CN1724065A - Medicine of treatment diabetes and preparation method thereof - Google Patents
Medicine of treatment diabetes and preparation method thereof Download PDFInfo
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Abstract
The medicine of treatment diabetes is made granule by the following weight proportion raw material: Rhizoma Coptidis 0.6～1, Radix Hedysari 2.5～3.2, the Radix Rehmanniae 2.5～3.2, Radix Scutellariae 1.6～2.2, Rhizoma Curcumae Longae 2.6～3.2.Its preparation method is: getting described medicine is solvent with 60% second alcohol and water, through immersion, heating and refluxing extraction, filtration, concentrate, spray granulation, oven dry and getting.The present invention shows to have blood sugar lowering, blood fat reducing, improve insulin resistant, protect many target spots action and efficacy such as vascular endothelial cell, anti peroxidation of lipid and oxygen free radical injury through the modern pharmacology drug efficacy study.Be be mainly used in the treatment phlegm-damp stagnate, the diabetes of deficiency of both QI and YIN blood stasis and effective Chinese traditional compound medicine of vascular complication thereof.Said preparation technology advanced person, steady quality are reliable, safe and effective.
Description
Technical field
The present invention relates to the medicine of diabetes and prevention and treatment of complication thereof and treatment, is the Chinese patent medicine of feedstock production with the Chinese herbal medicine specifically, the invention still further relates to the preparation method of this medicine.
Background technology
Diabetes (Diabets mellitus DM) are a kind of common endocrine and metabolic disorders diseases, behind, the receptor insensitive by islet secretion insufficient insulin or receptor in target cell in the cell defective cause insulin not play a role, cause that carbohydrate metabolism disturbance blood glucose is too high, glucose in urine is positive and then cause a series of metabolism disorders such as fat, protein, Water-Electrolyte, make the disease of degradation serious harm health under the immunity of organisms; It is the common frdquently encountered disease of serious harm human health.
To increase to 2.99 hundred million according to IDF's conference prediction to diabetics in 2025, diabetes have become the 5th the dead main cause in the world.The diabetics that increases newly is mainly in developing countries such as China, a seal subcontinent and Africa.Sharply the diabetics that increases mainly is a type 2 diabetes mellitus, and the prevalence of type 2 diabetes mellitus worldwide difference is huge, by being lower than about 1% to 50%.Think that in the past diversityes such as racial inheritance and region cause, think that now the increase of type 2 diabetes mellitus prevalence is so fast, mainly be to change by socio-economic development, life style, be modernization or westernization, high heat takes in particularly that high-energy such as refine saccharide and saturated fat food is taken in and physical exertion reduces and due to the environmental factors such as fat that causes fat.
The Europe diabetes association bright countries in the world of application form diabetes prevalence is all in rising trend, and developed country rises 45%, and developing country rises 200%.Diabetics often suffers from multiple complications, and the concurrent hypertension of type 2 diabetes mellitus accounts for 65.3%, heart disease or chronic heart failure person account for 22.2%, other types heart disease accounts for 34.2%, have that respiratory system disease person accounts for 12.9%, the cerebrovascular disease person accounts for 15.7%, arthritis person accounts for 60%.At present cardiovascular complication is still the severe complications of diabetes, and relevant diabetics in 1998 is because of 30,000 people/years of deaths from heart disease person male, 20,000 people/years of women.
In in the past 15 years of China, nineteen ninety-five was 2.5% to the prevalence of age type 2 diabetes mellitus in the crowd more than 25 years old less than 0.9% in 1980, estimated 2010 and can reach 6-8%.China's existing population 1,300,000,000, it is about 1,000,000,000 to remove the population of teenager (below 20 years old) more than 20 years old, by 5.0% calculate (reality is 6-8%), China has diabetes patient 50,000,000 people now.Also at the speed increase with people's every days 3000, can increase nearly 1,000,000 diabetes patients in 1 year, how huge visible diabetes patient's troop is.
