A composition for enhancing immunity and regulating blood sugar and its application

Abstract

The present invention belongs to the technical field of health foods, and particularly relates to a composition for enhancing immunity and regulating blood sugar and its application. The raw materials of the composition include active substances, and the active substances include 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. The composition obtained by compounding ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2, and chromium picolinate in the present invention has good effects of enhancing immunity and reducing blood sugar.

Description

Technical Field

[0001] The present invention belongs to the technical field of health foods, and particularly relates to a composition for enhancing immunity and regulating blood sugar and its application. Background Art

[0002] Panax notoginseng is a plant of the genus Panax in the family Araliaceae. It is a widely used and representative traditional Chinese medicine in China, and has pharmacological activities such as anti - inflammation, hemostasis, anti - aging, and anti - tumor. Chinese patent medicines with Panax notoginseng as the active ingredient are widely used, such as Sanqi Xueshangning Capsule, Compound Danshen Tablets, Sanqi Shangyao Tablets, Sanqi Tongshu Capsule, Sanqi Chromium Soft Capsule, etc.

[0003] In recent years, pharmaceutical preparations with the effective parts of traditional Chinese medicines as the main active ingredients have been continuously developed and studied. Saponins are one of the main active ingredients of Panax notoginseng. More than 200 saponin compounds have been found in Panax notoginseng so far. Representative monomer saponins such as ginsenoside Rg1, Rb1, Rb2, Rc, Rd, Re, and notoginsenoside R1, etc. Chinese patent medicines with total saponins of Panax notoginseng as the active ingredient include Xuesaitong Injection, Xuanshuantong Injection, Total Panax Notoginseng Glycosides Tablets, Total Panax Notoginseng Glycosides Capsules, etc.

[0004] The use of notoginsenosides for preparing drugs for enhancing immunity and regulating blood sugar has been developed and studied. For example, Chinese Patent No. CN114794478A discloses a composition capable of simultaneously reducing blood pressure, blood lipid and blood sugar, and its application. The weight ratio of each component of the composition capable of reducing blood pressure, blood lipid and blood sugar is: total saponins of Panax notoginseng: mogroside: L - 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 total saponins of Panax notoginseng, the antioxidant effect of mogroside, and the anti - anxiety and anti - depression effects of L - theanine by the synergistic compounding of total saponins of Panax notoginseng, mogroside and L - theanine.

[0005] Chinese Patent No. CN104873556A discloses the application of astragalus polysaccharide and total saponins of Panax notoginseng composition in the preparation of drugs for treating diabetic nephropathy, wherein the astragalus polysaccharide and total saponins of Panax notoginseng composition includes astragalus polysaccharide: total saponins of Panax notoginseng with a weight ratio of 1:1 - 3:1. The astragalus polysaccharide and total saponins of Panax notoginseng composition in this technical solution can reduce diabetic kidney damage, and its effect is better than that of using astragalus polysaccharide alone or total saponins of Panax notoginseng alone, suggesting that the combination of astragalus polysaccharide and total saponins of Panax notoginseng can produce a synergistic effect and delay the occurrence of diabetic nephropathy.

[0006] Chinese Patent No. CN110201016A discloses a notoginsenoside composition with blood-enriching effects, which is composed of notoginsenoside R1, 20S-R2, 20R-R2, and ginsenosides Rg1, Re, Rb1, Rd, 20S-Rg2, 20R-Rg2, 20S-Rh1, 20R-Rh1, F4, Rk3, Rh4, 20S-Rg3, 20R-Rg3, Rk1, and Rg5. The notoginsenoside composition provided by this technical solution combines the characteristics of each ginsenoside component to achieve the effects of promoting blood circulation and enriching blood. While improving the symptoms of blood deficiency, it can also enhance the body's immunity and has no toxic or side effects. However, whether it is notoginseng or total notoginsenosides, due to their complex components, it is not yet clear which specific component plays the main therapeutic role. Summary of the Invention

[0007] In view of the above problems, the present invention provides a composition for enhancing 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 enhancing immunity and reducing blood sugar, and has good stability and dissolution rate under the combined action of a carrier and excipients.

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

[0009] A composition for enhancing immunity and regulating blood sugar, 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 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 includes a carrier, and the carrier includes 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 the magnesium aluminum silicate is 2-3:1-2, preferably 2:1.

