Zhuang Yao ointment for improving immune disorder of human immunodeficiency virus (HIV) infected person, preparation method of Zhuang Yao ointment and navel patch

Abstract

The invention discloses Yao-strengthening ointment for improving immune disorder of an HIV infected person. The Yao-strengthening ointment is mainly prepared from the following raw materials: astragalus membranaceus, poria cocos, rhizoma cimicifugae, radix achyranthis bidentatae, roasted ephedra, prepared radix aconiti carmichaeli, asarum, roasted liquorice, philippine flemingia root, giantleaf ardisia rhizome, caulis sinomenii, tripterygium wilfordii and gynostemma pentaphylla. The preparation method of the Zhuang Yao ointment comprises the steps of medicinal material treatment, medicinal material extraction and ointment preparation. The whole formula is mainly used for strengthening the body resistance (tonifying qi and warming yang) and eliminating evil (dehumidifying, activating blood and detoxifying), through the compatibility of monarch, minister, assistant and guide, the traditional Chinese medicine aims at core qi deficiency and yang deficiency of immune disorder of HIV infected people and also eliminates pathological products such as dampness, stasis and heat toxin, meanwhile, honey-fried licorice root is used for regulating the medicine property, CD4 cells of the HIV infected people can be improved, immune disorder can be improved to a certain extent, and immune reconstitution is promoted.

Description

Technical Field

[0001] This invention relates to the field of Zhuang and Yao medicine technology, and in particular to a Zhuang and Yao medicine ointment for improving immune disorders in HIV-infected individuals, its preparation method, and an umbilical patch. Background Technology

[0002] AIDS, a serious public health problem threatening human health worldwide, is caused by the human immunodeficiency virus (HIV) continuously attacking the human immune system. HIV specifically targets key cells in the immune system, especially CD4+ T lymphocytes, leading to the gradual collapse of the immune system and making the body highly susceptible to various opportunistic infections and rare tumors. Currently, while highly active antiretroviral therapy (HAART) has achieved significant results in controlling HIV replication, it cannot completely cure AIDS, and long-term use can cause a series of toxic side effects such as liver and kidney damage, dyslipidemia, and gastrointestinal discomfort. Some patients also experience poor immune reconstitution. Furthermore, the high cost of treatment places a heavy economic burden on patients and society. Therefore, developing a safe, effective, and economical adjunctive therapy to improve the immune function of HIV-infected individuals and enhance their quality of life has become a crucial issue urgently needing to be addressed in the field of medical research.

[0003] In the treasure trove of traditional medicine, umbilical therapy, as a unique treatment method, primarily utilizes various techniques such as medicated plasters, moxibustion, and massage applied to the navel (Shenque acupoint). By stimulating the flow of Qi and blood through the meridians, it regulates the body's Yin-Yang balance, thereby achieving the purpose of preventing and treating diseases. In traditional Chinese medicine theory, the navel is considered a crucial hub in the body's meridian system, closely connected to the twelve meridians and also communicating with the five internal organs. The skin around the navel is thinner and more delicate than other areas, with abundant subcutaneous blood vessels, allowing medications to penetrate the skin more easily and quickly enter the bloodstream, thus exerting a systemic therapeutic effect.

[0004] Zhuang and Yao medicines are abundant and diverse, with some exhibiting unique advantages and good effects in treating immune-related diseases. This provides rich material and a solid theoretical foundation for developing therapeutic drugs targeting immune disorders in HIV-infected individuals. Combining Zhuang and Yao medicines with umbilical therapy to develop Zhuang and Yao ointments for improving immune disorders in HIV-infected individuals not only integrates the wisdom of traditional medicine but also meets the needs of modern medicine for innovative AIDS treatment, possessing broad research prospects and significant practical importance.

[0005] The information disclosed in this background section is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0006] The purpose of this invention is to provide a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals, which can effectively improve the immune disorder status of HIV-infected individuals.

[0007] Another object of the present invention is to provide a method for preparing a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals.

[0008] To achieve the above objectives, the present invention provides a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals. The Zhuang-Yao medicinal ointment is mainly composed of the following ingredients: Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Aconitum carmichaelii, Asarum sieboldii, processed Glycyrrhiza uralensis, Moghania macrophylla, Smilax china, Sinomenium acutum, Tripterygium wilfordii, and Gynostemma pentaphyllum.

[0009] Preferably, in the above technical solution, the Zhuangyao ointment for improving immune disorders in HIV-infected individuals comprises, by weight, the following ingredients: Astragalus membranaceus 25-35g, Poria cocos 13-18g, Cimicifuga foetida 8-12g, Achyranthes bidentata 8-12g, processed Ephedra sinica 8-12g, processed Aconitum carmichaelii 8-12g, Asarum heterotropoides 5-8g, processed Glycyrrhiza uralensis 5-8g, Smilax china 25-35g, Tripterygium wilfordii 8-12g, Sinomenium acutum 8-12g, Tripterygium wilfordii 5-8g, and Gynostemma pentaphyllum 13-18g.

[0010] Preferably, in the above technical solution, the Zhuangyao ointment for improving immune disorders in HIV-infected individuals comprises, by weight, the following ingredients: Astragalus membranaceus 30g, Poria cocos 15g, Cimicifuga foetida 10g, Achyranthes bidentata 10g, processed Ephedra sinica 10g, processed Aconitum carmichaelii 10g, Asarum heterotropoides 6g, processed Glycyrrhiza uralensis 6g, Moghania tetrandra 30g, Zygodium japonicum 10g, Sinomenium acutum 10g, Tripterygium wilfordii 6g, and Gynostemma pentaphyllum 15g.

[0011] This application also provides a method for preparing a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals, comprising the following steps:

[0012] (1) Processing of medicinal materials: Tripterygium wilfordii is processed by steaming with alcohol to reduce toxicity. After slicing and crushing, medicinal powder A is prepared for use. Prepared Aconitum carmichaelii needs to be soaked in water for 1 to 1.5 hours before use. Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum are soaked in water for 1 to 1.5 hours before use.