At present, the blood sugar lowering Western medicine that is used for the treatment of diabetes is more, the blood sugar lowering Western medicine mostly has effect preferably aspect blood sugar control, but there are some researches show that diabetic vascular sends out disease and unprovoked Blood glucose control and controlled, and all there is certain side effect in the blood sugar lowering Western medicine, it is obvious that taking dose is taken side effect greatly or over a long time, also is prone to inefficacy (drug resistance).Though the Chinese patent medicine of present available treatment diabetes also has much, therapeutic effect is unsatisfactory, and lacks the medicine at diabetic complication.
Summary of the invention
The deficiency that medicine curative effect at the diabetes of prior art and diabetic complication is undesirable, lack specific aim, the object of the present invention is to provide a kind of Chinese medicine compound granule for the treatment of diabetes and vascular complication thereof, be used for control and treatment diabetes and complication thereof.
Another object of the present invention provides the particulate preparation method of this diabetes drug treatment.
The object of the present invention is achieved like this: a kind of Chinese medicine compound granule medicament for the treatment of diabetes and vascular complication thereof, make granule by the following weight proportion raw material::
Rhizoma Coptidis 0.6～1 Radix Hedysari 2.5～3.2 Radix Rehmanniae 2.5～3.2 Radix Scutellariaes 1.6～2.2 Rhizoma Curcumae Longaes 2.6～3.2.
The optimum ratio scope of medicine of the present invention is:
Rhizoma Coptidis 0.8～1 Radix Hedysari 2.8～3.0 Radix Rehmanniae 2.8～3.0 Radix Scutellariaes 1.8～2.0 Rhizoma Curcumae Longaes 2.8～3.0.
The optimum weight proportioning of medicine of the present invention is:
Rhizoma Coptidis 1 Radix Hedysari 3 Radix Rehmanniae 3 Radix Scutellariaes 2 Rhizoma Curcumae Longaes 3.
Dosage form selection: the function of this product is that dampness consolidating YIN, QI invigorating are reinforced the kidney, blood stasis dispelling is promoted blood circulation.Be used for stagnating in the phlegm-damp, the thirst and liking drink due to the deficiency of both QI and YIN, blood stasis, dizzy vexed, diabetes such as vexed pain, urinary micturition, constipation and complication thereof are seen above-mentioned disease person in the heart.Want blood sugar lowering need select the preparation that can comparatively fast have an effect, the QI invigorating disperse blood stasis and dredge collateral that reinforces the kidney then to need the medication of long period, alternative dosage form has decoction, oral liquid, granule, tablet, capsule etc.Though decoction can reach quick-acting purposes, carry inconvenience and easily corrupt rotten; Though oral liquid carries taking convenience, liquid medicine stability is not good enough; Though tablet, capsule taking convenience, stability are good again, but without the Chinese medicine preparation of purifying, need take than heavy dose and just can reach therapeutic purposes, as make tablet, capsule, and once obey more than ten tablet or capsule, take patient for a long time and be difficult for accepting; Granule is water-soluble, absorbs soon, once can obey heavy dose, can reach quick-acting purposes and can take for a long time again, and is easy to carry, efficacy stability, and production technology is also fairly simple, thus select the dosage form of granule as we, and called after sugar arteries and veins spirit granule.
