CN117860827A - Traditional Chinese medicine composition for treating erythema nodosum and preparation method and application thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for treating erythema nodosum, which is prepared from the following raw materials in parts by weight: 3-15 parts of radix bupleuri, 3-20 parts of sweet wormwood herb, 3-15 parts of Chinese angelica, 3-15 parts of radix angelicae pubescentis, 3-20 parts of cortex lycii radicis, 3-15 parts of notopterygium root, 3-20 parts of fructus kochiae, 3-15 parts of fructus cnidii, 3-20 parts of cortex dictamni, 3-10 parts of liquorice, 3-20 parts of radix salviae miltiorrhizae, 3-15 parts of radix saposhnikoviae, 3-15 parts of tree peony bark, 3-10 parts of honeycomb, 3-12 parts of tripterygium wilfordii, 5-30 parts of hawthorn and 5-30 parts of oldenlandia diffusa. The composition can resolve rash and erythema nodosum, has low recurrence rate and better effect than methylprednisolone commonly used in clinic at present. The invention can effectively treat the nodular erythema related to connective tissue diseases and has clinical popularization and application values.

Description

Traditional Chinese medicine composition for treating erythema nodosum and preparation method and application thereof

Technical Field

The invention particularly relates to a traditional Chinese medicine composition for treating erythema nodosum, and a preparation method and application thereof.

Background

Erythema nodosum is a recurrent inflammatory skin disease of complex etiology, and is associated with a variety of factors, such as various pathogenic bacterial infections, and drugs, connective tissue diseases, behcet's disease, etc. Erythema nodosum is usually seen on the extending sides of the lower legs, and is clinically manifested as red or purplish red painful inflammatory nodules, which are good for young and middle-aged women, especially young women, and also have a certain seasonal onset, often seen in spring and autumn. Erythema nodosum caused by connective tissue disease is currently considered to be a delayed hypersensitivity reaction of the body to certain foreign antigens. The connective tissue disease has longer disease course, complex disease condition and high incidence, and the probability of recurrence of erythema nodosum caused by connective tissue disease is high.

At present, the treatment of erythema nodosum is mainly carried out by western medicines, such as antibiotics, non-steroidal anti-inflammatory drugs or glucocorticoids. The related researches on the treatment of traditional Chinese medicines are more, but the effect is not ideal, and most of traditional Chinese medicine formulas are required to be combined with western medicines to have good curative effect. Li Qingsong the effective rate of treating erythema nodosum can reach 90% only by adding flavor with Simiaoyong Antang and simultaneously using the Dragon bead ointment externally. It is necessary to provide a traditional Chinese medicine composition with high safety and few side effects and obvious effect of treating erythema nodosum, especially erythema nodosum related to connective tissue diseases, so as to be used clinically.

Disclosure of Invention

In order to solve the problems, the invention provides a traditional Chinese medicine composition for treating erythema nodosum, which is prepared from the following raw materials in parts by weight:

3-15 parts of radix bupleuri, 3-20 parts of sweet wormwood herb, 3-15 parts of Chinese angelica, 3-15 parts of radix angelicae pubescentis, 3-20 parts of cortex lycii radicis, 3-15 parts of notopterygium root, 3-20 parts of fructus kochiae, 3-15 parts of fructus cnidii, 3-20 parts of cortex dictamni, 3-10 parts of liquorice, 3-20 parts of radix salviae miltiorrhizae, 3-15 parts of radix saposhnikoviae, 3-15 parts of tree peony bark, 3-10 parts of honeycomb, 3-12 parts of tripterygium wilfordii, 5-30 parts of hawthorn and 5-30 parts of oldenlandia diffusa.

Further, the material is prepared from the following raw materials in parts by weight:

6 parts of bupleurum, 9 parts of sweet wormwood, 9 parts of angelica, 10 parts of radix angelicae pubescentis, 10 parts of cortex lycii radicis, 9 parts of notopterygium root, 15 parts of fructus kochiae, 10 parts of fructus cnidii, 12 parts of cortex dictamni, 6 parts of liquorice, 9 parts of radix salviae miltiorrhizae, 9 parts of radix sileris, 12 parts of cortex moutan, 3 parts of nidus vespae, 6 parts of tripterygium wilfordii, 9 parts of hawthorn and 15 parts of oldenlandia diffusa.

Further, the hawthorn is scorched hawthorn fruit.

Further, it is a preparation prepared from fine powder of raw materials or water or organic solvent extract of raw materials as active ingredients, and pharmaceutically acceptable auxiliary materials.

Still further, the formulation is an oral formulation.

Further, the oral preparation is granule, tablet, powder, pill or solution.

