CN102319289A - Hyperglycemic Chinese medicinal composition comprising cinnamon polyphenol and the like and preparation method of hyperglycemic Chinese medicinal composition - Google Patents
Hyperglycemic Chinese medicinal composition comprising cinnamon polyphenol and the like and preparation method of hyperglycemic Chinese medicinal composition Download PDFInfo
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Abstract
The invention relates to the field of natural medicaments, in particular to a hyperglycemic Chinese medicinal composition comprising cinnamon polyphenol and a preparation method of the hyperglycemic Chinese medicinal composition. The Chinese medicinal composition is characterized in that: active ingredients of the composition consist of cinnamon polyphenol, astragalus polysaccharides and ginseng stem leaf saponin. As proved by pharmacological testing, the hyperglycemic Chinese medicinal composition has the effect of collaboratively lowering blood sugar and can be used for preparing a medicament and a health-care product for treating and preventing diabetes mellitus.
Description
Technical field
The present invention relates to natural medicine field, be specifically related to a kind of Chinese medicine composition and method for preparing of forming by Cortex Cinnamomi polyphenol, astragalus polysaccharides and stem and leaf of Radix Ginseng saponin, and in preparation treatment and the medicine of prevent diabetes and the purposes aspect the health product.
Background technology
Diabetes (Diabetes Mellitus) are a kind of common, multiple endocrine and metabolic disorders diseases; The concrete cause of disease and pathogenesis are not clear; Be commonly considered as since in the body insulin deficit or its can not normally bring into play physiological action and cause carbohydrate metabolism disturbance; Then cause the disorderly a kind of syndrome of multiple substance metabolism such as protein, fat, water, electrolyte, belong to traditional traditional Chinese medical science " diabetes " category.Diabetes, clinical is outstanding feature with the hyperglycemia, mainly is divided into 1 type (insulin-dependent; IDDM) and 2 types (non-insulin-depending type, NIDDM) two kinds, the former definitely lacks because of insulin; Beta Cell of islet is secreted few insulin; So that can not suppress steatolysis, having a large amount of ketoboidies to produce and cause ketoacidosis (DKA), IDDM patient mainly is to rely on insulinize.Type 2 diabetes mellitus patient's beta Cell of islet still has a certain amount of insulin secretion function, is enough to suppress the too much free fatty of fatty tissue and discharges, and prevent the generation of spontaneous ketoacidosis, but hyperglycemia exists over a long time.Type 2 diabetes mellitus patient's disease mainly shows as Developmental and Metabolic Disorder, the most typically is exactly insulin resistant and insulin deficit, and these cause blood sugar increasing unusually, and then has promoted the possibility that cardiovascular aspect disease takes place.To type 2 diabetes mellitus, OHA commonly used at present is main with Drugs Promoting Insulin Secretion and euglycemic agent, and the former comprises sulphanylureas (glibenclamide), biguanides (metformin), and the latter is mainly rosiglitazone etc.Be used for the treatment of type 2 diabetes mellitus; Also has a kind of alpha-glucosidase inhibitor; The hyperglycemia medicine of new generation that is different from sulphanylureas and biguanides, this type medicine can improve muscle, fat to the picked-up of glucose and utilization, the output of inhibition liver glucose, blood sugar lowering.But type 2 diabetes mellitus is a kind of chronic disease, need take medicine throughout one's life, and in blood sugar control, the Western medicine untoward reaction occurs thereupon.Take medicine for a long time and can bring many organ injury to the patient, some reacts serious even causes death.Wherein untoward reaction comprises hypoglycemia, cardiovascular side effects, digestive tract side reaction, lactic acidosis and Liver and kidney toxicity etc.Therefore diabetics need forwardly easy to use, effect is efficient, stable, lasting, toxicity and side effect is less and can delay the hypoglycemic drug of complication incidence and development.
In recent years, the natural product that has the target diversion of seeking the treatment diabetes medicament hypoglycemic activity both at home and abroad.The natural product blood sugar reducing component has following characteristics: 1. action temperature with, stable and lasting; 2. few side effects, toxic reaction are very low; 3. most of natural product blood sugar reducing component stable in properties, but the administered through oral administration is easy to use; 4. in the natural product, common multiple sugar-lowering components is also deposited and can be acted on many target spots simultaneously; 5. generally have functions such as blood lipid regulation, hepatoprotective and antioxidation concurrently; 6. improve carbohydrate tolerance, effectively alleviate the complication incidence and development.Therefore the discovery that has the natural product of hypoglycemic activity, for the prevention and the treatment of diabetes provides new way, can be developed as new efficient, low toxicity, can be oral hypoglycemic drug.
Cortex Cinnamomi (Cinnamomum Zeylanicum) is the plant Cinnamomi cassia of Lignum cinnamomi camphorae section (Lauraceae), mainly is grown in the torrid areas, and China mainly is distributed in areas such as Guangdong and Guangxi Provinces, Yunnan and Fujian, and is wherein maximum with Guangdong and Guangxi Provinces.Its bark has medical value, is a kind of Chinese medicine, and it is fiery supporing yang to have benefit, conducting fire back to its origin, and dispersing cold for relieving pain, effects such as promoting blood circulation to remove obstruction in the collateral, the use in existing thousands of years is historical in China.Modern age, study of pharmacy showed, the Cortex Cinnamomi polyphenol that extracts from Cortex Cinnamomi has ILA, is a kind of euglycemic agent, can improve insulin resistant, and can improve the serum insulin secretion of diabetes rat, thereby blood sugar reducing function is arranged.Astragalus polysaccharides (Astragalus Polysaccharides; APS) be a kind of polysaccharide that extraction separation goes out from Chinese medicine astragalus (Astragalus membranaceus (Fisch.) Bge.var.momgholicus (Bge.) Hsiao); Modern pharmacy research shows that astragalus polysaccharides has the effect of blood sugar regulation, protection heart, protection kidney and prevention IDDM, can also improve the substance metabolism and the chronic complicating diseases of diabetics.APS has the effect of two-ways regulation blood glucose; Blood glucose to normal mouse does not have obvious influence; Make that the blood sugar level of mice significantly descends behind the glucose load; And the mouse blood sugar rising that can obviously cause antiadrenergic drug is reacted and phenformin causes mouse experiment property hypoglycemia, can improve the substance metabolism and the chronic complicating diseases of diabetics.Stem and leaf of Radix Ginseng saponin (Ginseng Saponin) is that extraction is made with extra care and got from the ground stem and leaf of Araliaceae Radix Ginseng (Panax ginseng C.A.Mey.); Zoopery and clinical report show that it can promote lipid metabolism; Biosynthesis, decomposition, conversion, the drainage of lipoprotein in cholesterol and the blood are quickened; Cholesterol there is disassimilation and promotes Excretion, triglyceride is then had promote it to change the effect in the fatty tissue over to.Stem and leaf of Radix Ginseng saponin can be corrected its lipid metabolism when reducing diabetic animal blood glucose unusual, and stem and leaf of Radix Ginseng saponin can improve the activity of body SOD, removes free radical, and suppress lipid peroxidation.
