Traditional Chinese medicine composition for stably maintaining disease activity of systemic lupus erythematosus as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for stably maintaining disease activity of systemic lupus erythematosus as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15-30 parts of radix rehmanniae, 9-15 parts of radix scrophulariae, 9-15 parts of radix paeoniae rubra, 12-15 parts of cortex moutan, 15-30 parts of artemisia apiacea, 15-30 parts of oldenlandia diffusa, 15-30 parts of hairyvein agrimony, 9-18 parts of gentiana macrophylla, 15-30 parts of rhizoma smilacis glabrae, 15-30 parts of centella asiatica and 6-15 parts of raw liquorice. The invention further provides a preparation method and application of the traditional Chinese medicine composition, the traditional Chinese medicine composition can stably maintain systemic lupus erythematosus disease activity for a long time, and is particularly suitable for mild and moderate disease activity (SLEDAI score lt; the traditional Chinese medicine composition can be used for treating systemic lupus erythematosus.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and more specifically to a traditional Chinese medicine composition for stabilizing and maintaining the disease activity of systemic lupus erythematosus, as well as a preparation method and application thereof. Background Art

[0002] Systemic lupus erythematosus (SLE) is one of the most difficult rheumatic and immunological diseases. It is prone to recurrent attacks, which affects long-term prognosis. Therefore, the stable maintenance treatment of SLE faces many challenges. First, although the continuous improvement of SLE diagnosis and treatment plans and the advent of new drugs have made the induction of remission of SLE more successful, a review of long-term cases found that the improvement of SLE patients' condition over 10 years is less than ideal, and the survival rate over 10-20 years has dropped "cliff-like". Therefore, there is still a lack of effective solutions for long-term stable maintenance. Secondly, during the treatment process, drug intolerance and drug-related adverse reactions are also important factors that affect patients' active treatment, forming a vicious cycle of "irregular medication-recurring disease-poor control". Thirdly, the withdrawal of therapeutic drugs (such as glucocorticoids) also carries the risk of inducing disease activity, which also requires clinicians to fully evaluate the disease and formulate a withdrawal plan.

[0003] Therefore, it is very meaningful to develop a drug that can be used to stabilize the activity of systemic lupus erythematosus, especially when used in combination with drugs such as glucocorticoids and immunosuppressants, so that SLE patients can maintain long-term stability for more than 10 years. Summary of the Invention

[0004] In response to the above technical problems, one object of the present invention is to provide a new traditional Chinese medicine composition that can stably maintain the disease activity of systemic lupus erythematosus, and is particularly suitable for systemic lupus erythematosus with mild to moderate disease activity (SLEDAI score <15 points).

[0005] Another object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition and the prepared Chinese medicine preparation.

[0006] Another object of the present invention is to provide the use of the above-mentioned Chinese medicine composition and Chinese medicine preparation in the preparation of drugs for stably maintaining the disease activity of systemic lupus erythematosus.

[0007] In order to achieve the above object, the present invention adopts the following technical solutions:

[0008] In a first aspect, the present invention provides a traditional Chinese medicine composition for stabilizing and maintaining the disease activity of systemic lupus erythematosus, wherein the raw materials of the traditional Chinese medicine composition include: raw rehmannia, scrophularia, red peony root, moutan bark, artemisia annua, oldenlandia diffusa, agrimony, gentiana macrophylla, smilax glabra, centella asiatica and raw licorice.

[0009] Preferably, the raw materials of the traditional Chinese medicine composition include, by weight, 15-30 parts of raw rehmannia, 9-15 parts of scrophularia, 9-15 parts of red peony root, 12-15 parts of moutan bark, 15-30 parts of artemisia annua, 15-30 parts of oldenlandia diffusa, 15-30 parts of agrimony, 9-18 parts of gentiana macrophylla, 15-30 parts of smilax glabra, 15-30 parts of centella asiatica, and 6-15 parts of raw licorice.

