Traditional Chinese medicine snorting agent with effects of inducing resuscitation and inducing resuscitation and preparation method of traditional Chinese medicine snorting agent
By preparing a nasal inhaler containing ingredients such as volatile oil from Acorus tatarinowii, and utilizing β-cyclodextrin inclusion technology, the problems of slow onset and high cost of existing stimulant drugs have been solved, providing a traditional Chinese medicine composition that can quickly stimulate the mind and improve brain function, suitable for daily life and clinical emergency care.
Patent Information
- Application Number
- CN202511420519.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-30
- Publication Date
- 2025-11-18
AI Technical Summary
Existing traditional Chinese medicine remedies for waking up the mind are slow to take effect, inconvenient to take, and expensive, making it difficult to meet the needs of special situations such as acute loss of consciousness or postoperative coma in modern society. In addition, Western medicine drugs have the problems of dependence and side effects.
Using ingredients such as volatile oil from Acorus tatarinowii, borneol, menthol, ginsenosides, Ginkgo biloba extract, and glycyrrhizic acid, a nasal inhaler is prepared through β-cyclodextrin inclusion complexation technology. This provides a fast-acting, refreshing, and sedative traditional Chinese medicine composition suitable for nasal administration.
It achieves rapid alertness and improves brain function, reduces drug costs, enhances user comfort and nasal absorption efficiency, is suitable for daily life and clinical emergency scenarios, and has high safety.
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Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the field of medical preparations, in particular to a traditional Chinese medicine nasal inhalant with the effect of awakening and opening the orifices and a preparation method thereof. BACKGROUND
[0002] In modern society, high-intensity mental work, long-term sleep deprivation, irregular living habits, and high-pressure environment lead to an increasing incidence of brain fatigue, decreased attention, memory decline, chronic fatigue syndrome, and other symptoms. These problems not only affect the work efficiency and quality of life of individuals, but also may cause more serious nervous system dysfunction in the long term. Western medicine treatment usually relies on drugs such as caffeine and central stimulants to relieve symptoms by increasing brain excitability in a short period of time, but these drugs often have a certain degree of dependence, and long-term use may lead to reduced adaptability of the nervous system, and even cause side effects such as anxiety, insomnia, and increased cardiovascular burden.
[0003] According to traditional Chinese medicine theory, symptoms such as brain fatigue and decreased attention are related to "spiritual confusion" and "obscuring of the orifices", and the pathogenesis involves factors such as poor blood circulation, phlegm-dampness and blood stasis, and deficiency of the heart, liver, and kidney. Traditional Chinese medicine treatment methods, represented by classic prescriptions such as Suhe Xiang Pill and Angong Niuhuang Pill, help patients recover from a conscious state through actions such as aromatic orifice-opening, heat-clearing and detoxifying, and blood-activating and stasis-removing. These drugs are mainly administered orally or by nasal feeding, and although they have good efficacy, they are limited in application due to slow onset and inconvenience, especially in acute cases of consciousness disorders or postoperative coma. Moreover, traditional awakening prescriptions are expensive in terms of medicinal materials (such as musk and cow-bezoar), and are difficult to popularize. Therefore, there is an urgent need for an innovative traditional Chinese medicine composition that can quickly awaken and open the orifices, improve brain function, and has safety and convenience, to meet the needs of modern medical clinical and daily health care. SUMMARY
[0004] In view of the above problems, the embodiments of the present application provide a traditional Chinese medicine nasal inhalant with the effect of awakening and opening the orifices and a preparation method thereof, which is low in cost and suitable for various scenarios such as daily life, work and study, and clinical first aid, providing a safe and reliable traditional Chinese medicine intervention method for long-term mental workers, postoperative coma patients, and post-stroke consciousness disorder patients.
[0005] According to an aspect of the embodiments of the present application, a traditional Chinese medicine nasal inhalant with the effect of awakening and opening the orifices is provided, comprising the following components: 10-20 parts of volatile oil of Acorus gramineus, 5-10 parts of borneol, 3-8 parts of menthol, 2-5 parts of ginsenosides, 5-15 parts of Ginkgo biloba extract, 1-3 parts of glycyrrhizic acid, and 50-300 parts of β-cyclodextrin.
