CN108114148A - A kind of Chinese medicine composition for treating diabetes and preparation method thereof - Google Patents

A kind of Chinese medicine composition for treating diabetes and preparation method thereof Download PDF

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Publication number
CN108114148A
CN108114148A CN201810127465.1A CN201810127465A CN108114148A CN 108114148 A CN108114148 A CN 108114148A CN 201810127465 A CN201810127465 A CN 201810127465A CN 108114148 A CN108114148 A CN 108114148A
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ginseng
medicine composition
chinese medicine
residue
radix astragali
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阮海连
方荣如
方安
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Jiangxi Lin Feng Pharmaceutical Co Ltd
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Jiangxi Lin Feng Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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Abstract

The present invention provides a kind of Chinese medicine composition for treating diabetes and preparation method thereof, wherein, the Chinese medicine composition of the treatment diabetes by weight percentage, including following raw material:Selenium-enriched tea leaf, rose hip extracting solution 15.50% 19.50%, ginseng 1.20% 1.50%, the tuber of dwarf lilyturf 10.30% 15.50%, Schisandra chinensis 8.50% 13.50%, Radix Astragali 10.20% 14.50%, Chinese yam 12.25% 17.50%, radix scrophulariae 1.50% 5.30%, Chinese cassia tree 1.00% 1.85%, cultivated land 4.00% 8.50%, Poria cocos 10.00% 15.50%, lily 2.50 5.60%, and the extracting solution is made through procedure below:Fresh selenium-enriched tea leaf, rose hip are placed in boiling water and decoct centrifuging and taking supernatant after 50 80min, residue centrifuges after being dissolved in water, and merges clear liquid twice;By cold soaking 30 minutes, centrifugation in residue and 35 times of NaCl solutions measured, supernatant is separated, and residue is added in into NaCl solution cold soaking 30 minutes, centrifuges, merges the clear liquid of clear liquid and the salt lift-off heart after the water lift-off heart.Chinese medicine composition provided by the invention including selenium-enriched tea leaf, which has, recovers insulin function, stabilizing blood sugar and prevention diabetic complication and other effects.

Description

A kind of Chinese medicine composition for treating diabetes and preparation method thereof
Technical field
The present invention relates to pharmaceutical technology fields, and in particular to a kind of Chinese medicine composition for treating diabetes and its preparation side Method.
Background technology
Diabetes are one group of metabolic diseases characterized by hyperglycaemia, and blood glucose is higher for a long time to cause various tissues, especially It is eye, kidney, heart, blood vessel, the chronic lesion of nerve, dysfunction, causes serious complication, influences health.Sugar Urine disease is divided into Type I diabetes, type II diabetes, wherein, Type I diabetes needs to rely on foreign aid's insulin to control blood glucose level, And the main pathogenic mechanism of type II diabetes is damaged for beta Cell of islet, insulin secretion be definitely not enough to cause Xu Tang metabolism by So as to show as blood glucose rise, blood glucose is stably controlled after the general oral hypoglycemic agents treatment of type II diabetes for resistance.The traditional Chinese medical science is for sugar The treatment of urine disease is long-standing, in history there are many discussion and effective drug, classical prescription treated on diabetes, and from Since Gu, just there is the common hypoglycemic therapy of tea therapy combination medication.In modern study, rich in tea polysaccharide, selenium, tea in tealeaves The substances such as pigment, tea polyphenols can play and improve insulin sensitivity, alleviate the damage for moving on to cell, adjusting glycometabolism correlation Enzymatic activity, improve body sugar tolerance, adjust the effects that related intestinal flora, to prevent diabetes.Wherein, the selenium in tealeaves is made For a kind of trace element, in recent years the study found that its between diabetes there are certain relation, the conjunction to insulin Into, secretion, storage, activity, tissue insulin sensitivity and energy substrate metabolism play an important role, can be used for aid in pancreas islet Extract for treating diabetes.
Middle treatment diabetes is general to select heat-clearing class or supplementing qi and nourishing yin class or replenish qi to invigorate the spleen class or Yin-nourishing and Yang-supporting class or QI invigorating Kidney tonifying class Chinese medicine, wherein, the Radix Astragali of rising Yang QI invigorating and the ginseng to reinforce vital energy are frequently used in Diabetes decoction, and by ginseng stilbene The dialectical treatment of two medicines also has much to add the prescription of his drug, such as ginseng stilbene side, ginseng, astragalus diabetes side.In modern study, Radix Astragali Hypoglycemic while can bidirectional modulation blood glucose, maintain glucostasis effect;And the ginsenoside in ginseng can significantly reduce blood Sugar simultaneously improves human body sugar tolerance.
