A traditional Chinese medicine preparation for treating joint disease of warming meridians and dredging collaterals and cold syndrome and a preparation method thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine preparation for preventing and treating arthralgia cold syndrome and a preparation method thereof, which comprises the following steps: weighing 2-5 parts of dried ginger, 8-12 parts of ephedra, 8-12 parts of radix angelicae dahuricae, 12-18 parts of radix paeoniae alba, 8-12 parts of radix morindae officinalis, 4-6 parts of herba epimedii, 8-12 parts of paederia scandens, and 25-35 parts of radix astragali, decocting the above ingredients, adding 4-6 parts of cassia bark before the end of decoction, continuing to decoct, and filtering to obtain the traditional Chinese medicine preparation. The present application replaces aconite in Wutou decoction with dried ginger and cassia bark, and does not contain toxic components of aconite. In the clinical application of 20 patients with knee osteoarthritis, the symptoms are significantly improved, the total effective rate is obviously better than that of the traditional prescription, the safety is good, and no toxic reaction is reported.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine preparation for treating cold-type joint diseases by warming the meridians and promoting blood circulation, and its preparation method. Background Technology

[0002] Knee osteoarthritis falls under the category of "Bi syndrome" in Traditional Chinese Medicine. It is a chronic joint disease characterized by degenerative changes in articular cartilage and damage to bone structure. It can cause inflammation of the synovium around the joint, mainly manifesting as joint pain, stiffness of surrounding muscles, and limited range of motion. In severe cases, it can lead to deformity and disability, and is one of the most common degenerative diseases in the elderly. Epidemiological surveys show that with the accelerating aging process and the increase in the obese population, the incidence of knee osteoarthritis continues to rise, reaching 8.1% in my country. Currently, there is no complete cure for this disease; the main clinical treatment goals are to slow disease progression, improve symptoms, and alleviate pain.

[0003] Western medicine treatment for knee osteoarthritis mainly includes oral medications and surgery. Oral medications primarily consist of nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, opioids, and chondroprotective agents. While these can improve symptoms to some extent, they are often accompanied by adverse reactions such as immunosuppression, gastrointestinal reactions, liver and kidney damage, and cardiovascular risks. Surgical treatment has limitations such as significant trauma, high cost, and long postoperative recovery period. Traditional Chinese medicine believes that the pathogenesis of knee osteoarthritis is closely related to the dysfunction of the kidney, spleen, and liver. External pathogenic factors such as wind-cold-dampness, falls, injuries, and deficiency of vital energy are common pathogenic factors. Cold-dampness obstruction syndrome is one of the core syndromes of knee osteoarthritis. Its pathogenesis is that cold-dampness obstructs the meridians, resulting in poor circulation of qi and blood, and insufficient nourishment of tendons and bones. Clinical manifestations include heavy and aggravated joint pain, which worsens with cold and is relieved by warmth, accompanied by lower back pain, pale tongue, white and greasy tongue coating, and a soft and slow pulse. The Aconite Decoction in the *Synopsis of Prescriptions of the Golden Chamber* is a classic formula for treating cold-dampness arthralgia. Composed of processed aconite, ephedra, astragalus, white peony root, and licorice, it has the effects of warming the meridians, dispelling cold, eliminating dampness, and relieving arthralgia. Its efficacy in treating joint pain due to cold-dampness obstruction has been proven clinically over a thousand years. However, the diester-type alkaloids contained in aconite are highly toxic. Despite processing and prolonged pre-decoction to reduce toxicity, reports of poisoning reactions such as numbness of the mouth and tongue and arrhythmia are still frequently seen in clinical practice. Its therapeutic window is narrow, and the requirements for decoction time and temperature are extremely strict. The risk is particularly high when patients decoct the medicine themselves, severely limiting the widespread application of Aconite Decoction in primary healthcare and long-term medication.

[0004] Chinese Patent Application Publication No. CN120285106A, published on July 11, 2025, discloses a traditional Chinese medicine composition for treating knee osteoarthritis of the cold-dampness obstruction type, its preparation method, and its uses. The main ingredients include white peony root, morinda root, poria cocos, saposhnikovia root, cyperus rhizome, achyranthes root, dendrobium, dioscorea rhizome, clematis root, eucommia bark, rehmannia root, licorice root, and angelica root. It aims to improve joint pain symptoms by tonifying the liver and kidneys and dispelling wind and dampness. However, this approach and other existing treatments for cold-dampness obstruction type arthritis often involve adding or subtracting herbs from aconite decoction or conventional wind-dispelling and dampness-removing formulas. This fails to fundamentally address the safety risks associated with the toxic components of aconite and still presents the following technical problems: (1) Although processed Aconitum carmichaelii and processed Aconitum kusnezoffii are processed, they still contain diester-type alkaloid toxic components. Their therapeutic window is narrow, and long-term use or improper decoction can easily lead to accumulation and poisoning. The safety hazards in clinical application have not been eliminated. (2) The formula focuses on dispelling pathogens and clearing the meridians, while neglecting to replenish qi and blood, and nourish the liver and kidneys to strengthen the body and consolidate the foundation. Long-term use can easily deplete qi and blood, which is especially detrimental to elderly patients. (3) There is a lack of systematic efficacy comparison and safety verification data with aconite decoction. The efficacy equivalence and safety advantages of the alternative are unclear, and there is insufficient basis for clinical promotion. Summary of the Invention

[0005] Therefore, this invention provides a traditional Chinese medicine preparation for treating cold-type joint diseases by warming the meridians and promoting circulation, and its preparation method, in order to solve the technical problem that existing aconite decoction-type prescriptions have poor drug safety and limited clinical application due to the toxicity of aconite.

