Traditional chinese medicine composition for preventing and / or treating aids damp-heat syndrome and use thereof

Abstract

A traditional Chinese medicine composition for preventing and / or treating AIDS damp-heat syndrome and use thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 1-5 parts of almond, 2-6 parts of Semen Coicis, 1-3 parts of Wurfbainia vera, 1-3 parts of ginger-processed Pinellia, 1-3 parts of talc, 1-5 parts of Rhizoma Atractylodis Macrocephalae, 1-5 parts of Cortex Magnoliae Officinalis, 0.5-1.5 parts of Medulla Tetrapanacis, and 1-3 parts of Herba Lophatheri.

Description

A traditional Chinese medicine composition for preventing and / or treating AIDS damp-heat syndrome and its application

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on December 20, 2023, with application number 202311763475.1 and application name “A Chinese medicine composition for preventing and / or treating AIDS damp-heat syndrome and its application”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for preventing and / or treating AIDS damp-heat syndrome and its application. Background Art

[0003] AIDS, also known as acquired immunodeficiency syndrome (AIDS), is a systemic disease caused by infection with the human immunodeficiency virus (HIV), also known as the AIDS virus. HIV infection can lead to varying degrees of immune deficiency in the human body. Untreated infected people are prone to various serious infections and malignant tumors in the late stages of the disease, which can ultimately be life-threatening. Patients infected with HIV can be divided into HIV-infected people (acute phase, asymptomatic phase) and AIDS patients (AIDS phase) according to the different stages of infection. There is still a lack of effective drugs to cure HIV infection. The current treatment goal is to maximally and permanently inhibit viral replication in the patient's body, enable the patient to reconstruct and maintain immune function, and at the same time reduce the morbidity and mortality of HIV infection and non-AIDS-related diseases.

[0004] Traditional Chinese medicine (TCM) treatment of AIDS adheres to the principle of integrating disease and symptoms, drawing on both ancient and modern approaches. By supporting vital energy and regulating yin and yang, it aims to enhance the patient's immunity, alleviate symptoms and signs, improve quality of life, delay onset, and reduce mortality. Combining traditional Chinese and Western medicine has achieved excellent results in reducing toxicity and enhancing efficacy, as well as treating opportunistic infections. However, different TCM compound formulas have varying efficacy, and their effects on AIDS are also variable. Currently, there are few reports on the use of TCM in treating the damp-heat syndrome of AIDS. Summary of the Invention

[0005] The present application provides a traditional Chinese medicine composition for preventing and / or treating AIDS damp-heat syndrome and its application. The traditional Chinese medicine composition has a significant improvement effect on AIDS damp-heat syndrome.

[0006] To solve the above technical problems, this application provides the following technical solutions:

[0007] The present application provides a traditional Chinese medicine composition for preventing and / or treating damp-heat syndrome of AIDS, comprising the following components in parts by weight: 1-5 parts of apricot kernel, 2-6 parts of coix seed, 1-3 parts of white cardamom, 1-3 parts of ginger and pinellia, 1-3 parts of talc, 1-5 parts of white atractylodes, 1-5 parts of magnolia bark, 0.5-1.5 parts of tongcao, and 1-3 parts of bamboo leaves.

[0008] The present application provides the use of the traditional Chinese medicine composition in preparing a medicine for preventing and / or treating AIDS damp-heat syndrome.

[0009] The present application provides a traditional Chinese medicine preparation, which includes the traditional Chinese medicine composition and a pharmaceutically acceptable carrier thereof. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 Analysis of the white-globulin ratio test results in the observation group before and after treatment.

[0011] Figure 2 Analysis of cytokine C1q concentration detection results before and after treatment in the three groups and the observation group.

[0012] Figure 3 Analysis of the detection results of cytokine C4BP concentrations in the three groups and the observation group before and after treatment.

[0013] Figure 4 Analysis of the detection results of cytokine MAC concentrations in the three groups and the observation group before and after treatment.

[0014] Figure 5. Grouping of in vitro experiments.

[0015] Figure 6 Analysis of cytokine C1q concentration detection results in cell experiments.

[0016] Figure 7 Analysis of cytokine C4BP concentration detection results in cell experiments.

[0017] Figure 8 Analysis of cytokine C3 concentration detection results in cell experiments.

