CN105747224B

CN105747224B - Application of Borojo in assisting blood sugar reduction

Info

Publication number: CN105747224B
Application number: CN201610173308.5A
Authority: CN
Inventors: 焦红; 梁公璧
Original assignee: Guangzhou Baolyukang Biotechnology Co ltd
Current assignee: Guangzhou Baolyukang Biotechnology Co ltd
Priority date: 2016-03-23
Filing date: 2016-03-23
Publication date: 2020-10-27
Anticipated expiration: 2036-03-23
Also published as: CN105747224A

Abstract

The invention discloses a new application of tylophora fruits in auxiliary blood sugar reduction, and provides a new application field for the tylophora fruits, so that the tylophora fruits can be widely applied to preparation of foods, medicines and health-care foods for auxiliary blood sugar reduction. In addition, the invention also discloses a Bordeaux valproate soft capsule and a Bordeaux valproate tablet for assisting in reducing blood sugar, and provides a new choice for products assisting in reducing blood sugar.

Description

Application of Borojo in assisting blood sugar reduction

Technical Field

The invention relates to a new application of Borojo, in particular to an application of Borojo in assisting blood sugar reduction, and Borojo soft capsules and Borojo tablets for assisting blood sugar reduction.

Background

Borojoa sorbilis Cuatrec, a fruit of the family Rubiaceae, grown in Ecuador in south America. The Bordetella powder is a fruit powder product obtained by performing enzymolysis and concentration on a Borojoa sorbilis Cuatrec fruit of a woody plant Borojoa sorbilis of the genus Ribes in the Heifield of south America, and the consumption of the Bordetella has been known for thousands of years in the places of origin, namely Ecuador and Columbia. In the last 10 years, the processed tylophora fruits into fruit powder, pulp, beverage, capsule and tablet are sold in south america producing areas and exported to the U.S. and japan markets, and the market sales of the tylophora fruits are continuously increased from 2010 to 2012.

The research proves that the tylophora fruit powder is rich in natural iridoid glycosides, polyphenol, flavonoid antioxidant substances, and rare natural nutrients such as B vitamins, mineral substances, essential amino acids of human body and the like in common tropical fruits, plays a key positive role in human health and disease prevention as an antioxidant ingredient known by the scientific community, and can help human tissues resist cell damage caused by free radicals and control the human aging process. The current research results show that the tylophora fruit powder has obvious effects of resisting oxidation, killing and inhibiting bacteria, resisting inflammation and enhancing immunity, and the processed food prepared from the tylophora fruit powder is suitable for all healthy adults and can supplement excellent natural dietary supplements and healthy foods for healthy adults. In view of their high content of terpene glycosides, minerals and polyphenols, the infant population is not advised to eat.

According to the research result of the nutrient component structure and the efficacy of the Bordeaux powder, the Bordeaux powder food raw material can be further processed into anti-fatigue health-care food, anti-oxidation health-care food, high-energy beverage, condiment, nutritional snack food, skin care product and the like, and becomes a novel, all-natural, organic and excellent new resource food raw material.

Jenkins et al proposed the concept of Glycemic Index (GI) in 1981, which is an effective index for measuring postprandial glycemic response of food, is a true reflection of the change of blood monosaccharides caused by digestion and absorption of food, and particularly for food containing high carbohydrate, can better illustrate the influence of food on human blood sugar. Originally, GI was applied only to nutrition education, dietary control, and the like for diabetic patients, but in recent years, the field of GI research has become wider. The low GI diet has relatively fewer requirements for insulin, helps to reduce insulin secretion by the pancreas, relieves the burden on the pancreas, improves insulin resistance, and ultimately can delay the onset of diabetes. Results of the study by Mckeown et al on 2834 cases of the Faming-ham suggest that a low GI diet can improve insulin resistance, reduce metabolic syndrome, and be more effective than other dietary fibers. Several hundred related studies on GI were analyzed by Opperman AM et al for Meta and showed that GI theory as a method of selecting CHO containing foods helped to improve blood glucose and lipid metabolism in patients. Studies by professor Giangennaro coppero, university of saleno, italy, of childhood psychiatry have found that a low glycemic index diet can treat some intractable childhood epilepsy.

Scientific studies in the late 90 s of the 20 th century have found that low GI foods help to lower glycated hemoglobin levels in type ii diabetics. Insulin resistance can be delayed when the animal diet contains low GI foods; the clinical study shows that the average blood sugar concentration of normal people, diabetics and hyperlipidaemia can be reduced after low GI diet, and the insulin secretion is reduced; reducing serum triacylglycerides in a patient with triacylglycerol deficiency; low GI foods can increase carbohydrate content entering the colon, promote colonic fermentation and short chain fatty acid production, affect systemic nitrogen and lipid metabolism and microbial changes in the colon. In contrast, continuous intake of high glycemic index foods increases the risk of chronic diseases, such as obesity, cardiovascular disease, and diabetes.

J.a.jenkins et al found that low GI and weight loss were the main factors in reducing glycated hemoglobin content by analyzing the eight factors that cause hemoglobin changes by regression analysis; the cohort study found that the Glycemic Index (GI) of food was positively correlated with the incidence of coronary heart disease, a complication of diabetes. Barclay AW et al found that GI was positively correlated with breast cancer risk. Gnagnarella P investigated the relationship of GI and GL to cancer risk by Meta analysis, and the results showed that both GI and GL had significant correlation with the development of colorectal and endometrial cancers.

Disclosure of Invention

The invention aims to provide a new application of Bordeaux valproate in assisting blood sugar reduction aiming at the prior art. Meanwhile, the invention also provides a Bordeaux soft capsule and a Bordeaux tablet for assisting in reducing blood sugar.

