CN107714820B - Pharmaceutical composition for treating allergic rhinitis and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating allergic rhinitis and preparation method and application thereof Download PDFInfo
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- CN107714820B CN107714820B CN201710883917.4A CN201710883917A CN107714820B CN 107714820 B CN107714820 B CN 107714820B CN 201710883917 A CN201710883917 A CN 201710883917A CN 107714820 B CN107714820 B CN 107714820B
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Abstract
The invention provides a pharmaceutical composition, which is prepared from the following raw materials in parts by weight: 5-15 parts of radix scrophulariae, 1-8 parts of magnolia flower, 1-10 parts of mint, 1-10 parts of patchouli, 1-10 parts of radix bupleuri, 1-10 parts of honeysuckle stem, 1-10 parts of platycodon grandiflorum, 1-8 parts of periostracum cicada, 1-8 parts of chrysanthemum, 1-8 parts of scutellaria baicalensis and 1-4 parts of liquorice. The invention also provides a preparation method and application of the pharmaceutical composition. The medicine composition has obvious curative effect on allergic rhinitis, especially on allergic rhinitis with lung meridian heat, less toxic side effect, simple preparation process and convenient use, provides a new choice for patients and has good application prospect.
Description
Technical Field
The invention relates to a pharmaceutical composition for treating allergic rhinitis, a preparation method thereof and application thereof
Use is provided.
Background
Allergic Rhinitis (AR) is an Allergic disease caused by contact of the nasal mucosa with allergens, and is characterized by itching, nasal obstruction, sneezing, thin nasal discharge, swelling of the nasal mucosa, and the like. The disease has already developed into a worldwide disease, the global prevalence rate of the disease is about 15% -20%, the learning, the work and the personal hygiene of patients are seriously affected, and the life quality of the patients is greatly reduced. Allergic rhinitis, also known as allergic rhinitis, is a common disease of rhinopathy and is a category of allergic rhinitis and allergic rhinitis in traditional Chinese medicine. Its pathogenesis includes deficiency-cold of viscera and latent heat of lung meridian, which are all the causes of yang qi failing to harmonize and benefiting.
The chronic rhinitis is known firstly in the book Huangdi's inner Jing, the book Su Wen & Yin Yang answer bibliographic theory in traditional Chinese medicine: the lung governs the nose.. the nose is opened; ling Shu & Ben Shen (Ling Shu & Ben Shen) states that the obstruction of nasal obstruction is caused by lung qi deficiency. The onset of disease is mainly caused by lung qi deficiency, and has a certain relationship with spleen and kidney deficiency. The lung heat is the source of profound science, and "the eastern medical science" states that "sneezing person" refers to the nose as the lung orifice, itching as the fire, and itching and sneezing when it occurs in the nose ", and" the miraculous effective prescriptions and the book fifty nine "(the book of book) also states that: for allergic rhinitis, it is also applicable to yin-deficiency lung meridian. The lung is delicate and vulnerable to attack of cold and heat, and wind-heat pathogen stagnates in the lung to burn body fluid for a long time to turn into heat, which is latent heat with phlegm fire. Nose is the orifice of lung, and it is caused by the invasion of pathogenic heat and the combination of internal and external pathogenic factors, which causes the latent heat of lung channel and the burning of nose orifice by phlegm fire.
At present, the treatment of allergic rhinitis mainly comprises treatment methods such as histamine H1 receptor antagonist, sympathetic nerve amine vasoconstrictor and corticosteroid on the basis of removing external allergens such as dust contact, mites and the like. However, in a large number of clinical observations, western medicine treatments have been found to present some problems: firstly, antihistamines do not completely relieve symptoms of some patients, particularly allergic rhinitis patients with vasomotor rhinitis, and side effects such as excessive salivation are difficult to avoid in effective cases; second, topical hormone therapy is good, but if the hormone is administered for a long period of time, side effects remain doubtful. Under the condition, the traditional Chinese medicine shows unique curative effect in treating allergic rhinitis.
