Composition for improving immunity and regulating blood sugar and application thereof

Abstract

The invention belongs to the technical field of health-care food, and particularly relates to a composition for improving immunity and regulating blood sugar and application of the composition. The raw materials of the composition comprise active substances, the active substances comprise ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate, and the mass ratio of the ginsenoside Rg2 to the notoginsenoside R1 to the ginsenoside Rh1 to the ginsenoside Rb2 to the chromium picolinate is (5-15): (2-6): (2-6): (1-5): (0.1-0.2). The composition obtained by compounding the ginsenoside Rg2, the notoginsenoside R1, the ginsenoside Rh1, the ginsenoside Rb2 and the chromium picolinate has good effects of improving the immunity and reducing the blood sugar.

Description

Technical Field

[0001] The invention belongs to the technical field of health food, and specifically relates to a composition for improving immunity and regulating blood sugar and an application thereof. Background Art

[0002] Panax notoginseng is a plant of the genus Panax in the Araliaceae family. It is a widely used and representative Chinese herbal medicine in my country, with pharmacological activities such as anti-inflammatory, hemostatic, anti-aging, and anti-tumor. Chinese patent medicines with Panax notoginseng as the active ingredient are widely used, such as Sanqi Xueshangning Capsules, Compound Danshen Tablets, Sanqi Shangyao Tablets, Sanqi Tongshu Capsules, and Sanqi Chromium Soft Capsules.

[0003] In recent years, pharmaceutical preparations with effective parts of Chinese medicinal materials as the main active ingredients have been continuously developed and researched. Saponin is one of the main effective active ingredients of Panax notoginseng. At present, more than 200 saponin compounds have been discovered in Panax notoginseng, including representative monomer saponins such as ginsenosides Rg1, Rb1, Rb2, Rc, Rd, Re and notoginseng saponin R1, etc. The Chinese patent medicines with Panax notoginseng total saponins as the active ingredients include Xuesaitong Injection, Xueshuantong Injection, Panax notoginseng total saponins tablets, Panax notoginseng total saponins capsules, etc.

[0004] The use of notoginseng saponins in the preparation of drugs for improving immunity and regulating blood sugar has been developed and studied. For example, the Chinese patent with publication number CN114794478A discloses a composition that can simultaneously reduce blood pressure, blood lipids and blood sugar, and its application. The weight ratio of each component of the composition that can reduce blood pressure, blood lipids and blood sugar is: notoginseng total saponins: mogroside: theanine = 1.5-2.5: 0.5-1.5: 1.5-2.5. This technical solution can effectively maintain blood sugar health through the lipid-lowering effect and neuroprotective effect of notoginseng total saponins and the antioxidant effect of mogroside, and the relief and relaxation of tension by theanine to achieve anti-anxiety and anti-depression effects.

[0005] The Chinese patent with publication number CN104873556A discloses the use of a combination of astragalus polysaccharide and notoginseng total saponin in the preparation of a drug for treating diabetic nephropathy, wherein the combination of astragalus polysaccharide and notoginseng total saponin comprises astragalus polysaccharide: notoginseng total saponin at a weight ratio of 1:1-3:1. The combination of astragalus polysaccharide and notoginseng total saponin in this technical solution can alleviate diabetic kidney damage, and its effect is better than that of astragalus polysaccharide or notoginseng total saponin alone, indicating that astragalus polysaccharide combined with notoginseng total saponin can produce a synergistic effect and delay the occurrence of diabetic nephropathy.

[0006] Publication number CN110201016A Chinese patent discloses a kind of notoginseng saponin composition with blood-tonifying effect, which is composed of notoginseng saponin R1, 20S-R2, 20R-R2 and ginsenoside Rg1, Re, Rb1, Rd, 20S-Rg2, 20R-Rg2, 20S-Rh1, 20R-Rh1, F4, Rk3, Rh4, 20S-Rg3, 20R-Rg3, Rk1, Rg5. The notoginseng saponin composition provided by the technical scheme, combined with the characteristics of each saponin component, plays the effect of promoting blood circulation and tonifying blood, while achieving the improvement of blood deficiency symptoms, it can also improve the immunity of human body, and has no toxic side effects. However, no matter it is notoginseng or notoginseng total saponins, due to its complex composition, it has not yet been studied clearly which specific component plays the main therapeutic effect. Summary of the invention

[0007] In view of the above problems, the present invention provides a composition for improving immunity and regulating blood sugar and its application. The composition obtained by compounding ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate has good effects of improving immunity and lowering blood sugar, and has good stability and solubility under the joint action of carriers and excipients.

