Traditional Chinese medicine composition for invigorating spleen to eliminate dampness and improving and reconstructing immune function

Abstract

The invention discloses a traditional Chinese medicine composition for invigorating spleen to eliminate dampness and improving and reconstructing immune functions. The traditional Chinese medicine composition comprises the following raw material medicines: fructus lycii, semen coicis, semen cuscutae, herba epimedii, poria cocos, rhizoma coptidis, pericarpium citri reticulatae, radix morindae officinalis, liquorice root, warm Chinese yam, radix codonopsis, antler powder tablets and raw rhizoma atractylodis macrocephalae. The invention also discloses a traditional Chinese medicine compound preparation prepared from the traditional Chinese medicine composition and an application of the traditional Chinese medicine composition or the traditional Chinese medicine compound preparation in preparation of a medicine for improving the symptom of immunocompromise. The traditional Chinese medicine composition or the traditional Chinese medicine compound preparation can improve the count of CD4 + T lymphocytes, improve the ratio of CD4 + / CD8 +, promote immune reconstruction and reduce the level of glutamic-pyruvic transaminase and glutamic oxalacetic transaminase of HIV infected patients. The traditional Chinese medicine composition or the traditional Chinese medicine compound preparation disclosed by the invention has great application potential and practical significance in the aspect of improving the symptom of low immune function of spleen and kidney deficiency patients caused by HIV infection, and has good social benefits and application values.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for strengthening the spleen and eliminating dampness, and enhancing and rebuilding immune function, as well as a preparation method and use thereof. Background Art

[0002] Acquired immunodeficiency syndrome (AIDS) is a chronic infectious disease caused by the human immunodeficiency virus (HIV). Since the HIV epidemic, 76 million people have been infected with HIV and about 33 million people have died from HIV. At the same time, AIDS has become an important public health issue that seriously threatens the public health of our country. After the HIV virus enters the human body, it destroys the human immune system, which not only affects the immune response of T lymphocytes, but also involves humoral immunity and natural immune response. The onset of AIDS is closely related to the state of the body's immune system. The immunopathological manifestations of AIDS patients are: CD4 + T lymphocyte dysfunction, CD4 + Decreased number of T lymphocytes, immune reconstitution, and abnormal immune activation, etc.

[0003] At present, anti-retroviral therapy (ART) is the main treatment for AIDS around the world. Combination antiretroviral therapy (cART) can inhibit viral replication, reduce opportunistic infections, significantly delay disease progression, improve the prognosis of AIDS patients, and reduce the mortality rate of patients. There are more than 30 drugs in six categories in the world, and more than 20 drugs in five categories in my country. The common ones are as follows: 1. Nucleoside reverse transcriptase inhibitors, including zidovudine, lamivudine, abacavir, emtricitabine and tenofovir. 2. Non-nucleoside reverse transcriptase inhibitors, including nevirapine, efavirenz, itravirine, rilpivirine, etc. 3. Protease inhibitors, including darunavir, atazanavir, lopinavir and ritonavir, etc. 4. Fusion immune preparations. 5. Integrase inhibitors, including dolutegravir, raltegravir, etc.

[0004] The main treatment strategy for AIDS is cocktail therapy, which is a combination of antiviral drugs, usually two nucleoside reverse transcriptase inhibitors combined with a non-nucleoside reverse transcriptase inhibitor, or combined with an integrase inhibitor or a protease inhibitor. The side effects of the combined use of different drugs during the treatment process are also different, but in general, they mainly include: First, gastrointestinal reactions. Almost all antiviral drugs may cause gastrointestinal reactions, such as nausea, vomiting, abdominal pain, and diarrhea. Especially in the early stage of treatment, but usually after 4-6 weeks of medication, it will gradually ease. The second is liver and kidney toxicity, especially liver toxicity. Nucleosides can cause fatty degeneration of the liver, which usually takes more than six months to appear, while proteases may cause liver toxicity at any stage. Third, allergic reactions are also included. All non-nucleoside and nucleoside drugs may cause mild or severe allergic reactions, such as erythroderma, severe erythema multiforme, drug hypersensitivity syndrome, etc. Finally, other adverse reactions such as drug resistance will also occur.

