CN101143180A - Medicine for treating diabetes - Google Patents
Medicine for treating diabetes Download PDFInfo
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- CN101143180A CN101143180A CNA200710149374XA CN200710149374A CN101143180A CN 101143180 A CN101143180 A CN 101143180A CN A200710149374X A CNA200710149374X A CN A200710149374XA CN 200710149374 A CN200710149374 A CN 200710149374A CN 101143180 A CN101143180 A CN 101143180A
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Abstract
The invention relates to a drug for remedying the diabetes and relates to the extraction method and preparation method of the drug. The drug mainly comprises a rehmannia root and a Chinese rose flower and also includes a kudzuvine root and/or a barbary wolfberry fruit. The pharmacological test testifies that the invention has the hypoglycemic effect.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of diabetes, also relate to its extracting method and preparation method.
Technical background
Diabetes spp is in the traditional Chinese medical science category of " quenching one's thirst ", and ancient Chinese medicine doctor is discussed quite detailed to primary disease.The name of quenching one's thirst, head sees " interior warp "." Medical Treasures of the Golden Chamber " upright specially piece of writing of quenching one's thirst proposes three types of diabetes symptom and the side's of treatment medicine.The primary disease pathogenic factor mainly is an eating and drinking without temperance, and long-term surfeit delicious food savoury causes the transporting and transforming function of the spleen and stomach dereliction of duty, accumulate in the long-pending heat, and the dryness-transformation impairment of body fluid, and send out to quenching one's thirst.In addition, also excessively relevant with disorder of emotion, the plain body deficiency of YIN, impairment caused by overstrain.
Modern doctor trained in Western medicine theory thinks that diabetes are endocrine-metabolic diseases.Its general pathology is explained and is: because insulin is absolute or relative deficiency, cause sugar, fat, protein and Secondary cases vitamin, water, metabolic disturbance of electrolyte, often can concurrent atherosclerosis, microangiopathies, nervous system lesion, thereby cause the infringement of a plurality of systems, a plurality of internal organs.
At present, along with factors such as the variation of the improvement of the raising of people's living standard, dietary structure and life style and gene, the sickness rate of diabetes is increased day by day.According to incompletely statistics, China has nearly 3,000 ten thousand people of diabetics now, and also increase progressively with 700,000 people's development speed every year.Diabetes are divided two kinds, I type and II type.The I type is an insulin-dependent, and the II type is a non-insulin-depending type.II type patient wherein, promptly the non-insulin-dependent diabetes mellitus patient accounts for diabetics total number of persons about 90%, and people's health and lives in serious threat, and does not still have a kind of ideal medicament of both having taken stopgap measures and having effected a permanent cure both at home and abroad at present.
The western medical treatment diabetes are used medicines such as sulphanylureas, biguanides and insulin mostly, though its hypoglycemic activity is obvious, but only can reach the degree of regulating metabolism disorder, and side effect is big, take grievous injury liver, kidney for a long time, influence gastrointestinal function, its complication is difficult to control especially, and " knock-on " phenomenon is in various degree all arranged after the drug withdrawal.And the treatment by Chinese herbs diabetes have been showed superiority day by day.
The Chinese patent CN2003 10121579.9 " Fols Rosae extract and its production and use " of Chinese patent CN 99103552.6 " application of Flos Rosae Chinensis in the treatment diabetes " and inventor's application all discloses the report of Flos Rosae Chinensis or Fols Rosae extract treatment diabetes, though the effect of folk prescription treatment diabetes is more remarkable, in order to remedy the deficiency of single medicinal material, better strengthen the treatment of diabetes effect, simultaneously according to understanding to onset diabetes mechanism, with reference to modern pharmacology research achievement, filter out Chinese medicine compound.
Recently the report Radix Rehmanniae has regulating action to unusual carbohydrate metabolism.The oligosaccharide that extracts from Radix Rehmanniae can obviously reduce alloxan diabetes rats hyperglycemia level, increase liver glycogen content, reduce hepatic glucose-6-phosphatase activity, but normal rat blood sugar is not had obvious influence, but the hyperglycemia that partial prophylaxis glucose and epinephrine cause; And behind the adrenalectomize, the Radix Rehmanniae oligosaccharide disappears to the preventive effect of glucose hyperglycemia.The carbohydrate metabolism disturbance and the physiological hyperglycemia state of Radix Rehmanniae oligosaccharide scalable artificial diabetes are described.
Puerarin can have certain blood sugar lowering ability to adrenolytic blood glucose increasing effect.
Lycium barbarum extracts can cause the remarkable and persistent reduction of rat blood sugar, and carbohydrate tolerance raises simultaneously.
The bibliographical information of not forming compound recipe about above medicine.
Summary of the invention
The medicament composing prescription that the purpose of this invention is to provide a kind of new treatment diabetes is to reach the purpose that significantly improves the treatment of diabetes effect.
The invention provides a kind of medicine for the treatment of diabetes, mainly make: 55～95 parts of Radix Rehmanniae, 40～80 parts of Flos Rosae Chinensiss by the medicine of following weight fraction.
Can also contain Radix Puerariae in the medicine of treatment diabetes, its parts by weight are 30～60 parts.
Can also contain Fructus Lycii in the medicine of treatment diabetes, its parts by weight are 30～60 parts.
Can also cooperate the nourishing class medicine of classes such as the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae to take in the medicine of treatment diabetes, also can be equipped with drugs for nourishing yin such as taking the Chinese patent medicine LIUWEI DIHUANG WAN.
Another object of the present invention provides the extraction process of this diabetes medicament.
When containing Radix Rehmanniae, Flos Rosae Chinensis in the medicine of treatment diabetes, its extracting method is as follows:
Take by weighing Radix Rehmanniae and Flos Rosae Chinensis by the prescription proportioning, water or 30%-70% alcohol heating reflux extract three times, and each 1 hour, the extracting solution that obtains was as active component.
