Acupoint application traditional Chinese medicine composition for treating AIDS (acquired immune deficiency syndrome) combined insomnia, acupoint patch and preparation method of acupoint patch

Abstract

The invention is applicable to the technical field of traditional Chinese medicines, and provides an acupoint application traditional Chinese medicine composition for treating AIDS (acquired immune deficiency syndrome) combined insomnia, an acupoint patch and a preparation method of the acupoint patch. The traditional Chinese medicine composition for acupoint application is prepared from the following raw material medicines in parts by weight: 10-30 parts of angelica sinensis, 10-30 parts of astragalus membranaceus, 20-50 parts of vine of multiflower knotweed, 10-30 parts of cortex albiziae, 5-15 parts of cinnamon, 10-30 parts of rhizoma acori graminei, 5-15 parts of fructus evodiae, 10-30 parts of radix paeoniae alba, 5-15 parts of mint and 10-30 parts of semen boitae. The application strictly follows the traditional Chinese medicine theory formula, the medicinal materials cooperate with the channel tropism characteristic by virtue of unique effects, the traditional Chinese medicine meridians and collaterals, the traditional Chinese medicine theory and the modern pharmacology are combined, acupuncture points are screened by virtue of multiple acupuncture point selection methods, one acupuncture point has one medicine, and the AIDS combined insomnia is treated by inducing resuscitation in the daytime and soothing the nerves at night, and the acupuncture point application is simple and convenient to operate and low in cost.

Description

Technical Field

[0001] This application belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition for treating AIDS complicated with insomnia, the acupoint patch, and the preparation method thereof. Background Technology

[0002] Insomnia, a common type of sleep disorder in clinical practice, is mainly characterized by difficulty falling asleep, frequent awakenings during the night, difficulty falling back asleep after waking, and poor sleep quality. Its incidence rate is increasing year by year with the accelerating pace of modern life. According to the World Health Organization, approximately 27% of the global population suffers from sleep disorders, and the incidence rate in my country is as high as 30%. Long-term insomnia not only severely reduces quality of life but also leads to a decline in the body's immunity, induces emotional and cognitive disorders, memory loss, anxiety, and depression, affecting work efficiency and mental health. In severe cases, it can even cause hypertension, coronary heart disease, and even sudden death, posing a significant threat to human health. Currently, Western medicine primarily treats insomnia with medications, including benzodiazepines, non-benzodiazepines, and diorhinone antagonists. While these treatments are effective for acute insomnia, their efficacy for chronic insomnia is limited, and long-term use can lead to adverse reactions such as drug dependence, addiction, and withdrawal syndrome. Non-pharmacological therapies, such as cognitive behavioral therapy and repetitive transcranial magnetic stimulation (rTMS), can avoid drug dependence, but they are limited by their complexity, high cost, and difficulty in implementation, hindering their widespread application.

[0003] Against this backdrop, traditional Chinese medicine acupoint application, as a non-invasive external treatment method guided by traditional Chinese medicine theory and integrated with modern medical technology, has opened up new avenues for insomnia treatment due to its advantages such as ease of operation, low cost, and sustained effects. Its mechanism of action encompasses multi-level synergistic effects, including local penetration of drug components to exert their efficacy, physiological regulatory effects from acupoint stimulation, harmonization of Qi and blood through the meridian system, and overall regulation through synergy between the drug and acupoints. Furthermore, its positive efficacy in improving insomnia symptoms has been confirmed by numerous studies. However, it is worth noting that the HIV / AIDS patient group with insomnia has unique characteristics. They not only suffer from insomnia but also experience complex conditions such as compromised immune systems and significant psychological stress due to HIV / AIDS. Existing traditional Chinese medicine acupoint application programs often do not fully consider these special factors, making it difficult to accurately and effectively address the problem of HIV / AIDS combined with insomnia. There is an urgent need to develop more targeted treatment plans. Summary of the Invention

[0004] The purpose of this application is to provide a traditional Chinese medicine composition for acupoint application in treating AIDS complicated with insomnia, aiming to solve the problem that existing traditional Chinese medicine acupoint application methods are difficult to accurately and effectively solve the problem of AIDS complicated with insomnia.

