CN101036722A - Health-caring food for easing and improving climacteric Syndrome of men and the preparation thereof - Google Patents
Health-caring food for easing and improving climacteric Syndrome of men and the preparation thereof Download PDFInfo
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Abstract
The invention relates to a male health food, in particular relates to a health food for alleviating fatigue and improving male climacteric syndrome, and a method for preparing the same. Based on weight ratio, the health food comprises the following materails as active ingredients of: 500-700 American ginseng, 450-650 herba epimedii, 350-450 fructus lycii, 450-600 puncturevine, 300-460 dodder seed, 350-450 raspberry , 270-370 semen cassiae, 20-80 radix puerariae, and 5-35 vitamin e. The invention is pure natural preparation which has three functions of activating gonad, nourishing testis, and powering blood. It is simple and convenient for taking the health food, safely and effectively, without toxic and side effect, thereby, the fatigue and the male climacteric syndrome are ultimately prevented, treated and improved from interior to exterior, and uneasiness and pain of the male are reduced.
Description
Technical field
The present invention relates to man's health food, specifically a kind of alleviating physical fatigue, the health food that improves male climacteric syndrome and preparation.
Background technology
People are scarcely out of swaddling-clothes to andropausal understanding at present, and existence, reply, the treatment for it also do not have definite embodiment in the world, is in the state of groping, and shoulders heavy responsibilities.For treatment, only rest on hormone therapy and non-hormone therapy aspect.Because pressure and androgen level tired or that step into involutional male descends is to some extent felt exhausted, health each several part function begins to go down, so the certain androgen of supply is kept previous level, can improve current symptom.Point out in " male climacteric syndrome " book of the academic leader professor Guo Yinglu chief editor of urology of China a new generation and andrology: simple supply androgen can not be treated at all and administration inconvenience (most of is injection), the blood drug level instability has certain potential safety hazard.As alkylation testosterone (methyltestosterone) liver toxicity is arranged, be difficult for a large amount of and life-time service; Testosterone undecanoate oral formulations (trade name:, absorb sexual stimulation oversaturation symptom, oligospermia, water-sodium retention phenomenon and gastrointestinal reaction by lymph though An Teer) do not have liver toxicity.Long-term androgen supplement therapy all has certain untoward reaction such as liver function injury, gastrointestinal symptom, lipid metabolic disorder, water-sodium retention, mammary gland increase, prostatic hyperplasia and carcinoma of prostate, sleep apnea etc.In addition, the non-hormone treatment also only limits to the treatment and the remissive treatment of surface symptoms, the meaning that " treating the head when the head aches; foot is cured foot bitterly " arranged, just take stable class medicine if any palpitation and insomnia and keep sleep, there is hyperosteogeny just to take calcium-supplementing preparation, has cardiovascular diseases, diabetes, prostatosis, sexual dysfunction just blindly to take some medicines that improve symptom relatively etc.These medicine major parts are Western medicine, and liver, strong, bad of nephrotoxicity glue should be more.Even if frequently making new advances of Chinese medicine preparation also all is at a certain treatment of conditions wherein, can not thoroughly fundamentally treat and improve disease, and most people not a kind of diseases of only single trouble that a few class medicines in Chinese and Western should also be noted that incompatibility between medicine with clothes.
Traditional Chinese medical theory thinks that the main performance of fatigue and climacteric syndrome is similar, mainly is divided into three types.
One is: liver-kidney yin deficiency: show as cardiopalmus unhappiness, insomnia and dreamful sleep, have a dizzy spell, tinnitus is forgetful, soreness of the waist and knees, dysphoria with feverish sensation in the chest palms and soles, hectic fever night sweat, premature ejacuation emission, rattiness;
It two is: liver-depression and spleen-insufficiency type: show as that fatigue and weakness, hypochondriac pain uncomfortable in chest, being irritable and getting angry easily, cardiopalmus are perspired, are off one's feed, hyposexuality;
It three is: the deficiency of both YIN and YANG type: show as mainly that body is more fat, cold extremities with aversion to cold, lusterless complexion, lethargy, hyposexuality, impotence due to deficiency of the kidney, frequent micturition, depressed of few words;
Therefore fatigue and male menopause are all caused by " deficiency of the kidney void declines " " QI and blood is two loses ", and it is easily sent out the age and is person in middle and old age, and is divided into jointly: " hepatic and renal YIN deficiency ", " stagnation of liver-QI with deficiency of the spleen " and three diseases such as " the two void of negative and positive ".Just be arteriosclerosis and hypertension as coronary heart disease and the common priming factors of apoplexy.Therefore as long as elimination arteriosclerosis and hypertension just can be prevented and treated coronary heart disease and apoplexy.In like manner as long as improvement and elimination " deficiency of the kidney void declines " and " QI and blood is two loses " cause of disease just can be prevented and treated fatigue and menopause syndrome.
Modern andrology is thought: the so-called kidney of the traditional Chinese medical science, and it is organized as gonad, and the core organ is a testis, and QI and blood is two thanks to then to be short of power for blood circulation.Very upright former expert group is on the basis of modern andriatria of research and summary Traditional Chinese medical theory, proposed " tired more phase " theory first: " middle-aging male is because gonad fatigue (kidney fatigue) QI and blood is thanks to two and testicular senescense makes hypogonadism; poor blood circulation, the testicular secretion androgen descends and disequilibrium causes the male fatigue and climacteric syndrome to occur.”
Male climacteric syndrome once can be defined as " the aging male androgen partly lacks syndrome " (being called for short PADAM) by Austrian urology in European andrology seminar in 1994.Main clinic symptoms shows as: tired, depressed, nervous, enrage easily, ability reduction, libido reduction, hypomnesis, sleep disorder, numbness, tingling, complexion hectic fever, paroxysmal perspire, and, can cause cardiovascular disease, diabetes, kidney disease, sexual dysfunction and prostatosis etc. with abdominal obesity, inappetence, constipation, alopecia, dim eyesight tinnitus, osteoporosis, cardiopalmus, insomnia.
Summary of the invention
The object of the present invention is to provide a kind for the treatment of both the principal and secondary aspects of a disease, little alleviating physical fatigue, the health food that improves male climacteric syndrome and the preparation of side effect, it is for integrating the pure galenical of " activate gonad, nourish testis, hemodynamics " three large effects, take simple and convenient, nontoxic, safe and effective, from inside to outside fundamentally prevention, treatment and improve fatigue and male climacteric syndrome, alleviated to the man bring uneasy and painful.
For achieving the above object, the technical solution used in the present invention is:
A kind of fatigue alleviating, improve the health food of male climacteric syndrome, count by weight, its active ingredient comprises, Radix Panacis Quinquefolii 500-700 part, Herba Epimedii 450-650 part, Fructus Lycii 350-450 part, Fructus Tribuli 450-600 part, Semen Cuscutae 300-460 part, Fructus Rubi 350-450 part, Semen Cassiae 270-370 part, Radix Puerariae 20-80 part, vitamin E 5-35 part.
