A pharmaceutical composition for treating rheumatic arthralgia, its formulation and application

Abstract

This invention discloses a pharmaceutical composition, its formulation, and its application for treating rheumatic arthralgia. The pharmaceutical composition comprises the following components in parts by weight: 20-40 parts of Salvia miltiorrhiza, 10-20 parts of Paeonia lactiflora, 20-40 parts of Panax notoginseng rootlets, 10-20 parts of Ligusticum chuanxiong, 9-20 parts of Angelica sinensis, 9-20 parts of Clematis chinensis, 9-20 parts of Angelica pubescens, 9-20 parts of Chaenomeles speciosa, 9-20 parts of Saposhnikovia divaricata, 9-20 parts of Achyranthes bidentata (processed with wine), and 9-20 parts of Carthamus tinctorius. Pharmaceutically acceptable excipients may be added to the pharmaceutical composition to prepare a formulation. The pharmaceutical composition and its formulation can be used to treat rheumatic arthralgia.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a pharmaceutical composition for treating rheumatic arthralgia, its preparation and application. Background Technology

[0002] The symptoms of rheumatic arthritis, rheumatic myofibrositis, and rheumatoid arthritis are mainly pain in the joints of the limbs. In traditional Chinese medicine, this disease is called Bi syndrome, which falls under the category of diseases of the limbs and meridians in internal medicine. It is a common and frequently occurring disease that threatens human health.

[0003] Bi syndrome is a condition caused by the invasion of pathogenic factors such as wind, cold, dampness, and heat, which obstruct the meridians and impede the flow of qi and blood, resulting in symptoms such as pain, swelling, soreness, numbness, heaviness, and limited mobility in the limbs and joints. Its pathogenesis mainly stems from a weak constitution, insufficient vital energy, and weakened defensive qi, leading to the invasion of wind, cold, and dampness, which flow into the meridians and joints, causing impeded qi and blood circulation and resulting in Bi syndrome. Bi syndrome is classified according to the predominance of the pathogenic factor: wandering Bi, painful Bi, fixed Bi, heat Bi, phlegm Bi, and blood stasis Bi. This formula is mainly used to treat joint pain, swelling, and heaviness caused by wind-cold invasion, cold-dampness obstruction, and impeded qi and blood circulation, sometimes accompanied by migratory redness, swelling, and pain in the joints; or pain, swelling, and morning stiffness in small joints. The *Suwen* (Plain Questions) states, "When wind, cold, and dampness combine, they form Bi syndrome. When wind predominates, it is wandering Bi; when cold predominates, it is painful Bi; when dampness predominates, it is fixed Bi." This provides a detailed discussion of its etiology, pathogenesis, syndrome classification, progression, and prognosis. Wind is the chief of all diseases; wind is a yang evil, its nature is to open and disperse; wind is mobile and frequently changes; wind is active. Common wind syndromes include: wind-cold, wind-dampness, wind-heat, and wind-dampness bi syndrome. Cold: Cold is a yin evil, easily damaging yang qi; cold has a stagnant nature; cold has a contracting nature. Common cold syndromes include: wind-cold, cold bi syndrome, etc. Dampness: Dampness is heavy and sticky; dampness is a yin evil, easily obstructing qi flow and damaging yang qi. Common dampness syndromes include: wind-dampness, damp bi syndrome, etc. Wandering Bi syndrome (predominantly wind evil): Pain in the limbs, joints, and muscles, wandering and unpredictable, difficulty in flexion and extension, or aversion to wind and fever, etc. Thin white tongue coating, floating pulse. Painful Bi syndrome (predominantly cold evil): Severe pain in the limbs and joints, aggravated by cold, relieved by heat, milder during the day and more severe at night, inability to flex or extend joints, no redness at the painful site, no heat to the touch. White and slippery tongue coating, wiry and tight pulse. Bi syndrome (predominantly due to dampness): Heaviness and soreness in the limbs and joints, with fixed location of pain, more severe in the lower limbs, sometimes accompanied by swelling, numbness of the skin, and worsening in damp or rainy weather. White and greasy tongue coating, and a soft and slow pulse.

