CN102824423A - Medicinal composition comprising albiflorin and arctiin and application - Google Patents

Medicinal composition comprising albiflorin and arctiin and application Download PDF

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CN102824423A
CN102824423A CN2012103447018A CN201210344701A CN102824423A CN 102824423 A CN102824423 A CN 102824423A CN 2012103447018 A CN2012103447018 A CN 2012103447018A CN 201210344701 A CN201210344701 A CN 201210344701A CN 102824423 A CN102824423 A CN 102824423A
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radix paeoniae
arctiin
paeoniae alba
glycosides
pharmaceutical composition
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CN102824423B (en
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王学政
鲁俞江
尤斌
林爱弟
陈旦凤
陈胜胜
杨海玲
孙卓亚
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NINGBO LIWAH PHARMACEUTICAL CO Ltd
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NINGBO LIWAH PHARMACEUTICAL CO Ltd
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Abstract

The invention discloses a medicinal composition comprising albiflorin and arctiin, wherein the weight ratio of the albiflorin to the arctiin is (0.05 to 0.5):1. The medicinal composition disclosed by the invention can be used for synergically treating the diabetes mellitus by oral administration, particularly can enable diabetics to be recovered and gets rid of the defect that the diabetics need to take medicine for life in the treating process.

Description

A kind of pharmaceutical composition and application that contains Radix Paeoniae Alba glycosides and Arctiin
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of pharmaceutical composition and application that contains Radix Paeoniae Alba total glucosides and Arctiin, the particularly a kind of pharmaceutical composition that contains Radix Paeoniae Alba total glucosides and Arctiin and application that can make the diabetics recovery from illness.
Background technology
The onset diabetes rate is still increasing year by year.According to data, diabetes have become the global the fifth-largest cause of the death, are considered to be only second to the noninfectious of cardiovascular and cerebrovascular disease and malignant tumor.Global diabetic population in 2005 is dilatation to 2.2 hundred million people, and the diabetics of China is no less than 4,000 ten thousand at present, and many patients exist the risk of impaired glucose tolerance disease.Comprise China in developing country, adult's prevalence is higher, and middle age has become the high-risk group of this disease, and begins to the development that becomes younger.It is fast especially to it should be noted that diabetes prevalence gathers way in developing country, especially in those developing countries from richening thoroughly.Diabetes are not an affluenza, and the area in economy and living standard generation drastic change exists the danger of diabetes eruption and prevalence realistically.China's diabetes are in explosive popular.Diabetic complication is perplexing patient and medical matters circle: the probability that diabetes can not get the concurrent nephropathy of suitable control, retinopathy, peripheral nervous pathological changes, heart change is very high, has a strong impact on quality of life.The direct medical treatment cost that China is used for diabetes every year surpasses 18,000,000,000, accounts for 4% of medical total cost.Although patient's quantity is so many; But lower diagnosis; The chronic course of disease of disease, to the needs of therapeutic alliance, the relatively poor patient's compliance that lacks the oral drugs of effective long-term treatment diabetes and be associated with injection for curing; All meaning at present still has many demands not to be met in this field.Medical in recent years worker has carried out the work of a large amount of relevant diabetes medicament research and development, has solved some problems in the treating diabetes, has also changed this treatment of diseases pattern simultaneously potentially.
The depletion of beta Cell of islet function is the major reason of onset diabetes; It is the basic reason that diabetics needs lifelong treatment that islet cell function can not effectively be recovered; And the oral hypoglycemic drug therapy that now the type ii diabetes patient is generally adopted; Its state of an illness of most patient all is to proceed to gradually to use heavy dose of insulin just can control blood glucose well; That is to say that existing orally-taken blood sugar reducing medicine is not well cured diabetes, do not produce active influence for the long-term prognosis of diabetics.
