CN103211859A - Pharmaceutical composition with hypoglycemic effect as well as preparation method and use of pharmaceutical composition - Google Patents
Pharmaceutical composition with hypoglycemic effect as well as preparation method and use of pharmaceutical composition Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition with a hypoglycemic effect as well as a preparation method and application of the pharmaceutical composition. The active ingredients of the pharmaceutical composition are prepared from the following raw materials in percentage by weight: 30%-50% of astragalus mongholicus extract, 20%-40% of kudzu vine root extract, 10%-30% of gymnema sylvestre extract and 5%-15% of siraidia grosvenorii extract, wherein in term of astragalus polysaccharide, the weight content of the astragalus mongholicus extract is 5%-25%; in term of kudzu root flavanone, the weight content of the kudzu vine root extract is 35%-60%; in term of gymnemic acid, the weight content of the gymnema sylvestre extract is 20-40%; and in term of siraidia grosvenorii total glycoside, the weight content of the siraidia grosvenorii is 70%-90%. Compared with the prior art, the pharmaceutical composition disclosed by the invention has a good hypoglycemic effect due to the synergistic effects of all the active ingredients including the astragalus mongholicus extract, the kudzu vine root extract, the gymnema sylvestre extract and the siraidia grosvenorii extract of the special active ingredient content.
Description
Technical field
The present invention relates to technical field of Chinese medicines, be specifically related to a kind of pharmaceutical composition and its production and use with hypoglycemic activity.
Background technology
Diabetes are a kind of common endocrine and metabolic disorders diseases, behind, the receptor insensitive by islet secretion insufficient insulin or receptor in target cell in the cell defective cause insulin not play a role, cause that carbohydrate metabolism disturbance blood glucose is too high, glucose in urine is positive, and then cause a series of metabolism disorders such as fat, protein, Water-Electrolyte, make the disease of degradation serious harm health under the immunity of organisms.
Big with respect to the Western medicine side effect, be prone to chemical sproof deficiency, the treatment by Chinese herbs diabetes are less because of side effect, and can reach certain blood sugar lowering control sugar effect, and selected by more diabetics.The Chinese medicine of present available treatment diabetes is a lot, as publication number is the patent of invention of CN101336965, a kind of Chinese patent medicine that is used to improve carbohydrate tolerance, blood sugar lowering is disclosed, the present invention of this Chinese patent medicine utilizes Fructus Phyllanthi to cooperate with the Radix Astragali, Radix Puerariae, Folium Mori, QI invigorating, consolidate the effect that reaches adjusting, blood sugar lowering, blood fat, improves the blood flow function, and play the effect that prevents to a certain extent and treat complication, for example prevent and prevent vascular lesion.And for example publication number is the patent of invention of CN101879278A, a kind of pharmaceutical composition that is formed through processing and preparing by crude drug Herb Gynostemmae Pentaphylli, the Radix Astragali, Radix Puerariae, Rhizoma Polygonati Odorati, Fructus Crataegi and Semen Trigonellae is disclosed, pharmacodynamic experiment shows that this pharmaceutical composition is to having hypoglycemic activity preferably.But have not yet to see the relevant report that effective ingredient is treated the Chinese medicine of diabetes that is combined as with Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and Fructus Momordicae extract.
Summary of the invention
The technical problem to be solved in the present invention provide a kind of with Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and Fructus Momordicae extract be combined as active component and hypoglycemic effect has pharmaceutical composition of hypoglycemic activity and its production and use preferably.
Pharmaceutical composition with hypoglycemic activity of the present invention, this active ingredient in pharmaceutical is to be made by following weight percentages:
Radix Astragali extract 30～50%, Radix Puerariae extract 20～40%, Gymnema P.E 10～30%, Fructus Momordicae extract 5～15%;
Wherein, Radix Astragali extract is in astragalus polysaccharides, and its weight content is 5～25%; Radix Puerariae extract is in Radix Puerariae total flavones, and its weight content is 35～60%; Gymnema P.E is in Gymnemic Acids, and its weight content is 20～40%; Fructus Momordicae extract is in the Fructus Momordicae general glycoside, and its weight content is 70～90%.