[0018] Figure 9 Analysis of the cytokine MASP2 concentration detection results in cell experiments.

[0019] Figure 10 Analysis of cytokine C4b2a concentration detection results in cell experiments.

[0020] Figure 11 Analysis of cytokine MAC concentration detection results in cell experiments.

[0021] Figure 12 Analysis of the detection results of cytokine MAC concentration in control group 2 (healthy control group).

[0022] Figure 13 Analysis of cytokine MBL concentration detection results in cell experiments.

[0023] Figure 14 Analysis of C5 concentration test results in control group 1 (unlicensed control group).

[0024] Figure 15 Analysis of C5 concentration detection results in the observation group (damp-heat syndrome group).

[0025] Figure 16 Analysis of cytokine C5 concentration detection results in cell experiments. DETAILED DESCRIPTION

[0026] The present application provides a traditional Chinese medicine composition for preventing and / or treating damp-heat syndrome of AIDS, comprising the following components in parts by weight: 1-5 parts of apricot kernel, 2-6 parts of coix seed, 1-3 parts of white cardamom, 1-3 parts of ginger pinellia, 1-3 parts of talc, 1-5 parts of white atractylodes, 1-5 parts of magnolia bark, 0.5-1.5 parts of smilax glabra, and 1-3 parts of bamboo leaf; preferably comprising the following components in parts by weight: 3 parts of apricot kernel, 4 parts of coix seed, 2 parts of white cardamom, 2 parts of ginger pinellia, 2 parts of talc, 3 parts of white atractylodes, 3 parts of magnolia bark, 1 part of smilax glabra, and 2 parts of bamboo leaf. The traditional Chinese medicine composition described in the present application is characterized by the fact that apricot kernel clears and promotes lung qi in the upper burner, as the lung governs the qi of the whole body, and when qi is transformed, dampness is also transformed; white cardamom is aromatic and eliminates dampness, promotes qi circulation and relieves fullness; and coix seed is sweet, mild and cold in nature, and can eliminate dampness and heat and strengthen the spleen. The three kernels are considered together: pungent in the upper burner, aromatic in the middle, and mild in the lower burner, dispersing qi in the three burners, and are collectively considered the monarch medicine. Raw Atractylodes macrocephala eliminates dampness and promotes diuresis, removing dampness from the middle burner. Talc, Smilax glabra, and Aralia oleifera are sweet, cold, and mildly penetrating, complementing Coix seed in its dampness-clearing and heat-clearing properties, forming the assistant herbs. Pinellia ternata and Magnolia officinalis promote qi and dissipate fullness, transform dampness, and harmonize the stomach, aiding White Cardamom in clearing dampness and dispelling dampness, forming the adjuvant herbs. The combination of these herbs, and the three kernels, promotes upward flow, promotes the flow of qi, clears dampness, strengthens the spleen, unblocks the three burners, and resolves all symptoms. Key features of this combination: It simultaneously removes dampness and heat, prioritizing dampness removal; promoting upward flow, promoting the flow of qi, and penetrating the three burners, alleviating dampness and heat in the three burners.

[0027] The Chinese medicine composition described herein is processed into granules by Wanxi Pharmaceutical Co., Ltd., using the company's enterprise standards established and filed in accordance with the Chinese Pharmacopoeia and the China Food and Drug Administration to ensure clinical safety and effectiveness. The Chinese medicine composition prepared herein contains 15-30g / package, preferably 22g / package.

[0028] The present application also provides the use of the Chinese medicine composition in the preparation of a drug for preventing and / or treating AIDS damp-heat syndrome. The Chinese medicine composition described in the present application is 0.5 to 1.5 packets each time, 1 to 3 times a day, taken with boiled water, 13 to 17 days as a course of treatment, and 1 to 3 courses of treatment are used continuously. As an implementable embodiment, the Chinese medicine composition described in the present application is 22g / packet. The Chinese medicine composition described in the present application can enhance the complement pathway function of patients with AIDS damp-heat syndrome, and can also increase the CD4+T lymphocyte level of patients with AIDS damp-heat syndrome, promote the return of differential gene prognosis to normal, and have a significantly improved therapeutic effect on AIDS damp-heat syndrome.

