CN104042944A - Medicinal preparation used for treating chloasma - Google Patents

Abstract

The invention provides a medicinal preparation used for treating chloasma. Raw medicines used in the invention comprise dahurian angelica root, Crocus sativus, Rhizoma Corydalis, Herba Selaginellae, Millettia dielsiana, Radix Morindae officinalis, Cuscuta chinensis Lam., Rhizoma Alismatis, Achyranthes bidentata, radix bupleuri, Semen Euryales, Radix Pseudostellariae, cassia twig, Fructus Citri Sarcodactylis, Concretio Silicea Bambusae, Cornus officinalis, Manyprickle Acathopanax Root, Styrax, Assorted Chinese Herbal Tea, myrrh, pawpaw, Rheum franzenbachii Munt., Cryptotaenia japonica Hassk., honeysuckle stem, Achillea sibirca, Rabdosia rubescens, Lithospermum erythrorhizon and Radix Scrophulariae. The medicinal preparation has the advantages of integral adjustment, small side effects, stable curative effect and the like in the chloasma treatment, so the medicinal preparation is an effective ideal approach for treating the chloasma.

Description

Be used for the treatment of the pharmaceutical preparation of chloasma

Technical field

The present invention relates to Chinese medicine technical field, relate in particular to a kind of pharmaceutical preparation that is used for the treatment of chloasma.

Background technology

Chloasma is a kind of clinical common acquired chromatopathy, is commonly called as " butterfly spot " " chloasma hepaticum " " cholasma uterinum ", belongs to the traditional Chinese medical science " chloasma " category.Its Clinical symptoms is faint yellow or yellowish-brown patch, and irregular forehead or the two cheek places of being distributed in, without squama, without symptoms such as prurituss.Chloasma is apt to occur in young and middle-aged women, main inducing spiritedness factor, Exposure to Sunlight, cosmetics improper use, gestation, oral contraceptive and antiepileptic etc.Its slower development, patient's condition is continuous, and has influence on patient's face appearance, causes some patients were to produce serious mental burden.Medical circle there is no satisfied therapy to this disease at present.。

The real pathogenic factor of chloasma it be unclear that at present, and it is relevant with following factor that great majority research is thought: ultraviolet radiation, estrogen, progesterone level, gestation, oral contraceptive, endocrine disturbance, ovary and uterus disease, serum copper content, chronic alcoholism, hepatopathy, cholecystitis, tuberculosis, hormone therapy, cosmetics, photosensitizer, oxygen-derived free radicals, the micro-ecological change of skin, antuepileptic, anxious state of mind, inherited genetic factors etc.May stimulate melanocyte secretion melanosome with estrogen, progestogen impel transhipment and the diffusion of melanosome, and Progesterone promotes that Pigmented development is relevant.Western medical treatment primary disease mainly adopts oral vitamin C, vitamin E, glutathion, local topical corticosteroid, tretinoin cream, hydroquinone, Azelaic Acid, Chemical peeling, mechanical grinding art, freezing, laser therapy, change skin etc., among said method, the side effect of part external used medicine is larger, as corticosteroid, in use procedure, be prone to atrophoderma and telangiectasis.And use Chemical peeling, freezing, mechanical grinding art, change the means treatments such as skin art and there is certain risk, such as misoperation, very easily there is secondary infection, after impact more, even leave scar tissue, and relapse rate is high.

Traditional Chinese medical science ancient books has saying of " chloasma person, water thanks to can not fire processed, can not magnificent meat a little less than blood, so that fiery dryness accumulated in the stomach and intestine spotting is black, color be withered not damp "; Cloud again: " dusty face be complexion as dust and dirt, with the passing of time coal is black, shape is withered not damp, or it is equal with face skin to play big or small black speck ", this is the typical case description to chloasma.More than discuss and be enough to illustrate primary disease and internal organs, especially very close with liver spleen kidney triadic relation.Stagnation of liver-QI, insufficiency of the spleen, deficiency of the kidney, visceral dysfunction causes QI-blood failing to nourish upward in face, and stasis blocking skin is sent out as speckle.The many simulataneous insufficiency and excessive of disease, but the stagnation of QI, blood deficiency, blood stasis are its pathogenesis and essence.The traditional Chinese medical science thinks that the etiology and pathogenesis of chloasma is summarised as the following aspects: asthenia of essence and blood, can not go up flourish in face; Or the QI and blood expectorant stasis of blood is stagnant subcutaneous, pigmentation and causing; Or stagnation of QI due to depression of the liver, strongly fragrant heat-transformation of a specified duration, the cloudy blood of burning, causes face qi-blood disharmony and fall ill; Or insufficiency of the spleen resulting in production of dampness, damp-heat accumulation, on steam due to the face; Also someone thinks and appoints relevantly with punching, and uterus has been appointed in punching, finally goes upward to face, and stagnation of liver-QI stasis wound is rushed times, and QI-blood failing to nourish upward is in face, therefore cause primary disease.This sick Therapeutic Principle, for taking blood circulation promoting and blood stasis dispelling as main, coordinates depressed liver-energy dispersing and QI regulating, invigorating the spleen and benefiting QI, kidney tonifying, essence replenishing.The present invention is exactly a kind of pharmaceutical preparation that is used for the treatment of chloasma proposing on this basis.

Summary of the invention

Technical problem to be solved by this invention is to provide a kind of pharmaceutical preparation that is used for the treatment of chloasma, and it has the advantages such as outstanding integrally-regulated, side effect is little, stable curative effect aspect chloasma in treatment, therefore become the effective desirable approach for the treatment of chloasma.

For solving the problems of the technologies described above, the invention provides a kind of pharmaceutical preparation that is used for the treatment of chloasma, its crude drug comprises the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Bupleuri, Semen Euryales, Radix Pseudostellariae, Ramulus Cinnamomi, Fructus Citri Sarcodactylis, Concretio Silicea Bambusae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, Styrax, assorted Chinese medicine tea, Myrrha, Fructus Chaenomelis, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, Caulis Lonicerae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae.

Wherein, in described pharmaceutical preparation, the weight of each crude drug is respectively Radix Angelicae Dahuricae 25g～35g, Stigma Croci 35g～45g, Rhizoma Corydalis 25g～35g, Herba Selaginellae 20g～30g, Caulis Spatholobi 35g～45g, Radix Morindae Officinalis 20g～30g, Semen Cuscutae 25g～35g, Rhizoma Alismatis 10g～20g, Radix Achyranthis Bidentatae 20g～30g, Radix Bupleuri 20g～30g, Semen Euryales 25g～35g, Radix Pseudostellariae 35g～45g, Ramulus Cinnamomi 25g～35g, Fructus Citri Sarcodactylis 15g～25g, Concretio Silicea Bambusae 20g～30g, Fructus Corni 30g～40g, Herba Taxilli 25g～35g, Radix Et Caulis Acanthopanacis Senticosi 30g～40g, Styrax 10g～20g, assorted Chinese medicine tea 20g～30g, Myrrha 15g～25g, Fructus Chaenomelis 15g～25g, Radix et Rhizoma Rhei Franzenbachii 25g～35g, Caulis et folium cryptotaeniae japonicae 20g～30g, Caulis Lonicerae 20g～30g, achillea millefolium 15g～25g, Rabdosia rubescens 25g～35g, Radix Arnebiae (Radix Lithospermi) 30g～40g and Radix Scrophulariae 25g～35g.

