A ganoderma lucidum compound composition for improving immunity and a preparation method thereof

Abstract

The application discloses a ganoderma lucidum compound composition for improving immunity, which is prepared from ganoderma lucidum, ginseng, astragalus, licorice, cistanche, schisandra chinensis, cyperus rotundus, pericarpium citri reticulatae viride, melia toosendan, radix codonopsis, atractylodes, dioscorea, chuanxiong, angelica sinensis, radix rehmanniae preparatae, ligustrum lucidum, medlar, pinellia ternata, poria cocos and white mustard seed, and can be used for treating low immunity caused by heart-lung qi deficiency by supplementing heart qi, tonifying lung and spleen, dispersing liver and resolving stagnation, and activating blood circulation.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, particularly a Ganoderma lucidum compound composition for enhancing immunity and its preparation method. Background Technology

[0002] The most direct manifestation of a weakened immune system is susceptibility to illness. Frequent illness exacerbates the body's depletion, generally leading to symptoms such as physical weakness, malnutrition, lethargy, fatigue, decreased appetite, and sleep disturbances. Traditional Chinese medicine believes that the causes of a weakened immune system may be related to various factors, including congenital deficiencies, improper diet, overwork, and emotional fluctuations. Among these, congenital deficiencies may lead to insufficient vital energy (Qi), making one more susceptible to disease; improper diet and overwork may deplete Qi and blood, damaging vital energy; and emotional fluctuations may affect the flow of Qi, causing stagnation of vital energy and thus impacting immunity. Summary of the Invention

[0003] The purpose of this invention is to provide a Ganoderma lucidum compound composition for enhancing immunity and its preparation method, so as to solve the problems mentioned in the background art.

[0004] To achieve the above objectives, the present invention provides the following technical solution: a Ganoderma lucidum compound composition for enhancing immunity, extracted from the following components in parts by weight: 30-50 parts Ganoderma lucidum, 20-30 parts ginseng, 25-35 parts Astragalus membranaceus, 20-30 parts Glycyrrhiza uralensis, 20-30 parts Cistanche deserticola, 15-25 parts Schisandra chinensis, 20-40 parts Cyperus rotundus, 20-30 parts Citrus reticulata peel, 25-35 parts Melia toosendan, 20-30 parts Codonopsis pilosula, 15-25 parts Atractylodes macrocephala, 20-30 parts Dioscorea opposita, 25-35 parts Ligusticum chuanxiong, 18-22 parts Angelica sinensis, 20-30 parts Rehmannia glutinosa, 25-35 parts Ligustrum lucidum, 20-30 parts Lycium barbarum, 15-25 parts Pinellia ternata, 20-30 parts Poria cocos, and 20-30 parts Sinapis alba.

[0005] The aforementioned Ganoderma lucidum compound composition for enhancing immunity consists of 40 parts Ganoderma lucidum, 25 parts ginseng, 30 parts Astragalus membranaceus, 25 parts Glycyrrhiza uralensis, 25 parts Cistanche deserticola, 20 parts Schisandra chinensis, 30 parts Cyperus rotundus, 25 parts Citrus reticulata peel, 30 parts Melia toosendan, 25 parts Codonopsis pilosula, 20 parts Atractylodes macrocephala, 25 parts Dioscorea opposita, 30 parts Ligusticum chuanxiong, 20 parts Angelica sinensis, 25 parts Rehmannia glutinosa, 30 parts Ligustrum lucidum, 25 parts Lycium barbarum, 20 parts Pinellia ternata, 25 parts Poria cocos, and 25 parts Sinapis alba.

[0006] The aforementioned Ganoderma lucidum compound composition for enhancing immunity consists of 30 parts Ganoderma lucidum, 30 parts ginseng, 25 parts Astragalus membranaceus, 30 parts Glycyrrhiza uralensis, 20 parts Cistanche deserticola, 25 parts Schisandra chinensis, 20 parts Cyperus rotundus, 30 parts Citrus reticulata peel, 25 parts Melia toosendan, 30 parts Codonopsis pilosula, 15 parts Atractylodes macrocephala, 30 parts Dioscorea opposita, 25 parts Ligusticum chuanxiong, 22 parts Angelica sinensis, 20 parts Rehmannia glutinosa, 35 parts Ligustrum lucidum, 20 parts Lycium barbarum, 25 parts Pinellia ternata, 20 parts Poria cocos, and 30 parts Sinapis alba.