[0029] The present application provides a traditional Chinese medicine preparation, which includes the traditional Chinese medicine composition and a pharmaceutically acceptable carrier thereof; the dosage form of the traditional Chinese medicine preparation includes but is not limited to granules, pills, tablets, capsules, injections, and decoctions; the traditional Chinese medicine composition accounts for 0.1 to 100% of the traditional Chinese medicine preparation.

[0030] In this application, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0031] This application has the following beneficial effects:

[0032] The Chinese medicine composition described in this application uses almonds to promote lung qi in the upper burner, as the lungs govern the body's qi, and when qi is transformed, dampness is also transformed; white cardamom is aromatic and eliminates dampness, promoting qi circulation and relieving fullness; coix seed is sweet, mild, and cold in nature, eliminating dampness and heat while strengthening the spleen. Taken together, the three kernels are pungent in nature, aromatic in nature, and mild in nature, penetrating the lower burner, dispersing dampness and heat, making them the monarch drug. Raw white atractylodes eliminates dampness and promotes diuresis, removing dampness from the middle burner; talcum powder, tongcao, and tanzhuye are sweet, cold, and mild in nature, complementing coix seed in its dampness-clearing and heat-clearing effects, making them the minister drugs. Pinellia ternata and Magnolia officinalis promote qi circulation, dissipate fullness, eliminate dampness and soothe the stomach, and assist white cardamom in its ability to clear dampness and dissipate dampness, making them the adjuvant drugs. The combination of these drugs, the three kernels, promote qi circulation in the upper burner, promote qi circulation in the middle burner, clear dampness, strengthen the spleen, and clear the three burners, eliminating various symptoms. Compatibility Features: It simultaneously dispels dampness and clears heat, with dampness removal as the primary focus; it simultaneously promotes upward circulation, unblocks the middle, and penetrates downward to eliminate dampness and heat in the three burners. Clinical application and in vitro cell-based studies on patients with AIDS damp-heat syndrome have shown that this Chinese medicine composition can enhance the complement pathway in these patients, increase CD4+ T lymphocyte levels, and promote the normalization of differential gene expression, significantly improving the symptoms of AIDS damp-heat syndrome.

[0033] The present application will be further described below with reference to the accompanying drawings and embodiments.

[0034] Unless otherwise specified, the methods used in the following examples are all conventional methods.

[0035] Example 1

[0036] A traditional Chinese medicine composition for preventing and / or treating damp-heat syndrome of AIDS is prepared from the following components in parts by weight: 3 parts of apricot kernel, 4 parts of coix seed, 2 parts of white cardamom, 2 parts of ginger and pinellia, 2 parts of talc, 3 parts of white atractylodes, 3 parts of magnolia bark, 1 part of tongcao, and 2 parts of bamboo leaf.

[0037] Processed and prepared into granules by Wanxi Pharmaceutical Co., Ltd., 22g / bag.

[0038] Example 2

[0039] A traditional Chinese medicine composition for preventing and / or treating damp-heat syndrome of AIDS is prepared from the following components in parts by weight: 5 parts of apricot kernel, 6 parts of coix seed, 3 parts of white cardamom, 3 parts of ginger and pinellia, 3 parts of talc, 5 parts of atractylodes, 5 parts of magnolia bark, 1.5 parts of tongcao, and 3 parts of bamboo leaf.

[0040] Processed and prepared into granules by Wanxi Pharmaceutical Co., Ltd., 22g / bag.

[0041] Example 3

[0042] A traditional Chinese medicine composition for preventing and / or treating damp-heat syndrome of AIDS is prepared from the following components in parts by weight: 1 part of apricot kernel, 2 parts of coix seed, 1 part of white cardamom, 1 part of ginger and pinellia, 1 part of talc, 1 part of atractylodes macrocephala, 2 parts of magnolia bark, 1 part of tongcao, and 1 part of bamboo leaf.

[0043] Processed and prepared into granules by Wanxi Pharmaceutical Co., Ltd., 22g / bag.

[0044] Example 4 Clinical application of Chinese medicine composition for patients with AIDS damp-heat syndrome

[0045] 1.1 Clinical case collection

[0046] Cluster sampling was conducted at the AIDS Research Center of Ruikang Hospital, Guangxi University of Chinese Medicine. Thirty patients with HIV / AIDS with damp-heat syndrome and 15 patients without damp-heat syndrome were recruited in a 2:1 ratio of observation to control. Fifteen non-HIV / AIDS clinical subjects from the same region and time period were also recruited. The HIV / AIDS damp-heat syndrome group served as the observation group, the HIV / AIDS non-damp-heat syndrome group served as control group 1, and the non-HIV / AIDS clinical subject group served as control group 2.

