CN105982970B - A Chinese medicinal composition for treating psoriasis, and its preparation method - Google Patents

Abstract

The invention relates to the field of traditional Chinese medicines, and particularly provides a traditional Chinese medicine composition for treating psoriasis, a preparation thereof and a preparation method thereof. The traditional Chinese medicine composition provided by the invention comprises the following traditional Chinese medicines in parts by weight: 20-80 parts of rheum officinale, 20-80 parts of radix sophorae flavescentis, 10-50 parts of artemisia anomala, 10-40 parts of pulsatilla chinensis and 5-30 parts of catechu. The invention also comprises a preparation method of the traditional Chinese medicine composition, a preparation containing the traditional Chinese medicine composition and a preparation method thereof, and pharmacological experiments and clinical tests prove that the traditional Chinese medicine composition has the characteristics of obvious curative effect on psoriasis vulgaris, high cure rate, no hormone toxic or side effect, and suitability for long-term use with psoriasis.

Description

A Chinese medicinal composition for treating psoriasis, and its preparation method

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating psoriasis, a preparation thereof and a preparation method thereof.

Background

Psoriasis is commonly called as psoriasis, and psoriasis in the concept of traditional Chinese medicine is a group of skin diseases of western medicine, including neurodermatitis, eczematous skin diseases and the like, and is not specifically referred to as psoriasis. The psoriasis dermatosis is recorded in the traditional Chinese medicine firstly in the theory of pathogenesis of all diseases in the Xichaoyuan prescription, which is called 'psoriasis' and 'tinea alba'; the medical books of Song, Ming and Qing dynasty are also called "Feng xuan", "Ping Pian xu", "Bai Bi", etc. Psoriasis is said to be inaccurate in nature, and because "stubborn and firm" skin rash is only one of the manifestations of psoriasis, many characteristic manifestations and histopathology, pathogenesis and genetic genes of psoriasis are fundamentally different from other skin diseases to which psoriasis belongs. Chinese has a history of more than 1400 years of writing on psoriasis, so far the root cause of the psoriasis is not completely cleared in the world, and the problem that the psoriasis is eradicated and does not relapse is not solved.

The clinical features of psoriasis with diagnostic value are mainly 3 phenomena: 1. wax droplet phenomenon: the primary rash is inflammatory papule or maculopapule with size from cap needle to hyacinth bean, is light red, can gradually expand or mutually fuse to form plaques, has clear boundaries, has slight red halo on the periphery, is covered with multiple layers of silvery-white scales on the surface, and scrapes layered scales like light scraping wax drops; 2. the thin film phenomenon: after the scales are lightly scraped, a layer of reddish and shiny semitransparent film is arranged; 3. punctate bleeding phenomenon: the film is scraped off, so that scattered small bleeding points can appear. The psoriasis has a long course, cannot quickly eliminate skin lesions, has slow effect and is mostly mild in summer and severe in winter. The disease can occur in all parts of the body, and the good hair parts are elbows, knees, heads and extending sides of four limbs, and occur symmetrically. Epidermal hyperplasia and angiogenesis in dermal papilla layers are the main pathological features of psoriasis, and genetic factors and environmental stimulation are two major factors of the psoriasis. The clinical manifestations of psoriasis are complex, are polygenic hereditary diseases, and involve some genetic polymorphisms of the immune system and keratinocyte abnormalities; its pathogenesis involves the following 4 major cell types: keratinocytes, lymphocytes, endothelial cells and neutrophils, of which the former two are the most critical. Most scholars believe that psoriasis is a chronic inflammatory disease mediated by T cells, activated T lymphocytes are proved to exist in epidermis and dermis in the psoriasis skin lesion, the activated T cells can release inflammatory factors, and therefore the inhibition of the activation of the T cells can directly inhibit normal skin from forming the psoriasis skin lesion; the T cell-based immune-mediated theory is a hot spot for many researchers to study.

The incidence of psoriasis is on the rise in recent years, which is closely related to the current environmental pollution, especially in young and old years, so the influence on the physical health and spirit of patients is great. The psoriasis has high incidence rate and long course of disease, is difficult to cure for decades, is easy to relapse after being resolved, and even cannot be cured for a long time, so the psoriasis cannot be cured radically, which becomes the current worldwide problem of dermatology.

The psoriasis is easy to diagnose clinically, and the current treatment methods mainly comprise three major types of external application, systemic treatment and physical treatment.

The dermatology department of Huashan Hospital, Zangzheng and Daizhi of Zangdan university: psoriasis vulgaris (accounting for about 95% of psoriasis) is treated externally. Professor dermatology, first hospital, Beijing university, also considers topical treatment of psoriasis as the safest first line treatment. The American Academy of Dermatology (AAD) published in 2009 "guidelines for psoriasis treatment for external use" indicating that 80% of psoriasis patients have mild to moderate disease states and are highly effective and safe when treated with external use alone. The external medicine is applied by skin application and patch to directly act on the lesion part, and the medicine is absorbed by the skin to enter the whole body blood circulation, thereby avoiding the adverse effects of liver first pass effect and intestine and stomach inactivation which may occur by oral administration and improving the treatment effect. At present, most of external medicines for clinically treating psoriasis are western medicines, including 1. glucocorticoid ointment preparations: halometasone, betamethasone dipropionate, fluocinonide, mometasone furoate (naloxone), clobetasone, dexamethasone, hydrocortisone butyrate, and the like; 2. vitamin D₃Derivative ointment preparation: cabriol, tacalcitol, calcitriol, and the like; 3. retinoid gels or emulsions: all-trans tretinoin, 13 cis tretinoin, tazarotene, etc.; 4. immunomodulators: methotrexate cytotoxic drugs, triptolide ointments, cyclosporins, and the like; 5. tar oils: 1-5% coal tar, 5% bran oil, 6. cytotoxic drug: 0.05% nitrogen mustard hydrochloride solution, etc.; 7. the antineoplastic agent is selected from BAIXUENING, AMOMETAXIN, SUBIANPURIN, and ETHYMINE. In addition, adjuvant therapeutic agents such as emollient, cutin promoter, and cutin debonding agent can be added. Although the medicines, especially glucocorticoid medicines, have the effects on psoriasis, some have strong effects and quick response, systemic adverse reactions are generated due to the absorption of the medicines after long-term large-scale external application, some are very serious, such as skin atrophy, telangiectasia, bacterial fungi and other secondary infections, even skin lesions rebound, aggravate and turn into pustular psoriasis, and the medicines also cause damage to hematopoietic systems and livers. The Chinese medicine is profound and urgentThe good product of the traditional Chinese medicine for treating psoriasis is developed. The 'quasi' word pure traditional Chinese medicine externally-applied preparation for treating psoriasis approved by the national food and drug evaluation center is few, and is clinically used as a hospital pharmacy preparation.