[0004] Bi syndrome is a disease caused by pathogenic factors such as wind, cold, and dampness obstructing the meridians, affecting the circulation of qi and blood, and leading to symptoms such as headache, heaviness, soreness, numbness, or difficulty in flexion and extension, stiffness, swelling, and deformity of the limbs, bones, joints, and muscles. In mild cases, the disease affects the joints and muscles of the limbs; in severe cases, it can affect the internal organs. Currently, there are many clinical studies on the treatment of Bi syndrome in Traditional Chinese Medicine (TCM), but the quality is generally not high. The Weilingxian Huoluo Formula, applied externally, greatly reduces the damage and side effects of oral treatment to the liver, kidneys, spleen, and stomach. Clinically, most patients find the pungent smell of oral TCM difficult to tolerate. However, with external TCM treatment, the medication is not taken orally but rather absorbed through foot baths, allowing it to enter the body through the skin, avoiding patient intolerance. TCM believes that the foot is the beginning of the three Yin meridians and the end of the three Yang meridians; a herbal foot bath allows the medicinal components to be rapidly distributed throughout the body via the meridians, shortening the onset time. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to provide a pharmaceutical composition, its formulation, and its application for treating rheumatic arthralgia. The pharmaceutical composition of the present invention has a good therapeutic effect on rheumatic arthralgia caused by wind, cold, and dampness.

[0006] The objective of this invention is achieved through the following technical solution: A pharmaceutical composition for treating rheumatic arthralgia, comprising the following components in parts by weight: 20-40 parts of Salvia miltiorrhiza, 10-20 parts of Paeonia lactiflora, 20-40 parts of Panax notoginseng rootlets, 10-20 parts of Ligusticum chuanxiong, 9-20 parts of Angelica sinensis, 9-20 parts of Clematis chinensis, 9-20 parts of Angelica pubescens, 9-20 parts of Chaenomeles speciosa, 9-20 parts of Saposhnikovia divaricata, 9-20 parts of Achyranthes bidentata (processed with wine), and 9-20 parts of Carthamus tinctorius.

[0007] Preferably, the pharmaceutical composition for treating rheumatic arthralgia comprises the following components in parts by weight: 20-35 parts of Salvia miltiorrhiza, 9-18 parts of Paeonia lactiflora, 20-35 parts of Panax notoginseng rootlets, 9-18 parts of Ligusticum chuanxiong, 9-18 parts of Angelica sinensis, 9-18 parts of Clematis chinensis, 9-18 parts of Angelica pubescens, 9-18 parts of Chaenomeles speciosa, 9-18 parts of Saposhnikovia divaricata, 9-18 parts of Achyranthes bidentata (processed with wine), and 9-18 parts of Carthamus tinctorius.

[0008] Preferably, the pharmaceutical composition for treating rheumatic arthralgia comprises the following components in parts by weight: 28-30 parts of Salvia miltiorrhiza, 12-16 parts of Paeonia lactiflora, 25-30 parts of Panax notoginseng rootlets, 12-16 parts of Ligusticum chuanxiong, 12-16 parts of Angelica sinensis, 12-16 parts of Clematis chinensis, 12-16 parts of Angelica pubescens, 12-16 parts of Chaenomeles speciosa, 12-16 parts of Saposhnikovia divaricata, 12-16 parts of Achyranthes bidentata (processed with wine), and 12-16 parts of Carthamus tinctorius.

[0009] Preferably, the pharmaceutical composition for treating rheumatic arthralgia further includes 3-15 parts of Gentiana macrophylla, 3-12 parts of Cinnamomum cassia, and 3-12 parts of Pueraria lobata.

[0010] Preferably, the pharmaceutical composition for treating rheumatic arthralgia further includes 3-15 parts of processed aconite, 3-15 parts of asarum, and 5-20 parts of dried ginger.

[0011] Preferably, the pharmaceutical composition for treating rheumatic arthralgia further includes 3-20 parts of Notopterygium incisum, 3-15 parts of Atractylodes lancea, and 3-15 parts of Coix lacryma-jobi.

[0012] The formulation of the pharmaceutical composition for treating rheumatic arthritis is prepared by adding pharmaceutically acceptable excipients to the pharmaceutical composition. Preferably, the formulation is a topical lotion prepared according to conventional methods.

