CN114209723A - 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 PDF

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CN114209723A
CN114209723A CN202111657410.XA CN202111657410A CN114209723A CN 114209723 A CN114209723 A CN 114209723A CN 202111657410 A CN202111657410 A CN 202111657410A CN 114209723 A CN114209723 A CN 114209723A
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ginseng
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CN114209723B (en
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周书繁
汪巍
王辉
张雪
秦培红
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Liaoning Herbpex Pharmaceutical Group Co ltd
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention relates to a composition for assisting in reducing blood fat, a product containing the composition and application. The ginseng and the pseudo-ginseng have good auxiliary blood fat reducing effect, the main active parts of the ginseng and the pseudo-ginseng are saponin components, and the probability of moisture absorption and degradation of the saponin active components can be effectively reduced by adopting dry granulation. In order to provide the active ingredient for reducing blood fat with better processing performance, the invention optimizes the extraction process of the saponin ingredients in the medicinal materials and provides a composition which has better drug effect activity and is more suitable for dry granulation.

Description

Composition for assisting in reducing blood fat, product containing composition and application
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 information in this background section is only for enhancement of 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 that is already known to a person of ordinary skill in the art.
Ginseng is a natural tonic, has the effects of treatment, health care, nourishing and body building and the like, mainly comprises ginsenoside, polypeptide, polysaccharide and the like, and is widely applied to the preparation of anti-tumor drugs, cardiovascular and cerebrovascular system protection drugs, nervous system protection drugs, liver injury prevention drugs and antiviral drugs at present.
Modern researches have proved that ginseng has a prominent effect in reducing blood lipid. The research results of the reported influences of ginseng on the hepatic lipid metabolism disorder of the mice with hyperlipidemia indicate that the ginseng with high, medium and low doses can effectively reduce the liver coefficient of the mice with hyperlipidemia, and simultaneously reduce the contents of LDL-C, ALT and TG in serum to realize the efficacy of reducing blood lipid. In the research of exploring ginseng total saponins from Liuwei to reduce blood fat of rats, research results show that the ginseng total saponins can obviously reduce the serum TG and TC contents of the rat with hyperlipidemic hypercholesterolemia, and the ginseng total saponins have the function of reducing blood fat.
Notoginseng radix, belonging to Panax genus of Araliaceae family, is a common clinical Chinese medicine with effects of stopping bleeding, relieving pain, relieving swelling, dispelling blood stasis, tonifying deficiency, strengthening body etc., and has effects of reducing blood cholesterol and blood lipid by using saponins, volatile oil, amino acids, flavonoids, organic acids etc. as main ingredients. Research on the blood lipid regulating function and mechanism of pseudo-ginseng powder is reported by the Dong Jing and the like, and the research proves that the pseudo-ginseng powder obviously reduces the TC, TG and LDL-C levels and the AST and ALT activities in the serum of hyperlipidemic rats; the histological observation result shows that the panax notoginseng powder obviously reduces the liver injury and fatty liver; the molecular level result shows 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 the protein expression of SREBP-2 and SCAP. The conclusion that the panax notoginseng powder has the functions of regulating blood fat and protecting the liver is probably related to the mechanism that the panax notoginseng powder up regulates SIRT1, down regulates LXR-alpha gene expression, further down regulates SCAP/SREBP-2 signal channels to inhibit cholesterol synthesis, and up regulates the gene expression of LDLR to improve the intake of LDL-C in blood circulation by the liver. In addition, the existing research also shows that the pseudo-ginseng can inhibit the proliferation of rat vascular smooth muscle cells stimulated by high-fat serum, and the effects of reducing blood fat and preventing atherosclerosis are proved.
In view of the above research background, the inventors believe that the active ingredients in ginseng and panax notoginseng are mainly saponins, which contain polysaccharide groups, and wet granulation is likely to cause the saponin extract to absorb moisture, thereby shortening the shelf life. The stability and activity of saponin components can be well guaranteed by dry granulation, but polysaccharide groups can be adhered to the surface of the 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 a pharmaceutical composition with an auxiliary blood fat reducing effect, which comprises a ginseng extract and a pseudo-ginseng extract, wherein active ingredients in ginseng and pseudo-ginseng can be effectively extracted by optimizing an extraction mode, and the extracted composition has good processing performance and can be well applied to dry granulation.