[0005] This application embodiment is implemented as follows: a traditional Chinese medicine composition for treating AIDS complicated with insomnia, wherein the acupoint patch traditional Chinese medicine composition is made from the following raw materials in parts by weight: Angelica sinensis 10-30 parts, Astragalus membranaceus 10-30 parts, Polygonum multiflorum vine 20-50 parts, Albizia julibrissin bark 10-30 parts, Cinnamomum cassia 5-15 parts, Acorus tatarinowii 10-30 parts, Evodia rutaecarpa 5-15 parts, Paeonia lactiflora 10-30 parts, Mentha haplocalyx 5-15 parts, and Platycladus orientalis seed 10-30 parts.

[0006] Another objective of this application is to provide an acupoint patch for treating AIDS complicated with insomnia, the acupoint patch being prepared from the aforementioned traditional Chinese medicine composition for treating AIDS complicated with insomnia.

[0007] Another objective of this application is a method for preparing the above-mentioned acupoint patch for treating AIDS complicated with insomnia, comprising: According to the above formula of the acupoint patch traditional Chinese medicine composition for treating AIDS complicated with insomnia, weigh out each raw material, remove impurities, wash, dry and then pulverize them separately to obtain fine powder of each medicinal material; The fine powders of Angelica sinensis and Astragalus membranaceus, Polygonum multiflorum vine and Albizia julibrissin bark, Cinnamomum cassia and Acorus tatarinowii, and Paeonia lactiflora and Mentha haplocalyx are mixed separately. The fine powders of Evodia rutaecarpa and Platycladus orientalis seeds are used separately. Each is mixed with honey to make medicinal beads, which are then placed in the center of the patch to make acupoint patches corresponding to Shenque, Neiguan, Dazhui, Sanyinjiao, Yongquan, and Shenmen acupoints.

[0008] The acupoint patch traditional Chinese medicine composition for treating AIDS complicated with insomnia provided in this application embodiment strictly follows traditional Chinese medicine theory, and is formulated with carefully selected medicinal materials including Angelica sinensis, Astragalus membranaceus, Polygonum multiflorum vine, Albizia julibrissin bark, Cinnamomum cassia, Acorus tatarinowii, Evodia rutaecarpa, Paeonia lactiflora, Mentha haplocalyx, and Platycladus orientalis seed. These medicinal materials each have unique efficacy and meridian tropism characteristics, and work synergistically to accurately treat different acupoints.

[0009] The acupoint patch for treating AIDS complicated with insomnia provided in this application embodiment selects acupoints based on meridian theory, disease differentiation, and syndrome differentiation, employing an innovative "one acupoint, one medicine" approach. During the day, the patch is applied to Shenque (CV8), Neiguan (PC6), and Dazhui (GV14) acupoints to improve the patient's daytime alertness; at night, it is applied to Yongquan (KI1), Sanyinjiao (SP6), and Shenmen (HT7) acupoints to promote restful sleep, thus comprehensively improving sleep quality. Based on traditional Chinese medicine meridian theory, this patch utilizes the principle of "awakening the mind during the day and calming the mind at night," providing a safe, effective, and economical treatment option for AIDS patients with insomnia through simple and inexpensive acupoint application. Detailed Implementation

