CN104689156A - Medicinal preparation for treatment of chloasma spleen deficiency syndrome of accumulated dampness-toxicity and preparation method thereof - Google Patents

Abstract

The invention discloses a medicinal preparation for the treatment of chloasma spleen deficiency syndrome of accumulated dampness-toxicity and a preparation method thereof, wherein the medicinal preparation comprises the following raw herbal materials: poria cocos, semen coicis, rhizoma cyper, herba aristolochiae, rhizoma nardostachyos, pericarpium arecae, white hyacinth bean, roots of wilford swallowwort, areca-nut, roots of red-rootsed salvia, leonurus, herba lycopi, roots of bidentate achyranthes, caulis spatholobi, lucid ganoderma, vine of multiflower knotweed, valerian, acanthopanax, ginseng, bighead atractylodes rhizome, astragalus membranaceus, Chinese yam, liquorice, rhodiola rosea, sea-buckthorn, tall monkshood roots, stigma croci and pubescent holly roots. The medicinal preparation for the treatment of chloasma spleen deficiency syndrome of accumulated dampness-toxicity and the preparation method thereof have the advantages that the effects of invigorating spleen, supplementing qi, clearing damp and removing ecchymosis are possessed, the majority function is the treatment on the chloasma spleen deficiency syndrome of accumulated dampness-toxicity, and the whole organism endocrine system is adjusted on the basis of the theory of the traditional Chinese medicine; the differential treatment is conducted, targeted therapy is conducted according to different symptoms, and the treatment effect is effective; the course of treatment is short, and the recurrence rate can be lowered; the mental press of a patient can be relieved significantly; the cost price is low, the administration route is convenient, reception of the medicine by the patient is easy, and value potential on the clinical marketing is possessed.

Description

A kind ofly treat insufficiency of the spleen wet pharmaceutical preparation and the preparation method of accumulateing card of chloasma

Technical field

The present invention relates to pharmaceutical technology, particularly a kind ofly treat insufficiency of the spleen wet pharmaceutical preparation and the preparation method of accumulateing card of chloasma.

Background technology

Chloasma is commonly called as " butterfly spot ", " chloasma hepaticum " or " cyasma ".Mainly occur in face, based on cheekbone portion, buccal, nose, forehead, chin portion.For the brown of obscure boundary Chu or the patch of black, mostly be symmetry.

Pathogenic factor

The appearance of chloasma is most relevant with endocrine, especially relevant with the estrogen level of women, menoxenia, gestation, takes contraceptive or liver function is bad and chronic nephropathy all may occur chloasma.In addition Exposure to Sunlight and Nervous and Mental Factors also can increase the weight of primary disease.Usually there is chloasma in 3 months in gestation in anemia of pregnant woman, majority are disappeared gradually when point the puerperium, menstruation recovery was normal later.If do not moved back for a long time, need to treat.

Symptom and sign

Be apt to occur in women, particularly the women of trimester of pregnancy, puerperal and oral contraceptive.Erythra symmetry distribution around face, volume, two cheeks, bridge of the nose both sides, lip, skin of chin, in refer to lid to coin size or in hand size, filbert or crineous in irregular shape sinks speckle, boundary is obvious or smudgy, can be fused into sheet.No conscious sympton, chronic process, Exposure to Sunlight postemphasis.A part is owing to can slowly disappear after point puerperium or inactive contraceptive.

Chinese medicine is thought, chloasma belongs to motherland's medical science " chloasma " category.Primary disease is many is main pathogenesis with the dirty QI-blood failing to nourish upward in close relations of liver,spleen,kidney three in face.Feelings will does not freely cause stagnation of QI due to depression of the liver, heat resulting from stagnation of QI, fumigates in face, the cloudy blood and giving birth to of burning; Or Chong and Ren channel disorder, deficiency of the liver and kindey, discordance between water(the kidney)and fire(the heart), caused by hyperactivity of deficient fire; Or chronic disease, battalion defends and becomes estranged, and QI-blood circulation is not smooth, qi depression to blood stasis, becomes homeless to support and form in face; Or eating and drinking without temperance, be worried excessively, impairing the spleen and stomach, dysfunction of the spleen in transportation, damp and hot interior life, stifling pathogenic.

The traditional Chinese medical science is divided into type in 4

1, Liver depression and Qi stagnation: be more common in women, speckle color depth is brown, fills the air distribution; With dysphoria, fullness and distention in the chest and hypochondrium, premenstrual distending pain of the breast, menoxenia, bitter taste in the mouth and dry throat; Red tongue, thin fur, stringy and thready pulse.

2, deficiency of the liver and kindey card: speckle color is brown black, dim complexion; With dizziness and tinnitus, soreness of the waist and knees, insomnia forgetfulness, dysphoria with feverish sensation in the chest palms and soles; The few tongue of red tongue, thready pulse.

3, insufficiency of the spleen wetting accumulates card: speckle color ash is brown, and shape such as dust adheres to; With fatigue and weak, indigestion and loss of appetite sleepy, menstruation color is light, and leucorrhea amount is many; There is indentation on the fat limit of light red tongue, soft pulse or thin.

4, syndrome of qi stagnation and blood stasis: speckle color ash is brown or dark brown; With chronic hepatopathy, or menstruation color secretly has clot, or dysmenorrhea; Tongue is dark red ecchymosis, hesitant pulse.

Western medical treatment chloasma avoids Exposure to Sunlight, the protopathy such as active treatment endocrine dysfunction, hepatopathy, strengthens nutrition, takes a good rest.A large amount of vitimin supplement C etc.Local topical depigmenting agent, as 3% Hydrochinone Cream, 20% Azelex, 0.025% tretinoin cream, 5% arbutin frost etc.But although western modern medicine treatment chloasma instant effect, toxic and side effects is more, and relapse rate is higher, causes certain mental pressure to the life of patient, work, study.

But Chinese medicine chloasma possesses unique advantage, feature: utilize Traditional Chinese medical theory, by regulating animal economy hormonal system; Carry out determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, according to different symptom targeted therapies, evident in efficacy; The course for the treatment of is shorter, can reduce relapse rate; Can the stress of obvious reduction of patient; Cost price is low, and route of administration is convenient, and patient is easy to accept, and has the value potentiality that clinical market is promoted.

Summary of the invention

The technical problem to be solved in the present invention is to provide one to have invigorating the spleen and benefiting QI, damp eliminating speckle removing effect, cures mainly the insufficiency of the spleen wet pharmaceutical preparation of accumulateing card of chloasma; The present invention utilizes Traditional Chinese medical theory, by regulating animal economy hormonal system; Carry out determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, according to different symptom targeted therapies, evident in efficacy; The course for the treatment of is shorter, can reduce relapse rate; Can the stress of obvious reduction of patient; Cost price is low, and route of administration is convenient, and patient is easy to accept, and has the value potentiality that clinical market is promoted.

In order to realize foregoing invention object, the invention provides and a kind ofly treat the insufficiency of the spleen wet pharmaceutical preparation of accumulateing card of chloasma, comprise following raw medicinal material: Poria, Semen Coicis, Rhizoma Cyperi, Herba Aristolochiae, Radix Et Rhizoma Nardostachyos, Pericarpium Arecae, Semen Lablab Album, Radix cynanchi wilfordii, Semen Arecae, Radix Salviae Miltiorrhizae, Herba Leonuri, Herba Lycopi, Radix Achyranthis Bidentatae, Caulis Spatholobi, Ganoderma, Caulis Polygoni Multiflori, Rhizoma et radix valerianae, Radix Et Caulis Acanthopanacis Senticosi, Radix Ginseng, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Dioscoreae, Radix Glycyrrhizae, Radix Rhodiolae, Fructus Hippophae, Radix aconiti sinomontani, Stigma Croci and Radix Ilicis Pubescentis.

In described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: Poria 22-39 part, Semen Coicis 23-38 part, Rhizoma Cyperi 12-27 part, Herba Aristolochiae 13-24 part, Radix Et Rhizoma Nardostachyos 11-27 part, Pericarpium Arecae 12-26 part, Semen Lablab Album 10-25 part, Radix cynanchi wilfordii 12-27 part, Semen Arecae 14-26 part, Radix Salviae Miltiorrhizae 22-36 part, Herba Leonuri 11-24 part, Herba Lycopi 14-28 part, Radix Achyranthis Bidentatae 16-37 part, Caulis Spatholobi 13-25 part, Ganoderma 27-42 part, Caulis Polygoni Multiflori 4-10 part, Rhizoma et radix valerianae 14-29 part, Radix Et Caulis Acanthopanacis Senticosi 14-30 part, Radix Ginseng 23-38 part, Rhizoma Atractylodis Macrocephalae 30-41 part, Radix Astragali 20-34 part, Rhizoma Dioscoreae 26-39 part, Radix Glycyrrhizae 22-36 part, Radix Rhodiolae 24-37 part, Fructus Hippophae 5-10 part, Radix aconiti sinomontani 3-10 part, Stigma Croci 8-19 part and Radix Ilicis Pubescentis 12-21 part.