[0010] The formula emphasizes raw rehmannia and scrophulariae, which are the main ingredients for nourishing yin, clearing heat and cooling blood; red peony root and moutan bark cool blood and disperse blood stasis, artemisia annua and white flower snake tongue grass clear heat and detoxify as assistant ingredients, while herb agrimony, astragalus macrophylla, wild yam, centella asiatica and raw licorice are the adjuvant ingredients for clearing heat and detoxifying, removing dampness, purging turbidity and stabilizing the body; all the herbs are used together to achieve the effects of nourishing yin, clearing heat and cooling blood, detoxifying, dispersing blood stasis and turbidity, and eliminating evil and stabilizing the body.

[0011] Illustratively, the Chinese medicine composition for stably maintaining the disease activity of systemic lupus erythematosus includes, in parts by weight, the raw materials of the Chinese medicine composition including: 30 parts of raw rehmannia, 12 parts of scrophulariae, 15 parts of red peony root, 15 parts of moutan bark, 15 parts of artemisia annua, 30 parts of oldenlandia diffusa, 15 parts of agrimony, 18 parts of gentiana macrophylla, 30 parts of wild yam, 30 parts of centella asiatica, and 9 parts of raw licorice.

[0012] Illustratively, the Chinese medicine composition for stably maintaining the disease activity of systemic lupus erythematosus includes, in parts by weight, the raw materials of the Chinese medicine composition: 15 parts of raw rehmannia, 12 parts of scrophulariae, 15 parts of red peony root, 12 parts of moutan bark, 15 parts of artemisia annua, 15 parts of oldenlandia diffusa, 30 parts of agrimony, 18 parts of gentiana macrophylla, 30 parts of wild yam, 15 parts of centella asiatica, and 9 parts of raw licorice.

[0013] Illustratively, the Chinese medicine composition for stably maintaining the disease activity of systemic lupus erythematosus includes, in parts by weight, the raw materials of the Chinese medicine composition: 15 parts of raw rehmannia, 15 parts of scrophulariae, 12 parts of red peony root, 12 parts of moutan bark, 15 parts of artemisia annua, 15 parts of oldenlandia diffusa, 30 parts of agrimony, 15 parts of gentiana macrophylla, 15 parts of smilax glabra, 15 parts of centella asiatica, and 6 parts of raw licorice.

[0014] The raw materials of the above-mentioned traditional Chinese medicine composition of the present invention constitute the basic formula. In specific embodiments, the above-mentioned traditional Chinese medicine composition can be adjusted based on clinical symptoms to achieve the purpose of stabilizing and maintaining the disease activity of systemic lupus erythematosus and improving certain specific clinical symptoms, further enhancing the adaptability of the composition of the present invention and improving the therapeutic effect. These adjustments based on the basic formula of the present invention are also within the scope of protection of this application.

[0015] In a second aspect, to facilitate implementation by those skilled in the art, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for stably maintaining the disease activity of systemic lupus erythematosus, the preparation method comprising:

[0016] (1) Take the above raw materials according to the weight of each raw material, add 5-8 times the weight of water of the total raw materials, boil at normal pressure for 30-40 minutes, and filter to obtain filtrate a and filter residue a for standby use;

[0017] (2) adding water 3-5 times the weight of the total raw material drug to the filter residue a obtained in step (1), boiling at normal pressure for 25-30 minutes, and filtering to obtain filtrate b and filter residue b, which are set aside;

[0018] (3) The filtrate a obtained in step (1) and the filtrate b obtained in step (2) are uniformly mixed to obtain the product.

[0019] Those skilled in the art should understand that the above preparation method is only exemplary and it is not necessary to use the above method to prepare the traditional Chinese medicine composition.