Ginseng stilbene side is made of ginseng 10g, Radix Astragali 25g, Radix Rehmanniae 20g, rhizoma anemarrhenae 15g, leech 5g, eupolyphage sece steleophaga 5g, has QI invigorating Yin-nourishing, it is promoting blood circulation and removing blood stasis the effect of, be that treatment quenches one's thirst that pathogenic QI in the body sun two is empty and effective prescriptions of blood stasis, through verifying for a long time effectively, be It is used to treat one of main Chinese patent drug of type II diabetes in modern clinic.
Ginseng, astragalus diabetes side is by ginseng 6g, tuber of dwarf lilyturf 15g, Schisandra chinensis 6g, Radix Astragali 20g, Chinese yam 20g, radix scrophulariae 20g, Chinese cassia tree 2g, fennel 5g, coptis 6g, tsaoko 10g, leech 6g, prepared RADIX ET RHIZOMA RHEI 6g, Poria cocos 15g compositions, in above-mentioned side raw material add water to cook take it is pan-fried Juice is taken, dialectical plus-minus, and water is wet more notably to add fuling peel, rhizoma atractylodis, Rhizoma Atractylodis Macrocephalae, rhizoma alismatis, plantain seed, umbellate pore furgus etc.;Damp and hot person add Radix Astragali, Mountain Cape jasmine, Cortex Phellodendri;Damp retention in middle-jiao person adds wrinkled giant hyssop, eupatorium, fructus amomi, can treat because of diabetes with the passing of time impairment of yin gas, yin deficiency affecting yang, gas the moon two Void, yin-yang deficiency, then pathogen usually intruding into collateral in protracted disease so that phlegm is turbid, oblique heat, blood stasis, the obstruction of the circulation of vital energy are mutually tied, make kidney body mutually damage, and kidney is with mistake department, treatment Microvascular complication caused by diabetes.
Ginseng, astragalus diabetes ball is hypoglycemic common Chinese patent drug, by ginseng, Radix Astragali, Chinese yam, Rhizoma Atractylodis Macrocephalae, Schisandra chinensis, Radix Ophiopogonis, jade Bamboo, prepared rhizome of rehmannia, the root of bidentate achyranthes, Poria cocos, rhizoma alismatis, great burdock achene, 13 taste Chinese medicine of stiff silkworm composition, can supplementing qi and nourishing yin, promote the production of body fluid to quench thirst, be usually used in disappearing Thirsty pathogenic QI in the body Yin bivacuity disease and type II diabetes are one of effective Chinese patent drugs for treating diabetes.
A kind of medicinal composition for treating diabetes and preparation method thereof is disclosed in CN1977884, wherein, ginseng, astragalus diabetes drug Composition includes following components in parts by weight:150-300 parts of ginseng, 200-350 parts of root of Chinese trichosanthes, 180-330 parts of Radix Astragali, Radix Ophiopogonis 180-250 part, 150-300 parts of pueraria lobata, 200-350 parts of Schisandra chinensis, 180-250 parts of Fructus Mume, 150-300 parts of Snakegourd Fruit, wingceltis It is 60-150 parts fragrant, 200-350 parts of loguat leaf;The preparation method for preparing the medicinal composition for treating diabetes is:(1) in parts by weight Weigh the prepared slices of Chinese crude drugs:150-300 parts of ginseng, 200-350 parts of root of Chinese trichosanthes, 180-330 parts of Radix Astragali, Radix Ophiopogonis 180-250 part, pueraria lobata 150-300 parts, 200-350 parts of Schisandra chinensis, 180-250 parts of Fructus Mume, 150-300 parts of Snakegourd Fruit, 60-150 parts of santal, loguat leaf 200-350 parts;(2) people is taken to participate in the roots of Chinese trichosanthes of 50-90 parts by weight, and to be ground into fine powder spare;Schisandra chinensis is returned with ethanol water heat Stream extracts to obtain Fructus Schisandrae Chinensis extractive solution, spare;Santal extracts volatile oil with the way of distillation, obtains santal volatile oil, santal liquid, point deposits standby With;It by the root of Chinese trichosanthes of surplus and Snakegourd Fruit, Radix Ophiopogonis, Radix Astragali, pueraria lobata, Fructus Mume, loguat leaf boiling, filters, concentration adds ethyl alcohol water-soluble Liquid turns molten, stirs evenly, and stands, and filtration merges with above-mentioned Fructus Schisandrae Chinensis extractive solution, santal liquid after ethyl alcohol is recovered under reduced pressure, is condensed into clear cream, The fine powder for adding in the root of Chinese trichosanthes and ginseng is mixed and made into bulky grain, dry, pulverize into fine powder, and particle is made, sieving, dry spray Enter santal volatile oil, mixing, closed placement, be made pill or tablet or granule or soft capsule or capsule or syrup or Sustained release tablets or pill.In the ginseng, astragalus diabetes composition, ginseng dosage is more, of high cost.