The traditional Chinese medicine is a great treasury, and the traditional Chinese medicine considers that the psoriasis is mainly caused by invasion of exogenous wind-toxin pathogenic qi caused by internal factors such as internal blood dryness, blood heat, blood deficiency, blood stasis and the like. Nearly modern doctors have more Chongming and clear viewpoints, famous old Chinese medical science such as Zhao' nan, Zhu ren kang, Zhou Ming Qi Qin and the like think that the occurrence of blood heat of psoriasis is a key factor, the excessive yang heat of the body is combined with the external attack of wind evil to cause the disease, and the disease consumes yin and blood for a long time, so that yin deficiency and blood dryness are caused, and the skin is not nourished. The rehabilitation therapy of the disease has internal treatment methods clinically: washing away tinea toxin, expelling pathogenic factors, expelling toxin, and harmonizing ying and wei; external treatment: kill tinea toxin and strengthen the wall and keep the body clean. At present, more traditional Chinese medicine preparations are clinically taken, and known as 'Keyin pill' and 'Keyin two prescription' of professor Zhurenkang in famous old traditional Chinese medicine; "blood cooling and toxicity removing decoction" of Zhao han nan old professor; "Xian Yin mixture" of Zheng Zhi faithful professor, etc. The Chinese pharmacopoeias of 2005 edition and 2010 edition successively take up 'Xiaoyin tablet' and 'psoriasis capsule'; and the external traditional Chinese medicine preparation approved by food and drug evaluation center and on the market is rarely seen clinically. It is urgent to develop and develop external traditional Chinese medicine treatment drugs which accord with the etiology and pathogenesis theory of psoriasis.

Disclosure of Invention

Aiming at the technical situation, the invention provides the traditional Chinese medicine compound composition for treating psoriasis, the preparation thereof and the preparation methods thereof, wherein the traditional Chinese medicine compound composition has definite curative effect and small toxic and side effect.

The traditional Chinese medicine composition mainly comprises two traditional Chinese medicines of a monarch drug, namely rhubarb and radix sophorae flavescentis; the prescription is from folk proved prescription, and the rhubarb and the lightyellow sophora root are determined to be used as two monarch drugs of the composition through laboratory and clinical pre-test. The traditional Chinese medicine composition is composed of 20-80 parts by weight of rheum officinale and 20-80 parts by weight of sophora flavescens; in a further embodiment, the content of the rhubarb is 30 to 70 parts, and the content of the sophora flavescens is 30 to 70 parts; in a further embodiment, the content of rhubarb is 35 to 65 parts, and the content of sophora flavescens is 35 to 65 parts; as a further embodiment, 40-60 parts of rumex madaio and 40-60 parts of sophora flavescens; in a further embodiment, the content of Rumex madaio is 30-50 parts, and the content of Sophora flavescens is 30-50 parts.

The invention also provides a traditional Chinese medicine composition consisting of rhubarb horsetails, flavescent sophora root and Siphonostegia chinensis Benth, wherein in the traditional Chinese medicine composition, rhubarb horsetails and flavescent sophora root are used as monarch drugs, and Siphonostegia chinensis Benth is used as minister drugs to play a role in promoting blood circulation and removing blood stasis; in one embodiment of the present invention, in the pharmaceutical composition comprising rheum officinale, sophora flavescens and artemisia peichiana, 20 to 80 parts of rheum officinale, 20 to 80 parts of sophora flavescens and 10 to 50 parts of artemisia peichiana are calculated by weight; preferably 20-50 parts of rheum officinale, 20-50 parts of radix sophorae flavescentis and 15-40 parts of artemisia anomala; in one embodiment, the traditional Chinese medicine composition comprises 30-50 parts of rumex madaio, 30-50 parts of radix sophorae flavescentis and 20-40 parts of artemisia anomala; in a further embodiment, the traditional Chinese medicine composition comprises 25-45 parts of rumex madaio, 25-45 parts of sophora flavescens and 20-35 parts of artemisia anomala.

The invention further provides a traditional Chinese medicine composition consisting of rhubarb root and rhizome, radix sophorae flavescentis, artemisia anomala, Chinese pulsatilla root and catechu, wherein the traditional Chinese medicine composition is composed of 20-80 parts of rhubarb root and rhizome, 20-80 parts of radix sophorae flavescentis, 10-50 parts of artemisia anomala, 10-40 parts of Chinese pulsatilla root and 5-30 parts of catechu by weight; in a further embodiment, the medicine comprises 20-50 parts of rheum officinale, 20-50 parts of radix sophorae flavescentis, 15-40 parts of artemisia anomala, 10-40 parts of pulsatilla chinensis and 10-30 parts of catechu; in a further embodiment, the rhubarb is 20 to 40 parts, the sophora flavescens is 20 to 40 parts, the artemisia anomala is 15 to 30 parts, the pulsatilla chinensis is 15 to 30 parts, and the catechu is 10 to 20 parts; in still another embodiment, the composition comprises 25 to 35 parts of rumex madaio, 25 to 35 parts of sophora flavescens, 15 to 25 parts of artemisia anomala, 15 to 25 parts of pulsatilla chinensis and 10 to 15 parts of catechu.