[0005] With the emergence of cocktail therapy, AIDS has now changed from a fatal disease to a controllable chronic disease, but the medical community has not yet developed a drug that can completely cure AIDS. cART treatment cannot completely eliminate the human immunodeficiency virus in the body, and abnormal immune activation still exists for a long time after the virus is completely suppressed. The immune system of some patients cannot achieve ideal reconstruction, resulting in poor immune reconstruction. At least 20% of patients have poor immune reconstruction, which has become a difficulty and hot spot in AIDS treatment, which is manifested by an increase in the level of immune activation and a decrease in CD4+T lymphocytes.

[0006] According to TCM, the kidney is the foundation of the innate constitution. The kidney stores essence and qi, controls bone production and marrow, contains the original yin and yang, and is the original source of life. It can promote the operation of all tissues and organs in the body and maintain the normal physiological functions of the human body. The spleen is the foundation of the acquired constitution and the source of qi and blood. Only when the spleen and stomach are healthy can the five internal organs and the limbs be nourished. The spleen is innate and the kidney is acquired. The two support each other and promote each other. The deficiency of the body and the invasion of evil are the fundamental causes of the immune function deficiency of AIDS. Replenishing the body's qi, strengthening the body and eliminating evil, and improving immunity are the key points of TCM to adjust the yin and yang organs and immune function. The key to strengthening the body and consolidating the foundation lies in protecting the innate and acquired foundation. For patients with incomplete immune reconstruction of AIDS, the pathogens have retreated, but the body's deficiency has not recovered. The treatment should focus on strengthening the body and treat the spleen and kidney. Paying attention to replenishing the spleen and kidney, and maintaining the innate and acquired foundation can promote the recovery of the deficiency of various internal organs. After more than 20 years of research and clinical experiments, it has been proved that TCM treatment of AIDS not only has its unique advantages and national characteristics, but also has specific therapeutic effects.

[0007] Compared with Western medicine, the advantages of TCM mainly include: 1. TCM's syndrome differentiation and treatment and individualized treatment can alleviate and reduce symptoms of AIDS patients and improve their quality of life. 2. Western medicine antiviral treatment needs to wait until the appropriate treatment conditions are met before it can be used, while TCM has certain potential and advantages in the treatment of asymptomatic HIV-infected patients. 3. It can stabilize or improve the patient's immune function in stages, delay the onset of the disease, and enable the patient to survive with the virus. 4. TCM can reduce certain toxic and side effects of antiviral drugs and increase patient compliance. 5. TCM has good drug accessibility and coverage; under the premise of accurate syndrome differentiation, toxic and side effects are relatively few.

[0008] In short, the use of traditional Chinese medicine to treat AIDS can, through dialectical treatment and adjustment, play the role of strengthening the kidney and consolidating the foundation, invigorating qi and strengthening the body, clearing away heat and detoxifying, and promoting blood circulation and removing blood stasis, thereby enhancing the body's immune function. Summary of the invention

[0009] The purpose of the present invention is to provide a Chinese medicine composition and compound preparation which can safely and effectively improve the low immune function of people with spleen and kidney deficiency caused by HIV infection, can strengthen the spleen and eliminate dampness, enhance and rebuild immune function, and can be used for the treatment of AIDS.

[0010] The technical solution adopted by the present invention is:

[0011] A traditional Chinese medicine composition for strengthening the spleen and eliminating dampness, and enhancing and rebuilding immune function. The traditional Chinese medicine composition comprises the following raw materials: wolfberry, coix seed, dodder seed, epimedium, tuckahoe, coptis root, tangerine peel, Morinda officinalis, liquorice, Chinese yam, codonopsis pilosula, pilose antler powder tablets, and raw atractylodes.

[0012] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight: 110-180 parts of wolfberry, 210-270 parts of coix seed, 110-180 parts of dodder seed, 110-180 parts of epimedium, 210-270 parts of tuckahoe, 110-180 parts of coptis root, 110-180 parts of tangerine peel, 110-180 parts of Morinda officinalis, 110-180 parts of licorice, 6-14 parts of warm yam, 200-270 parts of codonopsis pilosula, 34-45 parts of deer antler powder tablets, and 110-180 parts of raw atractylodes.