[0013] The pharmaceutical composition and preparation described above for treating rheumatic arthritis can be used to prepare drugs for treating rheumatic arthritis. Compared with the prior art, the beneficial effects of the present invention are as follows:

[0014] In this invention, Paeonia lactiflora contains monoterpenes and their glycosides, triterpenes, flavonoids, tannins, phenolic acids, and other chemical components, which have pharmacological effects such as protecting myocardial cells and nerve cells and stabilizing microcirculation. Panax notoginseng mainly contains notoginsenosides, ginsenosides Rb1, ginsenoside-Re, ginsenoside-R1, ginsenoside-Rd, ginsenoside-Rg1, ginsenoside-Rh1, ginsenoside-20(S)Rg3, ginsenoside-Rh4, and gypenosides-XVII, etc., and also contains flavonoids, notoginsenosides, polysaccharides, and other effective components. It has pharmacological effects in preventing coronary heart disease, angina pectoris, arteriosclerosis, hypertension, cerebral thrombosis, etc., and can also increase the body's immune function, delay aging, and strengthen the body. The main active components of Salvia miltiorrhiza are fat-soluble and water-soluble components. The fat-soluble components mainly include tanshinone compounds, while the water-soluble components mainly include salvianolic acid compounds. These components possess anti-inflammatory, hypoglycemic, anti-tumor, anti-myocardial ischemia, and anti-atherosclerotic effects. Angelica sinensis contains volatile oil (containing phthalyl lactones), organic acids, polysaccharides, flavonoids, monoterpenes and sesquiterpenes, aromatic compounds, aliphatic hydrocarbons and their derivatives, amino acids, nucleosides, and 23 trace elements. These components possess antioxidant, anti-tumor, anti-inflammatory, analgesic, anti-platelet aggregation, hepatoprotective, nephroprotective, and immune system, cardiovascular, and nervous system regulatory pharmacological effects. Angelica pubescens's main components are coumarins and volatile oils; Aralia elata's main components are diterpenes and triterpenes, along with other chemical components such as phytosterols, organic acids, and sugars. These components possess anti-inflammatory, sedative, analgesic, hypnotic, hypotensive, antiarrhythmic, anticoagulant, and anti-tumor pharmacological activities. Papaya mainly contains triterpenoids, phenylpropanoids, flavonoids and their glycosides, organic acids and their glycosides and esters, amino acids, oils, steroids and their glycosides, etc., and has pharmacological effects such as analgesia, anti-inflammation, immune enhancement, liver protection, anti-gastric ulcer and intestinal damage, and anti-tumor effects. The active chemical components of Achyranthes bidentata mainly include sterones, saponins, polysaccharides, and isoflavones. Wine-processing increases the levels of three known active ingredients: amaranthone, puerarin, and daidzein. Pharmacological experiments show that wine-processed Achyranthes bidentata has the effect of improving blood circulation and intervening in bone cell growth. Safflower mainly contains quinone chalcones, flavonoids, alkaloids, polyacetylenes, lignans, and fatty acids, and has pharmacological effects such as preventing and treating menstrual disorders, cerebral thrombosis, hypertension, traumatic injuries, joint pain, coronary heart disease, and angina pectoris. Ligusticum chuanxiong mainly contains phenols, phenolic acids, alkaloids, and polysaccharides, and is often used to treat dysmenorrhea, diabetes, and cerebral thrombosis. Clematis chinensis and Clematis davidii mainly contain saponins, while Clematis pubescens mainly contains flavonoids; pharmacological studies have shown that Clematis chinensis and Clematis davidii mainly possess anti-inflammatory, analgesic, and antitumor pharmacological effects. Saposhnikovia divaricata mainly contains chromones, polysaccharides, volatile oils, coumarins, and other chemical components; studies have confirmed that Saposhnikovia divaricata has antipyretic, anti-inflammatory, analgesic, and antitumor pharmacological activities.

