Lung-tonifying and orifice-clearing patch for treating allergic rhinitis of children and preparation method of lung-tonifying and orifice-clearing patch

Abstract

The invention relates to the technical field of rhinitis plasters, in particular to a lung-tonifying and orifice-clearing plaster for children allergic rhinitis, which is a traditional Chinese medicine ointment composed of magnolia flower, dahurian angelica root, Szechuan lovage rhizome, cocklebur fruit, white mustard seed, spina gleditsiae and ginger. Angelica dahurica and magnolia flower are taken as monarch drugs, and the two drugs are used together to achieve the effects of relieving exterior syndrome with pungent and warm natured drugs and dredging nasal orifices, so that nasal obstruction and running nose can be effectively relieved. Siberian cocklour fruit and ligusticum wallichii are used as ministerial drugs and co-assist monarch drugs, so that the effects of dredging orifices and dispelling wind are enhanced, qi and blood are dredged, and relapse of rhinitis can be relieved. The fried mustard seeds and the spina gleditsiae are used for enhancing the effect of reducing phlegm, assisting the monarch and ministerial drug effects and relieving the disadvantage of nasal orifices. The ginger is used as a conductant drug to help transdermal absorption of the drugs. The medicines are used together to achieve the effects of dredging orifices, dispelling wind, warming meridians, removing stasis, promoting qi circulation and activating collaterals. The lung-tonifying and orifice-clearing patch can effectively improve rhinitis symptoms and achieve a treatment effect.

Description

Technical Field

[0001] The invention relates to the technical field of rhinitis patches, and in particular to a lung-benefiting and orifice-clearing patch for children with allergic rhinitis and a preparation method thereof. Background Art

[0002] Allergic rhinitis, also known as allergic rhinitis, is a type I allergic disease that occurs in the nasal mucosa and is mediated by IgE after the body comes into contact with allergens, and involves a variety of cytokines and immune active cells. Its typical symptoms include sneezing, runny nose, nasal congestion and nasal itching. Although the symptoms of AR are not life-threatening, they can be accompanied by sinusitis, asthma, and secretory otitis media. Modern medicine mainly uses oral leukotriene receptor antagonists combined with intranasal hormones for treatment. Although the treatment is fast-acting, the effect is not long-lasting and the disease is prone to recurrence. Many children become less sensitive to drugs after long-term use, and adverse reactions are obvious.

[0003] Traditional Chinese medicine believes that allergic rhinitis in children belongs to the category of "nasal congestion". "Explanation of Names and Diseases" states: "Nasal congestion is called nasal congestion. Nasal congestion means long-term." The method of treating AR in children with traditional Chinese medicine is to start from the overall situation and treat it according to the symptoms and physical differences of each child. A large number of clinical studies and literature have shown that traditional Chinese medicine has special treatments for treating AR in children, especially acupoint application, which has the advantages of significant efficacy and simple operation. At present, traditional Chinese medicine nasal preparations are mostly used to treat local nasal diseases and acute diseases. There is a relative lack of varieties for the treatment of AR. Both the number of varieties and the types of diseases covered cannot meet clinical needs. Therefore, it is necessary to develop external preparations for the treatment of rhinitis to meet clinical drug needs. Summary of the invention

[0004] In view of the above-mentioned shortcomings of the prior art, the present invention provides a lung-benefiting and orifice-clearing patch for children's allergic rhinitis and a preparation method thereof, which can effectively solve the above-mentioned problems of the prior art.

[0005] Technical Solution

[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0007] The present invention provides a Chinese medicine composition for children with allergic rhinitis, which comprises four types of Chinese medicine decoction pieces raw materials: monarch, minister, assistant and envoy, wherein:

[0008] The monarch drug includes one or two of magnolia and angelica dahurica;

[0009] The ministerial drugs include one or two of Chuanxiong and Xanthium sibiricum;

[0010] The adjuvant includes one or two of white mustard seeds and Gleditsia sinensis thorns;

[0011] The adjuvant drug is ginger.

[0012] Furthermore, the monarch medicine includes magnolia and angelica dahurica; the minister medicine includes ligusticum chuanxiong and xanthium sibiricum; the adjuvant medicine includes mustard seeds and gleditsia thorn; and the guiding medicine is ginger.

