CN113813331A - Composition with throat clearing function and preparation method and application thereof - Google Patents

Abstract

The invention provides a composition with a throat clearing function and a preparation method and application thereof, belonging to the field of traditional Chinese medicines. The composition is a preparation prepared from the following raw material medicines in parts by weight: 1-5 parts of fritillary, 4-10 parts of honeysuckle, 1-5 parts of platycodon grandiflorum and 5-10 parts of loquat leaves. The composition has the advantages of precise and appropriate compatibility of medicines, throat clearing function, capability of improving symptoms such as pharyngalgia, pharynx itch, dry throat, dry cough, foreign body sensation, excessive speech and the like, is used for treating chronic pharyngitis, can be used for preparing related medicines, and has good application prospect.

Description

Composition with throat clearing function and preparation method and application thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a composition with a throat clearing function, and a preparation method and application thereof.

Background

The throat is the portal of the lung and stomach, and pharyngitis is the inflammation of the mucous membrane of the throat and the tissues under the mucous membrane, and is often part of the upper respiratory tract infection. The chronic pharyngitis is diffuse pharyngeal lesion caused by chronic infection, and is characterized by mainly chronic congestion of a pharyngeal mucosa layer, more lymphocyte infiltration around blood vessels, hyperplasia of connective tissues and lymphatic tissues under the mucosa, granular swelling of the pharyngeal posterior wall, hypertrophy of mucous glands and hypersecretion of serious patients. The main symptoms are pharyngeal discomfort, such as foreign body sensation, dry throat, pharynx itch, sore throat, cough, nausea and even vomiting. The etiology includes: the local factors are: acute pharyngitis attacks repeatedly and can be converted into chronic pharyngitis. Diseases of adjacent organs, such as chronic tonsillitis, odontitis, dental caries, chronic rhinitis, chronic sinusitis and other inflammatory secretion flow into pharynx, or chronic rhinopathy causes difficulty in nasal ventilation and mouth breathing, and chronic irritation of pharynx such as excessive smoking and drinking, dust, harmful gas and spicy food can cause the disease; whole body factors: such as anemia, dyspepsia, chronic inflammation of lower respiratory tract, cardiovascular diseases, endocrine function disorder, vitamin deficiency and hypoimmunity.

The chronic pharyngitis has a certain treatment effect when being taken with antibiotics, but the disease is easy to relapse, the disease course is long, and if the chronic pharyngitis is taken with antibiotics for a long time, various complications such as bacterial resistance, imbalance of normal flora in vivo and the like can be caused. The development of the traditional Chinese medicine preparation for treating the chronic pharyngitis is a reasonable choice. The traditional Chinese medicine considers that the pathogenesis of chronic pharyngitis is mainly caused by lung-kidney yin deficiency, body fluid deficiency, flaring-up of deficient fire and throat fumigation, and the treatment mainly aims at nourishing yin and lowering fire, but the clinical symptoms show that the curative effect of a plurality of patients is poor. At present, the pharmaceutical composition is not used for clearing heat from throat and treating chronic pharyngitis.

Disclosure of Invention

The invention aims to provide a composition with a function of clearing heat from throat, a preparation method and application thereof.

The invention provides a composition with a function of clearing heat from throat, which is a preparation prepared from the following raw material medicines in parts by weight: 1-5 parts of fritillary, 4-10 parts of honeysuckle, 1-5 parts of platycodon grandiflorum and 5-10 parts of loquat leaves.

Further, the composition is a preparation prepared from the following raw material medicines in parts by weight: 2 parts of fritillary bulb, 5 parts of honeysuckle, 3 parts of platycodon grandiflorum and 6 parts of loquat leaves.

Further, the fritillaria is fritillaria cirrhosa.

Further, the loquat leaves are eriobotrya japonica leaves.

Furthermore, the composition is a preparation prepared by taking medicinal powder of raw material medicines, water or organic solvent extract of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials according to the weight ratio.

