Traditional Chinese medicine composition for clearing arthralgia and relieving pain as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for clearing arthralgia and relieving pain and a preparation method and application thereof. The prescription of the traditional Chinese medicine composition is composed of paris polyphylla, ajuga decumbens, cortex phellodendri, polygonum cuspidatum, rheum officinale, radix angelicae, radix paeoniae alba, lumbricus and borneol. The preparation method comprises the following steps: taking medicinal materials; and extracting and preparing. The liniment for clearing arthralgia and relieving pain prepared from the traditional Chinese medicine composition can obviously improve the symptoms such as local arthralgia, scorching heat, redness and swelling, inconvenient movement and the like of arthralgia-damp-heat toxin accumulation arthralgia syndrome, has a remarkable clinical curative effect on damp-heat toxin accumulation arthralgia syndrome, and has great popularization and application values.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a traditional Chinese medicine composition for relieving pain and numbness, its preparation method, and its application. Background Technology

[0002] Gouty arthritis is an inflammatory joint disease caused by the deposition of urate crystals (especially monosodium urate) in joints and other tissues. It is directly related to hyperuricemia resulting from purine metabolism disorders and / or decreased uric acid excretion, and falls under the category of metabolic rheumatic diseases. Typical symptoms of gouty arthritis include acute, severe joint pain, which usually peaks at night or in the early morning, accompanied by redness, swelling, fever, and impaired joint function. In recent years, with the continuous improvement of living standards in my country, the incidence of gouty arthritis has increased significantly and is showing a trend towards affecting younger people, seriously endangering patients' health and greatly reducing their quality of life.

[0003] In Western medicine, commonly used drugs for treating gouty arthritis include probenecid and colchicine. While these drugs can achieve certain clinical efficacy, their significant side effects and high recurrence rate limit their clinical application. Traditional Chinese medicine (TCM), on the other hand, offers unique therapies such as topical herbal remedies and poultices. These methods address gouty arthritis holistically, effectively relieving symptoms and offering advantages such as lower toxicity and side effects.

[0004] Based on the clinical characteristics of gouty arthritis, Traditional Chinese Medicine (TCM) classifies it under the category of "Bi syndrome," believing its basic pathogenesis to be heat toxin, dampness, phlegm stagnation, and kidney deficiency. Overwork, trauma, alcoholism, emotional factors, and yin-yang imbalance can all induce gout, which, along with pathogenic factors such as wind, cold, dampness, and heat, obstructs the meridians, affecting the flow of qi and blood, leading to pain, heaviness, soreness, numbness, or limited joint flexibility, stiffness, swelling, and deformity in the limbs, bones, joints, and muscles. Therefore, treatment should focus on dispelling pathogenic factors and unblocking the meridians, eliminating the excess of pathogenic factors, and employing methods such as dispelling wind, dispersing cold, eliminating dampness, clearing heat, resolving phlegm, and promoting blood circulation, while also addressing the "unblocking of the meridians and relieving Bi syndrome." For those with chronic Bi syndrome and weakened constitution, emphasis should be placed on strengthening the body's resistance, using common methods such as tonifying the liver and kidneys and replenishing qi and blood.

[0005] The Qingbi Zhitong Formula is an experienced prescription used in our hospital for the treatment of gouty arthritis. It was created by Dr. Yang Yanzhi, a chief physician of Traditional Chinese Medicine in the Department of Internal Medicine II, based on the principles of pathogenesis and treatment of gouty arthritis, after years of theoretical research and clinical practice. This formula has achieved excellent results in long-term clinical application and is still in use today. This application aims to combine modern pharmaceutical technology to prepare the above formula into a liniment convenient for clinical application, providing a new drug option with significant efficacy and low side effects for the clinical treatment of gouty arthritis. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition for relieving pain and numbness and its preparation method.

[0007] Another object of the present invention is to provide the application of the above-mentioned traditional Chinese medicine composition in the preparation of a pain-relieving and pain-clearing medicine.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows: The traditional Chinese medicine composition for relieving pain and numbness according to the present invention is composed of the following components in parts by weight: 100-200 parts Paris polyphylla, 100-200 parts Prunella vulgaris, 30-70 parts Phellodendron chinense, 30-70 parts Polygonum cuspidatum, 25-55 parts Rheum palmatum, 30-70 parts Angelica dahurica, 50-100 parts Paeonia lactiflora, 20-40 parts Pheretima aspergillum, and 5-15 parts Borneol.

[0009] Preferably, the traditional Chinese medicine composition for relieving pain and numbness according to the present invention is composed of the following components in parts by weight: 125-175 parts of Paris polyphylla, 125-175 parts of Prunella vulgaris, 40-60 parts of Phellodendron chinense, 40-60 parts of Polygonum cuspidatum, 30-50 parts of Rheum palmatum, 40-60 parts of Angelica dahurica, 60-90 parts of Paeonia lactiflora, 25-35 parts of Pheretima aspergillum, and 8-12 parts of Borneol.

[0010] More preferably, the traditional Chinese medicine composition for relieving pain and numbness according to the present invention is composed of the following components in parts by weight: 150 parts Paris polyphylla, 150 parts Prunella vulgaris, 50 parts Phellodendron chinense, 50 parts Polygonum cuspidatum, 40 parts Rheum palmatum, 50 parts Angelica dahurica, 75 parts Paeonia lactiflora, 30 parts Pheretima aspergillum, and 10 parts Borneol.

[0011] The preparation method of the traditional Chinese medicine composition for relieving pain and relieving numbness according to the present invention is as follows: weigh out 8 medicinal materials according to the prescription, including Paris polyphylla, Prunella vulgaris, Phellodendron chinense, Polygonum cuspidatum, Rheum palmatum, Angelica dahurica, Paeonia lactiflora, and Pheretima aspergillum, pulverize them into coarse powder and set aside; add ethanol solution and soak; filter, add borneol to the filtrate and stir to dissolve; add the above ethanol solution to prepare, and the product is obtained.

[0012] Preferably, the preparation method of the traditional Chinese medicine composition for relieving pain and alleviating numbness according to the present invention specifically includes the following steps: S1. Obtaining medicinal materials: Weigh out the following 8 medicinal materials according to the prescription: Paris polyphylla, Prunella vulgaris, Phellodendron chinense, Polygonum cuspidatum, Rheum palmatum, Angelica dahurica, Paeonia lactiflora, and Pheretima aspergillum. Grind them into coarse powder that passes through a sieve of size 2 to 4 and set aside. S2. Extraction and Preparation: Add 45%~60% ethanol solution, which is 3 times the total mass of the crude powder of medicinal materials obtained in step S1, and soak for 2~7 days; filter, take the filtrate, add borneol according to the prescription amount and stir to dissolve; add the above ethanol solution to prepare, and you will get the product.

[0013] In a further preferred embodiment, in the preparation method of the traditional Chinese medicine composition for relieving pain and numbness according to the present invention, the coarse powder in step S1 is obtained by pulverizing the medicinal materials and passing them through a No. 2-3 sieve.

[0014] In a further preferred embodiment, in the preparation method of the traditional Chinese medicine composition for relieving pain and numbness according to the present invention, the coarse powder in step S1 is obtained by pulverizing the medicinal materials and passing them through a No. 2 sieve.

