CN114558051A - Chinese medicinal composition for treating diabetes and preparation method thereof - Google Patents

Chinese medicinal composition for treating diabetes and preparation method thereof Download PDF

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CN114558051A
CN114558051A CN202210246834.5A CN202210246834A CN114558051A CN 114558051 A CN114558051 A CN 114558051A CN 202210246834 A CN202210246834 A CN 202210246834A CN 114558051 A CN114558051 A CN 114558051A
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CN114558051B (en
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孙载明
孙思南
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Zhejiang Xinchang Natural Health Products Co ltd
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Beijing Ruicao Technology Co ltd
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Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof. The raw materials of the composition comprise 140 parts of balsam pear 100, 50-90 parts of mulberry leaf, 70-100 parts of American ginseng, 5-15 parts of propolis and 0.01-0.05 part of chromium picolinate. The preparation method comprises performing enzymolysis on fructus Momordicae Charantiae and radix Panacis Quinquefolii, concentrating to obtain enzymolysis solution, and filtering to obtain residue 1; then mixing the medicine residue 1 and part of mulberry leaves, extracting with alcohol, purifying and extracting with water to obtain eluent and polysaccharide; mixing the dry extract powder of the enzymolysis solution and the eluate with lecithin and sucrose ester, stirring to obtain a compound, mixing with polysaccharide, adding the rest folium Mori powder, propolis and chromium picolinate, and mixing. The composition prepared by the invention has good blood sugar reducing effect, high utilization rate of medicinal materials, no toxic or side effect on liver and kidney and good application prospect.

Description

Chinese medicinal composition for treating diabetes and preparation method thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof.
Background
Diabetes mellitus is a disease of endocrine metabolism complex characterized mainly by disorder of sugar metabolism, is caused by relative or absolute deficiency or utilization defect of insulin, and is manifested as hyperglycemia and diabetes mellitus, and is often accompanied with chronic complications of tissues and organs such as eyes, kidneys, nerves, skin, blood vessels, heart disease and the like.
The western medicines for treating diabetes mainly comprise the following medicines:
(ii) biguanides: biguanide hypoglycemic agents are drugs which play a role in reducing blood sugar mainly by inhibiting the recovery of glucose in intestinal tracts and promoting the decomposition of the glucose in tissues, thereby achieving the purpose of treating diabetes, and represent drugs such as metformin, phenformin and the like;
sulfonylureas: the hypoglycemic effect is achieved mainly by promoting the release of insulin and enhancing the sensitivity of target cells to insulin, and the representative drugs of the hypoglycemic agent have the functions of reducing blood sugar, Damekang sustained release tablets, Yueining and the like;
the glycosidase inhibitor belongs to a compound which has a hydrogen-containing pseudo-saccharide structure and can inhibit the formation of glycosidic bonds, reduces the conversion of disaccharide to monosaccharide (mainly glucose) by competitively inhibiting a-glycosidase of epithelial cells on the upper segment of the small intestine, thereby reducing postprandial hyperglycemia, relieving the stimulation of the postprandial hyperglycemia to B cells of pancreatic islets, increasing insulin sensitivity, and representing drugs such as acarbose, voglibose, miglitol and the like;
thiazolidinediones: it is activated after being combined with receptors in vivo, thereby improving insulin resistance, hyperinsulinemia and hyperglycosemia metabolism disorder of diabetic patients, and representing medicines such as pioglitazone and rosiglitazone maleate;
insulin.
The medicine has the characteristics of strong hypoglycemic effect and quick response, but often lacks the overall coordination, has obvious side effect on liver and kidney after long-term administration, and can reduce the hypoglycemic effect and generate certain drug resistance.
The traditional Chinese medicine has irreplaceable advantages for treating chronic diseases such as metabolic diseases and the like, small side effect and mild medicinal effect. The traditional Chinese medicine reduces blood sugar through multiple ways and multiple targets, relieves the damage and control of diabetes to organisms, and delays diabetic complications, and the effective components of the traditional Chinese medicine have the advantages of stable curative effect, low toxicity, less adverse reaction, convenient taking and the like, and are suitable for preventing and treating diabetes and diabetic complications.
