CN113521186B - Hypoglycemic drug and preparation method and application thereof - Google Patents
Hypoglycemic drug and preparation method and application thereof Download PDFInfo
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- CN113521186B CN113521186B CN202110840154.1A CN202110840154A CN113521186B CN 113521186 B CN113521186 B CN 113521186B CN 202110840154 A CN202110840154 A CN 202110840154A CN 113521186 B CN113521186 B CN 113521186B
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Abstract
The invention provides a preparation method of a hypoglycemic drug, which comprises the following steps: s1, inoculating a Poria cocos mixed fungus strain into a sterilized bran solid culture medium for culture; s2, transferring the strains in the bran solid culture medium to a sterilized potato glucose liquid culture medium for culture to obtain a primary strain culture solution; s3, inoculating the cultured primary strain culture solution with the volume fraction of 5-15% into a liquid culture medium consisting of potato glucose and ginseng glucose-reducing composition, and performing shaking culture at 20-30 ℃ and 160r/min for 5-10 days to obtain poria cocos transformed ginseng fermentation liquor; the poria cocos is converted into ginseng fermentation liquor, the ginseng fermentation liquor is subjected to vacuum pressure reduction concentration and freeze drying to obtain fermentation liquor concentrate, and the fermentation liquor concentrate is used for preparing medicines or foods, so that the blood sugar of a diabetic patient can be effectively reduced, the physical constitution of hyperglycemia and the diabetic patient can be improved, meanwhile, the medicine effect of the existing blood sugar-reducing medicine can be synergically enhanced, and the side effect after the medicine is used is remarkably reduced.
Description
Technical Field
The invention relates to the technical field of blood sugar reducing products, in particular to a blood sugar reducing medicine and a preparation method and application thereof.
Background
The incidence of diabetes in countries around the world is on an increasing trend year by year. According to the data related to the world health organization, the number of diabetics in the whole world exceeds 3.82 hundred million, about 1.5 hundred million people are diabetic in China, and 3.5 hundred million people are in the early stage of the diabetic. The rehabilitation of the diabetes patient becomes one of the important contents of the medical and sanitary work in China. Diabetes is a group of metabolic diseases characterized by hyperglycemia. Hyperglycemia is caused by a defect in insulin secretion or an impaired biological action, or both. The long-standing hyperglycemia causes chronic damage and dysfunction of various tissues, particularly eyes, kidneys, heart, blood vessels and nerves. More than half of the deaths due to diabetes are caused by cardiovascular and cerebrovascular diseases, and 10% of the deaths are caused by nephropathy. Patients who have had amputations due to diabetes are 10-20 times more non-diabetic. Clinical data show that about 10 years after diabetes mellitus occurs, 30-40% of patients have at least one complication, and once the complication occurs, the drug treatment is difficult to reverse, so that the early prevention of diabetes mellitus is emphasized.
Many people believe that diabetes can only be delayed by western medicine. However, according to long-term clinical observation, many diabetic patients take various chemical western medicines at the early stage of disease onset, the blood sugar can be rapidly reduced, the reduction is temporary and ignorable, the nutrition absorption of the human body is blocked, the reduction is generated under the condition that the medicines have great harm and side effects on the organism, the treatment result faces the embarrassment that the medicine dosage is gradually increased and various medicines are continuously taken for replacement until the medicine is invalid, the pancreatic island function can not be fundamentally recovered by adopting the western medicine treatment mode, the purpose of treating the diabetes is achieved by enabling the blood sugar to stably reduce, and the toxic and side effects of the medicines are accumulated in the organism for a long time along with the long-term, the body is more harmful, and the problem of causing various complications is the first.
Disclosure of Invention
The invention aims to provide a hypoglycemic drug, a preparation method and application thereof, which can effectively reduce the blood sugar of a diabetic patient, improve the hyperglycemia and the constitution of the diabetic patient, can simultaneously cooperate and enhance the drug effect of the existing hypoglycemic drug, and obviously reduce the side effect after the drug is taken.
The embodiment of the invention is realized by the following technical scheme:
a preparation method of a hypoglycemic drug comprises the following steps:
s1, inoculating a Poria cocos mixed fungus strain into a sterilized bran solid culture medium, and culturing for 5-10 days at a constant temperature of 20-30 ℃;
s2, transferring the strains in the bran solid culture medium into a sterilized potato glucose liquid culture medium, and carrying out shake culture for 2-8d at the temperature of 20-30 ℃ under the condition of 150-200r/min to obtain a primary strain culture solution;
s3, inoculating the cultured primary strain culture solution with the volume fraction of 5-15% into a liquid culture medium consisting of potato glucose and ginseng glucose-reducing composition, and performing shaking culture at 20-30 ℃ and 160r/min for 5-10 days to obtain poria cocos transformed ginseng fermentation liquor; vacuum concentrating Poria converted Ginseng radix fermentation liquid under reduced pressure, and freeze drying to obtain fermented concentrate;
s4, when the tablet is prepared, the method further comprises the following steps: crushing the fermentation concentrate in the step S3 to prepare superfine powder; sterilizing the superfine micropowder, adding 20-30 parts by mass of cyclodextrin and 8-14 parts by mass of water, mixing uniformly, and tabletting to obtain tablets; or when prepared into capsules, further comprises: sterilizing the superfine powder, and encapsulating to obtain capsule.
A hypoglycemic agent is prepared by the preparation method of the hypoglycemic agent.
The hypoglycemic drug is applied to the preparation of hypoglycemic, hypolipidemic or hypotensive drugs. The prepared medicine can be oral liquid, tablets, capsules, powder, granules or solid granules and the like.
The hypoglycemic medicine is applied to preparing foods for reducing blood sugar, blood fat or blood pressure. The obtained food has good health promotion effect, and can be made into beverage, gel candy or wine, etc.