In order to achieve the purpose, the invention adopts the technical scheme that: application of Borojo in preparing food, medicine and health food for reducing blood sugar is provided.

The inventor of the application discovers that the tylophora floribunda is a fruit with an extremely low GI value, the tylophora floribunda has an auxiliary blood sugar reducing effect, and a series of tests prove that the tylophora floribunda has the effect of obviously reducing fasting blood sugar and postprandial blood sugar levels, and a new application of the tylophora floribunda is provided. Therefore, the boletus can be used for preparing various foods, medicines and health-care foods for assisting in reducing blood sugar.

As a preferred embodiment of the application of the tylophora floribunda l of the invention in preparing foods, medicines and health-care foods for assisting in reducing blood sugar, the health-care foods are soft capsules or tablets. The tylophora can be used for preparing foods, medicines and health-care foods for assisting in reducing blood sugar, and when the tylophora is used for preparing the health-care foods for assisting in reducing blood sugar, the health-care foods can be made into soft capsules, tablets and the like according to requirements.

As a preferred embodiment of the use of the boletus of the present invention for preparing foods, medicines and health foods for assisting in lowering blood sugar, the soft capsule comprises a capsule shell and contents;

the rubber comprises gelatin, glycerin, tween 80, titanium dioxide, caramel pigment and purified water;

the content comprises Bordeaux powder and vegetable oil;

the mass percentage of the Bordeaux powder in the content is not less than 50%.

As a preferred embodiment of the application of the tylophora floribunda fruit in preparing foods, medicines and health-care foods for assisting in reducing blood sugar, the gelatin skin of the soft capsule contains the following substances in percentage by mass: gelatin 50%, glycerol 18%, tween 8012%, titanium dioxide 1%, caramel pigment 1% and purified water 18%.

As a preferred embodiment of the application of the boletus in preparing foods, medicines and health-care foods for assisting in reducing blood sugar, in the content of the soft capsule, the vegetable oil is preferably sunflower seed oil.

When the tylophora fruits are used for preparing the soft capsule for assisting in reducing blood sugar, the mass percentage of the tylophora fruits in the content is not less than 50%, so that the prepared soft capsule has an obvious blood sugar reduction effect.

As a preferred embodiment of the application of the boletus in preparing foods, medicines and health-care foods for assisting in reducing blood sugar, the mass ratio of the boletus powder to the vegetable oil in the contents is 1: 1. Powder: the reason that the oil is 1:1 is to ensure that the stability of the contents is good and avoid oil/powder layering; in addition, the content can keep certain fluidity in the process, the phenomena of machine blockage and tube explosion can not occur, and the smooth operation of filling and pressing pills is ensured.

As a preferred embodiment of the use of the boletus of the present invention for the preparation of foods, pharmaceuticals and health foods for the auxiliary reduction of blood sugar, the tablet comprises boletus powder and excipients. The excipient is available in the conventional tablet and can be selected according to the requirement.

As a preferred embodiment of the use of the tylosin according to the present invention for the preparation of foods, pharmaceuticals and health foods for assisting in lowering blood glucose, the excipient comprises maltodextrin, magnesium stearate, silicon dioxide, starch and a transparent film coating powder, the transparent film coating powder comprises hydroxypropyl methylcellulose, talc and triacetin, and the mass ratio of hydroxypropyl methylcellulose, talc and triacetin is 7:2: 1. As a more preferable embodiment of the application of the tylophora floribunda fruit in preparing foods, medicines and health-care foods for assisting in reducing blood sugar, the excipient comprises the following components in percentage by mass: 12 parts of maltodextrin, 1 part of magnesium stearate, 2 parts of silicon dioxide, 12.5 parts of starch and 2.5 parts of transparent film coating powder.

As a preferred embodiment of the application of the tylophora floribunda powder in preparing foods, medicines and health-care foods for assisting in reducing blood sugar, the tylophora floribunda powder is not less than 70% by mass of the tablets. When the tylophora fruits are used for preparing tablets for assisting in reducing blood sugar, the mass percentage of the tylophora fruits in the tablets is not less than 70%, so that the prepared tylophora fruits tablets have a remarkable blood sugar reducing effect.

As a preferred embodiment of the use of the tylosin according to the present invention for the preparation of foods, pharmaceuticals and health foods for the auxiliary reduction of blood glucose, the tylosin is tylosin powder. The Bordeaux powder is a fruit powder product of Bordeaux fruits subjected to enzymolysis, concentration and primary processing, can be prepared by adopting a common method in the prior art, and can also be directly purchased in the market.

In addition, another purpose of the invention is to provide a soft capsule of Bordeaux for assisting in reducing blood sugar, and in order to achieve the purpose, the technical scheme adopted by the invention is as follows: a Bordeaux valproate soft capsule for assisting in reducing blood sugar comprises a capsule shell and contents;

the content comprises Bordeaux powder and vegetable oil;

the mass percentage of the Bordeaux powder in the content is not less than 50%.

In the boletus soft capsule for assisting in reducing blood sugar, the content contains boletus powder and vegetable oil, and the rubber preferably but not limited to gelatin, glycerin, tween 80, titanium dioxide, caramel pigment and purified water.

As a preferred embodiment of the boletus edulis soft capsule for assisting in reducing blood sugar, the capsule shell of the soft capsule contains the following substances in percentage by mass: gelatin 50%, glycerol 18%, tween 8012%, titanium dioxide 1%, caramel pigment 1% and purified water 18%.