For example, the Chinese patent application CN110755598A discloses a compound bitter gourd peptide oral medicine for activating insulin and treating diabetes and a preparation method thereof, wherein the compound bitter gourd peptide oral medicine comprises 20-30 parts of bitter gourd brachial powder, 4-6 parts of American ginseng, 10-12 parts of astragalus root, 3-5 parts of ganoderma lucidum powder, 8-10 parts of yam powder, 10-15 parts of wheat bran, 10-12 parts of guava leaf powder, 5-10 parts of onion extract, 5-10 parts of medlar, 12-15 parts of gynura procumbens extract, 1-2 parts of coix seed, 5-8 parts of konjac glucomannan, 8-10 parts of lotus leaf and 5-8 parts of xylo-oligosaccharide.
For example, chinese patent application CN113057315A discloses a health food for assisting in lowering blood sugar and a preparation method thereof, which is prepared by adopting propolis powder, bitter gourd extract, American ginseng extract, mulberry leaf extract, turmeric extract, nameenriched yeast and sunned yeast as main raw materials. The preparation process mainly comprises the steps of material mixing, sol making, pelleting, shaping, drying, pill picking, packaging and the like.
The methods have a certain blood sugar reducing effect, but the medicines are too much in taste, or the clinical allocation and the utilization of medicinal material resources are poor, the utilization rate of the medicinal materials is low, the maximum medicinal effect is not exerted, and compared with chemical medicines, the effect is to be further improved.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides the composition for reducing blood sugar, which has the advantages of good blood sugar reducing effect, high utilization rate of medicinal materials and no toxic or side effect on liver and kidney.
In order to realize the purpose of the invention, the technical scheme is as follows:
the composition for reducing blood sugar comprises, by weight, 140 parts of bitter gourd, 50-90 parts of mulberry leaf, 70-100 parts of American ginseng, 5-15 parts of propolis and 0.01-0.05 part of chromium picolinate.
The medicinal material resources and effects in the prescription of the invention are as follows:
fructus Momordicae Charantiae (Momoradica charrantia L.) is a plant of Momordica of Cucurbitaceae, and is climbing-up and soft herb with multiple branches; the stem and branch are soft. The curly hair is fine and not divergent. Bitter and cold. Clear heat and remove toxicity, improve vision. The functional components in the balsam pear include terpenes, phytosterol, steroids, peptides and the like. The insulin extracted from the balsam pear has obvious effect of reducing the blood sugar of animals, and the average ratio of the insulin to the antibody for radioimmunoassay is 100 ug/mg.
The mulberry leaf is dry leaf of mulberry of the family Moraceae, is a main food of silkworm, is also named as mulberry, vitex negundo, mulberry leaf and the like, is cold in nature, sweet and bitter in taste, has the effects of dispelling wind and heat, clearing lung and moistening dryness, and clearing liver and improving eyesight, and can treat wind and heat cold, lung heat and dry cough, dizziness and headache, and conjunctival congestion and dim-sight diseases. Folium Mori has effects of inhibiting fatty liver formation, reducing serum fat and inhibiting atherosclerosis formation. The active ingredients include DNJ, phytosterol, flavonoids, etc.
American ginseng (Panax quinquefolius) is a perennial herb of Panax of Araliaceae, namely American ginseng, which are native to Dakuibek of Canada and Wisconsin of America, Beijing Huarou and Changbai mountain of China. American ginseng, name of traditional Chinese medicine. Is root of Panax quinquefolium L. of Panax of Araliaceae. Has the effects of invigorating qi, nourishing yin, clearing away heat, and promoting fluid production. It is mainly indicated for syndrome of both qi and yin deficiency, syndrome of lung qi deficiency and lung yin deficiency, thirst due to deficiency of body fluid due to deficiency of heat disease, and diabetes. American ginseng contains various ginsenosides, various volatile components, resin, starch, saccharides, amino acids, inorganic salts, etc. Modern medical research proves that the American ginseng has the effects of resisting fatigue, aging and shock, improving thinking, improving memory, regulating endocrine, enhancing human immunity, improving cardiovascular function and the like.
