Traditional Chinese medicine compound for preventing and treating AIDS immune reconstitution insufficiency, preparation method and application

Abstract

The invention discloses a traditional Chinese medicine compound for preventing and treating immune function reconstruction insufficiency and liver and kidney essence deficiency syndromes of AIDS patients as well as a preparation method and application of the traditional Chinese medicine compound. The traditional Chinese medicine compound mainly comprises the following raw materials in parts by weight: 25-55 parts of prepared rehmannia root, 45-80 parts of oriental wormwood, 15-45 parts of turmeric, 10-40 parts of schisandra chinensis and 10-40 parts of liquorice. The compound preparation embodies the compatibility characteristics of'open source closure 'and'tonifying and reducing simultaneously', and has the effects of tonifying kidney, generating marrow and promoting immune function reconstruction of AIDS patients with liver and kidney essence deficiency; the composition can assist in preventing and treating immune function reconstruction insufficiency and liver and kidney essence deficiency syndromes of AIDS patients, and can regulate body immunity.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and mainly relates to a traditional Chinese medicine compound for preventing and treating immune reconstitution failure in AIDS patients, its preparation method and application. Background Art

[0002] I. Changes in Immune Function after HIV Infection Acquired immune deficiency syndrome (AIDS) is caused by human immunodeficiency virus (HIV) infection. At present, highly active antiretroviral therapy (HAART) is the main treatment for AIDS, which can reduce the viral load of patients, promote the recovery of CD4+ T lymphocytes, reduce the risk of HIV / AIDS transmission, and the incidence and mortality of related complications. However, 20%-30% of patients still cannot achieve ideal immune function after antiviral treatment, which is called immunological non-response (INR) population. Due to the long-term inability to recover immune function, the incidence and mortality of opportunistic infections and non-AIDS related diseases are increased in the INR population.

[0003] Traditional Chinese medicine starts from the overall concept and attaches great importance to the strength of the healthy qi of the human body, which has the greatest connection with the functions of the lungs, spleen and kidneys among the five internal organs. In the theory of zang-fu organs, it is believed that the lungs govern qi, combine with the skin and hair, and are in charge of the defensive exterior. Therefore, when exogenous pathogens invade, they first attack the lungs. The lungs and defensive qi are the first line of defense against the invasion of exogenous pathogens, similar to the role of non-specific immunity in modern medicine. The lungs govern qi and respiration, which is closely related to the immune defense function. Research has found that the immune function of patients with lung qi deficiency decreases, and tonifying the lung qi can significantly improve the immune function of patients.

[0004] The spleen is in charge of transportation and transformation, which can affect the absorption of nutrients and the transformation of energy metabolism, and is closely related to the immune function. From the perspective of modern medicine, the physiological functions of the "spleen" include the intake and digestion of food and water, the distribution and utilization of nutrients in the body, the excretion of metabolites, the generation and circulation of blood, immune function, and neurohumoral regulation activities. The spleen is the foundation of acquired constitution and can provide the source of generation for the immune system. The number of immune cells in patients with blood deficiency is lower than that of healthy people, and there is also a tendency of low cellular immune function and hyperactive humoral immune function. Therefore, the spleen is closely related to the development and maturation of immune cells.

[0005] The kidneys are the location of the original yin and original yang of the human body. Research has found that the kidneys have the functions of the "hypothalamus-pituitary-adrenal cortex axis" and the "hypothalamus-pituitary-thyroid axis", and these two axes are precisely important links in immune regulation. In addition, the kidneys are also related to immune active cells and the thymus, and can regulate the body's cellular immune function. Traditional Chinese medicine believes that the kidneys are responsible for bone growth and marrow production, and immune cells originate from bone marrow stem cells. It can be seen that the "kidneys in traditional Chinese medicine" have an important relationship with the immune organ bone marrow. Research has found that the kidneys can secrete a large amount of erythropoietin, which is a polypeptide hormone that acts on the bone marrow. It can be seen that the functions of the kidneys are related to the immune system to a certain extent.