The preparation method of medicine of the present invention is:
1, by prescription get Rhizoma Coptidis, Rhizoma Curcumae Longae is a solvent with 60% ethanol, soaked 60 minutes, heating and refluxing extraction three times, for the first time the solvent consumption is 8～10 times of medical material weight, extracts 60 minutes for the first time, second and third time solvent consumption is 5～6 times of medical material weight, second and third time respectively extracted 50 minutes, merged medicinal liquid, filtered, reclaim ethanol, medicinal liquid is standby;
2, by prescription get Radix Hedysari, the Radix Rehmanniae and Rhizoma Coptidis, the Rhizoma Curcumae Longae medicinal residues are solvent with water, soak the heating and refluxing extraction secondary 60 minutes, for the first time the solvent consumption is 8～10 times of medical material weight, extracts 80 minutes for the first time, and the solvent consumption is 5～6 times of medical material weight for the second time, extracted 60 minutes for the second time, merge medicinal liquid, filter, left standstill 24 hours, filter, filtrate and Rhizoma Coptidis, Rhizoma Curcumae Longae extracting solution merge, and are concentrated into relative density about 1.20, add an amount of stevioside flavoring, standby;
3, getting Radix Scutellariae by prescription is solvent with 60% ethanol, and for the first time the solvent consumption is 6～8 times of medical material weight, soaks heating and refluxing extraction 60 minutes, 120 minutes for the first time, the solvent consumption was 5～6 times of medical material weight for the second time, heating and refluxing extraction, 100 minutes for the second time, merge medicinal liquid, filter; Reclaim ethanol, it is standby to be concentrated into relative density 1.20 left and right sides;
4, getting an amount of dextrin is substrate, and more than Zhi Bei extractum is binding agent (dextrin: extractum is 1: 5) spray granulation, and oven dry promptly gets product.
The present invention is complete, and the side is made up of medicines such as Rhizoma Coptidis, Radix Hedysari, the Radix Rehmanniae, Rhizoma Curcumae Longae, Radix Scutellariaes.Rhizoma Coptidis nature and flavor bitter cold in the side, GUIXIN, liver, stomach, large intestine channel, heat clearing and damp drying consolidating YIN, eliminating fire and detoxication are monarch drug; Have dampness consolidating YIN, QI invigorating is reinforced the kidney, blood stasis dispelling is promoted blood circulation effect.Adopt Rhizoma Coptidis dampness consolidating YIN in the side, defend tenaciously body fluid except that the phlegm-damp in the body, the Radix Hedysari QI invigorating rises Tianjin, promoting flow of QI and blood; Radix Rehmanniae enriching yin and nourishing kidney, with Radix Hedysari mutually 5, functional activities of the body fluid interpromoting relation in five elements, Radix Scutellariae helps Rhizoma Coptidis dampness, Rhizoma Curcumae Longae promoting flow of QI and blood, numbness relieving and pain relieving.Full side's compatibility has the dampness consolidating YIN, and QI invigorating is reinforced the kidney, the effect of blood stasis dispelling pain arteries and veins.The present invention is used for stagnating in the phlegm-damp, the thirst and liking drink due to the deficiency of both QI and YIN, blood stasis, dizzy vexed, diabetes such as vexed pain, urinary micturition, constipation and complication thereof are seen above-mentioned disease person in the heart.Studies confirm that through modern pharmacology it has blood sugar lowering, blood fat reducing, improves insulin resistant, protects effects such as vascular endothelial cell, anti peroxidation of lipid; Be be used for the treatment of in the phlegm-damp stagnate, the diabetes due to the deficiency of both QI and YIN blood stasis and effective Chinese traditional compound medicine of vascular complication thereof.The establishment of sugar arteries and veins spirit granule therapy principle and the medication of the side of choosing is to be based upon on the basis of Epidemiological study, in conjunction with a large amount of clinical practices, with the modern Chinese medicine pharmacological research, based on Chinese medical discrimination, filter out in the treatment phlegm-damp stagnate, the diabetes of deficiency of both QI and YIN blood stasis and effective Chinese traditional compound medicine of vascular complication thereof.
Solution of the present invention is based on motherland's medical science to diabetes and pathogenetic understanding of complication and Therapeutic Principle, on the basis of doctor holy Zhang Zhongjing " Medical Treasures of the Golden Chamber " classics side, add the prescription of distinguishing the flavor of in conjunction with modern pharmacological research achievement and our scientific research, clinical practice experience and form.On diabetes is fallen ill clinical syndrome Epidemiological study basis, be foundation with ancient literature research, and according to finding in the syndrome The Characteristics to different course of disease diabeticss, yin deficiency only has a universality in early days clinical; Blood stasis is controlled more than 10 years in the course of disease just has universality when not good, and damp (interior stagnating) disease all has universality in each diabetics, and the delay of prompting diabetes and complication thereof is difficult more accumulates in interior relevant deeply with the heresy of sticky noxious dampness dilatory.The present invention just is being based on the treatment diabetes of this ability specific aim development and the Chinese medicine compound granule of vascular complication thereof, is used for the control and the treatment of diabetes and complication thereof.
