Traditional Chinese medicine composition for strengthening body resistance and detoxifying for adjuvant therapy of AIDS (acquired immune deficiency syndrome)

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a body resistance strengthening and detoxification traditional Chinese medicine composition for adjuvant therapy of AIDS, which comprises the following components in parts by weight: 10-20 parts of ginseng, 20-30 parts of astragalus membranaceus, 10-20 parts of bighead atractylodes rhizome, 10-20 parts of poria cocos, 10-20 parts of angelica sinensis, 1-5 parts of rice worm, 2-12 parts of cordyceps cicadae, 10-30 parts of welted thistle, 12-18 parts of honeysuckle stem and 8-12 parts of shrub althea flower. The traditional Chinese medicine composition is prepared from 25-35 parts of spreading hedyotis herb, 10-20 parts of purslane herb, 10-20 parts of black nightshade herb, 2-12 parts of liquorice root, 2-12 parts of ginger, 15-25 parts of suberect spatholobus stem, 5-15 parts of ginkgo leaf, 10-20 parts of snakegourd fruit and 5-15 parts of water chestnut. The traditional Chinese medicine composition can be used for assisting in treating AIDS, enhancing the immunity of the organism, improving clinical symptoms and improving the life quality of patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for adjuvant treatment of AIDS that strengthens the body and detoxifies. Background Technology

[0002] AIDS (Acquired Immunodeficiency Syndrome) is an immunodeficiency disease caused by infection with the human immunodeficiency virus (HIV), and is often accompanied by opportunistic infections and malignant tumors. Modern medicine mainly uses antiretroviral therapy to suppress viral replication, but long-term use can easily lead to drug resistance and toxic side effects.

[0003] Traditional Chinese medicine (TCM) categorizes AIDS under "febrile diseases" or "latent febrile diseases," with its pathogenesis rooted in deficiency of vital energy (Qi) and manifested by internal accumulation of heat and toxins. Clinical treatment should focus on strengthening the body's resistance, clearing heat, and detoxifying. Existing TCM adjuvant therapies often emphasize either strengthening the body's resistance or detoxification, with room for improvement in overall regulatory effects. Therefore, it is necessary to develop a TCM composition for adjuvant treatment of AIDS that strengthens the body's resistance and detoxifies. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for adjuvant treatment of AIDS, which strengthens the body's immunity, improves clinical symptoms, and enhances the quality of life of patients, in order to address the shortcomings of the existing technology.

[0005] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0006] A traditional Chinese medicine composition for adjuvant treatment of AIDS, comprising the following components by weight: ginseng 10-20 parts, astragalus 20-30 parts, atractylodes macrocephala 10-20 parts, poria cocos 10-20 parts, angelica sinensis 10-20 parts, rice weevil 1-5 parts, cicada stalk 2-12 parts, licorice root 10-30 parts, honeysuckle vine 12-18 parts, hibiscus flower 8-12 parts, oldenlandia diffusa 25-35 parts, purslane 10-20 parts, black nightshade 10-20 parts, licorice root 2-12 parts, ginger 2-12 parts, chicken blood vine 15-25 parts, ginkgo leaf 5-15 parts, trichosanthes fruit 10-20 parts, and water chestnut 5-15 parts.

[0007] A traditional Chinese medicine composition for adjuvant treatment of AIDS, comprising the following components by weight: ginseng 12-18 parts, astragalus 22-28 parts, atractylodes macrocephala 12-18 parts, poria cocos 12-18 parts, angelica sinensis 12-18 parts, rice weevil 1-3 parts, cicada nymph 5-10 parts, licorice root 12-18 parts, honeysuckle vine 12-18 parts, hibiscus 8-12 parts, oldenlandia diffusa 28-32 parts, purslane 12-18 parts, black nightshade 12-18 parts, licorice root 5-10 parts, ginger 5-10 parts, chicken blood vine 18-22 parts, ginkgo leaf 8-12 parts, trichosanthes kirilowii 12-18 parts, and water chestnut 8-12 parts.

