CN105982970A - Traditional Chinese medicinal composition for treating psoriasis and preparation method of traditional Chinese medicinal composition - Google Patents

Abstract

The invention relates to the field of traditional Chinese medicine, and in particular provides a traditional Chinese medicinal composition and a preparation thereof for treating psoriasis and preparation methods of the traditional Chinese medicinal composition and the preparation. The traditional Chinese medicinal composition disclosed by the invention consists of the following traditional Chinese medicines in parts by weight: 20-80 parts of radix rumicis crispi, 20-80 parts of radix sophorae flavescentis, 10-50 parts of herba siphonostegiae, 10-40 parts of root of Chinese pulsatilla and 5-30 parts of catechu. The invention also provides the preparation method of the traditional Chinese medicinal composition, the preparation containing the traditional Chinese medicinal composition and the preparation method of the preparation; pharmacological experiments and clinical tests prove that the traditional Chinese medicinal composition disclosed by the invention is significant in curative effect on psoriasis vulgaris, high in cure rate and free from toxic and side effects caused by hormones; and the traditional Chinese medicinal composition conforms to the properties of the psoriasis which is relatively long in disease source and requires long-term use of the traditional Chinese medicinal composition.

Description

One treats psoriatic Chinese medicine composition and preparation method thereof

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to treat psoriatic Chinese medicine composition and preparation thereof and Their preparation method.

Background technology

Psoriasis is commonly called as psoriasis, one group of dermatosis of the psoriasis meaning doctor trained in Western medicine of Traditional Chinese Medical Concepts, also includes Neurodermatitis, eczematous dermatoses etc., non-refer in particular to psoriasis.Psoriasis class dermatosis is cured in motherland The head that records in sees " General Treatise on the Cause and Symptoms of Diseases " of Sui Dynasty's Chao Yuanfang (550-630 A.D.), referred to as " chronic eczema " " tinea alba "；Arrive Song, bright, Qing Dynasty medical book in be also called " tinea corporis ", " psoriasis ", " in vain " etc..Psoriasis is made Psoriasis appellation is the most inaccurate, because the erythra of " stupid hard and hard " is only one of psoriasis performance, The aspects such as the performance of psoriatic many distinctive erythra and histopathology, pathogeny and gene All there is this qualitative difference with other dermatosis belonging to psoriasis.There is literature record in China to psoriasis class The history reaching for more than 1400 years, and get the most former of morbidity the most completely clear Cause, also cannot solve the problem thoroughly eradicated, no longer recur of this disease.

Psoriasis has the Clinical symptoms of diagnostic value and mainly has 3 phenomenons: 1. wax drips phenomenon: primary rash For inflamed papules or the maculopapule of hatpin head to Seem Lablab Album size, in pale red, pimple can gradually expand or Merging into each other formation speckle, boundary understands, periphery has slight blush, and surface is covered with multilamellar silvery white squama Bits, strike off the squama of stratification and drip such as light paraffin cutting；2. film phenomenon: after gently striking off squama, has one layer Light red shinny semitransparent thin film；3. petechial hemorrhage phenomenon: strike off thin film again, may occur in which be dispersed in little Petechia.The psoriasis course of disease is longer, it is impossible to prompt resolution skin lesion, takes effect slowly, mostly is Xia Qingdong Weight.This disease can betide whole body everywhere, and predilection site is that elbow, knee joint, head and extremity stretch side, and right Claim to occur.In epidermal hyperplasia and papillary layer of corium, angiogenesis is psoriatic main pathological characteristic, loses Biography factor and environmental stimulus are two big principal elements of its morbidity.Psoriasis complicated clinical manifestation, for many Genetic hereditary diseases, relates to immune system and some gene pleiomorphisms of keratinocyte exception； It is fallen ill and relates to following 4 kinds of major cell types: keratinocyte, lymphocyte, endotheliocyte And neutrophilic granulocyte, wherein the most key with the former two.Most scholars think, psoriasis is a kind of T Cell-mediated chronic inflammation disease, psoriatic lesion mesocuticle and intradermal have proven to the T of activation Lymphocyte exists, the releasable inflammatory factor of T cell of activation, therefore suppression T cell activation may be straight Connect suppression normal skin and form psoriatic lesion；Immune-mediated theory with T cell as core becomes to be worked as The focus of modern numerous scholar's research.

The most psoriatic sickness rate is the most in rising trend, and this has close with current environmental pollution Cut relation, especially to invade person between twenty and fifty, thus the biggest to the healthy of patient and spiritual influence.By All being difficult to up to many decades of, course of disease length higher in primary disease sickness rate is cured, and easily recurs after disappearing again, Even cannot be cured all one's life, psoriasis can not effect a radical cure the world-famous puzzle having become current department of dermatologry.

Psoriasis diagnoses clinically and is easier to, and current Therapeutic Method mainly includes that medicine for external use, system are controlled Treat and naturopathy three major types.

Fudan University Huashan hospital dermatology department director professor Zheng Zhizhong says: psoriasis vulgaris (accounts for silver Bits sick 95%) external treatment is the main force.Peking University First Hospital department of dermatologry professor Tu Ping is also considered as silver Bits sick local treatment is safest first-line treatment.Dermatosis association of the U.S. (American Academy of Dematology, AAD) 2009 years deliver " psoriasis external medication guide " and pointed out the silver of 80% The state of an illness of bits patient belongs to mild to moderate, only just has higher effective percentage and peace with medicine for external use treatment Full rate.Medicine for external use applies through skin, patch mode is administered and directly acts on diseased region, and medicine is again through skin It is absorbed into systemic blood circulation, it is to avoid the contingent liver first-pass effect of oral administration and the intestines and stomach The harmful effect of inactivation, improves therapeutic effect.The medicine for external use that clinical treatment psoriasis uses at present Thing majority is Western medicine, including 1. glucocorticoids ointment formulations: halometasone, double betamethasone dipropionate, Fluocinonide, momestasone furoate (Eloson), halcinonidedcorten, dexamethasone, hydrocortisone butyrate, Deng；2. vitamin D₃Derivatives class ointment formulation: Kappa triol, tacalcitol, calcitriol etc.； 3. retinoid gel or Emulsion: all-trans retinoic acid, 13 along tretinoin, tazarotene etc.；4. exempt from Epidemic disease regulator: methotrexate class cytotoxic drug, Triptolide ointment and cyclosporine etc.； 5. tar class: 1-5% coal tar, 5% pityrol, 6. cytotoxic drug: 0.05% mustine hydrochlcride solution Deng；7. antitumor drug such as aminopterin, An Jiadie ridge, sulfur furrow purine, ethyliminum etc..The most still have Auxiliary therapeutic agent such as emollient, keratoplastics, keatolytics etc..These medicines especially sugar skin Though matter hormone medicine has effect to psoriasis, some effects are strong, instant effect, but long-term a large amount of external Can result in the untoward reaction of system due to the absorption of medicine, have is extremely serious, as skin withers Contracting, telangiectasis, the secondary infection such as bacterial fungus, even make skin lesion bounce, increase the weight of, change Become psoriasis pustulosa, also hemopoietic system and liver are caused damage.Motherland's medicine and pharmacology are of extensive knowledge and profound scholarship, The task of top priority answers focus development to treat psoriatic Chinese medicine non-defective unit.So far in state food drug evaluation The external preparation of the pure Treating Psoriasis with Chinese Drugs of " accurate " font size of heart approval is few, and use clinically mostly is doctor Institute's pharmacy preparation.

Motherland's medicine and pharmacology are great treasure-houses, and the traditional Chinese medical science thinks that the psoriatic cause of disease is mainly internal blood The endogenous causes of ill such as dry, heat in blood, blood deficiency, blood stasis are caused external pathogenic wind toxic pathogen and are invaded and fall ill.Modern times doctor The clear viewpoint in many Chongmings, as the distinguished veteran doctors of TCM such as Zhao Ping Nan, Zhu Renkang, Zhou Mingqi think psoriatic generation Heat in blood is key factor, and body sun heat is partially contained and attacked and be harmonious and fall ill outside ailment said due to cold or exposure, the sick impairment of YIN blood that consumes for a long time, so that Deficiency of YIN blood is dry, failure of skin and muscle to be nourished.The rehabilitation of this disease has internal treatment clinically: cleanse tinea poison, by heresy outside Going out, saturating poison is gone out, harmonizing yingfen and weifen；External treatment: kill tinea poison, strengthen defence works, evacuate noncombatants, and hide provisions and livestock.Current interior clinically The Chinese medicine preparation of clothes is more, " KEYIN PIAN " and " gram silver two side " of well-known old docter of TCM Zhu Renkang professor；Zhao Ping " the removing pathogenic heat from blood and toxic substance from the body soup " of the old professor in south；" the Xiaoyin mixture " of Zheng Zhizhong professor etc..Versions in 2005 and 2010 Year version Chinese Pharmacopoeia one has recorded " XIAOYIN PIAN " and " Yinxie capsule " in succession；And seldom see Food and medicine evaluates the Chinese medicine for outer use of center approval listing.Excavate development and meet Chinese medicine to silver bits The Chinese medicine external medicine of sick etiology and pathogenesis theory should be the task of top priority.

Summary of the invention

For above technical situation, the invention provides treatment psoriatic determined curative effect, toxic and side effects Little Traditional Chinese medicine compound composition and preparation thereof and their preparation method.

Chinese medicine composition of the present invention is mainly made up of monarch drug Radix Rumicis and Radix Sophorae Flavescentis two taste Chinese medicine；Prescription is originated In folk remedy, determine Radix Rumicis and Radix Sophorae Flavescentis as this combination through laboratory and clinical prerun again Two taste monarchs drug of thing.As one of embodiment of the present invention, described Chinese medicine composition by Radix Rumicis and hardship Ginseng composition, by weight, described Radix Rumicis be 20～80 parts, Radix Sophorae Flavescentis be 20～80 parts；As One of further embodiment, Radix Rumicis are 30～70 parts, Radix Sophorae Flavescentis is 30～70 parts；As entering again One of one step embodiment, Radix Rumicis are 35～65 parts, Radix Sophorae Flavescentis is 35～65 parts；As more entering one One of embodiment of step, Radix Rumicis are 40～60 parts, Radix Sophorae Flavescentis is 40～60 parts；As more entering one One of embodiment of step, Radix Rumicis are 30～50 parts, Radix Sophorae Flavescentis is 30～50 parts.

