CN102266368B - Traditional Chinese medicine composition with functions of regulating blood lipid and delaying aging and manufacturing method thereof - Google Patents

Traditional Chinese medicine composition with functions of regulating blood lipid and delaying aging and manufacturing method thereof Download PDF

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CN102266368B
CN102266368B CN2011102234999A CN201110223499A CN102266368B CN 102266368 B CN102266368 B CN 102266368B CN 2011102234999 A CN2011102234999 A CN 2011102234999A CN 201110223499 A CN201110223499 A CN 201110223499A CN 102266368 B CN102266368 B CN 102266368B
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chinese medicine
medicine composition
traditional chinese
blood lipid
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CN102266368A (en
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黄添友
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GUANGDONG JIUTIAN GREEN PHARMACEUTICAL CO Ltd
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GUANGDONG JIUTIAN GREEN PHARMACEUTICAL CO Ltd
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Abstract

The invention relates to a traditional Chinese medicine composition with functions of regulating blood lipid and delaying aging and a manufacturing method thereof, the traditional Chinese medicine composition is a medicament produced by pharmaceutical enterprises for prevention and auxiliary treatment of cardiovascular and cerebrovascular diseases of the middle-aged and elderly people, and the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-18 parts of Ginkgo leaf extract, 2-6 parts of Panax quinquefolium ultrafine granules and 1-3 parts of pseudo-ginseng ultrafine granules, wherein the Ginkgo leaf extract is obtained by extracting Ginkgo leaf with edible ethanol twice and concentrating the extract at the temperature of 20 DEG C until the specific gravity is 1.18. The manufacturing method comprises the following steps: (1) extracting the active ingredients of the Ginkgo leaf: extracting the Ginkgo leaf with edible ethanol and concentrating the extract at the temperature of 20 DEG C until the specific gravity is 1.18; (2) preparing Panax quinquefolium ultrafine powder and pseudo-ginseng ultrafine powder; and (3) preparing capsules. The traditional Chinese medicine composition provided by the invention is negative in mouse toxicity test and three genicity (carcinogenic, mutagenic and teratogenic) tests, so that the traditional Chinese medicine composition is proved to be non-toxic and safe. Anti-aging and blood lipid regulation experiments of animals prove that the traditional Chinese medicine composition has the functions of regulating blood lipid and resisting aging. The traditional Chinese medicine composition has unique formula and significant effect; the production process is simple and excellent; and the traditional Chinese medicine composition is suitable for industrial production.

Description

A kind of Chinese medicine composition and manufacturing approach with blood lipid regulation, slow down aging
Technical field
The present invention relates to medicine enterprise and be prevention of middle-aged and elderly people cardiovascular and cerebrovascular disease and adjuvant therapy medicaments.
Background technology
Cardiovascular and cerebrovascular disease is that present China and even whole world sickness rate, disability rate and mortality rate are the highest disease, has data to show that China has 3,000,000 people to die from cardiovascular and cerebrovascular disease every year approximately, accounts for about 40% of whole causes of death.And hypertension, dyslipidemia, overweight and fat, smoking, shortage physical exercise, unreasonable meals etc. are the main hazard factors of cardiovascular and cerebrovascular disease.The main pathogenesis of cardiovascular and cerebrovascular disease is " hyperlipemia ", and the atherosclerosis more than 80% is caused by hyperlipemia.Therefore, remove at ordinary times physical exercises of noting strengthening, clocklike life and rational meals are added the conditioning of certain effectively Chinese medicine, can reduce the generation of cardiovascular and cerebrovascular disease greatly more.At present, mark has blood fat reducing on the market, and health product such as vessel softening have tens kinds, but effect is not fully up to expectations reliably.
Summary of the invention
One of the object of the invention provides a kind of compositions that is applicable to old man's cardiovascular and cerebrovascular disease in prevention and the auxiliary treatment.
Another object of the present invention is the compositions manufacturing approach that is applicable to prevention and auxiliary treatment middle-aged and elderly people cardio-cerebrovascular disease.
A kind of Chinese medicine composition technical scheme with blood lipid regulation, slow down aging of the present invention is a weight portion
Extraction of Folium Ginkgo 10 ~ 18 food grade ethanol secondary parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
2 ~ 6 parts of superfine powder of Radix Panacis Quinquefolii with
1 ~ 3 part of superfine powder of Radix Notoginseng.
The above, it is formed with raw materials in weight portion:
Food grade ethanol second extraction that Folium Ginkgo is 12 ~ 16 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
3 ~ 5 parts of superfine powder of Radix Panacis Quinquefolii with
1.5 ~ 2.5 parts of superfine powder of Radix Notoginseng.
Raw materials in weight portion of the present invention is formed:
Food grade ethanol second extraction that Folium Ginkgo is 14 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
4 parts of superfine powder of Radix Panacis Quinquefolii with
2 parts of superfine powder of Radix Notoginseng.
