Traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus and application thereof.The traditional Chinese medicine composition is reasonably combined according to etiology and pathogenesis of systemic lupus erythematosus, pseudo-ginseng, ginseng, glossy privet fruit and syngnathus serve as monarch drugs, and the traditional Chinese medicine composition has the effects of promoting blood circulation to remove blood stasis, nourishing the liver and tonifying the kidney and directly tonifying yin deficiency of the liver and the kidney; salvia miltiorrhiza, safflower, peach kernel, American ginseng, codonopsis pilosula, prepared rhizome of rehmannia, wolfberry, mulberry and panax japonicus are taken as ministerial drugs and are matched to assist the monarch drugs and clear stasis heat, cornu cervi pantotrichum, herba epimedii, hippocampus, pericarpium citri reticulatae, polygonum multiflorum, angelica sinensis, radix paeoniae alba, rhizoma polygonati and dog kidney are taken as adjuvant and conductant drugs and assist the monarch and ministerial drugs to harmonize yin and yang, all the drugs are matched and have a synergistic effect, and the effects of nourishing kidney and replenishing essence, reinforcing qi and nourishing yin, promoting blood circulation to remove meridian obstruction, warming yang and removing stasis can be achieved. The traditional Chinese medicine can treat both symptoms and root causes, and can effectively treat systemic lupus erythematosus.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of pharmaceutical technology, in particular to a traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus and application thereof. BACKGROUND

[0002] Systemic lupus erythematosus (SLE) is an autoimmune disease involving many systemic organs. Under the interaction of various factors such as genetic factors, environmental factors and estrogen levels, T lymphocytes decrease, macrophage function is inhibited, B cells overgrow, a large number of autoantibodies are produced, and corresponding immune complexes are formed by combining with the corresponding autoantigens in the body, and deposited in the skin, joints, small blood vessels, glomeruli and other parts. Under the participation of complement, acute and chronic inflammation and tissue necrosis (such as lupus nephritis) are caused. It can involve skin, serosa, joints, kidneys and central nervous system, and is characterized by autoimmunity. Patients have multiple autoantibodies, which affect not only humoral immunity, but also cellular immunity, and the complement system also changes.

[0003] At present, systemic lupus erythematosus can be treated by using non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids (such as prednisone), immunosuppressants (such as cyclophosphamide, methotrexate, etc.) or antimalarial drugs (such as hydroxychloroquine, chloroquine, etc.). However, the use of the above drugs for treatment usually has large side effects. Systemic lupus erythematosus belongs to the category of "yin-yang toxin", "red butterfly rash", "sunburn", "butterfly rash" and "week bim" in traditional Chinese medicine. Many studies have shown that the use of traditional Chinese medicine for treatment has small side effects and can treat systemic lupus erythematosus to different degrees, and is favored in the clinical stage. Therefore, it is very meaningful to explore and develop more safe, reliable and effective traditional Chinese medicine agents for treating systemic lupus erythematosus. SUMMARY

[0004] Therefore, based on the above background, the present application provides a traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus and application thereof.

[0005] The technical scheme provided by the present application is as follows:

[0006] A traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus, which is composed of the following raw materials:

[0007] Salvia miltiorrhiza 10-20 parts, Panax notoginseng 150-350 parts, safflower 5-20 parts, peach kernel 5-15 parts, dried tangerine or orange peel 5-15 parts, ginseng 150-350 parts, Codonopsis pilosula 15-25 parts, American ginseng 10-20 parts, Panax japonicus 5-20 parts, angelica 10-20 parts, prepared rehmannia 20-50 parts, white peony root 10-20 parts, radix polygonati 3-10 parts, polygonatum 10-20 parts, medlar 10-20 parts, ligustrum 80-120 parts, mulberry 10-20 parts, sea horse 5-15 parts, sea dragon 80-150 parts, dog kidney 10-30 parts, deer horn 10-30 parts, Herba Epimedii 5-20 parts.