In the medicinal composition, the rhubarb and the radix sophorae flavescentis are monarch medicaments, and the artemisia anomala with the functions of activating blood circulation and removing stasis is added into the two monarch medicaments as a ministerial medicament; and adding radix Pulsatillae as adjuvant drug with effects of clearing heat, detoxicating, cooling blood, and Catechu as cathartic with effects of eliminating dampness, healing sore, promoting granulation and stopping bleeding.

Aiming at the causes of psoriasis vulgaris which are most common clinically, the Chinese medicinal composition selects the Chinese medicaments with the effects of clearing heat and cooling blood, clearing heat and drying dampness, dispelling wind and removing toxicity, promoting blood circulation to remove blood stasis, cooling blood and removing speckles, dispersing pathogenic accumulation and detumescence, relieving pain and itching and clearing heart fire to promote telangiectasis, improve the immunity of the organism and achieve the aim of treating psoriasis.

In the traditional Chinese medicine composition of the present invention, as one of the embodiments, the scientific names, the efficacy indications and the main material bases (chemical components) of the various medicines in the traditional Chinese medicine composition are as follows:

the Rumex madaio is dry root of Rumex madaio commonly called as multiple base sources in Rumex of Polygonaceae, and comprises wild and/or cultivated medicinal materials and decoction pieces and/or processed products thereof. Mainly comprises 16 varieties with a long history of medicine in the genus, wherein the first five varieties with local standards are preferred, namely, rumex patientia (R.patientia), rumex crispatus (R.crispus), rumex nebrodensis (R.nepalensis), rumex dentata (R.denttatus) and rumex obtusifolius (R.obtusifolius). Rumex japonicus (r. japonicum), rumex acetosa (r. acetosa), rumex acetosa (r. trisertifer), rumex dictyon (r. challepenisis), rumex gmelini (r. gmelinii), rumex angustifolia (r. stenophyllus), rumex aquaticum (r.aquaticus), rumex japonicus (r.psidontronatus), rumex longifolus (r.longifolius), rumex tianschanica (r.tianschanicanus) and rumex euphorbia (r.hastatus) are also known. The rumex patientia and rumex crispatus are recorded in the local standards of Beijing and Tianjin; niberr rumex acetosa and odontobutis acetosa are local standards of Guizhou; rumex blumei is the local standard of Anhui.

Tu Da Huang is cool in nature, bitter and pungent in flavor. It enters heart and lung meridians. The functional indications are as follows: clearing away heat and toxic material, cooling blood and arresting bleeding, purging fire and relaxing bowels, promoting blood circulation and removing blood stasis, killing parasites and treating . The clinical oral administration can treat constipation, diarrhea, hematochezia and other bleeding, constipation, upper respiratory tract infection, asthma, heat removal, and the like; it can be used for treating dermatoses such as alopecia areata , parasite killing, eczema, psoriasis, and fungal infection. The main chemical components are as follows: free anthraquinone: emodin, chrysophanol, and physcion; bound anthraquinone: emodin-8-0-beta-D-glucopyranoside, physcion-8-O-beta-D-glucopyranoside, chrysophanol-8-O-beta-D-glucopyranoside; and (3) flavonoids: kaempferol, kaempferol-3-0-alpha-L-rhamnopyranoside, quercetin-3-O-alpha-L-rhamnopyranoside, catechin, and epicatechin. Rumex acetosa and its glycosides, resveratrol, etc.;

the radix Sophorae Flavescentis is dried root of Sophra flavescens ait of Leguminosae, and comprises wild and/or cultivated medicinal materials and decoction pieces and/or processed products thereof;

flavescent sophora root: cold in nature and bitter in taste. It enters heart, liver, stomach, large intestine and bladder meridians. The functional indications are as follows: clear heat and dry dampness, kill parasites and induce diuresis. Can be used for treating dysentery with heat, hematochezia, jaundice, anuresis, leucorrhea with red and white discharge, vulvar swelling, pruritus vulvae, eczema, pruritus, and mustard leprosy; it can be used for treating trichomonas vaginitis. The main chemical components are as follows: contains 34 kinds of alkaloids including matrine, oxymatrine, oxysophocarpine, sophocarpine, sophoridine, and cytisine; contains 85 flavonoid compounds and 5 saponins mainly comprising norkurarinone, kurarinone and trifolioside.

The herba Artemisiae Anomalae is dry whole plant of Siphonostegia chinensis Benth of Scrophulariaceae, including wild and/or cultivated medicinal materials and decoction pieces and/or processed products thereof;

herba artemisiae anomala: cold in nature and bitter in taste. It is entered into spleen, stomach, liver and gallbladder meridians. The functional indications are as follows: promoting blood circulation, removing blood stasis, dredging meridians, relieving pain, cooling blood, stopping bleeding, clearing heat, promoting diuresis, relieving bitter taste, and clearing cold, and can be used for treating blood stasis and heat. Can be used for treating traumatic injury, traumatic hemorrhage, blood stasis, amenorrhea, menoxenia, puerperal pain, abdominal mass, dysentery, bloody stranguria, jaundice due to damp-heat pathogen, edema, abdominal distention, and leukorrhagia. The main chemical components are as follows: and (3) flavonoids: 5, 3 '-dihydroxy-4', 6, 7-trimethoxy flavone, 5, 7-dihydroxy-3, 4-dimethoxy flavone, apigenin, luteolin, etc. Quinic acid and ester compounds: 3, 4-dicaffeoylquinic acid, macranthoidin F, methyl 3, 4, 5-tricaffeoylquinic acid. Coumarins: 7-methoxycoumarin and 7-hydroxycoumarin. Organic acid: isoferulic acid, trans-p-hydroxycinnamic acid, 1R, 2R, 4R trihydroxy menthane and daucosterol.