[0015] In some preferred embodiments, the mesoporous silica is a mixture of XDP 3050 and SiSol TM 6035, and the mass ratio of XDP 3050 to SiSol TM 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 excipients.

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

[0019] In some preferred embodiments, the excipients are a mixture of hydrogenated vegetable oil, β-cyclodextrin and microcrystalline cellulose colloidal silica co-processed product; the mass ratio of the hydrogenated vegetable oil, β-cyclodextrin and microcrystalline cellulose colloidal silica 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 silica co-processed product includes SH-SMCC50 and / or SH-SMCC90, preferably SH-SMCC50.

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

[0023] S1. Mix the mesoporous silica and absolute ethanol, add ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, stir, and remove the absolute ethanol by rotary evaporation to obtain mixture A;

[0024] S2. Mix the magnesium aluminum silicate and absolute ethanol, add ginsenoside Rb2, stir, and remove the absolute ethanol by rotary evaporation to obtain mixture B;

[0025] S3. Mix mixture A, mixture B, chromium picolinate and excipients evenly to obtain the composition.

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

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

[0028] The present invention has no special 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, hard capsules, soft capsules, sustained-release or controlled-release capsules, tablets, sugar-coated tablets, powders, granules, dripping pills, honeyed pills, syrups or oral liquids; the injection dosage form can be, for example, solution type, suspension type, emulsion type or freeze-dried powder.

[0029] The second aspect of the present invention provides the application of the above composition in the preparation of health foods and drugs for enhancing 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 enhancing immunity and lowering blood sugar.

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

[0033] 3. The present invention improves the dissolution rate and stability of the composition by a specific preparation method. Detailed Embodiments

[0034] The present invention will be further illustrated below in conjunction with specific embodiments. It should be understood that the specific embodiments described herein are only for the purpose of illustrating and explaining the present invention, and are not intended to limit the present invention.

[0035] In the following examples, unless otherwise specified, the raw materials used are all commercially available or prepared by conventional methods in the art.

[0036] The sources of the 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] A composition for enhancing immunity and regulating blood sugar, which is composed 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 mixed evenly to obtain the composition.

[0042] Example 2

[0043] The composition for enhancing immunity and regulating blood sugar is composed 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 enhancing immunity and regulating blood sugar is composed 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 enhancing immunity and regulating blood sugar is composed 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 enhancing immunity and regulating blood sugar is composed 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] The composition for enhancing immunity and regulating blood sugar is composed of an active substance, a carrier and an adjuvant in a mass ratio of 1:2:1.5. The active substance is composed of Ginsenoside Rg2, Notoginsenoside R1, Ginsenoside Rh1, Ginsenoside Rb2 and Chromium Picolinate in a mass ratio of 10:4:4:3:0.15; the carrier is composed of mesoporous silica and magnesium aluminum silicate FH2 in a mass ratio of 2:1; the mesoporous silica is composed of XDP 3050 and SiSol in a mass ratio of 3:1 XDP 3050 and SiSol TMIt is composed of 6035; the auxiliary material is composed of hydrogenated castor oil, β-cyclodextrin and microcrystalline cellulose colloidal silica co-processed product SH-SMCC50 with a mass ratio of 18:3:1.

[0056] The preparation method of the composition is as follows:

[0057] S1. Mix mesoporous silica and absolute ethanol (the mass-volume ratio of mesoporous silica to absolute ethanol is 1 g:25 mL), add ginsenoside Rg2, notoginsenoside R1, and ginsenoside Rh1, stir, and remove absolute ethanol by rotary evaporation to obtain mixture A;

[0058] S2. Mix magnesium aluminum silicate FH2 and absolute ethanol (the mass-volume ratio of magnesium aluminum silicate FH2 to absolute ethanol is 1 g:12 mL), add ginsenoside Rb2, stir, and remove absolute ethanol by rotary evaporation to obtain mixture B;

[0059] S3. Mix mixture A, mixture B, chromium picolinate and the auxiliary material evenly to obtain the composition.