Further, the formulation is an oral formulation.

Further, the oral preparation is paste, decoction, powder, tablet, pill, capsule, granule, oral liquid, and tea bag;

preferably, the oral formulation is a tablet.

The invention also provides a preparation method of the composition, which comprises the following steps: directly pulverizing the raw materials in weight ratio, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.

The invention also provides application of the composition in preparing a medicament with a function of clearing heat from throat.

Further, the medicine is used for treating chronic pharyngitis;

preferably, the medicament is a medicament for treating sore throat, pharynx itch, dry throat, dry cough and/or foreign body sensation.

In the invention, the leaves of eriobotrya japonica: taking loquat leaf shreds, and parching with honey (appendix II D) until the leaves are not sticky. 20kg of refined honey is used for every 100kg of loquat leaf shreds.

In conclusion, the composition has precise and appropriate compatibility of medicines, has the function of clearing throat, can improve symptoms such as pharyngalgia, pharynx itch, dry throat, dry cough, foreign body sensation, excessive speech and the like, is used for treating chronic pharyngitis, can be used for preparing related medicines, and has good application prospect.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Detailed Description

The raw materials and equipment used in the embodiment of the present invention are known products and obtained by purchasing commercially available products.

Example 1 preparation of a composition according to the invention

The formula of the raw material medicine is as follows: 2kg of bulbus fritillariae cirrhosae, 5kg of honeysuckle, 3kg of platycodon grandiflorum and 6kg of loquat leaf.

The preparation method comprises the following steps: adding 10 times of water, decocting, concentrating to obtain extract, adding starch, granulating, and grading to obtain granule. Tabletting the granules to obtain the tablet.

Example 2 preparation of the composition of the invention

The formula of the raw material medicine is as follows: 1kg of bulbus fritillariae cirrhosae, 4kg of honeysuckle, 1kg of platycodon grandiflorum and 5kg of loquat leaf.

The preparation method comprises the following steps: the same as in example 1.

Example 3 preparation of a composition according to the invention

The formula of the raw material medicine is as follows: 5kg of bulbus fritillariae cirrhosae, 10kg of honeysuckle, 5kg of platycodon grandiflorum and 10kg of loquat leaf.

The preparation method comprises the following steps: the same as in example 1.

Example 4 preparation of a composition of the invention

The raw materials are weighed according to the raw material proportion in the embodiment 1-3, and can be prepared into conventional preparation forms such as paste, decoction, powder, pills, capsules, oral liquid, tea bags and the like according to conventional technical means in the field.

The advantageous effects of the present invention are demonstrated by specific test examples below.

Test example 1 human eating test of the composition of the present invention

The human body test for the composition of the invention is carried out by the analysis and test center of the national institutes of public health of western Sichuan university and the traditional Chinese medical hospital of elmin city together.

1. Materials and methods

1.1 test specimens

The test samples were tablets prepared according to the invention in example 1 and placebo (placebo prepared without a composition according to the invention, only with auxiliary materials). The test samples were in the form of brown to tan tablets, 1.0 g/tablet, 6 tablets/plate, 2 plates/box. The storage method comprises the following steps: the shelf life is 24 months at normal temperature and in a dry place. The recommended dosage for human body is 1 tablet for 6 times a day, namely the dosage is 6.0 g/day. The placebo, with the exception of the functional ingredients, was consistent with the test article in formulation, mouthfeel, appearance and packaging.

1.2 test subjects

1.2.1 subject inclusion criteria: selecting a chronic pharyngitis subject with the age of 18-65 years according to a voluntary principle, wherein the subject meets the inclusion standard, the subjective symptoms comprise pharyngalgia, pharynx itch, dry throat, dry cough, foreign body sensation, prolongation and the like, and the physical sign examination comprises pharyngeal mucosa congestion, mucosa edema, lymph follicular hyperplasia, secretion attachment and the like.