The extraction source of said extracted thing is the Radix Astragali, Radix Puerariae, Radix Gymnematis Sylvestris and Fructus Momordicae.Wherein, the Radix Astragali is the dry root of leguminous plant Radix Astagali Astragalus membranaceus (Fisch.) Bge.Var.mongholicus (Bge) Hsiao or pod membrane Radix Astragali Astragalus membranaceus (Fisch.) Bge..The Radix Astragali is sweet in flavor and warm in property, returns lung, spleen channel; Invigorating QI to consolidate the body surface resistance is arranged, expelling pus and toxin by strengthening QI, expelling pus and promoting granulation, inducing diuresis to remove edema effect.Radix Puerariae is the dry root of legume pueraria lobata Pueraria lobata (Willd.) Ohwi or Radix Puerariae rattan Pueraria thomsonii Benth.Radix Puerariae is sweet, hot, cold; Return spleen, stomach warp; Expelling pathogenic factors from muscles for reducing heat is arranged, rash, promoting the production of body fluid to quench thirst, yang invigorating anti-diarrhea effect.Radix Gymnematis Sylvestris is the root or the browse of dicotyledon medicine asclepiadaceae plant Largeleaf Gymnema.Radix Gymnematis Sylvestris is flat, bitter; GUIXIN, liver, spleen channel; Clearing away heat and cooling blood is arranged, evacuation of pus detumescence, pain relieving promoting muscle growth functions.Fructus Momordicae is the dry fruit of cucurbitaceous plant Fructus Momordicae Siraitia grosvenorii (Swingle) C.Jeffrey ex Lu et Z.Y.Zhang.The Fructus Momordicae nature and flavor are sweet cool in nature, return lung, spleen channel, and removing heat from the lung and relieving sorethroat is arranged, preventing phlegm from forming and stopping coughing, the effect of promoting the production of body fluid to quench thirst.
In the technique scheme, Radix Astragali extract is in astragalus polysaccharides, and its weight content is preferably 10～25%, and more preferably 20%; Radix Puerariae extract is in Radix Puerariae total flavones, and its weight content is preferably 35～50%, and more preferably 40%; Gymnema P.E is in Gymnemic Acids, and its weight content is 25～35%, and more preferably 30%; Fructus Momordicae extract is in the Fructus Momordicae general glycoside, and its weight content is 75～85%, and more preferably 80%.
The active component of aforementioned pharmaceutical compositions is preferably made by following weight percentages:
Radix Astragali extract 35～45%, Radix Puerariae extract 25～35%, Gymnema P.E 15～25%, Fructus Momordicae extract 8～12%.
More preferably, the active component of aforementioned pharmaceutical compositions is to be made by following weight percentages:
Radix Astragali extract 40%, Radix Puerariae extract 30%, Gymnema P.E 20%, Fructus Momordicae extract 10%.
The dosage form of above-mentioned pharmaceutical composition can be existing regular dosage forms such as tablet, granule, capsule, pill, is to get active component when making specifically, adds or does not add medicinal adjuvant, makes various pharmaceutical preparatioies according to a conventional method.
When the patient took pharmaceutical composition of the present invention and is used for the treatment of diabetes, recommending consumption was 1 gram/time (in compound recipe total amount), 3 times on the one.
Preparation of drug combination method with hypoglycemic activity of the present invention is: take by weighing Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and Fructus Momordicae extract by the said ratio amount, mix homogeneously, obtain active component, in active component, add or do not add medicinal adjuvant, make various pharmaceutical preparatioies according to a conventional method.
In the above-mentioned preparation method, described Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and Fructus Momordicae extract can directly be bought (during purchase, noticing that content of effective needs in above-mentioned limited range in each extract) by market, also can prepare voluntarily.When preparing voluntarily, various extracts can be undertaken by the existing conventional method, preferably carry out as follows:
The preparation method of described Radix Astragali extract is: get the Radix Astragali, clean being placed in the extraction pot adds the water heating and refluxing extraction, and extracting solution concentrates, and 95% ethanol that adds 2～3 times of concentrated solution volumes in the concentrated solution carries out precipitate with ethanol, isolates precipitation, will precipitate drying, promptly.Wherein, the temperature of reflux, extract, is 70～90 ℃.
The preparation method of described Radix Puerariae extract is: get Radix Puerariae, clean and be placed in the extraction pot adding 50～70% volume of ethanol heating and refluxing extraction, extracting solution concentrates, and concentrated solution is crossed macroporous resin column chromatography, with 50～70% volume of ethanol eluting, eluent concentrates, drying, promptly.Wherein, the temperature of reflux, extract, is 60～70 ℃, and the model of macroporous resin specifically can be D101, D102, HP-20, AB-8 or DM131 etc.
