CN102366595B - Medicine for treating diabetes and preparation method thereof - Google Patents
Medicine for treating diabetes and preparation method thereof Download PDFInfo
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- CN102366595B CN102366595B CN 201110289621 CN201110289621A CN102366595B CN 102366595 B CN102366595 B CN 102366595B CN 201110289621 CN201110289621 CN 201110289621 CN 201110289621 A CN201110289621 A CN 201110289621A CN 102366595 B CN102366595 B CN 102366595B
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Abstract
The invention discloses a medicine for treating diabetes. The medicine is a diet drug which is also known as Jiumei thirst-quenching glucose-lowering No.1, comprising active components or active components and pharmaceutically acceptable auxiliary materials, wherein, the active components are prepared by mixing turmeric, barberry bark, phyllanthus emblica, tribulus terrstris, and Gymnadenia conopsea according to a certain weight proportion. The medicine can be prepared into any general dosage form for oral administration. The medicine has the functions of nourishing liver and kidney, tonifying qi and moistening lung, generating body fluid and quenching thirst, and is used for treating diabetes. The medicine can be used for treating polydipsia, polyphagia, diuresis, emaciation, urinary glucose, hyperglycemia and other diabetes caused by swelling disorders in the Tibetan medicine aspect, and can be used for treating polydipsia, polyphagia, diuresis, emaciation, exhausted, ache and weak at limbs, giddy tinnitus, spontaneous perspiration, red tongue, easy thirsty, deep pulse, pulse counting, urinary glucose, hyperglycemia and other diabetes caused by Qi-Yin deficiency in the traditional Chinese medicine aspect.
Description
[technical field]
The present invention relates to a kind of medicine (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) for the treatment of diabetes and preparation method thereof, it is a kind of Tibetan medicine, belongs to the field of Chinese medicines.
[background technology]
Diabetes are a kind of common metabolism endocrinopathyes, and World Health Organization (WHO) classifies them one of as ten big difficult disease.Sickness rate is high, and the trend that rises is year by year arranged; According to statistics, India is present the first in the world diabetes big countries, has patient more than 4,000 ten thousand; China occupies second, and patient 3,000 ten thousand is arranged; There is patient more than 1,000 ten thousand in the 3rd in the U.S.; WHO estimates that by 2005, Chinese diabetes patient will reach 5,000 ten thousand; Developed country more than 60 years old crowd nearly 10% be diabetics, China estimates more than 60 years old that diabetics reaches more than 8% among the crowd; There is scholarly forecast China might after India, become the first in the world diabetes big country, this is not only because Chinese population radix maximum, also because Chinese Economy Development is quick, the compatriots overweight people that life is improved rapidly increases suddenly, and the obese people becomes diabetes Susceptible population; Type ii diabetes accounts for the 90%-95% of diabetics total number of persons, and diabetes account for preceding 5 of the cause of death, and it is one of serious threat people ' s health disease.
The up-to-date investigation of China diabetes association finds that the onset diabetes rate of China is up to 9.7%, and national diabetes patient is near one hundred million.China has surmounted India becomes diabetes first big country.
Diabetes rejuvenation trend is obvious, and onset diabetes increases the fastest in 30～45 years old " cause type " personage.In the adult more than 20 years old, the diabetes prevalence of age markization is 9.7%, and the ratio of prediabetes is more up to 15.5%, and being equivalent to just has a hyperglycemia state person among per four adults.
China is since reform and opening-up, and people's lives are greatly improved, but following, the diabetes that are known as affluenza also become a kind of commonly encountered diseases, frequently-occurring disease gradually.Over nearly 30 years, the progress of the relevant diabetes control in the whole world is very rapid, China is quite a few to the combination of Chinese and Western medicine research of diabetes control, but significantly break through seldom, compare with external progress and to have a long way to go, its reason is many-sided, but that one of them is science is not strong, therefore is difficult to have breakthrough.
Diabetes have become the human the fourth-largest cause of the death, and the whole world has 3,800,000 people of surpassing to die from diabetes and complication thereof every year.The whole world has 2.46 hundred million diabeticss at present.China over nearly 20 years the onset diabetes rate increased more than 5 times, be one of global fastest-rising country.
Over nearly 30 years, the progress of the relevant diabetes control in the whole world is very rapid, China is quite a few to the combination of Chinese and Western medicine research of diabetes control, but significantly break through seldom, compare with external progress and to have a long way to go, its reason is many-sided, but that one of them is science is not strong, therefore is difficult to have breakthrough.And the research of pure Tibetan medicine treatment diabetes yet there are no any report.