As a preferred embodiment of the boletus edulis soft capsule for assisting in reducing blood sugar, in the content of the soft capsule, the vegetable oil is preferably sunflower seed oil.

In the tylophora soft capsule for assisting in reducing blood sugar, the mass ratio of the capsule skin to the content is not particularly limited, and the conventional proportional relation in the prior art is adopted.

As a preferred embodiment of the boletus edulis soft capsule for assisting in reducing blood sugar, the content of the boletus edulis soft capsule comprises boletus edulis powder and vegetable oil in a mass ratio of 1: 1.

The preparation method of the boletus edulis soft capsule for assisting in reducing blood sugar is prepared by adopting a preparation method of a soft capsule commonly used in the prior art. Specifically, the boletus edulis soft capsule for assisting in reducing blood sugar is prepared by the following method:

(1) preparing glue solution: adding purified water into a gelatin melting tank, starting heating, adding gelatin when the temperature is heated to 50 ℃, stirring until the gelatin is dissolved, adding glycerol, titanium dioxide and caramel pigment when the temperature is heated to 65 ℃, continuously stirring, keeping stirring for 15 minutes at 70 ℃ when the temperature is heated to 70 ℃, then adding Tween 80, uniformly stirring, vacuumizing to-0.06 MPa of vacuum degree to enable white gelatin liquid to be bright yellow, discharging liquid, sieving with a 80-mesh sieve, and storing the gelatin liquid in a heat-preservation barrel at 55 ℃ for later use;

(2) preparation of contents: adding Bordeaux mixture powder into vegetable oil, stirring uniformly, and pressing to obtain the content;

(3) and (2) adjusting the temperature of the heat-preserving barrel for storing the glue solution in the step (1) to 68 ℃, the refrigerating temperature of a refrigerant to be 20 ℃, the temperature of the left spreading box and the temperature of the right spreading box to be 50 ℃ so as to facilitate smooth outflow of the glue solution, adjusting the temperature of the injector to be 44.1 ℃ after the thickness of the rubber sheet is adjusted to 0.8mm, carrying out pressure test on the rubber sheet, checking the seal of the rubber sheet, and pressing the rubber sheet after the determination is carried out, thereby preparing the soft capsule.

Finally, another object of the present invention is to provide a boletus tablet for assisting in lowering blood sugar, and to achieve the object, the technical solution adopted by the present invention is as follows: the tylophora fruit tablet for assisting in reducing blood sugar comprises tylophora fruit powder and an excipient, wherein the content of the tylophora fruit powder in the tylophora fruit tablet is not less than 70%.

As a preferred embodiment of the bolenoid tablet for assisting in reducing blood sugar according to the present invention, the excipient is an excipient that is available in existing common tablets, and can be selected according to needs. The excipient preferably, but not exclusively, comprises maltodextrin, magnesium stearate, silicon dioxide, starch and transparent film coating powder, the transparent film coating powder comprises hydroxypropyl methyl cellulose, talcum powder and glyceryl triacetate, and the mass ratio of the hydroxypropyl methyl cellulose, the talcum powder and the glyceryl triacetate is 7:2: 1. As a more preferable embodiment of the tylophora floribunda tablet for assisting in reducing blood sugar, the excipient comprises the following components in percentage by mass: 12 parts of maltodextrin, 1 part of magnesium stearate, 2 parts of silicon dioxide, 12.5 parts of starch and 2.5 parts of transparent film coating powder.

The invention discovers the new application of the tylophora fruits in the auxiliary blood sugar reduction, provides a new application field for the tylophora fruits, and enables the tylophora fruits to be widely applied to the preparation of foods, medicines and health-care foods for auxiliary blood sugar reduction. The invention also provides the tylophora soft capsules and the tylophora tablets for assisting in reducing blood sugar, and provides a new choice for products assisting in reducing blood sugar.

Drawings

FIG. 1 is a graph of the blood glucose response within 2h after dinner for Boleto in 15 volunteers.

FIG. 2 is a graph comparing glycemic indices of Bordeaux and internationally known fruits.

Detailed Description

To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to specific examples.

Example 1

Borojo glycemic index test

1. Materials and methods

1.1 materials

1.1.1 test substances and groups

Glucose tolerance group: glucose, analytically pure. Before use, 50g of each part is weighed and added with purified water to prepare 200ml for standby.

Boletus blood glucose response group: the ecuador x group provided the bola pulp without any additional ingredients or additives, and the early test showed 28.02% of the bola carbohydrate. Each part of the Baoleguo food is 100 multiplied by 50/28.02 multiplied by 178.0 g. 178 g of Bordeaux are weighed in each part and prepared into about 200ml by using hot purified water, and the mixture is fully stirred to be dissolved for later use.

Mixed food blood glucose response group: glucose equivalent to 50g carbohydrate and tylophora containing 25 g carbohydrate were mixed. Adding 89 g of Bordeaux mixture into 25 g of glucose in each part of the test substance to prepare 100ml of solution, and mixing and stirring uniformly for later use.

1.1.2 Instrument: AEROSET series full-automatic biochemical analyzer of Yapek company of America and company matched blood sugar test reagent.

1.1.3 statistics:

canadian GI Wolever analytical software, provided by the chinese CDC food safety institute food evaluation department.

1.2 study subjects

From 7/9/7/29/2010, 15 healthy adult human volunteers in Guangzhou city, 8 male and 7 female, were selected with their informed consent. Volunteers met the following conditions: the novel health food has the advantages of being healthy, free of any metabolic disease, family history of diabetes and other metabolic disease history; the age is between 20 and 45 years old; the weight of the third product is normal, and the BMI is 18.5-25 kg/m 2; fourthly, no carbohydrate intolerance; fifthly, removing: women with impaired glucose tolerance, overweight or obesity, lactose or carbohydrate intolerance, and menopause.