The preparation method of described Gymnema P.E is: get the Radix Gymnematis Sylvestris branch and leaf, clean being placed in the extraction pot adds the water reflux, extract,, and extracting solution concentrates, and concentrated solution is crossed macroporous resin column chromatography, and with 40～60% volume of ethanol eluting, eluent concentrates, drying, promptly.Wherein, the temperature of reflux, extract, is 70～90 ℃, and the model of macroporous resin specifically can be D101, D102, HP-20, AB-8 or DM131 etc.
The preparation method of described Fructus Momordicae extract is: get the Fructus Momordicae fresh fruit, clean being placed in the extraction pot adds the water reflux, extract,, and extracting solution concentrates, and concentrated solution is crossed macroporous resin column chromatography, and with 30～50% volume of ethanol eluting, eluent concentrates, drying, promptly.Wherein, the temperature of reflux, extract, is 70～90 ℃, and the model of macroporous resin specifically can be D101, D102, HP-20, AB-8 or DM131 etc.
In the above-mentioned various preparation method of extract, the number of times of reflux, extract, is generally 1～3 time, and water or alcoholic acid addition can be 5～8 times of raw material weight when extracting at every turn, and each time of extracting is 1～3h.Described concentrate is vacuum concentration, is that 50～70 ℃, vacuum are to carry out under the condition of 0.06～0.1Mpa in temperature normally.Described dry adopt conventional spray drying or vacuum drying.
The present invention comprises that also aforementioned pharmaceutical compositions has application in the medicine of hypoglycemic activity in preparation.
Compared with prior art, pharmaceutical composition of the present invention is with the active component that is combined as of Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and the Fructus Momordicae extract of specific active constituent content, and each extract synergism has good blood sugar lowering control sugar effect.In addition, preparation of pharmaceutical compositions method of the present invention is simple and easy to control.
The specific embodiment
The invention will be further described with specific embodiment below, but the present invention is not limited to these embodiment.
Below among each embodiment, concentration of ethanol is a volumetric concentration.
Embodiment 1
1) preparation of Radix Astragali extract: get the Radix Astragali, clean, section, take by weighing 100Kg and place extraction pot, the water that adds 8 times of raw material weights, the control temperature is 80 ℃, for the first time reflux, extract, 3h, extrude medicinal liquid then, medicinal residues add 5 times of raw material weight water again, and 80 ℃ of reflux, extract, 2h extrude medicinal liquid, merge the secondary medicinal liquid, obtain extracting solution; Extracting solution places under 60 ℃, 0.06Mpa condition and is concentrated into 1/20 of extracting solution original volume, 95% ethanol that adds 2 times of concentrated solution volumes in the gained concentrated solution carries out precipitate with ethanol, isolate precipitation, to precipitate vacuum drying, obtain the 4Kg Radix Astragali extract, after testing, wherein the content of astragalus polysaccharides is 20% weight (detection of phenolsulfuric acid method);
2) preparation of Radix Puerariae extract: get Radix Puerariae, clean, section, take by weighing 100Kg and place extraction pot, 60% ethanol that adds 6 times of raw material weights, the control temperature is 60 ℃, for the first time reflux, extract, 3h, extrude medicinal liquid then, medicinal residues add 60% ethanol of 5 times of raw materials again, and 60 ℃ of reflux, extract, 2h extrude medicinal liquid, merge the secondary medicinal liquid, obtain extracting solution; Extracting solution places under 60 ℃, 0.06Mpa condition and is concentrated into 1/20 of extracting solution original volume, and the gained concentrated solution is crossed the AB-8 macroporous resin column chromatography, washes resin column to effluent earlier with water and clarifies, and uses 60% ethanol elution then, and thin layer chromatography is followed the tracks of and detected, and collects eluent; Eluent is concentrated into extractum under 60 ℃, 0.06Mpa condition, spray drying obtains the 12Kg Radix Puerariae extract, after testing, wherein the content of Radix Puerariae total flavones is 40% weight (the ultraviolet determination method detects, referring to health food check and assessment technique standard (version in 2003));