1, external research to the prevention and treatment in Chinese and western diabetes:
Few to the prevention and treatment in Chinese and western diabetes study abroad, only there are 4 pieces to the research of Radix Ginseng as the american diabetes association annual meeting that has in June, 2,003 10,000 multi-experts to participate in.
2, the present situation of domestic prevention and treatment in Chinese and western diabetes study and problems analysis:
Look back China's prevention and treatment in Chinese and western diabetes study in recent decades, though some good achievements are also arranged, often do not take the formal international conference interchange of getting on, thus unknown to the public in the world.And more be some low-level repetitive operation, thereby science is not strong.
According to statistics, China has 6,000 ten thousand above diabeticss at present, at present to diabetes particularly diabetic complication still do not have effective method so far.
So high onset diabetes rate expedites the emergence of out the diabetes medication market that has a high potential.Diabetes medication field has also become the emphasis that each big medicine enterprise goes on an expedition.2008, global diabetes market total sales volume was up to 24,000,000,000 dollars, and in global diabetes medicament, the oral medicine market share is a little more than insulin preparation.
TCM treatment of diabetes has long history, particularly over nearly 30 years, along with the develop rapidly of modern science, adopts the method for the combination of Chinese and Western medicine, and treatment of diabetes has been had irreplaceable advantage.
According to statistics, diabetics accounts for 80% by the mortality rate that cardiovascular and cerebrovascular disease causes, and makes its life expectancy reduce 1/3.Diabetics merges blood fat rising person more than 80%, and blood viscosity rising person reaches 90%.
Chinese medicine is slow to the treatment of diabetes effect, but belongs to the category that effects a permanent cure, and when blood glucose descends body constitution is strengthened synchronously, and chronic complicating diseases is had preventive and therapeutic action preferably.
The traditional Chinese medical science thinks that the deficiency of YIN is the pathogenetic essence of glycosuria, insufficiency of the spleen be diabetes do not heal basic, blood stasis is the key that diabetic complications produces.Chinese medicine can be invigorated blood circulation the yin nourishing invigorating the spleen and benefiting QI and be combined dexterously, thereby diabetes are fundamentally effectively treated.Use Chinese medicine can make blood glucose, glucose in urine long-term stability in normal range.
The integral body of Chinese medicine is transferred and can be strengthened patient's body constitution in blood sugar lowering, corrects sugar, protein and fat metabolic disturbance, regulates number or the affinity of Insulin receptor INSR, to increase target cell to the sensitivity of insulin, the antagonism insulin resistant.
The integrally-regulated of Chinese medicine can prevent and treat the generation of diabetes multiple complications effectively.The diabetics majority exists that blood viscosity increases, hyperlipidemia and platelet aggregation rate increase these factors, has caused the basis of the concurrent cardiovascular and cerebrovascular disease of diabetics, peripheral angiopathy and important organ damage.Chinese medicine can reduce blood viscosity and blood fat etc. by benefiting QI for activating blood circulation, thereby prevent and treat complication in blood sugar lowering.
Tibetanmedicine calls diabetes " Jing Nisagu " disease, the general translations of Chinese " urine eliminating mass ".So-called " Jing Nisagu ", " capital Buddhist nun " means frequent micturition, and " Sa Gu " refers to consume the liquid of the muddiness of physical ability, that is to say that frequency of micturition, cloudy urine, consumption physical ability are the substitutive characteristics of primary disease." eight warps of medical science will originally be released " carries: " if ask this why because of, this be hindered by diet etc. and ' Baconic ' dissolve bladder.The thing that addles (waste matter), perspiration, oils and fats, precise and tiny elite in the body also can jeopardize ' red bar ' in the body and blood etc. under the diet of discomfort, thus, the thing that addles (waste matter) in the body, perspiration etc. all can be sneaked into urine, cause the urine muddiness, and people's physical ability is subdued.And therefore swelling in the body also can make human body ' seven big materials ' bladder that runs off, it is external to turn to the urine eliminating, thereby subdues physical ability." " ' Jing Nisagu ' its disease is seen: weak drowsiness, hyperhidrosis and companion's abnormal flavour are become thin, and hair and onyx are uninteresting simple and unadorned, and normal sense sweet taste and oropharynx are extremely dried in mouthful, have a liking for cold drink, and the dysphoria with feverish sensation in the chest palms and soles urine is turbid, and urine mark place often has insecticide such as Apis to assemble.”