Wherein, in described pharmaceutical preparation, the weight of each crude drug is respectively Radix Angelicae Dahuricae 28g～32g, Stigma Croci 38g～42g, Rhizoma Corydalis 28g～32g, Herba Selaginellae 23g～27g, Caulis Spatholobi 38g～42g, Radix Morindae Officinalis 23g～27g, Semen Cuscutae 28g～32g, Rhizoma Alismatis 13g～17g, Radix Achyranthis Bidentatae 23g～27g, Radix Bupleuri 23g～27g, Semen Euryales 28g～32g, Radix Pseudostellariae 38g～42g, Ramulus Cinnamomi 28g～32g, Fructus Citri Sarcodactylis 18g～22g, Concretio Silicea Bambusae 23g～27g, Fructus Corni 33g～37g, Herba Taxilli 28g～32g, Radix Et Caulis Acanthopanacis Senticosi 33g～37g, Styrax 13g～17g, assorted Chinese medicine tea 23g～27g, Myrrha 18g～22g, Fructus Chaenomelis 18g～22g, Radix et Rhizoma Rhei Franzenbachii 28g～32g, Caulis et folium cryptotaeniae japonicae 23g～27g, Caulis Lonicerae 23g～27g, achillea millefolium 18g～22g, Rabdosia rubescens 28g～32g, Radix Arnebiae (Radix Lithospermi) 33g～37g and Radix Scrophulariae 28g～32g.

Wherein, in described pharmaceutical preparation, the weight of each crude drug is respectively Radix Angelicae Dahuricae 30g, Stigma Croci 40g, Rhizoma Corydalis 30g, Herba Selaginellae 25g, Caulis Spatholobi 40g, Radix Morindae Officinalis 25g, Semen Cuscutae 30g, Rhizoma Alismatis 15g, Radix Achyranthis Bidentatae 25g, Radix Bupleuri 25g, Semen Euryales 30g, Radix Pseudostellariae 40g, Ramulus Cinnamomi 30g, Fructus Citri Sarcodactylis 20g, Concretio Silicea Bambusae 25g, Fructus Corni 35g, Herba Taxilli 30g, Radix Et Caulis Acanthopanacis Senticosi 35g, Styrax 15g, assorted Chinese medicine tea 25g, Myrrha 20g, Fructus Chaenomelis 20g, Radix et Rhizoma Rhei Franzenbachii 30g, Caulis et folium cryptotaeniae japonicae 25, Caulis Lonicerae 25g, achillea millefolium 20g, Rabdosia rubescens 30g, Radix Arnebiae (Radix Lithospermi) 35g and Radix Scrophulariae 30g.

Wherein, the dosage form of described pharmaceutical preparation is granule and capsule.

The present invention also provides the preparation method of said medicine preparation, in the time that the dosage form of described pharmaceutical preparation is granule, is specially:

The first step, the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Semen Euryales, Radix Pseudostellariae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, assorted Chinese medicine tea, Myrrha, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae are pulverized respectively, mix according to above-mentioned weight, be 25～35MPa by mixture at pressure, temperature is under 35～45 DEG C of conditions, adopts supercritical CO ₂extract 1～2 hour, collect extract, the coarse powder after extraction is for subsequent use; Extract adds determining alcohol 80～90% ethanol, the ethanol volume adding is extract 2～4 times, be heated to 55～65 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, and separates out precipitation, filter, dry, pulverize, obtain the first powder;

Second step, component under She is pulverized respectively, mix, it is the Chinese liquor of 50 DEG C～60 DEG C that the mixture after mix homogeneously is put into alcoholic strength, and sealing is soaked 5～10 days, subsequent boiling 1 hour～3 hours, leave standstill 12 hours, filter, the filtrate of acquisition is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder;

The 3rd step; the first powder and the second powder are mixed; in the powder mixing, add with respect to its quality 20%～30% cane sugar powder, taking determining alcohol as 75%～85% ethanol soft material processed; granulate with oscillating granulator; at 60 DEG C, dry, granulate, obtains described medicinal granule; splitting splendid attire, every bag of 10g.

The present invention also provides the preparation method of said medicine preparation, in the time that the dosage form of described pharmaceutical preparation is capsule, is specially:

The first step, the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Semen Euryales, Radix Pseudostellariae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, assorted Chinese medicine tea, Myrrha, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae are pulverized respectively, mix according to above-mentioned weight, be 25～35MPa by mixture at pressure, temperature is under 35～45 DEG C of conditions, adopts supercritical CO ₂extract 1～2 hour, collect extract, the coarse powder after extraction is for subsequent use; Extract adds determining alcohol 80～90% ethanol, the ethanol volume adding is extract 2～4 times, be heated to 55～65 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, and separates out precipitation, filter, dry, pulverize, obtain the first powder;

Second step, component under She is pulverized respectively, mix, it is the Chinese liquor of 50 DEG C～60 DEG C that the mixture after mix homogeneously is put into alcoholic strength, and sealing is soaked 5～10 days, subsequent boiling 1 hour～3 hours, leave standstill 12 hours, filter, the filtrate of acquisition is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder;

The 3rd step, the first powder and the second powder are mixed, the mixture obtaining is mixed homogeneously with starch, the amount of starch that every 100g mix products adds is 100g, add determining alcohol and be 25% alcohol granulation, the quality of the ethanol adding is equivalent to 0.1～0.2 times of mixture quality of mix products and starch, by particle drying, add magnesium stearate, the weight of magnesium stearate is equivalent to 0.01～0.02 times of mixture quality of mix products and starch, mix homogeneously, packs into in capsule, obtains capsule.

Beneficial effect of the present invention:

Pharmaceutical preparation provided by the invention has the advantages such as outstanding integrally-regulated, side effect is little, stable curative effect aspect chloasma in treatment, therefore become the effective desirable approach for the treatment of chloasma.

Detailed description of the invention

The invention provides a kind of pharmaceutical preparation that is used for the treatment of chloasma, its crude drug comprises the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Bupleuri, Semen Euryales, Radix Pseudostellariae, Ramulus Cinnamomi, Fructus Citri Sarcodactylis, Concretio Silicea Bambusae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, Styrax, assorted Chinese medicine tea, Myrrha, Fructus Chaenomelis, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, Caulis Lonicerae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae.

Further, described pharmaceutical preparation is only made up of above-mentioned raw materials medicine.

In described pharmaceutical preparation, the weight of each crude drug is respectively Radix Angelicae Dahuricae 25g～35g, Stigma Croci 35g～45g, Rhizoma Corydalis 25g～35g, Herba Selaginellae 20g～30g, Caulis Spatholobi 35g～45g, Radix Morindae Officinalis 20g～30g, Semen Cuscutae 25g～35g, Rhizoma Alismatis 10g～20g, Radix Achyranthis Bidentatae 20g～30g, Radix Bupleuri 20g～30g, Semen Euryales 25g～35g, Radix Pseudostellariae 35g～45g, Ramulus Cinnamomi 25g～35g, Fructus Citri Sarcodactylis 15g～25g, Concretio Silicea Bambusae 20g～30g, Fructus Corni 30g～40g, Herba Taxilli 25g～35g, Radix Et Caulis Acanthopanacis Senticosi 30g～40g, Styrax 10g～20g, assorted Chinese medicine tea 20g～30g, Myrrha 15g～25g, Fructus Chaenomelis 15g～25g, Radix et Rhizoma Rhei Franzenbachii 25g～35g, Caulis et folium cryptotaeniae japonicae 20g～30g, Caulis Lonicerae 20g～30g, achillea millefolium 15g～25g, Rabdosia rubescens 25g～35g, Radix Arnebiae (Radix Lithospermi) 30g～40g and Radix Scrophulariae 25g～35g.

