阅读说明：本技术 一种具有调节免疫功能的中药复方组合物与应用 (Traditional Chinese medicine compound composition with function of regulating immunity and application thereof ) 是由 万春平 顾瑛媛 于 2020-03-17 设计创作，主要内容包括：本发明公开了一种具有调节免疫功能的中药复方组合物与应用,由以下重量配比的原料组成：黄芪25-35g,人参5-15g,灵芝5-15g,半枝莲10-20g,白术10-20g,甘草10-20g。本发明提供的中药复方组合物配方中,黄芪与人参共为君药,补气升阳,复脉固脱；灵芝与白术均能健脾益气、扶助正气共为臣药,半枝莲辅佐黄芪、人参提高人体免疫力,又可牵制芪参温热、抗肿瘤,为佐药,甘草补中益气调和诸药为使药。上述六味药相辅相成,具有扶正祛邪、补虚功效,现代药理表明,本发明中药复方组合物能够增脾淋巴细胞的重量,提高脾淋巴细胞的增殖及IL-2分泌水平,从而达到增强肿瘤患者免疫力的效果,延长肿瘤患者的生存期,提高生存质量。(The invention discloses a traditional Chinese medicine compound composition with an immune regulation function and application thereof, wherein the traditional Chinese medicine compound composition comprises the following raw materials in parts by weight: 25-35g of astragalus membranaceus, 5-15g of ginseng, 5-15g of lucid ganoderma, 10-20g of sculellaria barbata, 10-20g of bighead atractylodes rhizome and 10-20g of liquorice. In the formula of the traditional Chinese medicine compound composition provided by the invention, the astragalus and the ginseng are used as monarch drugs together, so that the qi is tonified, the yang is risen, and the pulse is recovered and the collapse is relieved; the lucid ganoderma and the bighead atractylodes rhizome can both strengthen the spleen and replenish qi and assist healthy qi to serve as ministerial drugs, the barbed skullcap herb assists the astragalus and the ginseng to improve the immunity of a human body, the astragalus and the ginseng can be controlled to be warm and anti-tumor, and the liquoric root is an adjuvant drug and is used for tonifying the middle-jiao and replenishing qi and harmonizing the effects of the other drugs as a conductant drug. The six medicines supplement each other, and have the effects of strengthening body resistance, eliminating pathogenic factors and tonifying deficiency, and the modern pharmacology shows that the traditional Chinese medicine compound composition disclosed by the invention can increase the weight of spleen lymphocytes and improve the proliferation and IL-2 secretion level of the spleen lymphocytes, so that the effect of enhancing the immunity of a tumor patient is achieved, the life cycle of the tumor patient is prolonged, and the life quality is improved.)

1. A traditional Chinese medicine compound composition with the function of regulating immunity is characterized by comprising the following components by weight

The raw materials in proportion are as follows: 25-35g of astragalus membranaceus, 5-15g of ginseng, 5-15g of lucid ganoderma, 10-20g of sculellaria barbata, 10-20g of bighead atractylodes rhizome and 10-20g of liquorice.

2. The compound traditional Chinese medicine composition for regulating immune function according to claim 1, characterized in that

The feed is characterized by comprising the following raw materials in parts by weight: 30g of astragalus, 10g of ginseng, 10g of lucid ganoderma, 15g of barbed skullcap herb, 15g of largehead atractylodes rhizome and 10g of liquorice.

3. The traditional Chinese medicine compound composition for regulating the immune function according to claim 1, which is characterized by comprising the following raw materials in parts by weight: 25g of astragalus, 5g of ginseng, 5g of lucid ganoderma, 10g of sculellaria barbata, 10g of bighead atractylodes rhizome and 15g of liquorice.

4. The application of the compound traditional Chinese medicine composition for regulating the immune function in preparing the anti-tumor traditional Chinese medicine preparation according to the claims 1 to 3 is characterized in that the traditional Chinese medicine preparation is decoction, granules, tablets or pills.