[0006] To achieve the above objectives, on the one hand, the present invention provides a traditional Chinese medicine preparation for treating cold syndrome of joint diseases by warming the meridians and promoting circulation, which is composed of dried ginger, cinnamon, ephedra, angelica dahurica, white peony root, homalomena occulta, epimedium, piper kadsura, astragalus, clematis, angelica sinensis, and myrrh.

[0007] Further, it is made from the following raw materials in parts by weight: 2-5 parts dried ginger, 4-6 parts cinnamon, 8-12 parts ephedra, 8-12 parts angelica dahurica, 12-18 parts white peony root, 8-12 parts Homalomena occulta, 4-6 parts epimedium, 8-12 parts sea bream vine, 25-35 parts astragalus, 6-12 parts clematis chinensis, 8-15 parts angelica sinensis, and 3-10 parts myrrh.

[0008] Furthermore, the weight fraction of Astragalus membranaceus is 28 to 32 parts.

[0009] Furthermore, the weight of the Clematis chinensis is 8 to 10 parts.

[0010] Furthermore, the weight of the Angelica sinensis is 10 to 15 parts.

[0011] On the other hand, the present invention also provides a method for preparing a traditional Chinese medicine preparation for treating cold syndrome of joint diseases by warming the meridians and promoting blood circulation, comprising the following steps: Step S1: Soak the weighed medicinal materials to be decocted to obtain a decoction mixture, wherein the medicinal materials to be decocted are dried ginger, ephedra, angelica dahurica, white peony root, homalomena occulta, epimedium, piper kadsura, astragalus, clematis and angelica sinensis. Step S2: After adding water to the mixture to be decocted, a first decoction is performed. After the first decoction is completed, cinnamon is added, and after further decoction, the mixture is filtered to obtain the first decoction liquid. Step S3: Add water to the filtered dregs and decoct them a second time. After decoction, filter the decoction to obtain the second decoction. Step S4: Mix the first decoction and the second decoction, and concentrate under reduced pressure to obtain a concentrated ointment; Step S5: Mix the concentrated ointment with myrrh powder and granulate to obtain the traditional Chinese medicine preparation.

[0012] Furthermore, in step S2, the decoction time of the first decoction is 30 to 60 minutes, and the decoction time after adding cinnamon is 3 to 10 minutes.

[0013] Furthermore, in step S3, the second simmering time is 20 to 40 minutes.

[0014] Compared with the prior art, the present invention has the following beneficial effects: the present invention replaces the processed aconite in aconite decoction with dried ginger and cinnamon. Through the combination of dried ginger warming the middle and tonifying yang, dispelling cold and unblocking the meridians, and cinnamon warming and tonifying kidney yang and promoting blood circulation, the core effects of warming the meridians and dispelling cold of aconite are simulated and strengthened. It does not contain aconitine toxic components at all, does not require decoction to reduce toxicity, has a simple decoction process, and has a wide therapeutic window. It effectively avoids the clinical application safety hazards caused by aconite toxicity in aconite decoction and overcomes the technical problem of poor drug safety caused by aconite toxicity in existing aconite decoction formulas.

[0015] Furthermore, this invention, while retaining the warming and cold-dispersing therapeutic properties of Aconite Decoction, enhances its wind-dispelling, cold-dispersing, orifice-opening, and pain-relieving effects by adding Angelica dahurica; it also adds Homalomena occulta, Epimedium, and Piper kadsura to tonify the liver and kidneys, strengthen tendons and bones, and unblock meridians; it adds Clematis chinensis to dispel wind and dampness, unblock meridians, and relieve pain, while Piper kadsura enhancing its ability to expel numbness; it adds Angelica sinensis to nourish and invigorate blood, working synergistically with Paeonia lactiflora to soothe the liver, relieve spasms, and harmonize blood, thus eliminating pathogens without harming blood; and it adds Commiphora myrrha to invigorate blood, relieve pain, disperse blood stasis, and reduce swelling, working synergistically with Angelica sinensis to invigorate blood, nourish blood, resolve blood stasis, and relieve pain. It also heavily uses Astragalus membranaceus to tonify Qi and strengthen the exterior, harmonizing Ying and Wei, relieving spasms, and alleviating pain when combined with Paeonia lactiflora. The entire formula surpasses Aconite Decoction in both eliminating pathogens and supporting the body's resistance, achieving a synergistic effect of eliminating pathogens without harming the body's resistance and supporting the body's resistance without retaining pathogens, overcoming the technical defects of existing alternatives that focus on eliminating pathogens while neglecting to support the body's resistance.