[0008] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0009] A composition for improving immunity and regulating blood sugar, the raw materials comprising active substances, the active substances comprising ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate, the mass ratio of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate is 5-15:2-6:2-6:1-5:0.1-0.2.

[0010] In some preferred embodiments, the mass ratio of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate is 8-12:3-5:3-5:2-4:0.15.

[0011] Preferably, the mass ratio of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate is 10:4:4:3:0.15.

[0012] In some preferred embodiments, the composition further comprises a carrier, and the carrier comprises mesoporous silica and / or magnesium aluminum silicate.

[0013] In some preferred embodiments, the mass ratio of the active substance to the carrier is 1:1-3, preferably 1:2.

[0014] In some preferred embodiments, the mass ratio of the mesoporous silica to magnesium aluminum silicate is 2-3:1-2, preferably 2:1.

[0015] In some preferred embodiments, the mesoporous silica is XDP 3050 and SiSol TM A mixture of 6035, XDP 3050 and SiSol TM The mass ratio of 6035 is 3-4:1-2, preferably 3:1.

[0016] In some preferred embodiments, the average particle size of the magnesium aluminum silicate is 2-20 μm, preferably 10-20 μm.

[0017] In some preferred embodiments, the composition further comprises an auxiliary material.

[0018] In some preferred embodiments, the mass ratio of the active substance, the carrier and the auxiliary material is 1:2:1-2, preferably 1:2:1.5.

[0019] In some preferred embodiments, the auxiliary material is a mixture of hydrogenated vegetable oil, β-cyclodextrin and microcrystalline cellulose colloidal silicon dioxide co-processed product; the mass ratio of the hydrogenated vegetable oil, β-cyclodextrin and microcrystalline cellulose colloidal silicon dioxide co-processed product is 15-20:2-5:1, preferably 18:3:1.

[0020] In some preferred embodiments, the hydrogenated vegetable oil includes hydrogenated castor oil and / or hydrogenated soybean oil, preferably hydrogenated castor oil.

[0021] In some preferred embodiments, the microcrystalline cellulose colloidal silicon dioxide co-processed product comprises SH-SMCC50 and / or SH-SMCC90, preferably SH-SMCC50.

[0022] The preparation method of the above composition comprises the following steps:

[0023] S1, mixing mesoporous silica and anhydrous ethanol, adding ginsenoside Rg2, notoginsenoside R1, and ginsenoside Rh1, stirring, and removing anhydrous ethanol by rotary evaporation to obtain a mixture A;

[0024] S2, mixing magnesium aluminum silicate and anhydrous ethanol, adding ginsenoside Rb2, stirring, and removing anhydrous ethanol by rotary evaporation to obtain a mixture B;

[0025] S3. Evenly mix mixture A, mixture B, chromium picolinate and auxiliary materials to obtain a composition.

[0026] Preferably, the mass volume ratio of the mesoporous silica and anhydrous ethanol is 1 g: 20-30 mL.

[0027] Preferably, the mass volume ratio of the magnesium aluminum silicate and anhydrous ethanol is 1g:8-15mL.

[0028] The present invention has no particular limitation on the dosage form of the composition, for example, it can be an oral dosage form or an injection dosage form. The oral dosage form can be a liquid dosage form or a solid dosage form. The oral dosage form can be, for example, a hard capsule, a soft capsule, a sustained-release capsule, a compressed tablet, a sugar-coated tablet, a powder, a granule, a dripping pill, a honeyed pill, a syrup or an oral liquid; the injection dosage form can be, for example, a solution type, a suspension type, an emulsion type or a lyophilized powder.

[0029] The second aspect of the present invention provides the use of the above composition in the preparation of health food and medicine for improving immunity and regulating blood sugar.

[0030] Compared with the prior art, the present invention has the following beneficial effects:

[0031] 1. The composition provided by the present invention has good effects of improving immunity and lowering blood sugar.

[0032] 2. The present invention improves the solubility and stability of the composition by using specific carriers and excipients.