5. The application of the traditional Chinese medicine compound composition for regulating the immune function in preparing an anti-tumor traditional Chinese medicine preparation according to claim 4 is characterized in that the preparation method of the decoction is as follows:

1) decocting radix astragali, Ginseng radix, Ganoderma, herba Scutellariae Barbatae, Atractylodis rhizoma, and Glycyrrhrizae radix in water for 3 times, 1 hr each time, adding 8-12 times of water for the first time, 6-10 times of water for the second time, and 4-8 times of water for the third time to obtain mixed solution;

2) filtering the mixed solution through a 500-550-mesh sieve, sterilizing at high temperature and bottling to obtain the target product.

6. The application of the traditional Chinese medicine compound composition for regulating the immune function in preparing an anti-tumor traditional Chinese medicine preparation according to claim 4 is characterized in that the preparation method of the granules, the tablets or the pills is as follows:

s1, adding water into the astragalus, the ginseng, the ganoderma lucidum, the barbed skullcap herb, the largehead atractylodes rhizome and the liquorice according to the proportion, decocting and extracting for 3 times, wherein 1 hour is used for each time, 8-12 times of water is added for the first time, 6-10 times of water is added for the second time, 4-8 times of water is added for the third time, filtering extracting solutions, combining filtrates, and concentrating to obtain an extract with the relative density of 1.30-1.35;

s2, adding auxiliary materials into the extract, mixing uniformly, adding 0-100 ml of 75% ethanol, granulating, drying at 60-65 ℃, and preparing into granules, tablets or pills.

7. The application of the traditional Chinese medicine compound composition for regulating the immune function in preparing an anti-tumor traditional Chinese medicine preparation according to claim 5 is characterized in that the auxiliary materials are the following substances in parts by weight: 15-25g of sucrose powder and 70-75 g of dextrin.

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine compound composition with an immune regulating function and application thereof.

Background

The current treatment of tumors mainly comprises western medicine treatment, operations, chemotherapy, radiotherapy, targeted treatment, immunotherapy and the like, but the operations often have complications, and the chemoradiotherapy often has toxic and side effects. The traditional Chinese medicine theory considers that imbalance of yin and yang and exuberance of vital qi and pathogenic factors are key reasons for the occurrence and development of tumors. Regulating yin and yang, strengthening healthy qi to eliminate pathogenic factors are the key points of tumor treatment. The traditional Chinese medicine emphasizes that the body balance state of yin-yang balance and sufficient healthy qi is achieved by adjusting yin and yang and supporting healthy qi, thereby achieving the purposes of controlling tumor growth, improving clinical symptoms of patients, improving life quality of patients and the like.

Therefore, it is necessary to develop a traditional Chinese medicine which has the effects of strengthening body resistance, eliminating pathogenic factors, and tonifying deficiency, so as to adjust the immune function of a patient and achieve the effect of inhibiting the growth of tumor cells of the patient.

Disclosure of Invention

Aiming at the problems, the invention provides a traditional Chinese medicine compound composition with the function of regulating immunity, which has the effects of strengthening body resistance, eliminating evil and tonifying deficiency, achieves the effect of inhibiting the growth of tumor cells of a patient by regulating the immunity of the patient, prolongs the life of the patient and improves the life quality.

The purpose of the invention is realized by the following technical scheme:

a traditional Chinese medicine compound composition with an immunity regulating function is composed of the following raw materials in parts by weight: 25-35g of astragalus membranaceus, 5-15g of ginseng, 5-15g of lucid ganoderma, 10-20g of sculellaria barbata, 10-20g of bighead atractylodes rhizome and 10-20g of liquorice.

Preferably, the traditional Chinese medicine compound composition for regulating the immune function consists of the following raw materials in parts by weight: 30g of astragalus, 10g of ginseng, 10g of lucid ganoderma, 15g of barbed skullcap herb, 15g of largehead atractylodes rhizome and 10g of liquorice.

Preferably, the traditional Chinese medicine compound composition for regulating the immune function consists of the following raw materials in parts by weight: 25g of astragalus, 5g of ginseng, 5g of lucid ganoderma, 10g of barbed skullcap herb, 10g of largehead atractylodes rhizome and 15g of liquorice.

