CN103705723B - Pharmaceutical composition of a kind of kidney tonifying hypoglycemic and preparation method thereof and application - Google Patents
Pharmaceutical composition of a kind of kidney tonifying hypoglycemic and preparation method thereof and application Download PDFInfo
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Abstract
The invention provides a kind of pharmaceutical composition of kidney tonifying hypoglycemic. Described Chinese medicine compound prescription is made up of following bulk drug: ginseng, Fructus Corni, the Radix Astragali, prepared fleece flower root, the tuber of dwarf lilyturf, the root of kudzu vine, barrenwort processed, gekko, the fruit of Chinese magnoliavine, semen astragali complanati and Cordyceps sinensis. Pharmaceutical composition of the present invention has the function of beneficial gas, kidney tonifying, hypoglycemic, and described pharmaceutical composition is verified by animal experiment, proves that it has positive effect aspect reduction blood sugar.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, specifically, relate to a kind of medicine of kidney tonifying hypoglycemicCompositions and preparation method thereof and application.
Background technology
The diabetes traditional Chinese medical science is called quenches one's thirst, and its morbidity is because of the five internal organs natural endowment fragility, be added with disorder of emotion,The internal organs deficiency of Yin that the inducements such as eating and drinking without temperance cause is scorching, deficiency of both qi and yin, the defeated cloth of body fluid are not normal onePlant disease. The five internal organs natural endowment fragility is internal cause, and kidney controlling essence storage among the five internal organs, be subject to the vital organs of the human body itEssence and hide it, thanks to causes kidney essense and loses less in qi and blood, or the vital essence deficiency of congenital kidney, all can cause scorchingInterior life and send out for quenching one's thirst.
At present, the common drug for the treatment of diabetes has sulfonylureas, biguanides, medicine mouthfeelThere is metallic taste. Generally need Long-term taking medicine, can produce numerous bad reactions. Common manifestation isFeel sick, vomiting, appetite decline, stomachache, diarrhoea, incidence can reach 20%. Severe is bad anti-At once, patient also can be with symptoms such as headache, dizzinesses. When even more serious, patient's liver, kidneyHypofunction, causes Hypoxic disease, acute infection etc.
But Chinese medicine is not only symptomatic treatment, more emphasize the wholistic therapy side of mediation, balanceCase, therefore, the pharmaceutical composition of inventing a kind of kidney tonifying hypoglycemic is necessary.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition with kidney tonifying function of polysaccharide andPreparation method and application.
In order to realize the object of the invention, first the present invention provides a kind of pharmaceutical composition, described medicineCompositions is made up of following bulk drug: ginseng, Fructus Corni, the Radix Astragali, prepared fleece flower root, the tuber of dwarf lilyturf,The root of kudzu vine, barrenwort processed, gekko, the fruit of Chinese magnoliavine, semen astragali complanati and Cordyceps sinensis.
Further, described pharmaceutical composition is made up of the bulk drug of following weight portion:
As preferably, described pharmaceutical composition is made up of the bulk drug of following weight portion:
The present invention also provides the preparation method of described pharmaceutical composition, comprises the steps:
1) ginseng, the fruit of Chinese magnoliavine, Fructus Corni, Cordyceps sinensis and gekko are ground into fine powder, mistakeSieve, mixes;
2) all the other Six-element bulk drug boiling secondaries decoct 1.5 hours at every turn, collecting decoction,Filter, leave standstill, get supernatant, being concentrated into relative density is 1.32～1.35(50 DEG C), add 60%Ethanol equivalent makes precipitation, gets supernatant concentration and becomes thick paste;
3) by step 2) fine powder that makes of the thick paste that makes and step 1) mixes, to obtain final product.
The present invention also provides the preparation that contains described pharmaceutical composition. Preferably, described preparationFor capsule.
The present invention also provides the preparation method of above-mentioned capsule, specifically comprises the steps:
1) ginseng, the fruit of Chinese magnoliavine, Fructus Corni, Cordyceps sinensis and gekko are ground into fine powder, mistakeSieve, mixes;
2) all the other Six-element bulk drug boiling secondaries decoct 1.5 hours at every turn, collecting decoction,Filter, leave standstill, get supernatant, being concentrated into relative density is 1.32～1.35(50 DEG C), add 60%Ethanol equivalent makes precipitation, gets supernatant concentration and becomes thick paste;
3) by step 2) fine powder that makes of thick paste and step 1) mixes, and adds dextrin appropriate, mixedEven, granulation, dry, encapsulated, to obtain final product.
