CN111419959A - Compound pungent astragalus root nasal spray and its preparation method - Google Patents
Compound pungent astragalus root nasal spray and its preparation method Download PDFInfo
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- CN111419959A CN111419959A CN202010427794.5A CN202010427794A CN111419959A CN 111419959 A CN111419959 A CN 111419959A CN 202010427794 A CN202010427794 A CN 202010427794A CN 111419959 A CN111419959 A CN 111419959A
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Abstract
The invention belongs to the technical field of rhinitis sprays, and particularly relates to a compound pungent astragalus root nasal spray and a preparation method thereof. The compound pungent astragalus root nasal spray comprises the following raw materials: 100 and 150 parts of magnolia flower; 100 portions and 150 portions of raw astragalus root; 200 portions of mint 120-; 30-90 parts of schisandra chinensis; 90-150 parts of bighead atractylodes rhizome; 90-180 parts of rhizoma acori graminei; 40-90 parts of divaricate saposhnikovia root; 15-60 parts of lithospermum; 1-5 parts of agilawood. The factors which are released by the nerve-endocrine system are induced or stimulated by the medicinal components in the nasal spray, act on the immune system and act on the immune pathway at the same time, can directly act on the affected part, and are locally applied to the nasal cavity, so that the nasal spray has the advantages of convenience and simplicity in use, high absorption speed, full absorption, small side effect on the body, high compliance of patients and the like.
Description
Technical Field
The invention belongs to the technical field of rhinitis sprays, and particularly relates to a compound pungent astragalus root nasal spray and a preparation method thereof.
Background
Allergic rhinitis, also known as Allergic Rhinitis (AR), is a specific IgE-mediated type I allergy, is one of the most common clinical chronic refractory inflammatory diseases of the respiratory tract, and has a global prevalence of about 10% to 40%. According to the allergic rhinitis and the influence thereof on asthma, more than 5 hundred million allergic rhinitis patients are reported all over the world, wherein the number of the patients in Asia-Pacific region is the most, and exceeds 1.5 hundred million. The prevalence rate of allergic rhinitis in the population of continental areas in China is 4-38%, the average prevalence rate is 11.1%, especially in Beijing and inner Mongolia. Along with the development of society and the improvement of living standard of people, the prevalence rate is in a trend of rising obviously, and huge medical and health cost burden is brought to the whole society and individuals.
Not only local diseases but also general allergic reactions of the AR in the nose are often caused with various complications and complications if the patients are not treated in time, so that the respiratory function is directly damaged, the functions of organs of the whole body can be affected, and the life quality of the patients is seriously affected. The allergic rhinitis treatment medicine market in China consists of prescription medicines and Over The Counter (OTC), and comprises two major categories of chemical medicines and Chinese patent medicines. The chemical drugs include oral or nasal antihistamine, nasal corticosteroid, and leukotriene receptor antagonist. Clinical investigation and research show that the existing allergic rhinitis is usually treated by antihistamine medicines, the antihistamine medicines can only temporarily control symptoms and cannot completely treat the allergic rhinitis, and certain systemic adverse reactions and side effects such as lethargy, dry mouth, headache, hypodynamia and the like can be generated after long-term application. The 'prevention and treatment combined and four-in-one' standardized comprehensive prevention and treatment is applied to clinical practice in Tianjin version AR guidelines of 2015 years in China, but the clinical curative effect of some AR patients is still unsatisfactory, which is possibly closely related to the lack of discrimination of patients on the diseases, adverse reactions, side effects, medication period, clinical curative effect, patient compliance and the like of western medicines.
Disclosure of Invention
The invention provides a compound pungent astragalus root nasal spray and a preparation method thereof.
In order to solve the technical problems, the invention provides a nasal spray which comprises the following raw materials: 100 and 150 parts of magnolia flower; 100 portions and 150 portions of raw astragalus root; 200 portions of mint 120-; 30-90 parts of schisandra chinensis; 90-150 parts of bighead atractylodes rhizome; 90-180 parts of rhizoma acori graminei; 40-90 parts of divaricate saposhnikovia root; 15-60 parts of lithospermum; 1-5 parts of agilawood.