1.3 methods

1.3.1 glucose tolerance test

Subjects were fasted for 10h prior to the study. Taking 2ml of elbow venous blood on an empty stomach in the next morning, taking 200ml of 50g of glucose aqueous solution, taking venous blood at the time of 15min, 30 min, 45 min, 60 min, 90 min and 120min respectively, anticoagulating with sodium fluoride, and separating serum to determine the content of serum glucose.

1.3.2 Bordeaux valproate blood sugar response test

And (5) continuing the blood sugar response experiment of the tylophora on the next day for the patient with qualified glucose tolerance.

The same subject collected 2ml of cubital venous blood on an empty stomach in the early morning and tested for fasting blood glucose. Then, 200ml of an aqueous solution containing 178.0g of the pulp of the tylophora was taken, venous blood was collected at 15, 30, 45, 60, 90 and 120min, respectively, and the above experiment was repeated.

1.3.3 glucose and Bordeaux mixture blood sugar response test

One week after the blood glucose response test of Bordeaux valproate, 2ml of cubital venous blood was collected in the early morning on an empty stomach and the empty blood glucose was tested. The mixed food was then eaten, venous blood was collected at 15, 30, 45, 60, 90, 120min, respectively, and the above experiment was repeated.

1.4 correlation indices and calculations

1.4.1 glucose tolerance test:

the glucose oxidase method was used to determine the blood glucose concentration for each group at different time periods. At each group blood glucose concentration

And (5) drawing a blood glucose change curve in different time periods.

1.4.2 glycemic index GI of Bordeaux:

glucose with a GI value of 100 was used as a standard reference. The area of Appreciation (AUC) under the 2h blood glucose response curve for 50g carbohydrate tylophora fruit flesh was calculated (to

Expressed) to 50 grams of glucose response.

Wolever formula:

and (4) judging the standard: GI < 55 for low GI foods; medium GI chow 55 < GI < 75; GI greater than or equal to 75 is high GI food.

1.4.3 calculation of blood glucose load of the diet of Bordeaux mixture GL:

the content and intake quality of carbohydrate of different tested substances are combined to represent the degree of influence of a certain weight of food on the blood sugar of a human body, and the formula is as follows:

weight of carbohydrate GL ═ tyledo × GI value of tyledo ÷ 100

1.5 data statistical treatment:

all data were pooled in Excel, statistically analyzed using the spss13.0for Windows software package, and differences in blood glucose concentration and AUC at different time points were compared using LSD-t test and one-way ANOVA, with the significance level test using the rule of 0.05 culling.

1.6 quality control

Volunteers were selected strictly according to experimental requirements. The volunteers fasted for 10h before each experiment, and sit still for 10min before the fasting venous blood is extracted, so that the tension is avoided, and the violent activities are prohibited during the experiment. Each time a blood sample is taken, 1 part of serum is reserved for subsequent experimental correction. Blood samples are collected by the same blood collector at the same time and the same position in each experiment; only 1 test object is eaten in each experiment, the interval between the glucose tolerance test and the food blood sugar response test is more than 72 hours, and the interval between the food blood sugar response test and the mixed food blood sugar response test is 1 week.

2. Results

2.1. General conditions of the subjects

After 3 cases of 15 volunteers take the tylosin, slight loose stool appears, the symptoms disappear within 3 hours, and other patients have no adverse reaction. After 2 cases of glucose tolerance and Bordeaux valaciclovir glucose response experiments are completed, the experiments are quitted due to work movement, and after the rest 13 cases of the experiments, mixed glucose response experiments are carried out. There was no significant difference between fasting plasma glucose before the administration of three groups of subjects and mean plasma glucose 120 minutes after the administration of subjects in 15 volunteers. The subject met the experimental design requirements. Mixed food glycemic responses were statistically analyzed in 13 cases.

2.2 glucose tolerance test

15 volunteers have glucose tolerance test, before meal fasting blood glucose average number is 4.39 + -0.34, after meal two-hour blood glucose AUC is 194.08 + -95.61, blood glucose response curve rises within 15-45 minutes, peak is reached within 45 minutes, and maximum value is 6.98 + -1.28; the blood glucose level decreased to 4.64 +/-1.07 after 45 minutes and was slightly higher than the average fasting blood glucose level after 120 minutes. (Table 1)

TABLE 115 average postprandial glycemic response of three test subjects in volunteers: (

mmol·L^-1)

2.3. (ii) Glycemic Index (GI) after meal for Borojo group and glucose plus Borojo group

Average Glycemic Index (GI) and Glycemic Load (GL) of the palonol group and the glucose plus palonol group were obtained according to the Wolever calculation formula, respectively, using glucose as a standard reference food as shown in table 2:

TABLE 2 area of Appreciation (AUC) under the Bordeaux and Bordeaux plus glucose blood glucose curves, Glycemic Index (GI) and Glycemic Load (GL)

ANOVA test: f is 35.476, P < 0.001.

2.4. Bordeaux set postprandial blood glucose response curve

The average blood sugar of 15 volunteers is arranged in parallel lines within 15 to 120 minutes after eating the food without increasing; there were no significant differences in mean blood glucose in 15 volunteers over 7 time periods (p > 0.05). The blood sugar value of 1 volunteer tylosin after 15 minutes is reduced from 6.4 to 5.3 of fasting blood sugar, and after 30 minutes is reduced to 4.4. The glycemic index was 0 in 11 cases, 2.08, 3.90, 4.65, and 0.65 in 4 cases, respectively, and the incremental area AUC under the curve was 1.81 ± 3.80. The average GI was 0.75. See figure 1.