[0060] Example 7

[0061] A composition for enhancing immunity and regulating blood sugar, which is composed of an active substance, a carrier and an auxiliary material with a mass ratio of 1:2:1.5. The active substance is composed of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, ginsenoside Rb2 and chromium picolinate with a mass ratio of 10:4:4:3:0.15; the carrier is composed of mesoporous silica and magnesium aluminum silicate FH2 with a mass ratio of 2:1; the mesoporous silica is composed of XDP 3050 and SiSol TM It is composed of 6035; the auxiliary material is composed of hydrogenated soybean oil, β-cyclodextrin and microcrystalline cellulose colloidal silica co-processed product SH-SMCC90 with 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] A composition for enhancing immunity and regulating blood sugar, which is composed of ginsenoside Rg2 and chromium picolinate with a mass ratio of 10:0.1.

[0065] The preparation method of the composition is to mix ginsenoside Rg2 and chromium picolinate evenly to obtain it.

[0066] Comparative Example 2

[0067] A composition for enhancing immunity and regulating blood sugar, which is composed of ginsenoside Rg2, notoginsenoside R1 and chromium picolinate with a mass ratio of 8:2:0.1.

[0068] The preparation method of the composition is to uniformly mix ginsenoside Rg2, notoginsenoside R1 and chromium picolinate to obtain it.

[0069] Comparative Example 3

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

[0071] The preparation method of the composition is to uniformly mix ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1 and chromium picolinate to obtain it.

[0072] Comparative Example 4

[0073] The difference from Example 1 is that ginsenoside Rg2 is replaced with the same mass of ginsenoside Rg1, 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 with the same mass of ginsenoside Rb1, 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 enhancing immunity and regulating blood sugar is composed of notoginseng extract and chromium picolinate with a mass ratio of 500:1.

[0080] The preparation method of the notoginseng extract is as follows: pulverize notoginseng, sieve it through a 10-mesh sieve to obtain notoginseng powder; add 8 times the amount of 70% ethanol, soak for 0.5 h, and reflux extract 3 times. The first reflux extraction is for 2 h, and the latter two reflux extractions are for 1.5 h each to obtain an ethanol extract. Recover ethanol under reduced pressure, with a vacuum degree of 0.08 - 0.09 MPa and a temperature of 70 - 80 °C to obtain an extract; concentrate under reduced pressure, with a temperature of 80 °C and a vacuum degree of 0.08 MPa, concentrate to a relative density of 1.10 - 1.20 to obtain a thick extract; dry under reduced pressure, with a vacuum degree of 0.07 - 0.08 MPa and a temperature of 70 - 80 °C to obtain a dried product; pulverize and sieve it through a 100-mesh sieve to obtain the notoginseng extract.

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

[0082] Comparative Example 7

[0083] The difference from Example 6 is that the mesoporous silica is XDP 3050, and the rest are the same.

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

[0085] Comparative Example 8

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

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

[0088] Comparative Example 9

[0089] The difference from Example 6 is that mesoporous silica is replaced with colloidal silica Aerosil200pharma, and the rest are the same.

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

[0091] Comparative Example 10

[0092] The difference from Example 6 is that the microcrystalline cellulose colloidal silica co-processed product is 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 in Example 6.

[0094] Comparative Example 11

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

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

[0097] Comparative Example 12

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

[0099] S1. Mix magnesium aluminum silicate FH2 and absolute ethanol (the mass-volume ratio of magnesium aluminum silicate FH2 to absolute ethanol is 1 g: 25 mL), add ginsenoside Rg2, notoginsenoside R1, and ginsenoside Rh1, stir, and remove absolute ethanol by rotary evaporation to obtain mixture A;

[0100] S2. Mix mesoporous silica and absolute ethanol (the mass-volume ratio of mesoporous silica to absolute ethanol is 1 g: 12 mL), add ginsenoside Rb2, stir, and remove absolute ethanol by rotary evaporation to obtain mixture B;

[0101] S3. Mix mixture A, mixture B, chromium picolinate and excipients evenly to obtain the composition.

[0102] Experimental Example 1 Verifying the Blood Glucose-Regulating Effect of the Composition

[0103] 1. Experimental Animals

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

[0105] 2. Experimental Drugs

[0106] The compositions of Examples 1 - 5 and Comparative Examples 1 - 6, preparation method: prepared into a solution with the required concentration using distilled water.