Further preferably, in described pharmaceutical preparation, the weight of each crude drug is respectively Radix Angelicae Dahuricae 28g～32g, Stigma Croci 38g～42g, Rhizoma Corydalis 28g～32g, Herba Selaginellae 23g～27g, Caulis Spatholobi 38g～42g, Radix Morindae Officinalis 23g～27g, Semen Cuscutae 28g～32g, Rhizoma Alismatis 13g～17g, Radix Achyranthis Bidentatae 23g～27g, Radix Bupleuri 23g～27g, Semen Euryales 28g～32g, Radix Pseudostellariae 38g～42g, Ramulus Cinnamomi 28g～32g, Fructus Citri Sarcodactylis 18g～22g, Concretio Silicea Bambusae 23g～27g, Fructus Corni 33g～37g, Herba Taxilli 28g～32g, Radix Et Caulis Acanthopanacis Senticosi 33g～37g, Styrax 13g～17g, assorted Chinese medicine tea 23g～27g, Myrrha 18g～22g, Fructus Chaenomelis 18g～22g, Radix et Rhizoma Rhei Franzenbachii 28g～32g, Caulis et folium cryptotaeniae japonicae 23g～27g, Caulis Lonicerae 23g～27g, achillea millefolium 18g～22g, Rabdosia rubescens 28g～32g, Radix Arnebiae (Radix Lithospermi) 33g～37g and Radix Scrophulariae 28g～32g.

Most preferably, in described pharmaceutical preparation, the weight of each crude drug is respectively Radix Angelicae Dahuricae 30g, Stigma Croci 40g, Rhizoma Corydalis 30g, Herba Selaginellae 25g, Caulis Spatholobi 40g, Radix Morindae Officinalis 25g, Semen Cuscutae 30g, Rhizoma Alismatis 15g, Radix Achyranthis Bidentatae 25g, Radix Bupleuri 25g, Semen Euryales 30g, Radix Pseudostellariae 40g, Ramulus Cinnamomi 30g, Fructus Citri Sarcodactylis 20g, Concretio Silicea Bambusae 25g, Fructus Corni 35g, Herba Taxilli 30g, Radix Et Caulis Acanthopanacis Senticosi 35g, Styrax 15g, assorted Chinese medicine tea 25g, Myrrha 20g, Fructus Chaenomelis 20g, Radix et Rhizoma Rhei Franzenbachii 30g, Caulis et folium cryptotaeniae japonicae 25, Caulis Lonicerae 25g, achillea millefolium 20g, Rabdosia rubescens 30g, Radix Arnebiae (Radix Lithospermi) 35g and Radix Scrophulariae 30g.

Fang Zhong, the pharmacology of each crude drug is as follows:

The Radix Angelicae Dahuricae: latin name Angelicae Dahuricae Radix, acrid in the mouth, warm in nature, enter lung, spleen, stomach warp, there is the cold expelling of inducing sweat, wind-expelling pain-stopping, clearing the nasal passage, dampness leukorrhagia stopping, effect of detumescence and apocenosis, cures mainly headache, supraorbital bone pain, toothache, nasal sinusitis, cold-damp stomachache, hemorrhoidal hamorrhage anal fistula, leucorrhea with red and white discharge, ulcer sores, skin pruritus due to dryness, the cards such as scabies.

Stigma Croci: be the dry delicate branch and leaf of Cacumen Tamaricis section plant Cacumen Tamaricis, sweet in the mouth, property is flat, energy blood circulation promoting and blood stasis dispelling, dispersing stagnation and relieving accumulation of pathogens, pain relieving.Be used for the treatment of troubled thoughts pent-up, chest and diaphragm painful abdominal mass is vexed, spits blood, and typhoid fever is gone mad, frightened fear in a trance, women's amenorrhea, and stasis menoxenia, prolonged lochia, blood stasis is had a pain, measles, the cards such as traumatic injury.

Rhizoma Corydalis: bitter in the mouth, pungent, warm in nature, return liver, the heart, stomach warp, there is benefaction and wander away, can rise and can fall, have promoting blood circulation to remove blood stasis, effect of promoting the circulation of QI to relieve pain, cures mainly obstruction of qi in the chest and cardialgia, side of body rib, all pains of gastral cavity abdomen, headache, lumbago, colicky, bones and muscles pain, dysmenorrhea, amenorrhea, puerperal, the stasis of blood was suffered from abdominal pain, the cards such as traumatic injury.

Herba Selaginellae: latin name Selaginellae Herba is the dry herb of Spikemoss plant Herba Selaginellae or cushion Herba Selaginellae: acrid in the mouth, property is flat, returns liver, heart channel, has effect of promoting blood circulation to restore menstrual flow.For amenorrhea dysmenorrhea, leprosy abdominal mass mass in the abdomen, injury from falling down, spits blood, and metrorrhagia, has blood in stool, the cards such as proctoptosis.

Caulis Spatholobi: latin name spatholabi caulis, bitter in the mouth, sweet, warm in nature, return liver, kidney channel, there is blood vessel dilating, enrich blood and invigorate blood circulation, regulating menstruation, effect of relaxing muscles and tendons and activating QI and blood in the collateral, curing mainly blood deficiency has the menoxenia of silt, and limbs pain is meciless, the cards such as soreness of the waist and knees, pain.

Radix Morindae Officinalis: acrid in the mouth, sweet, warm in nature, return liver, kidney channel, there is reinforcing the kidney and supporting YANG; Bone and muscle strengthening; Effect of expelling wind and removing dampness, cures mainly impotence due to deficiency of the kidney; Seminal emission premature ejaculation; Few abdomen cold type of pain; Incontinence of urine; Cold womb is infertile; Anemofrigid-damp arthralgia; Soreness of the waist and knees; The cards such as rheumatism limb gas.

Semen Cuscutae: sweet in the mouth, pungent, property is flat, enters liver,kidney,spleen warp, has the kidney invigorating and essence nourishing, and the effect of nourishing the liver to improve visual acuity is mainly used in the sexual impotence of insufficiency of kidney-YANG, seminal emission premature ejaculation, frequent micturition, dizziness and tinnitus; The pain in the lumbar region of suffering from a deficiency of the kidney, married woman's leukorrhagia, nausea is solid; The binocular of both liver and kidney deficiency, deficiency of liver-blood is dim-sighted, blurring of vision; The loose stool stomachache of asthenia of both the spleen and kidney, the cards such as aqueous-grainy diarrhea.

Rhizoma Alismatis: sweet in the mouth, light, cold in nature, enter kidney, urinary bladder channel, there are promoting diuresis to eliminate damp pathogen, purging heat and treating stranguria, the lung that clears away heart-fire, rush down the effect of kidney fire, be mainly used in insufficiency of the spleen retention of water-damp, the wet hydrosarca of spreading unchecked of water; The tired resistance of heresy of diseases caused by retention of fluid phlegm-damp, causes dizzy that clear YANG failing to ascend voiced sound does not fall; The dysuria of damp invasion of lower energizer, red short puckery pain, and the card such as jaundice due to damp-heat, have inhibitory action to tubercule bacillus, the two ball coccuses of pneumonia, staphylococcus aureus etc.

