Traditional Chinese medicine composition for treating anaphylactoid purpura

Abstract

The invention provides a traditional Chinese medicine composition for treating anaphylactoid purpura. The invention also provides a traditional Chinese medicine extract. The invention further provides a preparation method of the traditional Chinese medicine extract. The invention further provides application of the traditional Chinese medicine composition or the traditional Chinese medicine extract in preparation of drugs for treating anaphylactoid purpura. The traditional Chinese medicine composition for treating anaphylactoid purpura can provide effective and safe traditional Chinese medicine treatment for anaphylactoid purpura patients who are poor in western medicine treatment effect or have taboo to western medicines clinically, meanwhile, the use treatment course of glucocorticoid can be shortened, and the treatment cost is reduced. The prognosis of anaphylactoid purpura and other diseases mainly including blood-heat syndrome is improved.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine pharmacy, and relates to a traditional Chinese medicine composition for treating allergic purpura, in particular to a traditional Chinese medicine composition for treating allergic purpura and preparation and application thereof. BACKGROUND

[0002] Purpura refers to submucosal hemorrhage of skin or mucosa, which leads to the phenomenon of purple or red spots. Unlike the skin erythema caused by blood vessel dilation, these spots usually do not fade after pressing. When the lesion involves the capillary walls of organs such as the gastrointestinal tract, joints and kidneys, the permeability and fragility of the capillary walls of the gastrointestinal tract, joints and kidneys are increased, resulting in hemorrhagic symptoms. Purpura is divided into two categories according to different causes: vascular / platelet purpura (non-inflammatory) and vasculitic purpura (inflammatory). Vascular / platelet purpura is mostly caused by fragile blood vessel walls or reduced platelet quantity and abnormal function. Thrombocytopenic purpura caused by a significant decrease in platelet quantity is a common type. Vasculitic purpura is mostly caused by blood leakage due to inflammation and necrosis of small blood vessels, and allergic purpura is one of the common types. Allergic purpura, also known as IgA vasculitis or Henoch-Schonlein syndrome, is a common vascular allergic disease, which often occurs in children and adolescents, and is mostly seen in the lower limbs of the stretched limbs. Subcutaneous hemorrhage above the skin surface is the typical manifestation. When a patient suffers from the disease, kidney damage is easily caused, thereby causing nephritis or nephropathy or damage to other kidney functions.

[0003] The disease belongs to the category of “blood syndrome”, “muscle bleeding” and “grape epidemic” in traditional Chinese medicine. Many doctors believe that the acute phase is mostly caused by external evils or dietary disorders, internal accumulation of heat, invasion of heat into the interior, transformation of fire into blood, forced blood extravasation and blood extravasation. Wind, heat and dampness, and dietary internal injury (such as fish, shrimp and seafood) are common causes. The current conventional treatment of the acute phase of the disease mainly includes oral administration of glucocorticoids, immunosuppressants and vitamin C, rutin tablets and other drugs for reducing capillary permeability. However, long-term use of some drugs can cause adverse effects on the endocrine system and liver and kidney functions of patients. Traditional medicine believes that the acute phase of the disease is mostly blood heat and blood stasis, and the main treatment principle is to clear heat and detoxify, cool blood and stop bleeding. SUMMARY

[0004] In view of the above-mentioned disadvantages of the prior art, the purpose of the present application is to provide a traditional Chinese medicine composition for treating allergic purpura, so as to provide effective and safe traditional Chinese medicine treatment for allergic purpura patients who have poor response to western medicine treatment or have contraindications to western medicine, so as to reduce the side effects of western medicine treatment: in the acute phase treatment, the traditional Chinese medicine can be used together with hormones to play the role of clearing heat and resolving toxins, cooling blood and stopping bleeding, and promoting the rapid subsidence of skin rash. During the hormone reduction period, the use of traditional Chinese medicine can help stabilize the disease and reduce symptom rebound and recurrence. At the same time, the yin-nourishing and fire-reducing traditional Chinese medicine in the prescription can alleviate the side effects such as dryness-heat, insomnia, and night sweats caused by hormones, and reduce the discomfort of patients. In addition, the treatment of allergic purpura by traditional Chinese medicine can adjust the immune state and visceral function of patients, improve the constitution, and reduce the long-term recurrence rate of the disease. For some refractory proteinuria and hematuria, the combination of traditional Chinese and western medicine treatment can often achieve better results.