[0033] 3. The present invention improves the solubility and stability of the composition through a specific preparation method. DETAILED DESCRIPTION

[0034] The present invention is further explained below in conjunction with specific embodiments. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0035] In the following examples, unless otherwise specified, all raw materials used were purchased from commercial sources or prepared by conventional methods in the art.

[0036] The sources of raw materials involved in the examples and comparative examples of the present invention are shown in Table 1;

[0037] Table 1

[0038]

[0039] Example 1

[0040] The composition for improving immunity and regulating blood sugar consists of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate in a mass ratio of 5:2:2:1:0.1.

[0041] The preparation method of the composition is as follows: ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate are uniformly mixed to obtain the composition.

[0042] Example 2

[0043] The composition for improving immunity and regulating blood sugar consists of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate in a mass ratio of 10:4:4:3:0.15.

[0044] The preparation method of the composition is the same as that of Example 1.

[0045] Example 3

[0046] The composition for improving immunity and regulating blood sugar consists of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate in a mass ratio of 15:6:6:4:0.2.

[0047] The preparation method of the composition is the same as that of Example 1.

[0048] Example 4

[0049] The composition for improving immunity and regulating blood sugar consists of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate in a mass ratio of 8:3:3:2:0.1.

[0050] The preparation method of the composition is the same as that of Example 1.

[0051] Example 5

[0052] The composition for improving immunity and regulating blood sugar consists of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate in a mass ratio of 12:5:5:4:0.1.

[0053] The preparation method of the composition is the same as that of Example 1.

[0054] Example 6

[0055] A composition for improving immunity and regulating blood sugar, comprising an active substance, a carrier and an excipient in a mass ratio of 1:2:1.5, wherein the active substance comprises ginsenoside Rg2, notoginseng saponin R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate in a mass ratio of 10:4:4:3:0.15; the carrier comprises mesoporous silica and magnesium aluminum silicate FH2 in a mass ratio of 2:1; the mesoporous silica comprises XDP 3050 and SiSol TM6035; the auxiliary material consists of hydrogenated castor oil, β-cyclodextrin and microcrystalline cellulose colloidal silicon dioxide co-processed product SH-SMCC50 in a mass ratio of 18:3:1.

[0056] The preparation method of the composition is:

[0057] S1, mixing mesoporous silica and anhydrous ethanol (the mass volume ratio of mesoporous silica to anhydrous ethanol is 1 g: 25 mL), adding ginsenoside Rg2, notoginsenoside R1, and ginsenoside Rh1, stirring, and removing anhydrous ethanol by rotary evaporation to obtain a mixture A;

[0058] S2, mixing magnesium aluminum silicate FH2 and anhydrous ethanol (the mass volume ratio of magnesium aluminum silicate FH2 and anhydrous ethanol is 1 g: 12 mL), adding ginsenoside Rb2, stirring, and removing anhydrous ethanol by rotary evaporation to obtain mixture B;

[0059] S3. Evenly mix mixture A, mixture B, chromium picolinate and auxiliary materials to obtain a composition.

[0060] Example 7

[0061] A composition for improving immunity and regulating blood sugar, comprising an active substance, a carrier and an excipient in a mass ratio of 1:2:1.5, wherein the active substance comprises ginsenoside Rg2, notoginseng saponin R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate in a mass ratio of 10:4:4:3:0.15; the carrier comprises mesoporous silica and magnesium aluminum silicate FH2 in a mass ratio of 2:1; the mesoporous silica comprises XDP 3050 and SiSol TM 6035; the auxiliary material consists of hydrogenated soybean oil, β-cyclodextrin and microcrystalline cellulose colloidal silicon dioxide co-processed product SH-SMCC90 in a mass ratio of 18:3:1.

[0062] The preparation method of the composition is the same as that of Example 6.

[0063] Comparative Example 1

[0064] The composition for improving immunity and regulating blood sugar consists of ginsenoside Rg2 and chromium picolinate in a mass ratio of 10:0.1.

[0065] The preparation method of the composition comprises the following steps: uniformly mixing ginsenoside Rg2 and chromium picolinate.

[0066] Comparative Example 2

[0067] The composition for improving immunity and regulating blood sugar consists of ginsenoside Rg2, notoginsenoside R1 and chromium picolinate in a mass ratio of 8:2:0.1.

