CN102475712B - Pharmaceutical composition used for preventing and treating diabetes and complications thereof - Google Patents
Pharmaceutical composition used for preventing and treating diabetes and complications thereof Download PDFInfo
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- CN102475712B CN102475712B CN 201010567525 CN201010567525A CN102475712B CN 102475712 B CN102475712 B CN 102475712B CN 201010567525 CN201010567525 CN 201010567525 CN 201010567525 A CN201010567525 A CN 201010567525A CN 102475712 B CN102475712 B CN 102475712B
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- Prior art keywords
- chromium
- radix ophiopogonis
- pharmaceutical composition
- ophiopogonis polysaccharide
- extract
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Abstract
The invention provides a pharmaceutical composition used for preventing and treating diabetes and its complications, the pharmaceutical composition comprises an ophiopogon japonicus polysaccharide extract, element chromium and an excipient which can be taken as the effective components. The ophiopogon japonicus polysaccharide extract is a water extract or a water-containing alcohol extract of ophiopogon root. The chromium is chromium salt, preferably chromium picolinate. In the pharmaceutical composition, the ratio of ophiopogon japonicus polysaccharide extract to chromium is 50000:1-1000. The pharmaceutical composition of the present invention has the effects of insulin resistance reduction and substantial hpyerglycemic effect, especially is capable of reducing blood fat and blood sterol level, and minimizing and improving the complications of diabetes.
Description
Technical field
The present invention relates to a kind of field of medicaments, relate in particular to the pharmaceutical composition for the treatment of and prevent diabetes and complication thereof.
Background technology
Diabetes are a kind of common chronic metabolism class diseases, and along with improving constantly of people's living standard, diabetics is increasing, and China is existing 9,200 ten thousand the patient of diabetes that surpasses at present, also have in addition 100,000,000 5000 people will become the patient.And as a kind of comprehensive disease of multi-pathogenesis, diabetes are difficult to cure, and the patient needs Long-term taking medicine, and the complication of diabetes often causes serious consequence.Diabetes are clinically take hyperglycemia as main feature, the performance such as polyuria, polydipsia, polyphagia can appear in model case, become thin, i.e. " three-many-one-little " symptom.And the complication of diabetes is except acute symptom such as ketoacidosis, hypoglycemic coma etc., and chronic complicating diseases mainly contains vascular lesion and neuropathy etc.Vascular lesion mainly comprises pedopathy, oculopathy, heart disease and nephropathy etc., and research finds that vascular lesion mainly is the blood vessel scleratheroma pathological changes of corresponding organ.Hyperlipoidemia and cause atherosis immediate cause.
Diabetics is according to different diabetes types at present, and Therapeutic Method commonly used comprises insulin injection and oral antidiabetic drug, and antidiabetic drug mainly comprises biguanides and sulphonyl urine class etc.These medicine long-term takings easily produce drug resistance, prolong in time, curative effect more and more not obvious and also when taking taboo many, toxic and side effects is large.Be proved meeting such as biguanides and caused lactic acidosis, especially to the diabetics of renal insufficiency, mortality rate can reach 50%.And sulphonyl urine class medicine often causes patient that hypoglycemic reaction etc. occurs.
Vegetable polysaccharides presents great potential in the anti-diabetic field, has caused the extensive concern of medical circle.Be the method that the Canadian patent application of CA20052520757 discloses a kind of ginseng polysaccharide and Effect of APS in Treating diabetes such as application number.
Diabetes belong to the category of " quenching one's thirst " in the traditional Chinese medical science, have YIN nourishing and the production of body fluid promoting Radix Ophiopogonis, the function that lung moistening clears away heart-fire.Be used for the treatment of dryness of the lung dry cough, Tianjin wound is thirsty, and interior-heat is quenched one's thirst etc., to improving immunity, prevents and treats diabetes significant.Application number is that 200810043279.6 Chinese patent application discloses the application of Radix Ophiopogonis polysaccharide medicine in the medicine of preparation diabetes.This report claims, separation and Extraction molecular weight out is that 5000 β-D-levan can improve the polyphagia polydipsia polyuria symptom of hyperglycemia model rat, have certain blood sugar decreasing effect from Radix Ophiopogonis extract.
