Traditional Chinese medicine composition for treating chronic rhinitis and preparation method thereof

Abstract

The invention belongs to the technical field of medicine, and discloses a traditional Chinese medicine composition for treating chronic rhinitis and a preparation method thereof.The composition is prepared from, by weight, 10-20 parts of astragalus membranaceus, 10-20 parts of radix saposhnikoviae, 10-20 parts of rhizoma atractylodis macrocephalae, 5-10 parts of schizonepeta, 5-10 parts of rhizoma acori graminei, 5-10 parts of cicada slough, 5-10 parts of endothelium corneum gigeriae galli and 5-10 parts of flos magnoliae. The preparation method of the composition comprises the following steps: S1, cleaning the traditional Chinese medicines with water, and soaking for 0.5-1 hour; s2, decocting the traditional Chinese medicinal materials treated in the step S1 with big fire for 20 minutes, then turning to soft fire, and stewing out medicine juice; s3, pouring out the liquid medicine obtained in the step S2, adding water again to submerge the medicinal materials, boiling with big fire, turning to soft fire, and decocting for 15 minutes; s4, mixing the liquid medicine obtained in the step S2 and the liquid medicine obtained in the step S3 to obtain the traditional Chinese medicine composition for treating rhinitis. The composition has the effects of invigorating the spleen, benefiting the lung, tonifying qi and opening orifices, and is stable in curative effect and short in treatment cycle.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a Chinese medicine composition for treating chronic rhinitis and a preparation method thereof. Background Art

[0002] Chronic rhinitis is a chronic inflammation of the nasal mucosa and submucosa. Its main characteristics are that the inflammation lasts for more than three months or recurs repeatedly, is lingering and cannot return to normal during the interval, and there is no clear pathogenic microorganism, accompanied by varying degrees of nasal congestion, increased secretions, swelling or thickening of the nasal mucosa and other disorders. According to the pathology and degree of functional disorder of chronic rhinitis, it can be divided into chronic simple rhinitis and chronic hypertrophic rhinitis. The former is a chronic inflammation of the nasal mucosa characterized by swelling of the nasal mucosa and increased secretions, and the latter is a chronic inflammation of the nasal cavity characterized by localized or diffuse hyperplasia and hypertrophy of the mucosa, submucosa and even bones.

[0003] Traditional Chinese medicine is one of the important methods for treating chronic rhinitis. Compared with Western medicine, it has the characteristics of less toxicity, long-term use, and stable efficacy. The present invention has developed a composition for treating chronic rhinitis based on the etiology and pathogenesis theory of chronic rhinitis and clinical medication experience, which is used to treat chronic rhinitis. Summary of the invention

[0004] The present invention aims to provide a Chinese medicine composition for treating chronic rhinitis and a preparation method thereof, and the composition can be used to treat patients with chronic rhinitis by strengthening the spleen and lungs, and replenishing qi and opening the orifices.

[0005] In order to achieve the above object, the present invention provides the following technical solutions:

[0006] A traditional Chinese medicine composition for treating chronic rhinitis, the composition is prepared from the following components by weight: 10-20 parts of astragalus, 10-20 parts of siler, 10-20 parts of atractylodes, 5-10 parts of schizonepeta, 5-10 parts of calamus, 5-10 parts of cicada slough, 5-10 parts of chicken gizzard lining, and 5-10 parts of magnolia.

[0007] Furthermore, the composition is made of the following components in parts by weight: 15 parts of Astragalus, 15 parts of Saposhnikovia, 15 parts of Atractylodes, 10 parts of Schizonepeta, 10 parts of Acorus calamus, 5 parts of Periostracum Cicadae, 10 parts of Gallus gallifolia, and 5 parts of Magnolia officinalis.

[0008] A method for preparing the above-mentioned Chinese medicine composition for treating rhinitis comprises the following steps:

[0009] S1. Wash the Chinese medicine with water and soak it for 0.5-1h;

[0010] S2, decocting the Chinese medicinal materials obtained in step S1 over high heat for 20 minutes, then turning to low heat to stew the medicinal juice;

[0011] S3, pour out the medicinal liquid obtained in step S2, add water again to cover the medicinal materials, boil over high heat, then turn to low heat, and boil for 15 minutes;

[0012] S4. Mix the medicinal solutions obtained in step S2 and S3 to obtain a Chinese medicinal composition for treating rhinitis.

