CN101352497B - Chinese medicinal composition for removing chloasma, and preparation method and uses thereof - Google Patents
Chinese medicinal composition for removing chloasma, and preparation method and uses thereof Download PDFInfo
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Abstract
The invention provides a Chinese medicine combination used for eliminating chloasma, and the Chinese medicine combination is a preparation prepared by the raw materials of salvia miltiorrhiza, angelica, medlar, rose and hawthorn. The invention also provides a preparation method thereof; the Chinese medicine combination of the invention can adjust the human body to a durable and stable state of yin-yang balance and smooth qi and blood circulation by regulating qi, activating blood, keeping qi and blood smooth, dredging the channels and collaterals as well as nourishing the liver and the kidneys, and can play the roles of resisting lipid peroxidation and eliminating free radicals, thus achieving the purposes of chloasma eliminating, youth keeping and face beautifying.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, Its Preparation Method And Use of functions of removing chloasma, belong to the field of Chinese medicines.
Background technology
Chloasma is a kind of pigment proliferative skin disorders that betides face.It is butterfly-like that its clinical manifestation is symmetry with face, or limitation is filbert or the brown patch is characteristics." the black pigment used by women in ancient times to paint their eyebrows black speck ", the category of " chloasma hepaticum " that belong to motherland's medical science.Be more common in the women, generation is all arranged from the adolescence to the menopause, be more common in the 2nd～May of trimester of pregnancy especially, therapeutic effect is not good enough.Prevalence is on the rise in recent years, gives current many people's spirit of liking to be beautiful and has in lifely caused great misery.
Chloasma belongs to dermatology common disease, and pathogenesis it be not immediately clear.Modern medicine is thought may be relevant with multiple factors such as endocrine disturbance, heredity, D﹠C, some chronic disease, the excessive irradiations of ultraviolet.Wherein the endocrine disturbance is primary pathogenic factors.Pigmented spots promptly can be multiple at first, tend to merge form not of uniform size, irregular patch, are symmetrically distributed in the face that exposure is exposed.The most outstanding with cheekbone portion, forehead, two cheeks, be butterfly wing sometimes, occasionally in upper lip.Clear-cut margin or be diffusivity, local NIP and squama.No conscious sympton, pigment can change slightly with factors such as season, Exposure to Sunlight, hormonal changes, does not often prolongedly move back, and a part can slowly disappear in minute puerperium or after withdrawing contraceptive.
The principle of modern medicine treatment primary disease mainly be suppress the melanocyte activity, suppress melanin synthetic, remove the melanin that generated, destroy the opacifier etc. that melanin granule and utilization have anti-photo effect.Mainly contain following several Therapeutic Method at present: (1) takes orally or vein gives vitamin C, cooperates vitamin E to use simultaneously, can stop the metabolic oxidizing process of melanin, suppresses melanin and forms.(2) local topical Hydrochinone Cream can suppress tyrosine and be converted into melanin and stop melanic biosynthesis, suppresses the particulate formation of black rope and increases its degraded, suppresses synthesizing according to pigment cell DNA and RNA.Or with being coated with outside 20% the Azelex part, Azelex is the competitive inhibitor of tryrosinase, can directly disturb biosynthesis.Do not influence normal melanocyte, certain curative effect is arranged in conjunction with wide spectrum opacifier treatment epidermis type and mixed type chloasma.Or local topical retinoic acid frost, can suppress the melanoma cells tyrosinase activity of In vitro culture, stop the transhipment of melanin to keratinocyte, reduce cutin simultaneously and form, increase drug osmotic.Or treatments such as external 3% Arbutin cream or lotion.
Theory of Chinese medical science is thought " have Zhu Neibi shape all outer ", and " vital organs of the human body 12 are through QI and blood, and are all up in face." stop in the generation of chloasma and human body depression of liver-QI, stagnation of blood stasis, caused by liver and kidney deficiency, insufficiency of vital energy and blood, expectorant are turbid etc. multiple because of Suo Youguan.Its pathogenesis or by depression of liver-QI, with the passing of time heat-transformation is fumigated in face and given birth to; Or because of qi depression to blood stasis, battalion defends and becomes estranged, and stops up the channels that stagnates, and ties in face and sends out; Or because of Liver and kidney deficient, Chong and Ren channel disorder, asthenia of essence and blood can not be gone up and flourish forms in face; Or be that insufficiency of the spleen mistake is strong, to give birth in the phlegm-damp, turbid pathogen blocks in face and causes.It is clinical adopts treatment approach such as treatment by oral administration of medicines, external treatment, acupuncture, massage more, lays particular emphasis on from liver,spleen,kidney and starts with, and corrects the function disorder, eliminates pathological factors such as gas, the stasis of blood, expectorant, wet, heat.Method of treatment commonly used has that dispersing the stagnated live-QI to relieve the stagnation of QI, vital energy regualting and blood circulation-promoting, nourishing the liver and kidney, soothing liver and strengthening spleen, warming YANG activating the spleen, dampness removing reduce phlegm, eliminating damp-heat etc.
In recent decades. the drug development of treatment chloasma is rapid, for the prevention and the treatment of chloasma provides strong weapon.Though clinical Western medicine has certain curative effect, it is satisfied that effect is still owed, and have side effect in various degree, and prolonged application easily causes severe complications.Up to the present, do not find the ideal product of control primary disease as yet.Chinese medicine is having complete treatment theoretical system and abundant clinical experience aspect the treatment chloasma, whole regulating functions of ZANG FU-organs special advantages is arranged, there is advantageous natural resources of Chinese medicinal materials in China simultaneously, so Chinese medicine is having wide prospect aspect the treatment chloasma.Develop treatment chloasma tcm product safely and effectively, will contribute for the misery that alleviates extensive patients, and produce great society and economic benefit.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition of functions of removing chloasma, it has vital energy regualting and blood circulation-promoting, nourishing the liver and kidney, the function of spot-removing beautifying face.
Another object of the present invention provides a kind of preparation method of Chinese medicine composition of functions of removing chloasma.
The Chinese medicine composition that another object of the present invention provides a kind of functions of removing chloasma is used for preparing the application for the treatment of the chloasma product.
In order to realize the object of the invention, the Chinese medicine composition of a kind of functions of removing chloasma of the present invention, it is to contain the preparation that the raw material of following components by weight percent is made:
100～1000 parts of Radix Salviae Miltiorrhizaes, 50～500 parts of Radix Angelicae Sinensis, 50～500 parts of Fructus Lycii, 50～500 parts of Flos Rosae Rugosaes, 50～500 parts of Fructus Crataegis.
Be preferably:
400～600 parts of Radix Salviae Miltiorrhizaes, 200～350 parts of Radix Angelicae Sinensis, 200～350 parts of Fructus Lycii, 200～350 parts of Flos Rosae Rugosaes, 200～350 parts of Fructus Crataegis.
In order to improve its effect, strengthen non-oxidizability, prolong the aging of skin, go back 6～80 parts of Semen Vitis viniferae extracts, 2～30 parts of vitamin E powders, 5～50 parts of vitamin Cs.
