A traditional Chinese medicine preparation for treating systemic lupus erythematosus

Abstract

The application discloses a traditional Chinese medicine preparation for treating systemic lupus erythematosus. It solves the problem of poor effect of the current treatment of systemic lupus erythematosus. The formula is as follows: 10-30 parts of raw Rehmannia glutinosa, 6-12 parts of cortex Paeoniae, 6-12 parts of Ophiopogon japonicus, 6-12 parts of red peony root, 20-40 parts of Scutellaria baicalensis, 20-40 parts of mulberry bark, 20-40 parts of Artemisia annua, 6-12 parts of Cyathula officinalis, and 6-12 parts of raw licorice. The traditional Chinese medicine preparation for treating systemic lupus erythematosus has a novel composition and pure traditional Chinese medicine ingredients, has the functions of nourishing yin and clearing heat and promoting blood circulation to remove blood stasis, has a good treatment effect on various types of systemic lupus erythematosus, and has a very good curative effect on symptoms of low fever, five heat, night sweat, hair loss, fresh red rash, dry mouth and throat pain, oral ulcer, joint and muscle pain, heel pain, and soreness of waist and knees, and has no toxic side effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine and is a traditional Chinese medicine preparation for treating systemic lupus erythematosus. Background Technology

[0002] Systemic lupus erythematosus (SLE) is a progressive autoimmune disease characterized by the formation of autoantibodies and immune complexes, leading to organ and tissue damage. The prevalence in my country is approximately 70 per 100,000 people, and is showing an increasing trend annually. The cause of this disease is unknown, and it is recognized worldwide as a difficult-to-treat disease. In Traditional Chinese Medicine (TCM), it can be categorized under "Butterfly Sore Flow" or "Yin-Yang Toxin." Clinical manifestations often include low-grade fever, five-center heat (palms, soles, and chest), night sweats, hair loss, bright red rashes, dry mouth and sore throat, oral ulcers, joint and muscle pain, heel pain, lower back and knee weakness, a red tongue with little coating, petechiae and ecchymoses, and a thready, heel-like pulse. The clinical manifestations vary depending on the degree of deficiency in Qi, blood, Yin, and Yang, but Yin deficiency and blood stasis are common.

[0003] Western medicine treats systemic lupus erythematosus (SLE) primarily with glucocorticoids combined with immunosuppressants, playing a positive role in controlling the disease, alleviating symptoms, maintaining organ function, and improving prognosis. However, long-term use of hormones and immunosuppressants can easily lead to a series of toxic side effects and complications, such as hyperlipidemia, hyperglycemia, hypertension, osteoporosis, bone marrow suppression, gastrointestinal ulcers, liver and kidney damage, and secondary infections, becoming a problem that must be addressed in the treatment of SLE. Traditional Chinese medicine (TCM) uses the "syndrome differentiation and treatment" approach to treat SLE patients, which has certain advantages in alleviating symptoms, reducing the toxic side effects of Western medicine, and improving patients' quality of life, achieving relatively good efficacy. However, clinical reports show that while many TCM preparations for treating SLE have acceptable short-term efficacy, their long-term efficacy is less than ideal. The most common reason for this is insufficient tonification or excessive purgation, resulting in a "decreasing effect with continued treatment." This seriously affects the actual efficacy of TCM in treating SLE. Therefore, there is an urgent need in China for drugs that are effective, have few side effects, and can significantly control the disease and alleviate clinical symptoms in the treatment of systemic lupus erythematosus. Summary of the Invention

[0004] The purpose of this invention is to address the current limitations in the efficacy of treatments for systemic lupus erythematosus (SLE) by providing a novel traditional Chinese medicine preparation with properties that nourish Yin, clear heat, promote blood circulation, and remove blood stasis. This aims to improve the effectiveness of traditional Chinese medicine in treating this disease, meet societal needs, and better serve a wider range of patients. This preparation has a simple composition, good efficacy, rapid onset of action, and no toxic side effects.

