CN114209723B - Composition for assisting in reducing blood fat, product containing composition and application - Google Patents
Composition for assisting in reducing blood fat, product containing composition and application Download PDFInfo
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- CN114209723B CN114209723B CN202111657410.XA CN202111657410A CN114209723B CN 114209723 B CN114209723 B CN 114209723B CN 202111657410 A CN202111657410 A CN 202111657410A CN 114209723 B CN114209723 B CN 114209723B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The invention relates to a composition for assisting in reducing blood fat, a product containing the composition and application thereof. The ginseng and the pseudo-ginseng under the forest have good auxiliary blood fat reducing effect, the main active part is the saponin component, and the probability of moisture absorption and degradation of the saponin active component can be effectively reduced by adopting dry granulation. In order to provide an active ingredient with better processability and blood lipid reduction, the invention optimizes the extraction process of the saponin ingredients in the medicinal materials, and provides a composition with better pharmacodynamic activity and more suitability for dry granulation.
Description
Technical Field
The invention belongs to the technical field of natural medicine extracts, and particularly relates to a composition for assisting in reducing blood fat, a product containing the composition and a method for assisting in reducing blood fat.
Background
The disclosure of this background section is only intended to increase the understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art already known to those of ordinary skill in the art.
Ginseng is a natural tonic, has effects of treating, promoting health, nourishing and strengthening body constitution, and has main activities including ginsenoside, polypeptide and polysaccharide, and is widely used for preparing antitumor, cardiovascular and cerebrovascular system protecting, nervous system protecting, liver injury preventing and antiviral drugs.
Modern researches have proved that ginseng has a remarkable effect in reducing blood fat. The influence of ginseng on liver lipid metabolism disorder of the mice with hyperlipidemia is reported by talking and bloodletting and the like, and the research results show that the high, medium and low doses of ginseng can effectively reduce the liver coefficient of the mice with hyperlipidemia, and simultaneously reduce the contents of LDL-C, ALT and TG in serum, thereby realizing the efficacy of reducing blood lipid. In the research of Liu Wei for exploring the total ginsenoside for reducing the blood fat of rats, the research result shows that the total ginsenoside can obviously reduce the contents of TG and TC in serum of rats with high-fat feeding and hypercholesterolemia, and the total ginsenoside has the effect of reducing the blood fat.
Notoginseng radix is a clinically common Chinese medicinal herb of Panax genus of Araliaceae, has hemostatic, analgesic, repercussive, blood stasis dispelling, deficiency tonifying, and strengthening effects, and contains saponins, volatile oil, amino acids, flavonoids, and organic acids as main ingredients, and has effects of reducing blood cholesterol and blood lipid. Dong et al report the lipid regulating effect of Notoginseng radix powder and the study of mechanism, and confirm that Notoginseng radix powder significantly reduces TC, TG and LDL-C levels and AST, ALT activities in serum of rat with hyperlipidemia; histological observation results show that the pseudo-ginseng powder obviously reduces liver injury and fatty liver; molecular level results show that the pseudo-ginseng powder can up-regulate LDLR and SIRT1 and down-regulate LXR-alpha gene expression. Meanwhile, the pseudo-ginseng powder obviously reduces protein expression of SREBP-2 and SCAP. Conclusion the Notoginseng radix powder has effects of regulating blood lipid and protecting liver, which may be related to the mechanism of Notoginseng radix powder for up-regulating SIRT1, down-regulating LXR-alpha gene expression, further down-regulating SCAP/SREBP-2 signal pathway to inhibit cholesterol synthesis, and up-regulating LDLR gene expression to improve LDL-C uptake in blood circulation. In addition, the prior study also shows that the pseudo-ginseng can inhibit proliferation of rat vascular smooth muscle cells stimulated by high-fat serum, and has the effects of reducing blood fat and preventing atherosclerosis.
Against the background of the above research, the inventors believe that the active ingredients in ginseng and notoginseng are mainly saponins, which contain polysaccharide groups, and wet granulation is easy to cause moisture absorption of the saponin extract, and the shelf life is shortened. The stability and activity of the saponin components can be well ensured by dry granulation, but at the same time, polysaccharide groups can be adhered to the surface of a granulator in the dry rolling process, so that the waste of raw materials is caused.