The radix Pulsatillae is dried root of Pulsatilla chinensis (Bge) Regel of Ranunculaceae, including wild and/or cultivated medicinal materials and decoction pieces and/or processed products thereof;

the Chinese pulsatilla root: cold in nature and bitter in taste. It enters stomach and large intestine meridians. The efficacy is mainly as follows: clear heat and remove toxicity, cool blood and stop dysentery. The traditional Chinese medicine composition is clinically used for treating pyretic and bloody dysentery, yellow water dripping, eczema, eruption sore sound, rheumatism and pyretic arthralgia, jaundice and dark urine. The main chemical components are as follows: triterpenes and triterpenoid saponins: triterpene sapogenin and dozens of saponins with lupane type and oleanane type (hederagenin is main), coumarin: 4, 7-dimethoxy-5-methylcoumarin. Organic acids: betulinic acid and betulonic acid. Cardiotonic ingredients: anemonin, pulsatilla chinensis, anemonin, etc. Lignans: (+) -pinoresinol, podophyllotoxin B, etc.

The Catechu is the barked branch of Acacia catechu (L.f.) of Leguminosae, Willd, dried soft extract and/or processed product thereof.

Catechu: bitter, astringent and slightly cold in nature. It enters lung and heart meridians. The functional indications are as follows: promoting blood circulation to stop pain, stopping bleeding and promoting granulation, astringing dampness and healing sore, clearing lung-heat and eliminating phlegm. Can be used for treating traumatic injury, traumatic hemorrhage, hematemesis, epistaxis, unhealing pyocutaneous disease, eczema, and cough due to lung heat. The main chemical components are as follows: contains mainly flavonoid: catechin, epicatechin, kaempferol, quercetin, alfasin, epiafzeocin, kaempferol, 3, 4 ', 7 ' -trihydroxy-3 ', 5-dimethoxyflavone, catechin, epicatechin, bergamottin, etc.; phenol, 4-hydroxybenzoic acid, and the like.

The traditional Chinese medicine composition can be prepared into a plurality of compositions according to set weight parts, and as one embodiment, the composition can be extracted or refined to obtain an 'extract' or a 'refined product' of the composition; then the extracts and refined products are used as raw material medicaments of various external or internal preparations, and auxiliary materials are added to prepare various external or internal preparations.

As one embodiment, the Chinese medicinal composition of the present invention can be prepared according to an "extraction process", wherein the "extraction process" comprises the following steps:

the extraction step comprises: the extraction solvent is water or 50-100% medicinal ethanol solution; the extraction method comprises soaking, heating and refluxing, percolating after soaking, ultrasonic extracting, microwave extracting, decocting or supercritical fluid extracting; wherein the dipping time is preferably 0.5-1.0 hour; the extraction times are 1-4 times, preferably 3 times; the extraction time is 1.0-2.0 hours, and the total amount of the solvent used for extraction is 15-20L/Kg; extraction as one embodiment of the present invention, before water extraction or alcohol extraction, the medicinal materials of the components in the composition of the present invention may be cut into coarse particles or thin pieces, mixed uniformly according to the weight parts of the components, and then extracted.

And (3) filtering: by adopting normal pressure sedimentation separation, pressurization or vacuum filtration and centrifugal separation, the dregs can be removed in the step to obtain clear extraction solution.

A concentration step: vacuum concentration, film concentration and evaporation by a film evaporator are adopted; as one embodiment, the temperature of the concentration is 60 ℃ or less; this step makes it possible to obtain a concentrate of the composition according to the invention.

And (3) drying: vacuum drying, spray drying, freeze drying or microwave drying; as an embodiment, the drying temperature is also preferably below 60 ℃.

The extract of the traditional Chinese medicine composition obtained by the method contains active substances capable of treating psoriasis, and also contains a plurality of micromolecular compounds such as monosaccharide, disaccharide, oligosaccharide, inorganic salt and the like and macromolecular impurities such as pectin, mucus, protein, resin and the like.

In order to further increase the content of the active ingredient, the extract may be further refined as one embodiment of the present invention. Refining by water extraction and ethanol precipitation, alcohol extraction and water precipitation, macroporous adsorbent resin chromatography, polyamide chromatography, ion exchange resin chromatography or membrane separation. The content of refined product is about 35% of total extract, after treatment, the ineffective impurities in the extract can be removed, the effective components are retained to the maximum extent, the content is increased, and the curative effect of the medicine is improved. As one embodiment of the present invention, when the purification is carried out by a macroporous adsorption resin method, wherein the macroporous adsorption resin is selected from the group consisting of nonpolar, weakly polar, moderately polar or polar resins, preferably AB-8, SP-825, D101, DM-130, HP-20, HPD100, HPD400, HPD600, X-5 or NKA-9 resins; preferably a medium or low polarity resin; further preferably AB-8, X-5, SP-825, HPD400 or DM 130;

as one embodiment of the present invention, when the extract of the Chinese medicinal composition of the present invention is refined by ion exchange resin method, the resin is selected from cation exchange resins, preferably the resin is suitable for the alkaloid component contained in the composition;

as one embodiment of the invention, when the 'extract' of the traditional Chinese medicine composition is refined by adopting a polyamide chromatography, a material with the specification of 30-60 meshes is selected; as one embodiment of the present invention, when the "extract" of the Chinese medicinal composition of the present invention is refined by using a membrane separation technique, the membrane separation technique should use an ultrafiltration membrane to intercept organic impurities such as macromolecular pectin, mucus, protein, resin, etc., and use a reverse osmosis membrane to intercept impurities such as micromolecular sugar, inorganic salts, etc.