The application of the hypoglycemic drug in preparing drugs for enhancing the drug effect of the hypoglycemic drug.
The application of the hypoglycemic drug in preparing the drug for reducing the dosage of insulin.
The hypoglycemic drug is applied to the preparation of the drug for restoring the function of the islet beta cells.
The technical scheme of the embodiment of the invention at least has the following advantages and beneficial effects:
1. the ginseng hypoglycemic composition fermentation liquor obtained by fermenting and converting the poria cocos has the advantages that the contents of flavone and polyphenol serving as hypoglycemic active ingredients are remarkably increased, the flavor is remarkably improved, the ginseng hypoglycemic composition fermentation liquor is integrally adjusted and treated, is safe, has no toxic or side effect, has a good hypoglycemic effect, and can effectively reduce the blood sugar of a diabetic patient and improve the constitution of the hyperglycemic patient.
2. The hypoglycemic drug can be used for synergically enhancing the drug effects of the existing hypoglycemic drugs such as metformin drugs, rosiglitazone drugs, thiazolidinedione drugs, sulfonylurea hypoglycemic drugs and insulin, and improving the hypoglycemic effect.
3. The hypoglycemic drug can improve the constitution of patients with hyperglycemia and diabetes, activate and recover the function of islet beta cells.
4. The hypoglycemic drug can obviously reduce the incidence of side effects of nausea, vomiting, diarrhea and edema of a diabetic patient.
5. The preparation method of the invention combines fermentation and conversion to produce the medicine with the function of reducing blood sugar, which not only can degrade impurities such as cellulose and the like and improve the content of active ingredients for reducing blood sugar, but also can reduce the degradation of macromolecular polysaccharide in the composition to produce new polysaccharide with low molecular weight, and the low molecular weight can play a stronger role of reducing blood sugar; meanwhile, a large amount of nutrient components (such as white matter, essential amino acid for human body and the like) generated in the fermentation process can play a role in improving the physique of the diabetes patients more excellently.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and those skilled in the art can also obtain other related drawings based on the drawings without inventive efforts.
FIG. 1 is a graph of blood glucose data for the hypoglycemic effects of the compositions of the invention on mice;
FIG. 2 is a graph of fasting plasma glucose data showing the synergistic effect of the composition of the present invention with metformin and rosiglitazone in lowering plasma glucose in mice;
FIG. 3 is a graph of abdominal insulin data for the synergistic effect of the composition of the present invention with metformin and rosiglitazone in lowering blood glucose in mice;
FIG. 4 is a graph of fasting plasma glucose data showing the synergistic effect of the composition of the present invention and insulin.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
The hypoglycemic agent provided by the embodiment of the invention, the preparation method and the application thereof are specifically explained below.
A preparation method of a hypoglycemic drug comprises the following steps:
s1, inoculating a Poria cocos mixed fungus strain into a sterilized bran solid culture medium, and culturing for 5-10 days at a constant temperature of 20-30 ℃;
s2, transferring the strains in the bran solid culture medium into a sterilized potato glucose liquid culture medium, and carrying out shake culture for 2-8d at the temperature of 20-30 ℃ under the condition of 150-200r/min to obtain a primary strain culture solution; wherein the mass ratio of the bran to the water in the bran solid culture medium is 1;
s3, inoculating the cultured primary strain culture solution with the volume fraction of 5-15% into a liquid culture medium consisting of potato glucose and the ginseng hypoglycemic composition, and performing shaking culture at the temperature of 20-30 ℃ and the speed of 160r/min for 5-10 days to obtain poria cocos solid-state conversion ginseng hypoglycemic composition fermentation liquor; vacuum concentrating the fermentation liquid under reduced pressure, and freeze drying at-40 deg.C to obtain fermentation concentrate;
s4, when the compound is prepared into tablets, the compound also comprises the following steps: crushing the fermentation concentrate in the step S3 to prepare superfine powder; sterilizing the superfine micro powder, adding 20-30 parts by mass of cyclodextrin and 8-14 parts by mass of water, mixing uniformly, and tabletting to obtain tablets; or when prepared into capsules, further comprises: sterilizing the superfine powder, and encapsulating to obtain capsule.
Further, the poria cocos mixed fungus strain in the S1 comprises the following components in parts by weight: 1-10 parts of poria cocos, 1-10 parts of coprinus comatus and 1-10 parts of shiitake mushroom.
Further, the potato dextrose liquid medium in S2 includes, by weight: 150-200 parts of potatoes, 15-20 parts of glucose, 15-20 parts of agar and 1000 parts of water.
Further, the ginseng hypoglycemic composition in the S3 comprises the following components in parts by weight: 1-20 parts of ginseng, 1-10 parts of dwarf lilyturf tuber, 1-10 parts of dogwood, 1-10 parts of glossy privet fruit, 1-30 parts of mulberry leaf, 1-20 parts of tuckahoe and 1-10 parts of yam.
The pharmacological effects of the components in the composition are as follows:
tuckahoe, poria cocos: is dried sclerotium of Wolf of Poria cocos (Schw.) Cos (belonging to family Polyporaceae). Property and taste: sweet and light taste, mild nature: it is entered into heart, lung, spleen and kidney meridians; the functional indications are as follows: induce diuresis and drain dampness, invigorate spleen and calm heart. Can be used for treating dyspepsia, abdominal distention and pain, spleen deficiency, anorexia, breast pain, and female hypogalactia. The pharmacological action is as follows: (1) Pachyman has effects of reducing fasting blood glucose of rat with diabetes induced by alloxan, and Malondialdehyde (MDA) and superoxide dismutase (SOD) in liver, and has effects of reducing blood glucose and resisting lipid peroxidation; (2) The pachymic acid in Poria can target PPARG to reduce triglyceride, free fatty acid and low density lipoprotein content in blood, and simultaneously can increase high density lipoprotein concentration in blood, and sensitize peripheral tissue to insulin; (3) The strain can be used as an excellent fermentation conversion strain, can remove impurity components and improve the content of active substances. Therefore, the ginseng hypoglycemic composition is transformed by adopting a poria cocos fungus fermentation method, and the contents of flavone, polyphenol and alkaloid which are hypoglycemic active ingredients can be increased.