The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:

(1) Weighing the raw materials according to the proportion;

(2) Grinding the raw materials into powder, or extracting with water or organic solvent, and adding adjuvants or auxiliary components commonly used in medicines.

The invention finally provides application of the traditional Chinese medicine composition in preparing a medicine for treating erythema nodosum.

Further, the medicament is a medicament for treating connective tissue disease-associated erythema nodosum.

The composition takes cortex moutan and radix salviae miltiorrhizae for clearing heat, cooling blood, promoting blood circulation and removing blood stasis, simultaneously takes radix bupleuri and relieving exterior and interior, takes radix tripterygii for promoting blood circulation and removing obstruction in collaterals, dispelling wind and eliminating dampness as principal drugs, takes angelica for nourishing blood and regulating ying, takes cortex lycii radicis for treating wind evil with indefinite exterior, takes cortex dictamni for dispelling wind and eliminating dampness, takes radix sileris pungent powder for dispelling evil as ministerial drugs for assisting with effects of expelling wind and relieving itching, takes fructus cnidii, fructus kochiae, nidus vespae and herba artemisiae annuae for clearing heat and detoxicating, and takes herba oldenlandiae for removing dampness as adjuvant drugs, cooperates with radix angelicae pubescentis and notopterygium root for dispelling wind and eliminating dampness and relieving pain, takes scorched hawthorn for resolving food and invigorating stomach, moves qi and removing blood stasis, takes liquorice for relieving pain and takes medicines as conducing drugs for slowing blood and removing stasis, and dispelling wind and relieving itching.

Clinical experiments prove that: the composition can resolve rash and erythema nodosum, has low recurrence rate and better effect than methylprednisolone commonly used in clinic at present. The invention can effectively treat erythema nodosum, especially the erythema nodosum related to connective tissue diseases, and has clinical popularization and application values.

It should be apparent that, in light of the foregoing, various modifications, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.

The above-described aspects of the present invention will be described in further detail below with reference to specific embodiments in the form of examples. It should not be understood that the scope of the above subject matter of the present invention is limited to the following examples only. All techniques implemented based on the above description of the invention are within the scope of the invention.

Detailed Description

The raw materials and equipment used in the specific embodiment of the invention are all known products and are obtained by purchasing commercial products, wherein the modern Chinese medicinal preparation prepared from the Chinese medicinal composition is prepared by a mature preparation process and by referring to the conventional method in the prior art.

EXAMPLE 1 preparation of the medicament of the invention

The formula comprises the following components: 3g of bupleurum, 3g of sweet wormwood, 3g of angelica, 3g of radix angelicae pubescentis, 3g of cortex lycii radicis, 3g of notopterygium root, 3g of fructus kochiae, 3g of fructus cnidii, 3g of cortex dictamni, 3g of liquorice, 3g of radix salviae miltiorrhizae, 3g of radix sileris, 3g of cortex moutan, 3g of nidus vespae, 3g of tripterygium wilfordii, 5g of scorched hawthorn fruit and 5g of oldenlandia diffusa

The preparation method comprises the following steps: weighing the raw materials according to the proportion, adding 10 times of water, decocting for 2 times, each time for 20-30 minutes, filtering, combining the filtrates, concentrating the filtrate under reduced pressure to obtain thick paste, adding common auxiliary materials in medicines, and preparing into tablets.

EXAMPLE 2 preparation of the medicament of the invention

The formula comprises the following components: 15g of bupleurum, 20g of sweet wormwood, 15g of angelica, 15g of radix angelicae pubescentis, 20g of cortex lycii radicis, 15g of notopterygium root, 20g of fructus kochiae, 15g of fructus cnidii, 20g of dittany bark, 10g of liquorice, 20g of radix salviae miltiorrhizae, 15g of radix sileris, 15g of cortex moutan, 10g of nidus vespae, 12g of tripterygium wilfordii, 30g of scorched hawthorn fruit and 30g of oldenlandia diffusa

The preparation method comprises the following steps: weighing the raw materials according to the proportion, adding 10 times of water, decocting for 2 times, each time for 20-30 minutes, filtering, combining the filtrates, concentrating the filtrate under reduced pressure to obtain thick paste, adding common auxiliary materials in medicines, and preparing into granules.

EXAMPLE 3 preparation of the medicament of the invention

The formula comprises the following components: 6g of bupleurum, 9g of sweet wormwood, 9g of angelica, 10g of radix angelicae pubescentis, 10g of cortex lycii radicis, 9g of notopterygium root, 15g of fructus kochiae, 10g of fructus cnidii, 12g of dittany bark, 6g of liquorice, 9g of red sage root, 9g of radix sileris, 12g of tree peony bark, 3g of honeycomb, 6g of tripterygium wilfordii, 9g of scorched hawthorn fruit and 15g of oldenlandia diffusa.

