CN109106774B - Traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof, and preparation method and application thereof - Google Patents

Traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof, and preparation method and application thereof Download PDF

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CN109106774B
CN109106774B CN201811230338.0A CN201811230338A CN109106774B CN 109106774 B CN109106774 B CN 109106774B CN 201811230338 A CN201811230338 A CN 201811230338A CN 109106774 B CN109106774 B CN 109106774B
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parts
complications
hypertrophy
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traditional chinese
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CN109106774A (en
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赵锡龙
尤佳
李�杰
李桂鹏
李东东
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Beijing Merson Pharmaceutical Co ltd
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Abstract

The invention relates to a traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof, and a preparation method and application thereof. The Chinese medicinal composition can be made into spray, powder spray, and inhalation solution for atomization, and is convenient for carrying and use.

Description

Traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof, and preparation method and application thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof, and a preparation method and application thereof. The preparation is prepared by mixing powder prepared from traditional Chinese medicines of hairyvein agrimony, clematis root, angelica dahurica, argyi leaf, rosemary, centipeda minima, cucurbitacin, tangerine peel and mint with pharmaceutically acceptable auxiliary materials to prepare a preparation acceptable to patients, wherein the preparation comprises a spray, a powder spray and an inhalation solution preparation for atomization, and the preparation is administrated through a nasal cavity and is used for treating adenoidal hypertrophy and complications thereof.
Background
Adenoids are also called pharyngeal tonsils and proliferators, and are located in the key areas between the posterior part of the nasal cavity and the pharyngeal portion. Is a part of the pharyngeal lymph ring, belongs to the immune organs of the human body, contains lymphocytes at various developmental stages, has the humoral immunity function and the cellular immunity function, and is the natural defense barrier of the human body. The adenoid body gradually enlarges after birth, physiologically hypertrophy appears in 2-10 years old, the adenoid body is maximum in 6 years old, gradually shrinks after 8 years old, and gradually disappears before puberty. Pathological hypertrophy of adenoids is often seen in children and adolescents, but also in some adults, often combined with chronic tonsillitis.
The children are susceptible to acute rhinitis, allergic rhinitis, influenza and the like in the period of time, repeated chronic infection of adenoids caused by various pathogens is a main pathogenic factor of adenoid hypertrophy, and the detected main pathogenic bacteria are staphylococcus aureus, streptococcus pneumoniae and klebsiella pneumoniae which are fewer than normal flora. If the nose is repeatedly attacked, then the pathologic reproduction of adenoids occurs, the nasal obstruction is aggravated, the nasal cavity drainage is blocked, and the secretion of nasosinusitis of rhinitis stimulates the adenoids to continuously proliferate, so as to form a causal vicious circle.
Adenoids are frequently clinically complicated with various diseases. Such as rhinitis and nasosinusitis, nasal obstruction, watery nasal discharge, mouth opening breathing, salivation, obstructive nasal noise during speaking, snoring in sleep and other symptoms of the patient; the auditory tube is blocked in pharynx, and can be accompanied by secretory otitis media, resulting in hearing loss and tinnitus, and suppurative or non-suppurative secretory otitis media; it can cause high fever, vague pain of nasopharynx, headache, general discomfort, nasal obstruction, snore when breathing with mouth, and Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in children. Secretions stimulate respiratory mucosa, often cause paroxysmal cough, breathe for a long time, influence facial bone development, grow the maxilla, arch the palatine, and irregular dentition, and are added with listlessness, dull facial expression and insipid appearance, namely 'adenoid appearance and face appearance'.
The existing treatment method for adenoid hypertrophy in the medical community comprises the following steps: the adenoid body can be removed simultaneously during tonsil operation or be removed independently, so that a person who is not suitable for operation can consider radiotherapy (but rarely applies the radiotherapy), pay attention to prevention of cold, improvement of immunity of the organism, general treatment such as conservative treatment and the like, and the adenoid body cannot be cured radically and is easy to relapse, thereby bringing great pain and economic burden to children and families.
There is no description of "adenoid hypertrophy" in the traditional literature of traditional Chinese medicine, but from the etiology, it can be analyzed from the position of adenoid, which is located at the junction of the upper wall and the posterior wall of nasopharynx and at the upper end of respiratory tract. If the lung is hot, the pathogenic heat fumigates upwards, causing the adenoids to become red and swollen, and to become hyperplastic and hypertrophic over time.
