CN102755568A - 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 to act on that body causes hypoinsulinism, insulin resistant etc. and a series of metabolism disorder syndromes such as the sugar that causes, protein, fat, power and water Xie Zhi by inherited genetic factors, immunologic function disorder, infected by microbes and toxin thereof, free radical toxin, Nervous and Mental Factors or the like various virulence factors; Be main feature clinically with the hyperglycemia; Performance such as polyuria, polydipsia, polyphagia can appear in model case, become thin; I.e. " three-many-one-little " symptom; Diabetes (blood glucose) cause complication in case control bad meeting, cause the depleted pathological changes at positions such as kidney, eye, foot, and can't cure.
The category that diabetes spp " is quenched one's thirst " in motherland's medical science, its name of disease head are shown in " discussing through strange disease in the emperor ", and the traditional Chinese medical science is discussed and quenched one's thirst, and lung-heat impairment of body fluid, thirsty polydipsia disappear on being, belong to 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 is a diabetes due to kidney-deficiency, belongs to kidney-heat and due to water loses.Lung-heat, gastric heat, suffer from a deficiency of the kidney and see, or have and stress, form and quench one's thirst, lack one and can not become this disease; And innate deficiency, the five internal organs weakness, eating and drinking without temperance, feelings will factor are the key factors of quenching one's thirst.The pathogenesis of diabetes is YIN fluid deficiency, and scorching inclined to one side Sheng, and be this with the deficiency of YIN scorchingly is mark.Quench one's thirst with the passing of time, deficiency of YIN leading to consumption of QI, deficiency of YIN affecting YANG then causes cloudy all need of gas.Disease is gone into network for a long time, hematogenous blockage, and then every hyperamization stasis of blood is for suffering from, and with the passing of time common change disease is numerous.The clinical disease of seeing deficiency of both QI and YIN more.The history in existing thousands of years of traditional Chinese medical science control diabetes, ancient Chinese medicine doctor to the understanding of primary disease many scorching with the deficiency of YIN be main, employing replenishing YIN and removing heat methods how treatment in.
Now, diabetes have become " No. three killer " who after tumor and cardiovascular and cerebrovascular disease, threatens the mankind in the world.No matter in developed country or developing country, the sickness rate of diabetes is all in rapid rising.According to the data that World Health Organization (WHO) announces, there were 3,000 ten thousand diabetes patients in the whole world in 1985, had increased to 1.35 hundred million by 1997.According to internal authority diabetes epidemiology scholarly forecast, by 2010, global diabetes patient will reach 2.4 hundred million, and the year two thousand fifty then can be increased to 300,000,000 people.Diabetes have become the great public health problem that countries in the world are paid close attention to as a kind of serious non-infectious chronic disease.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 the annual in recent years speed with 0.1% increases sharply.Extensive epidemiological investigation result to from 11 provinces in the whole nation, city people more than 40,000 shows; Among present 20～74 years old crowd of China; 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 surpassed 2,000 ten thousand, and " reserves " be 3,000 ten thousand people nearly then.And be type more than 90%, for this reason, the Chinese medicine health-care series products of researching and developing a kind of ability auxiliary hyperglycemic has extensively and profound significance.
Summary of the invention
Technical problem to be solved by this invention provides 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 adopts following technical scheme to realize:
A kind of health product of auxiliary hyperglycemic calculate according to composition by weight, 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, 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 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 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 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 method for preparing of the health product of aforementioned auxiliary hyperglycemic is: take by weighing each medical material by prescription, extract according to conventional method, add conventional pharmaceutic adjuvant and process preparation.
Specifically, the method for preparing of the health product of aforementioned auxiliary hyperglycemic is: take by weighing each medical material by prescription, merge decoction 2-3 time; For the first time add 4-10 times of water gaging, soaked heated and boiled 0.5-2h 0.5 hour; Add 4-6 times of water gaging later on respectively and decoct 0.5-2h, filter merging filtrate with 200 mesh sieves; Concentrating under reduced pressure adds adjuvant, processes preparation according to conventional method.
More particularly, the method for preparing of the health product of aforementioned auxiliary hyperglycemic is: take by weighing each medical material by prescription, merge decoction 2 times; For the first time add 6 times of water gagings, soaked heated and boiled 1h 0.5 hour; Add 4 times of water gagings later on respectively and decoct 1h, filter merging filtrate with 200 mesh sieves; Concentrating under reduced pressure adds adjuvant, processes preparation according to conventional method.