[0007] The aforementioned Ganoderma lucidum compound composition for enhancing immunity consists of 50 parts Ganoderma lucidum, 20 parts ginseng, 35 parts Astragalus membranaceus, 20 parts Glycyrrhiza uralensis, 30 parts Cistanche deserticola, 15 parts Schisandra chinensis, 40 parts Cyperus rotundus, 20 parts Citrus reticulata peel, 35 parts Melia toosendan, 20 parts Codonopsis pilosula, 25 parts Atractylodes macrocephala, 20 parts Dioscorea opposita, 35 parts Ligusticum chuanxiong, 18 parts Angelica sinensis, 30 parts Rehmannia glutinosa, 25 parts Ligustrum lucidum, 30 parts Lycium barbarum, 15 parts Pinellia ternata, 30 parts Poria cocos, and 20 parts Sinapis alba.

[0008] The Ganoderma lucidum compound composition for enhancing immunity is prepared as follows: Ginseng, Codonopsis pilosula, Angelica sinensis, and Ligusticum chuanxiong are weighed according to a specified ratio, and 8 times their weight of 80% ethanol is added. The mixture is refluxed and extracted three times, 45 minutes each time. The ethanol extract is then recovered under reduced pressure to obtain an ethanol extract. The residue remaining after ethanol extraction is added to 8 times their weight of water along with the other ginseng and Ginseng, and extracted twice, 1 hour each time. The aqueous extract is then recovered under reduced pressure. Ethanol is added to adjust the ethanol concentration to 65%, and the mixture is purified for 24 hours. The supernatant is collected, and the ethanol is recovered under reduced pressure to obtain an aqueous extract. The ethanol extracts are combined, evaporated in a water bath, and dried at 80°C under normal pressure to obtain an extract powder. The powder is then pulverized, passed through an 80-mesh sieve, and excipients are added to prepare a solid preparation.

[0009] The Ganoderma lucidum compound composition for enhancing immunity is available in solid dosage form, which may be one of capsules, granules, or tablets.

[0010] The Ganoderma lucidum compound composition for enhancing immunity is prepared as follows: Ginseng, Codonopsis pilosula, Angelica sinensis, and Ligusticum chuanxiong are weighed according to a specified ratio, and ginseng, Codonopsis pilosula, Angelica sinensis, and Ligusticum chuanxiong are added to 8 times their weight of 80% ethanol and refluxed three times, 45 min each time. The ethanol extract is then recovered under reduced pressure to obtain an ethanol extract. The residue remaining after ethanol extraction is added to 8 times their weight of water along with the other ginseng and Ginseng, and extracted twice, 1 h each time. The aqueous extract is then recovered under reduced pressure, and ethanol is added to adjust the ethanol concentration to 65%. The mixture is purified for 24 hours, and the supernatant is collected. The ethanol is recovered under reduced pressure to obtain an aqueous extract. The ethanol extracts are combined, and sucrose is added to prepare an oral liquid preparation.

[0011] The aforementioned Ganoderma lucidum compound composition for enhancing immunity is an oral liquid preparation, which is one of an oral liquid or a syrup.

[0012] The application of the Ganoderma lucidum compound composition for enhancing immunity in the preparation of health products for enhancing immunity.

[0013] The aforementioned Ganoderma lucidum compound composition for enhancing immunity is used in the preparation of health products for treating low immunity, which falls under the category of heart and lung qi deficiency syndrome.

[0014] In traditional Chinese medicine (TCM) theory, low immunity is generally considered to be caused by insufficient vital qi. Insufficient vital qi leads to a weakened resistance of the human body to external pathogenic factors, making it prone to contracting diseases. The TCM diagnosis of low immunity may include syndromes such as qi deficiency, blood deficiency, yin deficiency, and yang deficiency. Therefore, TCM believes that vital qi includes multiple aspects such as qi, blood, yin, and yang, among which qi deficiency is one of the main manifestations of insufficient vital qi.