[0015] In a further preferred embodiment, in the preparation method of the traditional Chinese medicine composition for relieving pain and numbness according to the present invention, step S2 specifically involves: adding a 50% to 60% ethanol solution, which is 3 times the total mass of the crude powder of medicinal materials obtained in step S1, and soaking for 5 to 7 days; filtering, taking the filtrate, adding borneol according to the prescription amount and stirring to dissolve; and adding the above ethanol solution to prepare the final product.

[0016] In a further preferred embodiment, in the preparation method of the traditional Chinese medicine composition for relieving pain and numbness according to the present invention, step S2 specifically involves: adding a 50% ethanol solution equal to 3 times the total mass of the crude powder of medicinal materials obtained in step S1, soaking for 5 days; filtering and taking the filtrate, adding borneol according to the prescription amount and stirring to dissolve; adding the above ethanol solution to prepare the final product.

[0017] The application of the traditional Chinese medicine composition described in this invention in the preparation of pain-relieving and pain-clearing drugs.

[0018] The beneficial effects of this invention are: 1. This invention provides a traditional Chinese medicine composition for relieving pain and numbness, and retrospectively analyzed its therapeutic effect on gouty arthritis. Analysis of TCM efficacy revealed that the overall effective rate of this TCM composition for gouty arthritis was 100%. Analysis of individual TCM symptom scores before and after treatment showed that after treatment with the pain-relieving liniment: 48% of joint pain symptoms disappeared, and 52% of joint pain symptoms were alleviated; 86% of local joint burning and swelling symptoms disappeared, and 14% of local joint burning and swelling symptoms were alleviated; 85% of mobility impairment symptoms disappeared, and 15% of mobility impairment symptoms were alleviated; statistical analysis of adverse reactions showed no significant adverse reactions during the treatment process. These results indicate that the TCM composition of this study can significantly improve symptoms such as local joint pain, burning and swelling, and mobility impairment in rheumatic arthritis (rheumatic fever syndrome), demonstrating significant clinical efficacy and good safety, and possessing great value for widespread application.

[0019] 2. This invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for relieving pain and numbness, and through experiments, the optimal preparation conditions for this traditional Chinese medicine composition were determined to be: using 50% ethanol solution as the extraction solvent; extraction time of 5 days; and solvent dosage of 3 times the total amount of medicinal materials. The preparation method of the traditional Chinese medicine composition of this invention is stable and feasible. Under the optimal process conditions, the yield and quality of the pain-relieving liniment are both high, providing technical support for the large-scale production of the pain-relieving liniment. Attached Figure Description

[0020] Figure 1 The HPLC chromatogram of Paris polyphylla saponin I reference standard; Figure 2 Typical HPLC chromatogram of the test solution (immersion time investigation) - 1; Figure 3 Typical HPLC chromatogram of the test solution (immersion time investigation) - 2; Figure 4 Typical HPLC chromatogram of the test solution (ethanol concentration investigation) - 1; Figure 5 Typical HPLC chromatogram of the test solution (ethanol concentration investigation) - 2; Figure 6 This is a typical HPLC chromatogram of the test solution (laboratory validation). Detailed Implementation

[0021] The technical solution of the present invention will be described in detail below with reference to specific embodiments. These embodiments are for explanation and illustration only and do not constitute a limitation on the technical solution of the present invention.

[0022] Example 1 The traditional Chinese medicine composition used for relieving pain and numbness consists of the following ingredients: 150 g Paris polyphylla, 150 g Prunella vulgaris, 50 g Phellodendron chinense, 50 g Polygonum cuspidatum, 40 g Rheum palmatum, 50 g Angelica dahurica, 75 g Paeonia lactiflora, 30 g Pheretima aspergillum, and 10 g Borneol.

[0023] Example 2 The traditional Chinese medicine composition used for relieving pain and numbness consists of the following ingredients: 100 g Paris polyphylla, 100 g Prunella vulgaris, 33 g Phellodendron chinense, 33 g Polygonum cuspidatum, 27 g Rheum palmatum, 33 g Angelica dahurica, 50 g Paeonia lactiflora, 20 g Pheretima aspergillum, and 7 g Borneol.

[0024] Example 3 The traditional Chinese medicine composition used for relieving pain and numbness consists of the following ingredients: 200 g Paris polyphylla, 200 g Prunella vulgaris, 67 g Phellodendron chinense, 67 g Polygonum cuspidatum, 53 g Rheum palmatum, 67 g Angelica dahurica, 100 g Paeonia lactiflora, 40 g Pheretima aspergillum, and 13 g Borneol.

[0025] Example 4 The traditional Chinese medicine composition used for relieving pain and numbness consists of the following ingredients: 125 g Paris polyphylla, 125 g Prunella vulgaris, 42 g Phellodendron chinense, 42 g Polygonum cuspidatum, 33 g Rheum palmatum, 42 g Angelica dahurica, 63 g Paeonia lactiflora, 25 g Pheretima aspergillum, and 8 g Borneol.

[0026] Example 5 The traditional Chinese medicine composition used for relieving pain and numbness consists of the following ingredients: 175 g Paris polyphylla, 175 g Prunella vulgaris, 58 g Phellodendron chinense, 58 g Polygonum cuspidatum, 47 g Rheum palmatum, 58 g Angelica dahurica, 88 g Paeonia lactiflora, 35 g Pheretima aspergillum, and 12 g Borneol.

[0027] Example 6 The preparation method of the traditional Chinese medicine composition for relieving pain and relieving numbness is as follows: (1) Obtaining medicinal materials: Weigh out 150 g of Paris polyphylla, 150 g of Prunella vulgaris, 50 g of Phellodendron chinense, 50 g of Polygonum cuspidatum, 40 g of Rheum palmatum, 50 g of Angelica dahurica, 75 g of Paeonia lactiflora and 30 g of Pheretima aspergillum according to the prescription. Grind the above 8 medicinal materials into coarse powder that passes through a No. 2 sieve and set aside. (2) Extraction and preparation: Take the crude powder of medicinal material obtained in the above steps, add 1.8 L of 50% ethanol solution, soak for 5 days; filter, take the filtrate, add 10 g of borneol and stir to dissolve; add the above ethanol solution to prepare 1000 mL, and you have the product.

[0028] Example 7 The preparation method of the traditional Chinese medicine composition for relieving pain and relieving numbness is as follows: (1) Obtaining medicinal materials: Weigh out 150 g of Paris polyphylla, 150 g of Prunella vulgaris, 50 g of Phellodendron chinense, 50 g of Polygonum cuspidatum, 40 g of Rheum palmatum, 50 g of Angelica dahurica, 75 g of Paeonia lactiflora and 30 g of Pheretima aspergillum according to the prescription. Grind the above 8 medicinal materials into coarse powder that passes through a No. 3 sieve and set aside. (2) Extraction and preparation: Take the crude powder of medicinal material obtained in the above steps, add 1.8 L of 60% ethanol solution, soak for 2 days; filter, take the filtrate, add 10 g of borneol and stir to dissolve; add the above ethanol solution to prepare 1000 mL, and you have the product.