Summary of the invention
The invention discloses a kind of effective ingredient in Chinese compound, can be used for preparing medicine and health product with blood sugar lowering, blood lipid regulation.
Blood sugar lowering Chinese medicine compound compositions of the present invention, its active constituents of medicine is made up of Cortex Cinnamomi polyphenol, astragalus polysaccharides and stem and leaf of Radix Ginseng saponin.
Wherein Cortex Cinnamomi polyphenol, astragalus polysaccharides and stem and leaf of Radix Ginseng saponin's weight ratio is preferably: 100: 50～300: 5～30.
The weight ratio of Cortex Cinnamomi polyphenol extract, astragalus polysaccharide extract and stem and leaf of Radix Ginseng saponin's extract is more preferably :=100: 50～250: 10～30, more preferably 100: 50～200: 10～20, most preferably be 100: 100～200: 15.
At present, Cortex Cinnamomi polyphenol, astragalus polysaccharides and three effective sites of stem and leaf of Radix Ginseng saponin are all from plant extract, and what that is to say usefulness all is extract, and Cortex Cinnamomi polyphenol content in its extract is preferably greater than 25%; Astragalus polysaccharides content in its extract is preferably greater than 50%; Stem and leaf of Radix Ginseng saponin's content in its extract is preferably greater than 80%, and the percentage ratio among the present invention all is weight percentage.
Cortex Cinnamomi polyphenol and astragalus polysaccharides can be prepared by following method:
The preparation of Cortex Cinnamomi polyphenol: use CO after the Cortex Cinnamomi pulverizing medicinal materials
2Supercritical extraction is removed volatile oil, and residue water or the heating of 30%～70% ethanol decoct, the decoction liquor centrifugalize, and filtrating vacuum concentration after drying gets Cortex Cinnamomi polyphenol crude extract.With of the alcohol reflux extraction of Cortex Cinnamomi polyphenol crude extract with 50%～80% acetone or 50%～80%; Sucking filtration, filtrating is prepared into SP207 resin column on the certain density aqueous solution after concentrating, with 40%～55% ethanol elution; Collect eluent; Revolve and steam to doing, get the Cortex Cinnamomi polyphenol extract, polyphenol content is greater than 25%.
The preferred method for preparing of Cortex Cinnamomi polyphenol: the Cortex Cinnamomi decoction pieces is ground into 40 order powder, adds the distilled water of 6～8 times of amounts, and 65～70 ℃ are extracted 1h down, are cooled to 18 ℃, add pectase, stir 45min.The water extract filters, and filtering residue continues to add the distilled water of 5～5 times of amounts, repeats once.Merging filtrate filters, and in filtrating, drips the glacial acetic acid acidify and ℃ revolves inspissation to pH＜6,65 and contract.Be concentrated into every ml and be equivalent to the dried medical material of 0.4～0.5g, add isopyknic 95% ethanol, 4 ℃ of cold preservation 12h in the refrigerator, sucking filtration, the filtrating distillation is reclaimed ethanol and is not gone up the SP-207 resin column to there being the alcohol flavor.With the 0.1% acetic acid aqueous solution flushing resin column of 2～3BV, use 2～3BV, 40%～50% ethanol water eluting then earlier, collect 50% ethanol elution part, 60～65 ℃ of rotary evaporations promptly get to doing.
The preparation of astragalus polysaccharides: Milkvetch Root is cut into decoction pieces, decocts with distilled water, and sucking filtration adds ethanol after concentrating; Get deposition, deposition gets astragalus polysaccharides powder bullion through dry, the dissolving of bullion adding distil water heated and boiled; Cold preservation is spent the night, and gets supernatant, sucking filtration, and filtrating concentrates; Concentrated solution adds ethanol precipitation, the leaching deposition, and deposition is used absolute ethanol washing, and vacuum drying promptly gets.
The preferred method for preparing of astragalus polysaccharides: Milkvetch Root is cut into the decoction pieces of 2～3mm thickness along section, and distilled water decocts 3 times, merges decoction liquor; Sucking filtration, 70 ℃ revolve to steam to be concentrated into and are equivalent to dried medical material 1～3 gram/ml, add 95% ethanol; 75%, the 4 ℃ of cold preservation that makes amount of alcohol reach cumulative volume is spent the night, and filters; Filtrating is extracted astragaloside, and deposition gets astragalus polysaccharides powder bullion through 70-80 ℃ of vacuum drying.Bullion adds 30～60 times of amount distilled water, the heated and boiled dissolving, and 4 ℃ of cold preservations are spent the night, and get supernatant; Sucking filtration, filtrating is concentrated into 10～30 times of amounts that are equivalent to bullion, adds ethanol precipitation and makes the alcohol amount of containing in the solution reach 80% of cumulative volume; Leave standstill clarification, leaching deposition, deposition is with absolute ethanol washing 2 times; In 70-80 ℃ of following vacuum drying, get astragalus polysaccharide extract, astragalus polysaccharides content is greater than 50%.
The stem and leaf of Radix Ginseng saponin can buy the crude drug that quality meets " Chinese Pharmacopoeia (2010 editions) " ministerial standard in market, also can the list of references method prepare, and also can preferably prepare in order to the below method:
Stem and leaf of Radix Ginseng saponin's preparation: the Stem and leaf of Radix Ginseng section of cutting ethanol water reflux, extract,, filter, revolve to steam and reclaim ethanol; Concentrate, concentrated solution decolours with activated magnesia, D101 macroporous adsorbent resin on the aqueous solution; Use earlier the distilled water eluting; Reuse 70% ethanol carries out eluting, collects 70% ethanol elution part, revolves to steam to doing promptly to get.