[0020] In a third aspect, the present invention provides a traditional Chinese medicine preparation for stabilizing and maintaining disease activity in systemic lupus erythematosus, the preparation being prepared using the aforementioned traditional Chinese medicine composition as a raw material. The traditional Chinese medicine composition of the present invention can be prepared according to conventional preparation methods in the art, such as decoction, maceration, reflux, and the like, and then formulated into various traditional Chinese medicine dosage forms. Optionally, pharmaceutically acceptable excipients may be added during preparation, depending on the actual formulation requirements.

[0021] The dosage forms of the Chinese medicine preparations include decoctions, soups, granules, capsules, tablets, powders, pills or oral liquids, etc.

[0022] In a fourth aspect, the present invention further provides the use of the above-mentioned Chinese medicine composition or the above-mentioned Chinese medicine preparation in the preparation of a drug for stably maintaining the disease activity of systemic lupus erythematosus.

[0023] Furthermore, the systemic lupus erythematosus disease activity refers to mild to moderate activity of systemic lupus erythematosus disease, with a SLEDAI score of <15 points.

[0024] In addition, unless otherwise specified, the raw materials of the Chinese medicine composition of the present invention can be obtained commercially, and any range recorded in the present invention, including the end values ​​and any numerical values ​​between the end values, and any sub-range of Chinese medicine compositions composed of the end values ​​or any numerical values ​​between the end values, can achieve the purpose of stably maintaining the disease activity of systemic lupus erythematosus.

[0025] The beneficial effects of the present invention are as follows:

[0026] The Chinese medicine composition of the present invention not only effectively controls disease activity and reduces relapses in the treatment of systemic lupus erythematosus (SLE), but also maintains a stable SLE condition for at least 10 years and facilitates steroid withdrawal. The inventors combined this Chinese medicine composition with standard SLE treatments, significantly improving the clinical efficacy of glucocorticoids and immunosuppressants. This allows clinicians to choose from a variety of treatment options. Combined with Western medicine, it achieves a "synergistic, stabilizing" effect, increasing patient compliance with medication, alleviating disease activity, maintaining stable disease response, facilitating steroid withdrawal, improving quality of life, and reducing complications and mortality. DETAILED DESCRIPTION

[0027] In order to explain the present invention more clearly, the present invention is further described below in conjunction with preferred embodiments. Those skilled in the art should understand that the following specific description is illustrative rather than restrictive and should not be used to limit the scope of protection of the present invention.

[0028] Example 1 A Chinese medicine composition for stabilizing and maintaining the disease activity of systemic lupus erythematosus

[0029] Raw material formula: 30g of Rehmannia glutinosa, 12g of Scrophularia ningpoensis, 15g of Red Peony Root, 15g of Cortex Moutan, 15g of Artemisia annua, 30g of Hedyotis diffusa, 15g of Agrimoniae, 18g of Gentiana macrophylla, 30g of Smilax glabra, 30g of Centella asiatica, and 9g of raw licorice.

[0030] Example 2 A Chinese medicine composition for stabilizing and maintaining the disease activity of systemic lupus erythematosus

[0031] Raw material formula: 15g of raw rehmannia, 12g of Scrophularia, 15g of red peony root, 12g of moutan bark, 15g of artemisia annua, 15g of oldenlandia diffusa, 30g of agrimony, 18g of gentiana, 30g of wild smilax, 15g of centella asiatica, and 9g of raw licorice.

[0032] Example 3 A Chinese medicine composition for stabilizing and maintaining the disease activity of systemic lupus erythematosus

[0033] Raw material formula: 15g of raw rehmannia, 15g of Scrophularia, 12g of red peony root, 12g of moutan bark, 15g of artemisia annua, 15g of oldenlandia diffusa, 30g of agrimony, 15g of gentiana, 15g of wild smilax, 15g of centella asiatica, and 6g of raw licorice.