Therefore, how to adopt the compatibility of the traditional Chinese medicines is the important thing for preparing the medicine for treating the allergic rhinitis, which has the advantages of simple preparation, convenient taking, exact curative effect and simple preparation process.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating allergic rhinitis.
The invention also aims to provide a preparation method and application of the pharmaceutical composition.
The invention provides a pharmaceutical composition, which is prepared from the following raw materials in parts by weight: 5-15 parts of radix scrophulariae, 1-8 parts of magnolia flower, 1-10 parts of mint, 1-10 parts of patchouli, 1-10 parts of radix bupleuri, 1-10 parts of honeysuckle stem, 1-10 parts of platycodon grandiflorum, 1-8 parts of periostracum cicada, 1-8 parts of chrysanthemum, 1-8 parts of scutellaria baicalensis and 1-4 parts of liquorice.
Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10 parts of figwort root, 4 parts of biond magnolia flower, 5 parts of mint, 5 parts of cablin potchouli herb, 5 parts of radix bupleuri, 5 parts of honeysuckle stem, 5 parts of platycodon grandiflorum, 3 parts of cicada slough, 3 parts of chrysanthemum, 3 parts of scutellaria baicalensis and 2 parts of liquorice.
Wherein the bupleuri radix is bupleuri radix.
The pharmaceutical composition is prepared by taking crude drug powder of the raw material drugs, or water or organic solvent extract as an active ingredient, and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients into the active ingredient to prepare a common preparation.
Wherein the preparation is in a nasal mucosa administration form, a gastrointestinal administration form and a percutaneous administration form.
Wherein, the dosage form of the gastrointestinal administration is mixture or oral liquid.
Wherein the auxiliary materials are polysorbate-80 and sorbic acid.
The invention also provides a preparation method for preparing the composition, which comprises the following steps:
a) weighing raw materials in each weight ratio;
b) distilling herba Menthae, flos Chrysanthemi, flos Magnoliae and herba Agastaches with water, collecting aromatic water and distilled mother liquor and residue respectively; adding polysorbate 80 into aromatic water, and mixing;
c) b, taking seven medicinal materials of figwort root, baical skullcap root, bamboo leaf and Chinese thorowax root, platycodon root, honeysuckle stem, cicada slough and liquoric root and the Chinese medicine residue in the step b, adding water for extraction, filtering, combining the distilled mother liquor in the step b, concentrating and removing impurities for later use;
d) and d, adding aromatic water into the liquid medicine subjected to impurity removal in the step c, adjusting the pH value, adding water, uniformly mixing, and subpackaging to obtain the traditional Chinese medicine.
Wherein, in the step b, 5 to 10 times of water is added for distillation extraction for 3 to 5 hours; preferably, 10 times of water is added, and distillation extraction is carried out for 5 hours; the aromatic water collection adopts heavy distillation, and the aromatic water collection is 400ml, preferably 300 ml.
In the step c, the extraction is carried out by decocting the raw materials with water for three times, 6 times of water is added for each time, and the raw materials are decocted for 40 minutes; concentrating under reduced pressure at 50-70 deg.C to relative density of 1.05-1.15 g/ml; preferably, concentration is carried out at 60 ℃ to a relative density of 1.05 g/ml.
The impurity removal is to add 50 to 70 percent of ethanol, refrigerate for 12 to 36 hours and concentrate; preferably, 95% ethanol is selected and added until the ethanol content reaches 60%, and the mixture is refrigerated for 24 hours, and supernatant is concentrated to 600 ml.
In the step d, the pH value is adjusted to 4.5-5.5; the water is added to 1000 ml.
The invention also provides application of the pharmaceutical composition in preparing a pharmaceutical composition for treating allergic rhinitis.
Wherein the allergic rhinitis is lung channel latent heat type allergic rhinitis.
The invention also provides application of the pharmaceutical composition in preparing a pharmaceutical composition with the effects of clearing heat, removing toxicity, ventilating lung and promoting resuscitation.
The preferred preparation process of the pharmaceutical composition of the present invention is shown in figure 1.