A kind of Chinese medicine composition manufacturing approach of the present invention with blood lipid regulation, slow down aging, its characteristic is pressed following order:
⑴, effective component of ginkgo leaf extract:
Get Folium Ginkgo 10 ~ 18 weight portions and put into the multi-functional Chinese medicine extraction pot, add 150 parts of 40% ~ 80% food grade alcoholic solution, after boiling; Reflux, extract, 2 hours is filtered extracting solution, filtrate for later use; Medicinal residues add 120 parts of 40% ~ 80% food grade alcoholic solution again; After boiling, reflux, extract, 1.5 hours is filtered extracting solution.Merge filtrate twice, in the ethanol recycling can, reclaim ethanol, change vacuum concentration pot then over to, being concentrated into liquid specific gravity is 1.18 (20 ℃), is mainly contained the flavonoid extracting solution, subsequent use;
⑵, Radix Panacis Quinquefolii, superfine notoginseng powder preparation:
Get 4 parts of Radix Panacis Quinquefoliis, 2 parts of Radix Notoginseng, put into heated-air circulation oven respectively, 50 ℃ of dryings 3 hours are carried out micronizing with fluid energy mill powder machine respectively, the above superfine powder of 200 orders.Then superfine powder is put into the high pressure steam sterilization cabinet, 115 ℃ of sterilizations 30 minutes change in the heated-air circulation oven again, and 50 ℃ of dryings 1 hour are subsequent use;
⑶, capsule preparation:
⑵ superfine powder is put into the grooved blender, add 4. extracting solution of ⑴ embodiment, mix homogeneously is put into oscillating granulator, processes 20 purpose wet granulars.Wet granular is put into heated-air circulation oven, and 60 ℃ of oven dry are made into uniform dried granule then in granulator, encapsulated with automatic capsule-packaging machines, the 500mg/ grain, and bottling, through after the assay was approved, packing gets product.
The present invention utilizes Folium Ginkgo to have: the ⑴ cholesterol reducing, and triglyceride reduces blood flow viscosity, the effect of protection Ischemic Heart; ⑵ improve the brain cell amount of blood supply, and to old and feeble dull-witted, disordered brain function has good improvement effect.Radix Panacis Quinquefolii has: the ⑴ effect for reducing blood fat; ⑵ immunoregulation effect; ⑶ anti-aging effects etc.Radix Notoginseng has blood circulation promoting and blood stasis dispelling, softening and eliminating sputum, the characteristics prescription of effects such as reducing swelling and alleviating pain.For a kind of blood lipid regulation that has is provided, vessel softening, mediation blood vessels, slow down aging is in being fit to, the health food taken for a long time of old people and people with hyperlipidemia.
Prescription of the present invention is to act on theory of Chinese medical science (hyperlipidemia belongs to the cause of disease category of motherland's medical science " stagnation of QI, turbid, the blood stasis of the stasis of blood ") and formulation principle; And combination modern science result of experiment; Folium Ginkgo, Radix Panacis Quinquefolii, Radix Notoginseng is combined, strengthened the blood lipid regulation and the slow down aging effect of three flavor medicines.It is unique that it is filled a prescription, scientific and reasonable, meets the formulation principle of China's theory of Chinese medical science " monarch, minister, help, make ", has the medicine letter and smart, with strong points, and the characteristic of the auxilliary effect of taking advantage of is mutually mutually arranged.
Contain effective active compositions such as abundant plant complex polysaccharide, ginsenoside, flavonoid, each seed amino acid, vitamin and various trace elements in the prescription, this chemical compound can play the liver protecting, blood lipid regulation, enhancing immunity, defying age, antioxidative effect well.
The Folium Ginkgo chemical constituent consists predominantly of flavonoid in the compositions, ginkegetin, different ginkegetin, demethyl ginkegetin, globulariacitrin, kaempferol-3-scillabiose, kaempferol, Quercetin, isorhamnetin etc.; Other contains bitter principle Semen Ginkgo three lactone A, B, C and the new lactone A of Semen Ginkgo etc.Pharmacological action mainly contains: 1. to the influence of cerebral circulation and blood brain barrier: gingko leaf preparation can improve the brain cell metabolism; Reduce blood-brain barrier permeability; Can obviously alleviate common carotid artery and inject rat brain hemisphere thromboembolism and the cerebral edema that the radioactivity microsphere causes; And making brain cell energy metabolism normalization, cerebral blood flow increases.2. to the effect that all has clear improvement of senile functional disorders of brain, brain insufficiency, insomnia, memory impairment.3. to the effect of cardiovascular system: to normal or loose heart, can protect ischemic myocardium, reduce the generation of arrhythmia.4. have effects such as the free radical of removing, anti peroxidation of lipid, anti-platelet activating factor, anticoagulant, blood fat reducing.
Main component is ginsenoside, flavonoid, polysaccharide and essential amino acid etc. in the Radix Panacis Quinquefolii.Confirmed that the Radix Panacis Quinquefolii effect comprises: 1. strengthen central nervous system function, the Saponin in the Radix Panacis Quinquefolii can effectively strengthen nervus centralis, reach with all worries set aside with fixed attention, effects such as allaying tiredness, memory reinforcing.2. promote albumen synthetic, human body immunity improving power, cancer is effectively resisted in the anticancer growth.3. Radix Panacis Quinquefolii can arrhythmia, resisting myocardial ischemia, anti-myocardium oxidation, strengthen cardiac contractility ability; Can effectively reduce temporary and the persistency blood pressure, help the recovery of diseases such as hypertension, arrhythmia, coronary heart disease, acute myocardial infarction, cerebral thrombosis.