[0029] Example 8 The preparation method of the traditional Chinese medicine composition for relieving pain and relieving numbness is as follows: (1) Obtaining medicinal materials: Weigh out 150 g of Paris polyphylla, 150 g of Prunella vulgaris, 50 g of Phellodendron chinense, 50 g of Polygonum cuspidatum, 40 g of Rheum palmatum, 50 g of Angelica dahurica, 75 g of Paeonia lactiflora and 30 g of Pheretima aspergillum according to the prescription. Grind the above 8 medicinal materials into coarse powder that passes through a No. 2 sieve and set aside. (2) Extraction and preparation: Take the crude powder of medicinal material obtained in the above steps, add 1.8 L of 50% ethanol solution, soak for 3 days; filter, take the filtrate, add 10 g of borneol and stir to dissolve; add the above ethanol solution to prepare 1000 mL, and you have the product.

[0030] Example 9 The preparation method of the traditional Chinese medicine composition for relieving pain and relieving numbness is as follows: (1) Obtaining medicinal materials: Weigh out 150 g of Paris polyphylla, 150 g of Prunella vulgaris, 50 g of Phellodendron chinense, 50 g of Polygonum cuspidatum, 40 g of Rheum palmatum, 50 g of Angelica dahurica, 75 g of Paeonia lactiflora and 30 g of Pheretima aspergillum according to the prescription. Grind the above 8 medicinal materials into coarse powder that passes through a No. 4 sieve and set aside. (2) Extraction and preparation: Take the crude powder of medicinal material obtained in the above steps, add 1.8 L of 45% ethanol solution, soak for 7 days; filter, take the filtrate, add 10 g of borneol and stir to dissolve; add the above ethanol solution to prepare 1000 mL, and you have the product.

[0031] To further verify the reliability of the present invention and select the optimal solution, the inventors conducted a series of experiments, as follows: 1. Formula Analysis The Qingbi Zhitong formula is an experienced prescription from the Traditional Chinese Medicine specialty ward of the Second Internal Medicine Department of our hospital, and has been used in our hospital for many years. Its clinical prescription is as follows: 30g of Paris polyphylla, 30g of Prunella vulgaris, 10g of Phellodendron chinense, 10g of Polygonum cuspidatum, 8g of Rheum palmatum, 10g of Angelica dahurica, 15g of Paeonia lactiflora, 6g of Pheretima aspergillum, and 2g of Borneol. The clinical usage is as follows: Soak the nine herbs (one dose) in three times their volume of white wine (approximately 40%-50% alcohol) for 5-7 days to obtain about 200 mL of medicinal wine. Apply externally to the affected area 2-3 times daily. Years of clinical practice have confirmed that the above-mentioned Qingbi Zhitong liniment has a good therapeutic effect on gouty arthritis. This study aims to combine modern pharmaceutical technology to prepare this formula into a liniment that is easy to use clinically, providing a new clinical medication option with significant efficacy and low side effects for the treatment of gouty arthritis.

[0032] The Qingbi Zhitong Liniment prescription uses Paris polyphylla and Prunella vulgaris as the main ingredients, possessing the effects of clearing heat and detoxifying, and promoting diuresis and eliminating turbidity. It is mainly used for damp-heat toxicity syndrome. Paris polyphylla is cold in nature and bitter in taste, rich in saponins, and has anti-inflammatory, antibacterial, detoxifying, and immunomodulatory effects. Prunella vulgaris contains flavonoids, terpenes, and other components, which can clear heat and detoxify, reduce swelling and relieve pain, and has a good effect on damp-heat toxicity. Phellodendron bark and Polygonum cuspidatum work together to clear heat and dry dampness. Polygonum cuspidatum contains resveratrol, which has anti-inflammatory, antibacterial, and antioxidant effects, while berberine in Phellodendron bark has effective antibacterial and anti-inflammatory effects. White peony root and Angelica dahurica are used together to dispel wind and relieve pain, and regulate blood. White peony root contains paeoniflorin, which has analgesic, anti-inflammatory, and antispasmodic effects, while Angelica dahurica contains coumarin compounds, which can reduce swelling and relieve pain. Rhubarb is bitter and cold and has a purgative effect, which can clear heat and promote bowel movement. It is rich in anthraquinone components, has significant anti-inflammatory and antibacterial effects, and can also eliminate damp-heat toxicity from the body. Earthworms contain porphyrin, which has anti-inflammatory, anticoagulant, and antispasmodic effects, helping to improve symptoms caused by damp-heat. Borneol is pungent and cool, with the effects of clearing heat and detoxifying, and relieving pain, and is often used for surgical infections. The entire formula is well-matched, and the various herbs work synergistically to fully exert their effects of clearing heat and detoxifying, and eliminating dampness and turbidity, showing significant therapeutic effects on damp-heat toxicity syndrome.

[0033] 2. Formulation process research 2.1 Source of medicinal materials This study used prepared medicinal materials. Among them, borneol was purchased from Guiyang Jirentang Chinese Medicine Slices Factory, and the rest were purchased from Guizhou Daosheng Health Industry Co., Ltd. The source and place of origin of the medicinal materials are shown in Table 1.

[0034] ; 2.2 Extraction Process Research The main chemical components of each ingredient in the Qingbi Zhitong Liniment prescription are shown in Table 2. The original clinical method involved soaking the nine medicinal herbs in baijiu (approximately 40%–50% alcohol) for 5–7 days to produce about 200 mL of medicinal wine. Ethanol of a certain concentration can dissolve certain water-soluble components, such as alkaloids and their salts, glycosides, sugars, and bitter substances; it can also dissolve some components that are soluble in non-polar solvents, such as resins, volatile oils, lactones, and aromatic compounds. A small amount of fat can also be dissolved by ethanol. Furthermore, ethanol is miscible with water in any proportion, and in practical applications, different concentrations of ethanol solutions are often used to selectively extract the effective components of medicinal materials. Generally, when the ethanol content is above 90%, it is suitable for extracting volatile oils, organic acids, resins, chlorophyll, etc.; when the ethanol content is between 50% and 70%, it is suitable for extracting alkaloids, glycosides, etc.; when the ethanol content is below 50%, it is suitable for extracting bitter substances, anthraquinone compounds, etc.; when the ethanol content is about 40%, it can delay the hydrolysis of many drugs such as esters and glycosides, and increase the stability of the preparation; when the ethanol content reaches 20% or more, it has a preservative effect.

[0035] ; Based on the main chemical composition of each medicinal herb in the Qingbi Zhitong Liniment prescription in Table 2, this study intends to use ethanol solutions of different concentrations as extraction solvents for extraction process research. The formulation is designed to be five times the clinical prescription, with a total prescription weight of 605 g, prepared into 1000 mL liniments, with each bottle containing 100 mL. The clinical prescription and formulation composition of Qingbi Zhitong Liniment are shown in Table 3.