[0006] In some embodiments, the traditional Chinese medicine nasal inhalant with the effect of refreshing and opening the orifices comprises the following components: 10-15 components of volatile oil of Acorus gramineus, 5-10 components of borneol, 3-8 components of menthol, 2-3 components of ginsenoside, 5-10 components of extract of Ginkgo biloba leaves, 1-2 components of glycyrrhizic acid, and 100-150 components of β-cyclodextrin.
[0007] In some embodiments, the traditional Chinese medicine nasal inhalant with the effect of refreshing and opening the orifices comprises the following components: 100 g of volatile oil of Acorus gramineus, 50 g of borneol, 45 g of menthol, 20 g of ginsenoside, 60 g of extract of Ginkgo biloba leaves, 12 g of glycyrrhizic acid, and 900 g of β-cyclodextrin.
[0008] According to another aspect of the present application, a preparation method of a traditional Chinese medicine nasal inhalant with the effect of refreshing and opening the orifices is provided, comprising the following steps: S1: extracting volatile oil of Acorus gramineus by distillation, collecting extract of Ginkgo biloba leaves, grinding borneol and menthol to a particle size of less than 100 nm respectively and collecting them respectively, and preparing standard ginsenoside and glycyrrhizic acid for use; S2: dissolving each active ingredient in S1 in a suitable solvent and adding β-cyclodextrin, wherein the sum of the mass of each active ingredient: the mass of β-cyclodextrin = 1:2-5, and stirring magnetically at room temperature for 12 hours to form a stable inclusion compound, and drying to obtain an inclusion powder; S3: filling after matching the excipients according to the required dosage form.
[0009] In some embodiments, the filling after matching the excipients according to the required dosage form in S3 is a nasal powder inhalation dosage form, the excipients are microcrystalline cellulose (MCC) and lactose, and the filling process is as follows: adding microcrystalline cellulose (MCC) and lactose to the inclusion powder obtained in S2, mixing uniformly, and then dispensing into a nasal inhaler bottle to obtain the nasal inhalant.
[0010] In some embodiments, the filling after matching the excipients according to the required dosage form in S3 is a nasal spray type, the excipients are polysorbate 80 and an osmotic regulator, and the filling process is as follows: dissolving the inclusion powder obtained in S2 in an ethanol-water mixture, adding polysorbate 80 and an osmotic regulator, filtering and sterilizing, and then filling into a nasal spray bottle to obtain the nasal inhalant.
[0011] In some embodiments, the distillation method for extracting volatile oil of Acorus gramineus in S1 is as follows: S101: cutting Acorus gramineus into pieces, soaking in water for 30 minutes, connecting to a distillation device, and passing water vapor into the extraction for 4 hours; S102: collecting the volatile oil layer, drying with anhydrous sodium sulfate, and then filtering; and S103: obtaining clear and transparent volatile oil of Acorus gramineus, and storing in a sealed and light-proof manner.
[0012] In some embodiments, the collection of ginkgo leaf extract in S1 is specifically: S111: add 600 mL of ethanol to 100 g of ginkgo leaves, reflux extraction for 2 times, 1 hour each time; S112: combine the extract, concentrate under reduced pressure to a thick paste, and then freeze-dry; S113: obtain the powder of ginkgo leaf extract, ready for use.
[0013] The beneficial effects in the present application are:
[0014] 1. The present application is suitable for improving brain fatigue, decreased attention, cognitive dysfunction, postoperative coma recovery and post-stroke consciousness disorders, etc., and is low in cost, without the need to use precious medicinal materials such as musk and ox gall, ensuring convenient application in various scenes such as daily life, work and study, and clinical first aid, etc., and providing a safe and reliable TCM intervention means for long-term brain workers, postoperative coma patients and post-stroke consciousness disorder groups.