In a second aspect, the present invention also provides a preparation method of a nasal spray, comprising: pulverizing flos Magnoliae, radix astragali, herba Menthae, fructus Schisandrae chinensis, Atractylodis rhizoma, rhizoma Acori Graminei, radix Saposhnikoviae, radix Arnebiae, and lignum Aquilariae Resinatum, and mixing to obtain Chinese medicinal powder; extracting the Chinese medicinal powder with water and precipitating with ethanol to obtain distillate; mixing the distillate with glycerol, and adding distilled water to 1000ml solution; adjusting pH to 5.8-6.2, and stirring; subpackaging; sterilizing to obtain the nasal spray.
The nasal spray and the preparation method thereof have the beneficial effects that after the action mechanism of allergic rhinitis is researched, factors released by a nerve-endocrine system are induced or stimulated through the medicinal components in the nasal spray, the factors act on the immune system and act on the immune pathway at the same time, the factors can directly act on an affected part, and the nasal spray can be locally applied to a nasal cavity.
Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.
In order to make the aforementioned and other objects, features and advantages of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a flow chart of the process for preparing the nasal spray of the present invention;
FIG. 2 is a schematic diagram of the action points of various drugs for regulating allergic rhinitis;
FIG. 3a is a graph comparing the levels of serum I L-4 between different groups in animal experiments;
FIG. 3b is a graph comparing the serum IFN- γ levels between different groups in animal experiments;
FIG. 3c is a graph comparing serum IgE levels among different groups in animal experiments.
Detailed Description
To make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
A first part: elucidating the specific technical scheme
The mechanism of action of allergic rhinitis is mainly represented by the imbalance of the balance between THI/TH2 in the immune system, and the upstream factor affecting the action of the immune system is the neuro-endocrine system, which is the so-called neuro-endocrine-immune network system. The existing allergic rhinitis is usually treated by antihistamine medicines, the antihistamine medicines can only temporarily control symptoms, the allergic rhinitis cannot be completely treated, and certain systemic adverse reactions and side effects can be generated after long-term application. Based on the above, the invention provides a nasal spray (namely a compound pungent stilbene nasal spray or a traditional Chinese medicine nasal spray), which comprises the following raw materials: 100 and 150 parts of magnolia flower; 100 portions and 150 portions of raw astragalus root; 200 portions of mint 120-; 30-90 parts of schisandra chinensis; 90-150 parts of bighead atractylodes rhizome; 90-180 parts of rhizoma acori graminei; 40-90 parts of divaricate saposhnikovia root; 15-60 parts of lithospermum; 1-5 parts of agilawood.
Optionally, the nasal spray comprises: 120 parts of magnolia flower; 120 parts of raw astragalus; 180 parts of mint; 60 parts of schisandra chinensis; 120 parts of bighead atractylodes rhizome; 120 parts of rhizoma acori graminei; 60 parts of divaricate saposhnikovia root; 30 parts of lithospermum; 2 parts of agilawood.
Optionally, the nasal spray comprises: 110 parts of magnolia flower; 140 parts of raw astragalus; 150 parts of mint; 75 parts of schisandra chinensis; 100 parts of bighead atractylodes rhizome; 160 parts of rhizoma acori graminei; 50 parts of divaricate saposhnikovia root; 45 parts of lithospermum; 4 parts of agilawood.
The development of allergic rhinitis is closely related to the imbalance of Th1/Th2, and the most major factor causing allergic rhinitis is the predominance of Th2 cytokines over Th1 cytokines during differentiation of T helper cell precursor cells (Th0 cells). As shown in FIG. 2, the development of molecular immunology reveals the role of cytokine regulatory network in the development of allergic rhinitis.865, Th2 cytokines differentiate into Th2 cells under the action of I L-10 secreted by antigen presenting cells, Th2 cells secrete characteristic factors I L-4, etc. to stimulate B cell synthesis, bind to receptor I on the surface of mast cells, keep the cells in a state of increased secretion of FcRc receptor I, and inhibit the secretion of Th2 cells into the mucosal tissue, thus leading to the development of inflammatory cytokine secretion, and further inhibit the secretion of IFN receptor gamma, thus inhibiting the secretion of Th 23 cell, and further inhibiting the secretion of inflammatory cytokine secretion of Th 0.