Wherein, in step 1) by ginseng, the fruit of Chinese magnoliavine, Fructus Corni, Cordyceps sinensis and gekko powderBe broken into fine powder, cross 60-200 mesh sieve, mix.
The present invention further provides aforementioned pharmaceutical composition in the medicine of preparation kidney tonifying hypoglycemicApplication.
In Chinese medicine composition of the present invention:
Taking Fructus Corni, prepared fleece flower root, barrenwort (system), Cordyceps sinensis as monarch, help kidney itVital essence; Gekko, the fruit of Chinese magnoliavine, semen astragali complanati are minister, and gekko principal drug assistance is invigorated the lung and the kidney, and the fruit of Chinese magnoliavine is puckeryEssence kidney tonifying, semen astragali complanati liver-kidney tonifying; Ginseng, Radix Astragali supplementing QI to prevent collapse, the tuber of dwarf lilyturf, root of kudzu vine yin-nourishing lifeTianjin is adjuvant altogether; Full side share, and plays altogether supplementing qi and nourishing yin, the merit of temperature male wind-supplying kidney.
Kidney tonifying of the present invention, beneficial gas, nourishing Yin and promoting production of body fluid, taking kidney tonifying as main, reach the balance internal organs deficiency of YinScorching object.
Beneficial effect of the present invention is:
1, prescription compatibility uniqueness of the present invention, not only can play the tradition Chinese medicine nourishing Yin and promoting production of body fluid of quenching one's thirstEffect, the more important thing is the scorching cause of disease of the balance internal organs deficiency of Yin;
2, preparation method's uniqueness of the present invention, the method for being used as medicine by part rare medicinal herbs powder subtractsLack the use of pharmaceutic adjuvant, and increased the crude drug content of unit medicine, ensured medicineCurative effect.
Detailed description of the invention
Following examples are used for illustrating the present invention, but are not used for limiting the scope of the invention.
Embodiment 1 pharmaceutical composition of the present invention
The proportioning of bulk drug:
Get ginseng 25g, Fructus Corni 150g, Radix Astragali 180g, prepared fleece flower root 100g, tuber of dwarf lilyturf 100g,Root of kudzu vine 100g, barrenwort (system) 100g, gekko 30g, fruit of Chinese magnoliavine 90g, semen astragali complanati 100gWith Cordyceps sinensis 25g.
Preparation method:
1, ginseng, the fruit of Chinese magnoliavine, Fructus Corni, Cordyceps sinensis and gekko are ground into fine powder, mistakeSieve, mixes;
2, all the other Six-element bulk drug boiling secondaries decoct 1.5 hours at every turn, collecting decoction,Filter, leave standstill, get supernatant, being concentrated into relative density is 1.32～1.35(50 DEG C), add 60%Ethanol equivalent makes precipitation, gets supernatant concentration and becomes thick paste;
3, the fine powder that thick paste step 2 being made and step 1 make mixes, and to obtain final product.
Embodiment 2 pharmaceutical composition of the present invention
The proportioning of bulk drug:
Get ginseng 15g, Fructus Corni 50g, Radix Astragali 250g, prepared fleece flower root 150g, tuber of dwarf lilyturf 50g,Root of kudzu vine 150g, barrenwort (system) 150g, gekko 15g, fruit of Chinese magnoliavine 50g, semen astragali complanati 150gWith Cordyceps sinensis 40g.
Preparation method is with embodiment 1.
Embodiment 3 pharmaceutical composition of the present invention
The proportioning of bulk drug:
Get ginseng 40g, Fructus Corni 200g, Radix Astragali 100g, prepared fleece flower root 50g, tuber of dwarf lilyturf 150g,Root of kudzu vine 50g, barrenwort (system) 50g, gekko 40g, fruit of Chinese magnoliavine 150g, semen astragali complanati 50g and winterWorm summer grass 15g.
Preparation method is with embodiment 1.
The preparation (tablet) that embodiment 4 contains pharmaceutical composition of the present invention
Get the pharmaceutical composition that embodiment 1 makes, add dextrin appropriate, mix, granulation,Add appropriate amount of starch and dolomol mixes compressing tablet.
The preparation (capsule) that embodiment 5 contains pharmaceutical composition of the present invention
Get the pharmaceutical composition that embodiment 1 makes, add dextrin appropriate, mix, granulation,Dry, encapsulated, to obtain final product.
1. proterties
This product is capsule, and content is brown particle or powder; Sour-puckery flavor.