2.5. Glucose and bolerole mixed postprandial blood glucose response curve

Before the glucose plus Baoleguo meal, the average fasting blood glucose is 4.30 +/-0.32, the average blood glucose curve rises within 15-30 minutes after the mixed meal, the peak is reached within 30 minutes, and the maximum blood glucose value is 7.81; the blood glucose level begins to decrease after 30 minutes, and decreases to 4.01 +/-0.34 after 120 minutes, which is less than the average value of fasting blood glucose of 0.27-0.31. The post-prandial 2h plasma glucose AUC was 147.62 + -58.27, and the glycemic index mean was 78.27. The glucose plus Baoleguo and the glucose tolerance are compared pairwise within 15-120 minutes, and the GI mean number has no obvious difference (t is 0.026-1.79; p is more than 0.05); however, when AUC is compared two by two, t is 2.273, p is 0.042<0.05, and the difference is significant. See table 1.

(one meal) Total Glycemic Index (GI) of blended food

When 89 grams of tylophora was mixed with 25 grams of glucose as a meal with 75 grams of carbohydrate, the total GI contribution was 66.95%. See table 3.

TABLE 3 glycemic index of blended foods

2.7 comparison of the International known fruit glycemic index GI with the glycemic index GI of Bordeaux

A comparison of the internationally known glycemic index GI of fruit with the glycemic index GI of Bordeaux is shown in FIG. 2. Prior to the present invention, the GI value of the fruit was highest at 72.0 for watermelon and lowest at 22.0 for cherry, while the GI value of the kola fruit was much lower than that of the cherry. The postprandial blood glucose response curve of the experiment Baoleguo is flat, the GI value of 11 cases is 0, and 1 case even reduces fasting blood glucose. The fruits of the tropical fruit Callerotia species are rare very low GI value fruits.

In order to know whether the tylophora has the auxiliary blood sugar reducing effect, the experiments further mix the tylophora and glucose for eating together, the AUC of the mixture after 2 hours is obviously lower than the AUC after glucose is eaten alone, the GI of the reference glucose can be obviously reduced from 100 to 78.27, the total glycemic index of a mixed meal containing 75% carbohydrate is only 66.95 actually, and the hyperglycemic food is reduced to the medium glycemic food. The peak of the blood sugar response curve appears and declines 15min earlier than the glucose tolerance test, and the average number of blood sugar after 120min declines by 0.27-0.31 compared with the average number of fasting blood sugar. Further proves that the boletus fruit has the function of obviously reducing fasting blood sugar and postprandial blood sugar level when being mixed with other high GI foods for diet.

Example 2

Auxiliary blood sugar reduction experiment of Borojo on hyperglycemic animals

1. Material

1.1 test substance: sample baoleguo powder, brown powder, bottled in glass.

1.2 dose design: the maximum gavage amount (3.0g/kg BW) of the sample is taken as a high dose, and a hyperglycemia control group and three low, medium and high dose groups are set, wherein the doses are as follows:

hyperglycemia control group purified water

Low dose group 0.75g/kg BW

Medium dose group 1.50g/kg BW

High dose group 3.00g/kg BW

1.3 preparation method of the test substance, 0.75g, 1.50g and 3.00g of samples are respectively weighed every day, purified water is added to be prepared into 20ml, the test substance is administered by intragastric administration according to the BW of 0.20ml/10g, and purified water is administered by intragastric administration according to the same volume of a hyperglycemic control group.

1.4 animals: SPF-grade Kunming female mice, 6-8 weeks old and 24-28 g in weight, are provided by southern medical university laboratory animal center.

1.5 animal laboratory conditions: the animal laboratory is SPF grade, and the experimental animals use license numbers: SYXK (Yue) 2008-. The room temperature is 22 +/-2 ℃, and the humidity is 60-70%.

1.6 Instrument: hitachi 7060 full-automatic biochemical analyzer.

1.7 reagent: alloxan, manufactured by Sigma company, usa; glucose powder, Guangzhou chemical Agents factory; the blood sugar determination kit is provided by Beijing Zhongsheng reagent company.

2. Method of producing a composite material

2.1 test methods:

2.1.1 model of hyperglycemia:

animals are adapted to three days under laboratory conditions, after 24 hours of fasting, the animals are weighed, 200mg/kg BW alloxan is injected into the abdominal cavity (the injection amount is 0.1ml/10g BW prepared by normal saline), the blood sugar value is measured by orbital blood collection after 5 hours of fasting on the fifth day, and the animals with the blood sugar value of 10-25 mmol/L are selected as hyperglycemic model animals.

2.1.2 fasting blood glucose lowering test

Selecting hyperglycemia model animals, dividing into a hyperglycemia control group and three sample dose groups, wherein each group comprises 10 animals, adjusting the difference of blood sugar values among the groups to be less than 1.1mmol/l, respectively administering different doses (0.75, 1.50 and 3.00g/kg BW) of test substances to the dose groups, respectively administering 0.2ml/10g BW purified water to the hyperglycemia control group, continuously administering for 45 days, determining fasting blood sugar values after fasting for 5 hours on 31 and 46 days, and comparing the blood sugar of each group after experiment with the blood sugar difference rate of the tested animals before and after the group. The blood sugar difference rate before and after the experiment is equal to (before experiment-after experiment)/before experiment is multiplied by 100 percent

2.1.3 test on the influence of normal animal fasting blood sugar

In the same batch of mice, fasting blood glucose value after 5 hours of fasting was measured, 20 mice were selected, 10 of the pure water control group were given 0.2ml/10g BW pure water, and another 10 mice were given 3.00g/kg BW test substance, and the fasting blood glucose lowering experiment was performed in the same manner.