In addition, known vitamin and some trace element to the treatment diabetes, improve diabetic symptom positive role arranged.
Chromium: insulin is the unique hormone with function of polysaccharide of human body, and the function of insulin can be assisted or strengthen to active chromium.If the biopotency of insulin reduced when activity in vivo chromium was not enough.Studies show that, the chromium content in the diabetes human body has decline, and diabetics has or not complication, course of disease length and chromium that relation is also arranged.The course of disease is longer, and the Serum Cr content decrease is remarkable; There is the chromium content of complication to be starkly lower than uncomplicated patient.If diabetes patient's Serum Cr value is lower than 15nmol/l, the probability of Nephropathy and retinopathy reaches respectively 71% and 77%.
The diabetes patient can owing to carbohydrate metabolism disturbance causes the cylinder electrolyte metabolism disorder, increase the chromium of discharge.The diabetes patient also exists the ability that chromium is changed into active chromium to reduce and to the relatively poor problem of the utilization rate of chromium, so normal diet chromium has not satisfied the demand of diabetes patient's health, and extra chromium supplement.
External report, approximately the state of an illness improves behind 70% diabetes patient's chromium supplement, and can reduce insulin or orally-taken blood sugar reducing pharmaceutical quantities, also can improve blood fat and blood cholesterol levels, comprises the level that reduces triglyceride, T-CHOL and raising high density lipoprotein in the blood.
The China and the United States expert has made to reach 4 months chromium supplement to 180 routine diabetes patients and has observed, and the indexs such as patient's blood glucose, insulin, cholesterol and glycolated hemoglobin have obtained remarkable improvement as a result, and this piece of writing report publication is on " diabetes " magazine in 1997.China expert was showing 10 months by a definite date chromium supplement clinical observation of 833 diabetes patients in 1999,90% Fasting Glucose and post-prandial glycemia improvement are only just arranged after 1 month, and maintain low-level state in 10 months always, patient behind the chromium supplement more than 85% has improved frequent micturition, the clinical symptoms such as thirsty and tired, does not see the appearance that side effect is arranged.The expert of Tianjin in 1999 is to after around diabetes patient's chromium supplement, and after the meal 2 hours blood glucoses of Discover the patients obviously descend, and effective percentage reaches 60%-73.3%, shows that chromium truly has the assistant hypoglycemic effect, and visible chromium is significant in diabetes mellitus prevention.
Trace element chromium has multiple valence state, and common is 3 valencys and 6 valencys, and the valence state heterogeneity is also different.6 valency chromium definitely can not eat the toxic effect of health.To our health useful be 3 valency chromium, existing result of study shows, every day, 3 valency chromium of oral 1000 micrograms were perfectly safe.
Vitamin: vitamin A has antioxidation, can produce material impact to lymphocytic activation, propagation, differentiation and apoptosis, if vitamin A deficiency just might cause that autoimmune is unusual, impel Intra-islet Apoptosis, increase the weight of the diabetes state of an illness, particularly very big on the impact of type i diabetes.Fatsoluble vitamin and vitamin C have antioxidation, eliminate the effect of oxygen-derived free radicals and lipid peroxide, but and the enhancing human body immunity function, vitamin C also can promote cholesterol metabolism.Vitamin D can suppress the autoimmune response of islet cells, can alleviate insulin resistant.Reduce if vitamin D deficiency can cause insulin secretion, become one of risk factor of diabetes.Vitamin E can be removed free radical, reduces vascular endothelial injury, if the vitamin E long-term lacking, blood plasma level is low, also can cause carbohydrate metabolism disturbance, and diabetic cardiovascular disease is increased.Vitamin B group and coenzyme function are closely related, can cause during shortage that carbohydrate metabolism disturbance increases the weight of, and increase the weight of the diabetes state of an illness.
But the cause of disease of diabetes is complicated, and single polysaccharide can not solve the series of symptoms of diabetes and serious complication.Similarly, solely use vitamin or trace element also to have identical problem.This area especially lacks the research to the synergistic function of vegetable polysaccharides and other effective ingredient at present.
