A traditional Chinese medicine composition for treating chronic urticaria, a preparation method and application thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating chronic urticaria and its preparation method and application, it is related to the technical field of traditional Chinese medicine, by weight parts, the traditional Chinese medicine composition for treating chronic urticaria includes the following components: 20-30 parts of dracocephalum heterophyllum, 20-30 parts of old hawk grass, 12-20 parts of astragalus, 8-15 parts of schizonepeta, 8-15 parts of duckweed, 10-15 parts of semen euryae, 10-15 parts of cortex meliae, 5-10 parts of fried ephedra, 10-15 parts of ophiopogon, 7-12 parts of siler. Compared with prior art, the traditional Chinese medicine composition provided by the present application is used by introducing suitable proportions of each component such as dracocephalum heterophyllum, old hawk grass, schizonepeta etc., and combined with reduced pressure reflux extraction and macroporous resin column chromatography purification process, the treatment effect of the obtained traditional Chinese medicine composition for chronic urticaria such as Wei Bie not fixed type is significantly improved, and a new traditional Chinese medicine treatment scheme is provided for chronic urticaria patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating chronic urticaria, its preparation method, and its application. Background Technology

[0002] Chronic urticaria (CU) is a common allergic dermatological disease characterized by recurrent wheals and itching, with a course lasting for months or even years. Modern medicine believes that this disease is mainly related to autoimmune abnormalities, mast cell activation, and the release of inflammatory mediators such as histamine. Currently, clinical treatment mainly relies on antihistamines (such as second-generation H1 receptor antagonists) for symptomatic relief. Although these can relieve itching and wheal symptoms in the short term, they have limitations such as easy relapse upon discontinuation and the potential for drowsiness or tolerance with long-term use. For refractory chronic urticaria, some patients even need long-term use of glucocorticoids, but the side effects such as endocrine disorders and decreased immunity should not be ignored.

[0003] In Traditional Chinese Medicine (TCM) theory, chronic urticaria falls under the categories of "urticaria" and "wind rash." Most physicians believe its pathogenesis primarily stems from inherent weakness and a lack of defensive qi, allowing wind-cold or wind-heat pathogens to invade the skin's surface, leading to disharmony between the body's defensive and nutritive qi, and impaired blood circulation; or from prolonged illness depleting qi and blood, resulting in blood deficiency, wind generation, and malnourishment of the skin. Among these, the "weak defensive qi type" is a very common TCM syndrome of chronic urticaria. Patients with this type often experience worsening rashes upon exposure to wind and cold, aversion to wind and spontaneous sweating, weak constitution, susceptibility to illness, and a tendency for recurrent attacks. While numerous TCM compound formulas exist for treating chronic urticaria, their therapeutic effects are unsatisfactory and require further improvement. Summary of the Invention

[0004] To address the above problems, this invention provides a traditional Chinese medicine composition for treating chronic urticaria, its preparation method, and its application.

[0005] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic urticaria, wherein the traditional Chinese medicine composition for treating chronic urticaria comprises the following components in parts by weight:

[0006] 20-30 parts of *Cymbidium goeringii*, 20-30 parts of *Gerberis vulgaris*, 12-20 parts of *Astragalus membranaceus*, 8-15 parts of *Schizonepeta tenuifolia*, 8-15 parts of *Lemna minor*, 10-15 parts of *Kochia scoparia*, 10-15 parts of *Dictamnus dasycarpus*, 5-10 parts of processed *Ephedra sinica*, 10-15 parts of *Ophiopogon japonicus*, and 7-12 parts of *Saposhnikovia divaricata*.

[0007] Furthermore, the weight ratio of the *Illicium heterophyllum* and the *Gerberis vulgaris* is 1:1.

[0008] Furthermore, the traditional Chinese medicine composition for treating chronic urticaria comprises the following components in parts by weight:

[0009] 25 parts of *Cymbidium goeringii*, 25 parts of *Gerberis vulgaris*, 15 parts of *Astragalus membranaceus*, 10 parts of *Schizonepeta tenuifolia*, 10 parts of *Lemna minor*, 12 parts of *Kochia scoparia*, 12 parts of *Dictamnus dasycarpus*, 8 parts of processed *Ephedra sinica*, 12 parts of *Ophiopogon japonicus*, and 10 parts of *Saposhnikovia divaricata*.