In a first aspect of the present invention, a composition for assisting blood lipid reduction is provided, the composition includes a ginseng extract and a panax notoginseng extract, and a preparation method of the ginseng extract includes: lyophilizing the alcoholic extract of Ginseng radix; the preparation of the pseudo-ginseng extract comprises the following steps: extracting lyophilized Notoginseng radix with ethanol.
In the composition of the first aspect, the mass ratio of the ginseng extract to the panax notoginseng extract is 1-6: 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, but not limited to, wild ginseng and mountain ginseng. As known in the art, the wild ginseng has the best medicinal effect, but the wild ginseng is scarce in quantity, the wild ginseng and the wild ginseng grow in the wild forest environment in the same way, and the components and the effects are close to those of the wild ginseng, so the ginseng is the wild ginseng in the forest in the preferred scheme of the invention.
Preferably, the ginseng product is Jilin or Liaoning, and further, the ginseng product comprises one or the combination of Jilin Tonghua, Liaoning New Bin 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 is preferably prepared by the following method: adding Ginseng radix into alcoholic solution, heating, reflux extracting, concentrating to obtain extract, and freeze drying to obtain lyophilized powder.
In the scheme, the alcohol solution is preferably a methanol solution or an ethanol solution, and further, the extraction of the total ginsenoside by the ethanol solution has a good effect, 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.
The times of the heating reflux extraction are preferably three times, and the total extraction time is 90-100 min.
Preferably, the dosage of the ethanol solution is 8-10 times of the mass of the 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 alcoholic solution for extraction. In the process research of drying the extracting solution, the invention discovers that the viscosity of the dried extract 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 stepped heating or cooling mode in the freeze-drying process.
In the above scheme, the freeze drying adopts a step-type cooling or heating, and the specific steps are as follows: and (3) carrying out reduced pressure concentration on the alcohol extract to obtain an extract, prefreezing the extract for 4-6 hours in an environment of-25 to-40 ℃, putting the extract into a freeze dryer, keeping the temperature at-25 to-30 ℃ for 1.5-2.5 hours, vacuumizing to 40-60pa, heating to the temperature of a shelf at-18 to 22 ℃, maintaining for 10-14 hours, heating to the temperature of-8 to 12 ℃, maintaining for 5-7 hours until sublimation is finished, heating the shelf to 38-42 ℃ until resolution is finished, and discharging.
In addition, in the embodiment of the first aspect, the preparation method of the notoginseng extract is as follows: freeze drying Notoginseng radix, pulverizing into coarse particles, 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 scheme, the pseudo-ginseng is preferably Yunnan wenshan pseudo-ginseng, and the pseudo-ginseng with the growth life of seven years or more is preferably selected.
Preferably, the diameter of the coarse particles is 0.1-0.2 cm.
Preferably, the concentration of the ethanol solution is 65-75%, further 68-71%, and 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 times.
Preferably, the extraction solution is searched and concentrated at a lower temperature to obtain an extract, wherein the lower temperature is 55-65 ℃, and the density of the extract is 1.1-1.20.
In a second aspect of the present invention, a product for assisting blood lipid reduction is provided, wherein the product comprises the pharmaceutical composition of the first aspect and a pharmaceutical carrier.
Preferably, the auxiliary blood fat reducing product is one of health products, medicines and special medical foods; further preferably, the auxiliary blood fat reducing product is a medicament.
The above-mentioned embodiment as an auxiliary hypolipidemic agent includes the case where the composition of the first aspect is prepared together with other active ingredients, and also includes the case where the composition of the first aspect is used alone as an active ingredient; in the above preparation cases, the composition accounts for 1-99% of the total amount of the drug, and the dosage of the active ingredient is the technical content that 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 a unit dosage form suitable for single administration of accurate dosage, and comprises oral liquid preparations such as decoction, suspension, syrup, mixture, tincture and the like, and can also be ointment, granules, pills (honeyed pills, water 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 medicine is a tablet or a 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: the composition of the first aspect, xylitol and citric acid are evenly mixed and then dry granulated.