[0036] ; 2.2.1 Investigation of Ethanol Addition Amount In this study, five samples were weighed at three times the amount prescribed in the clinical prescription. Except for borneol, all other medicinal materials were pulverized into coarse powder that passed through a No. 2 sieve. The five samples were labeled as 1, 2, 3, 4, and 5, respectively. Five times the amount of 50% ethanol was added to each sample, and they were soaked at room temperature for 8 hours to allow for full absorption of ethanol. After filtration, the weight of the medicinal materials after solvent absorption was measured, and the solvent absorption rate was calculated using the following formula: ; The results of the solvent absorption rate study of prescription medicinal materials are shown in Table 4.

[0037] ; As shown in Table 4, after thorough soaking, the solvent absorption rate of the prescription herbs is approximately 150%, meaning the amount of solvent absorbed after soaking is about 1.5 times the weight of the dry herbs. Based on our hospital's clinical usage, the amount of ethanol solution used is set at 3 times the weight of the herbs, which saves on waste materials while still achieving the desired extraction effect.

[0038] 2.2.2 Investigation of soaking time Four samples were weighed at five times the amount prescribed in the clinical prescription. Except for borneol, all other medicinal materials were pulverized into coarse powder that passed through a No. 2 sieve. The four samples were labeled 1, 2, 3, and 4. Three times the amount of 50% ethanol was added to each sample, and the samples were soaked for the corresponding time according to the experimental settings in Table 5, stirring once daily. The samples were filtered, and borneol was added to the filtrate and stirred until dissolved. A suitable amount of the solution was taken to determine the content of Paris polyphylla saponin I. Another 20 mL of the solution was placed in a constant-weight evaporating dish and evaporated to constant weight to determine the total solids content. The method for determining the content of Paris polyphylla saponin I is as follows: (1) Chromatographic conditions and system suitability test The chromatographic column was a Zafex Superfex JX-C. 18 (250×4.6 mm, 5 μm); acetonitrile-water (45:55) was used as the mobile phase; the mobile phase flow rate was 1.0 mL / min; the detection wavelength was 203 nm; the column temperature was 30℃; the theoretical plate number calculated based on the peak of Paris saponin I should not be less than 4000.

[0039] (2) Preparation of reference solution Take an appropriate amount of Paris saponin I reference standard, accurately weigh it, and add methanol to prepare a reference standard solution containing 0.2 mg per 1 mL.

[0040] (3) Preparation of test solution Accurately measure 5 mL of the drug solution and place it in a 25 mL volumetric flask. Add anhydrous ethanol to the mark, shake well, sonicate for 10 min, cool, filter, and collect the filtrate to obtain the final product.

[0041] (4) Determination method Accurately pipette 10 μL each of the reference solution and the test solution into the liquid chromatograph and determine the result.

[0042] The experimental setup and results for investigating soaking time are shown in Table 5. The HPLC chromatogram of Paris polyphylla saponin I reference standard is shown in Table 5. Figure 1 Typical HPLC chromatograms of the test solution (immersion time investigation) are shown below. Figures 2-3 Table 5 shows that soaking time has little effect on the content of Paris polyphylla saponin I; the total solids content increases with prolonged soaking time; and the total solids content is not significantly different between soaking for 5 days and 7 days. Taking all factors into consideration, a soaking time of 5 days is selected.

[0043] ; 2.2.3 Investigation of Ethanol Concentration Four samples were weighed at five times the amount prescribed in the clinical prescription. Except for borneol, all other medicinal materials were pulverized into coarse powder that passed through a No. 2 sieve. The four samples were labeled as 1, 2, 3, and 4, respectively. Three times the amount of ethanol solution of different concentrations was added to each sample according to the experimental setup in Table 6. The samples were soaked for 5 days, with stirring once a day. After filtration, borneol was added to the filtrate and stirred until dissolved. The content of Paris polyphylla saponin I in each sample was determined (the determination method is the same as in "2.2.2 Investigation of Soaking Time"). In addition, 20 mL of the sample was placed in a constant-weight evaporating dish, evaporated and dried to constant weight, and the total solids content was determined.

[0044] The experimental setup and results for the ethanol concentration investigation are shown in Table 6. Typical HPLC chromatograms of the test solution (ethanol concentration investigation) are shown in [Table 6]. Figures 4-5 Table 6 shows that the content of Paris saponin I was highest when extracted with 50% ethanol solution as the extraction solvent; the total solids content did not differ significantly when using ethanol solutions of different concentrations as extraction solvents. Considering all factors, 50% ethanol solution was chosen as the extraction solvent.

[0045] ; In summary, the optimal extraction process for the Qingbi Zhitong Liniment in this study is as follows: using 50% ethanol solution as the extraction solvent; soaking time of 5 days; and solvent dosage of 3 times the total amount of medicinal materials.

[0046] 2.3 Validation of Extraction Process 2.3.1 Laboratory Validation Three batches of process validation experiments were conducted, as follows: Three samples were weighed at five times the amount prescribed in the clinical prescription and labeled as 1, 2, and 3. The extract was prepared according to the aforementioned optimal extraction process, and the contents of Paris polyphylla saponin I and total solids were determined. The results are shown in Table 7. Typical HPLC chromatograms of the test solution (laboratory validation) are shown below. Figure 6 .

[0047] ; The results show that the detection indicators of Paris polyphylla saponin I and total solids in the three batches of sample solutions were stable. Therefore, the preparation process of Qingbi Zhitong Liniment is determined as follows: Prescription: Paris polyphylla 150 g, Prunella vulgaris 150 g, Phellodendron chinense 50 g, Polygonum cuspidatum 50 g, Rheum palmatum 40 g, Angelica dahurica 50 g, Paeonia lactiflora 75 g, Pheretima aspergillum 30 g, Borneol 10 g.

[0048] Preparation: Except for borneol, the other 8 medicinal materials, including Paris polyphylla, are pulverized into coarse powder that passes through a No. 2 sieve; add 3 times the amount of 50% ethanol solution and soak for 5 days; filter, add borneol to the filtrate and stir to dissolve; add 50% ethanol to 1000mL, mix well, and the product is ready.

[0049] 2.3.2 Pilot-scale process verification The optimal extraction process was validated in three pilot-scale batches, using 20 times the amount of medicinal herbs in the prescription to prepare 20 L of liniment. The main equipment used for the pilot-scale process validation is shown in Table 8, the yield of the Qingbi Zhitong liniment is shown in Table 9, and the test results of the Qingbi Zhitong liniment are shown in Table 10.

[0050] ; ; ; Three batches of pilot-scale testing of Qingbi Zhitong Liniment demonstrated that the production process of this study is scientific, stable, and reliable, and that the product quality meets the requirements.

[0051] 3. Clinical efficacy verification 3.1 Clinical Research 3.1.1 Research Subjects This study used a retrospective approach and collected data from 100 hospitalized cases of gouty arthritis from 2019 to 2024.

[0052] 3.1.2 Inclusion / Exclusion Criteria Inclusion criteria: (1) Meets the diagnostic criteria of traditional Chinese medicine syndromes.

[0053] Exclusion criteria: (1) Those who do not meet the diagnostic criteria for the preclinical and gout stages; (2) Cases that do not fall within the scope of drug action; (3) Those with obvious concurrent symptoms or complications; (4) Women who are breastfeeding, pregnant, or planning to become pregnant; (5) Individuals with allergic constitutions or allergies to multiple medications; (6) Patients with serious primary diseases of the liver, kidneys, hematopoietic system, endocrine system, etc., and patients with mental illness; (7) Those whose condition is critical and who cannot accurately evaluate the effectiveness and safety of the new drug.