[0016] Furthermore, through clinical trials at common locations of rheumatic diseases, this invention has verified the broad applicability of the formula to cold-dampness obstruction syndrome, facilitating precise clinical medication. Attached Figure Description

[0017] Figure 1 This is a flowchart illustrating the steps of preparing a traditional Chinese medicine preparation for treating cold-type joint diseases by warming the meridians and promoting blood circulation, according to the present invention. Figure 2 This is a flowchart of step S1 in an embodiment of the present invention; Figure 3 This is a flowchart of step S2 in an embodiment of the present invention; Figure 4 This is a flowchart of step S3 in an embodiment of the present invention; Figure 5 This is a flowchart of step S4 in an embodiment of the present invention; Figure 6 This is a flowchart of step S5 in an embodiment of the present invention. Detailed Implementation

[0018] To make the objectives and advantages of the present invention clearer, the present invention will be further described below with reference to embodiments; it should be understood that the specific embodiments described herein are merely for explaining the present invention and are not intended to limit the present invention.

[0019] Please see Figure 1 The diagram shows the steps of preparing a traditional Chinese medicine preparation for treating cold-type joint diseases by warming the meridians and promoting blood circulation, according to the present invention.

[0020] This invention provides a method for preparing a traditional Chinese medicine preparation for treating cold-type joint diseases by warming the meridians and promoting blood circulation, comprising the following steps: Step S1: Soak the weighed medicinal materials to be decocted to obtain a decoction mixture, wherein the medicinal materials to be decocted are dried ginger, ephedra, angelica dahurica, white peony root, homalomena occulta, epimedium, sea bream vine, astragalus, clematis chinensis and angelica sinensis.

[0021] Please see Figure 2 As shown, it is a flowchart of step S1 in an embodiment of the present invention.

[0022] Specifically, the process of step S1 includes: Step S11: Weigh the following raw materials by weight: 2-5 parts dried ginger, 8-12 parts ephedra, 8-12 parts angelica dahurica, 12-18 parts white peony root, 8-12 parts Homalomena occulta, 4-6 parts epimedium, 8-12 parts Piper kadsura, 25-35 parts astragalus, 6-12 parts clematis chinensis, 8-15 parts angelica sinensis, 3-10 parts myrrh, and 4-6 parts cinnamon. The cinnamon is set aside separately, and the myrrh is separately pulverized into a fine powder and passed through a 100-mesh sieve. Step S12: Mix the remaining 10 raw medicinal materials except for cinnamon and myrrh, and place them in a decoction container; Step S13: Add 6 to 10 times the total weight of the medicinal materials to the decoction container and soak at room temperature for 30 to 60 minutes to obtain the decoction mixture.

[0023] It is understandable that this invention soaks 10 medicinal herbs (excluding cinnamon and myrrh) before decoction to allow the dried herbs to fully absorb water and swell, softening their cell walls and facilitating the full dissolution of active ingredients during subsequent decoction. If decoction is performed directly without soaking, water cannot quickly penetrate the herbs, limiting the release of active ingredients and affecting the efficacy of the formula. Soaking at room temperature for 30-60 minutes allows water to gradually penetrate the herb tissues, enabling the initial dissolution of soluble components, while preventing protein coagulation and starch gelatinization that could clog cell wall pores under high temperatures. Furthermore, this application specifies cinnamon as a later addition and myrrh as a powdered medicine, a targeted treatment based on the differences in the physicochemical properties of their active ingredients. The main active ingredient in cinnamon is volatile oil. Cinnamaldehyde, being the main component, has poor thermal stability and is prone to volatilization and loss during prolonged decoction. Therefore, it is added after the first decoction and only decocted briefly. Myrrh, being a resinous herb, has active ingredients that are poorly soluble in water, resulting in a low dissolution rate during decoction. Pulverizing it into a fine powder and mixing it with the concentrated ointment preserves its effective components for promoting blood circulation and relieving pain. Through these differentiated treatment methods, it is ensured that each herb in the formula releases its active ingredients through the optimal pathway.

[0024] Step S2: After adding water to the mixture to be decocted, a first decoction is performed. After the first decoction is completed, cinnamon is added, and after further decoction, the mixture is filtered to obtain the first decoction liquid.

[0025] Please see Figure 3 As shown, it is a flowchart of step S2 in an embodiment of the present invention.

[0026] Specifically, the process of step S2 includes: Step S21: Add water to the mixture to be decocted obtained in step S13 until the liquid level is 2cm to 5cm above the surface of the medicinal materials to obtain the decoction. Step S22: Heat the liquid to be decocted to a boil, and simmer for 30 to 60 minutes to perform the first decoction. Step S23: After the first decoction is completed, add the cinnamon that was set aside separately in step S11, and continue to decoct for 3 to 10 minutes. Step S24: After decocting, filter the liquid and collect the filtrate to obtain the first decoction.

[0027] Understandably, this invention sets the first decoction time to 30-60 minutes, allowing for the full dissolution of non-volatile active ingredients in herbs such as dried ginger, ephedra, angelica, and clematis, including gingerol, ephedrine, ferulic acid, and oleanolic acid. Cinnamon's volatile oil components have poor thermal stability and are easily lost through prolonged heating; therefore, it is added after the first decoction and decocted for only 3-10 minutes. This segmented decoction process, with cinnamon added later, ensures the full release of non-volatile active ingredients in the principal herbs during prolonged decoction while avoiding excessive loss of volatile components such as cinnamaldehyde, achieving a balance between "long decoction for efficacy" and "light decoction for gas extraction." Furthermore, filtration immediately after the first decoction ensures timely separation of the dissolved active ingredients from the dregs, preventing re-adsorption and ensuring extraction efficiency.

[0028] Step S3: Add water to the filtered dregs and decoct them a second time. After decoction, filter the decoction to obtain the second decoction liquid.