At present, insulin treatment is a most effectively blood sugar lowering therapy known, that generally acknowledge, but this therapy is but effectively used.A lot of type ii diabetes patients have produced fear to insulin, rather than regard it as and can help the optimal a kind of effective therapy of their blood sugar control.And to use insulin when the diabetes early treatment be that a kind of view of threat has been strengthened to this fear by some doctors think.In fact insulin be blood sugar control the most effectively, conform with the method for rule most, and be reluctant to use or be reluctant intensive insulin therapy usually be since insulin form of medication---the mode of drug administration by injection is caused.Therefore for the treatment of diabetics,, can improve the compliance of patient's medication greatly like this with the form of oral administration, administration very easily, the function of recovery diabetics islet cells prevents that the sexual exhaustion that carries out of islet cells from being of paramount importance.
In in the past more than 40 year; More than 100 kind of hyperglycemia medicine developed in the whole world; Wherein there is 30% kind to be active on the China market at present; These kinds mainly are made up of for two big types OHA and insulin, if medicine mainly contains seven big verieties such as insulin, insulin analog, sulfonylurea, biguanides, alpha-glucosidase inhibitor, thiazolidine diketone derivative, amino acid derivativges by mechanism of action classification.Although OHA is of a great variety on the market, up to now, also there is not which kind of medicine can make the diabetics recovery from illness.
(total glucosides of paeonia is the effective site of extracting in China's Chinese medicine Radix Paeoniae Alba root TGP) to Radix Paeoniae Alba total glucosides, and its pharmacological action mainly contains antiinflammatory, antioxidation and immunoregulatory activity.TGP has been used for treating rheumatoid arthritis, immunological liver infringement, systemic lupus erythematosus (sle) and mesentery hyperplastic nephritis, determined curative effect, no obvious toxic-side effects in clinical and zoopery.People such as Yuan Liang (" Radix Paeoniae Alba total glucosides is to effect of diabetes rat kidney protection and part mechanism "; Chinese Pharmacological 2007 6 phases of circular) use streptozotocin and induce the rat diabetes model; Simultaneously irritate stomach every day and give TGP, TGP is relevant to ICAM-1 in diabetes rat kidney protection mechanism of action part and its inhibition nephridial tissue and TGF β 1 protein expression as a result.Fructus Arctii (Fructus arctii) is the dry mature fruit of Compositae (Compositae) Arctium (Arctium) plant Fructus Arctii Arctium lappa L., and " Chinese pharmacopoeia is recorded in order to go through version.The Fructus Arctii acrid in the mouth is bitter, cold in nature, returns lung stomach two warps, has effects such as dispelling wind and heat pathogens, detoxifcation rash, relieving sore throat and diminishing swelling; Be mainly used in treatment affection due to external wind and heat, cough with copious phlegm, laryngopharynx swelling and pain, fever and cough, measles initial stage, rash go out not smooth, and the wind heat rash is itched; Hot carbuncle toxin, mumps erysipelas, laryngopharynx swelling and pain etc.Modern pharmacology research proof, there is the effect of remarkable and persistent reduction rat blood sugar in Fructus Arctii extract; In the blood sugar lowering prescription, add Fructus Arctii, can strengthen hypoglycemic activity significantly.
At present, prior art is not also united the bibliographical information that is used for treating diabetes with Radix Paeoniae Alba total glucosides and Arctiin.
Summary of the invention
In view of the deficiency of prior art, the object of the present invention is to provide a kind of with Radix Paeoniae Alba total glucosides and Arctiin concertedness treatment diabetes, and the pharmaceutical composition that diabetics is fully recovered.
The objective of the invention is to realize like this:
A kind of pharmaceutical composition that contains Radix Paeoniae Alba total glucosides and Arctiin, the weight ratio of Radix Paeoniae Alba total glucosides and Arctiin are 0.05-0.5:1.
Preferably, the said pharmaceutical composition that contains Radix Paeoniae Alba total glucosides and Arctiin, active component is made up of Radix Paeoniae Alba total glucosides and Arctiin, and the weight ratio of Radix Paeoniae Alba total glucosides and Arctiin is 0.05-0.5:1.
Further preferably, the said pharmaceutical composition that contains Radix Paeoniae Alba total glucosides and Arctiin, the weight ratio of Radix Paeoniae Alba total glucosides and Arctiin is 0.1-0.3:1.