[0013] (2) Drug extraction: Take prepared Aconitum carmichaelii and Asarum heterotropoides, add 10-12 times the amount of distilled water, bring to a boil over high heat, then simmer over low heat for 1.5-2 hours until the liquid no longer has a numbing sensation on the tongue. Filter to obtain filtrate I, and retain dregs I. Mix dregs I with soaked Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum, add 8-10 times the amount of distilled water, soak for 1-1.5 hours, bring to a boil over high heat, then simmer over low heat for 1-1.5 hours, filter to obtain filtrate II, and retain dregs II. Add 6 times the amount of distilled water to dregs II, simmer for 1-1.5 hours, filter to obtain filtrate III. Combine filtrates I, II, and III, let stand for 24-30 hours, take the supernatant, and concentrate under reduced pressure at 80-90℃ to an extract with a relative density of 1.20-1.25 to obtain a mixed extract.

[0014] (3) Preparation of ointment: Take the mixed extract, add the medicinal powder A, and stir until uniform to obtain the primary ointment; add the matrix at a ratio of primary ointment: matrix = 2:1, stirring while adding, until a fine and particle-free Zhuang-Yao ointment is formed.

[0015] The present invention also provides an umbilical patch, which is prepared using the Zhuang-Yao medicinal ointment described above for improving immune disorders in HIV-infected individuals.

[0016] The drug raw materials used in this invention have the following drug mechanism:

[0017] Astragalus, in terms of properties and channels: sweet, slightly warm. It enters the lung and spleen channels. Pharmacological analysis: Main components: Astragalus polysaccharides, astragaloside (such as astragaloside A), flavonoids, etc. Core functions: Enhances immune function: Promotes lymphocyte proliferation, improves macrophage phagocytic capacity, and has a regulatory effect on immunocompromised individuals. Anti-fatigue and antioxidant: Improves the body's energy reserves, scavenges free radicals, and delays tissue aging. Cardiovascular protection: Improves myocardial blood supply, inhibits platelet aggregation, and reduces the risk of arteriosclerosis; it can also regulate blood pressure (bidirectional effect, raising blood pressure in hypotension and lowering blood pressure in hypertension). Regulates metabolism: Promotes protein synthesis and assists in regulating blood sugar (has a hypoglycemic effect in diabetic animal models).

[0018] Poria cocos, its properties and channels: sweet, bland, neutral. It enters the heart, spleen, and kidney channels. Pharmacological analysis: Main components: Poria cocos polysaccharides, pachymic acid, triterpenoids, etc. Core functions: Diuretic effect: By inhibiting renal tubular reabsorption, it increases urine output (without damaging kidney function). Immunomodulation: Poria cocos polysaccharides can enhance the body's non-specific immunity and have a certain inhibitory effect on tumor cells (adjuvant anti-tumor). Sedative and tranquilizing effect: It has a mild inhibitory effect on the central nervous system, helping to improve insomnia and anxiety. Gastrointestinal protection: It inhibits gastric acid secretion, enhances the gastric mucosal barrier, and relieves gastric ulcers.

[0019] Cimicifuga rhizome, its properties and channels: pungent, slightly sweet, slightly cold. It enters the lung, spleen, stomach, and large intestine channels. Pharmacological analysis: Main components: triterpenoid saponins (such as cimicifugain), phenolic acids, etc. Core functions: Antipyretic and anti-inflammatory: By inhibiting prostaglandin synthesis, it relieves fever and inflammation (such as rheumatoid arthritis). Lifting Yang and lifting prolapse: Promotes gastrointestinal motility and improves gastroptosis and uterine prolapse (possibly related to regulating smooth muscle tone). Antibacterial and antiviral: It has a certain inhibitory effect on Staphylococcus aureus, influenza virus, etc.

[0020] Achyranthes bidentata, its properties and channels: bitter, sweet, sour, neutral. It enters the liver and kidney channels. Pharmacological analysis: Main components: triterpenoid saponins (such as oleanolic acid), sterones, polysaccharides, etc. Core functions: Promoting blood circulation and regulating menstruation: improves blood circulation, inhibits platelet aggregation, and alleviates thrombosis (used for traumatic injuries and blood stasis). Tonifying the liver and kidneys, strengthening tendons and bones: promotes osteoblast activity, increases bone density, and assists in the treatment of osteoporosis. Diuretic and relieving strangury: increases urine output by dilating renal blood vessels, relieving urinary tract infections. Lowering blood pressure: has a certain antihypertensive effect in hypertensive model animals (possibly related to peripheral vasodilation).

[0021] Processed ephedra, properties and channels: pungent, slightly bitter, warm. It enters the lung and bladder channels (after processing, its pungent and warm properties are slightly reduced, making it more effective in relieving asthma). Pharmacological analysis: Main components: ephedrine, pseudoephedrine (content slightly reduced after processing), volatile oil, etc. Core functions: Relieving lung congestion and asthma: Ephedrine can stimulate β-receptors in bronchial smooth muscle, relieving bronchospasm (used for asthma and cough). Promoting diuresis and reducing edema: By dilating renal blood vessels and increasing urine output, it relieves edema. Inducing sweating and relieving exterior syndromes (weaker than raw ephedra): It promotes sweat gland secretion, helping to relieve the initial symptoms of wind-cold common cold.

[0022] Prepared aconite root, properties and channels: pungent, sweet, very hot; toxic. Enters the heart, kidney, and spleen channels (toxicity is reduced after processing). Pharmacological analysis: Main component: aconitine (converted into the less toxic benzoylaconitine and aconitine after processing). Core functions: Resuscitating Yang and rescuing from collapse: Significant cardiotonic effect, enhances myocardial contractility, improves microcirculation, used for shock and heart failure. Tonifying Yang: Promotes the secretion of adrenal cortex hormones, improves symptoms of kidney Yang deficiency (such as aversion to cold, cold pain in the lower back and knees). Dispersing cold and relieving pain: Significant anti-inflammatory and analgesic effects, relieves cold-dampness arthralgia (such as rheumatoid arthritis). Caution: Excessive dosage can easily lead to arrhythmia and respiratory depression; strict processing and dosage control are required.

[0023] Asarum sieboldii, Nature, flavor, meridian tropism: pungent, warm; slightly toxic. It belongs to the lung, kidney and heart meridians. Pharmacological analysis: Main components: volatile oils (methyl eugenol, safrole, etc.), lignans. Core functions: Relieving exterior syndrome and dispelling cold: Volatile oils can promote sweating and relieve wind-cold type cold (especially suitable for those with headache and body pain). Expelling wind and relieving pain: It has a significant analgesic effect and is effective for headache, toothache and joint pain (possibly related to inhibiting pain signal transmission). Opening the nasal passage: It can improve the blood circulation of nasal mucosa and relieve nasal congestion (used for rhinitis and sinusitis). Warming the lung and resolving fluid retention: It can inhibit bronchial secretions and relieve cold-phlegm cough and dyspnea. Note: Safrole has liver toxicity, and overdose (more than 3g) may cause poisoning.