[0015] The formula contains Danshen (Salvia miltiorrhiza): It invigorates blood circulation, removes blood stasis, unblocks meridians, relieves pain, clears the heart and eliminates irritability, cools the blood and reduces swelling; and Chishao (Paeonia lactiflora): It clears heat, cools the blood, disperses blood stasis, and relieves pain. These two herbs are the principal herbs, working together to invigorate blood circulation, unblock meridians, disperse blood stasis, and relieve pain; they are the key herbs in this formula. Sanqi (Panax notoginseng) and Chuanxiong (Ligusticum striatum) are the assistant herbs. Sanqi disperses blood stasis, relieves pain, reduces swelling, calms the pain, and unblocks meridians; Chuanxiong invigorates blood circulation, promotes qi circulation, dispels wind, and relieves pain. Together, they invigorate blood circulation without leaving blood stasis, calm the pain, and reduce swelling, assisting the principal herbs to ensure smooth blood and qi flow, remove blood stasis, unblock meridians, and relieve pain. Danggui (Angelica sinensis), Weilingxian (Clematis chinensis), Duhuo (Angelica pubescens), and Mugua (Chaenomeles speciosa) are the adjuvant herbs. Danggui nourishes and invigorates blood circulation, unblocks meridians, relieves pain, and moistens the intestines to promote bowel movements; Weilingxian dispels wind and dampness, unblocks meridians, disperses cold, and relieves pain; Duhuo dispels wind and dampness, relieves pain, disperses cold, and releases the exterior; and Mugua relaxes muscles and tendons, harmonizes the stomach, and resolves dampness. The above four ingredients assist the principal and assistant herbs in their function of clearing blockages and activating blood circulation, while also addressing concurrent symptoms such as blood deficiency, rheumatism, and muscle spasms, achieving the goal of eliminating pathogens without harming the body's vital energy. Saposhnikovia divaricata, Achyranthes bidentata (processed with wine), and Carthamus tinctorius serve as guiding herbs. Saposhnikovia divaricata dispels wind and releases the exterior, eliminates dampness and relieves pain, and stops spasms; it is a commonly used herb for rheumatic pain. Achyranthes bidentata (processed with wine) removes blood stasis, unblocks meridians, promotes joint mobility, strengthens tendons and bones, and promotes urination. Carthamus tinctorius invigorates blood, regulates menstruation, disperses blood stasis, and relieves pain. The combined use of Saposhnikovia divaricata, Achyranthes bidentata (processed with wine), and Carthamus tinctorius guides the herbs to the affected area, ensuring that all herbs reach the site of the disease, thus achieving the overall effects of the formula in relaxing muscles and tendons, promoting blood circulation, dispelling wind and cold, and eliminating dampness and relieving pain.

[0016] This invention leverages the unique advantages of traditional Chinese medicine, offering significant benefits in the treatment of rheumatic diseases, including high safety, low recurrence rate, and personalized treatment.

[0017] This formula is primarily used to treat joint pain, swelling, and heaviness caused by wind-cold invasion, cold-dampness obstruction, and poor blood circulation, sometimes accompanied by migratory redness, swelling, and pain in the joints; or pain, swelling, and morning stiffness in small joints. The *Suwen* (Plain Questions) chapter on Bi syndrome states: "When wind, cold, and dampness combine, they cause Bi syndrome. When wind predominates, it is called wandering Bi; when cold predominates, it is called painful Bi; when dampness predominates, it is called fixed Bi." This chapter provides a detailed discussion of its etiology, pathogenesis, syndrome classification, progression, and prognosis. Wind is the chief of all diseases; wind is a Yang evil, its nature is expansive; wind is mobile and frequently changes; wind is active. Common wind syndromes include: wind-cold, wind-dampness, wind-heat, and wind-Bi. Cold: Cold is a Yin evil, easily damaging Yang Qi; cold has a stagnant nature; cold has a contracting nature. Common cold syndromes include: wind-cold, cold-Bi. Dampness: Dampness is heavy; dampness is sticky; dampness is a Yin evil, easily obstructing Qi flow and damaging Yang Qi. Common types of dampness include: rheumatism, damp-bi syndrome, etc.

[0018] This formula is precisely formulated and has proven effective in clinical application with no side effects. It cleverly utilizes guiding herbs and dialysis agents to ensure the medicinal properties directly reach the affected area, clearing the meridians, strengthening muscles and bones, and harmonizing qi and blood. It possesses significant advantages among current medications for treating arthralgia. Detailed Implementation

[0019] The present invention will be further described below with reference to the embodiments, but the present invention is not limited to the embodiments. Example 1