The total glycosides that Radix Paeoniae Alba total glucosides of the present invention extracts from Radix Paeoniae Alba decoction pieces; Adopt biochemical the extraction; From Radix Paeoniae Alba dry root, obtain peoniflorin (paeoniflorin), Hydroxy peoniflorin (hydroxy-paeoniflorin), peonin (paeonin), lactone glucoside of Radix Paeoniae (albiflorin), benzoylpaeoniflorin (benzoylpaeoniflorin) etc. and have the physiological function mixture of ingredients; The general name Radix Paeoniae Alba total glucosides (total glucosides of paeonia, TGP).
Described Radix Paeoniae Alba total glucosides can be prepared from as follows: get the clean and exsiccant Radix Paeoniae Alba, pulverize, add in 60%-80% (v/v) ethanol of 8-12 times of weight; 65-75 ℃ of insulation extracted 1-3 time; Each 2-4h, merge extractive liquid, filters; Filtrating is through decompression and solvent recovery, and vacuum concentration becomes Radix Paeoniae Alba crude extract; Dissolve in 60%-80% (v/v) ethanol with 18-25 times of weight of gained Radix Paeoniae Alba crude extract adding, regulate pH=5.5-6.5, adopt the HPD-300 macroporous adsorbent resin of polystyrene skeleton that solution is adsorbed with sodium hydroxide solution; Be adsorbed to saturated after, first water suck up impurity is to the Molish reaction negative, 60%-80% (v/v) ethanol of reuse 8-13 times amount of resin; With 1-5 times of amount of resin/hour the flow velocity eluting, reclaim eluent, concentrate; Drying gets Radix Paeoniae Alba total glucosides.Press dry product and calculate peoniflorin (C 23H 28O 11) content is up to 65%-75%.
Arctiin of the present invention (arctiin) is extraction separation and the Lignanoids compounds that comes from the dry mature fruit Fructus Arctii of Fructus Arctii, 110~112 ℃ of fusing points, optical rotation-51.5 ° (c=2.0, ethanol).
Described Arctiin is prepared from as follows: get clean and exsiccant Fructus Arctii, pulverize, add the water logging bubble 8h of 1.5 times of medical material weight, extracting in water is 1-3 time then; Each amount of water is 10 times of medical material weight, and extraction time is 1h, merge extractive liquid; Concentrate, drying gets Arctiin.Press dry product and calculate Arctiin (C 27H 34O 11) content reaches more than 95%.
Find that according to animal experiment pharmaceutical composition oral administration of the present invention administration can be treated diabetes, especially can make the diabetics recovery from illness, the shortcoming that must take medicine all the life when breaking away from diabetic therapy.Therefore second purpose of the present invention is to provide a kind of new medicine use, the promptly above-mentioned application of pharmaceutical composition in the hypoglycemic medicine of preparation treatment that contains Radix Paeoniae Alba total glucosides and Arctiin.
According to the physicochemical properties of Radix Paeoniae Alba total glucosides and Arctiin, can process solid orally ingestible through the conventional formulation technology, comprise ordinary tablet, capsule etc.
Compared with prior art, the pharmaceutical composition that contains Radix Paeoniae Alba total glucosides and Arctiin that the present invention relates to has following advantage and obvious improvement:
(1) Radix Paeoniae Alba total glucosides and Arctiin concertedness treatment diabetes can make diabetics fully recover, and break away from the shortcoming that prior art must be taken medicine to treating diabetes all the life.We find that through experiment though Radix Paeoniae Alba total glucosides and Arctiin drug combination behind long-term oral administration, have very reduced the blood glucose of diabetes rat significantly, blood sugar lowering is steady in the whole administration cycle, not bounce-back.On the contrary; The second filial generation sulfonylurea hypoglycemic agent thing that the promoted insulin that is using clinically now discharges (like glipizide, gliclazide, than lattice row ketone, gliquidone etc.) is though can temporarily reduce the blood glucose of rat after medication; But but not only can not blood sugar lowering after long term administration; The trend that the rising rat blood sugar is arranged on the contrary, this disease progression process of diabetics clinically of also exactly having coincide now, a lot of diabeticss is after taking sulfonylurea hypoglycemic agent for a long time; The difficulty of glycemic control is increasing, must answer insulinize at last.