[0068] The preparation method of the composition comprises the following steps: uniformly mixing ginsenoside Rg2, notoginsenoside R1 and chromium picolinate.

[0069] Comparative Example 3

[0070] The composition for improving immunity and regulating blood sugar consists of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1 and chromium picolinate in a mass ratio of 6:2:2:0.1.

[0071] The preparation method of the composition comprises the following steps: uniformly mixing ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1 and chromium picolinate.

[0072] Comparative Example 4

[0073] The difference from Example 1 is that ginsenoside Rg2 is replaced by ginsenoside Rg1 of equal mass, and the rest are the same.

[0074] The preparation method of the composition is the same as that of Example 1.

[0075] Comparative Example 5

[0076] The difference from Example 1 is that ginsenoside Rb2 is replaced by ginsenoside Rb1 of equal mass, and the rest are the same.

[0077] The preparation method of the composition is the same as that of Example 1.

[0078] Comparative Example 6

[0079] The composition for improving immunity and regulating blood sugar consists of Panax notoginseng extract and chromium picolinate in a mass ratio of 500:1.

[0080] The preparation method of Panax notoginseng extract is as follows: crush Panax notoginseng, pass it through a 10-mesh sieve to obtain Panax notoginseng powder; add 8 times the amount of 70% ethanol, soak for 0.5h, reflux extraction 3 times, the first reflux extraction is 2h, and the next two reflux extractions are 1.5h respectively to obtain ethanol extract, reduce pressure to recover ethanol, the vacuum degree is 0.08-0.09MPa, the temperature is 70-80℃, to obtain extract; reduce pressure and concentrate, the temperature is 80℃, the vacuum degree is 0.08MPa, concentrate to a relative density of 1.10-1.20, to obtain a thick extract; reduce pressure and dry, the vacuum degree is 0.07-0.08MPa, the temperature is 70-80℃, to obtain a dry product; crush, pass through a 100-mesh sieve to obtain Panax notoginseng extract.

[0081] The preparation method of the composition is to mix the notoginseng extract and chromium picolinate.

[0082] Comparative Example 7

[0083] The difference from Example 6 is that the mesoporous silica is XDP 3050, all other components are the same.

[0084] The preparation method of the composition is the same as that of Example 6.

[0085] Comparative Example 8

[0086] The difference from Example 6 is that magnesium aluminum silicate is replaced by mesoporous silica, and the rest is the same.

[0087] The preparation method of the composition is the same as that of Example 6.

[0088] Comparative Example 9

[0089] The difference from Example 6 is that the mesoporous silica is replaced by colloidal silica Aerosil 200 pharma, and the rest are the same.

[0090] The preparation method of the composition is the same as that of Example 6.

[0091] Comparative Example 10

[0092] The difference from Example 6 is that the co-processed microcrystalline cellulose and colloidal silicon dioxide are replaced with microcrystalline cellulose AVICEL PH-105, and the rest are the same.

[0093] The preparation method of the composition is the same as that of Example 6.

[0094] Comparative Example 11

[0095] The difference from Example 6 is that β-cyclodextrin is replaced by microcrystalline cellulose and colloidal silicon dioxide co-processed product, and the rest is the same.

[0096] The preparation method of the composition is the same as that of Example 6.

[0097] Comparative Example 12

[0098] The difference from Example 6 is that the preparation method of the composition is:

[0099] S1, mixing magnesium aluminum silicate FH2 and anhydrous ethanol (the mass volume ratio of magnesium aluminum silicate FH2 and anhydrous ethanol is 1 g: 25 mL), adding ginsenoside Rg2, notoginsenoside R1, and ginsenoside Rh1, stirring, and removing anhydrous ethanol by rotary evaporation to obtain mixture A;

[0100] S2, mixing mesoporous silica and anhydrous ethanol (the mass volume ratio of mesoporous silica to anhydrous ethanol is 1 g:12 mL), adding ginsenoside Rb2, stirring, and removing anhydrous ethanol by rotary evaporation to obtain a mixture B;

[0101] S3. Evenly mix mixture A, mixture B, chromium picolinate and auxiliary materials to obtain a composition.

[0102] Experimental Example 1 Verification of the blood sugar regulating effect of the composition

[0103] 1. Experimental Animals

[0104] Clean grade Kunming male mice, weighing 24-27g.

