CN101716213B - Traditional Chinese medicine effective fraction composition for detoxification and lipid lowering and preparation method thereof - Google Patents

Traditional Chinese medicine effective fraction composition for detoxification and lipid lowering and preparation method thereof Download PDF

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CN101716213B
CN101716213B CN2009102136965A CN200910213696A CN101716213B CN 101716213 B CN101716213 B CN 101716213B CN 2009102136965 A CN2009102136965 A CN 2009102136965A CN 200910213696 A CN200910213696 A CN 200910213696A CN 101716213 B CN101716213 B CN 101716213B
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human body
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李捍雄
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Euphorbia Biological Medicine Co ltd
Guangdong Zerui Pharmaceutical Co ltd
Guangzhou Lianrui Pharmaceutical Co ltd
Guangzhou Runlin Pharmaceutical Technology Co ltd
GUANGZHOU YIPINHONG PHARMACEUTICAL CO Ltd
Yipinhong Pharmacy Co ltd
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Abstract

The invention discloses a traditional Chinese medicine effective fraction composition for detoxification and lipid lowering and a preparation method thereof. The composition mainly comprises raw materials of aristolochia recurvilabra, red flower, vitamin C and vitamin E, and the preparation method comprises the following steps of: crushing the raw materials to fine powder, uniformly mixing based on proportioning, and preparing into various dosage forms according to requirements. The composition has the effects of removing toxic elements in human body, reducing surplus lipid, enhancing the immunity function of human body, and repairing digestive organs and functions thereof.

Description

A kind of effective ingredient in Chinese composition and method of making the same that is used for detoxification and lipid lowering
Technical field
The present invention relates to pharmaceutical field, be specifically related to a kind of Chinese medicine live part composition and method of making the same that is used for detoxification and lipid lowering.
Background technology
Under the normal situation of human body metabolism, the food that people ate is through esophagus, stomach, duodenum, small intestinal, large intestine, excrete from anus at last, whole process generally can be finished in 12 ~ 24 hours, so just can guarantee that refuse can not stop excessively for a long time in intestinal, because it is of a specified duration more that metabolic waste is removed the time of intestinal wall, refuse just can be absorbed by human body unavoidably once more, thereby causes poisoning in the body.Although human body possesses certain gas defence function of detoxification, owing to tired, nervous or other Physiological Psychology reasons, cause human body metabolic function imbalance, endocrine regulation to occur, cause long-term the stop in vivo of refuse of human body.Can Yu refuse begins corruption in intestinal like this, and the flora in the colon will constantly decompose refuse, produces toxin, and these toxin are absorbed once more by colon, constantly oozes out, and pollutes internal milieu; Enter the Different Organs of human body through the blood circulation, cause various diseases in the body, hypomnesis, fatigue, complexion sallow, constipation, hemorrhoid and endocrine disturbance, obesity or the like disease occurs thereby enter.
The existing way of toxins in human body mainly contains following several:
1. free radical.Free radical is the biggest factor that causes human senility.An amount of free radical is beneficial, can protect health to avoid the disoperation of exotics such as chemical substance.But the intravital free radical of body is in a single day excessive, will produce very strong Oxidation and encroaches on cells in vivo, causes aging, skin black speck, allergy and cardiovascular disease.
2. cholesterol.Cholesterol is the indispensable a kind of nutrient substance of human body, the intravital cholesterol overwhelming majority of people is by the liver manufacturing, it is not only as the structure division of health, the raw material of still synthetic many important substance, but long-term a large amount of absorptions of cholesterol can make cholesterol raise, and increase the danger of cardiovascular disease.
3. stool.Stool is the outmoded stool of long-term alluvial in the intestinal, does not defecate in general 3 ~ 5 days and rests on excrement piece in the intestinal stool.Stool is the root of all toxin in the human body intestinal canal, after a large amount of toxin that it produced are absorbed by the body, will reduce body immunity, induces various diseases to produce the serious harm health.