The preparation method comprises the following steps: mixing the above materials with granule (produced by Guangdong party pharmaceutical Co., ltd.).

The advantageous effects of the present invention are described below by way of test examples.

Test example 1 clinical therapeutic Effect of the pharmaceutical composition of the present invention

1. Clinical data

Clinical study cases are derived from nodular erythema patients related to connective tissue diseases of the department of outpatient and hospitalization of the first affiliated hospital of the adult medical college, and are divided into an experimental group and a control group according to a random digital table method, wherein the experimental group is incorporated into 32 cases of male patients, 6 cases of female patients, 26 cases of female patients, the average age of 32.22+/-2.12 years, and the average course of disease of 2.73+/-0.91 years. The control group was included in 27 patients, 8 male patients, 19 female patients, and had an average age of 34.11.+ -. 2.91 years and an average course of 2.77.+ -. 0.69 years.

1.1 diagnostic criteria

(1) Western medicine inclusion criteria:

connective tissue disease uses the U.S. Sharp diagnostic criteria:

1) Main standard

(1) Severe myositis; (2) pulmonary involvement (carbon dioxide dispersion function less than 70%, pulmonary arterial hypertension, pulmonary biopsy showing proliferative vascular injury); (3) reynolds phenomenon/reduced esophageal peristalsis function; (4) swelling of joints, tenderness or hardening of fingers; (5) anti-nuclear antibody positive, titer >1:320, and/or ENA antibody positive.

2) Secondary standard

(1) Alopecia; (2) a decrease in white blood cell count; (3) anemia; (4) pleurisy; (5) pericarditis; (6) arthritis; (7) trigeminal neuropathy; (8) cheek erythema; (9) thrombocytopenia; mild myositis.

3) Diagnosis of the disease

(1) 4 main criteria; (2) serological antinuclear antibodies positive, titre >1:320, except for infectious or neoplastic diseases.

Erythema nodosum was diagnosed by clinical manifestations and pathological biopsies according to Zhu Xuejun, modern diagnostic manual of dermatology (according to typical skin lesions, best before the calf shank, with tenderness, no collapse, combined with skin histopathological examination, as indicated by small She Jiange subcutaneous fat panulitis).

(2) The Chinese medicine incorporates the standard:

the differentiation of erythema nodosum is based on the "Chinese clinical diagnosis and treatment terminology and syndrome type section

1.2 exclusion criteria

(1) Patients with serious diseases of heart, liver, lung, kidney, endocrine and other systems; (2) various infectious agents such as severe upward calling; (3) pregnant or lactating women; (4) the serious illness state may affect the effectiveness and safety of the study. (5) Allergic to the drug ingredients in this study.

2. Therapeutic method

Test group: the patients respectively take the pharmaceutical composition prepared in the embodiment 3 of the invention, and the dosage of each taking is 10-15g; the administration method is warm water infusion, three times a day, 7 days as a treatment course, and 4 treatment courses.

Control group: 8-16mg methylprednisolone is orally administered.

3. Therapeutic effect judgment criterion

According to the guidelines of clinical research on new traditional Chinese medicines, the clinical curative effects are classified into improvement, obvious effect and ineffective.

Improvement: the clinical symptoms (fever, myalgia, arthralgia, red swelling and pain at skin lesions) and signs (pimple, vitiligo, erythema, nodule and local edema) are obviously improved, and the integral reduction rate of the symptoms is more than or equal to 70%;

the effect is shown: the clinical symptoms and signs are improved, and the integral reduction rate of the symptoms is more than or equal to 30 percent;

invalidation: the clinical symptoms are not obviously improved or are obviously aggravated, and the symptom integral reduction rate is less than 30 percent.

Symptom score reduction rate = [ (pre-treatment score-post-treatment score)/pre-treatment score ] ×100%.

The erythema nodosum sign scoring reference (Gao Jinghong et al, university of Anhui university of Chinese medicine, 2016, 35 (05): 29-31.) is specifically scored as follows:

(1) pimple, no pimple, count 0 points; at most 2 papules per square centimeter, 1 point; 3-5 papules per square centimeter, counting 2 points; 6 or more than 6 papules per square centimeter, 3 points.

(2) Vitiligo is no vitiligo, and 0 score is calculated; carefully checking the visible vitiligo, counting 1 minute; immediately finding out vitiligo, counting for 2 minutes; the purple-depressive psychosis is evident, counting 3 minutes.