[0015] From the perspective of TCM, the heart and lungs mainly have a relationship of mutual assistance in qi and blood and coordination between the heart and lungs. 1. Mutual assistance in qi and blood: The heart governs blood vessels, and the lungs govern the qi of the whole body and are in charge of respiration, distributing qi to all the vessels. The qi of the lungs helps the heart promote blood circulation, and the heart blood transports the qi of the lungs. On the one hand, qi has the functions of generating, promoting, and controlling blood. Blood circulates in the vessels with the qi of the heart as the driving force, but it also needs the assistance of the lungs governing qi and distributing qi to all the vessels. On the other hand, blood has the functions of nourishing and transporting qi. Smooth circulation of the heart blood is beneficial to the respiration of the lungs. The heart and lungs are yang in the upper jiao, and the heart is the yang within yang, while the lungs are the yang within yin. Due to the dispersing and distributing functions of the heart and lungs in the upper jiao, nutrients such as refined grains of water and food are evenly distributed, presenting a state of being diffused and filling everywhere, referring to the distribution function of the heart and lungs in the upper jiao for qi, blood, and body fluids; 2. Coordination between the heart and lungs: The heart is the monarch organ, governing the mind and ruling over the five zang-organs and six fu-organs. The lungs are the official in charge of assisting, governing regulation, assisting the heart, and regulating the functions of the zang-fu organs and tissues. The cooperation of the monarch and the assistant jointly governs the zang-fu organs and maintains normal physiological functions. If there are diseases, the pathological changes of the qi of the heart and lungs can affect each other. For example, deficiency of the qi of the lungs or congestion of the qi of the lungs can affect the function of the heart in promoting blood circulation, leading to blood stasis in the heart vessels, presenting symptoms such as palpitations and chest pain. On the contrary, if the qi of the heart is insufficient and there is unsmooth blood circulation, it may also affect the functions of the lungs in respiration and dispersing and descending, leading to symptoms such as chest distress, coughing, and wheezing. Therefore, it is very easy to have deficiency of the qi of the heart and lungs.

[0016] Qi deficiency of the heart and lungs refers to the symptoms of simultaneous presence of qi deficiency of the heart and qi deficiency of the lungs. Clinically, it is mostly manifested as coughing, shortness of breath and wheezing, chest distress, palpitations, especially severe when moving, expectorating thin and clear phlegm, fatigue, spontaneous sweating, pale complexion, or pale purple lips and tongue, and weak pulse.

[0017] For those with qi deficiency of the heart and lungs, first, tonify the qi of the heart and supplement the qi of the lungs to strengthen the exterior. However, the liver generates the heart, that is, wood generates fire. For example, the liver stores blood to nourish the heart, and the dredging and dispersing function of the liver helps the heart promote blood circulation. Qi is the commander of blood, and blood is the mother of qi. Qi being the commander of blood includes that qi can generate blood, qi can promote blood circulation, and qi can control blood. Blood being the mother of qi means that qi is always inseparable from blood in its generation and circulation, including: blood can generate qi, and blood can carry qi. Qi can promote the circulation and generation of blood, and blood can receive qi, attach to it, and maintain its prosperity and decline. Qi and blood depend on each other, mutually root and mutually use. Therefore, so soothing the liver can also tonify the qi of the heart. The spleen generates the lungs, that is, earth generates metal. For example, the spleen transports and transforms, generating qi to replenish the lungs. Therefore, strengthening the spleen can supplement the qi of the lungs.

[0018] Qi is the commander of blood; the normal circulation of blood depends on the proper propulsion of Qi. If the original Qi is deficient, it lacks the strength to circulate blood, resulting in slow blood flow, stagnation, and blood stasis. The *Yilin Gaicuo* (Corrections of Errors in Medicine) states, "When the original Qi is deficient, it cannot reach the blood vessels; without Qi in the blood vessels, stagnation and blood stasis will occur." The *Nan Jing Ben Yi* (Original Meaning of the Classic of Difficult Issues) says, "Qi contains blood, and blood contains Qi; Qi and blood cannot be separated for even a moment, for they are mutually dependent on Yin and Yang, a natural principle." The *Yixue Zhenchuan* (True Transmission of Medicine) states, "The entire body is circulated by Qi and blood; Qi cannot be harmonious without blood, and blood cannot circulate without Qi; therefore, it is said, 'Qi governs warmth, and blood governs nourishment.'" This invention alleviates the symptoms of heart and lung Qi deficiency by promoting blood circulation and removing blood stasis.

[0019] The *Jingyue Quanshu* (Complete Works of Jingyue), in its section on "Records of Loyalty," states: "If the heart qi is deficient, the spirit will be unclear; if the lung qi is deficient, the body's regulatory functions will be impaired; if the spleen qi is deficient, the appetite and thirst will be weak; if the liver qi is deficient, the soul will be timid and restless; if the kidney qi is deficient, the yang channels will weaken, the essence will be scarce, and the will will be feeble; if the stomach qi is deficient, the granary will be empty, affecting all the meridians; if the triple burner is deficient, the upper, middle, and lower jiao will all lose their functions; if the gate of life (mingmen) is deficient, the essence, qi, and spirit will all be without root. Are all these not forms of qi deficiency?" However, the lung governs qi, the spleen is the source of qi and blood, and the kidney is the root of primordial qi; therefore, qi deficiency is particularly closely related to the lung, spleen, and kidney. The kidney is the root of qi and governs the intake of qi. If the kidney is deficient, the function of receiving qi will decline, which can easily lead to insufficient lung qi. Therefore, Rehmannia glutinosa, Ligustrum lucidum, and Lycium barbarum are used to tonify the kidney, strengthen the primordial qi, and astringe the lung qi.