The invention also provides application of the traditional Chinese medicine compound composition for regulating the immune function in preparing an anti-tumor traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation is decoction, granules, tablets or pills.

Preferably, the preparation method of the decoction is as follows:

1) decocting radix astragali, Ginseng radix, Ganoderma, herba Scutellariae Barbatae, Atractylodis rhizoma, and Glycyrrhrizae radix in water for 3 times, 40-60min each time, 8-12 times of water for the first time, 6-10 times of water for the second time, and 4-8 times of water for the third time to obtain mixed solution;

2) filtering the mixed solution through a 500-550-mesh sieve, sterilizing at high temperature and bottling to obtain the target product.

Preferably, the preparation method of the granules, tablets or pills is as follows:

s1, decocting radix astragali, ginseng, ganoderma lucidum, herba scutellariae barbatae, bighead atractylodes rhizome and liquorice in water for 3 times in proportion, wherein each time is 40-60min, 8-12 times of water is added for the first time, 6-10 times of water is added for the second time, 4-8 times of water is added for the third time, the extracting solution is filtered, the filtrates are combined, and the filtrate is concentrated to an extract with the relative density of 1.30-1.35;

s2, adding auxiliary materials into the extract, mixing uniformly, adding 0-100 ml of 75% ethanol, granulating, drying at 60-65 ℃, and preparing into granules, tablets or pills.

Preferably, the auxiliary materials are the following substances in parts by weight: 15-25g of sucrose powder and 70-75 g of dextrin.

Square solution:

astragalus root: has sweet taste, and has effects of invigorating qi, invigorating yang, invigorating defensive qi, consolidating superficial resistance, inducing diuresis, relieving swelling, removing toxic substance, promoting granulation, enhancing cardiac function, improving immunity, resisting aging, and resisting bacteria.

Ginseng: mild in nature, sweet, slightly bitter and slightly warm in taste. It enters spleen, lung and heart meridians. The efficacy is as follows: tonify primordial qi, recover pulse to stop collapse, tonify spleen and lung, promote the production of body fluid to quench thirst, induce tranquilization and promote intelligence. The main treatment is as follows: exhaustion, deficiency of qi, blood and body fluids.

Ganoderma lucidum: to replenish qi and blood, calm mind, strengthen spleen and stomach. It can be used for treating asthenia, palpitation, insomnia, dizziness, fatigue, chronic cough, asthma, coronary heart disease, silicosis, and tumor.

White atractylodes rhizome: sweet and bitter taste, warm in nature, and entering spleen and stomach meridians. The traditional Chinese medicine composition has the main effects of tonifying qi and strengthening spleen, eliminating dampness and promoting diuresis, arresting sweating and preventing miscarriage, can be used for treating symptoms of spleen qi deficiency, spleen strengthening and dampness, is mainly used for treating symptoms of anorexia and loose stool, diarrhea, phlegm retention and edema caused by spleen deficiency, and can be used for treating symptoms of phlegm-fluid retention, phlegm-dampness and middle boiling and the like caused by spleen deficiency and middle yang deficiency.

Barbed skullcap herb: pungent and cold in flavor and mild in nature. It enters lung meridian, liver meridian and kidney meridian. Has the effects of clearing away heat and toxic materials, promoting blood circulation, dispelling blood stasis, relieving swelling and pain, and preventing cancer; treating appendicitis, hepatitis, stomach ache, early hepatocarcinoma, lung cancer, cervical cancer, mastitis, etc.; it can be used for treating pain, furuncle, traumatic injury, and swelling and pain.

Licorice root, radix Glycyrrhizae is a guiding drug for tonifying the middle-jiao and qi.

