Traditional Chinese medicine composition for treating gout and hyperuricemia and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating gout and hyperuricemia and a preparation method thereof, and relates to the technical field of traditional Chinese medicine compositions.The key point of the technical scheme is that the traditional Chinese medicine composition comprises 120 g of vinegar myrrh, 120 g of vinegar frankincense, 120 g of garden balsam stem, 120 g of uncaria rhynchophylla, 120 g of caulis spatholobi, 120 g of eclipta, 120 g of herba lycopi, 30 g of ligusticum wallichii, 30 g of radix paeoniae rubra, 50 g of angelica sinensis, 50 g of carthamus tinctorius, 50 g of sappan wood, 50 g of pseudo-ginseng slices, 50 g of centella asiatica, 36 g of ground beeltle and 30 g of pericarpium citri reticulatae. , 80 g of notopterygium root, 80 g of radix angelicae pubescentis and 80 g of radix clematidis. The traditional Chinese medicine composition is used in cooperation with an orally taken western medicine xanthine oxidase inhibitor febuxostat in a foot bath mode, the gout symptom of a patient can be effectively relieved in a traditional Chinese and western medicine combined treatment mode, the blood uric acid level is reduced, and the life quality of the patient is improved.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and more specifically, to a traditional Chinese medicine composition for treating gout and hyperuricemia and its preparation method. Background Technology

[0002] Gout falls under the categories of "Bi syndrome," "Zeifeng," and "Baihu Lijie" in Traditional Chinese Medicine (TCM). In the TCM diagnostic and treatment system, patients are classified into different TCM syndrome types based on their different clinical manifestations: dampness-turbidity retention syndrome, damp-heat-toxin retention syndrome, cold-dampness obstruction syndrome, phlegm-blood stasis obstruction syndrome, and spleen-kidney deficiency syndrome.

[0003] Traditional Chinese medicine (TCM) internal treatment methods vary depending on the specific syndrome. For example, the treatment principle for dampness-turbidity syndrome is to dispel dampness and resolve turbidity, with Pingwei San combined with Wuling San being the preferred approach. The treatment principle for damp-heat-toxin syndrome is to clear heat and detoxify, with Simiao San being the preferred approach. The treatment principle for cold-dampness obstruction syndrome is to warm the meridians and dispel cold, with Guizhi Fuzi Tang being the preferred approach. The treatment principle for phlegm-blood stasis obstruction syndrome is to resolve phlegm and dissipate nodules, with Shuanghe Tang being the preferred approach. The treatment principle for spleen and kidney deficiency syndrome is to strengthen the spleen and benefit the kidneys, with Jisheng Shenqi Wan combined with Shenling Baizhu San being the preferred approach.

[0004] Traditional Chinese medicine external treatments can include topical application of Chinese herbal medicine, acupuncture, bloodletting, fumigation and washing with Chinese herbal medicine, enemas with Chinese herbal medicine, foot baths, transdermal drug delivery, circle therapy, and acupressure with Chinese herbal medicine, among other methods.

