CN104257755A - Composition with effect of treating diabetes as well as preparation method and application of composition - Google Patents
Composition with effect of treating diabetes as well as preparation method and application of composition Download PDFInfo
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Abstract
The invention discloses a composition with an effect of treating diabetes as well as a preparation method and application of the composition. The composition is prepared from the following raw materials in parts by weight: 1-12 parts of snow chrysanthemum and 1-12 parts of folium mori. On the basis of the traditional theories of the traditional Chinese medicine, with syndrome differentiation and treatment as guidance, research on traditional Chinese medicine proportions and components is carried out; and due to a scientific and reasonable extraction mode and a resin purifying technology, the composition is obtained. An experiment result shows that the composition disclosed by the invention is capable of effectively regulating and controlling glucose metabolism of the organism, reducing the in-vivo blood glucose level, improving the glucose-tolerant level, repairing the biological action of islet B cells, and improving insulin resistance, plays a good role of synergistic interaction, and is a novel medicament for preventing and treating diabetes.
Description
Technical field
The present invention relates to a kind of medicine, be specifically related to a kind of composition and method of making the same and the application with the effect for the treatment of diabetes.
Background technology
The metabolism disturbance syndrome of diabetes to be a kind of with hyperglycemia be feature.Blood glucose raise be then due to defect of insulin secretion or its biological agent impaired, or both have concurrently and cause.During diabetes, long-standing hyperglycemia can cause chronic lesion and the dysfunction thereof of various tissue, particularly eye, kidney, heart, blood vessel, nerve etc.At present, in the world, diabetes have become after cardiovascular and cerebrovascular disease and tumor, threaten the mankind " No. three killer ", no matter in developed country or developing country, the sickness rate of diabetes is all sharply rising, and age of onset constantly declines, diabetes not only bring great misery to patient, quality of life is greatly affected, and even threatens the life of patient, also brings heavy financial burden to society.JAMA (" JAMA ") one section of article claims: Chinese Adult diabetics reaches 11.6%, the many arrival 1.14 hundred million of number, and presents the growth of mad formula every year.In the offering, the research for novel control diabetes medicament is very urgent in the threat of diabetes.
Diabetes there is no the method for radical cure as a kind of at present with lifelong chronic disease, and it has become the great public health problem that countries in the world are paid close attention to, belongs to great difficult miscellaneous diseases.Diabetics needs by Long-term taking medicine, carrys out blood glucose balance in control agent, and therefore, how rational use of drug is particularly important with regard to what show.At present, the blood sugar lowering Western medicine that market is sold, as sulfonylurea, the medicines such as biguanides are the choice drugs for the treatment of diabetes, but, this kind of blood sugar lowering Western medicine is just as a double-edged sword, Patients' rights blood glucose can be helped fast, reduce the risk that chronic complicating diseases occurs, also may serve side effect to body band simultaneously, this type of hypoglycemic medicine of long-term taking can cause untoward reaction in various degree, as hypoglycemia, lactic acidosis, leukopenia and hemolytic anemia etc., be unfavorable for the health of human body, in order to the misery of reduction of patient, improve its quality of life, be necessary the blood sugar lowering of the Chinese medicine safely and effectively class medicine of development of new.
Diabetes belong to Chinese medicine diabetes category by its clinical manifestation, traditional medicine thinks that diabetes are how not enough by natural endowment, the ferritic deficiency of YIN, or because of temperament and interest uncomfortable, eating and drinking without temperance, work and rest mistake degree, diseases caused by exogenous pathogenic factor six climate exopathogens, the factors such as internal damage by the excessive seven emotions, consumption hinders the moon of Human Lung stomach kidney, cause that the deficiency of YIN is scorching, the five internal organs are weak, finally develop into diabetes.Treatment can be selected or enriching yin and nourishing kidney or invigorating the spleen and benefiting QI or the heat of lung heat clearing stomach or supplementing QI for promoting the production of body fluid or the different Therapeutic Method such as dispersing the stagnated live-QI to relieve the stagnation of QI or blood circulation promoting and blood stasis dispelling.Chinese medicine is thought: Folium Mori energy dispelling wind and heat pathogens, heat clearing away of inducing sweat, YIN nourishing and the production of body fluid promoting; Snow chrysanthemum is cool in nature, has the effects such as wind and heat dispersing, brain nourishing and eyesight improving, removing toxic substances and promoting subsidence of swelling.Both all kind dispelling wind and heat pathogens, Folium Mori are monarch drug, cold in nature, and effect is lung relatively, and it is strong that evacuation power comparatively avenges chrysanthemum; Snow chrysanthemum is ministerial drug, and cold nature acts on inclined liver, and suppressing the hyperactive liver improving eyesight comparatively Folium Mori is victory.Snow chrysanthemum assistant makes Folium Mori treat diabete, and both bring out the best in each other by compatibility, and common prescription forms a kind of Chinese prescription of novel therapeutic diabetes.