[0054] 3.1.3 Treatment plan and combined medications (1) Treatment plan This study selected 100 patients who met the diagnostic criteria as the subjects of observation. All patients were treated with Qingbi Zhitong Liniment during the treatment process. The dosage and administration method were as follows: for external use, 10-15 mL each time, apply to the affected area, 2-3 times a day or as directed by the doctor, for 7-14 days as one course of treatment.

[0055] (2) Combined medication When data was collected for this study, approximately 80% of patients were treated with Western medicines such as lornoxicam injection and magnesium sulfate injection (topical application), combined with topical application of Qingbi Zhitong liniment to enhance anti-inflammatory and analgesic effects, relieve patients' pain symptoms, and shorten the course of the disease.

[0056] 3.1.4 Data Collection This is a retrospective study, collecting, analyzing, and evaluating patients' records during their hospital visits. A case observation form was designed to record detailed clinical data, including patients' general information (age, medical history, diagnosis, etc.), TCM syndromes, treatment duration, and concurrent medications.

[0057] 3.1.5 Efficacy Evaluation Criteria Symptoms are indicated by “-”, “+”, “++”, and “+++” to indicate their severity: “-” indicates that the symptoms have disappeared or are absent; “+” indicates mild pain that does not affect activity; “++” indicates that the pain still exists, is new or recurring, and activity is limited or passive; “+++” indicates severe pain that prevents activity.

[0058] The specific treatment criteria are as follows: Significant effect: Symptoms improve to a milder level, and joint movement is no longer restricted; Effective: Symptoms improved, joint mobility improved; Ineffective: No improvement in symptoms, no change in joint movement.

[0059] 3.1.6 Observation of adverse reactions / events This study meticulously recorded the main symptoms, onset time, end time, duration, and severity of adverse reactions. It analyzed the causes of adverse reactions and their correlation with the study drug, assessed the impact of adverse reactions on the study, and accurately documented the specific measures taken in response to adverse events. The incidence rate of adverse reactions was calculated as follows: Adverse reaction rate = number of adverse reactions / total number of cases × 100%.

[0060] 3.1.7 Statistical Analysis This study uses descriptive statistical analysis, with qualitative indicators described as percentages or proportions, and quantitative indicators described as means, standard deviations, etc.

[0061] 3.1.8 Clinical Research Results 3.1.8.1 Summary of Basic Patient Information This study included 100 cases, of which: 6 were in 2019; 10 in 2020; 15 in 2021; 25 in 2022; 19 in 2023; and 25 in 2024. The distribution of cases is shown in Table 11, the general information of patients is shown in Table 12, and the summary of disease treatment is shown in Table 13.

[0062] ; ; ; 3.1.8.2 Summary of therapeutic effects (1) Analysis of the efficacy of traditional Chinese medicine The results of TCM efficacy are summarized in Table 14. The results show that among the 100 patients enrolled in this study, 46 were clinically cured, 44 showed significant improvement, 10 were effective, and 0 were ineffective, with a total effective rate of 100%.

[0063] ; (2) Analysis of TCM single symptom scores before and after treatment Table 15 shows the changes in symptom scores such as pain, skin temperature and color, and difficulty in movement before and after treatment in the patients enrolled in this study.

[0064] ; As shown in the table above, all patients enrolled in this study experienced varying degrees of pain, burning, redness, swelling, and limited mobility before treatment. After treatment with Qingbi Zhitong Liniment: 48% of patients experienced complete resolution of joint pain symptoms, and 52% experienced a reduction in joint pain symptoms; 86% of patients experienced complete resolution of local joint burning, redness, and swelling symptoms, and 14% experienced a reduction in local joint burning, redness, and swelling symptoms; 85% of patients experienced complete resolution of limited mobility symptoms, and 15% experienced a reduction in limited mobility symptoms. These results indicate that the Qingbi Zhitong Liniment provided in this study can significantly improve symptoms such as pain, burning, redness, swelling, and limited mobility caused by gouty arthritis.

[0065] (3) Adverse reaction statistics The adverse reaction statistics are shown in Table 16. The results show that none of the 100 cases enrolled in this study experienced adverse reactions, indicating that the drug has good safety.

[0066] ; 3.1.8.3 Conclusions and Analysis This retrospective study investigated the therapeutic effect of Qingbi Zhitong Liniment on gouty arthritis. The results showed that Qingbi Zhitong Liniment can significantly improve symptoms such as pain, burning redness and swelling and limited mobility caused by gouty arthritis, and has good safety.

[0067] 3.2 Typical Cases (1) Patient 1: Luo, male, 37 years old.

[0068] Admission Circumstances: The patient was admitted due to "recurrent pain in both knees and right ankle for 3+ months, worsening for 1+ days." Admission Symptoms: Significant pain in both knees and right ankle, more pronounced in the right ankle, presenting as persistent aching and distending pain. Pain was exacerbated by walking, climbing stairs, and squatting, resulting in slight limitation of movement. Slight weakness in both lower limbs was also observed. There was no chills, fever, nausea, vomiting, headache, dizziness, palpitations, or chest tightness during the pain. The patient's mental state, sleep, and appetite were poor, but bowel movements and urination were normal. The tongue was red with a yellow coating, and the pulse was slippery. Physical Examination: No deformities in both lower limbs; local tenderness and slight swelling were observed in both knees and the right ankle, with slightly elevated skin temperature. Patellar tap test, lateral knee compression test, and drawer test were negative bilaterally. The Patrick's test was negative bilaterally. No skin ulceration or bone crepitus was observed. Distal blood supply and sensation were normal, physiological reflexes were present, and no other pathological reflexes were elicited.

[0069] Admission diagnosis: Traditional Chinese medicine diagnosis: Bi syndrome (damp-heat toxin accumulation syndrome); Western medicine diagnosis: gouty arthritis; hyperlipidemia.

[0070] Treatment process: Apply "Qingbi Zhitong Chaji" (a traditional Chinese medicine liniment) to clear heat and detoxify, and promote diuresis and eliminate turbidity. Locations: left knee joint, right knee joint, right ankle joint. Acupressure with a medicated stick was used to unblock meridians. Acupoints selected: bilateral (Xuehai, Liangqiu, Zusanli, Waixiyan), right (Kunlun, Qiuxu). Low-frequency pulsed electrical stimulation was used to improve circulation. Locations: right knee joint, left knee joint. Cupping therapy was used to relax muscles and tendons, promote qi and blood circulation. Acupoints selected: bilateral (Fenglong, Xuehai, Liangqiu, Zusanli, Yanglingquan, Shangjuxu, Xiyangguan, Yinshi). Acupoint application was used to promote qi and blood circulation, remove blood stasis and relieve pain. Acupoints selected: bilateral (Neixiyan, Heding, Yinlingquan), right (Taixi, Shenmai, Zhaohai, Waimaojian). Intravenous infusion of naproxen sodium was administered for pain relief and symptomatic treatment.