[0010] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0011] Traditional Chinese medicine acupoint application, a non-invasive external treatment method guided by traditional Chinese medicine theory and integrated with modern medical technology, has opened up new avenues for the treatment of insomnia due to its advantages such as ease of operation, low cost, and sustained effects. It achieves overall regulation through local drug penetration, physiological regulation via acupoint stimulation, harmonization of meridian qi and blood, and synergistic effects of drugs and acupoints, showing significant efficacy in improving insomnia. However, existing treatments are insufficient to precisely address the special circumstances of HIV-positive patients with insomnia due to their impaired immune system and high psychological stress, necessitating targeted treatment plans. The research idea of ​​the acupoint patch (Riyue Anmian Patch) for treating HIV-positive insomnia provided in this application originates from traditional Chinese medicine theory: acupoints are the convergence points of meridian qi and blood and the channels of qi movement; stimulation can adjust yin and yang, dredge meridians, and harmonize qi and blood; traditional Chinese medicine acupoint application works by combining drugs with acupoints to stimulate the flow of qi and blood in the meridians. Based on the principle in *Li Yue Pian Wen Lue Yan* that "only those with strong flavors and aromas can be effective," this application selects drugs that penetrate the skin quickly. Since the lungs govern the skin and hair, and pungent flavors are associated with the lungs, pungent herbs are added to act on the skin and muscles. Through the properties and flavors of the herbs, the defensive qi is stimulated, circulation is regulated, and yin and yang are adjusted to improve sleep. Therefore, this application combines traditional Chinese medicine meridian theory, Chinese herbal medicine theory, and modern pharmacology. Acupoints are selected based on meridian pathways, disease differentiation, and syndrome differentiation. Different acupoints are matched with herbs that have corresponding effects and meridian tropism, employing a "one acupoint, one herb" combination. The treatment principle is "awakening the mind during the day and calming the mind at night," using acupoint application to treat insomnia associated with AIDS. The principles of treatment and medication are also based on this: During the day, select Shenque (CV8), Neiguan (PC6), and Dazhui (GV14) acupoints to awaken the mind. Shenque belongs to the Ren meridian; applying Angelica sinensis (to nourish and invigorate blood) and Astragalus membranaceus (to tonify Qi and assist Yang) can warm and tonify Yang, and regulate both Qi and blood. Neiguan belongs to the Pericardium meridian and connects to the Yin Wei meridian; combining Polygonum multiflorum (to nourish blood and calm the mind) and Albizia julibrissin (to relieve depression and calm the mind) can alleviate daytime restlessness. Dazhui is where the Yang Qi of the Du meridian converges; using Cinnamomum cassia (to warm Yang and unblock the meridians) and Acorus tatarinowii (to open the orifices and awaken the mind) can raise Yang, clear the brain, and calm the mind. At night, select Yongquan (KI1), Sanyinjiao (SP6), and Shenmen (HT7) acupoints to calm the mind. Yongquan (KI 1) is the Jing-Well point of the Kidney Meridian of Foot-Shaoyin. When combined with Evodia rutaecarpa (to warm the kidneys and dispel cold), it treats insomnia caused by "upward disturbance of deficient yang" and "disharmony between the heart and kidneys". Sanyinjiao (SP 6) is the meeting point of three meridians. Applying peony root (to nourish blood and soften the liver) and mint (to cool) nourishes yin, reduces fire, and helps with sleep. Shenmen (HT 7) is the Yuan-Source point of the Heart Meridian of Hand-Shaoyin. Applying cypress seed (to moisten the heart, nourish blood, calm the mind, and improve intelligence) benefits the heart and calms the mind.

[0012] Specifically, the acupoint patch traditional Chinese medicine composition for treating AIDS complicated with insomnia provided in this application embodiment is made from the following raw materials in parts by weight: Angelica sinensis 10-30 parts, Astragalus membranaceus 10-30 parts, Polygonum multiflorum vine 20-50 parts, Albizia julibrissin bark 10-30 parts, Cinnamomum cassia 5-15 parts, Acorus tatarinowii 10-30 parts, Evodia rutaecarpa 5-15 parts, Paeonia lactiflora 10-30 parts, Mentha haplocalyx 5-15 parts, and Platycladus orientalis seed 10-30 parts.

[0013] Preferably, the acupoint patch herbal composition is made from the following raw materials in parts by weight: Angelica sinensis 20 parts, Astragalus membranaceus 20 parts, Polygonum multiflorum vine 35 parts, Albizia julibrissin bark 15 parts, Cinnamomum cassia 10 parts, Acorus tatarinowii 20 parts, Evodia rutaecarpa 10 parts, Paeonia lactiflora 20 parts, Mentha haplocalyx 10 parts, and Platycladus orientalis seed 20 parts.

[0014] This application also provides an acupoint patch for treating AIDS complicated with insomnia, the acupoint patch being prepared from the above-mentioned acupoint patch traditional Chinese medicine composition for treating AIDS complicated with insomnia.

[0015] Meanwhile, this application also provides a method for preparing the above-mentioned acupoint patch for treating AIDS complicated with insomnia, including: According to the above formula of the acupoint patch traditional Chinese medicine composition for treating AIDS complicated with insomnia, weigh out each raw material, remove impurities, wash, dry and then pulverize them separately to obtain fine powder of each medicinal material. The fine powders of Angelica sinensis and Astragalus membranaceus, Polygonum multiflorum vine and Albizia julibrissin bark, Cinnamomum cassia and Acorus tatarinowii, and Paeonia lactiflora and Mentha haplocalyx are mixed separately. The fine powders of Evodia rutaecarpa and Platycladus orientalis seeds are used separately. Each is mixed with honey to make medicinal beads, which are then placed in the center of the patch to make acupoint patches corresponding to Shenque, Neiguan, Dazhui, Sanyinjiao, Yongquan, and Shenmen acupoints.