Propolis is a colloidal solid with aromatic odor, which is prepared by collecting resin from plant spore or trunk, and mixing the resin with secretion of palate gland and cerulean gland. Propolis contains abundant and unique bioactive substances, such as vitamins, microelements, amino acids, polyterpenes, organic acids, flavonoids, etc., so that it has multiple functions of resisting bacteria, diminishing inflammation, relieving itching, resisting oxidation, enhancing immunity, etc.
Chromium is a trace element necessary for human bodies, and has the main function of being used as a component of glucose milk and honeysuckle and the function of restoring glucose tolerance.
The compatibility of the above medicines makes the product have good auxiliary hypoglycemic effect.
Preferably, the raw materials of the composition comprise, by weight, 130 parts of bitter gourd 110-one, 60-80 parts of mulberry leaf, 75-90 parts of American ginseng, 5-10 parts of propolis and 0.01-0.03 part of chromium picolinate.
Preferably, the raw materials of the composition comprise, by weight, 120 parts of bitter gourd 110-80 parts, 70-80 parts of mulberry leaf, 75-85 parts of American ginseng, 5-8 parts of propolis and 0.02-0.03 part of chromium picolinate.
Still another object of the present invention is to provide a method for preparing the above composition, comprising the steps of:
(1) crushing bitter gourd and American ginseng, soaking in water, performing enzymolysis, concentrating to obtain an enzymolysis solution, and filtering to obtain residue 1;
(2) mixing the residue 1 and part of folium Mori, adding ethanol, and refluxing to obtain ethanol extractive solution and residue 2; concentrating and purifying the alcohol extract to obtain eluent;
(3) adding water into the residue 2, reflux-extracting to obtain water extract, precipitating with ethanol, and drying to obtain polysaccharide;
(4) mixing the enzymolysis solution and the eluent, drying to obtain dry extract powder, and then sequentially adding ethanol, lecithin and sucrose ester and stirring to obtain a compound;
(5) mixing the compound and polysaccharide, adding the rest folium Mori powder, propolis and chromium picolinate, and mixing.
The mixed medicinal powder can be filled into capsules by a capsule filling machine, or can be prepared into granules or further prepared into tablets after wet-method or dry-method granulation.
Preferably, the capsule is prepared for convenient administration and is filled with 0# capsule.
The steps are all finished in a 10 ten thousand grade clean production workshop. The ethanol is edible alcohol, and the high-quality edible grade meets the GB10343-1989 edible alcohol standard. The package should meet the YY0057-1991 solid medicinal polyolefin plastic bottle standard.
Preferably, the enzymes used in the enzymolysis in the step (1) are cellulase and bromelain; the mass ratio of the cellulase to the bromelain is 1: 6-10.
Preferably, the temperature of the enzymolysis is 30-40 ℃, the pH of the enzymolysis is 5.5-6.5, and the time of the enzymolysis is 1-2 h.
Preferably, the part of the mulberry leaves in the step (2) is 85-90% of mulberry leaves, the ethanol is 75-88% of ethanol water solution, and the extraction time is 1-2 h.
Preferably, the purification operation in step (2) is performed by passing through XAD-6 type adsorbent resin, eluting with 10-20% ethanol, discarding, eluting with 55-75% ethanol, concentrating, passing through HP-20 type resin column, eluting with 5BV of purified water, discarding, eluting with 30-40% ethanol and 75-90% ethanol, and collecting the eluate.
Preferably, the purification operation in step (2) is performed by passing through XAD-6 type adsorbent resin, eluting with 3-5BV of 10-20% ethanol, discarding, eluting with 3-5BV of 55-75% ethanol, concentrating, passing through HP-20 type resin column, eluting with 3-5BV of purified water, discarding, eluting with 1-3BV of 30-40% ethanol and 3-5BV of 75-90% ethanol, and collecting the eluate;
preferably, the mass ratio of all the resins to the concentrated solution on the upper column is 3-5:1, the diameter-height ratio of the resin column is 1:6-10, and the flow rate of all the elutions is 0.6-0.8 ml/min.