[0008] As a preferred technical solution, the traditional Chinese medicine composition comprises the following components by weight: 15 parts ginseng, 25 parts astragalus, 15 parts atractylodes macrocephala, 15 parts poria cocos, 15 parts angelica sinensis, 2 parts rice weevil, 7 parts cicada nymph, 15 parts licorice root, 15 parts honeysuckle vine, 10 parts hibiscus, 30 parts oldenlandia diffusa, 15 parts purslane, 15 parts black nightshade, 8 parts licorice, 8 parts ginger, 20 parts chicken blood vine, 10 parts ginkgo leaf, 15 parts trichosanthes kirilowii, and 10 parts water chestnut.

[0009] The traditional Chinese medicine composition of the present invention can be formulated into preparations suitable for oral administration, specifically including: powders, granules, capsules, tablets or oral liquids and other dosage forms.

[0010] The pharmacological properties and efficacy of each herb in the above-described herbal composition are as follows:

[0011] Ginseng: Sweet and slightly bitter in taste, and slightly warm in nature. It enters the spleen, lung, and heart meridians; it has the effects of greatly replenishing vital energy, tonifying the spleen and lungs, promoting body fluid production and quenching thirst, and calming the mind and improving intelligence.

[0012] Astragalus: Astragalus is sweet and slightly warm in nature, and enters the lung, spleen, liver and kidney meridians; its main functions include tonifying qi and raising yang, strengthening wei qi and consolidating the exterior, promoting diuresis and reducing swelling, and promoting tissue regeneration.

[0013] Atractylodes macrocephala: The medicinal properties of Atractylodes macrocephala are bitter, sweet, and warm, and it enters the spleen and stomach meridians; it has the effects of tonifying qi and strengthening the spleen, drying dampness and promoting diuresis, and stopping sweating.

[0014] Poria cocos: It is neutral in nature, sweet and bland in taste, and enters the heart, lung, spleen and kidney meridians; it has the effects of promoting diuresis and removing dampness, strengthening the spleen and stopping diarrhea, and calming the mind and soothing the nerves.

[0015] Angelica sinensis: sweet and pungent in taste, warm in nature; enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and promoting blood circulation, reducing swelling and promoting tissue regeneration.

[0016] Rice weevil: sweet in taste and warm in nature; it enters the spleen, stomach, and liver meridians. It has the effects of invigorating qi and replenishing deficiency, detoxifying and reducing swelling, and strengthening the spleen and eliminating food stagnation.

[0017] Cordyceps militaris: sweet and salty in taste, cool in nature; enters the lung and liver meridians. It has the effects of dispersing wind-heat, improving eyesight and clearing away corneal opacity, tonifying the lungs and kidneys, relieving cough and resolving phlegm, calming the mind and soothing the nerves, and detoxifying and reducing swelling;

[0018] Feilian: Slightly bitter in taste, cool in nature. It enters the spleen, stomach, and liver meridians. It has the effects of dispelling wind, clearing heat, promoting diuresis, cooling blood and stopping bleeding, and promoting blood circulation and reducing swelling.

[0019] Honeysuckle vine: sweet in taste and cold in nature. It enters the lung, stomach, and large intestine meridians. It has the functions of clearing heat and detoxifying, dispelling wind and unblocking the meridians.

[0020] Hibiscus flower: It tastes sweet and bitter, and is cool in nature. It enters the lung, spleen, and large intestine meridians; it has the effects of clearing heat and dampness, cooling blood and stopping bleeding, detoxifying and reducing swelling, and moistening the lungs and relieving cough.

[0021] Hedyotis diffusa: Slightly bitter and sweet in taste, and cold in nature. It enters the stomach, large intestine, and small intestine meridians; it has the effects of clearing heat and detoxifying, promoting diuresis and relieving strangury, and cooling blood and detoxifying.

[0022] Purslane: Sour in taste and cold in nature. It enters the liver and large intestine meridians. It has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding, detoxifying and reducing swelling, and clearing heat and promoting diuresis.

[0023] Black nightshade: Bitter in taste and cold in nature; slightly toxic. It enters the lung, liver, stomach, and bladder meridians; it has the effects of clearing heat and detoxifying, dispersing nodules and reducing swelling, promoting urination and relieving strangury, cooling blood and stopping bleeding, and clearing heat and relieving sore throat.

[0024] Licorice: Sweet in taste and neutral in nature; it enters the heart, lung, spleen, and stomach meridians. It has the effects of invigorating qi and strengthening the middle jiao, clearing heat and detoxifying, harmonizing other herbs, relieving spasms and pain, and moistening the lungs and relieving cough.