[0107] 3. Experimental Methods

[0108] 3.1 Model Establishment

[0109] After 3 days of adaptive feeding of the mice, the experiment was started. After the mice were fasted for 24 h, they were intraperitoneally injected with alloxan (50 mg / kg Bw) once to establish the model. After 7 days, they were fasted for 4 h, and blood was taken from the inner canthus of the eye to measure blood glucose. If the blood glucose value was 10 - 25 mmol / L, it could be considered that the establishment of the hyperglycemic model was successful.

[0110] 3.2 Grouping

[0111] The model mice were randomly divided into a model group, low-dose groups (125 mg / kg, equivalent to 5 times the recommended human dosage), medium-dose groups (250 mg / kg, equivalent to 10 times the recommended human dosage), high-dose groups (500 mg / kg, equivalent to 20 times the recommended human dosage) of Example 1, Example 2, Example 3, Example 4, and Example 5, a group of Comparative Example 1 (250 mg / kg, equivalent to 10 times the recommended human dosage), a group of Comparative Example 2 (250 mg / kg, equivalent to 10 times the recommended human dosage), a group of Comparative Example 3 (250 mg / kg, equivalent to 10 times the recommended human dosage), a group of Comparative Example 4 (250 mg / kg, equivalent to 10 times the recommended human dosage), a group of Comparative Example 5 (250 mg / kg, equivalent to 10 times the recommended human dosage), and a group of Comparative Example 6 (250 mg / kg, equivalent to 10 times the recommended human dosage), with 10 mice in each group. Another 10 normal mice (not modeled) were selected as the normal group.

[0112] 3.3 Administration of drugs

[0113] Gavage was performed at a volume of 10 mL / kg.BW once a day for 4 consecutive weeks. After 4 weeks, the mice were fasted for 3 h, and then their fasting blood glucose was measured using a blood glucose meter. The normal group and the model group were given the same volume of distilled water.

[0114] 3.4 Statistical methods

[0115] All data were statistically analyzed using SPSS 22.0 statistical software. The statistic was expressed as . One-way ANOVA was used for comparison between groups. P < 0.05 was considered statistically significant.

[0116] 4. Experimental results

[0117] Table 2 Fasting blood glucose levels of mice

[0118]

[0119] Experimental Example 2 verifies the effect of the composition on enhancing immunity

[0120] 1. Experimental animals: Nude mice, half male and half female, with a body weight of 18 - 22 g.

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

[0122] 3. Experimental method

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

[0127] 3.3 Experiment:

[0128] (1) Experiment on phagocytosis of chicken red blood cells by mouse peritoneal macrophages (drop - slide method): 4 days before the experiment, inject 0.2 mL of 2% packed sheep red blood cells into the peritoneal cavity of each mouse. After continuous gavage for 2 weeks, the mice were sacrificed by cervical dislocation. Inject 4 mL / only of Hank's solution with calf serum into the peritoneal cavity, gently massage the abdomen 20 times to fully wash out peritoneal macrophages, then cut a small opening in the abdominal wall, and use a rubber - tipped pipette to aspirate 2 mL of peritoneal lavage fluid into a test tube. Use a 1 mL pipettor to aspirate 0.5 mL of peritoneal lavage fluid and add it to a test tube containing 0.5 mL of 1% chicken red blood cell suspension, and mix well. Use a syringe to aspirate 0.5 mL of the mixed solution and add it to the agar circle on the slide. Place it in an incubator at 37 °C for 15 - 20 min. After incubation, quickly wash away the non - adherent cells with physiological saline, fix in methanol solution for 1 min, and stain with Giemsa solution for 15 min. Rinse with distilled water, air - dry, and count the phagocytosis index under a 40× microscope.

