Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of blood fat reducing function clear and definite, and the obvious results natural plant extracts health product.
Blood fat reducing health products disclosed by the invention contains the active ingredient that Fructus Crataegi extract, wolfberry fruit extract, Rhizoma Alismatis extract and soybean extract are formed, weight ratio between them is a Fructus Crataegi extract: wolfberry fruit extract: Rhizoma Alismatis extract: soybean extract=(60-180): (40-120): (25-75): (10-30), this active ingredient extract can directly be made various oral formulations, also can add the pharmaceutic adjuvant of various ratios or other Chinese medicine extract, Western medicine is formed various oral formulations; The active ingredient extractive total flavone is counted 50-160g/kg with hyperin (Hyporoside) in the oral formulations.
Oral formulations of the present invention is meant medically acceptable all kinds of preparations, as tablet, capsule, granule, oral liquid etc.
Pharmaceutic adjuvant of the present invention is excipient commonly used, correctives, disintegrating agent etc.
Another technical problem to be solved by this invention is the preparation method that discloses above-mentioned blood fat reducing health products.
The preparation method of blood fat reducing health products disclosed by the invention comprises the following steps:
1. the preparation of active ingredient extract
(1) preparation of Fructus Crataegi extract
Get the Fructus Crataegi medicinal part, be ground into coarse powder, decoct with water secondary, add 10 times of amounts of water for the first time, decocted 2 hours, add 8 times of amounts of water the second time, decocted collecting decoction 1 hour.Extracting solution is by macroporous resin (D
101Type) post, the washing decontamination is used 75% ethanol elution then, to there not being the flavone characteristic reaction, concentrates, 60-70 ℃ of drying, 2-4 hour, promptly.
(2) preparation of Rhizoma Alismatis extract
Get the Rhizoma Alismatis decoction pieces, be ground into coarse powder,, reclaim ethanol with 8 times of amount 80% alcohol reflux 4 hours, 60-70 ℃ of drying, 2-4 hour, promptly.
(3) preparation of soybean extract
The extracting degreasing Semen sojae atricolor is ground into coarse powder, with 70% ethanol extraction 2 times, adds 10 times of amounts of 70% ethanol, adds 8 times of amounts of 70% ethanol for the second time for the 1st time.Each 2 hours, reclaim ethanol, behind the dilute with water, by macroporous resin (D
101Type) post, 80% ethanol elution is used in the water washing removal of impurity then, to there not being the flavone characteristic reaction, reclaims ethanol, volatilize, 60-70 ℃ of drying, 2-4 hour, promptly.
(4) preparation of wolfberry fruit extract
Get Fructus Lycii, decoct with water secondary, add 8 times of amounts of water for the first time and decocted 2 hours, add 6 times of amounts of water for the second time and decocted 1.5 hours, collecting decoction concentrates, and adding ethanol is 70% to containing the alcohol amount, leaves standstill, and filters, and volatilizes ethanol, gets 60-70 ℃ of drying of precipitation, and 3-5 hour, promptly.
2. the preparation of oral formulations
Measure Fructus Crataegi extract, wolfberry fruit extract, Rhizoma Alismatis extract and soybean extract by prescription, mix homogeneously, make tablet, capsule, granule and oral liquid according to a conventional method, make in the preparation flavones content count 50-160g/Kg with hyperin (Hyporoside).
A technical problem more to be solved by this invention is to disclose the application of above-mentioned oral formulations in the preparation blood fat reducing health products.
Blood fat reducing health products taking dose disclosed by the invention is counted 1.2-2.4g/ days with active component extract, and Time of Administration is more than one month.
