A traditional Chinese medicine composition for treating AIDS and a preparation method thereof

Abstract

The application aims to provide a traditional Chinese medicine composition for treating AIDS.The traditional Chinese medicine composition is prepared from the following raw medicines: Huangqi, Dangshen, Xuanshen, white atractylodes processed with wheat bran, Shanyao, Chenpi, Dangui, Danshen, Chuanqiong, Chuan Niuxi, Shenganshi, Jiaoshanzha, Jiaoshenqu and Jiaoma. The pharmacodynamic test proves that the medicine can enhance the immune function of AIDS patients, delay the decline speed of CD4+ T cells, activate latent HIV virus and reservoir, slow down the disease progress, protect the liver function and relieve the clinical symptoms.

Description

Technical Field

[0001] This invention belongs to the field of medicine, specifically relating to a traditional Chinese medicine composition for treating AIDS and its preparation method. Background Technology

[0002] AIDS is caused by pathogenic factors such as dampness and heat invading the body, damaging the body's vital energy and weakening its resistance. This primarily manifests as deficiencies in the spleen and kidneys, specifically in the qi, blood, yin, and yang. Since the spleen is the foundation of acquired constitution and the source of qi and blood production, spleen deficiency prevents the generation of qi and blood, hindering the nourishment of innate constitution, leading to overall deficiency of qi, blood, yin, and yang. Therefore, strengthening the spleen and kidneys is one of the fundamental methods for treating AIDS. Our preliminary research shows that the Qi-tonifying and spleen-strengthening formula can enhance HIV-specific T-cell immune function. From a traditional Chinese medicine perspective, T-cell immune function is equivalent to the body's vital energy. The Qi-tonifying and spleen-strengthening formula's ability to enhance HIV-specific T-cell immune function strengthens the body's vital energy, achieving a "supporting the body's resistance" effect. HAART treatment kills the HIV virus, which from a traditional Chinese medicine perspective is "eliminating pathogenic factors." Therefore, the combination of the Qi-tonifying and spleen-strengthening formula with HAART antiviral therapy aligns with the fundamental principle of "supporting the body's resistance and eliminating pathogenic factors" in traditional Chinese medicine treatment of infectious diseases. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine composition for treating AIDS.

[0004] The pharmaceutical composition of the present invention is prepared from the following active pharmaceutical ingredients:

[0005] Astragalus membranaceus 15-60g, Codonopsis pilosula 7.5-30g, Scrophularia ningpoensis 7.5-30g, Atractylodes macrocephala (stir-fried with wheat bran) 5-20g, Dioscorea opposita 7.5-30g.

[0006] Tangerine peel 4.5-18g, Angelica sinensis 6-24g, Salvia miltiorrhiza 7.5-30g, Ligusticum chuanxiong 4.5-18g, Achyranthes bidentata 5-20g,

[0007] Raw licorice root 4.5-18g, charred hawthorn 5-20g, charred medicated leaven 5-20g, charred malt 5-20g.

[0008] Preferably, the pharmaceutical composition of the present invention is prepared from the following active pharmaceutical ingredients:

[0009] Astragalus membranaceus 30g, Codonopsis pilosula 15g, Scrophularia ningpoensis 15g, Atractylodes macrocephala (stir-fried with wheat bran) 10g, Dioscorea opposita 15g, Citrus reticulata 9g.

[0010] Angelica sinensis 12g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 9g, Achyranthes bidentata 10g, Glycyrrhiza uralensis 9g, Crataegus pinnatifida 10g

[0011] 10g of roasted Shenqu (a type of fermented wheat), 10g of roasted malt.

[0012] Another object of the present invention is to provide a method for preparing a pharmaceutical composition.

[0013] The preparation method of the present invention includes the following steps:

[0014] ① Preparation and cleaning of medicinal materials: Take 30g of Astragalus membranaceus, 15g of Codonopsis pilosula, 15g of Scrophularia ningpoensis, 10g of stir-fried Atractylodes macrocephala, 15g of Dioscorea opposita, 9g of Citrus reticulata peel, 12g of Angelica sinensis, 15g of Salvia miltiorrhiza, 9g of Ligusticum chuanxiong, 10g of Achyranthes bidentata, 9g of raw Glycyrrhiza uralensis, 10g of charred Crataegus pinnatifida, 10g of charred Shenqu (medicated leaven), and 10g of charred Hordeum vulgare malt. Mix the above Chinese medicinal materials together and wash them with clean water to remove impurities and dust from the surface.