Preferable active ingredient prescription is Radix Panacis Quinquefolii 600g, Herba Epimedii 550g, Fructus Lycii 400g, Fructus Tribuli 530g, Semen Cuscutae 370g, Fructus Rubi 400g, Radix Puerariae 50g, Semen Cassiae 330g, vitamin E2 0g;
Wherein also be added with the excipient that can be made into various dosage forms; Count by weight, described excipient can be, and makes starch 80-120 part, carboxymethyl starch sodium 8-20 part and magnesium stearate 1-6 part that tablet is used; Make Pulvis Talci 60-150 part that hard capsule uses Capsules of packing into; Make dextrin 50-120 part, starch 50-100 part that granule is used; After medicinal material extract become fluid extract, add the simple syrup of making the 65-75% that oral liquid uses; Or make the Mel that honey pill agent is used.
Its concrete preparation process is as follows,
1) to removing V
EOther outer component medical material screens, and selects clean, first-class medical material, takes by weighing medical material by formula ratio;
2) Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Semen Cassiae, Fructus Rubi seven flavor medicine material are cleaned in the rearmounted multi-function extractor, added water logging bubble 3-6 hour that 6-12 doubly measures, boil and extract 2-5 time, filtration, reserved filtrate;
3) filtrate is put in the vacuum concentration pot, concentrating under reduced pressure, vacuum 0.08MPa, is concentrated into the clear paste that proportion is 1.1-1.4 by temperature 60-80 ℃; Get dry extract through drying under reduced pressure, pulverized the 80-120 mesh sieve;
4) Radix Puerariae is cleaned rearmounted baking oven 60-80 ℃ oven dry, pulverizes the 80-120 mesh sieve then, and the sterilization back is standby;
5) with dry extract, powder of Radix Puerariae, V
EAnd mixed with excipients is made finished product after evenly.
The present invention has following advantage:
1. prescription rationally.Theory of Chinese medical science is thought " fatigue " genus " weakness " scope, and it is weak mainly to show as people's bromhidrosis, blood, yin, yang deficiency and function.Say " deficiency syndrome should be treated by tonifying method ", " damage person's benefit ", " diseases caused by over-strain should be treated by warming " in " element is asked the three body parts and nine pulse-taking sites opinion "; Therefore the present invention adopts the Chinese crude drug of with a long history, the stable curative effect with QI invigorating and temperature compensation effect, in strict accordance with the drug matching principle, through the refining pure natural plant preparation that forms of deep processing; Be monarch with the Radix Panacis Quinquefolii of strongly invigorating primordial QI and the Herba Epimedii of the strong muscles and bones of kidney invigorating and YANG supporting in the present invention prescription, with the Fructus Lycii of nourishing the liver and kidney, nourishing YIN and benefiting blood, be used for the Semen Cuscutae of Fructus Tribuli that the breast association of depression of liver-QI do not relax, tonifying both YIN and YANG and can liver and kidney tonifying can restrain astringent or styptic treatment for spontaneous sweating Fructus Rubi again being combined into minister, the nourishing that the monarch and his subjects' combination is played jointly is because of gas, blood, yin, yang deficiency or function weakness caused " deficient syndrome ", the i.e. health-care effect of alleviating physical fatigue; With the Radix Puerariae of the analgesic coronary dilating that promotes the production of body fluid, invigorates blood circulation, have the Semen Cassiae of clearing away heat to improve acuity of vision, functions of loosening bowel relieving constipation and the vitamin E of antioxidation and be assistant in square in addition,, reach tonification and don't produce showing tremendous enthusiasm purpose by increasing blood circulation and metabolism; Integral formula meets Chinese medicine monarch combination principle, mends and not dry, and science is reasonable again, can reach the health care purpose and the effect of " alleviating physical fatigue, improve climacteric syndrome ".
In a word, the present invention adopts the Chinese medicine health care theoretical and have " alleviating physical fatigue improves menopause syndrome " health care foods in conjunction with what modern medical theory developed.
2. preparation technology is simple, convenient, and stable effective ingredients is difficult for changing.In the extraction process of the present invention, select high-grade clean medical material, only clean once, soak time, decoction number of times and amount of water have reduced the loss of effective ingredient all through testing the laggard line operate of reasonable screening, have guaranteed the stable of product quality and effect.Preparation processing process of the present invention is all carried out at the dust proof workshop by the GMP authentication, select equipment implementation and operation advanced and that be fit to for use, effectively guaranteed the inherent quality of product and reached sanitary standard requirement (detection all can reach standard-required through the province disease prevention and control center).
3. taking convenience.The present invention often selects the solid orally ingestible tablet for use, and bottle packaging is convenient to orally, is easy to absorb, and is easy to carry.
4. effect is good.The present invention's (commodity very upright former Ai Nuo sheet by name) is the achievement of inventor through concentrating on studies for many years, and specialty treatment and improvement are in the fatigue under the pressure black hole and step into involutional middle-aging male health food.The present invention is the check by the disease prevention and control center, the result shows that 1. very upright former board Ai Nuo sheet can prolong the swimming time of 1.80g/kgBW, 1.20g/kgBW experimental mice, increase the Mouse Liver glycogen content, can reduce the mice serum urea nitrogen content, illustrate that this product has the function of fatigue alleviating, physical strength reinforcing.2. very upright former board Ai Nuo sheet all greater than 15.00g/kgBW, belongs to innocuous substance to the large and small Mus per os maximum tolerated dose (MTD) of two kinds of sexes; The result is all negative for three genetic toxicity tests (Salmonella reversion test, mouse marrow cell micro nuclear test, mouse sperm deformity test); The histopathology assay shows matched group and high dose group is female, the liver of male rat, kidney, stomach, intestinal, spleen, ovary and testis there is no obvious damaging pathological change.And confirmed by national drug-testing: stimulant, anesthetis, beta blocker, diuretic and the hormone medicine of not finding to contain International Olympic Committee's regulation forbidding in 2004.