[0034] Example 4 Typical Cases

[0035] Five respondents were selected as typical cases of the present invention's drug in the stable maintenance treatment of SLE, and are represented by codes A to E. The information of the respondents is as follows:

[0036] Table 1. Basic information of patients

[0037]

[0038] Typical case 1:

[0039] Zhang, a female patient designated A, was born in 1984. She presented with joint pain and rash in 2009, and subsequently developed positive ANA, positive ds-DNA, decreased complement, proteinuria (up to 1.1 g / 24 h), and leukocytopenia, leading to a diagnosis of systemic lupus erythematosus. She began attending our outpatient clinic in November 2009 with a SLEDAI score of 14. She began oral treatment with the traditional Chinese medicine preparation of the present invention, with subsequent adjustments based on follow-up visits. The basic Chinese medicine formula is as follows: 30 g of Radix Rehmanniae, 12 g of Scrophulariae, 15 g of Radix Paeoniae Rubra, 15 g of Cortex Moutan, 15 g of Artemisia Annua, 30 g of Hedyotis Diffusa, 15 g of Agrimoniae Herba, 18 g of Gentiana Macrophylla, 30 g of Smilax glabra, 30 g of Centella asiatica, and 9 g of Radix Glycyrrhizae (raw liquorice). This dose was taken once daily, taken warm in two divided doses after decoction. Alternatively, an equivalent dose of traditional Chinese medicine granules was administered. She continues to receive regular follow-up visits at our outpatient clinic.

[0040] Over the past 10 years, the patient has taken oral (or combined) glucocorticoids (maximum dose of prednisone 50mgqd), leflunomide, hydroxychloroquine, compound cyclophosphamide, mycophenolate mofetil, and tacrolimus for anti-inflammatory and immune suppression. Combined with the above-mentioned Chinese medicine compound and Western medicine treatment, the Chinese medicine preparation of the present invention is taken orally 1-2 times a day (1 dose). Overall, the condition is under stable control. The most recent follow-up visit time: January 30, 2024. The patient's symptoms are stable, the SLEDAI score is 2 points, and the blood routine + CRP (24-01-11) shows: WBC 6.24×10 9 / L, RBC 4.52×10 12 / L, HGB 139g / L, PLT 191×10 9 / L, CRP<0.5mg / L; erythrocyte sedimentation rate (24-01-11) showed: 7mm / h; complete biochemistry panel + rheumatology routine (24-01-11) showed: Cr 56umol / L, ALB 41g / L, complement C3 1.14g / L, complement C4 0.39g / L; urinalysis showed (24-01-30): white blood cells, red blood cells, and urine protein were all negative; ANA antibody spectrum showed (23-11-17): ANA positive (1:100 nuclear granular type), ds-DNA (-), anti-Sm (-).

[0041] Typical case 2:

[0042] Qin, a female patient designated B, was born in 1983. In 2001, she developed fever, facial erythema, and joint and muscle pain. After completing rheumatic immune antibody tests and other related tests at an external hospital, she was diagnosed with systemic lupus erythematosus. She was treated with glucocorticoids, cyclophosphamide, and hydroxychloroquine, with good symptom control, and her SLEDAI score fluctuated between 8 and 14. In May 2012, she began oral treatment with the traditional Chinese medicine preparation of the present invention due to recurrent joint and muscle pain accompanied by gastrointestinal discomfort. The basic TCM formula is as follows: 15g of Radix Rehmanniae, 15g of Scrophulariae, 12g of Radix Paeoniae Rubra, 12g of Cortex Moutan, 15g of Artemisia Annua, 15g of Hedyotis Diffusa, 30g of Agrimoniae, 15g of Gentiana Macrophylla, 15g of Smilax glabra, 15g of Centella asiatica, and 6g of Radix Glycyrrhizae. The dosage is one dose daily, taken warm in two divided doses after decoction. Alternatively, an equivalent dose of traditional Chinese medicine granules is available. She continues to receive regular follow-up in our outpatient clinic.