The pharmaceutical composition is prepared from eleven raw materials of figwort root, biond magnolia flower, mint, cablin potchouli herb, bamboo-leaf bupleurum, honeysuckle stem, platycodon root, cicada slough, chrysanthemum, baical skullcap root and liquoric root. Figwort, sweet, bitter, salty in flavor; slightly cold in nature. It enters lung, stomach and kidney meridians. Has the effects of clearing heat, cooling blood, purging fire, removing toxic substances, and nourishing yin. Therefore, the monarch drug of figwort root is used to clear lung heat and nourish yin, so as to overcome the defect of yin injury caused by heat pathogen. Flos Magnoliae, pungent in flavor and warm in property, enters lung and stomach meridians, and can dispel wind-cold and relieve nasal obstruction. Although it is warm in nature, it is combined with Xuan Shen to keep the action of dispelling wind and relieving stuffy nose, and helps Xuan Shen to ventilate lung and relieve stuffy nose, and is a ministerial drug. The mint, pungent and cool, enters lung and liver meridians, and has the efficacies of dispelling wind and heat, clearing head and eyes, relieving sore throat and promoting eruption, soothing liver and relieving depression and avoiding dirty. Caulis Lonicerae, flos Chrysanthemi, and periostracum Cicadae have effects of dispelling pathogenic wind, clearing heat, removing toxic substance, and dredging collaterals. Huoxiang has the action of dispelling wind and resolving turbidity. Bupleurum root, radix bupleuri and Baikal skullcap root, radix Scutellariae and radix Scutellariae serve as adjuvant drugs to enhance the effect of dispersing lung heat. Radix Platycodi, bitter and pungent in flavor, neutral in nature, can induce the herbs to clear and disperse, directly reach the lung orifice, and radix Glycyrrhizae can clear away heat and toxic materials, and harmonize the effects of the other drugs. The two herbs are used together as guiding drug. The traditional Chinese medicine composition has the effects of clearing heat and removing toxicity, and freeing lung and benefiting consciousness, and is mainly used for treating nasal obstruction and nasal distension, acid itching and discomfort, frequent sneezing, clear nasal discharge, nasal orifice myofascial swelling, red or dark red color, or lung channel volatile heat type allergic rhinitis with occasional cough, throat itching, dry mouth and dysphoria, red tongue with white fur, and wiry or smooth pulse.
The medicine composition has obvious curative effect on allergic rhinitis, especially on allergic rhinitis with lung meridian heat, less toxic side effect, simple preparation process and convenient use, provides a new choice for patients and has good application prospect.
Obviously, many modifications, substitutions, and alterations are possible in light of the above teachings of the invention, without departing from the basic technical ideas of the invention, as defined by the following general technical knowledge and conventional practices of the art.
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.
Drawings
FIG. 1 is a flow chart of the preparation of the pharmaceutical composition of the present invention
Detailed Description
EXAMPLE 1 preparation of a pharmaceutical composition of the invention
1. Raw materials: 10g of figwort root, 4g of biond magnolia flower, 5g of mint, 5g of cablin potchouli herb, 5g of bamboo-leaf bupleurum, 5g of honeysuckle stem, 5g of platycodon root, 3g of cicada slough, 3g of chrysanthemum, 3g of baical skullcap root and 2g of liquoric root.
2. The preparation method comprises the following steps:
adding 10 times of water into herba Menthae, flos Chrysanthemi, flos Magnoliae and herba Agastaches, distilling for 5 hr, redistilling to collect 300ml of aromatic water, adding polysorbate-8010 ml, mixing, and filtering the medicinal liquid; decocting the residue and the rest seven medicines such as radix scrophulariae for three times, adding 6 times of water each time, decocting for 40 minutes, filtering, mixing the filtrate with the chrysanthemum filtrate, concentrating until the relative density is 1.05(60 ℃), adding 95% ethanol until the ethanol content reaches 60%, refrigerating for 24 hours, taking the supernatant, concentrating to 600ml, adding aromatic water and 1.5g of sorbic acid, mixing uniformly, adjusting the pH to 4.5-5.5, adding water to 1000ml, mixing uniformly, and subpackaging to obtain the traditional Chinese medicine.