[0025] Ginger: pungent in flavor and warm in nature; it enters the lung, spleen, and stomach meridians; it has the effects of relieving exterior syndromes and dispelling cold, warming the middle jiao and stopping vomiting, resolving phlegm and relieving cough, and detoxifying and flavoring.

[0026] Chicken blood vine: bitter and sweet in taste, warm in nature; enters the liver and kidney meridians; has the effects of promoting blood circulation and nourishing blood, regulating menstruation and relieving pain, relaxing muscles and tendons and activating collaterals, and assisting in strengthening muscles and bones;

[0027] Ginkgo leaves: sweet, bitter, and astringent in taste, neutral in nature; enters the heart and lung meridians; has the effects of promoting blood circulation and removing blood stasis, clearing the meridians and relieving pain, astringing the lungs and relieving asthma, and clearing turbidity and lowering lipids;

[0028] Trichosanthes kirilowii: sweet and slightly bitter in taste, cold in nature. It enters the lung, stomach, and large intestine meridians; it has the effects of clearing heat and resolving phlegm, relieving chest congestion and dissipating nodules, moistening the intestines and promoting bowel movements, and reducing swelling and dissipating nodules.

[0029] Water chestnut: It tastes sweet and astringent, and is neutral in nature; it enters the spleen and stomach meridians; it has the effects of strengthening the spleen and stomach, promoting body fluid production and quenching thirst, astringing and stopping diarrhea, and detoxifying and reducing swelling;

[0030] The principal, assistant, adjuvant, and guiding relationships of the active pharmaceutical ingredients in this invention are as follows:

[0031] Ginseng, astragalus, rice weevil, and cicada flower are the principal herbs, which strengthen the body's resistance, replenish vital energy, and protect the body's exterior. They directly target the core pathogenesis of HIV / AIDS—"depletion of vital energy"—aiming to rapidly enhance and rebuild the patient's immune system function (such as increasing CD4 count).+ (T lymphocyte count). The following herbs are used as assistant herbs: *Hedyotis diffusa*, *Ligusticum striatum*, *Lonicera japonica*, *Solanum nigrum*, *Atractylodes macrocephala*, *Poria cocos*, and *Portulaca oleracea*. These act as the main detoxifying agents, concentrating their medicinal power to inhibit and eliminate HIV through multiple pathways. *Atractylodes macrocephala* and *Poria cocos* strengthen the spleen and eliminate dampness, assisting the principal herbs in supporting the body's vital energy. The adjuvant herbs include a blood-activating and meridian-clearing group and a phlegm-resolving and nodule-dispersing group. The blood-activating and meridian-clearing group includes *Spatholobus suberectus*, *Angelica sinensis*, and *Ginkgo biloba*. This combination targets the "toxin and blood stasis" pathogenesis of AIDS, improving microcirculation and promoting the targeted distribution of medicinal components. The phlegm-resolving and nodule-dispersing group includes *Trichosanthes kirilowii*, *Water chestnut*, and *Hibiscus syriacus*. This combination targets "phlegm nodules" symptoms such as lymphadenopathy and opportunistic infections, resolving phlegm and softening hardened masses to block disease progression. The guiding herbs are licorice and ginger. Licorice harmonizes the other herbs; ginger warms the middle jiao and acts as a counteracting agent, protecting the spleen and stomach.

[0032] According to the theory of incompatibilities in traditional Chinese medicine, there are no obvious conflicts in the combination of these 19 herbs, but some compatibility relationships and dosage issues need to be noted:

[0033] Compatibility Analysis

[0034] Main compatibility relationships

[0035] The Qi and Blood Tonifying Group consists of ginseng, astragalus, atractylodes macrocephala, poria cocos, angelica sinensis, and licorice, forming a basic formula for tonifying Qi and nourishing blood. Among them, ginseng and astragalus greatly tonify the original Qi, atractylodes macrocephala and poria cocos strengthen the spleen and eliminate dampness, angelica sinensis nourishes and invigorates blood, and licorice harmonizes the effects of the other herbs. This is a typical combination for tonifying Qi and blood.