Preferably, 30～45 parts of Semen Vitis viniferae extracts, 10～15 parts of vitamin E powders, 0～30 part of Catergen.
Described preparation is tablet, capsule, soft capsule, drop pill or granule.
The preparation method of the Chinese medicine composition of a kind of functions of removing chloasma of the present invention comprises the steps:
1) earlier by soaking 1～5 hour in 60～99% ethanol of said ratio with 5～12 times of Radix Salviae Miltiorrhizae amounts of Radix Salviae Miltiorrhizae adding, reflux, extract, 10～60 minutes is filtered, and residue is standby; Decompression filtrate recycling ethanol; Concentrating under reduced pressure becomes thick paste A (60 ℃ are surveyed relative density is 1.10～1.50), and is standby;
2) by said ratio Radix Angelicae Sinensis, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi and Radix Salviae Miltiorrhizae residue are merged then, the water logging that adds 5～12 times of doses was steeped 1～5 hour, decocted decocting time 1～3 hour 1～5 time, filter, it is 1.05～1.20 (60 ℃ of surveys) that collecting decoction, water extract are evaporated to relative density, adds 95% ethanol to containing alcohol amount 40～80%, precipitate 12～36 hours, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure get thick paste B (60 ℃ are surveyed relative density is 1.10～1.50);
3) thick paste A and thick paste B are merged, mixing, dry, pulverize, cross 40～80 mesh sieves, again with acceptable accessories, or with vitamin E powder, vitamin C, Semen Vitis viniferae extract and acceptable accessories, make tablet, capsule, soft capsule, drop pill, oral liquid or granule.
Wherein, the condition of decompression recycling ethanol is 0.01～0.09MPa in each step, 55～95 ℃ of temperature, and 55～95 ℃ of condition pressure 0.02～0.09MPa. temperature of concentrating under reduced pressure, the condition of drying under reduced pressure is pressure 0～0.095MPa, 50～120 ℃ of temperature.
Described Semen Vitis viniferae extract is made by following method:
Semen Vitis viniferae was smashed 14～60 mesh sieves. and add 1～6 times of amount petroleum ether and soaked 18～80 hours, filter; The Semen Vitis viniferae slag adds 3～8 times of amount 95% alcohol reflux 1～5 time, and each 1～3 hour, filter, decompression filtrate recycling ethanol is to there not being ethanol flavor (60 ℃ of relative densities are 1.10～1.20); Add 2～6 times of amount deionized waters sedimentation 1～6 hour, filter; Filtrate is used with the ethyl acetate extraction of volume 1～5 time, combining extraction liquid, the extract concentrating under reduced pressure, vacuum drying, pulverize Semen Vitis viniferae extract.
Wherein, the condition pressure 0.01～0.05MPa of reclaim under reduced pressure, 50～95 ℃ of temperature, exsiccant condition are vacuum 0～0.095MPa, 50～120 ℃ of temperature, the condition of concentrating under reduced pressure are pressure 0.02～0.09MPa, 50～95 ℃ of temperature.
The raw material of the Chinese medicine composition of functions of removing chloasma of the present invention comprises Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi, Semen Vitis viniferae extract, vitamin E and vitamin C.
Wherein, the Radix Salviae Miltiorrhizae bitter in the mouth, cold nature, the master goes into the heart, Liver Channel." book on Chinese herbal medicine justice " meaning: " Radix Salviae Miltiorrhizae is specially gone into blood system, and its merit is the promoting the circulation of blood of invigorating blood circulation.In reach internal organs and blood stasis dispelling stagnates ... outer profit joint and the network of promoting blood circulation." " book on Chinese herbal medicine is looked for the truth " carry: " Radix Salviae Miltiorrhizae can break stagnated blood, the benefit fresh blood." " herbal lease making " cloud: " eliminating blood stasis to promote regeneration of blood, menstruation regulating blood nourishing medicinal are controlled the disease of blood deficiency and blood stasis." so Radix Salviae Miltiorrhizae is gone into blood system, not only kind promoting blood circulation to restore menstrual flow. but also kind blood-supplementing blood-nourishing.The performance blood circulation promoting and blood stasis dispelling, blood-supplementing blood-nourishing, the function of collateral dredging speckle removing.
Radix Salviae Miltiorrhizae: mainly contain diterpene quinones composition such as Tanshinone I, TANSHINONES 1IA, TANSHINONES 1IB, cryptotanshinone etc.; Liposoluble ingredient such as salviol, saivianic acid A, second, the third, protocatechuic acid, protocatechualdehyde etc.Diterpenoid tanshinone has very strong anti peroxidation of lipid and free radical scavenging effect.Radix Salviae Miltiorrhizae Injection is to Fe
2+-H
2O
2The clearance rate of the hydroxy radical (OH) that system produces is 65%, the clearance rate of the superoxide anion that xanthine-xanthine oxidase system is produced is 100%, 7 kinds of water soluble ingredients of Radix Salviae Miltiorrhizae all have tangible scavenging action to the superoxide anion that xanthine-xanthine oxidase system produces, and wherein the Radix Salviae Miltiorrhizae rope is better than SOD to the scavenging action of superoxide anion.Total salvianolic acid can anti-Fe
2+The inductive hepatomicrosome lipid peroxidation of-cysteine, superoxide anion and Fe that the removing xanthine-the xanthine oxidase system produces
2+-H
2O
2The OH that system produces, and under Isodose, all be better than vitamin E.Clinical research shows, is that the main Chinese medicine compound of forming has excellent curative to chloasma with the Radix Salviae Miltiorrhizae.
Radix Angelicae Sinensis acrid in the mouth, sweet, warm in nature.Go into liver, the heart, spleen channel." book on Chinese herbal medicine just " carries: " Radix Angelicae Sinensis, its sweet in the mouth and weighing is so specially can enrich blood.Its gas is light and hot, again can promoting the circulation of blood.Invigorating middle warmer has, in the row benefit is arranged, the gas medicine in the sincere blood, and also the panacea in the blood is also." the Compendium of Material Medica meaning: " enrich blood with blood." " book on Chinese herbal medicine covers bamboo fish trap " speech: " Radix Angelicae Sinensis energy removing blood stasis blood, tissue regeneration promoting blood walk abreast unobstructed vessel and gas, flow round without stopping." so the sweet temperature compensation benefit of Radix Angelicae Sinensis, kind energy blood-supplementing blood-nourishing, Xin Wenhang looses, kind again blood circulation and channel invigorating.The effect of stasis-resolving spot-removing is nourished blood and blood in performance.