[0015] ② Soaking the herbs: Place the cleaned herbs in a decoction container, add enough cold water to cover the herbs by about 3-5 cm (usually add 800-1000 ml of water for every 100g of herbs), and soak for 30 minutes to allow the herbs to fully absorb water, which is conducive to the release of active ingredients.

[0016] ③ First decoction: After soaking, bring to a boil over medium heat. Once boiling, reduce to low heat and continue simmering for 10-15 minutes. Maintain a gentle simmer during decoction to avoid excessive boiling. After decoction, filter the liquid through gauze or a fine mesh and squeeze out the dregs to extract the remaining liquid.

[0017] ④ Second decoction: Put the dregs back into the decoction container, add water again (the amount is 2 / 3 of the first time, about 500-700ml of water for every 100g of herbs), bring to a boil over medium heat, then reduce to low heat and simmer for 5-10 minutes. After simmering, filter the liquid through gauze or fine mesh and squeeze out the dregs.

[0018] ⑤ Combine the decoctions: Combine the decoctions from the two decoctions and mix them thoroughly to obtain the aqueous decoction of this formula.

[0019] The pharmaceutically active substance of the present invention may constitute 0.1-99.9% by weight in the formulation, with the remainder being a pharmaceutically acceptable carrier. The pharmaceutical formulation of the present invention exists in unit dose form, where unit dose form refers to a unit of the formulation, such as each tablet, each capsule, each bottle of oral liquid, or each sachet of granules.

[0020] The pharmaceutical formulations of this invention can be any pharmaceutically acceptable dosage form, including oral, topical, and injectable dosage forms. These dosage forms include: tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, lozenges, granules, powders, pills, powders, ointments, elixirs, suspensions, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops, and patches. Preferably, the formulations of this invention are oral dosage forms, such as: capsules, tablets, oral liquids, granules, pills, powders, elixirs, and ointments.

[0021] The pharmaceutical formulations of the present invention, when administered orally, may contain commonly used excipients such as binders, fillers, diluents, tableting agents, lubricants, disintegrants, colorants, flavoring agents, and humectants, and the tablets may be coated if necessary.

[0022] Suitable fillers include cellulose, mannitol, lactose, and other similar fillers. Suitable disintegrants include starch, polyvinylpyrrolidone, and starch derivatives, such as sodium glycolate starch. Suitable lubricants include, for example, magnesium stearate. Suitable pharmaceutically acceptable wetting agents include sodium lauryl sulfate.

[0023] Solid oral compositions can be prepared using common methods such as mixing, filling, and tableting. Repeated mixing allows the active ingredient to be distributed throughout compositions that use a large amount of filler.

[0024] Oral liquid formulations may take the form of aqueous or oily suspensions, solutions, emulsions, syrups, or elixirs, or may be a dry product that can be reconstituted with water or other suitable carriers before use. Such liquid formulations may contain conventional additives, such as suspending agents like sorbitol, syrups, methylcellulose, gelatin, hydroxyethylcellulose, carboxymethylcellulose, aluminum stearate gel, or hydrogenated edible fats; emulsifiers like lecithin, dehydrated sorbitan monooleate, or gum arabic; non-aqueous carriers (which may include edible oils such as almond oil, fractionated coconut oil, oily esters such as glycerol, propylene glycol, or ethanol); preservatives such as methylparaben or propylparaben or sorbic acid; and, if desired, conventional flavorings or colorings.

[0025] For injectable formulations, the prepared liquid unit contains the active ingredient of this invention and a sterile carrier. Depending on the carrier and concentration, this compound can be suspended or dissolved. Solution preparation typically involves dissolving the active ingredient in a carrier, filtering and sterilizing it before filling it into a suitable vial or ampoule, and then sealing it. Excipients such as a local anesthetic, preservative, and buffer can also be dissolved in this carrier. To improve its stability, the composition can be frozen after filling into the vial, and water can be removed under vacuum.