[0015] 2. The present application can effectively reduce the volatilization rate of borneol, menthol, etc. by including them in the hydrophobic cavity of β-cyclodextrin, and gradually releases them in the nasal environment, making the drug effect more lasting.
[0016] 3. The inclusion technology used in the present application can reduce the irritating odor, improve the use comfort of the nasal inhalant, and enhance the solubility of water-soluble components such as ginsenosides, ginkgo leaf extract, glycyrrhizic acid, etc., and promote nasal absorption.
[0017] The above description is only a summary of the technical solutions of the present application, in order to more clearly understand the technical means of the present application, which can be implemented in accordance with the content of the specification, and in order to make the above and other purposes, features and advantages of the present application more obvious and easy to understand, the following specific embodiments of the present application are described. DETAILED DESCRIPTION
[0018] The embodiments of the technical solutions of the present application will be described in detail below. The following examples are only used to more clearly illustrate the technical solutions of the present application, and therefore only serve as examples, and cannot limit the protection scope of the present application. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as understood by those skilled in the art to which the present application belongs; the terms used herein are only for the purpose of describing specific embodiments, and are not intended to limit the present application; the terms in the specification and claims of the present application and the above "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion.
[0019] According to one aspect of the embodiments of the present application, a traditional Chinese medicine nasal inhalant with the efficacy of refreshing and opening the orifices is provided, comprising the following components: 10-20 parts of aurogie volatile oil, 5-10 parts of borneol, 3-8 parts of menthol, 2-5 parts of ginsenoside, 5-15 parts of ginkgo leaf extract, 1-3 parts of glycyrrhizic acid, and 50-300 parts of β-cyclodextrin.
[0020] In some embodiments, the traditional Chinese medicine nasal inhalant with the efficacy of refreshing and opening the orifices comprises the following components: 10-15 parts of aurogie volatile oil, 5-10 parts of borneol, 3-8 parts of menthol, 2-3 parts of ginsenoside, 5-10 parts of ginkgo leaf extract, 1-2 parts of glycyrrhizic acid, and 100-150 parts of β-cyclodextrin.
[0021] In some embodiments, the traditional Chinese medicine nasal inhalant with the efficacy of refreshing and opening the orifices comprises the following components: 100 g of aurogie volatile oil, 50 g of borneol, 45 g of menthol, 20 g of ginsenoside, 60 g of ginkgo leaf extract, 12 g of glycyrrhizic acid, and 900 g of β-cyclodextrin.
[0022] According to another aspect of the present application, a preparation method of the traditional Chinese medicine nasal inhalant with the efficacy of refreshing and opening the orifices is provided, comprising the following steps: S1: extracting aurogie volatile oil by distillation, collecting ginkgo leaf extract, grinding borneol and menthol to a particle size of less than 100 nm respectively and collecting them respectively, and preparing standard ginsenoside and glycyrrhizic acid for use; S2: dissolving the active ingredients in the above S1 in a suitable solvent and adding β-cyclodextrin, wherein the sum of the mass of the active ingredients: the mass of β-cyclodextrin = 1:2-5, and stirring magnetically at room temperature for 12 hours to form a stable inclusion compound, and drying to obtain an inclusion powder; S3: filling after matching the excipients according to the required dosage form.
[0023] In some embodiments, the filling after matching the excipients according to the required dosage form in S3 is a nasal powder inhalation dosage form, the excipients are microcrystalline cellulose (MCC) and lactose, and the filling process is: adding microcrystalline cellulose (MCC) and lactose to the inclusion powder obtained in S2, mixing uniformly, and then dispensing into a nasal inhaler bottle.
[0024] In some embodiments, the filling after matching the excipients according to the required dosage form in S3 is a nasal spray type, the excipients are polysorbate 80 and an osmotic regulator, and the filling process is: dissolving the inclusion powder obtained in S2 in an ethanol-water mixture, adding polysorbate 80 and an osmotic regulator, filtering and sterilizing, and then filling into a nasal spray bottle.