The traditional Chinese medicine has the comprehensive effects of resisting bacteria and diminishing inflammation, regulating the immune function, improving the blood circulation, inhibiting bacteria and the like, has the advantages of low drug resistance, few side effects, few adverse reactions and the like, is cheap and cheap, simple and feasible, and has unique advantages and wide development prospect in the treatment of adenoidal hypertrophy and complications thereof.
Disclosure of Invention
In order to solve the technical problems, the invention provides a composition for treating adenoid hypertrophy and complications thereof, which has obvious treatment effect and small side effect.
The specific technical scheme of the invention is as follows:
the invention provides a traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof, which is mainly prepared from the following traditional Chinese medicines in parts by weight:
0.5-2.0 parts of hairyvein agrimony, 0.5-2.0 parts of clematis root, 0.5-2.0 parts of angelica dahurica, 1-4 parts of folium artemisiae argyi, 1-4 parts of rosemary, 1-5 parts of centipeda minima and 0.1-0.5 part of cucurbitacin.
The composition provided by the invention has good curative effect on adenoid hypertrophy and complications thereof, and has the advantages of less side effect and low cost.
The composition provided by the invention can also comprise other traditional Chinese medicines, and the traditional Chinese medicines can further improve the curative effect of the composition on adenoid hypertrophy and complications thereof.
The preparation of the composition also comprises the following traditional Chinese medicines in parts by weight:
0.5-3 parts of dried orange peel and 0.5-3 parts of mint.
As a preferred scheme of the technology, the raw material medicines for preparing the composition comprise the following components in parts by weight:
1-1.5 parts of hairyvein agrimony, 1-1.5 parts of clematis root, 1-1.5 parts of angelica dahurica, 2-3 parts of folium artemisiae argyi, 2-3 parts of rosemary, 2-4 parts of centipeda minima and 0.2-0.4 part of cucurbitacin.
In a further improvement, the preparation of the composition also comprises the following traditional Chinese medicines in parts by weight:
1-1.5 parts of hairyvein agrimony, 1-1.5 parts of clematis root, 1-1.5 parts of angelica dahurica, 2-3 parts of folium artemisiae argyi, 2-3 parts of rosemary, 2-4 parts of centipeda minima, 0.2-0.4 part of cucurbitacin, 1.5-2.5 parts of dried orange peel and 1.5-2.5 parts of mint.
For convenience in use and carrying, the traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof is prepared into an inhalation preparation, and the inhalation preparation comprises but is not limited to a spray, a powder spray or a solution for atomization inhalation, and the inhalation preparation is obtained by a conventional preparation method of the spray, the powder spray or the solution for atomization inhalation.
In another aspect, the invention provides a preparation method of the Chinese medicinal composition, which can be obtained by extracting the medicaments in parts by weight with water.
Wherein the method of water extraction comprises the steps of:
firstly, soaking the raw materials in water at a volume ratio of 1: 5-1: 10 for 0.5 hour in warm water, decocting for 2 times, each time for 0.5 hour, filtering, and combining filtrates;
mixing the filtrates, adding appropriate amount of active carbon, heating to 100 deg.C, filtering, cooling, adjusting pH to 7.4, sterilizing, and filtering to obtain Chinese medicinal liquid;
adding 0.9% sodium chloride injection into the prepared liquid according to the proportion of 1:5, uniformly mixing, bottling, and preparing into spray for treating adenoid hypertrophy and complications;
or adding 0.9% sodium chloride injection into the prepared liquid according to the proportion of 1:2, and mixing uniformly to prepare an inhalation solution for atomization for treating adenoid hypertrophy and complications;
or freezing the liquid, drying, and making into powder;
adding 0.9% sodium chloride injection into the prepared powder according to the proportion of 1: 50-1: 100, uniformly mixing, and bottling to prepare the spray for treating adenoid hypertrophy and complications;
or pulverizing the powder with air flow to obtain uniform fine powder, and making into powder for treating adenoidal hypertrophy and complications;
or adding 0.9% sodium chloride injection into the prepared powder according to the proportion of 1: 20-1: 40, and uniformly mixing to prepare the inhalation solution for atomization for treating adenoid hypertrophy and complications.
