A kind of Chinese medicine composition for the treatment of diabetes
Technical field
The present invention relates to the Chinese medicine technical field, be specifically related to a kind of Chinese medicine composition for the treatment of diabetes.
Background technology
Diabetes are a kind of incretion metabolism diseases, are owing to the relative or absolute not enough carbohydate metabolism that causes of insulin in the body is disorderly, cause the water of sugar, protein, fat and secondary, the disease of metabolic disturbance of electrolyte.Diabetes are divided two types clinically: insulin dependent diabetes mellitus (IDDM) (being type i diabetes), non-insulin-dependent diabetes mellitus (being type ii diabetes).Wherein, the type ii diabetes rate is very high, accounts for about 90% of onset diabetes number.The harm of diabetes is mainly from complication, and its incidence rate is very high, has caused high fatality rate and high disability rate.Studies show that had the patient of 30%-40% to I haven't seen you for ages a kind of complication to occur behind the onset diabetes in 10 years.Common diabetic complication has nephropathy that diabetes cause, eyes pathological changes, nervous system lesion, cardiovascular pathological changes, fatty liver etc.
World Health Organization (WHO) announces recently, nineteen ninety-five, whole world diabetics was only about 3,000 ten thousand people, and to 1997 oneself increase to 1.35 hundred million, predict according to the authoritative sources, to reach 2.4 hundred million by 2010, by 2025, will have 3.3 hundred million people to be diagnosed as diabetes, and mortality rate is only second to malignant tumor and cardiovascular diseases, is the third-largest disease that jeopardizes human life's health.
Along with the raising of living standards of the people, the incidence rate of China's diabetics and mortality rate are also increasing severely year by year.The finding that distributes from China each department, the eighties China's diabetics sickness rate less than 1%, risen to 2.65% by 1997, and more increased rapidly with annual 0.1% speed in recent years, formed an ill colony that can not be ignored.
Diabetes are called again diabetes, and the traditional Chinese medical science is thought the many because surfeit delicious food of its origin cause of formation, eating and drinking without temperance, and congenital defect, plain body is cloudy to be lost, or gives up completely to natural impulse, and disorder of emotion, or impairment caused by overstrain excessively causes cloudy body fluid deficiency consumption scorchingly then more decreases cloudy Tianjin, the two reciprocal causation.Liver is take blood as body, take gas as usefulness, and liver controlling conveyance and dispersion, the balance the body physiological function, the irritability catharsis, then happy, QI and blood is gentle, if depressed emotion or rage impairing liver, strongly fragrant and fire-transformation, liquid is hindered in the Tianjin of then burning, and viscera function is disorderly, thereby causes diabetes.Prevent and treat the diabetes key and be to keep the steady control that reaches its complication of blood glucose.The method of control blood glucose is not simple treatment, it more or not simple Drug therapy, but according to the World Health Organization (WHO) the five-term measure of control diabetes is proposed, namely diet control, exercise therapy, Drug therapy, diabetes education, blood sugar monitoring come integrated control.Wherein, Drug therapy is the key of control blood glucose.Although the chemical sugar-lowering medicine can be controlled hyperglycemia to a certain extent, because itself toxic and side effects, the organs such as the liver of human body, kidney, the heart, brain are caused serious infringement, increase the weight of the development of complication.TCM treatment of diabetes then is particular about the whole body conditioning, and giving consideration to both the incidental and fundamental is its advantage but often take effect slow.
Make a general survey of the research direction of world's new drug, mainly be single chemicals and preparations thereof of research and development the eighties in the past, begins to develop biotechnology and natural medicinal plants after the eighties, and the drug research direction is tending towards multiformity.In conjunction with the modern Chinese medicine theory of development, from improving the angle of curative effect of medication, reduction side effect, through Chinese medicine ingredients being screened the preparation that extraction and/or compatibility make, its side effect is little, and is safe, has the advantage that chemical synthetic drug can not be compared.
Summary of the invention
Large in order to overcome existing diabetes chemotherapeutic agent toxic and side effects, the prior art that the treating diabetes effect is difficult to continue is not enough, the invention provides a kind of Chinese medicine composition for the treatment of diabetes, this Chinese medicine composition good effect, and side effect is little.