The present invention also provides for a kind of Chinese medicine composition being made up of Radix Rumicis, Radix Sophorae Flavescentis and siphonostegia chinensis, In Chinese medicine composition of the present invention, Radix Rumicis and Radix Sophorae Flavescentis as monarch drug, siphonostegia chinensis as ministerial drug at this Bright Chinese medicine composition plays the effect of blood circulation promoting and blood stasis dispelling；As one of embodiment of the present invention, by soil Radix Et Rhizoma Rhei, Radix Sophorae Flavescentis and siphonostegia chinensis composition pharmaceutical composition in, by weight, Radix Rumicis be 20～ 80 parts, Radix Sophorae Flavescentis be 20～80 parts, siphonostegia chinensis be 10～50 parts；Preferably Radix Rumicis be 20～50 parts, Radix Sophorae Flavescentis is 20～50 parts, siphonostegia chinensis is 15～40 parts；As one of embodiment, Radix Rumicis 30～ 50 parts, Radix Sophorae Flavescentis 30～50 parts, siphonostegia chinensis 20～40 parts；As one of further embodiment, Radix Rumicis 25～45 parts, Radix Sophorae Flavescentis 25～45 parts, siphonostegia chinensis 20～35 parts.

The present invention still further provides by Radix Rumicis, Radix Sophorae Flavescentis, siphonostegia chinensis, the Radix Pulsatillae, catechu group Become Chinese medicine composition, as in one of embodiment, Chinese medicine composition of the present invention, by weight, Radix Rumicis is 20～80 parts, Radix Sophorae Flavescentis is 20～80 parts, siphonostegia chinensis is 10～50 parts, the Radix Pulsatillae is 10～40 parts, catechu be 5～30 parts；It is 20～50 as one of further embodiment, Radix Rumicis Part, Radix Sophorae Flavescentis be 20～50 parts, siphonostegia chinensis be 15～40 parts, the Radix Pulsatillae be that 10-40 part, catechu are 10～30 parts；As further one of embodiment, described Radix Rumicis be 20～40 parts, Radix Sophorae Flavescentis be 20～40 parts, siphonostegia chinensis be 15～30 parts, the Radix Pulsatillae be 15～30 parts, catechu be 10～20 parts； As further one of embodiment, Radix Rumicis be 25～35 parts, Radix Sophorae Flavescentis be 25～35 parts, north Herba Artemisiae Anomalae is 15～25 parts, the Radix Pulsatillae is 15～25 parts, catechu is 10～15 parts.

In pharmaceutical composition of the present invention, Radix Rumicis and Radix Sophorae Flavescentis are monarch drug, add again tool in two taste monarchs drug There is the siphonostegia chinensis of blood circulation promoting and blood stasis dispelling effect as ministerial drug；Increase again and there is heat-clearing and toxic substances removing, removing heat from blood effect The adjuvant drug Radix Pulsatillae and have removing dampness sore, promoting regeneration of the tissue and arresting bleeding effect make medicine catechu.

Pharmaceutical composition of the present invention, for the cause of disease of the most common psoriasis vulgaris, selects tool There are clearing away heat and cooling blood, heat clearing and damp drying, dispel the wind removing toxic substances, blood circulation promoting and blood stasis dispelling, cooling blood and dissolving purpura, mass dissipating and swelling eliminating, town The most overworked, the Chinese medicine of clearing away heart-fire effect of pain, to promote telangiectasis, to improve body's immunity, Reach to treat psoriatic purpose.

In Chinese medicine composition of the present invention, as one of embodiment, in described Chinese medicine composition The formal name used at school of each herbal medicine, effect and main matter basis (chemical composition) are described as follows:

Described " Radix Rumicis " be in polygonaceae plant Rumex (Rumex) multiple Ji Yuan be commonly called as " Radix Rumicis " Dry root, including the wild and/or medical material of cultivation and decoction pieces and/or processed product.Mainly include this genus In 16 kinds of existing long history of being used as medicine, being wherein preferably first five kind has provincial standard, i.e. bar It Radix rumicis acetosae (R.patientia), curled dock (R.crispus), Ni Baier Radix rumicis acetosae (R.nepalensis), tooth Fruit acid mould (R.dentatus) and Rheum obtusifolia Linn. (R.obtosifolius).Still there are Radix Rumicis Japonici (R.japonicus), Radix rumicis acetosae (R.acetosa), golden dock (R.trisetifer), net fruit acid mould (R.chalepensis), Rumex gmelini Turcz. (R.gmelinii), narrow folic acid mould (R.stenophyllus), bloodwort (R.aquaticus), lanceolata Radix rumicis acetosae (R.psedonatronatus), rumex longiflius (R.longifolius), Tianshan Mountains Radix rumicis acetosae (R.tianschancus) and halberd Folic acid mould (R.hastatus).Rumex patientia Linn., curled dock are embodied in the provincial standard of Beijing and Tianjin；Buddhist nun Bai Er Radix rumicis acetosae, rumex dentatus are Guizhou Native standard；Rheum obtusifolia Linn. is Anhui's local standard.

Radix Rumicis is cool in nature, bitter in the mouth, pungent.GUIXIN, lung meridian.Function cures mainly: heat-clearing and toxic substances removing, and removing heat from blood is only Blood, pathogenic fire purging relieving constipation, promoting blood circulation to remove blood stasis, parasite killing is controlled.Clinical orally taken for curing relieving constipation antidiarrheal, have blood in stool and It is hemorrhage, constipation, upper respiratory tract infection, relievings asthma, heat extraction etc.；The bald mustard of external curing head, parasite killing, Eczema, psoriasis, the dermatosis such as fungal infection.Main chemical compositions: dissociated anthraquinone: rheum emodin, Chrysophanol and physcione；Combined anthraquinone: rheum emodin-8-0-β-D-pyranglucoside, rheum emodin Methyl ether-8-O-β-D-pyranglucoside, chrysophanol-8-O-β-D-glucopyranoside；Flavonoid: mountain Naphthols, kaempferol-3-0-α-L-rhamnopyranosyloxyhy glucosides, Quercetin, Quercetin-3-O-α-L-rhamnopyranose Glycosides, catechin, epicatechin.Rumicin and glycosides, resveratrol etc.；

Described " Radix Sophorae Flavescentis " is the dry root of leguminous plant Radix Sophorae Flavescentis Sophra flavescens Ait., including wild And/or the medical material of cultivation and decoction pieces and/or processed product；

Radix Sophorae Flavescentis: cold in nature, bitter in the mouth.GUIXIN, liver, stomach, large intestine, bladder warp.Function cures mainly: heat clearing away Dampness, parasite killing, diuresis.For hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva the moon is overworked, Eczema, eczema, skin scabies is overworked, mustard leprosy；External treatment trichomonal vaginitis.Main chemical compositions: Containing with matrine, oxymatrine, N-oxysophocarpine, sophocarpine, sophoridine, eulexine being 34 kinds of main alkaloids；Containing based on Vexibinol, kurarinone, 85 kinds of trifolirhizin Flavone compound and 5 saponinss etc..

Described siphonostegia chinensis is the dry of goatweed Herba Siphonostegiae Siphonostegia chinensis Benth. Dry herb, including the wild and/or medical material of cultivation and decoction pieces and/or processed product；

Siphonostegia chinensis: cold in nature, bitter in the mouth.Return spleen, stomach, liver, gallbladder meridian.Function cures mainly: blood circulation promoting and blood stasis dispelling, Inducing menstruation to relieve menalgia, cooling blood for hemostasis, clearing away heat-damp and promoting diuresis, hardship is let out cold clear, controls blood stasis and holds concurrently hot person.Damage for traumatic injury Wound, traumatic hemorrhage, blood stasis amenorrhea, menoxenia, puerperal stasis of blood pain, abdominal mass knot is poly-, dysentery, stranguria with blood, Jaundice due to damp-heat, edema abdominal distention, leukorrhagia.Main chemical compositions: flavonoid: 5,3 '-dihydroxy-4 ', 6,7-trimethoxy flavones, 5,7-dihydroxy-3,4-dimethoxy flavone, apigenin, apiin, sweet-scented osmanthus Grass element, luteoloside etc..Quinic acid and ester type compound: 3,4-bis-coffee acyl quinic acids, ash felt is born Winter element F, 3,4,5-tri-coffee acyl methyl quinicate.Coumarins: ayapanin, 7-hydroxyl Coumarin.Organic acid: Hesperetic acid, trans p hydroxycinnamic acid, 1R, 2R, 4R trihydroxy Herba Menthae Alkane and daucosterol etc..

The described Radix Pulsatillae is being dried of ranunculaceae plant Radix Pulsatillae Pulsatilla chinensis (Bge.) Regel Root, including the wild and/or medical material of cultivation and decoction pieces and/or processed product；

The Radix Pulsatillae: cold in nature, bitter in the mouth.Return stomach large intestine channel.Effect: heat-clearing and toxic substances removing, eliminating pathogenic heat from blood to cure dysentery. Being clinically used for toxic-heat and blood stasis, yellow fluid is dripping, eczema, mustard skin ulcer an ancient musical pipe, beriberoid pyretic arthralgia, jaundice dark coloured urine. Main chemical compositions: triterpene, triterpene saponin: with lupinane type and oleanane type (Caulis Hederae Sinensis Sapogenin is main) triterpenoid sapogenin, tens of kinds of saponin, Coumarins: 4,7-dimethoxy-5-first Butylcoumariii.Organic acid: Betulinic Acid, betulonic acid.Heart tonifying composition: Anemonin, Anemone cathayensis Kitag. Element, the Radix Pulsatillae spirit, the Radix Pulsatillae because of etc..Lignanoids: (+)-pinoresinol, peltatin B etc..

Described catechu is the peeling branch of leguminous plant catechu Acacia catechu (L.f.) Willd., dry being dried Soft extracts and/or its processed product.

Catechu: property is bitter, puckery, is slightly cold.Return lung, heart channel.Function cures mainly: promoting blood circulation and stopping pain, and hemostasis is raw Flesh, removing dampness sore, removing heat from the lung and dissipating phlegm.Flutterring the pain of injury for falling, traumatic hemorrhage, hematemesis and epistaxis, skin infection is not Hold back, eczema, eczema, cough due to lung-heat.Main chemical compositions: main containing flavonoid: catechin, table Theine, kaempferol, Quercetin, afzelechin, table afzelechin, kaempferol, 3,4 ', 7 '-trihydroxy -3 ', 5-dimethoxy flavone, catechin, epicatechin, aromadendrin etc.；Phenol, 4-HBA Deng.