[0047] 1.1.1 Diagnostic criteria

[0048] The diagnostic criteria for control group 1 and observation group were based on the 2018 edition of the Chinese Medical Association's "Guidelines for the Diagnosis and Treatment of AIDS in China"; the diagnostic criteria for damp-heat syndrome in the observation group used the scale in Table 1 (National Natural Science Foundation of China "Distribution Pattern of Traditional Chinese Medicine Syndrome and Establishment and Verification of Syndrome Standards for AIDS" project number: 90409004, which won the second prize of the China Association of Traditional Chinese Medicine Science and Technology Progress Award); the diagnostic criteria for control group 2 were: no epidemiological history and negative HIV antibody.

[0049] Table 1 Diagnostic scale for damp-heat syndrome in HIV / AIDS patients

[0050] 1.1.2 Inclusion criteria

[0051] (1) Meet the diagnostic criteria for HIV / AIDS; (2) Scale score ≥ 20 points; (3) Age 16-60 years old; (4) Sign the informed consent form; (5) Not be HIV / AIDS patients.

[0052] The inclusion of the observation group requires that the above four items are met simultaneously; the control group 1 requires that (1), (3), and (4) are met simultaneously; the control group 2 requires that (3), (4), and (5) are met simultaneously.

[0053] 1.1.3 Exclusion criteria

[0054] (1) Those who do not meet the diagnostic criteria; (2) Those aged <16 or >60 years; (3) Those who do not sign the informed consent form; (4) Those with mental illness or major organ disease.

[0055] 1.1.4 Clinical medication

[0056] The observation group took the Chinese medicine composition prepared in Example 1. Control groups 1 and 2 did not take the composition. Dosage: 1 packet each time, twice a day, with 200 ml of boiled water. 15 days constitutes one course of treatment, and two courses of treatment are required.

[0057] 1.1.5 Collection of clinical blood samples

[0058] Before and after medication administration, 5 ml of non-anticoagulated blood and 20 ml of EDTA-anticoagulated blood were collected from the observation group using a disposable blood collection needle. Blood samples were collected from control groups 1 and 2 at the same time as the observation group.

[0059] 1.1.6 Information Collection

[0060] A case observation form was created to collect basic information, physical examinations, and the four diagnostic methods of Traditional Chinese Medicine (TCM). The observation group was tested for routine blood, urine, stool, and biochemical tests.

[0061] General information: includes basic information, personal history, past medical history, marital history, allergies and medication history.

[0062] Four diagnostic information: tongue condition, pulse condition, symptoms, physical signs, etc.

[0063] A fully automated biochemical analyzer was used to detect four blood lipid items (TG, TC, HDL-C, LDL-C), blood routine, and liver and kidney function in the three groups of research subjects.

[0064] 1.1.7 Case dropout and treatment

[0065] All eligible subjects who withdraw from the trial at their own discretion, regardless of when or why they withdraw, are considered dropouts as long as they do not complete the observation period specified in the protocol, excluding those who stop taking the drug before completing the entire course of treatment due to symptom resolution.

[0066] Handling of cases who drop out of the trial midway or are lost to follow-up: (1) The researcher should take active measures, such as making appointments in person, by phone, or by letter, to contact the subject as much as possible to inquire about the reason, record the last time of taking the medicine, and complete the last test as much as possible. (2) For cases who drop out of the trial due to allergic reactions or adverse reactions, the researcher should actively take appropriate treatment measures based on the actual situation of the subject. (3) For all dropout cases, the trial conclusion form and the reason for dropout should be filled in the clinical observation form. When statistically analyzing dropout cases, the actual situation should be taken into consideration. If adverse reactions occur, they should be included in the statistics of adverse reactions; those who cannot complete the entire course of treatment are considered dropouts. There is no need to make up for dropouts. For all dropout cases, the research case record form and other information should be summarized and statistically analyzed.

[0067] 1.2 Statistical analysis

[0068] 1.2.1 Statistical Analysis Dataset: Per-Protocol population (PP) analysis was used to perform statistical analysis on all observation units and their observed values ​​that met the trial protocol and completed the analysis and measurement.