A kind of ginseng, astragalus diabetes dropping pills are disclosed in CN101024034, the raw material of the ginseng, astragalus diabetes dropping pills contains ginseng, Huang Stilbene, Chinese yam, Rhizoma Atractylodis Macrocephalae, Schisandra chinensis, Radix Ophiopogonis, radix polygonati officinalis, prepared rhizome of rehmannia, the root of bidentate achyranthes, Poria cocos, rhizoma alismatis, great burdock achene, 13 taste active Chinese drug component of stiff silkworm into The extract dry powder divided, its preparation method are:Ginseng is ground into coarse powder, carries out diacolation using percolation, collects liquid of filtering, recycles second Alcohol, it is spare;Remaining Radix Astragali, Chinese yam, Rhizoma Atractylodis Macrocephalae, Schisandra chinensis, Radix Ophiopogonis, radix polygonati officinalis, prepared rhizome of rehmannia, the root of bidentate achyranthes, Poria cocos, rhizoma alismatis, great burdock achene, stiff silkworm 12 taste medicinal materials add water to cook, and filtration, filtrate, which stands, makes precipitation, and supernatant is taken to merge with above-mentioned ginseng liquid percolation, is concentrated under reduced pressure Extremely, it is spray-dried;Using water-bath, oil bath or other mode of heatings, mixed material is heated, until obtaining extracting containing drug The molten liquid and/or emulsion and/or suspension of object and matrix, mixing, upper pill dripping machine, dripping pelletization.The ginseng, astragalus diabetes dropping pills The proportioning of related raw material is not disclosed, and preparation method is also conventional means, does not make related improvement.
The content of the invention
For the above situation, in order to overcome the shortcomings of the prior art, inventor is by largely testing to joining stilbene side And the ginseng stilbene preparation such as ginseng, astragalus diabetes side and tea side are screened and are compounded, and are found surprisingly that, by whole ginsengs and 1/5 Radix Astragali and alcohol After high pressure extraction, extracting solution is used as medicine together with filter residue, and adds in selenium-enriched tea leaf, rose hip extracting solution, can significantly reduce ginseng use While amount, the drug effect of the treatment diabetes of enhancing ginseng stilbene preparation.
The present invention reaches above-mentioned purpose by the following technical programs.
The present invention provides following technical solutions:
A kind of Chinese medicine composition for treating diabetes, by weight percentage, including following raw material:Selenium-enriched tea leaf, thorn rose Fruit extracting solution 15.50%-19.50%, ginseng 1.20%-1.50%, tuber of dwarf lilyturf 10.30%-15.50%, Schisandra chinensis 8.50%- 13.50%, Radix Astragali 10.20%-14.50%, Chinese yam 12.25%-17.50%, radix scrophulariae 1.50%-5.30%, Chinese cassia tree 1.00%- 1.85%, cultivated land 4.00%-8.50%, Poria cocos 10.00%-15.50%, lily 2.50-5.60%.
The selenium-enriched tea leaf, rose hip extracting solution are made through procedure below:Fresh selenium-enriched tea leaf, rose hip are placed in boiling water Centrifuging and taking supernatant after middle decoction 50-80min, residue centrifuge after being dissolved in water, and merge clear liquid twice;Residue and 3-5 times are measured NaCl solution (5%-8%) in cold soaking 30 minutes, centrifugation separates supernatant, and residue added in NaCl solution cold soaking 30 and is divided Clock centrifuges, and merges the clear liquid of clear liquid and the salt lift-off heart after the water lift-off heart.
The ginseng can be by ginseng:Ginseng stem:Folium panacis japonici cum caule:9:1~3:1~2 composition.