[0005] Traditional Chinese medicine (TCM) external application refers to applying processed Chinese medicine to the affected area or acupoints. Through transdermal absorption, the medicine penetrates the skin's epidermis and appendages, enters the systemic circulation, and reaches the target point to exert its therapeutic effect. Clinical studies have shown that external application formulations for treating gout include ointments, powders, tinctures, herbal poultices, herbal hot compresses, and acupoint patches. Ge Ruicai et al. believed that gout is caused by spleen and stomach dysfunction, leading to internal dampness and turbidity, which, over time, transforms into heat, resulting in blood stasis. Based on this, they formulated Linggu Zhitong San (containing Smilax glabra, Pseudobulbus Cremastrae, Polygonum cuspidatum, Achyranthes bidentata, Coix lacryma-jobi, Atractylodes lancea, Sargentodoxa cuneata, Borneol, and Lycopus lucidus) for external application to the gout attack site, showing significant efficacy in relieving acute pain. Du Sishuang observed the clinical effects of acupuncture on patients with acute gout of the damp-heat accumulation type, while the control group received conventional Western medicine. The results showed that the total effective rate of the treatment group was significantly better than that of the control group, with a statistically significant difference (P < 0.05). Du Sishuang also found that acupuncture could effectively improve patients' emotional and mental state, and improve their quality of life. This may be related to the fact that acupuncture can quickly relieve joint pain in patients during the acute phase and improve joint dysfunction. Bloodletting therapy involves puncturing the skin to induce bleeding, thereby expelling pathogenic factors, clearing the meridians, and balancing Yin and Yang. Mo Limin's clinical observation found that patients using bloodletting therapy (Neiting, Taibai, and Ashi points) experienced significantly better immediate pain relief than those treated with Western medicine within 1 hour (P < 0.05). Gout falls under the categories of "Bi syndrome" and "pain syndrome." Its cause is the stagnation of Qi and blood in the joints, which over time transforms into heat. Bloodletting therapy forces bleeding from the affected area, expelling pathogenic factors. Traditional Chinese medicine fumigation is a treatment method that uses herbal decoctions to fumigate and wash the affected area under the guidance of traditional Chinese medicine theory. It has the effects of dispelling wind and dampness, clearing heat and detoxifying, and promoting blood circulation and unblocking the meridians. In a study, Yao Nifang et al. included 40 patients in the acute phase of gout, dividing them into a treatment group and a control group. The control group received celecoxib capsules, while the treatment group received celecoxib capsules plus traditional Chinese medicine fumigation. After 7 days of treatment, the joint pain score in the treatment group was significantly reduced, indicating that traditional Chinese medicine fumigation had a good analgesic effect. Based on the theory that the lungs and large intestine are internally and externally related, and that the lungs govern all the blood vessels, traditional Chinese medicine enema therapy has good effects on diseases of various systems. In a study, Chen Ruilian et al. included 60 patients in the acute phase of gout, dividing them into two groups. The control group (n=30) received conventional Western medicine, while the treatment group (n=30) received conventional Western medicine plus traditional Chinese medicine retention enema (raw rhubarb, Smilax glabra, calcined oyster shell, Serissa japonica, and scorpion). The results showed that the onset time of joint swelling and pain in the treatment group was significantly shortened, and the pain score also decreased from 8.69 to 0.90. Ren Fei et al., through a clinical observation involving 70 patients with gouty nephropathy of the dampness-phlegm stagnation type, found that the combination of Gubenqushihuayu Decoction and traditional Chinese medicine foot bath (containing Clematis chinensis, Gentiana macrophylla, Smilax glabra, and Taraxacum mongolicum) significantly reduced 24-hour urinary protein quantification and BUA, and increased glomerular filtration rate. In addition, transdermal drug delivery, circle therapy, and traditional Chinese medicine acupoint application are also commonly used to treat gout.

[0006] In addition to separate internal or external traditional Chinese medicine (TCM) treatments, the combined internal and external TCM treatment can also be adopted for treating gout. Zeng Fen et al. used Jiawei Simiao Powder for oral administration combined with Jiuwei Shuangbai Ointment for external application to treat patients with gouty arthritis of damp-heat obstruction type. The results showed that compared with single use of colchicine, this therapy could significantly shorten the pain time, reduce the attack frequency, and lower the recurrence rate. Wang Guoshu et al. selected acupoints for acupuncture using Lv's paired acupoint method (Quchi, Weizhong, Hegu, Taichong, Zusanli, Sanyinjiao, and Yinlingquan on the affected side) and combined with oral administration of traditional Chinese medicine for treating patients with gouty arthritis of damp-heat obstruction type. The results showed that the combination of acupuncture and medicine could effectively reduce the serum uric acid level of patients and improve the clinical symptoms. Li Xiujuan et al. applied Lingnan Chen's bloodletting puncture (selecting the collaterals at the local affected joint and the Xi points on both sides of the meridian of the diseased part) combined with oral administration of Ermiao Powder to treat patients with damp-heat accumulation syndrome of gout. The results showed that this method had significant curative effects in relieving pain, improving joint mobility, and reducing the UA level, and was better than the single use of the two therapies. Wang Donglin used Qingre Tongbi Decoction combined with traditional Chinese medicine fumigation (the same as the oral formula) to treat gout patients. The results showed that it could significantly improve knee joint pain, improve knee joint function, and significantly reduce the UA and CRP levels, and the clinical curative effect was better than that of western medicine treatment.