Tibetan medicine's theory is thought: the trouble diabetes are relevant with " three categories of etiologic factors " imbalance of self body.Under normal circumstances, human body " dragon " (being equivalent to wind, gas), " red bar " (refer to gallbladder, fire, be the root that causes all heat symptom-complex diseases), " Baconic " (referring to water, soil, is the root that causes all sympotoms caused by cold factors diseases) " three categories of etiologic factors " be in poised state, could keep the normal operation of body function.The pathogenic factor of diabetes is because human body " three categories of etiologic factors " occurs seriously unbalance, usually comparatively significant performance is that " red bar " and " dragon " contained partially, " Baconic " is on the weak side, caused the seven big cereal nutrients (precise and tiny, blood, muscle, fat, skeleton, marrow, seminal fluid) of human body can not normally decompose, drain and carry, dirty thing in the blood is assembled too much, the vitals function that causes human bodies such as heart kidney is impaired, symptom such as show as easily famine, urine urgency-frequency, weak dreaminess of xerostomia clinically, become thin, the while is with symptoms such as heating, visual deterioration, skin pruritus.
The Tibetan medicine reaches and falls " red bar " and " dragon " by conditioning, balance " three categories of etiologic factors ", sets upright " Baconic " and is purpose, seven big cereal nutrients in the body are decomposed normally and drain, reduce harmful composition in the blood, make pancreas obtain nutrition, islet function progressively recovers; Regulate dietary simultaneously, the custom of making the life better, finally reach nutrition pancreas, blood sugar lowering improves complication, improves the purpose of patient's live and work quality.
The treatment of diabetes medicine comprises oral antidiabetic drug thing and insulin at present.The orally-taken blood sugar reducing medicine comprises: (1) sulfonylurea drugs; (2) biguanides; (3) meals glucose regulator; (4) alpha-glucosidase inhibitor; (5) aldose reductase inhibitor; (6) thiazolidinediones euglycemic agent; (7) other drug.
According to the difference of hypoglycemic mechanism, the orally-taken blood sugar reducing medicine can be divided into Drugs Promoting Insulin Secretion (sulphanylureas, meals glucose regulator), euglycemic agent (biguanides, thiazolidinediones euglycemic agent) and other drug (alpha-glucosidase inhibitor, non-insulin blood sugar lowering hormone medicine).
Sulfonylurea drugs is divided into the three generations, and the first generation comprises tolbutamide, chlorpropamide, tolazamide and acetohexamide; The second filial generation comprises glibenclamide, glipizide, glibornuride, gliclazide and gliquidone; The third generation just has glimepiride.
Biguanides comprises metformin and phenformin, and the latter abroad stops using at present, domestic also seldom use.
Meals glucose regulator has repaglinide and Nateglinide.
Alpha-glucosidase inhibitor has acarbose and voglibose.
The thiazolidinediones euglycemic agent has rosiglitazone, troglitazone and pioglitazone.
Non-insulin blood sugar lowering hormone medicine has Pramlintide and Exenatide.
The untoward reaction of Remedies for diabetes:
1, insulin:
The untoward reaction of insulin has: (1) anaphylaxis, and use the patient of insulin urticaria and vasodilation can occur in the injection site; (2) hypoglycemic reaction; (3) insulin resistant; (4) injection site is lipoatrophy or hypertrophy; (5) refraction of eye imbalance.
2, sulfonylurea drugs:
The untoward reaction of sulfonylurea drugs: accidental hypoglycemia, diarrhoea can be arranged, feel sick, vomit, have a headache, have a stomachache or discomfort, erythra is more rare, and rare and serious have jaundice, liver function injury, granulocytopenia (showing as pharyngalgia, heating, infection), a thrombocytopenia (showing as hemorrhage, purpura) etc.
3, biguanides:
The untoward reaction of biguanides is modal to be: gastrointestinal reaction, show as inappetence, nausea,vomiting,diarrhea, stomachache, mouthful in metallic taste etc.Sometimes the patient have weak, tired, lose weight, dizziness and erythra etc.
4, meals glucose regulator:
The untoward reaction of meals glucose regulator has: hypoglycemia, visual abnormality, gastrointestinal reaction, allergic rash, pruritus and urticaria etc.Only a few patient the liver transaminase occurs and increases, and its degree is light and be one to cross property, seldom causes drug withdrawal.
5, thiazolidinediones euglycemic agent:
The untoward reaction of thiazolidinediones euglycemic agent comprises: (1) anemia; (2) cardiovascular system reaction; (3) neural psychiatric system reaction; (4) hypoglycemic reaction; (5) gastrointestinal reaction etc.
6, non-insulin blood sugar lowering hormone medicine:
Non-insulin blood sugar lowering hormone medicine also has some untoward reaction, and it is the most common wherein to feel sick, and the severe hypoglycemia event easily betides to be used in the 3h of back, and anorexia, vomiting, weak and dizzy etc. also can appear in the patient.