From Radix Notoginseng, separate the chemical constituent obtain and mainly contain trace element such as a great number of elements such as saponin, flavone, volatile oil, aminoacid, polysaccharide, starch, protein etc. and part inorganic chemistry composition such as nitrogen, phosphorus, potassium and cobalt, molybdenum, caesium.Its main effect comprises: the 1. Radix Notoginseng total glycosides effect of invigorating blood circulation, can expand cardiovascular, and increase coronary flow, suppress thrombosis, antiplatelet aggregation, and can dissolve established thrombosis, having additional nutrients property myocardial flow.2. has the anti-liver injury effect.It is active that Radix Notoginseng total arasaponins can significantly reduce carbon tetrachloride hepatic injury mice serum alanine transaminase.3. the effect that has immune two-ways regulation agent, but the not normal immunoreation of interference body.
So composite formula of the present invention has following effect:
Formula components of the present invention is pure Chinese crude drug, is equipped with the advanced extraction mode effective component extracting of modern science, and through a large amount of scientific experiments data acknowledgements:
1, nontoxic: prescription of the present invention, through acute toxicity test in mice (LD50), the result has not found intoxicating phenomenon according to " toxicological evaluation of food safety procedure and method ", explains that this prescription belongs to nontoxic level material.The result is negative for the mouse bone marrow cells micronucleus test, explains that this prescription does not have mutagenesis to somatic cell.The mouse sperm deformity result of the test is negative, explains that this prescription does not have mutagenesis to sexual cell.The Salmonella reversion test result is negative, and the no direct or indirect mutagenic action of this prescription is described.
2, have the blood lipid regulation effect: Folium Ginkgo is rich in the flavonoid composition in the present invention's prescription; And flavone compound has blood vessel dilating; Improve blood circulation state; Have and purify the blood blood pressure lowering, blood fat reducing, blood sugar lowering, cholesterol reducing, blood viscosity lowering, effects such as arteriosclerosis and antithrombotic formation.Contained ginsenoside has nervus centralis adjusting, blood pressure regulation, blood fat reducing, antitumor action etc. in Radix Panacis Quinquefolii and the Radix Notoginseng.The present invention is according to " the health food function assessment assessment process and the method for inspection "; Through animal (rat) experiment confirm; The rat blood serum triglyceride of using the present invention's prescription obviously reduces; Serum high-density LP obviously raises, and confirms that through above result this invention prescription has the blood fat reducing effect.
2, have anti-aging effects: SOD plays crucial effects as antioxidase main in the body to the oxidation and the antioxidation balance of body.The height of SOD vigor has reflected the ability of body removing oxygen-derived free radicals indirectly, and with aging, tumor etc. substantial connection is arranged.MDA is that oxygen-derived free radicals is attacked unsaturated fatty acid in the biomembrane and the lipoperoxide that forms, and it can generate polymer and react with body internal protein and DNA, and proteinic structure is morphed, thereby causes cell to lose normal function.But the variation of oxygen-derived free radicals content in the variation indirect reaction tissue of MDA content.The result shows through zoopery; Compare with model group; The mouse aging MDA content of using prescription group of the present invention obviously reduces; The SOD activity then obviously increases, and according to the criterion of " the health food function assessment assessment process and the method for inspection ", confirms that present composition prescription has function in delaying senility.
4, compound composition characteristic: the present composition has only comprised three flavor Chinese medicines; Reach to the Chinese medicine preparation combination of tens flavors different with tens traditional flavors; Zoopery confirms; The combination of this three flavors Chinese medicine can reach the Chinese medicine preparation combination effect of tens flavors and even tens flavors, even is better than the combination of kinds of traditional Chinese medicines, this maybe and medicine between different chemical composition produce due to the antagonism.Therefore, screening single, two herbal medicine compatibilities, and have synergistic Chinese medicine ingredients, and not only can reduce cost, avoid the wasting of resources, and can improve curative effect.The present invention both had been based on this thinking, and selected three flavor Chinese medicines; Folium Ginkgo, Radix Panacis Quinquefolii and Radix Notoginseng all are the sage's article of YIN nourishing vessel softening and blood circulation promoting and blood stasis dispelling of fostering the spirit of nobility.Folium Ginkgo as monarch drug, has and astringes the lung in the present composition, relievings asthma blood circulation promoting and blood stasis dispelling, analgesic effect.And Radix Panacis Quinquefolii and Radix Notoginseng are used separately as ministerial drug and adjuvant drug, put down in writing in the supplementary Amplifications of the Compendium of Materia Medica: " ginseng qi-tonifying the first, Radix Notoginseng enrich blood first ".Therefore, combination and compatibility of the present invention meets the formulation principle of China's theory of Chinese medical science " monarch, minister, help, make ", has the auxilliary mutually merit of taking advantage of, and has strengthened the effects such as blood lipid regulation and slow down aging of three flavor medicines, and the zoopery result has also confirmed this effect.
5, the optimization of manufacturing process: the main effective ingredient of Folium Ginkgo is flavonoid glycoside and Ginkgo total lactones etc. in this prescription.Its method of extracting preparation is a lot, though the effective component yield that some method is extracted is very high, and organic solvent reject up hill and dale in the process of extracting, residual organic solvent is deleterious to human body.In order to screen the safety of best extraction process and guarantee extract, the present invention adopts the ethanol of food grade, has at first ensured the safety of extract.In order to ensure that the invention compositions has practicality; On the technology of extracting, done groping of a large amount of extraction conditions; Comprised the time of concentration of alcohol, temperature and reflux, extract, etc.; According to prepared active component content, finally the concentration of selected ethanol extraction is 50% then, and reflux, extract, 2 hours was an optimum condition.