Chinese medicine composition of the present invention can form multiple compositionss by the weight portion set, as embodiment party One of case, described compositions can carry out extracting or re-refining obtaining " extract " or " essence of said composition Thing processed "；Then with the material medicine that " extract " and " refined thing " they are various external or oral preparations, and Multiple external or oral preparations just it is prepared as after adding adjuvant.

As one of embodiment, Chinese medicine composition of the present invention can be prepared by " extraction process ", Wherein said " extraction process " comprises the following steps:

Extraction step: Extraction solvent is the medicinal alcohol solution of water or 50-100%；Extracting method includes leaching Stain, be heated to reflux, impregnate after percolation, supersound extraction, microwave extraction, decoction or supercritical liq carry Follow the example of；Wherein said dip time is preferably 0.5～1.0 hour；Extraction time is 1～4 time, preferably 3 Secondary；The time extracted is 1.0～2.0 hours, and the total amount extracting solvent for use is 15～20L/Kg；Extract As one of embodiment of the present invention, water carry or before alcohol extraction, can be by each in the present composition The medical material of component gives cataclasm one-tenth coarse grain or thin slice as one thinks fit, the parts by weight mix homogeneously arranged by each component, Extract the most again.

Filtration step: use normal pressure settlement separate, pressurization or vacuum filtration, centrifugation, this step Medicinal residues can be removed, it is thus achieved that the extraction solution of clarification.

Concentration step: use the evaporation of concentrating under reduced pressure, thin film concentration, membrane evaporator；As embodiment party One of case, the temperature of described concentration is less than 60 DEG C；This step can obtain the dense of the present composition Contracting thing.

Drying steps: be vacuum dried, be spray-dried, lyophilization or microwave drying；As embodiment party One of case, described baking temperature is it is also preferred that below 60 DEG C.

The extract of the Chinese medicine composition of the present invention that said method is obtained, except containing controlling in extract Treat that still to contain monosaccharide and disaccharide quite a lot, oligosaccharide, inorganic salt etc. outside psoriatic active substance little The macromole impurity such as molecular compound and pectin, lymphatic temperament, protein, resin.

In order to improve the content of active component further, as one of embodiment of the present invention, can be right This extract is made the most refined.Refining to use decoction and alcohol sedimentation technique, ethanol extract from water precipitation, macropore to inhale The methods such as attached resin chromatography method, polyamide chromatography method, ion exchange chromatography method or membrane separation technique method Refined.After refined, the content of " refined thing " is about about 35% that total " extract " is measured, can go after process Except the invalid impurity in extract, remain active ingredient the most to greatest extent and improve content, carrying Rise the curative effect of medicine.As one of embodiment of the present invention, carry out when using Flavonoids by Macroporous Adsorption Resin Time refined, wherein said macroporous adsorbent resin is selected from nonpolar, low pole, middle polarity or polar resin, Be preferably AB-8, SP-825, D101, DM-130, HP-20, HPD100, HPD400, HPD600, X-5 or NKA-9 resin；Polarity or low pole resin in being preferably；More preferably AB-8, X-5, SP-825, HPD400 or DM130；

As one of embodiment of the present invention, when using ion-exchange-resin process to Chinese medicine composition of the present invention When the extract of thing carries out refined, described resin is suitable for selected from cation exchange resin, preferably this resin The alkaloids composition contained in compositions；

As one of embodiment of the present invention, when using polyamide chromatography method to Chinese medicine composition of the present invention " extract " when carrying out refined, the material selecting specification to be 30～60 mesh；As embodiment party of the present invention One of case, when using membrane separation technique method " extract " of Chinese medicine composition of the present invention to be carried out refined, Membrane separation technique method should select ultrafilter membrane to retain the pectin of macromole, lymphatic temperament, protein, resin Deng organic impurities, reverse osmosis membrane is selected to retain the impurity such as small molecular sugar, inorganic salts.

As one of embodiment of the present invention, the preparation method of described Chinese medicine composition comprises the steps:

I) preparation of " extract ": take each component in the compositions of corresponding weight portion, cataclasm one-tenth respectively Coarse grain or cut into thin slice, then mix homogeneously, use the medicinal alcohol of water or 50-100% to make solvent, Use behind solvent impregnated about 0.5-1 hour of about 40 degree be heated to reflux etc. method extract three times (as Exemplary explanation, can be 8 times, 6 times, 6 times of L/kg), extract 1-2 hour, total solvent every time Amount is 15-20 (L/kg)；Backflow after normal pressure is settlement separate, use sucking filtration or centrifugal (4000rpm, Processing method 30min), obtain extracting solution；Extracting solution use below 60 DEG C reduction vaporization concentrate or The method recycling design such as thin film concentration are to concentrate；Concentrate is the method such as vacuum dried below 60 DEG C Obtain " extract "；

II) preparation of " refined thing ":

(A): the process for purification of " extract " with the medicinal alcohol of 50-100% as solvent: " extract " First process through water precipitating method, the vacuum dried rear preservation of water insoluble " precipitate " after process, remaining water-soluble Liquid passes through any one macroporous adsorbent resin such as AB-8, X-5, SP-825, HPD400 or DM130 The polyamide chromatography post of post or 30～60 mesh carries out separating to remove the impurity such as saccharide, inorganic salt；Resin Post blade diameter length ratio is 1: 6～1: 10, the water elution with flow velocity as 2-9BV/h, remove little molecule saccharide, The impurity such as inorganic salt and the pectin of macromole, mucus, resin, polysaccharide, protein, until saccharide etc. Impurity is the most only washed, and discards；Again with the ethanol gradient elution of 5%-80%, flow velocity is 3-10BV/h, Washing the adsorbate in most post with 95%-100% ethanol, collect eluent afterwards, concentrating under reduced pressure final vacuum is dried And merge with aforementioned water insoluble " precipitate ", it is " refined thing "；Or

(B) process for purification of " extract " with water as solvent, " water extract " is with the ethanol of several times amount " alcohol hypostasis " after precipitation, the predominantly pectin of macromole, mucus, protein, resin and polysaccharide etc. are miscellaneous Matter, discards；The molten part of alcohol uses macroreticular resin absorbing method, polyamide chromatography method or membrane separation technique Remove impurity, to remove the impurity such as the monosaccharide and disaccharide of little molecule, oligosaccharide and inorganic salt；Inhale with macroporous resin During attached method impurity removal and purification, solvent and resin column blade diameter length ratio are 1: 6～1: 10.As embodiment of the present invention it One, when using polyamide chromatography method to separate, the desirable alcohol molten part water being concentrated into small size Repeatedly dissolving, obtain the hydrotrope and water-insoluble two parts, the another device of the direct drying under reduced pressure of water-insoluble is protected Deposit；Water portion carries out polyamide chromatography post separation, and with water for solvent eluting, detection is to sugar-free in time Class thing is extremely；Again with the medicinal alcohol gradient elution of variable concentrations, finally wash most post with 95%～100% ethanol In adsorbate；Collect ethanol elution, include concentrating under reduced pressure, thin film concentration etc. with above-mentioned use Method concentrates and obtains " refined thing " after drying under reduced pressure processes.As one of embodiment of the present invention, When using membrane separation technique, select ultrafilter membrane to retain pectin, mucus, protein, resin etc. and divide greatly Sub-impurity component, then uses reverse osmosis membrane to retain the little molecules such as the saccharide in extract, inorganic salt miscellaneous Matter composition, obtains " refined thing ".

As one of embodiment, can be former with " extract " of pharmaceutical composition of the present invention or " refined thing " Material is prepared as multiple external preparation or oral preparations, and wherein said external preparation includes but not limited to gel Agent, ointment, ointment, liniment, dress powder, lotion, liniment, paste, aerosol, Spray or emplastrum；Described oral preparations include but not limited to tablet, granule, powder, pill, Capsule, syrup, drop pill, fluid extract and extractum or medicinal tea.

As one of embodiment of the present invention, gel, ointment or the emulsifiable paste in described external preparation The water-soluble base that agent mainly uses includes: carbomer, glycerin gelatine, glycerinum amyli, cellulose spread out Biology, Polyethylene Glycol, alginate, tragcanth, gelatine starch or the adjuvant of their combination in any； It is preferably carbomer gel substrate；Selectively include water-insoluble base or combine with water-soluble base Use；The substrate of described liniment includes polyvinyl alcohol (PVA), polyvinyl formal-acetal, polyethylene Ketopyrrolidine, carboxymethyl chitosan or carbomer, or their combination in any；Plasticizer include glycerol, Propylene glycol or dibutyl phthalate, or they combination in any.

Preparation prepared by the present invention should meet the relevant regulations of Chinese Pharmacopoeia, as embodiment party of the present invention One of case, preferably conforms to the requirement of the Chinese Pharmacopoeia annex I rules of preparations of version in 2010.

As one of embodiment of the present invention, when the preparation of described pharmaceutical composition is gel, solidifying The water-soluble base of colloid includes: carbomer, glycerin gelatine, glycerinum amyli, cellulose derivative, Polyethylene Glycol, alginate, tragcanth or their combination in any etc.；It is preferably carbomer gel Substrate；

As one of embodiment of the present invention, when the preparation of pharmaceutical composition of the present invention is liniment, The substrate of described liniment include polyvinyl alcohol (as exemplary explanation such as PVA124,1750 or 1788), polyvinyl formal-acetal, polyvinylpyrrolidone, acrylic resin, carbomer or carboxylic first Base enclosure polysaccharide, plasticizer glycerol, propylene glycol or dibutyl phthalate or their any group Close；

As one of embodiment of the present invention, when the preparation of pharmaceutical composition of the present invention is ointment or breast During unguentum, the water-soluble base of described ointment or ointment includes: glycerin gelatine, glycerinum amyli, Cellulose derivative, carbopol, alginate, tragcanth or Polyethylene Glycol or they appoint Meaning combination.Oil-soluble substrate can be selected for glyceryl monostearate, stearic acid Polyoxyethylene este (40), lima bean Cool acid esters, white vaseline or Cera Flava etc. or their combination in any, conventional by ointment or ointment Prepared by preparation method.