4. lipidosis.The modern often takes in the food that contains too high nutrition, and it is big to add quantity of motion, and moisture replenishes not enough, just is easy to cause hyperlipidemia.Along with increasing of haemoconcentration, will cause a large amount of lipidosiss at blood vessel, be each organ oxygen supply deficiency, cause diseases such as cerebral embolism.
5. uric acid.Uric acid also is the metabolic a kind of product of human body, is mainly discharged by kidney.When the concentration of uric acid in blood surpasses normal value, easily be deposited on soft tissue or arthritis and cause acute inflammatory reaction.
6. lactic acid.Symptoms such as the people is in sore waist and aching in the waist and the back can occur in the fatigue conditions, it is blunt to feel run-down, move, clumsiness, this is owing to the lactic acid accumulation causes.Lactic acid is that human body produces in prolonged exercise, and it and caramelan acid is constantly accumulation in vivo, can cause blood to be acid.
7. noxious water and blood stasis.The formation of noxious water is because human body has eaten too much ice-cold food or intravital water metabolism occurs unusual and body fluid skewness that cause.Blood stasis is intravital old, old, residual, the crimson blood liquid of people, is the morbid state and the not smooth product of tip circulation of gas, blood, water portion smoothness.Noxious water can cause diaphoresis, the unusual and edema of urinating, and blood stasis can cause cell.The nutrient deficiency of muscle causes symptoms such as obesity.
The foster treatment method of existing detoxification and lipid lowering is a lot, adopts the method for Chinese medicinal of rushing down mostly, though also can play certain curative effect, but a lot of side effect are arranged, in detoxification and lipid lowering, the intravital effective nutrient substance of people has also been excreted out.Though the intravital toxin of people is to have got rid of, body weight has also descended, and people's body constitution and immunologic function have also reduced.What is more, causes people's loss of appetite after taking medicine, lassitude, and working and learning are effectively taken for a long time or Drug abuse may cause potentiality disorder serious in the human body.Receive and progressivity renal insufficiency etc. as hypokalemia, chronic low blood, also may cause the variation of intestinal wall cell function and form, thereby cause the damage of big enteric epithelium, also may cause in addition this class cathartic is produced the vicious cycle that relies on.
Radix Aristolochiae often is used as the component in the QI regulating medicine, and it is warm in nature, bitter in the mouth, and effect is a depressed liver-energy dispersing and QI regulating, detoxifcation, chest and abdomen swelling and pain is controlled in detumescence, acute filthy disease, the enteritis dysentery, hypertension, hernia, Serpentis stings poison, carbuncle, furuncle, skin pruritus or wet mashed.But with Rhizoma Cyperi compatibility promoting the circulation of QI to relieve pain; With Radix Sophorae Flavescentis compatibility heat-clearing and toxic substances removing then.
Flos Carthami has another name called shuteria pampaniniana, thorn Flos Carthami, Flos Carthami or golden red flower, and is warm in nature, acrid in the mouth, can invigorate blood circulation latus rectum, eliminating stasis to stop pain, be usually used in that amenorrhea, dysmenorrhea, lochia are not all right, traumatic injury etc., also can treat the cardiovascular system relevant disease, certain effect is also being arranged aspect antalgic and sedative and the antiinflammatory.
Summary of the invention
The objective of the invention is to the deficiency that exists in the existing detoxification and lipid lowering medicine, a kind of intravital harmful toxins of people of both can having removed is provided, reduce superabundant fats, can strengthen the immunologic function of human body again, repair the impaired Alimentary compositions of human body.
A further object of the invention is to provide the preparation method of above-mentioned composition.
The present invention seeks to be achieved by following scheme:
The present composition is pressed mass fraction and is made up of following raw material: Radix Aristolochiae 10 ~ 60; Flos Carthami 40 ~ 85; Vitamin C 1 ~ 5; Vitamin E 1 ~ 5.
Above-mentioned composition is counted by weight by following raw material and is formed: Radix Aristolochiae 15 ~ 30; Flos Carthami 50 ~ 60; Vitamin C 1 ~ 5; Vitamin E 1 ~ 5, best results.