Preferably, the alcohol precipitation in the step (3) is to add ethanol into the water extract to 70-85% ethanol, stand and precipitate, and then wash the precipitate with petroleum ether, acetone and 95% ethanol in sequence to obtain the water extract.
Preferably, the mass of the ethanol in the step (4) is 5-8 times of that of dry extract powder, and the mass ratio of the dry extract powder to the lecithin to the sucrose ester is 1:0.5-0.6: 0.1-0.2; the stirring temperature is 45-55 ℃, the stirring time is 0.5-1.5h, and the compound is obtained by decompression drying after stirring.
The invention also aims to provide the application of the composition in preparing a product for reducing blood sugar.
Compared with the prior art, the invention has the beneficial effects that:
(1) the invention adopts the compatibility of balsam pear, mulberry leaf, American ginseng, propolis and chromium picolinate, adopts scientific proportion, and achieves the effect of obviously treating hyperglycemia. Compared with the existing common chemical drugs, the traditional Chinese medicine composition has no toxic or side effect, regulates the blood sugar of a body through multiple components, multiple targets and multiple layers, has no drug resistance, and is suitable for long-term administration.
(2) The invention further researches the preparation method aiming at the problems of complex active ingredients, incomplete extraction and incomplete absorption in vivo of the composition, and not only can decompose macromolecular proteins in the enzymolysis liquid into micromolecular peptides with efficacy effect through special enzymolysis, enrich active ingredients to the maximum extent, but also can remove impurities such as tannin and the like, and improve the color and taste of the dissolved liquid medicine.
(3) The mulberry leaves are partially extracted, and partial powder is used as the medicine, and experimental research shows that the mulberry leaves and the powder can have better hypoglycemic effect and better effect than the whole extraction or the powder is used as the medicine.
(4) According to the invention, unnecessary impurities are removed through the specific macroporous adsorption resin and the elution solvent, and the weak-polarity active ingredients are enriched in a large amount. Through further research, the invention adopts two substances of lecithin and sucrose ester to carry out cross-linking compounding on the enzymatic hydrolysate and the low-polarity active ingredient, improves the water solubility and the fat solubility of the active ingredient, improves the bioavailability, enhances the blood sugar reducing effect, and exerts obvious cooperativity on the compounding of the two substances to the ingredients.
Detailed Description
The present invention will be further described with reference to the following embodiments.
Example 1:
the raw materials of the embodiment are as follows: 120 parts of balsam pear, 80 parts of mulberry leaf, 85 parts of American ginseng, 8 parts of propolis and 0.022 part of chromium picolinate.
The preparation method of this example is as follows:
(1) crushing bitter gourd and American ginseng, adding 5 times of water, soaking for 30min, adding cellulase and bromelain for enzymolysis to obtain enzymolysis liquid, and filtering to obtain residue 1;
wherein the mass ratio of the cellulase to the bromelain is 1:6, the enzymolysis temperature is 30 ℃, the enzymolysis pH is 5.5, and the enzymolysis time is 1 h.
(2) Mixing the residue 1 and 87.5% folium Mori, adding 80% ethanol, and refluxing for 2 hr to obtain ethanol extractive solution and residue 2; concentrating the ethanol extractive solution to relative density of 1.2 (at 60 deg.C), passing the concentrated solution through XAD-6 type adsorbent resin, eluting with 5BV 15% ethanol, discarding, eluting with 5BV 75% ethanol, concentrating, separating with HP-20 type resin column, eluting with 5BV purified water, discarding, eluting with 2BV 40% ethanol and 5BV 75% ethanol, and collecting eluate;
wherein the mass ratio of all the resins to the concentrated solution on the column is 5:1, the diameter-height ratio of the resin column is 1:10, and the elution flow rate is 0.8 ml/min.
