CN102755568B - Health-care product for assisting in decreasing blood sugar and preparation method thereof - Google Patents
Health-care product for assisting in decreasing blood sugar and preparation method thereof Download PDFInfo
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Abstract
The invention provides a health-care product for assisting in decreasing blood sugar and a preparation method thereof. The health-care product is prepared from astragalus, coix seed, tree peony bark, dwarf lilyturf root and common anemarrhena according to a certain proportion. The health-care product has the effects of nourishing yin, promoting the production of body fluid and promoting blood circulation by removing blood stasis, and can be used for assisting in decreasing the blood sugar of a diabetic patient; and cooperative and synergistic actions can be achieved after the selected bulk pharmaceuticals are blended, the health-care product is safe and effective, and a good news is brought for diabetic patients.
Description
Technical field
The present invention relates to health product of a kind of auxiliary hyperglycemic and preparation method thereof, belong to the technical field of health product.
Background technology
Diabetes are by inherited genetic factors, immunologic function disorder, infected by microbes and toxin thereof, free radical toxin, the various virulence factors of Nervous and Mental Factors etc. act on body and cause hypoinsulinism, insulin resistant etc. and cause sugar, protein, fat, a series of metabolism disorder syndromes such as power and water Xie Zhi, clinically take hyperglycemia as main feature, can there is polyuria in model case, polydipsia, polyphagia, the performance such as become thin, i.e. " three-many-one-little " symptom, diabetes (blood glucose) cause complication once control bad meeting, cause kidney, eye, the exhaustion pathological changes at the positions such as foot, and cannot cure.
The category that diabetes spp " is quenched one's thirst " in motherland's medical science, its name of disease head sees " The Yellow Emperor's Canon of Internal Medicine strange sick opinion ", the traditional Chinese medical science is discussed and is quenched one's thirst, lung-heat impairment of body fluid, thirsty polydipsia on disappear, genus lung-heat; Stomach-fire is processed Sheng, rapid digestion of food and polyorexia disappears in being, belongs to gastric heat; Kidney is not taken the photograph water, frequent micturition disappears under being, belongs to due to kidney-heat and water loses.Lung-heat, gastric heat, suffer from a deficiency of the kidney and see, or having and stress, forming and quench one's thirst, lacking one and can not become this disease; And innate deficiency, the five internal organs weakness, eating and drinking without temperance, emotional factors are the key factors of quenching one's thirst.The pathogenesis of diabetes is YIN fluid deficiency, scorching inclined to one side Sheng, and take the deficiency of YIN as this, scorching is mark.Quench one's thirst with the passing of time, deficiency of YIN leading to consumption of QI, deficiency of YIN affecting YANG, causes cloudy all need of gas.Disease enters network for a long time, hematogenous blockage, and every hyperamization stasis of blood is for suffering from, and with the passing of time common change disease is numerous.The disease of clinical common deficiency of both QI and YIN.The traditional Chinese medical science control diabetes history of existing thousands of years, ancient Chinese medicine doctor to the understanding of primary disease mainly with the deficiency of YIN scorching be main, treatment in more than employing replenishing YIN and removing heat methods.
Now, diabetes have become " No. three killer " that after tumor and cardiovascular and cerebrovascular disease, threaten the mankind in the world.No matter, in developed country or developing country, the sickness rate of diabetes is all sharply rising.The data of announcing according to World Health Organization (WHO), within 1985, there are 3,000 ten thousand diabetes patients in the whole world, has been increased to 1.35 hundred million by 1997.According to the prediction of internal authority diabetes epidemiological specialist, by 2010, global diabetes patient will reach 2.4 hundred million, and the year two thousand fifty can be increased to 300,000,000 people.Diabetes, as a kind of serious non-infectious chronic disease, have become the great public health problem that countries in the world are paid close attention to.The situation of China is no exception.Have data to show, China adult's in 1979 onset diabetes rate less than 1%, has risen to 2.65% by 1997, and has increased sharply with 0.1% speed every year in recent years.To showing from 11, whole nation province, city people's more than 40,000 extensive epidemiological investigation result, in China crowd of current 20～74 years old, the sickness rate of diabetes is 3.21%, the sickness rate of impaired glucose tolerance (being prediabetes) is more up to 4.76%, this means that the present 20-74 of China year diabetics of age bracket crowd has exceeded 2,000 ten thousand, " reserves " 3,000 ten thousand people nearly.And more than 90% be type Ⅱdiabetes mellitus, for this reason, the Chinese medicine health-care series products of researching and developing a kind of energy auxiliary hyperglycemic has extensively and profound significance.