[0025] In some embodiments, the distillation method for extracting volatile oil of Acorus calamus described in S1 is as follows: S101, cut Acorus calamus into pieces, soak in water for 30 minutes, and then connect to a distillation device, and pass water vapor for 4 hours; S102: collect the volatile oil layer, dry with anhydrous sodium sulfate, and then filter; S103: obtain clear and transparent Acorus calamus volatile oil, and store in a sealed and light-proof manner.
[0026] In some embodiments, the collection of Ginkgo biloba extract described in S1 is as follows: S111: add 600 mL of ethanol to 100 g of Ginkgo biloba leaves, and reflux extract for 2 times, each for 1 hour; S112: combine the extract, concentrate under reduced pressure to a thick paste, and then freeze-dry; S113: obtain powder-like Ginkgo biloba extract, and reserve for use.
[0027] The following are experimental data, and the experiment adopts a random, double-blind, placebo-controlled trial;
[0028] Sample size: 170 subjects (100 in the test group, 20 in the placebo group, and 40 in the traditional reagent control group)
[0029] Subject characteristics: healthy adults aged 18-45 years old with recent fatigue and inattention symptoms
[0030] Test group: use the nasal inhaler for refreshing and unblocking (main components: Acorus calamus volatile oil, borneol, menthol, ginsenosides, Ginkgo biloba extract, and glycyrrhizic acid, 3 times a day, each time for unilateral nasal inhalation);
[0031] Placebo group: use a simulated nasal inhaler with no odor and no pharmacological activity (same frequency of use);
[0032] Control group: use traditional reagents, 3 times a day, each time for unilateral nasal inhalation;
[0033] Observation period: continuous use for 7 days, and follow-up for 14 days.
[0034] Experimental group 1
[0035] Traditional Chinese medicine composition: Acorus calamus volatile oil 200 g, borneol 20 g, menthol 30 g, ginsenosides 25 g, Ginkgo biloba extract 50 g, and glycyrrhizic acid 10 g.
[0036] Preparation process: dissolve 500 g of β-cyclodextrin in a solvent, then add the above-mentioned components of traditional Chinese medicine, and stir magnetically at room temperature for 12 hours to form a stable inclusion complex. After drying, the inclusion powder is obtained, and then mixed with microcrystalline cellulose (MCC) and lactose, uniformly mixed, and then divided into nasal inhaler bottles to prepare a nasal powder inhaler.
[0037] Experimental process: 10 subjects were recruited, all of whom were 18-45 years old healthy students and workers engaged in mental work, and had symptoms of fatigue and lack of concentration in the recent period. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0038] Experimental group 2
[0039] Traditional Chinese medicine composition: 200g of atractylodes rhizome volatile oil, 20g of borneol, 30g of menthol, 25g of ginsenoside, 50g of ginkgo leaf extract, and 10g of glycyrrhizinic acid.
[0040] Preparation process: 500g of β-cyclodextrin was dissolved in a solvent, and then the above-mentioned components of traditional Chinese medicine were added. After magnetic stirring at room temperature for 12 hours, a stable inclusion complex was formed. After drying, the inclusion powder was dissolved in an ethanol-water mixture, and polysorbate 80 and an osmotic regulator were added. After filtration and sterilization, it was filled into a nasal spray bottle to prepare a nasal spray.
[0041] Experimental process: 10 subjects were recruited, all of whom were 18-45 years old healthy students and workers engaged in mental work, and had symptoms of fatigue and lack of concentration in the recent period. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0042] Experimental group 3
[0043] Traditional Chinese medicine composition: 150g of atractylodes rhizome volatile oil, 30g of borneol, 50g of menthol, 55g of ginsenoside, 100g of ginkgo leaf extract, and 10g of glycyrrhizinic acid.
[0044] Preparation process: 500g of β-cyclodextrin was dissolved in a solvent, and then the above-mentioned components of traditional Chinese medicine were added. After magnetic stirring at room temperature for 12 hours, a stable inclusion complex was formed. After drying, the inclusion powder was mixed with microcrystalline cellulose (MCC) and lactose, and then evenly divided and filled into a nasal inhaler to prepare a nasal powder inhaler.