[0029] Please see Figure 4 As shown, it is a flowchart of step S3 in an embodiment of the present invention.

[0030] Specifically, the process of step S3 includes: Step S31: Add water, which is 4 to 8 times the total weight of the medicinal materials, to the dregs filtered in step S24. Step S32: Heat to a boil, maintain a gentle simmer for 20 to 40 minutes, and then proceed with the second simmering. Step S33: After decocting, filter the liquid and collect the filtrate to obtain the second decoction.

[0031] It is understood that the purpose of the second decoction following the first is to further extract the soluble active ingredients remaining in the dregs. During a single decoction, the concentration gradient inside and outside the medicinal material gradually decreases, and some active ingredients remain inside the medicinal tissue and are not fully released. Through the second decoction, the new solvent re-establishes the concentration gradient, allowing the remaining active ingredients to continue to diffuse into the solution, achieving a more thorough extraction. In this application, the second decoction time is set to 20 to 40 minutes, and the amount of water added is set to 4 to 8 times the total weight of the medicinal material. This ensures the full dissolution of the remaining active ingredients while avoiding the problems of excessive dissolution of impurities and excessive energy consumption in subsequent concentration.

[0032] Step S4: Mix the first decoction and the second decoction, and concentrate under reduced pressure to obtain a concentrated ointment.

[0033] Please see Figure 5 As shown, it is a flowchart of step S4 in an embodiment of the present invention.

[0034] Specifically, the process of step S4 includes: Step S41: Combine the first decoction collected in step S24 and the second decoction collected in step S33, and place them in a vacuum concentration device. Step S42: Start the vacuum concentration device, control the vacuum degree to -0.06MPa to -0.08MPa, and the temperature to 55℃ to 65℃, and carry out vacuum concentration. Step S43: Concentrate the extract to a relative density of 1.05 to 1.15 at 60°C to obtain a concentrated extract.

[0035] Understandably, this invention combines the two decoctions and then concentrates them under reduced pressure, based on the practical needs of large decoction volume, low concentration of active ingredients, and the need to increase solid content to facilitate subsequent formulation. By controlling the vacuum degree to -0.06MPa to -0.08MPa and the temperature to 55℃ to 65℃, the boiling point of water can be effectively lowered, allowing water to evaporate rapidly at a lower temperature. This avoids the decomposition and loss of volatile components of cinnamon and heat-sensitive components such as ephedrine, ferulic acid, and paeoniflorin due to prolonged high-temperature heating. Setting the concentration endpoint at a relative density of 1.05 to 1.15 at 60℃ ensures that the concentrated ointment has suitable fluidity and plasticity, facilitating uniform mixing with myrrh powder, while avoiding over-concentration that could harden the ointment and affect granulation.

[0036] Step S5: Mix the concentrated ointment with myrrh powder and granulate to obtain the traditional Chinese medicine preparation.

[0037] Please see Figure 6 As shown, it is a flowchart of step S5 in an embodiment of the present invention.

[0038] Specifically, the process of step S5 includes: Step S51: Add the myrrh powder obtained in step S11 to the concentrated ointment obtained in step S43, stir evenly, and obtain a mixed ointment. Step S52: Add pharmaceutically acceptable excipients to the mixed paste and mix to form a soft material; Step S53: The soft material is sieved, granulated, dried, and sized to obtain the traditional Chinese medicine preparation.

[0039] It is understandable that this invention adds myrrh in powder form after it has been concentrated into a paste, based on the characteristic that myrrh resinous medicinal materials are poorly soluble in water. If the active ingredients in myrrh, such as myrrh sterone and sesquiterpenes, are decocted with a decoction, the dissolution rate is extremely low, resulting in significant waste of medicinal materials. Furthermore, the decocted liquid is cloudy, has a poor taste, and leads to poor patient compliance. Pulverizing it into a fine powder and mixing it directly with the concentrated paste preserves its effective components for promoting blood circulation, relieving pain, dispersing blood stasis, and reducing swelling, while also improving the appearance and user experience of the preparation. Wet granulation of the mixed paste into granules ensures a uniform and controllable content of active ingredients in each unit, facilitating precise administration by patients. At the same time, granules offer advantages over decoctions, such as smaller dosage, easier portability and storage, and greater convenience of administration, thus improving patient medication compliance. The excipients added during granulation, such as dextrin, sodium carboxymethyl cellulose, and sucrose powder, serve to fill, bind, and flavor the ingredients. One or more of these can be used in combination as needed. The drying temperature is controlled at 50–60°C to avoid further damage to heat-sensitive components. Through the above process, this invention ultimately produces a traditional Chinese medicine preparation that retains its active ingredients intact, has accurate dosage, and is convenient to take.

[0040] The specific embodiments of the present invention are as follows: Example 1

[0041] Weigh the following raw materials according to the following weights: 3 parts dried ginger, 10 parts ephedra, 10 parts angelica dahurica, 15 parts white peony root, 10 parts senna root, 5 parts epimedium, 10 parts sea pine, 30 parts astragalus root, 10 parts clematis root, 12 parts angelica sinensis, 6 parts myrrh, and 5 parts cinnamon.