Said preparation is capsule, tablet, granule, oral liquid or water decoction.
Said capsule prepares like this: take by weighing each medical material by prescription, merge decoction 2 times, add 6 times of water gagings for the first time, soaked 0.5 hour; Heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h, and filtrating filters with 200 mesh sieves, merging filtrate; Be 1.25～1.30 thick paste when being evaporated to relative density and being 50 ℃～60 ℃, add the starch that thick paste amount 0.4-0.7 doubly measures, process granule, drying; Add the magnesium stearate of grain amount 0.2-0.3%, mixing incapsulates, and promptly gets.
Said oral liquid prepares like this: take by weighing each medical material by prescription, merge decoction 2 times, add 6 times of water gagings for the first time, soaked 0.5 hour; Heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h, and filtrating filters with 200 mesh sieves, merging filtrate; Be 1.05～1.10 clear paste when being evaporated to relative density and being 50 ℃～60 ℃, add the sodium benzoate of the amount of processing 0.1-0.3%, stir; Add water to full dose, stir, fill promptly gets.
Said tablet prepares like this: take by weighing each medical material by prescription, merge decoction 2 times, add 6 times of water gagings for the first time, soaked 0.5 hour; Heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h, and filtrating filters with 200 mesh sieves, merging filtrate; Be 1.25～1.30 thick paste when being evaporated to relative density and being 50 ℃～60 ℃, 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, process granule; Drying, the magnesium stearate of adding grain amount 0.05-0.1%, mixing; Tabletting, the bag film-coat promptly gets.
Said granule prepares like this: take by weighing each medical material by prescription, merge decoction 2 times, add 6 times of water gagings for the first time, soaked 0.5 hour; Heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h, and filtrating filters with 200 mesh sieves, merging filtrate; The concentrating under reduced pressure relative density is 1.25～1.30 thick paste when being 50 ℃～60 ℃, adds the dextrin that thick paste amount 2-3.5 doubly measures, and processes granule; Drying, packing promptly gets.
Said water decoction prepares like this: take by weighing each medical material by prescription, merge decoction 2 times, add 6 times of water gagings for the first time, soaked 0.5 hour, heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h, and filtrating is with the filtration of 200 mesh sieves, and merging filtrate concentrates, and promptly gets.
Diabetes are a kind of commonly encountered diseases, are difficult to cure, and needs of patients is taken medicine for a long time, and diabetic complication often causes serious consequence.Diabetes are divided type, type, gestational diabetes and secondary diabetes.Wherein IDDM is a kind of autoimmune disease (Autoimmune Disease); Be that pilosity is born in teenager because the immune system of health is made the pancreas beta cell (pancreatic beta cells) of self excreting insulin and attacked and kill them self making the immune system of attacking the diabetics that forms, and pancreas can not be secreted enough insulins as a result; Onset is anxious; Polydipsia, polyuria, polyphagia, symptom such as lose weight are obvious, and the ketoacidosis of generation tendency is arranged, and its insulin secretion lacks; Must rely on exogenous insulin and replenish earning a bare living, and the prevalence of this paradiabetes accounts for 10% of total diabetes cases.How type adult morbidity type diabetes fell ill after 35～40 years old, and onset is slow; Clinical symptoms light or lack as, no ketoacidosis is inclined to, but under some inducement effect; Ketoacidosis or hyperosmolar nonketotic diabetic coma can take place, the ability that produces insulin in patient's body is not to completely lose yet, and insulin even generation are too much in the patient's body that has; But the action effect of insulin is had a greatly reduced quality, so the intravital insulin of patient is a kind of relative shortage, and treatment does not rely on insulin; But in diet control and oral hypoglycemic drug therapy poor effect; Or when having complication and concomitant disease, need to use insulin, account for diabetics more than 90%.Secondary diabetes considers that owing to pancreatitis, cancer, big causer such as excision of pancreas should combine the medical history analysis patient has pigmentation, hepatosplenomegaly, the disorderly evidence of diabetes and iron metabolism.