[0013] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 120-160 parts of wolfberry, 220-260 parts of coix seed, 120-170 parts of dodder seed, 120-160 parts of epimedium, 220-260 parts of tuckahoe, 120-170 parts of coptis root, 120-160 parts of tangerine peel, 120-160 parts of Morinda officinalis, 120-160 parts of licorice, 8-12 parts of warm yam, 210-260 parts of codonopsis pilosula, 36-44 parts of pilose antler powder tablets, and 120-170 parts of raw atractylodes.

[0014] More preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 130-150 parts of wolfberry, 230-250 parts of coix seed, 130-150 parts of dodder seed, 130-150 parts of epimedium, 230-250 parts of poria, 130-150 parts of coptis root, 130-150 parts of tangerine peel, 130-150 parts of Morinda officinalis, 130-150 parts of liquorice, 9-11 parts of warm yam, 220-250 parts of codonopsis pilosula, 39-43 parts of pilose antler powder tablets, and 130-160 parts of raw atractylodes.

[0015] More preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 140 parts of wolfberry, 240 parts of coix seed, 140 parts of dodder seed, 140 parts of epimedium, 240 parts of poria, 140 parts of coptis root, 140 parts of tangerine peel, 140 parts of Morinda officinalis, 140 parts of licorice, 10 parts of warm yam, 240 parts of codonopsis pilosula powder, 40 parts of pilose antler powder tablets, and 140 parts of raw atractylodes.

[0016] The present invention also provides a Chinese medicine compound preparation prepared from the Chinese medicine composition for strengthening the spleen and eliminating dampness and enhancing and rebuilding immune function.

[0017] The dosage form of the Chinese medicine compound preparation includes pills, granules, tablets, capsules or decoctions. The Chinese medicine compound preparation can be prepared according to conventional pharmacy processes and pharmaceutical excipients acceptable to human body.

[0018] Furthermore, when the Chinese medicine compound preparation is a pill, it is prepared by the following method:

[0019] Take wolfberry, coix seed, dodder seed, epimedium, tuckahoe, coptis root, tangerine peel, liquorice, yam, and raw atractylodes, add water and boil twice, boil 9-10 times the amount of water for 60-80 minutes for the first time, boil 6-7 times the amount of water for 40-60 minutes for the second time, combine the liquid, cool and settle for 4 hours, take the supernatant, pass through a 100-mesh sieve, and concentrate to a relative density of 1.2-1.3 at 60°C. Dry the velvet antler powder, Morinda officinalis, and Codonopsis pilosula at 70-80°C for 7-8 hours, crush, and pass through an 80-mesh sieve to obtain fine powder. Mix the concentrate and powder thoroughly, make pills, polish, dry at 70-80°C / 6h, remove the damaged pills, and package them to obtain pills.

[0020] Furthermore, when the Chinese medicine compound preparation is a decoction, it is prepared by the following method:

[0021] Take wolfberry, coix seed, dodder seed, epimedium, poria, coptis root, tangerine peel, Morinda officinalis, licorice, warm yam, codonopsis pilosula, pilose antler powder slices, and raw atractylodes, add water and boil twice, the first time with 10 to 12 times the amount of water, boil for 90 to 100 minutes, the second time with 8 to 9 times the amount of water, boil for 60 to 80 minutes, combine the medicinal liquids, cool and settle for 4 to 5 hours, take the supernatant, pass through a 100-mesh sieve, concentrate to the relative density of the concentrate at 60°C of 1.2 to 1.3, refrigerate and let stand for 12 hours, remove the precipitate, take the supernatant, and prepare a decoction.

[0022] When the Chinese medicine compound preparation is in the form of granules, tablets or capsules, it is prepared by the following method:

[0023] Take wolfberry fruit, coix seed, dodder seed, epimedium, poria, coptis root, tangerine peel, Morinda officinalis, licorice, warm yam, codonopsis pilosula, pilose antler powder slices, and raw atractylodes, add water and boil twice, the first time with 10 to 12 times the amount of water, boil for 90 to 100 minutes, the second time with 8 to 9 times the amount of water, boil for 60 to 80 minutes, combine the medicinal liquids, cool and settle for 4 to 5 hours, take the supernatant, pass through a 100-mesh sieve, and concentrate to a relative density of 1.2 to 1.3 at 60°C. The obtained concentrate is prepared into granules, tablets or capsules with pharmaceutical excipients acceptable to humans.

