阅读说明：本技术 一种治疗风热所致鼻炎、鼻窦炎及咽喉炎的药物组合物 (A pharmaceutical composition for treating rhinitis, sinusitis and pharyngolaryngitis caused by wind-heat ) 是由 阮国永 杨建波 刘光军 张旭 胡辉 于 2020-07-27 设计创作，主要内容包括：本发明涉及医药技术领域,特别提供了一种治疗风热所致鼻炎、鼻窦炎及咽喉炎的药物组合物,包括如下重量份组分：羊耳菊488-732份、绣线菊624-936份、大蓟根624-936份、漆姑草416-624份、路路通624-936份、鹅不食草624-936份、鱼腥草单体32-58份,所述鱼腥草单体为α-蒎烯、癸酰乙醛、槲皮素、海藻酸钠；本发明的药物组合物和药物制剂,其利用度高,疗效显著,能够提高病人的顺应性；本发明的药物组合物和药物制剂,成本低,工艺简单,无须醇沉,无毒副作用,安全可靠。(The invention relates to the technical field of medicines, and particularly provides a pharmaceutical composition for treating rhinitis, nasosinusitis and sphagitis caused by wind heat, which comprises the following components in parts by weight: 488-732 parts of inula cappa, 624-936 parts of spirea crispa, 624-936 parts of cirsium japonicum root, 416-624 parts of Japanese gloriopsis japonica, 624-936 parts of fructus liquidambaris, 624-936 parts of centipeda minima and 32-58 parts of houttuynia cordata monomer, wherein the houttuynia cordata monomer is alpha-pinene, decanoyl acetaldehyde, quercetin and sodium alginate; the pharmaceutical composition and the pharmaceutical preparation have high utilization degree and obvious curative effect, and can improve the compliance of patients; the pharmaceutical composition and the pharmaceutical preparation have the advantages of low cost, simple process, no need of alcohol precipitation, no toxic or side effect, safety and reliability.)

1. A pharmaceutical composition for treating rhinitis, nasosinusitis and pharyngolaryngitis caused by wind heat is characterized by comprising the following components in parts by weight: 488-732 parts of inula cappa, 624-936 parts of spirea ulmaria, 624-936 parts of cirsium japonicum root, 624-624 parts of Japanese gloriopsis herb, 624-936 parts of beautiful sweetgum fruit, 624-936 parts of small centipeda herb and 32-58 parts of heartleaf houttuynia herb monomer.

2. The pharmaceutical composition of claim 1, wherein the houttuynia monomer is α -pinene, decanoyl acetaldehyde, quercetin, sodium alginate.

3. The pharmaceutical composition for treating rhinitis, sinusitis and pharyngolaryngitis caused by wind-heat according to claim 1, wherein the houttuynia cordata monomer comprises the following components in percentage by mass: 12-18% of alpha-pinene, 7-15% of decanoyl acetaldehyde, 0.8-2.4% of sodium alginate and the balance of quercetin.

4. The pharmaceutical composition for treating rhinitis, sinusitis and pharyngolaryngitis caused by wind-heat according to claim 1, wherein the preparation method of the pharmaceutical composition comprises the following steps:

1) processing herba Inulae Cappae, flos Spiraeae Fortunei, radix Cirsii Japonici, herba Saururi, fructus Lipuidambaris, and herba Centipedae respectively;

2) putting each component in herba Houttuyniae monomer in water to obtain suspension with concentration of 20%, and stirring at 35-40 deg.C for 10-15 min;

3) placing herba Centipedae, fructus Lipuidambaris, and herba Inulae Cappae in an extraction tank, adding water 2.5-3 times of the amount of the medicinal materials, soaking for 20-30min, heating to 80 deg.C, starting straight-through steam for steam distillation, controlling steam pressure at 0.03MPa, extracting and separating volatile oil for 4h, and collecting the distilled water solution in another container;

4) adding thistle roots, Japanese sumac and meadowsweet into an extraction tank, decocting for two times for 2-4 hours, filtering by using a 200-mesh sieve, combining decoction liquids of the two times, adding the distilled water solution obtained in the step 3) and the suspension obtained in the step 2), uniformly mixing, adding corn starch to enable the mass concentration of the corn starch in the system to be 0.1-0.2%, and uniformly mixing to obtain the corn starch.