Find through the cell pharmacological testing that (2) Radix Paeoniae Alba total glucosides and Arctiin drug combination can the utmost point promote the division growth of islet cells significantly, the vigor of increase islet cells prevents the depletion of islet cell function.These show that all drug combination, low molecule drug combination officinal salt or derivatives thereof have good prospect aspect the diabetes long-term treatment.
Specific embodiment
Below be specific embodiment of the present invention, technical scheme of the present invention is done further the description, but protection scope of the present invention is not limited to these embodiment.Every do not deviate from the change of the present invention design or be equal to substitute include within protection scope of the present invention.
Radix Paeoniae Alba total glucosides of the present invention is measured according to HPLC (two appendix V of Chinese Pharmacopoeia version in 2010 D).Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filler; Phosphate buffer [0.05mol/L dipotassium hydrogen phosphate liquid-0.05mol/L potassium dihydrogen phosphate solution (80:20), pH value is 7.4]-methanol (65:35) is mobile phase; The detection wavelength is 230nm.Number of theoretical plate calculates by the peoniflorin peak should be not less than 1500, and the separating degree of peoniflorin peak and adjacent peak should meet the requirements.Algoscopy: get the about 20mg of these article, the accurate title, decide, and puts in the 10ml measuring bottle, adds 50% dissolve with methanol and be diluted to scale, shakes up, and precision is measured 20 μ l, injects chromatograph of liquid, the record chromatogram; It is an amount of that other gets the peoniflorin reference substance, adds the also quantitative dilution of 50% dissolve with methanol and process the solution that contains 1mg among every 1ml, measures with method,, promptly gets with calculated by peak area by external standard method.
The following method of Arctiin case of the present invention is measured content:
Chromatographic condition: Waters 2695 type high performance liquid chromatographs (Waters2996 UV-detector), chromatographic column is Thermo C 18Post (4.6mm * 250mm, 5 μ m), mobile phase is acetonitrile one water (25:75), and flow velocity is 1.0ml/min, and the detection wavelength is 280nm.Under this chromatographic condition, can separate Arctiin preferably, other compositions are noiseless to measuring.Algoscopy: get the about 0.5g of these article powder, accurate claim surely, put in the 50ml volumetric flask, add the about 45ml of methanol, supersound process 20min is put coldly, adds methanol to scale, shakes up, and precision is measured 10 μ l, injects chromatograph of liquid, writes down chromatogram; It is an amount of that other gets the Arctiin reference substance, adds the also quantitative dilution of dissolve with methanol and process the solution that contains 1mg among every 1ml, measures with method,, promptly gets with calculated by peak area by external standard method.
 
The extraction purification of embodiment 1 Radix Paeoniae Alba total glucosides
Get the clean and exsiccant Radix Paeoniae Alba, pulverize, add in 70% (v/v) ethanol of 10 times of weight, 65-75 ℃ of insulation extracted 3 times, each 3h, and merge extractive liquid, filters, and filtrating is through decompression and solvent recovery, and vacuum concentration becomes Radix Paeoniae Alba crude extract; Dissolve in 70% (v/v) ethanol with 20 times of weight of gained Radix Paeoniae Alba crude extract adding, regulate pH=6, adopt the HPD-300 macroporous adsorbent resin of polystyrene skeleton that solution is adsorbed with sodium hydroxide solution; Be adsorbed to saturated after, first water suck up impurity is to the Molish reaction negative, 70% (v/v) ethanol of 10 times of amount of resin of reuse; With 3 times of amount of resin/hour the flow velocity eluting, reclaim eluent, concentrate; Drying gets fallow powder Radix Paeoniae Alba total glucosides.Press dry product and calculate peoniflorin (C 23H 28O 11) content is up to 72.2%.