The mechanism and the effect of the very upright former board Ai Nuo sheet of the present invention are:
One, activates gonad, increase kidney power: the so-called kidney major organs of the traditional Chinese medical science is organized as gonad axis, constitute by hypothalamus-hypophysis-testis three parts, its rapport is just as the relation of the commander-tissue-execution in army's tissue system, must keep the harmonious of height, wherein a certain link goes wrong and all can cause autonomic nervous dysfunction and the hormone disequilibrium causes tired more phase symptom.Gonad is as heart good operation under stress state continuously, yet after people in middle age, the continuous stress of decades has caused the fatigue of gonad, cause hypogonadism, the T material can stimulate the secretion of gonadotropin in the very upright former board Ai Nuo sheet plant component, eliminate the fatigue state of gonad, make it to return to normal stress state;
Two, nourish testis, delay atrophy: testicular senescense mainly shows two aspects: the one, testicular volume is dwindled, the normal man's of 2000 examples testicular volume was once measured in the village among the Japan expert of andrology, man's testis began atrophy later in 40 years old, and testicular volume only is equivalent to the boy's in 11-12 year testis in the time of 70 years old.The 2nd, the secretion testosterone obviously descends, and the 54pg/ml of the concentration in blood during by 30 years old is 18pg/ml only during by 60 years old, descended three times.Therefore, male's sexual function is along with the decline of testosterone is gone down.Tired more phase symptom reduces along with atrophy of testis and androgen secretion and increases the weight of simultaneously.Plant component in the very upright former board Ai Nuo sheet can increase the regeneration and the vigor of testicular cell, wherein multiple components such as Herba Epimedii glycoside, Fructus Tribuli glycoside is through the pharmacodynamics evaluation, proof can increase the testicular weight of aged Mus, and increase the secretion of its testosterone, therefore the very upright former board Ai Nuo sheet of proof can effectively nourish testis, delays atrophy to prevent testicular senescense;
Three, hemodynamics, increase flow: the normal circulation of blood is human life's a preceding topic, and the nutrition supply of each organ of human body and cell tissue is realized by blood circulation entirely." qi being the governor of blood ", vigour are the power of blood circulation, yet middle-aging male occurs all that QI and blood is two loses, and causes qi depression to blood stasis, causes cavernous body of penis congested not enough, have increased the weight of tired more phase disorder of erection function shape and impotence and premature ejaculation occurs.Ginsenoside that very upright former board Ai Nuo sheet contains and Radix Puerariae flavone composition can strongly invigorating primordial QI, blood vessel dilating, increase hemodynamics, make cavernous body of penis hyperemia more abundant, thereby improve the erection disturbance that causes because of congested deficiency;
In sum, the present invention has three large effects of " activate gonad, nourish testis, hemodynamics ", is the pure galenical of researching and developing at male's " tired more phase " specially.Be to improve and treatment male syndromic first-selected galenical of tired more phase; It contains the compositions such as Herba Epimedii glycoside of plant androgen-like action, the initial stage of taking can improve fast because of hypoandrogenism initiation symptom, take exclusive [FGT] composition for a long time, can make the gonad functional recovery by " activate gonad, nourish testis, hemodynamics ", increase kidney power, make aged testis refill vigor, thereby the testosterone secretory volume is increased, hormonal balance state when being returned to 40 years old, thus improve and eliminate tired more phase syndrome.
The specific embodiment
Embodiment 1
Formula for a product: Radix Panacis Quinquefolii 600g, Herba Epimedii 550g, Fructus Lycii 400g, Fructus Tribuli 530g, Semen Cuscutae 370g, Fructus Rubi 400g, Radix Puerariae 50g, Semen Cassiae 330g, vitamin E2 0g, starch 100g, carboxymethyl starch sodium 18g, magnesium stearate 3g.
Compound basis:
Fatigue is that body is under the certain environment condition, owing to crossing the state that labor efficiency trend that long-time or overwrought muscle power or mental work cause descends.Fatigue is owing to environment, life and labor condition cause the state that homeostasis gets muddled, and the people is in that this state can feel fatigue, lazyness is moved, is unable to pull oneself together, the sensation that occur getting a swelled head, hypomnesis, energy goes down etc.
Theory of Chinese medical science is thought: fatigue is " deficient syndrome ", is weak performance, as " element is asked and declared five gas pieces of writing " speech " five kinds of impairments caused by overstrain " is: impairment of blood by looking for a long time, excessive rest on bed impairing QI, prolonged sitting injuring the muscles, prolonged standing injuring bones, walking for a long time wound dish are the meaning five kinds of impairments caused by overstrain.Huangdi's Internal Classics speech: " have with overstrain, the shape weakness of QI is few "; Say again: " vim and vigour are to exhaust, and make us also separating ".Also point out: " deficiency of the liver, kidney, the insufficiency of the spleen body weight feeling of restlessness and irritation that all makes us "; " kidney disease of viscera connecting with this channel, drowsiness "; Deficiency of spleen-QI is flaccidity of the limbs then.As seen fatigue mostly belongs to the disease that gas, blood, yin, yang consumption injure the weak caused weakness of function of internal organs.
The deficiency of vital energy is the disease that internal organs hypofunction is showed, and blood deficiency internal organs hundred arteries and veins lose supports, the disease of performance asthenia universalis.The deficiency of YIN is yang hyperactivity then, easily gives birth to interior-heat, and blood and body fluid belong to cloudy, so the symptom attitude of blood deficiency and leptochymia can appear in the deficiency of YIN.Theory of Chinese medical science is thought: " kidney storing essence ", main growth promoter has close state with the life of human body, length, strong, old process, and other " kidney governing bones " suffered from a deficiency of the kidney and then shown the hyperhidrosis fatigue symptom.
This product is to adopt Chinese medicine, health care theory and the health food of developing in conjunction with modern medical theory with " alleviating physical fatigue " health care, prescription is main according to " reinforcement " in " prescription and method of treatment ", promptly by tonification, nourishing people bromhidrosis, blood, yin, yang or reinforcement function, improvement is because of gas, blood, yin, yang deficiency or internal organs weakness caused " deficient syndrome ", i.e. Pi Lao health care therapy.Say " deficiency syndrome should be treated by tonifying method ", " damage person's benefit ", " diseases caused by over-strain should be treated by warming " in " element is asked the three body parts and nine pulse-taking sites opinion ".
Therefore adopt has the Chinese crude drug of QI invigorating and temperature compensation effect to realize its health care more in the prescription
1. Radix Panacis Quinquefolii
Meridian distribution of property and flavor: sweet, little hardship, tepor.Return spleen, lung meridian.
Effect: strongly invigorating primordial QI, invigorating the spleen to benefit the lung, promoting the production of body fluid to quench thirst, calming the nerves increases intelligence, and multiple arteries and veins takes off admittedly.
Use: 1. be used for the deficiency of vital energy and desire to take off.Vigour is the most basic gas of human body, and this product energy strongly invigorating primordial QI is so there is the effect of saving collapse.
2. be used for deficiency of spleen-QI.The spleen and stomach provide the material basis of the acquired, the source of vital function, and deficiency of spleen-QI, biochemistry is unable, the disease of lassitude then can occur.
3. being used for lung qi loses empty.Lung is the dirty of main gas, and lung qi loses void diseases such as short of breath, weak, the deficient pulse spontaneous perspiration of action then can occur.
4. it is forgetful to be used for irritability, insomnia and dreamful sleep, palpitation with fear, and Radix Panacis Quinquefolii can strongly invigorating primordial QI, increases the effect of intelligence and have to calm the nerves, and is applicable to the above-mentioned disease that Qi and blood deficiency causes.
Main chemical: total panaquilon.
2. Herba Epimedii
Meridian distribution of property and flavor: hot, sweet, warm.Return the Liver and kidney warp.
Effect: kidney invigorating and YANG supporting, the dehumidifying that gets rid of illness, strong muscles and bones.
Use: 1. be used for the disease that sexual impotence, frequent micturition, weakness of the waist and knees and kidney yang deficiency cause.
2. be used for anemofrigid-damp arthralgia or varicosity numbness.
Main chemical: contain the flavone compound icariine.
3. Fructus Lycii
Meridian distribution of property and flavor: sweet, flat.Return liver, kidney, lung meridian.
Effect: nourishing the liver and kidney makes eye bright, lung moistening.
Use: diseases such as 1. being used for deficiency of yang of liver and kidney, having a dizzy spell, visual deterioration, soreness of waist and knee joint, seminal emission are quenched one's thirst.
2. be used for deficiency of YIN chronic cough.
Main chemical: contain betanin, compositions such as lycium barbarum polysaccharide.
4. Fructus Tribuli
Meridian distribution of property and flavor: bitter, hot, flat.Return Liver Channel.