[0069] 1.2.2 Statistical analysis software: SPSS21.0 software was used for statistical analysis.

[0070] 1.2.3 Statistical Analysis Methods: Test Level: All statistical tests were two-sided, with an α level of 0.05, and P ≤ 0.05 was considered statistically significant. Baseline Data: Demographic data were presented using row tables. Statistical Description: Numerical variables were presented using mean ± standard deviation, and categorical variables were presented using frequency (constituent ratio). Handling of Missing Values: If missing values ​​exceeded 20% of the study, the study was considered a failure. If missing values ​​were less than 20% of the total cases, the missing values ​​were replaced with the mean of the series data. Parameter Estimation: Parameters were estimated using 95% confidence intervals. Efficacy Analysis: Changes in symptom and sign frequency, symptom score, CD4+, CD8+, and viral load at different time points before and after treatment in the two groups were analyzed using analysis of variance, with the appropriate statistical results selected based on the results of the sphericity test. Paired t-tests were used for comparisons within the groups when normal distribution was observed; Wilcoxon signed-rank tests were used when normal distribution was not observed. Safety Analysis: Adverse events and changes in laboratory test results before and after treatment were described.

[0071] 1.3 Experimental Results

[0072] 1.3.1 Analysis of baseline data of selected cases

[0073] Table 2 Analysis of basic information of the three groups of people (Note: The majority of patients in the three groups were male, and there was no statistically significant difference in age.)

[0074] 1.3.2 Analysis of clinical data of selected cases

[0075] Table 3 Analysis of blood routine, liver and kidney function test results among the three groups (Note: Compared with control group 2, ☆P < 0.05; compared with control group 1, ★P < 0.05.)

[0076] Table 4 Analysis of immunological index test results among three groups of people (Note: Compared with control group 2, ☆P < 0.05; compared with control group 1, ★P < 0.05.)

[0077] The statistical results of three groups of immunological index detection showed that CD4 + / CD8 + The T lymphocyte ratios in the observation group, control group 1, and control group 2 showed statistically significant differences. Compared with control group 2, the difference in the observation group was more obvious than that in control group 1. + T lymphocytes, CD8 + The statistical results of T lymphocyte ratio showed that the difference between the observation group and the control group was statistically significant. + Compared with the control group 2, the immune function represented by T lymphocytes is still in a relatively low state of immune function damage, and the immune disorder of AIDS damp-heat syndrome is more obvious.

[0078] 1.3.3 Clinical symptom score analysis

[0079] The enrolled patients were primarily from high-incidence areas of AIDS in Guangxi Province. One patient dropped out after the observation period, resulting in a total of 29 cases included in the analysis.

[0080] Table 5 Analysis of the results of the damp-heat diagnostic scale before and after treatment in the observation group

[0081] By comparing the symptom scores before and after treatment, the results showed that the Chinese medicine composition prepared in this application can effectively alleviate the patients' damp-heat symptoms.

[0082] 1.3.4 Analysis results of blood routine and liver and kidney function indicators

[0083] Table 6 Analysis of blood routine and liver and kidney function indexes before and after treatment in the observation group

[0084] From Table 6 and Figure 1, it can be seen that the white-globulin ratio of patients with AIDS damp-heat syndrome was significantly higher before taking the medicine than after taking the medicine. After the T test, the P value of the two groups was less than 0.05, which showed a significant difference and was statistically significant.

[0085] 1.3.5 Complement pathway-related cytokine concentration detection results

[0086] Table 7 Analysis of the detection results of related cytokine concentrations in the three groups of people (Note: Compared with control group 2, ☆P < 0.05; compared with control group 1, ★P < 0.05.)

[0087] Table 8 Analysis of the results of related cytokine concentrations before and after treatment in the observation group

[0088] Table 7 and Figures 2-4 show significant differences in cytokine C1q among the three groups, with statistically significant differences. C4BP and MAC levels were significantly lower in the AIDS damp-heat syndrome group than in healthy controls, with statistically significant differences. Table 8 shows that MAC levels in patients with AIDS damp-heat syndrome were significantly higher after medication than before, with a P value less than 0.05 after a T-test, indicating a significant and statistically significant difference between the two groups. Clinical complement pathway-related cytokine assays showed that complement activation was lower in patients with AIDS damp-heat syndrome than in healthy controls and the undiagnosed AIDS group, and that medication enhanced the complement pathway.