[0026] The pharmaceutical formulation of the present invention may selectively incorporate a suitable pharmaceutically acceptable carrier during preparation. The pharmaceutically acceptable carrier is selected from: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine ​​hydrochloride, thioglycolic acid, methionine, vitamin C, disodium EDTA, sodium calcium EDTA, carbonates, acetates, phosphates or aqueous solutions of monovalent alkali metals, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and its derivatives, alginate, gelatin, polyvinylpyrrolidone, glycerol, Twenty-80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, β-cyclodextrin, phospholipids, kaolin, talc, calcium stearate, magnesium stearate, etc.

[0027] The pharmaceutical composition of the present invention has the following beneficial effects compared with existing pharmaceuticals:

[0028] 1. Qi-tonifying and spleen-strengthening formulas can slow down the decline in CD4+ T cells in HIV / AIDS patients, slow the progression of AIDS, protect liver function, and alleviate clinical symptoms.

[0029] 2. The Qi-tonifying and spleen-strengthening formula can enhance the immune function of HIV-specific T cells in AIDS patients;

[0030] 3. The Qi-boosting and spleen-strengthening formula can activate quiescent CD4+ T cells in AIDS patients, significantly increasing the ratio of activated CD4+ T cells (HLA-DR+CD4+ T).

[0031] 4. The Qi-tonifying and spleen-strengthening formula can activate the latent HIV virus reservoir outside the body, which is beneficial for clearing latent HIV viruses and thus achieving the effect of treating AIDS.

[0032] In the drug formula of this invention, Astragalus membranaceus, being sweet and warm in nature, is the principal herb, which can invigorate vital energy, strengthen the spleen and stomach, and replenish various deficiencies. Codonopsis pilosula, Atractylodes macrocephala, Glycyrrhiza uralensis, Dioscorea opposita, and Angelica sinensis, which invigorate qi and strengthen the spleen, are the assistant herbs. Citrus reticulata, being aromatic and invigorating to the spleen, combines the effects of sweet and warm invigorating with the function of regulating qi and strengthening the spleen, thus serving as the adjuvant herb.

[0033] Modern pharmacological studies suggest that Atractylodes macrocephala, Angelica sinensis, and Astragalus membranaceus can enhance immune function by replenishing qi and blood. Astragalus membranaceus can promote the proliferation of CD4+ T lymphocytes and enhance their function, increasing the CD4+ T / CD8+ T ratio and counteracting CD4+ T cell depletion. Domestic and international pharmacological studies consistently show that Codonopsis pilosula and Astragalus membranaceus can increase white blood cell count, and Dioscorea opposita can enhance the phagocytic function of neutrophils. The combined effects of these herbs are to replenish qi, strengthen the spleen, and support the body's vital energy.

[0034] The pharmaceutical composition of this invention can significantly improve clinical symptoms, enhance quality of life, delay the decline of CD4+ T cells, and reduce the toxic side effects of HAART in HIV / AIDS patients, and has certain advantages in protecting liver function. After preparation, the pharmaceutical composition of this invention should be stored in a cool, dry, and well-ventilated place by designated personnel. It is ensured that the drugs used in this project are from the same batch to avoid batch-to-batch variations.

[0035] Another object of the present invention is to provide the use of the pharmaceutical composition of the present invention in the preparation of a medicament for treating AIDS.

[0036] The application of the pharmaceutical composition of the present invention in the preparation of drugs that protect liver function, enhance immune function, slow down the decline of CD4+ T cells, and activate latent HIV virus and its reservoir.

[0037] Another object of the present invention is to provide the use of the pharmaceutical composition of the present invention in combination with HAART drugs in the preparation of a medicament for treating AIDS.

[0038] Another object of the present invention is to provide the application of the pharmaceutical composition of the present invention in combination with HAART drugs in the preparation of drugs that protect liver function, enhance immune function, slow down the decline of CD4+ T cells, and activate latent HIV virus and its reservoir.

[0039] Existing experimental results indicate that the Qi-tonifying and spleen-strengthening formula (YQJPF) alone is also effective in treating AIDS. Figure 7 , Figure 8 , Figure 9 The combined effect of HAART drugs is more significant.

