CN108653431B - Pharmaceutical composition for preventing and treating rhinitis, preparation method, application and preparation thereof - Google Patents

Pharmaceutical composition for preventing and treating rhinitis, preparation method, application and preparation thereof Download PDF

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CN108653431B
CN108653431B CN201810913288.XA CN201810913288A CN108653431B CN 108653431 B CN108653431 B CN 108653431B CN 201810913288 A CN201810913288 A CN 201810913288A CN 108653431 B CN108653431 B CN 108653431B
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essential oil
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pharmaceutical composition
allergic rhinitis
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万娜
伍振峰
朱根华
杨明
郑琴
王芳
罗莹
李艳
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Jiangxi University of Traditional Chinese Medicine
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a pharmaceutical composition for preventing and treating rhinitis, a preparation method, application and a preparation thereof. The invention relates to a pharmaceutical composition for preventing and treating rhinitis, which is mainly prepared from the following raw materials in parts by weight: 0.1 to 5 parts of ligusticum wallichii essential oil, 0.1 to 5 parts of magnolia flower essential oil, 0.05 to 1 part of fructus cnidii essential oil, 0.05 to 1 part of dittany bark essential oil, 0.08 to 3 parts of agastache rugosus essential oil and 0.01 to 0.3 part of centipeda minima essential oil. The invention utilizes the compatibility theory of traditional Chinese medicine, mainly takes ligusticum wallichii essential oil, magnolia flower essential oil, fructus cnidii essential oil, dittany bark essential oil, wrinkled gianthyssop essential oil and centipeda minima essential oil as raw materials, and utilizes the principle that mutual compatibility of the essential oils in the formula plays a synergistic effect to complement each other and enhance the effect, thereby enlarging the curative effect, and leading the rhinitis treatment effect to be obvious, the effect to be stable and no side effect to be caused.

Description

Pharmaceutical composition for preventing and treating rhinitis, preparation method, application and preparation thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a pharmaceutical composition for preventing and treating rhinitis, a preparation method, application and a preparation thereof.
Background
Allergic rhinitis, also called allergic rhinitis, refers to a non-infectious inflammatory disease of the nasal mucosa that is mainly released by IgE-mediated mediators (mainly histamine) and has various immune active cells and cytokines involved in the exposure of atopic individuals to allergens. Allergic rhinitis is a multifactorial common disease induced by interaction of genes and the environment, risk factors of the allergic rhinitis can exist in all ages, the allergic rhinitis is one of high-risk factors causing adult asthma, about one third of patients with poorly controlled allergic rhinitis can cause asthma, so the allergic rhinitis is a global health problem, causes much pain and inconvenience to the work and life of the patients, and can cause a plurality of concomitant diseases in severe cases or even cause the loss of labor force of the patients.
At present, the medical treatment aiming at allergic rhinitis is generally carried out by oral western medicines such as antihistamine, glucocorticoid, anti-leukotriene, chromone medicines, intranasal decongestant, intranasal anticholinergic medicines and the like to control the disease condition. The symptoms can be relieved by adopting oral western medicines, but the oral western medicines cannot be completely cured, are difficult to maintain and easy to repeat, have no long-term continuous curative effect after stopping taking the medicines, but the long-term repeated use of the medicines easily causes the inertia and dependence of the body, can cause the future allergic attack to be uncontrollable, have large toxic and side effects and high cost, and most of the oral administration causes the side effects of the whole body.
The traditional Chinese medicine has a long history in treating allergic rhinitis, and has the characteristics of treating both symptoms and root causes, being remarkable in curative effect, avoiding side effects of western medicines and the like. At present, the traditional Chinese medicine components for treating rhinitis mainly comprise qianbai rhinitis tablets, Huodan pills, Xinling granules and the like, but the traditional Chinese medicine components have low content of effective components, slow action and poor curative effect, and still cannot meet the medication requirements of patients. In addition, most of the traditional Chinese medicine essential oil for treating allergic rhinitis in the market at present is prepared by mixing single-component essential oil and base oil, and has single effect and insignificant curative effect.
In view of the above, the present invention is particularly proposed.
Disclosure of Invention
The invention provides a pharmaceutical composition for preventing and treating rhinitis, which is prepared from raw materials of ligusticum wallichii essential oil, magnolia flower essential oil, fructus cnidii essential oil, dittany bark essential oil, wrinkled gianthyssop essential oil and centipeda minima essential oil according to the compatibility theory of traditional Chinese medicines, and the essential oils are mutually compatible to exert the synergistic effect to supplement each other and enhance the effect, so that the curative effect is enlarged, the rhinitis-resistant curative effect is remarkable, the effect is stable, and no side effect is caused.
The second purpose of the invention is to provide a preparation method of the pharmaceutical composition for preventing and treating rhinitis, which has the advantages of few preparation procedures, simple and convenient operation, full play of the effects of all raw materials and good product stability.
The third purpose of the invention is to provide an application of the pharmaceutical composition for preventing and treating rhinitis in treating, preventing or relieving rhinitis, and the pharmaceutical composition for preventing and treating rhinitis can prevent, treat or relieve rhinitis more safely, effectively, long-acting and conveniently.
The fourth purpose of the invention is to provide a pharmaceutical preparation for preventing and treating rhinitis, which is prepared from the pharmaceutical composition, and has the advantages of high effective component, obvious curative effect on treating rhinitis, safety, no side effect and convenient use.
In order to achieve the above purpose of the present invention, the following technical solutions are adopted:
according to one aspect of the invention, the invention provides a pharmaceutical composition for preventing and treating rhinitis, which is mainly prepared from the following raw materials in parts by weight:
0.1 to 5 parts of ligusticum wallichii essential oil, 0.1 to 5 parts of magnolia flower essential oil, 0.05 to 1 part of fructus cnidii essential oil, 0.05 to 1 part of dittany bark essential oil, 0.08 to 3 parts of agastache rugosus essential oil and 0.01 to 0.3 part of centipeda minima essential oil.