The Radix Angelicae Sinensis master contains volatile oil, organic acid such as ferulic acid, materials such as saccharide and aminoacid.Radix Angelicae Sinensis has antioxidation and removes the effect of oxygen-derived free radicals, the effective ingredient ferulic acid by directly remove free radical, inhibited oxidation reacts and radical reaction, and the infringement that multiple mechanism antagonism radical pair tissue such as combines with biological film phospholipid.Discover that use Radix Angelicae Sinensis injection hot flushes in rats was carried out the vein successive administration after 20 days, blood SOD activity obviously increases, the lipid peroxide level descends, and illustrate that Radix Angelicae Sinensis injection can remove oxygen-derived free radicals, and the anti peroxidation of lipid thing reacts.Radix Angelicae Sinensis has the Antiradiation injury effect in addition, with the rabbit lumbar injection of Radix Angelicae Sinensis to radiation damage, injects continuously 9 days, and rabbit chromosome abnormal rate recovers normal fully.And external medication result and body innerlich anwenden are identical.Tryrosinase can produce the melanin that causes people's black speck, senile plaque. and its activity is high more, and then senile plaque etc. occurs more early, and quantity is also the more.The Radix Angelicae Sinensis aqueous solution has the active effect of extremely strong restraint of tyrosinase, suppresses melanic formation.And Radix Angelicae Sinensis can be expanded peripheral blood vessel, reduces vascular resistance, increases the blood circulation amount.Treatment chloasma, freckle isochrome disposition dermatosis there is good efficacy.
The Fructus Lycii sweet in the mouth, the property first is gone into liver, kidney channel." property of medicine opinion " carries: " sweet in the mouth, flat.The smart various symptoms and signs of deficiency of energy tonification, easily color becomes certainly, makes eye bright, and calms the nerves, and makes us long-lived." Compendium of Material Medica meaning: " and Gan Ping and moistening, property taste and mending ... can the kidney invigorating lung moistening, the spermatogenesis QI invigorating.This is the medicine of flat benefit." " herbal classic is met former " speech: " Fructus Lycii matter profit is rich, high invigorating the liver and kidney, dashes the essence and blood of superintending and directing." so Fructus Lycii sweet in the mouth matter profit, the performance nourishing the liver and kidney.Benefit intensive culture blood, the function of face-beautifying and spot-removing.
The chemical constituent of Fructus Lycii mainly contains effective ingredient such as lycium barbarum polysaccharide, betanin, carotenoid.The dominant mechanism that Fructus Lycii is used for chloasma is LPO inhibitor, and defying age reduces the generation of facial pigmented spots.Lycium barbarum polysaccharide has the effect of anti peroxidation of lipid and SOD activity improving, is one of main active of Fructus Lycii.Fructus Lycii extracting solution has antioxidation, anti-aging effects.Experiment also obviously suppresses the liver lipid peroxide and generates in the mice body, and makes that glutathione peroxidase activity and erythrocyte sod vigor increase in the blood.Human experimentation shows that obviously suppressing the serum lipid peroxide generates, and increases the vigor of glutathion peroxidase in the blood.Fructus Lycii water extract has the effect that carbon tetrachloride causes lipid peroxidation that suppresses.Clinical report contains Fructus Lycii kidney-nourishing tcm drug compound recipe and has remarkable result aspect the treatment chloasma.
Flos Rosae Rugosae sweet in the mouth, little hardship, gas perfume (or spice).Warm in nature.Go into liver, stomach warp.Supplementary Amplifications of the Compendium of Materia Medica carries: " gas perfume (or spice) is warm in nature, and sweet and slightly bitter taste is gone into spleen, Liver Channel, regulating and activating blood circulation." " property of medicine is examined " cloud: " Flos Rosae Rugosae is warm in nature, the promoting the circulation of blood removing mass." " book on Chinese herbal medicine is new again " meaning: " the strongly fragrant gas of soothing liver-QI gallbladder, spleen invigorating pathogenic fire reducing." so the hot fragrant row of Flos Rosae Rugosae looses the effect of performance promoting QI circulation for relieving depression and blood dissipating blood stasis speckle removing.
Fructus Crataegi sour in the mouth, sweet, slightly warm in nature." property of medicine is separated " cloud: " property is flat, and is nontoxic, goes into spleen channel for Fructus Crataegi, sweet in the mouth acid.Main strengthening the spleen to promote digestion, eliminating stagnation gas.The stagnant blood of row." " Bencao Congxin " carry: " Fructus Crataegi spleen invigorating circulation of qi promoting, the mill that helps digestion is long-pending." " must join book on Chinese herbal medicine " meaning: " the removing food stagnancy dissipating blood stasis, dispelling the stagnated QI reduces phlegm." " herbal lease making " speech: " and the spleen invigorating circulation of qi promoting, dissipating blood stasis reduces phlegm, and the meat that disappears amasss infantile dyspepsia." " Records of Tradition Chinese and Western Medicine in Combination ": claim: " be apt to into blood system is the key medicine of blood stasis dispelling blood .... and doublely go into edema caused by disorder of QI to open stagnation of QI expectorant knot." so the kind strengthening the spleen to promote digestion of Fructus Crataegi merit, circulation of qi promoting dissipating blood stasis, performance QI and blood regulating, the effect of dissolving stasis and dispelling spots.
The fatty enzyme of Fructus Crataegi master, flavonoid, active ingredients such as organic acid.Fructus Crataegi is by blood circulation promoting and blood stasis dispelling, and the accelerate blood circulation enhances metabolism, and helps melanin decomposition in the body, makes it and can not become mottle by precipitation form.The external application of clinical report Fructus Crataegi powder can promote facial blood circulation, improves the skin of face metabolism, and facial pigmentation is dribbled.Clinical practice shows, selects for use Fructus Crataegi to form speckle dispelling compound treatment chloasma through compatibility and can obtain satisfactory effect.
The Semen Vitis viniferae extract procyanidin has extremely strong anti-oxidation characteristics, and collagen protein is had powerful protective effect, can keep the complete of collagen protein, thereby improves the health status of skin.
Vitamin E is an important antioxidants in the body, and it can protect cell, and protection blood vessel, promotion blood flow are played an important role.Support one's family rope C as antioxidant, can reduce the infringement of free radical, slow down aging is played an important role.Zhu Pin cooperates, and brings out the best in each other, and plays vital energy regualting and blood circulation-promoting altogether.Nourishing the liver and kidney, the merit of spot-removing beautifying face.
Vitamin E has special affinity to the phospholipid of mitochondrion, endoplasm, reticular tissue or serous coat, at the specific part of these films, can prevent or stop lipid peroxidation, and the integrity and the stability of protection cell biological film are kept the cell normal function.Reverse skin aging, improve the elasticity and the permeability of blood capillary simultaneously, help the elimination of mottle.Clinical research is the result show, vitamin E can make chloasma faciei and pigmented spots reduce even disappear, and the treatment chloasma is had curative effect preferably, and its mechanism mainly is by LPO inhibitor, and can suppress gathering of the interior lipofuscin of cell.
Vitamin C can directly or indirectly be eliminated free radical, thereby can protect the biomembrane integrity as natural free radical scavenger, reduces the infringement of free radical, and slow down aging is played an important role.Vitamin C is the transporter of nitrogen in the redox of cell, participates in the metabolic process of aminoacid and carbohydrate, influence the formation and melanic the synthesizing of connective tissue, makes melanin be in reducing condition and can be used for pigmentation disease.There have report to utilize local vitamin C iontophoresis or vitamin C and medicine for external use to share treatment chloasma effect to be remarkable.
