CN115300542A - Preparation for treating rhinitis of children and preparation method thereof - Google Patents
Preparation for treating rhinitis of children and preparation method thereof Download PDFInfo
- Publication number
- CN115300542A CN115300542A CN202111077953.4A CN202111077953A CN115300542A CN 115300542 A CN115300542 A CN 115300542A CN 202111077953 A CN202111077953 A CN 202111077953A CN 115300542 A CN115300542 A CN 115300542A
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- children
- treating rhinitis
- rhinitis
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Abstract
The invention relates to the field of medicines, and particularly relates to a preparation for treating rhinitis of children and a preparation method thereof. The invention discloses a preparation for treating rhinitis of children, which comprises magnolia oil, menthol and octenidine. The invention provides a preparation for treating rhinitis of children, which can effectively relieve the rhinitis problem of children, and can improve the problems of nasal obstruction, nasal discharge, sense of smell decline, headache, dizziness, inappetence, fatigue, hypomnesis, insomnia and the like caused by the rhinitis after long-term use, thereby solving a series of problems caused by the rhinitis of children and avoiding adverse reaction.
Description
Technical Field
The invention relates to the field of medicines, in particular to an IPC classification number A61P11/02, and more particularly relates to a preparation for treating rhinitis of children and a preparation method thereof.
Background
Inflammatory diseases of the nasal cavity, also known as rhinitis, are inflammations of the mucous membranes of the nasal cavity caused by viruses, allergens, bacteria, various physicochemical factors and certain systemic diseases. Allergic rhinitis and chronic rhinitis are most common in rhinitis patients. Children and teenagers are in the development stage of the body and have poor resistance, and nasal cavities are communicated with various organs of the body, influence the functions and metabolism of other tissues and organs, cause symptoms such as headache, listlessness, memory reduction, dyspnea, sneeze and nasal discharge and the like, and seriously influence learning and life.
Chinese patent CN104971222A discloses a traditional Chinese medicine external preparation for treating rhinitis, a preparation method and an application thereof, which comprises the following raw material components in parts by weight: 15-30 parts of charcoal, 18-23 parts of viviparidae, 10-15 parts of bletilla striata, 5-8 parts of madder, 5-8 parts of trichosanthes root, 8-16 parts of dried alum, 20-26 parts of cocklebur fruit, 12-16 parts of centipeda minima, 5-10 parts of angelica dahurica, 7-13 parts of asarum and 10-15 parts of scutellaria baicalensis; safe and reliable, has obvious curative effect and good treatment effect on rhinitis, but has relatively complex components and preparation method and higher production cost. Chinese patent CN108295167A discloses a traditional Chinese medicine composition for treating rhinitis and nasosinusitis of children, and a preparation and an application thereof, wherein the traditional Chinese medicine composition is used for treating the rhinitis and the nasosinusitis of children on trial by taking chrysanthemum as a monarch drug and taking an exterior-releasing drug as an adjuvant, and mainly aims at symptoms including nasal obstruction, rhinorrhea, headache, dysosmia, swollen nasal turbinates, nasal cavity cleaning conditions and sinus region tenderness relieving conditions, but does not aim at the problems of dizziness, inappetence, fatigue, hypomnesis, insomnia and the like caused by rhinitis.
Based on the research, the invention provides a preparation for treating rhinitis of children, which treats the rhinitis of children from the root and can effectively solve the problems of nasal obstruction, nasal discharge, smell decline, headache, dizziness, inappetence, fatigue, hypomnesis, insomnia and the like caused by the rhinitis.
Disclosure of Invention
In order to solve the above problems, a first aspect of the present invention provides a preparation for treating rhinitis in children, comprising magnolia oil, menthol and octenidine.
The flos Magnoliae oil is oily effective substance extracted from flos Magnoliae of Magnoliaceae. Flos Magnoliae is warm in nature and has pungent flavor; it enters stomach and lung meridians. The main applications of magnolia flower are: (1) Flos Magnoliae can be used for treating rhinopathy, such as nasal obstruction caused by nasosinusitis, and symptoms of smelling smell and long running thick nasal discharge. (2) Magnolia flower is often used for the treatment of chronic rhinitis and allergic rhinitis, and for the treatment of nasal diseases such as hypertrophic rhinitis and maxillary sinusitis.