[0024] The present invention also provides the use of the Chinese medicine composition or the Chinese medicine compound preparation in preparing a medicine for improving the symptoms of immunosuppression.

[0025] Furthermore, the present invention also provides the use of the Chinese medicine composition or the Chinese medicine compound preparation in the preparation of a drug for improving the symptoms of low immune function in patients with spleen and kidney deficiency.

[0026] Furthermore, the present invention also provides the use of the Chinese medicine composition or the Chinese medicine compound preparation in the preparation of a drug for improving the symptoms of low immune function in patients with spleen and kidney deficiency caused by HIV infection.

[0027] In the present invention, the immunosuppression may be caused by spleen and kidney deficiency. Preferably, the immunosuppression may be caused by HIV infection-induced spleen and kidney deficiency. The Chinese medicine compound preparation of the present application may be used to improve the symptoms of immunosuppression in HIV infection-induced spleen and kidney deficiency.

[0028] The present invention also provides the use of the Chinese medicine composition or Chinese medicine compound preparation in preparing a medicine for treating acquired immunodeficiency syndrome, which can assist ART treatment.

[0029] The Chinese medicine composition or Chinese medicine compound preparation of the present invention can increase the CD4+T lymphocyte count, improve the CD4+ / CD8+ ratio, promote immune reconstruction, and reduce the levels of alanine aminotransferase and aspartate aminotransferase in HIV-infected patients.

[0030] The formula of the Chinese medicine compound preparation of the present invention follows the basic principle of TCM syndrome differentiation and treatment, selects the raw material composition and dosage ratio, and each component can coordinate and promote each other to play a synergistic effect. AIDS belongs to the categories of "deficiency and fatigue", "epidemic disease" and "hidden temperature disease" in TCM, with weak righteousness as the root and internal invasion of toxic evil as the symptom. The harmony of spleen and kidney is the basis of the abundance of righteousness, and immunity is closely related to righteousness. The spleen is the material basis of immunity. The healthy function of spleen and blood can directly affect the production of immune active substances and the balance of immune function. The kidney is the biochemical source of immunity. Only when the kidney qi is sufficient, the kidney essence is solid, and the storage is moderate, can the righteousness be strong and the immunity be regulated, which is not only less attacked by evil spirits, but also can expel evil spirits from the outside. The spleen and kidney are in a mutually supportive relationship of congenital and acquired nature, and they affect each other pathologically. Patients with incomplete AIDS immune reconstruction have been infected with pathogenic toxins for a long time, which have damaged their vital energy and caused spleen and kidney deficiency. Insufficient spleen and kidney can easily lead to dampness and phlegm, which can cause complications. In the late stage of AIDS, the pathogens are weak and the vital energy is more deficient, and symptoms of spleen and kidney deficiency often appear. Treatment should focus on strengthening the vital energy, treating the spleen and kidney, strengthening the spleen and kidney, and strengthening the vital energy.

[0031] The main drugs in this prescription are Codonopsis pilosula and velvet antler powder tablets; the ministerial drugs are Atractylodes macrocephala, Poria cocos, Epimedium officinale, Morinda officinalis; the adjuvant drugs are Chinese yam, Coix seed, Tangerine peel, Lycium barbarum, Cuscuta chinensis; the guiding drugs are Coptis chinensis and Licorice. Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Licorice are all sweet and warm, which can invigorate Qi and spleen, dispel cold and eliminate dampness; Chinese yam, Coix seed, Tangerine peel can harmonize the stomach and regulate Qi, and also have the function of benefiting the kidney; velvet antler powder tablets, Morinda officinalis, Epimedium officinale, Cuscuta chinensis, Lycium barbarum can warm and nourish kidney yang, and replenish essence and Qi; Coptis chinensis can clear away heat and dry dampness, and restrain warm and hot. All the drugs are used together to support the positive Qi, improve immunity, and achieve the effect of eliminating evil and restoring the positive Qi.