Blood lipid regulation effect animal experiment
1, test objective:
Observe " good fortune longevity recovering capsule " blood lipid regulation effect through animal experiment to hyperlipemia rat.
2, test material:
2.1, sample:
Good fortune longevity recovering capsule is every day 2 times according to recommended amounts, and each 2, every 0.5g counts 0.0333g/kg.b.w by the 60kg adult, test required each concentration and all dilutes formulated with pure water.
2.2, dosage:
If high lipid food matched group, normal diet matched group and basic, normal, high three dose groups, dosage is following respectively:
2.2.1, low dose group: 0.17g/kg.b.w, be equivalent to recommend 5 times of day dosing.
2.2.2, middle dose groups: 0.33g/kg.b.w, be equivalent to recommend 10 times of day dosing.
2.2.3, high dose group: 1.00g/kg.b.w, be equivalent to recommend 30 times of day dosing.
2.3, animal:
Male SD rat, body weight 188 ± 16g is provided quality certification 2001A046 by medical animal field, Guangdong Province.And rat normal feedstuff powder and pellet be provided.
2.4, instrument and reagent:
2.4.1, instrument: Hitachi's 7060 full automatic biochemical apparatus.
2.4.2, reagent: serum total cholesterol is used the COD 3-Hydroxysteroid oxidase method, and triglyceride is with 3-phosphorus GPO method, and HDL-C adopts direct COD 3-Hydroxysteroid oxidase method of two steps, by German Roche Holding Ag test kit is provided.
2.5, tried the thing approach: irritate stomach with 10ml/kg.b.w and tried thing every day.
3, test method:
3.1, laboratory animal divides into groups: set up normal diet matched group, positive controls, low dose group, middle dose groups, 5 experimental grouies of high dose group.
3.2, animal experiment: with 61 SD kinds is rat; Feed and give the base particle feedstuff wherein 13 (normal diet matched group) every day; Feed all the other 48 every days and give high fat nutrient fodder (prescription is: 79% normal feedstuff powder, 1% cholesterol, 10% yolk powder and 10% Adeps Sus domestica; In 80 ℃ of baking ovens, dry, process the high fat nutrient fodder of strip).
To before being tried thing, detect serum total cholesterol (TC), triglyceride (TG) level respectively, be divided into the normal diet matched group at random according to serum total cholesterol level, high lipid food matched group and basic, normal, high given the test agent group.Experimental group and high lipid food matched group all give high lipid food, and the normal diet matched group is fed and given the base particle feedstuff.Weigh weekly, receive thing according to body weight, continue 30 days, after weighing in the 31st day, get whole blood, separation of serum is surveyed three blood lipid levels.
4, result:
4.1, the green board good fortune longevity health of the Ninth Heaven is to the influence (seeing table one) of animal subject body weight:
Give the green board good fortune longevity recovering capsule of the Ninth Heaven after 30 days, each body weight and matched group comparison, difference do not have significance meaning (P>0.05).
Table one: the green board good fortune longevity recovering capsule of the Ninth Heaven is to the influence of animal subject body weight
Figure DEST_PATH_IMAGE001
4.2, the green board good fortune longevity health of the Ninth Heaven is to the influence (seeing table two) of animal subject serum total cholesterol (TC):
Give the green board good fortune longevity recovering capsule of the Ninth Heaven after 30 days, normal diet matched group serum total cholesterol (TC) and high lipid food matched group relatively, difference has highly significant property meaning (P < 0.01), shows that hyperlipidemia model sets up; Each dose groups serum cholesterol level (TC) and high lipid food matched group relatively, difference does not have significance meaning (P>0.05); The result shows that sample is to the negative result of the influence of T-CHOL index.
Table two: the green board good fortune longevity health of the Ninth Heaven is to T-CHOL result's influence
Figure 712399DEST_PATH_IMAGE002
4.3, the green board good fortune longevity health of the Ninth Heaven is to the influence (seeing table three) of animal subject serum triglycerides (TG) level
Give the green board good fortune longevity recovering capsule of the Ninth Heaven after 30 days, normal diet matched group serum triglycerides (TG) and high lipid food matched group relatively, difference has significance meaning (P < 0.01), shows that hyperlipidemia model sets up; High dose group serum triglycerides (TG) reduces than high lipid food matched group, with the high lipid food matched group relatively, difference has highly significant property meaning (P < 0.01), the result shows that sample is to the positive result of the influence of triglyceride index.
Table three: the green board good fortune longevity health of the Ninth Heaven is to the influence of triglyceride
Figure DEST_PATH_IMAGE003
Annotate: * * is that dose groups and high fat matched group compare P < 0.01
4.4, the green board good fortune longevity health of the Ninth Heaven is to the influence (seeing table four) of animal subject serum high-density LP cholesterol (HDL-C):
Give the green board good fortune longevity recovering capsule of the Ninth Heaven after 30 days, high dose group serum high-density LP cholesterol (HDL-C) raises than high lipid food matched group, with the high lipid food matched group relatively, difference has significance meaning (P < 0.05).