In another embodiment, the medicament is a capsule, and the preparation method of the capsule is as follows: dry granulation of the composition of the first aspect followed by encapsulation.
In a third aspect of the present invention, there is provided a method for reducing blood lipid, the method comprising administering the composition of the first aspect, or the auxiliary blood lipid-lowering product of the second aspect, to an individual in need thereof.
In the embodiment of the third aspect, the subject in need thereof includes but is not limited to subjects in need of treatment, improvement or prevention, and health care, and the dosage of the drug required for the above application is a routine adjustment that can be made by medical staff according to the administration target.
The beneficial effects of one or more technical schemes are as follows:
1. in one embodiment of the invention, the composition with the effect of assisting in reducing blood fat comprises ginseng extract and pseudo-ginseng extract. The existing research results show that the ginsenoside and the notoginsenoside both have certain blood fat reducing activity, but the mechanisms for regulating blood fat of the substances have certain difference, and the blood fat reducing effect can be effectively improved by compounding the substances. Therefore, the invention firstly provides a composition of ginseng extract and pseudo-ginseng extract, and the composition of ginseng extract and pseudo-ginseng extract can exert good blood fat reducing effect through the combination of the ginseng extract and the pseudo-ginseng extract.
2. In another embodiment of the present invention, there is also provided an extraction process of ginseng extract and notoginseng extract, and in view of the purpose of the present invention, it is further intended to provide an extract suitable for dry granulation, wherein the extraction process of the present invention is designed to reduce interference of polysaccharide on the granulation process by optimizing the extraction method and the drying process, and to provide a hypolipidemic composition having a simple preparation process and better industrial performance.
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.
As introduced in the background art, ginseng and pseudo-ginseng have good blood fat reducing effect, and dry granulation is adopted to effectively improve the stability of saponin active ingredients in the medicinal materials, but the saponin extract is usually interfered by polysaccharide ingredients and is easily adhered to the mechanical edge in the processing stage.
In order to make the technical solution of the present invention more clearly understood by those skilled in the art, the technical solution of the present invention will be described in detail below with reference to specific examples and comparative examples.
Example 1 examination of extraction Process
First, investigation of extraction process of mountain ginseng extract under forest
1. Raw material screening
Selecting wild ginseng of Liaoning and Jilin with different growth years, and determining saponin content. The most suitable raw material for producing the wild ginseng under forest is preferably selected.
TABLE 1 screening of raw materials for different varieties of ginseng
Figure BDA0003446093130000051
And (4) conclusion: the content of wild ginseng under the forest, which is regulated by Landmark in Liaoning province, is more than or equal to 4.5 percent of total saponins, the total content of ginsenoside Rg1 and ginsenoside Re is not less than 0.61 percent, and the content of ginsenoside Rb1 is not less than 0.41 percent. Selecting wild ginseng in forest for more than 15 years as raw material.
2. Screening by extraction
Taking the wild ginseng under the forest in the same producing area and the same growth period, respectively extracting by adopting different extraction modes, and screening the optimal extraction mode by taking the extraction rate of the total saponins as an index.
(1) Water extraction: taking 100g of mountain ginseng under forest, adding purified water of 8 times of the raw materials, heating and refluxing for 2 hours, filtering, adding purified water of 6 times of the filter residue, heating and refluxing 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 95% ethanol in an amount which is 8 times that of the raw materials, heating and refluxing for 2 hours, filtering, adding 95% ethanol in an amount which is 6 times that of the filter residue, heating and refluxing for 1 hour, filtering, combining the filtrates, and freeze-drying to obtain the freeze-dried powder.
TABLE 2 Total saponins extraction yield without extraction process
Figure BDA0003446093130000061
And (4) conclusion: the extraction rate of the total ginsenoside in the alcohol extraction mode is obviously higher than that in the water extraction mode, and the alcohol extraction mode is selected for extraction.