When containing Radix Rehmanniae, Flos Rosae Chinensis and Radix Puerariae in the medicine of treatment diabetes, its extracting method is as follows:
Take by weighing Radix Rehmanniae, Flos Rosae Chinensis and Radix Puerariae by the prescription proportioning, water or 30%-70% alcohol heating reflux extract three times, and each 1 hour, the extracting solution that obtains was an active component.
When containing Radix Rehmanniae, Flos Rosae Chinensis and Fructus Lycii in the medicine of treatment diabetes, its extracting method is as follows:
Take by weighing Radix Rehmanniae, Flos Rosae Chinensis and Fructus Lycii by the prescription proportioning, water heating and refluxing extraction three times, each 1 hour, the extracting solution that obtains was an active component.
When containing Radix Rehmanniae, Flos Rosae Chinensis, Radix Puerariae and Fructus Lycii in the medicine of treatment diabetes, its extracting method is as follows:
Take by weighing Radix Rehmanniae, Flos Rosae Chinensis, Radix Puerariae and Fructus Lycii by the prescription proportioning, water heating and refluxing extraction three times, each 1.5 hours, the extracting solution that obtains was an active component.
Another object of the present invention provides the preparation that contains the medicine for the treatment of diabetes, can add the required various conventional adjuvant of preparation different dosage form in the active component of treatment diabetes, as disintegrating agent, lubricant, binding agent or the like, method of Chinese medicinal with routine is prepared into any peroral dosage form commonly used, as pill, powder, tablet, capsule, oral liquid etc.
Simultaneously, show that by pharmacology test the medicine blood sugar reducing function of treatment diabetes has significant hypoglycemic activity.
The advantage of medicine of the present invention is:
1) energy blood sugar lowering, but normal rat blood sugar there is not obvious influence, medicine does not have influence to euglycemia, and the prompting clinical drug is used and that it(?) may not can be produced hypoglycemic reaction, has kept the advantage of traditional Chinese medicine;
2) the normal rat carbohydrate tolerance is not had obvious influence, but type ii diabetes rat blood sugar rising amplitude is starkly lower than glucose group, illustrate that medicine of the present invention improves significantly to type ii diabetes rat impaired glucose tolerance.
3) has synergistic function.
The specific embodiment
Further set forth preparation method and the pharmacodynamic study and the clinical research of medicine of the present invention by the following examples, but following examples should not become limitation of the present invention.
Embodiment 1: the hard capsule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 55g, Flos Rosae Chinensis 80g
2, extract active component: take by weighing above-mentioned two flavors by the prescription proportioning, use decocting respectively three times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and drying is pulverized, and gets extract powder.
3, the preparation of hard capsule: above-mentioned extract powder is sprayed into 90% ethanol, put in the mixer, stir, granulate with 14 mesh sieves, 60 ℃ of forced air dryings make water content below 9%, and 16 mesh sieve granulate add an amount of magnesium stearate mixing, incapsulate every 0.3g.
Embodiment 2: the tablet of treatment diabetes medicament
1, prescription: Radix Rehmanniae 65g, Flos Rosae Chinensis 70g
2, press embodiment 1 described method, carry out extraction of active ingredients, but the preparation method film-making agent of Chinese medicinal tablet routinely, every agreement that contracts a film or TV play to an actor or actress contains medicated powder 0.30g.
Embodiment 3: the granule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 75g, Flos Rosae Chinensis 60g
2, press the method for embodiment 1, carry out extraction of active ingredients, but the preparation method system of Chinese medicine granules sugar type granules routinely divides packing, every packed 4g.
Embodiment 4: the capsule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 95g, Flos Rosae Chinensis 40g
2, extract active component: take by weighing above-mentioned two flavor medicines by the proportioning of writing out a prescription, use 50% pure reflux three times respectively, each 1 hour, merge extractive liquid, filtered, and reclaimed ethanol and was concentrated into the thick paste shape, and drying is pulverized, and gets extract powder.
3, with above-mentioned extract powder, press step 3 granulation, drying among the embodiment 1, granulate incapsulates, every 0.3g.
Embodiment 5: the granule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 55g, Flos Rosae Chinensis 80g, Radix Puerariae 60g
2, take by weighing above-mentioned three flavor medicines by the prescription proportioning, use decocting respectively three times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and drying is pulverized, and gets extract powder.
3,, divide packing, every packed 5g with the above-mentioned extract powder preparation method system sugar type granules of Chinese medicine granules routinely.
Embodiment 6: the granule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 75g, Flos Rosae Chinensis 60g, Radix Puerariae 45g
2, press the method for embodiment 5, carry out extraction of active ingredients, but the preparation method system of Chinese medicine granules sugar type granules routinely divides packing, every packed 5g.
Embodiment 7: the capsule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 95g, Flos Rosae Chinensis 40g, Radix Puerariae 30g
2, take by weighing above-mentioned three flavor medicines by the proportioning of writing out a prescription, use 50% pure reflux three times respectively, each 1 hour, merge extractive liquid, filtered, and reclaimed ethanol and was concentrated into the thick paste shape, and drying is pulverized, and gets extract powder.
3, with above-mentioned extract powder, press step 3 granulation, drying among the embodiment 1, granulate incapsulates, every 0.32g.
Embodiment 8: the tablet of treatment diabetes medicament
1, prescription: Radix Rehmanniae 55g, Flos Rosae Chinensis 80g, Fructus Lycii 60g
2, take by weighing above-mentioned three flavor medicines by the prescription proportioning, use decocting respectively three times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and drying is pulverized, and gets extract powder.
3, with the preparation method film-making agent of Chinese medicinal tablet routinely of above-mentioned extract powder, every agreement that contracts a film or TV play to an actor or actress contains medicated powder 0.40g.
Embodiment 9: the capsule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 75g, Flos Rosae Chinensis 60g, Fructus Lycii 45g
2, make extract powder by embodiment 8 methods, but press step 3 granulation, drying among the embodiment 1, granulate incapsulates, every 0.35g.