[0005] To achieve the above-mentioned purposes and other related purposes, the first aspect of the present application provides a traditional Chinese medicine composition for treating allergic purpura, which comprises the following raw material components by weight:

[0006] Rehmannia 20-40 parts by weight;

[0007] Anemarrhena 1-20 parts by weight;

[0008] Chinese yam 5-25 parts by weight;

[0009] White kidney bean 5-25 parts by weight;

[0010] Eclipta 5-25 parts by weight;

[0011] Dendrobium 1-20 parts by weight;

[0012] Purslane 5-25 parts by weight;

[0013] Imperata 5-25 parts by weight;

[0014] Biota leaf 1-20 parts by weight;

[0015] Yin and Yang 20-40 parts by weight;

[0016] Centella asiatica 5-25 parts by weight;

[0017] Cyperus 1-20 parts by weight.

[0018] The second aspect of the present application provides a preparation method of the above-mentioned traditional Chinese medicine extract, which comprises: mixing the raw material components of the traditional Chinese medicine composition according to the first aspect of the present application according to the ratio, and obtaining the mixture by water decoction method.

[0019] The third aspect of the present application provides a traditional Chinese medicine extract, which is prepared by extracting the traditional Chinese medicine composition of the first aspect of the present application or by the preparation method of the traditional Chinese medicine extract of the second aspect of the present application.

[0020] The fourth aspect of the present application provides the use of the traditional Chinese medicine composition of the first aspect of the present application or the traditional Chinese medicine extract of the third aspect of the present application in the preparation of a medicament for treating allergic purpura.

[0021] As described above, the traditional Chinese medicine composition for treating allergic purpura provided by the present application can provide effective and safe traditional Chinese medicine treatment for allergic purpura patients who have poor treatment effect or contraindication to western medicine in clinic, and can shorten the treatment course of glucocorticoids. If the traditional Chinese medicine composition can be used as an in-hospital preparation and popularized in clinic, it will greatly reduce the adverse effects of glucocorticoids and immunosuppressants on the body of allergic purpura patients, shorten the treatment course, and improve the prognosis of allergic purpura and other diseases mainly with blood heat syndrome. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1a 、 1b The figure shows the comparison of the patient's face before and after the treatment of purpura, wherein, Figure 1a The figure shows the comparison of the patient's face before the treatment of purpura, Figure 1b The figure shows the comparison of the patient's face after the treatment of purpura.

[0023] Figure 2a 、 2b The figure shows the comparison of the patient's lower limbs before and after the treatment of purpura, wherein, Figure 2a The figure shows the comparison of the patient's lower limbs before the treatment of purpura, Figure 2b The figure shows the comparison of the patient's lower limbs after the treatment of purpura. DETAILED DESCRIPTION

[0024] Before further describing the specific embodiments of the present application, it should be understood that the scope of protection of the present application is not limited to the following specific embodiments; it should also be understood that the terms used in the embodiments of the present application are for the purpose of describing the specific embodiments, but not for limiting the scope of protection of the present application. The test methods in the following examples, if not specified, are usually carried out according to the conventional conditions or the conditions recommended by the manufacturers.

[0025] The first aspect of the present application provides a traditional Chinese medicine composition for treating allergic purpura, which comprises the following raw material components by weight:

[0026] Radix Rehmanniae 20-40 parts by weight; specifically, 20-25 parts, 25-35 parts, 35-40 parts;

[0027] Anemarrhena 1-20 parts by weight; specifically, 1-5 parts, 5-15 parts, 15-20 parts;

[0028] Yam 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts;

[0029] White kidney bean 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts;

[0030] Eclipta 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts;

[0031] Dendrobium 1-20 parts by weight; specifically, 1-5 parts, 5-15 parts, 15-20 parts;

[0032] Purslane 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts;

[0033] Imperata 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts;

[0034] Biota leaf 1-20 parts by weight; specifically, 1-5 parts, 5-15 parts, 15-20 parts;

[0035] Ladybell 20-40 parts by weight; specifically, 20-25 parts, 25-35 parts, 35-40 parts;

[0036] Centella asiatica 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts;

[0037] Rhizoma Cyperi 1-20 parts by weight; specifically, 1-5 parts, 5-15 parts, 15-20 parts.