[0013] Beneficial effects of the technical solution:

[0014] Astragalus: It has the effects of strengthening the spleen and replenishing the middle, strengthening the body's defense system and strengthening the exterior. It is helpful for rhinitis caused by deficiency of the lung and spleen qi.

[0015] Saposhnikovia divaricata: Saposhnikovia divaricata is pungent, warm and dispersing, and is good at dispelling wind. It has a mild nature, slightly warm but not dry, sweet and mild but not harsh. It has the effects of sweating, removing phlegm, dispelling wind and releasing wind.

[0016] Atractylodes: sweet and bitter in taste, warm in nature, enters the spleen meridian and stomach meridian, has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, and is mainly used to treat spleen deficiency, fatigue and other symptoms.

[0017] Schizonepeta: Spicy, cool in nature. It can dispel wind and clear heat. It is mainly used to treat exogenous wind-heat, headache and sore throat. It has a good therapeutic effect on nasal congestion and headache caused by chronic rhinitis.

[0018] Acorus calamus: Acorus calamus has the functions of removing dampness, stimulating appetite, opening the mind and removing phlegm, refreshing the mind and improving intelligence. It has the functions of regulating qi, promoting blood circulation, dispersing wind and removing dampness, which helps patients with chronic rhinitis to discharge nasal mucus and ensure the patency of the nasal passages.

[0019] Cicada slough: sweet, salty, cool in nature. Enters the lung and liver meridians. Has the effect of dispersing wind-heat, calming wind and stopping spasms. Used for wind-heat colds and the initial stage of febrile diseases.

[0020] Chicken's Gizzard Stone: Strengthens the stomach and aids digestion, astringes semen and stops nocturnal emission, can help indigestion caused by spleen deficiency, helps the spleen to transport and transform water and dampness, and reduces the formation of pathological phlegm.

[0021] Magnolia: pungent, warm. Enters the lung and stomach meridians. Good at clearing the nasal passages, has a good therapeutic effect on nasal congestion caused by chronic rhinitis.

[0022] In this prescription, Astragalus is the main drug, which is sweet and warm in nature. It can not only replenish the Qi of the spleen and lungs, but also consolidate the exterior and stop sweating. Atractylodes macrocephala and Saposhnikovia divaricata are the assistant drugs. Atractylodes macrocephala can nourish the spleen and stomach, replenish the middle and benefit the Qi, while Saposhnikovia divaricata can dispel wind and relieve the exterior. The two assist Astragalus membranaceus in enhancing the effect of replenishing Qi and consolidating the exterior. Nepeta tenuifolia and Cicadae Periostracum are the adjuvant drugs to dispel wind and relieve the exterior, while Acorus calamus can open the orifices and eliminate phlegm. Chicken gizzard lining can help digestion and strengthen the spleen, while Magnolia officinalis can clear the nasal passages. The combination of these drugs can strengthen the spleen and lungs, replenish Qi and open the orifices. It is clinically used to treat patients with chronic rhinitis caused by deficiency of the lung and spleen qi and has significant effect. DETAILED DESCRIPTION

[0023] The present invention is further described in detail below through embodiments:

[0024] A traditional Chinese medicine composition for treating chronic rhinitis is prepared from the following components by weight: 10-20 parts of astragalus, 10-20 parts of siler, 10-20 parts of atractylodes, 5-10 parts of schizonepeta, 5-10 parts of calamus, 5-10 parts of cicada slough, 5-10 parts of chicken gizzard lining, and 5-10 parts of magnolia.

[0025] Preferably, the composition is made of the following components in parts by weight: 15 parts of Astragalus, 15 parts of Saposhnikovia, 15 parts of Atractylodes, 10 parts of Schizonepeta, 10 parts of Acorus calamus, 5 parts of Periostracum Cicadae, 10 parts of Gallus gallifolia, and 5 parts of Magnolia officinalis.