[0071] Discharge Status: The patient reported no significant pain in both knees, and the pain in the right ankle had improved compared to before, with occasional swelling and pain. Movement was still possible. There was no significant weakness in both lower limbs. There was no chills, fever, nausea, vomiting, headache, dizziness, palpitations, or chest tightness during pain. The patient's mental state, sleep, and appetite were good, and bowel movements were normal. The tongue was pale red with a thin coating, and the pulse was slippery. Physical Examination: Vital signs were stable; no abnormalities were found in the heart, lungs, or abdomen; no deformities were found in both lower limbs; there was no significant tenderness or swelling in the knees and right ankle; skin temperature was acceptable; bilateral patellar tap test, bilateral lateral knee compression test, and drawer test were all negative; bilateral Patrick's test was negative; no skin ulceration or bone crepitus was observed; distal limb blood supply and sensation were good; physiological reflexes were present; other pathological reflexes were not elicited. The patient's condition had improved compared to before.

[0072] (2) Patient 2: Jiang, male, 75 years old.

[0073] Admission status: The patient was admitted due to "pain and swelling of the right ankle and dorsum of the foot for 2 days". Admission findings: Pain and swelling of the right ankle and dorsum of the foot, presenting as persistent distending pain, which was tolerable. Right ankle movement was limited. Tongue was red with a yellow, greasy coating; pulse was slippery and rapid. Physical examination: Redness and swelling of the right ankle and dorsum of the foot; no skin ulceration or purulent discharge; elevated skin temperature; significant tenderness; pitting edema; blood circulation and sensation were normal; movement was slightly limited.

[0074] Admission diagnosis: Traditional Chinese medicine diagnosis: Bi syndrome (damp-heat toxin accumulation syndrome); Western medicine diagnosis: gouty arthritis.

[0075] Treatment process: ① Sodium chloride injection (0.9%) 250ml intravenous infusion once a day; +8mg intravenous infusion once a day for pain relief; ② Magnesium sulfate external cold and hot compresses to reduce swelling and pain in the right ankle joint and dorsum of the foot; ③ Temporarily apply acupoint plasters to the right (Neiting, Taichong, Taibai, Zhaohai, Shangqiu, Kunlun) and two pairs of Ashi points to relax muscles and tendons and relieve pain, and apply Jinhuang San powder externally; ④ Apply "Qingbi Zhitong Chaji" Chinese medicine to clear heat and detoxify, and promote diuresis and eliminate turbidity, on the right ankle joint and dorsum of the right foot.

[0076] Discharge status: The patient reported significant improvement in pain in the right ankle and dorsum of the foot, with slight limitation in movement of the right ankle. General condition was fair; tongue was pale red with a yellow coating, and pulse was slippery and rapid. PE: Vital signs were stable. There was no obvious redness or swelling in the right ankle and dorsum of the foot, no skin ulceration or purulent discharge, skin temperature was not elevated, mild tenderness was present, there was no significant edema, and blood circulation and sensation were normal. The patient's condition was significantly improved compared to admission.

[0077] (3) Patient 3: Chen, male, 60 years old.

[0078] Admission Circumstances: The patient was admitted due to "recurrent polyarticular pain for 4+ years, with a recent worsening over the past 10 days." Admission symptoms included: redness, swelling, heat, and pain in multiple joints, primarily affecting the left knee and left ankle, with burning pain of varying duration, local swelling, significant tenderness upon palpation, and markedly limited joint movement. The patient also experienced aversion to wind, thirst, and restlessness. There was no fever, chills, chest tightness, shortness of breath, difficulty breathing, or constipation. The patient's mental state, sleep, and appetite were poor, but bowel movements were normal. The tongue was red with a yellow, greasy coating, and the pulse was slippery and rapid. Physical Examination: No spinal deformities were found. Significant local swelling and slightly elevated skin temperature were observed in the left knee and left ankle. Movement in the left knee and left ankle was restricted, and passive movement of these joints caused severe pain. The right knee, right ankle, and both wrists experienced milder pain, with normal local skin temperature and no swelling. No crepitus or bone crepitus was palpable in the limbs. Muscle strength and tone were normal in the remaining limbs. Sensation, blood circulation, and movement in the distal fingers and toes were normal.

[0079] Admission diagnosis: Traditional Chinese medicine diagnosis: Bi syndrome (damp-heat toxin accumulation syndrome); Western medicine diagnosis: gouty arthritis.

[0080] Treatment process: Apply Chinese herbal acupoint patches to relieve pain and promote bowel movement. Acupoints selected: left (Yanglingquan, Weizhong, Yinlingquan, Jiexi, Taichong, Pushen, Dazhong, Zhaohai); apply Chinese herbal ointment with the principle of "clearing heat and detoxifying, promoting diuresis and eliminating turbidity". Application site: right metatarsophalangeal joint. "Qingbi Zhitong Lini" was selected.

[0081] Discharge status: The patient reported no significant redness, swelling, heat, or pain in multiple joints of the limbs; joint movement was not significantly restricted; skin temperature was normal; there was no swelling; walking aggravated the pain; there was no pitting edema in both lower extremities; no fatigue; no fever, chills, chest tightness, shortness of breath, difficulty breathing, or difficulty defecating; mental state, sleep, and appetite were good; bowel movements were normal. The tongue was pale red with a thin coating; the pulse was deep. No adverse reactions such as rashes, itching, or skin ulceration were observed in the local joints. Physical examination: Vital signs were stable; cardiac, pulmonary, and abdominal examinations were the same as before. The patient's condition improved after treatment.

[0082] (4) Patient 4: Peng, male, 70 years old.

[0083] Admission Circumstances: The patient was admitted due to "recurrent pain in multiple joints throughout the body for 9 years, worsening for 5 days." Admission findings: The patient presented with localized swelling and pain in both knees, ankles, and toe joints. Significant redness and swelling were observed in the knee areas, significantly limiting walking due to pain in these areas. The skin temperature in the swollen areas of both knees was elevated. The tongue was red with a yellow, greasy coating, and the pulse was slippery and rapid. Physical Examination: No deformities of the limbs were observed. Varying degrees of swelling were present in both knees, ankles, and toe joints, with no localized ecchymosis or purplish discoloration. Significant localized swelling was observed in both knee areas. Tenderness was present in the medial and lateral regions of the left knee. Both knees showed limited range of motion. The maximum posterior knee flexion angle (angle between the femoral longitudinal axis and the lower leg longitudinal axis) was 60° for the left knee and 40° for the right knee. Extension of both knees was unrestricted. The local skin temperature was slightly elevated. The patient experienced severe pain upon palpation, described as needle-like. Sensation, blood supply, and movement in the distal extremities were normal. Movement in the right lower extremity was limited due to pain in the right first and second metatarsophalangeal joints. Muscle strength and tone in the remaining limbs were normal.

[0084] Admission diagnosis: Traditional Chinese medicine diagnosis: Bi syndrome (damp-heat toxin accumulation syndrome); Western medicine diagnosis: gouty arthritis; rheumatoid arthritis; hypokalemia; sequelae of cerebral infarction.