The preferred method for preparing of stem and leaf of Radix Ginseng saponin: the dry Stem and leaf of Radix Ginseng section of cutting adds the ethanol water of 6～10 times of amounts 50%, reflux, extract, 3 times, and each 1h extracts, and filters, and merging filtrate revolves to steam and reclaims ethanol, concentrates.Concentrated solution decolours with activated magnesia, D101 macroporous adsorbent resin on the aqueous solution, and earlier with 2～3 times of volume distilled water eluting, reuse carries out eluting with 70% ethanol, collects 70% ethanol elution part, revolves to steam to doing, and gets the stem and leaf of Radix Ginseng saponin.Ginsenoside Re's content is greater than 90%, and quality meets the standard of " Chinese Pharmacopoeia (2010 editions) " an one.
Above-mentioned three extracts can mechanical mixture get compositions, and resulting composition is brown powder with special aroma.Said composition belongs to non-poisonous material.
Blood-sugar lowering tcm drug preparation of compositions method among the present invention has industrially scalable, and products obtained therefrom is stable, the production technology good reproducibility.The effect that compositions of the present invention has to be increased insulin sensitivity, promote insulin secretion, blood sugar lowering has blood lipid regulation simultaneously, improves the effect of liver function.Compositions of the present invention is widely used in treatment and prevent diabetes, diabetic complication and blood lipid regulation medicine or health product.
Cause diabetic mice model evaluation compositions and respectively form the hypoglycemic activity of folk prescription extract through alloxan, the result shows that the hypoglycemic activity of compositions is superior to each folk prescription extract, and explaining has potentiation and synergism between each folk prescription in the compositions.
Compositions of the present invention can significantly reduce STZ and cause blood glucose in diabetic rats, blood lipid regulation in the scope of 50～400mg/kg/d, and has the effect that improves liver function.
Compositions of the present invention can be processed the oral formulations form of any routine through conventional method.Medicine or the health product processed with compositions of the present invention specifically can be granule, tablet, lyophilized powder, capsule, sublingual lozenge or other suitable shape.Compositions of the present invention can contain pharmaceutically acceptable carrier, diluent or excipient when being prepared into medicine or health product.Among the present invention, " pharmaceutically acceptable " composition is to be applicable to people and/or animal and not have excessive bad side reaction (like toxicity, stimulation and allergy), and the material of rational benefit/risk ratio is promptly arranged.
The blood sugar lowering effective dosage ranges of the Chinese medicine composition among the present invention is generally 50～400mg/kg/d (STZ causes diabetes rat).Term used herein " effective dose " refers to the therapeutic agent treatment, alleviates or prevent the amount of target disease or situation, or shows the amount of detectable treatment or preventive effect.Depend on the therapeutic agent that the nature and extent and selecting of build and health status, the disease of this object gives and/or the combination of therapeutic agent for the accurate effective dose of a certain object, also can depart from this scope according to the difference of the state of an illness.In addition, active substance of the present invention also can use with the other treatment agent.
Pharmacology test proves Chinese medicine composition of the present invention, effective blood sugar lowering, and effect obviously is better than each folk prescription extract, and safe in the dosage scope, nontoxic.Be that alloxan causes diabetic mice model evaluation compositions and respectively forms the test and the partial results of the hypoglycemic activity of folk prescription extract below:
One, compositions of the present invention causes the influence of mice diabetes blood glucose to alloxan (Alloxan)
The ICR mice, male, cleaning level, body weight 20 ± 2g.
Feedstuff: form by wheat flour, Semen Maydis powder, Testa Tritici, Semen sojae atricolor powder, fish flour, bone meal and multivitamin.
1. the foundation of mice diabetes model
Mice is raised condition: indoor temperature remains on 25 ℃, and humidity is about 50%, and light and shade cycle 12h freely drinks water and takes food.
Weighed once in per 3 days, and waited mice body weight length to about 22g, to begin modeling.Fasting 10～12h (freely drinking water) before the modeling, disposable tail vein injection alloxan (Alloxan) 70mgkg
-1Normal group tail vein injection equivalent normal saline continues the 72h that feeds, and behind the fasting 8h (freely drinking water), mice angular oculi vein clump is got blood, surveys fasting glucose with blood sugar test paper, and blood glucose value is higher than 11.1mmolL
-1The person is regarded as the modeling success.
2. animal divides into groups and administration
With the diabetic mice random packet that becomes mould, 10 every group, every day 1 gastric infusion, each administration group dosage is: (the dosage measurement unit is mgkg
-1)
(1), normal control group: distilled water
(2), model group: distilled water
(3), metformin group: 150
(4), Cortex Cinnamomi polyphenol high dose group: 400, Cortex Cinnamomi polyphenol low dose group: 10
(5), the astragalus polysaccharides high dose group: 400, astragalus polysaccharides low dose group: 200
(6), stem and leaf of Radix Ginseng saponin's high dose group: 30, stem and leaf of Radix Ginseng saponin's low dose group: 10
(7), Chinese medicine composition group: Cortex Cinnamomi polyphenol 100, astragalus polysaccharides 200, stem and leaf of Radix Ginseng saponin 15
Above-mentioned Cortex Cinnamomi polyphenol, astragalus polysaccharides, stem and leaf of Radix Ginseng saponin all prepare with embodiment 2 methods.
The morning every day 9:00～10:00 administration, 4 weeks of continuous irrigation stomach.
3. observation index and analytical method
Before the administration in the 1st day, mice fasting 8h (freely drinking water) gets blood from mice angular oculi vein clump, measures glucose level as initial blood sugar level value with blood sugar test paper.7th, fasting 8h (freely drinking water) after the administration in 14,21,28 days, the angular oculi vein clump is got blood, measures blood glucose value.
All expressions with
of experimental data are relatively checked and variance analysis with t between group.
Experimental result
1. general situation
Normal group mice well-grown, body weight continues to increase, and does not have other symptoms.Behind the injection alloxan, the part animal promptly shows typical diabetic symptoms such as " three-many-one-littles ", and fur is loose, body weight gain slowly, compare normal group and descend to some extent.Along with the prolongation of administration time, the polyuria situation of each administration group mice makes moderate progress, and body constitution also takes a turn for the better to some extent.