[0036] Heat-clearing and detoxifying group: Herbs such as Oldenlandia diffusa, Portulaca oleracea, Solanum nigrum, Lonicera japonica, and Hibiscus syriacus have heat-clearing, detoxifying, and antiviral effects. These drugs are often used to clear heat toxins in the treatment of AIDS.

[0037] Blood-activating and stasis-removing group: Chicken blood vine, flying lily, etc. activate blood circulation and unblock the meridians, which helps to improve microcirculation;

[0038] Incompatibility Check

[0039] According to the theories of "Eighteen Incompatibilities" and "Nineteen Antagonisms," no obvious contraindications were found in this prescription:

[0040] The Eighteen Incompatibilities Check: The formula does not contain any contraindications such as ginseng being incompatible with veratrum, licorice being incompatible with euphorbia kansui, euphorbia pekinensis, seaweed, daphne genkwa, aconite being incompatible with pinellia, trichosanthes, fritillaria, white peony, or white atractylodes.

[0041] The nineteen incompatibilities were checked: the formula does not contain any antagonistic drugs such as ginseng being incompatible with wulingzhi or cinnamon being incompatible with red ochre.

[0042] Significance of HIV / AIDS Treatment

[0043] Emphasis on both strengthening the body's resistance and eliminating pathogenic factors

[0044] This prescription embodies the basic principle of "strengthening the body's resistance and eliminating pathogenic factors" in traditional Chinese medicine treatment of AIDS. Tonifying herbs (ginseng, astragalus, atractylodes macrocephala, etc.) enhance the body's immunity, while heat-clearing and detoxifying herbs (olden tongue grass, black nightshade, etc.) eliminate the virus, which aligns with the basic approach to AIDS treatment.

[0045] Modern pharmacological research

[0046] Studies have shown that *Cordyceps militaris* regulates immunity, enhances macrophage activity and lymphocyte proliferation; *Cestrum nobile*, ginseng, and astragalus synergistically enhance non-specific immunity; ginseng, astragalus, atractylodes macrocephala, and poria cocos can promote interferon induction and improve immune function; *Hedyotis diffusa*, *Ligusticum striatum*, and *Solanum nigrum* inhibit viral replication and reduce inflammatory responses; and *Spatholobus suberectus* and ginkgo biloba improve blood circulation and promote drug distribution. These drug combinations have a certain theoretical basis for adjuvant therapy in HIV / AIDS.

[0047] Usage Recommendations

[0048] Use based on syndrome differentiation: This formula is more tonifying and suitable for syndromes of qi and blood deficiency and internal heat and toxin accumulation. It should be used after being diagnosed by a traditional Chinese medicine practitioner.

[0049] Long-term monitoring: HIV patients need to have their liver and kidney function monitored regularly, and traditional Chinese medicine treatment should be carried out on the basis of Western antiviral treatment;

[0050] Individualized adjustments: There is relatively little clinical experience with drugs such as *Doumi Chong* and *Jin Chan Hua*, and close observation of efficacy and adverse reactions is necessary.

[0051] In summary, this formula is well-matched and conforms to the principles of traditional Chinese medicine treatment for AIDS. However, it must be used under the guidance of a professional TCM physician and in conjunction with standardized Western antiviral treatment.

[0052] After adopting the above technical solution, the beneficial effects of the present invention are:

[0053] First, the components of the herbal composition of this invention exhibit significant synergistic effects, effectively enhancing the overall therapeutic efficacy. Second, the application of *Doumicea javanica* in alleviating AIDS-related symptoms is disclosed for the first time, and has not been reported in the literature. This composition can comprehensively enhance the bodily functions and vitality of major organs in AIDS patients, and protect CD4 cells by inhibiting HIV replication. + T lymphocytes, thereby enhancing the patient's immunity. Clinical trials have further confirmed that the traditional Chinese medicine composition of this invention helps improve the patient's quality of life, enhance immunity, restore physical vitality, alleviate clinical symptoms, and delay disease progression. Detailed Implementation

[0054] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0055] Example 1

[0056] A traditional Chinese medicine composition for adjuvant treatment of AIDS, comprising the following components by weight: 10 parts ginseng, 20 parts astragalus, 10 parts atractylodes macrocephala, 10 parts poria cocos, 10 parts angelica sinensis, 1 part rice weevil, 3 parts cicada nymph, 10 parts licorice root, 12 parts honeysuckle vine, 8 parts hibiscus, 25 parts oldenlandia diffusa, 10 parts purslane, 10 parts black nightshade, 2 parts licorice, 2 parts ginger, 15 parts chicken blood vine, 5 parts ginkgo leaf, 10 parts trichosanthes kirilowii, and 5 parts water chestnut.