The present invention also provides it is described treatment diabetes Chinese medicine composition preparation method, as described below:
(1) fresh selenium-enriched tea leaf, rose hip are placed in boiling water and decoct centrifuging and taking supernatant after 50-80min, residue adds water It is centrifuged after dissolving, merges clear liquid twice;By residue and cold soaking 30 minutes in the 3-5 times of NaCl solution (5%-8%) measured, centrifuge, Supernatant is separated, and residue is added in into NaCl solution cold soaking 30 minutes, centrifugation merges clear liquid and the salt lift-off heart after the water lift-off heart Clear liquid;
(2) weigh people by recipe ratio and participate in 1/5 Radix Astragali, conventional to crush, 10 times of amount 400MPa of 50%-65% ethanol solutions are carried It takes 3 minutes, filters, recycle ethyl alcohol, obtain ginseng, Radix Astragali extractum, and ginseng Radix Astragali filter residue is saved backup;
(3) by the Radix Astragali of surplus and the tuber of dwarf lilyturf of recipe ratio, Schisandra chinensis, Chinese yam, radix scrophulariae, Chinese cassia tree, cultivated land, Poria cocos, lily Respectively it is conventional crush after, add water to cook three times, filtering, by ginseng made from filtrate and step (2), Radix Astragali extractum and recipe ratio After selenium-enriched tea leaf, rose hip extracting solution are combined and concentrated to 1/2, ginseng Radix Astragali filter residue is added in, is uniformly mixed, continues to be condensed into leaching Cream, it is dry, obtain dry cream.
Tablet, capsule are further prepared into after the above-mentioned added auxiliary material of dried cream powder being prepared.
The invention has the advantages that:
It is (1) of the invention by the way that by after whole ginsengs and 1/5 Radix Astragali and alcohol high pressure extraction, extracting solution is used as medicine together with filter residue, And add in selenium-enriched tea leaf, rose hip extracting solution, can act synergistically with the medicines such as the tuber of dwarf lilyturf, Schisandra chinensis, significantly reduce ginseng dosage, While adding the utilization rate of ginseng, the drug effect of the Chinese medicine composition is enhanced.
(2) in the present invention, ginseng under ground portion is selected to be used as medicine jointly with ginseng aerial part, and is extracted jointly with Radix Astragali, The utilization rate of ginseng is substantially increased on the premise of drug effect is increased.
(3) certain density ethyl alcohol high pressure extraction Radix Astragali, people are passed through in the preparation method of the Chinese medicine composition in the present invention Ginseng, and concentration is mixed after being decocted with other medicinal materials, preparation method is simple and effective.
Specific embodiment
With reference to specific embodiment, the present invention is further described.
Embodiment 1
The preparation of Chinese medicine composition
Chinese medicine composition a
Chinese medicine composition a includes the raw material of following mass percent:Selenium-enriched tea leaf, rose hip extracting solution 17.50%, people Ginseng 1.20%, the tuber of dwarf lilyturf 10.30%, Schisandra chinensis 10.50%, Radix Astragali 10.75%, Chinese yam 17.25%, radix scrophulariae 4.50%, Chinese cassia tree 1.00%, cultivated land 8.50%, Poria cocos 14.00%, lily 4.50,
The selenium-enriched tea leaf is derived from the selenium-enriched tea leaf of Yichun City Bo Hui ecological agricultures Co., Ltd production.
The preparation method of Chinese medicine composition a is as follows:
(1) fresh selenium-enriched tea leaf, rose hip 10g are placed in the boiling water of 3 times of amounts centrifuging and taking supernatant after decoction 50-80min Liquid, residue centrifuge after being dissolved in water, and merge clear liquid twice;Cold soaking 30 minutes in the 5%NaCl solution that residue and 5 times are measured, from The heart separates supernatant, and residue is added in NaCl solution cold soaking 30 minutes, and centrifugation, merges the clear liquid after the water lift-off heart and salt carries The clear liquid of centrifugation;
(2) weigh people and participate in 1/5 Radix Astragali, conventional to crush, 50% 10 times of ethanol solution amount 400MPa is extracted 3 minutes, filtering, Ethyl alcohol is recycled, ginseng, Radix Astragali extractum is obtained, and ginseng Radix Astragali filter residue is saved backup;
(3) the Radix Astragali difference for weighing the tuber of dwarf lilyturf, Schisandra chinensis, Chinese yam, radix scrophulariae, Chinese cassia tree, cultivated land, Poria cocos, lily and surplus is normal It after rule crush, adds water to cook three times, filtering, by the Se rich tea of ginseng, Radix Astragali extractum and recipe ratio made from filtrate and step (2) After leaf, rose hip extracting solution are combined and concentrated to 1/2, ginseng Radix Astragali filter residue is added in, is uniformly mixed, continues to be condensed into medicinal extract, is done It is dry, obtain dry cream.