The present invention shows to have blood sugar lowering, blood fat reducing, improve insulin resistant, protect many target spots action and efficacy such as vascular endothelial cell, anti peroxidation of lipid and oxygen free radical injury through the modern pharmacology drug efficacy study.
Said preparation technology advanced person, steady quality are reliable, safe and effective, be mainly used in the treatment phlegm-damp stagnate, the diabetes of deficiency of both QI and YIN blood stasis and effective Chinese traditional compound medicine of vascular complication thereof.
Description of drawings
Fig. 1 pathogenesis that merges the blood vessels arthromyodynia of quenching one's thirst lapses to figure;
Among the figure: solid line is represented direct effect; Dotted line is represented indirect action.
Fig. 2 is a grain processing technique flow chart of the present invention.
The specific embodiment
Referring to Fig. 1, be that diabetes develop into the pathogenesis feature of coronary heart disease and the main theory foundation that the present invention selects the medicine prescription.
Embodiment 1: referring to Fig. 2, take by weighing Rhizoma Coptidis 277g, Radix Hedysari 831g, Radix Rehmanniae 831g, Radix Scutellariae 554g, Rhizoma Curcumae Longae 831g, granulate as follows:
1) get Rhizoma Coptidis, Rhizoma Curcumae Longae is a solvent with 60% ethanol, soaked 60 minutes, heating and refluxing extraction three times, for the first time the solvent consumption is 9 times of medical material weight, extracts 60 minutes for the first time, second and third time solvent consumption is 6 times of medical material weight, second and third time respectively extracted 50 minutes, merged medicinal liquid, filtered, reclaim ethanol, medicinal liquid is standby; 2) get Radix Hedysari, the Radix Rehmanniae by prescription, it is mixed with water with Rhizoma Coptidis, Rhizoma Curcumae Longae medicinal residues is solvent, soaks 60 minutes, the heating and refluxing extraction secondary, for the first time the solvent consumption is 8 times of medical material weight, extracts 80 minutes for the first time, for the second time the solvent consumption is 6 times of medical material amount, extracts 60 minutes for the second time, merges medicinal liquid, filter, left standstill 24 hours, filter, filtrate and Rhizoma Coptidis, Rhizoma Curcumae Longae extracting solution merge, be concentrated into relative density about 1.20, add an amount of stevioside flavoring, standby; 3) getting Radix Scutellariae by prescription is solvent with 60% ethanol, and for the first time the solvent consumption is 7 times of medical material amount, soaks heating and refluxing extraction 60 minutes, 120 minutes for the first time, the solvent consumption was 5 times of medical material weight for the second time, heating and refluxing extraction, 100 minutes for the second time, merge medicinal liquid, filter; Reclaim ethanol, it is standby to be concentrated into relative density 1.20 left and right sides; 4) getting an amount of dextrin is substrate, and more than Zhi Bei extractum is binding agent, (dextrin: extractum is 1: 5) spray granulation, and the described medicine of 1000g is made in oven dry.
Other reference examples: (unit: kilogram)
| Rhizoma Coptidis | Radix Hedysari | The Radix Rehmanniae | Radix Scutellariae | Rhizoma Curcumae Longae | |
| Prescription 1 | 10 | 30 | 30 | 20 | 30 |
| Prescription 2 | 6 | 25 | 25 | 16 | 26 |
| Prescription 3 | 8 | 28 | 28 | 18 | 28 |
| Prescription 4 | 10 | 32 | 32 | 22 | 32 |
In like manner, prescription 1～4 all can make the present invention's sugar arteries and veins spirit granule with reference to embodiment 1 preparation method.