[0016] Specifically, the steps of separately mixing the fine powders of Angelica sinensis and Astragalus membranaceus, Polygonum multiflorum vine and Albizia julibrissin bark, Cinnamomum cassia and Acorus tatarinowii, and Paeonia lactiflora and Mentha haplocalyx, and separately using the fine powders of Evodia rutaecarpa and Platycladus orientalis seeds, adding honey to each to form medicinal beads, and placing them in the center of the patch to make acupoint patches corresponding to Shenque (CV8), Neiguan (PC6), Dazhui (GV14), Sanyinjiao (SP6), Yongquan (KI1), and Shenmen (HT7) acupoints, include: Mix fine powders of Angelica sinensis and Astragalus membranaceus evenly, add honey to make medicinal beads, and place them in the center of the patch at the Shenque acupoint for daytime application. Mix fine powders of Polygonum multiflorum vine and Albizia julibrissin bark, add honey to make medicinal beads, and place them in the center of the patch at the Neiguan acupoint for daytime application. Mix fine powders of cinnamon and calamus, add honey to make medicinal beads, and place them in the center of the patch at the Dazhui acupoint for daytime application. Mix fine powders of white peony root and peppermint, add honey to make medicinal beads, and place them in the center of the patch to apply to the Sanyinjiao acupoint at night. Mix fine powdered Evodia rutaecarpa with honey to make medicinal beads, place them in the center of the patch, and apply to the Yongquan acupoint at night. Mix finely powdered cypress seeds with honey to make medicinal beads, place them in the center of the patch, and apply to the Shenmen acupoint at night.

[0017] Preferably, the drying process controls the moisture content of the medicinal materials to below 5%. Preferably, the fine powder of the medicinal material after pulverization is passed through a 100-mesh sieve. Preferably, the weight ratio of honey to the corresponding medicinal powder is 3:4. That is, the weight ratio of the total fine powder of Angelica sinensis and Astragalus membranaceus, the total fine powder of Polygonum multiflorum vine and Albizia julibrissin bark, the total fine powder of Cinnamomum cassia and Acorus tatarinowii, the total fine powder of Paeonia lactiflora and Mentha haplocalyx, the fine powder of Evodia rutaecarpa, and the fine powder of Platycladus orientalis seed to honey is 4:3.

[0018] Preferably, the diameter of the medicine bead is 1-2 cm.

[0019] The following are examples of the acupoint patch traditional Chinese medicine composition for treating AIDS complicated with insomnia, the acupoint patch and its preparation method. Unless otherwise specified, the experimental methods used in the following examples are conventional methods; the materials and reagents used are commercially available unless otherwise specified.

[0020] Additionally, it should be noted that the values ​​given in the following embodiments are as accurate as possible. However, those skilled in the art will understand that due to unavoidable measurement errors and experimental issues, each number should be understood as an approximation rather than an absolutely accurate value.

[0021] Example 1 In this embodiment, a traditional Chinese medicine composition for treating AIDS complicated with insomnia is prepared from the following raw materials: 20 parts Angelica sinensis, 20 parts Astragalus membranaceus, 35 parts Polygonum multiflorum, 15 parts Albizia julibrissin, 10 parts Cinnamomum cassia, 20 parts Acorus tatarinowii, 10 parts Evodia rutaecarpa, 20 parts Paeonia lactiflora, 10 parts Mentha haplocalyx, and 20 parts Platycladus orientalis.

[0022] In this embodiment, the preparation method of the acupoint patch for treating AIDS complicated with insomnia is as follows: Daytime application. Take 20 parts Angelica sinensis and 20 parts Astragalus membranaceus in the above proportions, grind and mix them, pass through a 100-mesh sieve, mix the powder with the corresponding proportion of honey, and make into beads with a diameter of 1-2 cm. Place the prepared beads in the center of the patch. In the morning, place the patch on the patient's Shenque acupoint and keep it for 6-8 hours, once a day. Take 35 parts Polygonum multiflorum vine and 15 parts Albizia julibrissin bark in the above proportions, grind and mix them, pass through a 100-mesh sieve, mix the powder with the corresponding proportion of honey, and make into beads with a diameter of 1-2 cm. Take 2cm-sized medicinal beads and place them in the center of the patch. In the morning, place the patch on the patient's Neiguan acupoint and leave it for 6-8 hours, once a day. Take 10 parts of cinnamon and 20 parts of calamus in the above proportion, grind and mix them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to make medicinal beads with a diameter of 1-2cm. Place the prepared medicinal beads in the center of the patch. In the morning, place the patch on the patient's Dazhui acupoint and leave it for 6-8 hours, once a day.