Disclosure of Invention
Based on the technical background, the invention aims to provide the pharmaceutical composition with the auxiliary blood fat reducing effect, which comprises ginseng extract and pseudo-ginseng extract, and the active ingredients in ginseng and pseudo-ginseng can be effectively extracted by optimizing the extraction mode, so that the extracted composition has good processing performance and can be well applied to dry granulation.
In a first aspect, the present invention provides a composition for assisting in reducing blood lipid, the composition comprising a ginseng extract and a notoginseng extract, the preparation method of the ginseng extract comprising: lyophilizing the alcoholic extract of Ginseng radix; the preparation of the pseudo-ginseng extract comprises the following steps: alcohol extraction is carried out on the freeze-dried pseudo-ginseng.
In the composition according to the first aspect, the mass ratio of the ginseng extract to the pseudo-ginseng extract is 1 to 6: 1-3, specifically, the mass ratio of the ginseng extract to the pseudo-ginseng extract is 4:1, or 2:1, or 1:1, or 6:1, or 2:3.
preferably, the ginseng is one of the group including, but not limited to, mountain ginseng under forest, wild ginseng, mountain ginseng. As known in the art, the wild ginseng has the best medicinal effect, but the quantity is rare, the wild ginseng in the forest grows in the wild forest environment as well, and the ingredients and the effects are close to those of the wild ginseng, so that in the preferred scheme of the invention, the ginseng is the wild ginseng in the forest.
Preferably, the ginseng product is Jilin or Liaoning, further, is one or combination of Jilin Tonghua, liaoning Xinbine and Liaoning Benxi; the growth period of the ginseng is preferably 10 years or more, and more preferably 15 years or more.
The ginseng extract according to the first aspect, which is preferably prepared as follows: adding Ginseng radix into alcohol solution, heating, reflux extracting, concentrating to obtain extract, and lyophilizing to obtain lyophilized powder.
In the above scheme, the alcohol solution is preferably methanol solution or ethanol solution, and further, the ethanol solution is adopted to extract the total saponins of ginseng, the concentration of the ethanol solution is 70-80%, the total reflux extraction time is 80-100 min, and the extraction times are 2-4 times.
The times of heating reflux extraction are preferably three times, and the total extraction time is 90-100 min.
Preferably, the ethanol solution is used in an amount of 8 to 10 times the mass of ginseng.
In the preparation process of the ginseng extract, the invention firstly proves that the transfer rate of the saponin components can be effectively improved by adopting the alcohol solution for extraction. In the process research aiming at drying the extracting solution, the invention discovers that the viscosity of the dried extracting solution can be effectively reduced by adopting a freeze-drying mode, and further discovers that the loss of saponin components can be effectively reduced and the volatilization effect of polysaccharide components can be increased by adopting a step-type heating or cooling mode in the freeze-drying process.
In the above scheme, the freeze drying adopts stepped cooling or heating, and the specific steps are as follows: concentrating the ethanol extract under reduced pressure to obtain an extract, pre-freezing the extract in an environment of-25 ℃ to-40 ℃ for 4-6 hours, then placing the extract into a freeze dryer, keeping the temperature of-25 ℃ to-30 ℃ for 1.5-2.5 hours, vacuumizing to 40-60pa, then heating to the shelf temperature of-18-22 ℃ for 10-14 hours, heating to the shelf temperature of-8-12 ℃ for 5-7 hours, and then heating to the shelf temperature of 38-42 ℃ until the analysis is completed, and discharging.
In addition, in the first aspect, the preparation method of the pseudo-ginseng extract comprises the following steps: freeze-drying Notoginseng radix, pulverizing into coarse granule, reflux-extracting with ethanol solution to obtain extractive solution, concentrating under reduced pressure to obtain extract, and spray-drying to obtain spray-dried powder.
In the above scheme, the Notoginseng radix is preferably Notoginseng radix of Yunnan Wenshan, and the growth period is preferably seven years or more.
Preferably, the diameter of the coarse particles is 0.1-0.2cm.
