CN114224845A - Fresh understory mountain ginseng dry powder inhalant and preparation method and application thereof - Google Patents
Fresh understory mountain ginseng dry powder inhalant and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a fresh wild ginseng dry powder inhalant and a preparation method and application thereof, belonging to the technical field of pharmaceutical preparations. The method comprises the steps of preparing the fresh wild ginseng extract, preparing the extract into micro powder by adopting a spray drying technology, and optimizing the addition of auxiliary materials, wherein the auxiliary materials comprise any one or more of mannitol, glycine, L-threonine, leucine, sorbitol and lactose. Researches show that the micro powder prepared from different auxiliary materials has larger property difference, wherein the micro powder prepared by taking mannitol as the auxiliary material has the best property, so that the auxiliary material can be selected to be mannitol, and the air inlet temperature, the liquid medicine mass fraction, the feeding volume flow and the like in the spray drying process are optimized. The fresh ginseng dry powder inhalant successfully prepared by the invention meets the related requirements of pharmacopeia on the dry powder inhalant, and simultaneously, the experiment proves that the inhalant has good anti-fatigue effect and good practical application value.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a fresh wild ginseng dry powder inhalant as well as a preparation method and application thereof.
Background
The information disclosed in this background of the invention is only for enhancement of understanding of the general background of the invention and is not necessarily to be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person skilled in the art.
The ginseng is dry root and rhizome of Panax ginseng C.A.Mey. of Araliaceae, has mild, sweet, slightly bitter and warm nature, and has effects of invigorating primordial qi, restoring pulse, strengthening and relieving depletion, invigorating spleen and benefiting lung, and can be used for treating asthenia, desire for depletion, cold limbs, slight pulse, and anorexia due to spleen deficiency. Ginsenoside is a characteristic active component in various chemical components of ginseng, and the content of the ginsenoside is an important evaluation index of the inherent quality of the ginseng. Modern pharmacological research shows that ginseng has the effect of resisting fatigue.
Administration by inhalation is a common mode of administration for the treatment of disease. Inhalation is a non-invasive administration way, and pulmonary administration is used for treating systemic diseases, and has the advantages of large absorption area, high speed, no liver first pass effect, low enzymatic degradation reaction and the like. In the pulmonary inhalation preparation, the dry powder inhalant is prepared by actively inhaling micronized medicine by a patient, and compared with a quantitative inhalant and an aerosol inhalant, the dry powder inhalant has the advantages of stable medicine, convenience in carrying and the like. However, there are few reports in the prior art that the ginseng was prepared into dry powder inhalant.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a fresh wild ginseng dry powder inhalant and a preparation method and application thereof. The invention prepares the fresh wild ginseng extract, adopts spray drying technology to prepare micro powder, and optimizes the addition of auxiliary materials, thereby successfully preparing the fresh wild ginseng dry powder inhalant, which meets the requirements of related pharmacopoeias on the dry powder inhalant, and simultaneously, tests prove that the invention has good anti-fatigue effect and good value of practical application.
In a first aspect of the present invention, there is provided a dry powder inhalant of fresh ginseng in forest, which is prepared from at least the following components:
a) active ingredient fresh wild ginseng micro powder; b) and (5) auxiliary materials.
Wherein the fresh understory mountain ginseng micro powder is prepared by adopting a spray drying mode for an extract of fresh understory mountain ginseng;
the auxiliary materials comprise one or more of mannitol, glycine, L-threonine, leucine, sorbitol and lactose. Researches show that the micro powder prepared from different auxiliary materials has large property difference, and the average particle size, yield and water content difference are large, wherein the micro powder prepared by taking mannitol as the auxiliary material has the best property, so the auxiliary material can be selected to be mannitol.
The mass ratio of the fresh mountain ginseng extract to the auxiliary materials is 1-10:1, such as 1:1, 3:1, 5:1, 8:1 or 10:1, preferably 3: 1.
The particle size of the micropowder of the fresh mountain ginseng dry powder inhalant is not more than 10 μm, and further not more than 5 μm. The experimental research shows that the range of the particle size span of the dry powder inhalant prepared by the application is small, the percentage of particles with the particle size of less than 5 mu m is 99.08%, the percentage of particles with the particle size of less than 10 mu m is 100%, and the requirements of pharmacopoeia are met.