Embodiment 10: the granule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 95g, Flos Rosae Chinensis 40g, Fructus Lycii 20g
2, make extract powder by embodiment 8 methods, but the preparation method system of Chinese medicine granules sugar type granules routinely divides packing, every packed 5g.
Embodiment 11: the granule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 90g, Flos Rosae Chinensis 40g, Radix Puerariae 60g, Fructus Lycii 30g
2, take by weighing above-mentioned 4 flavor medicines by prescription, add decocting respectively three times, each 1.5 hours, collecting decoction filtered, and filtrate is condensed into thick paste, and drying is pulverized, and gets extract powder.
3,, divide packing, every packed 5g with the above-mentioned extract powder preparation method system sugar type granules of Chinese medicine granules routinely.
Embodiment 12: the capsule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 80g, Flos Rosae Chinensis 55g, Radix Puerariae 40g, Fructus Lycii 40g.
2, make extract powder by embodiment 11 methods, press step 3 granulation, drying among the embodiment 1, granulate incapsulates, every 0.40g.
Embodiment 13: the tablet of treatment diabetes medicament
1, prescription: Radix Rehmanniae 75g, Flos Rosae Chinensis 60g, Radix Puerariae 45g, Fructus Lycii 45g.
2, make extract powder by embodiment 11 methods, the preparation method film-making agent of Chinese medicinal tablet routinely, every agreement that contracts a film or TV play to an actor or actress contains medicated powder 0.4g.
Embodiment 14: the capsule of treatment diabetes medicament
1, prescription: Radix Rehmanniae 55g, Flos Rosae Chinensis 80g, Radix Puerariae 30g, Fructus Lycii 60g.
2, make extract powder by embodiment 11 methods, the preparation method film-making agent of Chinese medicinal tablet routinely, every agreement that contracts a film or TV play to an actor or actress contains medicated powder 0.40g.
Simultaneously, the present invention has been undertaken curing mainly relevant Pharmacodynamic test of active extract with function by setting up animal model.
Embodiment 15: to the hypoglycemic activity of normal mouse
1. experiment material
1.1 trial drug: embodiments of the invention 3 are basic medicine.Reference substance: TANGMAIKANG KELI, lot number: 050902, specification: 5g/ bag is provided by Zhonghui Pharmacy Co., Ltd., Chengdu.Glucobay (acarbose), lot number: 106201, specification: the 50mg/ sheet is provided by the Bayer HealthCare Co BeiJing, China.
1.2 laboratory animal: 60 of Kunming mouses, regular grade, male and female half and half, 18-22g is provided by Shandong University's Experimental Animal Center.Credit number: SCXK (Shandong) 20030004 is signed and issued by Shandong Province science and technology bureau.
1.3 test apparatus equipment:
AY220 type electronic analytical balance, Tianjin, island company limited is produced; JY2001 type electronic balance, Shanghai Precision Scientific Apparatus Co., Ltd produces; Lab-500 type automatic clinical chemistry analyzer is produced by peach garden, Nanjing Applied Biotechnology company limited; TDL-5 table-type low-speed high capacity centrifuge, Jintan City, Jiangsu Province Medical Instruments factory produces.
2. test method
2.1 test grouping: get 60 of healthy mices, 18-22g, male and female half and half are divided into 6 groups at random by body weight, are respectively blank group, TANGMAIKANG KELI 2.5g/kg, glucobay (acarbose) 0.025g/kg group and month Qi hypoglycemic granule 4.0,2.0, three dosage groups of 1.0g/kg.
2.2 test method: each administration group is irritated the medicinal liquid that stomach (i.g) gives variable concentrations, administration volume 20ml/kg, and the blank group gives isometric purified water, once a day, continuous 15 days, fasting 12h before the last administration, 1h gets blood after by mouse orbit after the last administration, surveys fasting blood sugar.
3. data statistics and result judge:
Every group of rat numerical value is with mean ± standard deviation (x ± SD) expression.With spss13.0 each group data is carried out statistical analysis.
4. result of the test: see Table 1
Table 1: month Qi hypoglycemic granule is to the influence (x ± SD n=10) of normal mouse blood sugar
| Group | Dosage (g/kg) | Blood glucose (mmol/l) |
| Dosage group high dose group in the blank group glucobay (acarbose) group TANGMAIKANG group low dose group | /0.025 2.5 1.0 2.0 4.0 | 8.16±1.14 6.97±1.11 *7.23±1.36 7.89±0.82 7.54±0.89 7.30±1.10 |
Annotate: * P＜0.05 vs blank group
Found out by table 1: glucobay (acarbose) group and blank group relatively have significant difference; Other administration groups and blank group be no difference of science of statistics relatively.
Conclusion (of pressure testing): this experimental study the hypoglycemic activity of medicine of the present invention to normal mouse, result of the test shows: the high, medium and low dosage group gastric infusion of embodiment 3, once a day, continuous 15 days, normal mouse is not had obvious hypoglycemic activity.
Embodiment 16: to the influence of normal rat carbohydrate tolerance
1. experiment material
1.1 trial drug: the medicine that embodiments of the invention 3 provide; Metformin, lot number: 0511009, specification: the 0.25g/ sheet, healthy pharmaceutcal corporation, Ltd provides by Shandong; TANGMAIKANG KELI, lot number: 050902, specification: 5g/ bag is provided by Zhonghui Pharmacy Co., Ltd., Chengdu; 50% glucose injection, specification: 20ml/, lot number: 0511535, favorable to the people Pharmaceutical Co provides by Jinan.
1.2 laboratory animal:
The Wistar rat, regular grade, male and female half and half, 180-220g is provided by Shandong University's Experimental Animal Center.Credit number: SCXK (Shandong) 20030004 is signed and issued by Shandong Province science and technology bureau.