Chinese medicine composition b
Chinese medicine composition b includes the raw material of following mass percent:Selenium-enriched tea leaf, rose hip extracting solution 19.50%, people Ginseng 1.50%, the tuber of dwarf lilyturf 15.50%, Schisandra chinensis 13.50%, Radix Astragali 14.50%, Chinese yam 12.25%, radix scrophulariae 2.75%, Chinese cassia tree 1.00%, cultivated land 5.00%, Poria cocos 12.00%, lily 2.50
The preparation method of Chinese medicine composition b is different except raw material proportioning, remaining preparation method phase with Chinese medicine composition a Together.
Chinese medicine composition c
Chinese medicine composition c includes the raw material of following mass percent:Selenium-enriched tea leaf, rose hip extracting solution 15.50%, people Ginseng 1.35%, the tuber of dwarf lilyturf 13.30%, Schisandra chinensis 12.50%, Radix Astragali 13.50%, Chinese yam 14.20%, radix scrophulariae 2.80%, Chinese cassia tree 1.80%, cultivated land 7.50%, Poria cocos 13.00%, lily 4.55%
The preparation method of Chinese medicine composition c is different except raw material proportioning, other preparation method phases with Chinese medicine composition a Together.
Chinese medicine composition d
Chinese medicine composition d includes the raw material of following mass percent:Selenium-enriched tea leaf, rose hip extracting solution 15.50%, people Ginseng 1.35%, the tuber of dwarf lilyturf 13.30%, Schisandra chinensis 12.50%, Radix Astragali 13.50%, Chinese yam 14.20%, radix scrophulariae 2.80%, Chinese cassia tree 1.80%, cultivated land 7.50%, Poria cocos 13.00%, lily 4.55%, wherein, ginseng is by ginseng:Ginseng stem:Folium panacis japonici cum caule:9:2: 1 composition.
The preparation method of Chinese medicine composition d is different except raw material proportioning, other preparation method phases with Chinese medicine composition a Together.
Comparative example 1
Content disclosed in CN1977884:(1) ginseng 223g, root of Chinese trichosanthes 233g, Radix Astragali 233g, Radix Ophiopogonis 233g, Pueraria lobota are weighed Root 233g, Schisandra chinensis 233g, Fructus Mume 233g, Snakegourd Fruit 233g, santal 117g, loguat leaf 233g;(2) the above-mentioned whole weighed is taken It is spare that people's participation root of Chinese trichosanthes 60g is ground into fine powder;Schisandra chinensis percent by volume is 70% ethanol water circumfluence distillation 3 Secondary, every time plus the weight of ethanol water is 5 times of Schisandra chinensis weight, when extraction 10 is small, merges liquid, filters, is recovered under reduced pressure Ethyl alcohol obtains Fructus Schisandrae Chinensis extractive solution, spare;Santal extracts volatile oil with the way of distillation:Into santal plus water, the weight for adding water are santal 5 times of weight when extraction 10 is small, obtain santal volatile oil, santal liquid, point deposit spare;By the root of Chinese trichosanthes of surplus and Snakegourd Fruit, Radix Ophiopogonis, Radix Astragali, pueraria lobata, Fructus Mume, loguat leaf boiling 3 times, every time plus water weight is above-mentioned medicine materical crude slice weight 10 times, every time 10 it is small when, filter It crosses, when merging filtrate is concentrated into 80 DEG C, relative density 1.10, the percent by volume for adding 5 times of the volume of the concentrated liquid is 70%- 80% ethanol water turns molten, stirs evenly, and when standing 50 is small, Aspirate supernatant adds in precipitation and is equivalent to supernatant volume Two times of percent by volume is 70% ethanol water, is stirred evenly, and when standing 50 is small, ethyl alcohol is recovered under reduced pressure in filtration, merging filtrate Merge afterwards with above-mentioned Fructus Schisandrae Chinensis extractive solution, santal liquid, when being condensed into 80 DEG C, relative density is 1.25 clear cream, adds in the day The fine powder of pollen and ginseng is mixed and made into bulky grain, dry, pulverize into fine powder, and particle is made, sieving, dry to spray into being equivalent to The sandalwood oil that the ethanol water that the concentration of volume percent of santal 3 times of oil volume of volatilization is 95% dissolves, mixing are closed to put It puts, tablet is made.
