WO2025131140A1 - Traditional chinese medicine composition for preventing and/or treating aids damp-heat syndrome and use thereof - Google Patents

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

This application claims the priority of 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

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

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 endanger their lives. Patients infected with HIV can be divided into HIV-infected people (acute stage, asymptomatic stage) and AIDS patients (AIDS stage) according to 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.

Traditional Chinese medicine treats AIDS based on the principle of combining disease and syndrome, and referring to ancient and modern times. By supporting the positive energy and regulating yin and yang, it can enhance the patient's immunity, alleviate symptoms and signs, improve the patient's quality of life, delay the onset of the disease, and reduce the mortality rate. The combination of traditional Chinese and Western medicine can reduce toxicity and increase efficacy, treat opportunistic infections, and achieve good results. However, different traditional Chinese medicine compound prescriptions have different efficacy, and their effects on AIDS are also uneven. At present, there are few reports on the research of traditional Chinese medicine in the damp-heat syndrome of AIDS.

Summary of the invention

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

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

The present application provides a traditional Chinese medicine composition for preventing and/or treating AIDS damp-heat syndrome, 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 atractylodes, 1-5 parts of magnolia bark, 0.5-1.5 parts of tongcao, and 1-3 parts of lophatherum gracile.

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

The present application provides a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition and a pharmaceutically acceptable carrier thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

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

Fig. 5 Grouping of in vitro experiments.

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

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

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

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

Figure 10 Analysis of the detection results of cytokine C4b2a concentration in cell experiments.

Figure 11 Analysis of the detection results of cytokine MAC concentration in cell experiments.

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

Figure 13 Analysis of the detection results of cytokine MBL concentration in cell experiments.

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

Figure 15 Analysis of C5 concentration test results in the observation group (damp-heat syndrome group).

Figure 16 Analysis of the results of cytokine C5 concentration detection in cell experiments.

DETAILED DESCRIPTION

The present application provides a Chinese medicine composition for preventing and/or treating AIDS damp-heat syndrome, comprising the following components by weight: 1-5 parts of almond, 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 tongcao, 1-3 parts of light bamboo leaf; preferably comprising the following components by weight: 3 parts of almond, 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 tongcao, 2 parts of light bamboo leaf. The Chinese medicine composition described in the present application is almond to promote the upper-jiao lung qi, because the lung is the master of the whole body's qi, and when the qi is transformed, the dampness is also transformed; white cardamom is aromatic and dampness-transforming, and promotes qi and relieves the middle; coix seed is sweet and light in nature and cold in nature, and it can promote dampness and heat and strengthen the spleen. The three kernels are combined, and the pungent opens at the top, is aromatic in the middle, and is light in the bottom, and the three burners are divided and eliminated, and they are all monarch drugs. Raw Atractylodes macrocephala can dry dampness and promote diuresis, and remove dampness in the middle burner; Talc, Tongcao, and Lanzhuye are sweet, cold, and mildly penetrating, and they cooperate with Coix seeds to remove dampness and clear heat, and they are the assistant drugs. Pinellia ternata and Magnolia officinalis can promote qi and eliminate fullness, eliminate dampness and harmonize the stomach, and help white cardamom to clear dampness and remove dampness, and they are the adjuvant drugs. All the drugs are combined, and the three kernels are combined to promote qi upward, clear the middle, and penetrate downward, so that qi can be smooth and dampness can be removed, heat can be cleared, spleen can be strong, the three burners can be unobstructed, and all symptoms can be eliminated. Compatibility characteristics: removing dampness and clearing heat are used together, with removing dampness as the main purpose; promoting qi upward, clearing the middle, and penetrating downward are carried out simultaneously to eliminate dampness and heat in the three burners.

The Chinese medicine composition described in this application is processed and prepared into granules by Wanxi Pharmaceutical Co., Ltd., and the granules are prepared according to the enterprise standards prepared and filed by Wanxi Pharmaceutical Co., Ltd. in accordance with the requirements of the National Pharmacopoeia and the State Food and Drug Administration to ensure clinical safety and effectiveness. The Chinese medicine composition prepared in this application is 15-30g/bag, preferably 22g/bag.

The present application also provides the use of the Chinese medicine composition in the preparation of drugs for the prevention and/or treatment of 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 method, 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 differential gene conversion to normal, and have a significantly improved therapeutic effect on AIDS damp-heat syndrome.

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.