[0006] During the process of AIDS, the decline of the kidneys, spleen, and lungs also conforms to the theory of traditional Chinese medicine. Initially, the acquired foundation, the spleen, begins to decline. Insufficient spleen earth leads to the mother's disease affecting the child, and the lungs also become deficient. If the spleen deficiency persists for a long time, it will inevitably affect the congenital foundation, the kidneys. In the early stage of AIDS, it is mainly characterized by spleen qi deficiency. Subsequently, on the basis of spleen qi deficiency, lung qi also becomes deficient, and the main manifestations are the symptoms of the upper and middle jiao with the deficiency of the spleen and lungs. It will inevitably affect the kidneys. In the middle and late stages of AIDS, the pathogenesis of kidney qi deficiency becomes increasingly prominent, and the main manifestations are the symptoms of the middle and lower jiao with the deficiency of the spleen and kidneys. Moreover, the longer the disease lasts, the more the disease location tends to the kidneys, and the more obvious the symptoms of kidney qi deficiency become.

[0007] Internal and external factors such as genetics, metabolism, drugs, and abnormal immune activation can cause an imbalance in the generation and destruction mechanisms of CD4+ T lymphocytes in the body, all of which can lead to poor immune reconstitution in patients. Immune activation, as a physiological activity of the body, runs through the entire process of HIV and AIDS and drives the progression of AIDS. HIV continuously replicates in the body to produce antigens, stimulating T lymphocytes to express immune activation molecules, forming an abnormal immune activation state and affecting the immune reconstitution of patients. Our previous research has shown that the INR population is continuously in an immune activation state. The percentages of CD4 / DR and CD4 / 38 / DR in INR patients are higher than those in patients with good immune reconstitution and healthy individuals.

[0008] II. The Role of Traditional Chinese Medicine in Immune Repair Searching for highly effective and safe immune regulators in traditional Chinese medicine for the treatment of autoimmune-related diseases is a hot topic in current immunopharmacology. Therefore, there have been many new progress in the research on the regulation of immune function by traditional Chinese medicine in recent years. Generally, according to the different effects of traditional Chinese medicine or traditional Chinese medicine monomers on the immune system, they are divided into immune promoters, immune inhibitors, etc. Some studies believe that traditional Chinese medicine regulates immunity by promoting the proliferation and differentiation of T cells and adjusting the ratio of T cell subsets, thereby enhancing the body's immunity. T lymphocytes are important effector cells participating in immune responses, and their main function is to mediate cellular immunity and regulate the body's immune function.

[0009] The immune system is an important organ that maintains the life activities of the body, mainly having three major functions, namely, defense, surveillance, and homeostasis. Under normal circumstances, the body defends against the invasion of pathogenic microorganisms, neutralizes toxins, and plays an immune protection role, that is, the immune defense function; the body clears the continuously generated senescent and damaged cells in the body to maintain the physiological balance in the body, that is, the immune homeostasis function; the body monitors and clears a small number of abnormal cells that often appear in the body, that is, the immune surveillance function. The healthy qi in traditional Chinese medicine can enhance the immune function of the human body and is most closely related to the concepts of the spleen, lung, and kidney in traditional Chinese medicine. The tonifying category of traditional Chinese medicine has an immune-promoting effect. The promoting blood circulation to remove blood stasis and clearing heat and detoxifying categories have a two-way immunomodulatory effect and have unique effects in the treatment of immune system diseases. Guo Jing, Wang Juyong, Liu Zhongda and others have studied and proposed that traditional Chinese medicine and modern immunology have similarities in many aspects such as basic theories and thinking modes. Guided by traditional Chinese medicine theory and giving play to the overall regulatory advantages of traditional Chinese medicine will be an important research direction for studying the immune effects and mechanisms of traditional Chinese medicine. Some studies have proposed that most of the tonifying drugs for strengthening the healthy qi and consolidating the constitution in traditional Chinese medicine are used to treat the hypofunction of the spleen, lung, and kidney functions and have a promoting effect on the immune function. Some drugs can inhibit the release of allergic mediators, inhibit the production of antibodies by antigen-stimulated organisms, inhibit or consume antibody production, etc. Some drugs have a certain degree of promoting effect on the phagocytic function of macrophages, humoral immunity, and cellular immunity functions. At present, the research on traditional Chinese medicine and immunity has entered the stages of animal experiments and laboratory analysis and observation from simple clinical observations, and there are more and more studies on single herbs and compound prescriptions in clinical immunity. For example, notoginsenoside is the main active ingredient extracted from the rhizome of Panax notoginseng, a traditional Chinese medicine, and has a wide range of pharmacological effects, such as anti-fatigue, hypoglycemic, improving the ability to tolerate hypoxia, and enhancing the immune function of the body. Injecting notoginsenoside Rg1 into the striatum of a Parkinson's disease rat model, it was found that notoginsenoside Rg1 could significantly reduce the N-rotation behavior of the model rats, reduce the contents of TNF-α, IL-1β, and IL-6 in the damaged side of the striatum, adjust the immune function of the body, and reduce the damage of immune inflammatory reactions to dopaminergic neurons. Another example is the study of the traditional Chinese medicine compound Chongjiling tablets, which shows that it can enhance the proliferation of T and B cells in normal mice and immune suppression model mice induced by ConA or LPS, promote the secretion of IL-2 and the apoptosis of CD4+ T lymphocytes, and restore the immune function of immune-suppressed mice to a certain extent, with the characteristics of an immune enhancer. Summary of the Invention