Comparative example 2
Chinese medicine composition e
Chinese medicine composition e includes the raw material of following mass percent:Selenium-enriched tea leaf 8.50%, rose hip 9.00%, people Ginseng 1.20%, the tuber of dwarf lilyturf 10.30%, Schisandra chinensis 10.50%, Radix Astragali 10.75%, Chinese yam 17.25%, radix scrophulariae 4.50%, Chinese cassia tree 1.00%, cultivated land 8.50%, Poria cocos 14.00%, lily 4.50.
The preparation method of the Chinese medicine composition d of comparative example 2 and the preparation method of the Chinese medicine composition a in embodiment 1 are distinguished It is:Selenium-enriched tea leaf, rose hip such as step 1 are not operated and obtain selenium-enriched tea leaf, rose hip extracting solution, but after conventional crushing, Radix Astragali with the tuber of dwarf lilyturf, Schisandra chinensis, Chinese yam, radix scrophulariae, Chinese cassia tree, cultivated land, Poria cocos, lily and surplus in step (3) decocts together.
Comparative example 3
Chinese medicine composition f
Chinese medicine composition f includes the raw material of following mass percent:Selenium-enriched tea leaf, rose hip extracting solution 17.50%, people Ginseng 1.20%, the tuber of dwarf lilyturf 10.30%, Schisandra chinensis 10.50%, Radix Astragali 10.75%, Chinese yam 17.25%, radix scrophulariae 4.50%, Chinese cassia tree 1.00%, cultivated land 8.50%, Poria cocos 14.00%, lily 4.50.
The preparation method of the Chinese medicine composition e of comparative example 3 and the preparation method of the Chinese medicine composition a in embodiment 1 are distinguished It is:The filtrate that ginseng, the 1/5 Radix Astragali filter residue of step (2) acquisition are not added in step 3 concentrates together.
Embodiment 2
Hypoglycemic animal functional trial
1 material
1.1 Animals Male healthy adult mouse (25 ± 2g)
1.2 reagent alloxan mouse 35-50mg/kg.bw.iv (100-160mg/kg.bw.ip) use Fresh.
1.3 instrument blood glucose meters
The dried cream powder that the Chinese medicine composition c crushing prepared in 1.4 drug embodiments 1 forms
2 experimental methods
160 mouse are maintained feed to adapt to after feeding 1 week by 2.1 modelings with grouping, are randomly selected out 10 mouse and are made For normal group, whole process maintains feed raising, remaining mouse when animal fasting 24 is small, is given afterwards after forage feed is maintained 2 months Alloxan moulding is given, after 5 days, when fasting 5 is small, surveys blood glucose, blood glucose value 10-25mmol/L is hyperglycemia model success animal. Selecting 3 model groups and 3 dosage groups and 9 control groups at random from hyperglycemia model success animal, (difference is not more than between group 1.1mmol/L), every group of 10 mouse.Every group of gavage difference reagent continuous 30 days, surveys fasting blood sugar (when fasting 5 is small), than Compared with each group animal blood glucose value and blood glucose rate of descent.
Blood glucose value X100% before blood glucose rate of descent=(blood glucose value after blood glucose value-experiment before experiment)/experiment
2.2 dosage groups give basic, normal, high 3 dosage groups of the Chinese medicine composition c prepared in embodiment 1 respectively, point Not Wei 0.25g/kg, 0.5g/kg, 1.0g/kg, model group gives solvent metformin hydrochloride tablet basic, normal, high 3 dosage respectively Group, is respectively 0.25g/kg, 0.5g/kg, 1.0g/kg, and control group is given comparative example 1, comparative example 2, comparative example 3 and prepared respectively Basic, normal, high 3 dosage groups of drug are respectively 0.25g/kg, 0.5g/kg, 1.0g/kg, and normal group is given isometric distilled water.