Stagnation of QI due to depression of the liver, blood-stasis internal-depression, the double hepatic and renal YIN deficiency is the modal pattern of syndrome of chloasma.Liver controlling conveyance and dispersion can transfer to reach QI and blood happy feelings will.If depression of liver-QI is then qi-blood disharmony. qi depression to blood stasis. stop up the channels that stagnates, on tie in face and then cause speckle.Liver storing blood.Liver blood fill and, the strong face profit of body then.If deficiency of the liver and kindey, essence and blood loses empty, can not go up Rong Ze and easily give birth to speckle.The present invention controls from gas, stasis of blood opinion in line with the treatment rule of treatment must aim at the pathogenesis of disease, holds concurrently and sets upright with tonify deficiency.By vital energy regualting and blood circulation-promoting, transfer smooth QI and blood. dredging the meridian, hold concurrently with nourishing the liver and kidney, human body is adjusted to lastingly, stable equilibrium between yin and yang, the unobstructed state of QI and blood.Thereby reach spot-removing beautifying face, beautify the purpose of appearance.
In sum, modern pharmacological research shows that component of the present invention comprehensively has the effect of anti peroxidation of lipid and free radical scavenging.Have vital energy regualting and blood circulation-promoting, nourishing the liver and kidney, the function of spot-removing beautifying face is applicable to patient with chloasma.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
The Chinese medicine composition of present embodiment functions of removing chloasma is made capsule by following raw material: Radix Salviae Miltiorrhizae 500g, Radix Angelicae Sinensis 250g, Fructus Lycii 250g, Flos Rosae Rugosae 250g, Fructus Crataegi 250g, Semen Vitis viniferae extract 37.5g, vitamin E powder (50%) 25g, Catergen 5g, starch 112g, micropowder silica gel 0.5g.
Its preparation process is: 1) the 500g Radix Salviae Miltiorrhizae added the 4000g95% soak with ethanol 3 hours, and reflux, extract, 30 minutes is filtered.Residue is standby, decompression filtrate recycling ethanol (0.05MPa, 60 ℃ of temperature).Concentrating under reduced pressure (60 ℃ of pressure 0.08MPa. temperature) becomes thick paste A (60 ℃ are surveyed relative density is 1.30), and is standby.
2) merge by above-mentioned Radix Angelicae Sinensis, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi and the Radix Salviae Miltiorrhizae residue of measuring then, soaked 3 hours, decoct 2 times, 10 times, 8 times of amount of water, decocting time 1.5 hours, 1 hour, filter, collecting decoction, water extract concentrating under reduced pressure (pressure 0.08MPa, 60 ℃ of temperature) to relative density is 1.10 (60 ℃ of surveys), add 95% ethanol to containing alcohol amount 60%. precipitations 24 hours, filter decompression filtrate recycling ethanol (pressure 0.05MPa, 60 ℃), concentrating under reduced pressure (pressure 0.08MPa, 60 ℃ of temperature) gets thick paste B (60 ℃ are surveyed relative densities is 1.30).
3) again thick paste A and thick paste B are merged, mixing, drying under reduced pressure (pressure 0.08MPa, 70 ℃ of temperature) gets dry extract, and pulverizes.Cross 60 mesh sieves, it is standby to get fine powder C.
4) get vitamin E powder, vitamin C, Semen Vitis viniferae extract, the starch mix homogeneously that is up to the standards, cross 60 mesh sieves, get mixed powder D, standby.
5) get mixed powder C and mixed powder D mix homogeneously, mixed powder E, mixed powder E dry-pressing system granule, granulate (60 order), the adding micropowder silica gel. mix homogeneously. filling capsule, make altogether 1000 capsules (wherein containing Radix Salviae Miltiorrhizae ethanol extract 18g[paste-forming rate is 5%].Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi extract [paste-forming rate is 18.8%] 282g, Semen Vitis viniferae extract 37.5g[paste-forming rate is 10%], vitamin E powder (50%) 25g, Catergen 5g, starch 112g. micropowder silica gel 0.5g).0.5g/ grain. every day 2 times, each 4.
6) weigh after the assay was approved packing through moisture, grain.
Wherein, the preparation process of Semen Vitis viniferae extract is:
Semen Vitis viniferae was smashed 20 mesh sieves. and add 3 times of amount petroleum ether and soaked 48 hours, filter; The Semen Vitis viniferae slag adds 95% alcohol reflux 3 times (6 times, 5 times, 5 times), and each 1.5 hours, filter, decompression filtrate recycling ethanol (pressure 0.01MPa, 60 ℃ of temperature) is to there not being ethanol flavor (60 ℃ of relative densities are 1.10); Add 4 times of amount deionized waters sedimentation 2 hours, filter; Filtrate is used with the ethyl acetate extraction of volume 3 times, combining extraction liquid, extract concentrating under reduced pressure (pressure 0.05MPa, 60 ℃ of temperature), thick paste vacuum drying (vacuum 0.08MPa, 80 ℃ of temperature) gets dry extract, broken mistake 80 mesh sieves of dried cream powder, Semen Vitis viniferae extract.
Embodiment 2
The Chinese medicine composition of present embodiment functions of removing chloasma is made tablet by following raw material: Radix Salviae Miltiorrhizae 100g, Radix Angelicae Sinensis 500g, Fructus Lycii 500g, Flos Rosae Rugosae 50g, Fructus Crataegi 500g, Semen Vitis viniferae extract 6g, vitamin E powder (50%) 50g, vitamin C 5g, lactose 100 grams, starch 50 grams, 0.2 gram magnesium stearate.
Its preparation process is: 1) the 100g Radix Salviae Miltiorrhizae added the 500g85% soak with ethanol 4 hours, and reflux, extract, 50 minutes is filtered, and residue is standby, decompression filtrate recycling ethanol (0.01MPa, 55 ℃ of temperature).Concentrating under reduced pressure (70 ℃ of pressure 0.05MPa. temperature) becomes thick paste A (60 ℃ are surveyed relative density is 1.10), and is standby.
2) then by the above-mentioned Radix Angelicae Sinensis of measuring, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi and Radix Salviae Miltiorrhizae residue merge, soaked 2 hours, decoct 3 times, 12 times of amount of water, 10 times, 5 times, decocting time 3 hours, 2 hours, 1 hour, filter, collecting decoction, water extract concentrating under reduced pressure (pressure 0.02MPa, 55 ℃ of temperature) to relative density is 1.05 (60 ℃ of surveys), add 95% ethanol to containing alcohol amount 50%. precipitations 18 hours, filter decompression filtrate recycling ethanol (pressure 0.06MPa, 70 ℃), concentrating under reduced pressure (pressure 0.06MPa, 75 ℃ of temperature) gets thick paste B (60 ℃ are surveyed relative densities is 1.20).
3) again thick paste A and thick paste B are merged, mixing, drying under reduced pressure (pressure 0.06MPa, 85 ℃ of temperature) gets dry extract, and pulverizes.Cross 80 mesh sieves, it is standby to get fine powder C.
4) get vitamin E powder, vitamin C, Semen Vitis viniferae extract, lactose, the starch mix homogeneously that is up to the standards, cross 80 mesh sieves, get mixed powder D, standby.