In a second aspect of the present invention, a preparation method of the above fresh mountain ginseng dry powder inhalant is provided, the preparation method includes:
s1, preparing a fresh wild ginseng extract;
s2, mixing the fresh wild ginseng extract obtained in the step S1 with auxiliary materials, and carrying out spray drying.
In a third aspect of the invention, the application of the fresh ginseng dry powder inhalant in preparing anti-fatigue medicines and/or foods is provided.
The pharmaceutical dosage form is a dry powder inhaler, and the drug is targeted to lung tissues by adopting a pulmonary drug delivery system.
In a fourth aspect of the present invention, there is provided a method of resisting fatigue, the method comprising: administering the above dried powder inhalant to the subject.
The beneficial technical effects of one or more technical schemes are as follows:
the technical scheme reports that the fresh mountain ginseng dry powder inhalant is based on the mountain ginseng extract under forest, suitable auxiliary materials are screened, and the process is optimized, so that the fresh mountain ginseng dry powder inhalant under forest is successfully prepared, meets and is superior to the quality requirements of pharmacopeia, and meanwhile, tests prove that the fresh mountain ginseng dry powder inhalant under forest can rapidly improve the fatigue resistance of a subject, so that the fresh mountain ginseng dry powder inhalant under forest has good practical application and popularization values.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and together with the description serve to explain the invention and not to limit the invention.
Fig. 1 is a graph showing the results of particle size measurement of fine drug powder based on the response surface in the example of the present invention.
Detailed Description
It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.
The present invention will now be further described with reference to specific examples, which are provided for the purpose of illustration only and are not intended to be limiting. If the experimental conditions not specified in the examples are specified, the conditions are generally as usual or as recommended by the reagents company; reagents, consumables and the like used in the following examples are commercially available unless otherwise specified.
In an exemplary embodiment of the present invention, a dry powder inhaler for fresh ginseng under forest is provided, which is prepared from at least the following components:
a) active ingredient fresh wild ginseng micro powder; b) and (5) auxiliary materials.
Wherein the fresh understory mountain ginseng micro powder is prepared by adopting a spray drying mode for an extract of fresh understory mountain ginseng;
the auxiliary materials comprise one or more of mannitol, glycine, L-threonine, leucine, sorbitol and lactose. Researches show that the micro powder prepared from different auxiliary materials has large property difference, and the average particle size, yield and water content difference are large, wherein the micro powder prepared by taking mannitol as the auxiliary material has the best property, so the auxiliary material can be selected to be mannitol.
The mass ratio of the fresh mountain ginseng extract to the auxiliary materials is 1-10:1, such as 1:1, 3:1, 5:1, 8:1 or 10:1, preferably 3: 1.
The particle size of the micropowder of the fresh mountain ginseng dry powder inhalant is not more than 10 μm, and further not more than 5 μm. The experimental research shows that the range of the particle size span of the dry powder inhalant prepared by the application is small, the percentage of particles with the particle size of less than 5 mu m is 99.08%, the percentage of particles with the particle size of less than 10 mu m is 100%, and the requirements of pharmacopoeia are met.
In another embodiment of the present invention, a preparation method of the above dry powder inhalant of fresh ginseng under forest is provided, the preparation method includes:
s1, preparing a fresh wild ginseng extract;
s2, mixing the fresh wild ginseng extract obtained in the step S1 with auxiliary materials, and carrying out spray drying.
Wherein,
in the step S1, the specific preparation method includes:
extracting Ginseng radix Indici under reflux with 6-12 times of water for 2-3 times, mixing filtrates, and concentrating under reduced pressure to obtain water extractive solution;
the method can effectively recover the active pharmaceutical ingredients in the wild ginseng under the forest, and is also beneficial to the subsequent preparation.
Wherein the under-forest ginseng is fresh under-forest ginseng which is naturally dried in the shade, the reflux extraction time is 1.5-3h each time, and the concentration of the under-forest ginseng water extract is controlled to be 1.0-1.2 g/mL.
In the step S2, the specific preparation method includes:
the mass ratio of the fresh mountain ginseng extract to the auxiliary materials is controlled to be 1-10:1, such as 1:1, 3:1, 5:1, 8:1 or 10:1, and preferably 3: 1.