As exemplary explanation, take Chinese medicine composition of the present invention, wherein in terms of parts by weight, Radix Rumicis 35 parts, Radix Sophorae Flavescentis 35 parts, siphonostegia chinensis 30 parts, three kinds of medical materials or decoction pieces appropriateness are pulverized as coarse grain or cut Laminate and prepare " refined thing " by the inventive method, then with this " refined thing " material medicine as preparation, It is prepared as gel as follows.Take 2g carbomer-980, add distilled water 50 milliliters swelling completely, Stirring under blender, adding PH regulator triethanolamine to PH is about 4.0；Separately take present invention combination " the refined thing " of thing crosses 100 mesh sieves as medicine；Take 10g medicine, with 95% ethanol 10 grams, propylene glycol 30 grams, and wetting agent glycerol 5 grams dissolving medicine；Under agitation above-mentioned solution by portions time is added card ripple In nurse 980, then taking ethylparaben fine powder 0.5g in 5 grams of propylene glycol after ultrasonic dissolution stirring under again Adding in substrate, addition cutaneous permeable agent laurocapram etc. are equidirectional again stirs, finally in Tongfang Under stirring, adjust pH to about 7.0 with triethanolamine, supply 100ml with pure water.

In the present invention, described ointment, ointment, gel be mixed with substrate by medicine A kind of external use semi-solid preparation easily coating skin, mucosa or wound surface.Wherein use emulsion-type substrate Be also ointment；Water-soluble base is made up of naturally occurring or synthetic macromolecular water-soluble material, conventional Include glycerin gelatine, glycerinum amyli, cellulose derivative, carbopol and Polyethylene Glycol etc. or Their combination in any, exemplary preparation method includes: choose full-bodied CMC-Na, glycerol adding After mixing, adding appropriate amount of purified water mixing, place after being gel to swelling, stirring is lower to add by several times Above-mentioned raw materials medicine lysate, ethyl hydroxybenzoate water liquid, cutaneous permeable agent and antioxidant, continue stirring Until completely uniform, to obtain final product.Such substrate release medicine is very fast, without greasy, be easily coated with exhibition, washable Remove, to mucocutaneous nonirritant, can with aqueous solution and can absorptive tissue transudate, therefore multiplex In moistening, rotten to the corn skin ulcer face, the beneficially eliminating of secretions, it is particularly suitable for the treatment of psoriasis people.

The preparation of pharmaceutical composition of the present invention can be used common sense in the field by those skilled in the art It is prepared.

As one of embodiment of the present invention, described gel uses following preparation method to prepare:

Take " extract " or " refined thing " of Chinese medicine composition of the present invention, be ground into fine powder；Weigh carbomer In right amount, within 24 hours, obtain the carbomer clear gel of 2%-3% completely to swelling with distilled water immersion, Moving under blender overall process stirring, PH to 3.5-4 adjusted by dropping triethanolamine, selectively, basis The pH value of carbomer can first be adjusted or adjust afterwards by needs；Separately take gained " extract " or " refined thing " fine powder, point Secondary addition, it is also possible to be dissolved in propylene glycol and ethanol (wherein ethanol controls 10% or less) by several times Join in carbomer gel, stir, preservative ethyl hydroxybenzoate fine powder is dissolved in propylene glycol super Sound dissolves, and makes an addition to wherein, adds again wetting agent glycerol, sodium thiosulfate antioxidant and Laurel nitrogen Ketone cutaneous permeable agents etc., drip triethanolamine and adjust pH to 7, equidirectional be evenly stirred until after stirring Only form viscous gel agent, to obtain final product.The gel preparation of " extract " or " refined thing " is former with " extract " In the preparation of material medicine, the content of " extract " can be 20%-30%；In preparation with refined thing as crude drug The content of refined thing can be 10%～20%.

As one of embodiment of the present invention, can adopt and prepare translucent gels agent with the following method: take Chinese medicine composition of the present invention or " extract " of this drug composition or " refined thing " add polyoxyethylene sorbitan monoleate, PEG400 and glycerol mixing, heating for dissolving, be separately dissolved in sodium carboxymethyl cellulose and xanthan gum In 80ml water, it is heated to 85 DEG C and is gradually added into " the extraction of compositions described above or Chinese medicine composition Thing " or the solution of " refined thing " in, add cutaneous permeable agent azone, preservative ethyl hydroxybenzoate fine powder Propylene glycol liquid and antioxidant sodium thiosulfate is stirring while adding at room temperature cools down uniformly to 100ml, Translucent gels agent.

As one of embodiment of the present invention, the described dermatologic liniment following preparation method of employing: By PVA124, PVA1750, PVA1788, polyvinyl formal-acetal or the one-tenth of their combination in any Membrane material adds purified water or 80% ethanol and is allowed to fully be swelled into faint yellow half 80 DEG C of heating in water bath immersions Mobility liquid, moves to overall process stirring under blender, adds appropriate diethyl phthalate and increases Moulding agent mix homogeneously is (1) liquid；Separately take " extract " of Chinese medicine composition of the present invention or this drug composition Or " refined thing ", as raw material medicine, is crushed into impalpable powder, it is dissolved in propylene glycol-ethanol；By several times Add in (1) liquid, mix homogeneously；Add the ethyl hydroxybenzoate preservative being dissolved in propylene glycol and humidification again Agent, guarantor penetration enhancer, antioxidant, the placement that stirs is to bubble-free, and divided dose is loaded in vial, close Seal and get final product；

As one of embodiment of the present invention, described ointment or the ointment following preparation method of employing: Take Chinese medicine composition of the present invention or " extract " of said composition or " refined thing " as raw material medicine, It is ground into impalpable powder, adds appropriate propylene glycol-ethanol and make dissolving standby for (1) liquid；Alternative select stearic acid, Glyceryl monostearate, liquid Paraffin, azone oil phase substrate with selected from glycerol, water solublity lanoline Aqueous phase substrate be separately heated to 80 DEG C, blender stir under aqueous phase substrate is added in oil phase substrate, When being cooled to 40 DEG C, stirring is lower adds above-mentioned (1) liquid by several times, stirs, adds preservative hydroxyl Phenethyl ester, antioxidant and guarantor's penetration enhancer, continue stirring until completely uniformly, to obtain final product；Alternatively to The psoriasis with rotten to the corn skin ulcer face is artificially more conducive to absorptive tissue transudate, selects to use water-soluble base, Conventional has glycerin gelatine, cellulose derivative (CMC-Na), polyethylene glycols；Described preparation method Including: choose full-bodied CMC-Na, after glycerol adding mixing, add appropriate amount of purified water mixing, put Put after being gel to swelling, stirring is lower add by several times above-mentioned raw materials medicine lysate, ethyl hydroxybenzoate water liquid, Cutaneous permeable agent and antioxidant, continue stirring until completely uniformly, to obtain final product；

Other external preparation such as external pulvis can be adopted with the following method as the exemplary explanation present invention Preparation: " extract " or " refined thing " that take Chinese medicine composition, as raw material medicine, is respectively crushed into fine powder, Divided dose, packs and get final product.

Tincture is that the ethanol of medicine normal concentration leaches or dissolves the supernatant liquid preparation made, it is possible to Make with fluid extract dilution.Can adopt as exemplary explanation and prepare with the following method: take above-mentioned in Any one in drug composition, preparation method of the present invention: (1) infusion process: by each for present invention Chinese medicine composition Thing is ground into fine powder, mixing, with the ethanol as solvent of 60%, and slowly percolation, receipts after impregnating 48 hours Collection percolate is appropriate, adjusts its alcohol content to 60%, stirs, filter, to obtain final product.(2) dissolve Method: each for present invention Chinese medicine composition is impregnated 2 hours post-heating with 70% ethanol as solvent and refluxes 1.5 little Time filter, medicinal residues again with 70% alcohol reflux 2 times, filter, collect filtrates of refluxing 3 times, in right amount Concentrating, regulate to ormal weight with 70% second alcohol and water, making alcohol content is 60%～65%, filters and get final product.

When the present composition makes oral preparations, as one of embodiment of the present invention, when making During granule, can use and include but not limited to following methods: (1) extracts: take prescription medical material with suitably Solvent (water and 50%～95%) extracts, and when selecting water extraction, aqueous extract is concentrated into one through less than 60 DEG C Determine concentration, by 95% ethanol precipitation completely；Taking supernatant, to be concentrated into paste through less than 60 DEG C standby； (2) pelletize: above-mentioned concentration thick paste adds appropriate dry Icing Sugar or other excipient, mix homogeneously, Being wetting agent soft material with 70% ethanol, soft material granulation machine 12-14 mesh sieve makes granule；(3) it is dried: Wet granular is dried in low temperature baking oven.

As one of embodiment, the preparation method of described granule also includes: take Chinese drug-treated group of the present invention " extract " or " refined thing " of compound, as raw material medicine, was pulverized the fine powder of 80-160 mesh； Using oligomeric lactose or dextrin is molding adjuvant, uses spray drying, the technology of dry granulation to be prepared as Granule；

As one of embodiment of the present invention, when prepared as tablets, can use include but not limited to following Method: take " extract " or " refined thing " of Chinese medicine composition of the present invention as raw material medicine, pulverized Cross the fine powder of 80-160 mesh, add appropriate amount of auxiliary materials (hydroxypropylcellulose, hydroxyl beta cyclodextrin etc.) and use Ethanol is wetting agent, pelletizes, drying under reduced pressure (50-70 DEG C) tabletting, and coating to obtain final product；

As one of embodiment of the present invention, when making capsule, can use include but not limited to Lower method: take " extract " or " refined thing " of Chinese medicine composition of the present invention as raw material medicine, by its powder The broken fine powder crossing 80-160 mesh, and add the methylcellulose of 1-2%, silicone or hydroxyethyl cellulose Deng adjuvant, medicated powder is made to have good mobility, it is ensured that gelatin hard rapidly and precisely inserted by medicated powder Capsule and get final product, the filling of medicine needs to enter in about 25 DEG C and environment that relative humidity is 35%～45% OK.

As one of embodiment of the present invention, when making powder, can use include but not limited to following Method: " extract " or " refined thing " that take Chinese medicine composition of the present invention, as raw material medicine, is pulverized Cross the fine powder of 80-160 mesh, sieve, mix homogeneously and get final product.

Fluid extract, extractum be medical material with suitable solvent extraction effective ingredient, boil off partial solvent, Adjust the liquid dosage form that concentration to required standard is made, dipping, percolation, selection half adverse current can be used Multistage extract technologies etc. make.Can adopt as the exemplary explanation present invention and prepare with the following method. Preparation method: take with water or the extract of each compositions with 50-95% ethanol as solvent, to obtain final product.

Pharmaceutical composition of the present invention is possible not only to external and can also take orally, and focus is treated by external-applied ointment, Oral medicine for consolidating curative effect, prevention of recurrence.The extract of the present composition or refined thing and preparation thereof Being tested by pharmacological effect and clinical prerun proves evident in efficacy to psoriasis vulgaris, cure rate is high, Without the toxic and side effects of hormones, it is suitable for the psoriasis course of disease longer, needs the characteristic of life-time service.