[0010] The object of the present invention is to provide a traditional Chinese medicine compound for preventing and treating immune function reconstruction insufficiency of liver and kidney essence deficiency syndrome in AIDS patients, its preparation method and application. A traditional Chinese medicine compound for preventing and treating immune function reconstruction insufficiency of liver and kidney essence deficiency syndrome in AIDS patients with liver and kidney essence deficiency provided by the present invention is made from the following raw materials in parts by weight: 25 - 55 parts of Rehmannia glutinosa Libosch. preparata, 45 - 80 parts of Artemisia capillaris Thunb., 15 - 45 parts of Curcuma longa L., 10 - 40 parts of Schisandra chinensis (Turcz.) Baill., 10 - 40 parts of Glycyrrhiza uralensis Fisch. Preferably, the traditional Chinese medicine compound is made from the following raw materials in parts by weight: 30 - 50 parts of Rehmannia glutinosa Libosch. preparata, 50 - 70 parts of Artemisia capillaris Thunb., 20 - 40 parts of Curcuma longa L., 10 - 30 parts of Schisandra chinensis (Turcz.) Baill., 10 - 30 parts of Glycyrrhiza uralensis Fisch. Preferably, the traditional Chinese medicine compound is made from the following raw materials in parts by weight: 40 parts of Rehmannia glutinosa Libosch. preparata, 60 parts of Artemisia capillaris Thunb., 30 parts of Curcuma longa L., 20 parts of Schisandra chinensis (Turcz.) Baill., 20 parts of Glycyrrhiza uralensis Fisch.

[0011] A traditional Chinese medicine compound preparation, the preparation includes the above traditional Chinese medicine compound and pharmaceutically acceptable excipients, such as tablets, capsules, granules, etc.

[0012] The preparation method of the traditional Chinese medicine compound preparation: Weigh Rehmannia glutinosa Libosch. preparata, Artemisia capillaris Thunb., and Glycyrrhiza uralensis Fisch. according to parts by weight, decoct and extract 3 times, the water addition amounts are 8 - 10 times, 5 - 7 times, 5 - 7 times respectively, each time for 1.5 - 2 hours, filter the decoction liquid, combine and concentrate to obtain a concentrated water decoction, and set aside; Crush Schisandra chinensis (Turcz.) Baill. into the coarsest powder and set aside; Add 70% - 80% ethanol to the coarsest powder of Schisandra chinensis (Turcz.) Baill. and Curcuma longa L., reflux and extract 3 times, the alcohol addition amounts are 2 - 3 times, 1 - 2 times, 1 - 2 times respectively, each time for 0.75 - 1.5 hours, filter the extraction liquid, combine and concentrate to obtain a concentrated alcohol extraction, and set aside; Take the above concentrated water decoction and concentrated alcohol extraction, carry out vacuum drying, crush, make into granules, dry, add silicon dioxide, fill into capsules to obtain capsule preparations.

[0013] The present invention also provides the application of the above traditional Chinese medicine compound in the preparation of a drug for preventing and treating immune function reconstruction insufficiency in AIDS patients, which is used for preventing and treating AIDS patients with immune function reconstruction insufficiency of liver and kidney essence deficiency.

[0014] The components of the traditional Chinese medicine compound capsule preparation are helpful for immune repair.

[0015] Rehmannia glutinosa was first recorded in *Shennong Ben Cao Jing*. It is the fresh or dried tuberous root of the plant Rehmannia glutinosa Libosch of the family Scrophulariaceae. Clinically, it is divided into three types: fresh Rehmannia glutinosa, raw Rehmannia glutinosa, and prepared Rehmannia glutinosa. Prepared Rehmanniae polysaccharide (PRRP) is the main active ingredient of prepared Rehmannia glutinosa. As an important class of natural macromolecular compounds, it has various effects such as enhancing immunity, antioxidation, antimutation, and enhancing memory. Prepared Rehmanniae polysaccharide can increase the body weight, spleen index, and thymus index of mice with immune function damage induced by adriamycin, and can antagonize the atrophy of the thymus and spleen in mice with blood deficiency model.