As a further preferable technical scheme, the feed additive is mainly prepared from the following raw materials in parts by weight:
1 to 3 parts of ligusticum wallichii essential oil, 1 to 3 parts of magnolia flower essential oil, 0.2 to 0.5 part of fructus cnidii essential oil, 0.1 to 0.5 part of cortex dictamni essential oil, 0.5 to 1.5 parts of agastache rugosus essential oil and 0.05 to 0.15 part of centipeda minima essential oil.
As a further preferable technical scheme, the feed additive is mainly prepared from the following raw materials in parts by weight:
1.5 to 2.5 parts of ligusticum wallichii essential oil, 1.5 to 2.5 parts of magnolia flower essential oil, 0.25 to 0.45 part of fructus cnidii essential oil, 0.2 to 0.4 part of cortex dictamni essential oil, 0.85 to 1 part of agastache rugosus essential oil and 0.05 to 0.15 part of centipeda minima essential oil.
As a further preferable technical scheme, the oil-water-based paint further comprises 92-100 parts by weight of base oil, preferably 94-100 parts by weight of base oil, and further preferably 95-100 parts by weight of base oil;
preferably, the base oil comprises at least one of sweet almond oil, jojoba oil, grape seed oil, and wheat germ oil.
According to another aspect of the present invention, the present invention also provides a preparation method of the pharmaceutical composition for preventing and treating rhinitis, comprising the following steps:
the raw materials are uniformly mixed according to the formula amount, subpackaged and sealed to obtain the pharmaceutical composition for preventing and treating rhinitis.
According to another aspect of the invention, the invention also provides application of the pharmaceutical composition for preventing and treating rhinitis in treating, preventing or relieving rhinitis.
In a more preferred embodiment, the rhinitis includes at least one of rhinitis sicca, rhinitis medicamentosa, rhinitis atrophica, rhinitis seasonality, and rhinitis, preferably rhinitis.
According to another aspect of the invention, the invention also provides a pharmaceutical preparation prepared from the pharmaceutical composition for preventing and treating rhinitis.
As a further preferable technical scheme, the preparation is in a form of external preparation;
preferably, the preparation is in the form of nose drops, gels, paste, patches, liniments, tinctures, lotions, plastics or emplastrums.
As a further preferred technical scheme, the preparation also comprises pharmaceutically acceptable auxiliary materials;
preferably, the excipients include one or more of excipients, binders, fillers, lubricants, antioxidants, preservatives, and thickeners.
Compared with the prior art, the invention has the beneficial effects that:
1. the pharmaceutical composition for preventing and treating rhinitis provided by the invention utilizes the compatibility theory of traditional Chinese medicines, has targeted and reasonable compatibility, mainly takes ligusticum wallichii essential oil, magnolia flower essential oil, fructus cnidii essential oil, dittany bark essential oil, wrinkled gianthyssop herb essential oil and centipeda minima essential oil as raw materials, the raw material components are scientifically matched, the components are mutually influenced to obtain a synergistic effect, the principle of different volatilization speeds of the essential oils in the formula is utilized to complement each other and enhance the effect, the curative effect is enlarged, and the rhinitis-resistant curative effect is remarkable, the effect is stable and no side effect is caused.
2. On the basis of the combination of the compatibility theory of traditional Chinese medicines and the essential oil blending technology, the compound essential oil composition for preventing and treating rhinitis is prepared by taking the magnolia flower essential oil for dispelling wind cold and dredging nasal orifices and the ligusticum wallichii essential oil for relieving fever, easing pain, calming, improving blood rheology and resisting inflammation as monarch drugs, matching the cnidium monnieri essential oil for dispelling wind, eliminating dampness, killing insects and relieving itching, the dictamnus chinensis essential oil for clearing heat, eliminating dampness, dispelling wind and removing toxicity as ministerial drugs, taking the centipeda minima essential oil for dispelling wind, dispelling cold, eliminating dampness, removing nebula and dredging nasal obstruction as a conductant drug and then assisting with optional base oil.
3. The composition is processed by a modern process, essential oil is used as a raw material, the preparation method is simple, the preparation procedures are few, and the production efficiency is high; in addition, the medicine is convenient for patients to take, the paroxysmal sneeze can be relieved by smearing the nasal cavity, the symptoms of clear water-like nasal discharge, nasal obstruction, nasal itching and the like are eliminated, the pain of the patients is fundamentally solved, the curative effect is obvious, the side effect is low, and the medical expense can be reduced. In addition, the treatment of patients with allergic rhinitis proves that the compound essential oil disclosed by the invention has the advantages of quickly relieving symptoms in the aspect of treating allergic rhinitis, being good in treatment effect, remarkably improving the life quality of the patients and having good application prospect.
4. The pharmaceutical preparation for preventing and treating rhinitis prepared from the pharmaceutical composition provided by the invention has at least the same advantages as the pharmaceutical composition for preventing and treating rhinitis.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to embodiments and examples, but those skilled in the art will understand that the following embodiments and examples are only illustrative of the present invention and should not be construed as limiting the scope 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. Those who do not specify the conditions are performed according to the conventional conditions or the conditions recommended by the manufacturer.
In a first aspect, in at least one embodiment, a pharmaceutical composition for preventing and treating rhinitis is provided, which is mainly prepared from the following raw materials in parts by weight:
0.1 to 5 parts of ligusticum wallichii essential oil, 0.1 to 5 parts of magnolia flower essential oil, 0.05 to 1 part of fructus cnidii essential oil, 0.05 to 1 part of dittany bark essential oil, 0.08 to 3 parts of agastache rugosus essential oil and 0.01 to 0.3 part of centipeda minima essential oil.