1.2.2 subject exclusion criteria:

(1) acute stage of chronic pharyngitis or acute pharyngitis, vocal nodule, common cold or smoking;

(2) nasopharyngeal, pharyngeal, laryngeal, nasal, laryngeal, esophageal, cervical and tuberculosis metastatic lung cancer lesions;

(3) those with weak constitution who cannot accept test food;

(4) patients with serious systemic diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system;

(5) taking articles related to the function of the tested object in a short period of time to influence the result judger;

(6) if the test sample is not taken as required, the result of the test sample cannot be judged.

1.3 Experimental design and grouping

According to the evaluation and inspection method of the human body food trial test for the pharynx-clearing function of the national food and drug administration No. 2012-9, the random double-blind and parallel control food trial design is adopted, and the proportion of a food trial group to a control group is 1: 1, not less than 50 subjects in each group, and not less than 100 cases of the two groups with the observation completed. Meanwhile, considering the falling rate and the withdrawal rate of not more than 20 percent, the final sample size of the test food is determined to be 108 cases, wherein 54 cases are used as a test food group, and 54 cases are used as a control group.

1.4 sample size and eating method

The buccal tablet prepared in the embodiment 1 of the invention is taken by a test group, and the taking method comprises the following steps: it is taken orally 1 tablet 6 times a day. Control groups received an equal amount of placebo. The subject was administered for 15 consecutive days. The subjects did not change the original eating habits and normal diet during the test eating period, and did not take the drugs or other health care products with the function of clearing throat.

1.5 Main instruments, reagents and test Environment

Fully automatic biochemical analyzers (AU-5800, Beckmann Kort, USA); biochemical kits (AU5800, beckmann coulter, usa); a fully automatic hemocytometer (XS-800i, Sysmex, Japan); urine chemical analyzer (UF-1000i, Japan sysmex); b-ultrasonic machine (ALOKA-. alpha.7, Japan); x-ray fluoroscopy machine (DEr-800mA, Philips, Germany); an electrocardiograph: (ECG-3312B, trivia Guangzhou).

1.6 Observation index

1.6.1 safety index

(1) General conditions: including mental, sleep, diet, stool and urine, blood pressure, etc.

(2) Blood (red blood cell count, hemoglobin, white blood cell count, platelet count), urine, stool routine.

(3) And (3) biochemical index determination: serum Total Protein (TP), Albumin (ALB), Total Cholesterol (TC), Triglyceride (TG), high density lipoprotein cholesterol (HDL-C), alanine Aminotransferase (ALT), aspartate Aminotransferase (AST), urea nitrogen (BUN), and creatinine (Cr).

(4) Chest X-ray, electrocardiogram and B-ultrasonic examination of abdomen (examination 1 time before trial)

1.6.2 efficacy index

(1) And (3) observation of symptoms: the patient history is asked in detail to understand the conditions of the mental, sleep, diet, defecation and the like of the subject.

(2) The efficacy index is as follows: before and after the test food, the subjects were observed to have symptoms such as pharyngalgia, pharynx itch, dry throat, dry cough, foreign body sensation, and increase of speaking, and pharyngeal signs such as pharyngeal mucosa congestion, mucosa edema, lymphangiosis, and secretion attachment.

1.7 efficacy criteria

1.7.1 Observation of symptoms

Accurately recording pharyngeal subjective symptoms before and after trial feeding of a subject, wherein the main pharyngeal symptoms comprise: the method comprises the steps of calculating integral (1-1 point, 2-2 points and 3-3 points) according to the severity of symptoms, and counting integral change and symptom improvement rate.

1.7.2 Observation of body signs

Pharyngeal examination: congestion of pharyngeal mucosa, edema of mucosa, hyperplasia of lymph follicles in posterior pharyngeal wall, secretion, etc. And respectively recording the change of the physical signs before and after the test feeding according to the grade I, II and III of the light, medium and heavy weight of the examination result, and calculating the physical sign integral and the improvement rate.