EXAMPLE 2 preparation of pharmaceutical compositions of the invention
1. Raw materials: 5g of figwort root, 1g of magnolia flower, 1g of mint, 2g of cablin potchouli herb, 3g of bamboo-leaf bupleurum root, 1g of honeysuckle stem, 1g of platycodon root, 1g of cicada slough, 1g of chrysanthemum, 1g of scutellaria baicalensis and 1g of liquorice.
2. The preparation method comprises the following steps:
adding 10 times of water into herba Menthae, flos Chrysanthemi, flos Magnoliae and herba Agastaches, distilling for 5 hr, redistilling to collect 300ml of aromatic water, adding polysorbate-8010 ml, mixing, and filtering the medicinal liquid; decocting the residue and the rest seven medicines such as radix scrophulariae for three times, adding 6 times of water each time, decocting for 40 minutes, filtering, mixing the filtrate with the chrysanthemum filtrate, concentrating until the relative density is 1.05(60 ℃), adding 95% ethanol until the ethanol content reaches 60%, refrigerating for 24 hours, taking the supernatant, concentrating to 600ml, adding aromatic water and 1.5g of sorbic acid, mixing uniformly, adjusting the pH to 4.5-5.5, adding water to 1000ml, mixing uniformly, and subpackaging to obtain the traditional Chinese medicine.
EXAMPLE 3 preparation of a pharmaceutical composition of the invention
1. Raw materials: 15g of figwort root, 8g of biond magnolia flower, 10g of mint, 10g of cablin potchouli herb, 10g of bamboo-leaf bupleurum, 10g of honeysuckle stem, 10g of platycodon root, 8g of cicada slough, 8g of chrysanthemum, 8g of baical skullcap root and 4g of liquoric root.
2. The preparation method comprises the following steps:
adding 10 times of water into herba Menthae, flos Chrysanthemi, flos Magnoliae and herba Agastaches, distilling for 5 hr, redistilling to collect 300ml of aromatic water, adding polysorbate-8010 ml, mixing, and filtering the medicinal liquid; decocting the residue and the rest seven medicines such as radix scrophulariae for three times, adding 6 times of water each time, decocting for 40 minutes, filtering, mixing the filtrate with the chrysanthemum filtrate, concentrating until the relative density is 1.05(60 ℃), adding 95% ethanol until the ethanol content reaches 60%, refrigerating for 24 hours, taking the supernatant, concentrating to 600ml, adding aromatic water and 1.5g of sorbic acid, mixing uniformly, adjusting the pH to 4.5-5.5, adding water to 1000ml, mixing uniformly, and subpackaging to obtain the traditional Chinese medicine.
The following specific clinical tests prove the beneficial effects of the invention:
test example 1: clinical efficacy of the compositions of the invention
1. Clinical data
1.1 diagnostic criteria:
1.1.1 diagnostic standards of traditional Chinese medicine
The main symptoms are: itching, sneezing, clear nasal discharge, nasal obstruction.
The main signs are: the nasal mucosa is swollen, and is pale white or red, and the nasal cavity may have thin secretion.
The course of the disease is as follows: the disease course is long and the attack is repeated.
The medical history: some patients may have an allergy history or family history. Has more than 2 main symptoms, and can be diagnosed by combining local physical signs.
1.1.2 Chinese medicine syndrome differentiation Standard
The traditional Chinese medicine syndrome differentiation standard is as follows:
lung meridian latent heat type: allergic rhinitis is frequently initiated, or allergic rhinitis is frequently induced by intense heat and summer or by hot gas. Stuffy nose, soreness and itching, frequent sneezing and runny nose. The nasal orifices have the symptoms of myofascial swelling, red or dark red color, cough, throat itching, dry mouth, dysphoria with smothery sensation, red tongue, white fur and wiry or string-smooth pulse.