It is understood that the rhinitis according to the present invention refers to allergic rhinitis, i.e. allergic rhinitis, whose typical symptoms are mainly sneezing, watery nasal discharge, nasal obstruction and nasal itching. But not limited to, the pharmaceutical composition also has certain curative effect on other types of rhinitis such as drug rhinitis and the like.
The pure natural plant essential oil is extracted, the compatibility theory of traditional Chinese medicine is utilized, the ligusticum wallichii essential oil, the magnolia liliflora essential oil, the cnidium fruit essential oil, the dittany bark essential oil, the agastache rugosus essential oil and the centipeda minima essential oil are taken as raw materials for the first time, the optional base oil is taken as an auxiliary material, and the antiallergic rhinitis essential oil formula which can obviously relieve and cure the symptoms of paroxysmal sneeze, watery nasal discharge, nasal obstruction, rhinocnesmus and the like is prepared and combined. And aiming at allergic rhinitis, the essential oil pharmaceutical composition has triple curative effects: (1) the essential oil has certain effects of sterilizing and removing mites, so that the number of indoor dust mites can be reduced, and the probability of contacting allergens of a patient is reduced; (2) the essential oil has the property of fragrance flowing away, is administrated in combination with the nasal cavity, directly reaches the focus, acts on the nasal mucosa and plays a role; (3) the compound essential oil formula has the functions of clearing away heat and toxic materials, promoting blood circulation to remove blood stasis, and ventilating and smoothing the lung and relieving stuffiness, and can be used for pertinently treating allergic rhinitis caused by lung qi deficiency, defensive exterior insecurity and wind cold invasion; compared with single-component essential oil, the compound essential oil supplements each other and enhances the effect by utilizing the principle of different volatilization speeds of the essential oil in the formula on the basis of the compatibility theory of the traditional Chinese medicine, enlarges the curative effect, has obvious curative effect on allergic rhinitis and is very suitable for the public suffering from allergic rhinitis.
Furthermore, the design idea of selecting the essential oil as the raw material mainly comprises the following steps:
(1) micromolecule, high permeability, oleophylic and water-resistant transdermal absorption: the human epidermis has pores with a diameter of 60-80 microns (1000 microns to 1 mm), and the essential oil molecule is only 1/1000, which is 1/5000000 compared to human cells, so that the essential oil can permeate into skin and blood very rapidly. The essential oil has 70 times higher tragic property than Chinese herbal medicines (in the form of extractive solution and powder), so the essential oil can rapidly penetrate into skin deep layer and blood, reach epidermis layer in 3 s, dermis layer in 6 s, enter subcutaneous tissue in 3 min, and blood in 6 min for systemic blood circulation, and has effects of purifying human body tissue and resisting inherent bacteria. Can avoid the damage of the oral drug to the liver and kidney, adopts transdermal absorption, and the potency of the drug directly permeates the focus, and can quickly relieve symptoms.
(2) The efficacy is strong: the essential oil is the essence of herbs, 99.9 percent of the essential oil ensures the original efficacy of the plants, and as the penetration is extremely fast and the drug property is extremely high, a small amount of the essential oil can exert the drug effect to the utmost extent, the cost can be saved, the rapid effect can be achieved, the drug efficacy can directly reach the focus, the disease can be rapidly relieved, and the defects of small drug content, difficult absorption, easy allergy, great drug taste and difficult acceptance of the existing products are overcome.
(3) 100% natural organic plant essence: the essential oil does not contain artificially added chemical substances or preservatives, is extracted from natural pure plants, is natural, pure and healthy, only retains the most effective components in the raw materials in the extraction process, rejects any added and chemical components, and enables skin to enjoy zero pollution. With the improvement of living standard and the continuous strengthening of the concept of green environmental protection, more and more consumers pursuing high-quality life are pursued, so that the essential oil product is more and more popular, and the adaptability of the essential oil product is better.
(4) Is safer, healthy and non-irritant: at present, western medicines such as hormones and the like have the problems of strong toxic and side effects, easy generation of drug resistance, drug residues and the like, and are greatly limited in clinical application. The plant essential oil becomes an excellent substitute of antibiotics due to the characteristics of greenness, naturalness, safety, high efficiency and the like, does not bring unnecessary side effects to human bodies, and has positive effects on improving the immunity of the human bodies and enhancing the resistance of the organisms.
In addition, the advantages of nasal administration, the fragrance of the essential oil and the like are combined with the characteristics of the essential oils in the formula, and the nasal administration essential oil has the characteristics of quick response, good curative effect, stable medicinal effect, low recurrence rate and the like.
The efficacy and action of the essential oil raw material selected in the present invention will be further described below.
And (3) ligusticum wallichii essential oil: has antipyretic, analgesic, tranquilizing, blood rheology improving, nerve cell protecting, antiinflammatory, blood pressure lowering, blood circulation promoting, qi circulation promoting, pathogenic wind expelling, analgesic, microcirculation improving, and blood vessel dilating effects. In the invention, the typical but non-limiting contents of the ligusticum wallichii essential oil are as follows according to parts by weight: 0.1 part, 0.2 part, 0.5 part, 0.6 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.6 parts, 1.8 parts, 2 parts, 2.2 parts, 2.5 parts, 2.8 parts, 3 parts, 3.2 parts, 3.5 parts, 3.8 parts, 4 parts, 4.2 parts, 4.5 parts, 4.8 parts, or 5 parts.