[0023] Nighttime application: Take 10 parts of Evodia rutaecarpa in the above proportions, crush them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to form beads with a diameter of 1-2 cm. Place the prepared beads in the center of the patch. Before going to bed, place the patch on the patient's Yongquan acupoint and leave it for 6-8 hours, once a day. Alternatively, take 20 parts of Paeonia lactiflora and 10 parts of Mentha haplocalyx in the above proportions, crush and mix them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to form beads with a diameter of 1-2 cm. Take 20 parts of the above-mentioned proportion of cypress seed kernels, crush them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to make 1-2 cm diameter beads. Place the prepared beads in the center of the patch and apply it to the patient's Shenmen acupoint before bedtime, keeping it in place for 6-8 hours, once a day.

[0024] The weight ratio of honey to the total weight of the corresponding medicinal powder is 3:4.

[0025] Example 2 In this embodiment, a traditional Chinese medicine composition for treating AIDS complicated with insomnia is prepared from the following raw materials: 30 parts Angelica sinensis, 30 parts Astragalus membranaceus, 50 parts Polygonum multiflorum vine, 20 parts Albizia julibrissin bark, 15 parts Cinnamomum cassia, 30 parts Acorus tatarinowii, 20 parts Evodia rutaecarpa, 30 parts Paeonia lactiflora, 15 parts Mentha haplocalyx, and 30 parts Platycladus orientalis seed.

[0026] The weight ratio of the traditional Chinese medicine composition to honey is 4:3.

[0027] In this embodiment, the preparation method of the acupoint patch for treating AIDS complicated with insomnia is as follows: Daytime application. Take 30 parts Angelica sinensis and 30 parts Astragalus membranaceus in the above proportions, grind and mix them, pass through a 100-mesh sieve, mix the powder with the corresponding proportion of honey, and make into beads with a diameter of 1-2 cm. Place the prepared beads in the center of the patch. In the morning, place the patch on the patient's Shenque acupoint and keep it for 6-8 hours, once a day. Take 50 parts Polygonum multiflorum vine and 20 parts Albizia julibrissin bark in the above proportions, grind and mix them, pass through a 100-mesh sieve, mix the powder with the corresponding proportion of honey, and make into beads with a diameter of 1-2 cm. Take 2cm-sized medicinal beads and place them in the center of the patch. In the morning, place the patch on the patient's Neiguan acupoint and leave it for 6-8 hours, once a day. Take 15 parts of cinnamon and 30 parts of calamus in the above proportion, grind and mix them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to make medicinal beads with a diameter of 1-2cm. Place the prepared medicinal beads in the center of the patch. In the morning, place the patch on the patient's Dazhui acupoint and leave it for 6-8 hours, once a day.

[0028] Nighttime application: Take 20 parts of Evodia rutaecarpa in the above proportion, crush it, and pass it through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to form beads with a diameter of 1-2 cm. Place the prepared beads in the center of the patch. Before going to bed, place the patch on the patient's Yongquan acupoint and leave it for 6-8 hours, once a day. Alternatively, take 30 parts of Paeonia lactiflora and 15 parts of Mentha haplocalyx in the above proportion, crush and mix them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to form beads with a diameter of 1-2 cm. Take 30 parts of the above-mentioned proportion of cypress seed kernels, crush them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to make 1-2 cm diameter beads. Place the prepared beads in the center of the patch and apply it to the patient's Shenmen acupoint before bedtime, keeping it in place for 6-8 hours, once a day.

[0029] The weight ratio of honey to the total weight of the corresponding medicinal powder is 3:4.

[0030] Example 3 In this embodiment, a traditional Chinese medicine composition for treating AIDS complicated with insomnia is prepared from the following raw materials: 10 parts Angelica sinensis, 10 parts Astragalus membranaceus, 20 parts Polygonum multiflorum vine, 9 parts Albizia julibrissin bark, 5 parts Cinnamomum cassia, 10 parts Acorus tatarinowii, 5 parts Evodia rutaecarpa, 10 parts Paeonia lactiflora, 5 parts Mentha haplocalyx, and 10 parts Platycladus orientalis seed.