The Chinese medicine composition that the present invention treats diabetes is made by the raw material of following weight portion: Rhizoma dioscoreae 10-50 part, Poria 10-20 part, Radix Rehmanniae 5-20 part, Rhizoma Polygonati 5-15 part, Radix Pseudostellariae 5-15 part, Rhizoma Chuanxiong 1-10 part, Fructus Lycii 5-15 part, Radix Achyranthis Bidentatae 9-15 part, Fructus Citri 9-15 part, Herba Agrimoniae 5-15 part, Radix Ophiopogonis 1.5-9 part, Fructus Aurantii 5.5-15 part, Radix Paeoniae Rubra 0-10 part, Radix Gentianae Macrophyllae 0-7 part, Indigo Naturalis 0-5 part.
Further preferably, the present invention's Chinese medicine composition for the treatment of diabetes is made by the raw material of following weight portion: 30 parts of Rhizoma dioscoreaes, 15 parts of Poria, 15 parts in the Radix Rehmanniae, 10 parts of Rhizoma Polygonatis, 12 parts of Radix Pseudostellariaes, 7 parts of Rhizoma Chuanxiongs, 12 parts of Fructus Lyciis, 13 parts of Radix Achyranthis Bidentataes, 14 parts of Fructus Citris, 10 parts of Herba Agrimoniaes, 5 parts of Radix Ophiopogonis, 11 parts of Fructus Aurantiis, 7 parts of Radix Paeoniae Rubra, 5 parts of Radix Gentianae Macrophyllae, 2 parts of Indigo Naturaliss.
Rhizoma dioscoreae refers to the Rhizoma Dioscoreaes that is produced from ground such as Anhui, modern Jiangsu, and the Rhizoma dioscoreae stem is with aubergine usually, cures mainly insufficiency of the spleen lack of appetite, incessant chronic diarrhea, and the spleen reinforcing nourishing the stomach is arranged, the lung benefiting that promotes the production of body fluid, the effect of the kidney invigorating arresting seminal emission.
Poria is commonly called as Poria, and sweet in the mouth, light, property are flat, enter the heart, lung, spleen channel; Be used as medicine have promoting diuresis to eliminate damp pathogen, the function of strengthening the spleen stomach function regulating, mind tranquilizing and the heart calming; Modern medicine study: Poria energy enhancing human body immunity function, pachyman has obvious antitumor and protects the liver dirty effect.
The Radix Rehmanniae also is Radix Rehmanniae, the Scrophulariaceae herbaceos perennial; Sweet in the mouth, hardship, cold nature, GUIXIN, liver, kidney channel; The matter profit is fallen and is let out, and the nourishing YIN to relieve dryness effect of promoting the production of body fluid is arranged.
Rhizoma Polygonati is used as medicine with rhizome, has boosting qi and nourishing yin, spleen invigorating, lung moistening, kidney benefiting functions; Be used for the treatment of weakness of the spleen and stomach, fatigue and asthenia, xerostomia lack of appetite, deficiency of the lung cough caused by dryness, asthenia of essence and blood, the interior-heat disease such as quench one's thirst.
Radix Pseudostellariae has another name called Radix Ginseng, virgin ginseng; Tuber for Caryophyllaceae herbaceos perennial pseudostellaria heterophylla; Invigorating qi and benefiting blood arranged, promote the production of body fluid, the effect of tonifying the spleen and stomach; Be suitable for children's's summer heat of a specified duration do not move back, the disease of the weaknesses such as diet is depressed, the deficiency of the lung, cough, cardiopalmus and children's after being ill weak unable, spontaneous perspiration, night sweat, mouthful equality disease.
Rhizoma Chuanxiong, Xin Wenxiang is dry, walks and does not keep, can go loose, the up top, mountain peak that reaches; Enter again blood system, the descending sea of blood that reaches; The blood circulation promoting and blood stasis dispelling effect is extensive, the suitable various diseases of stagnation of blood stasis; Wind-expelling pain-stopping, effectiveness is excellent, can control the diseases such as wind syndrome of head headache, rheumatic arthralgia.