3 results
It is shown in Table 1.In table 1, dosage group be take high, normal, basic three dosage group blood glucose rates of descent of Chinese medicine composition c with it is normal Group compares, and blood glucose rate of descent is much larger than normal group, and difference has conspicuousness (P<0.05);And the blood that dosage group is more normally organized What 1 group of difference, the comparative example that the difference of sugared rate of descent is significantly greater than the blood glucose rate of descent that model group is more normally organized more normally was organized Blood glucose rate of descent shows that after taking Chinese medicine composition c blood glucose can be significantly reduced, and the effect for reducing blood glucose is better than hydrochloride Biguanides piece;Comparative example 2 and comparative example 3 are slightly larger and poor compared with the blood glucose rate of descent normally organized compared with the blood glucose rate of descent normally organized respectively It is different not have conspicuousness (P>0.05) the blood glucose rate of descent of the high, normal, basic arbitrary dosage, but far smaller than in dosage group, shows not Not concentrating ginseng, 1/5 Radix Astragali filter residue and filtrate together in addition selenium-enriched tea leaf, rose hip extracting solution or step (3) can be significantly Reduce hypoglycemic effect.
1 mouse blood sugar of table influences (n=10, X ± SD)
Embodiment 3
Human feeding trial
1 experimental design
Selection state of an illness after diet control or oral hypoglycemic agents treatment is relatively stablized, and need not replace types of drugs and dosage, The adult type-2 diabetes mellitus patient for only taking maintenance dose or hyperglycemia population totally 120, inclusion criteria:Fasting blood-glucose >= 7.8mmol/L or 2h-plasma glucose >=11.1mmol/L;Also may be selected 7.8mmol/L >=fasting blood-glucose >=6.7mmol/L or The hyperglycemia population of 11.1mmol/L >=2h-plasma glucose >=7.8mmol/L excludes:Type-1 diabetes mellitus patient;Age 18 years old with Lower or over-65s, gestation or women breast-feeding their children, to given the test agent allergy sufferers;Intentionally, the main organs such as liver, kidney complication or Entirely and there are other serious diseases, mental patient takes glucocorticoid or other influence hypoglycemic medicament persons;Diet cannot be coordinated It controls and influences observation result person;There are Diabetic ketosis, acid poisoning and the infected in nearly 3 months.
2 by test product
Be the Chinese medicine composition c in embodiment 1 by test product, reference substance is placebo, and by test product and reference substance dosage form, It is consistent in mouthfeel, appearance and packaging.
3 subjects are grouped
Experiment is using random grouping, between group and itself two kinds of control design.Examination is randomly divided by the blood glucose level of subject Food group and control group.
4 test methods
Gender, age, different labor intensity, ideal body weight are pressed with reference to original habits and customs to each subject before experiment It provides corresponding diet, adheres to diet control during test-meal, medicament categories and the dosage for treating diabetes are constant.Test-meal group is taking On the basis of medicine, daily edible by test product 2 times, control group is on the basis of medication, daily placebo 2 times.Experiment starts And observation index of detection of end, continuous experiment terminate for 30 days.
5 observation index
The percentage that fasting blood sugar and blood glucose decline before and after test-meal;Eaten before and after test-meal after 100g fine powder steamed buns 2 it is small when The percentage that blood glucose value and blood glucose decline.
6 data processings and result judgement
It the results are shown in Table 2, table 3.In table 2, itself compare before and after test-meal group fasting blood-glucose, 2h-plasma glucose experiment, difference has Pole conspicuousness (P<0.01), and after experiment the percentage of blood glucose decline is all higher than 10%;In table 3, fasting blood after test-meal group experiment Compared with the control group, difference has conspicuousness to sugared, 2h-plasma glucose blood glucose reduced rate.Therefore, it can determine that the given the test agent on an empty stomach Blood glucose, 2h-plasma glucose index result are positive, and the Chinese medicine composition c which prepares has reduction human body Blood glucose acts on.
2 type II diabetes people of table or hyperglycemia population test-meal blood glucose test results (X ± SD) before and after by test product
Blood glucose test results (X ± SD) before and after 3 type II diabetes people of table or hyperglycemia population test-meal reference substance
Embodiment 4
Model case
1st, Zhang, 50 years old, female, insomnia was lost the appetite, fatigue and asthenia, and hyperglycaemia medical history 2 years is double per diformazan is taken day by day 2 times/day of guanidine antidiabetic drug, and daily control diet cooperation moderate exercise, after taking this product three months while maintaining and taking medicine, two First biguanides dose can halve and blood glucose is steady, and immunity enhances, and constitution is light.