5) get mixed powder C and mixed powder D, the water mix homogeneously gets mixed powder E, granulates, and drying adds 0.2 gram magnesium stearate again, and tabletting promptly gets tablet.
Wherein, the preparation process of Semen Vitis viniferae extract is:
Semen Vitis viniferae was smashed 30 mesh sieves. and add 4 times of amount petroleum ether and soaked 36 hours, filter; The Semen Vitis viniferae slag adds 95% alcohol reflux 2 times (5 times, 3 times), and each 2 hours, filter, decompression filtrate recycling ethanol (pressure 0.01MPa, 50 ℃ of temperature) is to there not being ethanol flavor (60 ℃ of relative densities are 1.15); Add 3 times of amount deionized waters sedimentation 3 hours, filter; Filtrate is used with the ethyl acetate extraction of volume 2 times, combining extraction liquid, extract concentrating under reduced pressure (pressure 0.02MPa, 50 ℃ of temperature), thick paste vacuum drying (vacuum 0MPa, 120 ℃ of temperature) gets dry extract, broken mistake 80 mesh sieves of dried cream powder, Semen Vitis viniferae extract.
Embodiment 3
The Chinese medicine composition of present embodiment functions of removing chloasma is made drop pill by following raw material: Radix Salviae Miltiorrhizae 400g, Radix Angelicae Sinensis 200g, Fructus Lycii 350g, Flos Rosae Rugosae 350g, Fructus Crataegi 200g, Semen Vitis viniferae extract 45g, vitamin E powder (50%) 20g, vitamin C 30g, Macrogol 4000 800g, polyethylene glycol 6000 80g.
Its preparation process is: 1) the 400g Radix Salviae Miltiorrhizae added the 4000g70% soak with ethanol 2 hours, and reflux, extract, 40 minutes is filtered.Residue is standby, decompression filtrate recycling ethanol (0.02MPa, 65 ℃ of temperature).Concentrating under reduced pressure (55 ℃ of pressure 0.02MPa. temperature) becomes thick paste A (60 ℃ are surveyed relative density is 1.20), and is standby.
2) merge by above-mentioned Radix Angelicae Sinensis, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi and the Radix Salviae Miltiorrhizae residue of measuring then, soaked 5 hours, decoct 1 time, 5 times of amount of water, decocting time 3 hours, filter, collecting decoction, water extract concentrating under reduced pressure (pressure 0.06MPa, 75 ℃ of temperature) to relative density is 1.20 (60 ℃ of surveys), add 95% ethanol to containing alcohol amount 40%. precipitations 36 hours, filter decompression filtrate recycling ethanol (pressure 0.02MPa, 55 ℃), concentrating under reduced pressure (pressure 0.06MPa, 55 ℃ of temperature) gets thick paste B (60 ℃ are surveyed relative densities is 1.22).
3) thick paste A and thick paste B are merged, mixing must mix thick paste C, and is standby again.
4) get vitamin E powder, vitamin C, Semen Vitis viniferae extract, the starch mix homogeneously that is up to the standards, cross 40 mesh sieves, get mixed powder D, standby.
5) get mixing thick paste C and mixed powder D mix homogeneously, must mix thick paste E, 60 ℃ of heating and melting of taking polyethylene glycol 4000 and polyethylene glycol 6000 water-bath, add medicinal substances extract thick paste E, mix homogeneously splashes in the dimethicone liquid coolant while hot, drips to make drop pill, remove liquid coolant, promptly get Chinese medicine composition drop pill of the present invention.
Wherein, the preparation process of Semen Vitis viniferae extract is:
Semen Vitis viniferae was smashed 14 mesh sieves. and add 1 times of amount petroleum ether and soaked 70 hours, filter; The Semen Vitis viniferae slag adds 95% alcohol reflux 5 times (8 times, 6 times, 5 times, 5 times, 3 times), and each 1 hour, filter, decompression filtrate recycling ethanol (pressure 0.05MPa, 95 ℃ of temperature) is to there not being ethanol flavor (60 ℃ of relative densities are 1.20); Add 2 times of amount deionized waters sedimentation 5 hours, filter; Filtrate is used with the ethyl acetate extraction of volume 1 time, combining extraction liquid, extract concentrating under reduced pressure (pressure 0.09MPa, 95 ℃ of temperature), thick paste vacuum drying (vacuum 0.095MPa, 50 ℃ of temperature) gets dry extract, broken mistake 80 mesh sieves of dried cream powder, Semen Vitis viniferae extract.
Embodiment 4
The Chinese medicine composition of present embodiment functions of removing chloasma is made oral liquid by following raw material: Radix Salviae Miltiorrhizae 1000g, Radix Angelicae Sinensis 50g, Fructus Lycii 50g, Flos Rosae Rugosae 500g, Fructus Crataegi 50g, Semen Vitis viniferae extract 80g, vitamin E powder (50%) 4g, vitamin C 50g.
Its preparation process is: 1) the 1000g Radix Salviae Miltiorrhizae added the 6000g95% soak with ethanol 1 hour, and reflux, extract, 60 minutes is filtered.Residue is standby, decompression filtrate recycling ethanol (0.09MPa, 80 ℃ of temperature).Concentrating under reduced pressure (85 ℃ of pressure 0.06MPa. temperature) becomes clear paste A (60 ℃ are surveyed relative density is 1.15), and is standby.
2) then by the above-mentioned Radix Angelicae Sinensis of measuring, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi and Radix Salviae Miltiorrhizae residue merge, soaked 1 hour, decoct 3 times, 10 times of amount of water, 8 times, 6 times, decocting time 3 hours, 2.5 hour, 1.5 hour, filter collecting decoction, water extract concentrating under reduced pressure (pressure 0.09Mpa, 80 ℃ of temperature) to relative density be 1.15 (60 ℃ of surveys), add 95% ethanol to containing alcohol amount 60%. precipitations 30 hours, filter, decompression filtrate recycling ethanol (pressure 0.08MPa, 75 ℃), concentrating under reduced pressure (pressure 0.05MPa, 60 ℃ of temperature) gets clear paste B (60 ℃ are surveyed relative densities is 1.15).
3) get vitamin E powder, vitamin C, Semen Vitis viniferae extract, the starch mix homogeneously that is up to the standards, cross 80 mesh sieves, get mixed powder C, standby.
4) clear paste A and clear paste B are merged, add mixed powder C, mixing adds simple syrup 700ml, adds antiseptic ethyl hydroxybenzoate 0.6 gram, is concentrated into 1000ml, stirs evenly, and fill, sealing by fusing promptly get Chinese medicine composition oral solutions of the present invention.
Wherein, the preparation process of Semen Vitis viniferae extract is:
Semen Vitis viniferae was smashed 50 mesh sieves. and add 6 times of amount petroleum ether and soaked 80 hours, filter; The Semen Vitis viniferae slag adds 95% alcohol reflux 1 time (8 times), and 3 hours, filter, decompression filtrate recycling ethanol (pressure 0.01MPa, 60 ℃ of temperature) is to there not being ethanol flavor (60 ℃ of relative densities are 1.10); Add 6 times of amount deionized waters sedimentation 1 hour, filter; Filtrate is used with the ethyl acetate extraction of volume 5 times, combining extraction liquid, extract concentrating under reduced pressure (pressure 0.05MPa, 60 ℃ of temperature), thick paste vacuum drying (vacuum 0.08MPa, 80 ℃ of temperature) gets dry extract, broken mistake 80 mesh sieves of dried cream powder, Semen Vitis viniferae extract.
