Traditional Chinese medicine composition for treating children allergic rhinitis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating children allergic rhinitis and a preparation method, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises radices stellariae dichotomae, fructus schizandrae, fructus mume, radix arnebiae seu lithospermi, radix rubiae, herba ecliptae, fructus xanthii, flos magnoliae, radix angelicae and radix glycyrrhizae, and can be prepared into traditional Chinese medicine freeze-dried powder Clinical observation and animal experiments prove that the traditional Chinese medicine composition can remarkably improve allergic rhinitis symptoms such as rhinocnesmus, sneezing and running nose, and is good in safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating allergic rhinitis in children and its preparation method. Background Technology

[0002] Allergic rhinitis (AR) is a common pediatric disease. Its pathogenesis mainly involves a non-infectious inflammatory reaction of the nasal mucosa mediated by immunoglobulin E (IgE) after exposure to allergens. In recent years, the incidence of AR in children has shown a significant upward trend, becoming one of the major respiratory inflammatory diseases in children. Statistical data shows that the prevalence of AR in children in my country ranges from 13.94% to 17.2%, and is increasing year by year. The main clinical manifestations of this disease include sudden and recurrent nasal itching, sneezing, runny nose, and nasal congestion. If not treated promptly, it may further induce a series of complications such as bronchial asthma, allergic pneumonia, and secretory otitis media. In the field of modern medicine, the treatment of AR in children mainly focuses on symptomatic and supportive treatment such as anti-allergy drugs and topical medications, supplemented by environmental control, immunotherapy, or surgical treatment, primarily to control symptoms; there is currently no cure.

[0003] From the perspective of Traditional Chinese Medicine (TCM), childhood rhinitis (AR) falls under the category of "nasal congestion," with a complex and diverse pathogenesis. Common syndromes include lung qi deficiency and cold, spleen qi deficiency, kidney yang deficiency, and latent heat in the lung meridian. TCM has rich experience in regulating and treating childhood AR. Compared with Western medicine, TCM treatment for childhood AR has many advantages, such as definite efficacy, fewer adverse reactions, relatively shorter treatment cycles, and lower recurrence rates. Based on the unique advantages of TCM in treating childhood AR, clinically proven effective classic formulas can be further developed into safe, stable, and suitable TCM preparations for children, providing more options for drug treatment. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of the prior art and to provide a traditional Chinese medicine composition and preparation method for treating allergic rhinitis in children.

[0005] The specific technical solution adopted in this invention is as follows:

[0006] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating allergic rhinitis in children, the traditional Chinese medicine composition being made from the following raw materials: 3-9 parts of Stellaria dichotoma, 3-9 parts of Schisandra chinensis, 3-9 parts of Prunus mume, 3-9 parts of Lithospermum erythrorhizon, 3-9 parts of Rubia cordifolia, 3-9 parts of Eclipta prostrata, 3-10 parts of Xanthium sibiricum, 3-10 parts of Magnolia biondii, 5-30 parts of Angelica dahurica, and 1-5 parts of Glycyrrhiza uralensis.

[0007] Preferably, the traditional Chinese medicine composition is made from the following raw materials: 6 parts of Bupleurum chinense, 5 parts of Schisandra chinensis, 6 parts of Prunus mume, 6 parts of Lithospermum erythrorhizon, 6 parts of Rubia cordifolia, 6 parts of Eclipta prostrata, 5 parts of Xanthium sibiricum, 5 parts of Magnolia biondii, 10 parts of Angelica dahurica and 3 parts of Glycyrrhiza uralensis.

[0008] Secondly, the present invention provides a method for preparing a drug using the traditional Chinese medicine composition described in the first aspect, wherein the drug is a traditional Chinese medicine granule, and the specific preparation method is as follows:

[0009] S1: Mix the raw materials in the Chinese herbal medicine composition, add 10 times the amount of water and boil for 1-2 hours for the first extraction; then add 8 times the amount of water and boil for 1 hour for the second extraction.

[0010] S2: The liquid obtained from the secondary extraction is concentrated to a specific gravity of 1.05-1.15 under conditions of 50-80℃ and vacuum degree ≥0.060Mpa, and then vacuum dried to obtain traditional Chinese medicine granules; the vacuum drying temperature is ≤80℃ and the vacuum degree is ≥0.070Mpa.

[0011] Thirdly, the present invention provides a traditional Chinese medicine granule obtained by the method for preparing a drug according to the second aspect.