[0085] Treatment process: ① Apply "Qingbi Zhitong Chaji" (a traditional Chinese medicine liniment) to clear heat and detoxify, and promote diuresis and eliminate turbidity. The affected areas were: both knee joints, both ankle joints, and both toe joints. ② Apply acupoint patch therapy (bilateral points: Xiyangguan, Yinlingquan, Yanglingquan, Xuehai, Futu) to warm the meridians and promote blood circulation. ③ Apply a traditional Chinese medicine sealing pack (6*6cm area around both knee joints) to promote blood circulation and relieve pain. ④ Apply acupoint massage with a medicated stick (bilateral points: Heding, Sanyinjiao, Feiyang, Yangjiao, Fengshi) to promote qi circulation and promote blood circulation. ⑤ Apply medicated cupping (bilateral points: Yinshi, Liangqiu, Dubi, Zusanli, Diji, Shangjuxu, Ququan, Futu) to promote blood circulation and provide other symptomatic treatments.

[0086] Discharge status: The patient reported that the pain and limited range of motion in both knees had improved compared to before, and walking was possible. There was no dizziness or headache. There was no fatigue, night sweats, chest tightness, shortness of breath, difficulty breathing, or constipation. The tongue was pale red with a thin yellow coating, and the pulse was slippery and rapid. Physical examination: Slight swelling was found in the left knee joint. There was no obvious tenderness at the superior border and medial side of the left patella. The skin temperature in the left joint area was normal. The limited range of motion in the left knee had improved. The maximum range of motion of the left knee with posterior knee flexion was approximately 30°. The left patellar tap test was negative. The bilateral knee and hip flexion tests were negative. The bilateral skeletal nerve traction tests and bilateral "4" sign were negative. The patient felt that their condition had improved.

[0087] (5) Patient 5: Long, male, 22 years old.

[0088] Admission Status: Admitted due to "right ankle pain for 3+ days". Admission findings: right ankle pain, characterized by persistent throbbing pain, exacerbated by activity, slight local swelling, significantly limited joint movement, slight general weakness, no chills, fever, nausea, vomiting, headache, dizziness, palpitations, chest tightness, etc.; poor mental state, sleep, and appetite; normal bowel movements; red tongue with a thin yellow coating; slippery pulse. Physical Examination: No spinal deformities; no skin ulcers; significant tenderness and swelling in the right ankle joint with elevated skin temperature; limited right ankle movement due to pain; passive movement of the right ankle elicits severe pain; no skin ulcers or bone crepitus; distal blood supply and sensation are normal. Physiological reflexes are present; no pathological reflexes were elicited.

[0089] Admission diagnosis: Traditional Chinese medicine diagnosis: Bi syndrome (damp-heat toxin accumulation syndrome); Western medicine diagnosis: gouty arthritis; renal insufficiency; nasal turbinate hypertrophy.

[0090] Treatment process: ① Apply "Qingbi Zhitong Chaji" (a traditional Chinese medicine) to clear heat and detoxify, promote diuresis and eliminate turbidity. Location: right ankle joint (area: 1.5%); ② Apply acupoint patch therapy to promote blood circulation, unblock meridians and relieve pain. Acupoints: right side (Dadu, Taibai, Xingjian, Taichong, Gongsun, Taixi, Kunlun, Zhaohai, Shenmai, Fuliu).

[0091] Discharge Status: The patient reported no significant pain or swelling in the right ankle joint, good joint mobility, no general weakness, chills, fever, nausea, vomiting, headache, dizziness, palpitations, or chest tightness. Mental state, sleep, and appetite were good; bowel movements were normal; tongue was pale red with a thin coating; pulse was rapid. Physical Examination: Vital signs were stable; no abnormalities were found in the heart, lungs, or abdomen; no spinal deformities were observed; no skin ulcers were found; right ankle joint pain was present but not tender; no significant swelling was found; skin temperature was normal; movement was normal; no skin ulcers or bone crepitus were observed; distal limb blood supply and sensation were normal. Physiological reflexes were present; no pathological reflexes were elicited. The patient's condition had significantly improved compared to before.

[0092] (6) Patient 6: Wu, male, 58 years old.

[0093] Admission Circumstances: The patient was admitted due to "recurrent bilateral ankle, knee, and elbow pain for over 2 years, with a recurrence for over 1 month." Admission Symptoms: Pain in both ankles, knees, and elbows, characterized by throbbing pain, slightly elevated skin temperature, and increased pain upon activity. There was no ulceration, purulent discharge, chills, convulsions, chest tightness, or shortness of breath. Physical Examination: Redness and swelling at the joints of both ankles, knees, and elbows, elevated skin temperature, and significant tenderness. There was no ulceration, bleeding, or purulent discharge. Left hand amputation was performed.

[0094] Admission diagnosis: Traditional Chinese medicine diagnosis: Bi syndrome (damp-heat toxin accumulation syndrome); Western medicine diagnosis: gouty arthritis.

[0095] Treatment process: ① Apply Chinese herbal acupoint patches to both sides of the patient (Shangqiu, Shenmai, Xiyangguan, Yinlingquan, Quchi) to reduce swelling and relieve pain; ② Apply medicated sticks to acupoints on both sides (Shangqiu, Shenmai, Xiyangguan, Yinlingquan, Quchi) to dispel wind and dampness and relieve pain; ③ Apply "Qingbi Zhitong Chaji" Chinese herbal medicine to clear heat and detoxify, promote diuresis and eliminate turbidity, on both ankle joints, both knee joints, and both elbow joints.

[0096] Discharge status: The patient reported slight pain in both knees during activity, but no pain in the ankles or elbows, no ulceration or purulent discharge, no chills, convulsions, chest tightness, or shortness of breath. The tongue was pale red with a thin yellow coating, and the pulse was slippery and rapid. Physical examination revealed no obvious redness or swelling in the ankles, knees, or elbows; the skin temperature was normal; there was no significant tenderness; and no ulceration, bleeding, or purulent discharge. The left hand was amputated. The patient's condition improved.

[0097] (7) Patient 7: Yang, male, 30 years old.

[0098] Admission status: Admitted due to "right ankle pain for 3+ days". Admission symptoms: right ankle pain, persistent throbbing pain, significantly limited joint movement due to pain, accompanied by local redness and swelling, slight weakness, no palpitations, chest tightness, skin ulceration or effusion, no fever, chills, nausea, vomiting, chest pain, dyspnea, abdominal pain, diarrhea, etc.; poor mental state, sleep, and appetite; normal bowel movements; pale red tongue with a thin yellow coating; slippery and rapid pulse. Physical examination: significant swelling of the right ankle joint and right dorsum of the foot, no skin ulceration or effusion, slightly reddened skin, significantly elevated local skin temperature, significant tenderness, slightly limited right ankle joint movement, muscle strength grade 5 in all four limbs, normal muscle tone, no distal sensory or motor impairment, good peripheral blood supply, physiological reflexes present, no pathological reflexes elicited.

[0099] Admission diagnosis: Traditional Chinese medicine diagnosis: Bi syndrome (damp-heat toxin accumulation syndrome); Western medicine diagnosis: gouty arthritis.

[0100] Treatment process: Acupoint application therapy was used to clear heat and promote blood circulation. Acupoints selected: right (Taichong, Taixi, Chongyang, Zulinqi, Gongsun, Jiexi, Shangqiu, Kunlun, Qiuxu, Xiangu); "Qingbi Zhitong Chaji" Chinese herbal medicine was applied to clear heat, detoxify, and promote diuresis and eliminate turbidity. Location: right ankle joint.