[0020] A pharmaceutical composition for treating rheumatic arthralgia comprises the following components: 20g of Salvia miltiorrhiza, 10g of Paeonia lactiflora, 20g of Panax notoginseng rootlets, 10g of Ligusticum chuanxiong, 9g of Angelica sinensis, 9g of Clematis chinensis, 9g of Angelica pubescens, 9g of Chaenomeles speciosa, 9g of Saposhnikovia divaricata, 9g of Achyranthes bidentata (processed with wine), and 9g of Carthamus tinctorius. Example 2

[0021] A pharmaceutical composition for treating rheumatic arthralgia comprises the following components: 27g of Salvia miltiorrhiza, 12g of Paeonia lactiflora, 25g of Panax notoginseng rootlets, 12g of Ligusticum chuanxiong, 12g of Angelica sinensis, 12g of Clematis chinensis, 12g of Angelica pubescens, 12g of Chaenomeles speciosa, 12g of Saposhnikovia divaricata, 12g of Achyranthes bidentata (processed with wine), and 12g of Carthamus tinctorius. Example 3

[0022] A pharmaceutical composition for treating rheumatic arthralgia, comprising the following components: 35g of Salvia miltiorrhiza, 18g of Paeonia lactiflora, 35g of Panax notoginseng rootlets, 18g of Ligusticum chuanxiong, 18g of Angelica sinensis, 16g of Clematis chinensis, 18g of Angelica pubescens, 18g of Chaenomeles speciosa, 18g of Saposhnikovia divaricata, 18g of Achyranthes bidentata (processed with wine), and 18g of Carthamus tinctorius. Example 4

[0023] A pharmaceutical composition for treating rheumatic arthralgia comprises the following components: 40g of Salvia miltiorrhiza, 20g of Paeonia lactiflora, 40g of Panax notoginseng rootlets, 20g of Ligusticum chuanxiong, 20g of Angelica sinensis, 20g of Clematis chinensis, 20g of Angelica pubescens, 20g of Chaenomeles speciosa, 20g of Saposhnikovia divaricata, 20g of Achyranthes bidentata (processed with wine), and 20g of Carthamus tinctorius. Example 5

[0024] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 1, and 3g of Gentiana macrophylla, 3g of Cinnamomum cassia, and 3g of Pueraria lobata. Example 6

[0025] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 2, and 6g of Gentiana macrophylla, 9g of Cinnamomum cassia, and 9g of Pueraria lobata. Example 7

[0026] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 3, and 12g of Gentiana macrophylla, 12g of Cinnamomum cassia, and 12g of Pueraria lobata. Example 8

[0027] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 1, and 3g of processed aconite, 3g of asarum, and 5g of dried ginger. Example 9

[0028] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 2, and 6g of processed aconite root, 6g of asarum root, and 9g of dried ginger. Example 10

[0029] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 3, and 15g of processed aconite root, 15g of asarum, and 20g of dried ginger. Example 11

[0030] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 1, and 3g of Notopterygium incisum, 3g of Atractylodes lancea, and 6g of Coix lacryma-jobi. Example 12

[0031] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 2, and 9g of Notopterygium incisum, 9g of Atractylodes lancea, and 10g of Coix lacryma-jobi. Example 13

[0032] A pharmaceutical composition for treating rheumatic arthralgia, comprising: the pharmaceutical composition described in Example 3, and 20g of Notopterygium incisum, 15g of Atractylodes lancea, and 15g of Coix lacryma-jobi. Example 14

[0033] A preparation of a pharmaceutical composition for treating rheumatic arthralgia, comprising: taking the pharmaceutical composition described in any one of Examples 1-13; crushing Panax notoginseng; mixing it with other medicinal ingredients; adding water and decocting twice, each time adding 12 times the amount of water; decocting for 1.5 hours; filtering; combining the decoctions; letting stand for 24 hours; taking the supernatant; concentrating it to about 1000 ml; cooling; letting stand for 24 hours; filtering; taking the filtrate; adding 0.5% sodium benzoate and 0.05% ethylparaben; mixing well; adding water to 1000 ml to prepare a lotion. Example 15

[0034] A formulation of a pharmaceutical composition is prepared according to the following steps: (1) Take the above eleven ingredients, crush the Panax notoginseng, mix it with the other ingredients, add water and decoct twice, each time adding 12 times the amount of water, and decoct for 1.5 hours; (2) Filter, combine the decoctions, let stand for 24 hours, take the supernatant, concentrate to about 1000ml, cool, let stand for 24 hours, and filter; (3) Take the filtrate, add 0.5% sodium benzoate and 0.05% ethylparaben, mix well, add water to 1000ml, and the external wash is obtained.