Figure of description

Observed result figure under light microscopic after Fig. 1: pharmaceutical composition of the present invention and control formulation treatment.

Detailed description of the invention

The present invention is expanded on further the present invention by following example and experimental example, but the present invention is not limited In this.

The preparation of Chinese medicine composition

Embodiment 1

Component (weight portion): Radix Rumicis 700g, Radix Sophorae Flavescentis 300g；

Preparation method: above two tastes are given as one thinks fit cataclasm respectively, taken amount mixing, adds component gross weight the most respectively 8 times amount of amount, 6 times amount, the 50% medicinal alcohol reflux, extract, 3 times of 6 times amount, the 1st time 2 hours, The the one 2-3 time each 1.5 hours, merges 3 extracting solution after settlement separate, with several layers of filtered through gauze, the end The muddy part centrifugal of layer separates, and extracting solution is evaporated to thick paste below 60 DEG C, by thick paste to vacuum Exsiccator is drying to obtain " extract ".

Embodiment 2

Component (weight portion): Radix Rumicis 600g, Radix Sophorae Flavescentis 400g

Preparation method: above two tastes are given as one thinks fit cataclasm, taken amount mixing, adds the 8 of component weight the most respectively Times amount, 7 times amount, the 70% medicinal alcohol reflux, extract, 3 times of 5 times amount, the 1st time 2 hours, 2-3 Secondary each 1.5 hours, merge 3 extracting solution and filter with nylon cloth after settlement separate, bottom muddiness part Centrifugation, extracting solution is evaporated to alcohol-free thick paste below 60 DEG C, by thick paste use water repeatedly Dissolving, water-insoluble fraction preserves after drying；Water portion carries out AB-8 macroporous adsorbent resin separation, Resin column blade diameter length ratio is 1: 8, first with the water elution of 4-8BV/h, until the impurity such as saccharide are the most only washed, abandons Go.Again with the ethanol gradient elution of 5%-80%, flow velocity is 2-10BV/h, finally uses 95%-100% second Alcohol is washed the adsorbate in most post, is collected eluent, and concentrating under reduced pressure final vacuum is dried and and aforementioned " water is insoluble Dried object " merge, it is " refined thing ".It is that raw material medicine can make system of mourning in various external with " refined thing " Agent.

Embodiment 3

Component (weight portion): Radix Rumicis 350g, Radix Sophorae Flavescentis 650g

Preparation method: above two tastes are given as one thinks fit cataclasm, taken amount mixing, adds the 8 of component weight the most respectively Times amount, 6 times amount, the pure water reflux, extract, 3 times of 6 times amount, the 1st time 2 hours, the one 2-3 time each 1.5 hours, 3 times extracting solution filtered after settlement separate, and extracting solution is evaporated to thick below 60 DEG C Cream, is drying to obtain " extract " by thick paste to vacuum desiccator.

Embodiment 4

Component (weight portion): Radix Rumicis 300g, Radix Sophorae Flavescentis 450g, siphonostegia chinensis 250g

Preparation method: above three tastes are given as one thinks fit cataclasm respectively, taken amount mixing, adds component weight the most respectively 8 times amount, 7 times amount, the 60% medicinal alcohol reflux, extract, 3 times of 5 times amount, extraction time is respectively 2 hours, 1.5 hours, 1.0 hours, merge 3 extracting solution after settlement separate, with several layers of gauze Filtering, bottom muddiness part centrifugal separates, and extracting solution is evaporated to thick paste below 60 DEG C, by thick Cream to vacuum desiccator is drying to obtain " extract ".

Embodiment 5

Component (weight portion): Radix Rumicis 400g, Radix Sophorae Flavescentis 300g, siphonostegia chinensis 200g

Preparation method: above three tastes are given as one thinks fit cataclasm, taken amount mixing, is ground into fine powder, sieves the most respectively, Mixing, every 100g powder refined honey 20-30g adds appropriate water pill, is dried, makes water-honeyed pill.

Embodiment 6

Component (weight portion): Radix Rumicis 350g, Radix Sophorae Flavescentis 350g, siphonostegia chinensis 300g

Preparation method: above three tastes are given as one thinks fit cataclasm, taken amount mixing, adds the 8 of component weight the most respectively Times amount, 6 times amount, the 70% medicinal alcohol reflux, extract, 3 times of 6 times amount, the 1st time 2 hours, 2-3 Secondary each 1.5 hours, 3 times extracting solution filtered after settlement separate, and extracting solution is concentrating under reduced pressure below 60 DEG C To thick paste.Repeatedly being dissolved by thick paste water, the water-insoluble fraction obtained another device after drying preserves；Water Molten part carries out polyamide column (resin column blade diameter length ratio is 1: 8) chromatography, first with the water of 8-2BV/h Eluting, detection is to without saccharide thing extremely in time, discards；Again with the medicinal alcohol gradient elution of 5-80%, The adsorbate in most post is washed afterwards with 95%-100% ethanol；Collect ethanol elution, subtract below 60 DEG C Pressure concentrates, and through less than 60 DEG C vacuum drying treatment, also and aforementioned " the insoluble dried object of water " merging obtains " essence again Thing processed ".

Embodiment 7

Component (weight portion): Radix Rumicis 350g, Radix Sophorae Flavescentis 250g, siphonostegia chinensis 150g, the Radix Pulsatillae 150g, catechu 100g

Preparation method: the above five tastes are given as one thinks fit cataclasm respectively, taken amount mixing, adds component gross weight the most respectively 8 times amount of amount, 6 times amount, the 70% medicinal alcohol reflux, extract, 3 times of 6 times amount, the 1st time 2 hours, The the one 2-3 time each 1.5 hours, and 3 times extracting solution filters after settlement separate, and extracting solution subtracts below 60 DEG C Pressure is concentrated into without alcohol taste, obtains " water precipitating thing " and " hydrotrope ", " water after precipitating with the pure water of several times amount Hypostasis " vacuum dried rear preservation；The hydrotrope passes through AB-8 or SP-825 macroporous adsorptive resins, Resin column blade diameter length ratio is 1: 6～1: 10, first the water elution with flow velocity as 2-9BV/h, removes saccharide and nothing The impurity such as machine salt discard, then the ethanol gradient elution with 5%-100%, and flow velocity is 3-10BV/h, collect Eluent, concentrating under reduced pressure final vacuum is dried and merges with aforementioned " water precipitating thing ", is " refined thing "；

Embodiment 8

Component (weight portion): Radix Rumicis 300g, Radix Sophorae Flavescentis 300g, siphonostegia chinensis 200g, Radix Pulsatillae 150g, Catechu 50g

Preparation method: the above five tastes are given as one thinks fit cataclasm respectively, taken amount mixing, adds component weight the most respectively 8 times amount, 6 times amount, the pure water reflux, extract, 3 times of 6 times amount, extraction time be respectively 2 hours, 1.5 hours, 1.5 hours, merge 3 extracting solution after settlement separate, with several layers of filtered through gauze, the end The muddy part centrifugal of layer separates, and extracting solution is evaporated to thick paste below 60 DEG C, by thick paste to vacuum Exsiccator is drying to obtain " extract ".

Embodiment 9

Component (weight portion): Radix Rumicis 250g, Radix Sophorae Flavescentis 250g, siphonostegia chinensis 200g, Radix Pulsatillae 200g, Catechu 100g

Preparation method: the above five tastes are given as one thinks fit cataclasm respectively, taken amount mixing, adds component weight the most respectively 8 times amount, 6 times amount, the 80% medicinal alcohol reflux, extract, 3 times of 6 times amount, extraction time is respectively 2 hours, 1.5 hours, 1.0 hours, merge 3 extracting solution after settlement separate, with several layers of gauze Filtering, bottom muddiness part centrifugal separates, and extracting solution is evaporated to thick paste below 60 DEG C, by thick Cream to vacuum desiccator is drying to obtain " extract ".

The preparation of preparation

The preparation (two taste components) of embodiment 10 gel

The raw material of preparation: raw material medicine (extract) 30g that Example 1 obtains, pulverized 100 Mesh sieve.

Prepared by preparation: choosing 2g carbopol-974 is gel-type vehicle, adds 50ml pure water swelling 24 After hour, adjust PH to 4 with triethanolamine, stir to blender；" extracting of Example 1 Thing " 30g, uses each 5ml of propylene glycol 40ml, glycerol and ethanol to dissolve raw material medicated powder, by several times the most above-mentioned card ripple In nurse gel-type vehicle, stirring while adding uniformly；Under agitation add 4% cutaneous permeable agent laurocapram and The ethyl hydroxybenzoate preservative (finely ground) of 3 ‰ and the sodium thiosulfate antioxidant of 3 ‰, adjust with triethanolamine Full liquid PH to 7, equidirectional stirs, and makes the hydrophilic gel of uniform and smooth.

The preparation (three taste components) of embodiment 11 gel

The raw material of preparation: Example 6 gained raw material " refined thing " 10g, pulverized 100 mesh sieves and get final product.

The preparation of preparation: take sodium alginate 3g, adds 50ml pure water swelling to forming toughness gel, separately Take above-mentioned " refined thing " thin medicated powder, dissolve with 35ml propylene glycol and 10ml glycerol, stir to blender Mix uniformly；Separately take the finely ground ethyl hydroxybenzoate preservative of 3 ‰ add after 5ml propylene glycol ultrasonic dissolution in addition its In, add again the laurocapram cutaneous permeable agent of 3%, equidirectional stir；Again sodium alginate is glued Consistence gel is slowly added into wherein, is uniformly mixed and get final product under blender.

The preparation (Chinese medicine of the five flavours component) of embodiment 12 gel

Preparation raw material: take above-described embodiment 8 gained " extract " 30g, pulverized 120 mesh sieves.

The preparation of preparation: by above-mentioned 30g raw material medicated powder, 2ml polyoxyethylene sorbitan monoleate, 10g Polyethylene Glycol 400 and 40ml mixed with propylene glycol are heated to 80 DEG C, transparent shape solution, stir to blender, Add under stirring full dose 3 ‰ preservative ethyl hydroxybenzoate and the laurocapram of 3%；Separately take Xanthan gum 1g and sodium carboxymethyl cellulose 2g is dissolved in 45ml water, is heated to 85 DEG C and makes matrix liquid, Being gradually added into above-mentioned drug solution, stirring while adding uniformly finally benefit is filled with water to 100ml, At room temperature cool down, obtain translucent gel.