And (3) magnolia flower essential oil: flos Magnoliae, also called Magnolia biondii, belongs to Magnoliaceae plant, has effects of dispelling pathogenic wind and cold, and can be used for treating rhinitis and lowering blood pressure. Therefore, the magnolia flower essential oil has the effects of dispelling wind and cold and relieving stuffy nose. In the invention, the typical but non-limiting contents of the magnolia flower essential oil are as follows according to the parts by weight: 0.1 part, 0.2 part, 0.5 part, 0.6 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.6 parts, 1.8 parts, 2 parts, 2.2 parts, 2.5 parts, 2.8 parts, 3 parts, 3.2 parts, 3.5 parts, 3.8 parts, 4 parts, 4.2 parts, 4.5 parts, 4.8 parts, or 5 parts.
Cnidium fruit essential oil: fructus Cnidii is named as wild carrot seed, is dried mature fruit of cnidium monnieri (L.) DC of Umbelliferae, and has effects of warming kidney, tonifying yang, eliminating dampness, dispelling pathogenic wind, and killing parasite. Fructus Cnidii essential oil has effects of dispelling pathogenic wind, eliminating dampness, killing parasite, and relieving itching. According to the invention, the typical but non-limiting contents of the common cnidium fruit essential oil are as follows according to parts by weight: 0.05 part, 0.06 part, 0.08 part, 0.1 part, 0.2 part, 0.3 part, 0.4 part, 0.5 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part or 1 part.
Dittany bark essential oil: cortex Dictamni Radicis is root bark of Dictamnus dasycarpus and Dictamnus angustifolia of Rutaceae; has effects in clearing away heat, eliminating dampness, dispelling pathogenic wind, and removing toxic substances; modern researches show that the volatile oil has anticancer effect in vitro. The dittany bark essential oil has the effects of clearing heat, eliminating dampness, dispelling wind, relieving itching and detoxifying. According to the invention, the typical but non-limiting content of the dittany bark essential oil is as follows according to the parts by weight: 0.05 part, 0.06 part, 0.08 part, 0.1 part, 0.2 part, 0.3 part, 0.4 part, 0.5 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part or 1 part.
Agastache essential oil: agastache rugosus also called Hexiang, cang Zhu, shan Feng Zi, belonging to Labiatae family perennial herb; fragrant, resolving turbidity, regulating the middle warmer, arresting vomiting, relieving exterior syndrome and relieving summer-heat; can be used for treating damp obstruction in middle warmer, abdominal distention, emesis, summer-heat dampness syndrome, early stage of damp-warm syndrome, fever, listlessness, chest distress, cold-dampness, sunstroke, abdominal pain, emesis, diarrhea, nasosinusitis, and headache. The herba Agastaches essential oil has effects of dispelling summerheat, relieving exterior syndrome, eliminating dampness and regulating stomach function, and can be used for treating nasosinusitis. In the invention, the typical but non-limiting contents of the ageratum essential oil are as follows according to parts by weight: 0.08 part, 0.1 part, 0.2 part, 0.4 part, 0.5 part, 0.6 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.6 parts, 1.8 parts, 2 parts, 2.2 parts, 2.5 parts, 2.8 parts, or 3 parts.
Centipeda minima essential oil: centipeda minima, also known as Chinese feverfew, is a whole plant with flowers of Chinese Hydrocotyle of Compositae; has the effects of expelling pathogenic wind, dispelling cold, eliminating dampness, removing nebula, and relieving nasal obstruction; can be used for treating common cold, cold asthma, pharyngitis, pertussis, eruptive abdominal pain, amebic dysentery, malaria, infantile malnutrition, nasosinusitis, and nasal polyp. The centipeda minima essential oil has the functions of expelling wind, dispelling cold, eliminating dampness, removing nebula and dredging nasal obstruction. In the invention, the typical but non-limiting contents of the centipeda minima essential oil are as follows according to parts by weight: 0.01 part, 0.02 part, 0.05 part, 0.06 part, 0.08 part, 0.1 part, 0.12 part, 0.15 part, 0.18 part, 0.2 part, 0.22 part, 0.25 part, 0.28 part or 0.3 part.
The pharmaceutical composition for preventing and treating rhinitis utilizes the compatibility theory of traditional Chinese medicine, has targeted and reasonable compatibility, mainly takes ligusticum wallichii essential oil, magnolia liliflora essential oil, fructus cnidii essential oil, dittany bark essential oil, wrinkled gianthyssop essential oil and centipeda minima essential oil as raw materials, the raw material components are scientifically matched, the components are mutually influenced to obtain synergistic action, a natural, safe, effective and healthy pharmaceutical composition without toxic and side effects is provided for people, and the pharmaceutical composition has the characteristics of wide raw material source, low price, broad spectrum, high efficiency, rapidness, safety and no toxic and side effects, and has remarkable and stable curative effect.
In addition, when the ligusticum wallichii essential oil, the magnolia flower essential oil, the fructus cnidii essential oil, the dittany bark essential oil, the agastache rugosus essential oil and the centipeda minima essential oil are prepared according to the components and the proportion, the mutual influence among various components in the pharmaceutical composition for preventing and treating rhinitis supplements each other, the synergistic effect is better, and the value of the essential oil raw materials can be better reflected.
In a preferred embodiment, the composition is mainly prepared from the following raw materials in parts by weight:
1 to 3 parts of ligusticum wallichii essential oil, 1 to 3 parts of magnolia flower essential oil, 0.2 to 0.5 part of fructus cnidii essential oil, 0.1 to 0.5 part of cortex dictamni essential oil, 0.5 to 1.5 parts of agastache rugosus essential oil and 0.05 to 0.15 part of centipeda minima essential oil.
In a preferred embodiment, the composition is mainly prepared from the following raw materials in parts by weight:
1.5 to 2.5 parts of ligusticum wallichii essential oil, 1.5 to 2.5 parts of magnolia flower essential oil, 0.25 to 0.45 part of fructus cnidii essential oil, 0.2 to 0.4 part of cortex dictamni essential oil, 0.85 to 1 part of agastache rugosus essential oil and 0.05 to 0.15 part of centipeda minima essential oil.