1.8 data processing

The self-contrast data adopts paired t test, two groups of mean comparison adopts grouped t test, the latter needs to carry out the homogeneity test of variance, the data with non-normal distribution or uneven variance is subjected to proper variable conversion, and after the normal variance is satisfied, the converted data is used for carrying out the t test; if the converted data can not meet the requirement of normal variance, the t' test or the rank sum test is adopted; variance is squared but coefficient of variation is too large (e.g., CV)>50%) data application rank sum test. Effective rate and total effective rate adopt X²And (6) checking. And when the total number of the cases of the four-table is less than 40, or the total number of the cases is equal to or more than 40 but the theoretical number is equal to or less than 1, the exact probability method is adopted.

2. Results

2.1 general conditions

The test included 108 subjects, which were randomly divided into a test diet group and a control group. The effective subjects were the test-diet group (no visit), the control group (no visit) and the control group (no visit), wherein the effective subjects were the test-diet group (52) and the control group (52).

The subjects have no obvious abnormalities in blood routine, urine routine, stool routine, liver and kidney function, chest X-ray, electrocardiogram, B-ultrasonic examination and the like before the test. Before the test, the age, sex, total integral of symptoms, total integral of signs and the like of the two groups of subjects have no obvious difference (P is more than 0.05), and the general conditions before the test are compared and shown in a table 1.

TABLE 1 comparison of two general data sets

2.2 Effect on efficacy index

2.2.1 comparing the total scores of the symptoms of two groups of selected subjects before group entry, wherein the difference has no statistical significance (P is more than 0.05), which indicates that the clinical symptoms of the two groups are comparable when the subjects enter the group, and the clinical symptoms of the two groups after the test have significant difference (P is less than 0.05) when the total scores of the clinical symptoms are compared; the significant difference (P is less than 0.05) exists in the total integral group of symptoms before and after the test of the test group, and the significant difference (P is more than 0.05) does not exist in the total integral group of clinical symptoms before and after the test of the control group; the difference of the total integral of symptoms after the test between the two groups has significant difference (P is less than 0.05), which indicates that the tested substance can improve and increase the clinical symptoms of the tested person. Namely, the composition of the invention can obviously improve the clinical symptoms of patients.

TABLE 2 Total score comparison of clinical symptoms of two groups

2.2.2 clinical symptom improvement rates before and after the trial the results of the comparisons among the groups are shown in Table 3. After the composition is tried for 15 days, the improvement rates of pharyngalgia, pharynx itch, dry pharynx, dry cough, foreign body sensation and excessive speech exacerbation between two groups are remarkably different (P is less than 0.05).

TABLE 3 comparison of clinical symptom improvement rates between groups (n)

2.2.3 comparison of total integral of pharyngeal signs before and after the test, and between groups, see Table 4. The total integral comparison of the pharyngeal physical signs of two groups of selected subjects in the group has no statistical significance (P is more than 0.05), which indicates that the pharyngeal physical signs of the two groups of subjects in the group are always comparable, and the comparison of the total integral groups of the pharyngeal physical signs after the test has significant difference (P is less than 0.05); the total integral groups of the physical signs of the test group have significant difference (P is less than 0.05) before and after the test, and the total integral groups of the pharyngeal physical signs of the test group have no significant difference (P is more than 0.05) before and after the test of the control group; after the two groups of tests, the difference of the total integral of pharyngeal physical signs has significant difference (p is less than 0.05), which indicates that the tested substance (the composition of the invention) can improve and increase the total integral of pharyngeal physical signs of the tested subject.

TABLE 4 Total integral comparison of two groups of pharyngeal signs

2.2.4 comparison of pharyngeal signs improvement rate between groups before and after the test is shown in Table 5. After the composition is eaten for 15 days, the pharyngeal edema, the mucosal congestion, the retropharyngeal lymphangiovesicle hyperplasia and the secretion improvement rate between two groups have significant differences (P is less than 0.05).