[0020] Qi deficiency often leads to phlegm and dampness accumulation. Traditional Chinese medicine believes that qi has the functions of promoting, warming, defending, consolidating, and moving. Phlegm is a pathological product of abnormal body fluid metabolism. If a patient's qi is insufficient, body fluids cannot circulate normally, resulting in phlegm accumulation. Therefore, there is a connection between the two. This invention achieves the effect of replenishing qi deficiency through methods of eliminating phlegm and dampness.

[0021] In summary, this invention uses Ganoderma lucidum, ginseng, astragalus, and licorice to tonify the heart qi and lung qi, and strengthen the exterior. Since the symptoms are due to heart deficiency, salty herbs are used to tonify the heart, combined with Cistanche deserticola. Since the symptoms are due to lung deficiency, sour herbs are used to tonify the lungs, combined with Schisandra chinensis. These are the principal herbs. Cyperus rotundus, Citrus reticulata peel, and Melia toosendan are used to soothe the liver and dissipate stagnation. Codonopsis pilosula, Atractylodes macrocephala, and Dioscorea opposita are used to strengthen the spleen. These are the assistant herbs. Ligusticum chuanxiong and Angelica sinensis are used to invigorate blood and remove blood stasis. Rehmannia glutinosa, Ligustrum lucidum, and Lycium barbarum are used to tonify the kidneys. These are the adjuvant herbs. Pinellia ternata, Poria cocos, and Sinapis alba are used to eliminate phlegm and dampness. These are the guiding herbs. The entire formula consists of Ganoderma lucidum, ginseng, astragalus, licorice, Cistanche deserticola, Schisandra chinensis, Cyperus rotundus, Citrus reticulata peel, Melia toosendan, Codonopsis pilosula, Atractylodes macrocephala, Dioscorea opposita, Ligusticum chuanxiong, Angelica sinensis, Rehmannia glutinosa, Ligustrum lucidum, Lycium barbarum, Pinellia ternata, Poria cocos, and Sinapis alba. Together, they treat the weakened immunity caused by deficiency of heart and lung qi. Detailed Implementation

[0022] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, but these equivalent forms also fall within the scope defined by the appended claims.

[0023] Example 1: Take 40g of Ganoderma lucidum, 25g of ginseng, 30g of Astragalus membranaceus, 25g of Glycyrrhiza uralensis, 25g of Cistanche deserticola, 20g of Schisandra chinensis, 30g of Cyperus rotundus, 25g of Citrus reticulata peel, 30g of Melia toosendan, 25g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 25g of Dioscorea opposita, 30g of Ligusticum chuanxiong, 20g of Angelica sinensis, 25g of Rehmannia glutinosa, 30g of Ligustrum lucidum, 25g of Lycium barbarum, 20g of Pinellia ternata, 25g of Poria cocos, and 25g of Sinapis alba. The preparation method is as follows: Weigh the medicinal slices according to the proportions, and add 8 times the weight of ginseng, Codonopsis pilosula, Angelica sinensis, and Ligusticum chuanxiong. Extract the extract three times with 80% ethanol, reflux for 45 minutes each time, and recover the ethanol extract under reduced pressure to obtain an ethanol extract. Add 8 times the weight of water to the remaining residue after ethanol extraction and other medicinal slices, and extract twice, 1 hour each time. Recover the water extract under reduced pressure, add ethanol to adjust the ethanol concentration to 65%, and purify for 24 hours. Take the supernatant, recover the ethanol under reduced pressure to obtain a water extract. Combine the ethanol extracts, evaporate them in a water bath, and dry them at 80°C under normal pressure to obtain an extract powder. Crush the powder, pass it through an 80-mesh sieve, add dextrin, and prepare it into granules.