The composition has the advantages that the synergistic cooperation effect among the components is fully exerted by reasonably adjusting the proportion among the components, the treatment effect of the pharmaceutical composition for preventing and treating rhinitis is improved, the effect is stable, and the pharmaceutical composition has more remarkable effect on treating, preventing or relieving allergic rhinitis.
In a preferred embodiment, the pharmaceutical composition for preventing and treating rhinitis further comprises 92 to 100 parts by weight of base oil, preferably 94 to 100 parts by weight of base oil, and further preferably 95 to 100 parts by weight of base oil; typical, but non-limiting, amounts of base oil are, by weight: 92 parts, 93 parts, 94 parts, 95 parts, 96 parts, 97 parts, 98 parts, 99 parts or 100 parts.
Preferably, the base oil includes, but is not limited to, at least one of sweet almond oil, jojoba oil, grape seed oil, and wheat germ oil.
It should be noted that the source of the base oil and the base oil in the present invention is not particularly limited, and the base oils may be used as the above base oils, other types of base oils having the same or similar action and effect may be used, and commercially available base oils may be used, or they may be prepared by a method known to those skilled in the art.
In a preferred embodiment, the pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
1-3 parts of ligusticum wallichii essential oil, 1-3 parts of magnolia flower essential oil, 0.2-0.5 part of fructus cnidii essential oil, 0.1-0.5 part of cortex dictamni essential oil, 0.5-1.5 parts of agastache rugosus essential oil, 0.05-0.15 part of centipeda minima essential oil and 95-100 parts of base oil.
In a second aspect, in at least one embodiment, there is provided a method for preparing the above pharmaceutical composition for preventing and treating rhinitis, the method comprising the steps of:
the raw materials are uniformly mixed according to the formula amount, subpackaged and sealed to obtain the pharmaceutical composition for preventing and treating rhinitis.
Further, the preparation method comprises the steps of putting the base oil into a container, sequentially adding the essential oil raw materials according to the formula proportion (the proportion is from large to small), tightly covering the container, forcibly rolling to fully mix all the raw materials, subpackaging, covering and sealing.
The preparation method has the advantages of simple flow, convenient operation, full play of the efficacy of each raw material, good product stability, no need of adopting a complex equipment system and easy realization of industrial large-scale production.
In a third aspect, in at least one embodiment, there is provided a use of the above pharmaceutical composition for preventing and treating rhinitis in treating, preventing or relieving rhinitis.
Preferably, the rhinitis comprises at least one of rhinitis sicca, rhinitis medicamentosa, rhinitis atrophica, rhinitis seasonalis, and rhinitis, preferably rhinitis. The pharmaceutical composition for preventing and treating rhinitis can be used for preventing, treating or relieving rhinitis, particularly allergic rhinitis, more safely, effectively, long-acting and conveniently, but is not limited to the rhinitis, and has certain curative effect on other types of rhinitis.
In a fourth aspect, in at least one embodiment, there is provided a pharmaceutical preparation for the prevention and treatment of rhinitis, prepared from the pharmaceutical composition described above.
In a preferred embodiment, the formulation is in the form of a topical formulation;
preferably, the formulation includes, but is not limited to, any one of nasal drops, gels, pastes, patches, liniments, tinctures, lotions, plastics or emplastrums. The pharmaceutical composition provided by the invention can be prepared into various external preparations, the drug effect of the pharmaceutical composition is not changed, patients can select the pharmaceutical composition according to needs, and the adaptability is stronger. Preferably, pharmaceutically acceptable auxiliary materials can be added when the preparation is prepared into various preparations; preferably, the adjuvant may be, for example, one or more of an excipient, a binder, a filler, a lubricant, an antioxidant, a preservative, and a thickener.
In the invention, the use method of the pharmaceutical preparation can be as follows: the prepared medicinal preparation is coated on the Yingxiang acupoint and/or nasal cavity at two sides of nasal wing, and is absorbed by massaging slightly, once every morning and evening, and after a treatment course (20 days), the symptoms disappear and the patient is cured.
The essential oil composition is prepared into an external preparation, and the nasal administration is directly carried out by utilizing the nasal cavity, so that the nasal spray has more advantages compared with oral administration and operation, high-concentration medicines can directly act on the nasal part and directly reach a focus, and the nasal spray is quick in effect and free of side effect.
Further, the advantages of nasal administration are: (1) compared with oral administration, nasal administration can avoid degradation of the drug in gastrointestinal fluid and liver first-pass effect, and has high bioavailability. (2) Quick acting, large nasal mucosa area, rich blood vessels under mucosa, and interlaced artery, vein and capillary vessels into mesh, and the medicinal liquid can be absorbed rapidly and enter human body circulation from blood vessels. (3) The nasal cavity drug delivery is convenient to use, easy to accept by patients and convenient for self-administration compared with injection drug delivery. In addition, the advantages of nasal administration mode, the advantages of fragrance of the essential oil, and the like are combined with the characteristics of the essential oil of the formula, so that the effect is quick, the curative effect is good, the drug effect is stable, and the recurrence rate is low.
In summary, compared with the prior art, the pharmaceutical composition and the pharmaceutical preparation for preventing and treating rhinitis mainly have the following advantages:
(1) on the basis of the combination of the traditional Chinese medicine compatibility theory and the essential oil blending technology, the compound essential oil composition for preventing and treating rhinitis is prepared by taking the magnolia flower essential oil for dispelling wind cold and dredging nasal orifices, the ligusticum wallichii essential oil for relieving fever, easing pain and calming, improving blood rheology and resisting inflammation as monarch drugs, the fructus cnidii essential oil for dispelling wind, eliminating dampness, killing insects and relieving itching, the dittany bark essential oil for clearing heat and eliminating dampness, dispelling wind and removing toxicity and the wrinkled gianthyssop essential oil for dispelling summer-heat and relieving exterior syndrome, eliminating dampness and harmonizing stomach as ministerial drugs, the centipeda minima essential oil for dispelling wind, dispelling cold, eliminating dampness, removing nebula and dredging nasal obstruction as a conductant drug, and the sweet almond oil or jojoba oil or the grape seed oil or wheat germ oil as a base oil.