Fructus Lycii, sweet in the mouth, property is flat returns Liver Channel, kidney channel, lung meridian; Cure mainly: caused by liver and kidney deficiency, have a dizzy spell, the disease such as visual unclear, soreness of the waist and knees, impotence and seminal emission, cough due to consumptive disease, the taking fluids profusely of quenching one's thirst.
Radix Achyranthis Bidentatae is the plant of Amaranthaceae Achyranthes, and its property bitter but sweet flavor acid is flat, has promoting blood circulation to restore menstrual flow, invigorating the liver and kidney, bone and muscle strengthening, inducing diuresis for treating stranguria syndrome, draw the descending effect of blood (fire), be usually used in treating the gynaecopathia such as amenorrhea, dysmenorrhea, menoxenia, puerperal abdonimal pain of stagnation of blood stasis, traumatic injury, the soreness of waist and knee joint of suffering from a deficiency of the kidney, weakness of the lower extremities, hematuria, dysuria, Urethra astringent pain and intimately go up the cards such as headache that inflammation causes, dizzy, haematemesis, epistaxis.
Fructus Citri has another name called citron, is the Rutaceae citrus plant, and Fructus Citri acrid in the mouth, little hardship, acid are warm in nature; Return liver, lung, spleen channel; The fragrant row of gas is loose, can rise and can fall; Have depressed liver-energy dispersing and QI regulating, the chest stuffiness relieving reduces phlegm, dehumidifying and in effect, cure mainly distending pain in the chest and hypochondrium, cough with copious phlegm, gastral cavity abdomen painful abdominal mass pain, dyspepsia vomiting, edema beriberi.
Herba Agrimoniae, property is bitter, puckery, and is flat; GUIXIN, Liver Channel cure mainly astringing to arrest bleeding, dysentery relieving, parasite killing; Be widely used in various hemorrhage cards, for example: haematemesis, hematuria, have blood in stool, metrorrhagia, spitting of blood, epistaxis, dysentery, impairment caused by overstrain is taken off power, carbuncle, traumatic injury, the cards such as wound hemorrhage.
Have another name called Radix Ophiopogonis Radix Ophiopogonis, is Liliaceae Ophiopogon plant; Be used as medicine with tuber Radix Ophiopogonis; Nature,taste and action: sweet, little hardship, cold, Yin-nourishing and body fluid promoting, nourishing the lung to arrest cough, relieving restlessness clears away heart-fire; Cure mainly consumption of body fluid caused by febrile disease, vexed, thirsty, dry pharynx lung-heat, cough, pulmonary tuberculosis.
Fructus Aurantii, nature and flavor are bitter, acid, cold nature; Gui Jing: lung, spleen, liver, stomach, large intestine channel; Function cures mainly: the septum pectorale feeling of fullness, and distending pain over the hypochondrium, accumulation of food in the stomach and intes tine due to indigestion, distension and fullness in the abdomen, heavy behind the dysentery, proctoptosis, uterine prolapse.
Radix Paeoniae Rubra, function: clots absorbing, pain relieving, removing heat from blood, detumescence; Cure mainly: control that the stasis of blood stagnates that amenorrhea, hernia abdominal mass gather, stomachache, hypochondriac pain, epistaxis, dysentery, discharging fresh blood stool, conjunctival congestion, carbuncle, injury from falling down.
Radix Gentianae Macrophyllae has Eradicates rheumatism, Shujin network, the effect of clearind deficient heat; Cold in nature, salty in the mouth, the function clearing away heat-fire, removing pathogenic heat from blood and toxic substance from the body cures mainly pyretic toxicity and sends out the diseases such as speckle, haematemesis.
Indigo Naturalis, heat clearing away, removing heat from blood, detoxifcation; Control the epidemic febrile disease intenseness of heat, macule is spitted blood, is spat blood, pediatric epilepsy scared, and skin ulcer is swollen, erysipelas, snake bite and insect sting.
In order to express better Chinese medicine composition of the present invention, Chinese medicine composition of the present invention can be prepared into dosage form commonly used clinically.Such as, the preparations such as powderous preparations, powder, pill, sublimed preparation, unguentum, granule, oral liquid, syrup, tablet, capsule.Preferably, Chinese medicine composition of the present invention is prepared into powder, unguentum or water preparation according to conventional preparation technology.