[0024] Example 2: Take 30g of Ganoderma lucidum, 30g of ginseng, 25g of Astragalus membranaceus, 30g of Glycyrrhiza uralensis, 20g of Cistanche deserticola, 25g of Schisandra chinensis, 20g of Cyperus rotundus, 30g of Citrus reticulata peel, 25g of Melia toosendan, 30g of Codonopsis pilosula, 15g of Atractylodes macrocephala, 30g of Dioscorea opposita, 25g of Ligusticum chuanxiong, 22g of Angelica sinensis, 20g of Rehmannia glutinosa, 35g of Ligustrum lucidum, 20g of Lycium barbarum, 25g of Pinellia ternata, 20g of Poria cocos, and 30g of Sinapis alba. The preparation method is as follows: Weigh the medicinal slices according to the proportions, and add 8 times the weight of ginseng, Codonopsis pilosula, Angelica sinensis, and Ligusticum chuanxiong. Extract the extract three times with 80% ethanol, reflux for 45 minutes each time, and recover the ethanol extract under reduced pressure to obtain an ethanol extract. Add 8 times the weight of water to the remaining residue after ethanol extraction and other medicinal slices, and extract twice, 1 hour each time, recover the water extract under reduced pressure, add ethanol to adjust the ethanol concentration to 65%, and purify for 24 hours. Take the supernatant, recover the ethanol under reduced pressure to obtain a water extract. Combine the ethanol extracts, evaporate them in a water bath, and dry them at 80°C under normal pressure to obtain an extract powder. Crush the powder, pass it through an 80-mesh sieve, add starch, and prepare tablets.

[0025] Example 3: Take 50g of Ganoderma lucidum, 20g of ginseng, 35g of Astragalus membranaceus, 20g of licorice root, 30g of Cistanche deserticola, 15g of Schisandra chinensis, 40g of Cyperus rotundus, 20g of Citrus reticulata peel, 35g of Melia toosendan, 20g of Codonopsis pilosula, 25g of Atractylodes macrocephala, 20g of Dioscorea opposita, 35g of Ligusticum chuanxiong, 18g of Angelica sinensis, 30g of Rehmannia glutinosa, 25g of Ligustrum lucidum, 30g of Lycium barbarum, 15g of Pinellia ternata, 30g of Poria cocos, and 20g of Sinapis alba. The preparation method is as follows: Weigh the medicinal slices according to the proportions, and add 8 times the weight of ginseng, Codonopsis pilosula, Angelica sinensis, and Ligusticum chuanxiong. Extract the extract three times with 80% ethanol, reflux for 45 minutes each time, and recover the ethanol extract under reduced pressure to obtain an ethanol extract. Add 8 times the weight of water to the remaining residue after ethanol extraction and other medicinal slices, and extract twice, 1 hour each time. Recover the water extract under reduced pressure, add ethanol to adjust the ethanol concentration to 65%, and purify for 24 hours. Take the supernatant, recover the ethanol under reduced pressure to obtain a water extract. Combine the ethanol extracts, evaporate in a water bath, and dry at 80°C under normal pressure to obtain an extract powder. Crush the powder, pass it through an 80-mesh sieve, add dextrin, and prepare it into capsules.

[0026] Example 4: Take 40g of Ganoderma lucidum, 25g of ginseng, 30g of Astragalus membranaceus, 25g of licorice root, 25g of Cistanche deserticola, 20g of Schisandra chinensis, 30g of Cyperus rotundus, 25g of Citrus reticulata peel, 30g of Melia toosendan, 25g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 25g of Dioscorea opposita, 30g of Ligusticum chuanxiong, 20g of Angelica sinensis, 25g of Rehmannia glutinosa, 30g of Ligustrum lucidum, 25g of Lycium barbarum, 20g of Pinellia ternata, 25g of Poria cocos, and 25g of Sinapis alba. The preparation method is as follows: Weigh the medicinal slices according to the proportions. Ginseng, Codonopsis, Angelica sinensis, and Ligusticum chuanxiong were extracted three times with 8 times their weight of 80% ethanol under reflux for 45 minutes each time. The ethanol extract was then recovered under reduced pressure to obtain an ethanol extract. The residue after ethanol extraction was then extracted twice with 8 times their weight of water along with other medicinal slices for 1 hour each time. The aqueous extract was then recovered under reduced pressure. Ethanol was added to adjust the ethanol concentration to 65%, and the mixture was purified for 24 hours. The supernatant was collected, and the ethanol was recovered under reduced pressure to obtain an aqueous extract. The ethanol extracts were combined, and sucrose was added to prepare an oral liquid.

