Traditional Chinese medicine composition for treating Behcet's disease and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating Behcet's disease and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25-35 parts of celastrus orbiculatus, 10-20 parts of caulis spatholobi, 5-15 parts of radix rehmanniae, 5-15 parts of glossy privet fruit, 5-15 parts of radix paeoniae rubra, 5-15 parts of radix paeoniae alba, 3-8 parts of liquorice and 3-8 parts of fructus amomi. The celastrus orbiculatus is taken as a main formula, the caulis spatholobi and the radix paeoniae rubra are combined for activating and cooling blood and lowering the secretion level of inflammatory cytokines, meanwhile, the risks of menstrual disorder, liver and kidney dysfunction, blood cell decline and the like possibly caused by the celastrus orbiculatus can be reduced, a good treatment effect is achieved, the clinical curative effect is improved, and the pain of behcet disease patients is better relieved; the life quality of patients is improved and the disease recurrence rate is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating Behcet's disease and a preparation method thereof. Background Art

[0002] Behcet's disease (BD) is one of the most difficult chronic diseases to treat, and its pathogenesis is still unclear. Studies have shown that cytokines Th1 and Th2 are highly expressed in the serum of patients with Behcet's disease. With the progress of immunology, studies in recent years have shown that T lymphocyte subsets, especially the imbalance of Th1 / Th2 cytokines, play an important role in the pathogenesis of BD. Due to the imbalance of Th1 / Th2 cytokine ratio, BD patients initiate the inflammatory response process. It is currently believed that during the active phase of inflammation, glucocorticoid treatment can temporarily suppress inflammation, but long-term use cannot prevent recurrence, and recurrence can cause new damage during treatment. Treatment with immunosuppressants not only has great toxic side effects, but is also prone to recurrence after dose reduction or discontinuation. In recent years, treatment with traditional Chinese medicine has received more and more attention. The treatment of this disease can achieve satisfactory results and is not prone to recurrence. It is currently a good method for treating this disease. Behcet's disease belongs to the category of "fox-induced disease" in traditional Chinese medicine. Doctors of all dynasties believed that the etiology and pathogenesis of this disease are caused by exogenous dampness and heat, emotional distress, uncontrolled diet, and addiction to spicy stimulation, which lead to dysfunction of internal organs, or liver depression and heat, internal disturbance of virtual heat, or spleen deficiency and dysfunction, water and dampness cannot be transformed, heat and toxicity are accumulated, and dampness is retained in the muscles, joints, and meridians, causing disease, blood stasis and obstruction of the meridians. Long-term disease damages yin and yang, spleen and kidney deficiency, liver and kidney deficiency, and complex disease syndromes with both deficiency and excess, and a mixture of deficiency and excess. The basic pathogenesis is heat toxicity, dampness and heat, blood stasis, and physical weakness, among which heat toxicity is the key to the onset of the disease. The combination of dampness, heat, blood stasis and toxicity is the pathological basis of Behcet's disease, which runs through Behcet's disease.

[0003] Since modern medicine currently lacks drugs that can effectively cure Behcet's disease, long-term use of hormones and immunosuppressants is prone to toxic side effects, and discontinuation of medication is prone to relapse, so clinicians are committed to seeking a safe and effective treatment plan. Traditional Chinese medicine treats BD through syndrome differentiation, distinguishing the deficiency and excess of the symptoms and the root cause, taking into account both the pathogenic factors and the righteousness, combining syndrome differentiation with disease differentiation, and using modern pharmacology for targeted medication. This study provides data support and theoretical guidance for the treatment of BD with traditional Chinese medicine. If the southern celastrus preparation has a good effect on Behcet's disease, it will form a unique treatment model and be promoted clinically. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating Behcet's disease and a preparation method thereof. The Chinese medicine composition is mainly composed of Celastrus orbiculatus, and is combined with Millettia spatholobi and Paeonia lactiflora to promote blood circulation and cool blood, and to lower the secretion level of inflammatory cytokines. At the same time, the risks of menstrual disorders, abnormal liver and kidney functions, and decreased blood cells caused by Celastrus orbiculatus can be reduced. The Chinese medicine composition has a good therapeutic effect, improves the clinical efficacy, better relieves the pain of Behcet's disease patients, improves the quality of life of patients, and reduces the recurrence rate of the disease.