The present invention also provides a kind of preparation method for preparing above-mentioned Chinese medicine composition unguentum, and it mainly comprises following step: at first, get Rhizoma dioscoreae, Poria, the Radix Rehmanniae, Rhizoma Polygonati, Radix Pseudostellariae, Rhizoma Chuanxiong, Fructus Lycii, Radix Achyranthis Bidentatae, Fructus Citri, Herba Agrimoniae, Radix Ophiopogonis, Fructus Aurantii, Radix Paeoniae Rubra, Radix Gentianae Macrophyllae and Indigo Naturalis are broken into coarse powder, 4-9 according to the coarse powder gross weight doubly adds the alcoholic solution that volumetric concentration is 40%-95%, reflux, extract, three times, return time are 2-5h, filter, filtrate recycling ethanol, cold filtration washes with water, namely gets Chinese medical concrete after the drying; Next adds white vaseline, glyceryl monostearate, stearic acid and distilled water and makes unguentum.Those skilled in the art can be at the technical clinically conventional Chinese medicine pharmaceutical dosage form for preparing of this preparation method, such as tablet, capsule etc.
The present invention also asks for protection the purposes of above-mentioned Chinese medicine composition in preparation treatment diabetes medicament.Drug effect embodiment 15 of the present invention shows, there is significant synergism in Chinese medicine composition Chinese medicine composition of the present invention in treating diabetes, it is compared with the positive control drug pioglitazone, not only can significantly reduce fasting glucose and 2h-plasma glucose, and can be remarkable.This shows that Chinese medicine composition of the present invention not only can significantly improve the symptom of diabetes in treating diabetes, can also delay the development of diabetes, the generation of complication.
In a word, the present invention compared with prior art has following advantage:
1) compares with the positive control drug pioglitazone, pharmaceutical composition Chinese medicine composition of the present invention is not only more remarkable aspect reduction fasting glucose and 2h-plasma glucose, and also significantly be better than positive drug aspect reduction glycolated hemoglobin and the urine trace albumin, this shows that the present composition has significant synergism in treating diabetes, not only can significantly improve the symptom of diabetes, can also delay the development of diabetes, the generation of complication.
2) compare with the chemotherapeutic agent of current treatment diabetes, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, untoward reaction and side effect significantly reduce, and Chinese medicine composition effect of the present invention is comprehensive, medication effect is better, significantly improve the compliance of diabetics, and improved Quality of Life.
3) existing Remedies for diabetes diabetes initial stage therapeutic effect still can, but along with obvious drug resistance problem all appears in the prolongation for the treatment of time, the therapeutic effect of diabetes descends.Contain the multi-medicament component in the Chinese medicine composition of the present invention, action target spot is numerous, has effectively solved the Commpensation And Adaptation of Remedies for diabetes, and its therapeutic effect to diabetes does not descend because of the treatment time prolongation.
The specific embodiment
Below further describe the present invention by specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or within not breaking away from content of the present invention, spirit and scope, to change, combination or the replacement that the present invention carries out, be apparent for a person skilled in the art, and be included within the scope of the present invention.
First's Chinese medicinal composition preparation of the present invention, preparation and using method thereof
Embodiment 1-6 Chinese medicine composition composition powders
Table 1 Chinese medicine composition composition powders prescription of the present invention
Embodiment 1 preparation method: get each medical material in the compositions, grind to form powdery according to common process, cross 100 mesh sieves, little fire drying is for subsequent use, namely gets powder.During use, with directly taking after mixing it with water behind the water dissolution.Embodiment 2-6 preparation method is with embodiment 1.
Embodiment 7-12 Chinese medicine composition water preparation
Table 2 Chinese medicine composition water preparation prescription of the present invention
Embodiment 7 preparation methoies: get each medical material in the prescription, according to conventional decocting for Chinese herbal medicine technological operation, filtering medicinal residues and get final product.This water preparation (or claiming decoction) when being used for treating diabetes, take 2-3 time by every day.Embodiment 8-12 preparation method and using method are with embodiment 7.