The extraction method of the magnolia flower oil comprises the following steps:
(1) Preprocessing magnolia flower;
(2) Adding a buffer solution into the pretreated magnolia flower powder for soaking, and then carrying out ultrasonic treatment;
(3) Adding cellulase for reaction after ultrasonic treatment;
(4) And after the reaction is finished, centrifuging, extracting and distilling under reduced pressure to obtain the magnolia flower oil.
In some preferred embodiments, the extraction method of magnolia oil comprises the following steps:
(1) Cleaning flos Magnoliae, and oven drying at 55 deg.C; then crushing the magnolia flower powder by a crusher, and sieving the crushed magnolia flower powder by a 60-mesh sieve to obtain pretreated magnolia flower powder;
(2) Adding phosphate buffer solution into the pretreated magnolia flower powder for soaking, and then carrying out ultrasonic treatment;
(3) Adding cellulase after ultrasonic treatment for reaction for 3-5h;
(4) And after the reaction is finished, centrifuging, extracting and distilling under reduced pressure to obtain the magnolia flower oil.
The pH value of the phosphate buffer solution is 6.5-7, and the soaking time is 35-40min.
The ultrasonic treatment time is 20-40min.
The concentration of the cellulase is 1.5-2.5wt%.
The extracted organic solvent is one of n-hexane, petroleum ether and cyclohexane.
Menthol, the name of Chinese patent medicine. Menthol is extracted from the leaves and stems of peppermint, and is white crystal, which is the main component of peppermint and peppermint essential oils. Consists of a saturated cyclic alcohol obtained from peppermint oil. Menthol generally has two isomers (D and L), natural menthol being predominantly the levorotatory isomer (L-menthol), and menthol herein is generally referred to as racemic menthol (DL-menthol). Has effects of dispelling pathogenic wind, clearing away heat, and removing toxic substances. Is mainly used for treating headache, conjunctival congestion, wind-heat common cold, sore throat, teeth swelling and pain, skin pruritus, etc., and can be used for treating headache, dizziness, etc. caused by rhinitis.
Menthol is commercially available in this application, for example as JM0116 from jean junma perfumery ltd.
Octenidine is an antimicrobial agent, a special cleanser for skin, mucous membranes and wounds. Octenidine exhibits a broad spectrum of antimicrobial efficacy against gram-positive, negative bacteria and fungi. This efficacy is not affected by interferents such as blood, mucus, etc. Octenidine has a strong residual effect on the skin and can still be observed after 24 hours of application. Octenidine is useful for various topical rapid applications and exerts the necessary long-lasting effects due to its excellent antimicrobial efficacy and histocompatibility. Octenidine, which has high-efficiency action and spectral activity, has outstanding and ideal effects in the local treatment of microbial infections. Can inhibit bacteria, and can be used for treating rhinitis caused by bacteria, virus, etc.
In some preferred embodiments, the preparation for treating rhinitis of children comprises the following components in percentage by weight: 1 to 10 percent of magnolia flower oil, 0.01 to 0.3 percent of menthol, 0.1 to 1 percent of octenidine and the balance of water.
In some preferred embodiments, the preparation for treating rhinitis of children comprises the following components in percentage by weight: 3 to 8 percent of magnolia flower oil, 0.05 to 0.2 percent of menthol, 0.2 to 0.5 percent of octenidine and the balance of water.
In some preferred embodiments, the preparation for treating rhinitis of children comprises the following components in percentage by weight: 5.5% of magnolia flower oil, 0.12% of menthol, 0.35% of octenidine and the balance of water.
In some preferred embodiments, the preparation for treating rhinitis of children further comprises the following components in percentage by weight: 0.5 to 5 percent of matrine and 0.1 to 1 percent of lysozyme.