[0038] In the present application, the Rehmannia glutinosa is a dry root of Rehmannia glutinosa.

[0039] In the present application, the Anemarrhena asphodeloides is a dry rhizome of Anemarrhena asphodeloides.

[0040] In the present application, the Yam is a dry rhizome of Dioscorea opposita.

[0041] In the present application, the White kidney bean is a white seed of Dolichos lablab.

[0042] In the present application, the Eclipta prostrata is a dry aboveground part of Eclipta prostrata.

[0043] In the present application, the Dendrobium is a fresh or dry stem of Dendrobium candidum, Dendrobium chrysostachyum or Dendrobium fimbriatum and similar species of the same genus.

[0044] In the present application, the Purslane is an annual herb of Portulacaceae.

[0045] In the present application, the Imperata Cylindra is the dry rhizome of Imperata Cylindra.

[0046] In the present application, the Platycladus Orientalis is the dry branch and leaf of Platycladus Orientalis.

[0047] In the present application, the Agrimonia Pilae is the dry above-ground part of Agrimonia Pilae.

[0048] In the present application, the Centella Asiatica is the dry whole plant of Centella Asiatica.

[0049] In the present application, the Cyperus Rotundus is the dry rhizome of Cyperus Rotundus.

[0050] The above-mentioned raw medicinal materials (or medicinal materials) adopted in the present application can be purchased from ordinary medicine stores or Chinese medicinal material sales companies, and the specifications conform to the national medicine standards or relevant regulations of Chinese Pharmacopoeia, and are all in the category directory of the original State Health Department.

[0051] The traditional Chinese medicine composition for treating allergic purpura in the present application fully follows the syndrome differentiation and treatment principle of traditional Chinese medicine, wherein, Radix Rehmanniae Glutinosae is sweet and cold, can clear heat and cool blood, and nourish Yin and generate fluid; Rhizoma Anemarrhenae is sweet, bitter and cold, can clear heat and purge fire, and nourish Yin and moisten dryness; both of them enter the kidney meridian, nourish Yin and generate fluid to support the healthy, and can also purge heat in the blood system, clear and drain the fire, both of them support the healthy and eliminate the pathogenic, and are the monarch drugs. Rhizoma Dioscoreae, which enters the spleen, lung and kidney meridians, can tonify the spleen and stomach, generate fluid and benefit the lung, and tonify the kidney and astringe essence; Radix Labiati Albi, which enters the spleen and stomach meridians, can invigorate the spleen and transform dampness, and harmonize the center; Herba Euphorbiae Humifusae, which enters the kidney and liver meridians, can nourish the liver and kidney, cool blood and stop bleeding; Caulis Dendrobi, which enters the stomach and kidney meridians, can benefit the stomach and generate fluid, and nourish Yin and clear heat; the four of them regulate and tonify the spleen and kidney, benefit Qi to check blood, tonify the kidney and nourish Yin to clear the floating fire, so that the blood does not overflow outside the blood vessels, and the fire does not boil the blood, and are the ministerial drugs. Herba Portulagae is sour and cold, and enters the liver and large intestine meridians, can clear heat and resolve toxicity, and cool blood and stop bleeding; Imperata Cylindra and Platycladus Orientalis are cold, and enter the liver meridian, can cool blood and stop bleeding, and are the essential drugs for treating blood syndrome; Agrimonia Pilae enters the heart and liver meridians, can tonify deficiency, and also astringe and stop bleeding; the four of them are used together, can clear heat and cool blood without damaging the healthy, astringe and stop bleeding without assisting the fire, and are the auxiliary drugs. Centella Asiatica is bitter, pungent and cold, can clear heat and drain dampness, and resolve toxicity and dissipate swelling; Cyperus Rotundus enters the liver, spleen and triple energizer meridians, and can soothe the liver and regulate Qi, regulate the menstruation, and assist the drug to distribute the triple energizer, and are the assistant drugs.