Effect: suppressing the hyperactive liver, soothing the liver, dispelling pathogenic wind for improving eyesight.
Use: 1. be used for excessive rising of liver-YANG institute to headache, dizzy, have the suppressing the hyperactive liver and subsiding YANG effect.
2. it is flat easypro to be used for the hepatic depression blocked-up chest side of body." book on Chinese herbal medicine is looked for the truth " record can be controlled diseases such as lumbago impairment caused by overstrain.
Main chemical: contain Saponin, glycoside unit etc.
5. Semen Cuscutae
Meridian distribution of property and flavor: hot, sweet, flat.Return liver, kidney channel.
Effect: the YANG invigorating tonifying YIN, the controlling nocturnal emission with astringent drugs reducing urination, antidiarrheal makes eye bright.
Use: 1. be used for soreness of the waist and knees, sexual impotence, frequent micturition, this product not only kidney-replenishing but also tonifying kidney-yin.Merit with controlling nocturnal emission with astringent drugs reducing urination.
2. be used for poor vision and insufficiency of the spleen loose stool or diarrhea.
Main chemical: resinous pattern, sugar and starch.
6. Fructus Rubi
Meridian distribution of property and flavor: sweet, sour, tepor.Return liver, kidney channel.
Effect: kidney tonifying, controlling nocturnal emission with astringent drugs, reducing urination.
Use: solid, the seminal emission of being used to suffer from a deficiency of the kidney, frequent micturition, this product can restrain astringent or styptic treatment for spontaneous sweating again by liver and kidney tonifying.
Main chemical: contain organic acid, cupreol and vitamin A effect.
7. Semen Cassiae
Meridian distribution of property and flavor: sweet, bitter, salty, be slightly cold.Return liver, large intestine channel.
Effect: clearing away heat to improve acuity of vision, loosening bowel to relieve constipation.
Use: be used for the puckery pain of conjunctival congestion, dizzy, the constipation of headache.
Main chemical: contain chrysophanol, emodin, obtusin etc.
8. Radix Puerariae
This product is a Pachyrhizua angulatus.
Meridian distribution of property and flavor: sweet, hot, cool.Return spleen, stomach warp.
Effect: relieving muscles diaphoresis, invigorating YANG QI to promote eruption, analgesic promoting the production of body fluid.
Use: be used for diseases caused by exogenous pathogenic factor, headache, heating, stiff nape and back.And increase blood circulation and flow.
Main chemical: Radix Puerariae total flavones, puerarin.
9. vitamin E
According to introducing in " defying age canon ", vitamin E is powerful antioxidant, is the snperoxiaized the first line of defence of health antilipemic; Vitamin E is a kind of natural blood thinners simultaneously, can prevention of cardiac and enhancing human body immunity power.
From the characteristicness analysis of " fatigue " disease, belong to the scope of theory of Chinese medical science " weakness ", theory of Chinese medical science thinks that " void " is exactly not enough and weak, mainly shows people's bromhidrosis, blood, yin, yang deficiency and function and weak.Be monarch with the Radix Panacis Quinquefolii of strongly invigorating primordial QI and the Herba Epimedii of the strong muscles and bones of kidney invigorating and YANG supporting in the prescription, with nourishing the liver and kidney, grow Fructus Lycii that sun nourishes blood, the Semen Cuscutae of Fructus Tribuli that the breast side of body that is used for depression of liver-QI does not relax, tonifying both YIN and YANG and can liver and kidney tonifying can restrain astringent or styptic treatment for spontaneous sweating Fructus Rubi again and be combined into minister, the monarch and his subjects' combination, the nourishing of playing jointly is because of gas, blood, yin, yang deficiency or function weakness caused " deficient syndrome ", the i.e. health-care effect of alleviating physical fatigue.Promote the production of body fluid with analgesic in the side in addition, the Radix Puerariae of the coronary dilating of invigorating blood circulation has the Semen Cassiae of clearing away heat to improve acuity of vision, functions of loosening bowel relieving constipation and the vitamin E of antioxidation and is assistant.By increasing blood circulation and metabolism, reach tonification and don't produce showing tremendous enthusiasm purpose.Make integral formula balance science more, mend and not dry, reach the health care of " alleviating physical fatigue, improve climacteric syndrome " jointly.
Production technology
1. the pre-treatment of crude drug
1. respectively crude drug Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Fructus Rubi, Semen Cassiae, Radix Puerariae are cleaned, removal has impurity, the non-medicinal part of the iso-metamorphism that goes mouldy, damages by worms;
2. take by weighing the medical material of respectively distinguishing the flavor of after cleaning respectively by formula ratio, Radix Puerariae is clean with the circulating water washing separately, and all the other medical materials with the circulating water washing totally.
2. the extraction of medical material
1. decocting boils
Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Fructus Rubi, Semen Cassiae after cleaning are put in the multi-function extractor, added 10 times of weight water logging bubbles 4 hours, heated and boiled extracts twice, extracts 1.5 hours for the first time, filters; Add for the second time 8 times of water gagings and extracted 1 hour, filter merging filtrate with 120 order stainless steel sifts.
2. concentrate
Filtrate is put in the vacuum concentration pot, concentrating under reduced pressure, vacuum 0.08MPa, 80 ℃ of temperature, the clear paste that is concentrated into proportion 1.2 (60 ℃) is standby.
3. clear paste is put drying under reduced pressure in the vacuum drying apparatus, vacuum 0.08MPa, 80 ℃ of temperature get dry extract.
4. dry extract is pulverized with pulverizer, crossed 100 mesh sieves, it is standby to get dry extract.
3. the pulverizing of medical material
1. the Radix Puerariae after will cleaning places baking oven, 80 ℃ of oven dry.
2. the Radix Puerariae of oven dry is pulverized with pulverizer, crossed 100 mesh sieves, with cobalt 60 irradiation sterilizations, irradiation dose is 4kGy, and it is standby to get the Radix Puerariae fine powder.
4. starch slurry preparation: standby with the starch slurry that milk cooking process is made weight concentration 10% with 25g starch.
5. the pulverizing of supplementary material, sieve: with vitamin E, starch, carboxymethyl starch sodium, pulverize separately, it is standby to cross 100 mesh sieves.
6. mixing, granulation, drying
1. take by weighing carboxymethyl starch sodium fine powder, Radix Puerariae fine powder, appropriate amount of starch respectively by formula ratio, promote extract powder with liquid medicine in 7 kinds of the Radix Panacis Quinquefoliis etc. and mixes, again with the vitamin E fine powder of formula ratio, according to progressively increasing the dilution method mix homogeneously, always mixed powder.
2. will always mix powder and place trough type mixing machine, add starch slurry, make soft material; Cross 16 mesh sieves with oscillating granulator and make wet granular.
3. wet granular is placed drying baker, 80 ℃ of dryings, control moisture content＜5%.
7. granulate, tabletting: dried granule by 16 mesh sieve granulate, is sifted out fine powder in the dry granular, adds the magnesium stearate mixing, and then with dried granule mixing, measure functional component content qualified after, with 21 in the rotary tablet machine tabletting.Control strip heavily is 0.6g/ sheet (can be 0.57-0.63g); Press slice, thin piece and sift out fine powder, reject defective work.