In described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: Poria 24-37 part, Semen Coicis 25-36 part, Rhizoma Cyperi 14-25 part, Herba Aristolochiae 14-23 part, Radix Et Rhizoma Nardostachyos 13-24 part, Pericarpium Arecae 14-23 part, Semen Lablab Album 11-23 part, Radix cynanchi wilfordii 14-24 part, Semen Arecae 14-22 part, Radix Salviae Miltiorrhizae 24-33 part, Herba Leonuri 13-21 part, Herba Lycopi 14-25 part, Radix Achyranthis Bidentatae 16-32 part, Caulis Spatholobi 15-22 part, Ganoderma 27-37 part, Caulis Polygoni Multiflori 4-9 part, Rhizoma et radix valerianae 16-26 part, Radix Et Caulis Acanthopanacis Senticosi 17-27 part, Radix Ginseng 23-34 part, Rhizoma Atractylodis Macrocephalae 30-37 part, Radix Astragali 23-32 part, Rhizoma Dioscoreae 28-36 part, Radix Glycyrrhizae 25-31 part, Radix Rhodiolae 25-34 part, Fructus Hippophae 6-8 part, Radix aconiti sinomontani 4-9 part, Stigma Croci 8-17 part and Radix Ilicis Pubescentis 15-21 part.

In described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: 30 parts, Poria, Semen Coicis 32 parts, Rhizoma Cyperi 14 parts, Herba Aristolochiae 18 parts, Radix Et Rhizoma Nardostachyos 13 parts, Pericarpium Arecae 20 parts, Semen Lablab Album 11 parts, Radix cynanchi wilfordii 19 parts, Semen Arecae 14 parts, Radix Salviae Miltiorrhizae 30 parts, Herba Leonuri 13 parts, Herba Lycopi 24 parts, Radix Achyranthis Bidentatae 29 parts, Caulis Spatholobi 17 parts, Ganoderma 27 parts, Caulis Polygoni Multiflori 9 parts, Rhizoma et radix valerianae 16 parts, Radix Et Caulis Acanthopanacis Senticosi 21 parts, Radix Ginseng 23 parts, the Rhizoma Atractylodis Macrocephalae 31 parts, the Radix Astragali 23 parts, Rhizoma Dioscoreae 28 parts, 25 parts, Radix Glycyrrhizae, Radix Rhodiolae 28 parts, Fructus Hippophae 7 parts, Radix aconiti sinomontani 8 parts, Stigma Croci 8 parts and Radix Ilicis Pubescentis 18 parts.

In described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: 24 parts, Poria, Semen Coicis 36 parts, Rhizoma Cyperi 25 parts, Herba Aristolochiae 14 parts, Radix Et Rhizoma Nardostachyos 24 parts, Pericarpium Arecae 14 parts, Semen Lablab Album 23 parts, Radix cynanchi wilfordii 14 parts, Semen Arecae 22 parts, Radix Salviae Miltiorrhizae 24 parts, Herba Leonuri 21 parts, Herba Lycopi 25 parts, Radix Achyranthis Bidentatae 16 parts, Caulis Spatholobi 22 parts, Ganoderma 35 parts, Caulis Polygoni Multiflori 5 parts, Rhizoma et radix valerianae 26 parts, Radix Et Caulis Acanthopanacis Senticosi 27 parts, Radix Ginseng 34 parts, the Rhizoma Atractylodis Macrocephalae 37 parts, the Radix Astragali 32 parts, Rhizoma Dioscoreae 30 parts, 31 parts, Radix Glycyrrhizae, Radix Rhodiolae 25 parts, Fructus Hippophae 8 parts, Radix aconiti sinomontani 9 parts, Stigma Croci 13 parts and Radix Ilicis Pubescentis 21 parts.

In described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: 37 parts, Poria, Semen Coicis 25 parts, Rhizoma Cyperi 19 parts, Herba Aristolochiae 23 parts, Radix Et Rhizoma Nardostachyos 16 parts, Pericarpium Arecae 23 parts, Semen Lablab Album 17 parts, Radix cynanchi wilfordii 24 parts, Semen Arecae 18 parts, Radix Salviae Miltiorrhizae 33 parts, Herba Leonuri 15 parts, Herba Lycopi 14 parts, Radix Achyranthis Bidentatae 32 parts, Caulis Spatholobi 15 parts, Ganoderma 37 parts, Caulis Polygoni Multiflori 4 parts, Rhizoma et radix valerianae 23 parts, Radix Et Caulis Acanthopanacis Senticosi 17 parts, Radix Ginseng 29 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, the Radix Astragali 29 parts, Rhizoma Dioscoreae 36 parts, 27 parts, Radix Glycyrrhizae, Radix Rhodiolae 34 parts, Fructus Hippophae 6 parts, Radix aconiti sinomontani 4 parts, Stigma Croci 17 parts and Radix Ilicis Pubescentis 15 parts.

When the dosage form of described pharmaceutical preparation is decoction, its preparation method comprises the following steps:

Step one: purple casserole is put in described raw medicinal material mixing, adds clear water, to clear water dipped medical material upper surface 2-5cm, soak 3-10 hour;

Step 2: be placed in by purple casserole on fire, after intense fire boils, uses slow fire instead and decocts 30-50 minute slowly, filters, obtains filtrate a, for subsequent use;

Step 3: residue medicinal residues are added clear water again, to clear water dipped medical material upper surface 2-3cm, soaks 3-10 hour;

Step 4: be placed in by purple casserole on fire, after intense fire boils, uses slow fire instead and decocts 25-35 minute slowly, filters, obtains filtrate b, mixed by filtrate a and filtrate b.

When the dosage form of described pharmaceutical preparation is capsule, its preparation method comprises the following steps:

Poria, Semen Coicis, Rhizoma Cyperi, Herba Aristolochiae, Radix Et Rhizoma Nardostachyos, Pericarpium Arecae and Semen Lablab Album mix in described ratio by the first step, add the water extraction volatile oil relative to 4 ~ 6 times, mixture, by the volatile oil beta-cyclodextrin inclusion compound obtained, the mass ratio of volatile oil and beta-schardinger dextrin-is 1: 3 ~ 6, stir 60 minutes ~ 90 minutes, temperature 30 DEG C ~ 50 DEG C, obtains volatile oil clathrate compound, for subsequent use; Another when aqueous extract being concentrated into 60 DEG C relative density be the clear paste of 1.15 ~ 1.17;

Second step, Radix cynanchi wilfordii, Semen Arecae, Radix Salviae Miltiorrhizae, Herba Leonuri, Herba Lycopi, Radix Achyranthis Bidentatae, Caulis Spatholobi and Ganoderma are mixed in described ratio, add relative to mixture 5 ~ 8 times amount determining alcohol be 75% ~ 90% alcohol reflux 3 ~ 5 times, each 2 ~ 3 hours, filter respectively, each time filtrate merges, and reclaims ethanol, when being concentrated into 60 DEG C, relative density is the clear paste of 1.20 ~ 1.22, for subsequent use;

3rd step, will remain described raw medicinal material and mix in described ratio, add relative to mixture 8 ~ 10 times of water gagings, boil 6 ~ 8 hours, filter, and when being concentrated into 60 DEG C, relative density is the clear paste of 1.28 ~ 1.30;

4th step, mixed by the clear paste of the first step, second step, the 3rd step, 60 DEG C ~ 70 DEG C reduced vacuum dryings, get dry extract powder;

5th step, dried cream powder described in volatile oil clathrate compound described in the first step and the 4th step is fully mixed, add the mixture relative to volatile oil clathrate compound described in 100 weight portions and dried cream powder subsequently, 5 ~ 7 weight portion carboxymethyl starch sodium, 5 ~ 50 weight starch mix homogeneously, adding 150 ~ 200 weight portion determining alcohols is 80% ~ 90% alcohol granulation, dry, granulate, add the mixture relative to volatile oil clathrate compound described in 100 weight portions and dried cream powder subsequently, 3 ~ 5 weight portion magnesium stearate, then load in gelatine capsule.