Embodiment 5
The Chinese medicine composition of present embodiment functions of removing chloasma is made soft capsule by following raw material: Radix Salviae Miltiorrhizae 600g, Radix Angelicae Sinensis 350g, Fructus Lycii 200g, Flos Rosae Rugosae 200g, Fructus Crataegi 350g, Semen Vitis viniferae extract 30g, vitamin E powder (50%) 30g, Catergen 0g, Cera Flava 8g, olive oil 320g.
Its preparation process is: 1) the 600g Radix Salviae Miltiorrhizae added the 7200g60% soak with ethanol 5 hours, and reflux, extract, 10 minutes is filtered.Residue is standby, and decompression filtrate recycling ethanol (0.08MPa, 95 ℃ of temperature), concentrating under reduced pressure (95 ℃ of pressure 0.06MPa. temperature) become thick paste A (60 ℃ are surveyed relative density is 1.50), and be standby.
2) then by the above-mentioned Radix Angelicae Sinensis of measuring, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi and Radix Salviae Miltiorrhizae residue merge, soaked 1 hour, decoct 5 times, 12 times of amount of water, 10 times, 6 times, 5 times, 5 times, decocting time 3 hours, 2.5 hour, 2 hours, 1 hour, 1 hour, filter, collecting decoction, water extract concentrating under reduced pressure (pressure 0.05MPa, 55 ℃ of temperature) to relative density is 1.10 (60 ℃ of surveys), add 95% ethanol to containing alcohol amount 80%. precipitations 12 hours, filter decompression filtrate recycling ethanol (pressure 0.09MPa, 85 ℃), concentrating under reduced pressure (pressure 0.06MPa, 70 ℃ of temperature) gets thick paste B (60 ℃ are surveyed relative densities is 1.10).
3) again thick paste A and thick paste B are merged, mixing, drying under reduced pressure (pressure 0.02MPa, 120 ℃ of temperature) gets dry extract, and pulverizes.Cross 50 mesh sieves, it is standby to get fine powder C.
4) get vitamin E powder, vitamin C, Semen Vitis viniferae extract, the starch mix homogeneously that is up to the standards, cross 50 mesh sieves, get mixed powder D, standby.
5) get mixed powder C and mixed powder D mix homogeneously, get mixed powder E, mixed powder E adds olive oil 320 grams, and Cera Flava 8 grams mixed 30 minutes with colloid mill, and it is standby to get mixture F;
6) gelatin, glycerol, water are mixed with gelatin solution with the proportioning of 10:3:10, use automatic rotation rolling capsule machine to be pressed into the soft capsule of 0.6g/ grain with mixture F, drying is 24 hours under the condition of 20 ℃ of temperature, relative humidity 52%, take out, select ball, use washing with alcohol, dry 48 hours under these conditions, promptly get soft capsule.
Wherein, the preparation process of Semen Vitis viniferae extract is:
Semen Vitis viniferae was smashed 60 mesh sieves. and add 5 times of amount petroleum ether and soaked 18 hours, filter; The Semen Vitis viniferae slag adds 95% alcohol reflux 4 times (8 times, 6 times, 6 times, 3 times), and each 2 hours, filter, decompression filtrate recycling ethanol (pressure 0.02MPa, 60 ℃ of temperature) is to there not being ethanol flavor (60 ℃ of relative densities are 1.20); Add 5 times of amount deionized waters sedimentation 6 hours, filter; Filtrate is used with the ethyl acetate extraction of volume 4 times, combining extraction liquid, extract concentrating under reduced pressure (pressure 0.05MPa, 60 ℃ of temperature), thick paste vacuum drying (vacuum 0.08MPa, 80 ℃ of temperature) gets dry extract, broken mistake 80 mesh sieves of dried cream powder, Semen Vitis viniferae extract.
Embodiment 6
Substantially with embodiment 1, different is that the raw material of the Chinese medicine composition of functions of removing chloasma is: Radix Salviae Miltiorrhizae 800g, Radix Angelicae Sinensis 250g, Fructus Lycii 400g, Flos Rosae Rugosae 300g, Fructus Crataegi 100g.
Embodiment 7
Substantially with embodiment 1, different is that the raw material of the Chinese medicine composition of functions of removing chloasma is: Radix Salviae Miltiorrhizae 300g, Radix Angelicae Sinensis 300g, Fructus Lycii 100g, Flos Rosae Rugosae 150g, Fructus Crataegi 150g.
Embodiment 8
Substantially with embodiment 2, different is that the raw material of the Chinese medicine composition of functions of removing chloasma is: Radix Salviae Miltiorrhizae 700g, Radix Angelicae Sinensis 450g, Fructus Lycii 150g, Flos Rosae Rugosae 450g, Fructus Crataegi 300g, Semen Vitis viniferae extract 55g, vitamin E powder (50%) 60g, vitamin C 15g.
Experimental example 1 chloasma-dispelling function human feeding trial
1. object and method:
1.1 tried thing: prescription is provided by Zhuzhou Qianjin Pharmacy Co., Ltd for the capsule of embodiment 1.
1.2 study subject: press the principle of voluntariness and select 18-65 year, chloasma person is arranged.
1.2.1 diagnostic criteria: facial filbert to dark brown, well-defined patch, symmetry distributes usually, NIP performance and squama, subjective symptomss such as no sufferings.Certain seasonality is arranged, and Xia Chongdong is light.
1.2.2 the person's of including in standard: all volunteers that chloasma is arranged, all can carry out test-meal through medical fitness and observe.
1.2.3 eliminator's standard:
1.2.3.1 the age is under-18s or over-65s person, gestation or women breast-feeding their children, allergic constitution and to these health product allergy sufferers.
1.2.3.2 be associated with serious primary disease such as conscience kidney and hemopoietic system and endocrinopathy, the psychotic.
1.2.3.3 take in a short time or use the article relevant, have influence on judgement person to the result with being tried function.
1.2.3.4, can't judge effect or data not umbra sound effect or safety judgement person not in accordance with regulations with being tried thing.
1.3 contrast form: 100 routine chloasma experimenters, be divided into test-meal group and blank group at random, adopt two kinds of contrast forms between self and group.
1.4 taking dose and time: the test-meal group is taken and is tried thing (embodiment 1), and each 4, every day 2 times, the experimenter cuts out medicine or other health product and the cosmetics of relevant functions of removing chloasma at experimental session.
1.5 instrument and reagent: MEK-6318K type blood counting instrument (Japan produces), ten analysers of MIDIRON urine (Germany produces), RA1000 automatic clinical chemistry analyzer (U.S.'s product), Institute of Geography, Academia Sinica's development and design, Mapping Press published " practical standard colour atla " (front page) in 1992, and the biochemical reagents box is all provided by middle living company.