[0040] Terminology Definition

[0041] The terminology used in the description of this invention is for the purpose of describing particular embodiments only and is not intended to limit the invention. The nomenclature used herein and the laboratory procedures described herein in organic chemistry, medicinal chemistry, and biology are well-known and commonly used in the art. Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0042] As used in the description of embodiments of the invention and the appended claims, the singular forms of “a,” “an,” “the,” and “its” are used to refer to the singular and plural of the article, unless the context clearly indicates otherwise. For example, a compound comprises one or more compounds.

[0043] As used in this article, “and / or” means any and all possible combinations of one or more of the related listed items.

[0044] As used herein, the term “disease” or “patient” refers to any change in physical condition or organ that interrupts or interferes with the functioning of the organ and / or causes symptoms.

[0045] As used herein, the term "treatment" aims to alleviate or eliminate a targeted disease state or symptom. A subject is successfully "treated" if, in accordance with the methods described herein, a therapeutic amount of a compound or its pharmaceutically acceptable salt, isomer, polymorph, solvate, isotopically labeled compound, metabolite, or prodrug, or a pharmaceutical composition thereof, is received and one or more indications and symptoms show an observable and / or detectable reduction or improvement. It should also be understood that treatment of the disease state or symptom includes not only complete treatment but also the achievement of some biological or medically relevant outcome without achieving complete treatment.

[0046] As used herein, the term "subject" may refer to a patient or other animal that receives the compositions of the present invention to treat, prevent, reduce and / or alleviate the disease or condition described herein, and in particular to humans and mammals.

[0047] Further explanations are provided for any terms or English words appearing in the instruction manual:

[0048] HAART: Highly effective combination therapy with antiretroviral therapy. Attached Figure Description

[0049] Figure 1 The combination of Qi-tonifying and spleen-strengthening formula with HAART treatment enhanced HIV-specific T-cell immune responses (*P<0.05).

[0050] Figure 2 Different treatment time points: Qi-tonifying and spleen-strengthening formula combined with HAART for HIV-specific T-cell immune response.

[0051] Condition;

[0052] Figure 3 The treatment group combining Qi-tonifying and spleen-strengthening formula with HAART;

[0053] Figure 4 HAART treatment alone;

[0054] Figure 5 The ratio of activated CD4+ T cells in the two groups;

[0055] Figure 6 Dynamic changes in activated CD4+ T cells;

[0056] Figure 7 Dynamic changes in total HIV DNA at different time points;

[0057] Figure 8 , three Total HIV DNA content at each time point in the group;

[0058] Figure 9 , three Total HIV DNA content at different treatment time points in the group;

[0059] Figure 9 A: Total HIV DNA content at various time points in the HAART group alone

[0060] Figure 9 B: Total HIV DNA content at different treatment time points in the YQJPF group alone

[0061] Figure 9 C: Total HIV DNA content at each time point in the group treated with Qi-tonifying and spleen-strengthening formula combined with HAART. Detailed Implementation

[0062] The present invention will be further illustrated by the following examples.

[0063] The product and its preparation method according to the present invention will be further described below with reference to specific embodiments, but the present invention is not limited to the following embodiments. Unless otherwise specified, the methods described are conventional methods. Unless otherwise specified, the raw materials can be obtained from publicly available commercial sources.

[0064] Example 1: The pharmaceutical composition of the present invention

[0065] Astragalus membranaceus 30g, Codonopsis pilosula 15g, Scrophularia ningpoensis 15g, Atractylodes macrocephala (stir-fried with wheat bran) 10g, Dioscorea opposita 15g, Citrus reticulata 9g.

[0066] Angelica sinensis 12g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 9g, Achyranthes bidentata 10g, Glycyrrhiza uralensis 9g, Crataegus pinnatifida 10g

[0067] 10g of roasted Shenqu (a type of fermented wheat), 10g of roasted malt.

[0068] Example 2: The pharmaceutical composition of the present invention

[0069] Astragalus membranaceus 15g, Codonopsis pilosula 7.5g, Scrophularia ningpoensis 7.5g, Atractylodes macrocephala (stir-fried with wheat bran) 5g, Dioscorea opposita 7.5g.

[0070] 4.5g dried tangerine peel, 6g angelica root, 7.5g salvia miltiorrhiza, 4.5g chuanxiong rhizome, 5g achyranthes bidentata root.