3) preparation of Gymnema P.E: get the Radix Gymnematis Sylvestris branch and leaf, clean fragmentation, take by weighing 100Kg and place extraction pot, the water that adds 7 times of raw material weights, the control temperature is 80 ℃, for the first time reflux, extract, 2h, extrude medicinal liquid then, medicinal residues add 5 times of raw material weight water again, and 80 ℃ of reflux, extract, 2h extrude medicinal liquid, merge the secondary medicinal liquid, obtain extracting solution; Extracting solution places under 60 ℃, 0.06Mpa condition and is concentrated into 1/20 of extracting solution original volume, the gained concentrated solution is crossed the HP-20 macroporous resin column chromatography, washes resin column to effluent earlier with water and clarifies, and uses 50% ethanol elution then, thin layer chromatography is followed the tracks of and is detected, and collects eluent; Eluent places under 60 ℃, 0.06Mpa condition and is concentrated into extractum, and spray drying obtains the 0.8Kg Gymnema P.E, and after testing, wherein the content of Gymnemic Acids is 30% weight (detection of HPLC method);
4) preparation of Fructus Momordicae extract: get the Fructus Momordicae fresh fruit, clean fragmentation, take by weighing 100Kg and place extraction pot, the water that adds 6 times of raw material weights, the control temperature is 80 ℃, for the first time reflux, extract, 3h, extrude medicinal liquid then, medicinal residues add 6 times of raw material weight water again, and 80 ℃ of reflux, extract, 1h extrude medicinal liquid, merge the secondary medicinal liquid, obtain extracting solution; Extracting solution places under 60 ℃, 0.06Mpa condition and is concentrated into 1/20 of extracting solution original volume, the gained concentrated solution is crossed the DM131 macroporous resin column chromatography, washes resin column to effluent earlier with water and clarifies, and uses 40% ethanol elution then, thin layer chromatography is followed the tracks of and is detected, and collects eluent; Eluent places under 60 ℃, 0.06Mpa condition and is concentrated into extractum, and spray drying obtains the 1Kg Fructus Momordicae extract, and after testing, wherein the content of Fructus Momordicae general glycoside is 80% weight (detection of HPLC method);
5) take by weighing Radix Astragali extract 4Kg, the step 2 that step 1) makes) Fructus Momordicae extract 1Kg that the Radix Puerariae extract 3Kg that makes, the Gymnema P.E 2Kg that step 3) makes and step 4) make, mix homogeneously obtains active component;
6) the dextrin adjuvant of adding conventional amount used in the active component of step 5) gained, technology is made granule routinely, specification 1 gram/bag.
Embodiment 2
1) preparation of Radix Astragali extract: get the Radix Astragali, clean, section takes by weighing 100Kg and places extraction pot, adds the water of 10 times of raw material weights, and the control temperature is 75 ℃, and reflux, extract, 3h extrudes medicinal liquid then, obtains extracting solution; Extracting solution places under 50 ℃, 0.08Mpa condition and is concentrated into 1/20 of extracting solution original volume, 95% ethanol that adds 2 times of concentrated solution volumes in the gained concentrated solution carries out precipitate with ethanol, isolate precipitation, to precipitate vacuum drying, obtain the 8Kg Radix Astragali extract, after testing, wherein the content of astragalus polysaccharides is 10% weight (detection of phenolsulfuric acid method);
2) preparation of Radix Puerariae extract: get Radix Puerariae, clean, section, take by weighing 100Kg and place extraction pot, add 55% ethanol of 6 times of raw material weights, the control temperature is 65 ℃, reflux, extract, 3h extrudes medicinal liquid then for the first time, and medicinal residues add 60% ethanol of 5 times of raw materials again, 65 ℃ of reflux, extract, 3h extrude medicinal liquid, and medicinal residues add 70% ethanol of 5 times of raw materials again, 65 ℃ of reflux, extract, 1h, extrude medicinal liquid, merge three times medicinal liquid, obtain extracting solution; Extracting solution places under 60 ℃, 0.06Mpa condition and is concentrated into 1/25 of extracting solution original volume, and the gained concentrated solution is crossed the D101 macroporous resin column chromatography, washes resin column to effluent earlier with water and clarifies, and uses 60% ethanol elution then, and thin layer chromatography is followed the tracks of and detected, and collects eluent; Eluent is concentrated into extractum under 60 ℃, 0.06Mpa condition, spray drying obtains the 5.5Kg Radix Puerariae extract, after testing, wherein the content of Radix Puerariae total flavones is 60% weight (the ultraviolet determination method detects, referring to health food check and assessment technique standard (version in 2003));