[0043] The patient's condition remained stable (SLEDAI score ≤ 4 points) after receiving the above-mentioned Chinese herbal compound treatment, and the combined regimen was gradually stabilized to low-dose glucocorticoids + azathioprine. In 2019, due to the pressure of pregnancy preparation and work pressure, the patient began to interrupt the treatment of the Chinese medicine preparation of the present invention on her own. On the morning of August 2, she suddenly developed nausea, headache, convulsion, loss of consciousness, and vomiting, so she was rushed to the local hospital by 120. Brain CT showed cystic dilatation of the cistern magnum, and brain MRI showed: 1. Stenosis of the A2 segment of the left anterior cerebral artery 2. Abnormal signals around the ventricles on both sides of the posterior part of the centrum semiovale, which was considered to be a white matter lesion (demyelination) 3. Arachnoid cysts in the posterior part of the cerebellar hemispheres 4. Lack of uniform signals in the anterior pituitary gland. She was diagnosed with "lupus encephalopathy" and was given a large dose of glucocorticoids intravenous pulse for 3 days + human immunoglobulin intravenous infusion of 20 g / day * 3 days in combination with the above-mentioned oral Chinese medicine compound. The patient regained consciousness in the afternoon of the same day. When she was discharged from the hospital, her SLEDAI score was 14 points. Her routine blood test was (-), ESR 22 mm / h, Cr 46 μmol / L, and ALB. 33.1g / L, ANA homogeneous type 1:1000, urine protein (-). After that, the patient regularly visited our outpatient clinic and insisted on taking the Chinese medicine preparation of the present invention orally every day. The basic Chinese medicine prescription was adjusted as follows: 30g of Rehmannia glutinosa, 12g of Scrophularia ningpoensis, 15g of Red Peony Root, 15g of Paeonia lactiflora, 15g of Artemisia annua, 30g of Hedyotis diffusa, 15g of Agrimoniae, 18g of Gentiana macrophylla, 30g of Smilax glabra, 30g of Centella asiatica, 9g of Licorice root, combined with glucocorticoids, mycophenolate mofetil, compound cyclophosphamide, hydroxychloroquine, and sodium valproate. The condition has been stable so far. The last follow-up time was April 7, 2023. The patient's symptoms were stable (SLEDAI score: 4 points). The blood routine test (23-04-03) showed: WBC 3.68×10 9 / L, RBC 4.39×10 12 / L, HGB 137g / L, PLT 144×10 9 / L, CRP<0.5mg / L; erythrocyte sedimentation rate (23-04-03) showed: 2mm / h; complete biochemistry panel + routine rheumatology test (23-04-03) showed: Cr 66umol / L, ALB 41.4g / L, complement C3 0.74g / L↓, complement C4 0.11g / L; routine urinalysis (23-04-03) showed: white blood cells, red blood cells, and urine protein were all negative; ANA antibody spectrum showed (23-04-03): ANA positive (1:100 homogeneous type), ds-DNA (-), anti-Sm (-); antiphospholipid antibody spectrum (-); ANCA-related antibody spectrum (-).

[0044] Typical case three:

[0045] Code name C, Zhang, female, born in 1985, developed facial erythema, persistent low-grade fever, joint pain, and hair loss in 2011 due to work fatigue and cold. In February 2011, C3 0.26g / L, C4 0.03g / L, ANA 1:1280, anti-double-stranded DNA 1:80, titer >800, ESR 25, diagnosed with "systemic lupus erythematosus", SLEDAI score 13 points, and was given glucocorticoids (maximum dose of prednisone 50mg The patient was treated with 100mg of Radix Rehmanniae 15g, Radix Scrophulariae 12g, Radix Paeoniae Rubra 15g, Cortex Moutan 12g, Artemisia Annua 15g, Herba Hedyotis Diffusae 15g, Herba Agrimoniae 30g, Radix Gentianae Macrophyllae 18g, Rhizoma Smilacis Glabrae 30g, Herba Centellae 15g, and Radix Glycyrrhizae 9g, once a day, taken warm in two doses after decoction in water, or an equivalent dose of Chinese herbal granules. The symptoms were stable. In 2014, routine blood test, liver and kidney function, erythrocyte sedimentation rate, routine urine test, and abdominal ultrasound showed no obvious abnormalities, and the SLEDAI score was 0.