[0013] Preferably, the monarch drug is composed of magnolia and angelica dahurica; the ministerial drug is composed of ligusticum chuanxiong and xanthium sibiricum; the adjuvant drug is composed of mustard seeds and gleditsia thorn; and the guiding drug is ginger.

[0014] Among the main drugs, Angelica dahurica is pungent and warm, enters the lung, stomach and large intestine meridians, clears the orifices and promotes circulation, dispels wind and relieves pain, and clears the nasal orifices; Magnolia officinalis is pungent and warm, enters the lung and stomach meridians, is pungent and dispersing, warming and unblocking, and aromatic and opens the orifices. Angelica dahurica and Magnolia officinalis work together as the main drugs, which are pungent and dispersing, clear the orifices, promote the flow of qi, and relieve nasal congestion and runny nose.

[0015] Among the ministerial drugs, Xanthium sibiricum is pungent and warm, and enters the lung meridian, clears the orifices and dispels wind; Chuanxiong is pungent and fragrant, and warms and promotes blood circulation, dispels wind and clears the orifices. Xanthium sibiricum and Chuanxiong are ministerial drugs, which assist the monarch drug, strengthen the power of clearing the orifices and dispelling wind, and at the same time promote the flow of qi and blood, which helps to relieve the recurrence of rhinitis.

[0016] Among the adjuvants, white mustard seeds are pungent, dispersing, warming, and unblocking, and enter the lung and stomach meridians, unblock the collaterals and resolve phlegm, and promote qi, dissipate stagnation, and open the orifices. Stir-frying can utilize its transdermal effect, but reduce irritation to the epidermis. Gleditsia sinensis is pungent and warm, and enters the liver and lung meridians, activates blood circulation and dispels wind, dissipates stasis, dissipates stagnation, and unblocks the orifices. White mustard seeds and Gleditsia sinensis are used as adjuvants, which can unblock the orifices, dissipate stagnation, activate the collaterals and dissipate wind, help the power of the monarch and minister drugs, and relieve nasal orifice discomfort.

[0017] Among the adjuvant drugs, ginger is pungent, warm and penetrating, enters the lung and stomach meridians, clears the orifices and resolves phlegm, warms the meridians and dredges the collaterals. As an adjuvant drug, it helps the drugs to be absorbed through the skin.

[0018] The above-mentioned medicines are used together to achieve the effects of opening the orifices and dispelling wind, warming the meridians and dispersing nodules, and promoting qi and activating collaterals.

[0019] Furthermore, by weight, it includes 2-12 parts of magnolia, 2-12 parts of angelica dahurica, 2-12 parts of ligusticum chuanxiong, 1-9 parts of xanthium sibiricum, 0.1-8 parts of white mustard seeds, 0.1-8 parts of gleditsia thorns and 0.1-8 parts of ginger.

[0020] Furthermore, by weight, it includes 3-8 parts of magnolia, 3-8 parts of angelica dahurica, 3-8 parts of ligusticum chuanxiong, 2-6 parts of xanthium sibiricum, 1-6 parts of white mustard seeds, 1-6 parts of gleditsia thorns and 1-6 parts of ginger.

[0021] Further, by weight, it includes 6 parts of magnolia, 6 parts of angelica dahurica, 6 parts of ligusticum chuanxiong, 4 parts of xanthium sibiricum, 3 parts of white mustard seeds, 3 parts of gleditsia thorns and 3 parts of ginger.

[0022] A lung-benefiting and clearing-orifice patch for children's allergic rhinitis comprises an ointment, which is prepared by using the above-mentioned traditional Chinese medicine composition.