The traditional Chinese medical science thinks that diabetes spp is in " quenching one's thirst " sick category, and its pathogenesis mainly is YIN fluid deficiency, and scorching inclined to one side victory, and be this with the deficiency of YIN scorchingly is mark.Production of dryness-heat in the interior, the dried liquid in Tianjin is withered, and QI and blood is not smooth, is the stasis of blood for a long time.So it is main that TCM treatment of diabetes is worked as with replenishing YIN and removing heat, blood circulation promoting and blood stasis dispelling.The medicine of treatment diabetes according to the invention is processed by the Radix Astragali, Semen Coicis, Cortex Moutan, Radix Ophiopogonis and the Rhizoma Anemarrhenae.The Radix Astragali has the effect of invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation in the side, be used to treat 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.; Research confirms 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 that the blood sugar level of mice significantly descends behind the glucose load, and the mouse blood sugar level that can obviously cause antiadrenergic drug raises, and insulin hypoglycemia is not had obvious influence.The effect that the Rhizoma Anemarrhenae has clearing away heat-fire, promotes the production of body fluid and moisturize is used to treat that fever caused by exogenous pathogenic factors, hyperpyrexia excessive thirst, lung-heat type cough, osteopyrexia and fever, interior-heat are quenched one's thirst, the 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 possibly be the activity through the inhibition alpha-glucosidase, thereby the aminoacid of inhibition liver is converted into glucose (being glyconeogenesis) or suppresses glycogenolysis and realize.Have the effect that YIN nourishing and the production of body fluid promoting, lung moistening clear away heart-fire Radix Ophiopogonis, be used to treat 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, other contains ophiopogonin B, C, D, glycoside unit is diosgenin; Still contain multiple flavone compound: like Radix Ophiopogonis methyl flavanone A, B, Radix Ophiopogonis flavanone A, ophiopogonone A, B, methyl ophiopogonone A, B etc.Semen Coicis has the effect of spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal, clearing away heat and discharging pus, is used to treat 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, contain myristic acid (myristic acid), campesterol (campesterol), Palmic acid, 8-octadecenic acid, stigmasterol etc. in the oil, still contain aminoacid, protein and saccharide etc.Cortex Moutan has the effect of clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling, is used to treat 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 pounce on the pain of injury; Main component has paeoniflorin, OP, benzoylpaeoniflorin, paeonol, paeonolide, gallic acid etc.; Cortex Moutan is kind to purify the blood, and invigorates blood circulation, thereby the effect of cool the blood dissipate blood stasis is arranged, and makes blood flow freely and not stay the stasis of blood, the absurd clearly and not row of heat in blood; So to diseases such as intense heat in the blood, Liver and kidney hyperactivity of fire and stagnation of blood stasis, all to rely on and be key medicine, Shennong's Herbal is also on the books: main cold and heat, apoplexy clonic convulsion, convulsion, infantile convulsion pathogen are removed the hard blood stasis of disease and are stayed the house the intestines and stomach, and settling five organs is treated the carbuncle skin ulcer.More than all medicines share, play the effect of replenishing YIN and removing heat, blood circulation promoting and blood stasis dispelling altogether, can assist the blood glucose of reduction diabetics, the polydipsia of reduction of patient, polyuria, polyphagia and the symptom of becoming thin.
The present invention is that the inventor is according to theory of Chinese medical science; With replenishing YIN and removing heat, blood circulation promoting and blood stasis dispelling is the Therapeutic Principle, and the research that obtains through long-term, a large amount of experimentatioies proves, the present invention's ability adjuvant therapy of diabetes; And it is safe; More amazing is that result of study shows that also raw material prescription according to the invention has produced the effect of Synergistic.
It below is experimentation content of the present invention
Experimental example 1.Technical study
One, extraction, concentration technology:,, adopt L9 (3 so choosing uses water as extraction solvent because of containing more aqueous soluble active constituent in the prescription
4) orthogonal table carries out orthogonal design, to soak time, amount of water, decocting time, decoction number of times, 4 factors, 3 levels are carried out preferably, serve as to investigate the index index with dried cream yield, astragaloside, analyze comparison.Concrete operations are following:
(1) sample preparation: take by weighing the Radix Astragali, Radix Ophiopogonis, Semen Coicis, the Rhizoma Anemarrhenae and Cortex Moutan in the prescription ratio, extract by table 2 requirement, after medicinal liquid filters with 200 purpose filter clothes, concentrating under reduced pressure, drying, weighing and to calculate dried cream yield subsequent use.