Coprinus comatus: belongs to the phylum Eumycota, basidiomycotina, hymenomycetes, agaricales, coprinaceae. Nature and taste: sweet and mild; meridian tropism: the stomach channel; spleen meridian; the kidney channel; the functional indications are as follows: benefiting spleen and stomach, clearing heart fire, tranquilizing mind, and treating hemorrhoid. Is effective in promoting digestion, stimulating appetite, and treating hemorrhoid. The pharmacological action is as follows: (1) Is rich in 4, 5-dihydroxy-2-methoxybenzaldehyde, and has obvious blood sugar regulating effect; the yam decoction can obviously resist the mouse blood sugar rise caused by adrenalin. (2) When 2g of coprinus comatus concentrate per kg of body weight is administered to mice, the effect of reducing blood glucose concentration after 1.5 hours is most obvious.
Mushroom: is fruiting body of Lentinus Edodes (Berk.) Sing. Nature and taste: sweet in flavor and mild in nature; meridian tropism: it enters liver and stomach meridians; the functional indications are as follows: has the effects of strengthening body resistance, tonifying deficiency, invigorating spleen, stimulating appetite, dispelling pathogenic wind, promoting eruption, eliminating phlegm, regulating qi-flowing, removing toxic substances, and resisting cancer. Can be used for treating asthenia, listlessness, anorexia, dyspepsia, anemia, rickets, hypertension, hyperlipidemia, chronic hepatitis, night sweat, urinary incontinence, edema, measles, urticaria, poisonous mushroom poisoning, and tumor. The pharmacological action is as follows: the lentinan is rich in polysaccharide, and can regulate carbohydrate metabolism, improve sugar tolerance, promote liver glycogen synthesis, and reduce liver glycogen decomposition, thereby reducing blood sugar and relieving diabetes symptoms.
Ginseng: sweet, slightly bitter and mild; it enters spleen, lung and heart meridians. Tonify primordial qi, recover pulse to stop collapse, tonify spleen and lung, promote fluid production, induce tranquilization. Can be used for treating asthenia, collapse, cold limbs, weak pulse, spleen deficiency, anorexia, lung deficiency, cough, asthma, body fluid deficiency, thirst, internal heat, asthenia, palpitation, insomnia, sexual impotence, and cold womb; heart failure, cardiogenic shock.
The ginseng root contains 0.4% of ginsenoside and a small amount of volatile oil. The main component of the oil is 0.072% of ginseng alkene. The ginsenoside includes: ginsenosides A, B, C, D, E and F. Ginsenoside A is ginsenoside Rg1. The ginsenosides B and C are hydrolyzed to produce panaxatriol sapogenin, and ginsenosides D, E and F are hydrolyzed to obtain 20-epi-panaxadiol sapogenin. The aerial parts of ginseng contain flavonoids, which are called ginsenosides, trilobatin, kaempferol, ginsenoside, beta-sitosterol and saccharides. The composition has the effect of reducing blood sugar of animals with hyperglycemia caused by epinephrine; it has effects of improving symptoms, lowering blood sugar, and promoting insulin action. Specifically, the ginseng can reduce urine sugar of the light diabetic patients by 40-50 mg%, and the blood sugar can be still maintained for more than 2 weeks after the medicine is stopped; after a patient with moderate diabetes takes ginseng, although the effect of reducing blood sugar is not obvious, most of the general conditions are improved, such as thirst and other symptoms disappear or are relieved; the dosage of insulin can be reduced after some patients take Ginseng radix.
Radix ophiopogonis: sweet, slightly bitter and slightly cold. It enters heart, lung and stomach meridians. Nourish yin, promote the production of body fluid, moisten lung and clear away heart-fire. Can be used for treating dry cough due to lung dryness. Cough due to consumption of tuberculosis, thirst due to fluid consumption, vexation, insomnia, internal heat, diabetes, constipation; and (4) pharyngeal diphtheria.
Dogwood: sour and astringent taste, slightly warm in nature. It enters liver and kidney meridians. Tonify liver and kidney, astringe and induce depletion. Can be used for treating vertigo, tinnitus, soreness of waist and knees, sexual impotence, spermatorrhea, enuresis, frequent micturition, metrorrhagia, leukorrhagia, sweating, internal heat, and diabetes.
Glossy privet fruit: sweet, bitter and cool. It enters liver and kidney meridians. Nourishing liver and kidney, improving eyesight and blackening hair. Can be used for treating vertigo, tinnitus, soreness of waist and knees, premature gray hair, and dim eyesight. Contains ligustrin, oleuropein, oleanolic acid, 4-hydroxy-B-phenethyl-B-D-glucoside, betulin, etc. 1. Reducing blood lipid, resisting arteriosclerosis, reducing serum total cholesterol, lipid peroxide, and arterial wall total cholesterol, and reducing atherosclerosis incidence. 2. Reducing blood sugar, lowering blood sugar of normal mice, preventing and treating diabetes of mice caused by alloxan, and resisting blood sugar increase of mice caused by epinephrine or glucose.
Mulberry leaf: is dried leaf of Morus alba L of Moraceae. Nature and taste: bitter and sweet in taste, slightly cold in nature; meridian tropism: entering lung and liver meridians; the functional indications are as follows: the mulberry leaf has the effects of dispelling wind and heat, clearing lung and moistening dryness, and clearing liver and improving vision. And can be used for treating wind-heat type common cold, cough due to lung heat, dizziness, headache, conjunctival congestion, and dim flower. The pharmacological action is as follows: the mulberry leaves contain 1-Deoxynojirimycin (DNJ), which is an alkaloid only existing in the mulberry leaves, the content of the alkaloid is about 100mg/100g, and the alkaloid mainly has the effects of inhibiting the decomposition of sucrase, maltase, a-glucose mannose and a-amylase, stimulating the secretion of insulin and reducing the decomposition speed of the insulin.