Summary of the invention
In view of this, the purpose of this invention is to provide a kind of pharmaceutical composition that safely, has no side effect, improve patient's metabolism of blood glucose, reduce patient's blood glucose and blood fat, improve the blood circulation situation, the diabetes-alleviating complication.
The present inventor finds through after furtheing investigate, Radix Ophiopogonis polysaccharide and elemental chromium are share, improve patient's metabolism of blood glucose, reducing patient's blood glucose and blood fat, improving the blood circulation situation and alleviate and have obvious synergistic function aspect the diabetic complication, and finishing thus the present invention.
That is, the invention provides a kind of pharmaceutical composition for prevention and treatment diabetes and complication thereof, it comprises Radix Ophiopogonis polysaccharide extract, elemental chromium and excipient as effective ingredient.
Among the present invention, the water extract that described Radix Ophiopogonis polysaccharide extract is Radix Ophiopogonis or hydrous alcohol extraction thing.
Among the present invention, described chromium is generally chromic salts, is preferably chromium picolinate.
In the described pharmaceutical composition, the Radix Ophiopogonis polysaccharide extract is 50,000: 1～1000 with the ratio of chromium.
Preferably, the Radix Ophiopogonis polysaccharide extract is 15,000: 1～100 with the ratio of chromium, and more preferably the Radix Ophiopogonis polysaccharide extract is 5,000: 1～10 with the ratio of chromium.
Among the present invention, preferably, the product of described Radix Ophiopogonis polysaccharide extract for Tubers of Ophiopogon japonicus being pulverized, being obtained with ultrafiltration precipitate with ethanol behind the water extraction.
Preferably, described water extraction is carrying out below 70 ℃.
Preferably, aqueous extract carries out ultrafiltration and concentration with the following ultrafilter membrane of intercepting molecular weight 10,000 dalton.
Among the present invention, also can add vitamin or trace element or other effective ingredient in the described pharmaceutical composition.
The present invention also provides Radix Ophiopogonis polysaccharide and chromium to be combined in for the preparation of the application in the medicine that reduces blood sugar in diabetic patients and glycolated hemoglobin.
In addition, the present invention also provides Radix Ophiopogonis polysaccharide and chromium to be combined in for the preparation of the application in the medicine of the drinking-water that improves diabetics and diet.
Zoopery shows, pharmaceutical composition of the present invention can improve polyphagia, polydipsia and the polyuria symptom of diabetes rat, has certain blood sugar lowering and effect for reducing blood fat.Pharmaceutical composition group of the present invention is with independent use Radix Ophiopogonis polysaccharide extract or use separately the situation of chromium picolinate to compare in addition, blood sugar lowering and blood fat better effects if.Therefore, pharmaceutical composition of the present invention has significant blood sugar lowering, reduces insulin resistant and effect for reducing blood fat, by improving patient's immunity etc., can improve and reduce diabetic complication simultaneously.
The specific embodiment
Pharmaceutical composition for prevention and treatment diabetes and complication thereof of the present invention is comprised of Radix Ophiopogonis polysaccharide extract, elemental chromium and excipient as basic effective constituents.
Among the present invention, the water extract that described Radix Ophiopogonis polysaccharide extract is Radix Ophiopogonis or hydrous alcohol extraction thing.
As a better embodiment, the product of described Radix Ophiopogonis polysaccharide extract for Tubers of Ophiopogon japonicus being pulverized, being obtained with ultrafiltration precipitate with ethanol behind the water extraction.
Preferably, described Radix Ophiopogonis polysaccharide extract be by with behind the water extraction under the low temperature with extracting solution with the following ultrafilter membrane ultrafiltration and concentration of intercepting molecular weight 10,000 dalton, then obtain with the filtration of alcohol precipitation.
In the present invention, Radix Ophiopogonis polysaccharide can be used hot water extraction, also can use cold water extraction, but preferably uses cold water extraction, that is extracts at low temperatures.
Described low temperature refers to that temperature below room temperature to 70 ℃, is 35-65 ℃ preferably, is 45-60 ℃ better.