[0105] 2. Experimental drugs

[0106] The compositions of Examples 1-5 and Comparative Examples 1-6 are prepared by using distilled water to prepare solutions of desired concentrations.

[0107] 3. Experimental methods

[0108] 3.1 Modeling

[0109] The experiment started after the mice were adaptively fed for 3 days. After fasting for 24 hours, the mice were given a single intraperitoneal injection of tetraoxane (50 mg / kg Bw) to establish the model. After fasting for 4 hours 7 days later, blood was taken from the inner canthus of the eye to measure blood sugar. If the blood sugar value was 10-25 mmnol / L, the hyperglycemia model was considered to be successfully established.

[0110] 3.2 Grouping

[0111] The model mice were randomly divided into a model group, a low (125 mg / kg, equivalent to 5 times the recommended dose for humans), a medium (250 mg / kg, equivalent to 10 times the recommended dose for humans), and a high (500 mg / kg, equivalent to 20 times the recommended dose for humans) dose group of Example 1, a low (125 mg / kg, equivalent to 5 times the recommended dose for humans), a medium (250 mg / kg, equivalent to 10 times the recommended dose for humans), and a high (500 mg / kg, equivalent to 20 times the recommended dose for humans) dose group of Example 2, a low (125 mg / kg, equivalent to 5 times the recommended dose for humans), a medium (250 mg / kg, equivalent to 10 times the recommended dose for humans), and a high (500 mg / kg, equivalent to 20 times the recommended dose for humans) dose group of Example 3, a low (125 mg / kg, equivalent to 5 times the recommended dose for humans), a medium (250 mg / kg, equivalent to 10 times the recommended dose for humans), and a high (500 mg / kg, equivalent to 20 times the recommended dose for humans) dose group of Example 4. The invention discloses a group of 1000 mg / kg mice, each containing 10 mice. The group of Example 5 includes a low (125 mg / kg, equivalent to 5 times the recommended dosage for human body), a medium (250 mg / kg, equivalent to 10 times the recommended dosage for human body), a high dose (500 mg / kg, equivalent to 20 times the recommended dosage for human body) group, a group of Example 5 includes a low (125 mg / kg, equivalent to 5 times the recommended dosage for human body), a medium (250 mg / kg, equivalent to 10 times the recommended dosage for human body), a high dose (500 mg / kg, equivalent to 20 times the recommended dosage for human body) group, a comparative example 1 group (250 mg / kg, equivalent to 10 times the recommended dosage for human body), a comparative example 2 group (250 mg / kg, equivalent to 10 times the recommended dosage for human body), a comparative example 3 group (250 mg / kg, equivalent to 10 times the recommended dosage for human body), a comparative example 4 group (250 mg / kg, equivalent to 10 times the recommended dosage for human body), a comparative example 5 group (250 mg / kg, equivalent to 10 times the recommended dosage for human body), and a comparative example 6 group (250 mg / kg, equivalent to 10 times the recommended dosage for human body), each containing 10 mice. In addition, 10 normal mice (not modeled) were selected as the normal group.

[0112] 3.3 Administration

[0113] The mice were gavaged at a volume of 10 mL / kg.BW once a day for 4 consecutive weeks. After 4 weeks, the fasting blood glucose of the mice was tested with a blood glucose meter after fasting for 3 hours. The normal group and the model group were given the same volume of distilled water.

[0114] 3.4 Statistical methods

[0115] All data were analyzed using SPSS 22.0 statistical software. The comparison among the groups was performed by one-way analysis of variance, and P < 0.05 was considered statistically significant.

[0116] 4. Experimental results

[0117] Table 2 Fasting blood glucose levels in mice

[0118]

[0119] Experimental Example 2 Verification of the Immunity-enhancing Effect of the Composition

[0120] 1. Experimental animals: nude mice, half male and half female, weighing 18-22 g.

[0121] 2. Experimental drugs: the compositions of Examples 1-5 and Comparative Examples 1-6, preparation method: prepare a 0.6 g / mL solution with distilled water.

[0122] 3. Experimental methods

[0123] 3.1 Grouping

[0124] The mice were randomly divided into a control group, Example 1 group, Example 2 group, Example 3 group, Example 4 group, Example 5 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group, and Comparative Example 6 group, with 10 mice in each group (half male and half female).