2. table 1 is seen in the variation of mice body weight
Table 1. mice body weight change (n=10)
Annotate: with the normal group ratio
#P＜0.05,
##P＜0.01 is compared with model group
*P＜0.05,
*P＜0.01
Can know that by table 1 experimental data after 4 weeks of administration, model group mice body weight significantly is lower than normal group (P＜0.01); Compare with model group; The mice body weight of astragalus polysaccharides high and low dose group and compositions group significantly increases (P＜0.01); The mice weight increase of metformin group, Cortex Cinnamomi polyphenol high dose group and stem and leaf of Radix Ginseng saponin's high dose group (P＜0.05), and the mice body weight of Cortex Cinnamomi polyphenol low dose group and stem and leaf of Radix Ginseng saponin's low dose group is compared there was no significant difference (P＞0.05) with model group.This experimental result explains that compositions of the present invention and each folk prescription Chinese medicine extract can improve the symptom that the hyperglycemia mice loses weight, and present the dose dependent result.
3. table 2 is seen in the variation of mice fasting glucose (FPG)
The variation (n=10) of table 2. mice fasting glucose
Annotate: with the normal group ratio
##P＜0.01 is compared with model group
*P＜0.05,
*P＜0.01
Visible from table 2 experimental data, alloxan causes diabetes model, and the mouse blood sugar level also can increase gradually after the modeling, and 1～2 week reached peak value, and is stable gradually subsequently, can stablize more than one month.So the data of this experimental selection after 2 weeks of administration compare the influence of each administration group to mouse blood sugar.
Can know that from table 2 after 4 weeks of administration, the mouse blood sugar level of each administration group all descends to some extent.The metformin group reduces by 39.0%; Cortex Cinnamomi polyphenol high and low dose group reduces by 55.0% and 37.3% respectively; Astragalus polysaccharides high and low dose group reduces by 59.7% and 40.7% respectively, and stem and leaf of Radix Ginseng saponin's high and low dose group reduces by 49.7% and 17.3% respectively, and each folk prescription administration group high dose hypoglycemic effect all is superior to low dose group; Compositions group blood glucose reduces by 66.5%, and blood sugar decreasing effect is superior to each folk prescription high dose administration group.The mouse blood sugar reduction of each administration group all is time and concentration dependent.
The dosage of compositions is: Cortex Cinnamomi polyphenol 100mgkg
-1Astragalus polysaccharides 200mgkg
-1Stem and leaf of Radix Ginseng saponin 15mgkg
-1, respectively form high dose (the Cortex Cinnamomi polyphenol 200mgkg that dosage is lower than each folk prescription in the compositions
-1Astragalus polysaccharides 400mgkg
-1Stem and leaf of Radix Ginseng saponin 30mgkg
-1); But blood sugar decreasing effect is superior to the high dose group of each folk prescription; And can make the mice fasting glucose near normal value, explain that compositions of the present invention respectively forms between the folk prescription and to falling the blood glucose that alloxan causes diabetic mice potentiation and synergism to be arranged, the reasonable recipe of compositions of the present invention is described.
In sum; Cortex Cinnamomi polyphenol, astragalus polysaccharides, stem and leaf of Radix Ginseng saponin and the compositions of being made up of these 3 components all can reduce the blood glucose that alloxan causes diabetic mice; Improve the symptom that the diabetes body weight reduces; Composition effect is superior to each folk prescription administration group, can prevent administration or long term administration to reach better effect.
For the hypoglycemic effect of estimating compositions of the present invention further and blood lipid regulation with to the protective effect of liver, we have carried out streptozotocin (STZ) and have caused the model experiment of SD rat diabetes.
Two, compositions of the present invention causes the influence of SD rat diabetes blood glucose, blood fat to streptozotocin (STZ)
1. animal model is set up
The rat adaptability was raised 2 days, and indoor temperature remains on 25 ℃, and humidity is about 50%, and light and shade cycle 12h freely drinks water and takes food.Except that the normal control group gave the common standard feedstuff, all the other all gave high-sugar-fat-diet and feed back mensuration oral glucose tolerance experiment all around, fasting 10～12h then.Disposable celiac injection streptozotocin (STZ) 40mg/kg after one week, gets behind the fasting 8h rat angular oculi vein clump and gets blood and survey fasting glucose with blood sugar test paper, selects blood glucose value to be higher than 11.1mmol/L person and is regarded as the modeling success.
2. laboratory animal is divided into groups and administration
The compositions that this experiment is used is by embodiment 1 said method preparation; The total polyphenols content of Cortex Cinnamomi polyphenol: 28%; APS content in the astragalus polysaccharide extract: 65%; Ginsenoside Re's content among the stem and leaf of Radix Ginseng saponin: 90%, press the quality proportioning: Cortex Cinnamomi polyphenol: astragalus polysaccharides: stem and leaf of Radix Ginseng saponin=10: 20: 0.15, mechanical mixture gets compositions.
The type 2 diabetes mellitus rat that becomes mould is pressed the fasting blood sugar random packet, every day 1 gastric infusion, be respectively:
Metformin group: 100mg/kg;
Compositions high dose group: compositions 220mg/kg (Cortex Cinnamomi polyphenol 70mg/kg, astragalus polysaccharides 140mg/kg, stem and leaf of Radix Ginseng saponin 10mg/kg);
Compositions 2 low dose group: compositions 110mg/kg (Cortex Cinnamomi polyphenol 35mg/kg, astragalus polysaccharides 70mg/kg, stem and leaf of Radix Ginseng saponin 5mg/kg).
Model group and blank group give isopyknic distilled water, and morning every day, 9:00-10:00 irritated stomach, 4 weeks of continuous irrigation stomach.
3. the preparation of serum and serum biochemistry inspection
Before administration in the 1st day, fasting 8h after the administration in the 7th, 11,21,28 day, the angular oculi vein clump is got blood, low-temperature centrifugation (1500Xg, 15min, 4 ℃), separation of serum is sub-packed in the frozen pipe of 1.5mL, and-20 ℃ of refrigerators are preserved, with each biochemical indicator to be determined.
Adopt ELIASA to measure fasting glucose (FPG), T-CHOL (TC), triglyceride (TG), HDL-C (HDL-C), low-density lipoprotein cholesterol (LDL-C), alanine aminotransferase (ALT) and aspartic transaminase (AST) level according to the explanation of each test kit.Method mensuration serum insulin (FINS) level of exempting from is put in employing.
4. data analysis: all expressions of experimental data with
, relatively check between group with t.
Experimental result
1. body weight change
The body weight change of SD rat normal group, model group and each medication group is as shown in table 3.