8. packing, packing
1. packing: above-mentioned slice, thin piece is put packing on the tablet racking machine, and 80 every bottle, inner packaging material is the medicinal high-density polyethylene bottle of oral administration solid, meets the YBB001220002 of National Drug Administration's " national drug packing container (material) standard (trying) ";
2. pack: 100 bottles/case.
9. the product after the packing is carried out sampling inspection, the qualified products warehouse-in.
10. production environment:, be 300,000 grades of clean environments by the GMP requirement.
The description of product: this product is to be the health food that primary raw material is made with Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Fructus Rubi, Radix Puerariae, Semen Cassiae, vitamin E, starch, carboxymethyl starch sodium, magnesium stearate, prove to have the health care of alleviating physical fatigue through the animal function test;
Significant composition and content: every 100g contains: total saponins 1.49g, the sweet 637.1mg of Herba Epimedii, vitamin e1 .22g.
Health care: alleviating physical fatigue;
Suitable crowd: fatiguability person; Be not suitable for children, anemia of pregnant woman;
Eating method and amount: every day 2 times, each 3; Product specification: the 0.6g/ sheet '
Specification requirement:
Table 1 organoleptic indicator
| Project | Index |
| Color and luster, character | This product is long ovule, is sepia, and outward appearance is complete bright and clean, and color and luster is even |
| Abnormal smells from the patient, flavour | Gas perfume (or spice), bitter in the mouth, sweet |
The significant composition of table 2
| Project | Index |
| Total saponins (in the ginsenoside Re), g/100g 〉= | 1.49 |
| Icariin, mg/100g 〉= | 637.1 |
| Vitamin E, mg/100g | 9.760×10 2-2.196×10 3 |
Table 3 physical and chemical index
| Project | Index |
| Moisture, %≤ | 7 |
| Ash, %≤ | 10 |
| Arsenic (in As), mg/kg≤ | 0.3 |
| Plumbous (in Pb), mg/kg≤ | 0.5 |
| Disintegration, min≤ | 60 |
| Gamma Hexaochlorocyclohexane, mg/kg≤ | 0.2 |
| DDT，mg/kg ≤ | 0.1 |
Table 4 microbiological indicator
| Project | Index |
| Total plate count, cfu/g≤ | 1000 |
| Coliform, MPN/100g≤ | 40 |
| Mycete, cfu/g≤ | 25 |
| Yeast, cfu/g≤ | 25 |
| Pathogenic bacterium (referring to Salmonella, shigella, staphylococcus aureus and Hemolytic streptococcus) | Must not detect |
Table 5 net content and allowed minus deviation
| Net content, the g/ bottle | Allowed minus deviation, % |
| 48 | 9 |
The detection method of significant composition
The mensuration of icariin
Highly effective liquid phase chromatographic system: UV-detector; Data handling system; Supersonic generator.
Chromatographic condition
Chromatographic column: C
18Post (4.6mm * 200mm, 5 μ m);
Mobile phase: methanol+water (55+45);
Mobile phase speed: 0.8ml/min;
Detect wavelength: 270nm;
Detection sensitivity: 0.02AUFS;
Column temperature: 40 ℃;
Mobile phase is crossed 0.45 μ m filter membrane.
Reagent methanol: top grade is pure.
The icariin standard substance: originating is Nat'l Pharmaceutical ﹠ Biological Products Control Institute, purity 99.5%.
The icariin standard solution: precision takes by weighing icariin standard substance 5.0mg, is 10.0ml with dissolve with methanol and standardize solution, and this solution concentration is 0.5mg/ml.
The icariin standard is used liquid: precision is measured icariin standard solution 2.00ml, places the 10ml volumetric flask, is diluted to scale with methanol, mixing, and the icariin standard that is 0.1mg/ml is used liquid.
Assay method
Sample is handled: get and grind uniform solid sample 4.0g, add 70% ethanol 40ml, ultrasonic 30min after-filtration.With a small amount of 70% washing with alcohol residue, collect filtrate, be settled to 50ml, be sample treatment solution.
Measure: get said sample treatment fluid 1.0ml, to 5ml, cross 0.45 μ m filter membrane, get filtrate sample introduction 5.0 μ l, under above-mentioned instrument condition, analyze, measure peak area with 70% ethanol dilution.Get the icariin standard and use liquid 5.0 μ l, under same chromatographic condition, analyze, qualitative with relative retention time, peak area quantification.
Calculate x=h
1* C * V * 5 * 100/h
2* m
In the formula: x: content Determination of Icariin in the sample, mg/100g; h
1: sample peak height or peak area; C: concentration of standard solution, mg/ml; V: sample is measured volume, ml; h
2: standard solution peak height or peak area; M: sample size, g.
The mensuration of total saponins: the method by " health food check and assessment technique standard " (version in 2003) " mensuration of total saponins in the health food " regulation is measured.
The mensuration of vitamin E: the method for pressing GB/T 5009.82-2003 " mensuration of vitamin A and vitamin E in the food " regulation is measured.
Former, adjuvant quality standard: Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Fructus Rubi, Semen Cassiae, Radix Puerariae: the respective specified that should meet one one of the Pharmacopoeia of the People's Republic of China (version in 2000).
Starch, magnesium stearate: the respective specified that should meet two ones of the Pharmacopoeias of the People's Republic of China (version in 2000).
Sampling test:
Product of the present invention is the sepia tablet, and the recommendation daily intaking amount is 3.60g/60kgBW, hereinafter to be referred as the test sample.Sample solvent is a distilled water.
Reagent: rupture of membranes liquid, phosphate buffer, sodium chloride.
Laboratory animal and feedstuff: select the cleaning level 18-22g male mice in kunming of Chinese Medical Sciences University's Experimental Animal Center breeding for use, every group of 10 animals, the laboratory animal production licence number is SCXK (the Liao Dynasty) 2003-0009.Block Mus material is provided by Shenyang City's Yuhong District zoopery feed factory, and production licence number is SCXK (the Liao Dynasty) 2003-0011.
Experimental condition: the barrier system Animal Lab., constant temperature and humidity, 25 ± 1 ℃ of temperature, humidity 50% ± 10%, work illumination 160-2801z, artificial lighting 12h, night 12h, noise＜60dB, the laboratory animal occupancy permit number is SYXK (the Liao Dynasty) 2002-0001.
Test apparatus: AEL-160 type electronic analytical balance [sensibility reciprocal 0.0001g, the measurement verification certificate number is M411239 (the numbering synonym behind following each instrument)], Mettler PB1502-S type (M413073), Sartorius CP4202S-OCE type (the Liao Dynasty's meter 04031703102) and Sartorius CP2202S-OCE type (the Liao Dynasty's meter 04031703101) electronic balance (all have self calibration and animal weighing function, sensibility reciprocal 0.01g), (P451729 uses former factory calibration solution to Beckman-Coulter CX5 PRO type automatic clinical chemistry analyzer, control liquid and reagent), swimming case (80 * 50 * 40cm).
Dosage grouping:, divide 1.80g/kgBW, 1.20g/kgBW, three experimental grouies of 0.60g/kgBW and sample solvent matched group by 30 times, 20 times, 10 times designs recommending the human body daily intaking amount.Compound concentration is respectively 0.09g/mL, 0.06g/mL, 0.03g/mL, and per os filling stomach is tested and used sample, irritates gastric capacity 20ml/kgBW.Irritate stomach every day 1 time, measure every alleviating physical fatigue functional parameter after continuous 30 days respectively.