[0012] Fourthly, the present invention provides a method for preparing a drug using the traditional Chinese medicine composition described in the first aspect, wherein the drug is a freeze-dried powder of traditional Chinese medicine, and the specific preparation method is as follows:

[0013] S1: Mix the raw materials in the Chinese herbal medicine composition, add 10 times the amount of water and boil for 1-2 hours for the first extraction; then add 8 times the amount of water and boil for 1 hour for the second extraction.

[0014] S2: The liquid obtained from the secondary extraction is concentrated to a specific gravity of 1.28-1.35 under the conditions of temperature ≤80℃ and vacuum degree ≥0.060Mpa, and then vacuum dried, followed by pulverization and sieving to obtain freeze-dried Chinese medicine powder; the vacuum drying temperature is ≤80℃, the vacuum degree is ≥0.070Mpa, and the sieve mesh is 80 mesh.

[0015] Fifthly, the present invention provides a freeze-dried powder of traditional Chinese medicine obtained by the method for preparing medicine according to the fourth aspect.

[0016] Compared with the prior art, the present invention has the following advantages:

[0017] This invention uses a pure Chinese herbal formula, based on the TCM concept of "regulating the body to treat the root cause". It intervenes from the root cause of allergic constitution, which can not only significantly improve the symptoms of allergic rhinitis, but also has the advantages of high safety and low recurrence rate, which fully reflects the characteristics of TCM of "treating both the symptoms and the root cause".

[0018] The traditional Chinese medicine composition used in this invention focuses on dispelling wind and relieving allergies, clearing nasal passages and stopping bleeding, and is particularly suitable for children with allergic rhinitis during an attack, whose main symptoms include nasal congestion, nasal itching, sneezing, and runny nose. This composition utilizes herbs such as *Stellaria dichotoma* and *Angelica dahurica* to dispel wind and relieve allergies, *Xanthium sibiricum* and *Magnolia biondii* to clear nasal passages, *Lithospermum erythrorhizon* and *Rubia cordifolia* to cool the blood and stop bleeding, and *Schisandra chinensis* and *Prunus mume* to astringe and strengthen the exterior. The combined effects of these herbs dispel wind, clear nasal passages, cool the blood, and strengthen the exterior. The above composition is prepared into pharmaceutically acceptable granules and lyophilized powder using conventional pharmaceutical processes. Clinical observations and animal experiments have confirmed that this composition can significantly improve allergic rhinitis symptoms such as nasal itching, sneezing, and runny nose, and has good safety, providing a safe and effective treatment option for patients with allergic rhinitis. Attached Figure Description

[0019] Figure 1 The following is a comparison chart of the nasal symptom scores of rats in each group in Example 3, where (A) is the behavioral score, (B) is the number of times the nose was scratched within 30 minutes after the last provocation, and (C) is the number of times the nose was sneezed within 30 minutes after the last provocation.

[0020] Figure 2 The images show the pathological results of the nasal mucosa of rats in each group in Example 3;

[0021] Figure 3 The following is a graph showing the results of inflammatory factor indices in the nasal mucosa of rats in Example 3, where (A) is IgE, (B) is IL-4, (C) is IL-10, (D) is IL-13, (E) is IL-17, and (F) is IFN-γ.

[0022] Figure 4 Figure 3 shows the nasal epithelial barrier damage results in each group of rats in Example 3;

[0023] Figure 5 This is a comparative graph showing the data of Claudin-1 protein (A), Occlidin protein (B), and ZO-1 protein (C) in each group of rats in Example 3;

[0024] Figure 6 The VAS score results of patients during the treatment with traditional Chinese medicine granules in Example 4;

[0025] Figure 7 The results of the quality of life scale scores of patients during the treatment with traditional Chinese medicine granules in Example 4;

[0026] Figure 8 The results of the TCM syndrome scoring table for patients treated with traditional Chinese medicine granules in Example 4 are shown. Detailed Implementation

[0027] The present invention will be further described and illustrated below with reference to the accompanying drawings and specific embodiments. The technical features of each embodiment of the present invention can be combined accordingly, provided that there is no mutual conflict.

[0028] Example 1

[0029] This embodiment provides a freeze-dried powder of traditional Chinese medicine for treating allergic rhinitis in children. The specific preparation method is as follows:

[0030] Weigh out the following raw materials: 6g of Stellaria dichotoma, 5g of Schisandra chinensis, 6g of Prunus mume, 6g of Lithospermum erythrorhizon, 6g of Rubia cordifolia, 6g of Eclipta prostrata, 5g of Xanthium sibiricum, 5g of Magnolia biondii, 10g of Angelica dahurica, and 3g of Glycyrrhiza uralensis. Mix the above raw materials, add 10 times the amount of water, and boil for 2 hours for the first extraction; then add 8 times the amount of water and boil for 1 hour for the second extraction.