[0032] In summary, the Chinese medicine composition and Chinese medicine compound preparation of the present invention have great application potential and practical significance in improving the symptoms of immunosuppression, further improving the symptoms of immunosuppression in patients with spleen and kidney deficiency, especially improving the symptoms of immunosuppression in patients with spleen and kidney deficiency caused by HIV infection. The prescription is developed and prepared into dosage forms such as Chinese medicine pills using traditional technology, and further promoted and applied, which has good social benefits and application value. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical solution and advantages of the present application more clear, the embodiments of the present application are described in detail below. It should be noted that the embodiments and features in the embodiments of the present application can be combined with each other arbitrarily without conflict.

[0034] Example 1

[0035] Take 140g of wolfberry, 240g of coix seed, 140g of dodder seed, 140g of epimedium, 240g of tuckahoe, 140g of coptis root, 140g of tangerine peel, 140g of licorice, 10g of warm yam, and 140g of raw atractylodes. Add water and boil twice, 9 times the amount of water for 60 minutes for the first time, and 7 times the amount of water for 40 minutes for the second time. Combine the liquid and cool it for 4 hours. Take the supernatant, pass it through a 100-mesh sieve, and concentrate it to a relative density of 1.2 to 1.3 at 60°C. Dry 40g of velvet antler powder, 140g of Morinda officinalis, and 240g of Codonopsis pilosula at 70°C / 8h, crush it, pass it through an 80-mesh sieve, and get fine powder. Mix the concentrate and the powder thoroughly, make pills, polish them, dry them at 70°C / 6h, remove the damaged pills, and package them to get pills.

[0036] Example 2

[0037] Take 130g of wolfberry, 220g of coix seed, 150g of dodder seed, 160g of epimedium, 260g of tuckahoe, 120g of coptis root, 140g of dried orange peel, 130g of licorice, 12g of warm yam, 140g of raw atractylodes, add water and boil twice, the first time with 10 times the amount of water for 90min, the second time with 6 times the amount of water for 60min, combine the liquid, and cool for 4h. Take the supernatant, pass through a 100-mesh sieve, and concentrate to a relative density of 1.2 to 1.3 at 60℃. Dry 41g of velvet antler powder, 140g of Morinda officinalis, and 250g of Codonopsis pilosula at 80℃ / 8h, crush, pass through an 80-mesh sieve, and obtain fine powder. Mix the concentrate and powder thoroughly, make pills, polish, dry at 80℃ / 6h, remove the damaged pills, and package them to obtain pills.

[0038] Example 3

[0039] Take 150g of wolfberry, 220g of coix seed, 150g of dodder seed, 160g of epimedium, 220g of tuckahoe, 120g of coptis root, 130g of dried orange peel, 130g of licorice, 12g of yam, 140g of raw atractylodes, add water and boil twice, the first time with 10 times the amount of water for 90min, the second time with 6 times the amount of water for 60min, combine the liquid, and cool for 4h. Take the supernatant, pass through a 100-mesh sieve, and concentrate to a relative density of 1.2-1.3 at 60℃. Dry 39g of velvet antler powder, 160g of Morinda officinalis, and 260g of Codonopsis pilosula at 80℃ / 8h, crush, pass through an 80-mesh sieve, and obtain fine powder. Mix the concentrate and powder thoroughly, make pills, polish, dry at 80℃ / 6h, remove the damaged pills, and package them to obtain pills.

[0040] Example 4

[0041] Take 130g of wolfberry, 250g of coix seed, 150g of dodder seed, 150g of epimedium, 220g of tuckahoe, 120g of coptis root, 130g of dried orange peel, 130g of Morinda officinalis, 130g of licorice, 10g of yam, 220g of codonopsis pilosula, 41g of pilose antler powder tablets, 120g of raw atractylodes, add water and boil twice, the first time with 10 times the amount of water for 90min, the second time with 6 times the amount of water for 60min, combine the liquid, and cool for 4h. Take the supernatant, pass through a 100-mesh sieve, concentrate to a relative density of 1.2-1.3 at 60℃, refrigerate and let stand for 12h, remove the precipitate, divide and sterilize, and the decoction is obtained.