Radix Achyranthis Bidentatae: bitter in the mouth, acid, property is flat, enters liver, kidney channel, there is invigorating the liver and kidney, bone and muscle strengthening, promoting blood circulation to restore menstrual flow, ignite that (blood) is descending, effect of inducing diuresis for treating stranguria syndrome, treatment soreness of waist and knee joint, flaccidity and weakness of the lower limbs, amenorrhea due to stagnation of blood, dysmenorrhea, puerperal abdominal pain due to blood stasis, lump in the abdomen, retention of placenta, pyretic stranguria, stranguria with blood, traumatic injury, carbuncle malignant boil, the cards such as laryngopharynx swelling and pain.

Radix Bupleuri: latin name bupleuri radix, dry root for umbelliferae bupleurum or Radix Bupeuri Scorzonerfolii.: cold nature, bitter in the mouth, pungent, return Liver Channel, gallbladder meridian, there is effect of heat radiation, sterilization, cure mainly cold, fever, alternate attack of chill and fever, malaria, stagnation of QI due to depression of the liver, sternal rib pain, proctoptosis, the cards such as uterus comes off, menoxenia.

Semen Euryales: sweet in the mouth, puckery, property is flat, returns spleen, kidney channel, has reinforcing the kindey to control nocturnal emission, and effect of spleen reinforcing stopping leak, cures mainly seminal emission, stranguria with turbid discharge, leukorrhagia, incontinence of urine, the cards such as loose stool and diarrhea.

Radix Pseudostellariae: sweet in the mouth, micro-hardship, property is flat, returns spleen, lung meridian, has effect of air making-up and spleen enlivening, the lung moistening and production of body fluid promoting, cures mainly the inappetence due to deficiency-weakness of spleen-QI, fatigue and weakness, deficiency of the lung cough caused by dryness, dyspnea with rapid and short breath is breathed hard, the convalescent stage of febrile disease, hinder in gas Tianjin two, the thirsty card that waits of interior-heat.

Ramulus Cinnamomi: latin name cinnamomi ramulus is the dry twig of canella Cortex Cinnamomi, acrid in the mouth, sweet, warm in nature, GUIXIN, lung, urinary bladder channel, have diaphoresis expelling pathogenic factors from muscles, warming the meridian and promoting blood circulation, supporing yang activating QI, the effect of dispersing cold for relieving pain, warming the meridian and promoting blood circulation, horizontal logical podomere, for affection of exogenous wind-cold exterior syndrome, no matter have antiperspirant, losslessly all can apply, also for rheumatic arthralgia, cold syndrome of the stomach stomachache, amenorrhea, dysmenorrhea, rheumatic arthralgia, the cards such as shoulder arm podomere cold type of pain, phlegm retention syndrome and bladder water-retention, heart deficiency of spleen-YANG, retention of water-damp in the body, fullness and distention in the chest and hypochondrium, the dizzy phlegm retention syndrome that waits of cough with dyspnea

Fructus Citri Sarcodactylis: acrid in the mouth, hardship, warm in nature, return liver, stomach, lung meridian, there is soothing the liver circulation of qi promoting, and in the effect of reducing phlegm, for the distending pain in the chest and hypochondrium of stagnation of QI due to depression of the liver, incoordination between the liver and stomach, stagnation of QI in spleen and stomach, the cards such as vomiting and nausea lack of appetite.

Concretio Silicea Bambusae: sweet in the mouth, cold in nature, there is clear heat and eliminate phlegm, effect of cool heart arresting convulsion, cures mainly calentura coma delirium, and middle wind-phlegm fan in silence, twitch, epilepsy by infantile convulsion.The cards such as phlegm-heat cough.

Fructus Corni: sour in the mouth, puckery, slightly warm in nature, returns liver, kidney channel, has liver and kidney tonifying, effect of essence astringing and desertion stemming.For vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating collapse, the interior-heat card such as quench one's thirst.

Herba Taxilli: bitter in the mouth, sweet, property is flat, enters liver, kidney channel, have the effect of invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit, for the soreness of waist pain due to deficiency of the liver and kindey, muscles and bones flaccidity is soft, the foot and knee being feeble, deficiency of the liver and kindey, essence and blood is empty to be lost, the frequent fetal movement of liability to abortion, the cards such as waist abdomen pain.

Radix Et Caulis Acanthopanacis Senticosi: root, rhizome or stem and leaf for studies on plants of Acanthopanax Miq. in Araliaceae Radix Et Caulis Acanthopanacis Senticosi: acrid in the mouth, hardship, micro-sweet, warm in nature, enter 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 void is frail, traumatic injury, fracture, edema, beriberi, uncontrolled urination are itched.

Styrax: acrid in the mouth, micro-sweet, bitter, warm in nature, GUIXIN, spleen channel, having has one's ideas straightened out ward off dirty, dissipating depression of QI eliminating phlegm, effect of promoting the circulation of QI to relieve pain, cures mainly apoplexy, syncope due to accumulation of phlegm, the constipation due to cold pathogen of losing consciousness card, the cards such as turbid damp vomiting and diarrhea.

Assorted Chinese medicine tea: bitter in the mouth, pungent, cold nature, has blood stasis dispelling regulating menstruation, and effect of removing obstruction in the collateral to relieve pain cures mainly the cards such as menoxenia, puerperal abdonimal pain, treating swelling and pain by traumatic injury, hemiplegia.

Myrrha: bitter in the mouth, pungent, property is flat, enters liver, spleen, the heart, kidney channel, has effect of promoting blood circulation and stopping pain, detumescence and promoting granulation, cures mainly the cards such as breast abdomen stasis of blood pain, dysmenorrhea, amenorrhea, lump in the abdomen, traumatic injury, carbuncle skin infection, acute appendicitis, conjunctival congestion and swelling pain.

Fructus Chaenomelis: property is put down, is slightly cold, sweet in the mouth, returns liver, spleen channel, has suppressing the hyperactive liver relaxing muscles and tendons, and effect of stomach function regulating removing dampness cures mainly arthralgia chiefly caused by damp pathogen contracture, the heavy pain of waist knee joint acid, the convulsion of vomiting and diarrhoea, the cards such as beriberi edema.

Radix et Rhizoma Rhei Franzenbachii: latin name Radix et Rhizome Rhei Franzenbachii is the root and rhizome of polygonaceae plant rheum rhabarbarum, bitter in the mouth; Cold in nature, return stomach; Large intestine channel, has the removing toxic substances of purging heat; Effect of removing heat from blood clots absorbing, cures mainly jaundice due to damp-heat; Dysentery; Amenorrhea stomachache; Hematemesis and epistaxis; Traumatic injury stasis of blood pain; Carbuncle furunculosis; Aphthous stomatitis; The cards such as burn and scald.

Caulis et folium cryptotaeniae japonicae: acrid in the mouth, hardship; Property is put down, and has dispelling wind stopping cough; Eliminating damp, detoxifying; Effect of blood-activating analgetic, cures mainly pneumonia, pulmonary abscess, and gonorrhea, hernia, acute toothache, carbuncle furuncle is swollen, herpes zoster, the cards such as skin pruritus.