The side separates: " Ling Shu Miraculous Pivot or Divine Axis is originally dirty " " the crisp kind sick diseases due to endogenous heat of ZANG FU organs of spleen ".Because deficiency-weakness of spleen-QI, the evil poison invasion and attack of multiple sense, its healthy energy is more empty, transformation failure of spleen, water turbid damp heresy is accumulated in the body, wetly gathers into expectorant, stagnation of phlegm converting into fire, the three warmers that are jammed, so that ascending or descending movement of vital Qi is not normal cause clearly sun and do not give birth to turbid YIN failing to descend.Rhizoma Coptidis reducing phlegm and fever, regulating the stomach and sending down the abnormal ascending QI, 5 set upright with Radix Hedysari, and expectorant heat must be removed, and the taste lifting is normal.All medicines share in the side, resolving phlegm and drying damp and do not help heat, refrigerant expelling the heat-evil and do not love wetly, row is taken into account healthy energy in loosing, control fall in assistant floating to rise.Radix Rehmanniae enriching yin and nourishing kidney, with Radix Hedysari mutually 5, functional activities of the body fluid interpromoting relation in five elements, Radix Scutellariae helps Rhizoma Coptidis dampness, and heat-clearing and toxic substances removing is arranged, the clearing away heat-fire effect, so but clearing away lung-heat control and disappear, disappear during clearing away stomach-heat is controlled, clearind deficient heat is controled the inferior and is disappeared.The Rhizoma Curcumae Longae promoting flow of QI and blood, numbness relieving and pain relieving, full side's compatibility has the dampness consolidating YIN, and QI invigorating is reinforced the kidney, the effect that blood stasis dispelling is promoted blood circulation.
Medicine of the present invention is through clinical trial, has dampness consolidating YIN, QI invigorating is reinforced the kidney, blood stasis dispelling is promoted blood circulation effect.Be used for stagnating in the phlegm-damp, the thirst and liking drink due to the deficiency of both QI and YIN, blood stasis, dizzy vexed, diabetes such as vexed pain, urinary micturition, constipation and complication thereof are seen above-mentioned disease person in the heart.
Acute toxicity test: observe sugared arteries and veins spirit granule to the chmice acute toxic reaction, the result fails to detect mice median lethal dose(LD 50) (LD
50), record the maximum tolerance of one day and be the 60.0g/kg body weight.166.7 times of daily dosage are equivalent to be grown up.
Long term toxicity test: gavage 105 days continuously to rat body weight, organ coefficient, the morphologic influence of vital tissue organ pathology and the recovery situation after 2 weeks of drug withdrawal by observing the present invention's sugar arteries and veins spirit granule.Animal does not have death as a result, and general situation is no abnormal, the no abnormal change of indexs such as the weight of animals, organ coefficient, and 15 main organs gross examination of skeletal muscle and mirror are checked no toxic pathology change down.Each administration treated animal outward appearance, body weight, appetite, blood parameters, hepatic and renal function and each organ coefficient and matched group relatively do not have obvious change, the main organs pathological examination there is no pathological change, illustrates that this is subjected to reagent not have the target organ of overt toxicity in vivo, prompting the present invention sugar arteries and veins spirit granule clinical oral administration drug safety.The long-term oral growth promoter and the normal tissue morphology that can not influence the weight of animals and each main histoorgan.
Main pharmacodynamics research: the present invention's sugar arteries and veins spirit granule does not have influence to the blood glucose of normal mouse, animal hyperglycemia due to epinephrine and the alloxan there is significant hypoglycemic activity, experiment simultaneously also is presented under the same dosage situation, the particulate hypoglycemic activity of sugar arteries and veins spirit is better than TANGMAIKANG KELI, and the effect of sugared arteries and veins spirit granule high dose hypoglycemic activity and metformin is suitable.Sugar arteries and veins spirit granule has the effect of adjusting sugar, lipid metabolism, improving insulin resistant (IR), the zoopery result shows can improve experimental type 2 diabetes mellitus vascular complication rat sugar, lipid metabolism is unusual, be better than Western medicine group (metformin) and TANGMAIKANG KELI group aspect its vascular lesion of control, this is the result of this compound preparation Comprehensive Treatment effect by analysis.Its mechanism may be sugared with it arteries and veins spirit granule blood sugar lowering, blood fat reducing, improve the result of many target spots comprehensive functions such as IR, anti peroxidation of lipid and oxygen free radical injury.