3) preparation of Gymnema P.E: get the Radix Gymnematis Sylvestris branch and leaf, clean fragmentation, take by weighing 100Kg and place extraction pot, add the water of 8 times of raw material weights, the control temperature is 85 ℃, reflux, extract, 3h extrudes medicinal liquid then for the first time, and medicinal residues add 6 times of raw material weight water again, 85 ℃ of reflux, extract, 3h extrude medicinal liquid, and medicinal residues add 5 times of raw material weight water again, 85 ℃ of reflux, extract, 1h, extrude medicinal liquid, merge three times medicinal liquid, obtain extracting solution; Extracting solution places under 70 ℃, 0.1Mpa condition and is concentrated into 1/20 of extracting solution original volume, and the gained concentrated solution is crossed the D102 macroporous resin column chromatography, washes resin column to effluent earlier with water and clarifies, and uses 40% ethanol elution then, and thin layer chromatography is followed the tracks of and detected, and collects eluent; Eluent places under 60 ℃, 0.06Mpa condition and is concentrated into extractum, and spray drying obtains the 1Kg Gymnema P.E, and after testing, wherein the content of Gymnemic Acids is 20% weight (detection of HPLC method);
4) preparation of Fructus Momordicae extract: get the Fructus Momordicae fresh fruit, clean fragmentation, take by weighing 100Kg and place extraction pot, the water that adds 8 times of raw material weights, the control temperature is 75 ℃, for the first time reflux, extract, 3h, extrude medicinal liquid then, medicinal residues add 5 times of raw material weight water again, and 75 ℃ of reflux, extract, 3h extrude medicinal liquid, merge the secondary medicinal liquid, obtain extracting solution; Extracting solution places under 60 ℃, 0.08Mpa condition and is concentrated into 1/15 of extracting solution original volume, the gained concentrated solution is crossed the HP-20 macroporous resin column chromatography, washes resin column to effluent earlier with water and clarifies, and uses 40% ethanol elution then, thin layer chromatography is followed the tracks of and is detected, and collects eluent; Eluent places under 60 ℃, 0.08Mpa condition and is concentrated into extractum, and spray drying obtains the 1.2Kg Fructus Momordicae extract, and after testing, wherein the content of Fructus Momordicae general glycoside is 75% weight (detection of HPLC method);
5) take by weighing Radix Astragali extract 5Kg, the step 2 that step 1) makes) Fructus Momordicae extract 1.5Kg that the Radix Puerariae extract 2Kg that makes, the Gymnema P.E 1.5Kg that step 3) makes and step 4) make, mix homogeneously obtains active component;
6) the magnesium stearate adjuvant of adding conventional amount used in the active component of step 5) gained, technology is made capsule routinely, specification 0.5g/ grain.
Embodiment 3
Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and Fructus Momordicae extract are directly bought from the market in the present embodiment, wherein Radix Astragali extract is available from Nanjing Zelang Pharmaceutical Technology Inc., Radix Puerariae extract is available from the gloomy biological engineering company limited that reaches in Xianyang, Gymnema P.E is available from the kind edge in Shaanxi Bioisystech Co., Ltd, and Fructus Momordicae extract is available from the green biotechnology company limited of Xi'an gold.
1) gets 3.8Kg Radix Astragali extract (the astragalus polysaccharides weight content is 10%), 4Kg Radix Puerariae extract (the Radix Puerariae total flavones weight content is 35%), 1Kg Gymnema P.E (the Gymnemic Acids weight content is 40%) and 1.2Kg Fructus Momordicae extract (Fructus Momordicae general glycoside weight content is 90%), mix homogeneously obtains active component;
2) the magnesium stearate adjuvant of adding conventional amount used in active component, technology is made tablet routinely, specification 0.5g/ sheet.
Embodiment 4
Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and Fructus Momordicae extract are directly bought from the market in the present embodiment, wherein Radix Astragali extract is available from Nanjing Zelang Pharmaceutical Technology Inc., Radix Puerariae extract is available from Nanjing Zelang Pharmaceutical Technology Inc., Gymnema P.E is available from the Ba Shiman bio tech ltd, and Fructus Momordicae extract is available from Guilin pharmaceutcal corporation, Ltd of Xingda.