Summary of the invention
Technical problem to be solved by this invention is to provide health product of a kind of auxiliary hyperglycemic and preparation method thereof, and these health product have YIN nourishing and the production of body fluid promoting, and the function of blood circulation promoting and blood stasis dispelling can be assisted the blood glucose that reduces diabetics.
For solving the problems of the technologies described above, the present invention realizes by the following technical solutions:
Health product for auxiliary hyperglycemic, calculate according to composition by weight, by Radix Astragali 10-30 part, Semen Coicis 10-30 part, Cortex Moutan 4-16 part, Rhizoma Anemarrhenae 4-40 part, Radix Ophiopogonis 4-40 part and adjuvant be prepared from.
Preferably, the health product of aforementioned auxiliary hyperglycemic, calculate according to composition by weight, by 20 parts of the Radixs Astragali, 20 parts of Semen Coiciss, 8 parts of Cortex Moutans, Rhizoma Anemarrhenae 4-40 part, Radix Ophiopogonis 4-40 part and adjuvant be prepared from.
More preferably, the health product of aforementioned auxiliary hyperglycemic, calculate according to composition by weight, are prepared from by 20 parts of the Radixs Astragali, 20 parts of Semen Coiciss, 8 parts of Cortex Moutans, 8 parts of Radix Ophiopogonis, 8 parts of the Rhizoma Anemarrhenaes and adjuvant.
More preferably, the health product of aforementioned auxiliary hyperglycemic, calculate according to composition by weight, are prepared from by 20 parts of the Radixs Astragali, 20 parts of Semen Coiciss, 8 parts of Cortex Moutans, 4 parts of the Rhizoma Anemarrhenaes, 4 parts of Radix Ophiopogonis and adjuvant.
More preferably, the health product of aforementioned auxiliary hyperglycemic, calculate according to composition by weight, are prepared from by 20 parts of the Radixs Astragali, 20 parts of Semen Coiciss, 8 parts of Cortex Moutans, 40 parts of Radix Ophiopogonis, 40 parts of the Rhizoma Anemarrhenaes and adjuvant.
The preparation method of the health product of aforementioned auxiliary hyperglycemic is: take each medical material by prescription, extract according to conventional method, add conventional pharmaceutic adjuvant to make preparation.
Specifically, the preparation method of the health product of aforementioned auxiliary hyperglycemic is: take each medical material by prescription, merge and decoct 2-3 time, add for the first time 4-10 times of water gaging, soak 0.5 hour, heated and boiled 0.5-2h, adds respectively 4-6 times of water gaging later and decocts 0.5-2h, with 200 mesh sieves filtrations, merging filtrate, concentrating under reduced pressure, adds adjuvant, makes preparation according to conventional method.
More particularly, the preparation method of the health product of aforementioned auxiliary hyperglycemic is: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds respectively 4 times of water gagings later and decocts 1h, with 200 mesh sieves filtrations, merging filtrate, concentrating under reduced pressure, adds adjuvant, makes preparation according to conventional method.
Described preparation is capsule, tablet, granule, oral liquid or water decoction.
Described capsule is prepared like this: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decocts 1h, filtrate filters with 200 mesh sieves, and merging filtrate is 1.25～1.30 thick paste when being evaporated to relative density and being 50 ℃～60 ℃, the starch that adds thick paste amount 0.4-0.7 doubly to measure, granulation, dry, add the magnesium stearate of grain amount 0.2-0.3%, mix, incapsulate, to obtain final product.
Described oral liquid is prepared like this: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decocts 1h, filtrate filters with 200 mesh sieves, merging filtrate, is 1.05～1.10 clear paste when being evaporated to relative density and being 50 ℃～60 ℃, adds the sodium benzoate of the amount of making 0.1-0.3%, stir, add water to full dose, stir evenly, fill and get final product.
Described tablet is prepared like this: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decocts 1h, and filtrate filters with 200 mesh sieves, merging filtrate, when being evaporated to relative density and being 50 ℃～60 ℃, be 1.25～1.30 thick paste, add the starch that thick paste amount 0.4-0.6 doubly measures, the hyprolose that thick paste amount 0.01-0.03 doubly measures, granulation, dry, the magnesium stearate that adds grain amount 0.05-0.1%, mixes, tabletting, film coating, to obtain final product.
Described granule is prepared like this: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decocts 1h, filtrate filters with 200 mesh sieves, merging filtrate, concentrating under reduced pressure relative density is 1.25～1.30 thick paste while being 50 ℃～60 ℃, the dextrin that adds thick paste amount 2-3.5 doubly to measure, granulation, dry, subpackage, to obtain final product.