As one embodiment of the present invention, the preparation method of the Chinese medicinal composition comprises the following steps:

I) preparation of "extract": respectively taking the components in the composition according to the corresponding weight parts, crushing into coarse particles or cutting into slices, then uniformly mixing, adopting water or 50-100% medicinal ethanol as a solvent, soaking the components in the solvent at about 40 ℃ for about 0.5-1 hour, and then extracting for three times (as an exemplary illustration, 8 times, 6 times and 6 times of L/kg) by adopting a heating reflux method and the like, wherein the total solvent amount is 15-20(L/kg) after each extraction for 1-2 hours; after the reflux liquid is settled and separated under normal pressure, an extraction liquid is obtained by adopting a suction filtration or centrifugation (4000rpm, 30 min); recovering solvent from the extractive solution at below 60 deg.C by vacuum evaporation or thin film concentration to obtain concentrate; vacuum drying the concentrate at below 60 deg.C to obtain extract;

II) preparation of "refined product":

(A) the method comprises the following steps The refining method of the extract by taking 50-100% of medicinal ethanol as a solvent comprises the following steps: the extract is treated by a water precipitation method, the treated water-insoluble precipitate is stored after being dried in vacuum, and the residual water solution is separated by any one of macroporous adsorption resin columns such as AB-8, X-5, SP-825, HPD400 or DM130 or polyamide chromatographic columns of 30-60 meshes to remove impurities such as saccharides, inorganic salts and the like; eluting with water at flow rate of 2-9BV/h at resin column diameter-height ratio of 1: 6-1: 10, removing impurities such as micromolecular saccharides, inorganic salt and macromolecular pectin, mucus, resin, polysaccharide, protein, etc., until the impurities such as saccharides are washed out completely, and discarding; eluting with 5-80% ethanol at flow rate of 3-10BV/h, eluting with 95-100% ethanol, collecting eluate, vacuum drying, and mixing with the above water insoluble precipitate to obtain refined product; or

(B) Refining "extract" with water as solvent, precipitating "water extract" with ethanol in multiple times amount to obtain "ethanol precipitate", mainly containing impurities such as macromolecular pectin, mucus, protein, resin and polysaccharide, and discarding; removing impurities from the alcohol soluble part by macroporous resin adsorption, polyamide chromatography or membrane separation to remove small molecular monosaccharide, disaccharide, oligosaccharide and inorganic salt; the ratio of the solvent to the column diameter of the resin is 1: 6-1: 10 when the impurities are removed and refined by a macroporous resin adsorption method. As one embodiment of the invention, when polyamide chromatography is adopted for separation, the alcohol soluble part which is concentrated to a small volume can be repeatedly dissolved by water to obtain two parts of water soluble substance and water insoluble substance, and the water insoluble substance is directly dried under reduced pressure and stored in another container; separating the water-soluble part with polyamide chromatographic column, eluting with water as solvent, and detecting in time until no saccharide exists; then medicinal ethanol with different concentrations is used for gradient elution, and finally 95 percent to 100 percent ethanol is used for washing away adsorbate in the column; collecting ethanol eluate, concentrating by the above method including vacuum concentration and membrane concentration, and drying under reduced pressure to obtain "refined product". In one embodiment of the present invention, when a membrane separation technique is used, an ultrafiltration membrane is used to intercept macromolecular impurity components such as pectin, mucus, protein, and resin, and a reverse osmosis membrane is used to intercept small molecular impurity components such as saccharides and inorganic salts in the extract, thereby obtaining a "purified product".

As one embodiment, the "extract" or "refined extract" of the pharmaceutical composition of the present invention may be used as a raw material to prepare various external preparations or oral preparations, wherein the external preparations include, but are not limited to, gels, ointments, creams, plastics, powders, lotions, liniments, pastes, aerosols, sprays, or plasters; the oral preparation includes but is not limited to tablets, granules, powder, pills, capsules, syrup, dripping pills, fluid extract, extract or tea.

As one embodiment of the present invention, the water-soluble base mainly used for the gel, ointment or cream in the external preparation includes: carbomer, glycerogelatin, starch glycerol, cellulose derivatives, polyethylene glycol, alginate, tragacanth, gelatin starch or any combination thereof; preferably a carbomer gel matrix; optionally including or used in combination with a water-insoluble base; the matrix of the film coating agent comprises polyvinyl alcohol (PVA), polyvinyl formal acetaldehyde, polyvinylpyrrolidone, carboxymethyl chitosan or carbomer, or any combination thereof; the plasticizer comprises glycerin, propylene glycol, or dibutyl phthalate, or any combination thereof.

The preparation prepared by the invention should accord with relevant regulations of Chinese pharmacopoeia, and as one of the embodiments of the invention, the preparation preferably accords with the requirements of the general rule of Chinese pharmacopoeia appendix I preparation of 2010 edition.

As one embodiment of the present invention, when the formulation of the pharmaceutical composition is a gel, the water-soluble matrix of the gel comprises: carbomer, glycerogelatin, starch glycerol, cellulose derivatives, polyethylene glycol, alginate, tragacanth, or any combination thereof; preferably a carbomer gel matrix;

as one embodiment of the present invention, when the formulation of the pharmaceutical composition of the present invention is a film coating agent, the matrix of the film coating agent comprises polyvinyl alcohol (such as PVA124, 1750 or 1788 as an illustrative illustration), polyvinyl formal acetal, polyvinyl pyrrolidone, acrylic resin, carbomer or carboxymethyl chitosan, a plasticizer such as glycerin, propylene glycol or dibutyl phthalate, or any combination thereof;

as one embodiment of the present invention, when the formulation of the pharmaceutical composition of the present invention is an ointment or cream, the water-soluble base of the ointment or cream includes: glycerogelatin, starch glycerol, cellulose derivatives, carbopol, alginate, tragacanth or polyethylene glycol, or any combination thereof. The oil soluble matrix can be glyceryl monostearate, poly oxystearate (40), myristate, white vaseline or beeswax, or their mixture, and can be prepared into ointment or cream by conventional method.

By way of illustration, the traditional Chinese medicine composition is taken, wherein 35 parts of rheum officinale, 35 parts of radix sophorae flavescentis and 30 parts of artemisia anomala are calculated according to parts by weight, the three medicinal materials or decoction pieces are appropriately crushed into coarse particles or cut into slices to prepare a 'refined product' according to the method, and then the 'refined product' is used as a raw material medicine of a preparation to prepare the gel according to the following method. Taking 2g of carbomer-980, adding 50ml of distilled water, completely swelling, stirring with a stirrer, and adding triethanolamine serving as a pH regulator until the pH is about 4.0; the refined product of the composition is taken to pass through a 100-mesh sieve to be used as a medicine; dissolving 10g of medicine with 10g of 95% ethanol, 30g of propylene glycol and 5g of humectant glycerin; adding the solution into carbomer 980 in batches under stirring, dissolving 0.5g of ethylparaben fine powder in 5g of propylene glycol by ultrasonic wave, adding into the matrix under stirring, adding laurocapram serving as a transdermal absorbent, stirring uniformly in the same direction, adjusting pH to about 7.0 by using triethanolamine under stirring in the same direction, and adding purified water to 100 ml.

