CN114558051B

CN114558051B - Chinese medicinal composition for treating diabetes and preparation method thereof

Info

Publication number: CN114558051B
Application number: CN202210246834.5A
Authority: CN
Inventors: 孙载明; 孙思南
Original assignee: Zhejiang Xinchang Natural Health Products Co ltd
Current assignee: Zhejiang Xinchang Natural Health Products Co ltd
Priority date: 2022-03-14
Filing date: 2022-03-14
Publication date: 2023-07-04
Anticipated expiration: 2042-03-14
Also published as: CN114558051A

Abstract

The invention belongs to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof. The raw materials of the composition comprise 100-140 parts of balsam pear, 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; mixing the residue 1 with part of folium Mori, extracting with ethanol, purifying, and extracting with water to obtain eluent and polysaccharide; mixing the dry extract powder of the enzymolysis solution and the eluent with lecithin and sucrose ester, mixing with polysaccharide, adding the rest folium Mori powder, propolis and chromium picolinate, and mixing. The composition prepared by the invention has good hypoglycemic effect, high medicinal material utilization rate, 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 in particular relates to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof.

Background

Diabetes is an endocrine and metabolic complex disease mainly characterized by disorder of glucose metabolism, and is caused by relative or absolute deficiency of insulin or utilization of deficiency, and is manifested by hyperglycemia and diabetes, and is often accompanied by chronic complications of tissues and organs such as eye, kidney, nerve, skin, blood vessel and heart diseases.

The western medicines for treating diabetes mainly comprise the following medicines:

(1) biguanides: the biguanide hypoglycemic agent plays a role in reducing blood sugar mainly by inhibiting intestinal canal to recycle glucose and promoting the decomposition of glucose in tissues, thereby achieving the purpose of treating diabetes mellitus, and representative drugs include metformin, phenformin and the like;

(2) sulfonylureas: the drug mainly plays a role in reducing blood sugar by promoting insulin release and enhancing the sensitivity of target cells to insulin, and the drug is represented by eudragit, damoxicam sustained release tablets, rui Yi Ning and the like;

(3) glycosidase inhibitors belong to a class of compounds which have a hydrogen-containing pseudosaccharide structure and can inhibit glycosidase formation, and through competitive inhibition of a-glycosidase of epithelial cells of the upper segment of small intestine, the conversion of disaccharides to monosaccharides (mainly glucose) is reduced, so that postprandial hyperglycemia is reduced, the stimulation of postprandial hyperglycemia to islet B cells is reduced, insulin sensitivity is increased, and medicines such as acarbose, voglibose, miglitol and the like are represented;

(4) thiazolidinediones: the active compound is activated after being combined with an in-vivo receptor, so that insulin resistance, hyperinsulinemia and hyperglycosemia metabolic disorder of diabetics are improved, and the representative drugs include pioglitazone and rosiglitazone maleate;

(5) insulin.

The medicine has the characteristics of strong hypoglycemic effect and quick response, but often lacks of integral coordination, has obvious side effects on liver and kidney after long-term administration, and can reduce the hypoglycemic effect and present certain drug resistance.

The traditional Chinese medicine has the irreplaceable advantages of treating metabolic chronic diseases, and the like, has small side effect and mild medicine effect. The traditional Chinese medicine has the advantages of reducing blood sugar through multiple ways and multiple targets, relieving damage of diabetes to organisms, controlling and delaying diabetic complications, along with stable curative effect, low toxicity, less adverse reaction, convenient administration and the like, and is suitable for preventing and treating diabetes and the complications thereof.

For example, the Chinese patent application CN110755598A discloses an oral medicine of compound balsam pear peptide for activating insulin and treating diabetes and a preparation method thereof, wherein the oral medicine comprises 20-30 parts of balsam pear brachial powder, 4-6 parts of American ginseng, 10-12 parts of astragalus root, 3-5 parts of lucid ganoderma 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 semen coicis, 5-8 parts of konjak glucomannan, 8-10 parts of lotus leaf and 5-8 parts of xylooligosaccharide.