[0005] The technical solution of the present invention is achieved in this way:

[0006] The invention provides a traditional Chinese medicine composition for treating Behcet's disease. The composition is prepared from the following raw materials: Celastrus orbiculatus, Millettia spatholobi, Radix Rehmanniae, Fructus Ligustri Lucidi, Radix Paeoniae Rubra, Radix Paeoniae Alba, Radix Glycyrrhizae and Fructus Amomum.

[0007] As a further improvement of the present invention, the medicine is prepared from the following raw materials by weight: 25-35 parts of Celastrus orbiculatus, 10-20 parts of Millettia spatholobi, 5-15 parts of Rehmannia glutinosa, 5-15 parts of Ligustrum lucidum, 5-15 parts of Red Peony Root, 5-15 parts of White Peony Root, 3-8 parts of Licorice, and 3-8 parts of Amomum villosum.

[0008] As a further improvement of the present invention, it is prepared from the following raw materials by weight: 30 parts of Celastrus orbiculatus, 15 parts of Millettia spatholobi, 10 parts of Radix Rehmanniae, 10 parts of Fructus Ligustri Lucidi, 10 parts of Radix Paeoniae Rubra, 10 parts of Radix Paeoniae Alba, 6 parts of Glycyrrhizae uralensis, and 6 parts of Fructus Amomi.

[0009] The present invention further protects a method for preparing the above-mentioned Chinese medicine composition for treating Behcet's disease, comprising the following steps:

[0010] (1) boiling Celastrus orbiculatus with water to obtain a mixture 1;

[0011] (2) Mix Millettia reticulata, Licorice root, Radix Rehmanniae, Fructus Ligustri Lucidi, Red Peony Root, and White Peony Root evenly, add the mixture to mixture 1, and decoct to obtain mixture 2;

[0012] (3) Add Amomum villosum to the mixture 2, decoct, and filter to prepare a Chinese medicine composition for treating Behcet's disease.

[0013] As a further improvement of the present invention, the amount of water added in step (1) is 20-40 times the mass of the medicinal material.

[0014] As a further improvement of the present invention, the decocting time in step (1) is 20-40 times.

[0015] As a further improvement of the present invention, the decocting time in step (1) is 3.5 hours.

[0016] As a further improvement of the present invention, the decocting time in step (2) is 0.5-1h.

[0017] As a further improvement of the present invention, the decocting time in step (2) is 0.5 h.

[0018] As a further improvement of the present invention, the decocting time in step (3) is 10-15 minutes.

[0019] The present invention has the following beneficial effects:

[0020] Celastrus orbiculatus is a plant of the Celastrus genus of the Celastraceae family. It is abundant in Guangxi, Hunan, Yunnan, Jiangxi and other places. It is also known as the mountain maple frost red vine, golden willow, and old dragon skin. It tastes bitter and spicy, is slightly warm in nature, and belongs to the liver meridian and bladder meridian. It has the effects of promoting blood circulation and removing blood stasis, relieving inflammation and pain, reducing swelling and detoxification, and promoting blood circulation. Studies have shown that the main chemical components contained in Celastrus orbiculatus include alkaloids, terpenes, saponins, flavonoids, organic acids, steroids and tannins, etc., which can treat rheumatoid arthritis, ankylosing spondylitis, glomerulonephritis, systemic lupus erythematosus, tumors and other immune-related diseases through multiple signal targets and action pathways. Celastrus orbiculatus and Tripterygium wilfordii belong to the same Celastraceae family and have similar biological activities, but its toxicity is less than that of Tripterygium wilfordii. The triterpenoid components and alkaloid components in its active ingredients have anti-inflammatory, antibacterial, immunosuppressive, and anti-tumor effects. The active ingredients of Celastrus orbiculatus can reduce the expression of inflammatory cytokines L1B, TNF-α and p-NF-κB, and also have an inhibitory effect on COX-2, which is similar to the mechanism of action of glucocorticoids and non-steroidal anti-inflammatory drugs.