Preferably, the concentration of the ethanol solution is 65-75%, further 68-71%, in a specific example, 70%; the amount of the ethanol solution is 5-9 times of the mass of the pseudo-ginseng.
Preferably, the total reflux extraction time of the ethanol solution is 50-70 min, and the extraction times are 1-3.
Preferably, the extract is retrieved and concentrated at a lower temperature of 55-65 ℃ to obtain extract, and the density of the extract is 1.1-1.20.
In a second aspect of the present invention there is provided an auxiliary hypolipidemic product comprising a pharmaceutical composition according to the first aspect and a pharmaceutically acceptable carrier.
Preferably, the auxiliary blood lipid-lowering product is one of health products, medicines and special medical foods; further preferably, the auxiliary hypolipidemic product is a medicament.
In the above embodiments as an auxiliary hypolipidemic agent, the compositions of the first aspect are prepared together with other active ingredients, and the compositions of the first aspect are used as the active ingredients alone; in the above preparation cases, the composition accounts for 1-99% of the total amount of the medicine, and the dosage of the active ingredient is technical content which can be conventionally determined by those skilled in the art according to the purpose of use. In other embodiments, the amount of the drug is from about 0.5mg/kg body weight/day to about 50mg/kg body weight/day.
The dosage form of the medicine is unit dosage form suitable for single administration of precise dosage, and comprises oral liquid preparations such as decoction, suspension, syrup, mixture, tincture and the like, and also can be paste, granules, pills (honeyed pills, watered pills, paste pills, wax pills and concentrated pills), powder, tablets (enteric-coated tablets, film coated tablets, sugar-coated tablets, extract tablets, dispersible tablets, scratch tablets), capsules or drops and the like; further, the composition is in the form of a tablet or capsule.
In one embodiment, the medicament is a tablet, which further comprises a flavoring agent, a preservative, and a filler; considering that the medicine is applied to patients with hyperlipidemia, the flavoring agent is xylitol, and the specific preparation method is as follows: mixing the composition of the first aspect, xylitol and citric acid uniformly, and granulating by dry method.
In yet another embodiment, the medicament is a capsule, and the method of preparing the capsule is as follows: the composition of the first aspect is dry granulated and encapsulated.
In a third aspect of the invention, there is provided a method of reducing blood lipid comprising administering to a subject in need thereof a composition according to the first aspect, or an auxiliary blood lipid reducing product according to the second aspect.
In the above-described third aspect, the subject in need thereof includes, but is not limited to, a subject in need of treatment, amelioration or prevention, and health care, and the dosage of the drug to be administered is a routine adjustment by the healthcare worker according to the administration objective.
The beneficial effects of the above technical scheme are:
1. in one embodiment of the invention, a composition with an auxiliary blood lipid reducing effect is provided, which comprises ginseng extract and pseudo-ginseng extract. The existing research results show that the ginsenoside and the notoginsenoside have certain hypolipidemic activity, but the mechanisms of the substances for regulating blood lipid have certain differences, and the hypolipidemic effect can be effectively improved by compounding the substances. Therefore, the invention firstly provides a composition of ginseng extract and pseudo-ginseng extract, which can exert good blood lipid reducing effect through the combination of the ginseng extract and the pseudo-ginseng extract.
2. In still another embodiment of the present invention, an extraction process of ginseng extract and notoginseng extract is provided, and considering the purpose of the present invention is also to provide an extract suitable for dry granulation, the design of the extraction process of the present invention reduces the interference of polysaccharide to the granulation process by optimizing the extraction method and the drying process, and provides a lipid-lowering composition with simple preparation process and better industrial performance.
Detailed Description
It should be noted that the following detailed description is illustrative and is intended to provide further explanation of the invention. 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 present invention. As used herein, the singular is also intended to include the plural unless the context clearly indicates otherwise, and furthermore, it is to be understood that the terms "comprises" and/or "comprising" when used in this specification are taken to specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof.
As described in the background art, ginseng and pseudo-ginseng have good blood lipid reducing effect, and the stability of saponin active ingredients in the medicinal materials can be effectively improved by adopting dry granulation, however, the saponin extract is generally interfered by polysaccharide ingredients and is easy to adhere to the mechanical edge in the processing stage.