Embodiment 13-18 Chinese medicine composition unguentum of the present invention
Table 3 Chinese medicine composition unguentum prescription of the present invention
Embodiment 13 preparation technologies: at first, each traditional Chinese medicine powder of getting recipe quantity is broken into coarse powder, adding volumetric concentrations according to 5 times of the coarse powder gross weight is 80% alcoholic solution, reflux, extract, three times, the each 3h of return time filters, filtrate recycling ethanol, cold filtration washes with water, namely gets Chinese medical concrete after the drying; Next adds 100g white vaseline, 20g glyceryl monostearate, 120g stearic acid and an amount of distilled water and makes unguentum.
Embodiment 14-18 preparation technology is with embodiment 13.
Second portion Chinese medicine composition pharmacodynamic study of the present invention
Embodiment 15: Chinese medicine composition of the present invention causes the therapeutical effect of diabetes rat model to streptozotocin
1, experimental diabetic animal models preparation
Body weight 160-180gWistar rat, male and female half and half, feed first take high-sugar-fat-diet (albumen select matter 5%, carbohydrate 60% wherein sucrose as 30%, fat 32% wherein refines Adeps Sus domestica as 30%) after 4 weeks, rat fasting 18h.Lumbar injection 0.6% streptozotocin (STZ) 30mg/kg, STZ is dissolved in pH4.0, and in the 0.1mol/L citric acid-sodium citrate buffer, each dose is finished in 10min.Blank group rats by intraperitoneal injection equal-volume citric acid-sodium citrate buffer, the normal raising.Docked afterwards in 5 days and get blood survey whole blood sugar, the success take blood glucose value level>10.0mmol/L person as modeling.
2, experiment grouping and administration
Modeling success rat is divided into model control group at random according to blood sugar level, pioglitazone group, Chinese medicine composition A group, Chinese medicine composition B group, Chinese medicine composition C group, totally 6 groups of Chinese medicine composition D groups, 10 every group.Each group gives respectively following medicine:
Model control group: gavage gives the equal-volume normal saline;
The pioglitazone group: gavage gives pioglitazone 2.5mg/kgd;
Chinese medicine A group: the crude drug amount that gavage gives embodiment 1 preparation is the Chinese medicine composition composition powders of 1g/kgd;
Chinese medicine B group: the crude drug amount that gavage gives embodiment 7 preparations is the Chinese medicine composition water preparation of 3g/kgd;
Chinese medicine C group: the crude drug amount that gavage gives embodiment 13 preparations is the Chinese medicine composition unguentum of 3g/kgd;
Chinese medicine D group: the crude drug amount that gavage gives embodiment 18 preparations is 10g/kgd Chinese medicine composition unguentum
Above-mentioned administration group is administered once every day, continuous 10 weeks.Fasting glucose, the rear 2h blood glucose of feed, glycolated hemoglobin (HbAlc) and urine trace albumin are measured in blood sampling.
3, index determining
3.1 the mensuration of blood glucose: after modeling success rat random packet, according to dosage gastric infusion in continuous 10 weeks, is normally raised.All rats are respectively at getting weekly tail vein detection fasting glucose (FBG), 2h blood glucose (PBG) after the feed before treating and after the treatment in 4 weeks.The blood sample that takes out is put into protein precipitant, after room temperature is placed 7min, centrifugal 5min(3000r/min), get supernatant, survey whole blood sugar with glucose oxidase method.
3.2 the mensuration of glycolated hemoglobin (HbAlc): (grouping, the same blood sugar detection of administration) fasting 12h after the last administration, etherization, eye socket is got blood, presses description mensuration HbAlc in the test kit.
3.3 the mensuration of microalbumin in the urine:
Reagent: a, 10%(v/v) glacial acetic acid solution (PH2.8).
B, 0.303mol/L glycine-glacial acetic acid buffer (PH3.0): take by weighing the 22.72g glycine, be diluted to 1000ml with 10% glacial acetic acid solution, add NaN
3100mg, the room temperature sealing can be stablized 1 year.
C, bromophenol blue (1.924mmol/L) stock solution: accurately take by weighing 257,36mgBPB, molten to 200ml with dehydrated alcohol, 4 ℃ of refrigerators can be stablized 1 year.
D, bromophenol blue (0.231mmol/L) developer: get the 60mlBPB stock solution, add 2.5mlTriton X-100, be diluted to 500ml with glycine-glacial acetic acid buffer, the room temperature sealing can be preserved 1 year.