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

This application has the following beneficial effects:

The Chinese medicine composition described in this application uses almond to promote the upper-jiao lung qi, because the lung is the master of the whole body's qi, and when qi is transformed, dampness is also transformed; white cardamom is aromatic and dampness-removing, promoting qi and relieving fullness; coix seed is sweet and light and cold in nature, and it can promote dampness and heat and strengthen the spleen. The three kernels are combined, and they are pungent in the upper part, aromatic in the middle, and light in the lower part, and the three burners are divided and eliminated, and they are all monarch drugs. Raw white atractylodes is damp-removing and diuretic, and removes dampness in the middle burner; talcum powder, tongcao, and light bamboo leaves are sweet, cold, and light infiltration, and they cooperate with coix seed to promote dampness and clear heat, and they are minister drugs. Ginger pinellia and magnolia bark promote qi and eliminate fullness, eliminate dampness and harmonize the stomach, and help white cardamom to clear the middle and remove dampness, and they are adjuvant drugs. All the medicines are combined, and the three kernels are combined to promote the upper part, clear the middle and penetrate the lower part, so that qi is smooth and dampness is removed, heat is cleared, spleen is strong, the three burners are unobstructed, and all symptoms are eliminated. Compatibility characteristics: It can remove dampness and clear heat at the same time, with removing dampness as the main purpose; it can promote the upward movement, clear the middle and penetrate downward to eliminate dampness and heat in the three burners. The clinical application and in vitro cell test results on patients with AIDS damp-heat syndrome found that the Chinese medicine composition can enhance the complement pathway function of patients with AIDS damp-heat syndrome, increase the CD4+T lymphocyte level of patients with AIDS damp-heat syndrome, promote the normalization of differential gene conversion, and significantly improve AIDS damp-heat syndrome.

The present application is further described below in conjunction with the accompanying drawings and embodiments.

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

Example 1

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 pinellia, 2 parts of talc, 3 parts of atractylodes, 3 parts of magnolia bark, 1 part of tongcao, and 2 parts of lophatherum gracile.

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

Example 2

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 pinellia, 3 parts of talc, 5 parts of atractylodes, 5 parts of magnolia bark, 1.5 parts of tongcao, and 3 parts of lophatherum gracile.

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

Example 3

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 pinellia, 1 part of talc, 1 part of atractylodes macrocephala, 2 parts of magnolia bark, 1 part of tongcao, and 1 part of lophatherum gracile.

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

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

1.1 Clinical case collection

Cluster sampling was performed at the AIDS Research Center of Ruikang Hospital of Guangxi University of Chinese Medicine. Informed consent was signed. Thirty cases of HIV/AIDS damp-heat syndrome and 15 cases of HIV/AIDS non-damp-heat syndrome were collected in a ratio of 2:1 between the observation group and the control group. Fifteen non-HIV/AIDS clinical subjects from the same region and period were also collected. The HIV/AIDS damp-heat syndrome group was the observation group, the HIV/AIDS non-damp-heat syndrome group was the control group 1, and the non-HIV/AIDS clinical subject group was the control group 2.

1.1.1 Diagnostic criteria

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 (the National Natural Science Foundation of China's "Distribution of Traditional Chinese Medicine Syndrome for AIDS and Establishment and Verification of Syndrome Standards" project number is: 90409004, and won the second prize of the Chinese Association of Traditional Chinese Medicine for Scientific and Technological Progress); the diagnostic criteria for control group 2 were: no epidemiological history and negative HIV antibodies.

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

1.1.2 Inclusion criteria

(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.

To be included in the observation group, all four of the above items must be met simultaneously; control group 1 must meet items (1), (3), and (4) simultaneously; and control group 2 must meet items (3), (4), and (5) simultaneously.

1.1.3 Exclusion criteria

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

1.1.4 Clinical medication

The observation group took the Chinese medicine composition prepared in Example 1. The control groups 1 and 2 did not take it. Dosage: 1 pack each time, 2 times a day, with 200 ml of boiled water. 15 days is a course of treatment, and 2 courses of treatment are used in succession.

1.1.5 Collection of clinical blood samples

At two points before and after medication, 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 from control group 1 and control group 2 were collected at the same time as those from the observation group.

1.1.6 Information Collection

A case observation form was prepared to collect basic information, physical examination, and four diagnostic methods of traditional Chinese medicine of the three groups of clinical subjects. The observation group was tested for routine blood, urine, stool, and biochemical routine tests.

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

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

The 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 of the three groups of research subjects.