[0007] Thus, it can be seen that the internal and external treatment methods with TCM characteristics are diverse, flexible in use, and have significant curative effects, demonstrating unique advantages in the treatment of this disease. Moreover, the combination of traditional Chinese and western medicine has good synergistic effects, can effectively improve the clinical symptoms of patients, inhibit and reduce the generation of uric acid, promote the excretion of uric acid, relieve the pain of patients, effectively eliminate the inflammation in the body, reduce the acute attack and recurrence rate of gout, and is safe and reliable, worthy of further clinical research and discussion. Therefore, in this application, a traditional Chinese medicine composition for treating gout and hyperuricemia and its preparation method are proposed to be used in combination with western medicine for treating gout and hyperuricemia. Summary of the Invention

[0008] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating gout and hyperuricemia and its preparation method. The traditional Chinese medicine composition is used in the form of foot bath in combination with the western medicine febuxostat, a xanthine oxidase inhibitor for oral administration. In the way of integrated traditional Chinese and western medicine treatment, it can effectively relieve the gout symptoms of patients, reduce the serum uric acid level, and improve the quality of life of patients.

[0009] The above technical purpose of the present invention is achieved through the following technical solutions: A traditional Chinese medicine composition for treating gout and hyperuricemia, the traditional Chinese medicine composition includes 120 g of myrrh processed with vinegar, 120 g of frankincense processed with vinegar, 120 g of speranskia tuberculata, 120 g of uncaria rhynchophylla, 120 g of suberect spatholobus stem, 120 g of eclipta prostrata, 120 g of liriope spicata, 30 g of chuanxiong rhizome, 30 g of red peony root, 50 g of angelica sinensis, 50 g of safflower, 50 g of sappanwood, 50 g of notoginseng tablets, 50 g of centella asiatica, 36 g of ground beetle, 30 g of dried tangerine peel, 80 g of notopterygium root, 80 g of pubescent angelica root, and 80 g of clematis root.

[0010] The present invention is further configured such that the traditional Chinese medicine composition is an external powder.

[0011] The present invention is further configured such that the traditional Chinese medicine composition is most effective when used in combination with oral febuxostat.

[0012] The present invention further provides a method for preparing the above-mentioned traditional Chinese medicine composition for use: take 30g of the traditional Chinese medicine composition, add it to a foot bath basin, steep it with 3000ml of boiling water, and use it when the temperature reaches 37℃.

[0013] The present invention further provides an application method of the above-mentioned traditional Chinese medicine composition: the traditional Chinese medicine composition is used for foot bath.

[0014] The present invention is further configured such that: when the traditional Chinese medicine composition is used for foot bath, both feet are soaked in the liquid until the feet and ankles are submerged, twice a day, 30g of the traditional Chinese medicine composition is used each time, each time for 30 minutes, and the course of treatment is 17-23 days.

[0015] In summary, this invention has the following beneficial effects: The traditional Chinese medicine composition provided by this invention has the effects of dispelling wind and cold, promoting blood circulation and removing blood stasis, and relieving pain. Foot bath therapy, utilizing the warmth of the traditional Chinese medicine and its liquid, delivers drug ions from the liquid to the blood vessels and meridians through the skin and mucous membranes, effectively promoting local and systemic blood circulation, dilating local blood vessels, relieving vascular spasms, promoting blood circulation and unblocking meridians, allowing the patient's overall Qi and blood circulation to flow smoothly, regulating the internal organs and meridians, and improving metabolism. This stimulates the body's own regulatory functions and self-healing potential, fully demonstrating the comprehensive advantages of traditional Chinese medicine in treating gout from multiple targets, multiple links, and multiple pathways. Meanwhile, the Western medicine xanthine oxidase inhibitor febuxostat has a definite effect in lowering uric acid. Therefore, the combination of traditional Chinese and Western medicine can effectively alleviate gout symptoms, lower blood uric acid levels, and improve the patient's quality of life. Detailed Implementation

[0016] The present invention will now be described in further detail.