TABLE 5 efficient comparison of pharyngeal physical signs between groups (n)

2.2.5 Effect on human safety metrics

The test taker has no adverse reaction or anaphylactic reaction during the test eating period, and has no obvious changes in spirit, sleep, diet, stool and urine, etc. The results of the blood routine, urine routine and blood biochemical index before and after the test are shown in Table 6. Before and after the test, all indexes are not obviously abnormal, and the difference has no statistical significance (P is more than 0.05).

TABLE 6 analysis of laboratory safety examination results before and after treatment

In summary, 108 subjects were randomly divided into 2 groups, 54 of which were administered placebo as a control group and 54 of which were administered the composition prepared in example 1 of the present invention as a test group 6 times a day, 1 tablet at a time, and were continuously administered for 15 days. The trial process is completed for 104 persons, the trial group comprises 52 persons, 1 person is removed, and 1 person falls off; the control group had 52 persons, 2 persons who fell off. The daily life and dietary habits are kept during the test-eating period, and no adverse reaction is seen in the test-eating process. After the test food, the total score of clinical symptoms and the total score of pharyngeal physical signs of the test food group are obviously different from those of the control group (P is less than 0.05), and the improvement rates of the clinical symptoms and the pharyngeal physical signs of the test food group are obviously different from those of the control group (P is less than 0.05), so that the composition can obviously improve the clinical symptoms and the pharyngeal physical signs of the pharyngeal discomfort testees.

According to the evaluation and inspection method of the human food trial test for the pharynx-clearing function of the food and drug administration No. 2012-107-9 and the judgment standard of the pharynx-clearing function evaluation method, the result shows that the composition has the function of clearing the pharynx.

In conclusion, the composition has precise and appropriate compatibility of medicines, has the function of clearing throat, can improve symptoms such as pharyngalgia, pharynx itch, dry throat, dry cough, foreign body sensation, much aggravation in speech and the like, is used for treating chronic pharyngitis, can be used for preparing related medicines, and has good application prospect.

Claims (10)

1. A composition with a function of clearing heat from throat is characterized in that: the preparation is prepared from the following raw material medicines in parts by weight: 1-5 parts of fritillary, 4-10 parts of honeysuckle, 1-5 parts of platycodon grandiflorum and 5-10 parts of loquat leaves.

2. The composition of claim 1, wherein: the preparation is prepared from the following raw material medicines in parts by weight: 2 parts of fritillary bulb, 5 parts of honeysuckle, 3 parts of platycodon grandiflorum and 6 parts of loquat leaves.

3. The composition of claim 2, wherein: the Bulbus Fritillariae Cirrhosae is Bulbus Fritillariae Cirrhosae.

4. The composition of claim 2, wherein: the folium Eriobotryae is folium Eriobotryae.

5. The composition according to any one of claims 1 to 4, characterized in that: the preparation is prepared by taking medicinal powder of raw material medicines, water or organic solvent extracts of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials according to the weight ratio.

6. The composition of claim 5, wherein: the preparation is an oral preparation.

7. The composition of claim 6, wherein: the oral preparation is selected from paste, decoction, powder, tablet, pill, capsule, granule, oral liquid, and teabag;

preferably, the oral formulation is a tablet.

8. A method of preparing the composition of any one of claims 1 to 7, wherein: it comprises the following steps: directly pulverizing the raw materials in weight ratio, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.

9. Use of the composition of any one of claims 1 to 7 in the preparation of a medicament having a function of clearing heat from the throat.

10. Use according to claim 9, characterized in that: the medicine is used for treating chronic pharyngitis;

preferably, the medicament is a medicament for treating sore throat, pharynx itch, dry throat, dry cough and/or foreign body sensation.