[0045] Experimental process: 10 subjects were recruited, all of whom were 18-45 years old healthy students and workers engaged in mental work, and had symptoms of fatigue and lack of concentration in the recent period. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0046] Experimental group 4
[0047] Traditional Chinese medicine composition: 150g of atractylodes rhizome volatile oil, 30g of borneol, 50g of menthol, 55g of ginsenoside, 100g of ginkgo leaf extract, and 10g of glycyrrhizinic acid.
[0048] Preparation process: 500g of β-cyclodextrin was dissolved in solvent, and then the above-mentioned components of traditional Chinese medicine were added. After magnetic stirring at room temperature for 12 hours, stable inclusion compounds were formed. After drying, the inclusion powder was dissolved in an ethanol-water mixture, and polysorbate 80 and an osmotic regulator were added. After filtration and sterilization, it was filled into a nasal spray bottle to prepare a nasal spray type.
[0049] Experimental process: 10 subjects were recruited, all of whom were healthy students and workers engaged in mental work aged 18-45 years old, and had symptoms of fatigue and lack of concentration in the recent past. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0050] Experimental group 5
[0051] Traditional Chinese medicine composition: 50g of aconite oil, 30g of borneol, 30g of menthol, 45g of ginsenosides, 80g of ginkgo leaf extract, and 20g of glycyrrhizic acid.
[0052] Preparation process: 500g of β-cyclodextrin was dissolved in solvent, and then the above-mentioned components of traditional Chinese medicine were added. After magnetic stirring at room temperature for 12 hours, stable inclusion compounds were formed. After drying, the inclusion powder was mixed with microcrystalline cellulose (MCC) and lactose, and then evenly divided and filled into a nasal inhaler to prepare a nasal powder inhaler type.
[0053] Experimental process: 10 subjects were recruited, all of whom were healthy students and workers engaged in mental work aged 18-45 years old, and had symptoms of fatigue and lack of concentration in the recent past. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0054] Experimental group 6
[0055] Traditional Chinese medicine composition: 50g of aconite oil, 30g of borneol, 30g of menthol, 45g of ginsenosides, 80g of ginkgo leaf extract, and 20g of glycyrrhizic acid.
[0056] Preparation process: 500g of β-cyclodextrin was dissolved in solvent, and then the above-mentioned components of traditional Chinese medicine were added. After magnetic stirring at room temperature for 12 hours, stable inclusion compounds were formed. After drying, the inclusion powder was dissolved in an ethanol-water mixture, and polysorbate 80 and an osmotic regulator were added. After filtration and sterilization, it was filled into a nasal spray bottle to prepare a nasal spray type.
[0057] Experimental process: 10 subjects were recruited, all of whom were healthy students and workers engaged in mental work aged 18-45 years old, and had symptoms of fatigue and lack of concentration in the recent past. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0058] Experimental group 7 (optimal)
[0059] Traditional Chinese medicine composition: Acorus calamus volatile oil 100g, borneol 50g, mint 45g, ginsenoside 20g, ginkgo leaf extract 60g, glycyrrhizinic acid 12g.
[0060] Preparation process: 900g of β-cyclodextrin was dissolved in a solvent, and then the above-mentioned components of traditional Chinese medicine were added. After magnetic stirring at room temperature for 12 hours, a stable inclusion compound was formed. After drying, the inclusion powder was obtained. After adding microcrystalline cellulose (MCC) and lactose, they were mixed uniformly and then divided into nasal inhaler bottles to prepare a nasal powder inhalation dosage form.
[0061] Experimental process: 10 subjects were recruited, all of whom were healthy students and workers engaged in mental work aged 18-45 years old, and who had symptoms of fatigue and lack of concentration in the recent period. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0062] Experimental group 8 (optimal)
[0063] Traditional Chinese medicine composition: Acorus calamus volatile oil 100g, borneol 50g, mint 45g, ginsenoside 20g, ginkgo leaf extract 60g, glycyrrhizinic acid 12g.