Described water decoction is prepared like this: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decoct 1h, and filtrate filters with 200 mesh sieves, and merging filtrate is concentrated, to obtain final product.
Diabetes are a kind of commonly encountered diseases, are difficult to cure, and needs of patients Long-term taking medicine, diabetic complication often causes serious consequence.Diabetes are divided type Ⅰ diabetes mellitus, type Ⅱdiabetes mellitus, gestational diabetes and secondary diabetes.Wherein type 1 diabetes is a kind of autoimmune disease (Autoimmune Disease), because the immune system of health is made and attacked and kill them the pancreas beta cell (pancreatic beta cells) of self excreting insulin self making the immune system of attacking the diabetics forming, result pancreas can not be secreted enough insulins, the multiple teenager of being born in, onset is anxious, polydipsia, polyuria, polyphagia, the symptom such as lose weight is obvious, there is the ketoacidosis of generation tendency, its insulin secretion lacks, must rely on exogenous insulin supplements to sustain life, and the prevalence of this paradiabetes accounts for 10% of total diabetes cases.Type Ⅱdiabetes mellitus adult morbidity type diabetes, how after 35～40 years old, to fall ill, onset is slow, clinical symptoms light or lack as, be inclined to without ketoacidosis, but under some inducement effect, also can there is ketoacidosis or hyperosmolar nonketotic diabetic coma, the ability that produces insulin in patient body not completely loses, in some patient bodies, insulin even produces too much, but the action effect of insulin is had a greatly reduced quality, therefore the insulin in patient body is a kind of shortage relatively, treatment does not rely on insulin, but in diet control and oral hypoglycemic drug therapy poor effect, or while there is complication and concomitant disease, need application insulin, account for diabetics more than 90%.Secondary diabetes is because the causers such as pancreatitis, cancer, the excision of the large portion of pancreas should be considered in conjunction with medical history analysis, and patient has pigmentation, hepatosplenomegaly, diabetes and Iron metabolism disorder evidence.
The traditional Chinese medical science thinks, diabetes spp is in " quenching one's thirst " sick category, and its pathogenesis is mainly YIN fluid deficiency, scorching inclined to one side victory, and take the deficiency of YIN as this, scorching is mark.Production of dryness-heat in the interior, the dry liquid in Tianjin is withered, and QI and blood is not smooth, is the stasis of blood for a long time.Therefore TCM treatment of diabetes is worked as take replenishing YIN and removing heat, blood circulation promoting and blood stasis dispelling as main.The medicine for the treatment of diabetes of the present invention is made up of the Radix Astragali, Semen Coicis, Cortex Moutan, Radix Ophiopogonis and the Rhizoma Anemarrhenae.In side, the Radix Astragali has effect of invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation, be used for the treatment of that the deficiency of vital energy is weak, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle are difficultly burst, burst for a long time do not hold back, blood deficiency dull yellowish colored skin, interior-heat are quenched one's thirst etc.; Studies confirm that, Radix Astragali main component is Radix Astragali saponin, astragalus polysaccharides, aminobutyric acid, trace element (selenium, manganese, ferrum, zinc, copper) and calcium etc.; Astragalus polysaccharides wherein has the effect of two-ways regulation blood glucose, can make the blood sugar level of mice after glucose load significantly decline, and the mouse blood sugar level that can obviously cause antiadrenergic drug raises, and insulin hypoglycemia is had no significant effect.Effect that the Rhizoma Anemarrhenae has clearing away heat-fire, promotes the production of body fluid and moisturize, is used for the treatment of that fever caused by exogenous pathogenic factors, high hot excessive thirst, lung-heat type cough, osteopyrexia and fever, interior-heat are quenched one's thirst, dryness of the intestine constipation.Research shows, timosaponin 15g/L can significantly suppress the activity of α-glucosidase, suppression ratio reaches 73.09%, and can significantly improve the carbohydrate tolerance of alloxan model mice and reduce post-prandial glycemia, the hypoglycemic activity that timosaponin is described may be the activity by Inhibiting α-glucosidase, thereby the aminoacid of inhibition liver is converted into glucose (being glyconeogenesis) or suppresses glycogenolysis and realize.There is effect that YIN nourishing and the production of body fluid promoting, lung moistening clear away heart-fire Radix Ophiopogonis, be used for the treatment of that dryness of the lung dry cough, chronic consumptive disease cough, thirsty, the vexed insomnia of Tianjin wound, interior-heat are quenched one's thirst, dryness of the intestine constipation, pharyngeal diphtheria; Main component has multiple steroid saponin, Radix Ophiopogonis Saponin A, B, C, D, glycoside unit is ruscogenin, separately, containing ophiopogonin B, C, D, glycoside unit is diosgenin; Still