[0008] Further, it is composed of the following raw materials:

[0009] Salvia miltiorrhiza 10-20 parts, Panax notoginseng 150-350 parts, safflower 5-20 parts, peach kernel 5-15 parts, dried tangerine or orange peel 5-15 parts, ginseng 150-350 parts, Codonopsis pilosula 15-25 parts, American ginseng 10-20 parts, Panax japonicus 5-20 parts, angelica 10-20 parts, prepared rehmannia 20-50 parts, white peony root 10-20 parts, radix polygonati 3-10 parts, polygonatum 10-20 parts, medlar 10-20 parts, ligustrum 80-120 parts, mulberry 10-20 parts, sea horse 5-15 parts, sea dragon 80-150 parts, dog kidney 10-30 parts, deer horn 10-30 parts, Herba Epimedii 5-20 parts.

[0010] Further, it is composed of the following raw materials:

[0011] Salvia miltiorrhiza 10-20 parts, Panax notoginseng 150-350 parts, safflower 5-20 parts, peach kernel 5-15 parts, dried tangerine or orange peel 5-15 parts, ginseng 150-350 parts, Codonopsis pilosula 15-25 parts, American ginseng 10-20 parts, Panax japonicus 5-20 parts, angelica 10-20 parts, prepared rehmannia 20-50 parts, white peony root 10-20 parts, radix polygonati 3-10 parts, polygonatum 10-20 parts, medlar 10-20 parts, ligustrum 80-120 parts, mulberry 10-20 parts, sea horse 5-15 parts, sea dragon 80-150 parts, dog kidney 10-30 parts, deer horn 10-30 parts, Herba Epimedii 5-20 parts.

[0012] Further, it is composed of the following raw materials:

[0013] Salvia miltiorrhiza 10-20 parts, Panax notoginseng 150-350 parts, safflower 5-20 parts, peach kernel 5-15 parts, dried tangerine or orange peel 5-15 parts, ginseng 150-350 parts, Codonopsis pilosula 15-25 parts, American ginseng 10-20 parts, Panax japonicus 5-20 parts, angelica 10-20 parts, prepared rehmannia 20-50 parts, white peony root 10-20 parts, radix polygonati 3-10 parts, polygonatum 10-20 parts, medlar 10-20 parts, ligustrum 80-120 parts, mulberry 10-20 parts, sea horse 5-15 parts, sea dragon 80-150 parts, dog kidney 10-30 parts, deer horn 10-30 parts, Herba Epimedii 5-20 parts.

[0014] Based on the same inventive concept, the application also provides an application of a traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus in the preparation of a medicine for preventing / treating systemic lupus erythematosus.

[0015] Further, the medicine is an oral agent.

[0016] Further, the medicine is one of a powder, a pill, a capsule, a tablet, and an oral liquid.

[0017] The beneficial effects realized by the present application are:

[0018] Systemic lupus erythematosus is mainly caused by congenital deficiency or long-term disease consumption, imbalance of yin and yang, yin damage to yang, spleen and kidney yang deficiency, internal generation of deficiency fire or external invasion, blood thickening due to yin deficiency or blood decoction due to heat and toxin, leading to blood stasis, invasion of viscera, external injury of skin and disease, liver and kidney yin deficiency is the root, heat and blood stasis is the branch, according to the etiology and pathogenesis of systemic lupus erythematosus, the present application reasonably selects the medicine, with radix tienchi, radix ginseng, ligustrum lucidum and sea dragon as the monarch drug, promoting blood circulation and removing blood stasis, nourishing liver and kidney, directly supplementing liver and kidney yin deficiency, radix tienchi promoting blood circulation and removing blood stasis, dredging collaterals and relieving pain, improving microcirculation, radix ginseng greatly supplementing vital energy and benefiting qi and consolidating the exterior, ligustrum lucidum nourishing liver and kidney and clearing deficiency heat, sea dragon tonifying kidney and strengthening yang, resolving and dredging collaterals; with salvia miltiorrhiza, safflower, peach kernel, notoginseng, radix codonopsis, prepared rehmannia, medlar, mulberry, chimonobambusa utilis as the ministerial medicine, which is matched with the monarch drug and also clears stasis heat, salvia miltiorrhiza and safflower are matched to enhance the effect of promoting blood circulation and removing blood stasis, notoginseng and radix codonopsis are matched to tonify qi and yin, prepared rehmannia, medlar and mulberry are matched to nourish kidney and fill essence; with antler, epimedium, sea horse, tangerine peel, radix polygoni multiflori, angelica, radix paeoniae alba, rhizoma polygonati and dog kidney as the auxiliary medicine, which assists the monarch and ministerial medicine to balance yin and yang, antler, epimedium, sea horse and dog kidney are matched to warm kidney and assist yang, tangerine peel regulates qi and invigorates spleen to prevent greasy medicine from hindering stomach, radix polygoni multiflori supplements essence and blood and detoxifies, angelica and radix paeoniae alba are matched to nourish blood and tranquilize the mind, supplement blood and promote blood circulation, soften liver and spleen, sea horse and antler lead medicine into kidney meridian to enhance the effect of nourishing lower jiao, the matched medicines have the functions of nourishing kidney and filling essence, benefiting qi and nourishing yin, promoting blood circulation and dredging collaterals, warming yang and resolving, which can treat the root and branch and effectively treat systemic lupus erythematosus. DETAILED DESCRIPTION