Chinese yam: sweet and neutral. Enter lung, spleen and kidney meridians. To invigorate the spleen, tonify the lung, strengthen the kidney and replenish vital essence. It is indicated for diarrhea due to spleen deficiency, chronic dysentery, cough due to asthenia, diabetes, spermatorrhea, leukorrhagia, and frequent micturition. Tonify spleen and stomach, promote the production of body fluid and nourish lung, tonify kidney and astringe essence. Can be used for treating spleen deficiency, anorexia, chronic diarrhea, lung deficiency, cough, asthma, spermatorrhea, leukorrhagia, frequent micturition, and diabetes due to deficiency heat. Bran-fried Chinese yam can tonify spleen and strengthen stomach. Can be used for treating spleen deficiency, anorexia, diarrhea, loose stool, and leukorrhagia.
The composition is selected for synergistic action, and the tuckahoe, the dogwood and the glossy privet fruit are matched to achieve the effects of nourishing yin and promoting the production of body fluid; the ginseng, the dwarf lilyturf tuber and the mulberry leaf are matched to achieve the effects of clearing heat and moistening dryness; the ginseng blood glucose reducing composition is rich in various blood glucose reducing components such as flavone, polyphenol, alkaloid, polysaccharide and the like, can effectively reduce the blood glucose of diabetic patients, and achieves the advantages of improving the hyperglycemia and the physique of the diabetic patients.
Due to the traditional preparation method of grinding, mixing and decocting, a large amount of impurities such as cellulose and the like can be remained, so that the effective component ratio is low, and the content of thermosensitive active components can be reduced. Therefore, the preparation method firstly selects the tuckahoe mixed fungus strain which can be used as an excellent fermentation conversion strain to culture, can degrade impurity components, improve the content of active substances, generate new hypoglycemic components, and can keep thermosensitive components by normal-temperature fermentation; the ginseng hypoglycemic composition is converted by adopting the combination of fermentation and conversion, and the poria fungus fermentation method is utilized to convert the ginseng hypoglycemic composition, so that the impurities such as cellulose and the like can be degraded, the content of hypoglycemic active ingredients (flavone, polyphenol and alkaloid) is improved, and the degradation of macromolecular polysaccharides (such as ginseng polysaccharide, ophiopogon root polysaccharide and Chinese yam polysaccharide) in the ginseng hypoglycemic formula is reduced to generate new low-molecular-weight polysaccharides, and the low molecular weights can play a stronger hypoglycemic role; meanwhile, a large amount of various nutrient components (such as white matter, essential amino acid of human body and the like) are generated in the fermentation process to improve the physique of the diabetes patient.
The ginseng hypoglycemic composition fermentation liquor prepared by the method and fermented and converted from poria cocos has the advantages of remarkably increased contents of flavone and polyphenol as hypoglycemic active ingredients, remarkably improved flavor, integral regulation, safety, no toxicity, good hypoglycemic effect, effective reduction of blood sugar of diabetics, improvement of hyperglycemia and physique of the diabetics, activation of islet beta cells, enhancement of the existing drug effects of metformin drugs, thiazolidinedione drugs, sulfonylurea hypoglycemic drugs and insulin, and reduction of the incidence rate of side effects of nausea, vomiting, diarrhea and edema.
Further, the liquid culture medium composed of the potato glucose and ginseng hypoglycemic composition in the S3 comprises, by weight: 30-50 parts of potato glucose liquid culture medium and 50-70 parts of ginseng hypoglycemic composition.
A hypoglycemic agent is prepared by the preparation method of the hypoglycemic agent. Also comprises pharmaceutically acceptable auxiliary materials, such as starch, magnesium stearate, oligosaccharide and the like, and the prepared medicine can be oral liquid, tablets, capsules, powder, granules, solid granules and the like; it can also be made into beverage, gel candy, wine, etc.
The hypoglycemic agent can be used for preparing hypoglycemic, hypolipidemic or antihypertensive agents.
The hypoglycemic medicine is applied to preparing foods for reducing blood sugar, blood fat or blood pressure.
The application of the hypoglycemic drug in enhancing the drug effect of the hypoglycemic drug.
The application of the hypoglycemic drug in reducing the dosage of insulin.
The application of the hypoglycemic drug in restoring the function of islet beta cells.
Example 1
A preparation method of a hypoglycemic drug comprises the following steps:
s1, inoculating a poria cocos mixed fungus strain into a sterilized bran solid culture medium, and culturing at a constant temperature of 20 ℃ for 5d; wherein, the tuckahoe mixed fungus strain comprises the following components in parts by weight: 1 part of poria cocos, 10 parts of coprinus comatus and 1 part of shiitake mushroom;
s2, transferring the strains in the bran solid culture medium into a sterilized potato glucose liquid culture medium, and carrying out shake culture for 2d under the conditions of 20 ℃ and 150r/min to obtain a primary strain culture solution; the potato dextrose liquid culture medium comprises the following components in parts by weight: 150 parts of potato, 15 parts of glucose, 15 parts of agar and 1000 parts of water;
s3, inoculating the cultured primary strain culture solution with the volume fraction of 5% into a liquid culture medium consisting of potato glucose and ginseng glucose-reducing composition, and performing shaking culture at 20 ℃ and 160r/min for 5d to obtain poria cocos transformed ginseng fermentation liquor; vacuum concentrating Poria converted Ginseng radix fermentation liquid under reduced pressure, and freeze drying to obtain fermented concentrate. The ginseng hypoglycemic composition comprises the following components in parts by weight: 20 parts of ginseng, 1 part of dwarf lilyturf tuber, 10 parts of dogwood, 1 part of glossy privet fruit, 1 part of mulberry leaf, 20 parts of tuckahoe and 1 part of yam;
s4, crushing the fermentation concentrate in the S3 to prepare superfine powder; and (3) sterilizing the superfine micro powder, adding 20 parts of cyclodextrin and 8 parts of water, mixing uniformly, and tabletting to obtain the tablet.