In another aspect, the invention also provides the application of the composition and the preparation thereof, and the application of the composition and the preparation thereof in medicines for treating adenoid hypertrophy and complications.
The raw material medicaments of the invention are as follows:
agrimony: the product is dried aerial part of Agrimonia polosa ledeb of Rosaceae. Harvesting stems and leaves in summer and autumn when they are flourishing, removing impurities, and drying.
Clematis root: the product is dried root and rhizome of Clematis chinensis Osbeck, Clematis hexapetala pall or Clematis manshurica Pupr of Ranunculaceae. Collected in autumn, removed silt and dried in the sun.
Radix angelicae: the product is dried root of Angelica dahurica (Fisch. ex Hoffm.) Benth.et hook.f. or Angelica dahurica (Fisch. ex Hoffm.) Benth.et hook.f. var.fortusana (Boiss.) Shann et Yuan of Umbelliferae. Collected in summer and autumn when the leaves are yellow, removed fibrous root and silt, and dried in the sun or at low temperature.
Folium artemisiae argyi: the product is dried leaf of Artemisia argyi l v. Picking in summer when blooming, removing impurities, and drying in the sun.
Rosemary: the product is dried leaf of Rosmarinus officinalis of Labiatae. Collecting all the year round, removing impurities, drying in the shade, and drying in the shade.
Centipeda minima: the product is dried whole plant of Centipeda minima (L.) A.Br.et Aschers. Collected in summer and autumn when blooming, washed off silt and dried in the sun.
Seven gourds: the product is root and rhizome of ligularia fischeri of Compositae. Collected in summer and autumn and dried in the sun.
Dried orange peel: the product is dry mature pericarp of Citrus reticulata Blanco of Rutaceae and its cultivar. The medicinal materials are classified into pericarpium citri reticulatae and pericarpium citri reticulatae. Picking mature fruit, peeling peel, and drying in the sun or at low temperature.
Mint: the product is dried aerial parts of Mentha haplocalyx Brig. When stems and leaves flourish or flowers bloom to three rounds in summer and autumn, the plants are harvested and cut in parts on a sunny day, and dried in the sun or in the shade.
The traditional Chinese medicine composition for treating adenoid hypertrophy and complications thereof is obtained by combining clinical experience and repeated test verification on the basis of a collected prescription by the inventor, has the effects of tonifying qi and spleen, and reducing phlegm and resolving masses, and has a good curative effect on adenoid hypertrophy and complications; the traditional Chinese medicine has the advantages of quick response, short curative effect, cure rate of more than 80%, total effective rate of more than 90%, small side effect, few varieties of used traditional Chinese medicines and cost saving.
After being prepared into inhalation preparations such as spraying agent, powder inhalation, inhalation solution preparation for atomization and the like, the composition is more convenient to use and carry, and the utilization degree and the curative effect of the composition are further improved.
Detailed Description
Example 1
Raw materials: 100g of hairyvein agrimony, 150g of clematis root, 150g of angelica dahurica, 200g of folium artemisiae argyi, 200g of rosemary, 400g of centipeda minima and 40g of cucurbitacin.
The preparation method comprises the following steps:
firstly, taking the raw materials of hairyvein agrimony, clematis root, dahurian angelica root, Chinese mugwort leaf, rosemary, centipeda minima and cucurbitacin according to the weight, adding water with the volume ratio of 1:8(g/mL) for warm soaking for 0.5 hour, decocting for 2 times, 0.5 hour each time, filtering, and combining the filtrates;
mixing the filtrates, adding proper amount of active carbon, heating to 100 deg.C, filtering, cooling, regulating pH value to 7.4, sterilizing, filtering, freezing, drying, and making into powder to obtain the invented composition.
Example 1.1
Raw materials: 150g of clematis root, 150g of angelica dahurica, 200g of folium artemisiae argyi, 200g of rosemary, 400g of centipeda minima and 40g of cucurbitacin.
The preparation method comprises the following steps: prepared as described in example 1.