1.1.7 Case dropout and treatment

All qualified subjects who withdraw from the trial at any time and for any reason, as long as they do not complete the observation period specified in the protocol, except for those who stop taking the drug before the end of the treatment course due to symptom disappearance, are considered dropouts.

Treatment 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, calling, writing, etc., 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 withdraw from 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 table and the reason for dropout should be filled in the clinical observation form. The statistical analysis of dropout cases should be handled in light of the actual situation. 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 to have dropped out. There is no need to make up for patients who drop out. For all dropout cases, the research case record table and other information should be summarized and statistically analyzed.

1.2 Statistical analysis

1.2.1 Statistical Analysis Dataset: Per-Protocol population (PP) 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.

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

1.2.3 Statistical analysis methods: Test level: All statistical tests are two-sided tests, with α = 0.05 level, P ≤ 0.05 is statistically significant; Baseline data: Demographic data are described using row lists; Statistical description: Mean ± standard deviation is used for numerical variables, and frequency (constituent ratio) is used for categorical variables; Treatment of missing values: If the missing values of the subject exceed 20%, it will be treated as a failure. When the missing values are less than 20% of the total cases, the missing values are replaced by the average value of their series data; Parameter estimation: 95% CI is used for parameter estimation; Effectiveness analysis: The frequency of symptoms and signs, symptom scores, CD4+, CD8+, and viral load changes at different time points before and after treatment in the two groups were analyzed by variance analysis, and the corresponding statistical results were selected according to the results of the sphericity test; Paired t test was used for comparison of the self-control before and after the group if it was in line with the normal distribution, and Wilcoxon signed rank test was used if it could not be converted to normal. Safety analysis: Describe the adverse events and changes in laboratory test results before and after the trial.

1.3 Experimental Results

1.3.1 Analysis of baseline data of selected cases

Table 2 Analysis of basic information of the three groups of people

(Note: Most of the selected cases in the three groups were male, and there was no statistically significant difference in age.)

1.3.2 Analysis of clinical data of selected cases

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.)

Table 4 Analysis of immunological index test results of three groups of people

(Note: Compared with control group 2, ☆P＜0.05; compared with control group 1, ★P＜0.05.)

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

1.3.3 Clinical symptom score analysis

The patients were mainly from the high-incidence areas of AIDS in Guangxi Province. One patient dropped out after the observation, and 29 cases were finally included in the analysis.

Table 5 Analysis of the results of the damp-heat diagnosis scale before and after treatment in the observation group

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

1.3.4 Analysis results of blood routine, liver and kidney function indicators

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

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 was significantly different and statistically significant.

1.3.5 Complement pathway-related cytokine concentration detection results

Table 7 Analysis of the 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.)

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

From Table 7 and Figures 2-4, it can be seen that the cytokine C1q differed significantly among the three groups, and the differences were statistically significant. C4BP and MAC in the AIDS damp-heat group were lower than those in healthy people, and the differences were statistically significant. From Table 8, it can be seen that the cytokine MAC in patients with AIDS damp-heat syndrome was significantly higher after taking the medicine than before taking the medicine. The P value of the two groups after the T test was less than 0.05, which was significantly different and statistically significant. The results of the clinical complement pathway-related cytokine determination showed that the complement activation of AIDS damp-heat syndrome was lower than that of healthy people and the AIDS unrecognizable group, and taking the medicine enhanced the role of the complement pathway.

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

1. Grouping

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, and the serum was the supernatant of the fasting whole blood of the volunteers.

The experiment was divided into 6 groups, of which the drug-containing serum group and the non-drug-containing serum group were each divided into three groups: blank control group, CCLT inhibition group, and CCLT activation group. The stimuli in the CCLT activation group were MBL and C-reactive protein, the CCLT inhibition group was added with C1NH, and the blank control group was not added with stimuli.

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.

Monitor the expression of MASP/C4BP in plasma PBMC of HIV/AIDS damp-heat syndrome after taking the drug-containing serum of rats taking the Chinese medicine composition, and the regulation of CCLT pathway by MASP/C4BP and drug-containing serum of rats taking the Chinese medicine composition. Construct an in vitro network relationship among drug-containing serum of rats with the Chinese medicine composition of the present application, MASP/C4BP, and CCLT pathway. Use ELISA technology and standard curve method to qualitatively and quantitatively detect the expression of related proteins in the complement cascade reaction of AIDS damp-heat syndrome: the main target proteins MASP and C4BP; CCLT pathway downstream proteins C3, C4b2a, MAC; CCLT pathway activation marker C1q.