2. differentiate
2.1. get this product, put micro-Microscopic observation: calcium oxalate cluster crystal diameter 20～68 μ m, ribThe sharp point in angle. It is faint yellow or fallow that seed coat lithocyte is, and multiclass dihedral is seen on surface, wall thickness,Hole ditch is fine and closely woven, and cell is containing dark-brown thing. Mycelia is elongated, branch or not branch, intensive being crossed asRoll into a ball or fragment into joint, diameter 1.3～3 μ m.
2.2. get this product content 5g, add methyl alcohol 30ml, ultrasonic processing 30 minutes, filters, filterIt is upper that liquid adds neutral alumina column (100～120 orders, 5g, internal diameter 1cm), with 40% methyl alcohol 100mlWash-out, collects eluent, evaporate to dryness, and the residue 30ml that adds water makes to dissolve, and carries with water-saturated n-butanolGet 2 times, each 20ml, merges n-butanol liquid, washes with water 2 times, and each 20ml, discards waterLiquid, n-butanol liquid evaporate to dryness, residue adds methyl alcohol 1ml to be made to dissolve, as need testing solution. Separately getAstragaloside IV reference substance, adds methyl alcohol and makes the solution of every 1ml containing 1mg, product solution in contrast.According to thin-layered chromatography (annex VIB of Chinese pharmacopoeia version in 2010) test, draw above-mentioned twoPlant the each 5 μ l of solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water(13:7:2) lower floor's solution is solvent, launches, and takes out, and dries, and spray is with 10% sulfuric acidEthanolic solution, it is clear that hot blast blows to spot colour developing. In test sample chromatogram, with reference substance chromatogramOn corresponding position, the spot of aobvious same color.
2.3. get this product content appropriate, porphyrize, gets 5g, adds methyl alcohol 30ml, ultrasonic processing 30Minute, filter, filtrate evaporate to dryness, residue adds 8% hydrochloric acid solution 20ml, and ultrasonic processing makes to dissolve,Add again chloroform 20ml, add hot reflux 1 hour, let cool, put in separatory funnel, divide and get threeChloromethanes layer, evaporate to dryness, residue adds ethanol 1ml to be made to dissolve, as need testing solution. Separately get largeFlavine, Physcion reference substance, add ethanol and make the mixed solution that every 1ml respectively contains 1mg,Product solution in contrast. According to thin-layered chromatography (annex VIB of Chinese pharmacopoeia version in 2010)Test, draws the each 10 μ l of above-mentioned two kinds of solution, puts respectively on same silica gel g thin-layer plate, withN-hexane-ethyl acetate-formic acid (30:10:0.5) is solvent, launches, and takes out, dry,It is clear to smoke to spot colour developing with ammonia steam. In test sample chromatogram, corresponding with reference substance chromatogramOn position, the spot of aobvious same color.
2.4. get this product content appropriate, porphyrize, gets 2g, adds ethyl acetate 20ml, ultrasonic placeManage 20 minutes, filter, filtrate evaporate to dryness, 20ml is at twice for benzinum for residue (60～90 DEG C)Washing, discards benzinum liquid, and residue adds absolute ethyl alcohol 2ml again to be made to dissolve, molten as test sampleLiquid. Separately get ursolic acid reference substance, add absolute ethyl alcohol and make the solution of every 1ml containing 0.2mg, asReference substance solution. According to thin-layered chromatography (annex VIB of Chinese pharmacopoeia version in 2010) test,Draw the each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with toluene-secondAcetoacetic ester-formic acid (20: 4: 0.5) is solvent, launches, and takes out, and dries, and spray is with 10%Ethanol solution of sulfuric acid, is heated to spot colour developing at 105 DEG C clear. In test sample chromatogram, withOn the corresponding position of reference substance chromatogram, aobvious identical aubergine spot; Ultraviolet lamp (365nm)Under inspect, aobvious identical orange-yellow fluorescence spot.
3. check
(Chinese pharmacopoeia one of version in 2010 is attached should to meet every regulation relevant under capsule itemRecord IL).
Limit test of microbe method: get this product 10g, add the aseptic sodium chloride-albumen of pH7.0Peptone buffer solution is to 100ml, and jolting is uniformly dispersed, and makes into the test liquid of 1:10. Bacterium meterNumber adopts conventional method, gets test liquid 1ml and injects plate, and moulds and yeasts count, adoptsWith conventional method, get test liquid 1ml, inject plate, check (" Chinese pharmacopoeia " 2010 in accordance with the lawAn annex X III C of year version). EHEC, coliform inspection be according to conventional method, (" inState's pharmacopeia " 2010 years annex X III C of version).
4. assay
According to high performance liquid chromatography (annex VI D of " Chinese pharmacopoeia " version in 2010)Measure.