Record in Compendium of Material Medica: Folium Mori " juice decocts Dai Ming, can only quench one's thirst ".Modern study confirms, contribute to containing multiple the composition regulating blood glucose in Folium Mori, hypoglycemic effect is reached by there is synergism, wherein alkaloids composition 1-DNJ (DNJ) is by the suppression to alpha-glucosidase, thus reduce disaccharidase in enteral absorption, reduce post-prandial glycemia; Alkaloid fagomine, flavones in mulberry leaves and polysaccharide composition thereof all can promote islet β cell insulin, thus reach the effect regulating blood glucose balance in body.Folium Mori are as the Chinese medicine of medicine-food two-purpose, and edible safety is nontoxic, and its significant hypoglycemic activity, are more and more subject to popular favor, coming out one after another of some relevant new drugs and health food thereof.Snow chrysanthemum is Compositae golden pheasant Chrysanthemum (Compositae) plant, has another name called double-colored Coreopsis basalis, Herba Coreopsis tinctoria, high and cold snow chrysanthemum etc.Record in " Xinhua's book on Chinese herbal medicine outline ": herb: sweet in the mouth, property is put down.There is the function of heat-clearing and toxic substances removing, removing dampness.Modern study shows, in snow chrysanthemum, general flavone content reaches 12%, considerably beyond other various chrysanthemum classes.These biological general flavones, terpene substances, the sulfur-containing compound that are rich in snow chrysanthemum, being collectively referred to as the factor of tool immunoloregulation function, is element important in blood pressure lowering, blood fat reducing, adjustment blood glucose, antitumor and defying age related drugs.No matter be Folium Mori, still chrysanthemum is avenged, traditional tea-drinking mode, a lot of effective ingredient is not suggested, and causes effective ingredient in medical material to be underutilized, this for costliness snow chrysanthemum be a huge economic loss, even weaken curative effect, so, ensureing on the basis that its active ingredient does not lose, in conjunction with scientific and rational extracting mode and resin purification technique, both compatibilities are made the most of the advantage effect.
At present, the many relatively compound recipes of Chinese medicine for diabetes, its clinical dosage is large, and Chinese prescription is according to having nothing in common with each other, rule for the treatment of disunity, therefore based on traditional Chinese medicine theory, according to the pathogenesis of diabetes, be instruct to carry out the research of proportioning prescription with determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, actively find and make great efforts the new medicine blood sugar lowering prescription of the high effect nontoxic exploring treatment diabetes.
Summary of the invention
Goal of the invention: solve the deficiencies in the prior art, there is provided a kind of proportioning scientific and reasonable, determined curative effect, Clinical practice safety, the hypoglycemic composition that untoward reaction is low, and the preparation method of said composition and the application in treatment diabetes medicament thereof are provided, said composition has significant hypoglycemic activity, and preparation is efficient, equipment investment is few, be easy to suitability for industrialized production.
In order to realize above object, the invention provides a kind of compositions with the effect for the treatment of diabetes, it is made up of the raw material of following parts by weight: snow chrysanthemum 1 to 12 part, 1 to 12 part, Folium Mori.
Preferably, the above-described compositions with the effect for the treatment of diabetes, it is made up of the raw material of following parts by weight: snow chrysanthemum 1 to 6 part, 1 to 6 part, Folium Mori.
As more excellent scheme, the above-described compositions with the effect for the treatment of diabetes, it is made up of the raw material of following parts by weight: snow chrysanthemum 1 part, 3 parts, Folium Mori.
As more excellent scheme, the above-described compositions moderate snow chrysanthemum extract with the effect for the treatment of diabetes prepares by the following method:
1) get snow chrysanthemum, extract with moisture alcoholic solution, concentration of liquid medicine, filter to obtain snow chrysanthemum concentrated solution, reclaim described ethanol simultaneously;
2) by the macroporous adsorbent resin of described snow chrysanthemum concentrated solution by the good nonpolar or low pole of pretreatment;
3) wash described macroporous adsorbent resin with water, then use elution, collect eluent, concentrated, dry, obtain described snow chrysanthemum extract, reclaim described eluent simultaneously.
In described compositions, Folium Mori extract prepares by the following method:
1) get Folium Mori, chopping, extract with moisture alcoholic solution, medicinal residues are for subsequent use, and concentration of liquid medicine obtains Folium Mori alcohol extraction concentrated solution, reclaims described ethanol simultaneously;
2) by described medicinal residues, with water extraction, discard medicinal residues, concentration of liquid medicine obtains Folium Mori water extraction concentrated solution;
3) described Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged, filter to obtain Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution by the good cation exchange resin of pretreatment;
5) wash described cation exchange resin with water, water section is for subsequent use, then uses elution, collects eluent, concentrated, dries, obtains Folium Mori alkaloid class extract, reclaim described eluent simultaneously;
6) by described water section again by the macroporous adsorbent resin of the good middle polarity of pretreatment or low pole;
7) wash described macroporous adsorbent resin with water, then use elution, collect eluent, concentrated, dry, obtain described mulberry leaf polyphenol class extract, reclaim described eluent simultaneously;
8) described Folium Mori alkaloid class extract is merged and mulberry leaf polyphenol class extract obtains described Folium Mori extract.
The preparation method with the compositions for the treatment of diabetes effect of the present invention, is characterized in that, comprise the following steps:
1) get snow chrysanthemum, add the alcoholic solution of 30% ~ 80% of 5 ~ 15 times amount, soak 10 ~ 60min, extract 1 ~ 5 time, each 1 ~ 6h, filter, merging filtrate, reclaim ethanol, filtrate is concentrated into 0.1 ~ 2.0g crude drug/ml, and sucking filtration must avenge chrysanthemum concentrated solution.