For example, chinese patent application CN113057315a discloses a health food for assisting in reducing blood sugar and a preparation method thereof, which is prepared from propolis powder, balsam pear extract, american ginseng extract, mulberry leaf extract, turmeric extract, rich nameplate yeast and rich sun yeast as main raw materials. The preparation process mainly comprises the steps of proportioning, sol, pelleting, shaping, drying, pill picking, packaging and the like.

The method has a certain blood sugar reducing effect, but has the advantages of excessive medicinal flavor, poor utilization of clinical allocation and medicinal material resources, low utilization rate of medicinal materials, no maximum medicinal effect, and further improvement of the effect compared with chemical medicines.

Disclosure of Invention

Aiming at the defects existing in the prior art, the invention provides the composition for reducing blood sugar, which has good blood sugar reducing effect, high medicinal material utilization rate and no toxic or side effect on liver and kidney.

In order to achieve the purpose of the invention, the technical scheme adopted is as follows:

the composition for reducing blood sugar comprises, by weight, 100-140 parts of balsam pear, 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 prescription of the invention has the following medicinal material resources and effects:

balsam pear (Momordica charantia L.) is a plant of genus Momordica of family Cucurbitaceae, and is a annual climbing herb with weak constitution and multiple branches; the stems and branches are soft. Tendrils are fine and not divergent. Bitter and cold. Clear away heat and toxic materials, and improve eyesight. The effective components in Momordica Charantia include terpenes, phytosterols, steroids, peptides, etc. Insulin extracted from Momordica Charantia has remarkable effect in reducing blood sugar of animals, and the combined rate of insulin and antibody is 100ug/mg.

The mulberry leaf is the dry leaf of mulberry belonging to Moraceae, is the main food of silkworms, is also known as mulberry leaves, jing Sang, mulberry trees, yellow mulberry leaves and the like, has cold property, sweet and bitter taste, has the effects of dispelling wind-heat, clearing lung-heat, moistening dryness, clearing liver and improving vision, and can treat wind-heat type common cold, lung-heat dry cough, dizziness and headache, conjunctival congestion and dim flower. Mulberry leaf has effects of inhibiting fatty liver formation, reducing serum fat, and inhibiting atherosclerosis formation. The active ingredients comprise DNJ, phytosterol, flavonoid, etc.

American ginseng (Panax quinquefolius) is a perennial herb of the genus Panax of the family Araliaceae, and is also planted in areas such as American ginseng, maackia, wis., quebec, canada, and Changbai mountain, etc. American ginseng and Chinese medicine. Is root of Panax quinquefolium Panax quinquefolium L. Has effects of invigorating qi, nourishing yin, clearing heat and promoting fluid production. It is indicated for deficiency of both qi and yin, lung qi deficiency and lung yin deficiency, and thirst and diabetes due to deficiency of qi and body fluid caused by heat. The American ginseng contains various ginsenosides, various volatile components, resin, starch, saccharides, amino acid, inorganic salt and the like. Modern medical research proves that American ginseng has the functions 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 smell obtained by mixing resin collected from plant spore or trunk of bee with secretion of palate gland and wax gland. Propolis contains abundant and unique bioactive substances such as vitamins, microelements, amino acids, polyterpenes, organic acids, flavonoids, etc., so that it has various functions of resisting bacteria, diminishing inflammation, relieving itching, resisting oxidation, enhancing immunity, etc.

Chromium is a trace element essential for human body, and has the main function of recovering glucose tolerance as a constituent of glucose milk and two silvers.

The compatibility of the above herbs makes the product have good auxiliary blood sugar reducing effect.

Preferably, the raw materials of the composition comprise 110-130 parts by weight of balsam pear, 60-80 parts by weight of mulberry leaf, 75-90 parts by weight of American ginseng, 5-10 parts by weight of propolis and 0.01-0.03 part by weight of chromium picolinate.

Preferably, the raw materials of the composition comprise 110-120 parts by weight of balsam pear, 70-80 parts by weight of mulberry leaf, 75-85 parts by weight of American ginseng, 5-8 parts by weight of propolis and 0.02-0.03 part by weight of chromium picolinate.