[0024] Prepared Licorice Root, Nature, flavor, meridian tropism: sweet, neutral. It belongs to the heart, lung, spleen and stomach meridians (after processing, it is more inclined to invigorate the spleen and replenish qi). Pharmacological analysis: Main components: glycyrrhizin (glycyrrhizic acid), liquiritin, flavonoids, etc. Core functions: Invigorating the spleen and replenishing qi: It can promote the repair of gastrointestinal mucosa and improve dyspepsia and weakness of the spleen. Clearing heat and detoxifying: It has anti-inflammatory and antibacterial effects, inhibits various pathogens (such as bacteria and viruses), and helps relieve sore throat. Removing phlegm and relieving cough: It can inhibit the cough center and promote the discharge of phlegm (used for excessive phlegm and cough). Harmonizing various herbs: Glycyrrhizin can reduce the toxicity of drugs such as aconite and tripterygium wilfordii (by adsorption or metabolic transformation).

[0025] Flemingia philippinensis Merr. ex Rolfe, Nature, flavor, meridian tropism: sweet, slightly astringent, neutral. It belongs to the liver and kidney meridians (a commonly used herb in Lingnan area). Pharmacological analysis: Main components: flavonoids, phenols, triterpenoid saponins, etc. Core functions: Expelling wind and removing dampness: It has anti-inflammatory and analgesic effects and relieves rheumatic arthralgia (such as rheumatoid arthritis and lumbar muscle strain). Strengthening the tendons and bones: It can promote the repair of bone tissue and is used for soreness and weakness of the waist and knees and weakness of the lower limbs. Activating blood circulation and dredging collaterals: It can improve local blood circulation and assist in the treatment of traumatic injuries.

[0026] Ardisia gigantifolia Stapf, Nature, flavor, meridian tropism: pungent, bitter, warm. It belongs to the liver and kidney meridians (a commonly used herb in folk). Pharmacological analysis: Main components: volatile oils, flavonoids, alkaloids, etc. Core functions: Expelling wind and removing dampness: It can inhibit inflammatory factors and relieve rheumatoid arthritis and joint swelling and pain. Activating blood circulation and removing stasis: It can promote the absorption of stasis and is used for traumatic injuries and swelling and pain due to stasis. Reducing swelling and relieving pain: Topical application can improve local swelling (possibly related to promoting microcirculation).

[0027] Sinomenium acutum (Thunb.) Rehd. et Wils., Nature, flavor, meridian tropism: bitter, pungent, neutral. It belongs to the liver and spleen meridians. Pharmacological analysis: Main components: sinomenine (core active ingredient), magnoflorine, etc. Core functions: Expelling wind and dredging collaterals: Sinomenine can inhibit immune responses (such as inhibiting T cell activation) and relieve rheumatoid arthritis (clinically used to improve joint swelling and pain). Analgesia: By blocking nerve conduction, it is effective for chronic pain (the effect is similar to non-steroidal anti-inflammatory drugs, but with low addiction potential). Diuresis: It can increase urine output and assist in relieving edema.

[0028] Tripterygium wilfordii, properties and channels: bitter, pungent, cold; highly toxic. It enters the liver and kidney channels. Pharmacological analysis: Main components: triptolide, triptolide glycosides, alkaloids, etc. Core effects: Immunosuppression: Strongly inhibits cellular and humoral immunity, used for autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus). Anti-inflammatory and analgesic: Inhibits inflammatory mediators (such as prostaglandins, interleukins), relieving redness, swelling, heat, and pain. Caution: Extremely toxic, can cause liver damage, kidney failure, and reproductive system damage (such as amenorrhea, decreased sperm count). Strictly follow medical advice; long-term or excessive use is prohibited.

[0029] Gynostemma pentaphyllum, its properties and channels: sweet, bitter, cold. It enters the lung, spleen, and kidney channels. Pharmacological analysis: Main components: Gynostemma pentaphyllum saponins (similar to ginsenosides), flavonoids, polysaccharides, etc. Core functions: Invigorating Qi and strengthening the spleen: Regulates gastrointestinal function, improves spleen deficiency with poor appetite and fatigue. Lowering metabolic indicators: Reduces blood lipids (inhibits cholesterol synthesis) and blood sugar (promotes insulin secretion), assisting in the treatment of hyperlipidemia and diabetes. Enhancing immunity and anti-tumor effects: Stimulates immune cell activity, has a certain inhibitory effect on tumor cells (assisting in anti-cancer). Antioxidant: Scavenges free radicals, delays aging, and protects the cardiovascular system.

[0030] Compared with the prior art, the present invention has the following beneficial effects:

[0031] (1) The Zhuang-Yao medicinal ointment of this invention for improving immune disorders in HIV-infected individuals is designed according to the traditional Chinese medicine theory of monarch, minister, assistant, and guide. In this formula, the monarch herb (strengthening the body's resistance, invigorating qi and warming yang): Astragalus: greatly tonifies the qi of the spleen and lungs, raises yang qi, and consolidates the exterior to stop sweating. It can enhance cellular immunity, regulate immune balance, and inhibit abnormal immune activation. Prepared aconite: warms and tonifies kidney yang, circulates through the twelve meridians, warms the interior and dispels cold. Its effective components, such as aconitine (which can be controlled transdermally when used externally), have a certain immunomodulatory effect. Qianjinba (a Zhuang-Yao specialty herb): a key herb for tonifying deficiency and strengthening the body. In this formula, it tonifies qi and strengthens the spleen, strengthens tendons and bones, and works with astragalus and aconite to greatly tonify the original qi, enhance physical constitution, and improve fatigue and weakness. The minister herb (eliminating dampness and strengthening the spleen, dispelling wind and dampness, activating blood and unblocking collaterals): Poria: sweet and bland, eliminates dampness, strengthens the spleen and stomach. Eliminating dampness helps the spleen to function, so that tonification is not stagnant, improves digestive and absorptive functions, and indirectly supports the recovery of the body's resistance. It also has a mild sedative and calming effect. Zouma Tai (a Zhuang-Yao specialty medicine): dispels wind and invigorates blood circulation, strengthens muscles and bones, reduces swelling and relieves pain. This formula strengthens its wind-dispelling, dampness-removing, blood-activating, and meridian-clearing effects, improving lymphatic obstruction, especially addressing the Zhuang medical concept of "wind-dampness and toxic evils." Qingfeng Teng: dispels wind-dampness, clears meridians, and promotes urination. It is a commonly used medicine for treating rheumatic pain. Its active ingredient, Qingfeng alkaloid, has significant anti-inflammatory, analgesic, and immunosuppressive effects (regulating overactive immunity). Niuxi: invigorates blood circulation, removes blood stasis, tonifies the liver and kidneys, strengthens muscles and bones, and guides blood downwards. Its blood-activating and meridian-clearing properties help improve local microcirculation (such as lymph nodes and around joints), and its downward-moving properties direct the medicinal effect downwards (the area below the navel is governed by the liver and kidneys), assisting Fuzi in guiding fire back to its source and strengthening the waist and knees. Adjuvant herbs (opening pores, guiding the medicine to the affected area, clearing heat and detoxifying): Prepared Ephedra: Opens pores and disperses external pathogens (referring to toxins penetrating deep into the meridians), aiding transdermal absorption. Its mild diaphoretic effect may alleviate the symptoms of mild pathogen stagnation in immunosuppressed states. Cimicifuga: Raises Yang Qi, effectively guiding clear Yang (medicinal power) upwards, and also clears heat, detoxifies, and disperses nodules (targeting lymph node swelling due to heat toxin accumulation). Together with Achyranthes bidentata, it regulates Qi; it assists Astragalus membranaceus in raising and tonifying its effects upwards; its penetrating properties help Ephedra open meridian pathways, guiding the medicinal power through the pores and expelling toxins. Gynostemma pentaphyllum: Clears heat and detoxifies, tonifies Qi and nourishes Yin (or strengthens the spleen), eliminates phlegm and relieves cough; modern research shows it has clear immune-enhancing (especially non-specific immunity), anti-inflammatory, and antioxidant effects. Adding a purgative tonic targets the pathogenesis of "stasis and toxins," clearing chronic inflammatory factors in the microenvironment and protecting immune cells. Combined with externally applied meridian-clearing herbs, it clears "toxic pathogens" both internally and externally. Asarum: Its pungent and warm nature allows it to penetrate and clear the meridians, assisting ephedra and cimicifuga in opening the pores and deep skin, allowing the medicine to penetrate deeply. It can dispel cold and relieve pain (specifically for joint pain caused by cold), and its strong penetrating power helps to "search out" pathogenic toxins and stasis in the deep meridians. Tripterygium wilfordii: A key immunomodulatory drug. It has extremely strong effects in dispelling wind and dampness, clearing the meridians and relieving pain, and detoxifying and reducing swelling. Particularly valuable is its significant immunosuppressive effect, which improves the abnormally hyperactive immune state after HIV infection.Medicinal herbs (harmonizing medicinal properties, detoxifying and relieving urgency): Prepared licorice root: sweet and mild, harmonizing the middle, harmonizing various herbs, alleviating the harshness and toxicity of some herbs (such as aconite, ephedra, and tripterygium wilfordii) (especially when absorbed through skin contact), and preventing excessive local irritation.

[0032] (2) The Zhuangyao ointment of the present invention is used to improve the immune disorder of HIV-infected individuals. The whole formula is mainly to support the body's resistance (tonify qi and warm yang) while also taking into account the elimination of pathogens (remove dampness, promote blood circulation and detoxify). Through the combination of principal, assistant and adjuvant herbs, it not only targets the core qi deficiency and yang deficiency of the immune disorder of HIV-infected individuals, but also clears pathological products such as dampness, blood stasis and heat toxin. At the same time, roasted licorice is used to harmonize the medicinal properties, which can increase the CD4 cells of HIV-infected individuals and improve the immune disorder to a certain extent, and promote immune reconstruction. Detailed Implementation

[0033] The specific embodiments of the present invention will be described in detail below with reference to specific examples, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments.

[0034] The diagnostic criteria, selection criteria for Zhuang and Yao medicinal ointments, clinical evaluation time, and examples below can help those skilled in the art to more fully understand the present invention, but should not be construed as limiting the present invention in any way.

[0035] I. Description of Implementation Examples

[0036] Example 1

[0037] A Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals, wherein, by weight, the Zhuang-Yao medicinal ointment is mainly composed of the following ingredients: Astragalus membranaceus 25g, Poria cocos 13g, Cimicifuga foetida 8g, Achyranthes bidentata 8g, processed Ephedra sinica 8g, processed Aconitum carmichaelii 8g, Asarum heterotropoides 5g, processed Glycyrrhiza uralensis 5g, Smilax china 25g, Smilax china 8g, Sinomenium acutum 8g, Tripterygium wilfordii 5g, and Gynostemma pentaphyllum 13g.

[0038] The preparation method of the above-mentioned Zhuang-Yao medicinal ointment includes the following steps:

[0039] (1) Processing of medicinal materials: Tripterygium wilfordii is processed by steaming with alcohol to reduce its toxicity. After slicing and crushing, it is used to obtain medicinal powder A for later use. Prepared Aconitum carmichaelii needs to be soaked in water for 1 hour for later use. Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum are soaked in water for 1 hour for later use.

[0040] (2) Drug extraction: Take prepared Aconitum carmichaelii and Asarum heterotropoides, add 10 times the amount of distilled water, bring to a boil over high heat, then simmer over low heat for 1.5 hours until the liquid no longer has a numbing sensation on the tongue. Filter to obtain filtrate I, and retain dregs I. Mix dregs I with soaked Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum, add 8 times the amount of distilled water, soak for 1 hour, bring to a boil over high heat, then simmer over low heat for 1 hour, filter to obtain filtrate II, and retain dregs II. Add 6 times the amount of distilled water to dregs II, simmer for 1 hour, filter to obtain filtrate III. Combine filtrates I, II, and III, let stand for 24 hours, take the supernatant, and concentrate under reduced pressure at 80℃ to an extract with a relative density of 1.20 to obtain a mixed extract.