The preparation of embodiment 13 liniment

Preparation raw material: " the refined thing " that take above-described embodiment 2 preparation is raw material medicine, crosses 120 mesh sieves

The preparation of preparation: take PVA17-88 (concentration is 10%) and carbopol-940 respectively and be placed in In two beakers, PVA17-88 with the purified water swelling of 5 times amount, carbopol-940 with 60% ethanol warp Under magnetic agitation swelling after, respectively in 90 DEG C of water-baths heating be swelled into rubber cement (can not see block For standard), by filtered through gauze, standby.Take glycerol, tween 80 and ethylparaben to add In ethanol, stir to dissolving, under agitation add above-mentioned raw materials medicine fine powder by several times, add after stirring evenly The rubber cement mixing of PVA17-88 Yu carbopol-940, adds ethanol and purified water to full dose, adds three ethanol Amine aqueous solution regulation pH to 7, sonic oscillation, to bubble-free, to obtain final product.

The preparation of embodiment 14 tablet

Preparation raw material: " extract " that take above-described embodiment 8 is preparation raw material medicine

The preparation method of preparation: dry extract is size-reduced to 100-120 mesh, adds starch and mixes in right amount, system Tabletting after particle drying, to obtain final product.

The preparation of embodiment 15 granule

Preparation raw material: " extract " that take above-described embodiment 4 is preparation raw material medicine

Preparation method: be dried " extract " that take above-described embodiment 4 pulverized 80 mesh sieves, obtained " dry carrying Take thing powder " standby；Take described " dry extract powder " and dextrin according to the ratio of weight and number of 2: 1, and add Account for 85% ethanol of described dry powder and dextrin gross weight 30% as wetting agent, add again and account for described dry powder With the steviosin of dextrin gross weight 2%, make soft material, cross 16 mesh sieves and pelletize, 50 DEG C of drying, granulate, Subpackage i.e. obtains granule finished product.

The comparative study to experimental psoriasis model therapeutical effect of the experimental example 1. sample 1-4 topical administration

The preparation of sample: the refined thing weighing tetra-kinds of samples of 1-4 is dried the medicated powder (medicine that each sample is concrete Composition and ratio are shown in Table 1), it is deployed into corresponding thick paste before experiment with propylene glycol respectively, and adds appropriate Percutaneous absorption enhancer.

The medicine composition of table 1 tested material sample 1-4 (refined thing), ratio

Note: 1) preparation method of sample 1 is with sample 2.

2) sample 1 compares as the folk prescription of Radix Rumicis.

1.1 sample 1-4 cause the impact of Cavia porcellus skin of pinna Pigs with Psoriasis model to propranolol hydrochloride

Take body weight 300～350g Cavia porcellus 60, male and female half and half, at random Cavia porcellus is divided by sex, body weight Become Normal group 10, model group 50.Normal group is left intact, and model group is every The left side auricle skin of back 1ml syringe of animal is quantitatively smeared 5% propranolol hydrochloride Emulsion and is made Mould, 0.1ml/cm2, every day 2 times (interval more than 6h), continuous 2 weeks.24h hands after last modeling Art is taken off the modeling of normal group and each 2 Cavia porcelluss of model group and is picked up the ears wide skin sample, solid through 10% formaldehyde Fixed, HE dyes, and om observation evaluates modeling quality with this.

48 Cavia porcelluss of modeling group are divided into 6 groups by the auricle thickness of modeling side, often group 8, Experiment is divided into model group, positive drug halometasone ointment matched group, sample 1-4 group.Each sample group and the positive Comparison medicine group smears administration 2 times (interval more than 6h) every day respectively, continuous 2 weeks.Normal group Being left intact, model group is given and isometric drug matrices propylene glycol.Each group is tested during administration All with the next day of slide gauge measure animal auricle thickness, perusal medication pick up the ears exterior feature hardness, skin Skin color and squama situation of change.After being administered 2 weeks, operation takes (medication side) auricle skin on the left of Cavia porcellus Skin, 10% formaldehyde fixes, paraffin embedding, and HE dyes, light Microscopic observation ear skin cuticular layer, The change of granulosa, prickle cell layer, basal cell layer and lamina propria.After statistical procedures, comparison specimen Product 2-3 and the significant difference of folk prescription Radix Rumicis (sample 1).

Result: sample 1,2,3,4 seen from perusal and positive drug halometasone ointment group are after medicine 7 days, the auricle thickness of each test medicine presented thinning, deliquescing in various degree, and color also tends to In normally, argenteous squama fades away.After each sample medication 14 days, auricle thickness is bright compared with model group Aobvious decline, the results are shown in Table 1-1.

The comparison (X ± SD, n=8) to Cavia porcellus auricle thickness effect of the table 1-1 sample 1-4 group

Note: 1. compare with model control group, * P ＜ 0.05；* P ＜ 0.01；* * P ＜ 0.005；* * * P ＜ 0.001；

2. compare with 1 group of sample, #P ＜ 0.05；Lower same.

Table 1-1 result is visible, and propranolol hydrochloride model group Mice Auricle thickness is apparently higher than normal control Group (P ＜ 0.001), shows that propranolol hydrochloride causes the success of Cavia porcellus auricle Pigs with Psoriasis model.Respectively Sample all compares with model control group, and sample 1,2,3,4 all can obviously reduce the auricle of model guinea pigs Thickness (P ＜ 0.05 or P ＜ 0.01)；The action intensity of sample 2,3 is substantially better than sample 1 (P ＜ 0.05)；Sample 4 compares with sample 1, though showing certain effect trend, but no difference of science of statistics (P ＞ 0.05).

Under light microscopic, visible normal guinea pig skin of pinna is the most homogeneous horny layer；Granular layer is wire, There is an obvious black particle both sides, about 1～3 layer；Prickle cell layer mostly is dihedral cell, about 4～6 layers； Basal layer is simple columnar cell, and mitosis item reduces；Lamina propria is loose connective tissue；Hair follicle Show no obvious abnormalities.Model group cuticular layer parakeratosis or excessive, prickle cell layer is thickening, about 5～8 layers, Wherein 2/3 nucleus vacuolation；Basal layer Mitotic phase reduces, and has in partial sector basal cell matter More pitchy granular cell；Lamina propria has individual segments congested.The all visible cuticular layer of each sample group is equal More complete, only thin and thick seen from individual animal is irregular or in loose webs shape；Granular layer has more pitchy Granule forms；Prickle cell layer is thinning, about 3～7 layers, about 1/5 nucleus vacuolation (limitation)； Basal layer cell split coil method reduces, and has no obvious brown particles, and under mucosa, hair follicle is showed no the most different Often.This result is pointed out, and sample 1-4 is to the Cavia porcellus auricle psoriasiform caused by drug induccd propranolol hydrochloride Skin lesion has obvious inhibitory action, shows that sample 1-4 can obviously improve the pathologic damage of Cavia porcellus auricle. And the therapeutic effect of sample 2-4 is significantly better than that sample 1.Concrete outcome is shown in accompanying drawing 1.

1.2 impacts on mouse tail scale epidermis

Take healthy ICR mice 60, body weight 18～22g, male and female half and half, equal according to sex, weight Weighing apparatus is randomly divided into 6 groups, often group 10.Dividing Matrix controls group, positive control drug clobetasol propionate is soft Cream group (0.02%) and sample 1-4 group.The tail skin testing each group of mice smears administration 2 times every day (interval more than 6h), continuous use puts to death mice after 14 days, take the back at root of the tail about 1.5cm Epidermis, 10% formaldehyde is fixed, and carries out conventional organization section, and HE dyes.Optical microphotograph Microscopic observation Mus Tail epidermal skin cuticular layer, granular layer, prickle cell layer, skin corium and hair follicle etc. change, and count 100 (the scale epidermis between all two follicular orifices is arranged in the scale number that granular layer formed in individual scale The granular layer person of row is calculated as the scale that granular layer is formed).Histopathology sees the fruit display that comes to an end, just Often group mouse tail epidermal granular cell is less, and structure is normal.Positive drug group cuticular layer is uneven, has Section disappears, and granular layer has more little granule, spine cell's thickness 4～5 layers.Sample 1-4 group visible portions Sectional cuticular layer disappears, and granular layer endoparticle is more, spine cell's thickness 3～4 layers.Result shows sample Product 1-4 and positive control drug external are smeared after medication 2 weeks can obvious inducing mouse tail scale epidermis granule Layer is formed, and the prompting congruent main pathological manifestations of each sample group diagonalization has good therapeutical effect. Sample 2-4 group is all obvious compared with sample 1 drug action.The results are shown in Table 1-2.

The impact (n=10) that mouse tail scale granular layer of epidermis is formed by table 1-2 sample 1-4

The inhibitory action of the Mice Auricle inflammation of 1.3 pairs of Oleum Tiglii inductions

In more serious psoriatic, due to the long-term skin lesion of skin, therefore at cutaneous lesion also The inflammatory phenomena such as red, swollen, hot, the pain that the degree that also exists is different, therefore experimental observation sample 1-4 is to oozing The inhibitory action of going out property inflammation, and compare research with the antiinflammatory action of sample 1.

Take body weight 18～22g Kunming mouse 70, male and female half and half.It is randomly divided into 7 groups by weight, Often group 10.It is divided into Normal group, inflammatory model group, positive drug halometasone ointment group and sample 1-4 Group, tests each treated animal and every day mouse right ear exterior feature back is smeared administration (using left ear as self Comparison), every day 1 time, continuous use 7 days.Normal group auricle is left intact, Fructus Crotonis Oil model group mice gives drug matrices propylene glycol.After last medication 1 hour, respectively it is subject to warm water cleaning Examination thing, in addition to Normal group, remaining auricle positive and negative, right side respectively organizing mice is all coated with syringe Smearing each 50ul/ of Oleum Tiglii sample of 2%, within 3 hours, each tested material group is smeared and is administered once, for the last time 1h after medicine, puts to death mice, cuts ears, lay auricle with the card punch of diameter 8mm, be precisely weighed, Take the weight difference between its two ear as swelling value.After statistical procedures, t-inspection between organizing, than The significance of relatively antiinflammatory action.The results are shown in Table 1-3.

The inhibitory action research (X ± SD, n=10) of the Mice Auricle inflammation that Oleum Tiglii is induced by table 1-3 sample 1-4

Result shows, the Mice Auricle exudative inflammation that Oleum Tiglii is induced by sample 1-4 has and significantly presses down Make of (comparing with model group, P ＜ 0.05, P ＜ 0.01 or P ＜ 0.005), sample 2,3,4 Antiinflammatory action the most relatively sample the last 1.Antiinflammatory action strength sample 2 ＞ sample 3 ＞ sample 4 ＞ sample 1.