Example 1.2
Raw materials: 100g of hairyvein agrimony, 150g of clematis root, 150g of angelica dahurica, 200g of folium artemisiae argyi, 200g of rosemary and 40g of cucurbitacin.
The preparation method comprises the following steps: prepared as described in example 1.
Example 1.3
Raw materials: 100g of hairyvein agrimony, 150g of clematis root, 150g of angelica dahurica, 200g of folium artemisiae argyi, 200g of rosemary and 400g of centipeda minima.
The preparation method comprises the following steps: prepared as described in example 1.
Example 2
Raw materials: 50g of hairyvein agrimony, 50g of clematis root, 50g of angelica dahurica, 400g of folium artemisiae argyi, 400g of rosemary, 500g of centipeda minima and 50g of cucurbitacin.
The preparation method comprises the following steps: water was added in a volume ratio of 1:10(g/mL), and the remainder was prepared as described in example 1.
Example 3
Raw materials: 200g of hairyvein agrimony, 200g of clematis root, 200g of angelica dahurica, 100g of folium artemisiae argyi, 100g of rosemary, 100g of centipeda minima and 15g of cucurbitacin.
The preparation method comprises the following steps: water was added in a volume ratio of 1:5(g/mL), and the remainder was prepared as described in example 1.
Example 4
Raw materials: 100g of hairyvein agrimony, 150g of clematis root, 150g of angelica dahurica, 200g of folium artemisiae argyi, 200g of rosemary, 400g of centipeda minima, 40g of cucurbitacin, 150g of dried orange peel and 250g of mint.
The preparation method comprises the following steps:
firstly, taking the raw materials of hairyvein agrimony, clematis root, dahurian angelica root, Chinese mugwort leaf, rosemary, centipeda minima, cucurbitacin, dried orange peel and mint according to the weight ratio, adding water with the volume ratio of 1:8(g/mL) for warm immersion for 0.5 hour, decocting for 2 times, 0.5 hour each time, filtering, and combining the filtrates;
mixing the filtrates, adding proper amount of active carbon, heating to 100 deg.C, filtering, cooling, regulating pH value to 7.4, sterilizing, filtering, freezing, drying, and making into powder to obtain the invented composition.
Example 5
Raw materials: 50g of hairyvein agrimony, 50g of clematis root, 50g of angelica dahurica, 400g of folium artemisiae argyi, 400g of rosemary, 500g of centipeda minima, 50g of cucurbitacin, 50g of dried orange peel and 300g of mint.
The preparation method comprises the following steps: water was added in a volume ratio of 1:10(g/mL), and the remainder was prepared as described in example 4.
Example 6
Raw materials: 200g of hairyvein agrimony, 200g of clematis root, 200g of angelica dahurica, 100g of folium artemisiae argyi, 100g of rosemary, 100g of centipeda minima, 15g of cucurbitacin, 300g of dried orange peel and 50g of mint.
The preparation method comprises the following steps: water was added in a volume ratio of 1:5(g/mL), and the remainder was prepared as described in example 4.
Example 7
Raw materials: the same as in example 1.
The preparation method comprises the following steps:
firstly, taking the raw materials of hairyvein agrimony, clematis root, dahurian angelica root, Chinese mugwort leaf, rosemary, centipeda minima and cucurbitacin according to the weight, adding water with the volume ratio of 1:8(g/mL) for warm soaking for 0.5 hour, decocting for 2 times, 0.5 hour each time, filtering, and combining the filtrates;
mixing the filtrates, adding appropriate amount of active carbon, heating to 100 deg.C, filtering, cooling, adjusting pH to 7.4, sterilizing, and filtering to obtain Chinese medicinal liquid.
Example 8
Raw materials: the same as in example 4.
The preparation method comprises the following steps:
firstly, taking the raw materials of hairyvein agrimony, clematis root, dahurian angelica root, Chinese mugwort leaf, rosemary, centipeda minima, cucurbitacin, dried orange peel and mint according to the weight ratio, adding water with the volume ratio of 1:8(g/mL) for warm immersion for 0.5 hour, decocting for 2 times, 0.5 hour each time, filtering, and combining the filtrates;
mixing the filtrates, adding appropriate amount of active carbon, heating to 100 deg.C, filtering, cooling, adjusting pH to 7.4, sterilizing, and filtering to obtain Chinese medicinal liquid.