[0027] Example 5: Take 40g of Ganoderma lucidum, 25g of ginseng, 30g of Astragalus membranaceus, 25g of licorice root, 25g of Cistanche deserticola, 20g of Schisandra chinensis, 30g of Cyperus rotundus, 25g of Citrus reticulata peel, 30g of Melia toosendan, 25g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 25g of Dioscorea opposita, 30g of Ligusticum chuanxiong, 20g of Angelica sinensis, 25g of Rehmannia glutinosa, 30g of Ligustrum lucidum, 25g of Lycium barbarum, 20g of Pinellia ternata, 25g of Poria cocos, and 25g of Sinapis alba. The preparation method is as follows: Weigh the medicinal slices according to the proportions. Ginseng, Codonopsis, Angelica sinensis, and Ligusticum chuanxiong were extracted three times with 8 times their weight of 80% ethanol, refluxed for 45 minutes each time. The ethanol extract was then recovered under reduced pressure to obtain an ethanol extract. The residue after ethanol extraction was then extracted twice with 8 times their weight of water along with other medicinal slices, for 1 hour each time. The aqueous extract was then recovered under reduced pressure. Ethanol was added to adjust the ethanol concentration to 65%, and the mixture was purified for 24 hours. The supernatant was collected, and the ethanol was recovered under reduced pressure to obtain an aqueous extract. The ethanol extracts were combined and honey was added to prepare a syrup.

[0028] Example 6:

[0029] 6.1 Foot thickening method for studying delayed-type hypersensitivity in mice

[0030] Sixty mice were randomly divided into a blank control group, a model group, and an Example 1 group. The blank control group and the model group were given physiological saline, while the Example 1 group was given the drug (granules prepared in Example 1) at a dose of 10.0 g / kg. The mice were administered the drug by gavage for 4 weeks. After the third week, except for the blank control group, all other groups of mice were intraperitoneally injected with 55 mg / kg of the drug for 2 consecutive days. -1 Freshly prepared cyclophosphamide was used. Four days before the end of mouse administration, 0.2 mL of 2% (v / v) packed sheep red blood cell (SRBC) suspension was injected intraperitoneally into each group of mice for immunization. After the immunization, the thickness of the left hind paw was recorded using calipers. Then, 20 μL of 20% (v / v) SRBC was injected into the paw at the same measurement point. The change in thickness at this site was observed again after 24 hours. The degree of delayed-type hypersensitivity was expressed as the difference in thickness between the anteroposterior and posterior paws. The results are shown in Table 1.

[0031] Table 1. Effects of this invention on sheep erythrocyte (SRBC)-induced DTH in mice.

[0032] Group Difference in thickness of the left hind foot metatarsal region / cm Blank control group 0.074±0.023 Model group <![CDATA[0.038±0.019 ## ]]> Example 1 Group <![CDATA[0.069±0.038 ** ]]>

[0033] Compared with the blank control group, # P < 0.05 ## P < 0.01; compared with the model group, * P < 0.05 ** P < 0.01.

[0034] Compared with the blank control group, the model group showed a significant reduction in the thickness difference of the left hind paw metatarsal region (P < 0.01), indicating the successful establishment of the mouse immunosuppression model. In Example 1, compared with the model group, the drug-treated group showed an increase in the thickness difference of the left hind paw metatarsal region, with statistically significant differences. ** P < 0.01. This indicates that the present invention can increase the degree of sheep erythrocyte (SRBC)-induced swelling of the mouse paw and has the effect of promoting delayed-type hypersensitivity. Therefore, the present invention can enhance the cellular immune function of mice.

[0035] 6.2 Mouse carbon clearance test

[0036] Sixty mice were randomly divided into a blank control group, a model group, and an Example 1 group. The blank control group and the model group were given physiological saline, while the Example 1 group was given the drug (granules prepared in Example 1) at a dose of 10.0 g / kg. The mice were administered the drug by gavage for 4 weeks. After the third week, except for the blank control group, all other groups of mice were intraperitoneally injected with 55 mg / kg of the drug for 2 consecutive days. -1Freshly prepared cyclophosphamide was used. After the experiment, Indian ink was diluted 4 times with 0.9% NaCl solution, and then injected via the tail vein at a rate of 100 μL per 10 g body weight. Timing was started immediately after injection. At the 2nd and 10th minute of timing, 20 μL of blood was drawn from the internal canthal venous plexus. The blood was added to 2 mL of 0.1% Na2CO3 solution, and the optical density (OD) was measured at a wavelength of 600 nm. The spleen and liver of the mice were then removed, and the blood on the surface of the organs was cleaned. The phagocytic index was then calculated by weighing the spleen and liver. The results are shown in Table 2.

[0037] Table 2. Effects of this invention on the phagocytic index in mouse carbon clearance assay.

[0038] Group Phagocytosis index (α) Blank control group 6.73±1.46 Model group <![CDATA[4.28±1.12 ## ]]> Example 1 Group <![CDATA[7.12±1.97 ** ]]>

[0039] Compared with the blank control group, # P < 0.05 ## P < 0.01; compared with the model group, * P < 0.05 ** P < 0.01.