[0031] In this embodiment, the preparation method of the acupoint patch for treating AIDS complicated with insomnia is as follows: Daytime application. Take 10 parts Angelica sinensis and 10 parts Astragalus membranaceus in the above proportions, grind and mix them, pass through a 100-mesh sieve, mix the powder with the corresponding proportion of honey, and make into beads with a diameter of 1-2 cm. Place the prepared beads in the center of the patch. In the morning, place the patch on the patient's Shenque acupoint and keep it for 6-8 hours, once a day. Take 20 parts Polygonum multiflorum vine and 9 parts Albizia julibrissin bark in the above proportions, grind and mix them, pass through a 100-mesh sieve, mix the powder with the corresponding proportion of honey, and make into beads with a diameter of 1-2 cm. Take 2cm-sized medicinal beads and place them in the center of the patch. In the morning, place the patch on the patient's Neiguan acupoint and leave it for 6-8 hours, once a day. Take 5 parts cinnamon and 10 parts acorus tatarinowii in the above proportion, grind and mix them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to make medicinal beads with a diameter of 1-2cm. Place the prepared medicinal beads in the center of the patch. In the morning, place the patch on the patient's Dazhui acupoint and leave it for 6-8 hours, once a day.

[0032] Nighttime application: Take 5 parts of Evodia rutaecarpa in the above proportions, crush them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to form beads with a diameter of 1-2 cm. Place the prepared beads in the center of the patch. Before going to bed, place the patch on the patient's Yongquan acupoint and leave it for 6-8 hours, once a day. Alternatively, take 10 parts of Paeonia lactiflora and 5 parts of Mentha haplocalyx in the above proportions, crush them, mix them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to form beads with a diameter of 1-2 cm. Prepare medicinal beads of the above-mentioned size and place them in the center of the patch. Before going to sleep, place the patch on the patient's Sanyinjiao acupoint and keep it for 6-8 hours, once a day. Take 10 parts of the above-mentioned proportion of cypress seed kernels, crush them, and pass them through a 100-mesh sieve. Mix the powder with the corresponding proportion of honey to make medicinal beads with a diameter of 1-2cm. Place the prepared medicinal beads in the center of the patch. Before going to sleep, place the patch on the patient's Shenmen acupoint and keep it for 6-8 hours, once a day.

[0033] The weight ratio of honey to the corresponding fine powder of medicinal herbs is 3:4.

[0034] The acupoint patch (Riyue Anmian Patch) prepared above for treating AIDS-related insomnia was subjected to relevant experiments, as detailed below: 1. Objects and Methods 1.1 Research Design Research period: June 2023 to December 2024.

[0035] Study subjects: HIV / AIDS patients with insomnia.

[0036] Research method: randomized controlled trial.

[0037] Seventy-two HIV / AIDS patients with insomnia were included in the study, and they received intervention with Riyue Anmian Patch for 48 weeks. Eight patients dropped out during the treatment period, leaving a final enrollment of 64 participants: 33 in the treatment group and 31 in the control group.

[0038] 1.2 Research Subjects 1.2.1 Diagnostic criteria: The diagnostic criteria for the disease refer to the diagnostic criteria of the "Diagnostic Criteria for AIDS and HIV Infection" (WS293-2008) and the "Guidelines for the Diagnosis and Treatment of AIDS (2011 Edition)".

[0039] According to the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults", the diagnostic criteria are as follows: ① Difficulty falling asleep, easy awakening, or inability to fall back asleep after waking up, and waking up too early in the morning; ② Daytime drowsiness and fatigue; ③ Sleep duration of less than 5 hours for more than 1 month.

[0040] 1.2.2 Inclusion Criteria Meets diagnostic criteria: (1) Age 18-65, gender not limited; (2) Meets both the diagnostic criteria for AIDS and insomnia in both traditional Chinese and Western medicine; (3) Receiving antiviral therapy, and having HIV-RNA <20cp / ml and CD4 >200 cells / mm 3 ; (4) Voluntarily participate in this study and sign the informed consent form.

[0041] 1.2.3 Exclusion Criteria Those who meet the inclusion criteria but fall under one of the following conditions will be excluded: (1) Does not meet the diagnostic criteria for AIDS-related insomnia in both traditional Chinese and Western medicine; (2) Individuals with moderate to severe infections or serious primary diseases of the heart, liver, or kidneys; (3) Those with severe illness or persistent impaired consciousness who are unable to cooperate; (4) Individuals who have become dependent on tranquilizers; (5) Individuals who have been assessed by a specialist and have obvious suicidal tendencies; (6) Those who are alcoholics or misuse drugs; (7) Those who wish to become pregnant or are currently pregnant or breastfeeding; (8) Those whose acupoints are infected locally or whose skin is severely damaged and cannot be located; (9) Individuals who may have poor compliance or a fearful attitude; (10) Those who have participated in other clinical trials and whose participation has affected this study.