The variation of table 3. rat body weight (n=8)
| Group | Body weight/g (the 1st day) | Body weight/g (the 28th day) |
| Normally | 249.2±9.1 | 369.8±11.3 |
| Model | 243.8±19.2 | 203.9±10.5 ## |
| Metformin | 238.4±30.6 | 259.8±14.3 * |
| Compositions-Gao | 225.8±33.7 | 265.0±33.6 * |
| Compositions-low | 229.6±26.2 | 270.5±17.7 * |
Annotate: with the normal group ratio
##P＜0.01 is compared with model group
*P＜0.01
Before the result shows administration, more direct difference not statistically significant (P＞0.05) between normal group, model group and each the administration group.After 4 weeks of administration, with compared with normal, the body weight of model group obviously reduces (P＜0.01).Compare with model, metformin group, compositions group high and low dose group rat body weight of the present invention increase (P＜0.05) to some extent.Difference no statistical significance (P＞0.05) between 2 dose groups of compositions height.
2. the variation of sugar, lipid metabolism dependent interaction index
The FPI (FINS) of SD rat normal group, model group and each medication group serum, fasting glucose (FPG), T-CHOL (TC), triglyceride (TG), HDL-C (HDL-C), low-density lipoprotein cholesterol (LDL-C) level change as shown in table 4.
The index of correlation of table 4. carbohydrate metabolism and lipid metabolism effect changes (n=8)
Annotate: with the normal group ratio
#P＜0.05,
##P＜0.01 is compared with model group
*P＜0.05,
*P＜0.01
This experimental result shows that after 4 weeks of administration, model group FINS level is lower than normal group (P＜0.05); Compare with model group, metformin group FINS level changes little (P＞0.05), and the high low dose group FINS level of Chinese medicine composition all raises (P＜0.05), group difference no statistical significance (P＞0.05).Model group FPG level significantly is lower than normal group (P＜0.01); Compare with model group, each administration group FPG level is significantly decline (P＜0.01) all.
Compare with model group, Chinese medicine composition high dose group TC level significantly reduces (P＜0.01), and metformin group, Chinese medicine composition low dose group TC level reduce (P＜0.05), and Chinese medicine composition high dose group effect is superior to low dose group.Chinese medicine composition high dose group and metformin group TG level significantly reduce (P＜0.01), and Chinese medicine composition low dose group TG level reduces (P＜0.05), and Chinese medicine composition high dose group effect is superior to low dose group.Chinese medicine composition high dose group and metformin group HDL-C level significantly raise (P＜0.01), and Chinese medicine composition low dose group HDL-C level raises (P＜0.05), and Chinese medicine composition high dose group effect is superior to low dose group.Each administration group LDL-C level all reduces (P＜0.05).3. to the influence of alanine aminotransferase (ALT) and aspartic transaminase (AST) level
Alanine aminotransferase of diabetes rat (ALT) and aspartic transaminase (AST) result of variations after horizontal 4 weeks of administration is listed in the table 5.
The variation (n=8) of table 5. alanine aminotransferase (ALT) and aspartic transaminase (AST) level
Annotate: with the normal group ratio
##P＜0.01 is compared with model group
*P＜0.05,
*P＜0.01
After 4 weeks of administration, model group and compared with normal, ALT and AST level significantly raise (P＜0.01).Compare with model group, the ALT of metformin group, AST slightly descend but change not quite, and Chinese medicine composition high dose group ALT level significantly reduces (P＜0.01), and Chinese medicine composition low dose group ALT level reduces (P＜0.05).Compare with model group, the high low dose group AST average level of Chinese medicine composition significantly reduces (P＜0.01).Results suggest Chinese medicine composition of the present invention can improve liver function.
In sum, by compositions of the present invention can raise STZ cause diabetes rat the FINS level, reduce FPG, improve the symptom of diabetes rat weight loss; Reduce TC, TG and LDL-C level, thus rising HDL-C level blood lipid regulation; Can also reduce Serum ALT, AST level, improve liver function.Therefore, compositions of the present invention can be used for prevention or treatment diabetes, improves its disorders of lipid metabolism, improves liver function.
For further to data for clinical drug use the dosage foundation being provided, we have also studied Chinese medicine composition acute toxicity of the present invention.
Chinese medicine composition solution: the Chinese medicine composition by the embodiment of the invention 1 preparation is deployed into Chinese medicine composition solution with pure water, and concentration is: every ml solution contains Cortex Cinnamomi 350mg, stem and leaf of Radix Ginseng saponin 50mg, astragalus polysaccharides 700mg.
Get 10 of mices, male and female half and half as the blank group, behind the fasting 12h, give solvent (Robust pure water) with the 0.4ml/10g mice.10 of Chinese medicine composition groups (male and female half and half) are behind the fasting 12h, with the capacity gastric infusion of 0.4ml/10g mice (maximum administration capacity).At once observe behavioral activity and the survival of mice after the administration, observed continuously 14 days.
Experimental result:
Blank group mice behavioral activity is normal, does not have dead in 14 days.Observe the movable minimizing of mice after the administration of administration group, the behavior activity recovers normally gradually in 1 hour, and a couple of days observation animal behavior is normal afterwards, the dead generation of none example of mice in 14 days.Body weight change is seen table 6
The variation (n=10) of mice body weight before and after table 6. administration
Annotate: compare with the blank group,
*P＜0.05
Life of discovery mice in order during this; The no phenomena of mortality; So prognostic experiment can't be measured median lethal dose(LD 50) (LD50), mensuration maximum tolerated dose (MTD) is: compositions 44g/kg (Cortex Cinnamomi polyphenol 14g/kg, astragalus polysaccharides 28g/kg, stem and leaf of Radix Ginseng saponin 2g/kg).
According to fractionated six grade standards of the acute toxicity that adopts in China's food toxicology, Chinese medicine composition of the present invention belongs to nontoxic.