[0035] Application Examples—The pharmaceutical composition described in this invention is used to treat rheumatic arthralgia.

[0036] I. Research Objectives The clinical efficacy and adverse reactions of the drug combination of the present invention in treating diseases such as wind-cold-dampness arthralgia, rheumatoid arthritis, muscle paralysis, rheumatic joint pain, rheumatic myofibrositis, and rheumatoid arthritis were observed.

[0037] II. Research Methods We selected ≥100 patients who had received treatment at Sheng'ai Traditional Chinese Medicine Clinic in the past five years, used the drug combination formula of this invention externally, and met the inclusion criteria for the diagnosis and treatment of diseases. We then observed its clinical efficacy and adverse reactions.

[0038] III. Research Subjects When I visited Sheng'ai Traditional Chinese Medicine Clinic, the TCM diagnosis was divided into two main categories: wind-cold invasion and cold-dampness obstruction of the meridians.

[0039] (a) Diagnostic criteria 1. Traditional Chinese Medicine Diagnostic Criteria: Pain, swelling, or migratory pain in joints, skin, muscles, bones, etc., or numbness, heaviness, or difficulty in bending and stretching.

[0040] 2. Traditional Chinese Medicine Diagnosis: Based on the diagnostic criteria of traditional Chinese medicine internal medicine and long-term clinical treatment of rheumatic arthralgia, the main manifestations of rheumatic arthralgia are determined as follows: Main symptoms: pain in the neck, waist, and limb joints; pale red tongue with a thin white or greasy white coating.

[0041] Secondary symptoms: swelling, pain, or wandering pain in the neck, waist, and limb joints; numbness, heaviness, or difficulty in bending and stretching; aggravated by cold and relieved by heat.

[0042] (ii) Inclusion criteria (1) Age: ≥18 years and ≤70 years; (2) Meets the TCM diagnostic criteria and TCM syndrome differentiation criteria for this disease; (3) No other medications were used for treatment; (4) The patient provides informed consent and cooperates as required; (III) Exclusion Criteria (1) Those who take Western medicine or other drugs for a long time.

[0043] (2) Joint deformities, disabilities, or loss of labor capacity.

[0044] (3) Women under 18 years of age or over 70 years of age, pregnant or lactating women, and those allergic to this drug.

[0045] (4) Patients with serious primary diseases of the cardiovascular, liver, kidney and hematopoietic systems, or mental illness.

[0046] (5) Those who do not meet the inclusion criteria, do not take medication as required, cannot determine the efficacy or have incomplete data, etc., which affect the judgment of efficacy or safety.

[0047] IV. Treatment Methods For external use: Place 2 packets in a foot bath basin with 2000 ml of water, boil for 10 minutes, then add 10 ml of white wine and 20 ml of aged vinegar. First, apply the solution to the affected area with a towel, then soak your feet in the warm solution for 20-30 minutes each time, once a day. For more affected areas, add 1-2 packets. For severe cases, apply twice a day.

[0048] V. Criteria for Evaluating Therapeutic Effect Clinically effective: After 20-30 days of treatment, symptoms of pain in the neck, lower back, and limbs disappear, and the TCM syndrome score is ≥80%; Effective: After 30-40 days of treatment, symptoms of pain in the neck, lower back, and limb joints are significantly relieved, and the TCM syndrome score is ≥30% and <80%. Ineffective: After treatment, the pain symptoms in the neck, lower back, and limb joints did not significantly decrease or worsened, and the TCM syndrome score was <30%; VI. Clinical Use Results A total of 100 patients who visited Sheng'ai Traditional Chinese Medicine Clinic within 5 years were observed. Among them, 0 cases were clinically cured, 32 cases showed significant clinical improvement, 62 cases showed clinical improvement, and 6 cases showed no clinical improvement. The treatment efficacy is as follows: Clinical efficacy statistics of this invention in treating rheumatic arthralgia: Clinical efficacy statistics table During the clinical observation period, patients were advised to discontinue other medications during treatment and to use the pharmaceutical composition of this invention as required. Therefore, cases of concurrent medication use have been excluded.