It is still another object of the present invention to provide a method for preparing the above composition, comprising the steps of:

(1) Pulverizing fructus Momordicae Charantiae and radix Panacis Quinquefolii, soaking in water, performing enzymolysis, concentrating to obtain enzymolysis solution, and filtering to obtain residue 1;

(2) Mixing the residue 1 with part of folium Mori, and refluxing with ethanol to obtain ethanol extractive solution and residue 2; concentrating and purifying the alcohol extract to obtain eluent;

(3) Reflux extracting the residue 2 with water to obtain water extractive solution, precipitating with ethanol, and drying to obtain polysaccharide;

(4) Mixing and drying the enzymolysis solution and the eluent to obtain dry paste powder, and then sequentially adding ethanol, lecithin and sucrose ester, and stirring to obtain a compound;

(5) Mixing the compound with 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 tablets after wet or dry granulation.

Preferably, the capsule is prepared for convenient administration and is filled with the No. 0 capsule.

All the steps are completed in a 10-ten thousand-level clean production workshop. The ethanol is edible ethanol, has high quality and meets the edible ethanol standard of GB 10343-1989. The package should meet the standard of YY0057-1991 solid medical polyolefin plastic bottles.

Preferably, the enzymes used in the enzymolysis in step (1) are cellulases 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 enzymolysis time is 1-2h.

Preferably, in the step (2), the part of mulberry leaves is 85-90% mulberry leaves, the ethanol is 75-88% ethanol water solution, and the extraction time is 1-2h.

Preferably, the purification operation in the step (2) is carried out by passing through XAD-6 type adsorption resin, eluting with 10-20% ethanol, discarding, eluting with 55-75% ethanol, concentrating, loading on HP-20 type resin, eluting with 5BV purified water, discarding, eluting with 30-40% ethanol and 75-90% ethanol, and collecting eluate.

Preferably, the purification operation in the step (2) is carried out by passing through XAD-6 type adsorption resin, eluting with 3-5BV of 10-20% ethanol, discarding, eluting with 3-5BV of 55-75% ethanol, concentrating, loading on HP-20 type resin, 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 eluent;

preferably, the mass ratio of all the resin to the concentrated solution on the upper column is 3-5:1, the diameter-to-height ratio of the resin column is 1:6-10, and the flow rate of all the elution is 0.6-0.8ml/min.

Preferably, in the step (3), the alcohol precipitation is carried out by adding ethanol into water extract until 70-85% ethanol, standing for precipitation, washing precipitate with petroleum ether, acetone and 95% ethanol in sequence, and obtaining water extract.

Preferably, the mass of the ethanol in the step (4) is 5-8 times of that of the dry paste powder, and the mass ratio of the dry paste powder to lecithin and sucrose ester is 1:0.5-0.6:0.1-0.2; the temperature of stirring is 45-55 ℃, the stirring time is 0.5-1.5h, and the compound is obtained by drying under reduced pressure after stirring.

It is also an object of the present invention to provide the use of the above composition for the preparation of a product for the treatment of hypoglycaemia.

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, and adopts scientific proportion, thereby achieving the effect of obviously treating hyperglycemia. Compared with the existing common chemical medicine, the traditional Chinese medicine composition has no toxic or side effect, regulates the blood sugar of organisms through multiple components, multiple targets and multiple layers, has no drug resistance, and is suitable for long-term administration.

(2) Aiming at the problems of complex medicinal components, incomplete extraction and incomplete in vivo absorption of the composition, the invention further researches the preparation method, and through special enzymolysis, not only can macromolecular proteins in enzymolysis liquid be decomposed into small molecular peptides with efficacy, active components are enriched to the maximum extent, but also impurities such as tannins can be removed, and the color and taste of the liquid medicine after dissolution are improved.

(3) According to the invention, mulberry leaves are partially extracted and partial powder is used as a medicine, and experimental researches show that the mulberry leaves and the powder have better blood glucose reducing effect, and the effect is better than that of the whole extraction or the powder is used as a medicine.