Table four: the green board good fortune longevity recovering capsule of the Ninth Heaven is tried the influence of HDL-C level behind the thing
Figure 19752DEST_PATH_IMAGE004
Annotate: * is that dose groups and high fat matched group compare P < 0.05
5, conclusion:
5.1, the green board good fortune of Ninth Heaven longevity recovering capsule high dose group and high lipid food matched group relatively, serum triglycerides reduces.The high lipid food matched group relatively, difference has highly significant property meaning (P < 0.01).
5.2, the green board good fortune of Ninth Heaven longevity recovering capsule serum high-density LP cholesterol (HDL-C) high dose group raises than high lipid food matched group, with the high lipid food matched group relatively, difference has significance meaning (P < 0.05).
According to The above results,, confirm that the green board good fortune longevity recovering capsule of the Ninth Heaven has the effect of regulating animal lipid according to the criterion of " the health food function assessment assessment process and the method for inspection ".
The green board good fortune of Ninth Heaven longevity recovering capsule toxicology test
One, acute toxicity test in mice (LD50)
1, material:
1.1, test material:
Sample is a brown ceramic powder, is mixed with each test group experiment desired concn with distilled water.
1.2, animal:
By the NIH kind healthy mice that medical animal field, Guangdong Province provides, body weight 18-35g, male and female half and half.Quality certification 00A025.
2, method and result:
2.1, test method:
40 of NIH kind white mice, body weight 18-22g, female, male half and half, adopt the Horn`s method, at random mice is divided into 4 dose groups, irritated stomach twice, two minor tick 4 hours with the filling stomach amount of 0.2ml/10g.b.w on an empty stomach in 24 hours, observe a week, the result sees table one.
Table one: the green board good fortune of Ninth Heaven longevity recovering capsule The acute toxicity tests
Figure DEST_PATH_IMAGE005
2.2, the result:
Tried its mouse oral clothes various dose (LD50>21.5g/kg.b.w) good fortune longevity recovering capsule, all not observing mice has toxic reaction, shows that good fortune longevity recovering capsule is an innocuous substance.
Two, mouse bone marrow cells micronucleus test:
1, material:
1.1, test material:
Sample is a brown ceramic powder, is mixed with each test group experiment desired concn with distilled water.
1.2, animal:
By the NIH kind healthy mice that medical animal field, Guangdong Province provides, body weight 18-35g, male and female half and half.Quality certification 00A025.
2, method and result:
2.1, test method:
60 of NIH kind white mice, body weight 25-30g, female, hero half and half; At random mice is divided into 6 groups, test is undertaken by " toxicological evaluation of food safety procedure and method ", irritates stomach at twice; In irritating stomach after 6 hours for the second time, put to death mice and get bone marrow of sternum material smear, dyeing, microscopy, obtain and respectively organize micronuclear rates; The result is by Poisson distribution method statistics, and the result sees table two.
Table two: the green board good fortune of Ninth Heaven longevity recovering capsule mouse bone marrow cells micronucleus test result
Figure 124456DEST_PATH_IMAGE006
* and negative control group be p < 0.01 relatively.
2.2, the result:
The micronuclear rates of each dose groups and negative control group relatively, statistics there are no significant difference, result of the test is negative, shows that good fortune longevity recovering capsule does not have mutagenesis to somatic cell.
Three, mouse sperm deformity test:
1, material:
1.1, test material:
Sample is a brown ceramic powder, is mixed with each test group experiment desired concn with distilled water.
1.2, animal:
By the NIH kind healthy mice that medical animal field, Guangdong Province provides, body weight 18-35g, male and female half and half.Quality certification 00A025.
2, method and result:
2.1, test method:
25 of NIH kind male mices, body weight 25-35g is divided into 5 groups at random; Continuous irrigation stomach 5 days (the positive group of cyclophosphamide is made lumbar injection) is irritated stomach amount: 0.20ml/10g.b.w, after 35 days, puts to death animal and gets the bilateral epididymis by conventional film-making, dyeing; The oil mirror is checked 5000 of every group of complete sperms down; Obtain rate of teratosperm, carry out statistical procedures by Wilcoson rank test method, the result sees table three.
Table three: recovering capsule of green good fortune longevity of the Ninth Heaven is to the influence of mouse sperm form
Figure 988507DEST_PATH_IMAGE007
* and negative control group be p < 0.01 relatively.
2.2 result:
The rate of teratosperm of each dose groups and negative control group compare, difference meaning that there are no significant on statistics.Sample does not all find that at dosage sexual cell is had the effect of mutation deformity during up to 10.00g/kg.b.w, shows that good fortune longevity recovering capsule does not have mutagenesis to sexual cell.
Four mammal microsomal enzymes tests (Salmonella reversion test)
1 materials and methods:
1.1 test strain:
Through identifying satisfactory Salmonella typhimurium histidine defect type TA97, TA98, TA100, TA102 test strain.
1.2 metabolism activation system:
The inductive rat liver homogenate S9 of Polychlorinated biphenyls (PCB) liquid (when the metabolism activation, adding).
1.3 tried thing and dosage is selected:
With the sterile distilled water dilution, boiling water bath was for experiment after 30 minutes before the experiment.Through trial test, got minimum toxicity dose as maximum dose level to try thing.