The research shows that the preparation of the mountain ginseng dry powder under forest by the spray drying method is most convenient, the yield is highest and the particle size is more uniform by optimizing the preparation process, wherein the specific process conditions of the spray drying comprise:
the temperature of an air inlet is controlled to be 120-160 ℃, the powder yield shows the trend of increasing firstly and then decreasing along with the increase of the air inlet temperature, and reaches the maximum value at 140 ℃;
the mass fraction of the liquid medicine is 1-5%, and experimental research shows that the product yield shows a trend of increasing and then decreasing along with the increase of the density of the liquid medicine. While the particle size of the microparticles is increasing. Therefore, the concentration of the liquid to be sprayed is preferably about 3 percent;
the feeding volume flow is 350-750mL/h, and researches show that when the feeding flow is 350mL/h and 450mL/h, the average particle size of the dry powder is the minimum, the yield is the highest, and the yield is not obviously changed along with the change of the flow. When the feeding flow rate exceeds 550mL/h, the yield of the dry powder is gradually reduced because the diameter of the fog drops is increased along with the increase of the feeding flow rate of the spray drying, the drying time required by the whole process is increased, the phenomena of mutual adhesion and wall sticking are easy to occur at the moment, the particle size of the dry powder is increased, and the yield is reduced. When the flow of advancing a kind is too low, the droplet diameter also can diminish for the liquid droplet that comes out from spray dryer shower nozzle is thin too light, because negative pressure vortex effect makes the spraying powder glue on the shower nozzle around the shower nozzle, advances the flow when too low moreover, and whole dry efficiency just can reduce. Therefore, the feeding flow rate should be selected to be about 450 mL/h.
After the response surface is optimized, the optimum spray drying process of the mountain ginseng extract micro powder under the forest comprises the following steps: the air inlet temperature is 142.34 ℃, the liquid medicine mass fraction is 2.52%, the feeding volume flow is 485.35mL/h, the ratio of the auxiliary material to the fresh wild ginseng is 3:1, the auxiliary material is mannitol, the average particle size under the condition is 4.86 mu m, the yield is 52.31%, and the water content is 2.31%.
In another embodiment of the invention, the application of the above dried powder inhalant of fresh ginseng in forest in preparing anti-fatigue drugs and/or foods is provided.
The food can be health food or special medical food.
The drug dosage form is a dry powder inhalant, and the drug is targeted to lung tissues by adopting a pulmonary drug delivery system, so that the fatigue resistance of a subject is rapidly improved.
In yet another embodiment of the present invention, there is provided a method of resisting fatigue, the method comprising: administering the above dried powder inhalant to the subject.
The subject includes humans and non-human animals, including non-human mammals, such as rats, mice, orangutans, monkeys, and the like.
The invention is further illustrated by the following examples, which are not to be construed as limiting the invention thereto. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The following examples are test methods in which specific conditions are indicated, and are generally carried out under conventional conditions.
Examples
Method and result
1.1 materials
1.1.1 drugs and reagents
Fresh wild ginseng (Liaoning good nurse group Co., Ltd.); mannitol, glycine, L-threonine, leucine, sorbitol, lactose (national drug group chemical Co., Ltd.).
1.1.2 instruments
Spray dryer, gelatin capsule # 3, drug stability test chamber, next generation pharmaceutical impactor NGI (COPLEY, uk), dry powder inhalation device (jade research, YAN-30012), Titroline KF cartridge moisture titrator, MS3000 laser granulometer (marwen, uk).
1.2 preparation of extract of fresh wild ginseng in forest
Collecting 1000g of naturally dried wild ginseng in the shade, adding 6-12 times of water, reflux extracting for 2-3 times, each time for 1.5-3h, combining filtrates, concentrating under reduced pressure to obtain 1.0-1.2g/mL of wild ginseng aqueous extract, and spray drying to obtain spray dried powder for use.
1.3 evaluation index of spray drying Process
1.3.1 measurement of average particle diameter of Fine powder
The particle size measurement was carried out by dry method, each sample was measured in parallel 3 times, and the average value, d, was averaged(4，3)The value is the average particle diameter. The particle size distribution is represented by the Span (Span), Span ═ d0.9-d0.1)/d0.5The larger the Span, the broader the particle size distribution, and the more non-uniform the particle size.