In order to enable those skilled in the art to more clearly understand the technical scheme of the present invention, the technical scheme of the present invention will be described in detail below with reference to specific examples and comparative examples.
Example 1 extraction Process investigation
1. Investigation of extraction process of extract of ginseng under forest
1. Raw material screening
And (5) respectively selecting the mountain ginseng under the forest with different growth years of Liaoning and Jilin, and measuring the content of the saponins. Preferably selecting the mountain ginseng raw material under the forest which is most suitable for production.
TABLE 1 screening of different varieties of Ginseng radix raw materials
Conclusion: since Liaoning province specifies that the mountain ginseng content under forests should meet that the total saponin is more than or equal to 4.5%, the total amount of ginsenoside Rg1 and ginsenoside Re should not be lower than 0.61%, and the content of ginsenoside Rb1 should not be lower than 0.41%. And selecting the mountain ginseng under the forest for more than 15 years as a raw material.
2. Extraction mode screening
Taking mountain ginseng under forests in the same production place and the same growth period, respectively extracting by adopting different extraction modes, and screening the optimal extraction mode by taking the extraction rate of total saponins as an index.
(1) Water extraction: taking 100g of mountain ginseng under forest, adding 8 times of purified water into the raw materials, heating and reflux-extracting for 2 hours, filtering, adding 6 times of purified water into filter residues, heating and reflux-extracting for 1 hour, filtering, combining the filtrates, and freeze-drying to obtain freeze-dried powder;
(2) Alcohol extraction: taking 100g of mountain ginseng under forest, adding 8 times of 95% ethanol into the raw materials, heating and reflux-extracting for 2 hours, filtering, adding 6 times of 95% ethanol into filter residues, heating and reflux-extracting for 1 hour, filtering, combining the filtrates, and freeze-drying to obtain freeze-dried powder.
TABLE 2 Total saponins extraction without extraction process
Conclusion: the extraction rate of the ginseng total saponins is obviously higher than that of the ginseng total saponins extracted by water, and the extraction is carried out by selecting an alcohol extraction mode.
3. Extraction process screening
And (3) adopting an orthogonal test to examine the extraction solvent, the extraction time and the extraction times of the alcohol extraction process of the under-forest mountain ginseng extract.
TABLE 3 factor level Table
TABLE 4 results of orthogonal experiments
TABLE 5 analysis of variance table
Conclusion: by L 9 (3 4 ) Orthogonal test, taking total ginsenoside extraction rate as investigation index, and performing visual analysis, and the result shows that k2 > k3 > k1 in factor A, k2 > k1 > k3 in factor B, k3 > k1 > k2 in factor C, k3 > k2 > k1 in factor D, R value is A > D > C > B, namely the influence sequence of each factor is ethanol concentration > extraction times > extraction time > solvent amount, so that the optimal extraction combination is A 2 B 2 C 3 D 3 However, since only the concentration of ethanol and the number of times of extraction have significance for the influence of the total saponins extraction rate of ginseng, the finally determined extraction process is A 2 B 1 C 1 D 3 。
4. Freeze-drying process
Taking the mountain ginseng extract under the forest, pre-freezing for 5 hours in an environment of minus 25 ℃ to minus 40 ℃, then placing into a freeze dryer, keeping the temperature of minus 25 ℃ to minus 30 ℃ for 2 hours, vacuumizing to 40-60pa, then heating to the shelf temperature of minus 20 ℃ for 12 hours, heating to the shelf temperature of minus 10 ℃ for 6 hours, after sublimation is completed, heating to 40 ℃ until analysis is completed, and discharging.