(4) The invention removes unnecessary impurities through specific macroporous adsorption resin and eluting solvent, enriches a large amount of weak polar active ingredients, and discovers that partial components in the extracted composition have poor water solubility and the drug effect is obviously reduced after insoluble substances are removed on the basis of earlier research. Through further researches, the invention adopts two substances of lecithin and sucrose ester to carry out crosslinking compounding on enzymolysis liquid and weak polar active ingredients, improves the water solubility and fat solubility of the active ingredients, improves the bioavailability, enhances the hypoglycemic effect, and exerts obvious synergy on the compounding of the ingredients.

Detailed Description

The invention is further described in connection with the following detailed description.

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) Pulverizing fructus Momordicae Charantiae and radix Panacis Quinquefolii, soaking in 5 times of water for 30min, adding cellulase and bromelain, performing enzymolysis to obtain enzymolysis solution, 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 1h.

(2) Mixing the residue 1 with 87.5% folium Mori, and refluxing with 80% ethanol for 2 hr to obtain ethanol extractive solution and residue 2; concentrating the ethanol extract to relative density of 1.2 (60 ℃), passing the concentrated solution through XAD-6 type adsorption resin, eluting with 5BV of 15% ethanol, discarding, eluting with 5BV of 75% ethanol, concentrating, loading on HP-20 type resin, eluting with 5BV of purified water, discarding, eluting with 2BV of 40% ethanol and 5BV of 75% ethanol, and collecting eluate;

wherein the mass ratio of all the above resins to the concentrated solution on the upper column is 5:1, the diameter-to-height ratio of the resin column is 1:10, and the eluting flow rate is 0.8ml/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 eluent, drying under reduced pressure at 60 ℃ to obtain dry paste powder, sequentially adding 8 times of ethanol, lecithin and sucrose ester, stirring at 55 ℃ for 0.5h, and drying under reduced pressure to obtain the compound.

Wherein the mass ratio of the dry paste powder to lecithin to sucrose ester is 1:0.6:0.2.

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) Pulverizing fructus Momordicae Charantiae and radix Panacis Quinquefolii, soaking in 5 times of water for 10min, adding cellulase and bromelain, performing enzymolysis to obtain enzymolysis solution, 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 with 85% folium Mori, and refluxing with 75% ethanol for 1 hr to obtain ethanol extractive solution and residue 2; concentrating the ethanol extract to relative density of 1.2 (60 ℃), passing the concentrated solution through XAD-6 type adsorption resin, eluting with 5BV of 20% ethanol, discarding, eluting with 5BV of 75% ethanol, concentrating, loading on HP-20 type resin, 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 above resins to the concentrated solution on the upper column is 3:1, the diameter-to-height ratio of the resin column is 1:6, and the eluting flow rate is 0.6ml/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 eluent, drying under reduced pressure at 60 ℃ to obtain dry paste powder, sequentially adding 8 times of ethanol, lecithin and sucrose ester, stirring at 45 ℃ for 1.5h, and drying under reduced pressure to obtain the compound.

Wherein the mass ratio of the dry paste powder to lecithin to sucrose ester is 1:0.5:0.1.

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) Pulverizing fructus Momordicae Charantiae and radix Panacis Quinquefolii, soaking in 5 times of water, adding cellulase and bromelain, performing enzymolysis to obtain enzymolysis solution, and filtering to obtain 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 with 87.5% folium Mori, and refluxing with 80% ethanol for 1 hr to obtain ethanol extractive solution and residue 2; concentrating the ethanol extract to relative density of 1.2 (60 deg.C), passing the concentrate through XAD-6 type adsorption resin, eluting with 5BV of 10% ethanol, discarding, eluting with 5BV of 75% ethanol, concentrating, loading on HP-20 type resin, eluting with 3BV of purified water, discarding, eluting with 5BV of 35% ethanol and 80% ethanol, and collecting eluate;

(4) Mixing the enzymolysis solution and the eluent, drying under reduced pressure at 60 ℃ to obtain dry paste powder, sequentially adding 5 times of 95% ethanol, lecithin and sucrose ester, stirring at 45 ℃ for 1.5h, and drying under reduced pressure to obtain the compound.

Wherein the mass ratio of the dry paste powder to lecithin to sucrose ester is 1:0.6:0.1.