[0031] The liquid after secondary extraction was filtered, and the filtrate was concentrated to a specific gravity of 1.28–1.35 under conditions of temperature ≤80℃ and vacuum degree ≥0.060 MPa, followed by vacuum drying. The vacuum drying temperature was controlled at ≤80℃ and the vacuum degree ≥0.070 MPa. The dried product was then pulverized through an 80-mesh sieve to obtain freeze-dried traditional Chinese medicine powder.

[0032] Example 2

[0033] This embodiment provides a traditional Chinese medicine granule for treating allergic rhinitis in children, and the specific preparation method is as follows:

[0034] Weigh out the following raw materials: 6g of Stellaria dichotoma, 5g of Schisandra chinensis, 6g of Prunus mume, 6g of Lithospermum erythrorhizon, 6g of Rubia cordifolia, 6g of Eclipta prostrata, 5g of Xanthium sibiricum, 5g of Magnolia biondii, 10g of Angelica dahurica, and 3g of Glycyrrhiza uralensis. Mix the above raw materials, add 10 times the amount of water, and boil for 1 hour for the first extraction; then add 8 times the amount of water and boil for 1 hour for the second extraction.

[0035] After secondary extraction, the liquid is filtered and concentrated to a specific gravity of 1.05–1.15 under conditions of 50–80℃ and vacuum degree ≥0.060Mpa. Then, it is vacuum dried. The temperature of vacuum drying is controlled at ≤80℃ and the vacuum degree is ≥0.070Mpa, and finally, traditional Chinese medicine granules are obtained.

[0036] Example 3

[0037] This embodiment uses the freeze-dried powder of traditional Chinese medicine prepared in Example 1 to test SD rats, exploring the efficacy and mechanism of action of this traditional Chinese medicine in treating allergic rhinitis, and verifying its safety. The specific methods are as follows:

[0038] (1) Construction of diseased SD rat model

[0039] Several 3-week-old SD rats were selected, and each rat was injected intraperitoneally with ovalbumin (OVA) every 2 days from day 1 to day 13 to induce an allergic reaction.

[0040] (2) Treatment plan

[0041] The diseased SD rats were divided into a model control group (Model), a positive control group (Positive), a low-dose experimental group (JMT-0.76), and a high-dose experimental group (JMT-3.04). Rats in the model control group received no drug treatment, while rats in the positive control group were treated with cetirizine (0.85 mg / kg). The low-dose and high-dose experimental groups were treated with the lyophilized traditional Chinese medicine powder prepared in Example 1 via gavage at low and high doses, respectively. The low-dose dose was 0.76 g / kg, and the high-dose dose was 3.04 g / kg. Additionally, SD rats without disease model establishment were selected as the control group. The drugs were administered via gavage once daily from day 14 to day 27. Simultaneously, OVA solution was administered via nasal drops daily to induce allergic rhinitis symptoms. On day 28, OVA solution was administered via nasal drops, and the rats' nose-scratching, sneezing, and nasal discharge were observed and recorded within 30 minutes. The results are as follows: Figure 1 As shown in the image. Blood was then drawn via the abdominal aorta, serum was separated, and the levels of IgE, IL-4, IL-10, IL-13, IL-17, and IFN-γ in the serum were measured. The results are shown in the image. Figure 3 As shown; simultaneously, rat nasal bone tissue was collected, decalcified, and then subjected to HE staining and immunohistochemical staining analysis. The results are as follows. Figure 2 , Figure 4 and Figure 5 As shown.

[0042] Figure 1 The study showed the effect of traditional Chinese medicine freeze-dried powder treatment on nasal symptom scores in rats. The results showed that the behavioral scores of the high-dose treatment group were significantly reduced. Figure 2 The results showed that after 14 days of drug administration, the morphology of rat nasal mucosal epithelial cells and the integrity of cilia were improved, and the degree of inflammatory cell infiltration was reduced. Figure 3 The study showed that after drug administration, the levels of IgE, IL-4, IL-10, IL-13, and IL-17 in the rat blood decreased, while the level of IFN-γ increased. Based on... Figure 4 and Figure 5 It was found that, compared with the model group, the expression of key proteins occludin, claudin-1, and ZO-1 in tight junction (TJ) was significantly increased in the high-dose group, suggesting that the Chinese medicine component can repair the damaged nasal epithelial barrier in diseased rats.