1.3 test apparatus equipment: with embodiment 15
2. test method
Get 70 of healthy rats, 180-220g, male and female half and half are divided into 10 groups at random by body weight, be respectively blank group, glucose 2.5g/kg group, TANGMAIKANG KELI 2.0g/kg, among metformin 0.2g/kg group and the embodiment 3, low, high (0.7,1.5,3.0g/kg body weight) three dosage groups.
Each administration group is irritated the medicinal liquid that stomach gives variable concentrations, administration volume 10ml/kg, the blank group gives isometric purified water, once a day, continuous 5 days, 1h after the last administration (fasting 12h) surveys 0 o'clock blood glucose, and each organizes all lumbar injection glucose 2.5g/kg of rat (the blank group is outer), gets blood behind injection back 30min, 60min, the 120min socket of the eye and surveys blood glucose value.
3. data statistics and result judge:
Every group of rat numerical value is with mean ± standard deviation (x ± SD) expression.With spss13.0 each group data is carried out statistical analysis.
4. result of the test: see Table 2
Table 2 normal rat carbohydrate tolerance blood glucose (mmol/l) value changes (x ± SI n=10)
| Group | Dosage | 0min | 30min | 60min | 120min |
| Dosage group high dose group in the blank group glucose group TANGMAIKANG group metformin group low dose group | /2.5g/kg 2.0g/kg 0.2g/kg 0.7g/kg 1.5g/kg 3.0g/kg | 4.65±0.24 4.69±0.30 4.87±0.26 4.67±0.22 4.80±0.32 4.88±0.28 4.86±0.33 | 5.16±0.30 12.32±0.82 ##10.80±0.94 **8.51±0.69 **12.22±1.00 11.96±0.83 11.69±0.92 | 5.10±0.38 11.30±0.94 ##10.66±0.69 8.18±0.71 **10.93±0.98 10.62±0.75 10.66±0.68 | ?4.69±0.18 8.79±0.66 ##8.84±0.67 7.34±0.76 **9.18±0.61 8.84±0.49 8.79±0.30 |
*P＜0.05,
*P＜0.01 vs glucose group;
##P＜0.01 vs blank group
By table 2 as seen, the glucose group blood glucose value obviously raises, with the blank group significant difference is arranged relatively, metformin group blood glucose value and glucose group during 30-120mi n behind the injectable dextrose monohydrate relatively have utmost point significant difference (P＜0.01), and all the other each administration groups and glucose group are not seen notable difference.
5. conclusion (of pressure testing): this experimental study the influence of medicine of the present invention to the normal rat carbohydrate tolerance.The result shows: the metformin group relatively has utmost point significant difference (P＜0.01) with glucose group during 30-120min behind the injectable dextrose monohydrate, each dosage group of medicine and glucose group are not seen notable difference.Illustrate that this medicine does not have obvious influence to the normal rat carbohydrate tolerance.
Embodiment 17: to the influence of type ii diabetes rat carbohydrate tolerance
1. experiment material
1.1 trial drug: the medicine that the embodiment of the invention 3 provides; Metformin, lot number: 0511009, specification: the 0.25g/ sheet, healthy pharmaceutcal corporation, Ltd provides by Shandong.
1.2 reagent: streptozotocin, specification: the 1g/ bottle, Sigma company provides; Citric acid, specification: the 500g/ bottle is provided by Shandong Boshan chemical reagent factory; Sodium bicarbonate, specification: 500g/ bottle, lot number: on November 02nd, 2005, become the chemical reagent company limited to provide by Tianjin light.
1.3 laboratory animal: with embodiment 16
1.4 test apparatus equipment: with embodiment 15
2. test method
2.1 test modeling: 140 of healthy rats, 180-220g gets wherein 10 as the blank group; All the other animal fasting 12h (can't help water), lumbar injection streptozotocin 30 mg/kg (0.1mol/L citric acid pH4.2 is mixed with 1% solution, ice bath during injection), the next day once, continuous 2 times.14 d behind the injection streptozotocin get blood and survey blood glucose, select blood glucose to raise with the high heat feedstuff greater than the animal of 12.00mmol/L, and the normal group animal gives normal feedstuff.8 weeks back modeling animal is got blood, selects qualified rat to do carbohydrate tolerance test.
2.2 carbohydrate tolerance test:
The blood glucose value random packet press in modeling success back, is respectively three dosage groups of low middle high dose group (0.7,1.5,3.0g/kg) of blank group, model group, the positive group of metformin 0.2g/kg, embodiment 3.Each group gives corresponding medicine or solvent respectively, continuous 5 days, 1h after the last administration (fasting 12h) surveys 0 o'clock blood glucose, and each organizes all lumbar injection glucose 2.5g/kg of rat (the blank group is outer), gets blood behind injection back 30min, 60min, the 120min socket of the eye and surveys blood glucose value.Observe the influence of medicine to type ii diabetes rat carbohydrate tolerance.
3. data statistics:
Every group of rat numerical value is with mean ± standard deviation (x ± SD) expression.With spss13.0 each group data is carried out statistical analysis.
4. result of the test: as seen by table 3,30min blood glucose obviously raises behind the type ii diabetes rats by intraperitoneal injection glucose, the basic, normal, high dosage group blood sugar increasing amplitude of medicine of the present invention is starkly lower than glucose group, with glucose group significance or utmost point significant difference are arranged relatively, illustrate that medicine of the present invention improves significantly to type ii diabetes rat impaired glucose tolerance more than 0.7g/kg.