[0040] The basic principle of the carbon clearance assay is to intravenously inject a certain amount of Indian ink into experimental animals. After entering the animal's body, the Indian ink is rapidly phagocytosed by reticuloendothelial cells in organs such as the liver and spleen, thus significantly reducing its concentration in the plasma. The plasma absorbance is then measured using a spectrophotometer to calculate the clearance index, thereby understanding the phagocytic function of the entire mononuclear macrophage system. A higher carbon clearance index (K) indicates enhanced phagocytic capacity of mouse mononuclear macrophages. Compared with the blank control group, the model group showed a significantly lower phagocytic index, indicating successful model establishment. In Example 1, the drug-treated group showed an increased phagocytic index compared with the model group, and the differences were statistically significant. ** P < 0.01). This indicates that the present invention can significantly improve the phagocytic index (α), increase the number of phagocytes in immunosuppressed mice, improve the activity of phagocytes, enhance phagocytic function, and has a certain promoting effect on the innate immunity of immunosuppressed mice.

[0041] The results of this study show that the present invention enhances the delayed hypersensitivity response induced by SRBC in immunosuppressed mice and improves carbon clearance capacity, suggesting that the present invention improves the immune function of immunosuppressed mice to varying degrees.

[0042] Example 7; Clinical Study

[0043] 1. Case source: 100 patients with low immunity belonging to the cardiopulmonary qi deficiency syndrome who visited the clinic between January 2022 and January 2023 were selected.

[0044] 2. Diagnostic Criteria: ① Frequent colds. This means catching colds frequently, and then catching them again after recovery. ② Slow wound healing. People with low immunity have wounds that don't heal easily, and even with medication, recovery can take a long time. ③ Endocrine system disorders. Women may experience menstrual irregularities. Low immunity can lead to diabetes, hyperthyroidism, obesity, or being underweight. ④ Prone to allergies. This means that when resistance is low, allergies may recur for no apparent reason.

[0045] 3. Case selection: (1) Meeting the above diagnostic criteria; (2) Meeting the diagnostic criteria of low immunity and deficiency of heart and lung qi in traditional Chinese medicine; specifically: cough, shortness of breath and wheezing, chest tightness, palpitations, especially when exerted, clear and thin sputum, fatigue, spontaneous sweating, pale complexion, or pale purple lips and tongue, weak pulse.

[0046] 4. Efficacy evaluation criteria: Markedly effective: Clinical symptoms completely disappear or significantly improve; Effective: Clinical symptoms partially disappear or improve; Ineffective: Clinical symptoms do not improve.

[0047] 5. Treatment Process: The granule product prepared in Example 1 of this invention (daily prescription dosage: Ganoderma lucidum 40g, ginseng 25g, astragalus 30g, licorice 25g, cistanche deserticola 25g, schisandra chinensis 20g, cyperus rotundus 30g, tangerine peel 25g, Sichuan pepper 30g, codonopsis pilosula 25g, atractylodes macrocephala 20g, dioscorea opposita 25g, chuanxiong rhizome 30g, angelica sinensis 20g, rehmannia glutinosa 25g, privet fruit 30g, wolfberry fruit 25g, pinellia ternata 20g, poria cocos 25g, white mustard seed 25g) was used 3 times a day, 2 packets each time, for 1 month; the control group took Buzhong Yiqi Wan (approval number Z43020143, manufactured by Hunan Jiuzhitang Co., Ltd.), 9g each time, 3 times a day, for 1 month.

[0048] 6. The treatment results are shown in Table 3.

[0049] Table 3 Comparison of clinical efficacy between the two groups

[0050] Group Effective efficient invalid Overall effectiveness (%) control group 12 28 10 80.0 Example 1 Group 18 29 3 94.0

[0051] 7. Conclusion: Comparing the clinical efficacy of the two groups, the effective rate of the first group after treatment was 94.0%, which was significantly higher than the effective rate of 80.0% in the control group. This indicates that the present invention has a better therapeutic effect on the type of low immunity with heart and lung qi deficiency.

[0052] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. The application of a Ganoderma lucidum compound composition for enhancing immunity in the preparation of health products for treating low immunity, characterized in that: Low immunity belongs to the syndrome of heart and lung qi deficiency. The Ganoderma lucidum compound composition is extracted from the following components in parts by weight: Ganoderma lucidum 30-50 parts, ginseng 20-30 parts, astragalus 25-35 parts, licorice 20-30 parts, cistanche 20-30 parts, schisandra 15-25 parts, cyperus rotundus 20-40 parts, green tangerine peel 20-30 parts, Sichuan pepper 25-35 parts, codonopsis pilosula 20-30 parts, atractylodes macrocephala 15-25 parts, yam 20-30 parts, chuanxiong 25-35 parts, angelica sinensis 18-22 parts, rehmannia glutinosa 20-30 parts, privet fruit 25-35 parts, wolfberry fruit 20-30 parts, pinellia ternata 15-25 parts, poria cocos 20-30 parts, and white mustard seed 20-30 parts.