2) by described snow chrysanthemum concentrated solution with the flow velocity of 0.5 ~ 5BV/h by the good polystyrene type of pretreatment or crosslink propylene nitrilic type is nonpolar or the macroporous adsorbent resin of low pole, applied sample amount is 0.1 ~ 2.0g crude drug/ml wet resin, with 1 ~ 5BV distilled water with the flow velocity remove impurity of 0.5 ~ 8BV/h, eluting is carried out with the volume flow of 0.5 ~ 8BV/h again with 30% ~ 80% alcoholic solution of 1 ~ 12BV, collect eluent, concentrated, dry, obtain described snow chrysanthemum extract, reclaim eluent simultaneously;
3) Folium Mori are got, chopping, first add the alcoholic solution of 30% ~ 80% of 5 ~ 20 times amount, soak 10 ~ 60min, extract 1 ~ 5 time, each 1 ~ 6h, filter, merging filtrate, reclaim ethanol, concentrate and obtain Folium Mori alcohol extraction concentrated solution, the water that medicinal residues add 5 ~ 30 times amount extracts 1 ~ 5 time again, each 1 ~ 6h, filter, merging filtrate, concentrate and obtain Folium Mori water extraction concentrated solution, described Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged and be concentrated into 0.1 ~ 2.0g crude drug/ml, sucking filtration obtains Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution with the flow velocity of 0.5 ~ 5BV/h by the good functionalized polystyrene type highly acid of pretreatment or weakly acidic cation exchange resin, applied sample amount is 0.1 ~ 2.0g crude drug/ml wet resin, with 1 ~ 5BV distilled water with the flow velocity eluting of 0.5 ~ 8BV/h, collect loading effluent and water elution part for subsequent use, eluting is carried out with the volume flow of 0.5 ~ 8BV/h again with the ammonia spirit of 0% ~ 50% ethanol-0.5% ~ 5% of 1 ~ 25BV, collect eluent, concentrated, dry, obtain Folium Mori alkaloid class extract, reclaim eluent simultaneously, by after described loading effluent and the mixing of water elution part with the macroporous adsorbent resin of the flow velocity of 0.5 ~ 5BV/h by the good polystyrene type of pretreatment or crosslink propylene nitrilic type middle polarity or low pole, applied sample amount is 0.1 ~ 2.0g crude drug/ml wet resin, with 1 ~ 5BV distilled water with the flow velocity remove impurity of 0.5 ~ 8BV/h, eluting is carried out with the volume flow of 0.5 ~ 8BV/h again with 30% ~ 80% alcoholic solution of 1 ~ 12BV, collect eluent, concentrated, dry, obtain mulberry leaf polyphenol class extract, reclaim eluent simultaneously, Folium Mori alkaloid class extract is mixed with Polyphenols extract, obtain described Folium Mori extract,
5) by the weight fraction of described raw material, get step 2 respectively) and step 4) after each raw extract of obtaining mixes by 1:1 ~ 1:9, then be prepared into all acceptable dosage forms on the pharmaceuticss such as capsule, granule, tablet, pill, oral liquid with pharmaceutically acceptable carrier.
The preparation method with the compositions for the treatment of diabetes effect of the present invention, is characterized in that: step 1) and step 3) described in extracting method be reflux extraction, decocting method, percolation, infusion process or ultrasonic extraction.
Composition material proportioning of the present invention, it is characterized in that, based on traditional Chinese medicine theory, adopt determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, and by the best proportion compatibility of great many of experiments determination Folium Mori with snow chrysanthemum, and prepared the extract of snow chrysanthemum and Folium Mori by scientific and rational extracting mode and resin purification technique, and after the two compatible combination, the hypoglycemic activity there is Synergistic, bringing out the best in each other.
The compositions with the effect for the treatment of diabetes of the present invention, it is characterized in that, by the weight fraction of described raw material, described each raw extract and pharmaceutically acceptable carrier are prepared into all acceptable dosage forms on the pharmaceuticss such as capsule, granule, tablet, pill, oral liquid.
The application of compositions in preparation control diabetes medicament with the effect for the treatment of diabetes provided by the invention.
Beneficial effect: the present invention is based on Chinese medical theory, adopt the theory of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs to carry out Chinese prescription screening, compositions proportioning is scientific and reasonable, the hypoglycemic activity have Synergistic, bringing out the best in each other.Result of study shows, compositions provided by the invention has the Comprehensive Treatment effect of too many levels, Mutiple Targets, high effect nontoxic, effectively regulates and controls body carbohydrate metabolism, reduce blood sugar level in body, improve resistance to sugar amount, repair the biological agent of B cell, improve insulin resistant.The extract of each raw material provided by the invention can be prepared into suitable dosage form with pharmaceutically acceptable variety carrier, taking convenience clinically in addition, and oral dose is little, and both are all tea-drinking among the people, long-term taking, safety non-toxic.The preparation method of compositions provided by the invention simultaneously, technological design rationally, the effective component extracting rate of transform is high, content is high, workable, is applicable to industrialized great production.
Accompanying drawing explanation
Below in conjunction with drawings and the embodiments, the present invention is further detailed explanation:
The blank group of Fig. 1 pancreas HE dyeing pathological section: A.; B. model group; C. metformin group; D. Folium Mori group; E. chrysanthemum group is avenged; F. compatibility A group; G. compatibility B group; H. compatibility C group.