The preparation method of the present composition is as follows: selected natural Radix Aristolochiae and Flos Carthami, clean, after the removal of impurity, the section oven dry, Radix Aristolochiae and Flos Carthami two herbal medicines are cooked with distillator, oven dry is again pulverized, and adds vitamin C and vitamin E, ball milling becomes powder, obtains detoxification and lipid lowering compositions of the present invention with screening behind smalls.
Concrete needs according to treatment can be prepared into the present composition dosage forms such as tablet, capsule, granule, powder, pill, slow releasing agent.
Tradition Radix Aristolochiae and Radix Sophorae Flavescentis compatibility just can play the effect of heat-clearing and toxic substances removing, and the present invention is off the beaten track, with Radix Aristolochiae and be generally used for the Flos Carthami compatibility of blood circulation promoting and blood stasis dispelling, and have added vitamin C and vitamin E, and the pharmaceutical composition that obtains both can detoxify, again can blood fat reducing.
The compositions of the detoxification and lipid lowering by above-mentioned prescription and preparation method gained has following curative effect:
(1) the poisonous factor of releasing human body, as blood stasis due to qi deficiency, acne, facial colour spot etc., stomach-invigorating intestine-moisturizing, consumer product dredge stasis will accumulate long-pending various poisonous factor in vivo and get rid of external.
(2) superabundant fats of reduction human body, as obesity, hyperlipidemia, hypertension etc., blood circulation promoting and blood stasis dispelling, ascending the clear and descending the turbid reduces fat absorption, prevents the fattiness accumulation, and steatolysis around promoting reaches skin maintenance.
(3) immunologic function of enhancing human body, tonifying speen and tonifying kidney prevents senilism, reduces wrinkle, prevents insomnia, the centering of calming the nerves, raising people's quality of life.
(4) repair the digestive organs of human body, loosening bowel to relieve constipation is alleviated the flatulence pain in the lumbar region, removes the enteral stool, and the detoxifcation deodorization changes the living habit of anorexia and food preference, has the effect of reinforcement and elimination in combination.
Compared with prior art, the present composition has following beneficial effect:
Present composition compatibility novelty, curative effect is fast, and effect is obvious, takes simply, and dosage is few, and the medicine valency is cheap, has no side effect,
The specific embodiment
Below just embodiment further explain the present invention, but embodiment does not do any qualification to the present invention.
Embodiment 1
The consumption of Radix Aristolochiae, Flos Carthami, vitamin C, vitamin E sees Table 1.The Radix Aristolochiae and Flos Carthami is cleaned, after the removal of impurity, thinly sliced, and 6h is steamed with distillator in the oven dry back, and oven dry is again pulverized, and adds vitamin C and vitamin E, and ball milling becomes powder, from smalls, is prepared into detoxification and lipid lowering compositions (table 1) with screening.
Embodiment 2
1. medicine is prepared into the detoxification and lipid lowering oral liquid with the compositions that obtains among the embodiment 1 according to conventional method, and 8 times concentrate human body recommended dose 100ml/d during experiment.
2. animal ICR mice cleans level, body weight 18 ~ 22g, male and female half and half.The SD rat, cleaning level, body weight 55 ~ 75g, male and female half and half.
3. the maximum tolerated dose method is adopted in the acute toxicity test experiment.If dosage group of sample 20000mg/kg body weight.Get 20 of mices, male and female half and half, fasting (can't help water) is 12 hours before the experiment, gavages the detoxification and lipid lowering oral liquid by the 20ml/kg body weight.General situation, poisoning symptom and the death condition of record mice are observed two weeks of time limit.When experiment finishes, all animals is put to death dissection, the pathological changes situation of each main organs tissue of perusal calculates the mice median lethal dose(LD 50).
Experimental result shows, in the observation period, does not see that poisoning symptom and death condition appear in experiment mice, and body weight increases to some extent but do not see obesity.Gross necropsy does not see that internal organs of the body is unusual.Female, the male per os LD of this sample mice 50All greater than the 20000mg/kg body weight, according to acute toxicity grading criteria, its chmice acute per os toxicity belongs to non-toxic type, shows the oral safety of this sample, and clinical practice can be provided.