[0046] In 2018, the patient felt that her condition was under control and she began to have the desire to get pregnant. Therefore, she took the medicine irregularly and stopped the treatment of the Chinese medicine preparation of the present invention for more than half a year. The follow-up examination in October 2018 showed: blood routine: WBC 5.19×10 9 / L, HGB 143g / L, PLT 221×10 9 / L; Rheumatology routine test showed: Complement C3 0.38g / L↓, Complement C4 0.058↓g / L, IgM 0.32↓g / L; Rheumatology immune antibody profile showed: ANA (IgG) H1: 1280, anti-dsDNA 782IU / ml↑, anti-Sm (+), anti-RNP (+), anti-histone antibody ++, anti-nucleosome antibody +; Antiphospholipid antibody profile showed: β2GP1-IgA 54U / ml↑, ACL-IgAGM 16U / ml↑; Urinalysis (-), ESR (-). After the outpatient physician's reminder, the patient took medication regularly. In December 2018, the patient's urine HCG test was positive (+). The medication regimen was adjusted to: the traditional Chinese medicine preparation of the present invention + aspirin. The condition was under stable control. In June 2019, she developed "Listeria infection" during pregnancy. After anti-infection treatment, the symptoms stabilized, and the patient gave birth smoothly in July 2019.

[0047] The patient's follow-up in August 2019 showed: blood routine: WBC 6.52×10 9 / L, HGB 100g / L↓, PLT 314×10 9 / L; biochemistry + rheumatology routine showed: ALB 30.5g / L↓, complement C3 0.424g / L↓, IgM 0.201g / L↓; urinalysis (-); chest CT showed no abnormalities. The medication regimen was adjusted to: the Chinese herbal preparation of the present invention + low-dose glucocorticoids (prednisone 10mg daily) + hydroxychloroquine + azathioprine. The basic TCM formula was adjusted as follows: 30g of Radix Rehmanniae, 12g of Scrophulariae, 15g of Red Peony Root, 15g of Cortex Moutan, 15g of Artemisia Annua, 30g of Hedyotis Diffusa, 15g of Agrimoniae, 18g of Gentiana Macrophylla, 30g of Smilax glabra, 30g of Centella asiatica, and 9g of Licorice Root. In January 2022, due to stable condition, glucocorticoids were gradually withdrawn, and the SLEDAI score was 4. The patient continued to take the Chinese herbal preparation of the present invention + hydroxychloroquine + azathioprine daily, and his condition has remained stable to date.

[0048] Typical case 4:

[0049] Codenamed D, Zhang, female, born in 1985, developed recurrent low-grade fever, fatigue, facial erythema, joint pain, and decreased white blood cell count in 2006. She was diagnosed with "systemic lupus erythematosus" after examination. Her SLEDAI score fluctuated between 8 and 12 points, and she was treated with glucocorticoids and hydroxychloroquine. In 2013, she began to take oral treatment with the Chinese medicine preparation of the present invention. The basic Chinese medicine formula is as follows: 30g of Rehmannia glutinosa, 12g of Scrophularia ningpoensis, 15g of Red Peony Root, 15g of Cortex Moutan, 15g of Artemisia annua, 30g of Hedyotis diffusa, 15g of Agrimoniae, 18g of Gentiana macrophylla, 30g of Smilax glabra, 30g of Centella asiatica, and 9g of raw liquorice, one dose per day, taken warm in two doses after decocting rice, or an equivalent dose of Chinese medicine granules. Her symptoms improved significantly, and she is still regularly followed up in our outpatient clinic.