Postmortem: after the administration the 14th day with sacrifice of animal, important organs such as the postmortem heart, liver, spleen, lung, kidney, gastrointestinal tract, naked eyes are not seen obvious ANOMALOUS VARIATIONS.The ratio of each group's mouse heart, kidney, liver and body weight is seen table 7
The ratio of each group's mouse heart of table 7., kidney, liver and body weight
| Group | Heart body ratio | Kidney body ratio | Liver body ratio |
| Contrast | 0.0049±0.00034 | 0.0151±0.0014 | 0.0604±0.0033 |
| Chinese medicine composition | 0.0043±0.00033 * | 0.0151±0.0011 | 0.0658±0.0053 |
Annotate: compare with the blank group
*P＜0.05
Experimental data shows each internal organs of Chinese medicine composition group of the present invention and blank group and the ratio there was no significant difference of body weight (P＞0.05), and the prompting Chinese medicine composition does not have influence to each internal organs of mice.
The specific embodiment
Embodiment 1
The preparation of compositions method
1. the preparation of Cortex Cinnamomi polyphenol
(1) cinnamomic CO
2Supercritical extraction: use UHDE to produce CO in the present embodiment
2The supercritical extraction unit, extraction pot 1500L * 3 add 40 purpose Guangxi Cortex Cinnamomis (Cinnam om um cassia Presl) 450kg in each extraction pot, controlled pressure 33～34MPa, 51 ℃ of temperature, flow 5T/h goes out still after extracting 3h continuously.Altogether Oleum Cinnamomi 140kg.Contain wherein that cinnamic aldehyde is about 60%, coumarin is about 6%, oil substances is about 20%, other material 14%.Can be used as spice or food additive.
(2) preparation of Cortex Cinnamomi polyphenol crude extract: above-mentioned CO
2Cortex Cinnamomi residue 120kg joins in the 1500L stainless steel cauldron behind the supercritical extraction, adds deionized water 1200L, heat temperature raising to 65 ℃; Mechanical agitation 1.5h; Centrifugalize, filtrating is transferred to concentration kettle, is concentrated into d=1.05～1.1 0.05～0.1MPa, 65 ℃; Spray drying gets Cortex Cinnamomi polyphenol crude extract.This extract is that rufous has cinnamomic special aroma, measures to be that 6.7kg, total polyphenols content are 5.6%.
(3) purification of Cortex Cinnamomi polyphenol: take by weighing 270g SP207 macroporous resin (Mitsubishi Chemical, fast science equipment company limited rubs in Shanghai), be positioned in the large beaker, add 1000ml soaked in absolute ethyl alcohol 8h.Wet method is adorned post after removing floating thing and impurity, and resin bed is φ 4.5cm * 22cm, and column volume is about 350mL.Flow out ethanol to liquid level and rest on about the 3cm of resin bed top, with deionized water with the flow velocity of 2BV/H through resin bed, clean ethanol.Add 4% HCL solution, with the flow velocity 2BV volume flushing resin bed of 5BV/H and soak 3h, then be washed till eluent with same flow velocity and be neutrality (pH detection paper pH=7) with deionized water.Add 5% NaOH solution, with the flow velocity 2BV volume flushing resin bed of 5BV/H and soak 3h, then being washed till water lotion with deionized water with same flow velocity, to be neutrality subsequent use.Take by weighing the Cortex Cinnamomi crude extract 100g that extracts as stated above, add 600mL 80% aqueous acetone solution, 50 ℃ of backflow 2h, non-woven fabrics filters, and filtering residue reuse 400mL 80% aqueous acetone solution the same terms extracts twice, merges three times and extracts filtrating.50 ℃ of rotary evaporations reclaim acetone, are evaporated to add water 300mL about 300mL, and continue to revolve steaming and separate out to having to precipitate, sucking filtration, deposition is swung 50 ℃ of heating with low amounts of water and is washed sucking filtration, merging filtrate, the common 850mL that must filtrate, filtrating total polyphenols concentration is: 3.89mg/ml.Upper prop liquid 850mL all flows through resin column with the 1mL/min flow velocity.The upper prop liquid stream adds 1L 0.1% acetic acid aqueous solution behind resin bed, flow velocity is a 2ml/min flushing resin column.When the aqueous acid liquid level arrives the about 2～3cm in resin bed top, add 50% ethanol water eluting, effluent volume is 1000mL (3BV), and flow velocity 1d/s collects eluent, and 60～65 ℃ of rotary evaporations are to doing, and weigh and detect polyphenol content.Getting Cortex Cinnamomi polyphenol example weight is 12g, and total polyphenols content is 28.9%.
2. the preparation of astragalus polysaccharides
Round a Radix Astragali (Ashgallls) and become 5～10mm sheet, get lamellar Radix Astragali 500g, add the 5L distilled water and decoct 2h for 90～100 ℃ with scissor cut; Filtering residue continues to boil 1h with 4L and 3L decocting respectively, merges three times decoction liquor, sucking filtration; Filtrating 70 ℃ to revolve to steam is concentrated into 250ml (every 1ml is equivalent to crude drug 2g), adds 750ml 95% ethanol, and 4 ℃ of cold preservations are spent the night; Filter, obtain filtrating I and deposition I two parts.
Filtrating I reclaims ethanol and is concentrated into 150ml, adds 850ml 95% ethanol and fully stirs, and 4 ℃ of cold preservations are spent the night, and filters; Filtrate recycling ethanol also is concentrated into 100ml, by volume ratio extraction in 2: 13 times, merges n-butyl alcohol with water saturated n-butyl alcohol; Concentrate n-butyl alcohol to 300ml,, collect also reclaim under reduced pressure n-butyl alcohol with 1: 1 by volume extraction process of 1%NaOH solution 2 times; When being concentrated into 60ml,, get the astragaloside extract in 70-80 ℃ of vacuum drying.
I is at 70-80 ℃ of following vacuum drying for deposition, and with 1: 50 times distilled water heated and boiled dissolving, 4 ℃ of cold preservations are spent the night, and get supernatant then; Sucking filtration, filtrating is concentrated into 200ml, adds ethanol 800ml deposition; Leave standstill clarification, the leaching deposition, deposition is used absolute ethanol washing respectively 2 times; In 70～80 ℃ of following vacuum dryings, get astragalus polysaccharide extract 59g, measuring APS content is 64.9%.