[0016] Artemisia capillaris is bitter, pungent, and slightly cold in nature, and belongs to the spleen, stomach, liver, and gallbladder meridians. It was first recorded in *Shennong Ben Cao Jing*. Its functions are to clear heat and promote diuresis, and to promote bile secretion and reduce jaundice. It is a key herb for treating jaundice and is mainly used clinically to treat various liver and gallbladder diseases. Modern pharmacological studies have shown that the main chemical components of Artemisia capillaris include coumarins, chromones, flavonoids, caffeic acid, and volatile oils, which have various pharmacological activities such as antioxidation, anti-inflammation, and cytoprotection.

[0017] In clinical reports, Yinchenhao Decoction has achieved definite curative effects in improving the symptoms of patients with obstructive jaundice, as well as biochemical indexes such as jaundice index, alanine aminotransferase, and aspartate aminotransferase, enhancing immune function, reducing the level of inflammatory factors, reducing complications, and accelerating recovery. Some studies have proved that Yinchenhao Decoction can protect the liver function of the obstructive jaundice rat model and significantly reduce the levels of pro-inflammatory factors such as IL-6 and TNF-α in the blood, so as to play an anti-inflammatory role and reduce the body's inflammatory response and immune injury.

[0018] Curcumin is the main active ingredient of the traditional Chinese medicine Curcuma longa. It has various pharmacological activities such as anti-inflammation, antioxidation, and antiviral. In recent years, it has also been found to have a certain effect on tumor immunity. Some studies have shown that there are certain differences in the CD4+, CD8+, and CD4+ / CD8+ ratios in patients with cervical cancer compared with healthy normal people. The detection of cytokines such as CD4+ and CD8+ in clinical practice can be used as the basis for the diagnosis and treatment of cervical cancer. The research results also suggest that curcumin can regulate the body's T cells and enhance immune ability.

[0019] Schisandra chinensis, commonly known as "North Schisandra", generally refers to the dried ripe fruits of the plant Schisandra chinensis (Turcz.) Baill. of the Magnoliaceae family. Schisandra chinensis is warm in nature, sour and sweet in taste, and belongs to the lung, heart, and kidney meridians. It has the effects of astringing and astringing, replenishing qi and promoting fluid production, and tonifying the kidney and calming the mind, and also has good antioxidant, anti-inflammatory, anti-tumor, and immune-regulating effects. Some studies have shown that Schisandra polysaccharide can reverse the decrease of white blood cells and lymphocytes in the peripheral blood of mice after radiation, regulate the disorder of CD3+CD4+ and CD3+CD8+ T cell subsets in the peripheral blood and thymus of mice after radiotherapy, and restore the levels of serum IgG and complement C3, but it has no adverse effects on the immune function of normal mice.

[0020] Licorice is the dried root and rhizome of Glycyrrhiza glabra, Glycyrrhiza inflata, or Glycyrrhiza glabra var. glandulifera of the Leguminosae family. Related products occupy an important share both at home and abroad. Its chemical components are mainly triterpenoid saponins and flavonoids, and it has the effects of anti-ulcer, antibacterial, anti-inflammatory, antispasmodic, lipid-lowering, analgesic, anti-arrhythmic, anti-tumor, and antiviral. The in vivo anti-RSV experiment results of licorice suggest that the n-butanol fraction of licorice can increase the serum IFN-β level of mice infected with RSV and inhibit the immune escape of RSV.

[0021] In "Plain Questions: Discussion on Critical Febrile Diseases", there is a statement that "where pathogenic factors gather, the qi must be deficient", and the qi here refers to the healthy qi. The healthy qi includes defensive qi and primordial qi. Defensive qi has the function of protecting the body externally and internally, and its prosperity or decline also determines the strength of the body's external defense function. Modern research has confirmed that defensive qi is closely related to mucosal immunity, cellular immunity, the nerve-endocrine-immune network, immune active substances, and human leukocyte antigens. Defensive qi "originates" from the kidney, "is nourished" by the spleen, and "is diffused" by the lung. Defensive qi is a type of qi in the human body and is also a reflection of the overall function of the human body. Primordial qi refers to the innate immune function of the human body. If the primordial qi is insufficient and cannot transform nutrient qi, defensive qi, blood, and body fluids, internally it is insufficient to maintain physical and mental activities, and externally it cannot resist the invasion of exogenous pathogenic factors, resulting in various miscellaneous diseases. Research has shown that the CD4 T lymphocyte immune function of those with deficiency of primordial qi is relatively low, and the proliferative ability of T lymphocytes decreases significantly. The immunological indicators of AIDS patients mainly show a decrease in the number of CD4+ T lymphocytes, a decrease in the activity of natural killer (NK) cells, a decrease in the secretion of interleukin-2, and an inversion of the T4 / T8 ratio. These factors may lead to immune function deficiency or disorder in the human body.