[0052] The formula comprehensively supports the body's resistance and eliminates pathogenic factors, tonifies the spleen and kidneys, restores the body's regulatory function, and clears away excess heat, thus completely eliminating purpura. Specifically, the principle of synergistic action of the principal herbs: Rehmannia glutinosa (nourishing yin and cooling blood) and Anemarrhena asphodeloides (clearing heat and moistening dryness) work together to clear the heat in the blood, reduce vascular permeability, and inhibit histamine release. The assistant herbs enhance efficacy: Dioscorea opposita and Dolichos lablab strengthen the spleen and control bleeding, regulating immune function. Eclipta prostrata and Dendrobium nobile nourish kidney yin, inhibit excessive platelet aggregation, and assist the principal herbs in consolidating the root cause. The adjuvant herbs work synergistically: Portulaca oleracea and Imperata cylindrica have anti-inflammatory, blood-cooling, and hemostatic effects; Cyperus rotundus soothes the liver and regulates qi, improving local microcirculation; Centella asiatica detoxifies and promotes diuresis, reducing immune complex deposition. The principle of principal, assistant, adjuvant, and adjuvant herbs is to tonify the kidneys and nourish yin (principal) to treat the root cause, strengthen the spleen and control bleeding (assistant) to consolidate the middle jiao, cool the blood and astringe (adjuvant) to control the symptoms, and regulate qi and unblock the meridians (adjuvant) to promote efficacy. This allows them to exert a synergistic therapeutic effect.

[0053] In a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises, by weight, the following raw material components:

[0054] 25-35 parts of raw Rehmannia glutinosa; for example, 25 parts, 30 parts, or 35 parts, preferably 30 parts;

[0055] Anemarrhena asphodeloides: 5-15 parts; for example, 5 parts, 10 parts, 15 parts, preferably 10 parts;

[0056] 10-20 parts of yam; for example, 10 parts, 15 parts, or 20 parts, preferably 15 parts;

[0057] 10-20 parts white hyacinth beans; for example, 10 parts, 15 parts, 20 parts, preferably 15 parts;

[0058] 10-20 parts of Eclipta prostrata; for example, 10 parts, 15 parts, 20 parts, preferably 15 parts;

[0059] Dendrobium 5-15 parts; for example, 5 parts, 10 parts, 15 parts, preferably 10 parts;

[0060] Purslane 10-20 parts; for example, 10 parts, 15 parts, 20 parts, preferably 15 parts;

[0061] 10-20 parts of Imperata cylindrica root; for example, 10 parts, 15 parts, or 20 parts, preferably 15 parts;

[0062] Five to 15 parts of arborvitae leaves; for example, 5 parts, 10 parts, 15 parts, preferably 10 parts;

[0063] Agrimonia pilosa 25-35 parts; for example 25 parts, 30 parts, 35 parts, preferably 30 parts;

[0064] Centella asiatica 10-20 parts; for example 10 parts, 15 parts, 20 parts, preferably 15 parts;

[0065] Cyperus rotundus 5-15 parts; for example, 5 parts, 10 parts, 15 parts, preferably 10 parts.

[0066] The second aspect of the present application provides a preparation method of the traditional Chinese medicine extract, comprising: mixing each raw material component of the traditional Chinese medicine composition according to the first aspect of the present application according to a proportion, and obtaining a mixture; and extracting the mixture by a water decoction method.

[0067] In a preferred embodiment of the present application, the raw Rehmannia root and the Anemarrhena asphodeloides are soaked in water for 25-35 min, preferably for 30 min, before being mixed, which is beneficial to the dissolution of the effective components in the raw Rehmannia root and the Anemarrhena asphodeloides, such as glycosides.

[0068] In a preferred embodiment of the present application, the water decoction method comprises the following steps:

[0069] 1) filtering the mixture after the first decoction with water to obtain a first decoction and a residue;

[0070] 2) filtering the residue after the second decoction with water to obtain a second decoction;

[0071] 3) combining the first decoction and the second decoction, and concentrating to obtain the traditional Chinese medicine extract.