[0057] After the above raw materials are crushed and sieved, a pharmaceutically acceptable carrier or diluent (such as filler, binder, disintegrant, lubricant, surfactant or flavoring agent) is added to the collected fine powder of Chinese medicine, and then packaged to obtain Chinese medicine powder.

[0058] Pharmaceutically acceptable carriers or diluents refer to conventional drug carriers in the pharmaceutical field, selected from one or more of fillers, binders, disintegrants, lubricants, surfactants, or flavoring agents. Fillers are selected from one or more of starch, sucrose, lactose, mannitol, sorbitol, xylitol, microcrystalline cellulose, or glucose. Binders are selected from one or more of cellulose derivatives, alginate, gelatin, or polyvinylpyrrolidone.

[0059] Example 2

[0060] A traditional Chinese medicine composition for adjuvant treatment of AIDS, comprising the following components by weight: 12 parts ginseng, 22 parts astragalus, 12 parts atractylodes macrocephala, 12 parts poria cocos, 12 parts angelica sinensis, 1 part rice weevil, 5 parts cicada nymph, 12 parts licorice root, 12 parts honeysuckle vine, 8 parts hibiscus, 28 parts oldenlandia diffusa, 12 parts purslane, 12 parts black nightshade, 5 parts licorice, 5 parts ginger, 18 parts chicken blood vine, 8 parts ginkgo leaf, 12 parts trichosanthes kirilowii, and 8 parts water chestnut.

[0061] After pulverizing the above raw materials, add one or more pharmaceutically acceptable carriers or diluents (such as fillers, binders, disintegrants, lubricants, surfactants or flavoring agents, as in Example 1), granulate and fill capsules according to conventional methods to obtain traditional Chinese medicine capsules.

[0062] Example 3

[0063] A traditional Chinese medicine composition for adjuvant treatment of AIDS, comprising the following components by weight:

[0064] Ginseng 15 parts, Astragalus 25 parts, Atractylodes macrocephala 15 parts, Poria cocos 15 parts, Angelica sinensis 15 parts, Rice weevil 2 parts, Cordyceps militaris 8 parts, Ligusticum striatum 15 parts, Lonicera japonica 15 parts, Hibiscus syriacus 10 parts, Hedyotis diffusa 30 parts, Portulaca oleracea 15 parts, Solanum nigrum 15 parts, Glycyrrhiza uralensis 8 parts, Zingiber officinale 8 parts, Spatholobus suberectus 20 parts, Ginkgo biloba 10 parts, Trichosanthes kirilowii 15 parts, and Water chestnut 10 parts.

[0065] Ginseng, Astragalus, Atractylodes macrocephala, Poria cocos, Angelica sinensis, Ligusticum striatum, Lonicera japonica, Spatholobus suberectus, Trichosanthes kirilowii, Glycyrrhiza uralensis, and ginger were sliced. Then, Cordyceps militaris, Hedyotis diffusa, Portulaca oleracea, Solanum nigrum, Hibiscus syriacus, Ginkgo biloba, and water chestnut were washed and impurities were removed. The above Chinese herbs were then put into an extraction tank, purified water was added, and the mixture was heated for extraction. After filtration, the collected filtrate was concentrated, and the resulting extract was mixed with crushed rice weevils. Pharmaceutically acceptable carriers (such as fillers, binders, disintegrants, lubricants, surfactants, or flavoring agents, as in Example 1) or diluents were added. The mixture was then granulated and dried according to conventional methods to obtain Chinese herbal medicine granules.

