WO2021022891A1 - Composition having immunity-enhancing function and preparation method therefor - Google Patents

Abstract

A composition having an immunity-enhancing function and a preparation method therefor. The composition comprises any four or more of fructus ligustri lucidi, Herba Ecliptae, radix astragali, codonopsis pilosula, and poria cocos.

Description

Composition with function of enhancing immunity and preparation method thereof Technical field

The invention relates to the technical fields of medicines, health products and foods, and in particular to a composition with the function of enhancing immunity and a preparation method thereof.

Background technique

The body with low immunity is prone to infection or various diseases. Various reasons prevent the immune system from playing its protective role normally. In this case, it is very easy to cause infections such as bacteria, viruses, and fungi.

It manifests as frequent illnesses, which aggravate the consumption of the body. People with low immunity have physical weakness, malnutrition, malaise, fatigue, loss of appetite, sleep disturbance, etc., and it takes a long time to recover from illness each time, and they often have repeated attacks.

Modern people are under great pressure in life, and the proportion of "sub-healthy" people continues to increase. In more serious cases, they will suffer from fatigue, decreased sleep quality, dizziness, and decreased resistance. In addition to moderate work and rest, maintaining a happy spirit, and moderate exercise, daily diet conditioning is an ideal way to improve the body's immunity and also to improve immunity.

Summary of the invention

One of the objectives of the present invention is to provide a composition for enhancing immunity function and a preparation method thereof. The composition includes any four or more of Ligustrum lucidum, Eclipta prostrata, Astragalus, Codonopsis and Poria. Wherein, the composition and the raw materials used can be directly ground into powder, or it can be an extract prepared by conventional means or other forms. Preferably, among the four or more medicinal materials selected above, each medicinal material is respectively 1-11 parts by weight of Ligustrum lucidum, 1-11 parts by weight of Eclipta prostrata, 2-7 parts by weight of Astragalus, 1-5 parts by weight of Codonopsis and 1-5 parts by weight of Poria are mixed.

Further, the selected medicinal materials are respectively by weight: Ligustrum lucidum, and any three or more of Eclipta prostrata, Astragalus, Codonopsis and Poria.

Further, the selected medicinal materials by weight are: 1-9 parts of Ligustrum lucidum, 1-9 parts of Eclipta prostrata, 2-6 parts of Astragalus, 1-4 parts of Codonopsis, and 1-4 parts of Poria.

Further, the selected medicinal materials are respectively by weight: 1-5 parts of Ligustrum lucidum, 1-5 parts of Eclipta prostrata, 2-5 parts of Astragalus, 2-4 parts of Codonopsis, and 2-4 parts of Poria.

Preferably, the selected medicinal materials are 3 parts by weight of Ligustrum lucidum, 3 parts of Eclipta prostrata, 2 parts of Astragalus, 3 parts of Codonopsis, and 3 parts of Poria.

The present invention also proposes the application of any of the aforementioned compositions in the preparation of immunity enhancing drugs, health products or foods.

The invention also proposes medicines, health products or foods containing any of the foregoing compositions. In the medicine, health care product or food, the auxiliary materials that may be included are microcrystalline cellulose, hydroxypropyl cellulose, medicinal silicon dioxide, magnesium stearate, gastric-soluble film coating powder and the like.

Specifically, the health product or food is selected from beverages, capsules, tablets, powders, teas, granules, oral liquids or granules.

The present invention also proposes a method for preparing any one of the aforementioned health products or foods, which are selected from oral liquids, characterized in that the preparation method includes the following steps:

(1) Take Ligustrum lucidum, Eclipta prostrata, Astragalus, Codonopsis, Poria, add water 8-12 times, decoct 1-2 times, 1-3 hours each time, filter to obtain the water extract;

(2) Concentration and sterilization: the water extract is vacuum concentrated, filtered, added with auxiliary materials, centrifuged, bottled, and sterilized.

Specifically, the auxiliary materials added in the step (2) include one or more of erythritol, sorbitol, sucrose, erythritol, citric acid, and gluconic acid.

Preferably, the water extract is vacuum concentrated to a relative density of 1.03-1.05 at 60±5°C.