Embodiment 3
1. medicine is prepared into the detoxification and lipid lowering oral liquid with the compositions that obtains among the embodiment 1 according to conventional method, and 8 times concentrate human body recommended dose 100ml/d during experiment.
2. animal ICR mice cleans level, body weight 18 ~ 22g, male and female half and half.The SD rat, cleaning level, body weight 55 ~ 75g, male and female half and half.
3. the long term toxicity test rat was fed experiment in 30 days.3 dosage groups and matched group are established in experiment, basic, normal, high 3 dosage respectively by 41.7,83.3, the 166.7ml/kg body weight, be equivalent to 25 times, 50 times and 100 times of human body recommended dose.Get 80 of SD rats, divide 4 groups at random, 20 every group, male and female half and half, the single cage of rat is raised ad lib, drinking-water.Observed 30 days continuously, write down body weight and food-intake weekly and calculate food utilization.Experiment periods end vein is got blood and is carried out hematological examination, and broken end is got blood and carried out the blood biochemical analysis, and every rat is carried out the internal organs gross examination of skeletal muscle, gets liver,kidney,spleen simultaneously and weighs and calculate dirty body ratio, and carry out histopathologic examination's (table 2, table 3).
Embodiment 4
Outpatient service reaches the patient who diagnoses T2DM, dyslipidemia, NASH in hospital in the period of the province the People's Hospital 2006 ~ 2009, and meet following inclusion criteria person and include research in: (1) meets the diagnostic criteria of the relevant T2DM of WHO in 1999; (2) there is any one unusual person in serum levels of triglyceride (TG), T-CHOL (TC), HDL-C (HDL-C), the low-density lipoprotein cholesterol (LDL-C).(3) glutamate pyruvate transaminase (ALT) be higher than 2 times of the normal value upper limits and (or) companion glutamic oxaloacetic transaminase, GOT (AST), gamma glutamyl transpeptidase (GGT) rising person.Except viral hepatitis, alcoholic hepatitis, drug induced hepatic injury.(4) the B ultrasonic performance meets the fatty liver diagnostic criteria.Collect comparison to testing age between preceding two groups, sex, BMI, fasting glucose (FBG), two hours after the meal blood glucose (2hPBG), serum C peptide (CP), ALT, AST, GGT, TG, TC, HDL-C, basic documents such as LDL-C, MDA, two group differences do not have significance (P>0.05), have comparability.
Embodiment 5
Person's 32 examples that meet the inclusion criteria are by being randomized into detoxification and lipid lowering combination treatment group of the present invention and diet motion matched group after BMI, age, sex, the pairing of serum TG level.Matched group gives diet exercise therapy and insulin strengthening treatment.All patients give the education and the inspection of diet motion by the diabetic diet principle of movement.Use novolin series insulin blood sugar control, adjust consumption, make fasting glucose (FBG), the control of two hours after the meal blood glucose (2hPBG) (FBG<8mmol/L, 2hPBG<10mmol/L) up to standard.This group patient insulin dosage every day is 16 ~ 72u.Avoid using biguanides and thiazolidinediones antidiabetic drug, to get rid of its influence (table 4, table 5) to liver function and blood fat.
The result shows that behind matched group, the treatment group patient treatment, TG all obviously descends, but compares between two groups after the treatment, and there were significant differences for statistics.TC obviously descends behind the treatment group patient treatment, and behind the matched group patient treatment, TC does not have obvious decline, behind treatment group and the matched group patient treatment, HDL-C does not all have obvious rising, behind the treatment group patient treatment, LDL-C obviously descends, and behind the matched group patient treatment, LDL-C does not have obvious decline.And by the patient's body health survey is shown, treatment group patient complexion is ruddy glossy before than medication, no significant discomfort, and the defecation situation also makes moderate progress, and defecation was 1 ~ 2 time in average one day.