[0023] A method for preparing a Yifeiqingqiao patch for children's allergic rhinitis, comprising the following steps:

[0024] S1. Gleditsia sinensis, Chuanxiong rhizome and Angelica dahurica are crushed and sieved, and mixed to obtain powder;

[0025] S2, crushing white mustard seeds, magnolia, and Xanthium sibiricum, slicing ginger, mixing white mustard seeds, magnolia, Xanthium sibiricum and ginger to obtain a mixture, adding water 2-5 times the weight of the mixture, soaking for 20-50 minutes, boiling at normal pressure for 5-20 minutes, filtering and concentrating to obtain a concentrated solution for standby use;

[0026] S3, take 20-30 parts of honey by weight and heat until uniform light yellow fine bubbles appear in the pot, add it to the powder while it is hot and mix well, then add the concentrate and mix well, let it cool in a natural environment to obtain an ointment;

[0027] S4: Take the ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

[0028] Furthermore, in step S2, white mustard seeds, magnolia, and Xanthium sibiricum are crushed, ginger is sliced, white mustard seeds, magnolia, Xanthium sibiricum and ginger are mixed to obtain a mixture, and water 3 times the weight of the mixture is added, soaked for 30 minutes, extracted for 15 minutes, filtered and concentrated at normal pressure to 10% of the amount of water added to obtain a concentrated solution for use.

[0029] Further, in step S3, 24 parts of honey are taken by weight and heated until uniform light yellow fine bubbles appear in the pot, and then added to the powder while hot and mixed, and then the concentrated solution is added and mixed, and cooled in a natural environment to obtain an ointment. In the present invention, the honey refining step belongs to medium honey.

[0030] Furthermore, in step S1, the mesh size is 100-150 meshes, preferably 120 meshes.

[0031] Furthermore, the Yifei Qingqiao patch prepared as above can be used in combination with anti-leukotriene receptor antagonists and nasal hormones for combined treatment. Specifically, it can be topical mometasone furoate nasal spray and montelukast sodium chewable tablets.

[0032] According to traditional Chinese medicine, AR is located in the nasal cavity and is related to the lungs. Lung qi is connected to the nose. If the lungs are cold, the cold will enter the nose with the qi, so the body fluids and mucus cannot be collected. The main cause is insufficient lung qi and the external wind and cold evil qi. There is no deficiency to cause illness. Lung qi is insufficient, the defense is not solid, and the wind and cold attack the lungs. The lungs fail to descend, the wind is good at moving, the cold evil stagnates in the nasal cavity, and the water channel is not good, then there will be symptoms such as nasal congestion, nasal itching, sneezing, and runny nose. Therefore, the treatment should be pungent and warm to dispel cold, and to open the lungs and open the orifices. Long-term illness enters the collaterals, so for diseases with a long course and repeated attacks, it is better to use drugs that promote qi and blood circulation to help qi and blood flow. Therefore, I designed the Yifei Qingqiao patch, which can penetrate the meridians through the skin and reach the lungs, and can exert the effects of drugs and acupoints at the same time, so as to treat AR in children.

[0033] Beneficial Effects

[0034] Compared with the known public technology, the technical solution provided by the present invention has the following beneficial effects:

[0035] (1) Yifei Qingqiao Patch is a traditional Chinese medicine ointment composed of magnolia, angelica dahurica, chuanxiong, xanthium sibiricum, white mustard, sapodilla thorn, and ginger. The main drugs are angelica dahurica and magnolia. The two drugs are used together to play the role of warming and dispelling the exterior, and clearing the nasal passages, which can effectively relieve nasal congestion and runny nose. Xanthium sibiricum and chuanxiong are the ministers, which help the main drug to strengthen the power of clearing the passages and dispelling wind, and at the same time promote the flow of qi and blood, which helps to relieve the recurrence of rhinitis. Stir-fried mustard and sapodilla thorn are used to strengthen the effect of resolving phlegm, help the power of the main and minister drugs, and relieve nasal congestion. Ginger is used as a guiding drug to help the drugs absorb through the skin. The drugs are used together to play the role of clearing the passages and dispelling wind, warming the meridians and dispersing nodules, and promoting qi and activating collaterals.

[0036] (2) The results of the present invention show that after 2 weeks and 4 weeks of treatment, the symptoms of nasal congestion, runny nose, sneezing, nasal itching, etc. in each observation group were significantly improved compared with the basic group, and the TNSS of the observation group after 2 weeks of treatment was significantly lower than that before treatment, indicating that the Yifei Qingqiao Patch combined with oral leukotriene receptor antagonists and nasal spray hormones has a better effect and a shorter onset time. In particular, after 4 weeks, 27 children (45.8%) in the observation group were able to stop using anti-leukotriene receptor antagonists and nasal hormones, indicating that the longer the treatment time, the more obvious the efficacy of the Yifei Qingqiao Patch. DETAILED DESCRIPTION

[0037] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0038] The present invention will be further described below in conjunction with the embodiments.