Example 2
A preparation method of a hypoglycemic drug comprises the following steps:
s1, inoculating a Poria cocos mixed fungus strain into a sterilized bran solid culture medium, and culturing for 10 days at a constant temperature of 30 ℃; wherein, the tuckahoe mixed fungus strain comprises the following components in parts by weight: 10 parts of poria cocos, 1 part of coprinus comatus and 10 parts of shiitake mushrooms;
s2, transferring the strains in the bran solid culture medium into a sterilized potato glucose liquid culture medium, and performing shake culture for 8d at the temperature of 30 ℃ and at the speed of 200r/min to obtain a primary strain culture solution; the potato dextrose liquid culture medium comprises the following components in parts by weight: 200 parts of potatoes, 20 parts of glucose, 20 parts of agar and 1000 parts of water;
s3, inoculating the cultured primary strain culture solution with the volume fraction of 15% to a liquid culture medium consisting of potato glucose and ginseng blood glucose-reducing composition, and carrying out shake culture at 20 ℃ and 160r/min for 10d to obtain poria cocos transformed ginseng fermentation liquor; vacuum concentrating Poria converted Ginseng radix fermentation liquid under reduced pressure, and freeze drying to obtain fermented concentrate. The ginseng hypoglycemic composition comprises the following components in parts by weight: 1 part of ginseng, 10 parts of dwarf lilyturf tuber, 1 part of dogwood, 10 parts of glossy privet fruit, 30 parts of mulberry leaf, 1 part of tuckahoe and 10 parts of yam;
s4, crushing the fermentation concentrate in the step S3 to prepare superfine powder; sterilizing the superfine powder, and encapsulating to obtain capsule.
Example 3
A preparation method of a hypoglycemic drug comprises the following steps:
s1, inoculating a Poria cocos mixed fungus strain into a sterilized bran solid culture medium, and culturing for 7d at a constant temperature of 25 ℃; wherein, the tuckahoe mixed fungus strain comprises the following components in parts by weight: 5 parts of poria cocos, 5 parts of coprinus comatus and 5 parts of shiitake;
s2, transferring the strains in the bran solid culture medium into a sterilized potato glucose liquid culture medium, and carrying out shake culture for 7d under the conditions of 25 ℃ and 160r/min to obtain a primary strain culture solution; the potato dextrose liquid culture medium comprises the following components in parts by weight: 170 parts of potato, 16 parts of glucose, 16 parts of agar and 1000 parts of water;
s3, inoculating the cultured primary strain culture solution with the volume fraction of 10% into a liquid culture medium consisting of potato glucose and ginseng glucose-reducing composition, and performing shaking culture for 8d at the temperature of 25 ℃ and the speed of 160r/min to obtain poria cocos transformed ginseng fermentation liquor; vacuum concentrating Poria converted Ginseng radix fermentation broth under reduced pressure, and freeze drying to obtain fermentation concentrate; the ginseng hypoglycemic composition comprises the following components in parts by weight: 10 parts of ginseng, 5 parts of dwarf lilyturf tuber, 5 parts of dogwood, 5 parts of glossy privet fruit, 15 parts of mulberry leaf, 10 parts of tuckahoe and 5 parts of yam;
s4, crushing the fermentation concentrate in the step S3 to prepare superfine powder; and (3) sterilizing the superfine micro powder, adding 30 parts by mass of cyclodextrin and 14 parts by mass of water, uniformly mixing, and tabletting to obtain the tablet.
Example 4
This example differs from the preparation method of example 3 in that: the tuckahoe mixed fungus strain in the S1 comprises the following components in parts by weight: 6.5 parts of poria cocos, 6 parts of coprinus comatus and 6 parts of shiitake; the ginseng hypoglycemic composition in the S3 comprises the following components in parts by weight: 11.5 parts of ginseng, 6.5 parts of dwarf lilyturf tuber, 6.5 parts of dogwood, 7.5 parts of glossy privet fruit, 10.5 parts of mulberry leaf, 12.5 parts of tuckahoe and 5.5 parts of yam;
example 5
The present example differs from the preparation method of example 3 in that: the tuckahoe mixed fungus strain in the S1 comprises the following components in parts by weight: 7.5 parts of poria cocos, 7 parts of coprinus comatus and 7 parts of shiitake; the ginseng hypoglycemic composition in the S3 comprises the following components in parts by weight: 13.5 parts of ginseng, 5.5 parts of dwarf lilyturf tuber, 5.5 parts of dogwood, 5.5 parts of glossy privet fruit, 5.5 parts of mulberry leaf, 12.5 parts of tuckahoe and 6.5 parts of yam;
example 6
This example differs from the preparation method of example 3 in that: the tuckahoe mixed fungus strain in the S1 comprises the following components in parts by weight: 7.5 parts of poria cocos, 5 parts of coprinus comatus and 5 parts of shiitake; the ginseng hypoglycemic composition in the S3 comprises the following components in parts by weight: 13.5 parts of ginseng, 5.5 parts of dwarf lilyturf tuber, 5.5 parts of dogwood, 5.5 parts of glossy privet fruit, 5.5 parts of mulberry leaf, 12.5 parts of tuckahoe and 6.5 parts of yam.