In sum, each sample of each compositions of the present invention all demonstrates obvious function of resisting psoriasis, And sample 2-4 action intensity generally proximal to.

Experimental example 2. sample 1-4 takes the comparative study being administered experimental psoriasis model therapeutical effect orally

The preparation of sample: weigh sample 1-4 according to experimental example table 1 and refine the dry medicated powder of thing, with pure water It is configured to uniform suspendible medicinal liquid.

Cavia porcellus skin of pinna Pigs with Psoriasis caused by propranolol hydrochloride is controlled by 2.1 sample 1-4 gavages Treatment effect

Select with the experiment roughly the same Cavia porcellus 60 of 1.1 body weight, modeling method and the situation of packet all with Experiment 1.1, this experiment is using Etretinate as the positive control drug of oral administration medicament.During administration, model group is not Do any process, as skin lesion model clear-cutting forestland matched group；Each sample group gastric infusion every day 1 time, 0.333ml/100g body weight, successive administration 2 weeks, by each tested material of vernier caliper measurement next day of during administration The auricle thickness of treated animal, and observe color and the firmness change of auricle epidermis.The 14th upon administration My god, operation takes Guinea Pig Left side skin of pinna, fixes with 10% formaldehyde, paraffin embedding, and HE dyes, Om observation ear skin cuticular layer, granular layer, prickle cell layer, basal cell layer and the change of lamina propria Change.

Result: sample 1-4 seen from perusal and positive drug Etretinate group after medicine 7 days, the ear of Cavia porcellus Wide thickness presents thinning, deliquescing in various degree, and it is the best that skin color relatively model group situation has Turn；Sample 1-4 and positive drug be the ear of each test medicine of Etretinate group seen from perusal in 14 days after medicine Wide thickness relatively model group is decreased obviously (the results are shown in Table 2-1).Histopathology light microscopy checking result proves, Normal group skin of pinna tissue is normal；Model group animal model is picked up the ears popularity seen from exterior feature or stove shape Parakeratosis, companion granular layer thinning or disappear, major part animal have acanthosis, trochanterellus extend, The single core of corium and PMN infiltration, the feature such as telangiectasis.But sample 1-3 relatively model group All improving significantly, it is seen that parakeratosis alleviates, cell infiltration reduces, and epidermal area is thinning. Normal control and model control group light microscopic microscopy result substantially situation are substantially with experiment 1.1.Sample 1-4 is each The Cavia porcellus auricle thickness of group is significantly lower than model group (P ＜ 0.01, P ＜ 0.005 or P ＜ 0.001).But Comparing with sample 1, sample 2-4 is showed no significant difference.The results are shown in Table 2-1.

Table 2-1 sample 1-4 gastric infusion causes the impact (X ± SD, n=8) of Cavia porcellus auricle psoriasiform damage to propranolol hydrochloride

Note: compare with model control group, * P ＜ 0.05, * * P ＜ 0.01, * * * P ＜ 0.005, * * * * P ＜ 0.001, lower same.

The impact on mouse tail scale epidermis of the 2.2 sample 1-4 gastric infusions

Take the ICR mice 60 of body weight 18～22g, male and female half and half.Except positive control drug uses silver bits instead Outside spirit, animal packet situation equivalent experiments 1.2.Test each treated animal and all use gastric infusion every day 1 time, Continuous use 14 days, after last medicine, 24h puts to death mice, takes the back epidermis at root of the tail about 1.5cm, Carrying out conventional organization section, HE dyes.Observe rat-tail epidermis skin cuticular layer under an optical microscope, Granulosa, prickle cell layer, skin corium and hair follicle etc. change, and count in 100 scales and have granular layer shape The scale number become.The natural granular layer that lacks of normal mouse rat-tail scale epidermis, mouse tail seen from result Scale horny layer of epidermis keratinocyte remains with nucleus, and granular layer granular cell lacks, only Having a small amount of granular cell at hair follicle, epidermis is relatively thin.1,2,3,4 pairs of rat-tail squamas of tested material sample Sheet granular layer of epidermis is formed all has obvious facilitation (to compare with blank group, P ＜ 0.05 or P ＜ 0.01).The main pathological manifestations such as mouse tail parakeratosis are respectively provided with by this result prompting sample 1-4 Significantly therapeutical effect, and sample 2 is relative with the action intensity of sample 3 is better than sample 1 and sample 4. The results are shown in Table 2-2.

The impact (X ± sd, n=10) that mouse-tail scale epidermis granular layer is formed by table 2-2 sample 1-4 gastric infusion

The antiinflammatory action of the Mice Auricle inflammation that Oleum Tiglii is induced by 2.3 sample 1-4 gavages

Taking body weight 18～22g Male Kunming strain mice 70, the packet situation of animal is with experiment 1.3. Test each group equal every day gastric infusion, continuous use 7 days.After last medication 1 hour, except the most right Outside according to group, remaining is respectively organized Mice Auricle positive and negative and all smears each 50ul of Oleum Tiglii sample of 2% with syringe, After 3 hours, each tested material group is administered once again, 1h after last medicine, puts to death mice, cuts ears, Lay auricle with the card punch of diameter 8mm, be precisely weighed, take the difference between its two ear as swelling value. After statistical procedures, between organizing, t-inspection, compares the significance of antiinflammatory action.The results are shown in Table 2-3.

The impact (X ± SD, n=10) of the Mice Auricle inflammation that Oleum Tiglii is induced by table 2-3 sample 1-4 gastric infusion

Table 2-3 result shows, sample 1-4 gastric infusion 7 days to caused by Oleum Tiglii Mice Auricle inflammation It is respectively provided with obvious inhibitory action (P ＜ 0.05, P ＜ 0.01 or P ＜ 0.005).Sample 4 and sample 1 compares, P ＜ 0.05, and the antiinflammatory action intensity of each sample is followed successively by sample 4 ＞ sample 2 ＞ sample 3 ＞ Sample 1.

Claims (10)

1. treat psoriatic Chinese medicine composition, it is characterised in that described compositions is by Radix Rumicis and Radix Sophorae Flavescentis Composition；By weight: Radix Rumicis is 20～80 parts, Radix Sophorae Flavescentis is 20～80 parts；Preferably Radix Rumicis Be 35～65 parts, Radix Sophorae Flavescentis be 35～65 parts；Further preferably Radix Rumicis be 30～50 parts, Radix Sophorae Flavescentis be 30～50 parts.

2. contain the Chinese medicine composition of compositions described in claim 1, it is characterised in that described compositions It is made up of Radix Rumicis, Radix Sophorae Flavescentis and siphonostegia chinensis, by weight: Radix Rumicis is 20～80 parts, Radix Sophorae Flavescentis Be 20～80 parts, siphonostegia chinensis be 10～50 parts；Preferably Radix Rumicis be 20～50 parts, Radix Sophorae Flavescentis be 20 ～50 parts, siphonostegia chinensis be 15～40 parts；More preferably Radix Rumicis be 25～45 parts, Radix Sophorae Flavescentis be 25～ 45 parts, siphonostegia chinensis be 20～35 parts.

3. contain the Chinese medicine composition of compositions described in claim 1 or 2, it is characterised in that described should Compositions is made up of Radix Rumicis, Radix Sophorae Flavescentis, siphonostegia chinensis, the Radix Pulsatillae, catechu, by weight: soil Radix Et Rhizoma Rhei is 20～80 parts, Radix Sophorae Flavescentis is 20～80 parts, siphonostegia chinensis is 10～50 parts, the Radix Pulsatillae is 10 ～40 parts, catechu be 5～30 parts；Preferably Radix Rumicis be 20～50 parts, Radix Sophorae Flavescentis be 20～50 parts, Siphonostegia chinensis is 15～40 parts, the Radix Pulsatillae is 10-40 part, catechu is 10～30 parts；More preferably soil is big Huang is 20～40 parts, Radix Sophorae Flavescentis is 20～40 parts, siphonostegia chinensis is 15～30 parts, the Radix Pulsatillae is 15 ～30 parts, catechu be 10～20 parts；Further preferably Radix Rumicis be 25～35 parts, Radix Sophorae Flavescentis be 25～ 35 parts, siphonostegia chinensis be 15～25 parts, the Radix Pulsatillae be 15～25 parts, catechu be 10～15 parts.

4. according to the arbitrary described Chinese medicine composition of claim 1-3, it is characterised in that in described compositions:

Described " Radix Rumicis " is the 16 kinds of bases being commonly called as " Radix Rumicis " in polygonaceae plant Rumex (Rumex) The dry root in source, comprises the wild and/or medical material of cultivation and decoction pieces thereof and/or processed product；Preferably " soil is big Yellow " selected from Rumex patientia Linn. (R.patientia), curled dock (R.crispus), Ni Baier Radix rumicis acetosae (R.nepalensis), Radix Rumicis Japonici (R.japonicus), rumex dentatus (R.dentatus) and/or Rheum obtusifolia Linn. (R.obtosifolius) dry root of the multiple Ji Yuan of Rumex；

Described " Radix Sophorae Flavescentis " is the dry root of leguminous plant Radix Sophorae Flavescentis Sophora flavescens Ait., including open country Raw and/or the medical material of cultivation and decoction pieces thereof and/or processed product；

Described siphonostegia chinensis is the dry of goatweed Herba Siphonostegiae Siphonostegia chinensis Benth. Dry herb, including the wild and/or medical material of cultivation and decoction pieces and/or processed product；

The described Radix Pulsatillae is being dried of ranunculaceae plant Radix Pulsatillae Pulsatilla chinensis (Bge.) Regel Root, including the wild and/or medical material of cultivation and decoction pieces and/or processed product；Or

Described catechu is the peeling branch of leguminous plant catechu Acacia catechu (L.f.) Willd., dry being dried Soft extracts and/or its processed product.

5. the preparation method of the arbitrary described Chinese medicine composition of claim 1-4, it is characterised in that described side Method is prepared for the preparation technology that Chinese medicine composition is pressed " extract ", the preparation work of wherein said " extract " Skill comprises the following steps:

Extract: Extraction solvent is the medicinal alcohol solution of water or 50-100%；Extracting method include soak, Be heated to reflux, impregnate after percolation, supersound extraction, microwave extraction, decoction or supercritical fluid extraction method； Wherein said soak time is preferably 0.5～1.0 hour；Extraction time is 2-4 time；Extract time be 1.0～2.0 hours, the total amount extracting solvent for use was 15～20L/Kg；

Filter: normal pressure is settlement separate, pressurization or vacuum filtration, centrifugation or ultrafiltration；

Concentrate: concentration, thin film concentration, centrifugation or membrane evaporator evaporation are evaporated under reduced pressure, wherein The temperature of described concentration is less than 60 DEG C；With

It is dried: be vacuum dried, be spray-dried, lyophilization or microwave drying.