[0039] (I) Embodiment

[0040] Embodiment 1:

[0041] A method for preparing a Yifeiqingqiao patch for children's allergic rhinitis, comprising the following steps:

[0042] S1. According to weight, grind and sieve 3 parts of Gleditsia sinensis, 6 parts of Chuanxiong and 6 parts of Angelica dahurica, and mix them to obtain powder;

[0043] S2. By weight, 3 parts of white mustard seeds, 6 parts of magnolia, and 4 parts of Xanthium sibiricum were crushed, and 3 parts of ginger were sliced. The white mustard seeds, magnolia, Xanthium sibiricum and ginger were mixed to obtain a mixture, and water 3 times the weight of the mixture was added, soaked for 30 minutes, boiled at normal pressure for 15 minutes, filtered and concentrated at normal pressure to 10% of the amount of water added to obtain a concentrated solution for standby use;

[0044] S3. Take 24 parts of honey by weight and heat it until uniform light yellow fine bubbles appear in the pot. Add it to the powder while it is hot and mix well. Then add the concentrated solution and mix well. Let it cool in a natural environment to obtain an ointment. Among them, the honey refined in this step belongs to medium honey.

[0045] S4: Take 3g of ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

[0046] Embodiment 2:

[0047] A method for preparing a Yifeiqingqiao patch for children's allergic rhinitis, comprising the following steps:

[0048] S1. According to weight, 3 parts of white mustard seeds, 6 parts of magnolia flowers, and 4 parts of Xanthium sibiricum seeds were crushed and sieved, and mixed to obtain powder;

[0049] S2. By weight, 3 parts of Gleditsia sinensis, 6 parts of Chuanxiong, and 6 parts of Angelica dahurica were crushed, 3 parts of ginger were sliced, and the Gleditsia sinensis, Chuanxiong, Angelica dahurica and ginger were mixed to obtain a mixture, and water 3 times the weight of the mixture was added, soaked for 30 minutes, boiled at normal pressure for 15 minutes, filtered and concentrated at normal pressure to 10% of the amount of water added to obtain a concentrated solution for standby use;

[0050] S3. Take 24 parts of honey by weight and heat it until uniform light yellow fine bubbles appear in the pot. Add it to the powder while it is hot and mix well. Then add the concentrated solution and mix well. Let it cool in a natural environment to obtain an ointment. Among them, the honey refined in this step belongs to medium honey.

[0051] S4: Take 3g of ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

[0052] Embodiment 3:

[0053] The only difference from Example 1 is that 6 parts of Angelica dahurica are used to replace 6 parts of Magnolia officinalis.

[0054] A method for preparing a Yifeiqingqiao patch for children's allergic rhinitis, comprising the following steps:

[0055] S1. According to weight, grind and sieve 3 parts of Gleditsia sinensis, 6 parts of Chuanxiong and 6 parts of Angelica dahurica, and mix them to obtain powder;

[0056] S2. By weight, 3 parts of white mustard seeds, 6 parts of angelica dahurica, and 4 parts of Xanthium sibiricum were crushed, and 3 parts of ginger were sliced. The white mustard seeds, magnolia, Xanthium sibiricum and ginger were mixed to obtain a mixture, and water 3 times the weight of the mixture was added, soaked for 30 minutes, boiled at normal pressure for 15 minutes, filtered and concentrated at normal pressure to 10% of the amount of water added to obtain a concentrated solution for standby use;

[0057] S3. Take 24 parts of honey by weight and heat it until uniform light yellow fine bubbles appear in the pot. Add it to the powder while it is hot and mix well. Then add the concentrated solution and mix well. Let it cool in a natural environment to obtain an ointment. Among them, the honey refined in this step belongs to medium honey.

[0058] S4: Take 3g of ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

[0059] Embodiment 4:

[0060] The only difference from Example 1 is that 6 parts of Magnolia Flos are used to replace 6 parts of Angelica Dahuricae.