As can be seen from FIG. 2, the normal saline and nasal irrigation points are the nasal mucosa, which stimulate smooth muscle contraction and increase small vessel permeability, so that the secretion of the nasal mucosa is increased, and the treatment effect is weaker, the existing chemical drugs such as glucocorticoid, antihistamine or leukotriene receptor antagonist have the function of inhibiting inflammatory reaction or antagonizing inflammatory factors released by inflammatory cells, such as histamine, kininogenase, L Ts, PAF, PDG2, and the like, so that symptoms can be only temporarily controlled, and allergic rhinitis cannot be completely treated, the compound octyl nasal spray of the application belongs to a Chinese herbal compound preparation, the function points are usually multi-target multi-path, and the compound octyl nasal spray not only comprises immune inflammatory cells such as T cells, B cells, mast cells, eosinophils and the like, IFN-gamma secreted by Th1 cells, inhibits IgE synthesized by the B cells and inhibits Th0 cells from differentiating into 2 cells, but also can regulate the inflammatory reaction of endocrine factors such as neuropeptide released by a nerve-to the immune system and simultaneously generate the immune action to the immune system through TRPV1 and CCR3 related factors.
The specific mechanism of the compound pungent stilbene nasal spray is as follows:
allergic rhinitis, which is a chronic rhinitis in Chinese medicine, is mainly manifested by paroxysmal and multiple nasal discharge and sneezing, and is mainly caused by deficiency of the lung, spleen and kidney, deficiency of healthy qi, loose skin striae and insecurity of defensive exterior, which reduces the adaptability of the body to the external environment.
The compound flos magnoliae, mint, astragalus root, grassleaf sweelflag rhizome, Chinese magnoliavine fruit, lithospermum and other medicines are adopted, and the flos magnoliae, the divaricate saposhnikovia root, the mint and the grassleaf sweelflag rhizome are used for dispelling wind and eliminating evil and ventilating nasal orifices to treat the symptoms; radix astragali is used for tonifying defensive qi, and rhizoma atractylodis macrocephalae is used for tonifying spleen and qi and treating both the causes; the shizandra berry is used as an adjuvant drug for astringing lung qi and preventing excessive evacuation; the lithospermum clears away heat and toxic materials, and aims at the pathogenesis of stagnated heat in allergic rhinitis, and simultaneously, the adjuvant drugs and the prepared drugs are too pungent and dry; chen Xiang moves qi and receives qi, and regulates the ascending and descending of qi. The compound pungent astragalus nasal spray has the functions of dispelling wind and eliminating evil, nourishing defensive qi, nourishing in attacking and receiving in dispersing, treating both principal and secondary aspect of disease, being compatible and appropriate and being suitable for allergic rhinitis.
In addition, the magnolia flower volatile oil, the astragalus, the alkannin in the lithospermum and the like all have a regulating effect on the immunologic function of T helper cells (Th) for allergic rhinitis, can maintain the dynamic balance of Th1/Th2, regulate the levels of I L-4 and IFN-gamma, finally influence the expression of inflammatory mediators released by the immune helper cells, and play a role in treating the allergic rhinitis.
Further, the invention provides a preparation method of the nasal spray, which is mainly prepared by adopting a leaching method and specifically comprises the following steps: pulverizing flos Magnoliae, radix astragali, herba Menthae, fructus Schisandrae chinensis, Atractylodis rhizoma, rhizoma Acori Graminei, radix Saposhnikoviae, radix Arnebiae, and lignum Aquilariae Resinatum, and mixing to obtain Chinese medicinal powder; extracting the Chinese medicinal powder with water and precipitating with ethanol to obtain distillate; mixing the distillate with glycerol, and adding distilled water to 1000ml solution; adjusting pH to 5.8-6.2, and stirring; subpackaging; sterilizing to obtain the nasal spray.