When the dosage form of described pharmaceutical preparation is liniment, its preparation method comprises the following steps:

Step one: first described raw medicinal material is ground into coarse powder, then pulverizes further, cross 100 mesh sieves, the enable fine powder amount by 100 mesh sieves at least reaches 40%, collects and obtains fine powder a by the fine powder of 100 mesh sieves;

Step 2: the coarse powder not by 100 mesh sieves is dropped into multi-function extractor and extracts twice, first time adds weight portion 8-10 times amount soak by water 1-3 hour, and second time adds weight portion 6-10 times amount soak by water 1-3 hour, merges twice decocting liquid, filters to get filtrate; The heating of gained filtrate is concentrated into pasty state, and after putting into the oven dry of 80 DEG C, baking oven, room temperature cools, and grinds to form fine powder b;

Step 3: call in the glycerol accounting for a and b mixture gross mass 10% after being mixed with fine powder b by fine powder a and make liniment.

The beneficial effect that technical scheme provided by the invention is brought is: the present invention has invigorating the spleen and benefiting QI, effect of damp eliminating speckle removing, cures mainly insufficiency of the spleen the wetting of chloasma and accumulates card.The present invention utilizes Traditional Chinese medical theory, by regulating animal economy hormonal system; Carry out determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, according to different symptom targeted therapies, evident in efficacy; The course for the treatment of is shorter, can reduce relapse rate; Can the stress of obvious reduction of patient; Cost price is low, and route of administration is convenient, and patient is easy to accept, and has the value potentiality that clinical market is promoted.

Detailed description of the invention

Chinese medicine think primary disease many be main pathogenesis with the dirty QI-blood failing to nourish upward in close relations of liver,spleen,kidney three in face.Feelings will does not freely cause stagnation of QI due to depression of the liver, heat resulting from stagnation of QI, fumigates in face, the cloudy blood and giving birth to of burning; Or Chong and Ren channel disorder, deficiency of the liver and kindey, discordance between water(the kidney)and fire(the heart), caused by hyperactivity of deficient fire; Or chronic disease, battalion defends and becomes estranged, and QI-blood circulation is not smooth, qi depression to blood stasis, becomes homeless to support and form in face; Or eating and drinking without temperance, be worried excessively, impairing the spleen and stomach, dysfunction of the spleen in transportation, damp and hot interior life, stifling pathogenic.Golden Mirror of Medicine is said: " darkly begin secretly for a long time as dirt, because of the angry one-tenth of troubled thoughts." YE Tian shi cloud: " prolonged illness must control network, and it is unfavorable that the sick QI and blood for a long time of meaning is carried out, and the stasis of blood must be had among blood network to coagulate.”

Therefore, the present invention treats that chloasma is insufficiency of the spleen wet accumulates card with invigorating the spleen and benefiting QI, damp eliminating speckle removing for primary treatment principle, selects prescription: Poria, Semen Coicis, Rhizoma Cyperi, Herba Aristolochiae, Radix Et Rhizoma Nardostachyos, Pericarpium Arecae, Semen Lablab Album, Radix cynanchi wilfordii, Semen Arecae, Radix Salviae Miltiorrhizae, Herba Leonuri, Herba Lycopi, Radix Achyranthis Bidentatae, Caulis Spatholobi, Ganoderma, Caulis Polygoni Multiflori, Rhizoma et radix valerianae, Radix Et Caulis Acanthopanacis Senticosi, Radix Ginseng, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Dioscoreae, Radix Glycyrrhizae, Radix Rhodiolae, Fructus Hippophae, Radix aconiti sinomontani, Stigma Croci, Radix Ilicis Pubescentis.

Wherein, Poria, Semen Coicis, Rhizoma Cyperi, Herba Aristolochiae, Radix Et Rhizoma Nardostachyos, Pericarpium Arecae, Semen Lablab Album, Radix cynanchi wilfordii, Semen Arecae, Radix aconiti sinomontani regulating qi-flowing for strengthening spleen, eliminating dampness by diuresis speckle removing; Radix Salviae Miltiorrhizae, Herba Leonuri, Herba Lycopi, Radix Achyranthis Bidentatae, Caulis Spatholobi, Stigma Croci, Radix Ilicis Pubescentis promoting blood flow to regulate menstruation, diuretic speckle removing; Ganoderma, Caulis Polygoni Multiflori, Rhizoma et radix valerianae, Radix Et Caulis Acanthopanacis Senticosi are regulated the flow of vital energy and are calmed the nerves; Radix Ginseng, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Dioscoreae, Radix Glycyrrhizae, Radix Rhodiolae, Fructus Hippophae invigorating the spleen and benefiting QI, speckle removing of invigorating blood circulation.

Wherein, the pharmacology of above-mentioned raw materials medical material is as follows:

Poria: sweet, light is flat; GUIXIN warp, lung meridian, spleen channel, kidney channel.Function: diuretic medicine; Diuretics with the action of eliminating dampness." medication heart method ": " sweet with supporing yang, the panacea of dehumidifying also for Poria, the sharp key of light energy.The flat YANG invigorating of sweet in the mouth, strengthening the spleen is relieved oedema or abdominal distension through diuresis or purgation, inducing QI of promoting the production of body fluid.”

Semen Coicis: cool in nature is sweet in the mouth, light; Return spleen, stomach, lung meridian.Spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal, row is dense in heat clearing away.For edema, beriberi, dysuria, arthralgia chiefly caused by damp pathogen contracture, diarrhea due to hypofunction of the spleen, lung abscess, intestinal carbuncle; Verruca plana.

Rhizoma Cyperi: the pungent micro-hardship of nature and flavor is sweet, flat; Return liver, tri-jiao channel.Can to regulate the flow of vital energy resolving depression; Menstruction regulating and pain relieving; Antiabortive.Main distending pain over the hypochondrium; Mammary swelling is educated; Hernia pain; Menoxenia; Gastral cavity abdomen feeling of fullness pain; Belch acid regurgitation, vomiting and nausea; Abdominal pain during menstruation; Bleeding not during menses; Frequent fetal movement.For stagnation of QI due to depression of the liver, breast, the side of body, abdominal distention, dyspepsia, breast gastral cavity painful abdominal mass is vexed, and colic of cold type is suffered from abdominal pain, distending pain of the breast, menoxenia, amenorrhea dysmenorrhea.

Herba Aristolochiae: bitter, temperature; Return liver,spleen,kidney warp.Circulation of qi promoting removing dampness, promoting blood circulation and stopping pain.Treat for stomachache, colicky, edema during pregnancy, puerperal, vim and vigour were suffered from abdominal pain, rheumatalgia.Promoting flow of QI and blood, pain relieving, diuresis.Edema during pregnancy, breast is suffered from abdominal pain, colic, rheumatalgia.

Radix Et Rhizoma Nardostachyos: acrid in the mouth, sweet, warm in nature; Return spleen, stomach warp.Compendium of Material Medica: " Radix Et Rhizoma Nardostachyos, it is strongly fragrant that fragrance can open spleen, adds in taste medicine less, gas of being very amusing "." Japan hanako materia medica ": " control abdominal distnetion, the therapeutic method to keep the adverse QI flowing downwards." to have fragrance row loose for Radix Et Rhizoma Nardostachyos, warming spleen and stomach for dispelling cold, regulating QI to relieve pain, the effect of appetizing of being amusing.Cure mainly coldness and pain in the epigastrium distension, anorexia, chest pain, toothache, tumbling down is grieved, beriberi edema, cramp caused by acute vomiting and diarrhea.

Pericarpium Arecae: acrid in the mouth, slightly warm in nature; Return spleen, stomach, large intestine, small intestine meridian." Kaibao Bencao ": " main cold and hot gas is made a psychological attack abdomen, and large intestine stops up poison, expectorant diaphragm, the belching of acid from stomach.And decoct with Jiang Yantong, enter thin gas medicine good." " detailed outline ": " beriberi is stopped up inverse, subtertian malaria feeling of fullness, nausea malignant histocytosis feeling of distension and oppression for lowering the adverse flow of QI, aqueous vapor edema in the skin that disappears.”