[0061] A method for preparing a Yifeiqingqiao patch for children's allergic rhinitis, comprising the following steps:

[0062] S1. Grind and sieve 3 parts of Gleditsia sinensis, 6 parts of Rhizoma Chuanxiong and 6 parts of Flos Magnoliae by weight, and mix them to obtain powder;

[0063] S2. By weight, 3 parts of white mustard seeds, 6 parts of magnolia, and 4 parts of Xanthium sibiricum were crushed, and 3 parts of ginger were sliced. The white mustard seeds, magnolia, Xanthium sibiricum and ginger were mixed to obtain a mixture, and water 3 times the weight of the mixture was added, soaked for 30 minutes, boiled at normal pressure for 15 minutes, filtered and concentrated at normal pressure to 10% of the amount of water added to obtain a concentrated solution for standby use;

[0064] S3. Take 24 parts of honey by weight and heat it until uniform light yellow fine bubbles appear in the pot. Add it to the powder while it is hot and mix well. Then add the concentrated solution and mix well. Let it cool in a natural environment to obtain an ointment. Among them, the honey refined in this step belongs to medium honey.

[0065] S4: Take 3g of ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

[0066] Embodiment 5:

[0067] The only difference from Example 1 is that Xanthium sibiricum is used instead of Ligusticum chuanxiong.

[0068] A method for preparing a Yifeiqingqiao patch for children's allergic rhinitis, comprising the following steps:

[0069] S1. According to weight, 3 parts of Gleditsia sinensis, 6 parts of Xanthium sibiricum and 6 parts of Angelica dahurica were crushed and sieved, and mixed to obtain powder;

[0070] S2. By weight, 3 parts of white mustard seeds, 6 parts of magnolia, and 4 parts of Xanthium sibiricum were crushed, and 3 parts of ginger were sliced. The white mustard seeds, magnolia, Xanthium sibiricum and ginger were mixed to obtain a mixture, and water 3 times the weight of the mixture was added, soaked for 30 minutes, boiled at normal pressure for 15 minutes, filtered and concentrated at normal pressure to 10% of the amount of water added to obtain a concentrated solution for standby use;

[0071] S3. Take 24 parts of honey by weight and heat it until uniform light yellow fine bubbles appear in the pot. Add it to the powder while it is hot and mix well. Then add the concentrated solution and mix well. Let it cool in a natural environment to obtain an ointment. Among them, the honey refined in this step belongs to medium honey.

[0072] S4: Take 3g of ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

[0073] Embodiment 6:

[0074] The only difference from Example 1 is that Rhizoma Chuanxiong is used to replace Fructus Xanthii.

[0075] A method for preparing a Yifeiqingqiao patch for children's allergic rhinitis, comprising the following steps:

[0076] S1. According to weight, grind and sieve 3 parts of Gleditsia sinensis, 6 parts of Chuanxiong and 6 parts of Angelica dahurica, and mix them to obtain powder;

[0077] S2. Crush 3 parts of white mustard seeds, 6 parts of magnolia, and 4 parts of Chuanxiong by weight, slice 3 parts of ginger, mix the white mustard seeds, magnolia, Xanthium sibiricum and ginger to obtain a mixture, add water 3 times the weight of the mixture, soak for 30 minutes, boil at normal pressure for 15 minutes, filter and concentrate at normal pressure to 10% of the amount of water added to obtain a concentrated solution for standby use;

[0078] S3. Take 24 parts of honey by weight and heat it until uniform light yellow fine bubbles appear in the pot. Add it to the powder while it is hot and mix well. Then add the concentrated solution and mix well. Let it cool in a natural environment to obtain an ointment. Among them, the honey refined in this step belongs to medium honey.

[0079] S4: Take 3g of ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

[0080] Embodiment 7:

[0081] The only difference from Example 1 is that the ointment preparation method is different, which is as follows:

[0082] S1. According to weight, 3 parts of Gleditsia sinensis, 6 parts of Chuanxiong, 6 parts of Angelica dahurica, 3 parts of Sinapis alba, 6 parts of Magnolia officinalis, 4 parts of Xanthium sibiricum and 3 parts of dried ginger were crushed and sieved, and mixed to obtain powder;

[0083] S2. Take 32 parts of honey by weight and heat it until uniform light yellow fine bubbles appear in the pot. Add it to the powder while it is hot and mix well. Let it cool in a natural environment to obtain an ointment.