Treatment diabetes Chinese patent medicine commonly used mainly contains following several at present:
(1) diabetes pill; (2) JIANGTANGSHU; (3) YUQUAN WAN; (4) blood sugar lowering first sheet; (5) manna diabetes capsule; (6) LIUWEI DIHUANG WAN, MAIWEIDIHUANGWAN; (7) SHIHUYEGUANG WAN; (8) Radix Rehmanniae Pilulae for Improving Eyesight; (9) SHENQI JIANGTANG sheet; (10) KELENING capsule; (11) the clever sheet of quenching one's thirst; (12) JINQI JIANGTANG PIAN; (13) TANGMAIKANG KELI; (14) ten eight flavor Fructus Chebulae diuresis balls.But the curative effect of these Chinese medicine preparation still can not be satisfactory however.
Therefore, still there is tight demand in people's Chinese medicine (Tibetan medicine) preparation that curative effect is better treated diabetes.Up to now, also do not find the report of any relevant pharmaceutical composition of the present invention.The inventor is through research repeatedly, and the checking repeatedly by animal and clinical trial, has found the Tibetan medicine oral drugs (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) that the treatment of better curative effect diabetes are arranged finally, thereby has finished the present invention.
[summary of the invention]
The object of the invention just provides a kind of medicine of more effectively treating diabetes.
Another object of the present invention has provided the preparation method of this medicine.
Medicine of the present invention is a kind of Tibetan medicine, is formed or is made up of active component and acceptable accessories by active component, and wherein said active component is to be made by following bulk drugs: Rhizoma Curcumae Longae, Radix Berberidis Amurensis, Fructus Phyllanthi, Fructus Tribuli and Rhizoma Gymnadeniae.
It has selected Rhizoma Curcumae Longae, Radix Berberidis Amurensis, Fructus Phyllanthi, Fructus Tribuli and Rhizoma Gymnadeniae to make up as raw material, and wherein (1) Rhizoma Curcumae Longae is the dry rhizome of zingiberaceous plant Rhizoma Curcumae Longae Ccrcuma longaL., nature and flavor suffering, hardship, temperature, return spleen, Liver Channel, the removing blood stasis circulation of qi promoting is arranged, and inducing menstruation to relieve menalgia dispels the wind and treats the function of numbness; Be used for stagnation of QI and blood, costa sternales twinge, obstruction of qi in the chest and cardialgia, dysmenorrhea amenorrhea, rheumatism shoulder arm pain, tumbling and swelling, postpartum stagnation; Have and protect the liver function of gallbladder promoting, antiinflammatory, antitumor, anti-AIDS, accent blood fat, antifertility, pharmacological action such as antibiotic grade; The clinical anemofrigid-damp arthralgia that is used for the treatment of, scapulohumeral periarthritis, bony spur, biliary tract infection, hepatitis B, atrophic gastritis, cerebral thrombosis etc.(2) Radix Berberidis Amurensis is the dry skin of Berberidaceae plant kansu barberry bark Berbeis kansuensis Schneid., and nature and flavor cold, hardship have place heat clearly, separates pyretic toxicity, the function of holding back yellow fluid; Be used for epidemic disease, old calentura, grasserie; Berberine has hypoglycemic activity.(3) Fructus Phyllanthi is the dry mature fruit of euphorbia plant Fructus Phyllanthi Phyllanthusemblica L., and nature and flavor are sweet, sour, puckery, cool, attach to the lung and stomach meridians; Clearing away heat and cooling blood is arranged, the effect of promoting digestion and invigorating the stomach; Be used for the heat in blood blood stasis, dyspepsia, abdominal distention, cough, laryngalgia, xerostomia; Have anti-myocardial necrosis and blood fat reducing, antimutagenic, antibiotic, pharmacological actions such as antioxidation; The clinical hypertension that is used for the treatment of, hepatitis B, chronic pharyngitis, slow down aging etc. have good adjusting blood fat effect to diabetics.(4) Fructus Tribuli is the dry mature fruit of zygophyllaceae plant Tribulus terrestns L., and nature and flavor suffering, hardship, tepor are returned Liver Channel; The suppressing the hyperactive liver resolving depression is arranged, and promoting blood circulation by removing wind makes eye bright, antipruritic function; It is dizzy to be used for headache, sternal rib pain, and breast closes acute mastitis, conjunctival congestion cataracta, rubella pruritus; Have and resist myocardial ischemia blood pressure lowering accent blood fat, the effect of promotion glandular hormone sample, the anti-ageing pharmacological action of waiting for a long time; The clinical coronary heart disease that is used for the treatment of, cerebrovascular disorders, angioneurotic headache, infantile autumn diarrhea etc.(5) Rhizoma Gymnadeniae is the dry tuber of orchid Rhizoma Gymnadeniae Gymnadenia conopsea (L.) R.Br., sweet, warm, the profit of nature and flavor; Have and tonify Qi of the kidney, the effect of spermatogenesis lung moistening; Be used for pneumonopathy, cough and asthma due to lung deficiency, meat poison, seminal emission sexual impotence.Make each efficacy of drugs produce synergism these drug regimens, thereby can effectively treat diabetes.