[0049] The drug combination of this invention is mainly used for various joint pains caused by wind-cold-dampness syndrome. Therefore, this formula is mainly used to treat wind-cold-dampness syndrome, rheumatoid arthritis, muscle pain, rheumatic joint pain, rheumatic myofibrositis, rheumatoid arthritis, etc.

[0050] The drug combination formula of this invention has shown no obvious toxic side effects in clinical use and observation for diseases diagnosed by traditional Chinese medicine as rheumatic arthralgia (wind-cold invading the collaterals syndrome, cold-dampness obstructing the arthralgia syndrome). The clinical efficacy is definite. Moreover, the medicine is made entirely from traditional Chinese medicine combinations, with a wide range of medicinal sources and reliable efficacy. After being made into a topical Chinese medicine wash, it is convenient to use and can provide a Chinese medicine topical preparation with good efficacy, low risk, low cost and convenient use for a large number of patients with arthralgia. It is worth promoting and using in society.

[0051] IX. Typical Cases 1. Wu Moumou, male, 62 years old, first visit.

[0052] I have had recurring lower back and leg pain for 3 years.

[0053] The patient has experienced recurrent lower back and leg pain for the past three years, which worsens in cold weather, limiting mobility. The pain is also sometimes accompanied by numbness and pain in both knees and pain in the psoas muscles on both sides. The tongue is pale red with a thin, white, greasy coating, and the pulse is thready and tight.

[0054] Diagnosis: Rheumatic arthralgia Syndrome: Cold-damp stagnation, obstruction of blood vessels Treatment principle: Dispel cold and dampness, unblock meridians and relieve pain. Using Example 10, first apply a hot compress to the affected area with a towel soaked in the medicinal liquid, then soak the feet in the liquid for treatment, once a day.

[0055] On the second visit, after one month of treatment, the patient's lower back and leg pain had significantly improved, with no obvious limitation of movement; however, pain and numbness remained in both knee joints. The tongue was pale red with a thin white coating, and the pulse was thready and slippery. The diagnosis remained the same; the previous prescription was re-established, and treatment was administered according to the previous method.

[0056] After a third visit and another month of treatment, the patient's pain in the lower back, legs, and knees improved significantly, and he was able to move freely, was in good spirits, had a good appetite and sleep, and regular bowel movements. He had no other particular discomfort.

[0057] 2. Ms. Fu, 52 years old, first visit.

[0058] I have had neck pain for over two years, and it has recently worsened.

[0059] The patient has experienced neck pain for two years, with limited head movement during these episodes, often relieved by applying medicated plasters. Recently, the symptoms have worsened, with pain radiating to the right upper arm, accompanied by significant numbness, occasional headaches, and markedly limited neck movement. Appetite and sleep are fair, and bowel movements are normal. The tongue is dark red with a white, greasy coating, and the pulse is deep and thready.

[0060] Diagnosis: Rheumatic arthralgia Syndrome: Cold-damp stagnation, obstruction of blood vessels Treatment principle: Dispel cold and dampness, unblock meridians and relieve pain. Treatment with the medication from Example 6 involves soaking the feet and wiping the painful area. Soak the feet once daily, and wipe the affected area multiple times daily as needed.

[0061] On the second visit, after one month of use, the patient's neck and right upper arm pain had been relieved, although some limitation in movement remained, but it did not affect normal life. Appetite and sleep were good, and bowel movements were regular. The tongue was dark red with a white coating, and the pulse was deep and thready. The diagnosis remained the same, and the previous prescription was re-prescribed, with treatment following the same method.

[0062] After the third visit, the patient continued the treatment for another month. The pain in the neck and right upper arm was significantly relieved, and the attacks have not been obvious in recent months. Head and neck movements were normal, appetite and sleep were good, bowel movements were normal, and there were no other special discomforts.

[0063] 3. Ms. Chen, 30 years old, first visit.

[0064] I've had neck pain for over six months, and it's gotten worse in the past week.

[0065] The patient complained of neck pain and occasional dizziness for the past six months. The neck pain worsened significantly in the past week after exposure to cold, limiting forward and backward movement, while limb movement remained relatively normal. No other significant discomfort was reported. Appetite and sleep were good, and bowel movements were regular. The tongue was pale red with a thin white coating, and the pulse was thready and wiry.