 
The preparation of embodiment 2 Arctiin
Get clean and exsiccant Fructus Arctii, pulverize, add the water logging bubble 8h of 1.5 times of medical material weight, extracting in water is 3 times then, and each amount of water is 10 times of medical material weight, and extraction time is 1h, and merge extractive liquid, concentrates, and drying gets colourless crystallization property powder Arctiin.Press dry product and calculate Arctiin (C 27H 34O 11) content reaches more than 95%.
 
Embodiment 3 Radix Paeoniae Alba total glucosidess associating Arctiin is to the influence of islet cells vigor
Take out to give birth to 1~3 d SD rat, routine disinfection cuts open the belly that it is wild to expose art, and aseptic taking-up pancreas is removed the outer nethike embrane of pancreas, fatty tissue after 4 ℃ of Hanks liquid rinsing 2 ~ 3 times.With eye scissors pancreas is cut into 0.5mm 3Size is organized fragment, after the Hanks liquid rinsing 3 times, adds 5 times of volume 3g/L collagen type v enzymes (pH 7.4) mixing, vibration digestion 6~8 min in 37 ℃ of water-baths.During to the Digestive system muddiness, draw the upper strata after the natural sedimentation and digest turbid liquid, stop digestion with 4 ℃ of Hanks liquid.Residue not digestion tissue is added Digestive system continuation digestion.Press aforesaid operations and repeat 4-5 time, digest basically until pancreatic tissue and finish.Collect the centrifugal 5-7 min of each time turbid liquid 1000 r/min of digestion, sedimentation cell is inoculated in the T75 bottle of the PRMI1640 culture fluid that includes 15% hyclone, and cell moves to 37 ℃, 5%CO 2The CO of the complete humidifying of 95% air 2Cultivate in the incubator.Observation of cell growth conditions during cell culture 18 h.Bright when cell, refractivity strong, when the culture fluid color shoals, the indicator cells well-grown.
The cell of 96 well culture plates is divided into vehicle group, Radix Paeoniae Alba total glucosides group, Arctiin group, drug combination group.According to the cell attachment speed difference, cell is blown down at the bottom of bottle gently, low-speed centrifugal, sedimentation cell adds new culture fluid, with 2 * 10 4Individual/ml is inoculated in 96 well culture plates (every hole 200 μ L); Add the culture medium culturing 24h that does not contain hyclone behind the 2d; Change culture fluid then; Every group except containing the PRMI1640 culture fluid of 16.7mmol/L glucose, 15% hyclone, contains other medicines in addition respectively as follows: vehicle group: do not add any medicine; Radix Paeoniae Alba total glucosides group: 4mg/L Radix Paeoniae Alba total glucosides; Arctiin group: 15mg/L Arctiin; Drug combination group: 4mg/L Radix Paeoniae Alba total glucosides+15mg/L Arctiin.
Every 2d changes liquid 1 time (culture fluid divides preparation respectively by above-mentioned each composition), detects insulin secretion level in the original fluid with radioimmunology when changing liquid at every turn.
Result of the test: concrete result of the test numerical value is seen table 1.
Can be found out that by table 1 in the whole incubation of islet cells, the drug combination group is compared with vehicle group, at preceding 2 days of the islet cells cultivation, the vigor of cell uelralante was as broad as long.But along with the prolongation of time, the drug combination group compare with vehicle group and have significant difference ( P<0.05 or P<0.01); After cultivate at islet cells 6 days, the drug combination group compare with Arctiin group or Radix Paeoniae Alba total glucosides group and also have significant difference ( P<0.05 or P<0.01).As time goes on this explanation, the islet cells vigor of vehicle group and single medicine group and the function of uelralante descending, possibly be the depletion that function has appearred in islet cells; The cell of drug combination group does not resemble the cell of vehicle group or single medicine group the decline that occurs cell viability along with the prolongation of incubation time, but is keeping well cell viability in the incubation at 10 days always.This results suggest we, Arctiin and Radix Paeoniae Alba total glucosides drug combination after the life-time service, for the depletion that prevents patient's islet cell function, effectively protect the function of patient's islet cells and vigor that good effect will be arranged clinically.This result is also indicating simultaneously, takes the medicine that contains Arctiin group and Radix Paeoniae Alba total glucosides for a long time, and diabetics is well fully recovered.