Table 3 type ii diabetes rat carbohydrate tolerance blood glucose (mmol/l) changes (x ± SD n=10)
| Group | Dosage (g/kg) | 0min | 30min | 60min | 120min |
| Dosage group high dose group in the blank group model group glucose group metformin group low dose group | / / 2.5 0.2 0.7 1.5 3.0 | 6.96±1.20 19.64±4.31 19.79±4.48 19.90±4.71 19.97±4.77 19.86±4.84 19.90±4.78 | 7.19±0.89 19.85±3.96 28.63±4.19 ##26.29±5.06 28.30±5.13 28.44±5.16 29.02±4.86 | 7.41±0.79 19.31±3.33 28.99±3.94 ##23.73±5.27 **24.37±5.69 *23.97±4.89 *22.83±4.23 ** | 6.78±0.44 19.03±4.96 26.60±4.45 ##21.29±5.39 *22.24±5.86 *21.50±4.46 *21.75±4.74 * |
Annotate:
*P＜0.05,
*P＜0.01 vs glucose group
##P＜0.01 vs model group
5. conclusion (of pressure testing): this experimental study medicine of the present invention to type ii diabetes rat oral administration after the influence of carbohydrate tolerance.The result shows: 30min blood glucose obviously raises behind the type ii diabetes rats by intraperitoneal injection glucose, the basic, normal, high dosage group of medicine of the present invention blood glucose obviously reduces, with glucose group significance or utmost point significant difference are arranged relatively, illustrate that medicine of the present invention improves significantly to type ii diabetes rat carbohydrate tolerance more than 0.7g/kg.
Embodiment 18: to the therapeutical effect of type ii diabetes rat
1. test material:
1.1 trial drug: the medicine of the embodiment of the invention 3; Metformin, lot number: 0511009, specification: the 0.25g/ sheet, healthy pharmaceutcal corporation, Ltd provides by Shandong.TANGMAIKANG KELI, lot number: 050902, specification: 5g/ bag is provided by Zhonghui Pharmacy Co., Ltd., Chengdu.
1.2 reagent: streptozotocin, specification: the 1g/ bottle, Sigma company provides; Citric acid, specification: the 500g/ bottle is provided by Shandong Boshan chemical reagent factory; Sodium bicarbonate, specification: 500g/ bottle, lot number: on November 02nd, 2005, become the chemical reagent company limited to provide by Tianjin light.
1.3 laboratory animal: with embodiment 17
1.4 test apparatus equipment: with embodiment 15
2. test method
140 of healthy rats, 180-220g gets wherein 10 as the blank group; All the other animal fasting 12h (can't help water), lumbar injection streptozotocin 30 mg/kg (0.1mol/L citric acid pH4.2 is mixed with 1% solution, ice bath during injection), the next day once, continuous 2 times.14 d behind the injection streptozotocin get blood and survey blood glucose, select blood glucose to raise with the high heat feedstuff greater than the animal of 12.00mmol/L, and the normal group animal gives normal feedstuff.
8 weeks back modeling animal is got blood, select qualified rat to do carbohydrate tolerance test, after carbohydrate tolerance test finished, animal 2 days at interval was respectively by high, medium and low dosage group (15g, 7.5g, 3.5g/kg body weight), TANGMAIKANG KELI 2.0g/kg group, metformin 0.2g/kg group.Glucose group gives TANGMAIKANG, every day 1 time, continuous 4 weeks.Etherization rat behind the last medicine, abdominal aortic blood are measured fasting glucose, serum insulin and glycolated hemoglobin, observe medicine to the influence of blood glucose, serum insulin and glycolated hemoglobin and get pancreas and do pathology, observe its pathological change.
3. data statistics:
Every group of rat numerical value is with mean ± standard deviation (x ± SD) expression.With spss13.0 each group data is carried out statistical analysis.
4. result of the test: see Table 4,5.
By table 4, table 5 as seen, respectively organize relatively no significant difference of glycolated hemoglobin behind the medicine, but all be higher than the blank group, illustrate that rat is in the success of modeling of 8-12 week.Basic, normal, high dosage group blood glucose obviously reduces behind the medicine, with model group significance or utmost point significant difference is arranged relatively, and low dose group (0.7g/kg) blood glucose is suitable with the metformin group, and middle and high dosage group blood glucose reduces amplitude greater than the metformin group.Illustrate that medicine of the present invention has tangible blood sugar reducing function more than 0.7g/kg.The insulin model group is apparently higher than the blank group behind the medicine, illustrate that rat has produced insulin resistant, middle and high dosage group obviously reduces, and with model group significance or utmost point significant difference is arranged relatively, and be better than TANGMAIKANG and metformin group, illustrate that medicine can reduce resistance of insulin and reducing.
Blood glucose value before the table 4 type ii diabetes rat medicine (x ± SD)
| Group | Dosage (g/kg) | Blood glucose (mmol/l) |
| Blank group mould is not organized dosage group high dose group in the TANGMAIKANG group metformin group low dose group | / / 2.0 0.2 0.7 1.5 3.0 | 7.09±1.14 20.22±4.09 ##20.25±4.74 20.26±4.49 20.28±4.55 20.14±4.82 20.59±4.99 |
Annotate:
=P＜0.01 vs blank group
Blood glucose behind the table 5 type ii diabetes rat medicine, glycolated hemoglobin, insulin change (x ± SD)
| Group | Dosage (g/kg) | n | Blood glucose (mmol/l) | Glycolated hemoglobin (%) | Insulin (μ Iu/ml) |
| Dosage group high dose group in the blank group model group TANGMAIKANG group metformin group low dose group | / / 2.0 0.2 0.7 1.5 3.0 | 10 9 9 8 9 8 8 | 6.75±0.72 19.62±4.15 ##14.72±3.72 **15.61±4.46 *15.90±4.20 *13.66±3.34 **2.23±2.81 ** | 4.17±0.42 20.98±3.07 ##21.01±3.06 21.61±3.08 20.68±4.69 21.?25±3.32 20.90±3.58 | 13.40±4.41 23.00±9.11 ##14.99±5.45 *16.16±6.54 17.02±5.08 14.67±9.23 *12.42±8.35 ** |
Annotate:
*P＜0.05,
*P＜0.01 vs model group
##＜0.01 vs blank group
Pathological tissue is checked: blank group pancreas: body of gland is the lobulated structure, and the acinus epithelial cell is cone-shaped, and the karyon circle is positioned at substrate.Endochylema is the red graininess of dying.Islet distribution is spheric cell mass between acinus, around islets has a spot of reticular fiber, and the cell in the islets of langerhans is arranged in irregular strand, and iuntercellular has abundant blood capillary.Model group pancreas: islets of langerhans decreased number, smaller volume, beta Cell of islet vacuolar degeneration, necrosis, disappearance.Metformin group pancreas: islets of langerhans smaller volume, beta Cell of islet vacuolar degeneration, necrosis, disappearance.TANGMAIKANG pancreas: islets of langerhans decreased number, smaller volume, beta Cell of islet vacuolar degeneration, necrosis, disappearance.Medicine low dose group pancreas of the present invention: the islets of langerhans smaller volume, the beta Cell of islet vacuolar degeneration is more serious, most of β necrocytosis, disappearance.The other proliferation of fibrous tissue of blood capillary in the islets of langerhans; Middle dosage group pancreas: islets of langerhans decreased number, smaller volume, beta Cell of islet vacuolar degeneration; High dose group pancreas: islets of langerhans smaller volume, beta Cell of islet vacuolar degeneration, disappearance.Illustrate that medicine does not have obvious improvement effect to the damage of islet cells.