[0064] Preparation process: 900g of β-cyclodextrin was dissolved in a solvent, and then the above-mentioned components of traditional Chinese medicine were added. After magnetic stirring at room temperature for 12 hours, a stable inclusion compound was formed. After drying, the inclusion powder was obtained. The inclusion powder was dissolved in an ethanol-water mixture, and polysorbate 80 and an osmotic regulator were added. After filtration and sterilization, it was filled into a nasal spray bottle to prepare a nasal spray dosage form.
[0065] Experimental process: 10 subjects were recruited, all of whom were healthy students and workers engaged in mental work aged 18-45 years old, and who had symptoms of fatigue and lack of concentration in the recent period. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0066] Experimental group 9
[0067] Traditional Chinese medicine composition: Acorus calamus volatile oil 80g, borneol 60g, mint 45g, ginsenoside 15g, ginkgo leaf extract 60g, glycyrrhizinic acid 12g.
[0068] Preparation process: 900g of β-cyclodextrin was dissolved in a solvent, and then the above-mentioned components of traditional Chinese medicine were added. After magnetic stirring at room temperature for 12 hours, a stable inclusion compound was formed. After drying, the inclusion powder was obtained. After adding microcrystalline cellulose (MCC) and lactose, they were mixed uniformly and then divided into nasal inhaler bottles to prepare a nasal powder inhalation dosage form.
[0069] Experimental process: 10 subjects were recruited, all of whom were healthy students and workers engaged in mental work aged 18-45 years old, and who had symptoms of fatigue and lack of concentration in the recent period. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0070] Experimental group 10
[0071] Traditional Chinese medicine composition: Atractylodes rhizome volatile oil 80 g, borneol 60 g, mint 45 g, ginsenoside 15 g, ginkgo leaf extract 60 g, glycyrrhizic acid 12 g.
[0072] Preparation process: 900 g of β-cyclodextrin is dissolved in a solvent, and then the above-mentioned components of traditional Chinese medicine are added. After magnetic stirring at room temperature for 12 hours, a stable inclusion complex is formed. After drying, the inclusion powder is obtained. The inclusion powder is dissolved in an ethanol-water mixture, and polysorbate 80 and an osmotic regulator are added. After filtration and sterilization, it is filled into a nasal spray bottle to prepare a nasal spray type.
[0073] Experimental process: 10 subjects were recruited, all of whom were healthy students and workers engaged in mental work aged 18-45 years, and had symptoms of fatigue and lack of concentration in the recent period. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0074] Control group 1,
[0075] Suhe Xiang pill; Styrax 50 g, benzoin 100 g, borneol 50 g, artificial musk 75 g, sandalwood 100 g, costus 100 g, cyperus 100 g, frankincense (processed) 100 g, clove 100 g, amomum 100 g, atractylodes 100 g, Terminalia chebula 100 g, cinnabar (water flying) 100 g, rhinoceros horn (replaced with concentrated powder of water buffalo horn) 150 g.
[0076] Preparation process: 900 g of β-cyclodextrin is dissolved in a solvent, and then the above-mentioned components of traditional Chinese medicine are added. After magnetic stirring at room temperature for 12 hours, a stable inclusion complex is formed. After drying, the inclusion powder is obtained. The inclusion powder is dissolved in an ethanol-water mixture, and polysorbate 80 and an osmotic regulator are added. After filtration and sterilization, it is filled into a nasal spray bottle to prepare a nasal spray type.
[0077] Experimental process: 10 subjects were recruited, all of whom were healthy students and workers engaged in mental work aged 18-45 years, and had symptoms of fatigue and lack of concentration in the recent period. Continuous use for 7 days, 3 times a day, unilateral nasal inhalation each time.
[0078] The results are as follows:
[0079] Table 1, test results
[0080]
[0081] Adverse event rate:
[0082] Test group: 12 cases (12%), mainly mild nasal irritation (10 cases), and transient runny nose (2 cases), all without interrupting treatment.