[0010] Secondly, the present invention provides a method for preparing the traditional Chinese medicine composition for treating chronic urticaria as described in any one of the first aspects, such as... Figure 1 As shown, it includes the following steps:

[0011] The various Chinese herbs are mixed and pulverized to obtain a mixture;

[0012] The mixture was added to water and subjected to vacuum reflux extraction to obtain an extract.

[0013] The extract was concentrated to obtain a paste;

[0014] The extract was loaded onto a column and eluted with an ethanol-water mixture. The eluent was collected, concentrated, and dried to obtain a traditional Chinese medicine composition for treating chronic urticaria.

[0015] Furthermore, the working conditions parameters for the reduced pressure reflux extraction include: temperature of 45~55℃, pressure of 5~10KPa, extraction time of 60~90 minutes per extraction, extraction times of 1~3 times, and the weight of water added is 5~10 times the weight of the mixture.

[0016] Furthermore, the temperature of the vacuum reflux extraction is 50°C, and the pressure of the vacuum reflux extraction is 8 kPa.

[0017] Furthermore, the volume fraction of ethanol in the ethanol-water mixed solvent is 40-50%.

[0018] Further, the steps of eluting the extract onto a column, collecting the eluent, concentrating and drying it to obtain the traditional Chinese medicine composition for treating chronic urticaria include the following processes:

[0019] The extract and D101 macroporous resin were mixed at a mass ratio of 1:1.2 and then eluted onto a column. First, 5 to 8 column volumes of water were used for elution, followed by 10 to 20 column volumes of the ethanol-water mixed solvent. The eluent from the ethanol-water mixed solvent was collected and concentrated and dried under reduced pressure to obtain the traditional Chinese medicine composition for treating chronic urticaria.

[0020] Thirdly, the present invention provides the use of the traditional Chinese medicine composition for treating chronic urticaria as described in any one of the first aspects, or the traditional Chinese medicine composition for treating chronic urticaria prepared by the preparation method of the traditional Chinese medicine composition for treating chronic urticaria as described in any one of the second aspects, in the preparation of a drug for treating chronic urticaria.

[0021] Furthermore, the dosage form of the medication for treating chronic urticaria includes at least one of the following: liquid, tablet, traditional Chinese medicine extract, powder, and capsule.

[0022] The technical solutions provided in the embodiments of the present invention have at least the following advantages compared with the prior art:

[0023] This invention provides a traditional Chinese medicine composition for treating chronic urticaria. Compared with existing technologies, the traditional Chinese medicine composition provided by this invention significantly improves the therapeutic effect of the obtained traditional Chinese medicine composition on chronic urticaria, such as the Wei Biao Bu Gu type, by introducing appropriate proportions of various components such as Heterophyllum heterophyllum, Geranium wilfordii, and Schizonepeta tenuifolia, and combining them with vacuum reflux extraction and macroporous resin column chromatography purification processes. This provides a new traditional Chinese medicine treatment option for patients with chronic urticaria. Specifically:

[0024] In this invention, *Illicium thunbergii* and *Geranium wilfordii* are used as the principal herbs, targeting the deep-seated pathogenesis of chronic urticaria, which involves prolonged illness affecting the collaterals and liver stagnation transforming into heat. The core principle is to clear the liver and dispel wind; the two herbs work synergistically to exert multiple effects, including anti-inflammatory, antihistamine, and immunomodulatory effects. *Astragalus membranaceus* is used to tonify qi and strengthen the exterior, while *Schizonepeta tenuifolia* and *Saposhnikovia divaricata* dispel wind and promote rash eruption, serving as assistant herbs to address both the root cause and the symptoms. *Lemna minor*, *Kochia scoparia*, *Dictamnus dasycarpus*, and *Ephedra sinica* (processed) dispel wind and dampness, promote rash eruption, and relieve itching. *Ophiopogon japonicus* is added to nourish yin and generate fluids to counteract the pungent and drying properties of the other herbs, ensuring that the entire formula eliminates pathogens without harming the body's vital energy. The entire formula combines the four methods of "strengthening, penetrating, clearing, and nourishing," with each herb producing a significant synergistic effect under specific weight ratios, effectively solving the problem of ineffective treatment with existing single therapies or ordinary prescriptions. Attached Figure Description

[0025] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0026] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a schematic flowchart illustrating the preparation method of a traditional Chinese medicine composition for treating chronic urticaria provided in an embodiment of the present invention. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] Unless otherwise specified, all raw materials, reagents, instruments, and equipment used in this invention can be purchased from the market or prepared using existing methods. Furthermore, unless specifically limited or specified, the process steps and parameters involved can be carried out according to existing traditional Chinese medicine composition preparation processes or using existing equipment and conventional operating methods.