(3) Red spot, namely, no red spot, counting 0 minutes; slightly pale red, count 1 minute; obvious red spots which are easy to identify are counted for 2 minutes; obvious erythema, count 3 minutes.

(4) The knots are no knots, and 0 score is calculated; the number of the knots is less than or equal to 5, and 1 minute is counted; the number of the knots is more than 5 and less than or equal to 10, and the knots are counted to be 2 minutes; the number of the knots is more than 10 and is counted to be 3 minutes.

(5) The local edema is anhydrous swelling, and the score is 0; local area dermal edema is not easy to palpate, count 1 minute; well-defined dermal edema occurred at multiple sites, counting 2 points; dermal edema and infiltration occurred in a wide area, and were counted as 3 minutes.

4. Therapeutic effects

(1) The results of the clinical efficacy of the pharmaceutical composition of the present invention are shown in table 1. (note: improvement cases are included in the cases of significant effects)

TABLE 1 clinical efficacy results of the pharmaceutical compositions of the invention

	Number of examples	Display effect (example)	Improvement (example)	Invalidation (example)	Effective rate of
						Experimental group	32	29	26	3	90.63％
Control group	27	24	19	3	88.89％

(2) The recurrence rate of the pharmaceutical composition of the present invention is shown in table 2 following 3 months post-treatment. ( And (3) injection: the recurrence rate is counted from the total parameters and the cases, and the specific calculation formula is recurrence cases/total cases 100% )

TABLE 2 recurrence rate of the pharmaceutical compositions of the invention

	Number of examples	Recurrence (example)	Recurrence rate
				Experimental group	32	3	9.38％
Control group	27	4	14.81％

From the statistics of tables 1 and 2, it can be seen that: the pharmaceutical composition has good improvement effect on clinical symptoms of the connective tissue disease-related erythema nodosum, has better effect than methylprednisolone, can effectively treat the connective tissue disease-related erythema nodosum, and prevents recurrence.

In conclusion, the traditional Chinese medicine composition disclosed by the invention is accurate in compatibility, has the effects of cooling blood, removing stasis, dispelling wind, relieving itching, resolving masses and relieving pain, can effectively treat nodular erythema related to connective tissue diseases, is low in recurrence rate, and has clinical popularization and application values.

Claims (9)

1. A traditional Chinese medicine composition for treating erythema nodosum is characterized in that: the composite material is prepared from the following raw materials in parts by weight:

3-15 parts of radix bupleuri, 3-20 parts of sweet wormwood herb, 3-15 parts of Chinese angelica, 3-15 parts of radix angelicae pubescentis, 3-20 parts of cortex lycii radicis, 3-15 parts of notopterygium root, 3-20 parts of fructus kochiae, 3-15 parts of fructus cnidii, 3-20 parts of cortex dictamni, 3-10 parts of liquorice, 3-20 parts of radix salviae miltiorrhizae, 3-15 parts of radix saposhnikoviae, 3-15 parts of tree peony bark, 3-10 parts of honeycomb, 3-12 parts of tripterygium wilfordii, 5-30 parts of hawthorn and 5-30 parts of oldenlandia diffusa.

2. The traditional Chinese medicine composition according to claim 1, wherein: the composite material is prepared from the following raw materials in parts by weight:

6 parts of bupleurum, 9 parts of sweet wormwood, 9 parts of angelica, 10 parts of radix angelicae pubescentis, 10 parts of cortex lycii radicis, 9 parts of notopterygium root, 15 parts of fructus kochiae, 10 parts of fructus cnidii, 12 parts of cortex dictamni, 6 parts of liquorice, 9 parts of radix salviae miltiorrhizae, 9 parts of radix sileris, 12 parts of cortex moutan, 3 parts of nidus vespae, 6 parts of tripterygium wilfordii, 9 parts of hawthorn and 15 parts of oldenlandia diffusa.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: the fructus crataegi is charred fructus crataegi.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: the preparation is prepared from fine powder of raw materials or water or organic solvent extract of raw materials as active ingredients and pharmaceutically acceptable auxiliary materials.

5. The traditional Chinese medicine composition according to claim 4, wherein: the preparation is an oral preparation.

6. The traditional Chinese medicine composition according to claim 5, wherein: the oral preparation is granule, tablet, powder, pill or solution.

7. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 6, which is characterized in that: it comprises the following steps:

(1) Weighing the raw materials according to the proportion;

(2) Grinding the raw materials into powder, or extracting with water or organic solvent, and adding adjuvants or auxiliary components commonly used in medicines.

8. Use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a medicament for treating erythema nodosum.

9. Use according to claim 8, characterized in that: the medicine is used for treating connective tissue disease-related erythema nodosum.