[0043] Example 4

[0044] This embodiment uses the traditional Chinese medicine granules prepared in Example 2 for clinical treatment research on children with allergic rhinitis, as detailed below:

[0045] Baseline information was registered before treatment began: basic information (name, gender, age, height, weight), present illness history (onset time, diagnosis time), medication history (rhinitis-related medications and treatment courses), and past medical history (allergy history, family allergy history) of 49 patients were recorded. Clinical evaluation was conducted using the VAS score for allergic rhinitis, the patient quality of life scale, and the traditional Chinese medicine syndrome scoring scale.

[0046] The herbal granules (5g / sachet) prepared in Example 2 were administered according to age: 3-6 years old, 2 / 3 sachet per dose; 6-9 years old, 1 sachet per dose; 9-12 years old, 1.5 sachets per dose. The medication was taken twice daily, once after breakfast and once after dinner, for 7 days as one course of treatment. The scoring tables are shown in Tables 1-3. Scores were given before medication, after 1 week of medication, and after 2 weeks of medication.

[0047] Table 1. VAS Scoring Scale for Allergic Rhinitis

[0048]

[0049] The evaluation is based on a scale of 0 to 10, where "0" represents asymptomatic and "10" represents the most severe symptoms.

[0050] Table 2 Patient Quality of Life Table

[0051]

[0052] Table 3 Traditional Chinese Medicine Syndrome Scoring Table

[0053]

[0054]

[0055] The experimental results of this embodiment are as follows: Figures 6-8 As shown, after two weeks of treatment, the patient's symptoms, quality of life, and TCM syndrome showed significant improvement, and a significant therapeutic effect can be seen after one course of treatment.

[0056] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the invention. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of the invention. Therefore, all technical solutions obtained through equivalent substitution or transformation fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating allergic rhinitis in children, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: 3-9 parts of Bupleurum chinense, 3-9 parts of Schisandra chinensis, 3-9 parts of Prunus mume, 3-9 parts of Lithospermum erythrorhizon, 3-9 parts of Rubia cordifolia, 3-9 parts of Eclipta prostrata, 3-10 parts of Xanthium sibiricum, 3-10 parts of Magnolia biondii, 5-30 parts of Angelica dahurica, and 1-5 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating allergic rhinitis in children according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: 6 parts of Bupleurum chinense, 5 parts of Schisandra chinensis, 6 parts of Prunus mume, 6 parts of Lithospermum erythrorhizon, 6 parts of Rubia cordifolia, 6 parts of Eclipta prostrata, 5 parts of Xanthium sibiricum, 5 parts of Magnolia biondii, 10 parts of Angelica dahurica and 3 parts of Glycyrrhiza uralensis.

3. A method for preparing a drug using the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The drug is a traditional Chinese medicine granule, and the specific preparation method is as follows: S1: Mix the raw materials in the Chinese herbal medicine composition, add 10 times the amount of water and boil for 1-2 hours for the first extraction; then add 8 times the amount of water and boil for 1 hour for the second extraction. S2: The liquid obtained from the secondary extraction is concentrated to a specific gravity of 1.05-1.15 under conditions of 50-80℃ and vacuum degree ≥0.060Mpa, and then vacuum dried to obtain traditional Chinese medicine granules; the vacuum drying temperature is ≤80℃ and the vacuum degree is ≥0.070Mpa.

4. A traditional Chinese medicine granule prepared by the method of preparing the drug according to claim 3.

5. A method for preparing a drug using the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The drug is a freeze-dried powder of traditional Chinese medicine, and the specific preparation method is as follows: S1: Mix the raw materials in the Chinese herbal medicine composition, add 10 times the amount of water and boil for 1-2 hours for the first extraction; then add 8 times the amount of water and boil for 1 hour for the second extraction. S2: The liquid obtained from the secondary extraction is concentrated to a specific gravity of 1.28-1.35 under the conditions of temperature ≤80℃ and vacuum degree ≥0.060Mpa, and then vacuum dried, followed by pulverization and sieving to obtain freeze-dried Chinese medicine powder; the vacuum drying temperature is ≤80℃, the vacuum degree is ≥0.070Mpa, and the sieve mesh is 80 mesh.

6. A freeze-dried powder of traditional Chinese medicine obtained by the method for preparing a drug according to claim 5.

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