[0071] Raw licorice root 4.5g, charred hawthorn 5g, charred medicated leaven 5g, charred malt 5g.

[0072] Example 3: The pharmaceutical composition of the present invention

[0073] Astragalus membranaceus 60g, Codonopsis pilosula 30g, Scrophularia ningpoensis 30g, Atractylodes macrocephala (stir-fried with wheat bran) 20g, Dioscorea opposita 30g,

[0074] 18g dried tangerine peel, 24g angelica sinensis, 30g salvia miltiorrhiza, 18g chuanxiong rhizome, 20g achyranthes bidentata root.

[0075] Raw licorice root 18g, charred hawthorn 20g, charred medicated leaven 20g, charred malt 20g.

[0076] Example 4, Efficacy Experiment

[0077] Inclusion criteria for study participants: HIV / AIDS patients aged 18–50 years (diagnostic criteria based on the 2011 Guidelines for the Diagnosis and Treatment of AIDS);

[0078] Experimental grouping and treatment

[0079] ① HAART treatment group (40 people): Tenovudine (TDF, 300mg per tablet, Aspen Port Elizabeth (Pty) Ltd, batch number H20130589) 300mg once daily; Lamivudine (3TC, 300mg per tablet, Shandong Weifang Pharmaceutical Factory Co., Ltd., batch number H20133056) 300mg once daily; Efavirenz (EFV, 600mg per tablet, Zhejiang Huahai Pharmaceutical Co., Ltd., batch number H20133265) 600mg once daily.

[0080] ② Qi-tonifying and spleen-strengthening herbal formula + HAART treatment group (40 people): In addition to HAART treatment, the Qi-tonifying and spleen-strengthening herbal formula (Example 1) was administered, with monthly follow-up visits. The herbal medicine was prepared uniformly by our hospital's decoction room, with each dose prepared into two bags (vacuum-packed), each bag containing 150ml. One bag was taken twice daily, morning and evening. One dose was taken daily, one hour apart from the HAART medication, dissolved in hot water at approximately 80-100℃. The treatment period was 6 months. Each course of treatment lasted 3 months, for a total of 2 courses.

[0081] The Qi-Boosting and Spleen-Tonifying Formula can significantly improve clinical symptoms, enhance quality of life, delay the decline of CD4+ T cells, and reduce the toxic side effects of HAART in HIV / AIDS patients. It also has certain advantages in protecting liver function. The Qi-Boosting and Spleen-Tonifying Formula is manufactured into granules by Beijing Kangrentang Pharmaceutical Co., Ltd., in accordance with the industry quality control system and quality standards for traditional Chinese medicine granules. After preparation, the medicine is stored in a cool, dry, and well-ventilated place under the supervision of designated personnel. It is ensured that the medicine administered in this experiment is from the same batch to avoid batch-to-batch variations.

[0082] (1) Enhance HIV-specific T-cell immune function in HIV / AIDS patients

[0083] Long-term clinical practice has shown that HAART combined with "Qi-tonifying and Spleen-strengthening formula" can significantly improve clinical symptoms and signs, delay the decline of CD4+ T cells, and improve quality of life. It also has certain advantages in protecting liver function. The combination of Qi-tonifying and Spleen-strengthening formula and HAART can increase the secretion of IFN-γ by T cells, enhancing HIV-specific T-cell immune function in HIV / AIDS patients. Figure 1 , Figure 2 ).

[0084] (2) Research on activating CD4+ T cells

[0085] In our study on the effects of Qi-tonifying and spleen-strengthening formulas on T-cell immune function, we found that combining Qi-tonifying and spleen-strengthening formulas with HAART treatment increased the proportion of activated CD4+ T cells in peripheral blood. The mean proportion of HLA-DR+CD4+ T cells among CD4+ T cells in the Qi-tonifying and spleen-strengthening formulas combined with HAART treatment group was approximately 21%, while the mean proportion of HLA-DR+CD4+ T cells among CD4+ T cells in the HAART-only treatment group was approximately 6%. Figure 3 , Figure 4 The combined treatment of Qi-tonifying and spleen-strengthening herbs with HAART showed significantly higher efficacy than the HAART-only treatment group. Figure 5 ), and increases with the duration of treatment ( Figure 6 ).