The composition of the present invention includes Ligustrum lucidum, Eclipta prostrata, Astragalus, Codonopsis, and Poria. Among them, Ligustrum lucidum has the effect of nourishing the liver and kidney and improving eyesight and dark hair; Eclipta prostrata has many functions, it has the functions of nourishing kidney, yin, nourishing liver and improving eyesight; Astragalus has liver protection, diuresis, anti-aging, anti-stress Stimulates, lowers blood pressure and has a wide range of antibacterial effects, can eliminate experimental nephritis proteinuria, enhance myocardial contractility, and regulate blood sugar levels. Astragalus can not only expand the coronary arteries and improve the blood supply of the heart muscle, but also delay the process of cell aging. Codonopsis has the effects of nourishing the middle and nourishing qi, invigorating the spleen and lungs. Codonopsis has the effects of expanding blood vessels, lowering blood pressure, improving microcirculation, and enhancing hematopoietic function. Poria has calming heart and tranquility, detoxification and anti-cancer, its medicinal properties are peaceful, dampness and not hurting righteousness. The medicinal materials complement each other, and can be used as health care products or food for long-term use, as well as good medicines for curing diseases. Pharmacodynamic experiments have proved that it can enhance the humoral immune function and strengthen the immune function of mouse monocyte-macrophage by enhancing the rate of carbon particles in the mouse body to be eliminated, which has the effect of significantly enhancing immunity.

detailed description

The following describes the present invention in more detail through specific embodiments, so as to better understand the solutions of the present invention and its advantages in various aspects. However, the content of the specific embodiments described below is for illustrative purposes only, and is not a limitation to the present invention.

It should be noted that if the specific conditions are not specified, they will be carried out in accordance with the conventional conditions or the conditions recommended by the manufacturer. The raw materials or auxiliary materials used, and the reagents or instruments used without the manufacturer’s instructions are all commercially available Regular products. Unless otherwise stated, all percentages, ratios, ratios or parts are by weight.

Unless otherwise defined, all professional and scientific terms used in the text have the same meaning as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to the content described can be applied to the present invention.

Study on the immune effect of the composition of the present invention

1. Grouping and dose setting

Dosage setting principle: The recommended dosage of the composition of Example 1 of the present invention (that is, prepared according to steps (1)-(2)) is 60 ml/day for adults (based on 60 kg body weight), which is equivalent to 1 ml/day/kg body weight. The experiment set 5 times, 10 times, and 30 times the recommended amount of human body, namely 5ml/kg·BW, 10ml/kg·BW, 30ml/kg·BW per day as low, medium, and high dose groups. This experiment set up a blank group (normal saline group) and comparative examples 1-5 groups (decomposed group, 10ml/kg·BW). Each group of 10 rats were given intragastrically once a day. After continuous administration for 30 days, various indexes were measured.

2. Experimental animals

ICR mice, clean grade, 18-22g, male, purchased from the Center of Comparative Medicine of Yangzhou University, certificate number: SCXK(苏)2012-0004.

3. Test method

3.1 Effect on mouse cellular immunity

Method: use delayed allergy (DTH) (foot and plantar thickening method)

Mice were injected intraperitoneally with 2% (V/V) sheep red blood cell SRBC 0.2mL and 4 days after sensitization, the thickness of the left hind foot was measured, and then 20 μL 20% SRBC was subcutaneously injected at the measurement site, and the thickness of the left hind foot was measured 24 hours after injection , Measure the same part 3 times and take the average value. The degree of DTH is expressed by the difference in the thickness of the foot plantar before and after the injection of 20% SRBC (the degree of swelling of the foot distance).

3.2 Effect on mouse humoral immune function

Method: Determine the half hemolysis value (HC ₅₀ )

Each mouse was immunized with 0.2 mL of 2% (V/V) goat red blood cell SRBC into the abdominal cavity for 5 days and then blood was collected to prepare serum, which was diluted 200 times with SA buffer. Take 1 mL and add 0.5 mL of 10% SRBC and 1 mL of complement. Set up another control tube without serum. Incubate in a 37°C water bath for 30 minutes, and stop the reaction in an ice bath. Centrifuge at 2000r/min for 10min. Take 1mL of the supernatant and 3mL of Du's reagent in a test tube. At the same time, take 0.25 mL of 10% SRBC, add Duo's reagent to 4 mL, mix well in another test tube, and place for 1 min. Use the control tube as a blank at 540nm, measure the optical density of each tube, and calculate the HC50 by the following formula.

HC ₅₀ = (Optical Density Value of Mixed Powder Suspension of Composition ÷ Optical Density Value of SRBC Half Hemolysis) × Dilution Times

3.3. Test of phagocytosis of chicken red blood cells by mouse peritoneal macrophages

Each mouse was intraperitoneally injected with 1 mL of 20% chicken erythrocyte suspension, 30 minutes later, the animals were sacrificed, and 2 mL of normal saline was injected into the abdominal cavity, mixed well, sucked 1 mL of abdominal cavity washing liquid, and evenly dropped on 2 slides, and incubated at 37°C 30min. Rinse with normal saline, dry, fix, stain with Giemsa, and check with microscope.