The Fructus Crataegi extract master that the present invention adopts contains Fructus Crataegi flavone by regulating lipid metabolism, and main triglyceride reducing has the effect of cholesterol reducing, low density lipoprotein, LDL and raising high density lipoprotein simultaneously; Rhizoma Alismatis extract contains Rhizoma Alismatis terpene alcohol, reduces the synthetic of endogenous lipid, reduces T-CHOL in the blood plasma, suppresses intrahepatic fat and piles up; The wolfberry fruit extract master contains lycium barbarum polysaccharide, has the transhipment and the excretory effect that promote lipid, significantly the effect of cholesterol reducing and triglyceride; The soybean extract master contains soybean isoflavone and has effect for reducing blood fat.More than four kinds of extracts mix by a certain percentage, from reduce the endogenous lipid synthetic, promote the transhipment and the many-sides such as drainage, adjusting lipid metabolism of lipid to play effect for reducing blood fat.
Carry out relevant efficacy test with blood fat reducing oral formulations of the present invention:
Give high fat nutrient fodder to SD kind rat every day, give preparation of the present invention 5 times of recommended amounts 0.1g/kgb.w. simultaneously respectively, 10 times of recommended amounts 0.2g/kgb.w., three dosage preventions of 30 times of recommended amounts 0.6g/kgb.w. animal hyperlipemia, gave capsule of the present invention totally 30 days, the result obtains:
1.0.6g/kgb.w. the serum total cholesterol of dosage group (TC) level reduces, the reduction amplitude is 20.31%, compares with high fat matched group, and difference has significance meaning (P<0.05).
2.0.6g/kgb.w. the serum triglycerides of dosage group (TG) level and high fat matched group are relatively, the reduction amplitude is 32.03%, and difference has significance meaning (P<0.05).
Through experiment confirm: product of the present invention has the health care of blood lipid regulation, can suppress exogenous lipid absorption, triglyceride reducing and cholesterol are synthetic, high density lipoprotein increasing, promote cholesterol transport, reduce atherogenic index, avoid a series of organ diseases such as the cardiovascular and cerebrovascular vessel that cause because of hyperlipemia and Liver and kidney.
Oral formulations of the present invention proves safety non-toxic through the safety toxicological test:
1. its mouse oral clothes acute toxicity test, male and female mice LD
50>21.50g/kgb.w., submitted sample belong to nontoxic level material.
2. mouse bone marrow cells micronucleus test
1.25-10g/kgb.w. dosage, the micronucleus test result is negative, and somatic cell is not had mutagenesis.
3. mouse sperm distortion test
2.5-10g/kgb.w. dosage, the spermatic aberration test result is negative, and sexual cell is not had mutagenesis.
4.Ames test
0.5-5000 no matter add or do not add the S9 mixture in each dosage of μ g/ ware, result of the test does not find that this product has direct or indirect mutagenic action.
Along with the raising of people's living standard, quality of life is had higher requirement, particularly self health care is more and more paid attention to.Blood fat reducing health products safety non-toxic of the present invention, and have good effect for reducing blood fat, with every year for the health product that the hyperlipidemia crowd more than 1,000,000 provides a kind of exact efficacy, have good social benefit and economic benefit.
The specific embodiment
The preparation of embodiment 1 active component extract
(1) preparation of Fructus Crataegi extract
Get the Fructus Crataegi medicinal part, be ground into coarse powder, decoct with water secondary, add 10 times of amounts of water for the first time, decocted 2 hours, add 8 times of amounts of water the second time, decocted collecting decoction 1 hour.Extracting solution is by macroporous resin (D
101Type) post, the washing decontamination is used 75% ethanol elution then, to there not being the flavone characteristic reaction, concentrates, 60-70 ℃ of drying, 3 hours, promptly.
(2) preparation of Rhizoma Alismatis extract
Get the Rhizoma Alismatis decoction pieces, be ground into coarse powder,, reclaim ethanol with 8 times of amount 80% alcohol reflux 4 hours, 60-70 ℃ of drying, 4 hours, promptly.