The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each crude drug consumption is for all to have better curative effect in the following weight parts scope:
0.5～1.5 part of 0.5～1.5 part in Rhizoma Curcumae Longae, 0.5～1.5 part of Radix Berberidis Amurensis, 0.5～1.5 part of Fructus Phyllanthi, 0.5～1.5 part of Fructus Tribuli and Rhizoma Gymnadeniae.
Be preferably: 1 part of 1 part in Rhizoma Curcumae Longae, 1 part of Radix Berberidis Amurensis, 1 part of Fructus Phyllanthi, 1 part of Fructus Tribuli and Rhizoma Gymnadeniae.
The preparation of medicine activity component of the present invention can be the crude drug convection drying of above-mentioned consumption to be pulverized make; Also the crude drug of above-mentioned consumption can be adopted the conventional method of Chinese medicine preparation such as decoction and alcohol sedimentation technique or ethanol extract from water precipitation (referring to " pharmaceutics of Chinese drugs " 73-74 page or leaf of Cao Chunlin chief editor, Science and Technology of Shanghai publishing house publishes in November, 1986) to make.
The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine (referring to Cao Chunlin chief editor's " pharmaceutics of Chinese drugs ", Science and Technology of Shanghai publishing house publishes in November, 1986) be prepared into any peroral dosage form commonly used, as powder, pill, capsule, granule, tablet etc.
Medicine of the present invention has enriching yin and nourishing kidney, the QI invigorating lung moistening, and the function of promoting the production of body fluid and quenching one's thirst is used for the treatment of diabetes.Polydipsia, polyphagia, the polyuria that the Tibetan medicine aspect can be used for being caused by " dragon " imbalance, become thin, diabetess such as glucose in urine and blood sugar increasing.Traditional Chinese medical science aspect can be used for the diabetes due to the deficiency of both QI and YIN, and disease is seen: polydipsia, polyphagia, polyuria, become thin, spiritlessness and weakness, extremity are aching and limp, dizziness and tinnitus, spontaneous perspiration, red tongue are easily done, deep pulse is counted accurately, glucose in urine and blood sugar increasing etc.
The usage and dosage of medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) is: oral, take morning, is used with " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration "; 30 days is a course for the treatment of.A 1.2g, 1 time on the one.
Medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", the common nourishing kidney yin of forming of " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " three kinds of prescriptions, the lung moistening clearing stomach, promoting the production of body fluid to quench thirst, QI invigorating blood sugar lowering, balance " dragon ", " red bar ", " Baconic " physiological function.The Tibetan medicine: polydipsia, polyphagia, the polyuria that is used for being caused by " dragon ", " red bar ", " Baconic " imbalance, become thin, diabetess such as fatigue and lack of strength, glucose in urine and blood sugar increasing.The traditional Chinese medical science: be used for the diabetes due to the deficiency of both QI and YIN, disease is seen: polydipsia, polyphagia, polyuria, become thin, spiritlessness and weakness, spontaneous sweating, the lazy speech of breathing hard, dysphoria with feverish sensation in the chest palms and soles, palpitation and insomnia, limb fiber crops pain, extremity are aching and limp, dizziness and tinnitus, be hard and dry, glucose in urine and blood sugar increasing etc.
[specific embodiment]
Come further to set forth the preparation method of medicine of the present invention by the following examples.
The powder preparation of [embodiment 1] medicine of the present invention:
Take by weighing Rhizoma Curcumae Longae 10g, Radix Berberidis Amurensis 10g, Fructus Phyllanthi 10g, Fructus Tribuli 10g and Rhizoma Gymnadeniae 10g, be ground into fine powder after the mixing jointly, mixing, packing namely gets powder, is called U.S. lowering blood sugar and preventing thirst of a specified duration again and looses for No. 1.
The pill preparation of [embodiment 2] medicine of the present invention:
Take by weighing Rhizoma Curcumae Longae 200g, Radix Berberidis Amurensis 150g, Fructus Phyllanthi 150g, Fructus Tribuli 100g and Rhizoma Gymnadeniae 200g, be ground into fine powder after the mixing jointly, mixing is used water pill, dry below 60 ℃, and polishing, packing namely gets pill, is called No. 1 ball of U.S. lowering blood sugar and preventing thirst of a specified duration again.