[0101] Discharge Status: The patient reported no significant pain in the right ankle, normal joint movement, no obvious redness or swelling of the local skin, no fatigue, no palpitations, chest tightness, skin ulceration or effusion, no fever, chills, nausea, vomiting, chest pain, dyspnea, abdominal pain, diarrhea, or other discomfort. The patient's mental state, sleep, and appetite were good, and bowel movements were normal. The tongue was pale red with a thin white coating, and the pulse was slippery. Physical Examination: Vital signs were stable. No abnormalities were found in the heart, lungs, or abdomen. There was no significant swelling of the right ankle or dorsum of the right foot, no skin ulceration or effusion, no obvious redness or swelling of the skin, normal local skin temperature, and no local tenderness. Right joint movement was normal. Muscle strength in all four limbs was grade 5, muscle tone was normal, there was no distal sensory or motor impairment, peripheral blood supply was good, physiological reflexes were present, and pathological reflexes were not elicited. The patient's condition had significantly improved compared to before.

[0102] (8) Patient 8: Liu, male, 29 years old.

[0103] Admission status: Admitted due to "right ankle pain for 7+ days". Admission symptoms: right ankle pain and discomfort, persistent throbbing pain, slight redness and swelling on the medial side of the right ankle with slightly limited movement, slightly elevated skin temperature, red tongue with yellow coating, and slippery, rapid pulse. Physical examination: slight redness and swelling of the right ankle, no obvious deformity, no skin ulceration or purulent discharge, slightly elevated skin temperature upon touch, significant tenderness upon pressure, ankle rotation test (+-), sensation and blood circulation in the right lower extremity are normal.

[0104] Admission diagnosis: Traditional Chinese medicine diagnosis: Bi syndrome (damp-heat toxin accumulation syndrome); Western medicine diagnosis: gouty arthritis; right ankle arthritis; hyperuricemia.

[0105] Treatment process: ① Apply "Qingbi Zhitong Chaji" (a traditional Chinese medicine) to clear heat and detoxify, promote diuresis and eliminate turbidity, on the right ankle joint (area: 7.0%); ② Low-frequency pulsed electrical therapy to improve circulation, on the medial side of the right ankle joint; ③ Acupressure with a medicated stick to relax muscles and promote blood circulation, on the right (medial malleolus tip, Zhaohai, Rangu, Fuliu, Ashi point).

[0106] Discharge status: The patient reported slight pain and discomfort in the right ankle joint during activity, without nausea, vomiting, fever, chills, chest tightness, shortness of breath, dyspnea, abdominal pain, or abdominal distension. The tongue was pale red with a thin yellow coating, and the pulse was slippery. Physical examination: Chest, lungs, and abdomen were all negative; there was no edema in both lower extremities. Specialist examination: The right ankle joint showed no obvious redness or swelling, no obvious deformity, no skin ulceration or purulent discharge, and the skin temperature was not high upon touch. There was slight tenderness upon gentle pressure. The ankle rotation test was negative. Sensation and blood circulation in the right lower extremity were normal. The patient's right ankle joint pain significantly improved.

[0107] Although the present invention has been described in detail above with general descriptions, specific embodiments, and experiments, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made without departing from the spirit of the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for relieving pain and numbness, characterized in that, The traditional Chinese medicine composition consists of the following components in parts by weight: 100-200 parts Paris polyphylla, 100-200 parts Prunella vulgaris, 30-70 parts Phellodendron chinense, 30-70 parts Polygonum cuspidatum, 25-55 parts Rheum palmatum, 30-70 parts Angelica dahurica, 50-100 parts Paeonia lactiflora, 20-40 parts Pheretima aspergillum, and 5-15 parts Borneol.

2. The traditional Chinese medicine composition for relieving pain and numbness according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following components in parts by weight: 125-175 parts Paris polyphylla, 125-175 parts Prunella vulgaris, 40-60 parts Phellodendron chinense, 40-60 parts Polygonum cuspidatum, 30-50 parts Rheum palmatum, 40-60 parts Angelica dahurica, 60-90 parts Paeonia lactiflora, 25-35 parts Pheretima aspergillum, and 8-12 parts Borneol.

3. The traditional Chinese medicine composition for relieving pain and numbness according to claim 2, characterized in that, The traditional Chinese medicine composition consists of the following components in parts by weight: 150 parts Paris polyphylla, 150 parts Prunella vulgaris, 50 parts Phellodendron chinense, 50 parts Polygonum cuspidatum, 40 parts Rheum palmatum, 50 parts Angelica dahurica, 75 parts Paeonia lactiflora, 30 parts Pheretima aspergillum, and 10 parts Borneol.

4. The method for preparing the traditional Chinese medicine composition for relieving pain and alleviating numbness as described in any one of claims 1-3, characterized in that, The preparation method is as follows: Weigh out eight medicinal materials according to the prescription: Paris polyphylla, Prunella vulgaris, Phellodendron chinense, Polygonum cuspidatum, Rheum palmatum, Angelica dahurica, Paeonia lactiflora, and Pheretima aspergillum; pulverize them into coarse powder and set aside; add ethanol solution and soak; filter; add borneol to the filtrate and stir to dissolve; add the above ethanol solution to prepare the final product.

5. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, Specifically, the steps include the following: S1. Obtaining medicinal materials: Weigh out the following 8 medicinal materials according to the prescription: Paris polyphylla, Prunella vulgaris, Phellodendron chinense, Polygonum cuspidatum, Rheum palmatum, Angelica dahurica, Paeonia lactiflora, and Pheretima aspergillum. Grind them into coarse powder that passes through a sieve of size 2 to 4 and set aside. S2. Extraction and Preparation: Add 45%~60% ethanol solution, which is 3 times the total mass of the crude powder of medicinal materials obtained in step S1, and soak for 2~7 days; filter, take the filtrate, add borneol according to the prescription amount and stir to dissolve; add the above ethanol solution to prepare, and you will get the product.

6. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The coarse powder mentioned in step S1 is obtained by crushing the medicinal materials and passing them through a No. 2 or No. 3 sieve.

7. The method for preparing the traditional Chinese medicine composition according to claim 6, characterized in that, The coarse powder mentioned in step S1 is obtained by crushing the medicinal materials and passing them through a No. 2 sieve.

8. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, Step S2 specifically involves: adding a 50% to 60% ethanol solution, which is 3 times the total mass of the crude medicinal powder obtained in step S1, and soaking for 5 to 7 days; filtering, taking the filtrate, adding borneol according to the prescription amount and stirring to dissolve; and adding the above ethanol solution to prepare the final product.

9. The method for preparing the traditional Chinese medicine composition according to claim 8, characterized in that, Step S2 specifically involves: adding a 50% ethanol solution equal to three times the total mass of the crude medicinal powder obtained in step S1, soaking for 5 days; filtering and taking the filtrate, adding borneol according to the prescription amount and stirring to dissolve; adding the above ethanol solution to prepare the final product.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a pain-relieving and analgesic drug.

Images