Detailed description of the invention
The above-mentioned feature that the present invention mentions, or the feature that embodiment is mentioned can combination in any.All features that this case description discloses and any composition forms use, each feature disclosed in description, anyly can be provided identical, alternative features that is impartial or similar object replaced.Therefore apart from special instruction, the feature disclosed is only general example that is impartial or similar features.
Below in conjunction with specific embodiment, set forth the present invention further.Should be understood that these embodiments are only not used in for illustration of the present invention to limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, the usually conveniently conditioned disjunction condition of advising according to manufacturer.Unless otherwise stated, all percentage ratio and number are by weight.
Unless otherwise defined, all specialties used in literary composition and scientific words and one skilled in the art the same meaning be familiar with.In addition, any method similar or impartial to described content and material all can be applicable in the inventive method.Better implementation method described in literary composition and material only present a demonstration use.
Embodiment 1
1) get snow chrysanthemum 1 part, add the alcoholic solution of 60% of 12 times amount, soak 30min, reflux, extract, 2 times, each 2h, filter, merging filtrate, decompression recycling ethanol, filtrate is concentrated into 0.5g crude drug/ml, and sucking filtration must avenge chrysanthemum concentrated solution.
2) by above-mentioned snow chrysanthemum concentrated solution with the flow velocity of 2BV/h by the good AB-8 type macroporous adsorbent resin of pretreatment, applied sample amount is 0.8g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, eluting is carried out with the volume flow of 2BV/h again with 75% alcoholic solution of 7BV, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain snow chrysanthemum extract, reclaim eluent simultaneously;
3) get 3 parts, Folium Mori, chopping, first adds the alcoholic solution of 60% of 20 times amount, soak 30min, reflux, extract, 1.5h, filter, decompression recycling ethanol, concentrate and obtain Folium Mori alcohol extraction concentrated solution, medicinal residues add the water of 30,25 times amount successively, reflux, extract, 2 times, the time is respectively 1,0.5h, filters, merging filtrate, concentrating under reduced pressure obtains Folium Mori water extraction concentrated solution, and above-mentioned Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged and be concentrated into 0.5g crude drug/ml, sucking filtration obtains Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution with the flow velocity of 2BV/h by the good 001*7 type storng-acid cation exchange resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity eluting of 3BV/h, collect water section for subsequent use, then use the ammonia spirit eluting of 25% ethanol-5% of 20BV, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 60 DEG C of drying under reduced pressure, obtain Folium Mori alkaloid class extract, reclaim eluent simultaneously; By above-mentioned water section with the flow velocity of 2BV/h by the good HPD-826 type macroporous adsorbent resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, then use 7BV 75% alcoholic solution eluting, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain mulberry leaf polyphenol class extract, reclaim eluent simultaneously, Folium Mori alkaloid class extract is mixed with Polyphenols extract, obtains Folium Mori extract;
5) respectively by step 2) and step 4) after each raw extract mixing that obtains, then mix homogeneously with appropriate amount of starch, dextrin, granulate, dry, then incapsulate and make capsule.
Embodiment 2
1) get snow chrysanthemum 1 part, add the alcoholic solution of 60% of 12 times amount, soak 30min, reflux, extract, 2 times, each 2h, filter, merging filtrate, decompression recycling ethanol, filtrate is concentrated into 0.5g crude drug/ml, and sucking filtration must avenge chrysanthemum concentrated solution.
2) by above-mentioned snow chrysanthemum concentrated solution with the flow velocity of 2BV/h by the good AB-8 type macroporous adsorbent resin of pretreatment, applied sample amount is 0.8g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, eluting is carried out with the volume flow of 2BV/h again with 75% alcoholic solution of 7BV, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain snow chrysanthemum extract, reclaim eluent simultaneously;
3) get 3 parts, Folium Mori, chopping, first adds the alcoholic solution of 60% of 20 times amount, soak 30min, reflux, extract, 1.5h, filter, decompression recycling ethanol, concentrate and obtain Folium Mori alcohol extraction concentrated solution, medicinal residues add the water of 30,25 times amount successively, reflux, extract, 2 times, the time is respectively 1,0.5h, filters, merging filtrate, concentrating under reduced pressure obtains Folium Mori water extraction concentrated solution, and above-mentioned Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged and be concentrated into 0.5g crude drug/ml, sucking filtration obtains Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution with the flow velocity of 2BV/h by the good 001*7 type storng-acid cation exchange resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity eluting of 3BV/h, collect water section for subsequent use, then use the ammonia spirit eluting of 25% ethanol-5% of 20BV, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 60 DEG C of drying under reduced pressure, obtain Folium Mori alkaloid class extract, reclaim eluent simultaneously; By described water section with the flow velocity of 2BV/h by the good HPD-826 type macroporous adsorbent resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, then use 7BV 75% alcoholic solution eluting, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain mulberry leaf polyphenol class extract, reclaim eluent simultaneously, Folium Mori alkaloid class extract is mixed with Polyphenols extract, obtains Folium Mori extract;
5) respectively by step 2) and step 4) after each raw extract mixing that obtains, then mix homogeneously with appropriate amount of starch, dextrin, granulate, dry, make granule.