5. conclusion (of pressure testing): this experimental study the therapeutical effect of medicine of the present invention after to type ii diabetes rat oral administration.The result shows: basic, normal, high dosage group blood glucose obviously reduces behind the medicine, with model group significance or utmost point significant difference is arranged relatively, and low dose group (0.7g/kg) blood glucose is suitable with the metformin group, and middle and high dosage group blood glucose reduces amplitude greater than the metformin group.Illustrate that medicine of the present invention has tangible blood sugar reducing function more than 0.7g/kg.The model group serum insulin is apparently higher than the blank group behind the medicine, illustrate that rat has produced insulin resistant, basic, normal, high dosage group blood glucose obviously reduces, with model group significance or utmost point significant difference are arranged relatively, and serum insulin rising amplitude is lower than model group, illustrates that medicine can reduce resistance of insulin and reducing.Pathological tissue check result explanation medicine does not have obvious improvement effect to the damage of islet cells.
Embodiment 19: alloxan is added the therapeutical effect that glucose is made Π type diabetes insulin opposing model
1. test material
1.1 trial drug: the medicine that the embodiment of the invention 3 provides; TANGMAIKANG KELI, lot number: 050902, specification: 5g/ bag is provided by Zhonghui Pharmacy Co., Ltd., Chengdu; Metformin, lot number: 0511009, specification: the 0.25g/ sheet, healthy pharmaceutcal corporation, Ltd provides by Shandong.
1.2 experimental animal: Kunming mouse, regular grade, male and female half and half, 18-22g is provided by Shandong University's Experimental Animal Center.Credit number: SCXK (Shandong) 20030004 is signed and issued by Shandong Province science and technology bureau.
1.3 reagent: alloxan, Sigma company provides; Sodium chloride injection, specification: 250ml:2.25g, lot number: 06030312, there is Shangdong Hualu Pharmaceutical Co., Ltd. to provide.
1. 4 test apparatus equipment: with embodiment 15
2. test method
Get 140 of healthy mices, 18-22g, male and female half and half, get 10 (male and female half and half) mices and do the blank group, all the other tail vein injection alloxan normal saline solution 100mg/kg solution, get blood after 3 days and survey blood glucose, select the mice of blood glucose value, be divided into three dosage groups of model group, TANGMAIKANG KELI 2.5g/kg, metformin 0.25g/kg group, embodiment 3 basic, normal, high (1,2,4g/kg body weight) at random by blood glucose value at 12.89-30.80 mmol/l.
Each organizes the glucose 30g/kg that gavages high concentration every day, continuous 30 days, drink 5% G/W simultaneously, except blank is organized, respectively at test the 1st day and the 14th day tail vein injection alloxan normal saline solution 100mg/kg, give corresponding solution in modeling while test sample group and positive controls, continuous 4 weeks, get blood system for the last time from serum, survey blood glucose, and get pancreas and do pathology, observe its pathological change.
3. data statistics:
Each organizes data with mean ± standard deviation (x ± SD) expression.With spss13.0 each group data is carried out statistical analysis.The results are shown in Table 1.
4. result of the test: see Table 6 and table 7
Blood glucose value (x ± SD n=10) before the table 6 ∏ type diabetic mice medicine
| Group | Dosage | Blood glucose (mmol/l) |
| Dosage group high dose group in the blank group model group TANGMAIKANG group metformin group low dose group | / / 2.5g/kg 0.25g/kg 1g/kg 2g/kg 4g/kg | 7.09±0.99 20.66±5.89 ##20.59±6.35 20.55±6.65 19.92±6.30 19.20±4.26 19.76±4.31 |
##P＜0.01 vs blank group
Blood glucose value behind the table 7 ∏ type diabetic mice medicine (x ± SD)
| Group | Dosage | Number of animals (only) | Blood glucose (mmol/l) |
| Dosage group high dose group in the blank group model group TANGMAIKANG group metformin group low dose group | /2.5g/kg 0.25g/kg 1g/kg 2g/kg 4g/kg | 10 8 9 9 8 9 8 | 7.12±0.95 26.03±4.90 ##17.96±5.44 **20.05±5.40 *20.12±5.76 *17.93±4.02 **20.1?1±4.48 * |
Annotate:
##P＜0.01 vs blank group,
*P＜0.01 vs model group
By table 6, table 7 as seen, model group blood glucose obviously raises, and with the blank group utmost point significant difference (P＜0.01) is arranged relatively; The basic, normal, high dosage group of medicine of the present invention, TANGMAIKANG group and metformin group blood glucose obviously reduce, and with model group utmost point significant difference are arranged relatively.Histopathologic slide: matched group pancreas: body of gland is the lobulated structure, and the acinus epithelial cell is cone-shaped, and the karyon circle is positioned at substrate.Islet distribution is spheric cell mass between acinus, around islets has a spot of reticular fiber, and the cell in the islets of langerhans is arranged in irregular strand, and iuntercellular has abundant blood capillary.Model group pancreas: the cavity that occurs differing in size in the pars exocrina pancreatis acinus epithelial cell endochylema, the islets of langerhans structure is unclear, decreased number, smaller volume, beta Cell of islet vacuolar degeneration.Metformin pancreas: the islets of langerhans structure is clear, smaller volume, the degeneration of part beta Cell of islet, necrosis.TANGMAIKANG pancreas: islets of langerhans decreased number, smaller volume, beta Cell of islet vacuolar degeneration, necrosis.Medicine low dose group pancreas of the present invention: the cavity that occurs differing in size in the pars exocrina pancreatis acinus epithelial cell endochylema, islets of langerhans decreased number.Middle dosage group pancreas: islets of langerhans decreased number, smaller volume, beta Cell of islet vacuolar degeneration.High dose group pancreas: the islets of langerhans decreased number, smaller volume, beta Cell of islet vacuolar degeneration, necrosis, the prompting medicine does not have obvious improvement effect to the damage of islet cells.Illustrate that this medicine can obviously reduce the blood glucose of type ii diabetes mice more than 1g/kg, this dosage and metformin (0.25g/kg) are suitable.