5. Determination process of freeze-dried powder of ginseng under forest
Taking 500g of mountain ginseng under the forest, adding 4800g of 75% ethanol, carrying out reflux extraction for 30min, filtering, adding 4800g of 75% ethanol into filter residues, carrying out filtering, carrying out total extraction for 3 times, combining filtrate to obtain 15120g of filtrate, concentrating the filtrate under reduced pressure at 60 ℃ until the density is 1.20-1.30 g of extract 510g, putting the extract into a tray, pre-freezing (-25 ℃ to-40 ℃) for 5 hours, then putting the extract into a freeze dryer, maintaining the temperature at-25 ℃ to-30 ℃ for 2 hours, vacuumizing to 40-60pa, then heating to the shelf temperature of-20 ℃ for 12 hours, then heating to the shelf temperature of-10 ℃ for 6 hours until sublimation is completed, then heating to 40 ℃ until analysis is completed, discharging, crushing, and sieving through a 100-mesh sieve to obtain 250g of mountain ginseng under the forest.
6. Quality control
6.1 mass:
TABLE 6
6.2, a total saponin detection method comprises the following steps:
6.2.1 reagents
Amberlite-XAD-2 macroporous resin, sigma chemical company, u.s.a.
N-butanol was analytically pure.
Ethanol was analytically pure.
Neutral alumina chromatography, 100-200 mesh.
Ginsenoside Re is purchased from the institute of Chinese medicine biological products.
The vanillin solution was weighed 5g vanillin, dissolved in glacial acetic acid and taken to 100mL.
Perchloric acid analysis of alcohols
Glacial acetic acid analytically pure
Ginsenoside Re standard solution: accurately weighing 0.020g of ginsenoside Re standard, dissolving with methanol, and fixing the volume to 10.0mL, namely 2.0mg of ginsenoside Re is contained in each milliliter.
6.2.2 instruments
Colorimeter and chromatographic column
6.2.3 Experimental procedure
Sample treatment: about 1.000g of a sample (according to the parameters of the sample) is weighed, placed in a 100mL volumetric flask, added with a small amount of water, sonicated for 30min, then fixed to 100mL with water, shaken well, placed, and the supernatant liquid is sucked into 1.0mL for column chromatography.
Column chromatography: a10 mL syringe was used as a chromatographic tube, 3cm Amberlite-XAD-2 macroporous resin was placed therein, and 1cm neutral alumina was added thereto. Washing the column with 25mL of 70% ethanol, discarding the eluent, washing the column with 25mL of water, discarding the eluent, precisely adding 1.0mL of the treated sample solution, washing the column with 25mL of water, discarding the eluent, eluting the ginsenoside with 25mL of 70% ethanol, collecting the eluent, placing the eluent in an evaporation dish, and volatilizing in a water bath at 60 ℃ to obtain the final product for color development.
Color development: accurately adding 0.2mL of 5% vanillin glacial acetic acid solution into the volatilized evaporating dish, rotating the evaporating dish to completely dissolve residues, adding 0.8mL of perchloric acid, uniformly mixing, transferring into a 5mL centrifuge tube with a plug scale, heating for 10min on a water bath at 60 ℃, taking out, cooling in an ice bath, accurately adding 5.0mL of glacial acetic acid, shaking, and performing colorimetric determination with a standard tube at a wavelength of Chi Yu nm of 1 cm.
Standard tube: 100. Mu.l of the ginsenoside Re standard solution (2.0 mg/mL) was sucked into an evaporation dish, and the dish was put into a water bath for evaporation (below 60 ℃ C.) or dried with hot air (without overheating), and the absorbance value was measured as in the case of the sample. 6.2.4 calculation:
wherein:
x: total saponin amount (calculated by ginsenoside Re) in the sample, g/100g;
a1: absorbance value of the measured liquid
A2: absorbance value of standard solution
C: amount of ginsenoside Re, μg of standard tube
V: dilution volume of sample, mL
M: sample mass, g
The result of the calculation retains two significant digits.
2. Process investigation of notoginseng extract
Notoginseng radix total saponin is the main effective component of Notoginseng radix, and can be used for preventing and treating hyperlipidemia. The invention selects fresh notoginseng as raw material, and examines the notoginseng extraction process by taking the total saponin extraction rate of notoginseng as an index.
1. Raw material screening
1.1 growth years investigation
Notoginseng radix purchased from Yunnan mountain with different growth years is selected respectively, and the total saponin content of Notoginseng radix is determined. Preferably selecting the notoginseng raw material which is most suitable for production.