1) gets 3Kg Radix Astragali extract (the astragalus polysaccharides weight content is 25%), 3.5Kg Radix Puerariae extract (the Radix Puerariae total flavones weight content is 50%), 3Kg Gymnema P.E (the Gymnemic Acids weight content is 25%) and 0.5Kg Fructus Momordicae extract (Fructus Momordicae general glycoside weight content is 70%), mix homogeneously obtains active component;
2) the magnesium stearate adjuvant of adding conventional amount used in active component, technology is made tablet routinely, specification 0.5g/ sheet.
Embodiment 5
Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and Fructus Momordicae extract are directly bought from the market in the present embodiment, wherein Radix Astragali extract is available from Zhengzhou Ying He bio tech ltd, Radix Puerariae extract is available from Guanghan, Sichuan book on Chinese herbal medicine plant company limited, Gymnema P.E is available from Ba Shiman bio tech ltd company, and Fructus Momordicae extract is available from the green right bio tech ltd in Changsha.
1) gets 4.5Kg Radix Astragali extract (the astragalus polysaccharides weight content is 5%), 2.5Kg Radix Puerariae extract (the Radix Puerariae total flavones weight content is 45%), 2.5Kg Gymnema P.E (the Gymnemic Acids weight content is 25%) and 0.5Kg Fructus Momordicae extract (Fructus Momordicae general glycoside weight content is 80%), mix homogeneously obtains active component;
2) the dextrin adjuvant of adding conventional amount used in active component, technology is made granule routinely, specification 1 gram/bag.
Experimental example: pharmaceutical composition blood sugar lowering effect experiment of the present invention
1, experiment material
1.1 experiment medicine: the medicament composition granule agent of the embodiment of the invention 1 preparation, medicine is a brown; Acarbose (Dalian Mei Lun Bioisystech Co., Ltd).
1.2 laboratory animal: male mice in kunming (SPF level), in 6～8 ages in week, body weight 18～20g is provided by Medical Colleges Of Guilin's Experimental Animal Center.
1.3 experimental apparatus and reagent:
Instrument: HEA-230 blood glucose meter (Omron health medical treatment (China) company limited)
Reagent: HEA-STP30 blood sugar test paper (Omron health medical treatment (China) company limited), streptozotocin (Sigma company), alloxan (Sigma company), dextrin, Sal, aluminum nitrate, sodium nitrite, glucose etc.
2, experimental technique
2.1 the foundation of diabetes animal model
Get the normal male Kunming mouse, after high-sugar-fat-diet and 2% sucrose solution raised for 4 weeks, choose obesity mice fasting (normal drinking-water) 24h after, lumbar injection alloxan normal saline solution (200mg/kg), normal diet is recovered in the injection back.Fasting 8h after 3 days measures animal fasting glucose concentration, and the screening blood glucose value is greater than 40 of the mices of 11.1mmol/L, as the diabetes experimental model.
2.2 grouping and administration
Will select the diabetes laboratory animal by the blood sugar level grouping of fasting 8h, be divided into 4 groups: 1 model group, 1 matched group and 2 dosage groups (difference is not more than 1.1mmol/L between group), 10 every group; Each is organized, and (above four groups all is slight, severe diabetic mice half and half) 5 fasting glucose are slight diabetic mice at 11.1～20mmol/L in 10 hyperglycemia mices, and 5 fasting glucose are the severe diabetic mice more than 25mmol/L.And choose a normal blank and organize 10.
Outside the normal blank group feeding normal diet in grouping back, each group of modeling continues the feeding high-sugar-fat-diet, and the beginning administration.Granule high and low dose group of the present invention gavages medicament composition granule agent 1500mg/kg, the 500mg/kg that the embodiment of the invention 1 makes respectively, matched group (acarbose group) gavages acarbose 2mg/kg, and model group and normal group gavage the normal saline 2ml/kg of equivalent respectively.Every day 1 time, continuous 30 days.
2.3 blood sugar detection
GOD-POD method (use glucose kit):
β in the serum-D glucose is oxidized to maltonic acid under the effect of GOD, and generates H
2O
2The latter and 4-amino-antipyrine and phenol generate red benzophenone imines under the effect of peroxidase (POD), the depth of the ketone compounds color that generates is directly proportional with the content of glucose, the absorbance of difference bioassay standard pipe and sample tube, the content of calculating glucose.