4.1. chromatographic condition and system suitability
Taking octadecylsilane chemically bonded silica as filler; With oxolane-methyl alcohol-acetonitrile-0.05% phosphoric acid (1:4:8:87) is mobile phase; Column temperature is 40 DEG C; Detection wavelength is 237nm.Number of theoretical plate calculates and should be not less than 4000 by loganin peak.
4.2. the preparation of reference substance solution
Get loganin reference substance appropriate, accurately weighed, add 50% methyl alcohol and make every 1ml containing 20 μ gSolution, to obtain final product.
4.3. the preparation of need testing solution
Get this product content under content uniformity item appropriate, porphyrize, mixes, and gets the about 0.4g of fine powder,Accurately weighed, to put in tool plug conical flask, precision adds 50% methyl alcohol 50ml, and close plug is weighedWeight, ultrasonic (power 250W, frequency 30kHz) processes 1 hour, let cool, more weighedWeight, supplies the weight of less loss with methyl alcohol, shake up, with miillpore filter (0.45 μ m) filters,Get subsequent filtrate, to obtain final product.
4.4. determination method
Accurate reference substance solution and the each 10 μ l of need testing solution of drawing, inject liquid chromatogram respectivelyInstrument, measures, and to obtain final product.
Every of this product contains Fructus Corni with loganin (C17H26O10) meter, must not be less than 0.81mg.
Function with cure mainly
Supplementing qi and nourishing yin, temperature male wind-supplying kidney. For deficiency of both vital energy and Yin, yin-yang deficiency disease, disease is seen thirsty wishDrink, shortness of breath and fatigue, four limbs are not warm, soreness and weakness of waist and knees, impotence, premature ejaculation, frequent urination, tongue is lightTongue is white, deep,thready and forceless pulse etc. Western medicine diagnose type II diabetes is shown in above-mentioned disease person.
6. usage and consumption: oral. One time 4,3 times on the one.
7. points for attention: take 30 minutes ante cibum.
8. specification: every contains crude drug 1.00g, every dress 0.4g.
9. storage: sealing.
10. the term of validity: 1 year.
The preparation (capsule) that embodiment 6 contains pharmaceutical composition of the present invention
Get the pharmaceutical composition that embodiment 2 makes, add dextrin appropriate, mix, granulation,Dry, encapsulated, to obtain final product.
The preparation (capsule) that embodiment 7 contains pharmaceutical composition of the present invention
Get the pharmaceutical composition that embodiment 3 makes, add dextrin appropriate, mix, granulation,Dry, encapsulated, to obtain final product.
The pharmacodynamic experiment of experimental example 1 pharmaceutical composition of the present invention
1 materials and methods
1.1. medicine and reagent
The embodiment of the present invention 5 capsules, Streptozotocin (STZ), the import of Shenzhen Jing Mei company dividesDress, is dissolved in 0.1molL before use-1, the citric acid-sodium citrate buffer of pH4.2, putsIn on ice. Glibenclamide, Tianjin Pacific Pharmaceutical Co., Ltd., lot number: 110207. GlucoseKit, Sichuan I steps a gram scientific and technological company limited by shares and produces, lot number: 1205062. PancreasIsland element kit, Beijing North Institute of Biological Technology produces, lot number: 121020.
1.2. instrument
722S ultraviolet specrophotometer (Shanghai exact science instrument Co., Ltd),CENTRIFUGETDL mono-5 type centrifuges (Anting Scientific Instrument Factory, Shanghai), XW mono-80A revolvesWhirlpool blender (Instrument Factory, Shanghai Medical Science Univ.).
1.3. animal
Kunming mouse, clean level, male, body weight 18～25g, by the Chinese Academy of Medical SciencesExperimental Animal Center provides.
1.4. method
1.4.1. streptozotocin-diabetes mouse model preparation
After mouse fasting 12h, the freshly prepared Streptozotocin solution of lumbar injection150mg·kg-1, after 72h, animal fasting (can't help water) 12h, gets blood in the intraocular corner of the eyes, the whole blood of adoptingSolidify rear 3500rmin-1Centrifugal 15min, separation of serum, by glucose oxidase method,, use722S ultraviolet specrophotometer, 505nm place measures blood sugar, selects fasting blood sugar (FBG) largeIn 11.1mmolL-1Person is defined as diabetic rat model.