The ointment, the cream and the gel are externally applied semisolid preparations which are prepared by mixing the medicine and a substrate and are easily coated on skin, mucosa or wound surfaces. Wherein the emulsion matrix is also a cream; the water-soluble matrix is composed of natural or synthetic high molecular water-soluble substances, commonly used include glycerogelatin, starch glycerol, cellulose derivatives, carbopol, polyethylene glycol, and the like, or any combination thereof, and an exemplary preparation method comprises the following steps: selecting high-viscosity CMC-Na, adding glycerol, mixing, adding appropriate amount of purified water, standing to swell into gel, adding the above raw material solution, ethylparaben water solution, transdermal absorbent and antioxidant, stirring, and stirring to completely homogenize. The matrix releases the medicine quickly, has no greasiness, is easy to spread and wash away, has no irritation to skin and mucosa, can be mixed with aqueous solution and can absorb tissue exudate, so the matrix is mainly used for moistening and eroding sore surfaces, is beneficial to discharge secretion, and is particularly suitable for treating psoriasis patients.

The formulation of the pharmaceutical composition of the present invention may be prepared by those skilled in the art using common general knowledge in the art.

As one embodiment of the invention, the gel is prepared by adopting the following preparation method:

taking the 'extract' or 'refined product' of the traditional Chinese medicine composition, and crushing the 'extract' or the 'refined product' into fine powder; weighing an appropriate amount of carbomer, soaking in distilled water for 24 hours until swelling is complete to obtain 2% -3% carbomer transparent gel, transferring to a stirrer for stirring in the whole process, dropwise adding triethanolamine to adjust the pH value to 3.5-4, and optionally adjusting the pH value of carbomer firstly or secondly according to requirements; adding the fine powder of the obtained extract or refined product into carbomer gel, or dissolving in propylene glycol and ethanol (wherein ethanol content is controlled to be 10% or below), adding into carbomer gel, stirring, dissolving the fine powder of antiseptic ethylparaben in propylene glycol, ultrasonic dissolving, adding into it, adding humectant glycerol, sodium thiosulfate antioxidant and laurocapram transdermal absorbent, stirring, adding triethanolamine, adjusting pH to 7, and stirring in the same direction until viscous gel is formed. The content of the 'extract' in the 'extract' or 'refined product' gel preparation is 20-30% of the content of the 'extract' in the preparation of the raw material medicine; the content of the refined product in the preparation taking the refined product as the raw material medicine can be 10-20%.

As one embodiment of the present invention, a translucent gel may be prepared by the following method: adding polysorbate 80, polyethylene glycol 400 and glycerin into the traditional Chinese medicine composition or the 'extract' or 'refined product' of the traditional Chinese medicine composition, uniformly mixing, heating to dissolve, dissolving sodium carboxymethylcellulose and xanthan gum into 80ml of water, heating to 85 ℃, gradually adding the mixture into the solution of the 'extract' or 'refined product' of the traditional Chinese medicine composition or the 'extract' or 'refined product' of the traditional Chinese medicine composition, adding a transdermal absorbent azone, a propylene glycol solution of preservative ethylparaben fine powder and antioxidant sodium thiosulfate, uniformly stirring to 100ml while adding, and cooling at room temperature to obtain the translucent gel.

As one embodiment of the invention, the skin-applied film coating agent adopts the following preparation method: adding purified water or 80% ethanol into PVA124, PVA1750, PVA1788, polyvinyl formal acetaldehyde or film-forming materials of any combination thereof, heating and soaking in water bath at 80 ℃ to fully swell the mixture into yellowish semi-flowable liquid, moving the mixture to a stirrer for stirring in the whole process, adding a proper amount of diethyl phthalate plasticizer, and uniformly mixing to obtain a solution (1); taking the traditional Chinese medicine composition or the 'extract' or 'refined product' of the traditional Chinese medicine composition as a raw material medicine, crushing the raw material medicine into superfine powder, and dissolving the superfine powder in propylene glycol-ethanol; adding the mixture into the solution (1) in portions, and uniformly mixing; adding ethylparaben antiseptic, moisturizer, permeation-maintaining agent and antioxidant dissolved in propylene glycol, stirring, standing until no bubble exists, packaging in glass bottle, and sealing;

as one embodiment of the present invention, the ointment or cream is prepared by the following method: taking the traditional Chinese medicine composition or the extract or the refined product of the composition as raw material medicines, crushing the raw material medicines into fine powder, and adding a proper amount of propylene glycol-ethanol to dissolve the fine powder for later use as a liquid (1); alternatively, selecting oil phase matrix of stearic acid, glyceryl monostearate, liquid paraffin, azone and water phase matrix selected from glycerol and water soluble lanolin, respectively heating to 80 deg.C, adding water phase matrix into oil phase matrix under stirring, cooling to 40 deg.C, adding above solution (1) under stirring, adding antiseptic ethylparaben, antioxidant and penetration-protecting agent, and continuously stirring until completely uniform to obtain the final product; optionally, for psoriasis with erosive sore surface, the water soluble matrix is selected, such as glycerogelatin, cellulose derivative (CMC-Na), and polyethylene glycol; the preparation method comprises the following steps: selecting high-viscosity CMC-Na, adding glycerol, mixing, adding appropriate amount of purified water, mixing, standing to swell into gel, adding the above raw material medicine dissolved solution, ethylparaben water solution, transdermal absorbent and antioxidant, stirring, and stirring to completely homogenize;

other external preparations such as powder for external use are exemplified and the present invention can be prepared by the following method: taking the extract or refined product of the Chinese medicinal composition as raw material medicine, respectively pulverizing into fine powder, sub-dosing, sealing and packaging.