[0042] (1) Mix dried ginger, ephedra, angelica dahurica, white peony root, senna root, epimedium, sea breeze vine, astragalus root, clematis root and angelica root, add 8 times the amount of water, soak at 20℃ for 30 minutes to obtain the mixture to be decocted; (2) Heat the mixture to be decocted for the first decoction for 45 minutes, add cinnamon, continue to decoct for 5 minutes, filter, and collect the first decoction; (3) Add 7 times the amount of water to the filter residue for a second decoction, decoct for 30 minutes, filter, and collect the second decoction; (4) Mix the first decoction and the second decoction, and concentrate under reduced pressure to a thick paste with a relative density of 1.12 at 60°C; (5) Grind the myrrh using an ultrafine pulverizer, pass it through a 100-mesh sieve, and take the fine powder; (6) Mix the thick paste with myrrh powder, add dextrin and sodium carboxymethyl cellulose as fillers and binders, wet granulate, dry in a forced air at 60°C, and granulate to obtain the Chinese medicine preparation granules. Example 2

[0043] Weigh the following raw materials according to the following weights: 30 parts dried ginger, 100 parts ephedra, 100 parts angelica dahurica, 150 parts white peony root, 100 parts senna root, 50 parts epimedium, 100 parts sea pine, 300 parts astragalus, 100 parts clematis root, 120 parts angelica sinensis, 60 parts myrrh, and 50 parts cinnamon.

[0044] (1) Mix dried ginger, ephedra, angelica dahurica, white peony root, senna root, epimedium, sea breeze vine, astragalus root, clematis root and angelica root, add 8 times the amount of water and soak for 40 minutes to obtain the mixture to be decocted; (2) Heat the mixture to be decocted for the first decoction for 50 minutes, add cinnamon, continue to decoct for 5 minutes, filter, and collect the first decoction; (3) Add 6 times the amount of water to the filter residue for a second decoction, decoct for 35 minutes, filter, and collect the second decoction; (4) Mix the first decoction and the second decoction, and concentrate under reduced pressure to an extract with a relative density of 1.10 to 1.15 at 60°C; (5) Grind the myrrh using an ultrafine pulverizer, pass it through a 100-mesh sieve, and take the fine powder; (6) Mix the extract with myrrh powder, stir well, add appropriate amount of dextrin and sucrose powder as excipients, mix to form a soft material, granulate through a 14-mesh sieve, dry at 60℃, granulate, and package into 10 portions per bag to obtain granules. Take 1 bag each time, twice a day, dissolved in warm water. Example 3

[0045] Weigh each raw material according to the prescription amount in Example 2, extract and concentrate according to steps (1) to (4) of Example 2, vacuum dry the obtained extract and pulverize it into fine powder, pass it through a 100-mesh sieve to obtain dry extract powder; pulverize myrrh into fine powder and pass it through a 100-mesh sieve; mix the dry extract powder and myrrh fine powder evenly, add an appropriate amount of starch as a filler, mix evenly, and fill into hard capsule shells, each capsule containing 0.45 parts, to obtain capsules. Take 4 capsules each time, twice a day, with warm water. Example 4

[0046] Weigh the following ingredients by weight: 2 parts dried ginger, 4 parts cinnamon, 8 parts ephedra, 8 parts angelica dahurica, 12 parts white peony root, 8 parts *Homalomena occulta*, 4 parts epimedium, 8 parts *Piper kadsura*, 25 parts astragalus, 6 parts clematis, 8 parts angelica sinensis, and 3 parts myrrh. Place all ingredients except cinnamon and myrrh in a decoction container, add water, and decoct twice. The first decoction is for 45 minutes, and the second for 30 minutes. Combine the decoctions and filter. Crush the cinnamon and add it to the combined decoction, continue to decoct for 5 minutes, and filter again. Grind the myrrh into a fine powder, add it to the filtrate, mix well, and the decoction is obtained. Example 5

[0047] Weigh the following raw materials according to the indicated weight proportions: 5 parts dried ginger, 6 parts cinnamon, 12 parts ephedra, 12 parts angelica dahurica, 18 parts white peony root, 12 parts *Homalomena occulta*, 6 parts epimedium, 12 parts *Piper kadsura*, 35 parts astragalus, 12 parts clematis, 15 parts angelica sinensis, and 10 parts myrrh. Place all the herbs except cinnamon and myrrh in a decoction container, add water, and decoct twice. The first decoction is for 45 minutes, and the second decoction is for 30 minutes. Combine the decoctions and filter. Crush the cinnamon and add it to the combined decoction, continue to decoct for 5 minutes, and filter again. Grind the myrrh into a fine powder, add it to the filtrate, mix well, and the decoction is obtained. Example 6

[0048] Weigh the following ingredients by weight: 3 parts dried ginger, 5 parts cinnamon, 10 parts ephedra, 10 parts angelica dahurica, 15 parts white peony root, 10 parts *Homalomena occulta*, 5 parts epimedium, 10 parts *Piper kadsura*, 30 parts astragalus, 10 parts clematis, 12 parts angelica sinensis, and 6 parts myrrh. Place all the herbs except cinnamon and myrrh in a decoction container, add water and decoct twice. The first decoction is for 45 minutes, and the second is for 30 minutes. Combine the decoctions and filter. Crush the cinnamon and add it to the combined decoction, continue to decoct for 5 minutes, and filter again. Grind the myrrh into a fine powder, add it to the filtrate, mix well, and the decoction is obtained.

[0049] Comparative Example 1 (Formula without Astragalus) Weigh each raw material according to the proportions specified in Example 4, except that Astragalus membranaceus is omitted, while the other ingredients and their dosages remain unchanged. Prepare the decoction without Astragalus membranaceus according to the method described in Example 4.