Caulis Lonicerae: sweet in the mouth, cold in nature, attach to the lung and stomach meridians, there is heat-clearing and toxic substances removing, effect of dispelling wind dredging collateral, cures mainly epidemic febrile disease heating, toxic-heat and blood stasis, carbuncle skin infection, rheumatism pyretic arthralgia, the cards such as redness and swelling of joints burning pain.

Achillea millefolium: acrid in the mouth; Bitter; Property flat temperature, there is wind-expelling pain-stopping; Effect of promoting blood circulation and detoxication, cures mainly cold, fever; Wind syndrome of head pain; Toothache; Rheumatic arthralgia; Blood stasis amenorrhea; Abdominal part mass in the abdomen; Traumatic injury; Venom; The cards such as carbuncle sore tumefacting virus.

Rabdosia rubescens: bitter in the mouth, sweet, cold nature, returns lung, stomach, Liver Channel, has heat-clearing and toxic substances removing, and effect of promoting blood circulation and stopping pain cures mainly the cards such as laryngopharynx swelling and pain, tonsillitis, headache due to common cold, tracheitis, chronic hepatitis, joint rheumatalgia, snake bite and insect sting.

Radix Arnebiae (Radix Lithospermi): cold in nature, sweet in the mouth, one-tenth, GUIXIN, Liver Channel, have removing heat from blood and promoting blood circulation, effect of removing toxic substances rash.For heat in blood poison contain, macule purple is black, measles without adequate eruption, skin infection, eczema, burn due to hot liquid or fire.Clearing away heat and cooling blood, for measles, calentura skin eruption, eczema, hematuria, stranguria with blood, dysentery, skin infection, erysipelas, burn, the cards such as constipation with heat retention.

Radix Scrophulariae: sweet in the mouth, hardship, one-tenth, cold nature, returns lung, stomach, kidney channel, there is clearing away heat and cooling blood, eliminating fire and detoxication, YIN nourishing is supported effect of kidney, curing mainly pathogenic warmth joins the army, the pericardium that caves in, maculae caused by violent heat pathogen, the cards such as constipation, hectic fever due to YIN-deficiency chronic cough, conjunctival congestion, pharyngalgia, scrofula, diphtheria, carbuncle sore tumefacting virus are hindered in consumption of YIN caused by febrile disease, crimson tongue excessive thirst, Tianjin.

Described pharmaceutical preparation can adopt conventional dosage form preparation method to be prepared into various regular dosage forms, is preferably granule and capsule.

The present invention also provides the preparation method of said medicine preparation, in the time that the dosage form of described pharmaceutical preparation is granule, is specially:

The first step, the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Semen Euryales, Radix Pseudostellariae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, assorted Chinese medicine tea, Myrrha, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae are pulverized respectively, mix according to above-mentioned weight, be 25～35MPa by mixture at pressure, temperature is under 35～45 DEG C of conditions, adopts supercritical CO ₂extract 1～2 hour, collect extract, the coarse powder after extraction is for subsequent use; Extract adds determining alcohol 80～90% ethanol, the ethanol volume adding is extract 2～4 times, be heated to 55～65 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, and separates out precipitation, filter, dry, pulverize, obtain the first powder;

Second step, component under She is pulverized respectively, mix, it is the Chinese liquor of 50 DEG C～60 DEG C that the mixture after mix homogeneously is put into alcoholic strength, and sealing is soaked 5～10 days, subsequent boiling 1 hour～3 hours, leave standstill 12 hours, filter, the filtrate of acquisition is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder;

The 3rd step; the first powder and the second powder are mixed; in the powder mixing, add with respect to its quality 20%～30% cane sugar powder, taking determining alcohol as 75%～85% ethanol soft material processed; granulate with oscillating granulator; at 60 DEG C, dry, granulate, obtains described medicinal granule; splitting splendid attire, every bag of 10g.

The present invention also provides the preparation method of said medicine preparation, in the time that the dosage form of described pharmaceutical preparation is capsule, is specially:

The first step, the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Semen Euryales, Radix Pseudostellariae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, assorted Chinese medicine tea, Myrrha, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae are pulverized respectively, mix according to above-mentioned weight, be 25～35MPa by mixture at pressure, temperature is under 35～45 DEG C of conditions, adopts supercritical CO ₂extract 1～2 hour, collect extract, the coarse powder after extraction is for subsequent use; Extract adds determining alcohol 80～90% ethanol, the ethanol volume adding is extract 2～4 times, be heated to 55～65 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, and separates out precipitation, filter, dry, pulverize, obtain the first powder;

Second step, component under She is pulverized respectively, mix, it is the Chinese liquor of 50 DEG C～60 DEG C that the mixture after mix homogeneously is put into alcoholic strength, and sealing is soaked 5～10 days, subsequent boiling 1 hour～3 hours, leave standstill 12 hours, filter, the filtrate of acquisition is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder;

The 3rd step, the first powder and the second powder are mixed, the mixture obtaining is mixed homogeneously with starch, the amount of starch that every 100g mix products adds is 100g, add determining alcohol and be 25% alcohol granulation, the quality of the ethanol adding is equivalent to 0.1～0.2 times of mixture quality of mix products and starch, by particle drying, add magnesium stearate, the weight of magnesium stearate is equivalent to 0.01～0.02 times of mixture quality of mix products and starch, mix homogeneously, packs into in capsule, obtains capsule.

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 of reaching technique effect can fully understand and implement according to this.

The preparation of embodiment 1 granule 1

Radix Angelicae Dahuricae 30g, Stigma Croci 40g, Rhizoma Corydalis 30g, Herba Selaginellae 25g, Caulis Spatholobi 40g, Radix Morindae Officinalis 25g, Semen Cuscutae 30g, Semen Euryales 30g, Radix Pseudostellariae 40g, Fructus Corni 35g, Herba Taxilli 30g, Radix Et Caulis Acanthopanacis Senticosi 35g, assorted Chinese medicine tea 25g, Myrrha 20g, Radix et Rhizoma Rhei Franzenbachii 30g, Caulis et folium cryptotaeniae japonicae 25g, achillea millefolium 20g, Rabdosia rubescens 30g, Radix Arnebiae (Radix Lithospermi) 35g and Radix Scrophulariae 30g are pulverized respectively, mix, be 30MPa by mixture at pressure, temperature is under 40 DEG C of conditions, adopts supercritical CO ₂extract 2 hours, collect extract, the coarse powder after extraction is for subsequent use, extract adds determining alcohol 90% ethanol, the ethanol volume adding is extract 3 times, be heated to 60 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, separate out precipitation, filter, dry, pulverize, obtain the first powder, by Rhizoma Alismatis 15g, Radix Achyranthis Bidentatae 25g, Radix Bupleuri 25g, Ramulus Cinnamomi 30g, Fructus Citri Sarcodactylis 20g, Concretio Silicea Bambusae 25g, Styrax 15g, Fructus Chaenomelis 20g, Caulis Lonicerae 25g pulverizes respectively, mix, it is the Chinese liquor of 60 DEG C that mixture after mix homogeneously is put into alcoholic strength, sealing is soaked 10 days, subsequent boiling 2 hours, leave standstill 12 hours, filter, the filtrate obtaining is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder, the first powder and the second powder are mixed, in the powder mixing, add with respect to its quality 20% cane sugar powder, taking determining alcohol as 75% ethanol soft material processed, granulate with oscillating granulator, at 60 DEG C, dry, granulate, obtain described medicinal granule, splitting splendid attire, every bag of 10g.