Mice swimming with a load attached to the body test: last test with behind the sample 30min, weighs, and every Mus root of the tail portion 5% body weight sheet lead of loading places the depth of water 30 ± 1cm, 25 ± 1 ℃ of swimming of water temperature casees to swim, and agitate water makes the mice extremity keep moving frequently.Record is from the extremely dead time (min) of swimming beginning.
Hepatic glycogen is measured (anthrone method): last is tested with putting to death behind the sample 30min, gets liver, and cleaning is blotted, and accurately takes by weighing 100mg.Add 8.0mlTCA, every pipe homogenate 1min with the centrifugal 15min of homogenate 3000r/min, moves to another to supernatant in vitro.Get the 1.0ml supernatant and put into the 10ml centrifuge tube, every pipe adds 95% ethanol 4.0ml, and fully mixing is jumped a queue, and erects under the room temperature to place and spends the night, after precipitation is complete, and the centrifugal 15min of 3000r/min, abandoning supernatant makes test tube handstand 10min.With 2.0ml dissolved in distilled water hepatic glycogen, blank pipe adds the 2.0ml distilled water, standard pipe adds 0.5ml glucose titer and 1.5ml distilled water, and the 10.0ml anthrone reagent is firmly added each pipe, immediately test tube is put into cold water and is had a shower to water temperature, test tube is put into boiling water bath 15min, move to psychrolusia again, be cooled to room temperature, in wavelength 620nm place colorimetric, with the zeroing of blank pipe, calculate hepatic glycogen content.
Blood lactic acid is measured: last is tested with behind the sample 30min, weighs, and places the depth of water 30 ± 1cm, 30 ± 1 ℃ of swimming of water temperature case to swim, and agitate water makes the mice extremity keep motion frequently.10min takes out.Respectively at before the swimming, after the swimming immediately, rest 20min in swimming back is from the accurate blood sampling 20 μ l of the ophthalmic corner of the eyes, add in the 40 μ l rupture of membranes liquid, the smudge cells that fully vibrates is immediately measured the blood lactic acid content with the lactic acid instrument, calculate blood lactic acid area under curve, data are carried out statistical analysis.
The serum urea nitrogen determination: last is tested with behind the sample 30min, weighs, and places the depth of water 30 ± 1cm, 30 ± 1 ℃ of swimming of water temperature case to swim, and agitate water makes the mice extremity keep motion frequently.90min takes out, and plucks the eyeball blood sampling behind the rest 60min.Put 4 ℃ of refrigerator 3h, the centrifugal 15min of 2000r/min behind the hemopexis, it is standby to get serum.Beckman-Coulter CX5 PRO type automatic clinical chemistry analyzer (P451729 uses former factory calibration solution, control liquid and reagent).
General employing variance analysis, but need carry out homogeneity test of variance earlier by the program of variance analysis, variance is neat, calculates the F value, F value＜F
0.05, conclusion: each organizes the mean differences does not have significance; F value 〉=F
0.05, P≤0.05 is added up with the comparative approach in twos (least significant difference) of mean between a plurality of experimental grouies and matched group; The data of abnormal or heterogeneity of variance are carried out the conversion of suitable variable, wait to satisfy normal state or variance are neat require after, add up with the data after changing; If do not reach normal state or the neat purpose of variance yet after the variable conversion, must add up with rank test.
Assay
Mice swimming with a load attached to the body result of the test: by table 6 as seen, each experimental group body weight, weight gain and sample solvent matched group compare, and difference does not have significantly (P＞0.05); By table 7 as seen, 1.80g/kgBW, 1.20g/kgBW experimental group swimming time and sample solvent matched group compare, significant difference (P＜0.05); 0.06g/kgBW experimental group swimming time and sample solvent matched group are relatively, difference does not have significantly (P＞0.05).
Table 6 mice swimming with a load attached to the body test measured body weight is unit: g as a result
| Dosage g/kgB W | Number of animals only | Initial body weight | The test opisthosoma is heavy | Weight gain | ||||||
| X± | SD | The P value | X± | SD | The P value | X± | SD | The P value | ||
| 1.80 | 10 | 19.8 1 | 1.26 | 0.90 | 33.6 0 | 2.89 | 0.84 | 13.7 9 | 1.73 | 0.81 |
| 1.20 | 10 | 19.8 1 | 1.27 | 0.90 | 33.5 5 | 2.99 | 0.87 | 13.7 4 | 1.82 | 0.85 |
| 0.60 | 10 | 19.8 7 | 1.23 | 0.81 | 33.7 2 | 2.98 | 0.77 | 13.8 5 | 1.81 | 0.75 |
| Solvent control | 10 | 19.7 4 | 1.15 | 33.3 3 | 2.87 | 13.5 9 | 1.87 | |||
Table 7 mice swimming with a load attached to the body test swimming time measurement result
| Dosage g/kgBW | Number of animals only | Swimming time (min) | ||
| X± | SD | The P value | ||
| 1.80 | 10 | 48.70 | 30.23 | ＜0.01 |
| 1.20 | 10 | 48.20 | 33.03 | 0.02 |
| 0.60 | 10 | 38.50 | 30.25 | 0.10 |
| Solvent control | 10 | 17.00 | 17.77 | |
Mouse Liver glycogen measurement result: by table 8 as seen, each experimental group body weight, weight gain and sample solvent matched group compare, and difference does not have significantly (P＞0.05); By table 9 as seen, 1.80g/kgBW, 1.20g/kgBW experimental mice hepatic glycogen content and sample solvent matched group compare, significant difference (P＜0.05); 0.06g/kgBW experimental mice hepatic glycogen content and sample solvent matched group are relatively, difference does not have significantly (P＞0.05).
Table 8 Mouse Liver glycogen test measured body weight is unit: g as a result
| Dosage g/kgB W | Number of animals only | Initial body weight | The test opisthosoma is heavy | Weight gain | ||||||
| X± | SD | The P value | X± | SD | The P value | X± | SD | The P value | ||
| 1.80 | 10 | 19.9 8 | 1.17 | 0.70 | 33.7 9 | 2.44 | 0.50 | 13.8 1 | 1.39 | 0.40 |
| 1.20 | 10 | 19.9 3 | 1.11 | 0.77 | 33.4 1 | 2.70 | 0.71 | 13.4 8 | 1.63 | 0.68 |
| 0.60 | 10 | 19.8 8 | 1.25 | 0.84 | 33.6 7 | 2.63 | 0.56 | 13.7 9 | 1.48 | 0.41 |
| Solvent control | 10 | 19.7 7 | 1.29 | 32.9 4 | 3.30 | 13.1 7 | 2.10 |
Table 9 Mouse Liver glycogen content measurement result
| Dosage g/kgBW | Number of animals only | Hepatic glycogen content (mg/100g hepatic tissue) | ||
| X± | SD | The P value | ||
| 1.80 | 10 | 2420.46 | 531.03 | ＜0.01 |
| 1.20 | 10 | 2259.34 | 428.47 | 0.01 |
| 0.60 | 10 | 1941.74 | 343.76 | 0.28 |
| Solvent control | 10 | 1731.93 | 367.79 | |
Mice blood lactic acid measurement result: by table 10 as seen, each experimental mice body weight, weight gain and sample solvent matched group compare, and difference does not have significantly (P＞0.05); By table 11 as seen, each experimental mice blood lactic acid area under curve and sample solvent matched group compare, and difference does not have significantly (P＞0.05).