Semen Lablab Album: sweet light, tepor, flat; Return spleen channel, stomach warp.Spleen invigorating, removing dampness, relieves summer heat.Cure mainly insufficiency of the spleen resulting in production of dampness, anorexia and loose stool, leukorrhagia, heat-damp in summer is vomited and diarrhoea, and excessive thirst is uncomfortable in chest.Semen Lablab Album control heat-damp in summer vomit and diarrhoea, summer heat usually accompanied with dampness, summer heat-damp in summer damaging the spleen and stomach, incoordination between the spleen and stomach, easily causes vomiting and diarrhoea.

Radix cynanchi wilfordii: slightly warm in nature is nontoxic; Return liver, kidney two warp.Nourishing the liver and kidney, strengthening body, nourishes blood and enriches blood, crow palpus hair color, convergence vital essence, promoting tissue regeneration and ulcer healing, loosening bowel to relieve constipation.Control prolonged illness weakness, chronic migratory arthralgia, soreness of the waist and knees, anemia, enterorrhagia, early whitening of beard and hair, neurasthenia, deficiency of YIN chronic malaria, ulcer does not close up for a long time, old people constipation.

Semen Arecae: bitter in the mouth, pungent, warm in nature; Return stomach, large intestine channel.Have parasite killing, removing mass, sending down the abnormal ascending QI is capable stagnant, effect that row aquation is wet.Cure mainly rapid digestion of food to relieve oedema or abdominal distension through diuresis or purgation, kill intestinal volt corpse, proglottid of tapeworm; Except dampness, get round by bribery, sharp nine orifices, relieving restlessness, caking in broken abdomen; Also can control beriberi, edema, chest pain, dysentery, abdominal distention is suffered from abdominal pain, defecation is unfavorable, mental disorder dyspnea with rapid respiration, treat pernicious malaria, resist communicable subtropical diseases.

Radix Salviae Miltiorrhizae: bitter in the mouth, cold in nature; GUIXIN, Liver Channel, have the effect of blood circulation promoting and blood stasis dispelling, promoting tissue regeneration by removing blood stasis, removing heat from blood mind calming, be mainly used in the ambition of stagnation of QI and blood, the twinge of the breast side of body, sensation of oppression over the chest with shortness of breath, abdominal distention; The menoxenia of women's disharmony between QI and blood, dysmenorrhoea amenorrhea; Stagnation of QI-blood, the symptoms such as trusted subordinate's pain

Herba Leonuri: bitter in the mouth, pungent, cold nature; Return liver, pericardium channel, there is promoting blood flow to regulate menstruation, inducing diuresis to remove edema, the effect of heat-clearing and toxic substances removing, for the menoxenia caused by blood stasis, dysmenorrhea, amenorrhea, puerperal abdonimal pain or lochiorrhea, edema, dysuria, traumatic injury, the cards such as sore and toxic.

Herba Lycopi: bitter, pungent, tepor; Return liver, spleen channel.Effect blood circulation promoting and blood stasis dispelling, inducing diuresis to remove edema.Cure mainly blood stasis amenorrhea, stimulate the menstrual flow, lump in the abdomen, the stagnant stomachache of the stasis of blood in puerperal, body and face edema, injury from falling down, incised wound, sore and toxic, edema, ascites (edema of congestion retardance, the mutual resistance of the water stasis of blood is especially suitable).

Radix Achyranthis Bidentatae: bitter in the mouth, acid, property is put down; Return liver, kidney channel." Japan hanako materia medica ": " control waist knee joint soft timid cold weak, broken crux, evacuation of pus pain relieving, puerperal cardiac and abdominal pain blood fortune, fall tire, tonifying YANG." " the southern regions of the Yunnan Province book on Chinese herbal medicine ": " control furuncle, carbuncle, apply affected part.Also can have an abortion.Food is simmered, energy improving eyesight with Carnis Sus domestica." there is invigorating the liver and kidney, bone and muscle strengthening, promoting blood circulation to restore menstrual flow, ignite (blood) is descending, effect of inducing diuresis for treating stranguria syndrome, the inclined nourishing the liver and kidney of Radix Achyranthis Bidentatae merit, strong waist knee joint: the soreness of bones and muscles, the lumbocrural pain that cause for deficiency of the liver and kindey.

Caulis Spatholobi: nature and flavor are bitter, sweet, temperature; Return liver, kidney channel.Can relaxing muscles and tendons to promote blood circulation; Nourishing blood for regulating menstruation.Main numb hand and foot; Quadriplegia; Rheumatic arthralgia; Women has through uncomfortable; Dysmenorrhea; Amenorrhea.Function: enrich blood, invigorates blood circulation, dredging collateral.For menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia.

Ganoderma: sweet, flat; GUIXIN, liver, spleen, lung, the kidney Five Classics.Cure mainly asthenia, cough, asthma, insomnia, dyspepsia, malignant tumor etc.

Caulis Polygoni Multiflori: sweet in the mouth, micro-hardship, property is put down; GUIXIN, Liver Channel, have effect of energy tranquilizing by nourishing the heart, dispelling wind and removing obstruction in the collateral, cure mainly insomnia and dreamful sleep, blood deficiency general pain, rheumatic arthralgia; The cards such as skin pruritus, Caulis Polygoni Multiflori can be invigorated blood circulation, stimulate the menstrual flow, the detumescence of blood vessel dilating, blood circulation promoting, stimulating milk secretion.

Rhizoma et radix valerianae: pungent, sweet, warm; GUIXIN, Liver Channel." Traditional Chinese Medicine in Sichuan will ": " control cranial nerve and the heart, stomach is weak, the not normal and urine of chronic forms collapses." control irritability, stomach is weak, lumbago, menoxenia, traumatic injury.

Radix Et Caulis Acanthopanacis Senticosi: acrid in the mouth, hardship, micro-sweet, warm in nature; Return spleen, kidney, heart channel, there is replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, effect of expelling wind and removing dampness, soft for anemofrigid-damp arthralgia, lumbocrural pain, muscles and bones flaccidity, be slow in action, the card such as body weakness with emaciation is weak, traumatic injury, fracture, edema, beriberi, uncontrolled urination are itched.

Radix Ginseng: property is flat, sweet in the mouth, micro-hardship, tepor; Return spleen, lung meridian, heart channel.Function strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, invigorating the spleen to benefit the lung, promoting the production of body fluid to quench thirst, Fructus Alpiniae Oxyphyllae of calming the nerves.Cure mainly that impairment caused by overstrain is deficient, food told in lack of appetite, asthenia, regurgitation, stool lingering diarrhea, empty cough with asthma are short, spontaneous perspiration sudden collapse, palpitation with fear, forgetful, dizziness and headache, sexual impotence, frequent micturition, quench one's thirst, woman uterine bleeding, children's's intermittent infantile convulsion and prolonged deficiency be multiple, the disease of all qi-blood-body fluid deficiencies.

The Rhizoma Atractylodis Macrocephalae: sweet in the mouth, hardship, warm in nature; Return spleen, stomach warp, have spleen reinforcing promoting the circulation of QI, dampness diuretic, strengthening superficial resistance to stop perspiration, effect that activating the spleen is moisturized, cure mainly the feeling of fullness diarrhoea that dysfunction of the spleen in transportation, QI failing to transform into body fluid are caused, phlegm retention edema; The vexed lazyness speech of deficiency of QI in middle-JIAO, metrorrhagia and metrostaxis, proctoptosis with chronic dysentery; The cards such as solid in the playing of deficiency of the spleen causing weakness of QI, sweating due to debility spontaneous perspiration.

The Radix Astragali: sweet, tepor; Return lung, spleen, liver, kidney channel.Essentials of Matea Medica: " Radix Astragali, life consolidating superficial resistance losslessly can be sent out, and have antiperspirant to stop; Process with invigorating middle warmer, beneficial vigour, strong taste.Hemopoietic, granulation promoting, evacuation of pus expelling the toxic substance from the body with tonic, carbuncle sore panacea.Variola does not rise, and yang deficiency should it without hot person." " book on Chinese herbal medicine justice ": " replenishing vital QI with drugs of warm nature taste, all middle gas is depressed, and spleen soil is weak, and the person of sinking is the most suitable for clearing heat in QI system for the Radix Astragali, soil in tonification.Its skin goes directly the skin table muscle of people, and solid protection defends sun, and enriching table point, is its speciality, so all diseases of exterior deficiency, and the most refreshing agent." function consolidating superficial resistance arresting sweating, inducing diuresis to remove edema, the evacuation of pus of holder skin ulcer, regulating fluid apssage.The Radix Astragali makes contractile ability strengthen, and can improve the blood circulation of whole body, can coronary artery dilator, Renal vascular and Rhizoma Bistortae peripheral vessel, make cutaneous circulation vigorous; The nonspecific immunity power of body can be improved, protect the liver and fall hypoglycemic effect, have inhibitory action to staphylococcus, blood dissolubility streptococcus, Diplococcus pneumoniae, dysentery bacterium etc.