2. The application of the Ganoderma lucidum compound composition for enhancing immunity according to claim 1 in the preparation of health products for treating low immunity, characterized in that: The Ganoderma lucidum compound composition is extracted from the following components in parts by weight: 40 parts Ganoderma lucidum, 25 parts ginseng, 30 parts Astragalus membranaceus, 25 parts licorice, 25 parts Cistanche deserticola, 20 parts Schisandra chinensis, 30 parts Cyperus rotundus, 25 parts Citrus reticulata peel, 30 parts Melia toosendan, 25 parts Codonopsis pilosula, 20 parts Atractylodes macrocephala, 25 parts Dioscorea opposita, 30 parts Ligusticum chuanxiong, 20 parts Angelica sinensis, 25 parts Rehmannia glutinosa, 30 parts Ligustrum lucidum, 25 parts Lycium barbarum, 20 parts Pinellia ternata, 25 parts Poria cocos, and 25 parts Sinapis alba.

3. The application of the Ganoderma lucidum compound composition for enhancing immunity according to claim 1 in the preparation of health products for treating low immunity, characterized in that: The Ganoderma lucidum compound composition is extracted from the following components in parts by weight: 30 parts Ganoderma lucidum, 30 parts ginseng, 25 parts Astragalus membranaceus, 30 parts Glycyrrhiza uralensis, 20 parts Cistanche deserticola, 25 parts Schisandra chinensis, 20 parts Cyperus rotundus, 30 parts Citrus reticulata peel, 25 parts Melia toosendan, 30 parts Codonopsis pilosula, 15 parts Atractylodes macrocephala, 30 parts Dioscorea opposita, 25 parts Ligusticum chuanxiong, 22 parts Angelica sinensis, 20 parts Rehmannia glutinosa, 35 parts Ligustrum lucidum, 20 parts Lycium barbarum, 25 parts Pinellia ternata, 20 parts Poria cocos, and 30 parts Sinapis alba.

4. The application of the Ganoderma lucidum compound composition for enhancing immunity according to claim 1 in the preparation of health products for treating low immunity, characterized in that: The Ganoderma lucidum compound composition is extracted from the following components in parts by weight: 50 parts Ganoderma lucidum, 20 parts ginseng, 35 parts Astragalus membranaceus, 20 parts licorice, 30 parts Cistanche deserticola, 15 parts Schisandra chinensis, 40 parts Cyperus rotundus, 20 parts Citrus reticulata peel, 35 parts Melia toosendan, 20 parts Codonopsis pilosula, 25 parts Atractylodes macrocephala, 20 parts Dioscorea opposita, 35 parts Ligusticum chuanxiong, 18 parts Angelica sinensis, 30 parts Rehmannia glutinosa, 25 parts Ligustrum lucidum, 30 parts Lycium barbarum, 15 parts Pinellia ternata, 30 parts Poria cocos, and 20 parts Sinapis alba.

5. The application of the Ganoderma lucidum compound composition for enhancing immunity according to claim 1 in the preparation of health products for treating low immunity, characterized in that: The preparation method of the Ganoderma lucidum compound composition is as follows: Weigh the medicinal slices according to the proportion. Add 8 times the weight of 80% ethanol to ginseng, codonopsis, angelica, and chuanxiong, and reflux for 3 times, 45 min each time. Recover the ethanol extract under reduced pressure to obtain an ethanol extract. Add 8 times the weight of water to the remaining medicinal residue after ethanol extraction and other medicinal slices, and extract twice, 1 h each time. Recover the water extract under reduced pressure, add ethanol to adjust the ethanol concentration to 65%, and purify for 24 hours. Take the supernatant, recover the ethanol under reduced pressure to obtain a water extract. Combine the ethanol extracts, evaporate in a water bath, and dry at 80℃ under normal pressure to obtain an extract powder. Crush, pass through an 80-mesh sieve, add excipients, and prepare a solid preparation.

6. The application of the Ganoderma lucidum compound composition for enhancing immunity according to claim 5 in the preparation of health products for treating low immunity, characterized in that: Solid dosage forms are one of the following: capsules, granules, or tablets.