[0026] A method for preparing the above-mentioned Chinese medicine composition for treating rhinitis comprises the following steps:

[0027] S1. Wash the Chinese medicine with water and soak it for 0.5-1h;

[0028] S2, decocting the Chinese medicinal materials obtained in step S1 over high heat for 20 minutes, then turning to low heat to stew the medicinal juice;

[0029] S3, pour out the medicinal liquid obtained in step S2, add water again to cover the medicinal materials, boil over high heat, then turn to low heat, and boil for 15 minutes;

[0030] S4. Mix the medicinal solutions obtained in step S2 and S3 to obtain a Chinese medicinal composition for treating rhinitis.

[0031] Example 1

[0032] The patient is a 19-year-old male with recurrent nasal congestion and runny nose in the past year, mainly nasal congestion, which is more obvious during sleep, without nasal itching, sneezing, or runny nose; now with nasal congestion, no runny nose, and a sense of being prone to colds, normal appetite, soft stools, normal urination, and normal sleep; pale red tongue, thin white fur, and slippery and fine pulse. TCM diagnosis: nasal congestion, lung and spleen qi deficiency syndrome. Treatment: Strengthen the spleen and lungs, replenish qi and open the orifices. Take 225g of Astragalus, 225g of Saposhnikovia, 225g of Atractylodes, 150g of Schizonepeta, 150g of Acorus calamus, 75g of Periostracum Cicadae, 150g of Gallus gallus domestica, and 75g of Flos Magnoliae respectively; wash the taken Chinese medicine with water and soak for 1 hour; boil over high heat for 20 minutes, then turn to low heat to stew out the medicinal juice, and then pour the medicinal liquid into container A; add water again to cover the medicinal materials, bring to a boil over high heat, then turn to low heat and boil for 15 minutes, then pour the medicinal liquid into container A and mix it with the aforementioned medicinal liquid, and finally divide the medicinal liquid into 15 equal parts.

[0033] Usage: One serving per day, divided into morning and evening. Inhale the vapor of the liquid through the nose before taking the medicine.

[0034] Therapeutic effect: After taking the medicine, the patient's nasal congestion and runny nose symptoms improved, no runny nose, sleep and diet were normal, appetite was good, and urination and defecation were normal.

[0035] Example 2

[0036] The patient is a 31-year-old female. After recovering from COVID-19, she had repeated nasal congestion, no runny nose, and alternating bilateral nostrils, which affected her life. She now has nasal congestion, is afraid of cold on weekdays, has poor energy, has loose stools, and can urinate. She has a pale tongue, white fur, and a thin pulse. TCM diagnosis: nasal congestion, lung and spleen qi deficiency syndrome. Treatment: Strengthen the spleen and lungs, replenish qi and open the orifices. Take 135g of Astragalus, 135g of Saposhnikovia, 135g of Atractylodes, 90g of Schizonepeta, 90g of Acorus calamus, 45g of Periostracum Cicadae, 90g of Gallus gallus domesticus, and 45g of Magnolia officinalis respectively; wash the taken Chinese medicine with water and soak it for 1h; use high heat to simmer for 20 minutes and then turn to low heat to stew the juice, and then pour the liquid into container A; add water again to cover the medicinal materials, boil over high heat, turn to low heat, simmer for 15 minutes, then pour the liquid into container A and mix it with the above-mentioned liquid, and finally divide the liquid into 9 equal parts.

[0037] Usage: One serving per day, divided into morning and evening. Inhale the vapor of the liquid through the nose before taking the medicine.

[0038] Therapeutic effect: After taking the medicine, the patient's nasal congestion was significantly relieved, fear of cold was alleviated, daytime energy was enhanced, urination and defecation were normal, and sleep quality was improved.

