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 because insulin in body is relative or the definitely not enough carbohydate metabolism disorder caused, 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 90% left and right 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.Research shows after onset diabetes, within 10 years, have the patient of 30%-40%, to I haven't seen you for ages, a kind of complication occurs.The nephropathy that common diabetic complication has diabetes to 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, according to the authoritative sources, predict, 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, it 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 distributed 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 can not be ignored.
Diabetes are called again diabetes, and the traditional Chinese medical science thinks that its origin cause of formation is many due to the surfeit delicious food, 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 more damages cloudy Tianjin, the two reciprocal causation.Liver be take blood as body, take gas as use, liver controlling conveyance and dispersion, and the balance the body physiological function, the irritability catharsis, 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 burning, the viscera function disorder, thus cause diabetes.Preventing and treating the diabetes key is to keep blood glucose steadily to reach the control to its complication.The method of controlling blood glucose is not simple treatment, it not more simple Drug therapy, but propose to control the five-term measure of diabetes according to the World Health Organization (WHO), diet control, exercise therapy, Drug therapy, diabetes education, blood sugar monitoring carry out 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, due to the toxic and side effects of itself, the organs such as the liver of human body, kidney, the heart, brain are caused to serious infringement, increase the weight of the development of complication.TCM treatment of diabetes 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, be mainly single chemicals and preparations thereof of research and development the eighties in the past, starts 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 to the preparation that extraction and/or compatibility make, its side effect is little, 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 treating diabetes effect is difficult to lasting prior art deficiency, 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 Chinese medicine composition that the present invention treats diabetes is made by the raw material of following weight portion: 30 parts of Rhizoma dioscoreaes, 15 parts of Poria, 15 parts, 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, refer 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, be commonly called as Poria, and sweet in the mouth, light, property are flat, enter the heart, lung, spleen channel; Be used as medicine there is 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 be 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, have 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 weak unable, spontaneous perspiration, night sweat, mouthful equality disease after being ill.
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 various diseases of suitable 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, be the plant of Amaranthaceae Achyranthes, and its property bitter but sweet flavor acid is flat, there is 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, have another name called citron, is the Rutaceae citrus plant, and Fructus Citri acrid in the mouth, micro-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, 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 takes off power, carbuncle, traumatic injury, the cards such as wound hemorrhage.
Radix Ophiopogonis, have another name called Radix Ophiopogonis, is Liliaceae Ophiopogon plant; Be used as medicine Radix Ophiopogonis with tuber; Nature,taste and action: sweet, micro-hardship, cool, 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 hardship, 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 after dysentery, proctoptosis, uterine prolapse.
Radix Paeoniae Rubra, function: clots absorbing, pain relieving, removing heat from blood, detumescence; Cure mainly: control that the stagnant amenorrhea of the stasis of blood, hernia abdominal mass gather, stomachache, hypochondriac pain, epistaxis, dysentery, discharging fresh blood stool, conjunctival congestion, carbuncle, injury from falling down.
Radix Gentianae Macrophyllae, have Eradicates rheumatism, relaxing muscles and tendons 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, cure mainly pyretic toxicity and send out the diseases such as speckle, haematemesis.
Indigo Naturalis, heat clearing away, removing heat from blood, removing toxic substances; Control the epidemic febrile disease intenseness of heat, macule, spit blood, spit 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 is 2-5h, filters, filtrate recycling ethanol, cold filtration, wash with water, obtains Chinese medical concrete after drying; Next adds white vaseline, glyceryl monostearate, stearic acid and distilled water to make unguentum.Those skilled in the art can be at the technical conventional Chinese medicine pharmaceutical dosage form clinically for preparing of this preparation method, 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) with the positive control drug pioglitazone, compare, 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 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) with the chemotherapeutic agent of current treatment diabetes, compare, 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 improved the compliance of diabetics, and improved patient's 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 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, the change that the present invention is carried out, combination or replacement, 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 compositions, according to common process, grind to form powdery, cross 100 mesh sieves, little fire drying is standby, obtains powder.During use, with directly taking after mixing it with water after 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 prescription, according to conventional decocting for Chinese herbal medicine technological operation, filtering medicinal residues and get final product.This water preparation (or claim decoction) is during for treating diabetes, and take 2-3 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, 5 times according to the coarse powder gross weight add the alcoholic solution that volumetric concentration is 80%, reflux, extract, three times, the each 3h of return time, filter, filtrate recycling ethanol, cold filtration, wash with water, obtains Chinese medical concrete after drying; Next adds 100g white vaseline, 20g glyceryl monostearate, 120g stearic acid and appropriate distilled water to make 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, first feed 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 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.Within 5 days, dock afterwards and get blood survey whole blood sugar, take blood glucose value level>10.0mmol/L person as the modeling success.