Claims (5)
1, a kind of medicine for the treatment of diabetes is characterized in that it is the medicament of being made by the following weight proportion raw material:
Rhizoma Coptidis 0.6～1 Radix Hedysari 2.5～3.2 Radix Rehmanniae 2.5～3.2 Radix Scutellariaes 1.6～2.2 Rhizoma Curcumae Longaes 2.6～3.2.
2, the medicine of treatment diabetes according to claim 1, the optimum ratio scope of each raw material is:
Rhizoma Coptidis 0.8～1 Radix Hedysari 2.8～3.0 Radix Rehmanniae 2.8～3.0 Radix Scutellariaes 1.8～2.0 Rhizoma Curcumae Longaes 2.8～3.0.
3, the medicine of treatment diabetes according to claim 1, the optimum weight proportioning of each raw material is:
Rhizoma Coptidis 1 Radix Hedysari 3 Radix Rehmanniae 3 Radix Scutellariaes 2 Rhizoma Curcumae Longaes 3.
4,, it is characterized in that described medicament is a granule according to the medicine of claim 1,2 or 3 described treatment diabetes.
5, the preparation method of the medicine of the described treatment diabetes of claim 4 is characterized in that comprising the steps:
1) by prescription get Rhizoma Coptidis, Rhizoma Curcumae Longae is a solvent with 60% ethanol, soaked 60 minutes, heating and refluxing extraction three times, for the first time the solvent consumption is 8～10 times of medical material weight, extracts 60 minutes for the first time, second and third time solvent consumption is 5～6 times of medical material weight, second and third time respectively extracted 50 minutes, merged medicinal liquid, filtered, reclaim ethanol, medicinal liquid is standby;
2) by prescription get Radix Hedysari, the Radix Rehmanniae and Rhizoma Coptidis, the Rhizoma Curcumae Longae medicinal residues are solvent with water, soak the heating and refluxing extraction secondary 60 minutes, for the first time the solvent consumption is 8～10 times of medical material weight, extracts 80 minutes for the first time, and solvent weight is 5～6 times of medical material amount for the second time, extracted 60 minutes for the second time, merge medicinal liquid, filter, left standstill 24 hours, filter, filtrate and Rhizoma Coptidis, Rhizoma Curcumae Longae extracting solution merge, and are concentrated into relative density about 1.20, add an amount of stevioside flavoring, standby;
3) getting Radix Scutellariae by prescription is solvent with 60% ethanol, and for the first time the solvent consumption is 6～8 times of medical material weight, soaks heating and refluxing extraction 60 minutes, 120 minutes for the first time, the solvent consumption was 5～6 times of medical material weight for the second time, heating and refluxing extraction, 100 minutes for the second time, merge medicinal liquid, filter; Reclaim ethanol, it is standby to be concentrated into relative density 1.20 left and right sides;
4) getting an amount of dextrin is substrate, and more than Zhi Bei extractum is binding agent, spray granulation, and oven dry, promptly.
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| CN103893361A (en) * | 2012-12-28 | 2014-07-02 | 天津药物研究院 | Pharmaceutical composition for treating diabetes and application thereof |
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| CN106729451B (en) * | 2017-02-24 | 2020-06-26 | 贵州神奇药业有限公司 | Application of yin-nourishing preparation of radix scutellariae in preparing medicine for treating hypertension and/or hyperlipidemia |
| CN113082094A (en) * | 2021-04-26 | 2021-07-09 | 上海中医药大学 | Rhizoma coptidis aqueous extract and application of components thereof in preparation of medicine for preventing and treating diabetes |
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