[0125] 3.2 Administration

[0126] The drug was administered at a volume of 0.2 mL / 20 g.BW, once a day for 2 weeks, and the control group was given distilled water.

[0127] 3.3 Experiments:

[0128] (1) Experiment on phagocytosis of chicken red blood cells by mouse peritoneal macrophages (drop method): 4 days before the experiment, 0.2 mL of 2% packed sheep red blood cells was injected into the peritoneum of each mouse. After continuous gavage for 2 weeks, the mice were killed by cervical dislocation and 4 mL of Hank's solution with calf serum was injected into the peritoneum. The abdomen was gently massaged 20 times to fully wash out the peritoneal macrophages. Then a small incision was made in the abdominal wall and 2 mL of peritoneal washing fluid was drawn into a test tube with a rubber-tipped pipette. 0.5 mL of peritoneal washing fluid was drawn into a test tube containing 0.5 mL of 1% chicken red blood cell suspension using a 1 mL pipette and mixed. 0.5 mL of the mixed solution was drawn into the agar circle of the glass slide using a syringe. The slide was placed in an incubator at 37°C for 15-20 min. After the incubation, the non-adherent cells were quickly washed away with physiological saline, fixed in methanol solution for 1 min, and stained with Giemsa solution for 15 min. Rinse with distilled water, dry, and count the phagocytic index using a 40× microscope.

[0129] Phagocytic index = total number of phagocytic red blood cells / number of phagocytic cells counted

[0130] (2) DNFB-induced delayed allergic reaction in mice (ear swelling method): After continuous oral administration for 2 weeks, the abdominal hair of each mouse was shaved with a shaver, covering an area of ​​about 3 cm × 3 cm, and 50 μL of 10 mg / mL DNFB solution was evenly applied to induce sensitization. Five days later, 10 μL of 10 mg / mL DNFB solution was evenly applied to the right ear (both sides) of the mouse for attack. 24 hours after the attack, the mouse was killed by cervical dislocation, the left and right ear shells were cut off, and the 8 mm straight ear piece was removed with a punch and weighed.

[0131] Ear weight difference (mg) = right ear weight (mg) - left ear weight (mg)

[0132] 3.4 Statistical methods

[0133] All data were analyzed using SPSS 22.0 statistical software. The comparison among the groups was performed by one-way analysis of variance, and P < 0.05 was considered statistically significant.

[0134] 4. Experimental results

[0135] Table 3 Results of the experiment on phagocytosis of chicken red blood cells by mouse peritoneal macrophages and delayed-type hypersensitivity reaction induced by DNFB in mice

[0136]

[0137] Experimental Example 3 Verification of the dissolution and stability of the composition

[0138] 1. Preparation of soft capsules:

[0139] The compositions of Examples 6-7 and Comparative Examples 7-12 are used as capsule contents, and the components of the capsule shell are composed of 135 parts of gelatin, 54 parts of glycerin, 148.5 parts of water and 7.5 parts of caramel pigment, by mass. The preparation method is as follows: (1) preparing capsule liquid: first, add caramel pigment to an appropriate amount of purified water to completely dissolve it, so as to obtain a caramel pigment solution; separately, place glycerin and the remaining purified water in a gel tank, mix them evenly, add gelatin and caramel pigment solution when heated to 60°C, mix them evenly, heat them together to 80°C to melt into a uniform gel solution, keep the temperature constant for 2 hours, evacuate to remove bubbles in the gel solution, and when the temperature of the gel solution drops below 65°C, filter the gel with a 100-mesh filter to remove surface foam, and finally keep the temperature at 60°C-65°C for 8 hours for standby use.

[0140] (2) The capsule contents are pressed into pellets using a soft capsule machine, wherein the indoor temperature is controlled at 18-22° C. and the relative humidity is controlled at 40-50%, and each soft capsule weighs 0.5 g.

[0141] (3) After forming, the capsules are shaped, the indoor temperature is controlled at 18-22° C., the relative humidity is 40-50%, and the air is blown to dry for about 4 hours.

[0142] (4) Drying The shaped soft capsules are placed in a clean dry room at a room temperature of 24-28° C. and a relative humidity of 30-40% for static drying for 24 hours.

[0143] (5) The dried soft capsules were washed with food-grade 95% ethanol to remove oil stains on the soft capsule shells.