1.4.2. Streptozotocin is caused the impact of blood glucose in diabetic mice
Get 50 of streptozotocin-diabetes model mices, it is divided into 5 groups at random: diabetesModel group (ig equal-volume physiological saline), glibenclamide group (50mgkg-1), the embodiment of the present invention 5The high, medium and low dosage group of capsule (is equivalent to respectively crude drug 30,15,7.5gkg-1), normalControl group (ig equal-volume physiological saline). Each group gastric infusion respectively, every morning administration 1 time,Successive administration 15d, measures respectively administration the 5th by method under 1.4.1. item, the blood sugar of 10,15 days (Measure the front 12h animal fasting of blood sugar). In the time of medication 15d, measure 2h after the administration of each group of mouseBlood sugar (2hBG) situation.
2. result
2.1. Streptozotocin is caused the impact on the diabetic mice blood pool
With model group comparison, after high, the middle dosage group of the embodiment of the present invention 5 capsules medication 15dSignificantly reduce diabetic mice FBG (P < 0.01) and 2hBG (P < 0.01 or P < 0.05), and thisThe high, medium and low each dosage group FBG of inventive embodiments 5 capsule is along with the increase of administration timeProgressively reduce, have necessarily ageing. In table 1, table 2.
Table 1 embodiment of the present invention 5 capsules cause the impact (x ± s, n=10) of blood glucose in diabetic mice on Streptozotocin
Note: with model group comparison, * P < 0.05, * * P < 0.01
Table 2 embodiment of the present invention 5 capsules cause the impact (x ± s, n=10) of 2h blood sugar after diabetic mice administration on Streptozotocin
Note: with model group comparison, * P < 0.05, * * P < 0.01
This experiment shows, the middle and high dosage group of the present invention can significantly reduce mouse fasting blood sugar.
Through verification experimental verification, the embodiment of the present invention 6 all has similarly to Example 5 with embodiment 7Pharmacodynamic action.
Although, above with a general description of the specific embodiments the present invention has been done in detailMost description, but on basis of the present invention, can make some modifications or improvements it, this is to thisThose skilled in the art are apparent. Therefore, on the basis of not departing from spirit of the present inventionUpper these modifications or improvements, all belong to the scope of protection of present invention.
Claims (8)
1. a pharmaceutical composition for kidney tonifying hypoglycemic, is characterized in that, described pharmaceutical compositionBulk drug by following weight portion is made:
2. pharmaceutical composition according to claim 1, is characterized in that, described medicine groupCompound is made up of the bulk drug of following weight portion:
3. the preparation method of the pharmaceutical composition described in claim 1 or 2, is characterized in that,Comprise the steps:
1) ginseng, the fruit of Chinese magnoliavine, Fructus Corni, Cordyceps sinensis and gekko are ground into fine powder, mistakeSieve, mixes;
2) all the other Six-element bulk drug boiling secondaries decoct 1.5 hours at every turn, collecting decoction,Filter, leave standstill, get supernatant, being concentrated into relative density is 1.32～1.35, adds 60% ethanolEquivalent makes precipitation, gets supernatant concentration and becomes thick paste;
3) by step 2) thick paste and the step 1 that make) fine powder that makes mixes, to obtain final product.
4. contain the preparation of the pharmaceutical composition described in claim 1 or 2.
5. preparation according to claim 4, is characterized in that, described preparation is capsule.
6. the preparation method of preparation described in claim 5, is characterized in that, comprises the steps:
1) ginseng, the fruit of Chinese magnoliavine, Fructus Corni, Cordyceps sinensis and gekko are ground into fine powder, mistakeSieve, mixes;
2) all the other Six-element bulk drug boiling secondaries decoct 1.5 hours at every turn, collecting decoction,Filter, leave standstill, get supernatant, being concentrated into relative density is 1.32～1.35, adds 60% ethanolEquivalent makes precipitation, gets supernatant concentration and becomes thick paste;
3) by step 2) thick paste and step 1) fine powder that makes mixes, and adds dextrin appropriate, mixedEven, granulation, dry, encapsulated, to obtain final product.
7. preparation method according to claim 6, is characterized in that step 1) middle generalGinseng, the fruit of Chinese magnoliavine, Fructus Corni, Cordyceps sinensis and gekko are ground into fine powder, cross 60-200 mesh sieve,Mix.
8. the pharmaceutical composition described in claim 1 or 2 is in the medicine of preparation kidney tonifying hypoglycemicApplication.
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| CN1306830A (en) * | 2000-02-01 | 2001-08-08 | 谷越秀 | Medicine for treating Type-11 diabetes |
| CN103169854A (en) * | 2011-12-22 | 2013-06-26 | 谭建 | Drug composition for treating diabetes mellitus and complication thereof |
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