A second part: some examples are given below
Example 1
Crushing and mixing 120 parts of magnolia flower, 120 parts of raw astragalus, 180 parts of mint, 60 parts of schisandra chinensis, 120 parts of bighead atractylodes rhizome, 120 parts of rhizoma acori graminei, 60 parts of divaricate saposhnikovia root, 30 parts of lithospermum and 2 parts of agilawood to form traditional Chinese medicine powder, preparing the traditional Chinese medicine powder into distillate by a water extraction and alcohol precipitation method, mixing the distillate with 200ml of glycerin, adding distilled water to 1000ml of solution, adjusting the pH value to 5.8-6.2 by using 1 mol/L NaOH solution, stirring uniformly, subpackaging, sterilizing and subpackaging into 5ml of small bottles to obtain the nasal spray.
Example 2
100 parts of magnolia flower, 100 parts of raw astragalus, 120 parts of mint, 30 parts of schisandra chinensis, 90 parts of bighead atractylodes rhizome, 90 parts of grassleaf sweelflag rhizome, 40 parts of divaricate saposhnikovia root, 15 parts of lithospermum and 1 part of agilawood are crushed and mixed to form traditional Chinese medicine powder, the traditional Chinese medicine powder is prepared into distillate through a water extraction and alcohol precipitation method, the distillate is mixed with 200ml of glycerin, distilled water is added to the mixture to obtain 1000ml of solution, the pH value is adjusted to 5.8-6.2 through 1 mol/L of NaOH solution, the mixture is stirred evenly, subpackaged, sterilized and subpackaged into 5ml of small bottles to.
Example 3
Pulverizing and mixing 150 parts of magnolia flower, 150 parts of raw astragalus root, 200 parts of mint, 90 parts of Chinese magnoliavine fruit, 150 parts of bighead atractylodes rhizome, 180 parts of grassleaf sweelflag rhizome, 90 parts of divaricate saposhnikovia root, 60 parts of lithospermum and 5 parts of Chinese eaglewood to form traditional Chinese medicine powder, preparing the traditional Chinese medicine powder into distillate by a water extraction and alcohol precipitation method, mixing the distillate with 200ml of glycerin, adding distilled water to 1000ml of solution, adjusting the pH value to 5.8-6.2 by using 1 mol/L NaOH solution, stirring uniformly, subpackaging, sterilizing and subpackaging into 5ml of small bottles to obtain the nasal spray.
Example 4
The nasal spray is prepared by crushing and mixing 110 parts of magnolia flower, 140 parts of raw astragalus, 150 parts of mint, 75 parts of schisandra chinensis, 100 parts of bighead atractylodes rhizome, 160 parts of rhizoma acori graminei, 50 parts of divaricate saposhnikovia root, 45 parts of lithospermum and 4 parts of agilawood to form traditional Chinese medicine powder, preparing the traditional Chinese medicine powder into distillate by a water extraction and alcohol precipitation method, mixing the distillate with 200ml of glycerol, adding distilled water into the mixture to obtain 1000ml of solution, adjusting the pH value to 5.8-6.2 by using 1 mol/L NaOH solution, stirring the mixture evenly, subpackaging the mixture, sterilizing the mixture and subpackaging the mixture into 5.
And a third part: comparative analysis of performance parameters
The part carries out curative effect observation on the nasal spray prepared in the example 1 through rat animal experiments, namely, a rat allergic rhinitis model is prepared through intraperitoneal injection of ovalbumin and aluminum hydroxide and nasal drop attack of ovalbumin, then blood samples of rats with different intervention measures are collected, and the levels of serum I L-4, IFN-gamma and IgE of rats in different groups are detected so as to detect that the nasal spray has the effects of regulating and controlling I L-4/IFN-gamma balance of rats with allergic rhinitis and realizing anti-inflammatory and anti-allergy, and the results are shown in the following table 1.