[0050] During 2018-2020, the patient had to travel to many places due to occupational reasons and began to voluntarily interrupt the treatment of the Chinese medicine preparation of the present invention for nearly 1 year. During this period, he had intermittent attacks of blood system involvement after repeated infections (white blood cells and hemoglobin were repeatedly reduced, and WBC was as low as 2.02×10 9 / L, HGB as low as 93g / L), SLEDAI score was 12 points, glucocorticoid dosage increased (maximum dose to prednisone 50mg qd), immunosuppressants were successively increased tacrolimus and sirolimus, and gastrointestinal discomfort occurred many times during medication. From October to November 2020, he was hospitalized for "mesenteric lesion and pseudo-intestinal obstruction" due to severe gastrointestinal discomfort. During this period, he was given prednisone pulse treatment for 3 days. After that, the symptoms improved after combined with daily oral treatment of the traditional Chinese medicine preparation of the present invention. The basic Chinese medicine prescription was adjusted as follows: 15g of raw earth, 12g of Scrophularia, 15g of red peony root, 12g of moutan bark, 15g of artemisia annua, 15g of white flower snake tongue grass, 30g of hairy agrimony, 18g of gentian, 30g of smilax glabra, 15g of centella asiatica, and 9g of raw licorice. After that, the condition gradually stabilized and the patient regularly visited our outpatient clinic for follow-up. The most recent follow-up visit was on November 7, 2023. The main symptoms were intermittent fatigue, occasional joint pain, and no other special discomfort. The SLEDAI score was 4 points. The blood routine examination (23-10-16) showed: WBC 4.62×10 9 / L, RBC 4.28×10 12 / L, HGB 125g / L, PLT 282×10 9 / L; complete biochemistry panel + routine rheumatology test (23-10-16) showed: Cr 55umol / L, ALB 44g / L, complement C3 0.88g / L↓, complement C4 0.018g / L; routine urine test (-).

[0051] Typical case five:

[0052] Codenamed E, Ding, male, born in 1974, developed rash, joint pain, foamy urine, and fatigue in 2005. After examination, he was diagnosed with "systemic lupus erythematosus" with a SLEDAI score of 14. He was treated with glucocorticoids + hydroxychloroquine, but the symptoms recurred. Since 2008, the patient has been treated with oral administration of the Chinese medicine preparation of the present invention. The basic Chinese medicine prescription is as follows: 15g of Rehmannia glutinosa, 15g of Scrophularia ningpoensis, 12g of Paeonia lactiflora, 12g of Cortex Moutan, 15g of Artemisia annua, 15g of Hedyotis diffusa, 30g of Agrimoniae, 15g of Gentiana macrophylla, 15g of Smilax glabra, 15g of Centella asiatica, and 6g of Licorice root, one dose per day, taken warm in two doses after decocting rice, or Chinese medicine granules of the same dose. The symptoms have been significantly improved. Since then, the patient has received systematic diagnosis and treatment with standardized Chinese and Western medicine, and has insisted on taking the above-mentioned Chinese medicine compound orally every day. The condition has been stably controlled, the 24-hour urine protein quantity has been controlled at <0.53g, and no renal damage has occurred in the past 6 years. The patient is still regularly followed up in our outpatient clinic. The current regimen is: the Chinese medicine preparation of the present invention + hydroxychloroquine + mycophenolate mofetil.

[0053] The last follow-up visit was on November 29, 2023. The symptoms were under stable control, with scattered rashes on the chest and back. Fatigue was significantly improved compared with before, there was no foamy urine, and no other obvious discomfort. The SLEDAI score was 2. Reexamination: routine blood test + CRP (23-11-22) showed: no obvious abnormalities in white blood cells, red blood cells, hemoglobin, platelets, and CRP; 24-hour urine protein quantification and urine routine test (23-11-24) showed: no obvious abnormalities.