[0017] Example 1

[0018] A traditional Chinese medicine composition for treating gout and hyperuricemia, wherein the composition is an external powder, specifically comprising 120g of vinegar-processed myrrh, 120g of vinegar-processed frankincense, 120g of Clematis chinensis, 120g of Uncaria rhynchophylla, 120g of Spatholobus suberectus, 120g of Eclipta prostrata, 120g of Lycopus lucidus, 30g of Ligusticum chuanxiong, 30g of Paeonia lactiflora, 50g of Angelica sinensis, 50g of Carthamus tinctorius, 50g of Caesalpinia sappan, 50g of Panax notoginseng slices, 50g of Centella asiatica, 36g of Eupolyphaga sinensis, 30g of Citrus reticulata peel, 80g of Notopterygium incisum, 80g of Angelica pubescens, and 80g of Clematis chinensis.

[0019] In the above-mentioned Chinese herbal medicine composition, vinegar-processed myrrh can disperse blood stasis, reduce swelling and relieve pain; vinegar-processed frankincense can regulate qi and blood circulation, relieve pain and reduce swelling; Impatiens balsamina can dispel wind and dampness and promote joint mobility; Uncaria rhynchophylla can calm wind and relieve pain; Spatholobus suberectus can invigorate blood and replenish blood, invigorate blood circulation and relieve pain, relax muscles and tendons, inhibit uric acid synthesis, reduce uric acid concentration in the blood, relieve gout symptoms, and promote kidney excretion of uric acid; Eclipta prostrata can nourish the liver and kidneys and relieve pain; Lycopus lucidus can promote blood circulation and diuresis, invigorate blood and remove blood stasis; Ligusticum chuanxiong and Paeonia lactiflora can break up blood stasis and unblock meridians, invigorate blood and remove blood stasis, relieve pain and reduce swelling; Angelica sinensis can invigorate qi and raise yang; Carthamus tinctorius and Sappanwood It can promote blood circulation and remove blood stasis; Panax notoginseng tablets can reduce swelling and relieve pain; Centella asiatica can clear damp heat, detoxify and reduce swelling, promote blood circulation and diuresis; Eupolyphaga sinensis can break up blood stasis and remove blood stasis; Citrus reticulata peel can regulate qi and strengthen the spleen, dry dampness and resolve phlegm. Its main active substances, such as naringin and flavonoids, can inhibit the activity of xanthine oxidase in hepatocytes, thereby reducing the amount of uric acid synthesis; Notopterygium incisum and Angelica pubescens can dispel wind and cold, remove dampness and reduce swelling, promote qi and relieve pain; Clematis chinensis can dispel wind, remove dampness, clear heat and reduce swelling, unblock the meridians and relieve pain. Moreover, its animal experiments have shown that the effective components of Clematis chinensis can regulate the levels of tumor necrosis factor-α and interleukin-1 in the synovial fluid of rats with polyarthritis, and exert anti-inflammatory and analgesic effects.

[0020] The dosage of the above-mentioned Chinese herbal composition is 30g. Add it to a foot bath basin and steep it with 3000ml of boiling water. When the temperature reaches 37℃, you can start the foot bath. Soak both feet in the foot bath, ensuring that the liquid covers the ankles. Use 30g of the Chinese herbal composition twice a day for 30 minutes each time. The course of treatment is 17-23 days.

[0021] Foot bath therapy utilizes the warmth of traditional Chinese medicine and its medicinal liquid to deliver medicinal ions to the blood vessels and meridians through the skin and mucous membranes. This effectively promotes local and systemic blood circulation, dilates local blood vessels, relieves vascular spasms, invigorates blood circulation, and clears the meridians, allowing the patient's overall Qi and blood to flow smoothly, regulating the internal organs and meridians, and improving metabolism. This stimulates the body's self-regulating functions and self-healing potential, fully demonstrating the comprehensive advantages of traditional Chinese medicine in treating gout from multiple targets, multiple stages, and multiple pathways. Meanwhile, the efficacy of the Western medicine xanthine oxidase inhibitor febuxostat in lowering uric acid is already well-established with current technology. Therefore, the combination of traditional Chinese and Western medicine can effectively alleviate gout symptoms, lower blood uric acid levels, and improve the patient's quality of life.