Matrine is an alkaloid prepared by extracting dried root, plant and fruit of Sophora flavescens ait of Leguminosae with organic solvent such as ethanol, and is generally matrine, which contains matrine, sophocarpine, oxysophocarpine, sophoridine, etc., with highest content. The main pharmacological actions are as follows: diuretic effect, anti-pathogen effect, and central nervous system inhibiting effect. Because of its anti-pathogenic effect, it can be used in the treatment of rhinitis, and can resist external pathogens, and reduce the possibility of suffering from rhinitis.
The matrine in the present application may be commercially available, for example, as a product produced by seisabang biotechnology limited.
Lysozyme is also called muramidase or N-acetylmuramyl polysaccharide hydrolase, and is an alkaline enzyme capable of hydrolyzing mucopolysaccharide in bacteria. Lysozyme dissolves bacteria by breaking the beta-1, 4 glycosidic bond between N-acetylmuramic acid and N-acetylglucosamine in the cell wall, breaking down the cell wall insoluble mucopolysaccharide into soluble glycopeptides, causing the contents of the broken cell wall to escape. Lysozyme can also be directly combined with virus protein with negative charge, and forms a complex with DNA, RNA and apoprotein to inactivate viruses. The lysozyme can be used as a natural anti-infection substance with antibacterial effect, and has antibacterial, antiviral, hemostatic, repercussive, analgesic, and tissue recovery promoting effects. Can resist infection of foreign bacteria and viruses, and effectively relieve and treat rhinitis.
The lysozyme in this application may be commercially available, for example from Shandongtai Biotechnology Ltd under the brand name Tylon, model number FT11.
In some preferred embodiments, the preparation for treating rhinitis of children comprises the following components in percentage by weight: 2.5% of matrine and 0.6% of lysozyme.
In some preferred embodiments, the preparation for treating rhinitis of children further comprises the following components in percentage by weight: 0.1% -2% of Tween 80, and 0.1% -10% of carboxymethyl chitosan.
Tween 80, polyoxyethylene sorbitan monooleate, polysorbate-80 for short, is an organic compound. Is easily soluble in water, soluble in ethanol, vegetable oil, ethyl acetate, methanol, and toluene, and insoluble in mineral oil. It is gelatinized at low temperature and heated to recover. Often as a surfactant, a nonionic surfactant is used. Has emulsifying effect, and can be used as wetting agent for suspension. Can also be used as a cosolvent for oils.
Carboxymethyl chitosan is a water-soluble chitosan derivative, has strong antibacterial property and fresh-keeping effect, and is an amphoteric polyelectrolyte and the like. Has stable properties and pharmacological effects of resisting bacteria, infection, lipid and arteriosclerosis. Has important significance in the aspects of medicine, chemical industry, environmental protection and health care products.
In some preferred embodiments, the preparation for treating rhinitis of children comprises the following components in percentage by weight: 1.0% tween 80,5% carboxymethyl chitosan.
In some preferred embodiments, the preparation for treating rhinitis of children is a spray, and the size of the spray is any one of 10mL, 15mL, 20mL, 25mL, 30mL, 35mL, 40mL, 50mL, 60mL, 65mL, 70mL and 80 mL.
The second aspect of the invention provides a preparation method of the preparation for treating rhinitis of children, which comprises the steps of weighing the magnolia flower oil, the menthol, the octenidine, the matrine, the lysozyme, the tween 80 and the carboxymethyl chitosan according to the corresponding amount by weight percentage, then completely dissolving the weighed materials in water by ultrasound, and obtaining a clear and transparent solution by suction filtration.
Has the advantages that: the invention provides a preparation for treating rhinitis of children, which can effectively relieve the rhinitis problem of children, and can improve the problems of nasal obstruction, nasal discharge, sense of smell decline, headache, dizziness, inappetence, fatigue, hypomnesis, insomnia and the like caused by the rhinitis after long-term use, thereby solving a series of problems caused by the rhinitis of children and avoiding adverse reaction.
Detailed Description
Examples
The technical solution of the present invention is described in detail by the following examples, but the scope of the present invention is not limited to the examples. Unless otherwise specified, the starting materials in the present invention are all commercially available.
Menthol in this application is available from Ji' an courser perfumery Limited under the product designation JM 0116.