[0054] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not limitations on the implementation methods of the present invention. For ordinary technicians in the relevant field, other different forms of changes or modifications can be made based on the above description. It is impossible to list all the implementation methods here. All obvious changes or modifications derived from the technical solution of the present invention are still within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for stabilizing and maintaining the disease activity of systemic lupus erythematosus, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition include: 15-30 parts of raw rehmannia, 9-15 parts of figwort, 9-15 parts of red peony root, 12-15 parts of moutan bark, 15-30 parts of artemisia annua, 15-30 parts of oldenlandia diffusa, 15-30 parts of agrimony, 9-18 parts of gentiana macrophylla, 15-30 parts of smilax glabra, 15-30 parts of centella asiatica, and 6-15 parts of raw licorice.

2. The Chinese medicine composition according to claim 1, characterized in that In parts by weight, the raw materials of the traditional Chinese medicine composition include: 30 parts of raw rehmannia, 12 parts of scrophularia, 15 parts of red peony root, 15 parts of moutan bark, 15 parts of artemisia annua, 30 parts of oldenlandia diffusa, 15 parts of agrimony, 18 parts of gentiana, 30 parts of wild yam, 30 parts of centella asiatica, and 9 parts of raw licorice.

3. The Chinese medicine composition according to claim 2, characterized in that In parts by weight, the raw materials of the traditional Chinese medicine composition include: 15 parts of raw rehmannia, 12 parts of scrophulariae, 15 parts of red peony root, 12 parts of moutan bark, 15 parts of artemisia annua, 15 parts of oldenlandia diffusa, 30 parts of agrimony, 18 parts of gentiana macrophylla, 30 parts of smilax glabra, 15 parts of centella asiatica, and 9 parts of raw licorice.

4. The Chinese medicine composition according to claim 2, characterized in that In parts by weight, the raw materials of the traditional Chinese medicine composition include: 15 parts of raw rehmannia, 15 parts of scrophulariae, 12 parts of red peony root, 12 parts of moutan bark, 15 parts of artemisia annua, 15 parts of oldenlandia diffusa, 30 parts of agrimony, 15 parts of gentiana macrophylla, 15 parts of smilax glabra, 15 parts of centella asiatica, and 6 parts of raw licorice.

5. The method for preparing the traditional Chinese medicine composition for stabilizing and maintaining the disease activity of systemic lupus erythematosus according to any one of claims 1 to 4, characterized in that: The preparation method comprises: (1) Take the above raw materials according to the weight of each raw material, add 5-8 times the weight of water of the total raw materials, boil at normal pressure for 30-40 minutes, and filter to obtain filtrate a and filter residue a for standby use; (2) adding water 3-5 times the weight of the total raw material drug to the filter residue a obtained in step (1), boiling at normal pressure for 25-30 minutes, and filtering to obtain filtrate b and filter residue b, which are set aside; (3) The filtrate a obtained in step (1) and the filtrate b obtained in step (2) are uniformly mixed to obtain the product.

6. A Chinese medicine preparation for stabilizing and maintaining the disease activity of systemic lupus erythematosus, characterized in that: The traditional Chinese medicine preparation is prepared using the traditional Chinese medicine composition according to any one of claims 1 to 4 as a raw material.

7. The Chinese medicine preparation according to claim 6, characterized in that The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

8. The Chinese medicine preparation according to claim 6 or 7, characterized in that The dosage forms of the Chinese medicine preparation include decoction, soup, granules, capsules, tablets, powders, pills or oral liquids.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 or the traditional Chinese medicine preparation according to any one of claims 6 to 8 in the preparation of a drug for stabilizing and maintaining the disease activity of systemic lupus erythematosus.

10. The use according to claim 9, characterized in that The systemic lupus erythematosus disease activity refers to mild to moderate activity of systemic lupus erythematosus disease, with a SLEDAI score of <15 points.

Images