In the present invention, can contain a small amount of ethanol as the water that extracts solvent, be preferably described ethanol content below 20%, better below 10%.
In the present invention, will with time of water extraction Radix Ophiopogonis polysaccharide usually between 2-48 hour.Generally speaking, the temperature of the solvent of extraction time and use is inversely proportional to.The extraction temperature is high, and then extraction time is short.Be preferably, with 35-65 ℃ water extraction 2-8 hour, be preferably, with 45-60 ℃ water extraction 2-4 hour.
In the present invention, extraction is carried out repeatedly usually.Extraction time is many, is conducive to fully extract the polysaccharide in Radix Ophiopogonis, but after extracting certain number of times, the polysaccharide that then can extract is limited, and cost increases.Therefore, be preferably, extraction step carries out 2-4 time, carries out 2-3 time better.After the extraction, extracting solution is merged, be for further processing.
In the present invention, after will suitably concentrating by the Radix Ophiopogonis polysaccharide extracting solution that water extraction obtains, separate and further concentrating with ultrafiltration.
In the present invention, the kind of using ultrafilter membrane is not particularly limited, the material of ultrafilter membrane be such as can being polyvinyl alcohol, modified acrylic polymer of cellulose and derivant thereof, Merlon, polrvinyl chloride, Kynoar, polysulfones, polyether sulfone, polyacrylonitrile, polyamide, polysulfonamides, SPSF, interlinkage etc., but preferably by acetate fiber or with the similar macromolecular material of its performance and polyether sulfone.
In the present invention, the intercepting molecular weight of the ultrafilter membrane of use is below 40,000 dalton, preferably below 25,000 dalton, better below 10,000 dalton.This is because through preliminary animal experiment, and is more obvious with the hypoglycemic activity of the Radix Ophiopogonis polysaccharide extract of intercepting molecular weight after the following ultrafiltration membrance filter of 10,000 dalton is concentrated.
In the present invention, the ultrafilter membrane that meets above-mentioned requirements for example has intercepting molecular weight that U.S. Millipore company produces at the following Biomax-PB 10000 of 10,000 dalton.
When carrying out filtering and concentrating with ultrafilter membrane, preferably with ultrafilter membrane and the coupling of High Pressure Difference extractor.In the present invention, for example can be by using polyether sulfone Biomax-PB's
XL carries out ultrafiltration and concentration.
In the present invention, the Radix Ophiopogonis polysaccharide extracting solution that obtains behind the ultrafiltration and concentration is precipitated, separates by adding ethanol.
When carrying out precipitate and separate with ethanol, the amount of the ethanol of adding be generally the Radix Ophiopogonis polysaccharide concentrated solution that obtains by ultrafiltration and concentration volume 1-3 doubly, be 1-2 times preferably.
In the present invention, after adding ethanol precipitated in the Radix Ophiopogonis polysaccharide extracting solution, the temperature below room temperature was placed and is spent the night.Preferably spend the night in placement below 0 ℃, more preferably spend the night in placement below-10 ℃.
In the present invention, separate by centrifugal placing the Radix Ophiopogonis polysaccharide extracting solution that spends the night behind the alcohol shallow lake, the leaching precipitate, lyophilization obtains Radix Ophiopogonis polysaccharide extract of the present invention.
Polyoses content in the Radix Ophiopogonis polysaccharide extract is measured by the fixed sugared method of 3,5-dinitrosalicylic acid (DNS) colorimetric.
In the present invention, in the Radix Ophiopogonis polysaccharide extract that obtains with said method, except polysaccharide, also exist Saponin Radix Ophiopogonis (ophiopogonin) such as Radix Ophiopogonis Saponin A, B, B ', C, C ', D, D ', high flavone compound such as ophiopogonone A, B, methyl ophiopogonone A, B, dihydro ophiopogonone A, B, methyl dihydro ophiopogonone, 6-aldehyde radical different Radix Ophiopogonis of flavanone and the different ophiopogonone A of 6-aldehyde radical, B.In addition, also containing volatile oil becomes to grade with oligosaccharide kind with plant sterol and monosaccharide.