Example 9 spray
Example 1 the prepared powder 10g
Auxiliary materials: 0.9% sodium chloride injection 1kg
The preparation method comprises the following steps: taking 0.9% sodium chloride injection as matrix, adding the composition powder, stirring to dissolve, mixing, and packaging into spray bottle with manual pump, 10ml each bottle, and making into spray for treating adenoid hypertrophy and complications for nasal cavity injection administration.
Example 9.1 spray formulations
Example 1.1 preparation of powder 10g
Auxiliary materials: 0.9% sodium chloride injection 1kg
The preparation method comprises the following steps: taking 0.9% sodium chloride injection as matrix, adding the composition powder, stirring to dissolve, mixing, and packaging into spray bottle with manual pump, 10ml each bottle, and making into spray for treating adenoid hypertrophy and complications for nasal cavity injection administration.
Example 9.2 spray formulations
Example 1.2 powder 10g
Auxiliary materials: 0.9% sodium chloride injection 1kg
The preparation method comprises the following steps: taking 0.9% sodium chloride injection as matrix, adding the composition powder, stirring to dissolve, mixing, and packaging into spray bottle with manual pump, 10ml each bottle, and making into spray for treating adenoid hypertrophy and complications for nasal cavity injection administration.
Example 9.3 spray formulations
Example 1.3 powder 10g
Auxiliary materials: 0.9% sodium chloride injection 1kg
The preparation method comprises the following steps: taking 0.9% sodium chloride injection as matrix, adding the composition powder, stirring to dissolve, mixing, and packaging into spray bottle with manual pump, 10ml each bottle, and making into spray for treating adenoid hypertrophy and complications for nasal cavity injection administration.
Example 10 spray
Example 2 prepared composition 10g
Auxiliary materials: 0.9% sodium chloride injection 1kg
The preparation method comprises the following steps: taking 0.9% sodium chloride injection as matrix, adding the composition powder, stirring to dissolve, mixing, and packaging into spray bottle with manual pump, 10ml each bottle, and making into spray for treating adenoid hypertrophy and complications for nasal cavity injection administration.
Example 11 spray formulations
Example 3A 10g composition was prepared
Auxiliary materials: 0.9% sodium chloride injection 1kg
The preparation method comprises the following steps: taking 0.9% sodium chloride injection as matrix, adding the composition powder, stirring to dissolve, mixing, and packaging into spray bottle with manual pump, 10ml each bottle, and making into spray for treating adenoid hypertrophy and complications for nasal cavity injection administration.
EXAMPLE 12 spray
Example 4 prepared composition 10g
Auxiliary materials: 0.9% sodium chloride injection 1kg
The preparation method comprises the following steps: taking 0.9% sodium chloride injection as matrix, adding the composition powder, stirring to dissolve, mixing, and packaging into spray bottle with manual pump, 10ml each bottle, and making into spray for treating adenoid hypertrophy and complications for nasal cavity injection administration.
Example 13 Fine powder spray agent
Example 5 preparation of composition 10g
The preparation method comprises the following steps:
the preparation method comprises the following steps: jet milling the composition with jet mill under sample feeding pressure of 0.7MPa, air inlet pressure of 0.6MPa and sample feeding speed of 3 kg/hr to obtain uniform fine powder 8g, and transferring into capsule with a dose of 20mg per capsule to obtain powder spray for treating adenoid hypertrophy and complications.
The using method comprises the following steps: when the nasal inhalator is used, the capsule is put into a commercially available powder mist inhalator, then the nasal inhalator is put into the nasal cavity, the button is pressed by fingers, the two ends of the capsule are respectively punctured by the fine needle, the air is sucked forcefully, the capsule rapidly rotates along with the air flow, and the medicinal powder in the capsule is sprayed out of the capsule shell and enters the respiratory tract along with the air flow.
EXAMPLE 14 inhalation solution for nebulization
Example 6 prepared composition 10g
Auxiliary materials: 0.9% sodium chloride injection 0.2kg
The preparation method comprises the following steps: taking 0.9% sodium chloride injection as matrix, adding the composition powder, stirring to dissolve, mixing well, bottling, each bottle 2ml, and preparing into inhalation solution for atomization for treating adenoid hypertrophy and complications.