(3) Reflux-extracting the residue 2 with 5 times of water to obtain water extractive solution, concentrating the water extractive solution to half, adding ethanol to 70% ethanol, standing for precipitation, washing the precipitate with 1 time of petroleum ether, acetone and 95% ethanol, and drying to obtain polysaccharide;
(4) mixing the enzymolysis solution and the eluate, drying at 60 deg.C under reduced pressure to obtain dry extract powder, sequentially adding 8 times of ethanol, lecithin and sucrose ester, stirring at 55 deg.C for 0.5h, and drying under reduced pressure to obtain the compound.
Wherein the mass ratio of the dry paste powder to the lecithin and the sucrose ester is 1:0.6: 0.2.
(5) Mixing the compound and polysaccharide, adding the rest folium Mori powder, propolis and chromium picolinate, and mixing.
Example 2:
the raw materials of the embodiment are as follows: 130 parts of balsam pear, 90 parts of mulberry leaf, 100 parts of American ginseng, 15 parts of propolis and 0.03 part of chromium picolinate.
The preparation method of this example is as follows:
(1) crushing bitter gourd and American ginseng, adding 5 times of water, soaking for 10min, adding cellulase and bromelain for enzymolysis to obtain enzymolysis liquid, and filtering to obtain residue 1;
wherein the mass ratio of the cellulase to the bromelain is 1:10, the enzymolysis temperature is 40 ℃, the enzymolysis pH is 6.5, and the enzymolysis time is 2 hours.
(2) Mixing the residue 1 and 85% folium Mori, adding 75% ethanol, refluxing for 1 hr to obtain ethanol extractive solution and residue 2; concentrating the ethanol extractive solution to relative density of 1.2 (at 60 deg.C), passing the concentrated solution through XAD-6 type adsorbent resin, eluting with 5BV of 20% ethanol, discarding, eluting with 5BV of 75% ethanol, concentrating, loading onto HP-20 type resin column, eluting with 5BV of purified water, discarding, eluting with 3BV of 30% ethanol and 5BV of 90% ethanol, and collecting eluate;
wherein the mass ratio of all the resins to the concentrated solution on the column is 3:1, the diameter-height ratio of the resin column is 1:6, and the elution flow rate is 0.6 ml/min.
(3) Reflux-extracting the residue 2 with 5 times of water to obtain water extractive solution, concentrating the water extractive solution to half, adding ethanol to 85% ethanol, standing for precipitation, washing the precipitate with 1 time of petroleum ether, acetone and 95% ethanol, and drying to obtain polysaccharide;
(4) mixing the enzymolysis solution and the eluate, drying at 60 deg.C under reduced pressure to obtain dry extract powder, sequentially adding 8 times of ethanol, lecithin and sucrose ester, stirring at 45 deg.C for 1.5 hr, and drying under reduced pressure to obtain the compound.
Wherein the mass ratio of the dry paste powder to the lecithin and the sucrose ester is 1:0.5: 0.1.
(5) Mixing the compound and polysaccharide, adding the rest folium Mori powder, propolis and chromium picolinate, and mixing.
Example 3:
the raw materials of the embodiment are as follows: 100 parts of balsam pear, 60 parts of mulberry leaf, 75 parts of American ginseng, 5 parts of propolis and 0.01 part of chromium picolinate.
The preparation method of this example is as follows:
(1) crushing bitter gourd and American ginseng, adding 5 times of water for soaking, adding cellulase and bromelain for enzymolysis to obtain enzymolysis liquid, and filtering to obtain medicine residue 1;
wherein the mass ratio of the cellulase to the bromelain is 1:8, the enzymolysis temperature is 40 ℃, the enzymolysis pH is 6.5, and the enzymolysis time is 2 hours.
(2) Mixing the residue 1 and 87.5% folium Mori, adding 80% ethanol, and refluxing for 1 hr to obtain ethanol extractive solution and residue 2; concentrating the ethanol extractive solution to relative density of 1.2 (at 60 deg.C), passing the concentrated solution through XAD-6 type adsorbent resin, eluting with 5BV 10% ethanol, discarding, eluting with 5BV 75% ethanol, concentrating, separating with HP-20 type resin column, eluting with 3BV purified water, discarding, eluting with 5BV 35% ethanol and 80% ethanol, and collecting eluate;
wherein the mass ratio of all the resins to the concentrated solution on the column is 5:1, the diameter-height ratio of the resin column is 1:10, and the elution flow rate is 0.8 ml/min.