In the present invention, extract the Radix Ophiopogonis polysaccharide except using with preceding method.Also can use product on sale in the market, (it is a kind of white powder with the poor extraction of cryogenic high pressure to the Radix Ophiopogonis polysaccharide extract ZL-SE015 that produces such as Zeli Medicine Science-Technology Co., Ltd., Guangzhou.)。
In pharmaceutical composition of the present invention, described chromium is 3 valencys, and it is the most stable in living things system.
In the present invention, described chromium is preferably chromium picolinate with the form of chromic salts.
In the present invention, in the described pharmaceutical composition, the Radix Ophiopogonis polysaccharide extract is 50,000: 1～1000 with the ratio of chromium, is 15,000: 1～100 preferably, is 5,000: 1～10 better.
In the pharmaceutical composition of the present invention, with the active component that is combined as of Radix Ophiopogonis polysaccharide extract and chromium.But, except above-mentioned two kinds of active component, the effective ingredient that also can add other treatment and prevent diabetes, such as (such as sulfonylurea glipizide, gliclazide, glibenclamide, glibornuride, glimepiride etc.), biguanides (such as metformin etc.), α glycosidase inhibitor (such as acarbose, voglibose etc.), euglycemic agent (such as rosiglitazone, repaglinide etc.), also can add the Chinese medicine extract such as Radix Rehmanniae, Cortex Mori, Radix Ginseng, the Rhizoma Anemarrhenae, Rhizoma Coptidis.
In pharmaceutical composition of the present invention, also can add a small amount of vitamin and other trace element outside the dechromisation.
Described vitamin is one or more in vitamin A, compound vitamin B, vitamin C, vitamin D, the vitamin E.
Described trace element is one or more in zinc, selenium, copper, manganese, ferrum, the molybdenum.
The present invention also provides a kind of method for preparing Radix Ophiopogonis polysaccharide, and it comprises with the Tubers of Ophiopogon japonicus pulverizing, with behind the water extraction, obtains Radix Ophiopogonis polysaccharide by ultrafiltration, precipitate with ethanol.
The present invention also provides a kind of method for the preparation of preventing and treat the pharmaceutical composition of diabetes and complication thereof, it comprises with the Radix Ophiopogonis polysaccharide extract of ormal weight, chromium and as optional vitamin, trace element or other effective ingredient and the mixed with excipients of adjuvant, makes required dosage form.
In the present invention, described excipient refers to increase stability, pH value, permeability, bioavailability and the transparency etc. of preparation of the present invention and the additional material except principal agent that do not have side effects, do not affect the treatment, includes but not limited to binding agent, filler, disintegrating agent, lubricant, antiseptic, antioxidant, correctives, aromatic, cosolvent, emulsifying agent, solubilizing agent, osmotic pressure regulator, coloring agent etc.
Pharmaceutical composition of the present invention can be made into various pharmaceutical dosage forms such as being applicable to oral administration, intravenous administration sublingual administration.Use with forms such as solid, solution, emulsion, dispersion, micelle, liposomees, but concrete type of service comprises tablet, granule, pill, capsule, buccal tablet, aqueous suspension or oil suspending agent, tincture dispersion powder, solution, Emulsion, suspending agent and other suitable forms.Available carrier comprises that lactose, dextrin, microcrystalline Cellulose, arabic gum, gelatin, mannitol, gelatinized corn starch, magnesium stearate, Talcum, silica gel and other are applicable to the carrier with solid, semisolid or liquid form manufacture.Can use auxiliary reagent, stabilizing agent, thickening agent in addition, can also select one or more flavoring agents, coloring agent, antistaling agent etc. that the pharmaceutical preparation of good palatability is provided.Preferably, select microcrystalline Cellulose, dextrin, lactose, magnesium stearate as excipient substance.
It is 50,000 that the pharmaceutical composition of the present invention of making suitable dosage forms comprises ratio: 1～1000, be preferably 15,000: 1～100, more preferably the Radix Ophiopogonis polysaccharide extract of 5,000: 1～10 treatment effective dose and chromium and excipient.
