when continuing to be evaporated to 55 DEG C, relative density is 1.32 to alcohol, obtains extract, is designated as test sample 3.
The producing of embodiment 4 silymarin
Reference《When precious traditional Chinese medical science traditional Chinese medicines》Volume 23 the 3rd phase content of page 655 in 2012, produces silymarin.
This sample commodity can also be obtained, such as：Xi'an Jin Lv biotechnology company limited.
The producing of embodiment 5 silibinin
Reference《Inner Mongol Chinese medicine》The 2nd phase content of page 51 in 2009, produces silibinin monomeric compound, goes forward side by side Row Structural Identification, data is as follows：
HR-MS m/z：481.4361[M-H]-.
1H-NMR (600MHz, DMSO-d6)：11.88 (1H, s), 10.82 (1H, brs) .12 (1H, brs), 7.09 (1H, D, J=3.6Hz), 7.01 (1H, d, J=1.8Hz), 7.00 (1H, dd, J=3.6,7.8Hz), 6.97 (1H, d, J=7.8Hz), 6.87 (1H, dd, J=1.8,7.8Hz), 6.81 (1H, d, J=7.8Hz), 5.91 (1H, d, J=1.8Hz), 5.87 (1H, d, J =1.8Hz), 5.08 (1H, d, J=11.4Hz), 4.91 (1H, d, J=7.8Hz), 4.60 (1H, J=11.4Hz), 4.17 (1H, Ddd, J=3.0,4.2,7.8Hz), 3.78 (1H, s), 3.55 (1H, dd, J=4.2,12.0Hz), 3.35 (1H, dd, J=3.0, 12.0Hz).
13C-NMR (150MHz, DMSO-d6)：198.1,167.3,163.8,163.0,148.2,147.5,144.1, 143.7,130.6,128.0,121.7,121.0,117.1,116.8,115.9,112.3,101.0,96.6,95.5,83.0, 78.7,76.3,72.0,60.7,56.3.
This compound commodity can also be obtained, such as：Xi'an Jin Lv biotechnology company limited.
The producing of embodiment 6 rotundine
Reference《Guangxi Chemical Industry》The content of volume 25 the 2nd phase page 4 in 1996, produces rotundine monomeric compound, goes forward side by side Row Structural Identification, data is as follows：
HR-MS, m/z：356.1856[M+H]+.
1H-NMR (600MHz, CD3OD), δ：6.91 (d, 1H, J=8.4Hz), 6.87 (d, 1H, J=8.4Hz), 6.84 (s, 1H), 6.69 (s, 1H), 4.17 (d, 1H, J=15.6Hz), 3.81 (s, 9H), 3.78 (s, 3H), 3.48 (d, 1H, J= 11.4Hz), 3.46 (d, 1H, J=15.6Hz), 3.40 (dd, 1H, J=16.2,3.6Hz), 3.17 (dd, 1H, J=11.4, 3.6Hz), 3.07 (td, 1H, J=16.2), 2.66～3.04 (m, 2H), 2.59 (td, 1H, J=11.4,3.6Hz).
13C-NMR (150MHz, CD3OD)δ：151.7,149.2,149.1,146.2,130.6,128.9,128.6, 127.8,125.2,112.9,112.6,110.4,60.8,60.5,56.7,56.4,56.3,54.8,52.7,36.5,29.3.
This compound commodity can also be obtained, such as：Wuhan Xing Zhongcheng Science and Technology Ltd..
Embodiment 7 is with silymarin and rotundine for active component compatibility
By weight, by silymarin being obtained or buying and rotundine consumption：Silymarin 10%～90%, rotundine 10%～90% compatibility, and silymarin 51%～90%, rotundine 10%～49% compatibility, 2 group compositionss are obtained, are designated as Test sample 4 and test sample 5.
Embodiment 8 is with silibinin and rotundine for active component compatibility
By weight, by silibinin being obtained or buying and rotundine consumption：Silibinin 10%～90%, rotundine 10%～90% compatibility, and silibinin 51%～90%, rotundine 10%～49% compatibility, 2 group compositionss are obtained, are designated as Test sample 6 and test sample 7.
The impact to Spontaneous Diabetic GK rat blood sugar for the embodiment 9
Take 64 GK male rats of glucostasis value ＞ 9.0mmol/L, be randomly divided into 8 groups, every group 8, respectively mould Type matched group, the pharmaceutical composition group of the present invention of test sample 1～test sample 7, are separately normally right with 8 with week old Wistar rat According to group.Gastric infusion.
Using Johnson ＆ Johnson's surely bold and unconstrained type blood glucose meter, cut tail measuring blood sugar of blood extracting.Measure during the random blood sugar morning 9～10；Fasting blood Sugar is fasting 6 hours blood glucose (measuring during fasting afternoon 3 during the morning 9).
Cut tail before off-test and take blood, glycolated hemoglobin (HbA1c) is measured using Bio-Rad company HbA1c analyzer.
Result is referring to table 1, table 2 and table 3.
The impact to GK rat fasting blood-glucose for table 1 present composition
In table 1, * p ＜ 0.05, * * p ＜ 0.01 is compared with model control group.
Table 1 is visible, and each test sample of each compositions of the present invention is respectively provided with reduction GK rat fasting blood-glucose (p ＜ 0.05, p ＜ 0.01), and effect is significant, the drug effect of monomeric compound combination is better than medical material and combines.
The impact to GK rat random blood sugar for table 2 present composition
In table 2, * p ＜ 0.05, * * p ＜ 0.01 is compared with model control group.
Table 2 is visible, and each test sample of each compositions of the present invention all can significantly reduce GK rat random blood sugar (p ＜ 0.05, p ＜ 0.01), and effect is significant, the drug effect of monomeric compound combination is better than medical material combination.
The impact to GK rat glycolated hemoglobin (HbA1c) for table 3 present composition
In table 3, * p ＜ 0.05, * * p ＜ 0.01 is compared with model (comparison) group.
Table 3 is visible, and compared with model group, after each compositions of the present invention are administered 4 weeks, glycolated hemoglobin (HbA1c) declines Significantly (p ＜ 0.05, p ＜ 0.01), prompting each compositions of the present invention can effectively reduce the long term hyperglycemia state of GK rat.