[0005] To achieve the above objectives, the present invention adopts the following technical solution:

[0006] A traditional Chinese medicine preparation for treating systemic lupus erythematosus, comprising the following components by weight: 10-30 parts Rehmannia glutinosa, 6-12 parts Paeonia suffruticosa, 6-12 parts Ophiopogon japonicus, 6-12 parts Paeonia lactiflora, 20-40 parts Scutellaria baicalensis, 20-40 parts Morus alba root bark, 20-40 parts Artemisia annua, 6-12 parts Achyranthes bidentata, and 6-12 parts Glycyrrhiza uralensis.

[0007] Its components, by weight, are: 10 parts Rehmannia glutinosa, 6 parts Paeonia suffruticosa, 6 parts Ophiopogon japonicus, 6 parts Paeonia lactiflora, 20 parts Scutellaria baicalensis, 20 parts Morus alba root bark, 20 parts Artemisia annua, 6 parts Achyranthes bidentata, and 6 parts Glycyrrhiza uralensis.

[0008] Its components, by weight, are: 15 parts Rehmannia glutinosa, 9 parts Paeonia suffruticosa, 9 parts Ophiopogon japonicus, 9 parts Paeonia lactiflora, 30 parts Scutellaria baicalensis, 30 parts Morus alba root bark, 30 parts Artemisia annua, 9 parts Achyranthes bidentata, and 9 parts Glycyrrhiza uralensis.

[0009] Its components, by weight, are: 30 parts Rehmannia glutinosa, 12 parts Paeonia suffruticosa, 12 parts Ophiopogon japonicus, 12 parts Paeonia lactiflora, 40 parts Scutellaria baicalensis, 40 parts Morus alba root bark, 40 parts Artemisia annua, 12 parts Achyranthes bidentata, and 12 parts Glycyrrhiza uralensis.

[0010] The components used in this invention are analyzed as follows:

[0011] 1. Raw land

[0012] It is sweet, bitter, and cold in nature, and enters the heart, liver, and kidney meridians. Its functions are to clear heat and cool the blood, nourish yin and promote body fluid production. It is used for febrile diseases with a red tongue and irritability, yin deficiency with internal heat, bone steaming fever, internal heat and thirst, hematemesis, epistaxis, rashes, and constipation due to yin deficiency caused by febrile diseases.

[0013] 2. Moutan bark

[0014] It is bitter and pungent in taste, slightly cold in nature, and enters the heart, liver, and kidney meridians. Its functions include clearing heat and cooling the blood, promoting blood circulation and removing blood stasis, and reducing deficiency heat. It is used for febrile diseases with heat entering the blood level, rashes, vomiting blood, and nosebleeds; late-stage febrile diseases with latent heat in the yin aspect, and yin deficiency with steaming bone fever; amenorrhea due to blood stasis, dysmenorrhea; carbuncles, boils, traumatic injuries, and rheumatic fever.

[0015] 3. Ophiopogon japonicus

[0016] It is sweet and slightly bitter in taste, and cold in nature. It enters the heart, lung, and stomach meridians. Its functions are to nourish yin and generate fluids, moisten the lungs and clear the heart. It is used to treat dry cough due to lung dryness, cough due to yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0017] 4. Red peony root

[0018] It is bitter and slightly cold in nature, and enters the liver meridian. Its functions are to clear heat and cool blood, disperse blood stasis and relieve pain. It is used for febrile diseases with heat entering the blood level, purplish rashes, and hematemesis and epistaxis due to blood heat; red and swollen eyes caused by wind-heat in the liver meridian, and hypochondriac pain caused by blood stasis in the liver meridian; amenorrhea and dysmenorrhea caused by blood heat and blood stasis, masses and accumulations, as well as traumatic injuries, swelling and pain due to blood stasis, etc.

[0019] 5. Scutellaria baicalensis

[0020] It is bitter and cold in nature, and enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. Its functions include clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is used for damp-heat syndrome, summer-heat syndrome with chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, blood-heat vomiting and nosebleeds, carbuncles and boils, and threatened abortion.