1.2 inclusion criteria
(1) The Chinese medicinal diagnostic standard of the allergic rhinitis disease and the dialectical standard of the allergic rhinitis lung channel latent heat syndrome are met.
(2) The age is 2-18 years.
1.3 rule of exclusion:
(1) there are severe heart, liver, kidney, lung diseases or congenital diseases.
(2) The inclusion case criteria were not met and compliance was poor.
(3) According to the judgment of researchers, the judgment of curative effect or safety can be influenced.
2. Method of treatment
2.1 drug sources
(1) Test drugs the drugs of example 1 of the present invention were administered to the patient to prepare 10 ml/tube, and stored at room temperature.
(2) Control drugs: loratadine tablets (Keratan) were provided by Shanghai Xianlingbao pharmacy Co., Ltd., 10 mg/tablet, and stored at room temperature.
2.2 the specific administration method is as follows:
(1) treatment groups: the drug of example 1 of the present invention was administered. The preparation is administered for 2-6 years, 5ml each time, 6-12 years, 10ml each time, 12-18 years, 20ml each time, three times a day, half an hour after meals.
(2) Control group: loratadine tablet (Keratan) for 2-12 years, body weight less than 30kg, 5mg each time; the weight is more than or equal to 30kg, 10mg each time for over 12 years old, and once a day before sleeping at night.
3. Observation of therapeutic effects
3.1 therapeutic effect standard:
referring to the first version of the Chinese medicine dialectical standard of the textbook of 'Chinese medicine ear-nasopharynx-larynx science' compiled by the professor of Wangshiz: lung meridian latent heat type: allergic rhinitis is frequently initiated, or allergic rhinitis is frequently induced by intense heat and summer or by hot gas. Stuffy nose, soreness and itching, frequent sneezing and runny nose. The nasal orifices have the symptoms of myofascial swelling, red or dark red color, cough, throat itching, dry mouth, dysphoria with smothery sensation, red tongue, white fur and wiry or string-smooth pulse. The Chinese medicine syndromes are quantified in a grading manner and are shown in Table 1.
TABLE 1 hierarchical quantization chart of TCM syndromes
3.2 therapeutic results
Through clinical observation, 3 cases of 110 cases of the test group and 6 cases of the control group are dropped,
the gender distribution of the two groups before treatment is compared in table 2:
TABLE 2 comparison of two groups of gender distributions
As can be seen from table 2, the gender distribution of two groups of patients was tested by X2, P ═ 0.625>0.05 showed no significant difference, and the gender difference of the two groups showed no statistical significance, indicating that the two groups were comparable in gender.
The gender distribution of the two groups before treatment is compared in table 3:
TABLE 3 comparison of age distributions of two groups
As can be seen from Table 3, the gender distribution of the patients in the two groups was tested by X2, and the difference between P0.946 and 0.05 was not significant, and the difference between the ages of the two groups was not statistically significant, indicating that the two groups were comparable in age.
A comparison of the disease course of the two groups before treatment is shown in Table 4:
TABLE 4 two-group distribution comparison of disease course (moon)
As can be seen from Table 4, the disease course distribution of the two groups of patients is tested by X2, and the difference between P and 0.780>0.05 has no significant difference, and the difference between the two groups of disease courses has no statistical significance, which indicates that the two groups of patients have comparability in disease course.
2. Clinical efficacy analysis
The therapeutic effect analysis is shown in tables 5-8:
TABLE 5 integral analysis (integral) of symptom signs of the two groups before treatment
TABLE 6 two groups of symptom sign integral analysis (integral) 3 weeks after treatment
TABLE 7 comparison of symptom signs in each group after 3 weeks of treatment with those before treatment
TABLE 8 comparison of clinical efficacy of two groups after 3 weeks of treatment
X2＝8.21 P＝0.042<0.05
From tables 5-8, the effective rate of the medicine composition for treating the allergic rhinitis with the lung meridian heat is up to 92.30 percent, and the effect is obviously better than 79.60 percent of that of a control group (loratadine tablets); and the loratadine tablets are chemical drugs, have obvious side effects after being taken, and have adverse reactions of hypodynamia, headache, somnolence, dry mouth and rash in a control group.