[0042] Example 5

[0043] Take 130g of wolfberry, 230g of coix seed, 130g of dodder seed, 130g of epimedium, 210g of tuckahoe, 110g of coptis root, 120g of dried orange peel, 120g of Morinda officinalis, 120g of licorice, 9g of yam, 210g of codonopsis pilosula, 40g of pilose antler powder slices, 110g of raw atractylodes, add water and boil twice, the first time with 10 times the amount of water for 90 minutes, the second time with 6 times the amount of water for 60 minutes, combine the liquid, and cool for 4 hours. Take the supernatant, pass through a 100-mesh sieve, concentrate to a relative density of 1.2-1.3 at 60°C, boil and dry, add appropriate amount of auxiliary materials and granulate, and obtain granules, capsules or tablets by conventional methods.

[0044] Example 6

[0045] Take 140g of wolfberry, 240g of coix seed, 140g of dodder seed, 140g of epimedium, 140g of coptis root, 140g of dried orange peel, 140g of licorice, 10g of yam, 140g of raw atractylodes, add water and boil twice, 9 times the amount of water for 60min for the first time, 7 times the amount of water for the second time for 40min, combine the liquid, and cool for 4h. Take the supernatant, pass through a 100-mesh sieve, and concentrate to a relative density of 1.2 to 1.3 at 60℃. Dry 40g of velvet antler powder, 140g of Morinda officinalis, and 240g of Codonopsis pilosula at 70℃ / 8h, crush, and pass through an 80-mesh sieve to obtain fine powder. The concentrated solution and the powder are fully mixed, pelletized, polished, dried at 70°C / 6h, damaged pills are removed, and packaged to obtain pills (compared with Example 1, the preparation process is exactly the same, only the herbal material Poria cocos is missing).

[0046] Example 7

[0047] The efficacy of this prescription is summarized as follows:

[0048] A randomized controlled trial was used to evaluate and summarize the clinical efficacy of this patented Chinese herbal compound preparation in improving the symptoms of immunodeficiency in patients with spleen and kidney deficiency caused by HIV infection.

[0049] 1. Materials and Methods

[0050] 1 Inclusion criteria

[0051] HIV / AIDS patients who have been on HAART for ≥1 year, are confirmed to be HIV positive, are between 18 and 70 years old, meet the criteria of incomplete immune reconstitution, meet the criteria of spleen and kidney deficiency in traditional Chinese medicine, and are willing to participate in this study. Patients who have not received similar drugs and methods for treatment within 1 month before the trial; those who have informed consent to the relevant matters of this study; have good compliance and can cooperate with the doctor's treatment and follow-up.

[0052] 2 General Information

[0053] A total of 81 subjects were included in this trial, including 70 male patients and 11 female patients. All patients were given ART western medicine treatment according to the standard. In addition, the patients were divided into three groups according to the random number table method, with 27 cases in each group. There was one experimental group and two control groups. The three groups were comparable in age, gender, and disease course.

[0054] 3. Elimination criteria

[0055] Those with poor compliance and those who refuse to sign the informed consent.

[0056] 4 Intervention measures

[0057] 1) Experimental group: In this application, in addition to ART treatment, 27 patients who were given the Chinese medicine compound preparation of the present invention were randomly selected as the experimental group (the pills were prepared according to the method in Example 1: 140g of wolfberry, 240g of coix seed, 140g of dodder seed, 140g of epimedium, 240g of tuckahoe, 140g of coptis root, 140g of tangerine peel, 140g of Morinda officinalis, 140g of licorice, 10g of warm yam, 240g of codonopsis, 40g of pilose antler powder tablets and 140g of raw atractylodes), half a year as a course of treatment, once in the morning and evening every day, 20g of pills each time, and during the treatment period, the patients stopped taking other drugs to improve immune function. The biochemical indexes and blood routine, CD4+T, CD4+ / CD8+ indexes of the patients after one course of treatment were recorded.

[0058] 2) Control group 1: 27 cases were randomly selected and given ART treatment without Chinese medicine compound preparations. Biochemical indexes and blood routine, CD4+T, CD4+ / CD8+ indexes of patients after one course of treatment were recorded. The rest of the treatment methods were the same as those of the experimental group.