[0041] (3) Preparation of ointment: Take the mixed extract, add the powder A, and stir until uniform to obtain the primary ointment; add the matrix at a ratio of primary ointment: matrix = 2:1, stirring while adding until a fine and particle-free Zhuang-Yao ointment is formed; while adding and stirring, the temperature is controlled at 40-50℃ to avoid high temperature damage to the components. The matrix is ​​a mixture of petrolatum, lanolin and glycerin, with petrolatum: lanolin: glycerin = 5:3:2.

[0042] This invention also provides an umbilical patch, which is formed by placing a medicated paste in the center of a special dressing pad; each patch has an area of ​​3cm × 3cm and weighs approximately 5g. If not used immediately, it can be sterilized and then sealed.

[0043] Example 2

[0044] A Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals, wherein, by weight, the Zhuang-Yao medicinal ointment is mainly composed of the following ingredients: Astragalus membranaceus 30g, Poria cocos 15g, Cimicifuga foetida 10g, Achyranthes bidentata 10g, processed Ephedra sinica 10g, processed Aconitum carmichaelii 10g, Asarum heterotropoides 6g, processed Glycyrrhiza uralensis 6g, Smilax china 30g, Ephedra sinica 10g, Sinomenium acutum 10g, Tripterygium wilfordii 6g, and Gynostemma pentaphyllum 15g.

[0045] The preparation method of the above-mentioned Zhuang-Yao medicinal ointment includes the following steps:

[0046] (1) Processing of medicinal materials: Tripterygium wilfordii is processed by steaming with alcohol to reduce toxicity. After slicing and crushing, it is used to obtain medicinal powder A for later use. Prepared Aconitum carmichaelii needs to be soaked in water for 1.5 hours for later use. Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum are soaked in water for 1.5 hours for later use.

[0047] (2) Drug extraction: Take prepared Aconitum carmichaelii and Asarum heterotropoides, add 12 times the amount of distilled water, bring to a boil over high heat, then simmer over low heat for 2 hours until the liquid no longer has a numbing sensation on the tongue. Filter to obtain filtrate I, and retain dregs I. Mix dregs I with soaked Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum, add 10 times the amount of distilled water, soak for 1.5 hours, bring to a boil over high heat, then simmer over low heat for 1.5 hours, filter to obtain filtrate II, and retain dregs II. Add 6 times the amount of distilled water to dregs II, simmer for 1 hour, filter to obtain filtrate III. Combine filtrates I, II, and III, let stand for 30 hours, take the supernatant, and concentrate under reduced pressure at 90℃ to an extract with a relative density of 1.25 to obtain a mixed extract.

[0048] (3) Preparation of ointment: Take the mixed extract, add the powder A, and stir until uniform to obtain the primary ointment; add the matrix at a ratio of primary ointment: matrix = 2:1, stirring while adding until a fine and particle-free Zhuang-Yao ointment is formed; wherein, while adding and stirring, the temperature is controlled at 50℃ to avoid high temperature from damaging the components. The matrix is ​​a mixture of petrolatum, lanolin, and glycerin, with petrolatum: lanolin: glycerin = 5:3:2;

[0049] This invention also provides an umbilical patch, which is formed by placing a medicated paste in the center of a special dressing pad; each patch has an area of ​​4cm × 4cm and a weight of approximately 4g. If not used immediately, it can be sterilized and then sealed.

[0050] Example 3

[0051] A Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals, wherein, by weight, the Zhuang-Yao medicinal ointment is mainly composed of the following ingredients: Astragalus membranaceus 35g, Poria cocos 18g, Cimicifuga foetida 12g, Achyranthes bidentata 12g, processed Ephedra sinica 12g, processed Aconitum carmichaelii 12g, Asarum heterotropoides 8g, processed Glycyrrhiza uralensis 8g, Smilax china 35g, Smilax china 12g, Sinomenium acutum 12g, Tripterygium wilfordii 8g, and Gynostemma pentaphyllum 18g.

[0052] The preparation method of the above-mentioned Zhuang-Yao medicinal ointment includes the following steps:

[0053] (1) Processing of medicinal materials: Tripterygium wilfordii is processed by steaming with alcohol to reduce toxicity. After slicing and crushing, it is used to obtain medicinal powder A for later use. Prepared Aconitum carmichaelii needs to be soaked in water for 1.5 hours for later use. Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum are soaked in water for 1.5 hours for later use.

[0054] (2) Drug extraction: Take prepared Aconitum carmichaelii and Asarum heterotropoides, add 10 times the amount of distilled water, bring to a boil over high heat, then simmer over low heat for 1.5 hours until the liquid no longer has a numbing sensation on the tongue. Filter to obtain filtrate I, and retain dregs I. Mix dregs I with soaked Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum, add 10 times the amount of distilled water, soak for 1 hour, bring to a boil over high heat, then simmer over low heat for 1.5 hours, filter to obtain filtrate II, and retain dregs II. Add 6 times the amount of distilled water to dregs II, simmer for 1 hour, filter to obtain filtrate III. Combine filtrates I, II, and III, let stand for 24 hours, take the supernatant, and concentrate under reduced pressure at 85℃ to an extract with a relative density of 1.25 to obtain a mixed extract.

[0055] (3) Preparation of ointment: Take the mixed extract, add the powder A, and stir until uniform to obtain the primary ointment; add the matrix at a ratio of primary ointment: matrix = 2:1, stirring while adding until a fine and particle-free Zhuangyao ointment is formed; wherein, while adding and stirring, the temperature is controlled at 40℃ to avoid high temperature from damaging the components. The matrix is ​​a mixture of petrolatum, lanolin and glycerin, with petrolatum: lanolin: glycerin = 5:3:2;

[0056] This invention also provides an umbilical patch, which is formed by placing a medicated paste in the center of a special dressing pad; each patch has an area of ​​5cm × 5cm and a weight of approximately 3g. If not used immediately, it can be sterilized and then sealed.

[0057] In this invention, Example 4 is also disclosed. Example 4 differs from Example 2 in that the weight parts of the raw materials are different. Example 4 discloses a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals. The Zhuang-Yao medicinal ointment is mainly composed of the following raw materials by weight: Astragalus membranaceus 28g, Poria cocos 15g, Cimicifuga foetida 9g, Achyranthes bidentata 9g, Ephedra sinica (processed) 9g, Aconitum carmichaelii (processed) 9g, Asarum heterotropoides 5g, Glycyrrhiza uralensis (processed) 5g, Moghania tetrandra 28g, Rhizoma Smilacis Glabrae 9g, Stellaria media 9g, Tripterygium wilfordii 5g, and Gynostemma pentaphyllum 14g.