Claims (9)

1. a kind of compositionss are it is characterised in that take 0.5 part～5 parts of Herba Silybi mariani, 0.2～3 part of Radix Stephaniae Japonicae, plus 50v/ by weight V%～80v/v% alcohol reflux 2 times, wherein, is for the 1st time 10 times amount 50v/v%～80v/v% ethanol, 1～4 hour, It is for 2nd time 8 times amount 50v/v%～80v/v% ethanol, 1～4 hour, after filtration, merge 2 filtrates, decompression recycling ethanol is to no Alcohol taste, when continuing to be evaporated to 50 DEG C ± 5 DEG C, relative density is 1.20～1.34, obtains final product.
2. a kind of compositionss are it is characterised in that take 1～3 part of Herba Silybi mariani by weight, 0.2～2 part of Radix Stephaniae Japonicae, plus 50v/v% ～80v/v% alcohol reflux 2 times, wherein, is for the 1st time 10 times amount 50v/v%～80v/v% ethanol, 1～4 hour, the 2nd Secondary is 8 times amount 50v/v%～80v/v% ethanol, 1～4 hour, after filtration, merges 2 filtrates, decompression recycling ethanol is to no alcohol Taste, when continuing to be evaporated to 50 DEG C ± 3 DEG C, relative density is 1.20～1.34, obtains final product.
3. a kind of compositionss are it is characterised in that take 1～3 part of Herba Silybi mariani by weight, 0.5～1 part of Radix Stephaniae Japonicae, plus 50v/v% ～80v/v% alcohol reflux 2 times, wherein, is for the 1st time 10 times amount 50v/v%～80v/v% ethanol, 1～4 hour, the 2nd Secondary is 8 times amount 50v/v%～80v/v% ethanol, 1～4 hour, after filtration, merges 2 filtrates, decompression recycling ethanol is to no alcohol Taste, when continuing to be evaporated to 50 DEG C ± 3 DEG C, relative density is 1.20～1.34, obtains final product.
4. compositionss according to claims 1 to 3 are in medicine, food or the health product that preparation prevents and treats diabetes Application.
5. compositionss according to claims 1 to 3 are in medicine, food or the health product that preparation improves glycolated hemoglobin Application.
6. a kind of compositionss for preventing and treating diabetes, are become with the compositionss described in one of claims 1 to 3 for activity Point.
7. the compositionss for preventing and treating diabetes according to claim 6 are it is characterised in that described compositionss For medicine.
8. the compositionss for preventing and treating diabetes according to claim 6 are it is characterised in that described compositionss For food.
9. the compositionss for preventing and treating diabetes according to claim 6 are it is characterised in that described compositionss For health product.
CN201611164160.5A 2016-12-16 2016-12-16 Combination of two kinds of plant amedica and application thereof Pending CN106474194A (en)

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Application publication date: 20170308