1.3.2 measurement of yield of Fine powder
The total mass of the fresh wild ginseng extract and the auxiliary materials weighed before spray drying is recorded as W1And the total mass of the fresh under-forest mountain ginseng micro powder prepared after spray drying is recorded as W2The yield (%) of the fine powder was W2/W1×100％。
1.3.3 measurement of moisture content of Fine powder
The second method (reduced pressure drying method) of GB 5009.3-2016 is adopted, the physical property of the moisture in the food is utilized, the food is heated to 60 +/-5 ℃ after reaching 40-53 kPa, then the moisture in the sample is removed by adopting a reduced pressure drying method, and finally the moisture content is obtained through the numerical values before and after drying.
1.4 Single factor investigation of spray drying Process
1.4.1 investigation of different adjuvants
Taking average particle diameter, yield and hygroscopicity as indexes, controlling the temperature of an air inlet at 140 ℃, the volume flow of a feed inlet at 450mL/h, controlling the mass fraction of liquid medicine to be 3%, adopting mannitol, glycine, L-threonine, leucine, sorbitol, lactose, controlling the proportion of auxiliary materials and the fresh wild ginseng extract to be 3:1, and carrying out spray drying. The results are shown in table 1, and it can be seen that the mountain ginseng micro powder prepared from glycine, mannitol and sorbitol has a low average particle size, a high yield, and finally mannitol is selected as a preparation auxiliary material in combination with the result of water content.
TABLE 1 investigation of the Properties of the micropowder made with different adjuvants
1.4.2 inspection of air intake temperature
The flow rate of the fixed sample injection is 450mL/h, the mass fraction of the liquid medicine is 3%, the ratio of mannitol to the fresh mountain ginseng extract is 3:1, and the influence of the air inlet temperature (120, 130, 140, 150 and 160 ℃) on the spray drying is examined. The results are shown in Table 2. With the increase of the temperature of the inlet air, the powder yield shows the trend of increasing firstly and then decreasing, and reaches the maximum value at 140 ℃. When the air inlet temperature is lower, the extracting solution contains more polysaccharide, so that the extracting solution cannot be fully dried, is easy to adhere to each other and is attached to the tower wall of a spray drying machine, the average particle size is large, and the yield is lower; when the air inlet temperature is higher than 140 ℃, the evaporation speed of the water on the surface of the extract liquid material to be dried is high, and hard blocks can be formed, so that the water in the material can not be fully evaporated, the material is finally attached to the tower wall of a spray drying machine after moisture regaining, the average particle size is increased, and the yield of the dry powder is reduced. Therefore, the inlet air temperature is preferably 140 ℃.
TABLE 2 investigation of the properties of the micropowder produced at different inlet temperatures
1.4.3 investigation of volumetric flow of feed
The influence of the injection flow (350, 450, 550, 650 and 750mL/h) on the spray drying was examined by setting the fixed inlet air temperature at 140 ℃ and the liquid medicine mass fraction at 3%. The results are shown in Table 4, and the average particle size of the dry powder is the smallest and the yield is the highest at the feed flow rates of 350mL/h and 450mL/h, and the average particle size does not change obviously with the change of the flow rates. When the feeding flow rate exceeds 550mL/h, the yield of the dry powder is gradually reduced because the diameter of the fog drops is increased along with the increase of the feeding flow rate of the spray drying, the drying time required by the whole process is increased, the phenomena of mutual adhesion and wall sticking are easy to occur at the moment, the particle size of the dry powder is increased, and the yield is reduced. When the flow of advancing a kind is too low, the droplet diameter also can diminish for the liquid droplet that comes out from spray dryer shower nozzle is thin too light, because negative pressure vortex effect makes the spraying powder glue on the shower nozzle around the shower nozzle, advances the flow when too low moreover, and whole dry efficiency just can reduce. Therefore, the feed rate should be 450 mL/h.
TABLE 4 investigation of the properties of the micropowder obtained at different feed volume flows
1.4.5 investigation of the drug to adjuvant ratio
The average particle size, yield and water content were used as indexes to investigate the optimum ratio of mountain ginseng extract to mannitol in fresh forest, and the results are shown in table 5. After the proportion of mannitol is increased, the average particle size of the micro powder is relatively reduced, the yield is relatively increased, when the proportion of mannitol is too large, the drug loading is reduced, and the ratio of the extract under the fresh forest to the mannitol is determined to be 1: 3 in comprehensive consideration.