Experimental example 1
1.1 purpose of experiment: testing the effect of the compositions of the invention on lowering blood glucose in mice;
1.2 subjects: 120 Kunming mice, which are used for both male and female, and have the body weight of 26 +/-2 g;
1.3 Experimental methods:
the alloxan diabetes mouse model making: fasting for 24h, and injecting 180mg/kg body of reconstituted alloxan into abdominal cavity to make diabetic mouse model. After 5 days of feeding, fasting is carried out for 5 hours, tail vein blood sampling is carried out to measure blood sugar, and a mouse with blood sugar value of more than 13mmol/L is selected as an experimental diabetes model mouse and is used as a model group.
1.4 grouping and administration:
1) Grouping: experimental mice were randomly divided into 6 groups of 20 mice each, each group being:
comparative example 1 group, comparative example 2 group, example group, model group, blank control group, positive control group.
2) Administration:
comparative example 1 group: only poria cocos fermentation liquor (5 ml/(kg. D)) prepared from the poria cocos mixed fungus strain provided in the gavage example 3;
comparative example 2 group: a ginseng hypoglycemic composition prepared by only gavage the ginseng hypoglycemic composition provided in example 3 (5 g/(kg. D));
example set: intragastric administration the tablets prepared in example 3, (5 g/(kg. D));
model group and blank control group: perfusing stomach with 2ml of normal saline;
positive control group: 0.025 g/(kg. D) of intragastric rosiglitazone;
the administration is given once daily for 30 days without food intake. After 30 days, fasting was performed for 12 hours, and mice in each group were fasted for 12 hours and then were injected intraperitoneally with 2g/kg glucose, and blood glucose measurements were performed at 0, 0.5, 1, and 2 hours, respectively.
1.5 statistical methods: the significance difference between the groups was tested by t-test.
1.6 Experimental results: the blood glucose data of the mice in the groups after the experiment are shown in figure 1;
wherein, in fig. 1: v represents test P <0.05 compared to the blank control group; the symbol in the opposite side indicates that the t test P is less than 0.05 compared with the model group value; o-9633j represents a t-test P <0.05 for both the ginseng hypoglycemic formula group and the pure Poria broth group, respectively.
From the results of FIG. 1, it can be seen that: the example group has significant difference before and after taking, and the example group has significant difference compared with the control group and the model group, and the fasting blood sugar can be reduced by 37 percent after 20 days by continuously taking the medicine provided by the embodiment 3 of the invention, which shows that the medicine has significant effect of reducing the blood sugar index of mice with alloxan diabetes, and has significant curative effect compared with the blank control group and the model group. In addition, the blood sugar reducing effect of the traditional Chinese medicine provided by the embodiment 3 of the invention can reach the same level with the drug effect of the western medicine sold in the market, which shows that the traditional Chinese medicine composition has obvious curative effect on reducing blood sugar and can be used as a substitute drug of the western medicine product, and the side effect of the western medicine on human body is reduced.
Experimental example 2
2.1 purpose of experiment: testing the synergistic effect of the composition, metformin and rosiglitazone on reducing the blood sugar of mice;
2.2 subjects: 140 Kunming mice, female and male, weight 26 + -2 g.
2.3 Experimental methods:
tetraoxypyrimidine diabetic mouse modeling: after 24h of fasting, 180mg/kg body of reconstituted alloxan is injected into the abdominal cavity to make a diabetic mouse model. After 5 days of feeding, fasting for 5 hours, tail vein blood sampling and blood sugar measurement are carried out, and a mouse with the blood sugar value of more than 13mmol/L is selected as an experimental diabetes model mouse and is used as a model group.
2.4 grouping and administration:
1) Grouping: experimental mice were randomly divided into 7 groups of 20 mice each, each group being:
1 blank control group, 1 model group, example group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group.
2) Administration:
blank control and model groups: perfusing stomach with 2ml of normal saline;
example set: intragastric administration the tablets prepared in example 3, (5 g/(kg. D));
comparative example 1 group: the stomach-irrigation rosiglitazone has the stomach-irrigation dosage of 0.025 g/(kg d);
comparative example 2 group: the intragastric metformin group has intragastric administration dosage of 0.025 g/(kg d);
comparative example 3 group: gavage rosiglitazone + tablets prepared in example 3,
comparative example 4 group: gavage metformin + tablets prepared according to example 3.
The administration is continued for 30 days 1 time a day without drinking water. After 30 days, fasting for 12h, tail vein blood sampling to determine Fasting Plasma Glucose (FPG), and radioimmunoassay to determine Fasting Insulin (FINS) levels in rats.
2.5 statistical methods: significant differences between groups and within groups were tested using t-test.
Pancreatic islet β cell function index HOMA- β (HBCI): the formula is calculated as islet B cell function index =20 × FINS/(FPG-3.5). FINS is fasting insulin, FPG is fasting blood glucose.
2.6 Experimental results: fasting Plasma Glucose (FPG) data of the mice in the above groups are shown in FIG. 2 and abdominal insulin (FINS) level data are shown in FIG. 3;
wherein, in fig. 2: v represents t test P <0.05 compared to the blank control group; the symbol in the opposite side indicates that the t test P is less than 0.05 compared with the model group value; o represents that t-test P <0.05 compared to the example group (i.e., the inventive example 3 drug) for the combined administration group (i.e., the comparative example 3 group and the comparative example 4 group); Δ represents t-test P <0.05 in the combination administration group (i.e., in the comparative example 3 group and the comparative example 4 group) compared to rosiglitazone (i.e., the comparative example 1 group); 9633representing that the t-test P of the combination administration group (i.e., comparative example 3 and comparative example 4) compared to the metformin group (i.e., comparative example 2) was <0.05.