[0030] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed according to national standards. If no corresponding national standard exists, then generally accepted international standards, conventional conditions, or conditions recommended by the manufacturer are followed.

[0031] Example 1

[0032] This example provides a traditional Chinese medicine composition for treating chronic urticaria, which, by weight, comprises the following components:

[0033] 25 parts of *Cymbidium goeringii*, 25 parts of *Gerberis vulgaris*, 15 parts of *Astragalus membranaceus*, 10 parts of *Schizonepeta tenuifolia*, 10 parts of *Lemna minor*, 12 parts of *Kochia scoparia*, 12 parts of *Dictamnus dasycarpus*, 8 parts of processed *Ephedra sinica*, 12 parts of *Ophiopogon japonicus*, and 10 parts of *Saposhnikovia divaricata*.

[0034] The preparation method of the above-mentioned traditional Chinese medicine composition for treating chronic urticaria includes the following steps:

[0035] Step (1): Mix and pulverize the various Chinese herbs to obtain a mixture;

[0036] Step (2): Add the mixture to water and perform vacuum reflux extraction at a temperature of 50°C and a pressure of 8 kPa. The extraction time is 80 minutes per extraction and the extraction is performed twice. The weight of water added is 8 times the weight of the mixture; the extract is obtained.

[0037] Step (3): Concentrate the extract to obtain a paste;

[0038] Step (4): The extract and D101 macroporous resin are mixed at a mass ratio of 1:1.2 and then eluted on a column. First, elute with 6 column volumes of water, then elute with 15 column volumes of ethanol-water mixed solvent (ethanol volume fraction of 45%). Collect the eluent of the ethanol-water mixed solvent and concentrate and dry under reduced pressure to obtain the traditional Chinese medicine composition for treating chronic urticaria.

[0039] Example 2

[0040] This example provides a traditional Chinese medicine composition for treating chronic urticaria and its preparation method, which differs from Example 1 only in that:

[0041] (1) The weight of Cymbidium goeringii was adjusted to 30 parts;

[0042] (2) The weight of Geranium wilfordii was adjusted to 20 parts.

[0043] Comparative Example 1

[0044] This example provides a traditional Chinese medicine composition for treating chronic urticaria and its preparation method, which differs from Example 1 only in that:

[0045] (1) No *Cymbidium goeringii* was added.

[0046] Comparative Example 2

[0047] This example provides a traditional Chinese medicine composition for treating chronic urticaria and its preparation method, which differs from Example 1 only in that:

[0048] (1) No Geranium was added.

[0049] Comparative Example 3

[0050] This example provides a traditional Chinese medicine composition for treating chronic urticaria and its preparation method, which differs from Example 1 only in that:

[0051] (1) The temperature of the vacuum reflux extraction is 70℃ and the pressure of the vacuum reflux extraction is 20KPa.

[0052] (2) The volume fraction of ethanol in the ethanol-water mixed solvent is 20%.

[0053] Test case

[0054] This example aims to examine the therapeutic effect of the traditional Chinese medicine compositions obtained in Examples 1-2 and Comparative Examples 1-3 on chronic urticaria of the Wei-fa type.

[0055] Test samples: Chinese herbal extracts from Example 1, Example 2, Comparative Example 1, Comparative Example 2, and Comparative Example 3.

[0056] Positive control drug: Chlorpheniramine.

[0057] Experimental animals: SD rats, weighing 200-220g, half male and half female; Balb / C mice, weighing 18-22g, half male and half female.

[0058] Experimental methods:

[0059] 1. Preparation of anti-ovalbumin serum: Ten SD rats were immunized by intraperitoneal injection of 1 mL of a mixture of 1 mg ovalbumin and 10 mg aluminum hydroxide in physiological saline. The injection was repeated every other day for a total of 3 times. The rats were sacrificed 12 days after the last sensitization, and blood was collected from the abdominal aorta. The blood was centrifuged for 10 min, and the supernatant was collected to prepare anti-serum, which was stored at -20℃ for later use.