5. The pharmaceutical composition for treating rhinitis, sinusitis and pharyngolaryngitis caused by wind-heat as claimed in claim 4, wherein the processing comprises far infrared drying at 70-80 deg.C for 10-20s, and removing water to 15% or less in a hot air circulation oven at 70-80 deg.C.

6. A pharmaceutical preparation for treating rhinitis, sinusitis and pharyngolaryngitis caused by wind-heat is prepared from the pharmaceutical composition of any one of claims 1-5 and adjuvants.

7. The pharmaceutical preparation for treating wind-heat induced rhinitis, sinusitis and pharyngolaryngitis according to claim 6, wherein the pharmaceutical preparation is tablet, soft capsule, granule or syrup.

8. The pharmaceutical preparation for treating rhinitis, sinusitis and pharyngolaryngitis caused by wind-heat according to claim 7, wherein the syrup is prepared by the following steps:

1) concentrating the medicinal composition at 60 deg.C under reduced pressure to obtain fluid extract with relative density of 1.05-1.15;

2) adding sucrose, vitamin C and water into a syrup preparation tank, boiling for dissolving, adding caramel pigment, boiling, and cooling to obtain syrup;

3) mixing the fluid extract and syrup to make sucrose content 20-30g/mL and fluid extract content 3-8g/mL, standing for 48 hr, filtering, bottling, and sterilizing.

9. The pharmaceutical preparation for treating rhinitis, sinusitis and pharyngolaryngitis caused by wind-heat according to claim 8, wherein the vitamin C is 0.1-0.5% of the mass of sucrose.

10. The pharmaceutical preparation for treating rhinitis, sinusitis and pharyngolaryngitis caused by wind-heat according to any one of claims 7-9, wherein the syrup is prepared by the following steps: it is administered orally 2 times a day, 2-5mL each time.

Technical Field

The invention relates to the technical field of medicines, and particularly provides a pharmaceutical composition for treating rhinitis, nasosinusitis and sphagitis caused by wind heat.

Background

Rhinitis is a nonspecific inflammation of the mucous membrane of the nasal cavity caused by viruses, bacteria, allergens, various physicochemical factors, and certain systemic diseases. The main pathological changes of rhinitis are congestion, swelling, exudation, hyperplasia, atrophy or necrosis of nasal mucosa, and the causes are as follows: 1. viral infection or secondary bacterial infection on the basis of viral infection; more than 100 viruses are known to cause this disease, most commonly rhinoviruses, and secondly influenza and parainfluenza viruses, adenovirus, coronavirus, coxsackie virus and mucoid and paramyxovirus, among others. The mode of viral transmission is primarily via respiratory inhalation, and secondarily via contaminated or food entering the body. 2. Nasal mucosal susceptibility, which results from the frequent stimulation of antigenic material, depends on the number of mast cells, basophils and the ability to release chemical mediators in the nasal mucosal tissue. 3. An antigenic substance; the antigenic substance which stimulates the body to produce IgE antibodies is an allergen, which re-enters the nasal mucosa, facilitating the corresponding IgE binding to cause an allergic reaction. 4. Genetic factors.