The using method comprises the following steps: when the nasal cavity sprayer is used temporarily, a commercially available heating atomizer is used as the nasal cavity sprayer, the nasal cavity is atomized and inhaled for 10-15 minutes per time according to the increase and decrease of the disease condition, and the dosage is generally 2-4 ml per time.
Example 15 spray formulations
Example 7 200mL of the prepared composition
Auxiliary materials: 0.9% sodium chloride injection 1L
The preparation method comprises the following steps: adding 0.9% sodium chloride injection into the prepared liquid according to the proportion of 1:5, mixing uniformly, filling into spray bottles with manual pumps, wherein each bottle contains 10ml, and preparing into spray for treating adenoid hypertrophy and complications, wherein the spray is used for nasal cavity spraying administration.
EXAMPLE 16 inhalation solution for nebulization
Example 8 100mL of the prepared composition
Auxiliary materials: 0.9% sodium chloride injection 200m
The preparation method comprises the following steps: adding 0.9% sodium chloride injection into the prepared liquid according to the proportion of 1:2, uniformly mixing, bottling, and preparing the inhalation solution for atomization for treating adenoid hypertrophy and complications, wherein each bottle contains 2ml of the solution.
The using method comprises the following steps: when the nasal cavity sprayer is used temporarily, a commercially available heating atomizer is used as the nasal cavity sprayer, the nasal cavity is atomized and inhaled for 10-15 minutes per time according to the increase and decrease of the disease condition, and the dosage is generally 2-4 ml per time.
The following describes the application effect of the product:
clinical observation of traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof
1. Data and method
1.1 clinical data
The patients with adenoids hypertrophy and complications thereof diagnosed from 1 month to 2017 and 10 months in 2015 are all patients with age of 6-12 years, 240 patients are randomly divided into 160 cases in a treatment group and 80 cases in a control group. The 12 groups had no statistical significance in gender, age, course and disease distribution (P > 0.05).
1.2 diagnostic criteria
The clinical manifestations are as follows: intermittent or persistent upper airway obstruction symptoms, including repeated attacks of nasal obstruction, snoring during sleep, mouth opening breathing and even dyspnea. Frequently complicated chronic rhinosinusitis, secretory otitis media, obstructive sleep apnea hypopnea syndrome in children and adenoid face appearance visible in children.
Auxiliary inspection:
(1) nasal endoscopy evaluation:
Figure BDA0001836993170000091
(2) the imaging examination comprises the following steps of (1) examination of a lateral X-ray film of the nasopharynx part: taking the vertical distance from the most prominent point of the adenoid to the skull base bone surface as the thickness A of the adenoid, and the distance from the rear end of the hard palate to the intersection point of the wing plate and the skull base as the width N of the nasopharynx part, if A/N is less than or equal to 0.60, the range is a normal range, the range is moderate hypertrophy between 0.610 and 0.70, and the range is more than or equal to 0.71, namely the pathologic hypertrophy; secondly, nasopharyngeal CT examination: axial images show that the nasopharyngeal cavity is deformed and narrowed, the posterior naris is blocked to different degrees, and the soft tissue of the posterior wall is thickened. And (3) measuring axial phase, wherein the adenoid index is more than or equal to 0.70.
Infants with nasal endoscopy and imaging support, with partial clinical manifestations, can be diagnosed with adenoid hypertrophy and complications.
1.3 methods of treatment
Treatment group 1 for example 9, treatment group 2 for example 10, treatment group 3 for example 11, treatment group 4 for example 12, and treatment group 7 for example 15, administered by nasal spray with 3 puffs each time for 3 times/day, treatment course for 15 days;
treatment group 5 for example 13, nasal administration with powder aerosol, 1 granule (20mg) per time, 1 time per day, 15 days as a treatment course;
the treatment group 6 is the example 14, the treatment group 8 is the example 16, 2mL of the aerosol inhalation solution is used for heating, atomizing and spraying the nose, the treatment time is 10-15 min each time, 1 time/day, and the treatment lasts for 15 days;
control 1 was given to example 9.1, control 2 was given to example 9.2, control 3 was given to example 9.3, and control 4 was given the vehicle of example 9, respectively, without the prepared powder. The medicine is administered by spraying nasal spray, 3 times per day, and 15 days for the treatment course.