1.4 test method (flat board mixes method):
In the top layer culture medium, add 0.1ml test strain enrichment liquid, 0.1ml is tried thing solution and 0.5ml S9 mixed liquor (when the metabolism activation, adding), pours into behind the mixing on the bottom culture medium flat plate, and each dose groups is three wares.According to being tried thing toxicity test result, establish 5000,1000,200,40, five dose groups of 8ug/ ware, establish simultaneously from beaming back change, solvent control, the contrast of positive mutagenic agent, cultivated 48 hours down at 37 ℃, write down the every ware of each test group and return the change clump count.As tried thing and return the increase that becomes clump count and surpass solvent control more than 2 times, and dosage-partaker is arranged, be judged to be the mutagenesis positive.
2 results:
Visible by table four, table five; The green board good fortune longevity recovering capsule of the Ninth Heaven is to Salmonella typhimurium TA97, TA98, TA100, TA102 four strain test strains; When adding and do not add S9; 5000,1000,200,40, five dose groups of 8ug/ ware return and become the bacterium colony number average and surpass 2 times of solvent control clump counts, also do not have dose-response relationship.No matter when adding and do not add the S9 mixed liquor, each dose groups does not cause that all the recovery mutation colony number of test strain significantly increases, and shows that the Salmonella reversion test result is negative, also explains that good fortune longevity recovering capsule does not have direct or indirect mutagenic action.
Table four: the green board good fortune longevity recovering capsule of the Ninth Heaven to Salmonella typhimurium return to become result's (for the first time) ( ± s)
Table five: the green board good fortune longevity recovering capsule of the Ninth Heaven to Salmonella typhimurium return to become result's (for the second time) ( ± s)
Figure DEST_PATH_IMAGE009
The zoopery of defying age drug effect
1, test objective:
Observe the effect of " good fortune longevity recovering capsule " defying age medicine through animal experiment.
2, test material:
2.1, sample:
Good fortune longevity recovering capsule is every day 2 times according to recommended amounts, and each 2, every 0.5g counts 0.0333g/kg.b.w by the 60kg adult, test required each concentration and all dilutes formulated with pure water.
2.1.1, low dose group: 0.17g/kg.b.w, be equivalent to recommend 5 times of day dosing.
2.1.2, middle dose groups: 0.33g/kg.b.w, be equivalent to recommend 10 times of day dosing.
2.1.3, high dose group: 1.00g/kg.b.w, be equivalent to recommend 30 times of day dosing.
2.2, main agents: malonaldehyde (MDA), superoxide dismutase (SOD), Nanjing is built up bio-engineering research and is provided; Hydrocortisone injection 10mg/2mlx10 props up, the accurate word H41021173 of traditional Chinese medicines.
2.3, age in laboratory animal: 6-8 week 50 of kunming mices, body weight (20 ± 3) g, male and female half and half, Nanfang Medical Univ's Experimental Animal Center provides.Be divided into blank control group, model group, high dose group, middle dose groups, low dose group at random, 10 every group.
3, experimental technique:
3.1, the animal modeling: except that the blank group, other the group mice carry out intramuscular injection hydrocortisone 2.5mg/100g, once a day, continuous seven days.The observation animal sees that " it is hunchbacked to curl for movable minimizing the, bradykinesia, and the limb tail is cool, loses weight, and body temperature descends " is the modeling success.
3.2, zoopery: the mice after the modeling success is divided into model group, high dose group, middle dose groups, low dose group, 10 every group.The corresponding dosage gastric infusion that high dose group, middle dose groups, low dose group mice are grown up by 60kg, sooner or later respectively once, continuous 15 days.
After administration finishes, get blood after each treated animal weighed, drip respectively in heparin sodium anticoagulant test tube, 37 ℃ of temperature are bathed the centrifugal 20min of 3000r/min after 2 hours, get supernatant, and are to be measured.
3.3, MDA, SOD detect: MDA, SOD detection method are carried out according to the test kit description.
4, result:
4.1, blank control group and modeling group mice forebody-afterbody anharmonic ratio (seeing table one):
Table one, blank, two groups of mice Body Mass Indexs of modeling result's comparison mg/g -1
Figure 281134DEST_PATH_IMAGE010
Experiment mice is after injecting hydrocortisone in continuous 7 days, and model group is compared with the blank group, and model group mice body weight obviously reduces (P<0.05), has significant difference.
4.2, good fortune longevity recovering capsule is to the influence (see table two) of hydrocortisone to mouse aging MDA:
Table two: good fortune longevity recovering capsule is to the influence of hydrocortisone to mouse aging MDA
Figure DEST_PATH_IMAGE011
Mice after the modeling success, after pouring into good fortune longevity recovering capsule in continuous 15 days, each is organized mice and detects MDA content respectively.The result is visible: 1. model group MDA content obviously raises (P<0.05) than the blank group, and the modeling success is described; 2. the high, medium and low dosage intervention group of good fortune longevity recovering capsule MDA content significantly is lower than model group (P<0.05).Explain that the intravital MDA content of mice obviously reduces after using good fortune longevity recovering capsule, have significant difference (P<0.05).
MDA is that oxygen-derived free radicals is attacked unsaturated fatty acid in the biomembrane and the lipoperoxide that forms, and it can generate polymer and react with body internal protein and DNA, and proteinic structure is morphed, thereby causes cell to lose normal function.But the variation of oxygen-derived free radicals content in the variation indirect reaction tissue of MDA content.Experimental result shows, compares with model group, uses good fortune longevity recovering capsule group mouse aging MDA content and obviously reduces.