[0021] 6. Mulberry bark

[0022] It is sweet and cold in nature, and enters the lung meridian. Its functions include purging lung heat and relieving asthma, promoting diuresis and reducing swelling. It is used for latent lung heat with symptoms such as cough with copious, yellow, sticky phlegm that is difficult to expectorate, flushed face, and hot skin, especially severe in the late afternoon; lung heat with wheezing and shortness of breath with symptoms such as coughing, wheezing, rapid breathing, chest fullness, and excessive, sticky phlegm in the throat, often accompanied by fever, dark urine, and dry stools; liver fire attacking the lungs, with symptoms such as coughing and wheezing with symptoms such as flushed face, chest and rib pain, bitter taste in the mouth, dry throat, and sticky phlegm that is difficult to expectorate; it is also used for kidney-related generalized edema, or water retention in the lungs with symptoms such as coughing, wheezing, abdominal distension, excessive phlegm, and chest and rib pain.

[0023] 7. Artemisia annua

[0024] It is bitter, pungent, and cold in nature, and enters the liver and gallbladder meridians. Its functions include clearing deficiency heat, eliminating bone steaming fever, relieving summer heat, stopping malaria, and reducing jaundice. It is used for malaria complicated by external summer heat; in the later stages of febrile diseases, when the pathogenic heat enters the yin aspect, resulting in night fever and morning coolness, fever subsiding without sweating, or persistent fever after febrile diseases; five-center heat (palms, soles, and chest) and tidal fever with night sweats caused by yin deficiency and fire excess; and for summer heat with external invasion, dizziness, headache, fever, and no sweating.

[0025] 8. Achyranthes bidentata

[0026] It has a sweet and slightly bitter taste, is neutral in nature, and enters the liver and kidney meridians. Its functions include removing blood stasis and promoting menstruation, facilitating joint movement, and promoting urination. It is used for amenorrhea, retained placenta, injuries from falls, rheumatic pain, foot weakness, muscle spasms, hematuria, and blood in the urine.

[0027] 9. Raw licorice

[0028] It is sweet and neutral in nature, and enters the heart, lung, spleen, and stomach meridians. Its functions include tonifying qi and strengthening the middle jiao, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and moderating the properties of other herbs. It is used for heart qi deficiency, palpitations, irregular pulse, as well as spleen and stomach weakness, fatigue, and weakness. It is also used for carbuncles, sores, sore throat, and drug and food poisoning.

[0029] The formula uses Rehmannia glutinosa to nourish the kidneys and replenish Yin, and Paeonia suffruticosa to invigorate blood and remove blood stasis, these two herbs are the principal herbs; Ophiopogon japonicus to clear heat and generate fluids, and Paeonia lactiflora to cool the blood and remove blood stasis, these two herbs are the assistant herbs; Scutellaria baicalensis to clear heat and detoxify, Morus alba root bark to clear lung heat, Artemisia annua to clear deficiency heat, and Achyranthes bidentata to remove blood stasis and promote menstruation, these four herbs are the adjuvant herbs; Glycyrrhiza uralensis to harmonize the other herbs is the guiding herb. All the herbs work together to nourish Yin, clear heat, invigorate blood, and remove blood stasis.

[0030] This invention relates to a traditional Chinese medicine preparation for treating systemic lupus erythematosus (SLE). It possesses the functions of nourishing Yin and clearing heat, promoting blood circulation and removing blood stasis. It is used for symptoms such as low-grade fever, five-center heat (palms, soles, and chest), night sweats, hair loss, bright red rashes, dry mouth and sore throat, oral ulcers, joint and muscle pain, heel pain, lower back and knee weakness, red tongue with little coating, petechiae and ecchymosis, and a thready and hesitant pulse. It has good therapeutic effects on various types of SLE, especially for those exhibiting symptoms of Yin deficiency and blood stasis, such as low-grade fever, five-center heat, night sweats, hair loss, bright red rashes, dry mouth and sore throat, oral ulcers, joint and muscle pain, heel pain, and lower back and knee weakness. The efficacy is excellent, and it has no toxic side effects.