Table 10 mice blood lactic acid test measured body weight is unit: g as a result
| Dosage g/kgB W | Number of animals only | Initial body weight | The test opisthosoma is heavy | Weight gain | ||||||
| X± | SD | The P value | X± | SD | The P value | X± | SD | The P value | ||
| 1.80 | 10 | 19.8 1 | 1.26 | 0.97 | 33.5 0 | 3.17 | 0.87 | 13.6 9 | 1.98 | 0.81 |
| 1.20 | 10 | 19.8 3 | 1.19 | 0.94 | 33.6 8 | 2.35 | 0.76 | 13.8 5 | 1.36 | 0.67 |
| 0.60 | 10 | 19.8 4 | 1.17 | 0.93 | 33.8 0 | 2.79 | 0.70 | 13.9 6 | 1.78 | 0.58 |
| Solvent control | 10 | 19.7 9 | 1.19 | 32.2 8 | 3.37 | 13.4 9 | 2.27 | |||
Table 11 mice blood lactic acid content measurement result
| Dosage g/kgB W | Number of animals only | Blood lactic acid value (mmol/L) | Blood lactic acid area under curve | |||||||
| Before the swimming | Swimming back 0min | Swimming back 20min | X± | SD | The P value | |||||
| X± | SD | X± | SD | X± | SD | |||||
| 1.80 | 10 | 1.24 | 0.26 | 2.37 | 0.43 | 1.39 | 0.28 | 166. 89 | 31.2 9 | 0.39 |
| 1.20 | 10 | 1.15 | 0.21 | 2.38 | 0.52 | 1.33 | 0.25 | 164. 48 | 33.4 6 | 0.30 |
| 0.60 | 10 | 1.18 | 0.20 | 2.50 | 0.41 | 1.34 | 0.21 | 170. 19 | 26.4 2 | 0.54 |
| Solvent control | 10 | 1.28 | 0.24 | 2.49 | 0.34 | 1.58 | 0.36 | 178. 35 | 25.9 0 |
The measurement result of mice serum blood urea nitrogen: by table 12 as seen, each experimental mice body weight, weight gain and sample solvent matched group compare, and difference does not have significantly (P＞0.05); By table 13 as seen, each experimental mice serum urea nitrogen content and sample solvent matched group compare, significant difference (P＜0.05).
Table 12 mice serum blood urea nitrogen test measured body weight is unit: g as a result
| Dosage g/kgB W | Number of animals only | Initial body weight | The test opisthosoma is heavy | Weight gain | ||||||
| X± | SD | The P value | X± | SD | The P value | X± | SD | The P value | ||
| 1.80 | 10 | 19.8 7 | 1.23 | 0.93 | 33.6 0 | 2.48 | 0.89 | 13.7 3 | 1.42 | 0.86 |
| 1.20 | 10 | 19.7 7 | 1.28 | 0.93 | 33.2 1 | 3.12 | 0.87 | 13.4 4 | 1.92 | 0.83 |
| 0.60 | 10 | 19.8 5 | 1.25 | 0.96 | 33.3 4 | 2.61 | 0.95 | 13.4 9 | 1.44 | 0.88 |
| Solvent control | 10 | 19.8 2 | 1.23 | 33.4 2 | 3.03 | 13.6 0 | 1.87 | |||
Table 13 mice serum urea nitrogen content measurement result
| Dosage g/kgBW | Number of animals only | Blood urea nitrogen (mmol/L) | ||
| X± | SD | The P value | ||
| 1.80 | 10 | 8.50 | 0.92 | ＜0.01 |
| 1.20 | 10 | 8.43 | 1.40 | ＜0.01 |
| 0.60 | 10 | 8.97 | 1.30 | 0.02 |
| Solvent control | 10 | 10.17 | 0.82 | |
Result of the test shows: test does not have obvious influence with sample to the laboratory animal body weight and the weight gain of every test, can prolong 1.80g/kgBW, 1.20g/kgBW experimental mice swimming time; Can reduce each experimental mice serum urea nitrogen content; 1.80g/kgBW, the 1.20g/kgBW experimental group can increase the Mouse Liver glycogen content.Each experimental group fails to reduce mice blood lactic acid area under curve.
Embodiment 2
Difference from Example 1 is,
Formula for a product: Radix Panacis Quinquefolii 500g, Herba Epimedii 450g, Fructus Lycii 350g, Fructus Tribuli 450g, Semen Cuscutae 300g, Fructus Rubi 350g, Radix Puerariae 20g, Semen Cassiae 270g, vitamin E 8g, Pulvis Talci 75g;
Production technology
1. the pre-treatment of crude drug
1. respectively crude drug Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Fructus Rubi, Semen Cassiae, Radix Puerariae are cleaned, removal has impurity, the non-medicinal part of the iso-metamorphism that goes mouldy, damages by worms;
2. take by weighing the medical material of respectively distinguishing the flavor of after cleaning respectively by formula ratio, Radix Puerariae is clean with the circulating water washing separately, and all the other medical materials with the circulating water washing totally.
2. the extraction of medical material
1. decocting boils
Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Fructus Rubi, Semen Cassiae after cleaning are put in the multi-function extractor, added 6 times of weight water logging bubbles 3 hours, heated and boiled extracts twice, extracts 2 hours for the first time, filters; Add for the second time 8 times of water gagings and extracted 3 hours, filter merging filtrate with 80 order stainless steel sifts.
2. concentrate
Filtrate is put in the vacuum concentration pot, concentrating under reduced pressure, vacuum 0.08MPa, 60 ℃ of temperature, the clear paste that is concentrated into proportion 1.4 (60 ℃) is standby.
3. clear paste is put drying under reduced pressure in the vacuum drying apparatus, vacuum 0.08MPa, 60 ℃ of temperature get dry extract.
4. dry extract is pulverized with pulverizer, crossed 80 mesh sieves, it is standby to get dry extract.
3. the pulverizing of medical material
1. the Radix Puerariae after will cleaning places baking oven, 60 ℃ of oven dry.
2. the Radix Puerariae of oven dry is pulverized with pulverizer, crossed 80 mesh sieves, with cobalt 60 irradiation sterilizations, irradiation dose is 4kGy, and it is standby to get the Radix Puerariae fine powder.
4. the pulverizing of supplementary material, sieve: with vitamin E, Pulvis Talci, pulverize separately, it is standby to cross 80 mesh sieves.
5. mix, drying
1. take by weighing Pulvis Talci 75g, Radix Puerariae fine powder by formula ratio, promote extract powder with liquid medicine in 7 kinds of the Radix Panacis Quinquefoliis etc. and mixes, again with the vitamin E fine powder of formula ratio, according to progressively increasing the dilution method mix homogeneously, always mixed powder;
6. go up capsule filling machine and add Capsules and make hard capsule, aluminum-plastic packaged, the qualified products warehouse-in.Production environment:, be 300,000 grades of clean environments by the GMP requirement.