TABLE 5 investigation of the properties of micro-powders prepared from fresh mountain ginseng extract and mannitol in different ratios
1.4.6 examination of the liquid medicine Mass fraction
The average particle diameter, yield and moisture absorption rate were used as indices, and the results of the experiments were shown in Table 6, with the liquid medicine mass fractions of 1%, 2%, 3%, 4% and 5%, respectively. The liquid medicine has small mass fraction, high water content, good fluidity, easy atomization and uniform formation, but low drying efficiency and large energy consumption, and the obtained extract powder is too fine and is easy to absorb moisture. The liquid medicine has large mass fraction, viscosity, poor fluidity, large dry extract particles and uneven drying. As can be seen from Table 6, the yield of the product increased first and then decreased as the density of the feed solution increased. While the particle size of the microparticles is increasing. Therefore, it is preferable to select the concentration of the liquid to be sprayed to be 3%.
TABLE 6 examination of the properties of the fine powders prepared in different liquid medicine mass fractions
1.5 response surface method optimized spray drying process
1.5.1 response surface Experimental design
According to the single-factor test result, the ratio of the mountain ginseng extract to the auxiliary materials in the fresh forest is fixed to be 1: 3, because the air inlet temperature (A), the liquid medicine quality fraction (B) and the feeding volume flow (C) have great influence on the spray drying result, the 3 factors are used as independent variables, the comprehensive scores of the average particle size, the yield and the water content of the micro powder are used as evaluation indexes, the weight coefficients of the comprehensive scores of the average particle size, the yield and the moisture absorption rate are 0.4, 0.4 and 0.2 in sequence, and the comprehensive score is equal to the average particle size value multiplied by 0.4+ the yield value multiplied by 0.4+ the moisture absorption rate value multiplied by 0.2. Design-Expert10.0 software is used for designing a Box-Behnken response surface and analyzing data, and the factor level and the code are shown in a table 7.
TABLE 7 horizontal coding table for response surface test factors
1.5.2 response surface analysis
1.5.2.1 test design and results
The design and results of the response surface test for preparing the mountain ginseng micro powder under the fresh forest by the spray drying method are shown in table 8.
TABLE 8Box-Behnken test design and results
1.5.2.2 data analysis and model fitting
The experimental results in the table 8 are subjected to regression analysis by using Design-Expert 8.0.6.1 software, and after regression fitting, a quadratic polynomial regression equation of the comprehensive score (Y) to the air inlet temperature (A), the liquid medicine mass fraction (B) and the feeding volume flow (C) is obtained as follows:
Y＝+24.38+0.038A+0.038B-2.750-0.3C-0.075AB-3.250-4AC+2.250-4BC-0.49A2-0.49B2-0.42C2
the quadratic term coefficients in the response surface model fitting equation are all negative values, the response value Y and the three variables are all in negative correlation, and the opening of the paraboloid of the graph is downward and has the maximum value, so that optimization can be performed.
TABLE 9 regression model ANOVA
The results of the analysis of variance and the significance test of the regression equation are shown in Table 8, and the model regression is very significant (p)<0.0001), the quadratic regression model can remarkably fit the influence of the comprehensive score (Y) on the air inlet temperature (A), the liquid medicine mass fraction (B) and the feeding volume flow (C) on the spray drying of the fresh ginseng under the forest.Adjustment determination coefficient (determination coefficient) Adj R of model20.9836, indicating that the model can account for changes in 98.36% response values; coefficient of correlation R2When the model is 0.9928, the model is good in fitting degree, the predicted value and the actual value have good correlation, and the experimental error is small. Therefore, the model can be used for predicting the experiment of the spray drying process of the mountain ginseng in the fresh forest.
1.5.2.3 interaction analysis and process optimization
According to the regression equation, a response surface graph and a contour graph among different factors are obtained by using Design-Expert 8.0.6.1 software, such as the graph shown in FIG. 1. The values of F corresponding to AB, AC and BC in the chart set and the table 9 can reflect the influence of each factor and the interaction thereof on the comprehensive score. The interaction between the two factors A and B is strongest, and the interaction between A and C is weakest.
A, B, C values corresponding to the maximum response value (Y) obtained by Design-Expert 8.0.6.1 software are respectively 142.34, 2.52 and 485.35, namely the optimum spray drying process of the mountain ginseng extract micro powder under forest is as follows: the air inlet temperature is 142.34 ℃, the liquid medicine mass fraction is 2.52%, the feeding volume flow is 485.35mL/h, the ratio of the auxiliary material to the fresh wild ginseng is 3:1, the auxiliary material is mannitol, the average particle size under the condition is 4.86 mu m, the yield is 52.31%, and the water content is 2.31%.