[0031] The ingredients of this invention are scientifically formulated and the dosage is reasonable, which has the following advantages:

[0032] 1. Treating both the root cause and the symptoms. Systemic lupus erythematosus (SLE) is rooted in "kidney yin deficiency" and manifested by "blood stasis." Therefore, this invention uses Rehmannia glutinosa and Ophiopogon japonicus to nourish the kidneys and replenish yin to treat the root cause, while Paeonia suffruticosa, Paeonia lactiflora, and Achyranthes bidentata invigorate blood and remove blood stasis to treat the symptoms. Scutellaria baicalensis, Morus alba root bark, and Artemisia annua are added to clear internal heat. By treating both the root cause and the symptoms, good results are achieved.

[0033] 2. Regulating the Internal Organs. The development and progression of systemic lupus erythematosus are inseparable from the dysfunction of the internal organs. This invention, while nourishing Yin and promoting blood circulation, focuses on regulating the functions of the internal organs as a whole. It uses Rehmannia glutinosa to nourish the kidneys and Yin, Ophiopogon japonicus to nourish the lungs and Yin, Scutellaria baicalensis and Morus alba root bark to clear heat from the lungs, Artemisia annua to clear heat from the liver and gallbladder, Paeonia suffruticosa root bark and Paeonia lactiflora root bark to promote blood circulation and remove blood stasis in the heart and liver meridians, and Achyranthes bidentata root to promote blood circulation and remove blood stasis in the liver and kidney meridians.

[0034] 3. A combination of tonification and purgation. In this invention, Rehmannia glutinosa and Ophiopogon japonicus are tonifying herbs for the lungs and kidneys, while Paeonia suffruticosa, Paeonia lactiflora, and Achyranthes bidentata are purgatives for promoting blood circulation and removing blood stasis. Scutellaria baicalensis, Morus alba root bark, and Artemisia annua are added to clear internal heat. This combination of tonification and purgation enhances the therapeutic effect. This herbal preparation tonifies without causing stagnation, overcoming the common drawback of traditional tonifying preparations where the longer they are taken, the less effective they become. This is the unique feature of this invention.

[0035] This invention presents a unique traditional Chinese medicine formulation for treating systemic lupus erythematosus (SLE), with a simple composition of pure Chinese herbal ingredients. It is inexpensive, convenient to take, highly effective, fast-acting, and without toxic side effects. If it can be mass-produced and marketed, it will significantly alleviate the condition and clinical symptoms of SLE patients, reduce their financial burden, and bring substantial economic benefits to society. Detailed Implementation

[0036] The present invention will be further described below with reference to specific embodiments. The following examples will enable those skilled in the art to more fully understand the present invention, but do not limit the present invention in any way.

[0037] Example 1:

[0038] Weigh out 10g of Rehmannia glutinosa, 6g of Paeonia suffruticosa, 6g of Ophiopogon japonicus, 6g of Paeonia lactiflora, 20g of Scutellaria baicalensis, 20g of Morus alba root bark, 20g of Artemisia annua, 6g of Achyranthes bidentata, and 6g of Glycyrrhiza uralensis. Decocted in water twice daily and taken orally. During medication, patients should avoid wind and cold, regulate their diet, and maintain emotional well-being.

[0039] Example 2:

[0040] Weigh out 15g of Rehmannia glutinosa, 9g of Paeonia suffruticosa, 9g of Ophiopogon japonicus, 9g of Paeonia lactiflora, 30g of Scutellaria baicalensis, 30g of Morus alba root bark, 30g of Artemisia annua, 9g of Achyranthes bidentata, and 9g of Glycyrrhiza uralensis. Decocted in water twice daily and taken orally. During medication, patients should avoid wind and cold, regulate their diet, and maintain emotional well-being.

[0041] Example 3:

[0042] Weigh out 30g of Rehmannia glutinosa, 12g of Paeonia suffruticosa, 12g of Ophiopogon japonicus, 12g of Paeonia lactiflora, 40g of Scutellaria baicalensis, 40g of Morus alba root bark, 40g of Artemisia annua, 12g of Achyranthes bidentata, and 12g of Glycyrrhiza uralensis. Decocted in water twice daily and taken orally. During medication, patients should avoid wind and cold, regulate their diet, and maintain emotional well-being.