[0086] (3) Research on eliminating latent HIV reservoirs (total HIV DNA)

[0087] Our previous study investigated the latent HIV viral reservoir in three groups of patients after treatment: the group receiving Qi-tonifying and spleen-strengthening herbal formula alone, the group receiving HAART alone, and the group receiving Qi-tonifying and spleen-strengthening herbal formula combined with HAART. We found that after 48 weeks of treatment, the latent HIV viral reservoir (HIV DNA) in the group receiving Qi-tonifying and spleen-strengthening herbal formula combined with HAART was significantly lower than that in the HAART alone group and the group receiving Qi-tonifying and spleen-strengthening herbal formula alone. Figure 7 , Figure 8 and Figure 9 The results of this experiment indicate that the combination of Qi-tonifying and spleen-strengthening formula with HAART treatment can significantly reduce the latent HIV viral reservoir.

[0088] Example 5: Therapeutic Effect of the Invention

[0089] This invention is an improvement upon the original formula.

[0090]

[0091] During our use of the original formula, we found that most AIDS patients experienced anemia. Based on the clinical efficacy and patient feedback of the original formula, this invention has been improved. Details are as follows: Eight new medicinal herbs have been added: 1. Angelica sinensis: invigorates blood and replenishes blood, promotes blood circulation, and improves anemia caused by AIDS; 2. Ligusticum chuanxiong: promotes qi and blood circulation, helps alleviate qi deficiency and blood stasis caused by the disease, thereby improving the patient's overall vitality and energy level; 3. Scrophularia ningpoensis: nourishes yin and reduces fire, helps alleviate yin deficiency symptoms caused by long-term illness, enhances the patient's immune system resistance, and reduces the risk of inflammation and infection; 4. Citrus reticulata peel: regulates qi and strengthens the spleen, helps eliminate gastrointestinal dysfunction caused by long-term medication, improves nutrient absorption, and strengthens the body; 5. Achyranthes bidentata: guides the medicine downward and unblocks the meridians, helps improve weakness and discomfort in the limbs caused by long-term illness, and helps patients maintain good mobility; 6. Crataegus pinnatifida (roasted), 7. Massa fermentata (roasted), and 8. Hordeum vulgare (roasted): these three herbs can invigorate the spleen and stomach, and are beneficial in alleviating gastrointestinal adverse reactions of antiviral drugs. The invention removed two Chinese herbs: Ligustrum lucidum (for nourishing Yin and tonifying the kidneys) and Poria cocos (for promoting diuresis and eliminating dampness). The eight newly added herbs enhance the resistance of AIDS patients and reduce the occurrence of complications by improving immune function, promoting blood circulation, strengthening spleen and stomach function, and improving digestion and absorption. The revised invention thus has more prominent effects in invigorating Qi and strengthening the spleen, promoting Qi circulation and blood flow, and has better clinical efficacy.

[0092] Example 6: Comparison of the clinical efficacy of the present invention and the original formula

[0093] 1. Significantly enhanced clinical efficacy of the medication: ① Significantly improved anemia symptoms in AIDS patients. Clinically, it was found that most AIDS patients experienced anemia during the use of the original prescription. This invention incorporates Angelica sinensis to invigorate blood and replenish blood, and Ligusticum chuanxiong to promote qi and blood circulation, significantly improving anemia symptoms in AIDS patients. ② Further enhanced immune function in AIDS patients. This invention, based on the original prescription's function of invigorating qi and strengthening the spleen, adds Citrus reticulata peel to regulate qi and strengthen the spleen, enhancing the patient's spleen and stomach function and digestion and absorption, providing the necessary material basis for enhancing the patient's immune function. Simultaneously, the addition of Angelica sinensis to replenish blood and improve anemia symptoms, and Ligusticum chuanxiong to invigorate blood and promote blood circulation, further enhances the overall resistance and immune function of AIDS patients. ③ Significantly improved clinical symptoms such as fatigue and weakness in AIDS patients. Due to the long-term consumption caused by chronic illness, AIDS patients are prone to fatigue and weakness. This invention incorporates Achyranthes bidentata, which guides the medicine downwards and unblocks meridians, helping to improve limb weakness and discomfort caused by long-term illness, allowing patients to maintain better mobility, and significantly improving clinical symptoms such as fatigue and weakness in AIDS patients.