containing multiple flavone compound: as Radix Ophiopogonis methyl flavanone A, B, Radix Ophiopogonis flavanone A, ophiopogonone A, B, methyl ophiopogonone A, B etc.Semen Coicis has effect of spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal, clearing away heat and discharging pus, is used for the treatment of edema, beriberi, dysuria, arthralgia chiefly caused by damp pathogen contracture, diarrhea due to hypofunction of the spleen, lung abscess, acute appendicitis, flat with wart; Main component has coixenolide (coixenolide); And fatty oil, in oil, containing myristic acid (myristic acid), campesterol (campesterol), Palmic acid, 8-octadecenic acid, stigmasterol etc., still contain aminoacid, protein and sugar class etc.Cortex Moutan has effect of clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling, is used for the treatment of maculae caused by violent heat pathogen, hematemesis and epistaxis, night fever abating at dawn, lossless hectic fever due to YIN-deficiency, amenorrhea dysmenorrhea, carbuncle sore tumefacting virus, falls and flutter the pain of injury; Main component has paeoniflorin, oxypaeoniflorin, benzoylpaeoniflorin, paeonol, paeonolide, gallic acid etc.; Cortex Moutan is kind to purify the blood, and invigorates blood circulation, thereby has effect of cool the blood dissipate blood stasis, makes blood flow freely and not stay the stasis of blood, the absurd clearly and not row of heat in blood; Therefore to diseases such as intense heat in the blood, Liver and kidney hyperactivity of fire and stagnation of blood stasis, all rely on as key medicine, Shennong's Herbal is also on the books: main cold and heat, apoplexy clonic convulsion, convulsion, infantile convulsion pathogen, except the hard blood stasis of disease stays house the intestines and stomach, settling five organs, treats carbuncle skin ulcer.All medicines share above, play altogether the effect of replenishing YIN and removing heat, blood circulation promoting and blood stasis dispelling, can assist the blood glucose that reduces diabetics, polydipsia, polyuria, the polyphagia of reduction of patient and the symptom of becoming thin.
The present invention is that inventor is according to theory of Chinese medical science, take replenishing YIN and removing heat, blood circulation promoting and blood stasis dispelling as Therapeutic Principle, pass through long-term, a large amount of experimentatioies and studies have shown that of obtaining, energy adjuvant therapy of diabetes of the present invention, and safe, more amazing, result of study also shows, raw material prescription of the present invention has produced the effect of Synergistic.
It is below experimentation content of the present invention
Experimental example 1.Technical study
One, extraction, concentration technology: because containing more aqueous soluble active constituent in prescription, so choosing uses water as extraction solvent, adopt L9 (3
4) orthogonal table carries out orthogonal design, to soak time, amount of water, decocting time, decoction number of times, 4 factor 3 levels are carried out preferably, take dry cream yield, astragaloside as investigating index index, analyze comparison.Concrete operations are as follows:
(1) sample preparation: take the Radix Astragali, Radix Ophiopogonis, Semen Coicis, the Rhizoma Anemarrhenae and Cortex Moutan in prescription ratio, extract by table 2 requirement, medicinal liquid is with after 200 object filter-cloth filterings, and concentrating under reduced pressure, dry, weighs and calculate dry cream yield for subsequent use.
(2) Determination of Astragaloside: get above-mentioned dried cream powder and be broken into fine powder, carry out the assay of astragaloside according to method under 2010 editions " Chinese Pharmacopoeia " Radix Astragali assay items, result of the test is in table 2.
Table 1 factor level table
Table 2 extraction process orthogonal experiments
(3) interpretation of result: can find out from the extreme difference value of dry cream yield and Astragaloside content, the factor order that affects extraction effect is A > C > D > B, soak time on extraction effect impact significantly, preliminary definite, this prescription medical material preferably extraction process condition is A
2c
1d
2b
1the extraction process of this prescription medical material is: take medical material by prescription and merge decoction secondary, add for the first time 6 times of water, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decocts 1h, and 200 mesh sieves filter, merging filtrate, and to be evaporated to relative density be 1.05～1.30(50 ℃～60 ℃) extractum; Dry, for subsequent use.
(4) confirmatory experiment: take medical material with technique A preferably by prescription respectively
2c
1d
2b
1, measure as stated above the content (result of the test is in table 3) of dry cream yield and astragaloside, empirical tests, the optimum extraction process of determining this prescription is A
2c
1d
2b
1, take medical material by prescription and merge decoction secondary, add for the first time 6 times of water, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decocts 1h, 200 mesh sieves filter, merging filtrate, and to be evaporated to relative density be 1.25～1.30(50 ℃～60 ℃) extractum; Dry, for subsequent use.