[0059] 3) Control group 2: 27 patients were randomly selected and given ART treatment, and the Chinese medicine compound preparation of Example 6 of the present invention was given as control group 2 (Compared with Example 1, Example 6 has exactly the same process, except that the Chinese medicine Poria is removed: 140g of Lycium barbarum, 240g of Coix seeds, 140g of Cuscuta seeds, 140g of Epimedium, 140g of Coptis chinensis, 140g of Tangerine peel, 140g of Morinda officinalis, 140g of Licorice, 10g of Dioscorea opposita, 240g of Codonopsis pilosula, 40g of pilose antler powder tablets, and 140g of raw Atractylodes macrocephala). Half a year is a course of treatment, once in the morning and evening every day, 20g of pills each time, and during the treatment period, the patients stopped taking other drugs to improve immune function. The biochemical indexes and blood routine, CD4+T, CD4+ / CD8+ indexes of the patients after one course of treatment were recorded. The rest of the treatment methods are the same as the experimental group.

[0060] 5. Criteria for determining efficacy

[0061] The standards for immunological indicators refer to the "Stage and Evaluation Index System for the Evaluation of the Efficacy of Traditional Chinese Medicine in the Treatment of HIV / AIDS."

[0062] Effective: CD4+T lymphocyte count increased by 50 cells / mm before and after treatment 3 Or more than 30%.

[0063] Ineffective: CD4+T lymphocyte count decreased by 50 cells / mm before and after treatment 3 Or more than 30%.

[0064] Stable: The CD4+T lymphocyte count does not rise or fall by 50 cells / mm before and after treatment 3 or 30%.

[0065] 6. Efficacy Observation Index

[0066] 6.1 Detection of biochemical indicators

[0067] Urea nitrogen (BUN), creatinine (Cr).

[0068] 6.2 Routine blood test, CD4+T, CD4+ / CD8+.

[0069] Red blood cells (RBC), platelets (PLT), hemoglobin (HGB), T helper lymphocytes (CD4+T), T helper lymphocytes / T suppressor lymphocytes (CD4+ / CD8+).

[0070] 7 Statistical methods

[0071] SPSS 22.0 software was used and the data were The two samples were subjected to t-test, and P < 0.05 was considered statistically significant.

[0072] 2. Results

[0073] 1. Efficacy evaluation

[0074] Table 1 Comparison of blood indicators before and after treatment

[0075]

[0076]

[0077] Note: Compared with control group 1, ▲ P<0.05, ▲▲ P<0.01

[0078] Table 2 Analysis of liver and kidney function results before and after treatment

[0079] Baseline / efficacy indicators Experimental group (n=27) Control group 1 (n=27) Control group 2 (n=27) ALT (before administration) 21.9±12.6 22.3±12.8 <![CDATA[21.7±12.3 ▲ ]]> ALT (after administration) <![CDATA[18.13±8.54 ▲▲ ]]> 20.31±9.04 19.23±8.79 AST (before administration) 24.6±8.0 25.1±8.2 24.9±7.4 AST (after administration) <![CDATA[19.9±12.1 ▲ ]]> 23.9±12.6 <![CDATA[21.7±11.5 ▲▲ ]]> BUN (before administration) 5.1±1.4 5.5±1.2 5.2±1.3 BUN (after administration) 5.3±1.36 6.3±1.21 <![CDATA[5.4±1.39 ▲ ]]> Cr(before administration) <![CDATA[83.7±17.9 ▲ ]]> 84.2±16.5 82.6±13.9 Cr(after administration) 88.3±21.3 92.4±22.9 <![CDATA[85.6±20.8 ▲ ]]>

[0080] Note: Compared with control group 1, ▲ P<0.05, ▲▲ P<0.01

[0081] 2. Results Analysis

[0082] From the data in Table 1 and Table 2, it can be seen that the Chinese medicine compound preparation in the present invention has a good effect on improving the immunity of HIV patients, which also verifies the Chinese medicine theory corresponding to each medicinal material in the formula. In Table 1, the CD4+T cell count of the test group patient, the improvement of CD4+ / CD8+ ratio is significantly better than that of the patient (control group 1) who is not given the Chinese medicine compound preparation in the present invention, and is also better than the Chinese medicine compound preparation in the present invention that lacks a medicinal material (Poria), which shows that the lack of one medicinal material can cause the drug effect to be significantly reduced. It can be seen that the thirteen medicines in the prescription of the present invention are indispensable and cannot be simplified, and the synergistic effect reaches the best drug effect. The data in Table 2 illustrate that the Chinese medicine compound preparation in the present invention reduces the alanine aminotransferase and aspartate aminotransferase levels of HIV infected patients before treatment, and the test group does not find any adverse reactions and complications after taking, and the efficacy is determined, with certain application prospects and value.