[0072] In a further preferred embodiment of the present application, in step 1), the ratio of the mass (g) of the mixture to the volume (mL) of water added each time is 1:9-11, preferably 1:10. That is, 9-11 times, preferably 10 times, the amount of water is added to the mixture.

[0073] In a further preferred embodiment of the present application, in step 1), during the first decoction, after boiling, the mixture is decocted on a low heat, the temperature of the boiling is 95-105℃, preferably 100℃, the temperature of the decoction on a low heat is 75-85℃, preferably 80℃, and the maintaining time of the decoction on a low heat is 35-45 min, preferably 40 min. The decoction on a low heat can retain heat-labile components, such as agastaquin.

[0074] In a further preferred embodiment of the present application, in step 2), the ratio of the mass (g) of the residue to the volume (mL) of water added each time is 1:7.5-8.5, preferably 1:8. That is, 7.5-8.5 times, preferably 8 times, the amount of water is added to the mixture.

[0075] In a further preferred embodiment of the present application, in step 2), during the second decoction, after boiling, the mixture is decocted on a low heat, the temperature of the boiling is 95-105℃, preferably 100℃, the temperature of the decoction on a low heat is 75-85℃, preferably 80℃, and the maintaining time of the decoction on a low heat is 28-32 min, preferably 30 min.

[0076] In further preferred embodiments of the present application, in step 1) or 2), the filtering is a commonly used filtering mode, particularly, such as screen filtering, filter cloth filtering, etc., mainly used for removing impurities, and no residue of medicine dregs is required.

[0077] In further preferred embodiments of the present application, in step 3), the concentration temperature is 55-65℃, preferably 60℃. High temperature is avoided to destroy glycosides.

[0078] In further preferred embodiments of the present application, in step 3), the relative density of the concentrated decoction is 1.10-1.15.

[0079] The above water decoction method ensures that the extraction rate of small molecule active ingredients (such as radix rehmanniae tripterygium glycosides) is > 85% through segmented temperature control, while reducing the degradation of polysaccharide components.

[0080] The third aspect of the present application provides a traditional Chinese medicine extract, which is prepared by using the traditional Chinese medicine composition of the first aspect of the present application as raw material, or by using the preparation method of the traditional Chinese medicine extract of the second aspect of the present application.

[0081] The fourth aspect of the present application provides the use of the traditional Chinese medicine composition of the first aspect of the present application, or the traditional Chinese medicine extract of the third aspect of the present application in the preparation of a medicine for treating allergic purpura.

[0082] The present application will be further described in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate but not to limit the scope of protection of the present application.

[0083] The embodiments of the present application are described below through specific examples. Those skilled in the art can easily understand other advantages and effects of the present application from the disclosure of the present specification. The present application can also be implemented or applied through other different specific embodiments, and each detail in the present specification can be modified or changed based on different views and applications without departing from the spirit of the present application.

[0084] When the embodiments give numerical ranges, it should be understood that, unless otherwise specified by the present application, each numerical range of two endpoints and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present application have the same meaning as generally understood by those skilled in the art.

[0085] The production process, experimental method or detection method involved in the embodiments and comparative examples of the present application, if not specifically stated, are all conventional methods in the prior art, and their names and / or abbreviations are all conventional names in the art, which are very clear and explicit in the relevant application field. The skilled person in the art can understand the conventional process steps and use the corresponding equipment according to the name, and carry out the implementation according to the conventional conditions or the conditions recommended by the manufacturer.

[0086] The various instruments, equipment, raw materials or reagents used in the embodiments of the present application do not have special restrictions on the source, and are all conventional products that can be purchased through normal commercial channels, or can be prepared according to the conventional methods well known to those skilled in the art. The cells, animals, and drug sources involved in the embodiments of the present application are all commercially available, unless otherwise specified.