[0043] Five typical clinical cases are presented below:

[0044] Case 1: Ms. Zhang, 53 years old, company director. She had a 17-year history of recurrent facial erythema and a 1-month history of fever. In July 2006, she developed facial erythema and photosensitivity without any obvious cause, which she did not pay attention to at the time. In 2008, she sought medical attention at Renji Hospital in Shanghai, where tests showed ANA (+) and DS... - The patient tested positive for DNA and was diagnosed with systemic lupus erythematosus (SLE). After oral administration of methylprednisolone 48mg once daily, the condition improved, and the hormone dosage was gradually reduced until it was discontinued spontaneously in 2019. In late July 2023, the patient developed a fever, with a maximum temperature of 38.4°C, scattered skin rashes with itching, oral ulcers, and fatigue. The patient was admitted to our department on August 31, 2023. Treatment included intravenous ceftriaxone sodium 2.0g once daily for infection, intravenous dexamethasone 20mg once daily for strong anti-inflammatory effects, and intravenous human immunoglobulin 20g once daily to enhance immunity. The fever subsided after this treatment. The traditional Chinese medicine preparation of this invention was added to the treatment regimen. After one month of use, the patient reported a significant reduction in facial erythema, a significant improvement in fatigue, and no fever or oral ulcers.

[0045] Case 2: Ms. Wang, 39 years old, an employed worker. She had experienced polyarthritis accompanied by leukopenia for over 5 years. In February 2018, she developed pain in both hands without any obvious cause and did not receive systematic treatment. In November 2019, she experienced recurrent fever, with a highest temperature of 39 degrees Celsius. In our department, ANA was 1:1000, ds-DNA was 268.52 RU / ml, and blood tests showed a white blood cell count of 1.61 x 10^9 / L and an erythrocyte sedimentation rate of 37.0 mm / h. Bone marrow smears showed: 1. Functional iron deficiency indicated by iron staining; 2. Active proliferation of nucleated cells in the bone marrow, with proliferation of all three lineages (granulocytes, erythrocytes, and megaloblasts), iron deficiency changes in the erythroid lineage, and a low number of platelet-producing megaloblasts. She was diagnosed with "systemic lupus erythematosus (leukopenia)" and treated with medroxyprogesterone acetate 12mg twice daily, along with buprofen and teltasicephin, but the above symptoms recurred. On August 10, 2023, the patient was admitted to our department due to fatigue and began using the traditional Chinese medicine preparation of this invention. After taking it for 2 weeks, the patient reported that the fatigue was significantly reduced, appetite was good, sleep was good, and there was no fever, chest tightness, palpitations, or joint swelling and pain.

[0046] Case 3: Ms. Song, 55 years old, retired worker. She had experienced dry mouth and dry eyes for over a year, worsening in the past two months. In June 2021, she presented to Renji Hospital in Shanghai with numbness in her right lower limb, dry mouth, and weakness. An ANA test at 1:640 and DS... - DNA (ELISA method) 94.62 RU / ml, anti-SSA (+), anti-centromere B antibody (+), erythrocyte sedimentation rate 40 mm / h, considered "Sjögren's syndrome (complex with ds - The patient was diagnosed with systemic lupus erythematosus (SLE) and was given oral methylprednisolone 0.6 mg twice daily and oral cyproheptadine 0.2 mg once daily for immunosuppressive therapy. In September 2021, the patient was hospitalized at Shanghai Municipal Hospital of Traditional Chinese Medicine due to foamy urine (4+ proteinuria) and fatigue. The diagnosis was "1. Systemic lupus erythematosus nephritis; 2. Sjögren's syndrome". The patient was given intravenous methylprednisolone 80 mg once daily, which was gradually reduced thereafter. In early October 2021, cyclophosphamide 0.8 mg was added intravenously once a month (last use on July 26, 2023). In the past two months, the patient's fatigue worsened, and the patient was hospitalized in our hospital on September 25, 2023. The patient was given the traditional Chinese medicine preparation of this invention. After taking it for 2 weeks, the patient reported significant relief from fatigue and dry mouth, and the foamy urine disappeared.