In order to check the reliability of the response surface analysis result, the extraction process conditions are selected in consideration of the practical operation problem as follows: the air inlet temperature is 142.34 ℃, the liquid medicine mass fraction is 2.52%, the feeding volume flow is 485.35mL/h, the ratio of the auxiliary material to the fresh wild ginseng is 3:1, and the auxiliary material is mannitol. Under these conditions, the average particle diameters were measured in parallel 3 times, and were 4.87. mu.m, 4.85. mu.m, and 4.84. mu.m, respectively, and the theoretical predicted value was 4.86mg/g, and the relative error was about 0.2% as compared with the theoretical predicted value. The yields were 52.34%, 52.31%, 52.33%, respectively, the theoretical prediction was 52.36%, the relative error was about 0.1%, the water contents were 2.35%, 2.37%, 2.41%, respectively, the theoretical prediction was 2.63%, and the relative error was about 0.7%. Therefore, the model is feasible to predict the spray drying process conditions of the mountain ginseng in the fresh forest.
1.6 particle diameter and evaluation thereof
Particle size results are shown in table 10. According to the regulation of inhalation preparation item-0111 in the general rule of four preparations in the 'Chinese pharmacopoeia' 2020 edition: the particle size of the starting drug in the inhalation formulation should generally be controlled below 10 μm, most of which should be below 5 μm. The results show that: the span range of the particle size of the micro powder is small, the percentage of particles below 5 mu m is 99.08%, the percentage of particles below 10 mu m is 100%, and the requirements of pharmacopoeia are met.
TABLE 10 measurement results of particle size of fine drug powder
1.7 determination of angle of repose
The angle of repose of the powder can be determined using an angle of repose tester: 100g of solid powder is loaded in a funnel, a valve of the funnel is opened to enable the powder to naturally flow out and fall on a plane of a receiver, and an included angle between the plane of the receiver and a generatrix of a cone of the powder is an angle of repose theta. It is considered that the powder flow property is good when θ is 30 degrees or less, and the fluidity is better as the θ value is smaller. Do 3 times and calculate the average. The results were 21.51, 21.21, 21.34. The smaller the angle of repose, the smaller the friction force, the better the fluidity, the theta is less than or equal to 30 degrees, the good fluidity of the micro powder can meet the fluidity requirement in the production process.
1.8 determination of in vitro deposition property of mountain ginseng drug micropowder in fresh forest
Adopts a new generation of pharmaceutical impactor (NGI), and the regulation of 0951 of the 2020 version of Chinese pharmacopoeia is that the percentage of fine drug particles is not less than 10% of the marked amount of the content of each absorbed main drug except the other regulation. The results of in vitro deposition of the fine powder of fresh mountain ginseng under forest are shown in Table 11. The percentage of the fine drug particles of the mountain ginseng micro powder under the fresh forest is 13.53 percent, which accords with the regulation of pharmacopoeia.
TABLE 11 results of in vitro deposition Properties determination
Anti-fatigue effect of dried powder inhalant of mountain ginseng in forest
2.1 materials and reagents
2.1.1 materials
Dried powder inhalant of mountain ginseng under forest (self-made); lactose; pentobarbital.
2.1.2 instruments
An intratracheal dry powder administration device (Yuyan, YAN-30010), a BSA-124S electronic balance (Sidolisi scientific instruments (Beijing) Ltd.).
2.1.3 animals
Healthy SD mice, SPF grade, weight 17 ~ 25g, male and female dual purpose, provided by Liaoning Changsheng biology Limited company, animal license number: SCXK (Liao) 2015-0001. Animals were housed in Specific Pathogen Free (SPF) animals from Liaoning Biometrics Ltd for at least seven days prior to the study. During the raising period, food and water were freely taken, and the illumination time was 12h per day.