[0021] The invention uses Celastrus orbiculatus as the main prescription, and is combined with Millettia spatholobi and Paeonia lactiflora to invigorate blood circulation and cool blood, and lower the secretion level of inflammatory cytokines. Meanwhile, the risks of menstrual disorders, abnormal liver and kidney functions, and decreased blood cells caused by Celastrus orbiculatus can be reduced. The invention has a good therapeutic effect, improves the clinical efficacy, better relieves the pain of Behcet's disease patients, improves the quality of life of patients, and reduces the recurrence rate of the disease.

[0022] The present invention enriches and strengthens the TCM treatment theory of Behcet's disease, provides more reliable and objective data support and theoretical guidance for the clinical application of TCM in the treatment of Behcet's disease, and brings into play a greater therapeutic advantage of the combination of traditional Chinese and Western medicine. DETAILED DESCRIPTION

[0023] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0024] Example 1

[0025] Raw material composition (weight in g): 25g of Celastrus orbiculatus, 10g of Millettia spatholobi, 5g of Radix Rehmanniae, 5g of Fructus Ligustri Lucidi, 5g of Radix Paeoniae Rubra, 5g of Radix Paeoniae Alba, 3g of Licorice, and 3g of Fructus Amomum.

[0026] This embodiment provides a method for preparing a Chinese medicine composition for treating Behcet's disease, comprising the following steps:

[0027] (1) adding 20 times the weight of water to Celastrus orbiculatus and boiling for 3 hours to obtain a mixture 1;

[0028] (2) Mix Millettia reticulata, Glycyrrhiza uralensis, Radix Rehmanniae, Fructus Ligustri Lucidi, Radix Paeoniae Rubrae and Radix Paeoniae Alba evenly, add to mixture 1, and boil for 0.5 h to obtain mixture 2;

[0029] (3) Add Amomum villosum to mixture 2, decoct for 10 min, and filter to prepare a traditional Chinese medicine composition for treating Behcet's disease.

[0030] Example 2

[0031] Raw material composition (weight in g): Celastrus orbiculatus 35g, Millettia spatholobi 20g, Radix Rehmanniae 15g, Fructus Ligustri Lucidi 15g, Radix Paeoniae Rubra 15g, Paeoniae Alba 15g, Root of Licorice 8g, Fructus Amomi 8g.

[0032] This embodiment provides a method for preparing a Chinese medicine composition for treating Behcet's disease, comprising the following steps:

[0033] (1) adding 40 times the weight of water to Celastrus orbiculatus and boiling for 4 hours to obtain a mixture 1;

[0034] (2) Mix Millettia reticulata, Glycyrrhiza uralensis, Radix Rehmanniae, Fructus Ligustri Lucidi, Radix Paeoniae Rubrae and Radix Paeoniae Alba evenly, add to mixture 1, and boil for 1 h to obtain mixture 2;

[0035] (3) Add Amomum villosum to mixture 2, decoct for 15 minutes, and filter to prepare a traditional Chinese medicine composition for treating Behcet's disease.

[0036] Example 3

[0037] Raw material composition (weight in g): 30g of Celastrus orbiculatus, 15g of Millettia spatholobi, 10g of Radix Rehmanniae, 10g of Fructus Ligustri Lucidi, 10g of Radix Paeoniae Rubra, 10g of Radix Paeoniae Alba, 6g of Licorice, and 6g of Amomum villosum.

[0038] This embodiment provides a method for preparing a Chinese medicine composition for treating Behcet's disease, comprising the following steps:

[0039] (1) adding 30 times the weight of water to Celastrus orbiculatus and boiling for 3.5 hours to obtain a mixture 1;

[0040] (2) Mix Millettia reticulata, Glycyrrhiza uralensis, Radix Rehmanniae, Fructus Ligustri Lucidi, Radix Paeoniae Rubrae and Radix Paeoniae Alba evenly, add to mixture 1, and boil for 0.5 h to obtain mixture 2;

[0041] (3) Add Amomum villosum to mixture 2, decoct for 12 minutes, and filter to prepare a traditional Chinese medicine composition for treating Behcet's disease.

[0042] Test Example 1

[0043] 80 patients diagnosed with Behcet's disease were selected and randomly divided into 4 groups, each with 20 patients, namely Example 1-3 groups and a control group.

[0044] Inclusion criteria: Patients with Behçet's disease, according to the new 2014 international criteria for Behçet's disease (BD), Table 1.

[0045] Table 1

[0046]

[0047]

[0048] A total score ≥4 points suggests a diagnosis of Behçet's disease.