(2) The medicine is processed by modern technology, the essential oil is used as the raw material, the preparation method is simple, the preparation procedures are few, and the production efficiency is high; in addition, the medicine is convenient for patients to take, the paroxysmal sneeze is relieved by smearing the medicine through the nasal cavity, the symptoms of clear water-like nasal discharge, nasal obstruction, nasal itching and the like are eliminated, and the pain of the patients is fundamentally solved.
(3) The treatment of patients with allergic rhinitis proves that the compound essential oil has the advantages of quick symptom relief, good treatment effect and remarkable improvement of the life quality of the patients in the aspect of treating the allergic rhinitis.
(4) The essential oil composition with the specific application is provided for patients by implementing the invention, and the essential oil is used as a raw material, so that the preparation is simple, the administration for the patients is convenient, the curative effect is obvious, the side effect is low, the medical expense is reduced, and the application prospect is good.
The present invention will be further described with reference to specific examples and comparative examples.
Example 1
A pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
1 part of ligusticum wallichii essential oil, 2 parts of magnolia flower essential oil, 0.45 part of fructus cnidii essential oil, 0.5 part of cortex dictamni essential oil, 1 part of agastache rugosus essential oil, 0.05 part of centipeda minima essential oil and 95 parts of jojoba oil (the total parts are 100 parts, the same below).
Example 2
A pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
1.5 parts of ligusticum wallichii essential oil, 1.5 parts of magnolia flower essential oil, 0.5 part of fructus cnidii essential oil, 0.5 part of cortex dictamni essential oil, 0.85 part of agastache rugosus essential oil, 0.15 part of centipeda minima essential oil and 95 parts of sweet almond oil.
Example 3
A pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
3 parts of ligusticum wallichii essential oil, 1 part of magnolia flower essential oil, 0.2 part of fructus cnidii essential oil, 0.2 part of cortex dictamni essential oil, 0.5 part of agastache rugosus essential oil, 0.1 part of centipeda minima essential oil and 95 parts of wheat germ oil.
Example 4
A pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
1.5 parts of ligusticum wallichii essential oil, 0.5 part of magnolia flower essential oil, 1.1 part of fructus cnidii essential oil, 0.8 part of cortex dictamni essential oil, 0.08 part of agastache rugosus essential oil, 0.02 part of centipeda minima essential oil and 96 parts of grape seed oil.
Example 5
A pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
2 parts of ligusticum wallichii essential oil, 2 parts of magnolia flower essential oil, 0.8 part of fructus cnidii essential oil, 0.3 part of cortex dictamni essential oil, 0.82 part of agastache rugosus essential oil, 0.08 part of centipeda minima essential oil and 94 parts of sweet almond oil.
The preparation method of the pharmaceutical composition for preventing and treating rhinitis, which is disclosed in the embodiments 1 to 5, comprises the following steps:
putting the base oil into a container, sequentially adding the essential oil raw materials according to a formula ratio (from large to small), tightly covering the cover, forcibly rolling to fully and uniformly mix all the raw materials, subpackaging, covering and sealing to obtain the product.
COMPARATIVE EXAMPLE 1 (Western medicine group)
Western medicines for preventing and treating rhinitis: clindamycin phosphate gel.
Comparative examples 2-7 (Single essential oil)
Respectively taking single essential oil as a raw material, and taking 5: 95 by weight ratio.
In comparative example 2, 5 parts of ligusticum wallichii essential oil and 95 parts of base oil;
in comparative example 3, 5 parts of magnolia flower essential oil and 95 parts of base oil;
in comparative example 4, 5 parts of fructus cnidii essential oil and 95 parts of base oil;
in comparative example 5, 5 parts of dittany bark essential oil and 95 parts of base oil;
in comparative example 6, 5 parts of wrinkled giant hyssop essential oil and 95 parts of base oil;
in comparative example 7, 5 parts of centipeda minima essential oil and 95 parts of base oil.
Comparative example 8
A pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
10 parts of ligusticum wallichii essential oil, 7 parts of magnolia flower essential oil, 1.5 parts of fructus cnidii essential oil, 1.5 parts of dittany bark essential oil, 4.5 parts of agastache rugosus essential oil, 0.5 part of centipeda minima essential oil and 75 parts of jojoba oil.
Unlike example 1, the content of each of the essential oil materials in this comparative example was out of the content range provided by the present invention.
Comparative example 9
A pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
1.5 parts of ligusticum wallichii essential oil, 1.5 parts of magnolia flower essential oil, 1.7 parts of agastache rugosus essential oil, 0.3 part of centipeda minima essential oil and 95 parts of jojoba oil.
Unlike example 1, the raw materials of this comparative example did not contain cnidium fruit essential oil and dittany bark essential oil.
Comparative example 10
A pharmaceutical composition for preventing and treating rhinitis is mainly prepared from the following raw materials in parts by weight:
2.5 parts of magnolia flower essential oil, 0.45 part of fructus cnidii essential oil, 0.5 part of dittany bark essential oil, 1.5 parts of wrinkled gianthyssop essential oil, 0.05 part of centipeda minima essential oil and 95 parts of jojoba oil.
Unlike example 1, the raw material of this comparative example does not contain essential oil of chuanxiong rhizome.
Pharmacological experiments
Drug experiments were performed on the drugs of each example and comparative example, and the experimental materials included:
(1) animal(s) production
BALB/c mice, male and female halves, 22. + -.2 g, (nasal disease excluded).