[0050] Comparative Example 2 (Cinnamon-laden formula) Weigh each raw material according to the weight ratio of Example 4, except that cinnamon is omitted, while the other ingredients and their amounts remain unchanged. Prepare the decoction without cinnamon according to the method of Example 4.

[0051] Comparative Example 3 (Formula without Dried Ginger) Weigh each raw material according to the weight ratio of Example 4, except that dried ginger is omitted, while the other ingredients and their amounts remain unchanged. Prepare the decoction without dried ginger according to the method of Example 4.

[0052] Comparative Example 4 (Modified Aconite Decoction) Based on the modified Aconitum Decoction from *Synopsis of Prescriptions of the Golden Chamber*, the formula consists of: 6 parts prepared Aconitum carmichaelii (decocted first), 10 parts Ephedra sinica, 20 parts Astragalus membranaceus, 15 parts Paeonia lactiflora, and 6 parts Glycyrrhiza uralensis. The preparation method is as follows: Prepared Aconitum carmichaelii is decocted separately for 1 hour. The remaining herbs are decocted according to standard procedures (water is added to cover the herbs, and after boiling, it is simmered for 30 minutes). The decoction is then combined with the decoction of the remaining herbs to obtain the modified Aconitum Decoction formula. In the clinical controlled trial of this invention, two cases of mild numbness of the mouth and tongue occurred at this dosage. After adjusting the dosage to 3 parts prepared Aconitum carmichaelii and extending the decoction time to 1.5 hours, the symptoms disappeared. The remaining 18 cases were treated according to the original regimen (6 parts prepared Aconitum carmichaelii, decocted for 1 hour). The efficacy analysis included all 20 cases, and adverse reactions were reported truthfully in the safety evaluation.

[0053] 1. Grouping and administration methods Patients were randomly divided into a treatment group and three control groups, with 20 patients in each group. The treatment group received the decoction of Example 4 of this invention; control group 1 received the decoction of Comparative Example 1 without Astragalus membranaceus; control group 2 received a combined decoction of Comparative Example 2 without Cinnamomum cassia and Comparative Example 3 without Zingiber officinale, i.e., the decoction of Cinnamomum cassia and Zingiber officinale without Cinnamomum cassia. Since Cinnamomum cassia and Zingiber officinale were considered as a core warming yang medicine pair in prescription screening, they were combined as a single control after their absence to simplify statistical comparison; control group 3 received the modified decoction of Comparative Example 4, Aconitum carmichaelii, in which 6 parts of processed Aconitum carmichaelii were decocted for 1 hour first.

[0054] There were no statistically significant differences among the groups of patients in terms of gender, age, disease duration, and joint type (knee, shoulder, waist, neck and shoulder, upper limb, etc.) (P>0.05), making them comparable.

[0055] The dosage and treatment course were the same for all groups: one dose daily, taken warm in the morning and evening, for 7 days as one course of treatment, with two consecutive courses. All patients discontinued other related medications during the treatment period.

[0056] 2. Efficacy Evaluation Criteria Refer to the efficacy evaluation criteria for osteoarthritis in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines": Clinical control: Symptoms such as pain disappear, and joint movement returns to normal; Significant effect: Symptoms such as pain are significantly reduced, and joint mobility is significantly improved; Effective: Symptoms such as pain are reduced, and joint mobility is improved; Ineffective: Symptoms such as pain and joint mobility do not improve or worsen.

[0057] Overall effective rate = (number of cases with clinical control + significant effect + effective) / total number of cases × 100%.

[0058] Meanwhile, the Visual Analogue Scale (VAS) was used to evaluate the degree of joint pain (0-10 points, with higher scores indicating more severe pain), and the improvement in joint mobility was recorded.

[0059] 3. Treatment Results Table 1 Comparison of clinical efficacy among groups Group Number of examples Clinical control Effective efficient invalid Overall efficiency Treatment group (Example 4) 20 6 8 5 1 95.0% Control group 1 (lacking Astragalus membranaceus formula) 20 2 5 7 6 70.0% Control group 2 (combined formula lacking cinnamon and dried ginger) 20 1 4 6 9 55.0% Control group 3 (modified version of Aconitum Decoction) 20 3 6 8 3 85.0% As shown in Table 1, the total effective rate of the treatment group was 95.0%, significantly higher than the 70.0% of the formula lacking Astragalus and the 55.0% of the combined formula lacking Cinnamon and Dried Ginger, with statistically significant differences (P < 0.01). These results indicate that Astragalus, as an adjuvant to invigorate Qi and strengthen the body's defenses, and to counteract the excessive dispersing properties of Ephedra, along with Cinnamon and Dried Ginger as the core warming Yang herbs, are all indispensable components for the optimal efficacy of the composition of this invention. Compared with the modified Aconite Decoction (85.0%), the total effective rate of the treatment group was superior, suggesting that after removing the toxic components of Aconite, the warming and dispersing effects of this invention were not only not reduced, but actually enhanced.