The granule preparation of [embodiment 3] medicine of the present invention:
Take by weighing Rhizoma Curcumae Longae 50g, Radix Berberidis Amurensis 100g, Fructus Phyllanthi 80g, Fructus Tribuli 60g and Rhizoma Gymnadeniae 50g, be ground into fine powder after the mixing jointly, mixing adds adjuvant and makes granule, dry below 60 ℃, and granulate, packing namely gets granule, is called No. 1 granule of U.S. lowering blood sugar and preventing thirst of a specified duration again.
The capsule preparation of [embodiment 4] medicine of the present invention:
Take by weighing Rhizoma Curcumae Longae 160g, Radix Berberidis Amurensis 100g, Fructus Phyllanthi 60g, Fructus Tribuli 90g and Rhizoma Gymnadeniae 60g, be ground into fine powder after the mixing jointly, mixing, the gelatine capsule of packing into namely gets capsule, is called No. 1 capsule of U.S. lowering blood sugar and preventing thirst of a specified duration again.
The preparation tablets of [embodiment 5] medicine of the present invention:
Take by weighing Rhizoma Curcumae Longae 50g, Radix Berberidis Amurensis 70g, Fructus Phyllanthi 60g, Fructus Tribuli 50g and Rhizoma Gymnadeniae 50g, be ground into fine powder after the mixing jointly, mixing adds adjuvant and makes granule, dry below 60 ℃, and granulate, tabletting namely gets tablet, is called No. 1 sheet of U.S. lowering blood sugar and preventing thirst of a specified duration again.
Below further sets forth the beneficial effect of medicine of the present invention by testing example, these are tested pharmacodynamics test and the clinical observation on the therapeutic effect that examples have comprised medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " and test.
[test example 1] medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " are to the hypoglycemic pharmacodynamics test of diabetic mice:
Test material:
Anthology invention medicine (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration "; JIANGZHILING PIAN (phenformin hydrochloride tablet), the 25mg/ sheet, lot number: 200908032, Jintan City, Jiangsu Province pharmaceutical factory produces; Alloxan: Signa company provides; The glucose oxidase enzyme reagent kit: east, Wenzhou bowl biological engineering company limited is produced; The insulin test kit: China Atomic Energy Science Research Institute's coordination rope institute provides.
Experimental technique:
Get Kunming kind healthy mice, ♀ ♂ half and half, body weight 20 ± 2g, mice fasting 32h (can't help water), tail vein injection alloxan 100mg/kg, 72h posterior orbit vein is got hematometry fasting glucose (12h on an empty stomach), get blood glucose value 〉=11.1mmol/L, 50 is diabetes moulding mice, is divided into five groups at random, 10 every group, press Time of Administration respectively and irritate stomach medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration), " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " (0.6g/kg, 1.2g/kg, 2.4g/kg) low, in, high dose group, JIANGZHILING PIAN group (0.1g/kg.d) and normal saline equivalent blank group.The normal mouse matched group is 10 in addition, irritates stomach equivalent normal saline equally.
Behind the administration 10d, namely administration 11d gets hematometry by the eye socket vein: blood glucose adopts glucose oxidase method; Serum insulin adopts radioimmunology.
Carbohydrate tolerance test: each organizes mice by the glucose load filling amount of 2g/kg, and blood glucose is measured in 30min, 60min and each blood sampling of 120min behind the son filling stomach, and the mensuration of carbohydrate tolerance still adopts glucose oxidase method.
Experimental result:
Medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) sees Table 1 with " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " to the measurement result that influences of diabetic mice hyperglycemia.
Table 1 medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " are to the influence (n=10) of diabetic mice hyperglycemia
Illustrate: with the model matched group relatively:
△P＞0.05;
*P＜0.05;
*P＜0.01;
* *P＜0.001.
As seen from Table 1: model control group blood sugar detection result relatively has notable difference with the normal control group, and blood sugar increasing illustrates mice tail vein injection alloxan 100mg/kg on an empty stomach more than one times, and it is successful making hyperglycemia model; Medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) has hypoglycemic activity with " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " in the using dosage test, and along with its effect of increase of dosage strengthens, high dose (2.4g/kg) effect is the strongest, its effect is compared no significant difference with the insoral group, and both all can make the mice hyperglycemia be down to almost normal value (also higher slightly certainly).That is to say that medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) has hypoglycemic activity with " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration ", and suitable with blood sugar lowering Western medicine JIANGZHILING PIAN hypoglycemic effect.
Medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) sees Table 2 with " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " to the measurement result of the influence of diabetic mice serum insulin.