[0083] Placebo group: 1 case (5%), which was not related to the product.
[0084] Control group: 2 cases (5%), mild nasal irritation.
[0085] Serious adverse events: none in both groups.
[0086] Laboratory tests: There were no significant changes in blood routine, liver and kidney function, etc. before and after the test.
[0087] The above data is true and effective, and is carried out in accordance with the Good Clinical Practice (GCP).
[0088] 1. Fatigue test method
[0089] Fatigue assessment was conducted by combining subjective fatigue score scale (Visual Analogue Scale, VAS) and Multidimensional Fatigue Inventory (MFI-20). Before and after the test, the subjects marked their current fatigue on the VAS, which was 10 cm long, with "completely not tired" and "extremely tired" at both ends, and the quantitative score was 0-10. At the same time, MFI-20 scale was used to assess the structure of five dimensions of fatigue (general fatigue, physical fatigue, mental fatigue, motivation decline and activity reduction), each dimension consisting of 4 questions, using 7-level scoring method, the higher the value, the stronger the fatigue. The test time points were before using the nasal spray (baseline), 10 minutes, 30 minutes and 60 minutes after using. By comparing the score changes at each time point, the timeliness and sustainability of the product in relieving fatigue were evaluated.
[0090] 2. Subjective alertness test method
[0091] Subjective alertness was evaluated using the Karolinska Sleepiness Scale (KSS). The scale consists of 9 levels, with level 1 representing "extremely alert" and level 9 representing "extremely drowsy, ready to fall asleep" at any time. The subjects chose the most suitable one according to their own state to score. The test was set at multiple time points before and after the subjects used the nasal spray, such as 5 minutes, 15 minutes and 30 minutes, to record the score change trend. In addition, the Stanford Sleepiness Scale (SSS) was used as an auxiliary to further refine the evaluation of individual mental state and enhance the credibility of subjective evaluation.
[0092] 3. Concentration test method
[0093] Concentration assessment used the following two methods:
[0094] (1) Objective test method:
[0095] PASAT: This test requires the subject to listen to a series of fixed-interval numbers, and add the current number to the previous number and report the answer in real time, to test the information processing speed, attention persistence and working memory capacity.
[0096] Continuous Performance Test (CPT): By making accurate responses to a series of rapidly presented visual or auditory stimuli, it reflects the stability of attention and reaction time.
[0097] (2) Subjective scale assessment method:
[0098] Self-Rating Scale for Attention: Contains several items to assess the individual's subjective perception of their attention status, such as whether attention is easily distracted, easily disturbed by external interference, etc. Adopt Likert 5-level scoring system.
[0099] Each test was conducted before and within 10-30 minutes after the use of the nasal inhalant, and the trend of concentration change was analyzed, and the results of subjective and objective scoring were combined for comprehensive judgment.
[0100] Conclusion:
[0101] According to the above data, it can be found that the present application has obvious effect on quickening the mind, improving brain fatigue and cognitive dysfunction, and the performance in subjective alertness score change and fatigue score change is obviously superior compared with the control group 1 (traditional mind-quickening nasal inhalant), and the performance in attention concentration change is not lower than that of the traditional medicine. And the present application does not use high-value traditional Chinese medicinal materials such as musk and ox gall, and has low cost, is suitable for popularization, is convenient for the continuous use of the crowd, especially in experimental group 8 and experimental group 7, the content of volatile oil of Acorus gramineus is further reduced compared with experimental groups 1-4, but its effect basically remains stable, and the reduction of the content of volatile oil of Acorus gramineus will further reduce the unit cost of the nasal inhalant of the present application.
[0102] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, and are not intended to limit the present application; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that the technical solutions recorded in the foregoing embodiments can still be modified, or some or all of the technical features can be replaced by equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application, and they should be covered in the scope of the claims and the description of the present application. In particular, as long as there is no structural conflict, each technical feature mentioned in each embodiment can be combined in any way. The present application is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.