The dosage of pharmaceutical composition of the present invention is decided on patient's the situations such as symptom, the course of disease and body weight, but usually give Radix Ophiopogonis polysaccharide 1-200mg/kg body weight, chromium 0.1-20 μ g/kg body weight every day, preferably give Radix Ophiopogonis polysaccharide 5-40mg/kg body weight, chromium 0.5-15 μ g/kg body weight every day.Every day, administration was 2-3 time, every minor tick 4-8 hour.
The invention will be further described below in conjunction with embodiment, and still, following embodiment only is example of the present invention, and should not think limiting the scope of the invention.
Embodiment 1
Get liliaceous plant Radix Ophiopogonis (Ophiopogon japonicus (Thunb.) Ker-Gawl.) dried root 10kg, after the pulverizing, add 120L water, extracted 2 hours at 60 ℃.Extracting solution is carried out ultrafiltration and concentration with Biomax-PB 10000 (Millipore company product).After adding 80L water in the filtering residue, similarly carry out ultrafiltration and concentration at 60 ℃ after extracting 2 hours.In filtering residue, add 50L water again, similarly carry out ultrafiltration and concentration 60 ℃ of extractions after 2 hours.Each filtrate is merged, be evaporated to approximately 18L.Add 95% ethanol 18L in the concentrated solution, spend the night-15 ℃ of placements, centrifugal remove precipitation after, lyophilization obtains 470g Radix Ophiopogonis polysaccharide extract.The polyoses content that records in this Radix Ophiopogonis polysaccharide extract with 3,5-dinitrosalicylic acid (DNS) colorimetry is about 85%.
Embodiment 2:
Radix Ophiopogonis polysaccharide extract 200g and the chromium picolinate 66.7mg of embodiment 1 are joined in the 80mL water, make its dissolving evenly after, the extract thick paste joined in the 790g microcrystalline Cellulose stir.Other gets sodium carboxymethyl cellulose 10.0g, is mixed with 10% solution, joins in the above-mentioned microcrystalline cellulose mixt, and mixing is crossed 40 mesh sieves and granulated 60 ℃ of dryings, 40 mesh sieve granulate.The granule that must contain Radix Ophiopogonis polysaccharide and chromium picolinate.
Embodiment 3
At 5kN/cm
2Pressure under use tablet machine to be obtained by embodiment 2 granule 400g tabletting.Get the tablet that sheet focuses on 1000mg ± 5%.
Embodiment 4
To put into seed-coating machine by the tablet (140g) that embodiment 3 obtains, use the coating suspension that is formed by hydroxypropyl emthylcellulose (149.2g), titanium dioxide (20g), polyethylene glycol 6000 (30g), iron sesquioxide (0.8g) and water (2000g) to carry out coating, obtain film-coated tablet.
Embodiment 5
The granule porphyrize that will be obtained by embodiment 2 is got 300mg and is packed in the gelatine capsule, obtains capsule preparations.
Embodiment 6
Pharmaceutical composition blood sugar lowering experimentation
60 of laboratory animal cleaning level wistar rats, body weight (230 ± 20) g.The rat sub-cage rearing places temperature (20 ± 2) ℃, humidity 55%～65%, and illumination 12h～24h is under the environment of freely drinking water.
Feedstuff common standard feedstuff: flour 20%, rice flour 10%, Semen Maydis 20%, wheat bran 25%, bean material 20%, bone meal 2%, fish flour 2%
High-sugar-fat-diet: 10% Adeps Sus domestica, 20% sucrose, 10% yolk powder, 0.5% sodium cholate and 59.5% above-mentioned common standard feedstuff.
The foundation of diabetes rat model is divided into groups rat at random, wherein 10 as Normal group (blank group), give the common standard forage feed, all the other 50 are given the high glucose and high fat diet, with the animal of high-sugar-fat-diet feed, give 1% streptozotocin mycin (the being purchased from Sigma company) modeling of lumbar injection 0.75mL, after 72 hours after 5 weeks, fasting glucose＞16.7mmol/L is above as diabetes modeling success rat, 43 of modeling successes.10 of matched groups are fed with 5 weeks of normal diet 1% citrate buffer solution of lumbar injection equal-volume (0.75mL).