[0060] Table 2 Comparison of VAS scores and joint range of motion before and after treatment in each group (x±s) Group VAS score (before treatment) VAS score (post-treatment) Improvement in joint range of motion (°) Treatment group (Example 4) 7.2±1.1 2.3±0.8*# 18.5±4.2*# Control group 1 (lacking Astragalus membranaceus formula) 7.0±1.3 4.1±1.2* 11.3±3.8* Control group 2 (a combination formula lacking both cinnamon and dried ginger) 7.3±1.0 5.2±1.4* 8.1±3.5* Control group 3 (modified version of Aconitum Decoction) 7.1±1.2 2.8±0.9* 16.7±4.0* Note: Compared with the group before treatment, *P<0.05; compared with each control group after treatment, #P<0.05.

[0061] Table 2 shows that there were no statistically significant differences in VAS scores among the groups before treatment. After treatment, the VAS score in the treatment group decreased from 7.2±1.1 to 2.3±0.8, showing the largest decrease (a decrease of 4.9 points); the improvement in joint mobility was the most significant (18.5±4.2°), which was statistically significant compared with control groups 1 and 2 (P<0.05). Compared with control group 3 (modified Aconite Decoction), the treatment group showed slightly better improvement in VAS score and joint mobility, but the difference was not statistically significant (P>0.05), suggesting that the efficacy of this invention is comparable to that of the modified Aconite Decoction.

[0062] 4. Safety Evaluation During the treatment period, no significant adverse reactions were observed in either the treatment group or controls 1 and 2. Safety indicators such as blood routine tests, liver and kidney function, and electrocardiogram showed no abnormal changes before and after treatment. In control group 3 (a modified version of Aconitum carmichaelii decoction), two patients experienced mild numbness of the mouth and tongue. These symptoms disappeared after reducing the amount of processed Aconitum carmichaelii to 3 parts and extending the decoction time to 1.5 hours. These results indicate that the present invention has a significant safety advantage over Aconitum carmichaelii decoction-like formulas.

[0063] 5. Original materials used in clinical applications Table 3 shows some clinical case information of the Bone Pain Formula No. 2 of this invention (i.e., the traditional Chinese medicine preparation for warming the meridians and promoting blood circulation to treat cold syndrome of joint diseases).

[0064] Table 3 Clinical Application Case Information Serial Number diagnosis Intervention measures First visit Second consultation Third consultation Four diagnostic methods 1 Joint disease (knee) This invention 12.13 12.20 12.27 1.10 2 Joint (shoulder) This invention 2.8 2.14 3.14 3.21 3 Joint disease (lower back) This invention 3.1 (14 doses) 3.15 (14 doses) - - 4 Joint diseases (neck and shoulder) This invention 2.28 3.7 (14 doses) 3.21 - 5 Joint disease (lower back) This invention 3.1 3.7 3.14 3.21 6 Joint disease (lower back) This invention 1.10 2.7 2.21 3.7 7 Joints (lumbar spine) This invention 1.10 1.16 1.26 2.28 8 Joint (thumb) This invention 12.14 12.20 12.27 1.4 9 Joints (neck and shoulder) This invention 12.21 12.27 1.4 (14 doses) - 10 Joints (upper limbs) This invention 12.21 12.28 1.4 1.11 11 Joint (Sacrococcygeal region) This invention 12.20 12.27 1.4 1.10 12 Joint (shoulder) This invention 2.15 2.22 2.28 - 13 Joint disease (knee) This invention 1.4 1.10 - - 14 Joint disease (knee) This invention 12.13 12.20 - - 15 Joint (shoulder) This invention 1.10 2.21 - - 16 Joint disease (shoulder) This invention 11.21 12.7 - - 17 Joint disease (shoulder) This invention 12.27 1.4 - - 18 Joint disease (knee) This invention 10.12 10.18 10.25 11.1 19 Joint disease (lower back) This invention 9.13 9.21 9.28 10.11 20 Joint disease (lower back) This invention 9.13 9.20 9.27 10.11 The above 20 clinical cases involved joint diseases in eight different locations, including the knee, shoulder, lower back, neck and shoulder, lumbar spine, thumb, upper limb, and sacrum and coccyx. After 1-4 courses of treatment, all patients showed good compliance with follow-up visits, and most patients experienced continuous symptom improvement during the follow-up period. No significant adverse reactions were reported in any of the cases using the formulation of this invention, further validating the effectiveness and safety of this invention.

[0065] 6. Analysis of Treatment Results and Discussion of Prescription Principles The above experimental data show that: (1) This invention, by replacing processed aconite in aconite decoction with dried ginger and cinnamon, fully preserves the core effects of aconite decoction in warming the meridians, dispelling cold, eliminating dampness, and relieving pain. The total effective rate of the treatment group was 95.0%, which was significantly higher than that of the formula without astragalus (70.0%) and the formula without cinnamon and dried ginger (55.0%). This indicates that the properties of astragalus in tonifying qi and consolidating the exterior, and the properties of processing ephedra to dispel excessive dispersion, as well as the core medicinal pair of cinnamon and dried ginger in warming yang and dispelling cold, are all indispensable components for the composition of this invention to achieve the best therapeutic effect.

[0066] (2) The total effective rate (95.0%) and the decrease in VAS score (4.9 points) in the treatment group were better than those in the modified Aconite Decoction (85.0%, 4.3 points), indicating that the efficacy of the present invention increased rather than decreased after removing the toxic components of aconite. At the same time, there were no adverse reactions in the treatment group, while two cases of numbness of the mouth and tongue occurred in the modified Aconite Decoction. This invention has achieved a technological breakthrough of removing toxins without reducing efficacy and being safer and more effective.