[0060] 2. Grouping and Administration: Balb / C mice, half male and half female, were randomly divided into 8 groups of 8 mice each: normal group, model group, chlorpheniramine positive control group, Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group. The mice were administered the clinically equivalent dose by gavage, while the model group and normal group received the corresponding volume of purified water, for 30 consecutive days. The chlorpheniramine dose was 0.4 mg / kg. Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group were each given a test sample solution equivalent to 17.72 g / kg (crude drug weight).

[0061] 3. Establishment of an animal model of urticaria with unstable surface defense: Except for the normal group, all other groups swam at room temperature for 5 minutes per day. -1 Swimming in ice water (0±4℃) for 1 min·d -1 Smoke in a homemade smoking box for 30 minutes per day. -1 (Cigarettes: 3 cigarettes / box) for 30 consecutive days; on day 29, after gavage, the model group and the treatment group were shaved on the back and intradermally injected with a mixture of antiserum and Freund's adjuvant (1:1 mixture, injected at multiple points, 0.05 mL per point), while the normal group was injected intradermally with physiological saline. After the last administration, the mice were challenged with antigen and injected with 0.1 mL of 5% ovalbumin physiological saline solution via the tail vein. Swimming kept the mice's body surface in a cold and damp state for a long time, damaging the yang qi of the exterior; smoking damages the lungs, and lung deficiency further weakens the qi of the exterior, thus forming a weakened exterior. Then, urticaria was induced by subcutaneous injection of the mixture of antiserum and Freund's adjuvant and tail vein injection of ovalbumin, forming a weakened exterior urticaria type.

[0062] 4. Evaluation of Allergy Index for Unstable Urticaria: Skin allergy reaction was scored 30 minutes after the last injection of ovalbumin. The scoring criteria were as follows: Erythema: No erythema 0 points, mild erythema (barely visible) 1 point, moderate erythema (clearly visible) 2 points, severe erythema 3 points, purplish-red erythema to mild eschar formation 4 points; Edema: No edema 0 points, mild edema (barely visible) 1 point, moderate edema (clearly visible, with raised edges above the surrounding skin) 2 points, severe edema (skin raised approximately 1 mm, with clear outline) 3 points, extreme edema (skin raised more than 1 mm or with blisters or ulceration) 4 points. Average reaction value = (Total score for erythema formation + Total score for edema formation) / Total number of animals.

[0063] 5. Effect on serum INF-γ content in mice with unstable urticaria: After allergy index evaluation, mice were anesthetized, blood was collected from the orbital venous plexus, centrifuged at 2000 rpm for 15 min, serum was collected, and INF-γ content was measured using an enzyme-linked immunosorbent assay kit.

[0064] 6. Statistics and Analysis: Statistical analysis was performed using software, and the test results are shown in Table 1.

[0065] Table 1

[0066] Test group Average reaction value INF-γ (ng / L) normal group 0 19.10±1.88 Model group 6.500 9.97±1.05 Chlorpheniramine positive control group 2.000 18.42±1.93 Example 1 Group 1.375 18.79±1.67 Example 2 group 2.250 17.15±1.59 Comparative Example 1 4.750 14.86±1.42 Comparative Example 2 5.000 13.73±1.40 Comparative Example 3 Groups 3.750 15.98±1.56

[0067] As shown in Table 1, all the above test samples can improve the allergic reaction scores of model mice and alleviate urticaria symptoms. However, Examples 1 and 2 are significantly better than Comparative Examples 1, 2 and 3, indicating that the traditional Chinese medicine composition obtained by the present invention through specific raw material ratios and preparation methods can produce a synergistic effect and has a significant effect on treating chronic urticaria of the Wei-Feng type.

[0068] In summary, the embodiments of the present invention provide a traditional Chinese medicine composition for treating chronic urticaria, its preparation method, and its application. Compared with the prior art, the traditional Chinese medicine composition provided by the present invention significantly improves the therapeutic effect of the obtained traditional Chinese medicine composition on chronic urticaria such as the superficial urticaria type by introducing appropriate proportions of various components such as *Illicium verum*, *Gerberis vulgaris*, and *Schizonepeta tenuifolia*, and combining them with vacuum reflux extraction and macroporous resin column chromatography purification processes. This provides a new traditional Chinese medicine treatment option for patients with chronic urticaria.