(3) Reflux-extracting the residue 2 with 5 times of water to obtain water extractive solution, concentrating the water extractive solution to half, adding ethanol to 85% ethanol, standing for precipitation, washing the precipitate with 1 time of petroleum ether, acetone and 95% ethanol, and drying to obtain polysaccharide;
(4) mixing the enzymolysis solution and the eluate, drying at 60 deg.C under reduced pressure to obtain dry extract powder, sequentially adding 5 times of 95% ethanol, lecithin and sucrose ester, stirring at 45 deg.C for 1.5 hr, and drying under reduced pressure to obtain compound.
Wherein the mass ratio of the dry paste powder to the lecithin and the sucrose ester is 1:0.6: 0.1.
(5) Mixing the compound and polysaccharide, adding the rest folium Mori powder, propolis and chromium picolinate, and mixing.
Comparative example 1
The difference between the comparative example and the example 1 is that the raw material proportion is different; the method specifically comprises the following steps: 80 parts of balsam pear, 120 parts of mulberry leaf, 65 parts of American ginseng, 28 parts of propolis and 0.022 part of chromium picolinate. Otherwise refer to example 1.
Comparative example 2
The comparative example differs from example 1 in that the preparation method is different, specifically, bromelain in step (1) is replaced by papain, and the rest is the same as example 1.
Comparative example 3
The present comparative example differs from example 1 in that the preparation method is different, specifically, lecithin is removed in step (4); the mass ratio of the dry paste powder to the sucrose ester is 1: 0.8.
Comparative example 4
The comparative example differs from example 1 in that the preparation method is different, specifically, sucrose ester in step (4) is removed; the mass ratio of the dry paste powder to the lecithin is 1: 0.8.
Comparative example 5
This comparative example differs from example 1 in the type of resin used for purification in the preparation process. The method specifically comprises the following steps: passing the concentrated solution through D101 type adsorbent resin, eluting with 5BV 15% ethanol, discarding, eluting with 5BV 75% ethanol, concentrating, passing through AB-8 type resin column, eluting with 5BV purified water, discarding, eluting with 2BV 40% ethanol and 5BV 75% ethanol, and collecting the eluate. The rest corresponds to example 1.
Test example 1 human body test eating test
1.1 subject selection
Inclusion criteria were: the patient is 18-65 years old, and the patient is an adult type 2 diabetes mellitus patient who is stable after diet control or oral hypoglycemic drug treatment, does not need to change the variety and dosage of the drug and only takes a maintenance dose according to the diabetes diagnosis standard established by the international diabetes association of 1997, meets the above conditions and participates voluntarily and ensures that the coordinators can be included in the test.
Subject exclusion criteria:
(1) patients with type 1 diabetes (insulin-dependent);
(2) the B-ultrasonic examination, the chest X-ray examination and the electrocardiogram examination have serious complications such as serious gravity center, liver and kidney and serious intestinal diseases; or patients with other serious primary diseases, psychosis patients;
(3) those with diabetes, ketoacidosis and infections in the last month; those taking glucocorticoids and often other blood glucose affecting medications;
(4) taking articles related to the tested function in a short time affects the result judger;
(5) if the test sample is not suitable for inclusion and is not eaten according to the regulation, the efficacy or the safety is not judged to be affected by the incomplete data.
1.2 Experimental design and grouping
The test adopts double-blind random grouping, and two comparison designs between groups and the test itself. 166 patients with type 2 diabetes were selected according to the above criteria and were randomly divided into 56 patients of example 1, 55 patients of control group and 55 patients of positive group according to blood sugar, blood lipid level, sex, age, course of disease, and kinds of medication (sulfonylureas and bigua). The composition of example 1 was administered 3 times a day, 3g each time, placebo was administered to the control group, the original drug metformin or sulfonylurea was administered to the positive group according to the instructions, metformin was administered before the treatment, and after one month, the change of clinical symptoms was observed and the number of effective persons was counted.