[0042] In accordance with the Declaration of Helsinki, all patients signed informed consent forms before entering treatment and fully understood the purpose, procedures, and potential risks and benefits of participating in the study.

[0043] 1.3 Intervention Measures This study was divided into a treatment group and a control group.

[0044] Treatment group: ART + Sun and Moon Sleep Patches.

[0045] Control group: ART.

[0046] Western medicine antiviral treatment: Zidovudine (AZT) + tenofovir (TDF) + lamivudine (3TC) + nevirapine (NVP) or efavirenz (EFV), or TDF + 3TC + lopinavir / ritonavir (Lpv / r), and individualized medication plans are formulated according to the patient's specific situation (such as viral load, immune system status, comorbidity, and tolerance to specific drugs).

[0047] The Riyue Anmian Patch was provided by the China Academy of Chinese Medical Sciences and prepared according to the method in Example 1. One patch is applied to each acupoint once a day.

[0048] 1.4 Statistical Methods This study used R software for statistical analysis. Measurement indicators were expressed as mean and standard deviation. Differences in measurement indicators before and after treatment were calculated. Paired t-tests were used for differences following a normal distribution, while Wilcoxon rank-sum tests were used for differences not following a normal distribution. Hypothesis testing consistently used two-tailed tests. Test statistics and their corresponding p-values ​​are provided, with p < 0.05 considered statistically significant.

[0049] 2. Results Analysis 2.1 General Information Seventy-two subjects were randomly assigned to a treatment group and a control group, with 36 patients in the treatment group and 36 in the placebo group. Eight patients dropped out during the treatment period, leaving 64 patients included in the final analysis: 33 in the treatment group and 31 in the control group. In the treatment group, there were 25 males and 8 females, with a mean age of (55.28±12.29) years; in the control group, there were 21 males and 10 females, with a mean age of (53.23±10.80) years. There were no statistically significant differences in gender, age, or treatment duration between the two groups (P>0.05), indicating good comparability.

[0050] 2.2 Therapeutic Indicators a. Symptom and sign score; b. Pittsburgh Sleep Quality Index; c. Anxiety Self-Rating Scale; d. Quality of life scale.

[0051] 3. Results and Conclusions 3.1 Symptom and Sign Scoring Analysis The results showed that the symptom and sign scores of both groups of patients decreased significantly (P<0.05), and the treatment group showed significantly better improvement than the control group (P<0.05). See Table 1.

[0052] Table 1. Analysis of symptom and sign scores in the two groups of patients. Note: ^: P<0.05 compared with the group before treatment; *: P<0.05 compared with the treatment group after treatment.

[0053] 3.2 Pittsburgh Sleep Quality Index Analysis After treatment, the Pittsburgh Sleep Quality Index scores of both groups showed a significant decrease compared to before treatment (P<0.05), and the decrease in the treatment group was significantly greater than that in the control group (P<0.05). See Table 2.

[0054] Table 2. Analysis of Pittsburgh Sleep Quality Index in the two groups of patients. Note: ^: P<0.05 compared with the group before treatment; *: P<0.05 compared with the treatment group after treatment.

[0055] 3.3 Analysis of the Anxiety Self-Rating Scale After treatment, the anxiety self-rating scores of both groups showed a significant decrease compared to before treatment (P<0.05), and the decrease in the treatment group was significantly greater than that in the control group (P<0.05). See Table 3.

[0056] Table 3 Analysis of the Anxiety Self-Rating Scales in the Two Groups of Patients Note: ^: P<0.05 compared with the group before treatment; *: P<0.05 compared with the treatment group after treatment.

[0057] 3.4 Analysis of Quality of Life Scales After treatment, both groups of patients showed a significant improvement in quality of life scores compared to before treatment (P<0.05), and the scores of the treatment group were significantly higher than those of the control group (P<0.05). See Table 4.

[0058] Note: ^: P<0.05 compared with the group before treatment; *: P<0.05 compared with the treatment group after treatment.

[0059] In summary, the combination of Riyue Anmian Patch and ART can effectively reduce the symptom and sign scores, Pittsburgh Sleep Quality Index, and anxiety self-rating scores of HIV / AIDS patients with insomnia, and can effectively improve the quality of life of patients, with definite curative effect.