2.2 statistics: all data were analyzed for variance statistics using the SPSS11.0 software package.

3. And (3) test results:

3.1 influence of Bordeaux powder on the fasting blood glucose reduction of tetraoxypyrimidinic hyperglycemic mice: as can be seen from table 4, the difference between the blood glucose before and after the test (before the test-after the test)/before the test x 100% ] of the high dose group (3.00g/kg) after the test subject takes 30 days has a very significant significance (P <0.01) compared with the hyperglycemia control group; compared with a hyperglycemia control group, the difference of the medium-dose blood sugar after 45 days and the blood sugar difference rate before and after the experiment has significant significance (P is less than 0.05); compared with a hyperglycemia control group, the difference of the hyperglycemia and the blood glucose difference rate before and after the experiment with high dose of blood glucose has very significant significance (P is less than 0.01). The result shows that the Borojo powder has the function of reducing fasting blood glucose for the tetraoxypyrimidine hyperglycemia mice, and the test result is positive.

TABLE 4 influence of Baole fruit powder on fasting plasma glucose of hyperglycemic mice

Note: p is <0.01, and P is <0.05 compared with the hyperglycemic control group

3.2 effects of Bordeaux powder on fasting plasma glucose in normal mice: as can be seen from Table 5, the difference between the blood sugar of the high-dose group after the experiment and that of the blank control group has no significant significance, which indicates that the Borojo powder has no significant influence on the fasting blood sugar of normal mice.

TABLE 5 Effect of Bordeaux powder on fasting plasma glucose in Normal mice

3.3 effects of Bordeaux powder on the body weight of mice with alloxan hyperglycemia before and after the experiment: as can be seen from Table 6, the difference between the body weight of each dose group of mice before and after the experiment and the body weight of the hyperglycemia control group has no significant significance, and the influence of the sample on the body weight of the hyperglycemia animals is a negative result.

TABLE 6 influence of Baole fruit powder on the body weight of hyperglycemic mice

4. And (4) conclusion:

after 200mg/kg BW alloxan is injected into the abdominal cavity of SPF level Kunming mice to cause hyperglycemia model animals, 0.75, 1.50 and 3.00g/kg BW acorn concentrate powder is orally administered every day, fasting blood glucose values are measured at 15, 30 and 45 days, and fasting blood glucose is measured after 3.00g/kg BW is administered to normal mice for 30 days, and the results show that:

1. the test sample can reduce the fasting blood glucose value of the tetraoxypyrimidinic hyperglycemia mouse, and the result is positive.

2. The test sample had no significant effect on the fasting blood glucose values of normal mice.

After different sample doses are continuously given to the alloxan hyperglycemic mice every day and the regular mice are given with the Baoleguo powder with 3.00g/kgBW for 45 days, the fasting blood glucose value of the hyperglycemic mice can be reduced; has no obvious influence on the fasting blood sugar value of normal mice.

Example 3

Clinical auxiliary hypoglycemic test of Baoleguo soft capsule for type 2 diabetes patients

1. Study objectives and objects

According to the basic requirements of health food inspection and evaluation technical specifications (2003 edition) of Ministry of health, a plurality of biochemical detection items such as fasting insulin (Fins), alanine Aminotransferase (ALT), aspartate Aminotransferase (AST), glycated hemoglobin (HbA1c), blood routine and the like are added. 11 volunteers of adult II-type diabetes patients are selected by a diabetes rehabilitation treatment group of people hospitals in xx area of Guangzhou city to carry out preliminary feeding tests, so that whether the Borojo powder soft capsule has the health-care function of regulating the sugar metabolism of the II-type diabetes patients and whether the effect of reducing blood sugar is obvious or not are preliminarily observed, and a next scheme is provided according to preliminary experimental results.

Meanwhile, on the basis of the auxiliary blood sugar reduction inspection technical specification biochemical test, the test food test comprehensively knows whether the tylophora fruit powder has other adverse effects on the health of the testee.

All volunteers signed the volunteer-aware book and provided one glucose meter for free to each.

2. Materials and methods

2.1 design of the experiment

The patients with adult type II diabetes or hyperglycemia are stable after diet control or oral hypoglycemic drug treatment, and only take maintenance dose of adult type II diabetes or hyperglycemia population without changing drug varieties and doses, but are not satisfied with blood sugar control. Age 30-70 years, 11 in total, were used as subjects. This study was voluntarily accepted and met the following conditions:

● fasting blood sugar is not less than 7.8mmol/L but not more than 11.1 mmol/L;

● postprandial or random blood sugar is more than or equal to 10.0mmol/L but less than or equal to 16.7 mmol/L;

● glycated hemoglobin (HbA1c) is about 7.5% to about 9.0%;

● has no damage to liver and kidney function and no cardiopulmonary insufficiency.

The observation time was 12 weeks in total. Blood was drawn on the day before and on the last day after the test to test Fasting Plasma Glucose (FPG), fasting insulin (Fins), glutamic-pyruvic transaminase (ALT), glutamic-oxalacetic transaminase (AST), four items of blood fat [ Total Cholesterol (TC), Triglyceride (TG), high density lipoprotein cholesterol (HDL) and low density lipoprotein cholesterol (LDL) ], glycated hemoglobin (HbA1c), and blood routine, and peripheral blood glucose was monitored three meals a day each week.