1.3 clinical observations
After the test, 5 subjects in the example group were screened out because they could not judge the effect, and 4 subjects in the control group were screened out because they took the test article intermittently. Finally, 51 examples of the effective test population group, 51 controls and 55 positive groups.
(1) And (4) observation indexes are as follows:
symptom observation, inquiring the medical history in detail, knowing the diet and activity of the patient, observing the clinical symptoms such as polydipsia, polyphagia, hypodynamia and the like, counting the integral value before and after the test eating according to the degree of symptoms (3 scores of severe, 2 scores of moderate and 1 time of mild), and observing the symptom improvement rate according to the improvement of the main symptoms (2 scores of the improvement of each symptom are obvious, 1 score of the improvement is effective). The results are shown in tables 1 to 3 below.
TABLE 1 clinical symptom score statistics
Group of Number of examples Before tasting After eating trial
Control group 51 5.88±3.84 5.84±4.36
EXAMPLE 1 group 51 5.82±3.37 2.90±2.27*#
Positive group 55 5.56±3.51 3.78±1.04*#
Note:*comparing p with p before test feeding is less than 0.05; comparison of # with control p < 0.05.
TABLE 2 improvement of clinical symptoms
Figure BDA0003545370470000081
(2) And (4) judging a result:
effective, the basic symptoms are obviously improved, and the fasting blood sugar or the blood sugar 2h after meal is reduced by more than 10 percent compared with the blood sugar before the test.
The basic symptom is not obviously improved, and the fasting blood sugar or the blood sugar after 2 hours after meal is reduced by less than 10 percent compared with the blood sugar before the test
TABLE 3 comparison of efficacy of clinical observations
Group of Number of examples Is effective Invalidation
Control group 51 10 41
EXAMPLE 1 group 51 45 6
Positive group 55 42 13
Test example 2 animal test for lowering blood sugar
2.1 establishment of hyperglycemic animal models
The weight of a clean-grade Kunming breeder mouse provided by an experimental animal farm of animal science and technology institute of university of Hunan agriculture is 24g-28g, and the production license number of the experimental animal is SCXK (Xiang) 2003-0003.
After fasting for 24 hours, mice were injected with alloxan (36mg/kg · bw) in tail vein, after 5 days, they were fasted for 5 hours, and blood glucose values were measured, and blood glucose values of 10-25nmol/L were determined for the animals successful in the hyperglycemic model, and the animals successful in the hyperglycemic model were selected and randomly divided into 11 groups of examples 1-3, comparative examples 1-5, blank group, model group and positive group, and 10 animals were each group. The blank control group and the model control group are respectively given with equal amount of distilled water; the positive control group was administered metformin hydrochloride at 130mg/kg, and the remaining groups were each administered with the composition prepared in the corresponding group at a dose of 1.2g/kg · bw for 2 weeks.
Fasting blood glucose values were measured at 5 hours of fasting, and blood glucose values and percent blood glucose reductions were compared for each group of animals. Percent of blood glucose decrease (blood glucose value before experiment-blood glucose value after experiment)/blood glucose value before experiment x 100%.
The experimental data were statistically processed with SPSS13.0 software, the blood glucose values were expressed as mean. + -. standard deviation, and the comparisons between groups were performed using t-test.
2.2 results of the experiment
The results of blood glucose before and after each group are shown in Table 4.
TABLE 4 Effect of compositions on fasting plasma glucose
Figure BDA0003545370470000091
Figure BDA0003545370470000101
Note: in comparison with the set of models,*p is less than 0.05; in comparison with the group of example 1,#p is less than 0.05; compared with the positive group, the test results show that,P<0.05。
the above detailed description is specific to one possible embodiment of the present invention, and the embodiment is not intended to limit the scope of the present invention, and all equivalent implementations or modifications without departing from the scope of the present invention should be included in the technical scope of the present invention.

Claims (10)

1. The composition for reducing blood sugar is characterized by comprising the following raw materials in parts by weight: 100 portions of balsam pear 140 portions, 50 portions to 90 portions of mulberry leaf, 70 portions to 100 portions of American ginseng, 5 portions to 15 portions of propolis and 0.01 portion to 0.05 portion of chromium picolinate.