[0060] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

[0061] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A traditional Chinese medicine composition for acupoint application in treating AIDS complicated with insomnia, characterized in that, The acupoint patch herbal composition is made from the following raw materials in parts by weight: Angelica sinensis 10-30 parts, Astragalus membranaceus 10-30 parts, Polygonum multiflorum vine 20-50 parts, Albizia julibrissin bark 10-30 parts, Cinnamomum cassia 5-15 parts, Acorus tatarinowii 10-30 parts, Evodia rutaecarpa 5-15 parts, Paeonia lactiflora 10-30 parts, Mentha haplocalyx 5-15 parts, and Platycladus orientalis seed 10-30 parts.

2. The acupoint application traditional Chinese medicine composition for treating AIDS complicated with insomnia according to claim 1, characterized in that, The acupoint patch herbal composition is made from the following raw materials in parts by weight: Angelica sinensis 20 parts, Astragalus membranaceus 20 parts, Polygonum multiflorum vine 35 parts, Albizia julibrissin bark 15 parts, Cinnamomum cassia 10 parts, Acorus tatarinowii 20 parts, Evodia rutaecarpa 10 parts, Paeonia lactiflora 20 parts, Mentha haplocalyx 10 parts, and Platycladus orientalis seed 20 parts.

3. An acupoint patch for treating AIDS complicated with insomnia, characterized in that, The acupoint patch is prepared from the traditional Chinese medicine composition for treating AIDS complicated with insomnia as described in claim 1 or 2.

4. A method for preparing an acupoint patch for treating AIDS complicated with insomnia as described in claim 3, characterized in that, include: According to the formula of the acupoint patch traditional Chinese medicine composition for treating AIDS complicated with insomnia as described in claim 1 or 2, each raw material is weighed, and after removing impurities, washing, drying and pulverizing, each medicinal material is obtained as fine powder. The fine powders of Angelica sinensis and Astragalus membranaceus, Polygonum multiflorum vine and Albizia julibrissin bark, Cinnamomum cassia and Acorus tatarinowii, and Paeonia lactiflora and Mentha haplocalyx are mixed separately. The fine powders of Evodia rutaecarpa and Platycladus orientalis seeds are used separately. Each is mixed with honey to make medicinal beads, which are then placed in the center of the patch to make acupoint patches corresponding to Shenque, Neiguan, Dazhui, Sanyinjiao, Yongquan, and Shenmen acupoints.

5. The method for preparing the acupoint patch for treating AIDS complicated with insomnia according to claim 4, characterized in that, The steps of separately mixing the fine powders of Angelica sinensis and Astragalus membranaceus, Polygonum multiflorum vine and Albizia julibrissin bark, Cinnamomum cassia and Acorus tatarinowii, and Paeonia lactiflora and Mentha haplocalyx, and separately using the fine powders of Evodia rutaecarpa and Platycladus orientalis seeds, and adding honey to each to form medicinal beads, and placing them in the center of the patch to make acupoint patches corresponding to Shenque (CV8), Neiguan (PC6), Dazhui (GV14), Sanyinjiao (SP6), Yongquan (KI1), and Shenmen (HT7) acupoints, include: Mix fine powders of Angelica sinensis and Astragalus membranaceus evenly, add honey to make medicinal beads, and place them in the center of the patch at the Shenque acupoint for daytime application. Mix fine powders of Polygonum multiflorum vine and Albizia julibrissin bark, add honey to make medicinal beads, and place them in the center of the patch at the Neiguan acupoint for daytime application. Mix fine powders of cinnamon and calamus, add honey to make medicinal beads, and place them in the center of the patch at the Dazhui acupoint for daytime application. Mix fine powders of white peony root and peppermint, add honey to make medicinal beads, and place them in the center of the patch to apply to the Sanyinjiao acupoint at night. Mix fine powdered Evodia rutaecarpa with honey to make medicinal beads, place them in the center of the patch, and apply to the Yongquan acupoint at night. Mix finely powdered cypress seeds with honey to make medicinal beads, place them in the center of the patch, and apply to the Shenmen acupoint at night.

6. The method for preparing the acupoint patch for treating AIDS complicated with insomnia according to claim 4, characterized in that, The drying process controls the moisture content of the medicinal materials to below 5%.

7. The method for preparing the acupoint patch for treating AIDS complicated with insomnia according to claim 4, characterized in that, After pulverization, the fine powder of the medicinal material passes through a 100-mesh sieve.

8. The method for preparing the acupoint patch for treating AIDS complicated with insomnia according to claim 4, characterized in that, The weight ratio of the honey to the corresponding medicinal powder is 3:

4.

9. The method for preparing the acupoint patch for treating AIDS complicated with insomnia according to claim 4, characterized in that, The diameter of the medicine bead is 1-2 cm.

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