3. Screening of extraction Process
And (3) adopting an orthogonal test to investigate the extraction solvent, the extraction time and the extraction frequency of the alcohol extraction process of the mountain ginseng extract under forest.
TABLE 3 factor level table
Figure BDA0003446093130000062
TABLE 4 results of orthogonal experiments
Figure BDA0003446093130000063
Figure BDA0003446093130000071
TABLE 5 ANOVA TABLE
Figure BDA0003446093130000072
And (4) conclusion: by using L9(34) Orthogonal test, taking the extraction rate of total saponins of panax ginseng as an investigation index, carrying out visual analysis, and displaying the results that k2 is more than k3 is more than k1 in factor A, k2 is more than k1 is more than k3 in factor B, k3 is more than k1 is more than k2 in factor C, k3 is more than k2 is more than k1 in factor D, R value is A is more than D is more than C is more than B, namely the influence sequence of all factors is ethanol concentration, extraction frequency, extraction time and solvent amount, so the optimal extraction combination is A2B2C3D3However, since only the ethanol concentration and the extraction frequency have significance on the influence of the extraction rate of the total saponins of panax ginseng, the finally determined extraction process is A2B1C1D3
4. Freeze-drying process
Taking the mountain ginseng extract under forest, pre-freezing the mountain ginseng extract in an environment of-25 to-40 ℃ for 5 hours, putting the mountain ginseng extract into a freeze dryer, keeping the mountain ginseng extract at-25 to-30 ℃ for 2 hours, vacuumizing the mountain ginseng extract to 40 to 60pa, then heating the mountain ginseng extract to the temperature of-20 ℃ on a shelf, keeping the temperature for 12 hours, then heating the mountain ginseng extract to-10 ℃ on the shelf, keeping the temperature for 6 hours until sublimation is finished, heating the mountain ginseng extract to 40 ℃ on the shelf again until resolution is finished, and discharging the mountain ginseng extract.
5. Process for determining freeze-dried powder of mountain ginseng under forest
Taking 500g of wild ginseng under forest, adding 4800g of 75% ethanol, carrying out reflux extraction for 30min, filtering, adding 4800g of 75% ethanol into filter residues, filtering, extracting for 3 times in total, combining filtrates to obtain 15120g of filtrate, concentrating under reduced pressure at 60 ℃ to 510g of extract with the density of 1.20-1.30, putting the extract into a tray, pre-freezing for 5 hours at (-25 ℃ to-40 ℃), putting into a freeze dryer, keeping at-25 ℃ to-30 ℃ for 2 hours, vacuumizing to 40-60pa, heating to-20 ℃ of the shelf temperature, keeping for 12 hours, heating to-10 ℃ of the shelf temperature, keeping for 6 hours until sublimation is finished, heating to 40 ℃ of the shelf temperature until resolution is finished, discharging, crushing, and sieving with a 100-mesh sieve to obtain 250g of wild ginseng freeze-dried powder under forest.
6. Quality control
6.1 mass:
TABLE 6
Figure BDA0003446093130000081
6.2 the detection method of the total saponins comprises the following steps:
6.2.1 reagents
Amberlite-XAD-2 macroporous resin, sigma chemical, u.s.a.
And n-butanol is analyzed and purified.
The ethanol is analyzed and purified.
The neutral alumina is used for chromatography, 100-200 meshes.
Ginsenoside Re was purchased from China institute for drug and biological products.
Weighing 5g of vanillin in the vanillin solution, adding glacial acetic acid to dissolve the vanillin solution, and fixing the volume to 100 mL.
Perchloric acid analysis of alcohols
Glacial acetic acid analytically pure
Ginsenoside Re standard solution: accurately weighing 0.020g of ginsenoside Re standard substance, dissolving with methanol, and diluting to 10.0mL, namely, each milliliter contains 2.0mg of ginsenoside Re.
6.2.2 instruments
Colorimeter and chromatographic column
6.2.3 Experimental procedures
Sample treatment: weighing about 1.000g of sample (according to the amount of ginseng contained in the sample), placing the sample in a 100mL volumetric flask, adding a small amount of water, carrying out ultrasonic treatment for 30min, then adding water to fix the volume to 100mL, shaking up, placing, and absorbing 1.0mL of supernatant for column chromatography.