Each group of table 1 is tried the influence (μ IU/mL) of thing to the insulin secretion level of islet cells
Group 2d 4d 6d 10d
Vehicle group 115.0±14.9 101.9±15.1 90.8±14.6 74.3±12.2
The Radix Paeoniae Alba total glucosides group 111.7±12.6 103.4±11.5 82.6±12.3 65.7±9.5
The Arctiin group 118.2±12.1 111.5±13.8 93.4±13.6 88.4±10.0 *
The drug combination group 114.5±13.0 119.3±14.5 *¥ ? 121.0±17.8 **¥¥$ 113.3±15.6 **¥¥$$
Compare with vehicle group, * P<0.05; Compare with vehicle group, * P<0.01;
Compare with the Radix Paeoniae Alba total glucosides group, $ P<0.05; Compare with the Radix Paeoniae Alba total glucosides group, $$ P<0.01;
Compare with the Arctiin group, $ P<0.05; Compare with the Arctiin group, $$ P<0.01.
 
Embodiment 4 Radix Paeoniae Alba total glucosidess associating Arctiin is to the influence of diabetes rat model
65 of SD rats are taken out 5 rats at random as contrast, behind all the other 60 rat fasting 12h, and tail vein injection alloxan 60mg/kg, behind the 72h, fasting 5h surveys blood glucose, picks out not winner of modeling.
Modeling success rat is divided into model group at random according to blood sugar level, Radix Paeoniae Alba total glucosides group, Arctiin group, drug combination group, low molecule drug combination calcium group, 12 every group.Gastric infusion is following respectively for each group: model group: the normal saline Radix Paeoniae Alba total glucosides rat of equal volume; Radix Paeoniae Alba total glucosides group: 50mg/kg/d Radix Paeoniae Alba total glucosides; Arctiin group: 200mg/ (kg.d) Arctiin; Drug combination group: 50mg/kg/d Radix Paeoniae Alba total glucosides+200mg/ (kg.d) Arctiin.
After modeling success rat random packet, according to dosage gastric infusion in continuous 10 weeks, is normally raised.All rats respectively at administration after 4 weeks, 6 weeks, 8 weeks, get tail vein 10 weeks and detect fasting glucose (FBG).
Experimental result: can find out that by table 2 the Radix Paeoniae Alba total glucosides group is not obvious to the blood sugar level influence of diabetes rat.The Arctiin group has effectively been improved carbohydrate tolerance after the short-term administration, but but after long term administration, does not only have significant blood sugar lowering, and the trend of rising blood glucose is arranged on the contrary.And the drug combination group is compared with model group, Radix Paeoniae Alba total glucosides group, Arctiin group, and administration has shown utmost point significant difference after 16 weeks.This shows that Radix Paeoniae Alba total glucosides and Arctiin drug combination behind long-term oral administration, have very reduced the blood glucose of diabetes rat significantly, and blood sugar lowering is steady in the whole administration cycle, not bounce-back.From healing in the long term prospect of diabetics, pharmaceutical composition of the present invention is the blood sugar lowering level steadily, is superior to Western medicine such as euglycemic agent.
Each group of table 2 is tried the influence (mmol/L) of thing to the diabetes rat fasting glucose
Group 1 week 2 weeks 4 weeks 8 weeks 16 weeks
Model group 28.7±4.4 27.7±4.2 25.6±4.8 22.8±4.3 23.3±3.5
The Radix Paeoniae Alba total glucosides group 27.9±5.3 26.2±4.5 22.1±5.1 23.4±4.1 23.0±3.4
The Arctiin group 24.3±4.7 20.6±3.8 21.0±2.8 19.6±3.2 24.7±3.0
The drug combination group 25.7±3.5 25.3±3.3 21.2±3.1 18.3±2.9 * 11.2±2.3 **##&&
Compare with model group, * P<0.05; Compare with model group, * P<0.01;
Compare with the Radix Paeoniae Alba total glucosides group, $ P<0.05; Compare with the Radix Paeoniae Alba total glucosides group, $$ P<0.01;
Compare with the Arctiin group, $ P<0.05; Compare with the Arctiin group, $$ P<0.01.