TABLE 7
Conclusion: the content of total saponins of Notoginseng radix increases year by year with the increase of growth years of Notoginseng radix of 3-9 years, the rise amplitude decreases year by year after 7 years, and the total saponins content decreases instead after 10 years. In addition, most of the pseudo-ginseng in the market is 3-7 years, and the cost is high after 7 years, so that the 7-year-old pseudo-ginseng is finally selected as the raw material.
1.2 drying method investigation
Most of the commercial pseudo-ginseng is dried by adopting a drying or sun-drying processing mode, 7-year-old fresh pseudo-ginseng is selected for optimal drying mode, and the fresh pseudo-ginseng is processed by adopting different drying modes and the total saponin content of the pseudo-ginseng is measured respectively.
TABLE 8
Conclusion: according to the measurement result, no matter which drying mode is adopted, the total saponins of the pseudo-ginseng can be lost to a certain extent, especially the content loss is large by drying, the drying time is long, and the loss of the total saponins of the freeze-dried pseudo-ginseng is minimum, so that the 7-year-old freeze-dried pseudo-ginseng is finally selected as the raw material of the pseudo-ginseng extract.
2. Investigation of extraction process
Taking freeze-dried radix Notoginseng crushed into coarse particles (diameter of 0.1-0.2 cm), extracting radix Notoginseng extract by ethanol reflux extraction, respectively examining extraction solvent, extraction time and extraction times, and preferably extracting radix Notoginseng extract in optimal way.
TABLE 9 factor level Table
TABLE 10 results of orthogonal experiments
TABLE 11 analysis of variance table
Conclusion: by L 9 (3 4 ) Orthogonal test, taking total saponin extraction rate of Notoginseng radix as investigation index, and performing visual analysis, and the result shows that k2 > k3 > k1 in factor A, k2 > k3 > k1 in factor B, k3 > k2 > k1 in factor C, R value is A > B > C, that is, the influence sequence of each factor is ethanol concentration > extraction time > extraction times, so the optimal extraction combination is A 2 B 2 C 3 However, since only the concentration of ethanol has significance for the influence of the total saponins extraction rate of the pseudo-ginseng, the finally determined extraction process is A 2 B 2 C 2 。
3. Drying
Concentrating Notoginseng radix extractive solution at low temperature (60deg.C) under reduced pressure to obtain thick extract (density 1.1-1.20), and spray drying to obtain spray-dried powder.
4. Determination process of pseudo-ginseng extract
Taking 500g of freeze-dried pseudo-ginseng coarse particles with the diameter of 0.1-0.2cm, adding 4000g of 70% ethanol, reflux-extracting for 60min, filtering, adding 3000g of 70% ethanol into residues, reflux-extracting for 60min, filtering, and combining the two filtrates to obtain 7265g of filtrate. Concentrating the filtrate at low temperature (60deg.C) under reduced pressure to obtain extract with density of 1.1-1.20, collecting extract 267g, and spray drying to obtain spray-dried powder 125g.
3. Investigation of the formulation ratio
Respectively selecting different ratios of the formulations of the mountain under forest to participate in the pseudo-ginseng, carrying out experiments for improving the hyperlipidemia of the experimental rats, and optimizing the optimum ratio of the formulations
1 materials and methods
1.1 animals, materials and reagents
Healthy SPF grade adult male SD rats, 84, body weight (200±20) g at the end of the adaptation period. Raising in separate cages, 3 cages each, and drinking water. The temperature range of the animal raising experiment room is (25+/-1) DEG C, the relative humidity is 50-60%, and the day and night light and shade alternation time is 12 hours.
TABLE 12 different proportions of mountain ginseng samples
Freeze-dried powder of ginseng and notoginseng extract.
TC, TG, HDL-C, LDL-C test box purchased from Innovative (Xiamen) technologies Co., ltd.
Control group feed: the maintenance feed can meet the requirement of growth and development of rodents;
model group feed: 20.0% sucrose, 15.0% lard, 1.2% cholesterol, 0.2% sodium cholate, proper amount of casein, calcium hydrophosphate, stone powder and the like are added into the maintaining feed. Besides crude fat, the water content, crude protein, crude fat, crude fiber, crude ash, calcium and phosphorus of the model feed all reach the national standard of the maintenance feed.