Column chromatography: a10 mL syringe was used as a chromatography tube, and 3cm Amberlite-XAD-2 macroporous resin was placed therein, followed by addition of 1cm neutral alumina. Washing the column with 25mL of 70% ethanol, discarding the eluent, washing the column with 25mL of water, discarding the eluent, accurately adding 1.0mL of the treated sample solution, washing the column with 25mL of water, discarding the eluent, eluting ginsenoside with 25mL of 70% ethanol, collecting the eluent in an evaporation dish, and placing in a water bath at 60 ℃ to volatilize, thereby performing color development.
Color development: accurately adding 5% vanillin glacial acetic acid solution into the evaporated evaporation pan, rotating the evaporation pan to completely dissolve the residue, adding 0.8mL perchloric acid, mixing, transferring into 5mL centrifuge tube with plug, heating in water bath at 60 deg.C for 10min, taking out, cooling in ice bath, accurately adding glacial acetic acid 5.0mL, shaking, and performing colorimetric determination with standard tube at 560nm wavelength in 1cm cuvette.
Standard tubes: absorbing 100 μ l ginsenoside Re standard solution (2.0mg/mL) in an evaporation dish, evaporating in water bath (below 60 deg.C), or drying with hot air (without overheating), and determining absorbance value. 6.2.4 calculation:
Figure BDA0003446093130000091
in the formula:
x: the total saponin content (calculated by ginsenoside Re) in the sample is g/100 g;
a1: absorbance value of the measured liquid
A2: absorbance value of standard liquid
C: amount of Standard tube ginsenoside Re, μ g
V: sample dilution volume, mL
M: sample mass, g
The result of the calculation retains two significant digits.
Second, study of the extract technology of Panax notoginseng
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 panax notoginseng as raw material, and examines the extraction process of panax notoginseng by taking the extraction rate of panax notoginseng saponins as an index.
1. Raw material screening
1.1 years of growth investigation
Selecting Notoginseng radix from Yunnan Wenshan with different growth years, and determining Notoginseng radix total saponin content. The pseudo-ginseng raw material which is most suitable for production is preferably selected.
TABLE 7
Figure BDA0003446093130000101
And (4) conclusion: with the increase of the growth period of 3-9 years of panax notoginseng, the content of panax notoginseng saponins tends to increase year by year, the increase amplitude decreases year by year after 7 years, and the content of total saponins tends to decrease after 10 years. The pseudo-ginseng is sold in 3-7 years in the market, and the cost is high after 7 years, so that 7-year-old pseudo-ginseng is finally selected as a raw material.
1.2 examination of drying
Most of the commercial panax notoginseng is dried by adopting a drying or sun-drying processing mode, and as the optimal drying mode, 7-year-old fresh panax notoginseng is selected, and the fresh panax notoginseng is processed by adopting different drying modes and the content of panax notoginseng saponins is respectively measured.
TABLE 8
Figure BDA0003446093130000102
And (4) conclusion: according to the determination result, the panax notoginseng saponins are lost to a certain extent no matter which drying mode is adopted, especially drying is carried out, the content loss is large, the drying time is long, and the loss of the panax notoginseng saponins is minimum, so that 7-year-old freeze-dried panax notoginseng is finally selected as the raw material of the panax notoginseng extract.
2. Investigation of extraction Process
Extracting Notoginseng radix extract from lyophilized Notoginseng radix crushed into coarse particles (diameter of 0.1-0.2cm) by ethanol reflux extraction, and selecting the best extraction method for Notoginseng radix extract.