[0084] S3: Take 3g of ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

[0085] (II) Drug efficacy test

[0086] (1) Observation indicators

[0087] After enrollment, the age, gender, course of disease, and condition of the children were recorded. The nasal symptoms (TNSS) of the eight groups (basic group and observation group) were scored before and after treatment according to the table below, see Table 1 for details. Adverse events and drug-related adverse reactions were recorded truthfully, such as rash, abdominal pain, diarrhea, nausea, vomiting, palpitations, tremors, excitement, depression, irritability, etc.

[0088] Table 1 TNSS scoring standards

[0089]

[0090] (2) General Information

[0091] 480 patients were from the Department of Traditional Chinese Medicine, Department of Otolaryngology and Head and Neck, Department of Allergy, and Outpatient Clinic for the Treatment of Upper Airway Allergic Reaction with Chinese and Western Medicine in our hospital. They were of all genders and aged 3 to 16 years old. The diagnostic criteria were as follows: "Diagnosis and Treatment of Allergic Rhinitis in Children - Clinical Practice Guidelines", "Clinical Diagnosis and Treatment Guidelines for Pediatric Allergic Rhinitis in Traditional Chinese Medicine", "Diagnosis and Efficacy Standards for Chinese Medicine Diseases", and "Chinese Medicine Otolaryngology" for the diagnosis of allergic rhinitis. The patients were randomly divided into eight groups using the random number table method, including 60 cases in the basic group, 60 cases in the observation group 1, 60 cases in the observation group 2, 60 cases in the observation group 3, 60 cases in the observation group 4, 60 cases in the observation group 5, 60 cases in the observation group 6, and 60 cases in the observation group 7. During the treatment, 8 cases were excluded according to the exclusion criteria. Finally, there were 59 cases in the observation groups 1 to 7, and 59 cases in the basic group; among them, 297 were males and 175 were females. There was no significant difference in the gender, age, TNSS before treatment and other general data of the two groups of children after statistical processing (P>0.05), and they were comparable.

[0092] Table 2 Distribution of general characteristics

[0093]

[0094] Note: The values ​​in brackets in Table 2 are the age range or TNSS range of cases in the observation group or basic group, and the values ​​outside brackets are the average age or TNSS.

[0095] (3) Patient inclusion criteria

[0096] Inclusion criteria: ①Age 3 to 16 years old; ②Meet the diagnostic criteria for pediatric AR, with a medical history of ≥ 1 month; ③Symptom onset, TNSS score ≥ 2 points; ④Continuous treatment for 4 weeks. ⑤Legal guardian agrees and has signed informed consent.

[0097] Exclusion criteria: ① Those with nasal polyps or obvious abnormal nasal structure that may cause abnormal ventilation function; ② Those with past or current major diseases such as interstitial lung disease, muscular dystrophy, congenital immunodeficiency, malignant tumors, autoimmune diseases, airway developmental abnormalities; ③ Those with oral diseases, heart disease, chronic kidney disease, and gastric ulcer during the screening evaluation period (interview); ④ Those who have used systemic glucocorticoids within four weeks before taking the medicine; ⑤ Those who are allergic to the ingredients of the patch / have rashes or ulcers on the local skin (more than 2 acupuncture points); ⑥ Those who have participated in other clinical trials within three months; ⑦ Any other conditions that the researcher considers unsuitable for participating in the trial.

[0098] (4) Methods

[0099] The basic group received basic treatment: topical mometasone furoate nasal spray (mometasone furoate nasal spray (60 presses per bottle, MSD Belgium BVBA / SPRL, national medicine standard JX 20140277)), bilateral nasal spray, 2 times / day, 1 press / time, which can be reduced to once a day after symptoms are controlled, for 2 consecutive courses, and oral montelukast sodium chewable tablets (Merck Sharp Dohme Ltd, national medicine standard J 20130054), 1 time / day, 4 mg / time (3-5 years old), 5 mg / time (6-18 years old), taken before bedtime.