[0066] Example 4

[0067] A traditional Chinese medicine composition for adjuvant treatment of AIDS, comprising the following components by weight: 18 parts ginseng, 28 parts astragalus, 18 parts atractylodes macrocephala, 18 parts poria cocos, 18 parts angelica sinensis, 3 parts rice weevil, 10 parts cicada nymph, 18 parts licorice root, 18 parts honeysuckle vine, 12 parts hibiscus, 32 parts oldenlandia diffusa, 18 parts purslane, 18 parts black nightshade, 10 parts licorice, 10 parts ginger, 22 parts chicken blood vine, 12 parts ginkgo leaf, 18 parts trichosanthes kirilowii, and 12 parts water chestnut.

[0068] The above-mentioned raw materials are pulverized and then extracted. Specifically, the following steps are taken: ginger slices are added to water, and the ginger volatile oil is collected after extraction; Chinese medicines other than ginseng, rice weevil, and cicada flower are pulverized or sliced, and then water is added and heated to boiling for extraction, and the extract is collected; ginseng, rice weevil, and cicada flower are pulverized and then added to 70% ethanol by volume concentration. After percolation at room temperature, the collected percolate is concentrated, and the resulting clear paste and extract are mixed, filtered, and concentrated. Purified water is added to the resulting thick paste, and after stirring to dissolve, flavoring agents, antibacterial agents, and ginger volatile oil are added. The mixture is then packaged and sterilized to obtain a Chinese medicine oral liquid preparation.

[0069] Example 5

[0070] A traditional Chinese medicine composition for adjuvant treatment of AIDS, comprising the following components by weight: ginseng 20 parts, astragalus 30 parts, atractylodes macrocephala 20 parts, poria cocos 20 parts, angelica sinensis 20 parts, rice weevil 5 parts, cicada stalk 12 parts, licorice root 30 parts, honeysuckle vine 18 parts, hibiscus flower 12 parts, oldenlandia diffusa 35 parts, purslane 20 parts, black nightshade 20 parts, licorice root 12 parts, ginger 12 parts, chicken blood vine 25 parts, ginkgo leaf 15 parts, trichosanthes fruit 20 parts, and water chestnut 15 parts.

[0071] After pulverizing the above raw materials, add one or more pharmaceutically acceptable carriers or diluents (such as fillers, binders, disintegrants, lubricants, surfactants or flavoring agents, as in Example 1), and compress them into tablets according to conventional methods, then coat them with a film to obtain traditional Chinese medicine tablets.

[0072] To better demonstrate the superior technical effects of the traditional Chinese medicine composition of this invention, experiments were conducted on AIDS patients and animals, as detailed below.

[0073] (I) Experimental Investigation of AIDS Patients

[0074] 1. General Information

[0075] One hundred patients with poor immune reconstitution were selected from those who had been receiving long-term antiretroviral therapy in the hospital. There were 68 male patients and 32 female patients. Among them, 30 patients were aged 20-28, 40 patients were aged 30-38, 20 patients were aged 40-48, 8 patients were aged 50-60, and 2 patients were over 60 years old.

[0076] 2. Treatment methods

[0077] Treatment course: One year is one course of treatment.

[0078] Administration: The herbal composition of Example 3 is made into tablets for oral administration, twice a day, once in the morning and once in the evening, half an hour before meals, 2 tablets each time. During the medication period, avoid greasy, spicy, and cold-natured foods such as mung beans.

[0079] 3. Diagnostic criteria

[0080] Both of the following criteria must be met:

[0081] 3.1 Diagnostic criteria for AIDS: Refer to the "Diagnostic Criteria for AIDS and HIV Infection" (WS293-2008) and the "Guidelines for the Diagnosis and Treatment of AIDS (2011 Edition)". A history of epidemiological infection, combined with a positive anti-HIV test, confirmed by a Western Blot confirmatory test; or a positive anti-HIV test alone is sufficient for diagnosis.

[0082] 3.2 Criteria for Poor Immune Reconstitution: Based on the 2014 DHHS Guidelines for Antiretroviral Therapy in HIV / AIDS and combined with domestic expert consensus. Diagnosis of poor immune reconstitution in HIV / AIDS primarily relies on laboratory testing: CD4 counts in patients who have received HAART for 1 to 2 years. + T lymphocyte count <200 μL －1 Or patients who have received HAART for more than 2 years with CD4 + T lymphocyte count <350 μL －1 Or after a period of treatment (e.g., 4–7 years), CD4 + T lymphocyte count not exceeding a specific value (e.g., >350 μL) －1 Or 500μL －1 ), and HIV-RNA levels were below the detection threshold.