Embodiment 3
1) get snow chrysanthemum 1 part, add the alcoholic solution of 60% of 12 times amount, soak 30min, reflux, extract, 2 times, each 2h, filter, merging filtrate, decompression recycling ethanol, filtrate is concentrated into 0.5g crude drug/ml, and sucking filtration must avenge chrysanthemum concentrated solution.
2) by above-mentioned snow chrysanthemum concentrated solution with the flow velocity of 2BV/h by the good AB-8 type macroporous adsorbent resin of pretreatment, applied sample amount is 0.8g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, eluting is carried out with the volume flow of 2BV/h again with 75% alcoholic solution of 7BV, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain snow chrysanthemum extract, reclaim eluent simultaneously;
3) get 3 parts, Folium Mori, chopping, first adds the alcoholic solution of 60% of 20 times amount, soak 30min, reflux, extract, 1.5h, filter, decompression recycling ethanol, concentrate and obtain Folium Mori alcohol extraction concentrated solution, medicinal residues add the water of 30,25 times amount successively, reflux, extract, 2 times, the time is respectively 1,0.5h, filters, merging filtrate, concentrating under reduced pressure obtains Folium Mori water extraction concentrated solution, and above-mentioned Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged and be concentrated into 0.5g crude drug/ml, sucking filtration obtains Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution with the flow velocity of 2BV/h by the good 001*7 type storng-acid cation exchange resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity eluting of 3BV/h, collect water section for subsequent use, then use the ammonia spirit eluting of 25% ethanol-5% of 20BV, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 60 DEG C of drying under reduced pressure, obtain Folium Mori alkaloid class extract, reclaim eluent simultaneously; By described water section with the flow velocity of 2BV/h by the good HPD-826 type macroporous adsorbent resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, then use 7BV 75% alcoholic solution eluting, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain mulberry leaf polyphenol class extract, reclaim eluent simultaneously, Folium Mori alkaloid class extract is mixed with Polyphenols extract, obtains Folium Mori extract;
5) respectively by step 2) and step 4) after each raw extract mixing that obtains, then mix homogeneously with appropriate amount of starch, dextrin, granulate, dry, make pill.
Embodiment 4
1) get snow chrysanthemum 1 part, add the alcoholic solution of 60% of 12 times amount, soak 30min, reflux, extract, 2 times, each 2h, filter, merging filtrate, decompression recycling ethanol, filtrate is concentrated into 0.5g crude drug/ml, and sucking filtration must avenge chrysanthemum concentrated solution.
2) by above-mentioned snow chrysanthemum concentrated solution with the flow velocity of 2BV/h by the good AB-8 type macroporous adsorbent resin of pretreatment, applied sample amount is 0.8g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, eluting is carried out with the volume flow of 2BV/h again with 75% alcoholic solution of 7BV, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain snow chrysanthemum extract, reclaim eluent simultaneously;
3) get 3 parts, Folium Mori, chopping, first adds the alcoholic solution of 60% of 20 times amount, soak 30min, reflux, extract, 1.5h, filter, decompression recycling ethanol, concentrate and obtain Folium Mori alcohol extraction concentrated solution, medicinal residues add the water of 30,25 times amount successively, reflux, extract, 2 times, the time is respectively 1,0.5h, filters, merging filtrate, concentrating under reduced pressure obtains Folium Mori water extraction concentrated solution, and above-mentioned Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged and be concentrated into 0.5g crude drug/ml, sucking filtration obtains Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution with the flow velocity of 2BV/h by the good 001*7 type storng-acid cation exchange resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity eluting of 3BV/h, collect water section for subsequent use, then use the ammonia spirit eluting of 25% ethanol-5% of 20BV, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 60 DEG C of drying under reduced pressure, obtain Folium Mori alkaloid class extract, reclaim eluent simultaneously; By described water section with the flow velocity of 2BV/h by the good HPD-826 type macroporous adsorbent resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, then use 7BV 75% alcoholic solution eluting, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain mulberry leaf polyphenol class extract, reclaim eluent simultaneously, Folium Mori alkaloid class extract is mixed with Polyphenols extract, obtains Folium Mori extract;
5) respectively by step 2) and step 4) after each raw extract mixing that obtains, then mix homogeneously with the adjuvant such as dextrin, starch, sodium carboxymethyl cellulose, magnesium stearate, granulate, dry, then tablet made by tabletting.
Embodiment 5
1) get snow chrysanthemum 1 part, add the alcoholic solution of 60% of 12 times amount, soak 30min, reflux, extract, 2 times, each 2h, filter, merging filtrate, decompression recycling ethanol, filtrate is concentrated into 0.5g crude drug/ml, and sucking filtration must avenge chrysanthemum concentrated solution.