2, experiment grouping and administration
Modeling success rat is divided into to 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: gavage gives the Chinese medicine composition composition powders that the crude drug amount of embodiment 1 preparation is 1g/kgd;
Chinese medicine B group: gavage gives the Chinese medicine composition water preparation that the crude drug amount of embodiment 7 preparation is 3g/kgd;
Chinese medicine C group: gavage gives the Chinese medicine composition unguentum that the crude drug amount of embodiment 13 preparation is 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: by after modeling success rat random packet, according to dosage gastric infusion, continuous 10 weeks, normally raise.All rats are respectively at getting weekly tail vein detection fasting glucose (FBG), 2h blood glucose (PBG) after feed before treating and after treatment in 4 weeks.The blood sample of taking-up is put into to 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 in test kit and measures HbAlc.
3.3 the mensuration of microalbumin in urine:
Reagent: a, 10%(v/v) glacial acetic acid solution (PH2.8).
B, 0.303mol/L glycine-glacial acetic acid buffer (PH3.0): take the 22.72g glycine, with 10% glacial acetic acid solution, be diluted to 1000ml, add NaN
3100mg, the room temperature sealing can be stablized 1 year.
C, bromophenol blue (1.924mmol/L) stock solution: accurately take 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, with glycine-glacial acetic acid buffer, be diluted to 500ml, 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 metabolic cage and raises respectively, collect 12 hours overnight urine, accurate recording urine amount.Get 4ml, after sodium azide is processed, centrifugal (2000r/min) 10min, get supernatant and put-20 ℃ of Refrigerator store urinaryalbumin to be measured.Get the albumin standards 400 of respective concentration in corresponding cup, respectively add 200 developers, mix (preventing bubble), use ultraviolet spectrophotometer, under 600nm, measure absorbance A.
4, experimental result and discussion
4.1 the impact of Chinese medicine composition blood glucose in diabetic rats of the present invention
The impact of table 1 Chinese medicine composition of the present invention on diabetes rat fasting glucose and the rear 2h blood glucose of feed
*with model group, compare, P<0.05,
*compare P<0.01 with model group;
#with the pioglitazone group, compare, P<0.05,
##compare P<0.01 with the pioglitazone group.
Above-mentioned experimental result shows, Chinese medicine composition is compared with pioglitazone to reduce aspect fasting glucose and 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) with the pioglitazone group, compare, each group of Chinese medicine is having utmost point significant difference aspect the reduction fasting glucose;
3) with the pioglitazone group, compare, 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 the impact of Chinese medicine composition of the present invention on the diabetes rat glycolated hemoglobin
The impact of table 2 Chinese medicine composition of the present invention on diabetes rat HbAlc
*with model group, compare, P<0.05,
*compare P<0.01 with model group;
#with the pioglitazone group, compare, P<0.05,
##compare P<0.01 with the pioglitazone group.
Experimental result shows, Chinese medicine composition is compared with the pioglitazone group to reduce aspect glycolated hemoglobin effect better, between each composition of Chinese medicine composition, has remarkable synergism.Be embodied in:
1) with model control group, compare, 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) with model control group, compare, 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
The impact of table 3 Chinese medicine composition of the present invention on the 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
**## |
*with model group, compare, P<0.05,
*compare P<0.01 with model group;
#with the pioglitazone group, compare, P<0.05,
##compare P<0.01 with the pioglitazone group.
Experimental result shows, Chinese medicine composition has good synergism affecting aspect the diabetes rat microdose urine protein, 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, minimizing diabetic complication.Be in particular in:
1) with model group, compare, 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) with the pioglitazone group, compare, the urine trace albumin content of Chinese medicine B, C, D group has significant difference.