(2) Astragaloside content is measured: get above-mentioned dried cream powder and be broken into fine powder, " method is carried out the assay of astragaloside under the Chinese pharmacopoeia Radix Astragali assay item, and result of the test is seen table 2 according to 2010 editions.
Table 1 factor level table
Table 2 extraction process orthogonal experiments
(3) interpretation of result: can find out that from the extreme difference value of dried cream yield and Astragaloside content the factor that influences extraction effect is A in proper order>C>D>B, soak time to the extraction effect influence significantly confirms that tentatively the more excellent extraction process condition of this prescription medical material is A
2C
1D
2B
1, promptly the extraction process of this prescription medical material is: take by weighing medical material by prescription and merge the decoction secondary, add 6 times of water for the first time; Soaked 0.5 hour; Heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h, and 200 mesh sieves filter; Merging filtrate, and be evaporated to the extractum that relative density is 1.05～1.30 (50 ℃～60 ℃); Drying, subsequent use.
(4) confirmatory experiment: take by weighing medical material with more excellent technology A by prescription respectively
2C
1D
2B
1, measure the content (result of the test is seen table 3) of dried cream yield and astragaloside as stated above, empirical tests, the optimum extraction process of confirming this prescription is A
2C
1D
2B
1, promptly take by weighing medical material and merge the decoction secondary by prescription, add 6 times of water for the first time; Soaked 0.5 hour, heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h; 200 mesh sieves filter, merging filtrate, and be evaporated to the extractum that relative density is 1.25～1.30 (50 ℃～60 ℃); Drying, subsequent use.
Table 3 demonstration test result
Experimental example 2.The function assessment evaluation experimental
One, animal experiment
(1) experiment material
1, given the test agent: process capsule according to the embodiment of the invention 1 said method, the time spent is poured out content, is made into desired concn with distilled water and uses.
2, animal: Male Kunming strain mice, body weight 26 ± 2g is provided by Military Medical Univ No.3, P.L.A 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, ELIASA, 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 are kept 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 the healthy adult mice, divide into groups, select 1 matched group and 1 dose groups at random by 4 hours blood sugar level of fasting.Matched group gives the distilled water of equal volume, and dose groups gives high dose concentration capsule of the present invention (1.6g/kg), continuous 30 days, surveys fasting blood sugar (fasting is preceding with experiment), relatively two treated animal blood glucose values.
2, hyperglycemia model blood sugar lowering experiment
2.1 modeling method
Select the healthy adult mice, adapt to after 1 day, get 15 animal fasting 4 hours at random, survey fasting glucose, as this batch animal basis blood glucose value.Animal fasting subsequently 24 hours (freely drinking water), the modeling of injection alloxan (using preceding fresh), mice 48mg/kg BW.iv.The animal fasting is 4 hours after 5 days, surveys blood glucose, and blood glucose value 10-25mmol/L is a hyperglycemia model success animal.
2.2 hyperglycemia model animal blood sugar lowering experiment
Select the hyperglycemia model animal to divide into groups, select 1 model control group and 3 dose groups (difference is not more than 1.1mmol/L between group) at random by 4 hours blood sugar level of fasting.Dose groups gives variable concentrations capsule of the present invention ［ large, medium and small 3 dose groups (1.6,0.8,0.4g/kg) ］; Model control group gives the distilled water of equal volume; Continuous 30 days, survey fasting blood sugar (fasting is preceding with experiment), relatively each treated animal blood glucose value and blood glucose decline percentage rate.
(3) experimental result
1, capsule of the present invention is to the influence of normal mouse fasting glucose: the normal mouse fasting glucose is not had obvious influence (P＞0.05), and experimental result is seen table 4.
Table 4 capsule of the present invention is to the influence
of normal mouse fasting glucose
2, hyperglycemia model blood sugar lowering experiment
2.1 observe the result of modeling: experimental result shows that the blood glucose value of model group mice is 18.105 ± 3.421, is hyperglycemia model success animal between 10-25mmol/L, the result sees table 5.Table 5 alloxan is induced diabetic mice model result
2.2 hyperglycemia model animal blood sugar lowering experiment: can be known that by table 6 large, medium and small dose groups blood glucose value of capsule of the present invention and blood glucose decline percentage rate all reduce, relatively have significant statistical significance (P < 0.01) with model group, experimental result is seen table 6.