The collection of specimen and detection: in the 1st, 3,7 and 10 weeks rat is put in the metabolic cage respectively and raises, collect 12 hours overnight urine, accurate recording urine amount.Get 4ml, after sodium azide was processed, centrifugal (2000r/min) 10min got supernatant and puts-20 ℃ of Refrigerator store urinaryalbumin to be measured.Get the albumin standards 400 of respective concentration in the cup of correspondence, respectively add 200 developers, mixing (preventing bubble) is used ultraviolet spectrophotometer, measures absorbance A under 600nm.
4, experimental result and discussion
4.1 the impact of Chinese medicine composition blood glucose in diabetic rats of the present invention
Table 1 Chinese medicine composition of the present invention is on the impact of diabetes rat fasting glucose and the rear 2h blood glucose of feed
*Compare with model group, P<0.05,
*Compare P<0.01 with model group;
#Compare with the pioglitazone group, P<0.05,
##Compare P<0.01 with the pioglitazone group.
Above-mentioned experimental result shows, Chinese medicine composition is compared with pioglitazone in that to reduce aspect fasting glucose and the 2h-plasma glucose effect better.Be embodied in:
1) no matter be fasting glucose or 2h-plasma glucose, pioglitazone group and Chinese medicine A, B, C, D group have significant difference with model group, and Chinese drug-treated group and model group relatively have utmost point significant difference;
2) compare with the pioglitazone group, each group of Chinese medicine is having utmost point significant difference aspect the reduction fasting glucose;
3) compare with the pioglitazone group, Chinese medicine A, B, C group are having significant difference aspect the reduction 2h-plasma glucose, and Chinese medicine D group has been compared significant difference with the pioglitazone group.
4.2 Chinese medicine composition of the present invention is on the impact of diabetes rat glycolated hemoglobin
Table 2 Chinese medicine composition of the present invention is on the impact of diabetes rat HbAlc
*Compare with model group, P<0.05,
*Compare P<0.01 with model group;
#Compare with the pioglitazone group, P<0.05,
##Compare P<0.01 with the pioglitazone group.
Experimental result shows, Chinese medicine composition is compared with the pioglitazone group in that to reduce aspect the glycolated hemoglobin effect better, has remarkable synergism between each composition of Chinese medicine composition.Be embodied in:
1) compare with model control group, the glycolated hemoglobin no difference of science of statistics after the treatment of pioglitazone group, the saccharification hemoglobin content of each group of Chinese medicine all has significant difference;
2) compare with model control group, the saccharification hemoglobin content of each group of Chinese medicine all has significant difference, and wherein Chinese medicine C group and Chinese medicine D group have utmost point significant difference.
4.3 the impact of Chinese medicine composition diabetes rat microdose urine protein of the present invention
Table 3 Chinese medicine composition of the present invention is on the impact of diabetes rat microdose urine protein
Group |
n |
Absorbance A (600nm) |
Model control group |
10 |
0.6841±0.057 |
The pioglitazone group |
10 |
0.5496±0.102
* |
Chinese medicine A group |
10 |
0.5144±0.301
* |
Chinese medicine B group |
10 |
0.5037±0.124
**# |
Chinese medicine C group |
10 |
0.4867±0.187
**# |
Chinese medicine D group |
10 |
0.4201±0.155
**## |
*Compare with model group, P<0.05,
*Compare P<0.01 with model group;
#Compare with the pioglitazone group, P<0.05,
##Compare P<0.01 with the pioglitazone group.
Experimental result shows, Chinese medicine composition has good synergism aspect the diabetes rat microdose urine protein affecting, and its therapeutic effect significantly is better than positive control drug pioglitazone group.This shows that Chinese medicine composition is delaying to have outstanding treatment advantage aspect diabetes PD, the minimizing diabetic complication.Be in particular in:
1) compare with model group, the urine trace albumin content of each group of pioglitazone group and Chinese medicine all has significant difference, and wherein each group of Chinese medicine has utmost point significant difference;
2) compare with the pioglitazone group, the urine trace albumin content of Chinese medicine B, C, D group has significant difference.