4. Data processing

All data are in

Indicates that analysis of variance and X ² test are used.

5. Judgment basis for results

According to the "Technical Specification for Health Food Inspection and Evaluation)" (2003 edition), the delayed-type allergy (foot swelling method) is used to measure cellular immune function; the half hemolysis value (HC50) method is used to measure humoral immunity Function: The mouse carbon clearance method is used to determine the immune function of mononuclear-macrophages to determine whether it has the effect of enhancing immunity.

6. Experimental results

6.1 Effect on mouse cellular immunity

It can be seen from Table 1 that compared with the blank group, there was no statistically significant difference in plantar swelling of mice in each dose group and comparison group.

Table 1 Effects on mouse cellular immune function

Note: Compared with the blank group, * means P＜0.05, ** means P＜0.01; compared with the middle dose group, ^## means P＜0.01 ^# means P＜0.05.

6.2 Effect on mouse humoral immune function

It can be seen from Table 2 that compared with the blank group, the differences in the half hemolysis value and the number of hemolysis plaques of each composition and the disassembled group of mice are statistically significant. Among them, the low, medium and high dose groups of the composition can all enhance the humoral immune function, and each disassembled group can increase the humoral immune function to varying degrees; but compared with the middle dose group, the disassembled group is weaker in enhancing the humoral immune function.

Table 2 Effects on mouse humoral immune function

Note: Compared with the blank group, * means P<0.05, ** means P<0.01; comparing the split formula group with the middle dose group, ^# means P<0.05, ^## means P<0.01.

6.3 Effect on immune function of normal mouse monocyte-macrophage

Compared with the blank group, each composition and the disassembled group can significantly enhance the effect of the rate of carbon particles in the mouse body. Among them, the low, medium and high dose groups of the composition all enhance the immune function of macrophages, and each disassembled group can also increase the immune function of macrophages to varying degrees; compared with the medium dose group, the disassembled group is effective in enhancing mouse macrophages Immune function is weak. The results are shown in Table 3.

Table 3 Effects on mouse phagocyte function

Note: Compared with the blank group, * means P<0.05, ** means P<0.01; comparing the split group with the middle dose group, ^# means P<0.05, ^## means P<0.01.

7. Experimental conclusion

With reference to the effective daily dose (10ml/kg·BW) of Example 1, respectively, each dosage group of the composition of Example 2 was investigated. It also has the function of enhancing immunity and is within the safe dosage range.

In this experiment, after continuous intragastric administration of low-dose, medium-dose, and high-dose compositions to mice for 30 days, the low-dose, medium-dose and high-dose groups can all enhance the removal rate of carbon particles in mice and enhance body fluids Immune function, enhances the immune function of mouse monocyte-macrophages. According to the "Technical Specification for Health Food Inspection and Evaluation" (2003 Edition), if two of the four experiments are positive, it can be determined that the test sample has a positive result in an animal experiment with immunity enhancing function. Therefore, the composition of the present invention has the function of enhancing immunity and health care. Different medicinal flavors of the composition of the present invention have different effects on enhancing immunity. The lack of any blind flavor will reduce the effect of enhancing immunity, so that the effect of enhancing immunity is reduced. Among them, the split formula lacking Ligustrum lucidum is especially obvious in the comparative example 1. Therefore, compared with the disassembled groups, the composition of the present invention can further enhance the rate of carbon particles in mice to be eliminated, thereby improving the humoral immune function and enhancing the immune function of mouse monocytes-macrophages, which has more Significantly enhance immunity.

Example 1

Weigh the following raw materials: 3 parts of Ligustrum lucidum, 3 parts of Eclipta prostrata, 2 parts of Astragalus, 3 parts of Codonopsis, 3 parts of Poria (manufactured).

Prepare health food with immune enhancement function according to the following steps:

(1) Take Ligustrum lucidum, Eclipta prostrata, Astragalus, Codonopsis, Poria, rinse with clean water, add 10 times water, decoc 2 times for 2 hours each time, filter to obtain water extract;

(2) Concentration and sterilization: Concentrate the water extract in vacuum, concentrate to a relative density of 1.05 at 60±5°C, filter, add sucrose accessories, centrifuge, bottle, and sterilize (temperature 121°C, 30min), 20ml/bottle (0.23g crude drug/ml).

Example 2

Weigh the following raw materials by weight: 3 parts of Ligustrum lucidum, 4 parts of Eclipta prostrata, 1 part of Astragalus, 3 parts of Codonopsis, 4 parts of Poria (manufactured).