2) by above-mentioned snow chrysanthemum concentrated solution with the flow velocity of 2BV/h by the good AB-8 type macroporous adsorbent resin of pretreatment, applied sample amount is 0.8g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, eluting is carried out with the volume flow of 2BV/h again with 75% alcoholic solution of 7BV, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain snow chrysanthemum extract, reclaim eluent simultaneously;
3) get 3 parts, Folium Mori, chopping, first adds the alcoholic solution of 60% of 20 times amount, soak 30min, reflux, extract, 1.5h, filter, decompression recycling ethanol, concentrate and obtain Folium Mori alcohol extraction concentrated solution, medicinal residues add the water of 30,25 times amount successively, reflux, extract, 2 times, the time is respectively 1,0.5h, filters, merging filtrate, concentrating under reduced pressure obtains Folium Mori water extraction concentrated solution, and above-mentioned Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged and be concentrated into 0.5g crude drug/ml, sucking filtration obtains Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution with the flow velocity of 2BV/h by the good 001*7 type storng-acid cation exchange resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity eluting of 3BV/h, collect water section for subsequent use, then use the ammonia spirit eluting of 25% ethanol-5% of 20BV, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 60 DEG C of drying under reduced pressure, obtain Folium Mori alkaloid class extract, reclaim eluent simultaneously; By described water section with the flow velocity of 2BV/h by the good HPD-826 type macroporous adsorbent resin of pretreatment, applied sample amount is 1.0g crude drug/ml wet resin, with 3BV distilled water with the flow velocity remove impurity of 3BV/h, then use 7BV 75% alcoholic solution eluting, eluting is carried out with the volume flow of 2BV/h, collect eluent, concentrating under reduced pressure, 65 DEG C of drying under reduced pressure, obtain mulberry leaf polyphenol class extract, reclaim eluent simultaneously, Folium Mori alkaloid class extract is mixed with Polyphenols extract, obtains Folium Mori extract;
5) respectively by step 2) and step 4) after each raw extract mixing that obtains, the distilled water added containing appropriate sodium carboxymethyl cellulose dissolves, and sodium benzoate is a little, and correctives is appropriate, stir evenly, filter, embedding, sterilizing, subpackage (10ml/ props up), makes oral liquid.
Embodiment 6 pharmacological experiment study
1. laboratory animal:
ICR mice, body weight 18 ~ 22g, male, provided by Shanghai Slac Experimental Animal Co., Ltd., the quality certification is numbered: 2007000558278; Laboratory animal production licence number: SCXK (Shanghai) 2012-0002.
2. by reagent:
Blank group: normal saline, 0.1ml/10g
Model group: normal saline, 0.1ml/10g
Positive drug group: metformin hydrochloride tablet, 175mg/kg
Folium Mori group: Folium Mori extract, 20g crude drug/kg;
Snow chrysanthemum group: snow chrysanthemum extract, 20g crude drug/kg;
Compatibility A group: Folium Mori extract 15g crude drug/kg+ avenges chrysanthemum extract 5g crude drug/kg;
Compatibility B group: Folium Mori extract 10g crude drug/kg+ avenges chrysanthemum extract 10g crude drug/kg;
Compatibility C group: Folium Mori extract 5g crude drug/kg+ avenges chrysanthemum extract 15g crude drug/kg;
3. method and result
3.1 impacts alloxan being caused to the fasting glucose of ICR diabetes mice model
Get 200 ICR mices, fasting (freely drinking water) is after 12 hours, by the freshly prepared alloxan normal saline solution of tail i.v. bolus (dosage is 80mg/kg), fasting 12 hours after 84 hours, blood is got in docking, measure blood glucose value by blood glucose meter, get blood glucose value >=11.1mmol/L, and there is polydipsia, the mice of polyuria symptom is diabetic mice.By blood glucose value and body weight random packet, often organize 12, be respectively: blank group; Model group; Positive drug group; Folium Mori group; Snow chrysanthemum group; Compatibility A group; Compatibility B group; Compatibility C group.By above-mentioned dosage gastric infusion, every day 1 time, within the 7th, 15 day after administration, measure its fasting blood sugar respectively.The results are shown in Table 1.15th day, mouse orbit got blood, separation of serum, measured glycated serum protein GSP, triglyceride TG, T-CHOL TCH index, the results are shown in Table 2.Another often group is randomly drawed 10 mices and is taken pancreatic tissue, and fix through 10% formalin solution, routine is drawn materials, dehydration, paraffin embedding, film-making (4 μm are thick), HE dyes, the pathological changes of observation by light microscope pancreas, mainly refers to the situation of endocrine portion islets of langerhans.The results are shown in Table 3, Fig. 1.
Table 1 causes the impact of ICR diabetes mice model blood glucose to alloxan
Note: compare with model group: * P<0.05, * * P<0.01; #P<0.05 is compared, ##P<0.01 with snow chrysanthemum group; △ P<0.05 is compared, △ △ P<0.01 with Folium Mori group
As shown in Table 1: each administration group, all significantly can reduce fasting glucose (the P < 0.05 of model mice, P<0.01), show that extraction and purification process of the present invention is science, reasonably, remain the hypoglycemic effective ingredient of Folium Mori and snow chrysanthemum preferably, wherein compatibility A group, with Folium Mori, chrysanthemum is individually dosed compares for snow, also significant difference (P < 0.05 is had, P<0.01), compatibility B group, with Folium Mori, chrysanthemum is individually dosed compares for snow, also there are differences (P < 0.05), compatibility C group, with Folium Mori, chrysanthemum is individually dosed compares for snow, there is downward trend, but there is not significant difference.This result is pointed out, and Folium Mori of the present invention are scientific and rational with snow chrysanthemum compatibility as the Combination nova for the treatment of diabetes, and formula is accurate, has the effect significantly reducing fasting glucose, serves good Synergistic object.