[0069] Various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is merely for convenience and brevity and should not be construed as a hard limitation on the scope of the invention; therefore, it should be considered that the range description has specifically disclosed all possible subranges and single numerical values ​​within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range. Furthermore, whenever a numerical range is referred to herein, it means including any referenced number (fraction or integer) within the range referred to.

[0070] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A traditional Chinese medicine composition for treating chronic urticaria, characterized in that, The traditional Chinese medicine composition for treating chronic urticaria comprises the following components in parts by weight: 20-30 parts of *Cymbidium goeringii*, 20-30 parts of *Gerberis vulgaris*, 12-20 parts of *Astragalus membranaceus*, 8-15 parts of *Schizonepeta tenuifolia*, 8-15 parts of *Lemna minor*, 10-15 parts of *Kochia scoparia*, 10-15 parts of *Dictamnus dasycarpus*, 5-10 parts of processed *Ephedra sinica*, 10-15 parts of *Ophiopogon japonicus*, and 7-12 parts of *Saposhnikovia divaricata*.

2. The traditional Chinese medicine composition for treating chronic urticaria according to claim 1, characterized in that, The weight ratio of the *Cymbidium goeringii* and the *Gerberis vulgaris* is 1:

1.

3. The traditional Chinese medicine composition for treating chronic urticaria according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic urticaria comprises the following components in parts by weight: 25 parts of *Cymbidium goeringii*, 25 parts of *Gerberis vulgaris*, 15 parts of *Astragalus membranaceus*, 10 parts of *Schizonepeta tenuifolia*, 10 parts of *Lemna minor*, 12 parts of *Kochia scoparia*, 12 parts of *Dictamnus dasycarpus*, 8 parts of processed *Ephedra sinica*, 12 parts of *Ophiopogon japonicus*, and 10 parts of *Saposhnikovia divaricata*.

4. A method for preparing a traditional Chinese medicine composition for treating chronic urticaria according to any one of claims 1-3, characterized in that, Includes the following steps: The various Chinese herbs are mixed and pulverized to obtain a mixture; The mixture was added to water and subjected to vacuum reflux extraction to obtain an extract. The extract was concentrated to obtain a paste; The extract was loaded onto a column and eluted with an ethanol-water mixture. The eluent was collected, concentrated, and dried to obtain a traditional Chinese medicine composition for treating chronic urticaria.

5. The method for preparing the traditional Chinese medicine composition for treating chronic urticaria according to claim 4, characterized in that, The working conditions for the vacuum reflux extraction include: a temperature of 45-55℃, a pressure of 5-10 kPa, a single extraction time of 60-90 minutes, an extraction frequency of 1-3 times, and the amount of water added being 5-10 times the weight of the mixture.

6. The method for preparing the traditional Chinese medicine composition for treating chronic urticaria according to claim 5, characterized in that, The temperature of the vacuum reflux extraction is 50°C, and the pressure of the vacuum reflux extraction is 8 kPa.

7. The method for preparing the traditional Chinese medicine composition for treating chronic urticaria according to claim 4, characterized in that, The volume fraction of ethanol in the ethanol-water mixed solvent is 40-50%.

8. The method for preparing the traditional Chinese medicine composition for treating chronic urticaria according to claim 7, characterized in that, The steps of eluting the extract onto a column, collecting the eluent, concentrating and drying it to obtain the traditional Chinese medicine composition for treating chronic urticaria include the following: The extract and D101 macroporous resin were mixed at a mass ratio of 1:1.2 and then eluted onto a column. First, 5 to 8 column volumes of water were used for elution, followed by 10 to 20 column volumes of the ethanol-water mixed solvent. The eluent from the ethanol-water mixed solvent was collected and concentrated and dried under reduced pressure to obtain the traditional Chinese medicine composition for treating chronic urticaria.

9. The use of a traditional Chinese medicine composition for treating chronic urticaria as described in any one of claims 1-3, or a traditional Chinese medicine composition for treating chronic urticaria prepared by the preparation method of the traditional Chinese medicine composition for treating chronic urticaria as described in any one of claims 4-8, in the preparation of a drug for treating chronic urticaria.

10. The application according to claim 9, characterized in that, The dosage forms of the medication for treating chronic urticaria include at least one of the following: liquid, tablet, traditional Chinese medicine extract, powder, and capsule.

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