Comparative example 1

The comparative example differs from example 1 in the ratio of the raw materials; the method 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. The remainder was made to the method of example 1.

Comparative example 2

This comparative example differs from example 1 in that the preparation process is different, specifically the bromelain in step (1) is replaced by papain, and the remainder is identical to example 1.

Comparative example 3

The comparative example differs from example 1 in that the preparation method is different, specifically, lecithin in step (4) is removed; the mass ratio of the dry paste powder to the sucrose ester is 1:0.8.

Comparative example 4

This comparative example differs from example 1 in that the preparation process is different, specifically, sucrose ester is removed in step (4); 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 method. The method comprises the following steps: the concentrated solution is firstly passed through D101 type adsorption resin, is eluted by 15% ethanol of 5BV, is discarded, is then eluted by 75% ethanol of 5BV, is concentrated, is then put on the AB-8 type resin, is firstly eluted by 5BV of purified water, is discarded, is then eluted by 40% ethanol of 2BV and 75% ethanol of 5BV, and is collected. The remainder was identical to example 1.

Test example 1 human test feeding test

1.1 subject selection

Inclusion criteria: the age of 18-65 years, according to the diabetes diagnosis standard established by 1997 international diabetes society, the condition is stable after the treatment of diet control or oral hypoglycemic agent is selected, the drug variety and dosage are not required to be replaced, and only the adult type 2 diabetes patient with the maintenance quantity is taken, and the patient meets the conditions and voluntarily participates in and ensures that the fitter can be included in the test.

Subject exclusion criteria:

(1) Type 1 diabetes (insulin dependent);

(2) Complications such as severe barycenter, liver, kidney and the like exist in B ultrasonic examination, chest radiography examination and electrocardiographic examination, and severe intestinal diseases exist; or patients with other serious primary diseases, mental patients;

(3) People with diabetes, ketoacidosis and infection in recent month; those taking glucocorticoids and often other drugs that affect blood glucose;

(4) Taking items related to the tested function in a short period of time affects the outcome judgment person;

(5) If the inclusion mark is not met, the tested sample is not eaten according to the regulation, and the efficacy or the data is not fully affected, or the safety is judged.

1.2 Experimental design and grouping

The test adopts double-blind random grouping and two control designs between groups and self. 166 cases of type 2 diabetics were selected according to the above criteria, and were randomly classified into 56 persons in example 1, 55 persons in control group and 55 persons in positive group according to blood sugar, blood lipid level, sex, age, course of disease, type of administration (sulfonylurea and biguanide). The composition of example 1 was administered 3 times per day, 3g each time, the control group was administered placebo, the positive group was administered the original drug metformin or sulfonylurea according to the instructions, the previously untreated group was administered metformin, and after one month, the change in clinical symptoms was observed and the number of significant persons was counted.

1.3 clinical observations

After the test, 5 subjects in the example group were screened for the effect of the treatment, and 4 subjects in the control group were screened for the intermittent administration of the test product. And finally, 51 effective test population examples, 51 control groups and 55 positive groups.

(1) And (3) observing the indexes:

and (3) observing symptoms, namely inquiring medical history in detail, knowing the diet condition and activity of a patient, observing clinical symptoms such as polydipsia, polyphagia and hypodynamia, counting integral values before and after trial feeding according to the light and heavy symptoms (3 times of severe symptoms, 2 times of moderate symptoms and 1 time of mild symptoms), improving main symptoms (each symptom is improved by 2 times of effective symptoms, and improvement is effective by 1 time), and observing the symptom improvement rate. The results are shown in tables 1-3 below.

TABLE 1 integral statistics of clinical symptoms

Group of	Number of examples	Before taking the test food	After taking the food
				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 that: ^* comparing p with p < 0.05 before trial feeding; # p < 0.05 compared to control.

TABLE 2 improvement of clinical symptoms

(2) And (3) result judgment:

the effect is that the basic symptoms are obviously improved, and the fasting blood sugar or postprandial blood sugar is reduced by more than 10 percent compared with the blood sugar before the test.