Table 3 demonstration test result
Experimental example 2.Function assessment evaluation experimental
One, animal experiment
(1) experiment material
1, given the test agent: make capsule according to method described in the embodiment of the present invention 1, the used time is poured out content, is made into desired concn with distilled water and applies.
2, animal: Male Kunming strain mice, body weight 26 ± 2g, is provided by Military Medical Univ No.3, P.L.A's Animal Experimental Study center.
3, main agents and instrument: alloxan, glucose or medical starch, blood sugar detection reagent paper or test kit, triglyceride, T-CHOL are measured test kit; Blood glucose meter, full automatic biochemical apparatus, visible spectrophotometer, microplate reader, balance.
4, high thermal energy fodder: Adeps Sus domestica 10%, sucrose 15%, yolk powder 15%, casein 5%, cholesterol 1.2%, sodium cholate 0.2%, calcium bicarbonate 0.6%, stone powder 0.4%, Mus maintain material 52.6%.
5, feeding environment: laboratory animal room's conditional request, 22 ℃～25 ℃ of indoor temperatures, relative humidity 50%～60%, is provided with feedstuff, freely drinks water.
(2) experimental technique carries out with reference to the auxiliary hyperglycemic function method of inspection and rule of operation in " health food check and assessment technique standard ".
1, intact animal's blood sugar lowering experiment
Select healthy adult mice, by the grouping of the fasting blood sugar level of 4 hours, select at random 1 matched group and 1 dosage group.Matched group gives the distilled water of same volume, and dosage group gives high dose concentration capsule of the present invention (1.6g/kg), continuous 30 days, surveys fasting blood sugar (fasting is with before testing), relatively two treated animal blood glucose values.
2, hyperglycemia model blood sugar lowering experiment
2.1 modeling method
Select healthy adult mice, adapt to, after 1 day, get at random 15 animal fasting 4 hours, survey fasting glucose, as this batch of animal basis blood glucose value.Animal fasting subsequently 24 hours (freely drinking water), the modeling of injection alloxan (with front fresh preparation), mice 48mg/kg BW.iv.Animal fasting 4 hours after 5 days, surveys blood glucose, and blood glucose value 10-25mmol/L is hyperglycemia model success animal.
2.2 hyperglycemia model animal blood sugar lowering experiments
Select hyperglycemia model animal by the grouping of the fasting blood sugar level of 4 hours, select at random 1 model control group and 3 dosage groups (the poor 1.1mmol/L that is not more than between group).Dosage group gives variable concentrations capsule of the present invention ［ large, medium and small 3 dosage groups (1.6,0.8,0.4g/kg) ］, model control group gives the distilled water of same volume, continuous 30 days, survey fasting blood sugar (fasting is with before testing), more each treated animal blood glucose value and blood glucose decline percentage rate.
(3) experimental result
1, the impact of capsule of the present invention on normal mouse fasting glucose: normal mouse fasting glucose is had no significant effect to (P > 0.05), and experimental result is in table 4.
The impact of table 4 capsule of the present invention on normal mouse fasting glucose
2, hyperglycemia model blood sugar lowering experiment
2.1 observe the result of modelings: experimental result shows, the blood glucose value of model group mice is 18.105 ± 3.421, be the successful animal of hyperglycemia model between 10-25mmol/L, the results are shown in Table 5.Table 5 alloxan induction diabetic mice model result
2.2 hyperglycemia model animal blood sugar lowering experiments: as shown in Table 6, capsule of the present invention large, medium and small dosage group blood glucose value and blood glucose decline percentage rate all reduce, relatively have significant statistical significance (P<0.01) with model group, experimental result is in table 6.
The impact of table 6 capsule of the present invention on blood glucose in diabetic mice
Note: with model group comparison,
* *p<0.01
2.3 hyperglycemia model animal carbohydrate tolerance experiment: dosage grouping and given the test agent give the time and test with hyperglycemia model animal blood sugar lowering.Each treated animal fasting 4 hours, measure to glucose (0 hour) blood glucose value, dosage group gives variable concentrations given the test agent, model control group gives same volume solvent, after 15-20 minute, each group per os gives glucose 2.0g/kg BW, measure to each group blood glucose value of 0.5,2 hour after glucose, result shows dosage group and model control group comparison, has significant difference (P<0.05) to arbitrary time point blood glucose decline in 0.5,2 hour after glucose.