[0047] Case 4: Ms. Chen, 25 years old, a company employee. She had been diagnosed with thrombocytopenia for nearly 3 years and experienced multiple joint pain for one week. In September 2021, the patient experienced chest pain and a platelet count of 20 x 10^9 / L was found at a local hospital. She then went to Ruijin Hospital in Shanghai, where ANA was found to be 1:320 and ds-DNA was 356.1 RU / ml. She was diagnosed with "1. Systemic lupus erythematosus; 2. Secondary thrombocytopenia" and was prescribed prednisone 20mg twice daily orally, cyclosporine 50mg twice daily orally, and intravenous infusion of betaine. For the past week, the patient experienced multiple joint pains accompanied by fatigue. She was given the traditional Chinese medicine preparation of this invention. After two weeks of treatment, she reported significant relief of joint pain and fatigue, with no fever, chest tightness, or palpitations.

[0048] Case 5: Ms. Zheng, 36 years old, company employee. She had experienced fatigue for 3 years and foamy urine for 2 years. In 2021, she developed fatigue without any obvious cause and did not receive systematic treatment. In 2022, she developed generalized edema and foamy urine, and sought medical attention at Shanghai Songjiang Central Hospital. A urine protein test revealed ++++, and a kidney biopsy showed lupus nephritis type V. She was treated with hormones + mycophenolate mofetil + fentanyl + aspirin (details unknown), but the foamy urine did not improve significantly. She had previously been treated with abatacept and cyclophosphamide, but the foamy urine continued to recur. On March 14, 2024, she visited our hospital and was given the traditional Chinese medicine preparation of this invention. After taking it continuously for 2 months, she reported a significant reduction in foamy urine and fatigue, with no fever or lower extremity edema.

[0049] In conclusion, this invention has a significant therapeutic effect on patients with systemic lupus erythematosus, contributing to the development of human health and fully leveraging the advantages of traditional Chinese medicine in treating systemic lupus erythematosus. It meets all the requirements and conditions for an invention patent, therefore, an invention patent application is filed in accordance with the law.

Claims

1. A traditional Chinese medicine preparation for treating systemic lupus erythematosus, characterized in that: Its components, by weight, are: 10-30 parts Rehmannia glutinosa, 6-12 parts Paeonia suffruticosa, 6-12 parts Ophiopogon japonicus, 6-12 parts Paeonia lactiflora, 20-40 parts Scutellaria baicalensis, 20-40 parts Morus alba root bark, 20-40 parts Artemisia annua, 6-12 parts Achyranthes bidentata, and 6-12 parts Glycyrrhiza uralensis.

2. The traditional Chinese medicine preparation for treating systemic lupus erythematosus according to claim 1, characterized in that: Its components, by weight, are: 10 parts Rehmannia glutinosa, 6 parts Paeonia suffruticosa, 6 parts Ophiopogon japonicus, 6 parts Paeonia lactiflora, 20 parts Scutellaria baicalensis, 20 parts Morus alba root bark, 20 parts Artemisia annua, 6 parts Achyranthes bidentata, and 6 parts Glycyrrhiza uralensis.

3. The traditional Chinese medicine preparation for treating systemic lupus erythematosus according to claim 1, characterized in that: Its components, by weight, are: 15 parts Rehmannia glutinosa, 9 parts Paeonia suffruticosa, 9 parts Ophiopogon japonicus, 9 parts Paeonia lactiflora, 30 parts Scutellaria baicalensis, 30 parts Morus alba root bark, 30 parts Artemisia annua, 9 parts Achyranthes bidentata, and 9 parts Glycyrrhiza uralensis.

4. The traditional Chinese medicine preparation for treating systemic lupus erythematosus according to claim 1, characterized in that: Its components, by weight, are: 30 parts Rehmannia glutinosa, 12 parts Paeonia suffruticosa, 12 parts Ophiopogon japonicus, 12 parts Paeonia lactiflora, 40 parts Scutellaria baicalensis, 40 parts Morus alba root bark, 40 parts Artemisia annua, 12 parts Achyranthes bidentata, and 12 parts Glycyrrhiza uralensis.