[0039] Clinical Validation

[0040] 1. Clinical data and methods

[0041] 1. Diagnostic criteria:

[0042] Western medicine diagnostic criteria: The inclusion criteria refer to the relevant standards in "Expert consensus on the classification and diagnosis of rhinitis and nasal medication regimen" (Li Huabin, Wang Xiangdong, Wang Hongtian, et al. Expert consensus on the classification and diagnosis of rhinitis and nasal medication regimen [J]. Chinese Journal of Otorhinolaryngology and Skull Base Surgery, 2019, 25(06): 573-577.) for diagnosis;

[0043] TCM diagnostic criteria: The inclusion criteria are in accordance with the TCM symptom diagnostic criteria for nasal congestion in the national TCM higher education textbook "TCM Otorhinolaryngology". The syndrome type is lung and spleen qi deficiency syndrome: nasal congestion is sometimes light and sometimes heavy, or alternating, mucus is white and sticky, symptoms worsen when exposed to cold, and the nasal mucosa and nasal concha are light red and swollen. Fatigue, lack of breath and lazy to speak, aversion to wind and spontaneous sweating, cough with thin sputum, and susceptibility to colds. Poor appetite, loose stools, heavy head and dizziness, pale tongue, white fur, and slow and weak pulse are the key points of syndrome differentiation.

[0044] 2. Exclusion criteria: (1) Patients with allergic diseases such as bronchial asthma and allergic rhinitis; patients with primary ciliary immobility syndrome, cystic fibrosis, fungal sinusitis, autoimmune diseases, aspirin intolerance triad, and various benign and malignant tumors of the nasal cavity and paranasal sinuses; (2) Patients with a known history of autoimmune diseases, such as rheumatoid arthritis, irritable bowel syndrome, or inflammatory bowel disease; (3) Patients with a history of malignant tumors or gastrointestinal surgery; (4) Pregnant and lactating patients.

[0045] 3. Source of patients: All cases were from the outpatient department of Otolaryngology, the First Affiliated Hospital of Hunan University of Chinese Medicine.

[0046] Patient profile: A total of 78 patients who met the diagnostic criteria for chronic rhinitis and were diagnosed with chronic rhinitis by clinical examination in the Department of Otolaryngology from 2023 to 2024 were selected. Patients who met the case selection criteria were randomly divided into a treatment group and a control group according to the random grouping method. Among them, there were 40 cases in the treatment group and 38 cases in the control group. All subjects were informed and signed informed consent.

[0047] 4. Treatment Methods

[0048] Treatment group: took the Chinese medicine decoction prepared in Example 1 orally, one serving per day, once in the morning and once in the evening.

[0049] Control group: treated with nasal spray of fluticasone propionate, according to the instructions. The fluticasone propionate was purchased from GlaxoWellcome.SA (National Medicine Standard HJ20140117).

[0050] Each group had a course of treatment of 15 days, and the drugs were used together for 1 month, during which time other drugs for the treatment of chronic rhinitis were discontinued.

[0051] 5. Observation indicators

[0052] ①Safety observation: including general vital signs (blood pressure, heart rate, respiration), blood routine, urine routine, liver and kidney function and adverse reaction detection.

[0053] ②Efficacy observation:

[0054] A. Subjective evaluation criteria

[0055] a. Efficacy evaluation: Markedly effective: clinical symptoms showed significant improvement; Effective: the patient's clinical symptoms were relieved; Ineffective: the patient's clinical symptoms had no significant change.

[0056] b. Specific scale SNOT-20: observes the improvement of the nasal cavity in patients with chronic rhinitis. The evaluation items include 20 items including nasal symptoms, which are set at 0-3 points according to their severity, with a total score of 60 points.

[0057] c. Incidence of adverse reactions: mainly including nasal bleeding, ulcers or erosions, diarrhea, dizziness, headache and other discomfort symptoms caused by medication during treatment.

[0058] B. Objective Evaluation Criteria

[0059] a..MLK nasal endoscopy score: mainly polyps, edema, and secretions, divided into three levels from 0 to 2. Each item is divided into 3 levels, polyps: 0 points: no polyps; 1 point: polyps only exist in the middle of the tract; 2 points: polyps exceed the middle of the tract. Edema: 0 points: no edema of the mucosa; 1 point: mild edema of the mucosa; 2 points: severe edema of the mucosa. Rhinorrhoea: 0 points: no rhinorrhoea; 1 point: clear and thin rhinorrhoea; 2 points: sticky and purulent rhinorrhoea.

[0060] 6. Efficacy evaluation

[0061] ① Safety observation: There were no abnormal changes in general vital indicators (blood pressure, heart rate, respiration), blood routine, urine routine, liver and kidney function tests of patients in each group before and after treatment, and there was no statistically significant difference between the two groups.