5. conclusion (of pressure testing): this experimental study behind the medicine Π type diabetes insulin opposing model mice oral administration of the present invention to the variation of mouse blood sugar level and observe its pathological change.The result shows: model group blood glucose obviously raises, with the blank group relatively have utmost point significant difference (
*P＜0.01); The basic, normal, high dosage group of medicine of the present invention, TANGMAIKANG group and metformin group blood glucose obviously reduce, and with model group utmost point significant difference are arranged relatively.Pathological tissue inspection prompting medicine does not have the improvement effect to the damage of islet cells.The above results illustrates that this medicine can obviously reduce the blood glucose of type ii diabetes mice more than 1g/kg, and this dosage and metformin (0.25g/kg) are suitable.
Embodiment 20: to alloxan type hyperglycemia model rat blood sugar reducing function
Trial drug: for embodiment 6,9,13 is basic medicine, solvent for use is a distilled water, is mixed with the suspension of desired concn with distilled water.
Experimental animal: be ICR strain white mice, SD strain rat, Japan's white big ear rabbit provides by Xian Medical Univ's Experimental Animal Center, the moving card of Shan doctor word 08-005 number, mice body weight: 22～25g, rat body weight: 180～250g, rabbit body weight: 2.2～2.5kg, male and female half and half, every treated animal number is 10 every group of mice rats, 6 every group of rabbit.
Test grouping: 120 rats are divided into 12 groups at random, every group 10, male and female half and half, comprise: the normal saline matched group, model group, embodiment 6 basic, normal, high dosage (0.25,0.5,1.0g/kg body weight), embodiment 9 high, medium and low dosage (1.0,0.5,0.25g/kg body weight), embodiment 13 high, medium and low dosage (1.0,0.5,0.25g/kg body weight) group, Flos Rosae Chinensis 1.5g/kg group, Radix Rehmanniae 1.5g/kg group, Radix Puerariae 2.0g/kg group, Fructus Lycii 2.0g/kg group.
Test method: behind the animal fasting 12h, except that the normal saline matched group, all the other animals at different levels all in venae subcutaneae injection alloxan 40mg/kg modeling, are irritated stomach simultaneously and give 20% glucose solution 3ml/100g body weight, with the prevention hypoglycemia shock.
Behind the modeling 48h, blood glucose is surveyed in blood sampling on an empty stomach, and conclusive evidence blood glucose raises.Behind the modeling 72h, the beginning gastric infusion waits capacity 2ml/100g, once a day, continuous 10d, behind the last administration 4h, blood glucose is surveyed in the docking blood sampling on an empty stomach, and calculating blood glucose reduces absolute value, and data are organized a t check.The results are shown in Table 8.
Table 8: embodiment 6,9,13 Capsules group are to the influence of alloxan hyperglycemia model rat blood sugar
| Group | Number of animals (n) | Blood sugar level (mmol/L) | ||
| Before the modeling | Before the modeling administration | After the modeling administration | ||
| Dosage group embodiment 13 low dose group among the dosage group embodiment 9 low dose group embodiment 13 high dose group embodiment 13 among the dosage group embodiment 6 low dose group embodiment 9 high dose group embodiment 9 among the high sugared model saline group Flos Rosae Chinensis group Radix Rehmanniae group Radix Puerariae group Fructus Lycii group embodiment 6 high dose group embodiment 6 of normal saline matched group | 10 10 10 10 10 10 10 10 l0 10 10 10 10 10 10 | 3.8±1.50 4.06±1.51 3.61±1.84 3.72±1.52 3.80±1?61 3.67±1.46 3.94±1.78 3.56±0.61 3.82±1.33 3.64±1.78 3.73±0.61 3.58±1.33 3.84±1.78 3.66±0.61 3.81±1.33 | 3.08±1.64 20.6±17.92 ▲▲19.6±17.22 ▲▲20.7±16.82 ▲▲20.5±15.80 ▲▲20.19±18.0 ▲▲18.8±16.43 ▲▲?20.4±17.96 ▲▲20.5±19.89 ▲▲19.8±16.43 ▲▲20.5±17.96 ▲▲20.1±19.89 ▲▲19.8±16.43 ▲▲20.3±17.05 ▲▲20.5±14.59 ▲▲ | 3.48±1.41 19.15±6.49 9.28±1.54 **13.19±2.14 *12.30±1.97 *12.67±2.30 *7.3±3.13 **※&&$$8.51±2.34 **&$9.02±6.61 **7.20±3.13 **※&&##8.34±2.34 **	.02±6.61 **6.21±3.13 **※&&$$##8.23±2.34 **&$#9.12±6.6 ** |
Annotate: with before the modeling relatively:
▲ ▲Compare with the sugared model saline of high group p＜0.01
*Compare with the Flos Rosae Chinensis group p＜0.01
※P＜0.05; Compare with the Radix Rehmanniae group
﹠amp;P＜0.05
﹠amp; ﹠amp;P＜0.01; Compare with Radix Puerariae
$P＜0.05
$$P＜0.01; Compare with Fructus Lycii
#P＜0.05
##P＜0.01
Table 8 shows, high sugared model group animal blood glucose level is level (p＜0.01) before the modeling very, the modeling success.After the administration, compare with the sugared model saline of high group, Flos Rosae Chinensis group, embodiment 6,9,13 high, medium and low dosage group blood glucose reduce obviously (p＜0.01), and Radix Rehmanniae group, Radix Puerariae group, Fructus Lycii group blood glucose reduce (p＜0.05); Compare with the Flos Rosae Chinensis group, embodiment 6,9,13 high dose group blood sugar lowering effects are (p＜0.05) obviously; Compare with the Radix Rehmanniae group, embodiment 6,9,13 height, middle dosage group all have different hypoglycemic activity (p＜0.01, p＜0.05); Compare with the Radix Puerariae group, embodiment 6,13 height, middle dosage group have different hypoglycemic activity (p＜0.01, p＜0.05); Compare with the Fructus Lycii group, embodiment 9,13 height, middle dosage group have different hypoglycemic activity (p＜0.01, p＜0.05).