At present, with the improvement of the living standard of people in China and the change of dietary structure, the incidence rate of wind-heat rhinitis rises in proportion in adolescent students and office workers, and symptoms such as headache, nasal obstruction, hyposmia, yellow and thick nasal discharge and the like which often appear seriously affect learning, work and life. Wind-heat type rhinitis is caused by wind-heat invasion, lung failure or stagnation of liver-qi, gallbladder failure and stagnation of qi; or the dampness-heat is endogenous due to the fact that the alcohol-philic meat is fat and sweet, and pathogenic toxin flows upwards along the channels to stagnate the nasal orifices. Researches find that the traditional Chinese medicine or the composition thereof with the effects of clearing away heat and toxic materials, dispelling wind and reducing swelling, and relieving sore throat and dredging orifices can be used for treating acute and chronic rhinitis, nasosinusitis and pharyngolaryngitis caused by wind heat, wherein the patent application No. CN200510003191.8 discloses a capsule for treating rhinitis and a preparation method thereof, and the capsule is prepared from inula cappa, houttuynia cordata, spiraea, thistle roots, beautiful sweetgum fruits, Japanese sumac, centipeda minima, cyclodextrin, oily liquid substances and appropriate auxiliary materials; the invention has the effects of clearing away heat and toxic material, dispelling wind and reducing swelling, and relieving sore throat and dredging orifices, and is used for treating acute and chronic rhinitis, nasosinusitis and pharyngolaryngitis caused by wind heat; the scheme adopts cyclodextrin inclusion technology to include the extracted volatile oil in cyclodextrin molecules, and adds oily liquid substances into the extracted active substances, so that the medicine has the advantages of good curative effect, short disintegration time, fast dissolution and absorption, high bioavailability, difficult moisture absorption and deterioration, stable quality and the like.

Patent application No. CN02128155.6 discloses a Bikang tablet, which is prepared from seven Chinese herbal medicines of inula cappa, houttuynia cordata, spiraea hydropiper, radix cirsii, Japanese white atractylodes rhizome, beautiful sweetgum fruit and centipeda minima.

Although the inula cappa, the houttuynia cordata, the spiraea salicifolia, the radix cirsii, the Japanese lacquer plant, the beautiful sweetgum fruit and the centipeda minima are used in combination at present, the combined medicine can be used for treating rhinitis, nasosinusitis and sphagitis caused by wind heat, and the safety and the curative effect of the combined medicine are still worth further optimizing.

Disclosure of Invention

The invention provides a pharmaceutical composition for treating rhinitis, nasosinusitis and pharyngolaryngitis caused by wind heat, aiming at the defects of the prior art.

The method is realized by the following technical scheme:

the first purpose of the invention is to provide a pharmaceutical composition for treating rhinitis, nasosinusitis and pharyngolaryngitis caused by wind heat, which comprises the following components in parts by weight: 488-732 parts of inula cappa, 624-936 parts of spirea ulmaria, 624-936 parts of cirsium japonicum root, 624-624 parts of Japanese gloriopsis herb, 624-936 parts of beautiful sweetgum fruit, 624-936 parts of small centipeda herb and 32-58 parts of heartleaf houttuynia herb monomer.

The houttuynia cordata monomer is alpha-pinene, decanoyl acetaldehyde, quercetin and sodium alginate.

Further, the houttuynia cordata monomer comprises the following components in percentage by mass: 12-18% of alpha-pinene, 7-15% of decanoyl acetaldehyde, 0.8-2.4% of sodium alginate and the balance of quercetin.

A second object of the present invention is to provide a method for preparing the aforementioned pharmaceutical composition, comprising the steps of:

1) processing herba Inulae Cappae, flos Spiraeae Fortunei, radix Cirsii Japonici, herba Saururi, fructus Lipuidambaris, and herba Centipedae respectively;

2) putting each component in herba Houttuyniae monomer in water to obtain suspension with concentration of 20%, and stirring at 35-40 deg.C for 10-15 min;

3) placing herba Centipedae, fructus Lipuidambaris, and herba Inulae Cappae in an extraction tank, adding water 2.5-3 times of the amount of the medicinal materials, soaking for 20-30min, heating to 80 deg.C, starting straight-through steam for steam distillation, controlling steam pressure at 0.03MPa, extracting and separating volatile oil for 4h, and collecting the distilled water solution in another container;

4) adding thistle roots, Japanese sumac and meadowsweet into an extraction tank, decocting for two times for 2-4 hours, filtering by using a 200-mesh sieve, combining decoction liquids of the two times, adding the distilled water solution obtained in the step 3) and the suspension obtained in the step 2), uniformly mixing, adding corn starch to enable the mass concentration of the corn starch in the system to be 0.1-0.2%, and uniformly mixing to obtain the corn starch.