[0022] Experimental studies have shown that Rehmannia glutinosa has the effects of enriching blood and nourishing yin, replenishing essence and marrow, and treating various symptoms of blood deficiency and liver-kidney yin deficiency. Modern pharmacological studies have shown that the main chemical components of Artemisia capillaris include coumarins, chromones, flavonoids, coumaric acid, and volatile oils, which have various pharmacological activities and functions such as antioxidant, anti-inflammatory, and cell protection. Artemisia capillaris, Curcuma longa, and Schisandra chinensis also have significant effects in improving immune function. Previous studies found that the serum containing the traditional Chinese medicine compound of the present invention can down-regulate the expression levels of TLR4 and TLR8 in monocytes of patients with incomplete immune reconstruction of AIDS, and also down-regulate the expression levels of cytokines IL-2 and TNF-α. Combining with the abnormal immune activation state of patients after human immunodeficiency virus infection, it is confirmed that the components of this compound can inhibit the over-activation of immune function by down-regulating the expression of TLR4 and TLR8 and related signaling pathways in peripheral blood monocytes of patients after human immunodeficiency virus infection, so as to restore or reconstruct the immune function of AIDS patients. This compound preparation embodies the compatibility characteristics of "opening the source and cutting off the flow" and "treating both deficiency and excess", and has the effect of tonifying the kidney and generating marrow to promote the immune function reconstruction of AIDS patients with liver-kidney essence deficiency.

[0023] The traditional Chinese medicine theory basis for the compound of the present invention to prevent and treat AIDS patients with incomplete immune function reconstruction and liver-kidney essence deficiency: First, the classical theory holds that "the kidney is the innate foundation of the body", and the root cause of deficiency syndromes lies in the "kidney". Liver-kidney essence deficiency is the common pathogenesis of chronic liver diseases and incomplete immune reconstruction of AIDS. "Different diseases are treated with the same method". The traditional Chinese medicine compound of the present invention can not only tonify the kidney to generate essence and marrow to nourish the liver, but also tonify the kidney to generate essence and marrow to regulate immune function. Second, based on the innovative theory of "the liver governs dispersion", traditional Chinese medicine for tonifying the kidney and generating marrow can regulate the imbalance between liver injury and liver regeneration to prevent and treat liver diseases, and can also treat incomplete immune function reconstruction of AIDS by regulating the imbalance between immune cell injury and regeneration and repair through tonifying the kidney and generating marrow. Detailed implementation method

[0024] Example 1: Traditional Chinese medicine compound capsule Prescription composition: Rehmannia glutinosa 267g, Artemisia capillaris 400g, Curcuma longa 200g, Schisandra chinensis 133g, Glycyrrhiza uralensis 133g.

[0025] Preparation method: Take Rehmannia glutinosa, Artemisia capillaris, and Glycyrrhiza uralensis, decoct and extract 3 times, with the water addition amounts being 9.6, 6.3, and 6.3 times respectively, and each time for 1.5 hours. Filter the decoction, combine them, and concentrate under reduced pressure to a relative density of 1.22 (Baume hydrometer, 55 °C), release it, and obtain the concentrated water decoction for standby. Powder Schisandra chinensis into the coarsest powder for standby. Take the coarsest powder of Schisandra chinensis and Curcuma longa, add 75% ethanol, and reflux and extract 3 times, with the alcohol addition amounts being 2.23, 1.61, and 1.61 times respectively, and each time for 1 hour. Filter the extraction solution, combine them, and recover ethanol under reduced pressure to a relative density of 1.19 (Baume hydrometer, 55 °C), release it, and obtain the concentrated alcohol extraction solution for standby. Take the above concentrated water decoction and concentrated alcohol extraction solution, dry under reduced pressure, pulverize, make into granules, dry, add silicon dioxide, and fill into capsules to obtain the product.