As shown in Table 2: each administration group, all significantly can improve GSP, TG and TSP index (P < 0.05 of diabetic mice, P<0.01), and individually dosed group and compatibility group TG and TSP index are better than positive drug group, point out Folium Mori of the present invention and snow chrysanthemum compatibility effectively can improve the biochemical indicator relevant with diabetes of diabetic mice as the Combination nova for the treatment of diabetes, part index number is better than positive drug group, and the blood sugar lowering Western medicine of having proved the present invention more classical has dominance.
From table 3, Fig. 1: this experimental diabetes pancreas major lesions is that endocrine portion islets of langerhans quantity reduces, volume reduces, shape irregularity, and edge owes neat, and islets of langerhans inner cell mostly is fusiformis, arrangement slightly closely.Medicine all has effect (the P < 0.05 significantly increasing islets of langerhans number and increase islet area, P<0.01), by effect order from high to low, be followed successively by compatibility A group, compatibility B group, compatibility C group, Folium Mori group, snow chrysanthemum group, positive drug group.This result is pointed out, and Folium Mori of the present invention are feasible with snow chrysanthemum compatibility as the Combination nova for the treatment of diabetes.
Table 2 causes the impact of ICR diabetes mice model GSP, TG, TCH to alloxan
Note: compare * p < 0.05, * * p<0.01 with model group
Table 3 mouse islets pathological change average product score value
Note: compare * p < 0.05, * * p<0.01 with model group
The present invention is based on Chinese medical theory, the research of proportioning prescription is carried out for instructing with the theory of the determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs of science, shown by above experimental result, compositions provided by the invention can regulate and control body carbohydrate metabolism effectively, reduce blood sugar level in body, improve resistance to sugar amount, repair the biological agent of B cell, improve insulin resistant, and serve good synergistic function, and the preparation method of compositions provided by the invention is reasonable in design, the effective component extracting rate of transform is high, content is high, workable, be applicable to industrialized great production, be expected to be developed to the novel medicine preventing and treating diabetes.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, under the premise without departing from the principles of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (9)
1. have a compositions for treatment diabetes effect, it is characterized in that, it is made up of the raw material of following parts by weight: snow chrysanthemum 1 ~ 12 part, 1 ~ 12 part, Folium Mori.
2. the compositions with the effect for the treatment of diabetes according to claim 1, it is characterized in that, it is made up of the raw material of following parts by weight: snow chrysanthemum 1 ~ 6 part, 1 ~ 6 part, Folium Mori.
3. the compositions with the effect for the treatment of diabetes according to claim 2, it is characterized in that, it is made up of the raw material of following parts by weight: snow chrysanthemum 1 part, 3 parts, Folium Mori.
4. the compositions with the effect for the treatment of diabetes according to any one of claims 1 to 3, it is characterized in that, described compositions moderate snow chrysanthemum extract prepares by the following method:
1) get snow chrysanthemum, extract with moisture alcoholic solution, concentration of liquid medicine, filter to obtain snow chrysanthemum concentrated solution, reclaim described ethanol simultaneously;
2) by the macroporous adsorbent resin of described snow chrysanthemum concentrated solution by the good nonpolar or low pole of pretreatment;
3) wash described macroporous adsorbent resin with water, then use elution, collect eluent, concentrated, dry, obtain described snow chrysanthemum extract, reclaim described eluent simultaneously;
In described compositions, Folium Mori extract prepares by the following method:
1) get Folium Mori, chopping, extract with moisture alcoholic solution, medicinal residues are for subsequent use, and concentration of liquid medicine obtains Folium Mori alcohol extraction concentrated solution, reclaims described ethanol simultaneously;
2) by described medicinal residues, with water extraction, discard medicinal residues, concentration of liquid medicine obtains Folium Mori water extraction concentrated solution;
3) described Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged, filter to obtain Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution by the good cation exchange resin of pretreatment;
5) wash described cation exchange resin with water, water section is for subsequent use, then uses elution, collects eluent, concentrated, dries, obtains Folium Mori alkaloid class extract, reclaim described eluent simultaneously;
6) by described water section again by the macroporous adsorbent resin of the good middle polarity of pretreatment or low pole;
7) wash described macroporous adsorbent resin with water, then use elution, collect eluent, concentrated, dry, obtain described mulberry leaf polyphenol class extract, reclaim described eluent simultaneously;
8) described Folium Mori alkaloid class extract is merged and mulberry leaf polyphenol class extract obtains described Folium Mori extract.
5. the compositions with the effect for the treatment of diabetes according to any one of claims 1 to 3, it is characterized in that, described each raw extract and pharmaceutically acceptable carrier are prepared into all acceptable dosage forms on the pharmaceuticss such as capsule, granule, tablet, pill, oral liquid.