In the formula, the astragalus and the ginseng are monarch drugs together, so that qi is tonified, yang is risen, and pulse recovery and desertion are prevented; the lucid ganoderma and the bighead atractylodes rhizome can both strengthen the spleen and replenish qi and assist healthy qi as ministerial drugs, the barbed skullcap herb assists the astragalus and the ginseng to improve the immunity of a human body, can also restrain the astragalus and the ginseng to be warm and anti-tumor, and is an adjuvant drug, and the liquorice can tonify the middle-jiao and replenish qi and harmonize the effects of the other drugs as conductant drugs; the six medicines supplement each other to strengthen the body resistance and eliminate pathogenic factors.

The influence of the traditional Chinese medicine compound composition on the immunity of a tumor organism is shown in the following tests:

the test method comprises the following steps:

first, H22 tumor-bearing mouse model establishment, grouping and administration

Selecting S180 mouse, sterilizing abdominal skin, collecting ascites, centrifuging, removing supernatant, and adjusting cell concentration to 1 × 10 with PBS⁶Each mouse is inoculated with 0.2ml of the right axilla of each mouse subcutaneously, the inoculated mice are randomly divided into 4 groups, namely a tumor-bearing model group, a CTX positive group, a traditional Chinese medicine compound composition and a CTX combined compound radix astragali oral liquid group, and each group comprises 8 mice. The CTX positive group is injected with 30mg/kg of cyclophosphamide in the abdominal cavity, and the traditional Chinese medicine compound composition is administrated by intragastric administration in the form of decoction at the dosage of 100 mg/kg. CTX is combined with the traditional Chinese medicine compound composition group to be used for performing intraabdominal injection on the basis of 30mg/kg of cyclophosphamide and 100mg/kg of intragastric administration. The tumor-bearing model group was perfused with physiological saline of equal volume once a day for 16 consecutive days. After 24h of the last dose, the mice were sacrificed by cervical dislocation, tumor tissue was stripped, weighed and tumor inhibition was calculated: tumor weight inhibition (%) (average tumor weight in control group-treatment)Mean tumor weight of treatment group)/mean tumor weight of control group × 100%.

1. Preparation of splenic lymphocytes

Mice were sacrificed by spondyle removal and their spleens were aseptically removed. The spleen was ground with a glass slide, filtered and centrifuged at 1200rpm for 5 minutes. The supernatant was discarded, and the pellet was added with erythrocyte lysate (about 1ml per spleen), mixed well, left to stand for 1 minute, added with PBS, and centrifuged. Adding PBS, filtering, and centrifuging. After washing the remaining cells 1-2 times, the cells were adjusted to the desired concentration with 10% FBS in RPMI-1640.

2. Detection of proliferative function of splenic lymphocytes

Spleen lymphocytes of each group were seeded in a 96-well plate (4 × 10)⁵One/well), 2.5. mu.g/ml ConA was added for stimulation, the cells were cultured in an incubator containing 5% CO2 for 48 hours, and the proliferation of splenic lymphocytes of each group was measured by the MTT method.

3. Enzyme linked immunosorbent assay for detecting IL-2 production level

Spleen lymphocytes of each group were seeded in a 96-well plate (4 × 10)⁵One/well), adding 2.5 mu g/ml ConA for stimulation, culturing the cells in an incubator containing 5% CO2 for 16h, collecting culture supernatant, detecting by an enzyme-linked immunosorbent assay, and detecting the cytokine production level of the culture supernatant.

Second, test results

1. The influence of the traditional Chinese medicine compound composition on the spleen weight of H22 tumor-bearing mouse lymphocyte

Table 1 the results show that 16 days after drug intervention, spleens were isolated and weighed; the result shows that compared with the tumor-bearing model group mice, the spleen of the chemotherapy drug cyclophosphamide group is obviously lower than that of the tumor-bearing model group mice, and the difference has obvious significance; compared with a chemotherapy drug cyclophosphamide group, the decoction of the traditional Chinese medicine compound composition provided by the invention is intervened by drugs, so that the weight of the spleen of a mouse in the cyclophosphamide group is obviously increased, and the traditional Chinese medicine compound composition provided by the invention has a certain effect on immune organs.