Table 6 capsule of the present invention is to the influence
of blood glucose in diabetic mice
Annotate: compare with model group,
* *P<0.01
2.3 hyperglycemia model animal carbohydrate tolerance experiment: dosage divides into groups and given the test agent gives the time and tests with hyperglycemia model animal blood sugar lowering.Each treated animal fasting 4 hours; Measure and give glucose (promptly 0 hour) blood glucose value, dose groups gives the variable concentrations given the test agent, and model control group gives with the volume solvent; Respectively organize per os after 15-20 minute and give glucose 2.0g/kg BW; Respectively organize 0.5,2 hour blood glucose value after measure giving glucose, the result shows dose groups and model control group relatively, and arbitrary time point blood glucose decline in 0.5,2 hour has significant difference (P < 0.05) after giving glucose.
3, to the influence of blood fat: after experiment finishes; Measure triglyceride and T-CHOL respectively; The result shows, triglyceride is existing obviously to raise (P < 0.001), but that T-CHOL raises is not obvious; The heavy dose of group of capsule of the present invention obviously triglyceride reducing content (P < 0.01), middle dose groups then has the effect of demulcent adjusting triglyceride, and the result sees table 7.
Table 7 capsule of the present invention is to the influence
of diabetic mice serum cholesterol and triglyceride
Annotate: compare with model group,
*P<0.05,
*P<0.01
(4) conclusion
Can know that by above result of the test the present invention has tangible reduction effect to diabetic mice.
Two, human feeding trial
(1) experiment material
1, given the test agent: process capsule, the 0.4g/ grain according to the embodiment of the invention 1 said method.
2, the experimenter selects: select by " health food check and assessment technique standard " requirement.
3, EXPERIMENTAL DESIGN and grouping: standard compliant diabetics balancedly is divided into test-meal group and matched group at random, wherein test-meal group 80 examples, matched group 80 examples.
(2) experimental technique
The test-meal group is taken the capsule of processing according to the embodiment of the invention 1 said method, and each 5,2 times on the one, matched group is taken placebo, and instructions of taking, dosage are identical with the test-meal group, observe continuously 30 days.
(3) experimental result
1, safety indexes
(1) general situation sign: test-meal group and matched group are before and after experiment, and no significant changes such as spirit, sleep, diet, defecation, blood pressure are all acted normally.
(2) blood, urine, just routine examination: test-meal group and matched group are before and after experiment, and blood, urine, just routine examination has 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 are checked all normal.
2, effect index
Detailed medical history-taking is understood patient's diet situation, medicining condition, and activity is observed 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, and compares with matched group, and significant difference is arranged, and (* P＜0.05, * *＜P0.a1), experimental result is seen table 8.
Table 8 clinical symptoms is improved situation
Annotate: compare * P＜0.05, * *＜P0.01 with matched group
(2) fasting glucose: after the test-meal of test-meal group with test-meal before relatively, fasting glucose descends to some extent, and significant difference (* *＜P0.01) is arranged; 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 are relatively after the test-meal; Significant difference (* *＜P0.01) is arranged; And the test-meal group is estimated fasting glucose decline percentage rate＞l0%, explains that capsule of the present invention has the effect of remarkable reduction fasting glucose, and experimental result is seen table 9.
The variation
of fasting glucose before and after table 9 test-meal
(3) 2h blood glucose after the meal: after the test-meal of test-meal group before post-prandial glycemia and the test-meal relatively, significant difference (* *＜P0.01) is arranged; The preceding two groups of 2h blood glucose there was no significant differences after the meal of test-meal; Test-meal group post-prandial glycemia fall and decline percentage rate and matched group are relatively after the test-meal; Significant difference (* *＜P0.01) is arranged; And the test-meal group is estimated fasting glucose decline percentage rate＞10%, explains that capsule of the present invention has the remarkable reduction effect of 2h blood glucose after the meal, and experimental result is seen table 10.
Table 10 test-meal front and back are 2h changes of blood glucose
after the meal
(4) experiment conclusion: can know 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 Animal Experimental Study center.
2, given the test agent: process capsule according to the embodiment of the invention 1 said method, the time spent is poured out content, is made into required confession reagent liquid with distilled water.
3, solvent: distilled water.
4, condition: temperature 22-25 ℃, humidity is 50%-60%.