[0026] The applicant studied by preparing drug-containing serum of this traditional Chinese medicine compound capsule for rats and blank control serum, sorting peripheral blood mononuclear cells of the immune reconstitution incomplete patient group and the immune reconstitution good patient group by the Ficoll method, and culturing the peripheral blood mononuclear cells of the two groups of samples with the drug-containing serum of rats and the blank control serum respectively. Then, RNA was extracted by the Trizol method, and the expression levels of TLR4 and TLR8 were detected by qRT-PCR; at the same time, the contents of cytokines (IL-1B, IL-2, IL-6, TNF-α) in the culture supernatant were detected by flow cytometry. Based on the expression levels of TLR4 and TLR8 and the contents of downstream cytokines, the regulation of the immune response of peripheral blood monocytes of patients with immune reconstitution incomplete after highly active anti-retroviral therapy (HAART) by the drug-containing serum of this traditional Chinese medicine compound capsule was explored. By sorting out the experimental data, it was found that the drug-containing serum of this traditional Chinese medicine compound capsule could down-regulate the expression levels of TLR4 and TLR8 in monocytes of AIDS patients with immune reconstitution incomplete, and down-regulate the expression levels of cytokines IL-2 and TNF-α. Combining with the abnormal immune activation state of patients after human immunodeficiency virus infection, it was confirmed that the components of this traditional Chinese medicine compound capsule could down-regulate the expression of TLR4 and TLR8 and related signaling pathways in peripheral blood monocytes of patients after human immunodeficiency virus infection.

[0027] Furthermore, a clinical study was continued. Using a randomized, double-blind, placebo-controlled research method, HIV / AIDS patients with immune function reconstitution incomplete (liver and kidney essence deficiency syndrome) after HAART were collected and randomly divided into a "treatment group" and a "control group". On the basis of the original HAART regimen, the traditional Chinese medicine treatment group was given this traditional Chinese medicine compound capsule, and the placebo control group was given a placebo, and the treatment was observed for 6 months. By obtaining blood specimens of the subjects to detect the immune level-related indicators, it was confirmed that the traditional Chinese medicine compound capsule of the present invention inhibited the over-activation of immune function and achieved the restoration or reconstruction of the immune function of AIDS patients.

Claims

1. A traditional Chinese medicine compound for preventing and treating immune reconstitution incomplete in AIDS patients, characterized in that, The traditional Chinese medicine compound is prepared from the following raw materials in parts by weight: 25 - 55 parts of prepared rehmannia root, 45 - 80 parts of virgate wormwood herb, 15 - 45 parts of turmeric, 10 - 40 parts of Chinese magnoliavine fruit, and 10 - 40 parts of liquorice root.

2. The traditional Chinese medicine compound according to claim 1, wherein The traditional Chinese medicine compound is prepared from the following raw materials in parts by weight: 30 - 50 parts of prepared rehmannia root, 50 - 70 parts of virgate wormwood herb, 20 - 40 parts of turmeric, 10 - 30 parts of Chinese magnoliavine fruit, and 10 - 30 parts of liquorice root.

3. The traditional Chinese medicine compound according to claim 1, wherein The traditional Chinese medicine compound is prepared from the following raw materials in parts by weight: 40 parts of prepared rehmannia root, 60 parts of virgate wormwood herb, 30 parts of turmeric, 20 parts of Chinese magnoliavine fruit, and 20 parts of liquorice root.

4. A traditional Chinese medicine compound preparation, characterized in that, The preparation comprises the traditional Chinese medicine compound according to claim 1 or 2 or 3 and a pharmaceutically acceptable excipient.

5. A preparation method for preparing the traditional Chinese medicine compound preparation as described in claim 4, characterized in that: Take prepared rehmannia root, virgate wormwood herb, and liquorice root according to parts by weight, decoct and extract 3 times, each time for 1.5 - 2 hours, filter the decoction, combine and concentrate to obtain a concentrated water decoction for standby; take Chinese magnoliavine fruit and pulverize it into the coarsest powder for standby; take the coarsest powder of Chinese magnoliavine fruit and turmeric, add 70% - 80% ethanol, reflux and extract 3 times, each time for 0.75 - 1.5 hours, filter the extract, combine and concentrate to obtain a concentrated ethanol extract for standby; take the above - mentioned concentrated water decoction and concentrated ethanol extract, carry out vacuum drying, pulverize, make into granules, dry, add silicon dioxide, fill into capsules to obtain the capsule preparation.

6. Use of the traditional Chinese medicine compound according to claim 1 in the preparation of a drug for preventing and treating immune reconstitution incomplete in AIDS patients.