2. observation index:
Each is checked once before and after the experiment.
2.1 safety indexes:
2.1.1 general situation: spirit, sleep, diet, defecation, blood pressure etc.
2.1.2 blood, routine urinalysis, just routine examination:
Red blood cell count(RBC), hemoglobin, numeration of leukocyte, routine urinalysis, just routine examination.
2.1.3 blood biochemistry index is measured:
Serum albumin ALB, total protein TP, darling renal function (glutamic oxaloacetic transaminase, GOT AST, glutamate pyruvate transaminase ALT, carbamide UREA, creatinine CRE), blood glucose GLU, blood fat (T-CHOL TC, triglyceride TG).
2.1.4 Abdominal B type ultrasonography, electrocardiogram, the fluoroscopy of chest of x line.(checking once before the test-meal)
2.1.5 allergy and untoward reaction are observed
2.2 effect index:
2.2.1 observation of symptoms:
Detailed medical history-taking is understood experimenter's diet situation, observes main clinic symptoms: feeling of fatigue, agitation, sleep etc.Before and after test-meal, add up integrated value by symptom weight (serious symptom 3 minutes, moderate 2 minutes, light disease 1 minute), and improve (2 fens produce effects of each doing well,improving are improved 1 and are divided into effectively), calculate the improvement rate with regard to its cardinal symptom.
2.2.2 women's head-ornaments portion chloasma detects:
2.2.2.1 the area size changes: the major diameter and the wide footpath of same chloasma before and after being tried with tape measure, reference area (cm
2).
2.2.2.2 shade changes:
According to Institute of Geography, Academia Sinica's development and design, brown (Y+M+BK i.e. Huang+magenta+black folded color) colour atla in " practical standard colour atla " (front page) that Mapping Press published in 1992 is the criterion of chloasma shade: I degree (15,20,5), II degree (30,40,10), III degree (40,60,15).
3. date processing and result judge:
3.1 with the STATE6.0 of statistical software computational analysis data.All own control data adopt paired t-test, two groups of means relatively adopt t check in groups, and the latter need carry out homogeneity test of variance, and the number of nonnormal distribution or heterogeneity of variance is carried out suitable variable conversion, after waiting to satisfy the normal state homogeneity of variance, carry out the t check with data converted; If translation data still can not satisfy the requirement of normal state homogeneity of variance, use t ' check or rank test instead; But the coefficient of variation is too big as the data of (CV〉50%) is used rank test.The effect index is checked with X2.
3.2 spot-removal function is judged:
Effectively: chloasma color decline I degree, or area dwindle 〉=10%, chloasma area and color relatively more all have significant difference with matched group before and after the test-meal group self.
Invalid: chloasma area and color do not have significant change.
4. experimental result:
4. general situation:
Observe chloasma experimenter 100 examples altogether, spirit, sleep, diet, defecation, blood pressure belong to normal range substantially.The test-meal group is the women, minimum 22 years old of age, maximum 59 years old, average 41.90 ± 9.36 years old, average course of disease 5.04 ± 4.25 years.Matched group is the women, minimum 23 years old of age, maximum 59 years old, average 41.06 ± 7.82 years old, average course of disease 5.80 ± 4.26 years.
4.2 the chloasma shade changes:
Table 1 chloasma shade changes
| Colour atla (degree) | The example number | Before the test-meal | After the test-meal | Difference |
| The test-meal group | 50 | 1.88±0.39 | 1.28±0.45 | -0.60±0.49 **# |
| Matched group | 50 | 1.75±0.45 | 1.68±0.51 | -0.07±0.30 |
Self relatively
*#P＜0.05 relatively between P＜0.01 group
4.3 chloasma area size variation:
Table 2 chloasma area size variation
| Chloasma area (cm2) | The example number | Before the test-meal | After the test-meal | Difference |
| The test-meal group | 50 | 59.68±36.08 | 53.30±34.40 | -6.386.77 **# |
| Matched group | 50 | 67.81±36.34 | 67.15±35.80 | -0.66±2.90 |
Self relatively
*#P＜0.05 relatively between P＜0.01 group
4.4 effect evaluation
The evaluation of table 3 effect
| Example number (percentage ratio) | Effectively | Invalid | Total effective rate |
| The test-meal group | 30(60.00％) | 20(40.00％) | 60.00％# |
| Matched group | 3(6.00％) | 47(94.00％) | 6.00％ |
Compare #P＜0.05 between group
4.5 doing well,improving situation:
Table 4 cardinal symptom is improved situation
| Cardinal symptom | The example number | Produce effects | Effectively | Invalid | Total effective rate |
| Feeling of fatigue | 31(26) | 2(0) | 16(7) | 13(19) | 58.06％(26.92％0 |
| Irritated | 34(25) | 4(0) | 17(8) | 13(17) | 61.76％(32.00％ |
| Sleep | 33(22) | 1(0) | 17(6) | 15(16) | 54.55％(27.27％ |
() is matched group
4.6 symptom integral changes
Table 5 symptom integral changes
| Group | The example number | Before the test-meal | In the test-meal | After the test-meal |
| The test-meal group | 50 | 3.24±2.78 | 2.70±2.60 ** | 2.86±3.91 ** |
| Matched group | 50 | 3.60±2.71 | 3.52±2.74 | 3.42±2.73 * |
*P＜0.05
*P＜0.01, integration has significant difference before test-meal mid-term, test-meal later stage and the test-meal.
4.7 safety indexes detects:
Table 6 safety indexes detects
| Group | The test-meal group | Matched group | |||
| Project | The example number | Before the test-meal | After the test-meal | Before the test-meal | After the test-meal |
| TP(g/L) | 50 | 73.61±3.45 | 73.88±3.46 | 73.15±4.31 | 73.54±3.81 |
| ALB(g/L) | 50 | 41.28±3.44 | 42.88±3.43 | 73.61±3.45 | 73.61±3.45 |
| ALT(u/L1) | 50 | 16.28±7.31 | 16.20±6.33 | 73.61±3.45 | 73.61±3.45 |
| AST(u/L) | 50 | 15.56±5.70 | 17.56±6.24 | 73.61±3.45 | 73.61±3.45 |
| GLU(mmol/L) | 50 | 5.06±0.65 | 4.95±0.72 | 73.61±3.45 | 73.61±3.45 |
| TC(mmol/L) | 50 | 5.31±0.76 | 5.30±0.63 | 73.61±3.45 | 73.61±3.45 |
| TG(mmol/L) | 50 | 1.11±0.36 | 1.18±0.40 | 73.61±3.45 | 73.61±3.45 |
| UREA(mmol/L) | 50 | 4.53±1.13 | 4.34±1.00 | 73.61±3.45 | 73.61±3.45 |
| CRE(umol/L) | 50 | 95.98±10.34 | 93.04±10.88 | 92.33±10.03 | 91.04±10.88 |
| HGB(g/L) | 50 | 134.92±8.99 | 134.86±10.2 | 128.42±7.80 | 128.66±7.57 |
| RBC(×10 12/L) | 50 | 4.40±0.30 | 4.41±0.33 | 4.35±0.35 | 4.37±0.35 |
| WBC(×10 9/L) | 50 | 5.79±1.41 | 5.73±1.27 | 5.75±0.96 | 5.77±0.99 |
| Routine urinalysis | 50 | Normally | Normally | Normally | Normally |
| Just conventional | 50 | Normally | Normally | Normally | Normally |
Every index is substantially in normal range before and after the test-meal.