The tincture is a clear liquid preparation prepared by leaching or dissolving the medicine with ethanol with specified concentration, and can also be prepared by diluting with fluid extract. The following methods may be used as exemplary illustrations: taking any one of the traditional Chinese medicine compositions, the preparation method of the invention comprises the following steps: (1) the dipping method comprises the following steps: pulverizing the traditional Chinese medicine composition into fine powder, mixing uniformly, soaking for 48 hours by using 60% ethanol as a solvent, slowly percolating, collecting proper amount of percolate, adjusting the alcohol content to 60%, stirring uniformly, and filtering to obtain the traditional Chinese medicine composition. (2) A dissolution method: soaking the traditional Chinese medicine composition for 2 hours by using 70 percent ethanol as a solvent, heating, refluxing for 1.5 hours, filtering, refluxing medicine dregs for 2 times by using 70 percent ethanol, filtering, collecting 3 times of reflux filtrate, concentrating a proper amount, adjusting the reflux filtrate to a specified amount by using 70 percent ethanol and water to ensure that the alcohol content is 60 to 65 percent, and filtering to obtain the traditional Chinese medicine composition.

When the composition of the present invention is formulated into an oral preparation, as one of the embodiments of the present invention, when formulated into granules, the following methods including, but not limited to: (1) extraction: extracting the medicinal materials in the prescription by using a proper solvent (water and 50-95 percent), concentrating a water extracting solution to a certain concentration at the temperature of below 60 ℃ when water is selected for extraction, and completely precipitating by using 95 percent ethanol; concentrating the supernatant at below 60 deg.C to obtain soft extract; (2) and (3) granulating: adding appropriate amount of dried sugar powder or other excipient into the above concentrated soft extract, mixing, making soft mass with 70% ethanol as humectant, and granulating with granulator with 12-14 mesh sieve; (3) and (3) drying: and drying the wet granules in a low-temperature oven.

As an embodiment, the method of preparing the granule also includes: taking the 'extract' or 'refined product' of the traditional Chinese medicine composition as a raw material medicine, and crushing the raw material medicine into fine powder of 80-160 meshes; using oligolactose or dextrin as forming auxiliary material, and adopting spray drying and dry granulation technology to prepare granules;

as one embodiment of the present invention, when made into tablets, methods including, but not limited to, the following may be employed: taking the 'extract' or 'refined product' of the traditional Chinese medicine composition as a raw material medicine, crushing the raw material medicine into fine powder of 80-160 meshes, adding a proper amount of auxiliary materials (hydroxypropyl cellulose, hydroxyl beta cyclodextrin and the like) and adopting ethanol as a wetting agent, granulating, drying under reduced pressure (50-70 ℃) and tabletting, and coating to obtain the traditional Chinese medicine composition;

as one embodiment of the present invention, when made into capsules, methods including, but not limited to, the following may be employed: the extract or refined product of the traditional Chinese medicine composition is taken as a raw material medicine, the extract or refined product is crushed into fine powder of 80-160 meshes, and 1-2% of auxiliary materials such as methyl cellulose, silicone or hydroxyethyl cellulose and the like are added, so that the medicine powder has good fluidity, the medicine powder is ensured to be quickly and accurately filled into a gelatin hard capsule, and the medicine is filled in an environment with the temperature of about 25 ℃ and the relative humidity of 35-45%.

As an embodiment of the present invention, when making a powder, methods including, but not limited to, the following may be employed: the extract or refined product of the Chinese medicinal composition is taken as a raw material medicament, and is crushed into 80-160 meshes of fine powder, sieved and uniformly mixed to obtain the Chinese medicinal composition.

A liquid extract is prepared through extracting the active components from Chinese-medicinal materials with proper solvent, steaming, regulating concentration to predefined standard, immersing, percolating, and semi-countercurrent multi-stage extracting. The present invention may be prepared by the following method as an exemplary illustration. The preparation method comprises the following steps: extracting with water or 50-95% ethanol as solvent to obtain extract.

The pharmaceutical composition can be used for external application and oral administration, the focus is treated by using the ointment for external application, and the oral administration is used for consolidating the curative effect and preventing relapse. The extract or the refined product of the composition and the preparation thereof are proved to have obvious curative effect on psoriasis vulgaris, high cure rate and no hormone toxic or side effect by pharmacological and pharmacodynamic experiments and clinical pre-tests, and are suitable for the characteristics of long course of psoriasis and long-term use.

Drawings

FIG. 1: the invention relates to an observation result chart under a light microscope after treatment of the pharmaceutical composition and the control preparation.

Detailed Description

The present invention is further illustrated by the following examples and experimental examples, but the present invention is not limited thereto.

Preparation of Chinese medicinal composition

Example 1

The components (parts by weight): 700g of rhubarb and 300g of lightyellow sophora root;

the preparation method comprises the following steps: respectively crushing the two medicines, respectively mixing the two medicines according to the weight parts, adding 8 times, 6 times and 6 times of 50 percent medicinal ethanol of the total weight of the components, reflux-extracting for 3 times, 2 hours for the 1 st time and 1.5 hours for the 2 nd to 3 th times respectively, combining the 3 times of extracting solutions, filtering by using a plurality of layers of gauze after sedimentation and separation, centrifugally separating turbid parts at the bottom layer, concentrating the extracting solution under reduced pressure below 60 ℃ to obtain thick paste, and drying the thick paste to a vacuum dryer to obtain the 'extract'.