The result shows that behind treatment group, the matched group patient treatment, ALT all obviously descends, but between two groups of treatment backs ALT relatively, there were significant differences for statistics.AST obviously descends behind the treatment group patient treatment, and AST does not have obvious decline behind the matched group patient treatment.GGT obviously descends behind the treatment group patient treatment, and matched group patient GGT does not have obvious decline.MDA obviously descends behind the treatment group patient treatment, and matched group patient MDA does not have obvious decline.
Embodiment 6
All adopt venous blood on an empty stomach before and after the treatment, use BACKMAN SYNCHROW CLINICAL SYSTEM LX9 automatic clinical chemistry analyzer (production of U.S. BACKMAN company) and detect serum TG, TC, HDL-C, LDL-C, ALT, AST, GGT, FBG, 2hPBG.Using 7230 spectrophotometers (production of Shanghai analytical tool factory), Nanjing builds up bio-engineering research institute test kit and carries out that malonaldehyde (MDA) detects, human serum MDA range of normal value: 3.46 ~ 4.66nmol/ml, the liver ultrasound diagnosis steps the digital black and white compuscan of auspicious DP-9900, fixing operation personnel with Shenzhen.Two groups all before and after treatment routine detect liver, according to the strong and weak of echo in the liver and decay, the many indexs such as traveling of blood vessel in the liver, to fatty liver make diagnosis and and make light, in, severe classification (table 6).
By the result as can be known, after the treatment of treatment group, the ultrasound diagnosis fatty liver is obviously alleviated, and compares with matched group, and there were significant differences for statistics.
Table 1 prescription consumption
Figure G2009102136965D00051
Table 2 detoxification and lipid lowering oral liquid is to the influence of rat hemoglobin, erythrocyte, numeration of leukocyte and classification thereof
Figure G2009102136965D00061
Table 3 detoxification and lipid lowering oral liquid is to the influence of blood biochemistry of rats index
Group Dosage (mg/kg) The Mus number Glutamate pyruvate transaminase (u/L) Glutamic oxaloacetic transaminase, GOT (u/L) Blood urea nitrogen (mmol/L) Creatinine (μ mol/L) Cholesterol (mmol/L) Triglyceride (mmol/L)
Blank group - 10 32.7± 10.1 155.0± 15.9 8.8±1.7 47.6± 5.6 1.96±0.3 0.62±0.1
Small dose group 41.7 10 30.2± 6.4 152.0± 17.0 9.6±2.2 49.1± 8.8 2.08±0.3 0.68±0.1
Middle dosage group 83.3 10 30.0± 4.6 159.1± 20.4 7.7±1.7 48.3± 6.4 1.94±0.3 0.77±0.2
High 66.7 10 33.3± 161.1± 8.9±2.0 44.2± 2.07±0.4 0.78±0.2
The dosage group 11.6 27.9 3.5
Table 4 detoxification and lipid lowering compositions is to the influence of blood fat
Figure G2009102136965D00071
Table 5 detoxification and lipid lowering compositions is to the influence of Serum ALT, AST, GGT, MDA
Figure G2009102136965D00072
Liver B ultrasonic fatty liver degree relatively before and after the table 6 liang group treatment
Figure G2009102136965D00073

Claims (2)

1. an effective ingredient in Chinese compositions that is used for detoxification and lipid lowering is characterized in that its crude drug is composed as follows according to the mass fraction: Radix Aristolochiae 10~60; Flos Carthami 40~85; Vitamin C 5~22; Vitamin E 5~22; The preparation method of described effective ingredient in Chinese is selected natural Radix Aristolochiae and Flos Carthami, cleans, after the remove impurity, and the section oven dry is put into distillator and cooked, and dries, pulverizes, and adds vitamin C and vitamin E, and ball milling becomes powder, with screening from smalls, promptly.
2. the effective ingredient in Chinese compositions that is used for detoxification and lipid lowering as claimed in claim 1 is characterized in that its crude drug is composed as follows according to the mass fraction: Radix Aristolochiae 15~30; Flos Carthami 50~60; Vitamin C 5~8; Vitamin E 5~8.
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