[0058] In this invention, Example 5 is also disclosed. Example 5 differs from Example 2 in that the weight parts of the raw materials are different. Example 5 discloses a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals. The Zhuang-Yao medicinal ointment is mainly composed of the following raw materials by weight: Astragalus membranaceus 32g, Poria cocos 16g, Cimicifuga foetida 11g, Achyranthes bidentata 11g, Ephedra sinica (processed) 11g, Aconitum carmichaelii (processed) 11g, Asarum heterotropoides 7g, Glycyrrhiza uralensis (processed) 7g, Moghania tetrandra 33g, Rhizoma Spatholobi 11g, Stellaria media 11g, Tripterygium wilfordii 7g, and Gynostemma pentaphyllum 16g.

[0059] In this invention, Example 6 is also disclosed. Example 6 differs from Example 2 in that the weight parts of the raw materials are different. Example 6 discloses a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals. The Zhuang-Yao medicinal ointment is mainly composed of the following raw materials by weight: Astragalus membranaceus 31g, Poria cocos 16g, Cimicifuga foetida 9g, Achyranthes bidentata 11g, processed Ephedra sinica 11g, processed Aconitum carmichaelii 11g, Asarum heterotropoides 8g, processed Glycyrrhiza uralensis 5g, Smilax china 26g, Tripterygium wilfordii 11g, Sinomenium acutum 11g, Tripterygium wilfordii 5g, and Gynostemma pentaphyllum 15g.

[0060] II. Experimental Procedure

[0061] 1.1 General Information

[0062] One hundred HIV-infected patients with immune disorders who visited the Care Clinic of the Affiliated Ruikang Hospital of Guangxi University of Chinese Medicine from January 2023 to December 2024 were selected. A complete block randomization design was used, and random numbers were generated using SPSS 23.0 to divide them into a treatment group and a control group, with 50 patients in each group. The treatment group consisted of 36 males and 14 females, aged 26–69 years, with a mean age of (47.96±12.79) years. The CD4 level was (374.76±98.01) cells / μl, the CD8 level was (557.5±292.85) cells / μl, and the CD4 / CD8 ratio was (0.77±0.30). The control group consisted of 33 males and 17 females, aged 30–69 years, with a mean age of (49.42±11.50) years. The CD4 level was (357.86±101.92) cells / μl, the CD8 level was (637.86±344.50) cells / μl, and the CD4 / CD8 ratio was (0.72±0.40). There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0063] 1.2 Diagnostic Criteria HIV infection diagnosis is based on the "Diagnostic Criteria for AIDS and HIV Infection" [i]: A diagnosis can be made if one of the following criteria is met: ① Positive HIV antibody screening test and positive HIV supplementary test (positive antibody supplementary test or positive nucleic acid qualitative test or nucleic acid quantification greater than 5000 copies / mL); ② Positive HIV isolation test; ③ Acute HIV infection syndrome or epidemiological history.

[0064] 1.3 Inclusion Criteria

[0065] ① Meets the Western medical diagnostic criteria for HIV infection;

[0066] ②CD4 < 500 cells / mm3;

[0067] ③ Age 18-70 years, gender and course of disease are not limited;

[0068] ④ Obtain informed consent and voluntarily participate in the trial.

[0069] 1.4 Exclusion Criteria

[0070] ①Those who are currently participating in other drug clinical trials or have terminated their trials less than 3 months ago, and those who have received immunomodulatory therapy within 1 month prior to enrollment;

[0071] ②Pregnant or breastfeeding women;

[0072] ③ Patients with severe heart, liver (more than twice the normal value of ALT), or kidney disease (abnormal BUN and CR), tuberculosis, or mental illness;

[0073] ④ Patients with a history of alcoholism (consuming more than 250ml of alcohol per day); patients with intellectual or language impairments who cannot fully understand the test content or cooperate with the test;

[0074] 1.5 Shedding Criteria and Rejection Criteria

[0075] ① Those who fail to comply with the treatment protocol prescribed by this study after being included in the study, such as using drugs unrelated to this study or adjusting treatment methods without authorization;

[0076] ②Those who participated in other clinical research projects during the trial;

[0077] ③Those who do not cooperate with treatment, have poor compliance, or withdraw from the clinical study midway.

[0078] 1.6 Termination Criteria

[0079] ① Patients who experience severe adverse reactions during the trial and are therefore unsuitable to continue treatment;

[0080] ② Patients who experience serious complications or even life-threatening conditions during the trial and require emergency measures.

[0081] 1.7 Sample Size Estimation

[0082] According to the formula: α and β were set to 0.05 and 0.1, respectively. The estimated efficacy rate of Zhuangyao ointment therapy combined with HAART treatment for HIV-infected patients was 70%, and the estimated efficacy rate of HAART treatment alone for HIV-infected patients was 40%. Therefore, π1 = 70% and π2 = 40% were taken. Substituting these values ​​into the formula, N = 94 cases was calculated. Considering a dropout rate of 6%, the sample size was set to a minimum of 100 cases, with 50 cases in each group.

[0083] 1.8 Treatment methods

[0084] Both groups received regular health education (medication adherence education) from medical staff; the content included explanations of HIV / AIDS-related knowledge (the preventability, controllability, and treatability of HIV / AIDS), the latest progress in HIV / AIDS prevention and control, in order to enhance the infected individuals' confidence in overcoming the disease.

[0085] 2.1 Intervention Measures

[0086] 2.1.1 Control Group

[0087] The recommended treatment regimens according to the Chinese Guidelines for the Diagnosis and Treatment of HIV / AIDS (2021 Edition) [ii] (hereinafter referred to as the "Guidelines") include lamivudine (3TC) + tenofovir (TDF) + efavirenz (EFV), 3TC + zidovudine (AZT) + EFV, and 3TC + AZT + nevirapine (NVP). The specific drug usage and dosage should be consistent with the Guidelines. After HAART is initiated, lifelong treatment is required. During the treatment period, attention should be paid to assessing adverse drug reactions, viral resistance, and other conditions.

[0088] 2.1.2 Treatment Group

[0089] (1) Preparation of preparation: The Zhuangyao ointment obtained in Example 2 was used.