[0067] (3) In the formula of this invention, dried ginger warms the middle and tonifies yang, dispels cold and unblocks the meridians, while cinnamon warms and tonifies kidney yang and promotes blood circulation. Together, they mimic the effect of aconite in dispelling cold and relieving pain by circulating through the twelve meridians. Homalomena occulta, epimedium, and cassia argentea tonify the liver and kidneys, strengthen tendons and bones, and unblock the meridians, thus compensating for the deficiency of aconite decoction in dispelling pathogens but not in supporting the body's vital energy. Clematis chinensis dispels wind and dampness, unblocks the meridians and relieves pain, thus helping cassia argentea and homalomena occulta to enhance their ability to dispel pain and unblock the meridians. Angelica sinensis nourishes blood, invigorates blood, regulates the body's vital energy, and harmonizes blood. Together with white peony root, it soothes the liver, relieves urgency, and harmonizes the body's vital energy. Myrrh invigorates blood, relieves pain, disperses blood stasis and reduces swelling. Together with angelica sinensis, it invigorates blood, nourishes blood, resolves blood stasis and relieves pain. Astragalus membranaceus is used in large quantities to tonify qi and strengthen the exterior. Together with white peony root, it harmonizes the body's vital energy, relieves urgency and pain. The whole formula uses both warming and tonifying methods to dispel cold and dampness and promote the circulation of yang qi, strengthen tendons and bones and improve joint mobility.

[0068] In summary, this invention, through the reconstruction of the principal and assistant herbs by replacing aconite with dried ginger and cinnamon, the heavy use of astragalus, and the optimization of the compatibility of herbs that tonify the liver and kidneys, achieves the complete preservation and transcendence of the core efficacy of aconite decoction in warming the meridians and dispelling cold, without the presence of any toxic herbs. Clinical verification has confirmed that it is effective without reducing efficacy and is safer and more effective, providing a safe and efficient clinical medication plan for cold syndromes of joint diseases.

[0069] The technical solution of the present invention has been described above with reference to the preferred embodiments shown in the accompanying drawings. However, it will be readily understood by those skilled in the art that the scope of protection of the present invention is obviously not limited to these specific embodiments. Without departing from the principles of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will all fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating cold-type joint diseases by warming the meridians and promoting circulation, characterized in that, It is composed of dried ginger, cinnamon, ephedra, angelica dahurica, white peony root, senna root, epimedium, piper kadsura, astragalus root, clematis root, angelica sinensis, and myrrh.

2. The traditional Chinese medicine preparation for warming the meridians and promoting circulation in the joints with cold syndrome according to claim 1, characterized in that, Made from the following raw materials by weight: 2-5 parts dried ginger, 4-6 parts cinnamon, 8-12 parts ephedra, 8-12 parts angelica dahurica, 12-18 parts white peony root, 8-12 parts Homalomena occulta, 4-6 parts epimedium, 8-12 parts sea bream vine, 25-35 parts astragalus, 6-12 parts clematis chinensis, 8-15 parts angelica sinensis, and 3-10 parts myrrh.

3. The traditional Chinese medicine preparation for warming the meridians and promoting circulation in the joints with cold syndrome according to claim 2, characterized in that, The weight of Astragalus membranaceus is 28 to 32 parts.

4. The traditional Chinese medicine preparation for warming the meridians and promoting circulation in the joints with cold syndrome according to claim 3, characterized in that, The weight of the Clematis chinensis is 8 to 10 parts.

5. The traditional Chinese medicine preparation for warming the meridians and promoting circulation in the joints with cold syndrome according to claim 4, characterized in that, The weight of the Angelica sinensis is 10 to 15 parts.

6. The use of the traditional Chinese medicine preparation according to any one of claims 1-5 in the treatment of rheumatoid arthritis.

7. The use of the traditional Chinese medicine preparation according to any one of claims 1-5 in the treatment of osteoarthritis.

8. The method for preparing a traditional Chinese medicine preparation for treating cold-type joint diseases according to any one of claims 1-5, characterized in that, Includes the following steps: Step S1: Soak the weighed medicinal materials to be decocted to obtain a decoction mixture, wherein the medicinal materials to be decocted are dried ginger, ephedra, angelica dahurica, white peony root, homalomena occulta, epimedium, piper kadsura, astragalus, clematis and angelica sinensis. Step S2: After adding water to the mixture to be decocted, a first decoction is performed. After the first decoction is completed, cinnamon is added, and after further decoction, the mixture is filtered to obtain the first decoction liquid. Step S3: Add water to the filtered dregs and decoct them a second time. After decoction, filter the decoction to obtain the second decoction. Step S4: Mix the first decoction and the second decoction, and concentrate under reduced pressure to obtain a concentrated ointment; Step S5: Mix the concentrated ointment with myrrh powder and granulate to obtain the traditional Chinese medicine preparation.

9. The method for preparing the traditional Chinese medicine preparation for warming the meridians and promoting circulation in the joints with cold syndrome according to claim 8, characterized in that, In step S2, the decoction is simmered for 30 to 60 minutes, and the decoction is simmered for 3 to 10 minutes after adding cinnamon.

10. The method for preparing the traditional Chinese medicine preparation for warming the meridians and promoting circulation in the joints with cold syndrome according to claim 9, characterized in that, In step S3, the second simmering time is 20 to 40 minutes.

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