Matrine in this application was purchased from a product produced by seisabang biotechnology limited.
The lysozyme in this application was purchased from Shandong Fengtai Biotechnology Co., ltd, with a brand of Tylon and a model number of FT11.
Example 1
Example 1 provides a preparation for treating rhinitis in children, comprising the following components in percentage by weight: 5.5% of magnolia oil, 0.12% of menthol, 0.35% of octenidine, 2.5% of matrine, 0.6% of lysozyme, 1.0% of tween 80,5% of carboxymethyl chitosan and the balance of water.
The extraction method of the magnolia flower oil comprises the following steps:
(1) Cleaning flos Magnoliae, and oven drying at 55 deg.C; then crushing the magnolia flower powder by a crusher, and sieving the crushed magnolia flower powder by a 60-mesh sieve to obtain pretreated magnolia flower powder;
(2) Adding phosphate buffer solution into the pretreated magnolia flower powder for soaking, and then carrying out ultrasonic treatment;
(3) Adding cellulase after ultrasonic treatment for reaction for 4 hours;
(4) Centrifuging at 5500r/min after the reaction is finished, extracting the upper layer solution for 3 times by using an organic solvent, drying the extract by using anhydrous sodium sulfate, and distilling under reduced pressure to obtain the magnolia flower oil.
The pH value of the phosphate buffer solution is 6.8, and the soaking time is 38min.
The time of the ultrasonic treatment is 30min.
The concentration of the cellulase is 2wt%.
The organic solvent for extraction is n-hexane.
The weight ratio of the organic solvent to the magnolia flower powder is 10:1.
the preparation method comprises the following steps: weighing flos Magnoliae oil, mentholum, octenidine, matrine, lysozyme, tween 80 and carboxymethyl chitosan according to the corresponding amount by weight percentage, then dissolving in water completely by ultrasonic, and filtering to obtain clear and transparent solution.
Example 2
Example 2 provides a preparation for treating rhinitis in children, comprising the following components in percentage by weight: 1% of magnolia oil, 0.01% of menthol, 0.1% of octenidine, 0.5% of matrine, 0.1% of lysozyme, 0.1% of tween 80,0.1% of carboxymethyl chitosan and the balance of water.
The extraction method of the magnolia flower oil comprises the following steps:
(1) Cleaning flos Magnoliae, and oven drying at 55 deg.C; then crushing the magnolia flower powder by a crusher, and sieving the crushed magnolia flower powder by a 60-mesh sieve to obtain pretreated magnolia flower powder;
(2) Adding phosphate buffer solution into the pretreated magnolia flower powder for soaking, and then carrying out ultrasonic treatment;
(3) Adding cellulase after ultrasonic treatment for reaction for 4 hours;
(4) Centrifuging at 5500r/min after the reaction is finished, extracting the upper layer solution for 3 times by using an organic solvent, drying the extract by using anhydrous sodium sulfate, and distilling under reduced pressure to obtain the magnolia flower oil.
The pH value of the phosphate buffer solution is 6.8, and the soaking time is 38min.
The time of the ultrasonic treatment is 30min.
The concentration of the cellulase is 2wt%.
The organic solvent for extraction is n-hexane.
The weight ratio of the organic solvent to the magnolia flower powder is 10:1.
the preparation method comprises the following steps: weighing flos Magnoliae oil, mentholum, octenidine, matrine, lysozyme, tween 80 and carboxymethyl chitosan according to the corresponding amount by weight percentage, then dissolving in water completely by ultrasonic, and filtering to obtain clear and transparent solution.
Example 3
Example 3 provides a formulation for treating rhinitis in children, comprising the following components in percentage by weight: 10% of magnolia flower oil, 0.3% of menthol, 1% of octenidine, 5% of matrine, 1% of lysozyme, 2% of tween 80, 10% of carboxymethyl chitosan and the balance of water.