The preparation method of Chinese medicine composition the most according to claim 5, it is characterised in that described method Below also including that " extract " that process for refining, described process for refining include obtaining " extraction process " uses Method refines:

Flavonoids by Macroporous Adsorption Resin: wherein said macroporous resin is selected from nonpolar, low pole, middle polarity or pole Property resin, model is AB-8, SP-825, DM-130, X-5, HPD400, HP-20, D101, HPD100, HPD600 or NKA-9；Polarity or low pole resin in being preferably；More preferably AB-8, X-5, SP-825, HPD400 or DM130；

Ion-exchange-resin process: described resin selects cation exchange resin, preferably this resin to be applicable to group The alkaloids composition contained in compound；

Polyamide chromatography method: select the polyamide of 30～60 mesh, it is adaptable to the flavone contained in compositions Constituents；Or

Membrane separation technique method: select ultrafilter membrane to retain the organic impurities of macromole, reverse osmosis time refined Film retains the impurity of little molecule.

7. according to the preparation method of Chinese medicine composition described in claim 5 or 6, it is characterised in that described Method comprises the steps:

I) preparation of " extract ": take each component in the compositions of corresponding weight portion respectively and give as one thinks fit cataclasm, Mix homogeneously, makees solvent with the medicinal alcohol of water or 50-100%, with the solvent soakings of about 40 DEG C about Use after 0.5-1 hour and the method such as be heated to reflux and extract three times, extract 1.0-2.0 hour, total solvent amount every time For 15-20 (L/kg)；Backflow, after normal pressure is settlement separate, uses sucking filtration or centrifugal (4000rpm, 30min) One or both methods process obtain extracting solution；Extracting solution uses reduction vaporization to concentrate below 60 DEG C Or one or both method recycling design such as thin film concentration are to concentrate；Concentrate warp below 60 DEG C is true The methods such as sky is dried obtain " extract "；Suitable system can be prepared as after " extract " size-reduced one-tenth fine powder Agent.

II) preparation of " refined thing ":

(A): the process for purification of alcohol " extract ": " extract " is first after the process of water precipitating method, processing Preserving after " water precipitating thing " is vacuum dried, the remaining hydrotrope passes through AB-8, SP-825 or X-5 macropore Adsorption resin column, resin column blade diameter length ratio is 1: 6～1: 10, first the water elution with flow velocity as 2-9BV/h, Remove the impurity such as saccharide and inorganic salt to discard, then the ethanol gradient elution with 5%-100%, flow velocity is 3-10BV/h, collects eluent, and concentrating under reduced pressure final vacuum is dried and merges with aforementioned " water precipitating thing ", is " refined thing "；Or

(B): the process for purification of water " extract ": " water extract " obtains after precipitating with the ethanol of several times amount To " alcohol hypostasis " and " alcohol soluble substance ", in " alcohol hypostasis ", the impurity containing macromole discards；In the molten part of alcohol " water-insoluble " drying preserve；Its " hydrotrope " need to use macroreticular resin absorbing method or aramid layer Analysis method removes small molecular sugar and inorganic salt, it is possible to selective membrane isolation technics method carries out remove impurity；With blade diameter length ratio When being 1: 6～1: 10 Flavonoids by Macroporous Adsorption Resin remove impurity, first the water elution with flow velocity as 5-2BV/h, eliminates Small molecular sugar and inorganic salt discard, then the ethanol gradient elution with 5%-100%, and flow velocity is 3-10BV/h, Collecting eluent, concentrating under reduced pressure merges " refined thing " after drying with aforesaid " water-insoluble " dried object.

8. contain the arbitrary described Chinese medicine composition of claim 1-7 or its " extract " or " refined thing " Preparation；It is characterized in that described preparation includes external preparation or oral preparations, wherein said external preparation For gel, ointment, ointment, liniment, dress powder, lotion, liniment, paste, gas Mist agent, spray or emplastrum；Described oral preparations is tablet, granule, powder, pill, glue Wafer, syrup, drop pill, fluid extract, extractum or medicinal tea.

Preparation the most according to claim 8, it is characterised in that in external preparation, described gel, The water-soluble base that ointment or ointment mainly use includes: carbomer, glycerin gelatine, starch are sweet Oil, cellulose derivative, Polyethylene Glycol, alginate, tragcanth, gelatin or they any group The adjuvant closed；It is preferably carbomer gel substrate；Selectively include water-insoluble base or with water-soluble Property substrate combination use；The substrate of described liniment includes polyvinyl alcohol (PVA), polyvinyl alcohol contracting first and second Aldehyde, polyvinylpyrrolidone, carboxymethyl chitosan or carbomer, or their combination in any；Plasticising Agent includes glycerol, propylene glycol or dibutyl phthalate, or they combination in any.

10. the preparation method of Chinese medicine preparation described in claim 8 or 9, it is characterised in that:

(1) preparation method of the gel of described water-soluble base includes: take claim 1-4 arbitrary described Compositions or " extract " or " essence of Chinese medicine composition prepared through the arbitrary described method of claim 5-7 Thing processed " it is raw material medicine, take and be ground into fine powder in right amount；Weigh carbomer appropriate, with distilled water immersion 24 Hour obtain the carbomer clear gel of 2%-3% completely to the most swelling, move to overall process stirring under blender, PH to 3.5-4 adjusted by dropping triethanolamine, selectively, the most first adjusts or the rear PH adjusting carbomer Value；Separately take gained " extract " or " refined thing " fine powder, add by several times, it is also possible to be dissolved in propylene glycol or In propylene glycol and ethanol, (ethanol accounts for about the 10% of solvent) joins in carbomer gel by several times, stirs Mix uniformly, preservative ethyl hydroxybenzoate fine powder is dissolved in ultrasonic dissolution in propylene glycol, makes an addition to wherein, again Adding wetting agent glycerol, sodium thiosulfate antioxidant and laurocapram cutaneous permeable agent etc., stirring is all After even, dropping triethanolamine adjusts pH to 7, equidirectional being evenly stirred until only to form viscous gel agent, to obtain final product " extract " or the gel preparation of " refined thing "；With " extract " in the preparation that " extract " is crude drug Content can be 20-30%；In preparation with refined thing as crude drug, the content of refined thing can be 10%～20%；

(2) preparation method of described dermatologic liniment includes: select PVA (124,1750, Or 1788) or polyvinyl formal-acetal class water soluble film-forming material add purified water or 80% ethanol 80 DEG C heating in water bath soaks and is allowed to fully be swelled into faint yellow half mobility liquid, moves to full mistake under blender The lower operation of journey stirring, adding appropriate diethyl phthalate plasticizer mix homogeneously is (1) liquid； Take the arbitrary described compositions of claim 1-4 or the Chinese medicine prepared through the arbitrary described method of claim 5-7 " extract " of compositions or " refined thing " is raw material medicine, is crushed into impalpable powder, is dissolved in the third two In alcohol-ethanol；Add in (1) liquid by several times, mix homogeneously；Add the oxybenzene second being dissolved in propylene glycol again The placement that stirs of ester preservative and humidizer, guarantor's penetration enhancer, antioxidant is to bubble-free, and divided dose is loaded on In vial, seal and get final product；

(3) described ointment or the preparation method of ointment: take the arbitrary described combination of claim 1-4 Thing or " extract " or " refined thing " of Chinese medicine composition prepared through the arbitrary described method of claim 5-7 For raw material medicine, it is ground into impalpable powder, adds appropriate propylene glycol-ethanol and make dissolving standby；Separately take tristearin Acid, glyceryl monostearate, liquid Paraffin, azone oil phase substrate with selected from glycerol, water solublity sheep The aqueous phase substrate of hair fat and ethyl hydroxybenzoate is separately heated to 80 DEG C, is added by aqueous phase under blender stirs In oil phase, when being cooled to 40 DEG C, stirring is lower adds above-mentioned raw materials medicine lysate by several times, continues stirring straight To the most uniformly, to obtain final product；Artificially it is more conducive to absorb alternatively to the psoriasis with rotten to the corn skin ulcer face Tissue exudates, selects to use water-soluble base, and conventional has glycerin gelatine, cellulose derivative (CMC-Na), polyethylene glycols；Described preparation method includes: chooses full-bodied CMC-Na, adds After glycerol mixing, adding appropriate amount of purified water mixing, place after being gel to swelling, stirring is lower by several times Add above-mentioned raw materials medicine lysate, ethyl hydroxybenzoate water liquid, cutaneous permeable agent and antioxidant, continue Stirring is until completely uniformly, to obtain final product；

(4) preparation method of described tablet includes: take the arbitrary described compositions of claim 1-4 or warp " extract " or " refined thing " of Chinese medicine composition prepared by the arbitrary described method of claim 5-7 is former Material medicine, is ground into the fine powder of 80-160 mesh, adds appropriate amount of auxiliary materials (hydroxypropylcellulose, hydroxyl Beta cyclodextrin etc.) employing ethanol is wetting agent, pelletizes, drying under reduced pressure (50-70 DEG C) tabletting, coating, Obtain；

(5) preparation method of described granule includes: take the arbitrary described compositions of claim 1-4 or " extract " or " refined thing " of the Chinese medicine composition prepared through the arbitrary described method of claim 5-7 is Raw material medicine, is ground into the fine powder of 80-160 mesh；Using oligomeric lactose or dextrin is molding adjuvant, Spray drying, the technology of dry granulation is used to be prepared as granule；

(6) preparation method of described powder includes: take the arbitrary described compositions of claim 1-4 or warp " extract " or " refined thing " of Chinese medicine composition prepared by the arbitrary described method of claim 5-7 is former Material medicine, is ground into the fine powder of 80-160 mesh, sieves, mix homogeneously and get final product；Or

(7) preparation method of described capsule includes: take the arbitrary described compositions of claim 1-4 or " extract " or " refined thing " of the Chinese medicine composition prepared through the arbitrary described method of claim 5-7 is Raw material medicine, is ground into the fine powder of 80-160 mesh, and is added the methylcellulose of 1-2%, poly-silicon The adjuvant such as ketone or hydroxyethyl cellulose, makes medicated powder have good mobility, it is ensured that medicated powder is quickly smart Really insert snap fit capsule and get final product；The filling process of medicine needs The environment of 35%～45% is carried out.