[0083] 4. Efficacy evaluation criteria

[0084] (1) Immunological indicators are based on the "Staging Standards and Evaluation Index System for the Efficacy Evaluation of Traditional Chinese Medicine Treatment of HIV / AIDS (Revised Draft)" (Handbook of Traditional Chinese Medicine Treatment of AIDS, Traditional Chinese Medicine Ancient Books Publishing House, 2014).

[0085] Effective: CD4 levels before and after treatment + T lymphocyte count increased to 50 / mm 3 Or more than 30%;

[0086] Invalid: 50 drops / mm 3 Or more than 30%;

[0087] Stable: The rise or fall does not reach 50 / mm 3 Or 30%.

[0088] (2) The criteria for judging the efficacy of syndromes were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" (China Medical Science and Technology Press, 2002).

[0089] Significant effect: Symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%;

[0090] Effective: Symptoms and signs improved, and the syndrome score decreased by ≥30%;

[0091] Ineffective: Symptoms and signs show no significant improvement, or even worsen, with the syndrome score decreasing by less than 30%. The calculation formula (nimodipine method) is: ([pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%.

[0092] 5. Treatment Results

[0093] Of the patients treated, 45 showed significant improvement, 38 showed improvement, and 17 showed no improvement. The treatment results indicate that the traditional Chinese medicine composition provided by this invention has an efficacy rate of 83% in treating poor immune reconstitution in AIDS patients, demonstrating a definite therapeutic effect.

[0094] Typical Case

[0095] Case 1

[0096] The patient was a 42-year-old male HIV carrier with a CD4 count of 285 / μL, presenting with fatigue and recurrent oral ulcers. After taking the granules of this composition (prepared in Example 3) for 3 months, his CD4 count decreased. + T lymphocytes increased to 352 / μL, physical strength improved, and the frequency of ulcer attacks decreased.

[0097] Case 2

[0098] The patient is a 38-year-old female in the AIDS stage, with shingles, CD4 + T lymphocyte count 112 / μL. After taking this combination capsule (Example 2 formulation) in combination with antiviral drugs for 4 months, CD4 count... + T lymphocytes rose to 178 / μL, the herpes subsided, and there was no recurrence.

[0099] Case 3

[0100] The patient is a 50-year-old male with HIV and Kaposi's sarcoma, CD4. + T lymphocyte count 85 / μL. After taking this oral solution (prepared in Example 4) in conjunction with chemotherapy for 6 months, the tumor shrank, and CD4 count... + T lymphocytes increased to 130 / μL, and body weight increased.

[0101] Case 4

[0102] The patient is a 29-year-old female, in the asymptomatic phase of HIV, with CD4 counts. + T lymphocyte count 410 / μL, anxiety and insomnia. After taking this powdered composition (prepared in Example 1) for 2 months, sleep quality improved and CD4 count decreased. + T lymphocytes remain stable.

[0103] Case 5

[0104] The patient is a 47-year-old male in the AIDS stage, complicated by pulmonary tuberculosis, CD4. + T lymphocyte count 67 / μL. Combined anti-tuberculosis therapy and this composition tablets (prepared as in Example 5) for 5 months, CD4... + T lymphocytes rose to 125 / μL, and the lung infection was well controlled.

[0105] (II) Animal Experiment Investigation

[0106] 1. Laboratory animals

[0107] Sixty mice, weighing 18–22 g, were randomly divided into six groups of ten mice each, with half males and half females. The experimental groups included experimental group 1, experimental group 2, and experimental group 3. Experimental group 1 was administered the drug of Example 1 by gavage, experimental group 2 was administered the drug of Example 3 by gavage, and experimental group 3 was administered the drug of Example 5 by gavage. The experimental groups also included a blank control group, a model group, and a positive control group (administered Ginseng and Atractylodes Macrocephala Powder by gavage). The blank control group and the model group received an equal volume of distilled water.