[0062] ② Subjective evaluation criteria

[0063] a. Evaluation of therapeutic effect: (Table 1) After treatment with the present invention, the patient's symptoms and signs were significantly relieved, proving that the present invention has good clinical efficacy. Compared with the control group, there was no statistically significant difference in the total effective rate between the two groups, but the effective rate of the Chinese medicine group was higher than that of the control group, and the difference was statistically significant (P≤0.05).

[0064]

[0065] Table 1 Comparison of efficacy evaluation between two groups Unit: case (%)

[0066] b. Specificity scale SNOT-20: (Table 2) After treatment with the present invention, the SNOT-20 score of the patient was significantly reduced, and the difference was statistically significant (P≤0.01); and compared with the control group after treatment, the score of the Chinese medicine group was significantly reduced, and the difference was statistically significant (P≤0.05).

[0067]

[0068] Table 2 Comparison of SNOT-20 scores between the two groups Unit: Minutes

[0069] c. Incidence of nasal adverse reactions: During the treatment period, the number of adverse reactions in the control group was 4, and the incidence rate was 10.53%, including continuous sneezing caused by nasal spray (2 cases), nasal pain after nasal spray (1 case), and dizziness after nasal spray (1 case); the number of adverse reactions in the treatment group was 1, and the incidence rate was 2.5%, which was diarrhea in the early stage of medication (1 case). The incidence rate in the observation group was lower than that in the control group (P≤0.05).

[0070] ③Objective evaluation criteria

[0071] d.MLK nasal endoscopy score: (Table 3) After treatment with the present invention, the edema and secretion scores of the patients were significantly reduced, and the difference was statistically significant (P≤0.01); and the edema and secretion scores were lower than those of the control group, and the difference was statistically significant (P≤0.01).

[0072]

[0073] Table 3 Comparison of MLK endoscopic scores between the two groups Unit: Minutes

[0074] It can be seen from this study that the present invention has significant efficacy on patients with chronic rhinitis and lung and spleen qi deficiency, and has few adverse reactions. Compared with nasal glucocorticoids, it has higher efficacy, lower SNOT-20 score, and fewer adverse reactions. It is superior to nasal glucocorticoids in reducing nasal mucosal edema and nasal secretions. It proves that the present invention is a Chinese medicine composition with significant efficacy, stable efficacy, high safety, and no serious adverse reactions.

[0075] The above is only an embodiment of the present invention, and the common knowledge such as the known specific technical solutions or characteristics in the solution is not described in detail here. It should be pointed out that for those skilled in the art, several modifications and improvements can be made without departing from the technical solution of the present invention, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A Chinese medicine composition for treating chronic rhinitis, characterized in that: The composition is prepared from the following components by weight: 10-20 parts of Astragalus, 10-20 parts of Saposhnikovia, 10-20 parts of Atractylodes, 5-10 parts of Schizonepeta, 5-10 parts of Acorus calamus, 5-10 parts of Periostracum Cicadae, 5-10 parts of Gallus galli, and 5-10 parts of Magnolia officinalis.

2. A Chinese medicine composition for treating rhinitis according to claim 1, characterized in that: The composition is prepared from the following components by weight: 15 parts of Astragalus, 15 parts of Saposhnikovia, 15 parts of Atractylodes, 10 parts of Schizonepeta, 10 parts of Acorus calamus, 5 parts of Periostracum Cicadae, 10 parts of Gallus gallus tuber, and 5 parts of Magnolia.

3. A method for preparing the Chinese medicine composition for treating rhinitis according to claim 2, characterized in that: The following steps are involved: S1. Wash the Chinese medicine with water and soak it for 0.5-1h; S2, decocting the Chinese medicinal materials obtained in step S1 over high heat for 20 minutes, then turning to low heat to stew the medicinal juice; S3, pour out the medicinal liquid obtained in step S2, add water again to cover the medicinal materials, boil over high heat, then turn to low heat, and boil for 15 minutes; S4. Mix the medicinal solutions obtained in step S2 and S3 to obtain a Chinese medicinal composition for treating rhinitis.

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