4.8 blood pressure is substantially in normal range before and after Abdominal B type ultrasonography, electrocardiogram, the fluoroscopy of chest of X line, the test-meal.
5. conclusion
5.1 100 routine chloasma experimenters are divided into test-meal group and matched group at random, test-meal group chloasma area on average dwindles 6.38 ± 6.77cm
2(P＜0.01), color shoals, and colour atla on average reduces by 0.60 ± 0.49 degree (P＜0.01), effective 30 examples, total effective rate 60.00%, matched group chloasma area on average dwindles 0.66 ± 2.90cm
2, color shoals, and colour atla on average reduces by 0.07 ± 0.30 degree, effective 3 examples, 6.00%, two group of contrast of total effective rate has significant difference, illustrates that Chinese medicine composition of the present invention has the effect of functions of removing chloasma.
5.2 Chinese medicine composition of the present invention has the improvement effect to symptoms such as chloasma experimenter's feeling of fatigue, agitation, sleeps.
5.3 before and after the Chinese medicine composition test-meal of the present invention, routine blood test, routine urinalysis, just routine and blood biochemistry index illustrate that substantially in normal range this product has no adverse effects to the experimenter is healthy.
5.4 after the Chinese medicine composition test-meal of the present invention, do not meet quick and other untoward reaction.
Though above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (8)
1. the Chinese medicine composition of a functions of removing chloasma is characterized in that, its preparation for being made by the raw material of following components by weight percent:
100～1000 parts of Radix Salviae Miltiorrhizaes, 50～500 parts of Radix Angelicae Sinensis, 50～500 parts of Fructus Lycii, 50～500 parts of Flos Rosae Rugosaes, 50～500 parts of Fructus Crataegis, 6～80 parts of Semen Vitis viniferae extracts, 2～30 parts of vitamin E powders, 5～50 parts of vitamin Cs;
Described Semen Vitis viniferae extract is made by following method:
Semen Vitis viniferae was smashed 14～60 mesh sieves, added 1～6 times of amount petroleum ether and soaked 18～80 hours, filtered; The Semen Vitis viniferae slag adds 3～8 times of amount 95% alcohol reflux 1～5 time, and each 1～3 hour, filter, decompression filtrate recycling ethanol is not to there being the ethanol flavor, and 60 ℃ of relative densities are 1.10～1.20; Add 2～6 times of amount deionized waters sedimentation 1～6 hour, filter; Filtrate is used with the ethyl acetate extraction of volume 1～5 time, combining extraction liquid, the extract concentrating under reduced pressure, vacuum drying, pulverize Semen Vitis viniferae extract.
2. the Chinese medicine composition of functions of removing chloasma according to claim 1 is characterized in that, its preparation for being made by the raw material of following components by weight percent:
400～600 parts of Radix Salviae Miltiorrhizaes, 200～350 parts of Radix Angelicae Sinensis, 200～350 parts of Fructus Lycii, 200～350 parts of Flos Rosae Rugosaes, 200～350 parts of Fructus Crataegis, 30～45 parts of Semen Vitis viniferae extracts, 10～15 parts of vitamin E powders, 20～30 parts of vitamin Cs.
3. the Chinese medicine composition of functions of removing chloasma according to claim 1 and 2 is characterized in that, described preparation is tablet, capsule, drop pill, oral liquid or granule.
4. the Chinese medicine composition of functions of removing chloasma according to claim 3 is characterized in that, described capsule is a soft capsule.
5. the method for the Chinese medicine composition of any described functions of removing chloasma of preparation claim 1-4 is characterized in that, comprises the steps:
1) earlier by soaking 1～5 hour in 60～99% ethanol of said ratio with 5～12 times of amounts of Radix Salviae Miltiorrhizae adding, reflux, extract, 10～60 minutes is filtered, and residue is standby; Decompression filtrate recycling ethanol; Concentrating under reduced pressure becomes thick paste A, surveys relative density for 60 ℃ and is 1.10～1.50, and is standby;
2) by said ratio Radix Angelicae Sinensis, Fructus Lycii, Flos Rosae Rugosae, Fructus Crataegi and Radix Salviae Miltiorrhizae residue are merged then, the water logging that adds 5～12 times of doses was steeped 1～5 hour, decocted 1～5 time, decocting time 1～3 hour, filter, the relative density that collecting decoction, water extract are evaporated to 60 ℃ of surveys is 1.05～1.20, add 95% ethanol to containing alcohol amount 40～80%, precipitate 12～36 hours, filter decompression filtrate recycling ethanol, concentrating under reduced pressure gets thick paste B, and 60 ℃ are surveyed relative density is 1.10～1.50;
3) thick paste A and thick paste B are merged, mixing, drying is pulverized, and crosses 40～80 mesh sieves, with vitamin E powder, vitamin C, Semen Vitis viniferae extract and acceptable accessories, makes tablet, capsule, drop pill, oral liquid or granule again.
6. the preparation method of the Chinese medicine composition of functions of removing chloasma according to claim 5, it is characterized in that, the condition of decompression recycling ethanol is 0.01～0.09MPa in each step, 55～95 ℃ of temperature, condition pressure 0.02～the 0.09MPa of concentrating under reduced pressure, 55～95 ℃ of temperature, the condition of drying under reduced pressure are pressure 0～0.095MPa, 50～120 ℃ of temperature.
7. the preparation method of Chinese medicine composition according to claim 5, it is characterized in that, when described Semen Vitis viniferae extract prepares, condition pressure 0.01～the 0.05MPa of described reclaim under reduced pressure, 50～95 ℃ of temperature, exsiccant condition are vacuum 0～0.095MPa, 50～120 ℃ of temperature, the condition of concentrating under reduced pressure is pressure 0.02～0.09MPa, 50～95 ℃ of temperature.
8. application that any described Chinese medicine composition of claim 1-4 is used for preparing treatment chloasma product.
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| CN106666756A (en) * | 2016-12-20 | 2017-05-17 | 芜湖市诺康生物科技有限公司 | Protein powder for facial beautification and preparation method thereof |
| CN107467308A (en) * | 2017-09-26 | 2017-12-15 | 宁国平衡健康管理有限公司 | A kind of tea bag of functions of removing chloasma and preparation method thereof |
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| CN1144671A (en) * | 1995-09-07 | 1997-03-12 | 海春旭 | Menstruation-regulating and speckle-removing capsule and preparation thereof |
| CN1613477A (en) * | 2003-11-06 | 2005-05-11 | 上海市中药研究所 | Medicine composition with spot dispelling function and preparation thereof |
| CN1709474A (en) * | 2005-07-14 | 2005-12-21 | 杜越新 | Cosmetic formulation for skin spot-eliminating, whitening and wrinkle-removing, and its preparing method |
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| CN101352497A (en) | 2009-01-28 |
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