[0129] Phagocytosis index = Total number of chicken red blood cells phagocytized / Number of phagocytic cells counted

[0130] (2) DNFB-induced delayed-type hypersensitivity in mice (ear swelling method): After continuous intragastric administration for 2 weeks, the abdominal hair of each mouse was shaved off with a hair clipper in an area of approximately 3 cm × 3 cm, and 50 μL of a 10 mg / mL DNFB solution was evenly applied for sensitization. Five days later, 10 μL of a 10 mg / mL DNFB solution was evenly applied to the right ear (both sides) of the mice for challenge. After the challenge, the mice were sacrificed by cervical dislocation 24 h later. The left and right ear shells were cut off, and ear pieces with a diameter of 8 mm were punched out 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 statistically analyzed using SPSS 22.0 statistical software. The statistic is represented by , and one-way ANOVA was used for comparison between groups. 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 peritoneal macrophages in mice and DNFB-induced delayed-type hypersensitivity in mice

[0136]

[0137] Experimental example three verifies 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 were used as the capsule contents. The components of the capsule shell, by mass, consisted of 135 parts of gelatin, 54 parts of glycerol, 148.5 parts of water, and 7.5 parts of caramel pigment. The preparation method was as follows: (1) Preparation of the capsule liquid: First, the caramel pigment was added to an appropriate amount of purified water to completely dissolve it to obtain a caramel pigment solution; then, glycerol and the remaining purified water were placed in a gelatinization tank, mixed evenly, heated to 60 °C, and gelatin and the caramel pigment solution were added and mixed evenly again. Then, the mixture was heated to 80 °C to melt into a uniform gelatinous liquid, kept at a constant temperature for 2 h, and the air bubbles in the gelatinous liquid were removed by vacuum pumping. When the temperature of the gelatinous liquid dropped below 65 °C, the gelatinous liquid was released and filtered through a 100-mesh sieve to remove the surface foam. Finally, it was kept at 60 °C - 65 °C and allowed to stand for 8 hours for use.

[0140] (2) The capsule contents were pressed into pills using a soft capsule machine. Among them, the temperature in the control room was controlled at 18 - 22 °C, and the relative humidity was controlled at 40 - 50%. Each soft capsule content weighed 0.5 g.

[0141] (3) After forming, shape the capsules, control the indoor temperature at 18 - 22 °C, the relative humidity at 40 - 50%, and dry them by blowing air for about 4 hours.

[0142] (4) Drying Place the shaped soft capsules in a clean and dry room with an indoor temperature of 24 - 28 °C and a relative humidity of 30 - 40%, and dry them statically for 24 hours.

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

[0144] (6) Place the washed soft capsules in a clean and dry room for static drying for 2 hours, keeping the indoor temperature at 24 - 28 °C and the indoor relative humidity at 30 - 40% to obtain the product.

[0145] 2. Dissolution test: Take 10 capsules each from the examples and comparative examples for determination. Use 950 mL of pH 6.8 artificial intestinal fluid (weigh 6.46 g of potassium dihydrogen phosphate and 0.89 g of sodium hydroxide, dissolve in water, and dilute to 950 mL, then degas by ultrasonic treatment to obtain) as the dissolution medium, with a rotation speed of 100 r / min. Operate according to the law. At 10 min, 15 min, 30 min, and 45 min after dissolution, take an appropriate amount of the solution, filter it through a 0.45 - μm microporous filter membrane (aqueous system, diameter 13 mm), discard the first 2 mL of the initial filtrate, and determine the contents of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, and ginsenoside Rb2 in the subsequent filtrate. The injection volume is 20 μL. Separately, take appropriate amounts of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, and ginsenoside Rb2 reference substances, accurately weigh them, dissolve them separately in methanol and quantitatively dilute to make solutions containing approximately 2 μg per 1 mL. Determine in the same way, with an injection volume of 10 μL. Calculate the average dissolution of ginsenoside Rg2, notoginsenoside R1, ginsenoside Rh1, and ginsenoside Rb2 according to 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 General Principles 9001 Guidelines for Stability Testing of Raw Drugs and Preparations in the Fourth Part of the Chinese Pharmacopoeia 2015 Edition. Place the samples under the conditions of temperature 40 ± 2 °C and relative humidity 75 ± 5% for 6 months. Take samples once at the end of the 1st, 3rd, and 6th months during the test period, and 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 limiting the protection scope of the present invention. Any simple modification or equivalent replacement made by those of ordinary skill in the art to the technical solution of the present invention shall not depart 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, which are composed of 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 a mixture of SYLOID® XDP 3050 and SiSol™ 6035, and the mass ratio of SYLOID® XDP 3050 to SiSol™ 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.

Images