(2) Laboratory apparatus and reagent
Dexamethasone, Ovalbumin (OVA), a mouse serum immunoglobulin E (IgE) content determination kit, a mouse serum histamine determination kit, a DK-S24 electric heating constant temperature water bath, a BioPowerWaveXS ultraviolet visible enzyme labeling instrument and an AR 1140 electronic analysis balance.
(3) Experimental drugs
The drugs prepared in examples 1 to 5 and comparative examples 1 to 10 were used as experimental samples, respectively;
OVA solution was used as a control group instead of the test sample.
(4) Experimental methods
a) Establishing a model: experiment 1, 7, 14 days each mouse was injected intraperitoneally with 200. mu.L of 0.5g/L OVA solution and 20g/L Al (OH)3 solution. From day 22, 20. mu.L of 50g/LOVA solution was instilled into each mouse nasal cavity. Continuous instillation 10 d. The OVA was replaced with saline in the control group. The animal's behavior of scratching the nose, sneezing and nasal discharge was observed within 30min of the last challenge to determine whether the molding was successful or not. The following b) treatment experiments were performed on mice successfully modeled, with n ═ 10 per group.
b) Treatment:
control group: continuously carrying out nasal drip for 7 days, and dripping 10 mu L of 50g/LOVA solution;
comparative example 1 western medicine group (dexamethasone): dexamethasone was dissolved in normal saline at a dose of 5mg/kg, injected through the abdominal wall 0.5h prior to OVA stimulation, and dripped into the nose at 10 μ LOVA, again continuously for 7 days;
comparative examples 2-7 essential oil monoliths: 20 μ L of single-component essential oil is dripped into nose 0.5h before OVA stimulation, 10 μ LOVA is dripped into nose, and the same process is continued for 7 days;
comparative examples 8 to 10 and examples 1 to 5: 20 μ L of each sample essential oil is dripped into the nose 0.5h before OVA stimulation, 10 μ LOVA is dripped into the nose, and the two samples are also continuously dripped for 7 days;
the rhinitis symptoms of each group of animals are scored within 30min after the last excitation of the animal modeling of each group, blood is taken from eyeballs of the mice after 6h, the blood is kept stand for 2-3 h, 850g at 4 ℃ is centrifuged for 15min, supernate is transferred to a new tube and is stored at-80 ℃, and the contents of serum IgE and histamine of the mice are detected by an ELISA method according to the specification of a kit.
(5) Evaluation index and result thereof
Rhinitis symptom scoring:
itching of the nose: 1 minute is 1-2 times of gentle nasal scratching, more than 3 minutes is needed for acutely scratching the nasal surface, and 2 minutes is left between the gentle nasal scratching and the acutely scratching; sneezing: 1 to 3 are 1 minute, 4 to 10 are 2 minutes, more than 11 are 3 minutes; running nose: the flow to the anterior nares is 1 minute, 2 minutes beyond the anterior nares and 3 minutes full of nasal discharge.
All the indexes adopt a superposition quantitative scoring method. The results are shown in Table I.
The serum IgE and histamine contents of the mice are measured, and the results are shown in the second table.
TABLE-mouse rhinitis symptom Scoring results
Group of n Rhinitis symptom scoring
Control group 10 8.2±0.3
Comparative example 1 10 2.8±0.1**
Comparative example 2 10 3.7±0.2*
Comparative example 3 10 4.0±0.1*
Comparative example 4 10 5.8±0.2*
Comparative example 5 10 6.1±0.1*
Comparative example 6 10 4.5±0.3*
Comparative example 7 10 3.8±0.2*
Comparative example 8 10 3.4±0.3*
Comparative example 9 10 4.3±0.2*
Comparative example 10 10 3.9±0.2*
Example 1 10 2.6±0.2**
Example 2 10 2.3±0.2**
Example 3 10 2.1±0.3**
Example 4 10 2.4±0.2**
Example 5 10 2.5±0.2**
Note: p <0.01, P <0.05 compared to control
As shown in the table I, compared with a control group, the anti-allergic rhinitis compound essential oil pharmaceutical composition prepared by the invention has the effect of obviously relieving allergic rhinitis symptoms, and the relieving and treating effect is higher than that of the western medicine group in the comparative example 1.
In comparative examples 2 to 7, each single essential oil has an effect of improving allergic rhinitis symptoms, wherein the effect of alleviating chuanxiong rhizome essential oil is stronger than that of magnolia flower essential oil, cnidium fruit essential oil, dittany bark essential oil, agastache rugosus essential oil and centipeda minima essential oil. Compared with each single essential oil, the anti-allergic rhinitis compound essential oil prepared by the invention can obviously relieve the symptoms of allergic rhinitis, which shows that the compatibility and the efficacy of the invention are obviously enhanced, and each essential oil has synergistic interaction; in addition, as can be seen from the comparative analysis of comparative examples 8 to 10 and example 1, the therapeutic effect is deteriorated by changing the ratio of each raw material in the composition such that the ratio of the raw materials is out of the range protected by the present invention, or by deleting any one or more components thereof. The compositions of examples 1-5 were on a similar scale, and example 3 was most effective in treating allergic rhinitis.
TABLE II measurement of serum IgE and Histamine content in mice
Figure BDA0001760973540000181
Figure BDA0001760973540000191
Note: p <0.01, P <0.05 compared to control
As can be seen from the table two, the single essential oil, the essential oil composition of the experimental group and the western medicine group can obviously inhibit the increase of serum IgE and histamine contents. The inhibition effect of each single essential oil is weaker than that of an experimental group and a western medicine group, so that the compatibility and the drug effect of the invention are obviously enhanced, and the essential oils have a synergistic interaction effect; the inhibition effect of the experimental group is slightly higher than that of the western medicine group, and the compound essential oil composition for resisting allergic rhinitis has unique advantages in curative effect compared with the western medicine group, and has the advantages of safety and no side effect.