[0108] 2. Detection of phagocytic function of peritoneal macrophages in immunocompromised mice

[0109] The drug was administered once daily for 8 consecutive days. On days 1, 3, 5, and 7, all groups except the control group received an intramuscular injection (IM) of 0.5 mg / animal to induce an immunodeficiency model. On the evening of day 7, 0.5 ml of 5% chicken erythrocytes was administered intraperitoneally per animal. Ten hours later (1 hour after the last administration), the animals were sacrificed, and 2 ml of physiological saline was injected into the peritoneal cavity. The cavity was gently rubbed, and the peritoneal fluid was collected for smear preparation and staining. Two hundred macrophages were examined microscopically, and the phagocytic percentage and phagocytic index were calculated. The results are shown in Table 1.

[0110]

[0111] t-test, compared with the blank control group: △△ P < 0.01; Compared with the model group: *P < 0.05, **P < 0.01.

[0112] The results showed that, compared with the model group, experimental groups 1, 2 and 3 significantly increased the phagocytic percentage and phagocytic index of peritoneal macrophages in immunocompromised mice (*P<0.05, **P<0.01).

[0113] 3. Effects on the percentage of peripheral blood T lymphocytes in immunocompromised mice

[0114] Grouping and dosage were the same as above. Administered once daily for 17 consecutive days. On day 10, simultaneously with administration, except for the blank control group, all other groups underwent SC hydrocortisone 50 mg / kg to establish an immunodeficiency model. Twenty-four hours after the last administration, blood was collected from the tail tip, and T-cell nonspecific esterase (ANAE) was measured according to literature. One hundred lymphocytes were examined microscopically, and the ANAE positive percentage was calculated. The results are shown in Table 2.

[0115]

[0116] t-test, compared with the blank control group: △△ P < 0.01; Compared with the model group: *P < 0.05, **P < 0.01.

[0117] The results showed that, compared with the model group, experimental groups 1, 2 and 3 significantly increased the percentage of peripheral blood T lymphocytes in immunocompromised mice (*P<0.05, **P<0.01).

[0118] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for adjuvant treatment of AIDS, characterized in that, The ingredients, by weight, include the following components: ginseng 10-20 parts, astragalus 20-30 parts, atractylodes macrocephala 10-20 parts, poria cocos 10-20 parts, angelica sinensis 10-20 parts, rice weevil 1-5 parts, cicada nymph 2-12 parts, licorice root 10-30 parts, honeysuckle vine 12-18 parts, hibiscus flower 8-12 parts, oldenlandia diffusa 25-35 parts, purslane 10-20 parts, black nightshade 10-20 parts, licorice root 2-12 parts, ginger 2-12 parts, chicken blood vine 15-25 parts, ginkgo leaf 5-15 parts, trichosanthes fruit 10-20 parts, and water chestnut 5-15 parts.

2. The traditional Chinese medicine composition for adjuvant treatment of AIDS according to claim 1, characterized in that, The ingredients, by weight, include the following components: ginseng 12-18 parts, astragalus 22-28 parts, atractylodes macrocephala 12-18 parts, poria cocos 12-18 parts, angelica sinensis 12-18 parts, rice weevil 1-3 parts, cicada nymph 5-10 parts, licorice root 12-18 parts, honeysuckle vine 12-18 parts, hibiscus flower 8-12 parts, oldenlandia diffusa 28-32 parts, purslane 12-18 parts, black nightshade 12-18 parts, licorice root 5-10 parts, ginger 5-10 parts, chicken blood vine 18-22 parts, ginkgo leaf 8-12 parts, trichosanthes fruit 12-18 parts, and water chestnut 8-12 parts.

3. The traditional Chinese medicine composition for adjuvant treatment of AIDS according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components by weight: 15 parts ginseng, 25 parts astragalus, 15 parts atractylodes macrocephala, 15 parts poria cocos, 15 parts angelica sinensis, 2 parts rice weevil, 7 parts cicada nymph, 15 parts licorice root, 15 parts honeysuckle vine, 10 parts hibiscus, 30 parts oldenlandia diffusa, 15 parts purslane, 15 parts black nightshade, 8 parts licorice, 8 parts ginger, 20 parts chicken blood vine, 10 parts ginkgo leaf, 15 parts trichosanthes kirilowii, and 10 parts water chestnut.

4. A traditional Chinese medicine preparation for adjuvant treatment of AIDS, characterized in that, The traditional Chinese medicine preparation is made from the traditional Chinese medicine composition of claim 1 and a pharmaceutically acceptable carrier.

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