[0019] In order to make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below in combination with the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the protection scope of the present application.

[0020] Embodiment 1: A traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus, which is composed of the following raw materials:

[0021] Salvia miltiorrhiza 15 parts, radix tienchi 300 parts, safflower 10 parts, peach kernel 10 parts, tangerine peel 10 parts, radix ginseng 300 parts, radix codonopsis 20 parts, notoginseng 15 parts, chimonobambusa utilis 10 parts, angelica 13 parts, prepared rehmannia 30 parts, radix paeoniae alba 15 parts, radix polygoni multiflori 6 parts, rhizoma polygonati 15 parts, medlar 15 parts, ligustrum lucidum 100 parts, mulberry 15 parts, sea horse 9 parts, sea dragon 100 parts, dog kidney 15 parts, antler 15 parts, epimedium 10 parts.

[0022] Example 2: A traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus, which is composed of the following raw materials:

[0023] Salvia miltiorrhiza 10 parts, Panax notoginseng 300 parts, safflower 8 parts, peach kernel 10 parts, dried tangerine or orange peel 10 parts, ginseng 300 parts, Codonopsis pilosula 20 parts, American ginseng 10 parts, Panax japonicus 10 parts, angelica 15 parts, prepared rehmannia 25 parts, white peony root 10 parts, radix falcaliae 6 parts, polygonatum 15 parts, medlar 10 parts, ligustrum lucidum 100 parts, mulberry 20 parts, sea 15 parts, sea dragon 100 parts, dog kidney 15 parts, deer horn 15 parts, herba epimedii 20 parts.

[0024] Example 3: A traditional Chinese medicine composition for preventing / treating systemic lupus erythematosus, which is composed of the following raw materials:

[0025] Salvia miltiorrhiza 10 parts, Panax notoginseng 300 parts, safflower 8 parts, peach kernel 10 parts, dried tangerine or orange peel 10 parts, ginseng 300 parts, Codonopsis pilosula 20 parts, American ginseng 10 parts, Panax japonicus 10 parts, angelica 15 parts, prepared rehmannia 25 parts, white peony root 10 parts, radix falcaliae 6 parts, polygonatum 15 parts, medlar 10 parts, ligustrum lucidum 100 parts, mulberry 20 parts, sea 15 parts, sea dragon 100 parts, dog kidney 15 parts, deer horn 15 parts, herba epimedii 20 parts.

[0026] The traditional Chinese medicine composition of Example 1 to Example 3 can be prepared into a powder medicine, and the preparation operation is specifically as follows:

[0027] After the raw materials are taken according to the amount and dried respectively, mixed, crushed, and then sieved through a 200-mesh screen, they are packaged in sealed bags at 20 g / bag or in capsule shells at 2 g / capsule.

[0028] Example 4: Clinical data

[0029] A review of 33 patients with systemic lupus erythematosus treated with the powder prepared from the traditional Chinese medicine composition of Example 1 showed that the patients were 17-58 years old, including 27 females and 6 males, and the average disease duration was 13.25±4.08 months. None of the patients met the following conditions: active patients, severe systemic lupus erythematosus patients, pregnant or lactating women, or patients with the intention of pregnancy, or patients using other immunosuppressants in addition to hormones and hydroxychloroquine, or patients with severe infections, liver and kidney dysfunction.

[0030] The patients were treated with the powder prepared from the traditional Chinese medicine composition of Example 1, 20 g per day, taken with honey water in the morning and evening, and the efficacy was statistically analyzed after 24 weeks of continuous treatment.