From the results of FIG. 2, it can be seen that: as can be seen from the data of the example group, after the drug of example 3 of the present invention is continuously administered for 30 days, compared with the model group, the fasting blood glucose is decreased by 14%, the fasting blood glucose is decreased by 30% when used in combination with rosiglitazone, and the fasting blood glucose is decreased by 30% when used in combination with metformin. The food for reducing blood sugar can enhance the drug effects of the existing hypoglycemic drugs such as metformin drugs and Roglitazone drugs, even thiazolidinedione drugs and sulfonylurea hypoglycemic drugs. In addition, as can be seen from the data in the above figure, the pancreatic β cell function activity of the drug of example 3 of the present invention was recovered by 39% after the drug was continuously administered for 30 days, compared with the model group, which indicates that the hypoglycemic food prepared by the present invention can recover the pancreatic β cell function and effectively improve the physical fitness of the diabetic.
Experimental example 3
3.1 Experimental purposes: testing the synergistic effect of the invention and insulin;
3.2 subjects: kunming mouse, 75, both male and female, weight 26 + -2 g.
3.3 Experimental methods:
the alloxan diabetes mouse model making: after 24h of fasting, 180mg/kg body of reconstituted alloxan is injected into the abdominal cavity to make a diabetic mouse model. After 5 days of feeding, fasting is carried out for 5 hours, tail vein blood sampling is carried out to measure blood sugar, and a mouse with blood sugar value of more than 13mmol/L is selected as an experimental diabetes model mouse.
3.4 grouping and administration:
1) Grouping: experimental mice were randomly divided into 5 groups of 15 each, only:
blank control group, model group, example group, high dose insulin group, low dose insulin, combination administration group.
2) Administration:
blank control and model groups: gavage 2ml of normal saline;
example set: intragastric administration the tablets prepared in example 3, (5 g/(kg. D));
high dose insulin group: 0.5U/ml insulin is injected subcutaneously according to 0.054ml/10 g;
low dose insulin group: 0.5U/ml insulin is injected subcutaneously at 0.027ml/10 g;
combination dosing group (example group + low dose islet combination group): gavage the tablet prepared in example 3 +0.5U/ml insulin was injected subcutaneously at 0.027ml/10 g.
The administration is continued for 30 days 1 time a day without drinking water. After 30 days, fasting for 12h, tail vein blood sampling was performed to determine Fasting Plasma Glucose (FPG).
3.5 statistical methods: significant differences between groups and within groups were tested using t-test.
3.6 Experimental results: the Fasting Plasma Glucose (FPG) data of the mice in the above groups are shown in FIG. 4;
wherein, in fig. 4: v represents t test P <0.05 compared to the blank control group; the symbol in the opposite side indicates that the t test P is less than 0.05 compared with the model group value; o,. 9633j, representing that P <0.05 was detected at the same time as t-test of the example group, low-dose insulin group, respectively, in the combined administration group.
From the results of FIG. 4, it can be seen that: the effect of the combination of the drug of example 3 of the present invention and the low dose insulin group is the same as that of the high dose insulin group and is not different from that of the normal group, indicating that the hypoglycemic agent of the present invention can significantly reduce the amount of insulin used.
Experimental example 4
4.1 purpose of experiment: the clinical effect and side effect of the invention on reducing postprandial blood sugar are tested;
4.2 subjects: type 2 diabetes volunteers were recruited to meet WHO diagnostic criteria. Eliminating infection, allergy, hypertension, heart failure, tumor and other diseases. 114 enrolled cases, 62 men and 52 women; between 30 and 65 ages, with an average of 53 years.
4.3 grouping and administration:
1) Grouping: the 114 selected cases were randomly divided into two groups, 57 cases of hypoglycemic drugs and 57 cases of blank control group.
2) Administration:
the hypoglycemic drug group comprises: each diabetic patient observed Fasting Plasma Glucose (FPG) and Postprandial Blood Glucose (PBG) for 30 days without eating the hypoglycemic food of the present invention, observed fasting plasma glucose levels in the morning and 2 hours after the lunch and dinner every day, and observed the frequency of nausea, vomiting and diarrhea. After 30 days, each diabetic took 10g of the hypoglycemic food formulated in example 4 of the present invention 2h after breakfast and 2h after lunch, and after 30 consecutive days, observed the fasting blood glucose level in the morning and 2h after lunch and the blood glucose level after dinner every day, and observed the frequency of nausea, vomiting and diarrhea.
Blank control group: normal meals were observed daily for fasting blood glucose levels in the morning and 2h after the evening meal.
4.4 Experimental methods: the blood sugar measuring method adopts a glucometer to measure. One of nausea, vomiting and diarrhea occurs, and one side effect is frequently added.
4.5 Experimental results:
the influence of taking the hypoglycemic food of the invention on the postprandial blood sugar of diabetics for 2h and the side effect is shown in the table 1 and the table 2,
TABLE 1 Effect of hypoglycemic foods of the invention on postprandial blood glucose of diabetic patients for 2 hours
From the data in table 1: the invention can reduce the postprandial blood sugar by 32 percent and the fasting blood sugar by 30 percent after being continuously taken for 30 days, and can effectively reduce the postprandial blood sugar of diabetics.
Table 2: the influence of the hypoglycemic food on the side effect of the diabetic patient
As can be seen from the data in Table 2: the invention can reduce the frequency of nausea, vomit and diarrhea by 54 percent after being continuously taken for 30 days, which shows that the hypoglycemic drug can obviously reduce the side effect after being taken and improve the use safety and comfort of users.
Experimental example 5
5.1 purpose of experiment: the physical improvement condition of the invention to the diabetes patient is tested;
5.2 subjects: type 2 diabetes volunteers were recruited to meet WHO diagnostic criteria. Eliminating infection, allergy, hypertension, heart failure, tumor and other diseases. 104 cases were selected, 54 men and 50 women; age 30-65, mean 49 years old.
5.3 grouping and administration:
1) Grouping: 104 selected cases are randomly divided into two groups, namely 52 cases of hypoglycemic drugs and 52 cases of blank control groups.