3, the impact on blood fat: after experiment finishes, measure respectively triglyceride and T-CHOL, result shows, triglyceride is increased significantly (P<0.001), but it is not obvious that T-CHOL raises, the heavy dose of group of capsule of the present invention can obviously reduce content of triglyceride (P<0.01), middle dosage group the adjusting triglyceride effect of mitigation, the results are shown in Table 7.
The impact of table 7 capsule of the present invention on diabetic mice serum cholesterol and triglyceride
Note: with model group comparison,
*p<0.05,
*p<0.01
(4) conclusion
From above result of the test, the present invention has obvious reducing effect to diabetic mice.
Two, human feeding trial
(1) experiment material
1, given the test agent: make capsule according to method described in the embodiment of the present invention 1,0.4g/ grain.
2, experimenter selects: select by " health food check and assessment technique standard " requirement.
3, EXPERIMENTAL DESIGN and grouping: standard compliant diabetics is balancedly divided into test-meal group and matched group at random, wherein test-meal group 80 examples, matched group 80 examples.
(2) experimental technique
Test-meal group is taken the capsule of making according to method described in the embodiment of the present invention 1, and each 5,2 times on the one, matched group is taken placebo, and instructions of taking, dosage are identical with test-meal group, Continuous Observation 30 days.
(3) experimental result
1, safety indexes
(1) general status sign: test-meal group and matched group are before and after experiment, and spirit, sleep, diet, defecation, blood pressure etc., without significant change, are all acted normally.
(2) blood, urine, feces routine examination: test-meal group and matched group are before and after experiment, and blood, urine, feces routine examination have no significant change.
(3) liver, kidney function test: test-meal group and matched group are before and after experiment, and liver, kidney function test have no significant change.
(4) Chest X-rays, electrocardiogram, Abdominal B type ultrasonography inspection: test-meal group and matched group are before experiment, and Chest X-rays, electrocardiogram, Abdominal B type ultrasonography inspection are all normal.
2, effect index
Detailed medical history-taking, understands patient's diet situation, medicining condition, and activity, observes the main clinic symptoms such as thirsty polydipsia, polyorexia, fatigue and weakness, polyuria, and improves with regard to its cardinal symptom, observes clinical symptoms improvement rate.
(1) observation of symptoms: test-meal group clinical symptoms has clear improvement, with matched group comparison, has significant difference (* P < 0.05, * * < P0.a1), and experimental result is in table 8.
Table 8 clinical symptoms is improved situation
Note: with matched group comparison, * P < 0.05, * * < P0.01
(2) fasting glucose: compare after the test-meal of test-meal group with before test-meal, fasting glucose declines to some extent, has significant difference (* * < P0.01); Fasting glucose there was no significant difference before two groups of test-meals, test-meal group fasting glucose fall and decline percentage rate and matched group comparison after test-meal, there is significant difference (* * < P0.01), and test-meal group is evaluated fasting glucose decline percentage rate > l0%, illustrate that capsule of the present invention has the effect of remarkable reduction fasting glucose, experimental result is in table 9.
The variation of fasting glucose before and after table 9 test-meal
(3) 2h-plasma glucose: compare before post-prandial glycemia and test-meal after the test-meal of test-meal group, have significant difference (* * < P0.01); The front two groups of 2h-plasma glucose there was no significant differences of test-meal, test-meal group post-prandial glycemia fall and decline percentage rate and matched group comparison after test-meal, there is significant difference (* * < P0.01), and test-meal group is evaluated fasting glucose decline percentage rate > 10%, illustrate that capsule of the present invention has the effect of remarkable reduction 2h-plasma glucose, experimental result is in table 10.
The variation of 2h-plasma glucose before and after table 10 test-meal
(4) experiment conclusion: known according to above result: capsule of the present invention has the effect of auxiliary hyperglycemic function.
Experimental example 3.Acute toxicity test
(1) experiment material and condition
1, animal: Kunming mouse, body weight 20 ± 2g, male and female half and half, are provided by Military Medical Univ No.3, P.L.A's Animal Experimental Study center.
2, given the test agent: make capsule according to method described in the embodiment of the present invention 1, the used time is poured out content, is made into required for reagent liquid with distilled water.
3, solvent: distilled water.
4, condition: temperature 22-25 ℃, humidity is 50%-60%.
(2) experimental technique
1, animal grouping: establish four dosage groups, every group of 10 mices, male and female half and half.
2, dosage and give mode: experiment establishes 1000,2150,4640, a 10000mg/kg/d4 dosage group.Adopt the administration of per os gavage mode, every day gavage 1 time, Continuous Observation 7 days.
(3) experimental result: experimental result is in table 11.