3. stem and leaf of Radix Ginseng saponin's preparation
Dry Stem and leaf of Radix Ginseng (Laiyang, Shandong, life in the 4 years) section of cutting of 300kg places 3 cubic metres rustless steel to extract still, adds 2.2 ton 80% ethanol water; Reflux, extract, 2h emits extracting solution, and filtering residue continues to extract 1h with 1.5 ton of 80% reflux, extract, twice at every turn; Merging filtrate filters, and ethanol is reclaimed in distillation; Be concentrated into 1000L, concentrated solution is with 50kg activated magnesia decolouring, adds water and is adjusted to 3000L and treats upper prop.250kg D101 macroporous adsorbent resin (Tianjin Chemical Plant of Nankai Univ.), conventional method are handled, the wet method stainless steel column of 0.48m * 3.8m of packing into.With above-mentioned upper prop liquid upper prop, be used for comprehensive utilization with 0.8 ton of distilled water eluting earlier behind the upper prop, 1 ton of 70% ethanol of reuse carries out eluting; Be used for comprehensive utilization with 80% ethanol elution then; Collect 70% ethanol elution part, vacuum evaporation becomes dried cake, and 105 ℃ of dry 3h of vacuum drying oven get stem and leaf of Radix Ginseng saponin 14.5kg; Ginsenoside Re's content is 90.5%, and quality meets the standard of " Chinese Pharmacopoeia (2010 editions) " an one.
4. Cortex Cinnamomi polyphenol (the total polyphenols content 28.9%) 70g of above method preparation, astragalus polysaccharides (APS content 64.5%) 140g, stem and leaf of Radix Ginseng saponin's (ginsenoside Re's content 90.5%) 10g mechanical mixture gets compositions.
Embodiment 2
Preparation of compositions
1. the preparation of Cortex Cinnamomi polyphenol
Cortex Cinnamomi decoction pieces (available from Jiangsu Province's medical material company, Anhui consonance Pharmaceutical decoction pieces company limited is produced for Guangxi Cortex Cinnamomi, Cinnam om um cassia Presl) is ground into 40 order powder, takes by weighing 501.7g and places stainless-steel pan, adds the 3L distilled water.Electromagnetic oven heating, mechanical agitation is extracted temperature and is controlled at 65～70 ℃ simultaneously.Extract 1h postcooling to 18 ℃, add the 0.5516g pectase, stir 45min.The water outlet extract that from pot, inclines filters through the gauze Cotton Gossypii, the filtrating pale red.Filtering residue continues to add the 2.5L distilled water, repeats said process.Merge filtrating twice, filter, must about 4L pale red filtrating.In filtrating, drip the 8ml glacial acetic acid, 65 ℃ revolve inspissation and contract.Be concentrated into 1300ml, add isopyknic 95% ethanol, 4 ℃ of cold preservation 12h in the refrigerator, sucking filtration is filtrated to clarifying orange red, and distillation is reclaimed ethanol to there not being the alcohol flavor, is concentrated into the 300ml volume, treats upper prop.Take by weighing the pretreated SP-207 resin of 23g (weight in wet base), in the chromatographic column of packing into, resin bed φ 1.25cm * 24.5cm; Column volume is about 30mL; After the distilled water balance, continuous in above-mentioned Cortex Cinnamomi polyphenol extracting solution with the flow velocity of 1ml/min, the upper prop liquid stream is behind resin bed; Add 100ml 0.1% acetic acid aqueous solution, flow velocity is a 2ml/min flushing resin column.Then, add 100ml 50% ethanol water eluting, flow velocity 1d/s collects eluent, and 60～65 ℃ of rotary evaporations are to doing, and getting Cortex Cinnamomi polyphenol example weight is 2.5g, and Cortex Cinnamomi total polyphenols content is 26%.
2. the preparation of astragalus polysaccharides
Round a Radix Astragali (Ashgallls) and become 5～10mm sheet, get lamellar Radix Astragali 200g, add the 2L distilled water and decoct 2h for 90～100 ℃ with scissor cut; Filtering residue continues to boil 1h with 1.5L and 1L decocting respectively, merges three times decoction liquor, sucking filtration; Filtrating 70 ℃ to revolve to steam is concentrated into 100ml (every 1ml is equivalent to crude drug 2g), adds 300ml 95% ethanol, and 4 ℃ of cold preservations are spent the night; Filter, obtain filtrating I and deposition I two parts.I is at 70-80 ℃ of following vacuum drying for deposition, and with 1: 50 times distilled water heated and boiled dissolving, 4 ℃ of cold preservations are spent the night, and get supernatant then; Sucking filtration, filtrating is concentrated into 75ml, adds ethanol 200ml deposition; Staticly settle, filter, deposition is used absolute ethanol washing respectively 2 times; In 70～80 ℃ of following vacuum dryings, get astragalus polysaccharide extract 35g, measuring APS content is 61.2%.
3. stem and leaf of Radix Ginseng saponin's preparation
The dry Stem and leaf of Radix Ginseng shears of the 200g section of cutting adds 75% ethanol 1.5L reflux, extract, 1h, filters, and filtering residue is with 1L 75% alcohol reflux 1h; The same terms repeats 1 time, and merging filtrate filters, and decompression recycling ethanol is to there not being the alcohol flavor; Filtrating is concentrated into 300ml, adds 300ml petroleum ether extraction twice, and water layer is with the water saturated n-butanol extraction of 300ml 3 times; Merge n-butanol layer, the reclaim under reduced pressure n-butyl alcohol gets the light yellow solid powder.Pressed powder mixes with the 50g neutral alumina after with an amount of 50% dissolve with methanol; The dress post, with the desorbing of 200ml50% methanol solution, stripping liquid concentrates; Reclaim methanol; Vacuum concentration is to doing, and 105 ℃ of dryings of vacuum drying oven got faint yellow solid powder 9.8g, ginsenoside Re's content 92% in 3 hours.Quality meets the standard of " Chinese Pharmacopoeia (2010 editions) " an one.
4. Cortex Cinnamomi polyphenol (the total polyphenols content 26%) 2g of above method preparation, astragalus polysaccharides (APS content 61.2%) 2g, ground and mixed gets compositions in stem and leaf of Radix Ginseng saponin's (ginsenoside Re's content 92%) 0.3g agate mortar.
Embodiment 3
Preparation of compositions
1. the preparation of Cortex Cinnamomi polyphenol
Take by weighing 400g Cortex Cinnamomi decoction pieces powder, spend the night with 500ml water logging bubble.With agitator agitating heating 1h, in the process of boiling, add water gradually in 75 ℃ of water-baths, the about altogether quintuple of the control water yield.Non-woven fabrics filters, and collects filtrating, and with 500ml water washing filtering residue, merging filtrate.Add acetic acid 8ml, control pH=4-5,65 ℃ are concentrated into about 150ml, vacuum drying 4h use the 300ml water dissolution, adds 95% ethanol of 400ml afterwards, treat that deposition is complete after, sucking filtration.The filtrating rotary evaporation is to 200ml, and 75 ℃ of water temperatures are divided three extractions with the 500ml petroleum ether, keeps water, divides four extractions with the 600ml ethyl acetate.Collect the ethyl acetate phase, rotary evaporation gets Cortex Cinnamomi polyphenol 3.2g, Cortex Cinnamomi total polyphenols content 39% to doing.