4.3, good fortune longevity recovering capsule is to the influence (see table three) of hydrocortisone to mouse aging SOD:
Table three: good fortune longevity recovering capsule is to the influence of hydrocortisone to mouse aging SOD
Figure 344904DEST_PATH_IMAGE012
Mice after the modeling success, after pouring into good fortune longevity recovering capsule in continuous 15 days, each is organized mice and detects SOD content respectively.The result is visible: 1. model group SOD content is starkly lower than blank group (P<0.01), and the modeling success is described; 2. the high, medium and low dosage intervention group of good fortune longevity recovering capsule SOD content is significantly higher than model group (P<0.01).Explain that the intravital SOD content of mice obviously increases after using good fortune longevity recovering capsule, have significant difference (P<0.01).
SOD plays crucial effects as antioxidase main in the body to the oxidation and the antioxidation balance of body.The height of SOD vigor has reflected the ability of body removing oxygen-derived free radicals indirectly, and with aging, tumor etc. substantial connection is arranged.Experimental result shows, compares with model group, uses good fortune longevity recovering capsule group and can obviously improve mouse aging SOD activity.
According to The above results,, confirm that the green board good fortune longevity recovering capsule of the Ninth Heaven has function in delaying senility according to the criterion of " the health food function assessment assessment process and the method for inspection ".
The specific embodiment
(1) a kind of Chinese medicine composition with blood lipid regulation, slow down aging, form by following raw materials in weight portion:
Compositions embodiment one:
Food grade ethanol second extraction that Folium Ginkgo is 14 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
4 parts of superfine powder of Radix Panacis Quinquefolii with
2 parts of superfine powder of Radix Notoginseng
Compositions embodiment two:
Food grade ethanol second extraction that Folium Ginkgo is 10 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
6 parts of superfine powder of Radix Panacis Quinquefolii with
3 parts of superfine powder of Radix Notoginseng
Compositions embodiment three:
Food grade ethanol second extraction that Folium Ginkgo is 18 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
2 parts of superfine powder of Radix Panacis Quinquefolii with
1 part of superfine powder of Radix Notoginseng
Compositions embodiment four:
Food grade ethanol second extraction that Folium Ginkgo is 12 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
5 parts of superfine powder of Radix Panacis Quinquefolii with
2.5 parts of superfine powder of Radix Notoginseng
Compositions embodiment five:
Food grade ethanol second extraction that Folium Ginkgo is 16 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
3 parts of superfine powder of Radix Panacis Quinquefolii with
1.5 parts of superfine powder of Radix Notoginseng
(2) the present invention has the Chinese medicine composition of blood lipid regulation, slow down aging, and its dosage form is tablet, oral liquid, capsule.
(3) the present invention has the manufacturing approach of the Chinese medicine composition of blood lipid regulation, slow down aging, comprises the following steps:
(1), effective component of ginkgo leaf extracts:
Compositions manufacturing approach embodiment is 80% ethanol extract 1.: get 10 parts of weight portions of Folium Ginkgo and put into the multi-functional Chinese medicine extraction pot, add 150 parts of 80% food grade alcoholic solution, after boiling; Reflux, extract, 2 hours is filtered extracting solution, filtrate for later use; Medicinal residues add 120 parts of 80% food grade alcoholic solution again; After boiling, reflux, extract, 1.5 hours is filtered extracting solution.Merge filtrate twice, in the ethanol recycling can, reclaim ethanol, change vacuum concentration pot then over to, being concentrated into liquid specific gravity is 1.18 (20 ℃), is mainly contained the flavonoid extracting solution, subsequent use.
Compositions manufacturing approach embodiment is 70% ethanol extract 2.: get 12 parts of weight portions of Folium Ginkgo and put into the multi-functional Chinese medicine extraction pot, add 150 parts of 70% food grade alcoholic solution, after boiling; Reflux, extract, 2 hours is filtered extracting solution, filtrate for later use; Medicinal residues add 120 parts of 70% food grade alcoholic solution again; After boiling, reflux, extract, 1.5 hours is filtered extracting solution.Merge filtrate twice, in the ethanol recycling can, reclaim ethanol, change vacuum concentration pot then over to, being concentrated into liquid specific gravity is 1.18 (20 ℃), is mainly contained the flavonoid extracting solution, subsequent use.
Compositions manufacturing approach embodiment is 60% ethanol extract 3.: get 14 parts of weight portions of Folium Ginkgo and put into the multi-functional Chinese medicine extraction pot, add 150 parts of 60% food grade alcoholic solution, after boiling; Reflux, extract, 2 hours is filtered extracting solution, filtrate for later use; Medicinal residues add 120 parts of 60% food grade alcoholic solution again; After boiling, reflux, extract, 1.5 hours is filtered extracting solution.Merge filtrate twice, in the ethanol recycling can, reclaim ethanol, change vacuum concentration pot then over to, being concentrated into liquid specific gravity is 1.18 (20 ℃), is mainly contained the flavonoid extracting solution, subsequent use.
Compositions manufacturing approach embodiment is 50% ethanol extract 4.: get 16 parts of weight portions of Folium Ginkgo and put into the multi-functional Chinese medicine extraction pot, add 150 parts of 50% food grade alcoholic solution, after boiling; Reflux, extract, 2 hours is filtered extracting solution, filtrate for later use; Medicinal residues add 120 parts of 50% food grade alcoholic solution again; After boiling, reflux, extract, 1.5 hours is filtered extracting solution.Merge filtrate twice, in the ethanol recycling can, reclaim ethanol, change vacuum concentration pot then over to, being concentrated into liquid specific gravity is 1.18 (20 ℃), is mainly contained the flavonoid extracting solution, subsequent use.