In conclusion, the medicine composition has obvious curative effect on allergic rhinitis, especially on the allergic rhinitis with the lung meridian latent heat, has small toxic and side effect, simple preparation process and convenient use, provides a new choice for patients and has good application prospect.
Claims (16)
1. A traditional Chinese medicine composition for treating lung meridian latent heat type allergic rhinitis is characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:
10 parts of figwort root, 4 parts of biond magnolia flower, 5 parts of mint, 5 parts of cablin potchouli herb, 5 parts of radix bupleuri, 5 parts of honeysuckle stem, 5 parts of platycodon grandiflorum, 3 parts of cicada slough, 3 parts of chrysanthemum, 3 parts of scutellaria baicalensis and 2 parts of liquorice.
2. The traditional Chinese medicine composition according to claim 1, characterized in that: the bupleuri radix is herba Lophatheri bupleuri radix.
3. The traditional Chinese medicine composition according to claim 1 or 2, wherein: the preparation is prepared by taking crude drug powder of the raw material medicines, or water or organic solvent extract as an active ingredient, and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients into the active ingredient to prepare a common preparation.
4. The traditional Chinese medicine composition according to claim 3, wherein: the preparation is in the form of nasal mucosa administration, gastrointestinal administration, or transdermal administration.
5. The traditional Chinese medicine composition according to claim 4, wherein: the gastrointestinal administration dosage form is mixture or oral liquid.
6. The traditional Chinese medicine composition according to claim 3, wherein: the auxiliary materials are polysorbate-80 and sorbic acid.
7. A method of preparing the composition of claim 1 or 2, wherein: it comprises the following steps:
a) weighing raw materials in each weight ratio;
b) distilling herba Menthae, flos Chrysanthemi, flos Magnoliae and herba Agastaches with water, collecting aromatic water and distilled mother liquor and residue respectively; adding polysorbate 80 into aromatic water, and mixing;
c) b, taking seven medicinal materials of figwort root, baical skullcap root, Chinese thorowax root, platycodon root, honeysuckle stem, cicada slough and liquoric root and the Chinese medicine residues in the step b, adding water for extraction, filtering, combining the distilled mother liquor in the step b, concentrating and removing impurities for later use;
d) and d, adding aromatic water into the liquid medicine subjected to impurity removal in the step c, adjusting the pH value, adding water, uniformly mixing, and subpackaging to obtain the traditional Chinese medicine.
8. The method of claim 7, wherein: in the step b, 5 to 10 times of water is added for extraction, and distillation extraction is carried out for 3 to 5 hours; collecting 200 ml of aromatic water and 400ml of aromatic water.
9. The method of claim 8, wherein: in the step b, 10 times of water is added, and distillation extraction is carried out for 5 hours; 300ml of aromatic water was collected.
10. The method of claim 7, wherein: in the step c, the extraction is carried out by decocting with water for three times, 6 times of water is added for each time, and the decoction is carried out for 40 minutes; concentrating under reduced pressure at 50-70 deg.C to relative density of 1.05-1.15 g/ml.
11. The method of claim 10, wherein: in step c, concentration was carried out at 60 ℃ to a relative density of 1.05 g/ml.
12. The method of claim 7, wherein: in the step c, the impurity removal is to add ethanol until the alcohol content is 50-70%, refrigerate for 12-36 hours, concentrate.
13. The method of claim 12, wherein: in the step c, the impurity removal is to add 95 percent ethanol until the ethanol content reaches 60 percent, refrigerate for 24 hours, take supernatant fluid and concentrate to 600 ml.
14. The method of claim 7, wherein: in the step d, adjusting the pH value to 4.5-5.5; the water is added to 1000 ml.
15. Use of the Chinese medicinal composition of claim 1 or 2 for the preparation of a pharmaceutical composition for the treatment of allergic rhinitis.
16. Use according to claim 15, characterized in that: the allergic rhinitis is lung meridian latent heat type allergic rhinitis.
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