[0089] Example 5 Analysis of the in vitro effectiveness of Chinese medicine composition against AIDS

[0090] 1. Grouping

[0091] The grouping of Example 4 was adopted, and the separated serum samples were used in the in vitro experiments of the observation group, control group 1 and control group 2. The serum was the supernatant of the fasting whole blood of the volunteers.

[0092] Six groups were tested, including three groups each: the drug-containing serum group and the non-drug-containing serum group: a blank control group, a CCLT inhibition group, and a CCLT activation group. The CCLT activation group was stimulated with MBL and C-reactive protein, the CCLT inhibition group was stimulated with C1NH, and the blank control group was not stimulated.

[0093] The drug-containing serum is the drug-containing serum of rats of the traditional Chinese medicine composition prepared in Example 1 of the present application.

[0094] The expression of MASP / C4BP in plasma PBMCs of HIV / AIDS patients with damp-heat syndrome was monitored after administration of serum containing a traditional Chinese medicine composition, and the regulation of the CCLT pathway by MASP / C4BP and serum containing the composition was investigated. An in vitro network relationship between serum containing the composition, MASP / C4BP, and the CCLT pathway was constructed. Using ELISA and a standard curve assay, the expression of proteins involved in the complement cascade in HIV / AIDS patients with damp-heat syndrome was qualitatively and quantitatively detected: the main target proteins MASP and C4BP; the downstream CCLT pathway proteins C3, C4b2a, and MAC; and the CCLT pathway activation marker C1q.

[0095] 2. Preparation of Rat Drug-containing Serum

[0096] 1) Twenty SD rats weighing 300 ± 50 g were purchased and randomly divided into two groups: a Chinese medicine combination group and a model group, with 10 rats in each group;

[0097] 2) Rats were housed in a secondary animal laboratory for 3 days at room temperature of 20°C and humidity of approximately 70%.

[0098] 3) The rats in the Chinese medicine composition group were orally administered with a high dose of 12.5 g / kg for one week, and the rats in the model group were orally administered with 2 ml / 100 g of normal saline for one week, once daily.

[0099] 4) On the seventh day, before the final drug administration, the subjects were fasted for 12 hours. Under ether anesthesia, 3 ml of non-anticoagulated whole blood was collected via the abdominal aorta and centrifuged at 2500 rpm for 10 minutes to collect serum.

[0100] 5) Incubate in a constant temperature water bath at 56°C for 30 minutes and filter through a microporous filter membrane tube;

[0101] 6) The filtered serum is adjusted to 5% and 20% serum concentrations respectively and added to the culture medium for later use.

[0102] 3. Isolation and Culture of PBMCs

[0103] PBMCs isolation and culture were performed according to standard procedures. PBMC cultures were divided into six groups, with three groups each for the drug-containing serum group and the non-drug-containing serum group: a blank control group, a CCLT inhibition group, and a CCLT activation group. The CCLT activation group received MBL and C-reactive protein as stimulants, the CCLT inhibition group received C1NH, and the blank control group received no stimulants (Figure 5).

[0104] 4. CCLT pathway regulation research

[0105] In vitro experiments were conducted to examine the immune regulation of complement and its related factor, MASP / C4BP, in the CCLT pathway before and after administration of the Chinese herbal composition. The results of the in vitro experiments examining the concentrations of complement-related cytokines are as follows.

[0106] Table 9 Analysis of in vitro C1q expression concentration detection results

[0107] Table 10 Analysis of in vitro C4BP expression concentration detection results

[0108] Table 11 Analysis of in vitro C3 expression concentration detection results

[0109] Table 12 Analysis of in vitro MASP2 concentration detection results

[0110] Table 13 Analysis of in vitro C4b2a concentration detection results

[0111] Table 14 Analysis of in vitro MAC concentration detection results

[0112] Table 15 Analysis of in vitro MBL concentration detection results

[0113] Table 16 Analysis of in vitro C5 concentration detection results

[0114] As shown in Tables 9-16 and Figures 6-16, in the cell-based experiments, the blank plus drug-containing serum group showed increases in the concentrations of all factors, except for a decrease in C4b2a and unchanged MAC, compared to the blank control group. In the inhibitor group, addition of drug-containing serum increased C1q, C4BP, MAC, and MASP2, while C4b2a, MBL, C3, and C5 all decreased. In the activator group, addition of drug-containing serum decreased C4b2a, while MASP2 and C5 remained largely unchanged, while all other factors showed significant increases. Analysis of the concentrations of complement pathway-related factors in the cell-based experiments revealed that the traditional Chinese medicine composition prepared herein generally enhances the function of the complement pathway.