TABLE 9 factor level table
Figure BDA0003446093130000111
TABLE 10 results of orthogonal experiments
Figure BDA0003446093130000112
TABLE 11 ANOVA TABLE
Figure BDA0003446093130000113
Figure BDA0003446093130000121
And (4) conclusion: by using L9(34) Orthogonal test, using the extraction rate of panax notoginseng saponins as an investigation index to carry out visual analysis, and displaying the result that k2 is more than k3 is more than k1 in the factor A, k2 is more than k3 is more than k1 in the factor B, k3 is more than k2 is more than k1 in the factor C, and R value is A is more than B is more than C, namely the influence sequence of all factors is ethanol concentration is more than extraction time and more than extraction times, so the optimal extraction combination is A2B2C3However, because the influence of the concentration of only ethanol on the extraction rate of the panax notoginseng saponins is significant, the finally determined extraction process is A2B2C2
3. Drying
Concentrating Notoginseng radix extractive solution at low temperature (60 deg.C) under reduced pressure to obtain thick extract (density of 1.1-1.20), and spray drying to obtain spray dried powder.
4. Process for determining notoginseng extract
Collecting coarse powder of lyophilized Notoginseng radix with diameter of 0.1-0.2cm (500 g), extracting with 70% ethanol (4000 g) under reflux for 60min, filtering, extracting residue with 3000g 70% ethanol under reflux for 60min, filtering, and mixing the filtrates to obtain filtrate 7265 g. Concentrating the filtrate at low temperature (60 deg.C) under reduced pressure to obtain extract with density of 1.1-1.20, to obtain 267g extract, and spray drying to obtain spray dried powder 125 g.
Third, investigation of composition ratio
Selecting different formulation ratios of the ingredients of the Sanxia mountain ginseng and the pseudo-ginseng respectively to perform experiments of improving the hyperlipidemia of experimental rats, and preferably selecting the optimal formulation ratio
1 materials and methods
1.1 animals, materials and reagents
Healthy SPF grade adult male SD rats, 84, were weighing (200 ± 20) g at the end of the acclimation period. The breeding is carried out in cages, each cage is provided with 3 cages, and the feeding and drinking water are free. The temperature range of the animal feeding laboratory is (25 +/-1) DEG C, the relative humidity is 50-60%, and the light and dark alternating time of day and night is 12 h.
TABLE 12 samples of mountain ginseng and notoginseng in different proportions
Figure BDA0003446093130000122
Figure BDA0003446093130000131
Freeze dried mountain ginseng powder and notoginseng extract.
TC, TG, HDL-C, LDL-C test cassettes, purchased from Hippocampus Kazaki Kaisha (Xiamen) science and technology Co.
Control group feed: the feed is maintained, and the requirement of rodent growth and development can be met;
model group feed: the maintenance feed is added with 20.0 percent of cane sugar, 15.0 percent of lard, 1.2 percent of cholesterol, 0.2 percent of sodium cholate, and proper amount of casein, calcium hydrophosphate, stone powder and the like. Except for the crude fat, the water content, crude protein, crude fat, crude fiber, crude ash, calcium and phosphorus of the model feed all reach the national standards of maintaining the feed.
1.2 instruments and devices
High speed refrigerated centrifuge (Thermo Fisher corporation); metler tloedo Pl303 electronic analytical balance (Shanghai Merle-Teledo, Inc.); an electric heating constant temperature water bath (Beijing Changan scientific instruments Co., Ltd.); type 722 spectrophotometer (shanghai precision scientific instruments ltd); vortex mixer (Shanghai Jingke industries, Ltd.).
1.3 methods
1.3.1 dose grouping and test sample administration time
Male SD rats, 84, were divided into 7 experimental groups of 12 animals each. 5 sample groups, 1 blank control group and 1 model control group with different proportions of the mountain ginseng and the pseudo-ginseng under forest are established in the experiment. The test sample was given for 28 days.
1.3.2 animal modeling, grouping and administration
1.3.3 Adaptation period
Rats were fed maintenance feed under a barrier system for 7 d.
1.3.4 moulding phase
The animals were randomly divided into 2 groups according to body mass, and 12 rats were fed with maintenance feed as a blank control group and 72 rats were fed with model feed as a model group. Body weight was weighed 1 time per week.