Embodiment 3
Difference from Example 1 is,
Formula for a product: Radix Panacis Quinquefolii 700g, Herba Epimedii 650g, Fructus Lycii 450g, Fructus Tribuli 600g, Semen Cuscutae 460g, Fructus Rubi 450g, Radix Puerariae 80g, Semen Cassiae 370g, vitamin E 35g, dextrin 90g, starch 80g makes granule;
Production technology
1. the pre-treatment of crude drug
1. respectively crude drug Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Fructus Rubi, Semen Cassiae, Radix Puerariae are cleaned, removal has impurity, the non-medicinal part of the iso-metamorphism that goes mouldy, damages by worms;
2. take by weighing the medical material of respectively distinguishing the flavor of after cleaning respectively by formula ratio, Radix Puerariae is clean with the circulating water washing separately, and all the other medical materials with the circulating water washing totally.
2. the extraction of medical material
1. decocting boils
Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Fructus Rubi, Semen Cassiae after cleaning are put in the multi-function extractor, added 12 times of weight water logging bubbles 6 hours, heated and boiled extracts twice, extracts 1 hour for the first time, filters; Add for the second time 8 times of water gagings and extracted 2 hours, filter merging filtrate with 120 order stainless steel sifts.
2. concentrate
Filtrate is put in the vacuum concentration pot, concentrating under reduced pressure, vacuum 0.08MPa, 70 ℃ of temperature, the clear paste that is concentrated into proportion 1.1 (60 ℃) is standby.
3. clear paste is put drying under reduced pressure in the vacuum drying apparatus, vacuum 0.08MPa, 70 ℃ of temperature get dry extract.
4. dry extract is pulverized with pulverizer, crossed 120 mesh sieves, it is standby to get dry extract.
3. the pulverizing of medical material
1. the Radix Puerariae after will cleaning places baking oven, 70 ℃ of oven dry.
2. the Radix Puerariae of oven dry is pulverized with pulverizer, crossed 120 mesh sieves, with cobalt 60 irradiation sterilizations, irradiation dose is 4kGy, and it is standby to get the Radix Puerariae fine powder.
4. the pulverizing of supplementary material, sieve: with vitamin E, dextrin, starch, pulverize separately, it is standby to cross 120 mesh sieves.
5. mix, drying
1. take by weighing dextrin, starch, Radix Puerariae fine powder by formula ratio, promote extract powder with liquid medicine in 7 kinds of the Radix Panacis Quinquefoliis etc. and mixes, again with the vitamin E fine powder of formula ratio, according to progressively increasing the dilution method mix homogeneously, always mixed powder; To always mix powder and place trough type mixing machine, add suitable quantity of water, make soft material; Cross 16 mesh sieves with oscillating granulator and make wet granular, wet granular is placed drying baker, 70 ℃ of dryings, control moisture content＜5%;
With granule racking machine packing on the aluminum-plastic composite membrane, pack qualified products warehouse-ins.Production environment:, be 300,000 grades of clean environments by the GMP requirement.
Claims (5)
- A fatigue alleviating, improve the health food of male climacteric syndrome, it is characterized in that: count by weight, its active ingredient comprises, Radix Panacis Quinquefolii 500-700 part, Herba Epimedii 450-650 part, Fructus Lycii 350-450 part, Fructus Tribuli 450-600 part, Semen Cuscutae 300-460 part, Fructus Rubi 350-450 part, Semen Cassiae 270-370 part, Radix Puerariae 20-80 part, vitamin E 5-35 part.
- 2. according to the described health food of claim 1, it is characterized in that: its active ingredient comprises, Radix Panacis Quinquefolii 600g, Herba Epimedii 550g, Fructus Lycii 400g, Fructus Tribuli 530g, Semen Cuscutae 370g, Fructus Rubi 400g, Radix Puerariae 50g, Semen Cassiae 330g, vitamin E 20g.
- 3. according to the described health food of claim 1, it is characterized in that: wherein also be added with the excipient that can be made into various dosage forms.
- 4. according to the described health food of claim 3, it is characterized in that: count by weight,Described excipient is to make starch 80-120 part, carboxymethyl starch sodium 8-20 part and magnesium stearate 1-6 part that tablet is used;Make Pulvis Talci 60-150 part that hard capsule uses Capsules of packing into;Make dextrin 50-120 part, starch 50-100 part that granule is used;After medicinal material extract become fluid extract, add the simple syrup of making the 65-75% that oral liquid uses;Or the Mel that honey pill agent is used is made in adding.
- 5. the preparation of the described health food of claim 1, it is characterized in that: detailed process is as follows,1) to removing V EOther outer component medical material screens, and selects clean, first-class medical material, takes by weighing medical material by formula ratio;2) Radix Panacis Quinquefolii, Herba Epimedii, Fructus Lycii, Fructus Tribuli, Semen Cuscutae, Semen Cassiae, Fructus Rubi seven flavor medicine material are cleaned in the rearmounted multi-function extractor, added water logging bubble 3-6 hour that 6-12 doubly measures, boil and extract 2-5 time, filtration, reserved filtrate;3) filtrate is put in the vacuum concentration pot, concentrating under reduced pressure, is concentrated into the clear paste that proportion is 1.1-1.4 by temperature 60-80 ℃; Get dry extract through drying under reduced pressure, pulverized the 80-120 mesh sieve;4) Radix Puerariae is cleaned rearmounted baking oven 60-80 ℃ oven dry, pulverizes the 80-120 mesh sieve then, and the sterilization back is standby;5) with dry extract, powder of Radix Puerariae, V EAnd mixed with excipients is made finished product after evenly.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101204412B (en) * | 2007-12-17 | 2010-05-26 | 贵州富华药业有限责任公司 | Compound traditional Chinese traditional medicine for osteoporosis |
| CN105920057A (en) * | 2016-06-03 | 2016-09-07 | 通化师范学院 | Application of icariin |
| CN106420963A (en) * | 2016-09-27 | 2017-02-22 | 张舸 | Medicinal and edible active rooting preparation (tablet) and preparation method thereof |
| CN107427538A (en) * | 2015-04-17 | 2017-12-01 | 株式会社山田养蜂场本社 | Nourishing tonic containing honeybee |
| CN110326787A (en) * | 2019-08-13 | 2019-10-15 | 北京联合大学 | A kind of plant composition and preparation method thereof for alleviating physical fatigue |
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2006
- 2006-03-15 CN CNA2006100460477A patent/CN101036722A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101204412B (en) * | 2007-12-17 | 2010-05-26 | 贵州富华药业有限责任公司 | Compound traditional Chinese traditional medicine for osteoporosis |
| CN107427538A (en) * | 2015-04-17 | 2017-12-01 | 株式会社山田养蜂场本社 | Nourishing tonic containing honeybee |
| CN105920057A (en) * | 2016-06-03 | 2016-09-07 | 通化师范学院 | Application of icariin |
| CN106420963A (en) * | 2016-09-27 | 2017-02-22 | 张舸 | Medicinal and edible active rooting preparation (tablet) and preparation method thereof |
| CN110326787A (en) * | 2019-08-13 | 2019-10-15 | 北京联合大学 | A kind of plant composition and preparation method thereof for alleviating physical fatigue |
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