Get 43 of above-mentioned diabetes model rats (DM rat), be divided at random 4 groups, be respectively: model group (N=10), Radix Ophiopogonis polysaccharide+chromium picolinate (the Radix Ophiopogonis polysaccharide extract 30mg+ chromium picolinate 100 μ g/kg of embodiment 1) treatment group (N=11), Radix Ophiopogonis polysaccharide (the extract 30mg/kg of embodiment 1) treatment group (N=11), chromium picolinate (100 μ g/kg) treatment group (N=11).Each organizes every day by said medicine dosage gavage, and Normal group gives the normal saline of 1mL/100g every day, and the DM rat continues to feed high-sugar-fat-diet, and blank group is fed normal diet, treats for 9 weeks.
Experimental index and assay method:
Blood sugar detection, fasting adopted the docking saccharimetry after 8 hours, measured with blood glucose meter.
Lipid determination, early morning is interior blood sampling on an empty stomach, and enzymic colorimetric is measured triglyceride, cholesterol.
The mensuration of diet, drinking-water, urine amount adopts metabolic cage, measures diet, drinking-water and the collection 24h urine of rat respectively at the 3rd week, the 6th week, the 9th week, observes its variation.
The mensuration of body weight respectively at the body weight of the 3rd week, the 6th week, the 9th all weighing rats, is observed its variation.
The results are shown in following table.
Respectively organize the variation (unit: g/24 hour) of diet after table 1 modeling
Upper table shows, the 3rd week after administration, the 6th week, the 9th week, to compare with Normal group, and the diet of each rat model group all has remarkable increase; But compare with model group, all there is remarkable reduction in 6 weeks, 9 weeks of Radix Ophiopogonis polysaccharide+chromium group diet after administration, and Radix Ophiopogonis polysaccharide group and 9 weeks of chromium picolinate group diet after administration also decrease.
The variation (unit: ml/24 hour) of each group drinking-water after table 2 modeling
Upper table shows, the 3rd week after treatment, the 6th week, the 9th week, to compare with Normal group, and the drinking-water of rat model group significantly increases; But compare with model group, the rat drinking-water of three treatment groups significantly reduces.
Respectively organize the variation (unit: ml/24 hour) of urine amount after table 3 modeling
Upper table shows, each organizes the variation of urine amount during the rat treatment: the 3rd week after treatment, the 6th week, the 9th week, to compare with Normal group, and the urine amount of each rat model group obviously increases.Compare with model group urine amount, Radix Ophiopogonis polysaccharide+the chromium group obviously reduces, and Radix Ophiopogonis polysaccharide group and chromium picolinate group urine amount slightly reduce.
Respectively organize body weight after table 4 modeling in the situation (g) of different time sections
Upper table shows, compares with the blank group during whole administration, and significantly reducing appears in each rat model group body weight.Compare with model group, Radix Ophiopogonis polysaccharide+chromium group body weight obviously increases to some extent, and Radix Ophiopogonis polysaccharide group and chromium picolinate group body weight change are not remarkable.
Whole variation (the unit: mmol/L) that respectively organizes blood glucose, glycolated hemoglobin latter stage of table 5 experiment
Upper table shows, compares with Normal group, and blood glucose, the glycolated hemoglobin of each rat model group significantly raise; Compare with model group, Radix Ophiopogonis polysaccharide+chromium group blood glucose and glycolated hemoglobin significantly reduce, and Radix Ophiopogonis polysaccharide group and chromium picolinate group blood glucose obviously reduce, but hemoglobin is without significant change.
Whole variation (the unit: mmol/L) that respectively organizes blood fat latter stage of table 6 experiment
Research finds that the pathology reason of diabetic complication pedopathy, heart disease, oculopathy mainly is the blood vessel scleratheroma pathological changes of corresponding organ.And cause arteriosclerotic immediate cause to be what of blood fat.
Upper table shows, compare with Normal group, each rat model group blood fat all significantly rise; And compare with model control group, the blood fat of Radix Ophiopogonis polysaccharide treatment group obviously reduces, and Radix Ophiopogonis polysaccharide group and chromium picolinate group blood fat descend to some extent simultaneously, but and not obvious.