After the model group is fed with model feed for 2 weeks, the rats of the blank control group and the model group are fasted to take blood (tail), serum is separated as soon as possible after blood taking, and the TC, TG and LDL-C, HDL-C contents of the serum are determined. The model groups are randomly divided into 5 groups of 12 according to the TC content, and the TC, TG and LDL-C, HDL-C content difference of each group is compared after the grouping.
1.3.5 test sample administration
After successful modeling and grouping, 5 dose groups are intragastrically administered with panax notoginseng samples with different proportions every day, and a blank control group and a model control group are intragastrically administered with distilled water with the same volume every day. The gavage amount is 1mL/(100 g.d). The blank control group was continued to be given maintenance feed, and the model control group and 5 sample groups were continued to be given model feed. Each mouse was weighed and recorded 1 time per week, and the gavage amount was adjusted according to the body mass. The 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 are fasted for 12 hours without water prohibition, blood is collected from femoral artery, and centrifugation is carried out for 10min at 3000 r/min. And (4) sucking the serum, and detecting the contents of TC, TG and HDL-C, LDL-C in the serum according to the kit specification.
1.4 statistical results
All experimental data are as follows
Figure BDA0003446093130000142
And (4) showing. SPSS 13.0 software is adopted to carry out one-factor variance analysis, and P less than 0.05 represents statistical significance.
Fourthly, the result and analysis of the drug effect of the composition
As shown in Table 13, compared with the blank control group, the serum TC and LDL-C, TG content of the rats in the model control group are both increased remarkably (P < 0.01) and the serum HDL-C content of the rats in the model control group is reduced remarkably (P < 0.01). Compared with a model control group, the contents of TC and LDL-C, HDL-C, TG in rat serum and the contents of LDL-C, HDL-C, TG in different proportions of the wild ginseng and the pseudo-ginseng have no obvious change (P is more than 0.05), but are improved to different degrees, wherein the proportion of the wild ginseng to the pseudo-ginseng is 1: 2, the blood fat improvement is most obvious.
TABLE 13 influence of fresh Underwood Panax schinseng C.A. Meyer product on blood lipid content of high lipid model rat (+ -s, n-12)
Figure BDA0003446093130000141
Note: the difference was very significant compared to the blank control group (P < 0.01).
Fifth, conclusion
When the ratio of mountain ginseng to pseudo-ginseng under forest is 1: 2 (equivalent to raw medicinal materials), the degree of improving the blood fat of experimental rats is most obvious, although no significant difference is found compared with model groups, the trend of improving the blood fat state is obvious, each group is improved in different degrees, the product effect is exact, and the method is worthy of popularization.
Example 2
In the embodiment, an auxiliary hypolipidemic tablet is provided, and the preparation method of the tablet comprises the following steps: uniformly mixing 250g of mountain ginseng freeze-dried powder (equivalent to 500g of fresh mountain ginseng), 250g of pseudo-ginseng extract (equivalent to 1000g of freeze-dried pseudo-ginseng), 85g of xylitol and 10g of citric acid, and performing dry granulation, wherein the granulation parameters are as follows: feeding at 35rpm, pressing at 6rpm, pressing at 35bar, discharging at 100rpm, sieving with 0.8mm sieve, adding magnesium stearate 5g, mixing, tabletting, and making into tablet 0.6 g/tablet to obtain 1000 tablets.
Example 3
In the embodiment, a capsule for assisting in reducing blood fat is provided, and the preparation method of the capsule comprises the following steps: uniformly mixing 250g of mountain ginseng freeze-dried powder (equivalent to 500g of fresh mountain ginseng) and 250g of pseudo-ginseng extract (equivalent to 1000g of freeze-dried pseudo-ginseng), and performing dry granulation, wherein the granulation parameters are as follows: feeding at 35rpm, pressing at 6rpm, pressing at 35bar, discharging at 100rpm, and sieving with 0.8mm sieve, encapsulating to obtain capsule, and making into capsule at 0.5 g/capsule to obtain 1000 granules.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. The composition for assisting in reducing blood fat is characterized by comprising a ginseng extract and a pseudo-ginseng extract, and 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: extracting lyophilized Notoginseng radix with ethanol.