2nd, Lee, 79 years old, man, hyperglycaemia medical history 15 years, first three was only by keeping on a diet and coordinating moderate exercise, but not Blood glucose level can be effectively controlled, it is every always afterwards to take 2 times/day of melbine antidiabetic drug day by day and coordinate rational diet and fortune Dynamic, after taking this product half a year while maintaining and taking medicine, melbine dose can halve and maintain blood glucose steady.
3rd, poplar, 17 years old, man, 16 years old when, was found blood glucose value rise larynx and starts oral hypoglycemic agents, start after half a year to Injection of insulin is given to treat, after taking this product half a year while continuing and giving injection of insulin treatment afterwards, insulin is given Dosage can halve and patient blood glucose, blood pressure maintain to balance substantially.
4th, Fang An, man, 70 years old, 22 years diabetes medical histories had needed injection to give insulin always since diseased, three times a day, 10 units every time, take this product the year before, and after taking five months, insulin dose is reduced to three times a day, 7 notes Unit is penetrated, and blood glucose is steady, the state of mind is good.

Claims (5)

1. a kind of Chinese medicine composition for treating diabetes, which is characterized in that by weight percentage, including following raw material:Selenium-rich Tealeaves, rose hip extracting solution 15.50%-19.50%, ginseng 1.20%-1.50%, tuber of dwarf lilyturf 10.30%-15.50%, the five tastes Sub- 8.50%-13.50%, Radix Astragali 10.20%-14.50%, Chinese yam 12.25%-17.50%, radix scrophulariae 1.50%-5.30%, meat Osmanthus 1.00%-1.85%, cultivated land 4.00%-8.50%, Poria cocos 10.00%-15.50%, lily 2.50-5.60%.
2. a kind of Chinese medicine composition for treating diabetes according to claim 1, which is characterized in that the selenium-enriched tea leaf, Rose hip extracting solution is made through procedure below:Fresh selenium-enriched tea leaf, rose hip are placed in boiling water after decocting 50-80min and centrifuged Supernatant, residue is taken to be centrifuged after being dissolved in water, merges clear liquid twice;It will be in residue and the 3-5 times of NaCl solution (5%-8%) measured Cold soaking 30 minutes, centrifugation separate supernatant, and residue are added in NaCl solution cold soaking 30 minutes, centrifugation, after merging the water lift-off heart Clear liquid and the salt lift-off heart clear liquid.
3. a kind of Chinese medicine composition for treating diabetes according to claim 1, which is characterized in that the ginseng can be by people Join root:Ginseng stem:Folium panacis japonici cum caule:9:1~3:1~2 compositions.
4. the preparation method of the Chinese medicine composition of the treatment diabetes is prepared using traditional Chinese medicine composite described in claim 1 It is as follows:
(1) fresh selenium-enriched tea leaf, rose hip are placed in boiling water and decoct centrifuging and taking supernatant after 50-80min, residue is dissolved in water After centrifuge, merge clear liquid twice;It by residue and cold soaking 30 minutes in the 3-5 times of NaCl solution (5%-8%) measured, centrifuges, separation Supernatant, and residue is added in NaCl solution cold soaking 30 minutes, centrifugation merge the clear of the clear liquid after the water lift-off heart and the salt lift-off heart Liquid;
(2) weigh people by recipe ratio and participate in 1/5 Radix Astragali, conventional to crush, 10 times of amount 400MPa extractions 3 of 50%-65% ethanol solutions Minute, ethyl alcohol is recycled in filtering, obtains ginseng, Radix Astragali extractum, and ginseng Radix Astragali filter residue is saved backup;
(3) Radix Astragali of surplus and the tuber of dwarf lilyturf of recipe ratio, Schisandra chinensis, Chinese yam, radix scrophulariae, Chinese cassia tree, cultivated land, Poria cocos, lily are distinguished It after conventional crushing, adds water to cook three times, filtering, by the selenium-rich of ginseng, Radix Astragali extractum and recipe ratio made from filtrate and step (2) After tealeaves, rose hip extracting solution are combined and concentrated to 1/2, ginseng Radix Astragali filter residue is added in, is uniformly mixed, continues to be condensed into medicinal extract, It is dry, obtain dry cream.
5. the preparation method of the Chinese traditional medicine composition for the treatment of diabetes according to claim 4, the dry cream warp being prepared Tablet, capsule are further prepared into after addition auxiliary material.
CN201810127465.1A 2018-02-08 2018-02-08 A kind of Chinese medicine composition for treating diabetes and preparation method thereof Pending CN108114148A (en)

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Application publication date: 20180605