(2) experimental technique
1, animal divides into groups: establish four dose 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 dose groups.Adopt per os to irritate the administration of stomach mode, irritate stomach every day 1 time, observed continuously 7 days.
(3) experimental result: experimental result is seen table 11.
Table 11 capsule of the present invention is to chmice acute toxicity test result
Can know that by table 10 do not see in the observation period that poisoning symptom and death condition appear in experiment mice, capsule of the present invention is to the LD of 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.The Synergistic experimentation
One, experiment material, condition and method
1. material and condition
1.1 animal: Male Kunming strain mice: body weight 26 ± 2g.Chongqing Third Military Medical University Experimental Animal Center provides.
1.2 condition experiment: temperature 22-25 ℃; Humidity 50-60%.
1.3 given the test agent: according to the said prescription of table 12, process extractum, be made into distilled water respectively and supply reagent liquid according to experimental example 1 said process conditions.
2. method
2.1 modelling: get Male Kunming strain mice, adapt to 48h, after water 12h is can't help in fasting, weigh and perform labelling in laboratory animal room.Tail vein injection alloxan (Alloxan) 60mg/kg (face and use preceding preparation), every day 1 time, continuous 5 days, water 4h was can't help in fasting after 5 days, took out 12 at random and surveyed blood glucose value.
2.2 animal divides into groups: with diabetic mice, be divided into 5 experimental grouies at random, each experimental group is divided into 3 groups again, 12 every group, the equal tail vein of each administration group 1ml/kg supplies reagent liquid, and 30d measures blood glucose (GLU) level with semi-automatic biochemical analyzer continuously.
3. sample divides into groups, and sees table 12:
Table 12
Two, experimental result:
1, one group of experimental result, see table 13:
One group of influence of table 13
to blood glucose in diabetic mice
Conclusion: can be known that by table 13 experimental result the q value is 1.31, showing behind this group drug combination has synergistic function significantly.
2, two groups of experimental results, see table 14:
Two groups of influences of table 14
to blood glucose in diabetic mice
Conclusion: can be known that by table 14 experimental result the q value is 1.23, showing behind this group drug combination has synergistic function.
3, three groups of experimental results, see table 15:
Three groups of influences of table 15
to blood glucose in diabetic mice
Conclusion: can be known that by table 15 experimental result the q value is 1.25, showing behind this group drug combination has synergistic function.
4, four groups of experimental results, see table 16:
Four groups of influences of table 16
to blood glucose in diabetic mice
Conclusion: can be known that by table 16 experimental result the q value is 0.83, showing behind this group drug combination does not have synergistic function.
2, five groups of experimental results, see table 17:
Five groups of influences of table 17
to blood glucose in diabetic mice
Conclusion: can be known that by table 17 experimental result the q value is 0.84, showing behind this group drug combination does not have synergistic function.
After this test adopted golden formula equation to estimate the Radix Astragali+Semen Coicis+Cortex Moutan and Radix Ophiopogonis+Rhizoma Anemarrhenae two combination usefulness, to the influence of blood glucose in diabetic mice, the result showed that one, two, three group of drug combination can produce synergistic function.
Compared with prior art, health product according to the invention have YIN nourishing and the production of body fluid promoting, and the effect of blood circulation promoting and blood stasis dispelling can be assisted the blood glucose that reduces diabetics; The polydipsia of reduction of patient, polyuria, polyphagia and the symptom of becoming thin; Have no side effect, and the effect that can also produce Synergistic behind the material medicine compatibility of selecting for use, meet the selection principle of modern formulation " quick-acting, efficient; that dosage is little, toxic and side effects is little "; Be a kind of safe and effective health promoting product,, reached goal of the invention for diabetics has brought Gospel.
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.
Technology: take by weighing each medical material by prescription, merge decoction 2 times, add 6 times of water gagings for the first time, soaked heated and boiled 1h 0.5 hour; Add for the second time 4 times of water gagings and decoct 1h, filtrating is with the filtration of 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, process granule, drying adds magnesium stearate; Mixing incapsulates, and processes 50, promptly gets 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.
Technology: take by weighing each medical material by prescription, merge decoction 3 times, add 10 times of water gagings for the first time, soaked heated and boiled 2h 0.5 hour; Add 6 times of water gagings later on respectively and decoct 2h, with the filtration of 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, process granule, drying adds magnesium stearate; Mixing is pressed into 40, and the bag film-coat promptly gets 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.