2. The composition for assisting in reducing blood fat according to claim 1, wherein the mass ratio of the ginseng extract to the panax notoginseng extract in the composition is 1-6: 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.
3. the composition for assisting in reducing blood lipid according to claim 1, wherein the ginseng is one of, but not limited to, wild ginseng, mountain ginseng under forest; preferably, the ginseng is mountain ginseng under forest;
preferably, the ginseng product is Jilin or Liaoning, and further, the ginseng product comprises one or the combination of Jilin Tonghua, Liaoning New Bin and Liaoning Benxi; the growth period of the ginseng is preferably 10 years or more, and further, the ginseng is a wild ginseng under forest which grows for 15 years or more.
4. The composition for assisting in reducing blood lipid according to claim 1, wherein the ginseng extract is prepared by the following method: adding Ginseng radix into alcoholic solution, heating, reflux extracting, concentrating to obtain extract, and freeze drying to obtain lyophilized powder.
5. The composition for assisting in reducing blood lipid according to claim 4, wherein the alcohol solution is preferably a methanol solution or an ethanol solution, and further, the extraction of the total ginsenoside by the ethanol solution has a good effect, 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;
or the number of times of heating reflux extraction is preferably three, and the total extraction time is 90-100 min;
or the dosage of the ethanol solution is 8-10 times of the mass of the ginseng.
6. The composition for assisting in reducing blood lipid according to claim 4, wherein the freeze-drying adopts a stepwise temperature reduction or temperature rise, and the specific steps are as follows: and (3) carrying out reduced pressure concentration on the alcohol extract to obtain an extract, prefreezing the extract for 4-6 hours in an environment of-25 to-40 ℃, putting the extract into a freeze dryer, keeping the temperature at-25 to-30 ℃ for 1.5-2.5 hours, vacuumizing to 40-60pa, heating to the temperature of a shelf at-18 to 22 ℃, maintaining for 10-14 hours, heating to the temperature of-8 to 12 ℃, maintaining for 5-7 hours until sublimation is finished, heating the shelf to 38-42 ℃ until resolution is finished, and discharging.
7. The composition for assisting in reducing blood lipid according to claim 1, wherein the notoginseng extract is prepared by the following method: freeze drying Notoginseng radix, pulverizing into coarse particles, reflux extracting with ethanol solution to obtain extractive solution, concentrating under reduced pressure to obtain extract, and spray drying to obtain spray dried powder;
preferably, the pseudo-ginseng is preferably Yunnan wenshan pseudo-ginseng, and the pseudo-ginseng with the growth life of seven years or more is preferably selected;
preferably, the diameter of the coarse particles is 0.1-0.2 cm;
preferably, the concentration of the ethanol solution is 65-75%, further 68-71%, and 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 times;
preferably, the extraction solution is searched and concentrated at a lower temperature to obtain an extract, wherein the lower temperature is 55-65 ℃, and the density of the extract is 1.1-1.20.
8. A product for assisting in reducing blood lipid, comprising the pharmaceutical composition of any one of claims 1 to 7 and a pharmaceutically acceptable carrier;
preferably, the auxiliary blood fat reducing product is one of health products, medicines and special medical foods; furthermore, the auxiliary blood fat reducing product is a medicine;
the dosage form of the medicine is a unit dosage form suitable for single administration of accurate dosage, and comprises oral liquid preparations such as decoction, suspension, syrup, mixture, tincture and the like, ointment, granules, pills, powder, tablets, capsules or drops; further, the medicine is a tablet or a capsule.
9. The product of claim 8, wherein the pharmaceutical is a tablet, and the tablet further comprises flavoring agents, preservatives, and fillers;
preferably, the flavoring agent is xylitol, and the specific preparation method is as follows: mixing the composition of any one of claims 1-7, xylitol, and citric acid, and granulating by dry method;
preferably, the medicine is a capsule, and the preparation method of the capsule comprises the following steps: dry granulation of the composition according to any of claims 1 to 7 followed by encapsulation.
10. A method of reducing blood lipids, comprising administering to a subject in need thereof a composition according to any one of claims 1-7, or a supplemental blood lipid lowering product according to claim 8 or 9.
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