The extraction method of the magnolia flower oil comprises the following steps:
(1) Cleaning flos Magnoliae, and oven drying at 55 deg.C; then crushing the magnolia flower powder by a crusher, and sieving the crushed magnolia flower powder by a 60-mesh sieve to obtain pretreated magnolia flower powder;
(2) Adding phosphate buffer solution into the pretreated magnolia flower powder for soaking, and then carrying out ultrasonic treatment;
(3) Adding cellulase after ultrasonic treatment for reaction for 4 hours;
(4) Centrifuging at rotation speed of 5500r/min after reaction is finished, extracting the upper layer solution with organic solvent for 3 times, drying the extract with anhydrous sodium sulfate, and distilling under reduced pressure to obtain flos Magnoliae oil.
The pH value of the phosphate buffer solution is 6.8, and the soaking time is 38min.
The time of the ultrasonic treatment is 30min.
The concentration of the cellulase is 2wt%.
The organic solvent for extraction is n-hexane.
The weight ratio of the organic solvent to the magnolia flower powder is 10:1.
the preparation method comprises the following steps: weighing flos Magnoliae oil, mentholum, octenidine, matrine, lysozyme, tween 80 and carboxymethyl chitosan according to the corresponding amount by weight percentage, then dissolving in water completely by ultrasonic, and filtering to obtain clear and transparent solution.
Comparative example 1
Comparative example 1 provides a preparation for treating rhinitis in children, comprising the following components in percentage by weight: 5.5% of magnolia oil, 0.12% of menthol, 0.35% of octenidine, 2.5% of matrine, 0.6% of lysozyme and the balance of water.
The preparation method of the magnolia flower oil is shown in example 1.
The preparation method comprises the following steps: weighing flos Magnoliae oil, mentholum, octenidine, matrine, and lysozyme at corresponding amount by weight percentage, dissolving in water by ultrasound, and vacuum filtering to obtain clear and transparent solution.
Comparative example 2
Comparative example 2 provides a preparation for treating rhinitis in children, comprising the following components in percentage by weight: 0.35% octenidine, 2.5% matrine, 0.6% lysozyme, 1.0% Tween 80,5% carboxymethyl chitosan, and the balance water.
The preparation method comprises the following steps: weighing octenidine, matrine, lysozyme, tween 80 and carboxymethyl chitosan according to the corresponding weight percentage, then dissolving the octenidine, matrine, lysozyme, tween 80 and carboxymethyl chitosan in water by ultrasound, and filtering to obtain a clear and transparent solution.
Wherein the comparative examples were conducted by reducing one or both of the ingredients and the other ingredients were conducted in accordance with the preferred examples. Sprays were prepared according to the above examples and comparative examples for performance evaluation thereof.
Evaluation of Performance
1. Anti-inflammatory assay Performance test
36 healthy Kunming mice are selected and randomly divided into 6 groups, wherein one group is a control group, 6 mice are selected in each group, the weight is 20 +/-2 g, and the number of the mice is half of the number of the mice. Each group of mice was administered nasally to both nostrils with a microsyringe at 10. Mu.L per side, and the control group was administered with an equal volume of deionized water for 3 days continuously. 1h after the last administration, 20 mul of dimethylbenzene was uniformly coated on the right ear and the left ear of each mouse as the control of normal ear. After 30 minutes of inflammation, the mice are sacrificed by adopting a vertebral dislocation method, round ear pieces are respectively punched at the symmetrical parts of the left ear and the right ear by a puncher with the diameter of 6mm, the weighing is carried out precisely, and the swelling degree and the swelling inhibition rate are calculated. Mice in each group are expressed as mean values. The specific calculation method comprises the following steps:
swelling degree = right ear weight-left ear weight
Swelling inhibition (%) = (control group average swelling degree-administration group average swelling degree)/control group average swelling degree × 100%
The specific results are as follows:
TABLE 1 conclusions of anti-inflammatory experiments
From the in vitro anti-inflammatory experimental conclusions in table 1, we can see that: the swelling inhibition rate was the highest and the anti-inflammatory effect was the best in example 1. In comparative examples 1 to 2, the swelling inhibition rate was significantly reduced and the anti-inflammatory effect was also reduced, as compared with examples 1 to 3. Illustrating the synergistic relationship between the components in the present application, the absence of one or more of the components may affect its anti-inflammatory effect.