2. the astragalus polysaccharides method for preparing is with example 1.
3. the stem and leaf of Radix Ginseng saponin buys from market, meets " Chinese Pharmacopoeia (2010 editions) " ministerial standard, ginsenoside Re's content 89%.
With Cortex Cinnamomi polyphenol, astragalus polysaccharides and stem and leaf of Radix Ginseng saponin mixed by weight 100: 150: 15 compositions.
Embodiment 4
The preparation of composition tablet
Prescription:
Preparation:
First in the prescription ratio with Cortex Cinnamomi polyphenol, astragalus polysaccharides and stem and leaf of Radix Ginseng saponin's mix homogeneously, again with compositions and adjuvant mix homogeneously.Single punch tablet machine, No. 9 moulds, 0.65MPa pressure lower sheeting gets 2900, and average every heavy 299mg/ sheet is calculated in weighing.Stability and dissolution are qualified.Contain in every: Cortex Cinnamomi polyphenol 112.1mg, astragalus polysaccharides 112.1mg, stem and leaf of Radix Ginseng saponin 16.6mg.
Claims (9)
1. hypoglycemic Chinese medicine compound compositions is characterized in that active constituents of medicine is made up of Cortex Cinnamomi polyphenol, astragalus polysaccharides and stem and leaf of Radix Ginseng saponin.
2. the Chinese medicine compound compositions of claim 1, wherein Cortex Cinnamomi polyphenol, astragalus polysaccharides and stem and leaf of Radix Ginseng saponin's weight ratio is 100: 50～300: 5～30.
3. the Chinese medicine compound compositions of claim 2, wherein Cortex Cinnamomi polyphenol, astragalus polysaccharides and stem and leaf of Radix Ginseng saponin's weight ratio is 100: 50～200: 10～20.
4. claim 1,2 or 3 Chinese medicine compound compositions, wherein the Cortex Cinnamomi polyphenol in extract content greater than 25%; Astragalus polysaccharides in extract content greater than 50%; The stem and leaf of Radix Ginseng saponin, all is weight percentage greater than 80% at extractive content.
5. the Chinese medicine compound compositions of claim 1, wherein the Cortex Cinnamomi polyphenol is made by following method: use CO after the Cortex Cinnamomi pulverizing medicinal materials
2Supercritical extraction is removed volatile oil, and residue water or the heating of 30%～70% ethanol decoct the decoction liquor centrifugalize; Filtrating concentrates after drying and gets Cortex Cinnamomi polyphenol crude extract, and Cortex Cinnamomi polyphenol crude extract is extracted sucking filtration with 50%～80% acetone or 50%～80% alcohol reflux; Filtrating concentrates the back and goes up the SP207 resin column; With 40%～55% ethanol elution, collect eluent, revolve steaming and promptly get to doing.
6. the Chinese medicine compound compositions of claim 1, wherein astragalus polysaccharides is made by following method: Milkvetch Root is cut into decoction pieces, decocts with distilled water, and sucking filtration adds ethanol after concentrating; Get deposition, deposition gets astragalus polysaccharides powder bullion through dry, the dissolving of bullion adding distil water heated and boiled; Cold preservation is spent the night, and gets supernatant, sucking filtration, and filtrating concentrates; Concentrated solution adds ethanol precipitation, the leaching deposition, and deposition is used absolute ethanol washing, and vacuum drying promptly gets.
7. the Chinese medicine compound compositions of claim 1, wherein the stem and leaf of Radix Ginseng saponin is made by following method: the Stem and leaf of Radix Ginseng section of cutting ethanol water reflux, extract,, filter; Revolve to steam and reclaim ethanol, concentrate, concentrated solution decolours with activated magnesia; D101 macroporous adsorbent resin on the aqueous solution is used the distilled water eluting earlier, and reuse 70% ethanol carries out eluting; Collect 70% ethanol elution part, revolve steaming and promptly get to doing.
8. the Chinese medicine compound compositions of claim 1 also contains pharmaceutically acceptable carrier.
9. the Chinese medicine compound compositions of claim 1 is used to prepare the purposes of the medicine of treatment or prevent diabetes or hyperlipemia.
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| CN107468868A (en) * | 2017-09-20 | 2017-12-15 | 云南万绿生物股份有限公司 | Composition of prevention and/or treatment IDDM and preparation method and application |
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| CN109007785A (en) * | 2018-09-26 | 2018-12-18 | 上饶市康可得生物科技有限公司 | A kind of auxiliary hyperglycemic blood fat reducing healthcare food |
| CN113667033A (en) * | 2021-09-10 | 2021-11-19 | 中国林业科学研究院林产化学工业研究所 | Cinnamon homogeneous polysaccharide and application thereof in reducing blood sugar |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106924374A (en) * | 2017-05-05 | 2017-07-07 | 中国农业科学院特产研究所 | A kind of composition and preparation method thereof and the application in hypoglycemic and/or reducing blood lipid product is prepared |
| CN106924374B (en) * | 2017-05-05 | 2020-09-29 | 中国农业科学院特产研究所 | Composition, preparation method thereof and application of composition in preparation of products for reducing blood sugar and/or blood fat |
| CN107468868A (en) * | 2017-09-20 | 2017-12-15 | 云南万绿生物股份有限公司 | Composition of prevention and/or treatment IDDM and preparation method and application |
| CN108042643A (en) * | 2017-12-13 | 2018-05-18 | 广西中医药大学 | A kind of preparation method of Traditional Chinese medicine for reducing blood glucose compound |
| CN109007785A (en) * | 2018-09-26 | 2018-12-18 | 上饶市康可得生物科技有限公司 | A kind of auxiliary hyperglycemic blood fat reducing healthcare food |
| CN113667033A (en) * | 2021-09-10 | 2021-11-19 | 中国林业科学研究院林产化学工业研究所 | Cinnamon homogeneous polysaccharide and application thereof in reducing blood sugar |
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