Table 2 medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " are to the influence (n=10) of diabetic mice serum insulin
Illustrate: with the model matched group relatively:
*P＜0.01;
*P＜0.05;
△P＞0.05.
As seen from Table 2: the model control group serum insulin relatively reduces by more than 50 with the normal control group, and P＜0.01 illustrates that the β cell in the moulding mouse islets is destroyed in a large number, causes the interior serum insulin of body obviously to descend (and causing blood glucose to rise).After the medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) of irritating the stomach various dose to diabetic mice and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " are treated, serum insulin has increase in various degree, and proportional with dosage, show that medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " have the trend that improves the diabetic mice serum insulin levels.
The carbohydrate tolerance test measurement result sees Table 3.
Table 3 medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " are to the influence (n=10) of hyperglycemia model mice oral glucose carbohydrate tolerance
Illustrate: compare with the normal control group:
##* P＜0.05, * * P＜0.01 are compared with model group in P＜0.01.
As seen from Table 3: the hyperglycemia mice that medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " cause alloxan, behind the oral administration, have blood sugar lowering, and blood sugar increasing time and blood sugar lowering peak concentration behind the deferrable mice oral glucose.This explanation medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) may weaken alloxan to the damage of beta Cell of islet or improve the function of damaged cell with " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration ", is of value to the condition of illness of diabetes-alleviating mice.
[test example 2] medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " are to the observation of curative effect of diabetes patient's hypoglycemic activity:
Physical data:
My institute's out-patient clinic and hospitalization diabetics, it is undesired to have a medical check-up, fat or become thin.Polydipsia, polyuria, polyphagia symptom are obvious, and fasting glucose 〉=7.8mmol/L, OGTT check blood glucose 〉=11.1mmol/L behind (being oral glucose 75 grams) 2h, are diagnosed as sugared sick II type patient 123 examples, male 68 examples wherein, and women 55 examples are used as the clinical observation object.Be divided into treatment in 123 examples at random and organize 63 examples (man 35, woman 28); Matched group 60 examples (man 33, woman 27).
Therapeutic Method:
1, treatment group: adopt medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration), take morning, is used with " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration "; 30 days is a course for the treatment of.1.2g/ inferior, 1 time/d.During the treatment, regularly inquire about more than three, body weight, Signs, 0d, 15d, 30d measure the fasting glucose record respectively, add in case of necessity to look into OGTT, determine with.
2, matched group: adopt diamicron (Diamicron) 80～160mg/ time, 3 times/d, one month is a course for the treatment of, equally treats observed and recorded with the treatment group.
The clinical efficacy evaluation criteria
Recovery from illness: subjective symptoms more than three disappears fasting glucose≤7.8mmol/L;
Produce effects: subjective symptoms more than three is improved, and fasting glucose obviously descends, but is not down to normal level; Progressive: subjective symptoms more than three takes a turn for the better, but fasting glucose does not have significant change;
Invalid: state of an illness no change, conscious symptom more than three do not have improvement even increase the weight of.
Recovery from illness adds produce effects and adds up to effective percentage.
Clinical observation result sees Table 4.
The observation of curative effect of table 4 medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " treatment diabetes hypoglycemic activity:
I.e. treatment group effective percentage 82.54%, matched group effective percentage 80.00%.But recovery from illness refers to transference cure more than three at that time in the table, and fasting glucose is recovered normal level, namely≤7.8mmol/L, is not that source of disease is eradicated or is completely cured.
Clinical observation (table 4) shows: medicine of the present invention (No. 1, U.S. lowering blood sugar and preventing thirst of a specified duration) and " No. 2, U.S. lowering blood sugar and preventing thirst of a specified duration ", " No. 3, U.S. lowering blood sugar and preventing thirst of a specified duration " treatment diabetes type II patient 63 examples, 22 routine produce effects 30 examples of fully recovering, total effective rate 82.54%, matched group diamicron (blood sugar lowering Western medicine) is observed 60 examples equally, 20 examples of fully recovering, produce effects 28 examples, total effective rate is 80.00%, two groups are obvious to diabetics blood sugar lowering curative effect, but no significant difference (P＜0.05).
Claims (9)
1. medicine for the treatment of diabetes, it is characterized in that it is made up of active component or is made up of active component and acceptable accessories, wherein said active component is to be made by following bulk drugs: 0.5～1.5 part of 0.5～1.5 part in Rhizoma Curcumae Longae, 0.5～1.5 part of Radix Berberidis Amurensis, 0.5～1.5 part of Fructus Phyllanthi, 0.5～1.5 part of Fructus Tribuli and Rhizoma Gymnadeniae.