The test takes the form of a patient's own front-to-back control. The matching t test before and after eating is carried out on 13 biochemical indexes of FPG, Fins, ALT, AST, four blood fat, HbA1c, blood routine and the like. Differences were considered statistically significant when P < 0.05.

2.2 Experimental drugs

The content of the Bordeaux powder soft capsule is 1g per capsule: the formula comprises 50% of Baole fruit powder and 50% of sunflower seed oil, and no suspending agent is added in the formula. The content of each soft capsule contains 500mg of Borax powder and 500mg of sunflower seed oil. The soft capsule comprises gelatin, glycerin, Tween 80, titanium dioxide, caramel pigment and purified water, and is prepared by the conventional method.

2.3 method of administration

The capsule is taken 4 capsules each time and 3 times a day for 12 weeks continuously to ensure that the total daily dosage of the Bordeaux mixture is more than 6 g. Diet and exercise amount must be kept relatively constant during the test period, and if there is no obvious hypoglycemia, the original medication scheme is not changed, and if necessary, it is adjusted.

2.4 statistical treatment

Data analysis was performed using SPSS 20 software. The self-control data adopts a paired t test.

3 results

3.1 general conditions and results

The method is characterized in that 11 patients with type II diabetes mellitus are observed at the same time, wherein the age is 51 years minimum and 70 years maximum, and 1 male patient and 10 female patients are observed; average age 58.36 years; mean course of disease 111.3 months; average bodyWeight index 28.06kg/m²。

TABLE 7 general data of type II diabetic patients before observation

TABLE 8 Biochemical test results 13 items before and after taking medicine (before and after taking medicine)

As shown in table 8, after 11 patients took the boletus powder soft capsule, the average values of seven biochemical indexes in blood, such as fasting blood glucose, glutamic-pyruvic transaminase, total cholesterol, low-density lipoprotein cholesterol, glycated hemoglobin, red blood cells, platelets, etc. were reduced in different ranges; the six biochemical means of fasting insulin, glutamic-oxalacetic transaminase, triglyceride, high-density lipoprotein cholesterol, hemoglobin, leucocyte and the like are increased to different degrees, and particularly, the average number of the glycosylated hemoglobin of a patient is reduced by 0.37. But the rise and fall results were not statistically significantly different.

3.2 peripheral blood sugar test results before and after taking medicine

Three meals prior to peripheral blood glucose were monitored weekly for one day, and 11 subjects, one each, lacked the three meal prior to the trial peripheral blood glucose test. The results are shown in Table 9. As can be seen from Table 9, the mean and standard deviation of peripheral blood glucose after administration were respectively reduced by 0.40. + -. 1.29, 0.23. + -. 3.84 and 0.14. + -. 3.22, but the difference was not significant (P >0.05) in statistical examination, compared with the patients before and after administration.

TABLE 9 mmol/L of peripheral blood glucose measurement results before and after taking medicine for type II diabetic patients

3.3 Total peripheral blood glucose results before and after dosing

As can be seen from Table 10, the mean and standard deviation of peripheral blood glucose before and after administration were 0.26. + -. 0.13, but the difference was not significant by statistical examination (P > 0.05).

TABLE 10 Total peripheral blood glucose test results of type II diabetic patients before and after administration mmol/L

3.4 fasting blood sugar test results before and after taking medicine

As can be seen from Table 11, the mean fasting glucose decreased by 1.33. + -. 2.52 after administration, but the difference was not significant by statistical test (P >0.05), compared with the patients before and after administration.

TABLE 11 detection results of mmol/L of fasting plasma glucose before and after taking medicine for type II diabetic patients

3.5 blood lipid test results before and after administration

As can be seen from Table 12, the mean of Total Cholesterol (TC) was decreased by 0.19. + -. 0.72, the mean of High Density Lipoprotein (HDL) was increased by 0.06. + -. 0.14, and the mean of Low Density Lipoprotein (LDL) was decreased by 0.16. + -. 0.25, as compared with the blood lipid of the patients before and after administration, but the difference was not significant in the statistical test (P > 0.05). The mean Triglyceride (TG) increases by 0.86 ± 1.29, the difference was significant as determined statistically (P ═ 0.05).

TABLE 12 mmol/L of blood lipid test results before and after taking medicine for type II diabetic patients

3.6 routine test results of blood before and after taking medicine

As can be seen from Table 13, the average numbers of hemoglobin and white blood cells increased by 2.00 + -5.20 and 0.84 + -1.54, respectively, and the average numbers of red blood cells and platelets decreased by 0.12 + -0.23 and 13.09 + -23.08, respectively, compared with the blood routine of the patients before and after the administration of the medicine, but the difference of the statistical test was not significant (P > 0.05).

TABLE 13 routine test results of blood before and after taking medicine for type II diabetic patients

3.7 results of other Biochemical assays

As can be seen from Table 14, the mean fasting insulin, glutamic-pyruvic transaminase, glutamic-oxalacetic transaminase and glycated hemoglobin were increased by 0.84. + -. 6.78, 0.64. + -. 4.55, 0.45. + -. 4.59 and 0.37. + -. 0.93 before and after administration, but the differences were not significant (P > 0.05).

TABLE 14 Biochemical test results before and after taking medicine for type II diabetic patients

3.8 fasting plasma glucose and glycated hemoglobin before and after administration to patients with body Mass indices <30 and >30

As can be seen from Table 15, after patients with a body mass index of less than 30kg/m 2 took the medicine, the mean values of fasting plasma glucose and glycated hemoglobin were decreased by 2.03. + -. 2.89 and 0.50. + -. 1.12; after the patients with the body mass index of more than 30kg/m < 2 > take the medicine, the average fasting blood glucose is increased by 1.06 plus or minus 0.90, and the glycosylated hemoglobin is reduced by 0.14 plus or minus 0.52.