1.4 evaluation method of therapeutic Effect
The clinical symptoms, signs and changes in efficacy index were recorded before treatment, at the end of treatment and 15 days after drug withdrawal, respectively. The relevant index scores are answered by parents of the sick children and recorded by the same physician.
1.4.1 Observation indicators:
1.4.1.1 clinical symptoms: the method comprises the steps of nasal obstruction symptoms, postnasal drip syndrome, cough, snoring, secretory otitis media or obstructive sleep apnea hypopnea syndrome, grading the severity of symptoms by using a grading table, and adding the grades of all symptoms to obtain the final total grade of clinical symptoms. The total score was: 0, the symptom disappears or basically disappears; 1-9 hours, the improvement is obvious; when the temperature is 10-18 hours, the improvement is achieved; when the temperature is 19-27 ℃, the effect is not obviously improved or even increased.
1.4.1.1.1 clinical chief complaint score criteria:
TABLE 1 Primary symptom score grading Scale
Figure BDA0001836993170000101
Figure BDA0001836993170000111
1.4.1.1.2 clinical secondary symptoms scoring criteria:
TABLE 2 grading and scoring criteria for degree of illness
Figure BDA0001836993170000112
1.4.1.2 physical sign (fiber nasopharyngoscope examination physical sign)
TABLE 3 grading and scoring criteria for physical symptoms
Figure BDA0001836993170000113
Figure BDA0001836993170000121
And (4) scoring the severity of the physical symptoms of each case by using a scoring table, and adding the scores of the physical symptoms to obtain the final total score of the physical symptoms. The total score was: 0, the symptom disappears or basically disappears; 1-6 hours, the improvement is obvious; when the temperature is 7-12 hours, the improvement is achieved; 13-18 hours, no obvious improvement or even weight increase.
1.4.1.3 curative effect index (representing the change before and after treatment by quality of life assessment (OSA-18 scale))
TABLE 4 OSA-18 Scale
Figure BDA0001836993170000122
The score before and after treatment was integrated for each case using the scoring table, and then the score was counted, and the degree of change in the score was compared between 15 days after treatment and before treatment (nimodipine method: therapeutic efficacy index ═ integration before treatment-integration after treatment)/integration before treatment × 100%) after treatment.
1.4.2 treatment efficacy assessment criteria:
the observed clinical symptoms, physical signs and the change condition of the curative effect index are calculated according to the following treatment effect evaluation standard, and the curative effect is evaluated.
And (3) healing: clinical symptoms and physical signs disappear or basically disappear, and the curative effect index is more than or equal to 95 percent;
the effect is shown: the clinical symptoms and physical signs are obviously improved, and the curative effect index is more than or equal to 70 percent and less than 95 percent;
the method has the following advantages: the clinical symptoms and physical signs are improved, and the curative effect index is more than or equal to 30 percent and less than 70 percent;
and (4) invalidation: the clinical symptoms and physical signs are not obviously improved or even aggravated, and the curative effect index is less than 30 percent.
The total effective rate (%) - (cure + significant effect + effective) cases/group number × 100%.
Statistical methods the data counted are expressed in terms of rate (%) and statistical analysis of the data was performed using SPSS 19.0 software, with Chi for comparisons between groups2Inspection, P<0.05 tests that the difference is statistically significant.
1.5 results
The results are shown in Table 5.
TABLE 5 comparison of clinical efficacy of each group
Figure BDA0001836993170000131
The difference was statistically significant (P < 0.05).
1.6 conclusion
The traditional Chinese medicine composition for treating rhinitis and the inhalation preparation thereof provided by the invention have obvious curative effects on adenoidal hypertrophy and complications thereof, and no relapse of patients in a treatment group is observed in the follow-up process; and in the process of verifying the curative effect, no adverse reaction and toxic or side effect are found.

Claims (8)

1. A traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof is characterized by being prepared from the following traditional Chinese medicines in parts by weight:
0.5-2.0 parts of hairyvein agrimony, 0.5-2.0 parts of clematis root, 0.5-2.0 parts of angelica dahurica, 1-4 parts of folium artemisiae argyi, 1-4 parts of rosemary, 1-5 parts of centipeda minima and 0.1-0.5 part of cucurbitacin.