2. Preparation of drug-containing serum in rats

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

2) The rats were routinely raised in a secondary animal laboratory for 3 days, with a room temperature of 20°C and a room humidity of about 70%;

3) The rats in the Chinese medicine combination group were gavaged with a high dose of 12.5 g/kg for one week, and the rats in the model group were gavaged with 2 ml/100 g of normal saline for one week, once a day;

4) On the seventh day, the subjects were fasted and deprived of water for 12 hours before the last drug infusion. After ether anesthesia, 3 ml of non-anticoagulated whole blood was collected through the abdominal aorta and centrifuged at 2500 rpm for 10 minutes to collect serum.

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

6) The filtered serum is adjusted to 5% and 20% serum concentrations respectively and placed in culture medium for later use.

3. Isolation and Culture of PBMCs

The isolation and culture of PBMCs were performed as routine operations; PBMCs culture was divided into six groups, of which the drug-containing serum group and the non-drug-containing serum group were each divided into three groups: blank control group, CCLT inhibition group, and CCLT activation group. The stimuli in the CCLT activation group were MBL and C-reactive protein, the CCLT inhibition group was added with C1NH, and the blank control group was not added with stimuli (Figure 5).

4. CCLT pathway regulation research

In the in vitro experiment, the immune regulation of complement and related factors MASP/C4BP in the CCLT pathway was detected before and after the administration of the Chinese medicine composition. The results of the in vitro experiment on the concentration of cytokines related to the complement pathway are as follows.

Table 9 Analysis of in vitro C1q expression concentration detection results

Table 10 Analysis of the results of in vitro C4BP expression concentration detection

Table 11 Analysis of the results of in vitro C3 expression concentration detection

Table 12 Analysis of in vitro MASP2 concentration detection results

Table 13 Analysis of in vitro C4b2a concentration detection results

Table 14 Analysis of in vitro MAC concentration detection results

Table 15 Analysis of in vitro MBL concentration detection results

Table 16 Analysis of in vitro C5 concentration test results

As shown in Tables 9-16 and Figures 6-16, in the cell experiment, compared with the blank control group, the blank plus drug-containing serum group, except for the decrease in factor C4b2a and the unchanged MAC, the concentrations of the other factors increased. After the addition of drug-containing serum to the inhibitor group, the C1q, C4BP, MAC, and MASP2 factors increased, and C4b2a, MBL, C3, and C5 all decreased; after the addition of drug-containing serum to the activator group, C4b2a decreased, and MASP2 and C5 remained basically unchanged, while the others increased significantly. The analysis of the results of the determination of the concentration of complement pathway-related factors in the cell experiment showed that the Chinese medicine composition prepared in the present application was generally in an enhanced trend for the function of the complement pathway.

Example 6 Transcriptomics study of Chinese medicine composition on HIV/AIDS damp-heat syndrome

1. Study Case Collection

16 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 came 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, they were screened according to the "Diagnostic Scale for AIDS Damp-Heat Syndrome", and 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. Medication method: 1 pack each time, 2 times a day, 200 ml of boiled water. 1 course of treatment is 3 months, and 2 courses are taken.

Table 17 Clinical baseline data of the two groups

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

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

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).

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 (10)

A traditional Chinese medicine composition for preventing and/or treating AIDS damp-heat syndrome, characterized in that it 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 ginger pinellia, 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. The traditional Chinese medicine composition as described in claim 1 is characterized in that it 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, 3 parts of Magnolia officinalis, 1 part of tongcao, and 2 parts of lophatherum gracile. Use of the traditional Chinese medicine composition as claimed in claim 1 in the preparation of a medicine for preventing and/or treating AIDS damp-heat syndrome. The use as claimed in claim 3 is characterized in that the Chinese medicine composition is 15 to 30 g/packet, 0.5 to 1.5 packs are taken 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 taken continuously. The use according to claim 3 is characterized in that the Chinese medicine composition enhances the complement pathway effect in patients with AIDS damp-heat syndrome. The use according to claim 3 is characterized in that the Chinese medicine composition improves the level of CD4+T lymphocytes in patients with AIDS damp-heat syndrome. The use as claimed in claim 3 is characterized in that the Chinese medicine composition promotes the differential gene progression towards normal. A Chinese medicine preparation, characterized in that it comprises the Chinese medicine composition according to claim 1 or 2 and a pharmaceutically acceptable carrier thereof. The Chinese medicine preparation according to claim 8, characterized in that the dosage form of the Chinese medicine preparation includes granules, pills, tablets, capsules, injections or decoctions. 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.