TABLE 1 serum IFN-. gamma.I L-4, IgE levels in rats of different groups
| Group of | n | IFN-γ(pg·mL-1) | IL-4(pg·mL-1) | IgE(μg·mL-1) |
| High dose group | 6 | 0.351±0.007 | 0.262±0.013 | 0.250±0.011 |
| Middle dose group | 6 | 0.336±0.011 | 0.286±0.017 | 0.268±0.010 |
| Low dose group | 6 | 0.302±0.013 | 0.313±0.009 | 0.293±0.018 |
| Budesonide group | 6 | 0.279±0.010 | 0.331±0.015 | 0.336±0.015 |
| Model set | 6 | 0.220±0.020 | 0.391±0.022 | 0.398±0.015 |
| Blank control group | 10 | 0.367±0.015 | 0.221±0.009 | 0.222±0.016 |
| F value | - | F＝108.451 | F＝123.059 | F＝128.301 |
| P value | - | P＜0.001 | P＜0.001 | P＜0.001 |
As shown in Table 1, the results of multiple analyses and comparisons by the S-N-K method show that the serum IFN-gamma content of rats in each group except the high dose group and the blank control group is in different subsets at a test level of α & lt0.05, which indicates that the serum I L-4 content of rats in each group except the high dose group and the blank control group is statistically different, as shown in FIG. 3a, the serum I L-4 content of rats in each group is considered to be the same as the level of the blank control group and the high dose group, and both the medium dose group & gtthe low dose group & gtthe budesonide group & gtmodel group, the serum I L-4 content of rats in each group is in different subsets at a test level of α & lt0.05, which indicates that the serum I L-4 content of rats in each group is statistically different, as shown in FIG. 3b, the serum IFN-gamma content of rats in each group is considered to be the serum I L-4 content of rats in different subsets, the blank control group & ltmedium dose group & ltlow dose group & ltmodel group & ltIgE & lt0.05, and each group is considered to be the serum C & ltIgE & lt0.590.
Animal experiment results show that the compound octastragalus nasal spray can realize an anti-inflammatory and anti-allergic mechanism by regulating and controlling the balance of allergic rhinitis model rat I L-4/IFN-gamma, thereby relieving allergic rhinitis symptoms and achieving the purpose of treatment, namely the compound octastragalus nasal spray has the action points of multi-target point and multi-path for allergic rhinitis, can lead IFN-gamma secreted by Th1 cells to inhibit B cells from synthesizing IgE and inhibiting Th0 cells from differentiating into Th2 cells, thereby leading factors released by a nerve-endocrine system to act on an immune system and simultaneously act on the immune path, and leading the compound octastragalus nasal spray to act on the whole nerve-endocrine-immune system through TRPV1 and CCR3 related factors to act on the whole nerve-endocrine-immune system to take effect.
In conclusion, after the action mechanism of allergic rhinitis is researched, the nasal spray and the preparation method thereof provided by the invention act on an immune system and act on an immune pathway through factors which are induced or stimulated by medicinal components in the nasal spray to release the factors, can directly act on an affected part, and can be used for local administration in a nasal cavity.
In light of the foregoing description of the preferred embodiment of the present invention, many modifications and variations will be apparent to those skilled in the art without departing from the spirit and scope of the invention. The technical scope of the present invention is not limited to the content of the specification, and must be determined according to the scope of the claims.
Claims (3)
1. The nasal spray is characterized by comprising the following raw materials:
100 and 150 parts of magnolia flower;
100 portions and 150 portions of raw astragalus root;
200 portions of mint 120-;
30-90 parts of schisandra chinensis;
90-150 parts of bighead atractylodes rhizome;
90-180 parts of rhizoma acori graminei;
40-90 parts of divaricate saposhnikovia root;
15-60 parts of lithospermum;
1-5 parts of agilawood.
2. A nasal spray according to claim 1,
120 parts of magnolia flower;
120 parts of raw astragalus;
180 parts of mint;
60 parts of schisandra chinensis;
120 parts of bighead atractylodes rhizome;
120 parts of rhizoma acori graminei;
60 parts of divaricate saposhnikovia root;
30 parts of lithospermum;
2 parts of agilawood.
3. A method for preparing a nasal spray, comprising:
pulverizing flos Magnoliae, radix astragali, herba Menthae, fructus Schisandrae chinensis, Atractylodis rhizoma, rhizoma Acori Graminei, radix Saposhnikoviae, radix Arnebiae, and lignum Aquilariae Resinatum, and mixing to obtain Chinese medicinal powder;
extracting the Chinese medicinal powder with water and precipitating with ethanol to obtain distillate;
mixing the distillate with glycerol, and adding distilled water to 1000ml solution;
adjusting pH to 5.8-6.2, and stirring;
subpackaging;
sterilizing to obtain the nasal spray.
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