Technology: take by weighing each medical material by prescription, merge decoction 3 times, add 8 times of water gagings for the first time, soaked 0.5 hour; Heated and boiled 0.5h adds 5 times of water gagings later on respectively and decocts 0.5h, filters merging filtrate with 200 mesh sieves; Being evaporated to relative density is the thick paste of 1.25～1.30 (50 ℃～60 ℃), adds dextrin, processes granule, drying; 100g is processed in packing, promptly gets 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.
Technology: take by weighing each medical material by prescription, merge decoction 2 times, add 6 times of water gagings for the first time, soaked 0.5 hour; Heated and boiled 1h adds 4 times of water gagings later on respectively and decocts 2h, filters merging filtrate with 200 mesh sieves; Being evaporated to relative density is the clear paste of 1.05～1.10 (50 ℃～60 ℃), adds sodium benzoate, stirs; Add water to 300ml, stir, fill promptly gets.
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.
Technology: said water decoction prepares like this: take by weighing each medical material by prescription, merge decoction 2 times, add 6 times of water gagings for the first time; Soaked 0.5 hour, heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h; Filtrating 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 (10)
1. the health product of an auxiliary hyperglycemic is characterized in that: calculate according to composition by weight, 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.
2. the health product of auxiliary hyperglycemic according to claim 1 is characterized in that: calculate according to composition by weight, 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.
3. the health product of auxiliary hyperglycemic according to claim 1 or claim 2 is characterized in that: calculate according to composition by weight, be prepared from 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.
4. the health product of auxiliary hyperglycemic according to claim 1 or claim 2 is characterized in that: calculate according to composition by weight, be prepared from 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.
5. the health product of auxiliary hyperglycemic according to claim 1 or claim 2 is characterized in that: calculate according to composition by weight, be prepared from 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.
6. the method for the health product of each said auxiliary hyperglycemic among the preparation claim 1-5 is characterized in that: take by weighing each medical material by prescription, extract according to conventional method, add conventional pharmaceutic adjuvant and process preparation.
7. the method for preparing of the health product of auxiliary hyperglycemic described in claim 6 is characterized in that: take by weighing each medical material by prescription, merge decoction 2-3 time; For the first time add 4-10 times of water gaging, soaked heated and boiled 0.5-2h 0.5 hour; Add 4-6 times of water gaging later on respectively and decoct 0.5-2h, filter merging filtrate with 200 mesh sieves; Concentrating under reduced pressure adds adjuvant, processes preparation according to conventional method.
8. like the method for preparing of the health product of claim 6 or 7 said auxiliary hyperglycemics, it is characterized in that: said preparation is capsule, tablet, granule, oral liquid or water decoction.
9. like the method for preparing of the health product of the said auxiliary hyperglycemic of claim 8, it is characterized in that: said capsule prepares like this: take by weighing each medical material by prescription, merge and decoct 2 times, add 6 times of water gagings for the first time; Soaked 0.5 hour, heated and boiled 1h adds 4 times of water gagings for the second time and decocts 1h, and filtrating filters with 200 mesh sieves; Merging filtrate is 1.25～1.30 thick paste when being evaporated to relative density and being 50 ℃～60 ℃, adds the starch that thick paste amount 0.4-0.7 doubly measures; Process granule, drying, the magnesium stearate of adding grain amount 0.2-0.3%; Mixing incapsulates, and promptly gets.
10. like the method for preparing of the health product of the said auxiliary hyperglycemic of claim 8, it is characterized in that: said oral liquid prepares like this: take by weighing each medical material by prescription, merge and decoct 2 times; For the first time add 6 times of water gagings, soaked heated and boiled 1h 0.5 hour; Add for the second time 4 times of water gagings and decoct 1h, filtrating filters with 200 mesh sieves, merging filtrate; Be 1.05～1.10 clear paste when being evaporated to relative density and being 50 ℃～60 ℃, add the sodium benzoate of the amount of processing 0.1-0.3%, stir; Add water to full dose, stir, fill promptly gets.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111603536A (en) * | 2020-06-12 | 2020-09-01 | 广西医科大学 | Oyster-carambola composite extract, tablet candy and preparation method thereof |
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| CN111603536A (en) * | 2020-06-12 | 2020-09-01 | 广西医科大学 | Oyster-carambola composite extract, tablet candy and preparation method thereof |
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