[0115] Example 6 Transcriptomics Study on the Effect of Traditional Chinese Medicine Composition on HIV / AIDS Damp-Heat Syndrome

[0116] 1. Study Case Collection

[0117] Sixteen patients with HIV / AIDS damp-heat syndrome were clinically intervened with the Chinese medicine composition prepared in Example 1 of the present application, and 20 healthy volunteers from the same region were used as controls. The clinical baseline data of the two groups are shown in Table 17. The study cases were from a high-incidence area of ​​AIDS in China, and all AIDS patients in the village were listed as the initial subjects. After obtaining the informed consent of the initial subjects, screening was carried out according to the "Diagnostic Scale for AIDS Damp-Heat Syndrome". Those who met the screening criteria were listed as the research cases of this project, and healthy people from the same village were collected as the control group. Dosage: 1 packet each time, 2 times a day, with 200 ml of boiled water. 1 course of treatment is 3 months, and 2 courses of treatment are taken.

[0118] Table 17 Clinical baseline data of the two groups

[0119] Table 18 Changes in immunological indicators before and after treatment of AIDS damp-heat syndrome with Chinese medicine combination

[0120] Table 19 Genes of damp-heat syndrome before and after treatment with Chinese medicine combination

[0121] After 6 months of medication, it was found that the patient's CD4+T lymphocyte level increased, with a significant difference compared with before treatment (Table 18), and the prognosis of 25 differential genes tended to be normal (Table 19).

[0122] The above is only a preferred embodiment of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application. These improvements and modifications should also be regarded as the scope of protection of the present application.

Claims

1. A Chinese medicine composition for preventing and / or treating AIDS damp-heat syndrome, characterized in that: The invention comprises the following components in parts by weight: 1-5 parts of apricot kernel, 2-6 parts of coix seed, 1-3 parts of white cardamom, 1-3 parts of pinellia tuber, 1-3 parts of talc, 1-5 parts of atractylodes macrocephala, 1-5 parts of magnolia bark, 0.5-1.5 parts of tongcao, and 1-3 parts of lophatherum gracile.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components in parts by weight: 3 parts of apricot kernel, 4 parts of coix seed, 2 parts of white cardamom, 2 parts of ginger pinellia, 2 parts of talc, 3 parts of atractylodes macrocephala, 3 parts of magnolia bark, 1 part of tongcao, and 2 parts of lophatherum gracile.

3. Use of the Chinese medicine composition as claimed in claim 1 in preparing a medicine for preventing and / or treating AIDS damp-heat syndrome.

4. The use according to claim 3, characterized in that The Chinese medicine composition is 15-30g / packet, 0.5-1.5 packs are taken each time, 1-3 times a day, taken with boiled water, 13-17 days as one course of treatment, and 1-3 courses of treatment are required in succession.

5. The use according to claim 3, characterized in that The Chinese medicine composition enhances the complement pathway effect of patients with AIDS damp-heat syndrome.

6. The use according to claim 3, characterized in that The Chinese medicine composition improves the CD4+T lymphocyte level in patients with AIDS damp-heat syndrome.

7. The use according to claim 3, characterized in that The Chinese medicine composition promotes the differential gene progression to return to normal.

8. A Chinese medicine preparation, characterized in that: The traditional Chinese medicine preparation comprises the traditional Chinese medicine composition according to claim 1 or 2 and a pharmaceutically acceptable carrier thereof.

9. The Chinese medicine preparation according to claim 8, characterized in that: The dosage form of the traditional Chinese medicine preparation includes granules, pills, tablets, capsules, injections or decoctions.

10. The Chinese medicine preparation according to claim 8, characterized in that: The Chinese medicine composition accounts for 0.1 to 100% of the Chinese medicine preparation.

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