Diabetics is in the Drug therapy process, and the control of its blood glucose target is unsatisfactory, and diabetes still need lifelong administration and progressive developing into must make insulinize, and are the process of the continuous depletion of islet cells in this process.So present treatment theory is not have under other medicine prerequisite that can make the diabetes recovery from illness; The weaken boundary of 1 type, type ii diabetes therapeutic modality is used insulin as early as possible, recovers the function of islet cells as early as possible; To alleviate the burden of diabetics islet cells; So more help the rehabilitation of diabetics, foundation of the present invention is exactly the progress immediately following this treatment theory, actively seeks the new drug that prevents that islet cell function is depleted.
The present invention is immediately following the progress of this treatment theory of diabetes; The pathogeny that combines diabetes again; Find that through repetition test the long-term oral pharmaceutical composition that contains Radix Paeoniae Alba total glucosides and Arctiin is favourable until the recovery ten minutes of the diabetes state of an illness to the glycemic control of rat diabetes model.Rat diabetes model due to the alloxan has a process of slowly recovering, and in experimentation, finds, Radix Paeoniae Alba total glucosides associating Arctiin has very quickened this recovery process significantly.

Claims (6)

1. pharmaceutical composition that contains Radix Paeoniae Alba glycosides and Arctiin, it is characterized in that: the weight ratio of Radix Paeoniae Alba glycosides and Arctiin is 0.05-0.5:1.
2. according to the said pharmaceutical composition that contains Radix Paeoniae Alba glycosides and Arctiin of claim 1, it is characterized in that: active component is made up of Radix Paeoniae Alba glycosides and Arctiin.
3. according to the said pharmaceutical composition that contains Radix Paeoniae Alba glycosides and Arctiin of claim 2, it is characterized in that: the weight ratio of Radix Paeoniae Alba glycosides and Arctiin is 0.1-0.3:1.
4. according to each said pharmaceutical composition that contains Radix Paeoniae Alba glycosides and Arctiin of claim 1-3, it is characterized in that: Radix Paeoniae Alba glycosides is prepared from as follows: get the clean and exsiccant Radix Paeoniae Alba, pulverize; Add in 60%-80% (v/v) ethanol of 8-12 times of weight, 65-75 ℃ of insulation extracted 1-3 time, each 2-4h; Merge extractive liquid; Filter, filtrating is through decompression and solvent recovery, and vacuum concentration becomes Radix Paeoniae Alba crude extract; Dissolve in 60%-80% (v/v) ethanol with 18-25 times of weight of gained Radix Paeoniae Alba crude extract adding, regulate pH=5.5-6.5, adopt the HPD-300 macroporous adsorbent resin of polystyrene skeleton that solution is adsorbed with sodium hydroxide solution; Be adsorbed to saturated after, first water suck up impurity is to the Molish reaction negative, 60%-80% (v/v) ethanol of reuse 8-13 times amount of resin; With 1-5 times of amount of resin/hour the flow velocity eluting, reclaim eluent, concentrate; Drying gets Radix Paeoniae Alba glycosides.
5. according to each said pharmaceutical composition that contains Radix Paeoniae Alba glycosides and Arctiin of claim 1-3, it is characterized in that: Arctiin is prepared from as follows: get clean and exsiccant Fructus Arctii, pulverize; Add the water logging bubble 8h of 1.5 times of medical material weight, extracting in water is 1-3 time then, and each amount of water is 10 times of medical material weight; Extraction time is 1h, and merge extractive liquid, concentrates; Drying gets Arctiin.
6. the said application of pharmaceutical composition in the hypoglycemic medicine of preparation treatment that contains Radix Paeoniae Alba glycosides and Arctiin of claim 1.
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WO2020020342A1 (en) * 2018-07-26 2020-01-30 张作光 Use of total glucosides of paeonia for preventing or treating diabetes

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