[0031] Marked effect: the TCM symptoms and signs basically disappeared, and the symptom score decreased by ≥95%;

[0032] Effective: both TCM symptoms and signs are improved, symptom score is reduced by ≥30%, <95%;

[0033] Invalid: TCM symptoms and signs are not improved, even aggravated, symptom score is reduced by <30%;

[0034] Total effective rate = (number of cases with marked effect + number of cases with effect) / total number of cases x 100%.

[0035] TCM symptom score is calculated according to "TCM Diagnosis and Treatment Scheme for 22 Specialties and 95 Disease Types", i.e. 0, 1, 2, 3 points are given to joint pain, muscle pain, facial erythema, mouth sore and alopecia according to no, mild, moderate and severe degree, respectively, and then the scores are added.

[0036] Results are shown below:

[0037] 9 patients had marked effect, 21 patients had effect, 3 patients had no effect, and the effective rate was 90.9%.

[0038] SLEDAI score is used to evaluate disease activity index before and after treatment, i.e. ≥15 points is severe activity, 10-14 points is moderate activity, 5-9 points is mild activity, and 0-4 points is basically no activity.

[0039] The average SLEDAI score before treatment was 9.74 points, and the average SLEDAI score after treatment was 4.98 points, which showed that the patient's condition was significantly improved.

[0040] The renal function of the patient before and after treatment was detected, the supernatant of the fasting venous blood of the patient was detected by immunofluorescence method to determine the albumin, and the immunoturbidimetry method was used to determine the serum creatinine (SCr) level, and the automatic biochemical instrument was used to detect the complement C3, C4, the quantitative detection of anti-dsDNA antibody was carried out by using the Euroimmun anti-double stranded DNA (dsDNA) antibody immunoglobulin G detection kit, and the immunotransmission method was used to detect IgA, IgG and IgM.

[0041] The results are shown in Table 1 below.

[0042] Table 1: Detection of serum related indexes before and after treatment

[0043]

[0044] As shown in Table 1, after treatment, the levels of IgA, IgG and IgM of the patient decreased, the levels of complement C3 and C4 increased, and the level of anti-dsDNA antibody decreased. It can be seen that the decrease of the patient's level after treatment indicates that the inflammation is relieved, the disease activity is reduced, and the immune homeostasis is restored.

[0045] The patient who is ineffective to the treatment is stopped to be treated by the application, after the comprehensive diagnosis, the dressing treatment is changed, the effective patient continues to take the application to strengthen the treatment, the effective patient continues to take the application to treat according to the diagnostic result and the will of the patient, or the dressing treatment is changed.

[0046] Typical cases:

[0047] Case 1: Ms. Li, 52 years old, female, in August 2021, due to arm suddenly can't lift up and walk difficulty, etc., after blood test and multiple examinations, it is diagnosed as systemic lupus erythematosus (blood involvement and joint involvement), the test anti-nuclear antibody is high to 1:1000 (positive) particles, and is accompanied by joint swelling and pain, skin allergy, hair loss, oral ulcer and a series of physical discomfort symptoms, take the powder of example 1 for treatment, after taking, the physical discomfort symptoms are improved day by day, the test result is also gradually normal, after 8 months, the anti-nuclear antibody is reduced to 1:320 (positive) particles to 1:110 (positive) particles, continue to take the strengthening treatment. In September 2024, the review index is normal, the anti-nuclear antibody has also completely turned to negative, in April 2025, the review index is normal, the anti-nuclear antibody is still negative.

[0048] The above describes the application and its embodiments, which is not limited, the example shown is only one of the embodiments of the application, the actual structure is not limited. In general, if the ordinary skilled in the art is inspired, without departing from the purpose of the application, without creative design, similar structure and examples of the technical scheme, should belong to the protection scope of the application.