2. Clinical experiments
In the experiment, 60 rhinitis patients are selected to participate, the age is between 5 and 16 years old, the main symptoms of the rhinitis patients are mostly nasal obstruction, nasal discharge, hyposmia, headache, dizziness, inappetence, tiredness, hypomnesis, insomnia and the like, and 20 rhinitis patients are averagely selected in each group. The spray is applied 3 times a day, 4 times a day, 2 times a nasal cavity, and continuously for 30 days. The specific performance of the patient before and after use is recorded to judge the actual effect of the example or the comparative example.
The therapeutic effect standard is drawn up according to the traditional Chinese medicine diagnosis therapeutic effect standard which is implemented by the national traditional Chinese medicine administration in 1994 as follows:
and (3) healing: the clinical symptoms and physical signs of the traditional Chinese medicine disappear or basically disappear;
the effect is shown: the clinical symptoms and physical signs of the traditional Chinese medicine are obviously changed;
the method has the following advantages: the clinical symptoms and physical signs of the traditional Chinese medicine are improved;
and (4) invalidation: the clinical symptoms and physical signs of the traditional Chinese medicine are not obviously improved;
the specific results are shown in the following table:
TABLE 2 treatment of rhinitis
From the effect profile of treating rhinitis in table 2 we can derive: example 1 the treatment of rhinitis was best and the overall efficacy was highest. In examples 2 and 3, although the total effective rate is reduced, the total effective rate is more than 90%, and the treatment effect is still acceptable.
Claims (10)
1. A preparation for treating rhinitis of children is characterized by comprising magnolia flower oil, menthol and octenidine;
the extraction method of the magnolia flower oil comprises the following steps:
(1) Preprocessing magnolia flower;
(2) Adding a buffer solution into the pretreated magnolia flower powder for soaking, and then carrying out ultrasonic treatment;
(3) Adding cellulase for reaction after ultrasonic treatment;
(4) And after the reaction is finished, centrifuging, extracting and distilling under reduced pressure to obtain the magnolia flower oil.
2. The preparation for treating rhinitis in children according to claim 1, which comprises the following components by weight percent: 1 to 10 percent of magnolia oil, 0.01 to 0.3 percent of menthol, 0.1 to 1 percent of octenidine and the balance of water.
3. The preparation for treating rhinitis in children according to claim 2, comprising the following components by weight percent: 3 to 8 percent of magnolia flower oil, 0.05 to 0.2 percent of menthol, 0.2 to 0.5 percent of octenidine and the balance of water.
4. The preparation for treating rhinitis in children according to claim 3, comprising the following components by weight percent: 5% of magnolia flower oil, 0.1% of menthol, 0.3% of octenidine and the balance of water.
5. The preparation for treating rhinitis in children according to claim 4, further comprising the following components by weight percent: 0.5 to 5 percent of matrine and 0.1 to 1 percent of lysozyme.
6. The preparation for treating rhinitis in children according to claim 5, which comprises the following components by weight percent: 2% of matrine and 0.5% of lysozyme.
7. The preparation for treating rhinitis in children according to claim 6, further comprising the following components by weight percent: 0.1% -2% of Tween 80, and 0.1% -10% of carboxymethyl chitosan.
8. The preparation for treating rhinitis in children according to claim 7, comprising the following components by weight percent: 0.8% of Tween 80, and 1% -5% of carboxymethyl chitosan.
9. The method for preparing a preparation for treating rhinitis of children according to any one of claims 1 to 8, wherein the preparation is prepared by weighing flos Magnoliae oil, mentholum, octenidine, matrine, lysozyme, tween 80 and carboxymethyl chitosan according to the corresponding amount by weight percentage, dissolving in water completely by ultrasonic treatment, and filtering to obtain clear and transparent solution.
10. The preparation for treating rhinitis in children according to any one of claims 1 to 8, wherein the preparation is a spray, and the size of the spray is any one of 10mL, 15mL, 20mL, 25mL, 30mL, 35mL, 40mL, 50mL, 60mL, 65mL, 70mL and 80 mL.
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