Table 11 capsule of the present invention is to chmice acute toxicity test result
As shown in Table 10, in the observation period, have no experiment mice and occur poisoning symptom and death condition, the LD of capsule of the present invention to mice
50value is greater than 10000mg/kg, and according to acute toxicity grading criteria, its acute toxicity belongs to actual non-toxic type.
Experimental example 4.Synergistic experimentation
One, experiment material, condition and method
1. material and condition
1.1 animals: Male Kunming strain mice: body weight 26 ± 2g.Chongqing Third Military Medical University Experimental Animal Center provides.
1.2 condition experiments: temperature 22-25 ℃; Humidity 50-60%.
1.3 given the test agent: according to formula described in table 12, make extractum according to process conditions described in experimental example 1, be made into for reagent liquid with distilled water respectively.
2. method
2.1 models are set up: get Male Kunming strain mice, adapt to 48h in laboratory animal room, fasting be can't help, after water 12h, weighing and performing labelling.Tail vein injection alloxan (Alloxan) 60mg/kg (preparation before use), every day 1 time, continuous 5 days, after 5 days, water 4h was can't help in fasting, took out at random 12 and surveyed blood glucose value.
2.2 animals groupings: by diabetic mice, be divided at random 5 experimental grouies, each experimental group is divided into 3 groups again, 12 every group, the equal tail vein of each administration group 1ml/kg is for reagent liquid, and 30d continuously measures blood glucose (GLU) level with semi-automatic biochemical analyzer.
3. sample grouping, in table 12:
Table 12
Two, experimental result:
1, one group of experimental result, in table 13:
The impact on blood glucose in diabetic mice of one group, table 13
Conclusion: from table 13 experimental result, q value is 1.31, shows after this group drug combination and has synergistic function significantly.
2, two groups of experimental results, in table 14:
The impact on blood glucose in diabetic mice of two groups, table 14
Conclusion: from table 14 experimental result, q value is 1.23, shows after this group drug combination and has synergistic function.
3, three groups of experimental results, in table 15:
The impact on blood glucose in diabetic mice of three groups, table 15
Conclusion: from table 15 experimental result, q value is 1.25, shows after this group drug combination and has synergistic function.
4, four groups of experimental results, in table 16:
The impact on blood glucose in diabetic mice of four groups, table 16
Conclusion: from table 16 experimental result, q value is 0.83, shows after this group drug combination without synergistic function.
2, five groups of experimental results, in table 17:
The impact on blood glucose in diabetic mice of five groups, table 17
Conclusion: from table 17 experimental result, q value is 0.84, shows after this group drug combination without synergistic function.
This test adopts golden formula equation to evaluate after the Radix Astragali+Semen Coicis+Cortex Moutan and Radix Ophiopogonis+Rhizoma Anemarrhenae two combination use, on the impact of blood glucose in diabetic mice, and result demonstration, one, two, three group of drug combination can produce synergistic function.
Compared with prior art, health product of the present invention have YIN nourishing and the production of body fluid promoting, and effect of blood circulation promoting and blood stasis dispelling can be assisted the blood glucose that reduces diabetics; Polydipsia, polyuria, the polyphagia of reduction of patient and the symptom of becoming thin, have no side effect, and the effect that can also produce Synergistic after the material medicine compatibility of selecting, meet the selection principle of modern formulation " quick-acting, efficient; dosage is little, toxic and side effects is little ", be a kind of safe and effective health promoting product, for diabetics has brought Gospel, reached goal of the invention.
The specific embodiment
Embodiment 1:
Prescription: Radix Astragali 20g, Semen Coicis 20g, Cortex Moutan 8g, Radix Ophiopogonis 8g, Rhizoma Anemarrhenae 8g, starch 7g, magnesium stearate 0.05g.
Technique: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decocts 1h, filtrate filters with 200 mesh sieves, and merging filtrate is 1.25～1.30 thick paste when being evaporated to relative density and being 50 ℃～60 ℃, add starch, granulation, dry, add magnesium stearate, mix, incapsulate, make 50, obtain capsule.
Specification: 0.4g/ grain.
Usage and dosage: oral, each 5,2 times on the one.
Embodiment 2:
Prescription: Radix Astragali 20g, Semen Coicis 20g, Cortex Moutan 8g, Rhizoma Anemarrhenae 4g, Radix Ophiopogonis 4g, starch 6g, hyprolose 0.2g, magnesium stearate 0.012g.
Technique: take each medical material by prescription, merge and decoct 3 times, add for the first time 10 times of water gagings, soak 0.5 hour, heated and boiled 2h, adds respectively 6 times of water gagings later and decocts 2h, filter with 200 mesh sieves, merging filtrate, is 1.25～1.30 thick paste when being evaporated to relative density and being 50 ℃～60 ℃, add starch and hyprolose, granulation, dry, add magnesium stearate, mix, be pressed into 40, film coating, obtains tablet.