Use blood glucose meter to measure fasting blood sugar.
3, test item and result
During continuous 30 days feedings, administration, respectively organize mice fasting blood sugar (fasting with experiment before) every measuring in 10 days, respectively organize mouse blood sugar value and blood glucose decline percentage rate.
Blood glucose decline percentage rate is calculated as follows:
Blood glucose value * 100% before blood glucose decline percentage rate=(blood glucose value before the experiment-test back blood glucose value)/experiment
Carry out the carbohydrate tolerance experiment in the time of each measuring blood, promptly behind mice fasting 4h, give 2.0g/kg glucose, measure to give behind the glucose 0,0.5 the blood glucose value of 2h is observed the variation to area under each time point blood glucose curve behind the glucose of model group, matched group and high and low dose group of the present invention.Area is calculated as follows under the blood glucose curve:
Area under the blood glucose curve=0.25 * (0h blood glucose value+4 * 0.5h blood glucose value+3 * 2h blood glucose value)
All (X ± SD) expression, significance test are the T check to experimental data with mean scholar standard deviation.
Experimental result is respectively shown in following table 1,2,3,4,5 and 6.
Table 1: different pharmaceutical is to the general impacts of mice fasting glucose (mmol/L)
Table 2: different pharmaceutical is to the influence of mice carbohydrate tolerance
Table 3: different pharmaceutical is to the influence of slight diabetic mice fasting glucose (mmol/L)
Table 4: different pharmaceutical is to the influence of slight diabetic mice carbohydrate tolerance
Table 5: different pharmaceutical is to the influence of severe diabetic mice fasting glucose (mmol/L)
Table 6: different pharmaceutical is to the influence of severe diabetic mice carbohydrate tolerance
By the data in the above-mentioned table as can be known, each is organized mice and compares with model group after administration significant difference is all arranged, and compares with self also to have significant difference.From above-mentioned data as seen, in slight diabetic mice, the high dose group of pharmaceutical composition of the present invention is close to the reduction amplitude and the matched group of blood glucose, and the range of decrease more than 12% is arranged; Suitable with matched group on carbohydrate tolerance further, be 35.6%; And to surpass high dose group at the increase rate of its sugared patience of low dose group, reach 37.9% close with matched group.This explanation is for patients with mild, and only the pharmaceutical composition of the present invention that need take than low dosage just can improve self tolerance to sugar well.Because slight its initial fasting glucose of diabetic mice is just lower, normal fluctuation will influence its blood glucose value in addition, thereby the result of carbohydrate tolerance is obviously more useful in this group.
In the severe diabetic mice, though high dose group is lower than matched group 26.4% to the range of decrease of the fasting glucose of mice, still has and reduce effect preferably, reach 25% the range of decrease.With further reference to the testing result of carbohydrate tolerance, high dose group rises to 34.5% to carbohydrate tolerance, goes back high than 33.5% of matched group acarbose.
As seen, pharmaceutical composition of the present invention can improve the too high problem of blood glucose of mice well, has hypoglycemic effect preferably.
Claims (10)
1. pharmaceutical composition with hypoglycemic activity, it is characterized in that: this active ingredient in pharmaceutical is to be made by following weight percentages:
Radix Astragali extract 30～50%, Radix Puerariae extract 20～40%, Gymnema P.E 10～30%, Fructus Momordicae extract 5～15%;
Wherein, Radix Astragali extract is in astragalus polysaccharides, and its weight content is 5～25%; Radix Puerariae extract is in Radix Puerariae total flavones, and its weight content is 35～60%; Gymnema P.E is in Gymnemic Acids, and its weight content is 20～40%; Fructus Momordicae extract is in the Fructus Momordicae general glycoside, and its weight content is 70～90%.
2. the pharmaceutical composition with hypoglycemic activity according to claim 1 is characterized in that: this active ingredient in pharmaceutical is to be made by following weight percentages:
Radix Astragali extract 30～50%, Radix Puerariae extract 20～40%, Gymnema P.E 10～30%, Fructus Momordicae extract 5～15%;
Wherein, Radix Astragali extract is in astragalus polysaccharides, and its weight content is 10～25%; Radix Puerariae extract is in Radix Puerariae total flavones, and its weight content is 35～50%; Gymnema P.E is in Gymnemic Acids, and its weight content is 25～35%; Fructus Momordicae extract is in the Fructus Momordicae general glycoside, and its weight content is 75～85%.