Rhizoma Dioscoreae: sweet in the mouth, property is put down; Return lung, spleen, kidney channel, there is strengthening the spleen and tonifying the lung, stomach reinforcing the kidney invigorating, benefit of reinforcing the kidney essence, hearing-improing and eyesight improving, help the five internal organs, bone and muscle strengthening, long will are calmed the nerves, effect of life lengthening, cure mainly that weakness of the spleen and stomach, lassitude, inappetence, chronic diarrhea and dysentery, insufficiency of lung-QI are dry, phlegm dyspnea cough, kidney qi loss, soreness of the waist and knees, lower limb flaccidity be weak, the red card such as swollen, fat of frequent micturition of quenching one's thirst, premature ejaculation of passing out semen, leukorrhagia nebulousurine, skin.

Radix Glycyrrhizae: nature and flavor are sweet, flat; Return spleen, stomach, lung meridian." herbal classic " is said: " main the five internal organs six mansion cold and heat pathogen, hard muscles and bones, longue meat, times power, incised wound swells, removing toxic substances "." property of medicine opinion " is said: " in main abdomen, cold type of pain, controls infantile convulsion, except distention and fullness in the abdomen; Tonification the five internal organs; Make all poison of drug; Support kidney qi internal injury, make flaccidity; Housewife's human blood drop lumbago; Empty and frequent fever; Add and with it ".Can QI invigorating invigorating middle warmer, relieving spasm to stop pain, nourishing the lung to arrest cough, eliminating fire and detoxication, coordinating the actions of various ingredients in a prescription.Main asthenia lack of appetite, leanness yellowish complexion, shortness of breath and palpitation, stomachache loose stool, the anxious pain of extremity contraction, hysteria, cough and asthma, laryngopharynx swelling and pain, carbuncle skin ulcer swells and ache, infantile carbuncle, and medicine, alimentary toxicosis.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.

Radix Rhodiolae: sweet is bitter, flat; Return lung, heart channel.The kidney invigorating, regulates the flow of vital energy and nourishes blood, and has promoting blood circulation and hemostasis, clearing away lung-heat to relieve cough, antipyretic, and the effect under leukorrhagia stopping, the side effect of Radix Rhodiolae does not temporarily find.Radix Rhodiolae energy improving water flood, blood-enriching and blood-promoting circulation, anti-cerebral anoxia, resisting fatigue, promoting blood circulation and hemostasis, clearing away lung-heat to relieve cough, change become silted up detumescence, antipyreticly to bring down a fever, nourish the effects such as vigour; Be used for the treatment of traumatic injury and burn and scald outward.

Fructus Hippophae: sour, puckery, temperature.Eliminating phlegm and stopping cough, relieving dyspepsia, promoting blood circulation to remove blood stasis.For cough with copious phlegm, dyspepsia, abdominal pain due to retention of food, blood stasis amenorrhea, falls and flutters congestive edema.

Radix aconiti sinomontani: toil, temperature; The heart; Liver; Lung; Spleen channel expelling wind and removing dampness, regulating QI to relieve pain, promoting blood circulation to remove blood stasis.Dispelling the wind and dampness pathogens lumbago and skelalgia, eruptive disease is suffered from abdominal pain, stomachache, cardiopalmus, traumatic injury impairment caused by overstrain, scrofula, furuncle.

Stigma Croci: sweet is flat; GUIXIN, Liver Channel.Blood circulation promoting and blood stasis dispelling, removing pathogenic heat from blood and toxic substance from the body, resolving stagnation for tranquilization.For amenorrhea lump in the abdomen, postpartum stagnation, maculae caused by violent heat pathogen, melancholy painful abdominal mass is vexed, and palpitation with fear is gone mad.

Radix Ilicis Pubescentis: bitter, flat; Return lung; Liver; Large intestine channel blood circulation and channel invigorating, reducing swelling and alleviating pain, heat-clearing and toxic substances removing.For angina pectoris, myocardial infarction, thromboangiitis obliterans, central serous chorioretinopathy, tonsillitis, pharyngolaryngitis, infantile pneumonia, chilblain.

Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.

Embodiment 1 decoction of the present invention

Get Poria 30g, Semen Coicis 32g, Rhizoma Cyperi 14g, Herba Aristolochiae 18g, Radix Et Rhizoma Nardostachyos 13g, Pericarpium Arecae 20g, Semen Lablab Album 11g, Radix cynanchi wilfordii 19g, Semen Arecae 14g, Radix Salviae Miltiorrhizae 30g, Herba Leonuri 13g, Herba Lycopi 24g, Radix Achyranthis Bidentatae 29g, Caulis Spatholobi 17g, Ganoderma 27g, Caulis Polygoni Multiflori 9g, Rhizoma et radix valerianae 16g, Radix Et Caulis Acanthopanacis Senticosi 21g, Radix Ginseng 23g, Rhizoma Atractylodis Macrocephalae 31g, Radix Astragali 23g, Rhizoma Dioscoreae 28g, Radix Glycyrrhizae 25g, Radix Rhodiolae 28g, Fructus Hippophae 7g, Radix aconiti sinomontani 8g, Stigma Croci 8g and Radix Ilicis Pubescentis 18g.

Its preparation method comprises the following steps:

Step one: purple casserole is put in described raw medicinal material mixing, adds clear water, to clear water dipped medical material upper surface 3cm, soak 4 hours;

Step 2: be placed in by purple casserole on fire, after intense fire boils, uses slow fire instead and decocts 40 minutes slowly, filters, obtains filtrate a, for subsequent use;

Step 3: residue medicinal residues are added clear water again, to clear water dipped medical material upper surface 3cm, soaks 4 hours;

Step 4: be placed in by purple casserole on fire, after intense fire boils, uses slow fire instead and decocts 30 minutes slowly, filters, obtains filtrate b, mixed by filtrate a and filtrate b.

       

Embodiment 2 capsule of the present invention

Get Poria 24g, Semen Coicis 36g, Rhizoma Cyperi 25g, Herba Aristolochiae 14g, Radix Et Rhizoma Nardostachyos 24g, Pericarpium Arecae 14g, Semen Lablab Album 23g, Radix cynanchi wilfordii 14g, Semen Arecae 22g, Radix Salviae Miltiorrhizae 24g, Herba Leonuri 21g, Herba Lycopi 25g, Radix Achyranthis Bidentatae 16g, Caulis Spatholobi 22g, Ganoderma 35g, Caulis Polygoni Multiflori 5g, Rhizoma et radix valerianae 26g, Radix Et Caulis Acanthopanacis Senticosi 27g, Radix Ginseng 34g, Rhizoma Atractylodis Macrocephalae 37g, Radix Astragali 32g, Rhizoma Dioscoreae 30g, Radix Glycyrrhizae 31g, Radix Rhodiolae 25g, Fructus Hippophae 8g, Radix aconiti sinomontani 9g, Stigma Croci 13g and Radix Ilicis Pubescentis 21g.

Its preparation method comprises the following steps:

Poria, Semen Coicis, Rhizoma Cyperi, Herba Aristolochiae, Radix Et Rhizoma Nardostachyos, Pericarpium Arecae and Semen Lablab Album mix in described ratio by the first step, add the water extraction volatile oil relative to 5 times, mixture, by the volatile oil beta-cyclodextrin inclusion compound obtained, the mass ratio of volatile oil and beta-schardinger dextrin-is 1: 3, stir 90 minutes, temperature 50 C, obtains volatile oil clathrate compound, for subsequent use; Another when aqueous extract being concentrated into 60 DEG C relative density be the clear paste of 1.17;

Second step, Radix cynanchi wilfordii, Semen Arecae, Radix Salviae Miltiorrhizae, Herba Leonuri, Herba Lycopi, Radix Achyranthis Bidentatae, Caulis Spatholobi and Ganoderma are mixed in described ratio, add relative to mixture 5 times amount determining alcohol be 90% alcohol reflux 4 times, each 2 hours, filter respectively, each time filtrate merges, and reclaims ethanol, when being concentrated into 60 DEG C, relative density is the clear paste of 1.22, for subsequent use;

3rd step, will remain described raw medicinal material and mix in described ratio, add relative to mixture 8 times of water gagings, boil 7 hours, filter, and when being concentrated into 60 DEG C, relative density is the clear paste of 1.30;

4th step, mixed by the clear paste of the first step, second step, the 3rd step, 70 DEG C of reduced vacuum dryings, get dry extract powder;

5th step, dried cream powder described in volatile oil clathrate compound described in the first step and the 4th step is fully mixed, add the mixture relative to volatile oil clathrate compound described in 100 weight portions and dried cream powder subsequently, 6 weight portion carboxymethyl starch sodium, 30 weight starch mix homogeneously, adding 200 weight portion determining alcohols is 90% alcohol granulation, dry, granulate, add the mixture relative to volatile oil clathrate compound described in 100 weight portions and dried cream powder subsequently, 4 weight portion magnesium stearate, then load in gelatine capsule.