The preparation of embodiment 2 granules 2

Radix Angelicae Dahuricae 28g, Stigma Croci 38g, Rhizoma Corydalis 28g, Herba Selaginellae 23g, Caulis Spatholobi 38g, Radix Morindae Officinalis 23g, Semen Cuscutae 28g, Semen Euryales 28g, Radix Pseudostellariae 38g, Fructus Corni 33g, Herba Taxilli 28g, Radix Et Caulis Acanthopanacis Senticosi 33g, assorted Chinese medicine tea 23g, Myrrha 18g, Radix et Rhizoma Rhei Franzenbachii 28g, Caulis et folium cryptotaeniae japonicae 23g, achillea millefolium 18g, Rabdosia rubescens 28g, Radix Arnebiae (Radix Lithospermi) 33g and Radix Scrophulariae 28g are pulverized respectively, mix, be 30MPa by mixture at pressure, temperature is under 40 DEG C of conditions, adopts supercritical CO ₂extract 2 hours, collect extract, the coarse powder after extraction is for subsequent use, extract adds determining alcohol 90% ethanol, the ethanol volume adding is extract 3 times, be heated to 60 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, separate out precipitation, filter, dry, pulverize, obtain the first powder, by Rhizoma Alismatis 13g, Radix Achyranthis Bidentatae 23g, Radix Bupleuri 23g, Ramulus Cinnamomi 28g, Fructus Citri Sarcodactylis 18g, Concretio Silicea Bambusae 23g, Styrax 13g, Fructus Chaenomelis 18g, Caulis Lonicerae 23g pulverizes respectively, mix, it is the Chinese liquor of 60 DEG C that mixture after mix homogeneously is put into alcoholic strength, sealing is soaked 10 days, subsequent boiling 2 hours, leave standstill 12 hours, filter, the filtrate obtaining is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder, the first powder and the second powder are mixed, in the powder mixing, add with respect to its quality 20% cane sugar powder, taking determining alcohol as 75% ethanol soft material processed, granulate with oscillating granulator, at 60 DEG C, dry, granulate, obtain described medicinal granule, splitting splendid attire, every bag of 10g.

The preparation of embodiment 3 granules 3

Radix Angelicae Dahuricae 32g, Stigma Croci 42g, Rhizoma Corydalis 32g, Herba Selaginellae 27g, Caulis Spatholobi 42g, Radix Morindae Officinalis 27g, Semen Cuscutae 32g, Semen Euryales 32g, Radix Pseudostellariae 42g, Fructus Corni 37g, Herba Taxilli 32g, Radix Et Caulis Acanthopanacis Senticosi 37g, assorted Chinese medicine tea 27g, Myrrha 22g, Radix et Rhizoma Rhei Franzenbachii 32g, Caulis et folium cryptotaeniae japonicae 27g, achillea millefolium 22g, Rabdosia rubescens 32g, Radix Arnebiae (Radix Lithospermi) 37g and Radix Scrophulariae 32g are pulverized respectively, mix, be 30MPa by mixture at pressure, temperature is under 40 DEG C of conditions, adopts supercritical CO ₂extract 2 hours, collect extract, the coarse powder after extraction is for subsequent use, extract adds determining alcohol 90% ethanol, the ethanol volume adding is extract 3 times, be heated to 60 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, separate out precipitation, filter, dry, pulverize, obtain the first powder, by Rhizoma Alismatis 17g, Radix Achyranthis Bidentatae 27g, Radix Bupleuri 27g, Ramulus Cinnamomi 32g, Fructus Citri Sarcodactylis 22g, Concretio Silicea Bambusae 27g, Styrax 17g, Fructus Chaenomelis 22g, Caulis Lonicerae 27g pulverizes respectively, mix, it is the Chinese liquor of 60 DEG C that mixture after mix homogeneously is put into alcoholic strength, sealing is soaked 10 days, subsequent boiling 2 hours, leave standstill 12 hours, filter, the filtrate obtaining is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder, the first powder and the second powder are mixed, in the powder mixing, add with respect to its quality 20% cane sugar powder, taking determining alcohol as 75% ethanol soft material processed, granulate with oscillating granulator, at 60 DEG C, dry, granulate, obtain described medicinal granule, splitting splendid attire, every bag of 10g.

The preparation of embodiment 4 capsules

Radix Angelicae Dahuricae 30g, Stigma Croci 40g, Rhizoma Corydalis 30g, Herba Selaginellae 25g, Caulis Spatholobi 40g, Radix Morindae Officinalis 25g, Semen Cuscutae 30g, Semen Euryales 30g, Radix Pseudostellariae 40g, Fructus Corni 35g, Herba Taxilli 30g, Radix Et Caulis Acanthopanacis Senticosi 35g, assorted Chinese medicine tea 25g, Myrrha 20g, Radix et Rhizoma Rhei Franzenbachii 30g, Caulis et folium cryptotaeniae japonicae 25g, achillea millefolium 20g, Rabdosia rubescens 30g, Radix Arnebiae (Radix Lithospermi) 35g and Radix Scrophulariae 30g are pulverized respectively, mix, be 30MPa by mixture at pressure, temperature is under 40 DEG C of conditions, adopts supercritical CO ₂extract 2 hours, collect extract, the coarse powder after extraction is for subsequent use, extract adds determining alcohol 90% ethanol, the ethanol volume adding is extract 3 times, be heated to 60 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, separate out precipitation, filter, dry, pulverize, obtain the first powder, by Rhizoma Alismatis 15g, Radix Achyranthis Bidentatae 25g, Radix Bupleuri 25g, Ramulus Cinnamomi 30g, Fructus Citri Sarcodactylis 20g, Concretio Silicea Bambusae 25g, Styrax 15g, Fructus Chaenomelis 20g, Caulis Lonicerae 25g pulverizes respectively, mix, it is the Chinese liquor of 60 DEG C that mixture after mix homogeneously is put into alcoholic strength, sealing is soaked 10 days, subsequent boiling 2 hours, leave standstill 12 hours, filter, the filtrate obtaining is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder, the first powder and the second powder are mixed, the mixture obtaining is mixed homogeneously with starch, the amount of starch that every 100g mix products adds is 100g, add determining alcohol and be 25% alcohol granulation, the quality of the ethanol adding is equivalent to 0.1～0.2 times of mixture quality of mix products and starch, by particle drying, add magnesium stearate, the weight of magnesium stearate is equivalent to 0.01～0.02 times of mixture quality of mix products and starch, mix homogeneously, pack into in capsule, obtain capsule.

Embodiment 5 toxicology tests

Acute toxicity test

Animal: Kunming mouse, body weight 21～24g, male and female half and half.

LD ₅₀calculate: adopt improvement karber's method, mice is divided into 5 groups at random, 10 every group, male and female half and half, granule adding distil water prepared by embodiment 1 dissolves, and is made into Cmax, by the administration of the maximum permission capacity of mice, institute is followed successively by 18,14.4 to dosage by crude drug amount, 11.5,9.2,7.4 (g/kg), in animal fasting (can't help water) after 18 hours, administration at twice in one day (interval half an hour), each 0.5ml, observes animal dead situation.

Maximum tolerated dose is measured (MTD value): get 20 of mices, each 10 of male and female.Granule adding distil water is dissolved, be made into maximum concentration, by the maximum tolerated dose of animal, fill with hello device and can twitch and be as the criterion to inject.In animal fasting (can't help water) after 18 hours, administration at twice in one day (interval half an hour), each 0.5ml (every ml is containing crude drug 0.36g), total dose is 18g crude drug/kgd, 300 times of quite clinical adult 50Kg body weight consumption.Continuous Observation 7 days after administration.