From above-mentioned five observation indexs, can find out that Radix Ophiopogonis polysaccharide+after 9 weeks of chromium complex administration, the diet of this group rat, drinking-water, urine amount obviously reduce, body weight increases.And testing whole latter stage, the blood glucose of this group, glycolated hemoglobin and blood fat are compared with model group has obvious reduction.Illustrate that the pharmaceutical composition that is comprised of Radix Ophiopogonis polysaccharide and chromium of the present invention has more significant blood sugar lowering and blood fat.Contrast simultaneously the experimental result of equivalent Radix Ophiopogonis polysaccharide treatment group and chromium picolinate treatment group, can find, the therapeutic effect when after the combination of Radix Ophiopogonis polysaccharide and chromium hyperglycemia and lipid therapy effect being much better than both and using separately separately.Explanation has synergistic function between Radix Ophiopogonis polysaccharide and the chromium in the pharmaceutical composition of the present invention thus, has beyond thought gain effect after the combination.According to the present invention, the pharmaceutical composition that is formed by Radix Ophiopogonis polysaccharide and chromium compatibility has more significant blood sugar lowering and effect for reducing blood fat, and diabetes and diabetic complication vascular lesion are had significant therapeutic effect.
How the above explanation of being undertaken by embodiment is just implemented in order to help to understand the present invention.Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention and essence, can change and improve the present invention, these changes and improvement be also thought in the scope of protection of present invention.
Claims (9)
1. pharmaceutical composition that is used for prevention and treatment diabetes and complication thereof, it comprises Radix Ophiopogonis polysaccharide extract, elemental chromium and excipient as effective ingredient;
Described Radix Ophiopogonis polysaccharide extract for Tubers of Ophiopogon japonicus is pulverized, with the product that ultrafiltration precipitate with ethanol behind the water extraction obtains, described chromium is chromium picolinate.
2. pharmaceutical composition according to claim 1 is characterized in that, described Radix Ophiopogonis polysaccharide extract is 50,000:1～1000 with the ratio of chromium.
3. pharmaceutical composition according to claim 2 is characterized in that, described Radix Ophiopogonis polysaccharide extract is 15,000:1～100 with the ratio of chromium.
4. pharmaceutical composition according to claim 3 is characterized in that, described Radix Ophiopogonis polysaccharide extract is 5,000:1～10 with the ratio of chromium.
5. pharmaceutical composition according to claim 1 is characterized in that, described water extraction is carrying out below 70 ℃.
6. pharmaceutical composition according to claim 1 is characterized in that, aqueous extract carried out ultrafiltration and concentration with the intercepting molecular weight at the following ultrafilter membrane of 10,000 dalton.
7. pharmaceutical composition according to claim 1 is characterized in that, described pharmaceutical composition also comprises vitamin and/or trace element.
8. Radix Ophiopogonis polysaccharide and chromium is combined in for the preparation of the application in the medicine that reduces blood sugar in diabetic patients and glycolated hemoglobin; Described Radix Ophiopogonis polysaccharide extract for Tubers of Ophiopogon japonicus is pulverized, with the product that ultrafiltration precipitate with ethanol behind the water extraction obtains, described chromium is chromium picolinate.
9. Radix Ophiopogonis polysaccharide and chromium is combined in for the preparation of the application in the medicine of the drinking-water that improves diabetics and diet; Described Radix Ophiopogonis polysaccharide extract for Tubers of Ophiopogon japonicus is pulverized, with the product that ultrafiltration precipitate with ethanol behind the water extraction obtains, described chromium is chromium picolinate.
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| CN101433667A (en) * | 2007-11-16 | 2009-05-20 | 北京因科瑞斯医药科技有限公司 | Pharmaceutical composition with function for reducing blood sugar and preparation method thereof |
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| CN101450174A (en) * | 2007-11-30 | 2009-06-10 | 北京因科瑞斯医药科技有限公司 | Medicine composition with blood-sugar reduction function and preparation method thereof |
| CN101342309A (en) * | 2008-06-13 | 2009-01-14 | 北京冠五洲生物科学研究院 | Medicament composition for preventing birth defect and improving memory |
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