[0100] On the basis of the basic group, observation groups 1 to 7 were given the Yifei Qingqiao patch prepared in Examples 1-7, which was applied to the acupoints: Feishu point (double), Dazhui point, Tiantu point, and Tanzhong point. Twice a week, each time, the patch was removed after about 4 to 6 hours, and the treatment course was 4 weeks in total.

[0101] (5) Statistical processing

[0102] SPSS 26.0 software was used for statistical analysis of the data, and the Mann-Whitney U test or Kruskal-Wallis H test was used for comparison; the count data were expressed as rate (%), and the Fisher test was used for comparison. P < 0.05 was considered statistically significant.

[0103] (6) Results

[0104] 1) Comparison of TNSS after 2 weeks of treatment

[0105] After treatment, the nasal symptoms of the children in the observation group were significantly relieved, and the difference was statistically significant (P<0.05). There was no statistical difference in the nasal symptom scores of the children in the basic group before and after treatment (P>0.05). Compared with the other groups, the TNSS score of the observation group was significantly better than that of the basic group (P<0.001). See Table 3 for details.

[0106] Table 3 Comparison of TNSS after 2 weeks of treatment (n=59)

[0107]

[0108] Note: The values ​​in brackets in Table 3 are the TNSS ranges of cases in the observation group or basic group, and the values ​​outside brackets are the average TNSS values.

[0109] 2) Comparison of TNSS after 4 weeks of treatment

[0110] After 4 weeks of treatment, the TNSS scores were lower than before treatment, and the reduction of TNSS scores in each observation group was significantly better than that in the basic group (P<0.001). See Table 4 for details. After 4 weeks of treatment, the number of cases of remission in the observation group 1 and the basic group was 58 cases (98.3%) and 53 cases (89.8%), respectively. The number of cases of discontinuation of symptomatic treatment drugs in the observation group 1 and the basic group after 4 weeks of treatment was 27 cases (45.8%) and 3 cases (5.1%), respectively.

[0111] Table 4 Comparison of TNSS after 4 weeks of treatment (n=59)

[0112]

[0113]

[0114] Note: The values ​​in brackets in Table 4 are the TNSS ranges of cases in the observation group or basic group, and the values ​​outside brackets are the average TNSS values.

[0115] Table 5 Number of cases where anti-leukotriene receptor antagonists and nasal hormones could be discontinued after 4 weeks of treatment

[0116] Group Number of cases of drug discontinuation Observation Group 1 27 cases Observation Group 2 11 cases Observation Group 3 17 cases Observation Group 4 15 cases Observation Group 5 21 cases Observation Group 6 19 cases Observation Group 7 7 cases Basic Group 3 cases

[0117] The results of the present invention show that after 2 weeks and 4 weeks of treatment, the nasal congestion, runny nose, sneezing, nasal itching and other conditions of each observation group were significantly improved compared with the basic group, and the TNSS of the observation group after 2 weeks of treatment was significantly lower than that before treatment, indicating that the Yifei Qingqiao patch combined with oral leukotriene receptor antagonists and nasal spray hormones has a better effect and a short onset time. In particular, after 4 weeks, 27 children (45.8%) in the observation group were able to stop using anti-leukotriene receptor antagonists and nasal hormones, indicating that the longer the treatment time, the more obvious the efficacy of the Yifei Qingqiao patch.

[0118] In summary, Yifei Qingqiao Patch combined with oral leukotriene receptor antagonists and mometasone furoate nasal spray is effective in treating AR in children, with a short effective time. It can effectively improve the allergic immune response and inflammatory response of the nasal mucosa in children, alleviate their symptoms, and help them reduce or stop symptomatic medications as soon as possible.

[0119] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements will not cause the essence of the corresponding technical solutions to deviate from the protection scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for children's allergic rhinitis, characterized in that: It includes four types of Chinese herbal medicine raw materials: monarch, minister, assistant and envoy, among which: The monarch drug includes one or two of magnolia and angelica dahurica; The ministerial drugs include one or two of Chuanxiong and Xanthium sibiricum; The adjuvant includes one or two of white mustard seeds and Gleditsia sinensis thorns; The adjuvant drug is ginger.