The basic symptoms are not obviously improved, and the fasting blood sugar or postprandial blood sugar is reduced by less than 10 percent compared with the blood sugar before the test

Table 3 comparison of efficacy in clinical observations

Group of	Number of examples	Effective and effective	Invalidation of
				Control group	51	10	41
Example 1 group	51	45	6
				Positive group	55	42	13

Test example 2 blood sugar-reducing animal experiment

2.1 establishment of hyperglycemic animal models

Clean Kunming species peak mice provided by Hunan university of agriculture animal science and technology laboratory animal farms, with weights of 24g-28g, and laboratory animal production license number of SCXK (Hunan) 2003-0003.

Mice were fasted for 24 hours, and then were given a tail vein injection of tetraoxypyrimidine (36 mg/kg. Bw), and after 5 days, the blood glucose level was measured for 5 hours, and 10-25nmol/L of blood glucose was determined as a hyperglycemia model successful animal, and the hyperglycemia model successful animal was selected and randomly divided into 11 groups of examples 1-3, comparative examples 1-5, blank group, model group and positive group, each group having 10 animals. The blank control group and the model control group are respectively given with equal amount of distilled water; the positive control group was given 130mg/kg of metformin hydrochloride, and the other groups were given the compositions prepared in the respective groups at a dose of 1.2 g/kg.bw for 2 consecutive weeks.

Fasting blood glucose values were measured for 5 hours and blood glucose values and percent decrease in blood glucose were compared for each group of animals. Percent blood glucose decrease = (pre-experimental blood glucose value-post-experimental blood glucose value)/pre-experimental blood glucose value × 100%.

Experimental data were all statistically processed using SPSS13.0 software, blood glucose levels were expressed as mean.+ -. Standard deviation, and t-test was used for group comparisons.

2.2 experimental results

The blood glucose results before and after each test are shown in Table 4.

Table 4 effects of compositions on empty abdominal blood glucose

Note that: 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; in comparison with the positive group, ^△ P＜0.05。

the foregoing detailed description is directed to one of the possible embodiments of the present invention, which is not intended to limit the scope of the invention, but is to be accorded the full scope of all such equivalents and modifications so as not to depart from the scope of the invention.

Claims

1. The composition for reducing blood sugar is characterized by comprising the following raw materials in parts by weight: 100-140 parts of balsam pear, 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 of the composition comprises the following steps:

(5) Mixing the compound with polysaccharide, adding the rest folium Mori powder, propolis and chromium picolinate, and mixing;

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;

the purification operation in the step (2) is carried out by passing through XAD-6 type adsorption resin, eluting with 3-5BV of 10-20% ethanol, discarding, eluting with 3-5BV of 55-75% ethanol, concentrating, loading on HP-20 type resin, 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 eluent; the mass ratio of the resin to the concentrated solution on the upper column is 3-5:1, the diameter-to-height ratio of the resin column is 1:6-10, and the flow rate of all elution is 0.6-0.8ml/min;

the mass of the ethanol in the step (4) is 5-8 times of that of the dry paste powder, and the mass ratio of the dry paste powder to lecithin and sucrose ester is 1:0.5-0.6:0.1-0.2; the temperature of stirring is 45-55 ℃, the stirring time is 0.5-1.5h, and the compound is obtained by drying under reduced pressure after stirring.

2. The composition according to claim 1, wherein the raw materials of the composition consist of the following components in parts by weight: 110-130 parts of balsam pear, 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 material package of the composition comprises the following components in parts by weight: 110-120 parts of balsam pear, 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 process for the preparation of a composition as claimed in any one of claims 1 to 3, comprising the steps of:

5. The 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 1-2h; in the step (2), part of mulberry leaves are 85-90% mulberry leaves, and the ethanol is 75-88% ethanol water solution.

6. The method according to claim 4, wherein the alcohol precipitation in the step (3) is carried out by adding ethanol into the water extract until the ethanol concentration is 70-85%, standing for precipitation, and washing the precipitate with petroleum ether, acetone and 95% ethanol in sequence.

7. Use of a composition according to any one of claims 1-3 for the preparation of a hypoglycemic agent.