(3) preparation of soybean extract
The extracting degreasing Semen sojae atricolor is ground into coarse powder, with 70% ethanol extraction 2 times, adds 10 times of amounts of 70% ethanol, adds 8 times of amounts of 70% ethanol for the second time for the 1st time.Each 2 hours, reclaim ethanol, behind the dilute with water, by macroporous resin (D
101Type) post, 80% ethanol elution is used in the water washing removal of impurity then, to there not being the flavone characteristic reaction, reclaims ethanol, volatilize, 60-70 ℃ of drying, 4 hours, promptly.
(4) preparation of wolfberry fruit extract
Get Fructus Lycii, decoct with water secondary, add 8 times of amounts of water for the first time and decocted 2 hours, add 6 times of amounts of water for the second time and decocted 1.5 hours, collecting decoction concentrates, and adding ethanol is 70% to containing the alcohol amount, leaves standstill, and filters, and volatilizes ethanol, gets 60-70 ℃ of drying of precipitation, and 5 hours, promptly
The preparation of embodiment 2 capsules
Prescription: Fructus Crataegi extract: wolfberry fruit extract: Rhizoma Alismatis extract: soybean extract=60: 60: 75: 30
Extract each active component by the method for embodiment 1, mix with the recipe quantity proportioning, recording hyperin content is 59.4g/kg, then with the dextrin mixing of 0.33 times of amount, in the glue shell of packing into promptly, every capsules 0.3g.
The preparation of embodiment 3 tablets
Prescription:
Fructus Crataegi extract: wolfberry fruit extract: Rhizoma Alismatis extract: soybean extract=180: 40: 25: 10
Extract each active component by the method for embodiment 1, mix with the recipe quantity proportioning, recording hyperin content is 120g/kg, then with the dextrin mixing of 0.2 times of amount, and one-step palletizing, tabletting promptly gets tablet, the 0.3g/ sheet.
The preparation of embodiment 4 granules
Prescription: Fructus Crataegi extract: wolfberry fruit extract: Rhizoma Alismatis extract: soybean extract=120: 80: 50: 20
Extract each active component by the method for embodiment 1, mix with the recipe quantity proportioning, recording hyperin content is 80.5g/kg, then with the dextrin mixing of 0.11 times of amount, and one-step palletizing, packing is promptly.
Embodiment 5 uses
With capsule 0.3g/ grain of the present invention, take twice every day, to take one month, hyperlipemia all takes an evident turn for the better, and experimental result is as follows:
Sequence number | Sex | Age | Cholesterol mmol/L (3.10-5.17) | Triglyceride mmol/L (0.56-2.30) | High-density lipoprotein mmol/L (0.90-1.50) | Low-density lipoprotein mmol/L (0.00-3.36) |
1 | The man | 54 | Before taking | 3.79 | 2.43 | 1.33 | 2.40 |
After taking | 4.23 | 1.26 | 1.45 | -- |
2 | The woman | 60 | Before taking | 5.32 | 3.09 | 1.23 | 3.20 |
After taking | 5.14 | 1.34 | 1.47 | -- |
3 | The man | 34 | Before taking | 5.23 | 1.85 | 0.95 | 3.70 |
After taking | 5.09 | 1.57 | 1.03 | -- |
4 | The man | 32 | Before taking | 3.94 | 2.44 | 1.32 | 2.60 |
After taking | 4.17 | 1.04 | 1.44 | -- |
5 | The man | 29 | Before taking | 5.56 | 2.74 | 1.50 | 3.60 |
After taking | 5.61 | 1.37 | 1.47 | 3.00 |
6 | The man | 66 | Before taking | 6.60 | 2.05 | 1.50 | 4.70 |
After taking | 5.82 | 0.92 | 1.21 | 4.10 |
7 | The woman | 59 | Before taking | 6.20 | 2.57 | 1.50 | 4.60 |
After taking | 6.45 | 2.00 | 1.42 | -- |
8 | The man | 35 | Before taking | 5.68 | 1.88 | 1.50 | 4.30 |
After taking | 4.87 | 1.37 | 0.91 | 3.10 |