TABLE 1 influence of decoction of Chinese medicinal composition of the present invention on splenic weight of lymphocyte of H22 tumor-bearing mouse (n＝8)

Comparison with tumor-bearing model group:^*P﹤0.05，^**p < 0.01; comparison with the Cyclophosphamide group^#P﹤0.05，^##P﹤0.01

2. The influence of the traditional Chinese medicine compound composition on the lymphocyte proliferation function of H22 tumor-bearing mice

Table 2 shows that after 16 days of drug intervention, splenic lymphocytes of each group were isolated and T lymphocytes were clonally proliferated under induction of ConA, thereby inducing T lymphocytes to proliferate; MTT detection results show that compared with a cyclophosphamide group, the OD value of an intervention group or a combined drug group of the traditional Chinese medicine compound composition is obviously higher than that of a tumor-bearing model group, and differences have obvious meanings (P < 0.01); compared with a cyclophosphamide chemotherapy group, the traditional Chinese medicine compound composition has the advantages that the OD value of the combined cyclophosphamide medicine group is obviously improved, and the difference has obvious significance (P < 0.01).

TABLE 2 Effect of the invention on the lymphocyte proliferation function of H22 tumor-bearing mice by the compound composition group of the invention (n＝8)

Group of	Dosage (mg/kg)	OD value
			Tumor-bearing model group	—	0.36±0.03
The invention relates to a traditional Chinese medicine compound composition group	100mg/kg	0.34±0.07
			Cyclophosphamide derivatives of formula (I)	30mg/kg	0.26±0.10
Combination drug group	100mg/kg+30mg/kg	0.51±0.02**##

Comparison with tumor-bearing model group:^*P﹤0.05，^**p < 0.01; comparison with the Cyclophosphamide group^#P﹤0.05，^##P﹤0.01

3. The effect of the traditional Chinese medicine compound composition on the IL-2 production of H22 tumor-bearing mouse lymphocyte

The results in table 3 show that, compared with the tumor-bearing model group mice, cyclophosphamide drug intervention significantly inhibited the level of splenic lymphocyte IL-2 production; compared with a cyclophosphamide medicine intervention group, the level of IL-2 production of splenic lymphocytes of mice in the traditional Chinese medicine intervention group or the combined medicine group is obviously higher than that of mice in a control group.

TABLE 3 Effect of the Chinese medicinal composition of the present invention on IL-2 production level of splenic lymphocytes from H22 tumor-bearing mice: (n＝8)

Comparison with tumor-bearing model group:^*P﹤0.05，^**p < 0.01; comparison with the Cyclophosphamide group^#P﹤0.05，^##P﹤0.01

The results show that the traditional Chinese medicine compound composition can obviously improve the proliferation of splenic lymphocytes and the IL-2 secretion level, thereby enhancing the tumor immunity of tumor-bearing mouse organisms.

The invention has the beneficial effects that: in the traditional Chinese medicine compound composition formula provided by the invention, the astragalus and the ginseng are used as monarch drugs, so that the qi is tonified, the yang is risen, and the pulse is recovered and the collapse is prevented; the lucid ganoderma and the bighead atractylodes rhizome can both strengthen the spleen and replenish qi and assist healthy qi to serve as ministerial drugs, the barbed skullcap herb assists the astragalus and the ginseng to improve the immunity of a human body, the astragalus and the ginseng can be controlled to be warm and anti-tumor, and the liquoric root is an adjuvant drug and is used for tonifying the middle-jiao and replenishing qi and harmonizing the effects of the other drugs as a conductant drug. The six medicines supplement each other and have the effects of strengthening body resistance, eliminating pathogenic factors and tonifying deficiency; modern pharmacology shows that the traditional Chinese medicine compound composition can increase the weight of spleen lymphocytes and improve the proliferation and IL-2 secretion level of the spleen lymphocytes, so that the effect of enhancing the immunity of tumor patients is achieved, the life cycle of the tumor patients is prolonged, and the life quality is improved.

Detailed Description

The invention is further illustrated by the following examples, which are not intended to limit the scope of the invention.