[0022] Example 2

[0023] Eighty-five gout patients aged 18-75 years, including 47 males and 38 females, were selected from our hospital. Their symptoms met the diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Gout and Hyperuricemia with Integrated Traditional Chinese and Western Medicine" issued by the Rheumatology Committee of the Chinese Association of Integrative Medicine. Informed consent was obtained from the hospital's ethics committee, and patients were able to take medication as prescribed. Patients with malignant tumors, secondary gout, serious cardiovascular or cerebrovascular diseases, mental illnesses, hematopoietic system diseases, liver or kidney diseases, allergies, poor compliance, pregnancy, lactation, or skin ulceration at the foot bath site were excluded.

[0024] The foot bath was administered by combining oral febuxostat with the traditional Chinese medicine composition described in Example 1, following the method and course of treatment as described in Example 1.

[0025] The efficacy of this treatment method was observed, and the evaluation criteria were based on the TCM syndrome scoring in the "Guidelines for the Diagnosis and Treatment of Gout and Hyperuricemia Using Integrated Traditional Chinese and Western Medicine".

[0026] Clinical cure: Clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥ 95%;

[0027] Significant effect: Clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥ 70%;

[0028] Effective: Clinical symptoms and signs improved, and the syndrome score decreased by ≥ 30%;

[0029] Ineffective: Clinical symptoms and signs show no significant improvement, or even worsen, with a decrease in symptom score of <30%.

[0030] The calculation formula is: [(Pre-treatment score - Post-treatment score) / Pre-treatment score] × 100%;

[0031] Blood biochemical indicators: serum uric acid, serum creatinine, blood urea nitrogen, blood glucose, blood lipids, etc.

[0032] Inflammatory markers: tumor necrosis factor-α, interleukin-1β, C-reactive protein;

[0033] Adverse reactions: such as allergies.

[0034] Of these, 5 patients were judged to be cured, 36 patients showed significant improvement, 38 patients showed improvement, and 6 patients showed no improvement.

[0035] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating gout and hyperuricemia, characterized in that: The herbal composition includes 120g of vinegar-processed myrrh, 120g of vinegar-processed frankincense, 120g of Clematis armandii, 120g of Uncaria rhynchophylla, 120g of Spatholobus suberectus, 120g of Eclipta prostrata, 120g of Lycopus lucidus, 30g of Ligusticum chuanxiong, 30g of Paeonia lactiflora, 50g of Angelica sinensis, 50g of Carthamus tinctorius, 50g of Caesalpinia sappan, 50g of Panax notoginseng slices, 50g of Centella asiatica, 36g of Eupolyphaga sinensis, 30g of Citrus reticulata peel, 80g of Notopterygium incisum, 80g of Angelica pubescens, and 80g of Clematis chinensis.

2. The traditional Chinese medicine composition for treating gout and hyperuricemia according to claim 1, characterized in that: The traditional Chinese medicine composition is a powder for external use.

3. The traditional Chinese medicine composition for treating gout and hyperuricemia according to claim 1, characterized in that: The above-mentioned traditional Chinese medicine composition is most effective when used in combination with oral febuxostat.

4. The method for preparing a traditional Chinese medicine composition for treating gout and hyperuricemia according to claim 1, characterized in that: Take 30g of the herbal composition, add it to a foot bath basin, pour in 3000ml of boiling water, and use it when the temperature reaches 37℃.

5. The application of the traditional Chinese medicine composition for treating gout and hyperuricemia according to claim 1, characterized in that: The traditional Chinese medicine composition is used for foot baths.

6. The application of the traditional Chinese medicine composition for treating gout and hyperuricemia according to claim 5, characterized in that: When the herbal composition is used for foot bath, soak both feet in the liquid until the feet and ankles are submerged. Use 30g of the herbal composition twice a day for 30 minutes each time, for a course of 17-23 days.