Embodiment 3 liniment of the present invention

Get Poria 37g, Semen Coicis 25g, Rhizoma Cyperi 19g, Herba Aristolochiae 23g, Radix Et Rhizoma Nardostachyos 16g, Pericarpium Arecae 23g, Semen Lablab Album 17g, Radix cynanchi wilfordii 24g, Semen Arecae 18g, Radix Salviae Miltiorrhizae 33g, Herba Leonuri 15g, Herba Lycopi 14g, Radix Achyranthis Bidentatae 32g, Caulis Spatholobi 15g, Ganoderma 37g, Caulis Polygoni Multiflori 4g, Rhizoma et radix valerianae 23g, Radix Et Caulis Acanthopanacis Senticosi 17g, Radix Ginseng 29g, Rhizoma Atractylodis Macrocephalae 30g, Radix Astragali 29g, Rhizoma Dioscoreae 36g, Radix Glycyrrhizae 27g, Radix Rhodiolae 34g, Fructus Hippophae 6g, Radix aconiti sinomontani 4g, Stigma Croci 17g and Radix Ilicis Pubescentis 15g.

Its preparation method comprises the following steps:

Step one: first described raw medicinal material is ground into coarse powder, then pulverizes further, cross 100 mesh sieves, the enable fine powder amount by 100 mesh sieves at least reaches 40%, collects and obtains fine powder a by the fine powder of 100 mesh sieves;

Step 2: the coarse powder not by 100 mesh sieves is dropped into multi-function extractor and extracts twice, first time adds weight portion 10 times amount soak by water 1 hour, and second time adds weight portion 10 times amount soak by water 1 hour, merges twice decocting liquid, filters to get filtrate; The heating of gained filtrate is concentrated into pasty state, and after putting into the oven dry of 80 DEG C, baking oven, room temperature cools, and grinds to form fine powder b;

Step 3: call in the glycerol accounting for a and b mixture gross mass 10% after being mixed with fine powder b by fine powder a and make liniment.

For solving the problems of the technologies described above, the invention provides and a kind ofly treat the insufficiency of the spleen wet pharmaceutical preparation of accumulateing card of chloasma, pharmaceutical dosage form can be: tablet, enteric coated tablet, sugar coated tablet, capsule, hard capsule, oral liquid, suck agent, soft capsule, film coated tablet, electuary, honey pill agent, powder, granule, sublimed preparation, solution, injection, suppository, plaster, syrup, powder.

Medicine is decocted decoction in use and is taken, and every day 1 dose, decocting takes at twice, and every 3 months is a course for the treatment of; When this pharmaceutical preparation is lotion, spray, when liniment uses, 3-6 time on the one, every 3 months is a course for the treatment of; When this pharmaceutical preparation be capsule, honey refining pill, granule take time, 3 times on the one, every 3 months is a course for the treatment of.

Acute toxicity test:

Application NIH mice 40, SPF level, male and female half and half, body weight 18 ~ 22g, carries out acute toxicity test.Mice is divided into two groups at random, often organizes 20, i.e. matched group and administration group, fasting 12 hours before experiment; By decoction prepared by embodiments of the invention 1, (concentration is 6.58g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg(and unit dosage form is 32.9 crude drugs/kg), matched group gives normal saline, administration in a day 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Mouse oral gavage decoction LD50>32.9 crude drug/kg of the present invention, every day, maximum dosage-feeding was 65.8 crude drugs/kg/ day.Pharmaceutical preparation clinical application amount of the present invention be 4.4g crude drug/day/people, adult body weight in 60KG, average dosage is 0.073g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 20g) oral administration gavage pharmaceutical preparation of the present invention is 901 times of quantity.Therefore the decoction acute toxicity of the embodiment of the present invention 1 is low, clinical drug safety.

Long term toxicity test:

The capsule of the embodiment of the present invention 2 presses 10.78,20.35 and 33.48g crude drug/kg continuous use 16 weeks (1.0ml/100g body weight to mice, every day 2 times) and drug withdrawal after 4 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of pharmaceutical preparation of the present invention to mice all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 16 weeks and drug withdrawal are after 4 weeks, and Organs of Mice is all without obviously changing.Illustrate that the capsule of the embodiment of the present invention 2 is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.

Acute skin irritation test:

These product are according to 6.3 joints in Ministry of Public Health " cosmetics health specification " (2002) Part II " skin irritation/corrosion test ", male 4 of Japan large ear rabbit, body weight 2kg ~ 3kg, the liniment prepared by embodiments of the invention 3 directly to be wiped on the left of animal on skin (opposite side in contrast), adopt blocking test, 4 hours application time, tested material is remained with warm water washing after off-test, 1h after removing tested material, 24h, 48h and 72h observes the dermoreaction of the tested district of animal and check plot respectively, top average is " 0 ", judge that these product are to animal skin nonirritant.

Hypersensitive test:

Get healthy albino guinea-pig 18, body weight 250-300g, male and female dual-purpose, reject both sides dorsal body setae before test, every side 3 × 3cm, is divided into test group, blank group (substrate) and positive controls at random.Positive controls DNFB, sensitization 1% concentration, excites and uses 0.1% concentration; The test group liniment of the embodiment of the present invention 3.The liniment 0.1g getting the embodiment of the present invention 3 is applied to unhairing district, back, the next day 1 time, totally 3 times.In latter 14 days of last contact, at back, the same area smeared this product 0.1g, at once observes after removing medicine after 6h, and in 24,48,72h observes with or without anaphylaxis.Blank group and positive controls excite by same method and contact and observe.Result of the test: namely positive controls animal skin occurs localized erythema and slight edema in sensitization after 1 hour, within 24 hours, symptoms of allergic increases the weight of, and have scleroma to be formed, sensitization rate is 100%, all there is not any symptoms of allergic in test group and blank treated animal skin, sensitization rate is 0%.

Clinical data:

Case selection: choose my institute and meet insufficiency of the spleen wet patient 188 example of accumulateing card of chloasma.Age 27-48 year, average (36.4 ± 5.6) year; The course of disease 1 year-10 years; Be divided into six groups at random, six groups of contrasts situation no significant difference such as age, course of disease (P>0.05), have comparability.

Decoction treatment group: 31 people.

Capsule treatment group: 31 people.

Liniment treatment group: 31 people.

Decoction+liniment treatment group: 31 people

Capsule+liniment treatment group: 32 people

Western medicine group: 32 people.

Diagnostic criteria

Formulate according to " clinical diagnosis of chloasma and criterion of therapeutical effect " (2003 annual overhauls are finalized a text) that Dermatology Professional Committee of CAIM (Chinese Association Of Integrative Medicine) pigment disease group is formulated:

1, face is filbert to dark brown, well-defined patch, usual symmetry distribution, NIP performance and squama;

2, without obvious subjective symptoms;

3, women is multiple, after mainly occurring in adolescence;

4, the state of an illness can have seasonality, and the Chang Xiachong winter is light;

5, other diseases is got rid of, as the pigmentation that naevus fuscocaerules zygomaticus, Rieh1 melanosis and pigmentosa actinic lichen planus etc. cause;

6, pigment is greater than more than 20% of self facial average optical density value along zone leveling optical density value.

Insufficiency of the spleen wetting accumulates card: speckle color ash is brown, and shape such as dust adheres to; With fatigue and weak, indigestion and loss of appetite sleepy, menstruation color is light, and leucorrhea amount is many; There is indentation on the fat limit of light red tongue, soft pulse or thin.