Result of the test

At LD ₅₀in calculating, in the time giving mice with maximum acceptable concentration and maximum permission capacity (18g/Kgd), have no dead mouse, do not measure LD ₅₀, ask only maximum tolerated dose, in 7 day observation period, its appetite of animal, activity, hair color, the mental status etc. are all normal, grow normally, there are no death.Select 300 times of doses that are equivalent to clinical dosage, and have no adverse reaction, show that acute toxicity is minimum, MTD > 18g/Kgd.

Aggregate toxicity test

Granule adding distil water prepared by embodiment 1 dissolves, to mice by 7.69,19.18 and 15 weeks (1.0ml/100g body weight of 43.21g crude drug/kg continuous use, every day 2 times) and drug withdrawal after 3 weeks, result shows: the index such as the hair of Chinese medicine preparation of the present invention to rat, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat all has no significant effect, internal organs naked eyes do not find that difference changes and histological examination result shows, medication 15 weeks and drug withdrawal are after 3 weeks, and the each internal organs of rat are all without obviously changing.After Chinese medicine preparation of the present invention granules of rats long-term prescription for oral administration is described, toxicity is little, also there is no difference reaction, application safety after drug withdrawal.

Embodiment 6 clinical datas

Physical data: case derives from January, 2011～2013 year June, the personnel that suffer from chloasma for the treatment of before coming.Be divided into two groups of each 120 examples.Wherein year at treatment group age (34.3 ± 11.2); The course of disease (3.3 ± 1.6) year.Year at matched group age (36.1 ± 8.4); The course of disease (2.9 ± 1.0) year.Two groups of physical data are learned processing by statistics, and the equal statistical significance of difference (P > 0.05), has comparability.

Diagnostic criteria: (1) face is filbert to dark brown, well-defined patch, and symmetry distributes conventionally, NIP performance and squama.(2) without obvious subjective symptoms.(3) women is multiple, mainly occurs in after adolescence.(4) state of an illness can have seasonality, and the Chang Xiachong winter is light.(5) get rid of the pigmentation that other diseases (as cheekbone portion Fuscocaeruleus, Riehl melanosis and pigment actinic lichen planus etc.) causes.

Inclusive criteria: at 18～65 years old (1) age, can be First episode or recidivist; (2) meet diagnostic criteria, be ready as study subject and accept on request to observe female patient, and the person that signs Informed Consent Form; (3) unglazed allergies, without cosmetic allergic contact dermatitis history, without important allergies such as the Radixs Angelicae Dahuricae; (4) duration of test office work, can avoid the person of tanning by the sun.

Exclusion standard: (1) sensitive skin, there is photosensitivity history, have cosmetic allergic contact dermatitis history person, or to trial drug allergy sufferers; (2) be associated with the serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychiatric patient; In (3) 1 months, once took medicine, health product and other antioxidant medicines person for the treatment of primary disease; (4) do not meet inclusive criteria, external is smeared therapist, cannot be judged curative effect person in accordance with regulations.

Therapeutic Method: all patients, according to clinical randomized controlled experimental study scheme, are divided into two groups at random.Treatment group is taken granule 1 prepared by the embodiment of the present invention 1, and dissolve and take with warm water at every turn, every day 3 times, each 10g, matched group: vitamin C 0.2g, oral, 3 times on the 1st; Vitamin E 0.1g, oral, 1 time on the 1st.During treatment, note sun-proofly, avoid and take contraceptive, do not abuse cosmetics, take a good rest, avoid psychentonia, keep emotion happy.Within 4 weeks, be 1 course for the treatment of, treat altogether 2 post-evaluation course for the treatment of curative effects.

Therapeutic evaluation

Criterion of therapeutical effect: substantially cure: (1) naked eyes are depending on the mottle area > 90% that disappears, and color disappears substantially; (2) point system is calculated, decline index >=0.8 after treatment.Effective: (1) naked eyes are depending on the mottle area > 60% that disappears, and color is obviously thin out; (2) point system is calculated, decline index >=0.5 after treatment; Take a turn for the better: (1) naked eyes are depending on the mottle area > 30% that disappears, and color is thin out; (2) point system is calculated, decline index >=0.3 after treatment.Invalid: (1) naked eyes are depending on the mottle area <30% that disappears, and change color is not obvious; (2) point system is calculated, decline index >=0 after treatment.

Methods of marking: (1) skin lesion area scoring: 0 is to be area <2cm without skin lesion, 1 ², 2 be area 2-4cm ², be skin lesion area > 4cm ²; (2) skin lesion color scoring: 0 be the normal colour of skin, 1 for filbert, 2 for brown, 3 be dark brown; (3) total mark=area scoring+color scoring; (4) point system decline index calculation method: total mark before decline index=(the rear total mark of total mark-treatment before treatment)/treatment.

Statistical procedures

Adopt SPSS11.0 systems soft ware deal with data, measurement data is with (x ± s) represent, relatively adopts one factor analysis of variance between group, enumeration data adopts x ²inspection, P<0.05 is that difference has statistical significance.

Result

Clinical curative effect analysis, the results are shown in Table 1.

Table 1 liang group Clinical efficacy comparison

Group	Number of cases	Basic healing	Effective	Take a turn for the better	Invalid	Total effective rate (%)
							Treatment group	120	67	27	21	5	95.8
Matched group	120	16	46	35	23	80.8

As can be seen from Table 1, the therapeutic effect of employing Chinese medicine composition pharmaceutical preparation of the present invention will be significantly better than matched group.

Two groups of chloasma scorings relatively, the results are shown in Table 2.

Table 2 liang group chloasma scoring relatively

Group	Number of cases	Time	Skin lesion area	Skin color	Total mark
						Treatment group	120	Before treatment	2.35+0.93	2.75+0.21	6.13+0.27
?	?	After treatment	0.51+0.23	0.43+0.12	1.17+0.36
						Matched group	120	Before treatment	2.38+0.72	2.72+0.26	5.91+0.30
?	?	After treatment	0.93+0.17	0.70+0.17	1.62+0.31

As can be seen from Table 2, adopt that effect before and after Chinese medicine preparation for treating provided by the invention will be significantly better than matched group.

All above-mentioned these intellectual properties of primary enforcement, do not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing amendment, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.

The above, be only preferred embodiment of the present invention, is not the restriction of the present invention being made to other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not depart from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (7)

1. be used for the treatment of a pharmaceutical preparation for chloasma, it is characterized in that: crude drug comprises the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Bupleuri, Semen Euryales, Radix Pseudostellariae, Ramulus Cinnamomi, Fructus Citri Sarcodactylis, Concretio Silicea Bambusae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, Styrax, assorted Chinese medicine tea, Myrrha, Fructus Chaenomelis, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, Caulis Lonicerae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae.