[0087] Example 1

[0088] Take each raw material component in the traditional Chinese medicine composition for treating allergic purpura, respectively: Rehmannia 30g, Anemarrhena 10g, Dioscorea 15g, Lablab 15g, Euphorbia humifusa 15g, Dendrobium 10g, Portulaca oleracea 15g, Imperata cylindra 15g, Biota orientalis 10g, Agrimonia 30g, Centella asiatica 15g, Cyperus 10g, obtain traditional Chinese medicine composition sample 1#.

[0089] Example 2

[0090] Take each raw material component in the traditional Chinese medicine composition for treating allergic purpura, respectively: Rehmannia 30g, Anemarrhena 10g, Dioscorea 15g, Lablab 15g, Euphorbia humifusa 15g, Dendrobium 10g, Portulaca oleracea 15g, Imperata cylindra 15g, Biota orientalis 10g, Agrimonia 30g, Centella asiatica 15g, Cyperus 10g, obtain traditional Chinese medicine composition sample 1#.

[0091] Example 3

[0092] Take each raw material component in the traditional Chinese medicine composition for treating allergic purpura, respectively: Rehmannia 30g, Anemarrhena 10g, Dioscorea 15g, Lablab 15g, Euphorbia humifusa 15g, Dendrobium 10g, Portulaca oleracea 15g, Imperata cylindra 15g, Biota orientalis 10g, Agrimonia 30g, Centella asiatica 15g, Cyperus 10g, obtain traditional Chinese medicine composition sample 1#.

[0093] Example 4

[0094] The Chinese medicine composition sample 1# of Example 1 was mixed according to the proportion, and then the effective components were extracted by water decoction method. That is, the mixture was added with 10 times amount of water for the first decoction, boiled at 100℃ and then decocted at 80℃ for 40 min, filtered, to obtain the first decoction and the residue. The residue was added with 8 times amount of water for the second decoction, boiled at 100℃ and then decocted at 80℃ for 30 min, filtered, to obtain the second decoction. The first decoction and the second decoction were combined, and concentrated at 60℃ to a relative density of 1.12, to obtain the Chinese medicine extract sample 1*.

[0095] Example 5

[0096] The Chinese medicine composition sample 2# of Example 2 was mixed according to the proportion, and then the effective components were extracted by water decoction method. That is, the mixture was added with 9.5 times amount of water for the first decoction, boiled at 105℃ and then decocted at 85℃ for 38 min, filtered, to obtain the first decoction and the residue. The residue was added with 8.5 times amount of water for the second decoction, boiled at 105℃ and then decocted at 85℃ for 27 min, filtered, to obtain the second decoction. The first decoction and the second decoction were combined, and concentrated at 63℃ to a relative density of 1.14, to obtain the Chinese medicine extract sample 2*.

[0097] Example 6

[0098] The Chinese medicine composition sample 3# of Example 3 was mixed according to the proportion, and then the effective components were extracted by water decoction method. That is, the mixture was added with 10.5 times amount of water for the first decoction, boiled at 95℃ and then decocted at 78℃ for 44 min, filtered, to obtain the first decoction and the residue. The residue was added with 7.5 times amount of water for the second decoction, boiled at 95℃ and then decocted at 78℃ for 33 min, filtered, to obtain the second decoction. The first decoction and the second decoction were combined, and concentrated at 58℃ to a relative density of 1.11, to obtain the Chinese medicine extract sample 3*.

[0099] Test Example 1

[0100] 1. Case selection

[0101] 1.1 Patient condition

[0102] 118 cases of allergic purpura patients were selected in our hospital from May 2023 to May 2025, among which 65 cases were male, aged 5-55 years, with an average age of 30.4 years, the disease course was 3 days-2.5 years, the average course was 1.5 years, 53 cases were female, aged 5-52 years, with an average age of 30.2 years, the disease course was 3 days-2 years, the average course was 1.3 years, all patients had the main feature of skin purpura, purpura was papular, more in the trunk of limbs, symmetrical distribution, batch appearance, pressure not retreat, itching discomfort; some even had joint pain or abdominal pain, hematochezia, low back pain, hematuria and other signs; the platelet count, bleeding time and coagulation time of the patients were normal when blood routine examination was performed; female patients were non-pregnant or lactating women, and patients with brain, heart, kidney dysfunction and severe systemic diseases, blood diseases were excluded. Randomly divided into observation group (54 cases) and control group (54 cases), the control group used conventional western medicine treatment, the observation group combined with cooling blood and purpura soup on the basis of western medicine treatment. The therapeutic effects of the two groups were observed and compared. There was no significant difference in age, gender, disease course and other aspects between the two groups (P>0.05), which was comparable.