6. the preparation method with the compositions for the treatment of diabetes effect according to any one of claims 1 to 3, is characterized in that, comprise the following steps:
1) get snow chrysanthemum, add the alcoholic solution of 30% ~ 80% of 5 ~ 15 times amount, soak 10 ~ 60min, extract 1 ~ 5 time, each 1 ~ 6h, filter, merging filtrate, reclaim ethanol, filtrate is concentrated into 0.1 ~ 2.0g crude drug/ml, and sucking filtration must avenge chrysanthemum concentrated solution;
2) by described snow chrysanthemum concentrated solution with the flow velocity of 0.5 ~ 5BV/h by the good polystyrene type of pretreatment or crosslink propylene nitrilic type is nonpolar or the macroporous adsorbent resin of low pole, applied sample amount is 0.1 ~ 2.0g crude drug/ml wet resin, with 1 ~ 5BV distilled water with the flow velocity remove impurity of 0.5 ~ 8BV/h, eluting is carried out with the volume flow of 0.5 ~ 8BV/h again with 30% ~ 80% alcoholic solution of 1 ~ 12BV, collect eluent, concentrated, dry, obtain described snow chrysanthemum extract, reclaim eluent simultaneously;
3) Folium Mori are got, chopping, add the alcoholic solution of 30% ~ 80% of 5 ~ 20 times amount, soak 10 ~ 60min, extract 1 ~ 5 time, each 1 ~ 6h, filter, merging filtrate, reclaim ethanol, concentrate and obtain Folium Mori alcohol extraction concentrated solution, the water that medicinal residues add 5 ~ 30 times amount extracts 1 ~ 5 time again, each 1 ~ 6h, filter, merging filtrate, concentrate and obtain Folium Mori water extraction concentrated solution, described Folium Mori alcohol extraction concentrated solution and water extraction concentrated solution are merged and be concentrated into 0.1 ~ 2.0g crude drug/ml, sucking filtration obtains Folium Mori concentrated solution;
4) by described Folium Mori concentrated solution with the flow velocity of 0.5 ~ 5BV/h by the good highly acid of pretreatment or weakly acidic cation exchange resin, applied sample amount is 0.1 ~ 2.0g crude drug/ml wet resin, with 1 ~ 5BV distilled water with the flow velocity eluting of 0.5 ~ 8BV/h, collect loading effluent and water elution part for subsequent use, eluting is carried out with the volume flow of 0.5 ~ 8BV/h again with the ammonia spirit of 0% ~ 50% ethanol-0.5% ~ 5% of 1 ~ 25BV, collect eluent, concentrated, dry, obtain Folium Mori alkaloid class extract, reclaim eluent simultaneously, with the macroporous adsorbent resin of the flow velocity of 0.5 ~ 5BV/h by the good polystyrene type of pretreatment or crosslink propylene nitrilic type middle polarity or low pole after described loading effluent and water elution part are mixed, applied sample amount is 0.1 ~ 2.0g crude drug/ml wet resin, with 1 ~ 5BV distilled water with the flow velocity remove impurity of 0.5 ~ 8BV/h, eluting is carried out with the volume flow of 0.5 ~ 8BV/h again with 30% ~ 80% alcoholic solution of 1 ~ 12BV, collect eluent, concentrated, dry, obtain mulberry leaf polyphenol class extract, reclaim eluent simultaneously, Folium Mori alkaloid class extract is mixed with Polyphenols extract, obtain described Folium Mori extract,
5) by the parts by weight described in any one of claims 1 to 3, get step 2 respectively) and step 4) after each raw extract of obtaining mixes by 1:1 ~ 1:9, then be prepared into all acceptable dosage forms on the pharmaceuticss such as capsule, granule, tablet, pill, oral liquid with pharmaceutically acceptable carrier.
7. the preparation method with the compositions for the treatment of diabetes effect according to claim 6, is characterized in that: step 1) and step 3) described in extracting method be reflux extraction, decocting method, percolation, infusion process or ultrasonic extraction.
8. the preparation method with the compositions for the treatment of diabetes effect according to claim 6, is characterized in that: step 4) described in highly acid or weakly acidic cation exchange resin be selected from functionalized polystyrene type highly acid or weakly acidic cation exchange resin.
9. the application of the compositions with the effect for the treatment of diabetes in preparation control diabetes medicament described in any one of claims 1 to 3.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104860871A (en) * | 2015-06-01 | 2015-08-26 | 赣州华汉生物科技有限公司 | Method of DNJ extraction and purification |
| CN106665891A (en) * | 2017-01-09 | 2017-05-17 | 中国农业大学 | Preparation and use method of snow chrysanthemum polyphenol |
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|---|---|---|---|---|
| CN102429146A (en) * | 2011-10-21 | 2012-05-02 | 陕西科技大学 | Method for producing mulberry leaf oral liquid |
| CN102726576A (en) * | 2012-07-05 | 2012-10-17 | 徐州林泉绿色食品饮料厂 | Mulberry leaf blood sugar reducing health care tea and preparation method thereof |
| CN103168871A (en) * | 2013-03-12 | 2013-06-26 | 河南科技大学 | Tea with blood sugar reducing efficacy and preparation method of tea |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102429146A (en) * | 2011-10-21 | 2012-05-02 | 陕西科技大学 | Method for producing mulberry leaf oral liquid |
| CN102726576A (en) * | 2012-07-05 | 2012-10-17 | 徐州林泉绿色食品饮料厂 | Mulberry leaf blood sugar reducing health care tea and preparation method thereof |
| CN103168871A (en) * | 2013-03-12 | 2013-06-26 | 河南科技大学 | Tea with blood sugar reducing efficacy and preparation method of tea |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104860871A (en) * | 2015-06-01 | 2015-08-26 | 赣州华汉生物科技有限公司 | Method of DNJ extraction and purification |
| CN106665891A (en) * | 2017-01-09 | 2017-05-17 | 中国农业大学 | Preparation and use method of snow chrysanthemum polyphenol |
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