[0090] (2) Acupoint preparation:

[0091] Acupoint: Shenque (navel).

[0092] Cleaning: Before applying the patch, clean the navel and surrounding skin with a warm towel or a cotton ball soaked in 75% alcohol, and dry thoroughly. Do not use on broken skin, redness, swelling, or eczema.

[0093] (3) Application procedure:

[0094] To take the medicine: Take about 3-5g of the prepared ointment and place it in the center of the special dressing pad (or medical absorbent cotton / gauze).

[0095] Application: Gently fill the umbilical fossa with the dressing containing the ointment, ensuring full contact between the ointment and the skin. Cover and secure with breathable medical tape (such as hypoallergenic tape), or use a special umbilical patch.

[0096] Sealing: If using adhesive tape for fixation, it can be applied in a crisscross or overlapping manner to prevent the ointment from overflowing or shifting.

[0097] (4) Application time:

[0098] First time: 2-4 hours, observe skin tolerance.

[0099] After tolerance is established: Apply the patch during periods of peak Yang energy, such as Chenshi (7-9 AM), Wushi (11 AM-1 PM), and Youshi (5-7 PM). Each application should last 6-8 hours.

[0100] Frequency: Once a day for the first 3 days, then once every other day thereafter.

[0101] Treatment course: Apply the patches continuously for 3 months.

[0102] Remove and clean:

[0103] Gently peel off the adhesive tape / patch, remove any remaining ointment, and gently wipe the navel and surrounding skin clean of any remaining medication with a warm, damp towel.

[0104] Check the skin for any abnormalities (redness, swelling, blisters, itching, etc.). If there are no abnormalities, apply a small amount of petroleum jelly or a non-irritating moisturizer to protect the skin.

[0105] 2.2 Observation Indicators and Methods

[0106] 2.2.1 Indicator Observation Points

[0107] Follow-up and sampling were conducted before treatment and 3 months after treatment.

[0108] 2.2.2 Observation indicators:

[0109] ① Laboratory indicators: Safety indicators (complete blood count, liver and kidney function tests, blood glucose, blood lipid tests, etc.);

[0110] ② Immunological indicators: CD4, CD8, and CD4 / CD8 were detected using a multifunctional enzyme-linked immunosorbent assay (ELISA) reader and flow cytometer, while Caspase-1, Caspase-3, NLRP3, IP-10, TNF, IL-2, IL-4, IL-6, and IL-10 were detected using ELISA.

[0111] 2.3 Statistical Methods

[0112] SPSS 23.0 statistical software was used for statistical analysis. Quantitative data were expressed as mean ± standard deviation (x ± s), and categorical data were expressed as case (n). For quantitative data conforming to a normal distribution, t-tests were used; for comparisons between groups, independent samples t-tests were used; for comparisons within groups, paired samples t-tests were used. If the data did not conform to a normal distribution, nonparametric rank-sum tests were used; for comparisons between groups, independent samples rank-sum tests were used; for comparisons within groups, paired samples rank-sum tests were used. For categorical data, the χ² test was used. Spearman correlation analysis was used for correlation analysis. P < 0.05 was considered statistically significant.

[0113] 3. Results

[0114] 3.1 There were no statistically significant differences in the general characteristics of the two groups of patients (P>0.05), making them comparable. See Table 1.

[0115] Table 1. Baseline comparison between the two groups of HIV-infected individuals

[0116]

[0117] 3.2 Comparison of CD4, CD8 and CD4 / CD8 ratios before and after treatment in the two groups of patients.

[0118] After 3 months of treatment, CD4 levels in both groups increased significantly, with statistically significant differences (P < 0.05 or P < 0.05); after treatment, the CD4 / CD8 ratio in the treatment group improved more significantly than that in the control group, with statistically significant differences (P < 0.05), as shown in Table 2.

[0119] Table 2 Comparison of CD4, CD8, and CD4 / CD8 levels before and after treatment in the two groups of patients.

[0120]

[0121] Note: Compared with the group before intervention, *P<0.05, **P<0.01; compared with the control group after intervention, △P<0.05. 3.3. Comparison of upstream related inflammatory factors between the two groups after treatment.

[0122] After treatment, the release of Caspase-1 decreased in both groups, and the difference was statistically significant (P < 0.05); the reduction of NLRP3 after treatment was better in the treatment group than in the control group (P < 0.05); see Tables 3 to 5.

[0123] Table 3 Comparison of upstream-related inflammatory factors before and after treatment in the two groups of patients.

[0124]

[0125] Note: Compared with the group before intervention, *P<0.05; compared with the control group after intervention, △P<0.05.

[0126] 3.4. Comparison of downstream related inflammatory factors between the two groups of patients after treatment

[0127] After intervention, the release of IL-2, IL-6, and IL-10 in the treatment group was significantly reduced (P < 0.05); in the control group, the release of IL-2 was significantly reduced after treatment compared to before treatment (P < 0.05). See Table 4.

[0128] Table 4 Comparison of downstream related inflammatory factors before and after treatment in the two groups

[0129]

[0130] Note: *P<0.05 compared with the group before intervention; compared with the control group after intervention.

[0131] Pyroptosis is a programmed cell death mechanism activated by caspase and NLRP3 (NOD-like receptor family protein 3) inflammasomes, including classical and non-classical pathways. NLRP3, as a key inflammasome in pyroptosis, plays an important role in both classical and non-classical pathways, directly or indirectly inducing the release of inflammatory mediators and generating inflammatory responses [iii]. Cell death induced by caspase-1 and caspase-3 are important pathways for CD4 cell deletion during HIV infection. Studies have shown that HIV-infected CD4 cells undergo apoptosis, but the vast majority of uninfected CD4 bypass cells die through the pyroptosis pathway. More than 95% of resting CD4 cells undergo pyroptosis mediated by caspase-1. Therefore, pyroptosis is the main cause of CD4 cell reduction in HIV-infected individuals. The interleukin family of cytokines are produced by lymphocytes, monocytes, or other non-monocytes, playing important regulatory roles in cell-cell interactions, immune regulation, and inflammation. As pro-inflammatory cytokines, IL-2 and IL-6 are crucial substances involved in acute inflammatory responses and the body's immune response, inducing and transmitting these responses during tissue inflammation. Interleukin-4 (IL-4) is a pleiotropic cytokine involved in the immune regulation of B cells, T cells, mast cells, and macrophages. IL-4 also increases the expression of class II MHC molecules and CD23 in B cells to participate in the immune response. Interleukin-10 is a multicellular, multifunctional cytokine that regulates cell growth and differentiation, participates in inflammatory and immune responses, and is a recognized inflammatory and immunosuppressive factor.