TABLE 15 measurement results of fasting plasma glucose and glycated hemoglobin before and after administration for patients with different body mass indexes

Different body mass indexes of patients with type II diabetes mellitus have different expressions on 2 reaction indexes of fasting blood glucose and glycosylated hemoglobin of the Bordeaux powder soft capsules, the mean fasting blood glucose of the patients with body mass indexes smaller than 30 is reduced by 2.03 +/-2.89 after the patients take the medicine, and the mean fasting blood glucose of the patients with body mass indexes larger than 30 is increased by 1.06 +/-0.90 after the patients take the medicine. The average number of the glycosylated hemoglobin of the patient with the body mass index of less than 30 after the medicine taking is reduced by 0.50 plus or minus 1.12, and the average number of the glycosylated hemoglobin of the patient with the body mass index of more than 30 after the medicine taking is reduced by 0.14 plus or minus 0.52.

4. Conclusion

The primary clinical study on the blood sugar reducing effect of the tylophora powder soft capsule is carried out in the embodiment. After 11 patients with type II diabetes eat the Baoleguo powder soft capsules for 12 weeks, 13 main biochemical indexes such as FPG, Fins, ALT, AST, blood fat, HbA1c, blood routine and the like are changed, but the change range is in a normal range, and the changed results are not significant through statistical analysis, which indicates that the Baoleguo powder soft capsules have no negative influence on 11 patients with type II diabetes eating the Baoleguo powder soft capsules.

After 11 type II diabetics take the Baoleguo powder soft capsules for 12 weeks, 5 biochemical indexes of blood hollow abdominal insulin, glutamic-oxaloacetic transaminase, high-density lipoprotein, hemoglobin, white blood cells and the like are increased in different degrees. Type II diabetics have low fasting insulin originally resulting in elevated fasting glucose. At present, 11 type II diabetes patients try to take the Baoleguo powder soft capsules, and the result is accompanied with the decrease of the average fasting blood glucose of the 11 type II diabetes patients. The soft capsule of the boletus fruit powder is prompted to have the effect of increasing and improving the insulin secretion of patients. Fasting blood glucose, glutamic-pyruvic transaminase, total cholesterol, low density lipoprotein and glycated hemoglobin are reduced, and a better auxiliary hypoglycemic trend is shown.

Example 4

Clinical auxiliary hypoglycemic test of Borojo tablet for type 2 diabetics

The procedure is as in example 3 except that the experimental drug is a Bordeaux tablet. The tylophora fruit tablets used in this example contain tylophora fruit powder and excipients, each tablet contains 700mg of tylophora fruit powder and 300mg of excipients, and the 300mg excipients comprise: 120mg of maltodextrin, 10mg of magnesium stearate, 20mg of silicon dioxide, 125mg of starch and 25mg of transparent film coating powder (17.5 mg of hydroxypropyl methyl cellulose, 5mg of talcum powder and 2.5mg of glyceryl triacetate). The taking method comprises the following steps: the Borojo tablet is taken 5 granules per time and 2 times per day for 12 weeks continuously in a test period, so that the total daily dosage of Borojo powder is ensured to be more than 6 g. The test results in this embodiment are substantially the same as those in embodiment 3, and are not described again. This example further demonstrates that the baoleguo powder tablet also has a good effect of assisting in reducing blood glucose.

Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. The application of the boletus edulis in preparing the health food for treating the type 2 diabetes is characterized in that the health food is a soft capsule;

the soft capsule consists of a rubber sheet and contents;

the rubber consists of gelatin, glycerol, tween 80, titanium dioxide, caramel pigment and purified water;

the content consists of Baole fruit powder and vegetable oil;

the mass percentage content of the Borojo powder in the content is not less than 50 percent;

in the contents, the mass ratio of the Baole fruit powder to the vegetable oil is 1: 1;

the dosage of the Borojo powder is not less than 6 g per day;

the Bordeaux mixture is prepared by mixing Bordeaux mixture with Bordeaux mixture, and performing enzymolysis, concentration and spray on Bordeaux mixture to obtain Bordeaux mixture.

2. The application of the boletus in preparing the health food for treating the type 2 diabetes is characterized in that the health food is a tablet, and the tablet consists of boletus powder and an excipient; the mass percentage of the Bordeaux powder in the tablet is not less than 70%.

3. A Bordeaux soft capsule for treating type 2 diabetes is characterized in that the Bordeaux soft capsule consists of a capsule shell and contents;

the content consists of Baole fruit powder and vegetable oil;

in the contents of the Bordeaux mixture soft capsule, the weight ratio of Bordeaux mixture powder to vegetable oil is 1: 1;

the dosage of the Borojo powder is not less than 6 g per day; the Bordeaux powder is a full-ingredient Bordeaux powder product which is primarily processed by enzymolysis, concentration and spraying of Bordeaux fruits.

4. The tylophora floribunda tablet for treating type 2 diabetes is characterized by consisting of tylophora floribunda powder and an excipient, wherein the content of the tylophora floribunda powder in the tylophora floribunda tablet is not less than 70%, and the dosage of the tylophora floribunda powder is not less than 6 g per day; the Bordeaux powder is a full-ingredient Bordeaux powder product which is primarily processed by enzymolysis, concentration and spraying of Bordeaux fruits.