Specification: the heavy 0.4g of substrate.
Usage and dosage: oral, each 5,2 times on the one.
Embodiment 3:
Prescription: Radix Astragali 20g, Semen Coicis 20g, Cortex Moutan 8g, Radix Ophiopogonis 40g, Rhizoma Anemarrhenae 40g, dextrin 50g.
Technique: take each medical material by prescription, merge and decoct 3 times, add for the first time 8 times of water gagings, soak 0.5 hour, heated and boiled 0.5h, adds respectively 5 times of water gagings later and decocts 0.5h, filter with 200 mesh sieves, merging filtrate, being evaporated to relative density is 1.25～1.30(50 ℃～60 ℃) thick paste, add dextrin, granulation, dry, subpackage, make 100g, obtain granule.
Specification: 5g/ bag.
Usage and dosage: warm boiled water, each 1 bag, 2 times on the one.
Embodiment 4:
Prescription: Radix Astragali 30g, Semen Coicis 30g, Cortex Moutan 16g, Rhizoma Anemarrhenae 40g, Radix Ophiopogonis 40g, sodium benzoate 0.6g.
Technique: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds respectively 4 times of water gagings later and decocts 2h, with 200 mesh sieves filtrations, merging filtrate, being evaporated to relative density is 1.05～1.10(50 ℃～60 ℃) clear paste, add sodium benzoate, stir, add water to 300ml, stir evenly, fill and get final product.
Specification: 20ml/ bottle.
Usage and dosage: warm boiled water, each 1 bottle, 2 times on the one.
Embodiment 5:
Prescription: Radix Astragali 10g, Semen Coicis 10g, Cortex Moutan 4g, Rhizoma Anemarrhenae 4g, Radix Ophiopogonis 4g.
Technique: described water decoction is prepared like this: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, adds for the second time 4 times of water gagings and decocts 1h, filtrate filters with 200 mesh sieves, merging filtrate, and be concentrated into the medicinal liquid that volume is 200ml.
Usage and dosage: oral, each 150ml, 2 times on the one.
Claims (6)
1. health product for auxiliary hyperglycemic, is characterized in that: calculate according to composition by weight, be prepared from by 20 parts of the Radixs Astragali, 20 parts of Semen Coiciss, 8 parts of Cortex Moutans, 8 parts of Radix Ophiopogonis, 8 parts of the Rhizoma Anemarrhenaes and adjuvant.
2. the method for the health product of auxiliary hyperglycemic described in preparation claim 1, is characterized in that: take each medical material by prescription, extract according to conventional method, add conventional pharmaceutic adjuvant to make preparation.
3. the preparation method of the health product of auxiliary hyperglycemic described in claim 2, it is characterized in that: take each medical material by prescription, merge and decoct 2-3 time, add for the first time 4-10 times of water gaging, soak 0.5 hour, heated and boiled 0.5-2h, adds respectively 4-6 times of water gaging later and decocts 0.5-2h, with 200 mesh sieves filtrations, merging filtrate, concentrating under reduced pressure, adds adjuvant, makes preparation according to conventional method.
4. the preparation method of the health product of auxiliary hyperglycemic as described in claim 2 or 3, is characterized in that: described preparation is capsule, tablet, granule, oral liquid or water decoction.
5. the preparation method of the health product of auxiliary hyperglycemic as claimed in claim 4, it is characterized in that: described capsule is prepared like this: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, add for the second time 4 times of water gagings and decoct 1h, filtrate filters with 200 mesh sieves, merging filtrate, it when being evaporated to relative density and being 50 ℃～60 ℃, is 1.25～1.30 thick paste, the starch that adds thick paste amount 0.4-0.7 doubly to measure, granulation, dry, add the magnesium stearate of grain amount 0.2-0.3%, mix, incapsulate, obtain.
6. the preparation method of the health product of auxiliary hyperglycemic as claimed in claim 4, it is characterized in that: described oral liquid is prepared like this: take each medical material by prescription, merge and decoct 2 times, add for the first time 6 times of water gagings, soak 0.5 hour, heated and boiled 1h, add for the second time 4 times of water gagings and decoct 1h, filtrate filters with 200 mesh sieves, merging filtrate, it when being evaporated to relative density and being 50 ℃～60 ℃, is 1.05～1.10 clear paste, the sodium benzoate that adds the amount of making 0.1-0.3%, stirs, and adds water to full dose, stir evenly fill and get final product.
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