1.2 instruments and apparatus
A high-speed cryocentrifuge (Thermo Fisher); metler tloedo Pl303 electronic analytical balance (Metrehler-Telido, inc. of Shanghai); electric heating thermostatic water bath (Beijing Changan science instruments Co., ltd.); 722 spectrophotometer (Shanghai precision scientific instruments Co., ltd.); vortex mixer (Shanghai precision industries, inc.).
1.3 method
1.3.1 dose grouping and time of administration of test samples
Male SD rats were divided into 7 experimental groups of 12 animals. The experiment sets up 5 sample groups, 1 blank control group and 1 model control group of the mountain under forest to participate in the pseudo-ginseng with different proportion ratios. The administration time of the test sample was 28d.
1.3.2 animal modeling, grouping, and administration
1.3.3 adaptation period
Rats were fed maintenance feed under barrier system for 7d.
1.3.4 modeling period
The animals were randomly divided into 2 groups according to body mass, 12 rats were fed with maintenance feed as a blank group, and 72 rats were fed with model feed as a model group. Body weight was weighed 1 time per week.
The rats in the control group and the model group were fasted to collect blood (tail) 2 weeks after the model group had been given the model feed, and serum was separated as soon as possible after blood collection, and the content of serum TC, TG, LDL-C, HDL-C was measured. Model groups were randomly divided into 5 groups according to TC content, 12 groups each, and the difference in TC, TG, LDL-C, HDL-C content was compared for each group after grouping.
1.3.5 administration of test samples
After modeling is successful and grouping is carried out, the ginseng pseudo-ginseng samples with different proportions are administrated by 5 dose groups through daily gastric lavage, and distilled water with the same volume is administrated by a blank control group and a model control group through daily gastric lavage. The gastric lavage volume was 1 mL/(100 g.d). The blank control group continued to be given maintenance feed, the model control group and 5 sample groups continued to be given model feed. Each mouse was weighed and recorded 1 time per week, and the stomach-lavage amount was adjusted according to the body mass. Rats were observed daily for appetite behavior, status, hair and animal death.
1.3.6 sample collection and related serum index detection
At the end of the experiment, rats were fasted without water for 12h, sampled in femoral artery and centrifuged at 3 000r/min for 10min. Serum was aspirated and assayed for TC, TG, HDL-C, LDL-C content according to kit instructions.
1.4 statistics results
All experimental dataAnd (3) representing. CollectingA one-way analysis of variance was performed using SPSS 13.0 software, with P < 0.05 indicating statistical significance.
4. Results and analysis of pharmaceutical efficacy of the composition
As shown in Table 13, the serum TC and LDL-C, TG contents of the rats in the model control group were extremely significantly increased (P < 0.01) and the serum HDL-C content was extremely significantly decreased (P < 0.01) as compared with the blank control group. Compared with the model control group, the contents of serum TC and LDL-C, HDL-C, TG of the wild ginseng and the notoginseng sample rats in different proportions are not obviously changed (P is more than 0.05), but are improved in different degrees, wherein the proportion of the wild ginseng and the notoginseng is 1:2, the improvement of blood lipid is most obvious.
Table 13 influence of fresh woody mountain ginseng product on lipid content in high lipid model rats (+/-s, n=12)
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Note that: the differences were very significant (P < 0.01) compared to the blank.
5. Conclusion(s)
When the ratio of the mountain under the forest to the pseudo-ginseng is 1:2 (corresponding to the raw medicinal materials), the degree of improving the blood fat of the experimental rats is most obvious, and the trend of improving the blood fat state is obvious although no obvious difference exists compared with a model group, and each group is improved to different degrees, so that the product has definite action and is worthy of popularization.