Allly meet above-mentioned clinical criteria and be diagnosed as chloasma, Chinese medical discrimination meets and insufficiency of the spleenly wetly accumulates card.

Therapeutic Method:

Decoction treatment group: take decoction prepared by the embodiment of the present invention 1, every day 2 times 3 months is 1 course for the treatment of.

Capsule treatment group: take lotion prepared by the embodiment of the present invention 2, every day 3 times, each 33 months is 1 course for the treatment of.

Liniment treatment group: use liniment prepared by the embodiment of the present invention 3, every day 5 times 3 months is 1 course for the treatment of.

Decoction+liniment treatment group: take decoction prepared by the embodiment of the present invention 1, every day 2 times, use liniment prepared by the embodiment of the present invention 3, every day 3 times 3 months is 1 course for the treatment of simultaneously.

Capsule+liniment treatment group: take capsule prepared by the embodiment of the present invention 2, every day 3 times, each 3, use liniment prepared by the embodiment of the present invention 3, every day 3 times 3 months is 1 course for the treatment of simultaneously.

Western medicine group: oral vitamin C0.3 g, vitamin E 0.1g, every day 3 times; Orally taken hemostatic naphthenic acid 0.25 g, every day 3 times.It within 3 months, is 1 course for the treatment of.

Efficacy assessment standard:

" clinical diagnosis of chloasma and criterion of therapeutical effect " (2003 annual overhauls are finalized a text) that efficacy determination is formulated with reference to CAIM (Chinese Association Of Integrative Medicine) Dermatology Professional Committee pigment disease group, according to mottle area, integration decline index clinical efficacy is divided into basic healing, effective, take a turn for the better, invalid level Four.

Basic healing: perusal mottle area abatement is greater than more than 90%, and color disappears substantially, and decline after treatment index >=0.8;

Effective: perusal mottle area abatement is greater than 60%, and color is obviously thin out, and decline after treatment index >=0.5;

Take a turn for the better: perusal mottle area abatement is greater than 30%, and color is thin out, and decline after treatment index >=0.3;

Invalid: perusal mottle area abatement is less than 30%, and color change is not obvious, decline index <0.3 after treatment.

Decline index calculation method: total mark before decline index=(before treatment the rear total mark of total mark/treatment)/treatment.

Effective percentage computational methods: effective percentage=[(basic healing+effective)/total number of cases] * 100%.

Therapeutic outcome:

See table 1 and table 2, as can be seen from Table 1, adopt pharmaceutical preparation of the present invention to treat insufficiency of the spleen the wetting of chloasma and accumulate card, relative to Western medicine on therapeutic effect, there is significant improvement; As can be seen from Table 2, adopting pharmaceutical preparation of the present invention to treat, chloasma is insufficiency of the spleen wet accumulates card, relative to Western medicine, treatment course for the treatment of significantly shortens.

Clinical efficacy comparison example after 3 months treated respectively by six groups, table 1

Group	Number of cases	Basic healing	Effective	Take a turn for the better	Invalid	Effective percentage
							Decoction treatment group	31	15	10	4	2	80.6%
Capsule treatment group	31	14	11	4	2	80.6%
							Liniment treatment group	31	8	13	6	4	67.7%
Decoction+liniment treatment group	31	19	9	2	1	90.3%
							Capsule+liniment treatment group	32	21	8	2	1	90.6%
Western medicine group	32	6	9	9	8	46.9%

Basic healing and effective number and time comparative example (%) to be treated after 3 months respectively by six groups, table 2

Group	Number of cases	January	February	March
					Decoction treatment group	25	5(20.0%)	16(64%)	4(16%)
Capsule treatment group	25	5(20.0%)	15(60%)	5(20%)
					Liniment treatment group	21	3(14.3%)	14(66.7%)	4(19.0%)
Decoction+liniment treatment group	28	8(28.6%)	18(64.3%)	2(7.1%)
					Capsule+liniment treatment group	29	9(31.0%)	18(62.1%)	2(6.9%)
Western medicine group	15	1(6.7%)	6(40%)	8(53.3%)

According to the clinical statistics in above table, pharmaceutical preparation provided by the invention have rapid-action, effective percentage is high, determined curative effect, safety are high, the advantage that has no side effect.

Model case: patient Liu, female, 39 years old.In July, 2012 goes to a doctor.Patient facial region's deep brown spot 2 years half, once used Chinese medicine and western medicine innerwear outer treatment, poor effect.Patient's speckle color ash is brown, and shape such as dust adheres to; Tired, sleepy, menstruation color is light, and leucorrhea amount is many; There is indentation on the fat limit of light red tongue, thready pulse.Be diagnosed as chloasma, card belongs to insufficiency of the spleen wetting and accumulates card.Take decoction every day 2 times of the embodiment of the present invention 1, use the liniment of the embodiment of the present invention 3, every day 3 times simultaneously, treat 1 month effective, continue medication and substantially heal for 1 month, follow up a case by regular visits to and do not recur for 1 year.

The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, within the spirit and principles in the present invention all, any amendment done, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.

Claims (9)

1. treat the insufficiency of the spleen wet pharmaceutical preparation of accumulateing card of chloasma for one kind, it is characterized in that, comprise following raw medicinal material: Poria, Semen Coicis, Rhizoma Cyperi, Herba Aristolochiae, Radix Et Rhizoma Nardostachyos, Pericarpium Arecae, Semen Lablab Album, Radix cynanchi wilfordii, Semen Arecae, Radix Salviae Miltiorrhizae, Herba Leonuri, Herba Lycopi, Radix Achyranthis Bidentatae, Caulis Spatholobi, Ganoderma, Caulis Polygoni Multiflori, Rhizoma et radix valerianae, Radix Et Caulis Acanthopanacis Senticosi, Radix Ginseng, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Dioscoreae, Radix Glycyrrhizae, Radix Rhodiolae, Fructus Hippophae, Radix aconiti sinomontani, Stigma Croci and Radix Ilicis Pubescentis.

2. pharmaceutical preparation according to claim 1, it is characterized in that, in described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: Poria 22-39 part, Semen Coicis 23-38 part, Rhizoma Cyperi 12-27 part, Herba Aristolochiae 13-24 part, Radix Et Rhizoma Nardostachyos 11-27 part, Pericarpium Arecae 12-26 part, Semen Lablab Album 10-25 part, Radix cynanchi wilfordii 12-27 part, Semen Arecae 14-26 part, Radix Salviae Miltiorrhizae 22-36 part, Herba Leonuri 11-24 part, Herba Lycopi 14-28 part, Radix Achyranthis Bidentatae 16-37 part, Caulis Spatholobi 13-25 part, Ganoderma 27-42 part, Caulis Polygoni Multiflori 4-10 part, Rhizoma et radix valerianae 14-29 part, Radix Et Caulis Acanthopanacis Senticosi 14-30 part, Radix Ginseng 23-38 part, Rhizoma Atractylodis Macrocephalae 30-41 part, Radix Astragali 20-34 part, Rhizoma Dioscoreae 26-39 part, Radix Glycyrrhizae 22-36 part, Radix Rhodiolae 24-37 part, Fructus Hippophae 5-10 part, Radix aconiti sinomontani 3-10 part, Stigma Croci 8-19 part and Radix Ilicis Pubescentis 12-21 part.

3. pharmaceutical preparation according to claim 1, it is characterized in that, in described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: Poria 24-37 part, Semen Coicis 25-36 part, Rhizoma Cyperi 14-25 part, Herba Aristolochiae 14-23 part, Radix Et Rhizoma Nardostachyos 13-24 part, Pericarpium Arecae 14-23 part, Semen Lablab Album 11-23 part, Radix cynanchi wilfordii 14-24 part, Semen Arecae 14-22 part, Radix Salviae Miltiorrhizae 24-33 part, Herba Leonuri 13-21 part, Herba Lycopi 14-25 part, Radix Achyranthis Bidentatae 16-32 part, Caulis Spatholobi 15-22 part, Ganoderma 27-37 part, Caulis Polygoni Multiflori 4-9 part, Rhizoma et radix valerianae 16-26 part, Radix Et Caulis Acanthopanacis Senticosi 17-27 part, Radix Ginseng 23-34 part, Rhizoma Atractylodis Macrocephalae 30-37 part, Radix Astragali 23-32 part, Rhizoma Dioscoreae 28-36 part, Radix Glycyrrhizae 25-31 part, Radix Rhodiolae 25-34 part, Fructus Hippophae 6-8 part, Radix aconiti sinomontani 4-9 part, Stigma Croci 8-17 part and Radix Ilicis Pubescentis 15-21 part.