[0049] * A pinprick test is optional and was not included in the original scoring system, but if a pinprick test is performed and the result is positive, an additional point is added.

[0050] Exclusion criteria:

[0051] (1) Patients who do not meet the inclusion criteria;

[0052] (2) Those who are allergic to or intolerant of therapeutic drugs;

[0053] (3) Patients with other rheumatic and immune diseases other than BD;

[0054] (4) Patients with other serious systemic chronic diseases or organ dysfunction;

[0055] (5) Those with severe malnutrition or diagnosed with malignant tumors;

[0056] (6) Men and women who are planning to have children, and women of childbearing age who are pregnant or breastfeeding;

[0057] (7) Irregular menstruation;

[0058] (8) People suffering from persistent infectious diseases (such as hepatitis B, hepatitis C, HI, etc.).

[0059] Control group: Thalidomide tablets (Changzhou Youchang Co., Ltd., trade name: Thalidomide, approval number: National Medicine Standard H32026129, specification: 25mg*20 tablets / bottle), 50mg.

[0060] Treatment group: Based on the treatment plan of the control group, the Chinese medicine composition for treating Behcet's disease prepared in Examples 1-3 was added, one dose (10 g) per day, decocted in water, 200 ml each morning and evening after meals, decocted by the Chinese medicine pharmacy of this hospital. The efficacy of the patients was evaluated after 4 weeks and 8 weeks of treatment.

[0061] The evaluation criteria are shown in Table 2.

[0062] Table 2

[0063]

[0064] The results are shown in Table 3.

[0065] Table 3

[0066] Group Clinically cured (person) Significant effect (people) Effective (person) Invalid (person) Control group 2 5 7 6 Example 1 5 7 4 4 Example 2 5 6 6 3 Example 3 6 7 6 1

[0067] It can be seen from the above table that the Chinese medicinal compositions for treating Behcet's disease prepared in Examples 1-3 of the present invention have obvious effects on treating Behcet's disease.

[0068] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating Behcet's disease, characterized in that: It is prepared from the following raw materials: Celastrus orbiculatus, Millettia spatholobi, Radix Rehmanniae, Fructus Ligustri Lucidi, Red Peony Root, White Peony Root, Liquorice and Fructus Amomum.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 25-35 parts of Celastrus orbiculatus, 10-20 parts of Millettia spatholobi, 5-15 parts of Radix Rehmanniae, 5-15 parts of Fructus Ligustri Lucidi, 5-15 parts of Radix Paeoniae Rubra, 5-15 parts of Radix Paeoniae Alba, 3-8 parts of Licorice, and 3-8 parts of Fructus Amomi.

3. The Chinese medicine composition according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 30 parts of Celastrus orbiculatus, 15 parts of Millettia spatholobi, 10 parts of Radix Rehmanniae, 10 parts of Fructus Ligustri Lucidi, 10 parts of Radix Paeoniae Rubrae, 10 parts of Radix Paeoniae Albae, 6 parts of Radix Glycyrrhizae, and 6 parts of Fructus Amomi.

4. A method for preparing a Chinese medicine composition for treating Behcet's disease as claimed in any one of claims 1 to 3, characterized in that: The following steps are involved: (1) boiling Celastrus orbiculatus with water to obtain a mixture 1; (2) Mix Millettia reticulata, Licorice root, Radix Rehmanniae, Fructus Ligustri Lucidi, Red Peony Root, and White Peony Root evenly, add the mixture to mixture 1, and decoct to obtain mixture 2; (3) Add Amomum villosum to the mixture 2, decoct, and filter to prepare a Chinese medicine composition for treating Behcet's disease.

5. The preparation method according to claim 4, characterized in that: The amount of water added in step (1) is 20-40 times the mass of the medicinal material.

6. The preparation method according to claim 4, characterized in that: The decocting time in step (1) is 3-4 hours.

7. The preparation method according to claim 4, characterized in that: The decocting time in step (1) is 3.5 hours.

8. The preparation method according to claim 4, characterized in that: The decoction time in step (2) is 0.5-1h.

9. The preparation method according to claim 4, characterized in that: The decoction time in step (2) is 0.5 h.

10. The preparation method according to claim 4, characterized in that: The decocting time in step (3) is 10-15 minutes.

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