[0066] Diagnosis: Rheumatic arthralgia Syndrome: Cold-damp stagnation, obstruction of blood vessels Treatment principle: Dispel cold and dampness, unblock meridians and relieve pain. Example 8: Soak feet and wipe the painful area together. Soak feet once a day, and wipe multiple times a day as needed.

[0067] On the second visit, the patient's neck pain was significantly relieved, although limited mobility remained, but general activity was still possible. No other significant discomfort was observed. Appetite and sleep were good, and bowel movements were normal. The tongue was pale red with a thin white coating, and the pulse was thready and wiry. The diagnosis remained the same, and the previous prescription was re-established, with treatment following the same method.

[0068] On the third visit, the patient reported that the neck pain had not recurred significantly in the past month, with occasional discomfort, but it did not affect normal life and work. In the past month, the patient's appetite and sleep have been good, the mental state is good, bowel movements are normal, and there are no other special discomforts.

[0069] The above cases are only a portion of those observed in clinical practice, and the drug compositions used are only a portion of those compositions. In actual clinical use, the dosage of specific drugs in the drug compositions can be arbitrarily selected within the scope of this invention, depending on the different clinical symptoms of the patients.

[0070] In clinical practice, prescriptions can be adjusted and modified according to different patients: (1) If the patient suffers from severe "wandering arthralgia", Gentiana macrophylla, cinnamon, and kudzu root can be added. Gentiana macrophylla and cinnamon can dispel wind and cold, while kudzu root can invigorate blood circulation, unblock collaterals, relieve muscle tension and pain. Combined with the present invention, it can effectively relieve the migratory pain caused by wandering arthralgia and reduce symptoms such as pain and soreness in the limbs, joints, and muscles.

[0071] (2) If the patient suffers from severe "painful arthralgia", prepared aconite, asarum, and dried ginger can be added. Prepared aconite, asarum, and dried ginger can all warm the meridians, dispel cold, and relieve pain. They can enhance the dampness-removing and cold-dispelling effects of this invention.

[0072] (3) If the patient suffers from severe "bi syndrome", Qianghuo, Cangzhu, and Yiyiren can be added. Yiyiren and Cangzhu can invigorate qi, strengthen the spleen and remove dampness; Qianghuo can dispel wind and remove dampness. The above three herbs, when used in combination with the present invention, can effectively target symptoms of bi syndrome such as soreness, heaviness and pain in the limbs, joints and muscles, limited joint movement, and numbness of the skin.

Claims

1. A pharmaceutical composition for treating rheumatic arthralgia, characterized in that, The composition comprises, by weight, 20-40 parts of Danshen, 10-20 parts of Chishao, 20-40 parts of Sanqi Xugen, 10-20 parts of Chuanqiong, 9-20 parts of Danggui, 9-20 parts of Weilingxian, 9-20 parts of Duhuo, 9-20 parts of Mugua, 9-20 parts of Fangfeng, 9-20 parts of Jiuchuuniuwei, and 9-20 parts of Honghua.

2. A pharmaceutical composition for treating rheumatism, characterized by, The composition of claim 1 further comprises 3-12 parts of Qianjiawei, 3-12 parts of Rougui, and 3-12 parts of Gegen.

3. A pharmaceutical composition for treating rheumatism, characterized by, The composition of claim 1 further comprises 3-15 parts of Zhishu, 3-15 parts of Xixin, and 5-20 parts of Ganjiang.

4. A pharmaceutical composition for treating rheumatism, characterized by, The composition of claim 1 further comprises 3-20 parts of Qianghuo, 3-15 parts of Cangzhu, and 3-15 parts of Yiyiren.

5. A formulation of the pharmaceutical composition for treating rheumatic arthralgia according to any one of claims 1 to 4, characterized in that, The composition is added with pharmaceutically acceptable adjuvants to form a preparation.

6. The formulation of the pharmaceutical composition for treating rheumatic arthralgia according to claim 5, characterized in that, The preparation is in the form of a lotion prepared according to conventional methods.

7. Use of the pharmaceutical composition for treating rheumatic arthralgia of any one of claims 1-4 in the preparation of a medicament for treating rheumatic arthralgia.

8. Use of the preparation of the pharmaceutical composition for treating rheumatic arthralgia of claim 5 in the preparation of a medicament for treating rheumatic arthralgia.