4. according to the arbitrary described pharmaceutical preparation of claim 1-3, it is characterized in that, in described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: 30 parts, Poria, Semen Coicis 32 parts, Rhizoma Cyperi 14 parts, Herba Aristolochiae 18 parts, Radix Et Rhizoma Nardostachyos 13 parts, Pericarpium Arecae 20 parts, Semen Lablab Album 11 parts, Radix cynanchi wilfordii 19 parts, Semen Arecae 14 parts, Radix Salviae Miltiorrhizae 30 parts, Herba Leonuri 13 parts, Herba Lycopi 24 parts, Radix Achyranthis Bidentatae 29 parts, Caulis Spatholobi 17 parts, Ganoderma 27 parts, Caulis Polygoni Multiflori 9 parts, Rhizoma et radix valerianae 16 parts, Radix Et Caulis Acanthopanacis Senticosi 21 parts, Radix Ginseng 23 parts, the Rhizoma Atractylodis Macrocephalae 31 parts, the Radix Astragali 23 parts, Rhizoma Dioscoreae 28 parts, 25 parts, Radix Glycyrrhizae, Radix Rhodiolae 28 parts, Fructus Hippophae 7 parts, Radix aconiti sinomontani 8 parts, Stigma Croci 8 parts and Radix Ilicis Pubescentis 18 parts.

5. according to the arbitrary described pharmaceutical preparation of claim 1-3, it is characterized in that, in described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: 24 parts, Poria, Semen Coicis 36 parts, Rhizoma Cyperi 25 parts, Herba Aristolochiae 14 parts, Radix Et Rhizoma Nardostachyos 24 parts, Pericarpium Arecae 14 parts, Semen Lablab Album 23 parts, Radix cynanchi wilfordii 14 parts, Semen Arecae 22 parts, Radix Salviae Miltiorrhizae 24 parts, Herba Leonuri 21 parts, Herba Lycopi 25 parts, Radix Achyranthis Bidentatae 16 parts, Caulis Spatholobi 22 parts, Ganoderma 35 parts, Caulis Polygoni Multiflori 5 parts, Rhizoma et radix valerianae 26 parts, Radix Et Caulis Acanthopanacis Senticosi 27 parts, Radix Ginseng 34 parts, the Rhizoma Atractylodis Macrocephalae 37 parts, the Radix Astragali 32 parts, Rhizoma Dioscoreae 30 parts, 31 parts, Radix Glycyrrhizae, Radix Rhodiolae 25 parts, Fructus Hippophae 8 parts, Radix aconiti sinomontani 9 parts, Stigma Croci 13 parts and Radix Ilicis Pubescentis 21 parts.

6. according to the arbitrary described pharmaceutical preparation of claim 1-3, it is characterized in that, in described pharmaceutical preparation, the ratio of weight and number of each raw medicinal material is: 37 parts, Poria, Semen Coicis 25 parts, Rhizoma Cyperi 19 parts, Herba Aristolochiae 23 parts, Radix Et Rhizoma Nardostachyos 16 parts, Pericarpium Arecae 23 parts, Semen Lablab Album 17 parts, Radix cynanchi wilfordii 24 parts, Semen Arecae 18 parts, Radix Salviae Miltiorrhizae 33 parts, Herba Leonuri 15 parts, Herba Lycopi 14 parts, Radix Achyranthis Bidentatae 32 parts, Caulis Spatholobi 15 parts, Ganoderma 37 parts, Caulis Polygoni Multiflori 4 parts, Rhizoma et radix valerianae 23 parts, Radix Et Caulis Acanthopanacis Senticosi 17 parts, Radix Ginseng 29 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, the Radix Astragali 29 parts, Rhizoma Dioscoreae 36 parts, 27 parts, Radix Glycyrrhizae, Radix Rhodiolae 34 parts, Fructus Hippophae 6 parts, Radix aconiti sinomontani 4 parts, Stigma Croci 17 parts and Radix Ilicis Pubescentis 15 parts.

7., according to the arbitrary described pharmaceutical preparation of claim 1-6, it is characterized in that, when the dosage form of described pharmaceutical preparation is decoction, its preparation method comprises the following steps:

Step one: purple casserole is put in described raw medicinal material mixing, adds clear water, to clear water dipped medical material upper surface 2-5cm, soak 3-10 hour;

Step 2: be placed in by purple casserole on fire, after intense fire boils, uses slow fire instead and decocts 30-50 minute slowly, filters, obtains filtrate a, for subsequent use;

Step 3: residue medicinal residues are added clear water again, to clear water dipped medical material upper surface 2-3cm, soaks 3-10 hour;

Step 4: be placed in by purple casserole on fire, after intense fire boils, uses slow fire instead and decocts 25-35 minute slowly, filters, obtains filtrate b, mixed by filtrate a and filtrate b.

8., according to the arbitrary described pharmaceutical preparation of claim 1-6, it is characterized in that, when the dosage form of described pharmaceutical preparation is capsule, its preparation method comprises the following steps:

Poria, Semen Coicis, Rhizoma Cyperi, Herba Aristolochiae, Radix Et Rhizoma Nardostachyos, Pericarpium Arecae and Semen Lablab Album mix in described ratio by the first step, add the water extraction volatile oil relative to 4 ~ 6 times, mixture, by the volatile oil beta-cyclodextrin inclusion compound obtained, the mass ratio of volatile oil and beta-schardinger dextrin-is 1: 3 ~ 6, stir 60 minutes ~ 90 minutes, temperature 30 DEG C ~ 50 DEG C, obtains volatile oil clathrate compound, for subsequent use; Another when aqueous extract being concentrated into 60 DEG C relative density be the clear paste of 1.15 ~ 1.17;

Second step, Radix cynanchi wilfordii, Semen Arecae, Radix Salviae Miltiorrhizae, Herba Leonuri, Herba Lycopi, Radix Achyranthis Bidentatae, Caulis Spatholobi and Ganoderma are mixed in described ratio, add relative to mixture 5 ~ 8 times amount determining alcohol be 75% ~ 90% alcohol reflux 3 ~ 5 times, each 2 ~ 3 hours, filter respectively, each time filtrate merges, and reclaims ethanol, when being concentrated into 60 DEG C, relative density is the clear paste of 1.20 ~ 1.22, for subsequent use;

3rd step, will remain described raw medicinal material and mix in described ratio, add relative to mixture 8 ~ 10 times of water gagings, boil 6 ~ 8 hours, filter, and when being concentrated into 60 DEG C, relative density is the clear paste of 1.28 ~ 1.30;

4th step, mixed by the clear paste of the first step, second step, the 3rd step, 60 DEG C ~ 70 DEG C reduced vacuum dryings, get dry extract powder;

5th step, dried cream powder described in volatile oil clathrate compound described in the first step and the 4th step is fully mixed, add the mixture relative to volatile oil clathrate compound described in 100 weight portions and dried cream powder subsequently, 5 ~ 7 weight portion carboxymethyl starch sodium, 5 ~ 50 weight starch mix homogeneously, adding 150 ~ 200 weight portion determining alcohols is 80% ~ 90% alcohol granulation, dry, granulate, add the mixture relative to volatile oil clathrate compound described in 100 weight portions and dried cream powder subsequently, 3 ~ 5 weight portion magnesium stearate, then load in gelatine capsule.

9., according to the arbitrary described pharmaceutical preparation of claim 1-6, it is characterized in that, when the dosage form of described pharmaceutical preparation is liniment, its preparation method comprises the following steps:

Step one: first described raw medicinal material is ground into coarse powder, then pulverizes further, cross 100 mesh sieves, the enable fine powder amount by 100 mesh sieves at least reaches 40%, collects and obtains fine powder a by the fine powder of 100 mesh sieves;

Step 2: the coarse powder not by 100 mesh sieves is dropped into multi-function extractor and extracts twice, first time adds weight portion 8-10 times amount soak by water 1-3 hour, and second time adds weight portion 6-10 times amount soak by water 1-3 hour, merges twice decocting liquid, filters to get filtrate; The heating of gained filtrate is concentrated into pasty state, and after putting into the oven dry of 80 DEG C, baking oven, room temperature cools, and grinds to form fine powder b;

Step 3: call in the glycerol accounting for a and b mixture gross mass 10% after being mixed with fine powder b by fine powder a and make liniment.