Results suggest: medicine of the present invention has obvious reduction effect to alloxan hyperglycemia model rat blood sugar level, relatively has synergistic function than Flos Rosae Chinensis group, Radix Rehmanniae group, Radix Puerariae group, Fructus Lycii group.
Claims (8)
1. a medicine for the treatment of diabetes is characterized in that mainly being made by the medicine of following weight fraction: 55～95 parts of Radix Rehmanniae, 40～80 parts of Flos Rosae Chinensiss.
2. the medicine of treatment diabetes according to claim 1 can also contain Radix Puerariae, and its parts by weight are 30～60 parts.
3. the medicine of treatment diabetes according to claim 1 and 2 can also contain Fructus Lycii, and its parts by weight are 30～60 parts.
4. the medicine of treatment diabetes according to claim 1, its extracting method is as follows: take by weighing Radix Rehmanniae and Flos Rosae Chinensis by the prescription proportioning, water or 30%～70% alcohol heating reflux extract three times, and each 1 hour, the extracting solution that obtains was an active component.
5. the medicine of treatment diabetes according to claim 2, its extracting method is as follows: take by weighing Radix Rehmanniae, Flos Rosae Chinensis and Radix Puerariae by the prescription proportioning, water or 30%～70% alcohol heating reflux extract three times, and each 1 hour, the extracting solution that obtains was an active component.
6. the medicine of treatment diabetes according to claim 3, its extracting method is as follows: take by weighing Radix Rehmanniae, Flos Rosae Chinensis, Fructus Lycii by the prescription proportioning, water heating and refluxing extraction three times, each 1 hour, the extracting solution that obtains was an active component.
7. the medicine of treatment diabetes according to claim 3, its extracting method is as follows: take by weighing Radix Rehmanniae, Flos Rosae Chinensis, Fructus Lycii and Radix Puerariae by the prescription proportioning, water heating and refluxing extraction three times, each 1 hour, the extracting solution that obtains was an active component.
8. pharmaceutical composition for the treatment of diabetes, it is characterized in that and to add the required various conventional adjuvant of preparation different dosage form in claim 4,5,6 or 7 active component that extract, as disintegrating agent, lubricant, binding agent or the like, method of Chinese medicinal with routine is prepared into any peroral dosage form commonly used, as pill, powder, tablet, capsule, oral liquid.
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| CN104688918A (en) * | 2015-04-02 | 2015-06-10 | 河南中医学院 | Traditional Chinese medicine for preventing and treating complication anxiety disorder of diabetes |
| CN105853794A (en) * | 2016-05-16 | 2016-08-17 | 吴文 | Medicine for treating diabetes as well as application and preparation method thereof |
| CN111450108A (en) * | 2020-04-16 | 2020-07-28 | 安徽九方制药有限公司 | Pharmaceutical composition and application thereof in preparing medicament for treating diabetes |
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| CN1108952A (en) * | 1994-12-23 | 1995-09-27 | 李强 | Xiaokelin capsule for diabetes |
| CN1201757C (en) * | 2002-03-19 | 2005-05-18 | 郭世维 | Boneset pills |
| CN1317009C (en) * | 2003-03-25 | 2007-05-23 | 张占胜 | Medicine for treating diabetes and its producing method |
| CN1330351C (en) * | 2003-07-30 | 2007-08-08 | 上海玉森新药开发有限公司 | Hypoglycemic oral liquid prepn and its production process |
| CN100346817C (en) * | 2004-11-08 | 2007-11-07 | 北京万邦医药投资有限公司 | Chinese medicine composition for preventing and treating hypertension, hyperlipemia and hyperglycemia |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104688918A (en) * | 2015-04-02 | 2015-06-10 | 河南中医学院 | Traditional Chinese medicine for preventing and treating complication anxiety disorder of diabetes |
| CN104688918B (en) * | 2015-04-02 | 2018-05-01 | 河南中医学院 | Prevent the Chinese medicine of diabetes complicated anxiety disorder |
| CN105853794A (en) * | 2016-05-16 | 2016-08-17 | 吴文 | Medicine for treating diabetes as well as application and preparation method thereof |
| CN111450108A (en) * | 2020-04-16 | 2020-07-28 | 安徽九方制药有限公司 | Pharmaceutical composition and application thereof in preparing medicament for treating diabetes |
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