[0083] 3. Summary and Discussion

[0084] (1) The Chinese herbal compound preparation of the present invention can increase the CD4+T cell count of HIV patients, improve the CD4+ / CD8+ ratio, and promote immune reconstruction.

[0085] (2) The patented Chinese medicine compound preparation can reduce the levels of alanine aminotransferase and aspartate aminotransferase in HIV-infected patients compared with before treatment, and there is no significant change in the levels of white blood cells, red blood cells, platelets, hemoglobin, urea nitrogen and blood creatinine in blood routine tests, and the safety is good.

[0086] In summary, the Chinese medicine compound preparation of this patent is effective in improving the symptoms of low immune function in patients with spleen and kidney deficiency caused by HIV infection and promoting immune reconstruction, and has good safety and tolerability, has good application prospects, and is worthy of further development.

Claims

1. A Chinese medicine composition for strengthening the spleen and eliminating dampness, improving and rebuilding immune function, characterized in that The Chinese medicine composition comprises the following raw materials: wolfberry, coix seed, dodder seed, epimedium, tuckahoe, coptis root, tangerine peel, Morinda officinalis, liquorice, Chinese yam, codonopsis pilosula, pilose antler powder tablets and raw atractylodes.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 110-180 parts of wolfberry, 210-270 parts of coix seeds, 110-180 parts of dodder seeds, 110-180 parts of epimedium, 210-270 parts of tuckahoe, 110-180 parts of coptis roots, 110-180 parts of tangerine peel, 110-180 parts of Morinda officinalis, 110-180 parts of liquorice, 6-14 parts of yam, 200-270 parts of codonopsis pilosula, 34-45 parts of pilose antler powder tablets, and 110-180 parts of raw atractylodes.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 120-160 parts of wolfberry, 220-260 parts of coix seeds, 120-170 parts of dodder seeds, 120-160 parts of epimedium, 220-260 parts of tuckahoe, 120-170 parts of coptis roots, 120-160 parts of tangerine peel, 120-160 parts of Morinda officinalis, 120-160 parts of liquorice, 8-12 parts of yam, 210-260 parts of codonopsis pilosula, 36-44 parts of pilose antler powder tablets, and 120-170 parts of raw atractylodes.

4. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 130-150 parts of wolfberry, 230-250 parts of coix seeds, 130-150 parts of dodder seeds, 130-150 parts of epimedium, 230-250 parts of tuckahoe, 130-150 parts of coptis roots, 130-150 parts of tangerine peel, 130-150 parts of Morinda officinalis, 130-150 parts of liquorice, 9-11 parts of yam, 220-250 parts of codonopsis pilosula, 39-43 parts of pilose antler powder tablets, and 130-160 parts of raw atractylodes.

5. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following raw materials in parts by weight: 140 parts of wolfberry, 240 parts of coix seed, 140 parts of dodder seed, 140 parts of epimedium, 240 parts of tuckahoe, 140 parts of coptis root, 140 parts of tangerine peel, 140 parts of Morinda officinalis, 140 parts of liquorice, 10 parts of yam, 240 parts of codonopsis pilosula powder, 40 parts of pilose antler powder tablets, and 140 parts of raw atractylodes.

6. A Chinese medicine compound preparation prepared from the Chinese medicine composition according to any one of claims 1 to 5.

7. The Chinese medicinal compound preparation according to claim 6, characterized in that The dosage form of the Chinese medicine compound preparation includes pills, granules, tablets, capsules or decoctions.

8. Use of the Chinese medicine composition according to claim 1 or the Chinese medicine compound preparation according to claim 6 in the preparation of a medicament for improving the symptoms of immunosuppression.

9. Use of the Chinese medicine composition according to claim 1 or the Chinese medicine compound preparation according to claim 6 in the preparation of a medicament for improving the symptoms of low immune function in patients with spleen and kidney deficiency.

10. Use of the Chinese medicine composition according to claim 1 or the Chinese medicine compound preparation according to claim 6 in the preparation of a drug for improving the symptoms of low immune function in patients with spleen and kidney deficiency caused by HIV infection.

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