2. pharmaceutical preparation as claimed in claim 1, it is characterized in that: the weight of each crude drug is respectively Radix Angelicae Dahuricae 25g～35g, Stigma Croci 35g～45g, Rhizoma Corydalis 25g～35g, Herba Selaginellae 20g～30g, Caulis Spatholobi 35g～45g, Radix Morindae Officinalis 20g～30g, Semen Cuscutae 25g～35g, Rhizoma Alismatis 10g～20g, Radix Achyranthis Bidentatae 20g～30g, Radix Bupleuri 20g～30g, Semen Euryales 25g～35g, Radix Pseudostellariae 35g～45g, Ramulus Cinnamomi 25g～35g, Fructus Citri Sarcodactylis 15g～25g, Concretio Silicea Bambusae 20g～30g, Fructus Corni 30g～40g, Herba Taxilli 25g～35g, Radix Et Caulis Acanthopanacis Senticosi 30g～40g, Styrax 10g～20g, assorted Chinese medicine tea 20g～30g, Myrrha 15g～25g, Fructus Chaenomelis 15g～25g, Radix et Rhizoma Rhei Franzenbachii 25g～35g, Caulis et folium cryptotaeniae japonicae 20g～30g, Caulis Lonicerae 20g～30g, achillea millefolium 15g～25g, Rabdosia rubescens 25g～35g, Radix Arnebiae (Radix Lithospermi) 30g～40g and Radix Scrophulariae 25g～35g.

3. pharmaceutical preparation as claimed in claim 1 or 2, it is characterized in that: the weight of each crude drug is respectively Radix Angelicae Dahuricae 28g～32g, Stigma Croci 38g～42g, Rhizoma Corydalis 28g～32g, Herba Selaginellae 23g～27g, Caulis Spatholobi 38g～42g, Radix Morindae Officinalis 23g～27g, Semen Cuscutae 28g～32g, Rhizoma Alismatis 13g～17g, Radix Achyranthis Bidentatae 23g～27g, Radix Bupleuri 23g～27g, Semen Euryales 28g～32g, Radix Pseudostellariae 38g～42g, Ramulus Cinnamomi 28g～32g, Fructus Citri Sarcodactylis 18g～22g, Concretio Silicea Bambusae 23g～27g, Fructus Corni 33g～37g, Herba Taxilli 28g～32g, Radix Et Caulis Acanthopanacis Senticosi 33g～37g, Styrax 13g～17g, assorted Chinese medicine tea 23g～27g, Myrrha 18g～22g, Fructus Chaenomelis 18g～22g, Radix et Rhizoma Rhei Franzenbachii 28g～32g, Caulis et folium cryptotaeniae japonicae 23g～27g, Caulis Lonicerae 23g～27g, achillea millefolium 18g～22g, Rabdosia rubescens 28g～32g, Radix Arnebiae (Radix Lithospermi) 33g～37g and Radix Scrophulariae 28g～32g.

4. the pharmaceutical preparation as described in claims 1 to 3, it is characterized in that: the weight of each crude drug is respectively Radix Angelicae Dahuricae 30g, Stigma Croci 40g, Rhizoma Corydalis 30g, Herba Selaginellae 25g, Caulis Spatholobi 40g, Radix Morindae Officinalis 25g, Semen Cuscutae 30g, Rhizoma Alismatis 15g, Radix Achyranthis Bidentatae 25g, Radix Bupleuri 25g, Semen Euryales 30g, Radix Pseudostellariae 40g, Ramulus Cinnamomi 30g, Fructus Citri Sarcodactylis 20g, Concretio Silicea Bambusae 25g, Fructus Corni 35g, Herba Taxilli 30g, Radix Et Caulis Acanthopanacis Senticosi 35g, Styrax 15g, assorted Chinese medicine tea 25g, Myrrha 20g, Fructus Chaenomelis 20g, Radix et Rhizoma Rhei Franzenbachii 30g, Caulis et folium cryptotaeniae japonicae 25, Caulis Lonicerae 25g, achillea millefolium 20g, Rabdosia rubescens 30g, Radix Arnebiae (Radix Lithospermi) 35g and Radix Scrophulariae 30g.

5. the pharmaceutical preparation as described in claim 1 to 4, is characterized in that: the dosage form of described pharmaceutical preparation is granule and capsule.

6. the preparation method of pharmaceutical preparation described in claim 1 to 5, is characterized in that: in the time that the dosage form of described pharmaceutical preparation is granule, comprises,

The first step, the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Semen Euryales, Radix Pseudostellariae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, assorted Chinese medicine tea, Myrrha, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae are pulverized respectively, mix according to above-mentioned weight, be 25～35MPa by mixture at pressure, temperature is under 35～45 DEG C of conditions, adopts supercritical CO ₂extract 1～2 hour, collect extract, the coarse powder after extraction is for subsequent use; Extract adds determining alcohol 80～90% ethanol, the ethanol volume adding is extract 2～4 times, be heated to 55～65 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, and separates out precipitation, filter, dry, pulverize, obtain the first powder;

Second step, component under She is pulverized respectively, mix, it is the Chinese liquor of 50 DEG C～60 DEG C that the mixture after mix homogeneously is put into alcoholic strength, and sealing is soaked 5～10 days, subsequent boiling 1 hour～3 hours, leave standstill 12 hours, filter, the filtrate of acquisition is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder;

The 3rd step; the first powder and the second powder are mixed; in the powder mixing, add with respect to its quality 20%～30% cane sugar powder, taking determining alcohol as 75%～85% ethanol soft material processed; granulate with oscillating granulator; at 60 DEG C, dry, granulate, obtains described medicinal granule; splitting splendid attire, every bag of 10g.

7. the preparation method of pharmaceutical preparation described in claim 1 to 5, is characterized in that: in the time that the dosage form of described pharmaceutical preparation is capsule, comprises,

The first step, the Radix Angelicae Dahuricae, Stigma Croci, Rhizoma Corydalis, Herba Selaginellae, Caulis Spatholobi, Radix Morindae Officinalis, Semen Cuscutae, Semen Euryales, Radix Pseudostellariae, Fructus Corni, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, assorted Chinese medicine tea, Myrrha, Radix et Rhizoma Rhei Franzenbachii, Caulis et folium cryptotaeniae japonicae, achillea millefolium, Rabdosia rubescens, Radix Arnebiae (Radix Lithospermi) and Radix Scrophulariae are pulverized respectively, mix according to above-mentioned weight, be 25～35MPa by mixture at pressure, temperature is under 35～45 DEG C of conditions, adopts supercritical CO ₂extract 1～2 hour, collect extract, the coarse powder after extraction is for subsequent use; Extract adds determining alcohol 80～90% ethanol, the ethanol volume adding is extract 2～4 times, be heated to 55～65 DEG C, constantly stir, dissolve rear filtered while hot, reject float and insoluble matter, filtrate lets cool, and separates out precipitation, filter, dry, pulverize, obtain the first powder;

Second step, component under She is pulverized respectively, mix, it is the Chinese liquor of 50 DEG C～60 DEG C that the mixture after mix homogeneously is put into alcoholic strength, and sealing is soaked 5～10 days, subsequent boiling 1 hour～3 hours, leave standstill 12 hours, filter, the filtrate of acquisition is concentrated into removes all Chinese liquor, pulverize and be dried, obtain the second powder;

The 3rd step, the first powder and the second powder are mixed, the mixture obtaining is mixed homogeneously with starch, the amount of starch that every 100g mix products adds is 100g, add determining alcohol and be 25% alcohol granulation, the quality of the ethanol adding is equivalent to 0.1～0.2 times of mixture quality of mix products and starch, by particle drying, add magnesium stearate, the weight of magnesium stearate is equivalent to 0.01～0.02 times of mixture quality of mix products and starch, mix homogeneously, packs into in capsule, obtains capsule.