Compositions manufacturing approach embodiment is 40% ethanol extract 5.: get 18 parts of weight portions of Folium Ginkgo and put into the multi-functional Chinese medicine extraction pot, add 150 parts of 40% food grade alcoholic solution, after boiling; Reflux, extract, 2 hours is filtered extracting solution, filtrate for later use; Medicinal residues add 120 parts of 40% food grade alcoholic solution again; After boiling, reflux, extract, 1.5 hours is filtered extracting solution.Merge filtrate twice, in the ethanol recycling can, reclaim ethanol, change vacuum concentration pot then over to, being concentrated into liquid specific gravity is 1.18 (20 ℃), is mainly contained the flavonoid extracting solution, subsequent use.
2, Radix Panacis Quinquefolii, superfine notoginseng powder preparation:
Get Radix Panacis Quinquefolii 4 weight portions, Radix Notoginseng 2 weight portions, put into heated-air circulation oven respectively, 50 ℃ of dryings 3 hours are carried out micronizing with fluid energy mill powder machine respectively, the above superfine powder of 200 orders.Then superfine powder is put into the high pressure steam sterilization cabinet, 115 ℃ of sterilizations 30 minutes change in the heated-air circulation oven again, and 50 ℃ of dryings 1 hour are subsequent use.
3, capsule preparation:
⑵ superfine powder is put into the grooved blender, add 4. extracting solution of ⑴ embodiment, mix homogeneously is put into oscillating granulator, processes 20 purpose wet granulars.Wet granular is put into heated-air circulation oven, and 60 ℃ of oven dry are made into uniform dried granule then in granulator, encapsulated with automatic capsule-packaging machines, the 500mg/ grain, and bottling, through after the assay was approved, packing gets product.

Claims (5)

1. Chinese medicine composition with blood lipid regulation, slow down aging is characterized in that forming with materials of weight proportions:
Food grade ethanol second extraction that Folium Ginkgo is 10 ~ 18 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
2 ~ 6 parts of superfine powder of Radix Panacis Quinquefolii with
1 ~ 3 part of superfine powder of Radix Notoginseng.
2. according to the said a kind of Chinese medicine composition of claim 1, it is characterized in that it forms with raw materials in weight portion with blood lipid regulation, slow down aging:
Food grade ethanol second extraction that Folium Ginkgo is 12 ~ 16 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
3 ~ 5 parts of superfine powder of Radix Panacis Quinquefolii with
1.5 ~ 2.5 parts of superfine powder of Radix Notoginseng.
3. according to the said a kind of Chinese medicine composition of claim 2, it is characterized in that it forms with raw materials in weight portion with blood lipid regulation, slow down aging:
Food grade ethanol second extraction that Folium Ginkgo is 14 parts and warp are concentrated into the extracting solution deal that proportion 1.18 obtains for 20 ℃
4 parts of superfine powder of Radix Panacis Quinquefolii with
2 parts of superfine powder of Radix Notoginseng.
4. according to claim 1,2 or 3 described a kind of Chinese medicine compositions with blood lipid regulation, slow down aging, said said composition is a tablet, oral liquid, perhaps capsule.
5. Chinese medicine composition manufacturing approach with blood lipid regulation, slow down aging, its characteristic are by following order:
⑴, effective component of ginkgo leaf extract:
Get Folium Ginkgo 10 ~ 18 weight portions and put into the multi-functional Chinese medicine extraction pot, add 150 parts of 40% ~ 80% food grade alcoholic solution, after boiling; Reflux, extract, 2 hours is filtered extracting solution, filtrate for later use; Medicinal residues add 120 parts of 40% ~ 80% food grade alcoholic solution again; After boiling, reflux, extract, 1.5 hours is filtered extracting solution;
Merge filtrate twice, in the ethanol recycling can, reclaim ethanol, change vacuum concentration pot then over to, be concentrated into liquid specific gravity and in the time of 20 ℃, reach 1.18, mainly contained the flavonoid extracting solution, subsequent use;
⑵, Radix Panacis Quinquefolii, superfine notoginseng powder preparation:
Get 4 parts of Radix Panacis Quinquefoliis, 2 parts of Radix Notoginseng, put into heated-air circulation oven respectively, 50 ℃ of dryings 3 hours are carried out micronizing with fluid energy mill powder machine respectively, the above superfine powder of 200 orders;
Then superfine powder is put into the high pressure steam sterilization cabinet, 115 ℃ of sterilizations 30 minutes change in the heated-air circulation oven again, and 50 ℃ of dryings 1 hour are subsequent use;
⑶, capsule preparation:
⑵ superfine powder is put into the grooved blender, add the Folium Ginkgo 16 weight portions 50% food grade ethanol extract in (1), mix homogeneously is put into oscillating granulator, processes 20 purpose wet granulars;
Wet granular is put into heated-air circulation oven, and 60 ℃ of oven dry are made into uniform dried granule then in granulator, encapsulated with automatic capsule-packaging machines, the 500mg/ grain, and bottling, through after the assay was approved, packing gets product.
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