Claims

1. A traditional Chinese medicine composition for the prevention / treatment of systemic lupus erythematosus, characterized in that, It is composed of the following raw materials: Salvia miltiorrhiza 10-20 parts, Panax notoginseng 150-350 parts, Carthamus tinctorius 5-20 parts, Prunus persica 5-15 parts, Citrus reticulata 5-15 parts, Panax ginseng 150-350 parts, Codonopsis pilosula 15-25 parts, Panax quinquefolius 10-20 parts, Panax japonicus 5-20 parts, Angelica sinensis 10-20 parts, Rehmannia glutinosa 20-50 parts, Paeonia lactiflora 10-20 parts, Polygonum multiflorum 3-10 parts, Polygonatum sibiricum 10-20 parts, Lycium barbarum 10-20 parts, Ligustrum lucidum 80-120 parts, Morus alba 10-20 parts, Hippocampus 5-15 parts, Pterocarya stenoptera 80-150 parts, Citrus reticulata 10-30 parts, Citrus deer antler 10-30 parts, Epimedium brevicornu 5-20 parts.

2. The traditional Chinese medicine composition for the prevention / treatment of systemic lupus erythematosus according to claim 1, characterized in that, It is composed of the following raw materials: Salvia miltiorrhiza 15 parts, Panax notoginseng 300 parts, Carthamus tinctorius 10 parts, Prunus persica 10 parts, Citrus reticulata 10 parts, Panax ginseng 300 parts, Codonopsis pilosula 20 parts, Panax quinquefolius 15 parts, Panax japonicus 10 parts, Angelica sinensis 13 parts, Rehmannia glutinosa 30 parts, Paeonia lactiflora 15 parts, Polygonum multiflorum 6 parts, Polygonatum sibiricum 15 parts, Lycium barbarum 15 parts, Ligustrum lucidum 100 parts, Morus alba 15 parts, Hippocampus 9 parts, Pterocarya spp. 100 parts, Citrus reticulata 15 parts, Citrus aurantium 15 parts, Citrus reticulata 15 parts, Epimedium brevicornu 10 parts.

3. The traditional Chinese medicine composition for the prevention / treatment of systemic lupus erythematosus according to claim 1, characterized in that, It is composed of the following raw materials: Salvia miltiorrhiza 10 parts, Panax notoginseng 300 parts, Carthamus tinctorius 8 parts, Prunus persica 10 parts, Citrus reticulata 10 parts, Panax ginseng 300 parts, Codonopsis pilosula 20 parts, Panax quinquefolius 10 parts, Panax japonicus 10 parts, Angelica sinensis 15 parts, Rehmannia glutinosa 25 parts, Paeonia lactiflora 10 parts, Polygonum multiflorum 6 parts, Polygonatum sibiricum 15 parts, Lycium barbarum 10 parts, Ligustrum lucidum 100 parts, Morus alba 20 parts, Seaweed 15 parts, Sea dragon 100 parts, dog kidney 15 parts, deer antler 15 parts, Epimedium brevicornu 20 parts.

4. The traditional Chinese medicine composition for the prevention / treatment of systemic lupus erythematosus according to claim 1, characterized in that, It is composed of the following raw materials: Salvia miltiorrhiza 20 parts, Panax notoginseng 200 parts, Carthamus tinctorius 10 parts, Prunus persica 8 parts, Citrus reticulata 15 parts, Panax ginseng 300 parts, Codonopsis pilosula 20 parts, Panax quinquefolius 15 parts, Panax japonicus 15 parts, Angelica sinensis 20 parts, Rehmannia glutinosa 50 parts, Paeonia lactiflora 15 parts, Polygonum multiflorum 10 parts, Polygonatum sibiricum 20 parts, Lycium barbarum 15 parts, Ligustrum lucidum 100 parts, Morus alba 20 parts, Hippocampus 15 parts, Pterocarya stenoptera 100 parts, Paeonia lactiflora 25 parts, Polygonatum sibiricum 15 parts, Lycium barbarum 15 parts, Ligustrum lucidum 100 parts, Morus alba 20 parts, Hippocampus 15 parts, Pterocarya stenoptera 100 parts, Citrus reticulata 25 parts, Citrus deer antler 15 parts, Epimedium brevicornu 15 parts.

5. The use of the traditional Chinese medicine composition for the prevention / treatment of systemic lupus erythematosus according to any one of claims 1 to 4 in the preparation of a medicament for the prevention / treatment of systemic lupus erythematosus.

6. The application according to claim 5, characterized in that, The drug is an oral medication.

7. The application according to claim 6, characterized in that, The drug is one of the following: powder, pill, capsule, tablet, or oral liquid.

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