2. medicine according to claim 1, wherein said active component is to be made by following bulk drugs: 1 part of 1 part in Rhizoma Curcumae Longae, 1 part of Radix Berberidis Amurensis, 1 part of Fructus Phyllanthi, 1 part of Fructus Tribuli and Rhizoma Gymnadeniae.
3. medicine according to claim 1 and 2, it is peroral dosage form.
4. medicine according to claim 3, it is tablet, pill, granule, capsule or powder.
5. the preparation method of the described medicine of claim 1, it comprises the following steps: to take by weighing the raw material of following weight portion: 0.5～1.5 part of 0.5～1.5 part in Rhizoma Curcumae Longae, 0.5～1.5 part of Radix Berberidis Amurensis, 0.5～1.5 part of Fructus Phyllanthi, 0.5～1.5 part of Fructus Tribuli and Rhizoma Gymnadeniae; Mix, be ground into fine powder afterwards jointly, mixing is made active component.
6. the preparation method of the described medicine of claim 1, it comprises the following steps: to take by weighing the raw material of following weight portion: 0.5～1.5 part of 0.5～1.5 part in Rhizoma Curcumae Longae, 0.5～1.5 part of Radix Berberidis Amurensis, 0.5～1.5 part of Fructus Phyllanthi, 0.5～1.5 part of Fructus Tribuli and Rhizoma Gymnadeniae; Mix, adopt decoction and alcohol sedimentation technique or ethanol extract from water precipitation to make active component.
7. according to claim 5 or 6 described preparation methoies, wherein take by weighing the raw material of following weight portion: 1 part of 1 part in Rhizoma Curcumae Longae, 1 part of Radix Berberidis Amurensis, 1 part of Fructus Phyllanthi, 1 part of Fructus Tribuli and Rhizoma Gymnadeniae.
8. according to claim 5 or 6 described preparation methoies, it also comprises the following steps: active component and acceptable accessories are made tablet, pill, granule, capsule or powder.
9. preparation method according to claim 7, it also comprises the following steps: active component and acceptable accessories are made tablet, pill, granule, capsule or powder.
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| CN103961551A (en) * | 2014-05-24 | 2014-08-06 | 青海省通天河藏药制药有限责任公司 | Traditional Tibetan medicine for treating diabetes |
| CN103961550A (en) * | 2014-05-25 | 2014-08-06 | 青海省通天河藏药制药有限责任公司 | Preparation method of traditional Tibetan medicine for treating diabetes |
| CN109331147A (en) * | 2018-11-27 | 2019-02-15 | 平措绕吉 | A kind of Tibetan medicine and its preparation method and application for diabetes |
| CN112755153A (en) * | 2021-02-04 | 2021-05-07 | 平措绕吉 | A Chinese medicinal composition for treating diabetes |
| CN113876907A (en) * | 2021-10-28 | 2022-01-04 | 西藏神猴药业有限责任公司 | Application of four-ingredient turmeric decoction powder in prevention and treatment of diabetic peripheral neuropathy |
| CN114404550A (en) * | 2022-02-10 | 2022-04-29 | 尕藏校郎 | A Chinese medicinal composition for treating diabetes and its complications |
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Denomination of invention: Medicine for treating diabetes and its preparing process Effective date of registration: 20200525 Granted publication date: 20130710 Pledgee: Qinghai Chuangqi Finance Leasing Co.,Ltd. Pledgor: Jiumei Pengcuo Registration number: Y2020630000001 |
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Date of cancellation: 20210517 Granted publication date: 20130710 Pledgee: Qinghai Chuangqi Finance Leasing Co.,Ltd. Pledgor: Jiumei Pengcuo Registration number: Y2020630000001 |
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Denomination of invention: Medicine for treating diabetes and preparation method thereof Effective date of registration: 20210602 Granted publication date: 20130710 Pledgee: Qinghai Chuangqi Finance Leasing Co.,Ltd. Pledgor: Jiumei Pengcuo Registration number: Y2021630000003 |
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Date of cancellation: 20230608 Granted publication date: 20130710 Pledgee: Qinghai Chuangqi Finance Leasing Co.,Ltd. Pledgor: Jiumei Pengcuo|Qinghai Jiumei Zang Drug Drug Co.,Ltd. Registration number: Y2021630000003 |
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Effective date of registration: 20230830 Address after: Room 1231, Building 11, No. 90 Wusi West Road, Chengxi District, Xining City, Qinghai Province, 810000 Patentee after: Yang Cuoji Address before: 810003 18, No. three, Qinghai biological science and Technology Industrial Park, Qinghai, Xining Patentee before: Jiumei Pengcuo |
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