Prepare health food with immune enhancement function according to the following steps:

(1) Take Ligustrum lucidum, Eclipta prostrata, Astragalus, Codonopsis, Poria, rinse with clean water, add 8 times water, decoc once, 1.5 hours each time, filter to obtain water extract;

(2) Concentration and sterilization: Concentrate the water extract in vacuum, concentrate to a relative density of 1.04 at 60±5°C, filter, add citric acid auxiliary materials, centrifuge, bottling, and sterilize (temperature 121°C, 30min), 20ml/ Bottle (0.25g crude drug/ml).

Comparative example 1

Ligustrum lucidum, Eclipta prostrata: 3 parts, Astragalus: 2 parts, Codonopsis: 3 parts, Poria: 3 parts, according to the steps (1) (2) of Example 1 to prepare an oral liquid with the same specifications.

Comparative example 2

Eclipta prostrata, Ligustrum lucidum: 3 parts, Astragalus: 2 parts, Codonopsis: 3 parts, Poria: 3 parts, according to the steps (1) (2) of Example 1 to prepare an oral liquid with the same specifications.

Comparative example 3

Lack of Astragalus, 3 parts of Ligustrum lucidum, Eclipta prostrata: 3 parts, Codonopsis: 3 parts, Poria: 3 parts, according to the steps (1) and (2) of Example 1 to prepare an oral liquid with the same specifications.

Comparative example 4

Codonopsis pilosula, 3 parts of Ligustrum lucidum, Astragalus: 2 parts, Eclipta prostrata: 3 parts, Poria: 3 parts, according to the steps (1)-(2) of Example 1 to prepare an oral liquid with the same specifications.

Comparative example 5

Tuckahoe, Ligustrum lucidum 3 parts, Astragalus: 2 parts, Codonopsis: 3 parts, Eclipta prostrata: 3 parts, according to the steps (1) (2) of Example 1 to prepare an oral liquid with the same specifications.

The description of the above embodiments is only used to help understand the method and core idea of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

Claims (10)

1. A composition with a function of enhancing immunity, which is characterized in that the composition includes any four or more of Ligustrum lucidum, Eclipta prostrata, Astragalus, Codonopsis and Poria.
2. The composition according to claim 1, wherein the composition comprises Ligustrum lucidum, and any three or more of Eclipta prostrata, Astragalus, Codonopsis and Poria; wherein each selected medicinal material By weight, they are 1-11 parts by weight of Ligustrum lucidum, 1-11 parts by weight of Eclipta prostrata, 2-7 parts by weight of Astragalus, 1-5 parts by weight of Codonopsis and 1-5 parts by weight of Poria.
3. The composition according to claim 1, wherein the selected medicinal materials are 1-9 parts by weight of Ligustrum lucidum, 1-9 parts of Eclipta prostrata, 2-6 parts of Astragalus, and Codonopsis 1- 4 servings, 1-4 servings of Poria.
4. The composition according to claim 1, wherein the selected medicinal materials are 1-5 parts by weight of Ligustrum lucidum, 1-5 parts of Eclipta prostrata, 2-5 parts of Radix Astragali, and Codonopsis 2- 4 parts, 2-4 parts of Poria.
5. The composition of claim 1, wherein the selected medicinal materials are 3 parts by weight of Ligustrum lucidum, 3 parts of Eclipta prostrata, 2 parts of Astragalus, 3 parts of Codonopsis, and 3 parts of Poria cocos.
6. Use of the composition of any one of claims 1 to 5 in the preparation of immunity enhancing drugs, health products or foods.
7. A medicine, health care product or food containing a composition capable of enhancing immunity according to any one of claims 1-5.
8. A method for preparing health care products or foods according to claim 7, when the health care products or foods are selected from oral liquids, characterized in that, the preparation method comprises the following steps:

   (1) Take Ligustrum lucidum, Eclipta prostrata, Astragalus, Codonopsis, Poria, add water 8-12 times, decoct 1-2 times, 1-3 hours each time, filter to obtain the water extract;

   (2) Concentration and sterilization: the water extract is vacuum concentrated, filtered, added with auxiliary materials, centrifuged, bottled, and sterilized.
9. The preparation method according to claim 8, wherein the auxiliary materials added in step (2) include one or more of erythritol, sorbitol, sucrose, erythritol, citric acid, and gluconic acid. Kind.
10. The preparation method according to claim 8 or 9, characterized in that the water extract is vacuum concentrated to a relative density of 1.03-1.05 at 60±5°C.