2. The composition according to claim 1, wherein the raw materials of the composition comprise the following components in parts by weight: 130 parts of bitter gourd, 60-80 parts of mulberry leaf, 75-90 parts of American ginseng, 5-10 parts of propolis and 0.01-0.03 part of chromium picolinate.
3. The composition according to claim 1, wherein the raw materials of the composition comprise the following components in parts by weight: 120 parts of bitter gourd, 70-80 parts of mulberry leaf, 75-85 parts of American ginseng, 5-8 parts of propolis and 0.02-0.03 part of chromium picolinate.
4. A method of preparing a composition according to any one of claims 1 to 3, comprising the steps of:
(1) crushing bitter gourd and American ginseng, soaking in water, performing enzymolysis, concentrating to obtain an enzymolysis solution, and filtering to obtain residue 1;
(2) mixing the residue 1 and part of folium Mori, adding ethanol, and refluxing to obtain ethanol extractive solution and residue 2; concentrating and purifying the alcohol extract to obtain an eluent;
(3) adding water into the residue 2, reflux-extracting to obtain water extract, precipitating with ethanol, and drying to obtain polysaccharide;
(4) mixing the enzymolysis solution and the eluent, drying to obtain dry extract powder, and then sequentially adding ethanol, lecithin and sucrose ester and stirring to obtain a compound;
(5) mixing the compound and polysaccharide, adding the rest folium Mori powder, propolis and chromium picolinate, and mixing.
5. The method according to claim 4, wherein the enzymes used in the enzymatic hydrolysis in step (1) are cellulase and bromelain; the mass ratio of the cellulase to the bromelain is 1: 6-10.
6. The preparation method according to claim 4, wherein the temperature of the enzymolysis in the step (1) is 30-40 ℃, the pH of the enzymolysis is 5.5-6.5, and the enzymolysis time is 1-2 h; in the step (2), the part of mulberry leaves is 85-90% of mulberry leaves, and the ethanol is 75-88% of ethanol water solution.
7. The process according to claim 4, wherein the purification operation in the step (2) is carried out by passing through XAD-6 type adsorbent resin, eluting with 3-5BV of 10-20% ethanol, discarding, eluting with 3-5BV of 55-75% ethanol, concentrating, passing through HP-20 type resin column, eluting with 3-5BV of purified water, discarding, eluting with 1-3BV of 30-40% ethanol, eluting with 3-5BV of 75-90% ethanol, and collecting the eluate; the mass ratio of the resin to the concentrated solution on the column is 3-5:1, the diameter-height ratio of the resin column is 1:6-10, and the flow rate of all elutions is 0.6-0.8 ml/min.
8. The preparation method according to claim 4, wherein the alcohol precipitation in the step (3) is that the water extract is added with ethanol until the ethanol concentration is 70-85%, then the mixture is kept still for precipitation, and the precipitate is washed by petroleum ether, acetone and 95% ethanol in sequence.
9. The preparation method according to claim 4, wherein the mass of the ethanol in step (4) is 5 to 8 times that of the dry extract powder, and the mass ratio of the dry extract powder to the lecithin to the sucrose ester is 1:0.5 to 0.6:0.1 to 0.2; the stirring temperature is 45-55 ℃, the stirring time is 0.5-1.5h, and the compound is obtained by decompression drying after stirring.
10. Use of a composition according to any one of claims 1 to 3 for the preparation of a product for the treatment of hyperglycemia.
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CN104147132A (en) * 2014-08-20 2014-11-19 哈尔滨顺亿堂医药生物科技开发有限公司 Soft gel capable of reducing blood sugar and adjusting insulin secretion and production method
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CN101045088A (en) * 2006-03-28 2007-10-03 山西亚宝药业集团股份有限公司 Medicine composition for treating diabetes and its preparing method
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CN111939223A (en) * 2019-05-15 2020-11-17 上海天龙生物科技有限公司 Traditional Chinese medicine composition with auxiliary blood sugar reduction effect and preparation method thereof

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