2) Administration:
hypoglycemic drug group: each diabetic did not eat the hypoglycemic food of the present invention to observe fasting blood glucose (FPG) and Postprandial Blood Glucose (PBG) for 10 days, each diabetic took 10g of the hypoglycemic food prepared in example 4 above at 2h after breakfast and at 2h after lunch, continuously took 30 days, stopped taking 10 days, and observed the fasting blood glucose level in the morning and the blood glucose level at 2h after lunch and after dinner continuously for 10 days.
Blank control group: normal meals were observed daily for fasting blood glucose levels in the morning and 2h after the evening meal.
5.4 detection method: the blood sugar measuring method adopts a glucometer to measure.
5.5 Experimental results: the influence of the hypoglycemic medicament on the postprandial blood sugar of a diabetic patient for 2h and the fasting blood sugar after taking the hypoglycemic medicament for 20 days is shown in the table 3,
TABLE 3 Effect of hypoglycemic agents of the invention on postprandial 2h blood glucose and fasting glucose in diabetic patients
As can be seen from the data in Table 3: after the hypoglycemic drug group stops taking the hypoglycemic drug for 10 days, compared with the group before taking the hypoglycemic drug, the fasting blood sugar is averagely reduced by 13 percent, the postprandial blood sugar is averagely reduced by 22 percent, and the group after taking the hypoglycemic drug has significant difference compared with a control group, and the result shows that the hypoglycemic drug can effectively improve the physique of a diabetic patient after taking the hypoglycemic drug for a long time.
Typical case data:
1. tang dynasty women, age 51 years old, married, diagnosed as type II diabetes mellitus for more than 6 years, no infection, allergy, hypertension, heart failure, tumor and other diseases, before eating the present invention, the average blood sugar after meal is 13.16mmol/L, the average fasting blood sugar is 9.98mmol/L, after using the blood sugar reducing product formulated in example 4 for 30 days continuously, the product is stopped for 10 days, the average blood sugar after meal is recovered to 10.16mmol/L, and the average fasting blood sugar is recovered to 7.56mmol/L.
2. History, age 46 years old, married, diagnosed as type II diabetes mellitus type more than 3 years old, without infection, allergy, hypertension, heart failure, tumor and other diseases, before eating the present invention, the average postprandial blood glucose is 17.66mmol/L, the average fasting blood glucose is 11.64mmol/L, after using the hypoglycemic product prepared in example 4 for 30 days continuously, the average postprandial blood glucose is recovered to 11.03mmol/L and the average fasting blood glucose is recovered to 8.27mmol/L after stopping using for 10 days.
3. Mr. old, age 63, maid, diagnosed as type II diabetes for more than 10 years, no infection, allergy, hypertension, heart failure, tumor and other diseases, before eating the present invention, the average postprandial blood glucose is 16.54mmol/L, the average fasting blood glucose is 10.97mmol/L, after using the blood glucose lowering product formulated in example 4 for 30 days continuously, the average postprandial blood glucose is restored to 9.65mmol/L and the average fasting blood glucose is restored to 7.73mmol/L after the use for 10 days.
The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes will occur to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (7)
1. The preparation method of the hypoglycemic drug is characterized by comprising the following steps:
s1, inoculating a poria cocos mixed fungus strain into a sterilized bran solid culture medium, and culturing at a constant temperature of 20-30 ℃ for 5-10 days; the poria cocos mixed fungus strain comprises the following components in parts by weight: 1-10 parts of poria cocos, 1-10 parts of coprinus comatus and 1-10 parts of shiitake;
s2, transferring the strains in the bran solid culture medium into a sterilized potato glucose liquid culture medium, and performing shake culture for 2-8 days at 20-30 ℃ under the condition of 150-200r/min to obtain a primary strain culture solution;
s3, inoculating the cultured primary strain culture solution with the volume fraction of 5-15% into a liquid culture medium consisting of potato glucose and ginseng blood glucose-reducing composition, and performing shaking culture at 20-30 ℃ and 160r/min for 5-10 days to obtain poria cocos solid-state transformed ginseng fermentation liquor; vacuum concentrating Poria solid transformed Ginseng radix fermentation liquid under reduced pressure, and freeze drying to obtain fermented concentrate; the ginseng hypoglycemic composition is composed of, by weight, 1-20 parts of ginseng, 1-10 parts of radix ophiopogonis, 1-10 parts of dogwood, 1-10 parts of glossy privet fruit, 1-30 parts of mulberry leaves, 1-20 parts of poria cocos and 1-10 parts of Chinese yam.
2. The process for producing a hypoglycemic agent according to claim 1, wherein the potato dextrose broth in S2 comprises, by weight, 150 to 200 parts of potato, 15 to 20 parts of dextrose, 15 to 20 parts of agar, and 1000 parts of water.
3. The method for preparing a hypoglycemic agent according to claim 1, wherein the liquid medium comprising the combination of potato dextrose and ginseng hypoglycemic agent in S3 comprises 30 to 50 parts by weight of potato dextrose liquid medium and 50 to 70 parts by weight of ginseng hypoglycemic agent.
4. A hypoglycemic agent characterized by being produced by the process for producing a hypoglycemic agent according to any one of claims 1 to 3.
5. The hypoglycemic agent according to claim 4, wherein the fermentation concentrate in S3 is pulverized to obtain ultrafine powder; sterilizing the superfine micropowder, adding 20-30 parts by mass of cyclodextrin and 8-14 parts by mass of water, mixing uniformly, and tabletting to obtain the tablet.
6. Use of the hypoglycemic agent according to claim 4 or 5 for the preparation of a medicament for enhancing the pharmacological effect of the hypoglycemic agent.
7. Use of the hypoglycemic agent according to claim 4 or 5 for the preparation of a medicament for reducing the amount of insulin used.
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