[0103] 2. Test method

[0104] 2.1 Observation group

[0105] On the basis of conventional western medicine treatment, the patient was given the traditional Chinese medicine extract sample 1 prepared in Example 4, 1 dose per day, taken twice, 1 week as a course of treatment, and the results were observed after continuous administration for 4 courses.

[0106] 2.2 Control group

[0107] Western medicine treatment: give patients with loratadine, compound rutin and other drug conventional treatment, appropriately add prednisone tablets for oral use according to the situation; one course per week, observe the results after continuous treatment for 4 courses.

[0108] 2.3 Observation index and method

[0109] (1) Clinical symptom improvement time: rash subsidence time, abdominal pain disappearance time, joint pain relief time, urine routine recovery time. (2) Inflammatory index: before and after treatment, white blood cell count (WBC) was detected by automatic blood cell analyzer, C-reactive protein (CRP) level was detected by enzyme-linked immunosorbent assay, and erythrocyte sedimentation rate (ESR) was detected by blood sedimentation detector. (3) Adverse reaction monitoring.

[0110] 2.4 Efficacy evaluation criteria

[0111] Efficacy evaluation criteria: Markedly effective: Complete absorption of skin purpura lesions (no new skin lesions for more than 72 hours), complete disappearance of abdominal symptoms (such as colic, melena) and joint symptoms (such as swelling, limited mobility), and normalization of laboratory indicators (urine red blood cell count <5 / HPF and 24-hour urine protein quantification <0.15g / 24h); Effective: Reduction of skin purpura area ≥50%, significant improvement of abdominal / joint symptoms (VAS score decrease ≥3 points), reduction of 24-hour urine protein quantification >40% or reduction of urine red blood cell count >50%; Ineffective: Failure to meet the above criteria. Total effective rate = (Markedly effective + Effective) / Total number of cases × 100%.

[0112] 2.5 Statistical methods

[0113] SPSS 25.0 statistical software was used to process and analyze the data. Quantitative data were... Data expressed as frequency or percentage (%) were analyzed using a t-test; count data were expressed as frequency or percentage (%) and analyzed using a chi-square test. 2 Test. P < 0.05 is considered statistically significant.

[0114] 3 Test Results

[0115] 3.1 Comparison of clinical efficacy and adverse reactions: The total effective rate of the combined two-drug group (observation group) was 92.6%, which was higher than that of the Western medicine-only treatment group (control group) (75.9%). χ² 2 =8.21, the difference in efficacy between the two groups was statistically significant (P<0.05). Four cases of adverse reactions occurred in the control group, accounting for 7.4%. Detailed results are shown in Table 1.

[0116] Table 1. Comparison of treatment effects and adverse reactions between the observation group and the control group [n(%)]

[0117]

[0118] 3.2 Comparison of clinical symptom improvement time: The time for rash to subside, abdominal pain to disappear, joint pain to be relieved, and urinalysis to return to normal were all shorter in the combined two-drug group (observation group) than in the group treated with Western medicine alone (control group) (P<0.05). Specific results are shown in Table 2.

[0119] Table 2 Comparison of clinical symptom improvement time between the observation group and the control group.

[0120]

[0121] 3.3 Comparison of inflammatory indicators: Before treatment, there was no statistically significant difference in WBC, CRP, and ESR between the two groups (P>0.05); after 7-14 days of treatment, the WBC, CRP, and ESR of the two groups were lower than before treatment, and the CRP and ESR of the observation group were lower than those of the western medicine combination treatment group (control group) (P<0.05), and there was no statistically significant difference in WBC between the two groups (P>0.05). The specific results are shown in Table 3.