2.2 Experimental methods and results
2.2.1 grouping and administration
50 mice were randomly divided into 5 groups of 10 mice each. The method comprises dividing into blank group, inhaling high, medium and low doses (3.2g/kg, 1.6g/kg, 0.8g/kg (based on crude drug)) of fresh mountain ginseng dry powder, and intragastric administration (3.2g/kg (based on crude drug)) of fresh mountain ginseng dry powder. Weighing the weight of the mice, and except for the blank group, feeding the fresh wild ginseng dry powder inhalation group by using an endotracheal dry powder feeding device, and feeding the fresh wild ginseng dry powder in the fresh wild ginseng dry powder intragastric administration group by intragastric gavage. The lead sheet with the weight of 5% of the body mass of the mouse loaded on the tail is placed in a swimming tank (the water temperature is 25 ℃, and the depth is 30cm), and the time is counted from the time when the mouse enters water until the mouse sinks into the water bottom for more than 10s and is placed on a plane to be incapable of finishing the righting reaction, and the time is recorded as the exhaustion swimming time of the mouse.
2.3 measurement data
Expressed by mean ± standard deviation
The group comparison is carried out by One-way ANOVA test, repeated measurement data is analyzed by repeated measurement variance, and multiple comparisons are carried out by an LSD method. All data statistics, analysis and mapping were done using SPSS 16.0, with P < 0.05 indicating statistical significance.
2.4 results
In the experimental process, the mental state, the activity state and the state of food and water intake of each group of rats are normal. As shown in Table 1, the exhaustive swimming time of mice inhaled by fresh ginseng in forest is obviously increased (P is less than 0.01) compared with that of mice inhaled by a blank control group and those inhaled by lavage group, and the exhaustive swimming time of the lavage group and the blank control group is unchanged. Prompting the effect that the intake administration of the mountain ginseng under the forest can quickly improve the anti-fatigue capability of the mice.
TABLE 1 Effect on weight bearing swimming of mice
Note: compared with the blank control group, the composition of the composition,*P＜0.01。
the above embodiments are merely illustrative of the technical ideas and features of the present invention, and the purpose thereof is to enable those skilled in the art to understand the contents of the present invention and implement the present invention, and not to limit the protection scope of the present invention. All equivalent changes and modifications made according to the spirit of the present invention should be covered within the protection scope of the present invention.
Claims (10)
1. The fresh mountain ginseng dry powder inhalant is characterized by being prepared from at least the following components:
a) active ingredient fresh wild ginseng micro powder; b) an auxiliary material;
wherein the fresh understory mountain ginseng micro powder is prepared by adopting a spray drying mode for an extract of fresh understory mountain ginseng;
the auxiliary materials comprise one or more of mannitol, glycine, L-threonine, leucine, sorbitol and lactose.
2. The dry powder inhalant of fresh wild ginseng as claimed in claim 1, wherein the mass ratio of the extract of fresh wild ginseng to the auxiliary material is 1-10:1, preferably 3: 1.
3. The dry powder inhaler of fresh understory mountain ginseng as claimed in claim 1, wherein the particle size of the micropowder of the dry powder inhaler of fresh understory mountain ginseng is not more than 10 μm, and further not more than 5 μm.
4. The method for preparing the fresh wild ginseng dry powder inhalant as claimed in any one of claims 1 to 3, wherein the preparation method comprises the following steps:
s1, preparing a fresh wild ginseng extract;
s2, mixing the fresh wild ginseng extract obtained in the step S1 with auxiliary materials, and carrying out spray drying.
5. The method according to claim 4, wherein in step S1, the method comprises:
extracting Ginseng radix Indici under reflux with 6-12 times of water for 2-3 times, mixing filtrates, and concentrating under reduced pressure to obtain water extractive solution.
6. The method according to claim 5, wherein the under-forest ginseng is a fresh under-forest ginseng naturally dried in the shade, the time for each reflux extraction is 1.5 to 3 hours, and the concentration of the under-forest ginseng aqueous extract is controlled to be 1.0 to 1.2 g/mL.
7. The method according to claim 4, wherein in step S2, the method comprises:
the mass ratio of the fresh wild ginseng extract to the auxiliary materials is controlled to be 1-10:1, preferably 3: 1;
the specific process conditions of the spray drying comprise:
controlling the temperature of the air inlet to 120-;
the mass fraction of the liquid medicine is 1-5%;
the feeding volume flow is 350-750 mL/h.
8. Use of the dried powder inhalant of fresh ginseng under forest as claimed in any one of claims 1 to 3 for preparing anti-fatigue drugs and/or foods.
9. The use according to claim 8, wherein the food is a health food or a specialist food.
10. A method of resisting fatigue, the method comprising: administering to the subject the dried powder inhalant of fresh ginseng under forest according to any one of claims 1 to 3.
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