3. the pharmaceutical composition with hypoglycemic activity according to claim 1 is characterized in that: this active ingredient in pharmaceutical is to be made by following weight percentages:
Radix Astragali extract 30～50%, Radix Puerariae extract 20～40%, Gymnema P.E 10～30%, Fructus Momordicae extract 5～15%;
Wherein, Radix Astragali extract is in astragalus polysaccharides, and its weight content is 20%; Radix Puerariae extract is in Radix Puerariae total flavones, and its weight content is 40%; Gymnema P.E is in Gymnemic Acids, and its weight content is 30%; Fructus Momordicae extract is in the Fructus Momordicae general glycoside, and its weight content is 80%.
4. according to each described pharmaceutical composition with hypoglycemic activity in the claim 1～3, it is characterized in that: this active ingredient in pharmaceutical is to be made by following weight percentages:
Radix Astragali extract 35～45%, Radix Puerariae extract 25～35%, Gymnema P.E 15～25%, Fructus Momordicae extract 8～12%.
5. the pharmaceutical composition with hypoglycemic activity according to claim 4 is characterized in that: this active ingredient in pharmaceutical is to be made by following weight percentages:
Radix Astragali extract 40%, Radix Puerariae extract 30%, Gymnema P.E 20%, Fructus Momordicae extract 10%.
6. according to each described pharmaceutical composition in the claim 1～3, it is characterized in that: get active component, add or do not add medicinal adjuvant, make pharmaceutical preparation according to a conventional method with hypoglycemic activity.
7. the described preparation of drug combination method of claim 1 with hypoglycemic activity, it is characterized in that: take by weighing Radix Astragali extract, Radix Puerariae extract, Gymnema P.E and Fructus Momordicae extract by proportional quantity, mix homogeneously, obtain active component, in active component, add or do not add medicinal adjuvant, make various pharmaceutical preparatioies according to a conventional method.
8. the preparation of drug combination method with hypoglycemic activity according to claim 7 is characterized in that:
The preparation method of described Radix Astragali extract is: get the Radix Astragali, clean being placed in the extraction pot adds the water heating and refluxing extraction, and extracting solution concentrates, and 95% volume of ethanol that adds 2～3 times of concentrated solution volumes in the concentrated solution is carried out precipitate with ethanol, isolates precipitation, drying, promptly;
The preparation method of described Radix Puerariae extract is: get Radix Puerariae, clean and be placed in the extraction pot adding 50～70% volume of ethanol heating and refluxing extraction, extracting solution concentrates, and concentrated solution is crossed macroporous resin column chromatography, with 50～70% volume of ethanol eluting, eluent concentrates, drying, promptly;
The preparation method of described Gymnema P.E is: get the Radix Gymnematis Sylvestris branch and leaf, clean being placed in the extraction pot adds the water reflux, extract,, and extracting solution concentrates, and concentrated solution is crossed macroporous resin column chromatography, and with 40～60% volume of ethanol eluting, eluent concentrates, drying, promptly;
The preparation method of described Fructus Momordicae extract is: get the Fructus Momordicae fresh fruit, clean being placed in the extraction pot adds the water reflux, extract,, and extracting solution concentrates, and concentrated solution is crossed macroporous resin column chromatography, and with 30～50% volume of ethanol eluting, eluent concentrates, drying, promptly.
9. the preparation of drug combination method with hypoglycemic activity according to claim 8 is characterized in that: in the preparation method of described Radix Astragali extract, the temperature of reflux, extract, is 70～90 ℃; In the preparation method of described Radix Puerariae extract, the temperature of reflux, extract, is 60～70 ℃; In the preparation method of described Radix Astragali extract, the temperature of reflux, extract, is 70～90 ℃; In the preparation method of described Gymnema P.E, the temperature of reflux, extract, is 70～90 ℃; In the preparation method of described Fructus Momordicae extract, the temperature of reflux, extract, is 70～90 ℃.
10. each described pharmaceutical composition has application in the medicine of hypoglycemic activity in preparation in the claim 1～6.
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Application publication date: 20130724 |