[0122] Table 3 Comparison of inflammatory indicators before and after treatment in the observation group and the control group

[0123]

[0124] Test Example 2

[0125] The traditional Chinese medicine extract sample 1* of Example 4 was subjected to sample testing, and the specific test results are shown in Figure 1a 、 1b 2a, 2b. As can be seen from Figure 1a 、 1b 2a, 2b, after 4 weeks of sample testing, the color of the purpura rash of the patients became lighter, the range was reduced, and some rashes completely subsided without leaving traces.

[0126] The above is only a preferred embodiment of the present application, and is not a limitation on the form and substance of the present application. It should be noted that for ordinary skilled persons in the art, without departing from the method of the present application, some improvements and supplements can be made, and these improvements and supplements should be considered as the protection scope of the present application. For those skilled in the art, without departing from the spirit and scope of the present application, some changes, modifications and equivalent changes can be made based on the disclosed technical content, which are equivalent embodiments of the present application; at the same time, any equivalent changes, modifications and evolution of the above-mentioned embodiments according to the essential technology of the present application are still within the scope of the technical solutions of the present application.

Claims

1. A traditional Chinese medicine composition, comprising the following ingredients by weight: Radix Rehmanniae 20-40 parts; Anemarrhena 1-20 parts; Chinese yam 5-25 parts; White kidney bean 5-25 parts; Herba Ecliptae 5-25 parts; Dendrobium 1-20 parts; Herba Portulacae 5-25 parts; Imperata cylindrical 5-25 parts; Biota orientalis 1-20 parts; Herba Agrimoniae 20-40 parts; Herba Centellae 5-25 parts; Rhizoma Cyperi 1-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, comprising the following ingredients by weight: Radix Rehmanniae 25-35 parts; Anemarrhena 5-15 parts; Chinese yam 10-20 parts; White kidney bean 10-20 parts; Herba Ecliptae 10-20 parts; Dendrobium 5-15 parts; Herba Portulacae 10-20 parts; Imperata cylindrical 10-20 parts; Biota orientalis 5-15 parts; Herba Agrimoniae 25-35 parts; Herba Centellae 10-20 parts; Rhizoma Cyperi 5-15 parts.

3. A method of preparing a traditional Chinese medicine extract, comprising: The mixture is obtained by mixing the ingredients of the traditional Chinese medicine composition according to any one of claims 1-2 according to the ratio, and the mixture is extracted by water decoction method.

4. The preparation method of claim 3, characterized in that, The Radix Rehmanniae and Anemarrhena in the traditional Chinese medicine composition are soaked in water for 25-35 minutes before mixing.

5. The preparation method of claim 3, characterized in that, The water decoction method comprises the following steps: 1) filtering the mixture after the first decoction with water to obtain the first decoction and the residue; 2) filtering the residue after the second decoction with water to obtain the second decoction; 3) combining the first decoction and the second decoction and concentrating to provide the traditional Chinese medicine extract.

6. The preparation method of claim 3, characterized in that, In step 1), any one or more of the following conditions is included: 11) the ratio of the mass of the mixture to the volume of water added each time is 1:9-11, g / mL; 12) in the first decoction, after boiling, decocting on a low fire, the boiling temperature is 95-105℃, and the low fire decoction temperature is 75-85℃, and the low fire decoction time is 35-45 minutes.

7. The preparation method of claim 3, characterized in that, In step 2), any one or more of the following conditions is included: 21) the ratio of the mass of the residue to the volume of water added each time is 1:7.5-8.5, g / mL; 22) in the second decoction, after boiling, decocting on a low fire, the boiling temperature is 95-105℃, and the low fire decoction temperature is 75-85℃, and the low fire decoction time is 28-32 minutes.

8. The preparation method of claim 3, characterized in that, In step 3), any one or more of the following conditions is included: 31) the concentration temperature is 55-65℃; 32) the relative density of the decoction after concentration is 1.10-1.

15. 9.A traditional Chinese medicine extract, which is prepared from the traditional Chinese medicine composition according to any one of claims 1-2, or prepared by the preparation method of the traditional Chinese medicine extract according to any one of claims 3-8. 10.The use of the traditional Chinese medicine composition according to any one of claims 1-2, or the traditional Chinese medicine extract according to claim 9, in the preparation of a drug for treating allergic purpura.

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