[0132] As shown in Table 2, CD4 levels and CD4 / CD8 ratios were significantly increased. The improvement in the treatment group was also greater than that in the control group, and the difference was statistically significant (P<0.05). This indicates that Zhuang-Yao herbal umbilical patch therapy can increase CD4 cells in HIV-infected individuals and improve immune disorders to a certain extent, thus promoting immune reconstitution.

[0133] As shown in Table 3, the release of NLRP3 and Caspase-1 decreased after treatment in the Zhuangyao ointment group. Compared with the control group, this suggests that the Zhuangyao ointment intervention reduced the expression of pyroptosis-related factors Caspase-1 / NLRP3 protein.

[0134] As shown in Table 4, the release of IL-2 and IL-6 was significantly reduced after treatment with Zhuangyao ointment, suggesting that the treatment group reduced the release of pro-inflammatory factors such as IL-2 and IL-6.

[0135] In summary, the present invention focuses on strengthening the body's resistance (tonifying Qi and warming Yang) while also addressing pathogenic factors (eliminating dampness, promoting blood circulation, and detoxifying). Through the combination of principal, assistant, and adjuvant herbs, it targets the core of the immune disorder in HIV-infected individuals—"Qi deficiency and Yang deficiency"—while also clearing pathological products such as dampness, blood stasis, and heat toxins. At the same time, the use of prepared licorice root harmonizes the medicinal properties, embodying the treatment approach of "strengthening the body's resistance and eliminating pathogenic factors, addressing both the root cause and the symptoms," making it suitable for improving the immune disorder state of HIV-infected individuals.

[0136] The foregoing description of specific exemplary embodiments of the invention is for illustrative and explanatory purposes. These descriptions are not intended to limit the invention to the precise forms disclosed, and it will be apparent that many changes and variations can be made in accordance with the foregoing teachings. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application, thereby enabling those skilled in the art to implement and utilize various different exemplary embodiments of the invention, as well as various different choices and variations. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals, characterized in that, The Zhuang-Yao medicinal ointment is mainly composed of the following ingredients: Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Aconitum carmichaelii, Asarum sieboldii, processed Glycyrrhiza uralensis, Smilax china, Smilax glabra, Tripterygium wilfordii, and Gynostemma pentaphyllum.

2. The Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals according to claim 1, characterized in that, The Zhuang-Yao medicinal ointment comprises the following ingredients by weight: Astragalus membranaceus 25-35g, Poria cocos 13-18g, Cimicifuga foetida 8-12g, Achyranthes bidentata 8-12g, processed Ephedra sinica 8-12g, processed Aconitum carmichaelii 8-12g, Asarum heterotropoides 5-8g, processed Glycyrrhiza uralensis 5-8g, Smilax china 25-35g, Ephedra sinica 8-12g, Sinomenium acutum 8-12g, Tripterygium wilfordii 5-8g, and Gynostemma pentaphyllum 13-18g.

3. A Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals according to claim 2, characterized in that, The Zhuang-Yao medicinal ointment comprises the following ingredients by weight: Astragalus membranaceus 30g, Poria cocos 15g, Cimicifuga foetida 10g, Achyranthes bidentata 10g, processed Ephedra sinica 10g, processed Aconitum carmichaelii 10g, Asarum heterotropoides 6g, processed Glycyrrhiza uralensis 6g, Smilax china 30g, Ephedra sinica 10g, Sinomenium acutum 10g, Tripterygium wilfordii 6g, and Gynostemma pentaphyllum 15g.

4. A method for preparing a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals as described in any one of claims 1 to 3, characterized in that, Includes the following steps: (1) Processing of medicinal materials: Tripterygium wilfordii is processed by steaming with alcohol to reduce toxicity. After slicing and crushing, medicinal powder A is prepared for use. Prepared Aconitum carmichaelii needs to be soaked in water for 1 to 1.5 hours before use. Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum are soaked in water for 1 to 1.5 hours before use. (2) Drug extraction: Take prepared Aconitum carmichaelii and Asarum heterotropoides, add 10-12 times the amount of distilled water, bring to a boil over high heat, then simmer over low heat for 1.5-2 hours until the liquid no longer has a numbing sensation on the tongue. Filter to obtain filtrate I, and retain dregs I. Mix dregs I with soaked Astragalus membranaceus, Poria cocos, Cimicifuga foetida, Achyranthes bidentata, processed Ephedra sinica, processed Glycyrrhiza uralensis, Smilax glabra, Smilax china, Sinomenium acutum, and Gynostemma pentaphyllum, add 8-10 times the amount of distilled water, soak for 1-1.5 hours, bring to a boil over high heat, then simmer over low heat for 1-1.5 hours, filter to obtain filtrate II, and retain dregs II. Add 6 times the amount of distilled water to dregs II, simmer for 1-1.5 hours, filter to obtain filtrate III. Combine filtrates I, II, and III, let stand for 24-30 hours, take the supernatant, and concentrate under reduced pressure at 80-90℃ to an extract with a relative density of 1.20-1.25 to obtain a mixed extract. (3) Preparation of ointment: Take the mixed extract, add the medicinal powder A, and stir until uniform to obtain the primary ointment; add the matrix at a ratio of primary ointment: matrix = 2:1, stirring while adding, until a fine and particle-free Zhuang-Yao ointment is formed.

5. The method for preparing a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals according to claim 4, characterized in that, Each plaster has an area of ​​3cm×3cm to 5cm×5cm, a thickness of 0.2 to 0.3cm, and a weight of approximately 1.5 to 1.6g per plaster.

6. The method for preparing a Zhuang-Yao medicinal ointment for improving immune disorders in HIV-infected individuals according to claim 4, characterized in that, The matrix is ​​a mixture of petrolatum, lanolin, and glycerin.

7. An umbilical patch, characterized in that, The umbilical patch is prepared using a Zhuang-Yao medicinal ointment as described in any one of claims 1-3 for improving immune disorders in HIV-infected individuals.

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