[0144] (6) Place the washed soft capsules in a clean dry room and dry them statically for 2 hours, maintaining the room temperature at 24-28° C. and the indoor relative humidity at 30-40%.

[0145] 2. Dissolution test: 10 tablets of each of the examples and comparative examples were taken for determination, and 950 mL of pH 6.8 artificial intestinal fluid (6.46 g of potassium dihydrogen phosphate and 0.89 g of sodium hydroxide were weighed, dissolved in water, and diluted to 950 mL, and ultrasonic degassed to obtain the result) was used as the dissolution medium, the speed was 100 r / min, and the operation was carried out according to the law. At 10 min, 15 min, 30 min, and 45 min of dissolution, appropriate amounts of the solution were taken and filtered through a 0.45 μm microporous filter. The samples were filtered through a membrane (water system, 13 mm in diameter), 2 mL of the initial filtrate was discarded, and the subsequent filtrate was used to determine the content of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, and ginsenoside Rb2. The injection volume was 20 uL. Another appropriate amount of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, and ginsenoside Rb2 reference substances were taken, accurately weighed, dissolved in methanol, and quantitatively diluted to make a solution containing about 2 μg per 1 mL. The solution was determined in the same way, and the injection volume was 10 uL. The average dissolution of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, and ginsenoside Rb2 was calculated by the external standard method. The results are shown in Table 4.

[0146] Table 4 Dissolution results

[0147]

[0148]

[0149] 3. Accelerated stability test: refer to the accelerated test in the 2015 edition of the Chinese Pharmacopoeia, Part IV, General Chapter 9001, Guidelines for Stability Tests of Active Pharmaceutical Ingredients and Preparations. Place the capsules at a temperature of 40±2°C and a relative humidity of 75±5% for 6 months. Take samples once at the end of the 1st, 3rd and 6th month of the test to examine the odor and precipitation of the soft capsule contents. The results are shown in Table 5.

[0150] Table 5 Accelerated stability results

[0151]

[0152] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A composition for improving immunity and regulating blood sugar, characterized in that: The raw materials include active substances, and the active substances include ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate. The mass ratio of notoginsenoside R1, ginsenoside Rg2, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate is 5-15:2-6:2-6:1-5:0.

1.

2. The composition according to claim 1, characterized in that The mass ratio of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate is 8-12:3-5:3-5:2-4:0.

1.

3. The composition according to claim 2, characterized in that The mass ratio of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate is 10:4:4:3:0.

1.

4. The composition according to claim 1, characterized in that The composition further comprises a support comprising mesoporous silica and / or magnesium aluminum silicate.

5. The composition according to claim 4, characterized in that The mass ratio of the mesoporous silica to magnesium aluminum silicate is 2-3:1-2.

6. The composition according to claim 4, characterized in that The mesoporous silica is XDP 3050 and SiSol TM A mixture of 6035, XDP 3050 and SiSol TM The mass ratio of 6035 is 3-4:1-2.

7. The composition according to claim 1, characterized in that The composition also includes auxiliary materials, which are a mixture of hydrogenated vegetable oil, beta-cyclodextrin and microcrystalline cellulose colloidal silicon dioxide co-processed product; the mass ratio of the hydrogenated vegetable oil, beta-cyclodextrin and microcrystalline cellulose colloidal silicon dioxide co-processed product is 15-20:2-5:

1.

8. The composition according to claim 7, characterized in that The hydrogenated vegetable oil includes hydrogenated castor oil and / or hydrogenated soybean oil.

9. The composition according to any one of claims 4 to 8, characterized in that The preparation method of the composition comprises the following steps: S1, mixing mesoporous silica and anhydrous ethanol, adding ginsenoside Rg2, notoginsenoside R1, and ginsenoside Rh1, stirring, and removing anhydrous ethanol by rotary evaporation to obtain a mixture A; S2, mixing magnesium aluminum silicate and anhydrous ethanol, adding ginsenoside Rb2, stirring, and removing anhydrous ethanol by rotary evaporation to obtain a mixture B; S3. Evenly mix mixture A, mixture B, chromium picolinate and auxiliary materials to obtain a composition.

10. Use of the composition according to any one of claims 1 to 8 in the preparation of health food and medicine for improving immunity and regulating blood sugar.

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