The processing is carried out by far infrared drying at 70-80 deg.C for 10-20s, and removing water to less than or equal to 15% in hot air circulation oven at 70-80 deg.C.

The third purpose of the invention is to provide a pharmaceutical preparation for treating rhinitis, nasosinusitis and pharyngolaryngitis caused by wind heat, which is prepared from the pharmaceutical composition and auxiliary materials.

The medicinal preparation is tablet, soft capsule, granule, or syrup.

The preparation method of the syrup comprises the following steps:

1) concentrating the medicinal composition at 60 deg.C under reduced pressure to obtain fluid extract with relative density of 1.05-1.15;

2) adding sucrose, vitamin C and water into a syrup preparation tank, boiling for dissolving, adding caramel pigment, boiling, and cooling to obtain syrup;

3) mixing the fluid extract and syrup to make sucrose content 20-30g/mL and fluid extract content 3-8g/mL, standing for 48 hr, filtering, bottling, and sterilizing.

The vitamin C accounts for 0.1-0.5% of the mass of the cane sugar.

The use method of the syrup is as follows: it is administered orally 2 times a day, 2-5mL each time.

According to the technical scheme, on the basis of the existing drug relationship of the nasal health tablets, the houttuynia cordata, the beautiful sweetgum fruit, the centipeda minima, the inula cappa, the spiraea japonica, the cirsium japonicum and the Japanese sumac herb are distinguished from monarch drug, ministerial drug, messenger drug and adjuvant drug, and active ingredients in the drugs are analyzed, and finally, the results show that: research on anti-inflammatory components in the houttuynia cordata shows that the safety and the drug effect of the pharmaceutical composition can be greatly improved and the dosage of the pharmaceutical composition is greatly reduced by adding the alpha-pinene, the decanoyl acetaldehyde and the quercetin in the houttuynia cordata into the formula; meanwhile, considering that the decanoyl acetaldehyde is unstable in property, is easily oxidized into decanoyl acetic acid when being heated, and then is decarboxylated to generate methyl n-nonanone, in order to ensure the stability of decanoyl acetaldehyde, sodium alginate has been unexpectedly found to play a good protection role on decanoyl acetaldehyde.

The combined form of far infrared drying and hot air circulation drying is adopted in the technical scheme, so that the rapid dehydration is realized, the energy consumption is saved, and the hot air drying time is shortened, so that the influence of the hot air on the structure and the influence of sundry bacteria carried in the hot air are avoided, and the safety and the effectiveness of the raw materials are improved.

In the technical scheme, the added corn starch not only increases the stability, but also effectively prevents the loss of volatile active ingredients, and plays a role in slow release, so that the medicine taking times can be reduced, the maintenance time of the active ingredients can be prolonged, and the compliance can be improved more importantly.

In the technical scheme, the medicinal composition and the sucrose syrup are combined to prepare syrup, wherein the sucrose has a flavoring effect and a tonifying effect, the sucrose increases the osmotic pressure of a medicinal liquid, the growth and the reproduction of microorganisms are inhibited, and an antiseptic effect is achieved.

Has the advantages that:

the pharmaceutical composition and the pharmaceutical preparation have the effects of clearing away heat and toxic materials, dispelling wind and eliminating swelling, and relieving sore throat and dredging orifices, are mainly used for treating rhinitis, nasosinusitis and sphagitis caused by wind heat, have good stability, and effectively avoid loss of volatile active ingredients.

The pharmaceutical composition and the pharmaceutical preparation have high utilization degree and obvious curative effect, and can improve the compliance of patients.

The pharmaceutical composition and the pharmaceutical preparation have the advantages of low cost, simple process, no need of alcohol precipitation, no toxic or side effect, safety and reliability.

Detailed Description

The following is a detailed description of the embodiments of the present invention, but the present invention is not limited to these embodiments, and any modifications or substitutions in the basic spirit of the embodiments are included in the scope of the present invention as claimed in the claims.