2. The traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof as claimed in claim 1, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight:
1-1.5 parts of hairyvein agrimony, 1-1.5 parts of clematis root, 1-1.5 parts of angelica dahurica, 2-3 parts of folium artemisiae argyi, 2-3 parts of rosemary, 2-4 parts of centipeda minima and 0.2-0.4 part of cucurbitacin.
3. A traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof is characterized by being prepared from the following traditional Chinese medicines in parts by weight:
0.5-2.0 parts of hairyvein agrimony, 0.5-2.0 parts of clematis root, 0.5-2.0 parts of angelica dahurica, 1-4 parts of folium artemisiae argyi, 1-4 parts of rosemary, 1-5 parts of centipeda minima, 0.1-0.5 part of cucurbitacin, 0.5-3 parts of dried orange peel and 0.5-3 parts of mint.
4. The traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof as claimed in claim 3, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight:
1-1.5 parts of hairyvein agrimony, 1-1.5 parts of clematis root, 1-1.5 parts of angelica dahurica, 2-3 parts of folium artemisiae argyi, 2-3 parts of rosemary, 2-4 parts of centipeda minima, 0.2-0.4 part of cucurbitacin, 1.5-2.5 parts of dried orange peel and 1.5-2.5 parts of mint.
5. The Chinese medicinal composition for treating adenoidal hypertrophy and complications thereof as claimed in any one of claims 1 to 4, wherein the Chinese medicinal composition is obtained by extracting the medicament in parts by weight with water.
6. The Chinese medicinal composition for treating adenoidal hypertrophy and complications thereof as claimed in any one of claims 1 to 4, wherein the dosage form of the Chinese medicinal composition is selected from spray, powder inhalation or atomized inhalation solution.
7. The method for preparing a Chinese medicinal composition for treating adenoidal hypertrophy and complications thereof as claimed in any one of claims 1 to 4, comprising the steps of:
firstly, soaking the raw materials in water at a volume ratio of 1: 5-1: 10 for 0.5 hour in warm water, decocting for 2 times, each time for 0.5 hour, filtering, and combining filtrates;
mixing the filtrates, adding appropriate amount of active carbon, heating to 100 deg.C, filtering, cooling, adjusting pH to 7.4, sterilizing, and filtering to obtain Chinese medicinal liquid;
adding 0.9% sodium chloride injection into the prepared liquid according to the proportion of 1:5, uniformly mixing, bottling, and preparing into spray for treating adenoid hypertrophy and complications;
or adding 0.9% sodium chloride injection into the prepared liquid according to the proportion of 1:2, and mixing uniformly to prepare an inhalation solution for atomization for treating adenoid hypertrophy and complications;
or freezing the liquid, drying, and making into powder;
adding 0.9% sodium chloride injection into the prepared powder according to the proportion of 1: 50-1: 100, uniformly mixing,
bottling, and making into spray for treating adenoid hypertrophy and complications;
or pulverizing the powder with air flow to obtain uniform fine powder, and making into powder for treating adenoidal hypertrophy and complications;
or adding 0.9% sodium chloride injection into the prepared powder according to the proportion of 1: 20-1: 40, and uniformly mixing to prepare the inhalation solution for atomization for treating adenoid hypertrophy and complications.
8. The use of the Chinese medicinal composition for the treatment of adenoidal hypertrophy and its complications as claimed in any one of claims 1 to 4 in the preparation of a medicament for adenoidal hypertrophy and its complications.
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CN104857490A (en) * 2015-06-04 2015-08-26 郑娟 Traditional Chinese medicine preparation for treating adenoidal hypertrophy and preparation method thereof
CN105030972A (en) * 2015-09-16 2015-11-11 陈红 Traditional Chinese medicine preparation for treating adenoidal hypertrophy of children
CN108126036A (en) * 2017-12-31 2018-06-08 陈�峰 A kind of collunarium oil for children with adenoid hypertrophy, and preparation method thereof and application method

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CN105030972A (en) * 2015-09-16 2015-11-11 陈红 Traditional Chinese medicine preparation for treating adenoidal hypertrophy of children
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