Claims
1. A traditional Chinese medicine nasal inhalant having the efficacy of refreshing and opening the orifices, characterized in that, The composition comprises the following components: Aconitum kusnezoffii volatile oil 10-20 components, borneol 5-10 components, menthol 3-8 components, ginsenoside 2-5 components, Ginkgo biloba extract 5-15 components, glycyrrhizic acid 1-3 components, and β-cyclodextrin 50-300 components. 2.The traditional Chinese medicine nasal inhalant with the effect of refreshing and opening orifices according to claim 1, characterized in that, The composition comprises the following components: Aconitum kusnezoffii volatile oil 10-15 components, borneol 5-10 components, menthol 3-8 components, ginsenoside 2-3 components, Ginkgo biloba extract 5-10 components, glycyrrhizic acid 1-2 components, and β-cyclodextrin 100-150 components. 3.The traditional Chinese medicine nasal inhalant with the effect of refreshing and opening orifices according to claim 1, characterized in that, The composition comprises the following components: Aconitum kusnezoffii volatile oil 10-15 components, borneol 5-10 components, menthol 3-8 components, ginsenoside 2-3 components, Ginkgo biloba extract 5-10 components, glycyrrhizic acid 1-2 components, and β-cyclodextrin 100-150 components.
4. A method for preparing the traditional Chinese medicine nasal inhalant according to claims 1-3, characterized in that, The composition comprises the following components: Aconitum kusnezoffii volatile oil 10-15 components, borneol 5-10 components, menthol 3-8 components, ginsenoside 2-3 components, Ginkgo biloba extract 5-10 components, glycyrrhizic acid 1-2 components, and β-cyclodextrin 100-150 components. The method comprises the following steps: S1: Aconitum kusnezoffii volatile oil is extracted by distillation, Ginkgo biloba extract is collected, borneol and menthol are ground to a particle size of less than 100 nm and collected respectively, and standard ginsenoside and glycyrrhizic acid are prepared for use; S2: The active components in S1 are dissolved in a suitable solvent, β-cyclodextrin is added, the mass ratio of the active components to β-cyclodextrin is 1:2-5, and the mixture is stirred magnetically at room temperature for 12 hours to form a stable inclusion compound, which is dried to obtain an inclusion powder; 5. The preparation method of the traditional Chinese medicine nasal inhalant with the effect of refreshing and opening orifices according to claim 4, characterized in that, S3: The inclusion powder is filled after being mixed with excipients according to the required dosage form.
6. The preparation method of the traditional Chinese medicine nasal inhalant with the effect of refreshing and opening orifices according to claim 4, characterized in that, In S3, the inclusion powder obtained in S2 is mixed with microcrystalline cellulose (MCC) and lactose, and then evenly distributed into a nasal inhaler to obtain a nasal powder inhalation dosage form.
7. The preparation method of the traditional Chinese medicine nasal inhalant with the effect of refreshing and opening orifices according to claim 4, characterized in that, In S3, the inclusion powder obtained in S2 is dissolved in an ethanol-water mixture, and then mixed with polysorbate 80 and an osmotic regulator, and then filtered and sterilized to obtain a nasal spray dosage form. In S1, Aconitum kuznezoffii volatile oil is extracted by distillation as follows: S101: Aconitum kuznezoffii is crushed, soaked in water for 30 minutes, and then connected to a distillation device, and water vapor is introduced for 4 hours; S102: The volatile oil layer is collected, dried with anhydrous sodium sulfate, and then filtered; 8. The preparation method of the traditional Chinese medicine nasal inhalant with the effect of refreshing and opening orifices according to claim 4, characterized in that, S103: A clear and transparent Aconitum kuznezoffii volatile oil is obtained, which is stored in a sealed and dark place. In S1, Ginkgo biloba extract is collected as follows: S111: 100 g of Ginkgo biloba leaves are added with 600 mL of ethanol, and reflux extraction is performed twice, each for 1 hour; S112: The extraction solutions are combined, concentrated under reduced pressure to a thick paste, and then freeze-dried; S113: A powder-like Ginkgo biloba extract is obtained, which is ready for use.