2. A Chinese medicine composition for children's allergic rhinitis according to claim 1, characterized in that: The monarch drugs include magnolia and angelica dahurica; the minister drugs include ligusticum chuanxiong and xanthium sibiricum; the adjuvant drugs include mustard seeds and gleditsia thorn; and the guiding drug is ginger.

3. A Chinese medicine composition for children's allergic rhinitis according to claim 2, characterized in that: In parts by weight, it comprises 2-12 parts of magnolia, 2-12 parts of angelica dahurica, 2-12 parts of ligusticum chuanxiong, 1-9 parts of xanthium sibiricum, 0.1-8 parts of white mustard seeds, 0.1-8 parts of gleditsia thorns and 0.1-8 parts of ginger.

4. A Chinese medicine composition for children's allergic rhinitis according to claim 2, characterized in that: In parts by weight, it comprises 3-8 parts of magnolia, 3-8 parts of angelica dahurica, 3-8 parts of ligusticum chuanxiong, 2-6 parts of xanthium sibiricum, 1-6 parts of white mustard seeds, 1-6 parts of gleditsia thorns and 1-6 parts of ginger.

5. A Chinese medicine composition for children's allergic rhinitis according to claim 2, characterized in that: In parts by weight, it includes 6 parts of magnolia, 6 parts of angelica dahurica, 6 parts of ligusticum chuanxiong, 4 parts of xanthium sibiricum, 3 parts of white mustard seeds, 3 parts of gleditsia thorns and 3 parts of ginger.

6. A lung-benefiting and clearing patch for children's allergic rhinitis, characterized in that: The invention comprises an ointment, which is prepared by using the traditional Chinese medicine composition according to any one of claims 1 to 5.

7. A method for preparing the Yifei Qingqiao patch for children's allergic rhinitis as claimed in claim 6, characterized in that: It includes the following steps: S1. Gleditsia sinensis, Chuanxiong rhizome and Angelica dahurica are crushed and sieved, and mixed to obtain powder; S2, crushing white mustard seeds, magnolia, and Xanthium sibiricum, slicing ginger, mixing white mustard seeds, magnolia, Xanthium sibiricum and ginger to obtain a mixture, adding water 2-5 times the weight of the mixture, soaking for 20-50 minutes, boiling at normal pressure for 5-20 minutes, filtering and concentrating to obtain a concentrated solution for standby use; S3, take 20-30 parts of honey by weight and heat until uniform light yellow fine bubbles appear in the pot, add it to the powder while it is hot and mix well, then add the concentrate and mix well, let it cool in a natural environment to obtain an ointment; S4: Take the ointment, roll it into a ball, put it into a blank patch, and after preparation, put it into a sealed bag and store it in a cool and dry place.

8. The method for preparing the Yifei Qingqiao patch for children's allergic rhinitis according to claim 7, characterized in that: In the step S2, white mustard seeds, magnolia, and Xanthium sibiricum are crushed, ginger is sliced, white mustard seeds, magnolia, Xanthium sibiricum and ginger are mixed to obtain a mixture, and water 3 times the weight of the mixture is added, soaked for 30 minutes, boiled at normal pressure for 15 minutes, filtered and concentrated at normal pressure to 10% of the amount of water added to obtain a concentrated solution for standby use.

9. The method for preparing the Yifei Qingqiao patch for children's allergic rhinitis according to claim 7, characterized in that: In step S3, 24 parts of honey are taken by weight and heated until uniform light yellow fine bubbles appear in the pot, then added to the powder while hot and mixed, and then the concentrated solution is added and mixed, and then cooled in a natural environment to obtain an ointment; In step S1, the mesh number is 100-150 meshes; preferably, the mesh number is 120 meshes.

10. A pediatric allergic rhinitis Yifei Qingqiao patch as claimed in claim 6 and a pediatric allergic rhinitis Yifei Qingqiao patch prepared by the preparation method of any one of claims 7 to 9, characterized in that: The Yifei Qingqiao patch can be used in combination with anti-leukotriene receptor antagonists and nasal hormones for combined treatment.

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