[0094] 2. This invention significantly improves the side effects such as diarrhea caused by the original formula. Some patients experienced diarrhea during clinical use of the original formula. The invention modifies the medication by adding three herbs—charred hawthorn, charred Shenqu (a type of fermented wheat), and charred malt—to invigorate the spleen and improve appetite, effectively alleviating gastrointestinal adverse reactions and significantly improving diarrhea symptoms.

[0095] The drugs of this invention are combined in a way that reduces side effects while producing a very good synergistic effect.

Claims

1. A pharmaceutical composition for treating AIDS, characterized in that, The combination of a traditional Chinese medicine composition and a HAART drug, wherein the traditional Chinese medicine composition is processed from the following raw materials: Astragalus membranaceus 15-60g, Codonopsis pilosula 7.5-30g, Scrophularia ningpoensis 7.5-30g, Atractylodes macrocephala (stir-fried with wheat bran) 5-20g, Dioscorea opposita 7.5-30g. Tangerine peel 4.5-18g, Angelica sinensis 6-24g, Salvia miltiorrhiza 7.5-30g, Ligusticum chuanxiong 4.5-18g, Achyranthes bidentata 5-20g, Raw licorice root 4.5-18g, charred hawthorn 5-20g, charred medicated leaven 5-20g, charred malt 5-20g, The HAART drugs are: tenovudine, lamivudine, and efavirenz.

2. The pharmaceutical composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 30g, Codonopsis pilosula 15g, Scrophularia ningpoensis 15g, Atractylodes macrocephala (stir-fried with wheat bran) 10g, Dioscorea opposita 15g, Citrus reticulata 9g. Angelica sinensis 12g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 9g, Achyranthes bidentata 10g, Glycyrrhiza uralensis 9g, Crataegus pinnatifida 10g 10g of roasted Shenqu (a type of fermented wheat), 10g of roasted malt.

3. The pharmaceutical composition according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is an oral preparation.

4. The pharmaceutical composition according to claim 1, characterized in that, The preparation method of the traditional Chinese medicine composition includes the following steps: (1) Preparation and cleaning of medicinal materials: Take 30g of Astragalus membranaceus, 15g of Codonopsis pilosula, 15g of Scrophularia ningpoensis, 10g of stir-fried Atractylodes macrocephala, 15g of Dioscorea opposita, 9g of Citrus reticulata peel, 12g of Angelica sinensis, 15g of Salvia miltiorrhiza, 9g of Ligusticum chuanxiong, 10g of Achyranthes bidentata, 9g of raw Glycyrrhiza uralensis, 10g of charred Crataegus pinnatifida, 10g of charred Shenqu (medicated leaven), and 10g of charred Hordeum vulgare. Mix the above Chinese medicinal materials and wash them with clean water to remove impurities and dust from the surface. (2) Soaking the herbs: Place the cleaned herbs in a decoction container, add enough cold water, add 800-1000ml of water for every 100g of herbs, and soak for 30 minutes to allow the herbs to fully absorb water, which is conducive to the release of effective ingredients; (3) First decoction: After soaking, bring to a boil over medium heat. After boiling, reduce to low heat and continue simmering for 10-15 minutes. When simmering, keep the boiling slightly and avoid excessive boiling. After simmering, filter the liquid with gauze or fine mesh and squeeze the dregs to extract the liquid. (4) Second decoction: Put the dregs back into the decoction container, add water again, the amount is 500-700ml of water per 100g of medicinal materials, bring to a boil again over medium heat, then reduce to low heat and decoct for 5-10 minutes. After decoction, filter out the liquid with gauze or fine mesh and squeeze out the dregs. (5) Combine the decoctions: Combine the decoctions from the two decoctions to obtain the extract.

5. The use of the pharmaceutical composition of claim 1 in the preparation of a medicament for treating AIDS.

6. According to the application described in claim 5, the pharmaceutical composition has the effects of protecting liver function, enhancing immune function, slowing down the decline rate of CD4+ T cells, and activating latent HIV virus and its reservoir.

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