Crowd probation survey
In order to test the actual use effect of the essential oil composition, 200 patients with allergic rhinitis diagnosis meeting the clinical diagnosis standard of the disease are selected for population trial investigation. The groups were randomly divided into two groups, where there were no systematic differences between groups.
The patients in the control group adopt the mixture of 5mg of dexamethasone and 8 ten thousand units of gentamicin for aerosol inhalation treatment for 1 time per day. The patients in the experimental group applied the compound essential oil prepared in example 3 of the present invention to the Yingxiang acupoints and nasal cavity on both sides of the nasal wing, and took massage and absorption for a little, once a day in the morning and evening. Two groups of patients take 20 days as a treatment course, and the treatment course is one treatment course. The clinical treatment results are shown in table three.
The evaluation criteria are as follows:
and (3) curing: clinical symptoms of a patient disappear, the mucous membrane in the nasal cavity is inspected by a nasoscope to have no edema and secretion, and the patient has no relapse within 1 year;
the effect is shown: the clinical symptoms of the patient basically disappear, the mucosa in the nasal cavity is checked by a nasoscope to have no obvious edema and secretion, and the patient has relapse within 1 year;
the method has the following advantages: the clinical symptoms of the patients are improved, and the mucous membrane edema and secretion in nasal cavities are improved through the inspection of a nasoscope;
and (4) invalidation: the clinical symptoms and signs of the patients are unchanged.
The total clinical effective rate is (cure + significant effect + effective)/total people is 100%.
Comparison of clinical efficacy of exterior three
Figure BDA0001760973540000201
Note: p <0.01, P <0.05 compared to control
As can be seen from the third table, comparing the clinical efficacy of the two groups, the total clinical effective rate of the compound essential oil prepared in the embodiment 3 of the invention is 92%, which is obviously higher than 88% of the control group.
As can be shown above, the pharmaceutical composition for preventing and treating rhinitis can prevent, treat or relieve allergic rhinitis more safely, effectively, long-term and conveniently.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (14)

1. The pharmaceutical composition for preventing and treating allergic rhinitis is characterized by being prepared from the following raw materials in parts by weight:
0.1 to 5 parts of ligusticum wallichii essential oil, 0.1 to 5 parts of magnolia flower essential oil, 0.05 to 1 part of fructus cnidii essential oil, 0.05 to 1 part of dittany bark essential oil, 0.08 to 3 parts of agastache rugosus essential oil and 0.01 to 0.3 part of centipeda minima essential oil.
2. The pharmaceutical composition for preventing and treating allergic rhinitis according to claim 1, which is prepared from the following raw materials in parts by weight:
1 to 3 parts of ligusticum wallichii essential oil, 1 to 3 parts of magnolia flower essential oil, 0.2 to 0.5 part of fructus cnidii essential oil, 0.1 to 0.5 part of cortex dictamni essential oil, 0.5 to 1.5 parts of agastache rugosus essential oil and 0.05 to 0.15 part of centipeda minima essential oil.
3. The pharmaceutical composition for preventing and treating allergic rhinitis according to claim 1, which is prepared from the following raw materials in parts by weight:
1.5 to 2.5 parts of ligusticum wallichii essential oil, 1.5 to 2.5 parts of magnolia flower essential oil, 0.25 to 0.45 part of fructus cnidii essential oil, 0.2 to 0.4 part of cortex dictamni essential oil, 0.85 to 1 part of agastache rugosus essential oil and 0.05 to 0.15 part of centipeda minima essential oil.
4. A pharmaceutical composition for the prevention and treatment of allergic rhinitis, which comprises the pharmaceutical composition for the prevention and treatment of allergic rhinitis according to any one of claims 1 to 3, and 92 to 100 parts by weight of a base oil.
5. A pharmaceutical composition for the prevention and treatment of allergic rhinitis, which comprises the pharmaceutical composition for the prevention and treatment of allergic rhinitis according to any one of claims 1 to 3 and 94 to 100 parts by weight of base oil.
6. A pharmaceutical composition for the prevention and treatment of allergic rhinitis, which comprises the pharmaceutical composition for the prevention and treatment of allergic rhinitis according to any one of claims 1 to 3 and 95 to 100 parts by weight of base oil.
7. The pharmaceutical composition for the prevention and treatment of allergic rhinitis according to any one of claims 4 to 6, wherein the base oil comprises at least one of sweet almond oil, jojoba oil, grape seed oil and wheat germ oil.
8. The method for preparing a pharmaceutical composition for the prevention and treatment of allergic rhinitis according to any one of claims 1 to 7, comprising the steps of:
the raw materials are uniformly mixed according to the formula amount, subpackaged and sealed to obtain the allergic rhinitis prevention and treatment pharmaceutical composition.
9. Use of the pharmaceutical composition for preventing and treating allergic rhinitis according to any one of claims 1 to 7 in the preparation of a medicament for treating, preventing or relieving allergic rhinitis.
10. A pharmaceutical preparation for the prevention and treatment of allergic rhinitis, prepared from the pharmaceutical composition according to any one of claims 1 to 7.
11. The pharmaceutical preparation for the prevention and treatment of allergic rhinitis according to claim 10, wherein the formulation is in the form of an external preparation.
12. The pharmaceutical preparation for preventing and treating allergic rhinitis according to claim 10, wherein the preparation is in the form of nasal drops, gels, pastes, liniments, tinctures, lotions, or plastics.
13. The pharmaceutical preparation for the prevention and treatment of allergic rhinitis according to claim 10, wherein the preparation further comprises pharmaceutically acceptable excipients.
14. The pharmaceutical formulation for preventing and treating allergic rhinitis according to claim 13, wherein the adjuvant comprises one or more of excipient, binder, filler, lubricant, antioxidant, preservative and thickener.
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