Example 2
In this embodiment, an auxiliary hypolipidemic tablet is provided, and the preparation method of the tablet is as follows: mixing 250g of ginseng freeze-dried powder under forest (corresponding to 500g of fresh ginseng under forest), 250g of notoginseng extract (corresponding to 1000g of freeze-dried notoginseng), 85g of xylitol and 10g of citric acid uniformly, granulating by a dry method, wherein the granulating parameters are as follows: the feeding speed is 35rpm, the rotation speed of a press roller is 6rpm, the pressure is 35bar, the discharging speed is 100rpm, the screen is 0.8mm, 5g of magnesium stearate is added, the mixture is uniformly mixed, tabletting is carried out, and the tablet is prepared, wherein the tablet is 0.6 g/tablet, and 1000 tablets are prepared.
Example 3
In this embodiment, an auxiliary hypolipidemic capsule is provided, and the preparation method of the capsule is as follows: mixing 250g of under-forest mountain ginseng freeze-dried powder (corresponding to 500g of fresh under-forest mountain ginseng) and 250g of pseudo-ginseng extract (corresponding to 1000g of freeze-dried pseudo-ginseng), granulating by a dry method, wherein the granulating parameters are as follows: the feed speed is 35rpm, the press roller rotation speed is 6rpm, the pressure is 35bar, the discharge speed is 100rpm, the screen is 0.8mm, the materials are filled into capsule shells, and the materials are prepared into capsules, and the weight of the capsules is 0.5 g/granule, so that 1000 granules are prepared.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (3)
1. A pharmaceutical composition for assisting in reducing blood fat, which is characterized by comprising ginseng extract and pseudo-ginseng extract; the preparation method of the ginseng extract comprises the following steps: lyophilizing the alcoholic extract of Ginseng radix; the preparation of the pseudo-ginseng extract comprises the following steps: alcohol extraction is carried out on freeze-dried pseudo-ginseng;
the ginseng is one of the mountain ginseng under the forest and the wild ginseng and the mountain ginseng moving;
the preparation method of the ginseng extract comprises the following steps: taking 500g of mountain ginseng under the forest, adding 4800g of 75% ethanol, carrying out reflux extraction for 30min, filtering, adding 4800g of 75% ethanol into filter residues, filtering, carrying out total extraction for 3 times, combining filtrate to obtain 15120g of filtrate, concentrating the filtrate under reduced pressure at 60 ℃ until the density is 1.20-1.30 g of extract 510g, respectively loading the extract into a tray, pre-freezing the extract at-25 ℃ to-40 ℃ for 5 hours, then putting the extract into a freeze dryer, maintaining the temperature at-25 ℃ to-30 ℃ for 2 hours, vacuumizing to 40-60pa, then heating to the shelf temperature of-20 ℃ for 12 hours, then heating to the shelf temperature of-10 ℃ for 6 hours until sublimation is completed, then heating the shelf temperature to 40 ℃ until analysis is completed, discharging, crushing, and sieving the extract through a 100-mesh sieve to obtain 250g of mountain ginseng under the forest;
the preparation method of the pseudo-ginseng extract comprises the following steps: taking 500g of freeze-dried pseudo-ginseng coarse particles with the diameter of 0.1-0.2cm, adding 4000g of 70% ethanol, reflux-extracting for 60min, filtering, adding 3000g of 70% ethanol into residues, reflux-extracting for 60min, filtering, and combining the two filtrates to obtain 7265g of filtrate; concentrating the filtrate under reduced pressure at 60deg.C to obtain extract with density of 1.1-1.20, collecting extract 267g, and spray drying to obtain spray-dried powder 125g;
in the composition, the mass ratio of the ginseng extract to the pseudo-ginseng extract is 1:2.
2. An auxiliary hypolipidemic product comprising the pharmaceutical composition of claim 1 and a pharmaceutically acceptable carrier;
the auxiliary blood lipid-lowering product is a medicament;
the dosage form of the medicine is unit dosage form suitable for single administration of precise dosage, and is selected from tablets and capsules.
3. The auxiliary hypolipidemic product of claim 2,
the medicine is a tablet, and the tablet also comprises a flavoring agent, a preservative and a filler;
the flavoring agent is xylitol, and the specific preparation method is as follows: uniformly mixing the composition of claim 1, xylitol and citric acid, and granulating by a dry method;
the medicine is a capsule, and the preparation method of the capsule comprises the following steps: the composition of claim 1 is encapsulated after dry granulation.
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