Example 2

The components (parts by weight): 600g of rhubarb and 400g of lightyellow sophora root

The preparation method comprises the following steps: cutting the above two materials, mixing, adding 8 times, 7 times and 5 times of 70% medicinal ethanol, reflux-extracting for 3 times, 1 st 2 hr, 2-3 times each for 1.5 hr, mixing 3 times of extractive solutions, precipitating, separating, filtering with nylon cloth, centrifuging turbid part, concentrating the extractive solution at below 60 deg.C under reduced pressure to obtain soft extract, dissolving the soft extract with water repeatedly, drying water insoluble part, and storing; separating water soluble part with AB-8 macroporous adsorbent resin with column diameter/height ratio of 1: 8, eluting with 4-8BV/h water until impurities such as saccharide are completely removed, and discarding. Eluting with 5-80% ethanol at flow rate of 2-10BV/h, eluting with 95-100% ethanol, collecting eluate, vacuum drying, and mixing with the above water insoluble dry extract to obtain refined extract. The refined product can be used as raw material medicine to make various external and oral preparations.

Example 3

The components (parts by weight): 350g of rhubarb and 650g of lightyellow sophora root

The preparation method comprises the following steps: cutting the above two materials, mixing, adding 8 times, 6 times and 6 times of purified water, reflux-extracting for 3 times, 1 time for 2 hours, 2-3 times for 1.5 hours, filtering after 3 times of extraction solution is settled and separated, concentrating the extraction solution under reduced pressure below 60 deg.C to obtain soft extract, and drying the soft extract in vacuum drier to obtain the final product.

Example 4

The components (parts by weight): 300g of rhubarb, 450g of lightyellow sophora root and 250g of Siphonostegia chinensis

The preparation method comprises the following steps: respectively crushing the three medicines, respectively mixing the three medicines according to the weight parts, adding 8 times, 7 times and 5 times of 60% medicinal ethanol of the total weight of the components, performing reflux extraction for 3 times, wherein the extraction time is respectively 2 hours, 1.5 hours and 1.0 hour, combining the 3 times of extraction solutions, performing sedimentation separation, filtering by using a plurality of layers of gauze, performing centrifugal separation on turbid parts at the bottom layer, concentrating the extraction solution at the temperature of below 60 ℃ under reduced pressure to obtain thick paste, and drying the thick paste in a vacuum dryer to obtain the 'extract'.

Example 5

The components (parts by weight): 400g of rhubarb, 300g of lightyellow sophora root and 200g of Siphonostegia chinensis

The preparation method comprises the following steps: the three medicines are cut off, mixed evenly according to the weight portion, crushed into fine powder, sieved and mixed evenly, each 100g of powder is added with 20-30g of refined honey and proper amount of water to be made into pills, and the pills are dried and prepared into water-honeyed pills.

Example 6

The components (parts by weight): 350g of rhubarb, 350g of lightyellow sophora root and 300g of Siphonostegia chinensis

The preparation method comprises the following steps: the three medicines are cut off, the three medicines are respectively and uniformly mixed according to the weight part, 70 percent medicinal ethanol with the weight of 8 times, 6 times and 6 times of the total weight of the components is added for reflux extraction for 3 times, the 1 st time is 2 hours, the 2 nd time to 3 rd time is 1.5 hours respectively, the 3 times of extracting solution is filtered after sedimentation separation, and the extracting solution is decompressed and concentrated to thick paste below 60 ℃. Dissolving the soft extract with water repeatedly, drying the obtained water insoluble part, and storing in another container; separating water soluble part with polyamide column (resin column diameter/height ratio of 1: 8) chromatography, eluting with 8-2BV/h water, detecting in time until no sugar is present, and discarding; gradient eluting with 5-80% medicinal ethanol, and eluting with 95-100% ethanol to remove adsorbate; collecting ethanol eluate, concentrating under reduced pressure below 60 deg.C, vacuum drying below 60 deg.C, and mixing with the water insoluble dry extract to obtain refined extract.

Example 7

The components (parts by weight): 350g of rhubarb, 250g of radix sophorae flavescentis, 150g of artemisia anomala, 150g of Chinese pulsatilla root and 100g of catechu

The preparation method comprises the following steps: respectively crushing the five medicines, respectively mixing the medicines uniformly according to the weight parts, adding 70 percent medicinal ethanol with the weight of 8 times, 6 times and 6 times of the total weight of the components, refluxing and extracting for 3 times, 1 time for 2 hours, 2-3 times for 1.5 hours respectively, filtering after settling and separating 3 times of extracting solution, concentrating the extracting solution at the temperature of below 60 ℃ under reduced pressure until no alcohol smell exists, precipitating with purified water with the quantity of several times to obtain a 'water precipitate' and a 'water soluble substance', and storing the 'water precipitate' after vacuum drying; passing the water-soluble substance through an AB-8 or SP-825 macroporous adsorption resin column with the diameter-diameter ratio of 1: 6-1: 10, eluting with water at the flow rate of 2-9BV/h, removing impurities such as saccharides and inorganic salts, discarding, gradient eluting with 5% -100% ethanol at the flow rate of 3-10BV/h, collecting the eluate, concentrating under reduced pressure, vacuum drying, and mixing with the water precipitate to obtain a refined substance;

example 8

The components (parts by weight): 300g of rhubarb, 300g of radix sophorae flavescentis, 200g of artemisia anomala, 150g of Chinese pulsatilla root and 50g of catechu

The preparation method comprises the following steps: respectively crushing the five Chinese medicines, respectively mixing the five Chinese medicines according to the weight parts, adding 8 times, 6 times and 6 times of purified water of the total weight of the components, refluxing and extracting for 3 times, wherein the extraction time is respectively 2 hours, 1.5 hours and 1.5 hours, combining the 3 times of extracting solutions, filtering by using a plurality of layers of gauze after settling and separating, centrifugally separating turbid parts at the bottom layer, concentrating the extracting solution under reduced pressure below 60 ℃ to obtain thick paste, and drying the thick paste to a vacuum dryer to obtain the 'extract'.

Example 9

The components (parts by weight): 250g of rhubarb horsetails, 250g of flavescent sophora root, 200g of Siphonostegia chinensis Benth, 200g of Chinese pulsatilla root and 100g of catechu

The preparation method comprises the following steps: respectively crushing the five Chinese medicines, respectively mixing the five Chinese medicines according to the weight parts, adding 8 times, 6 times and 6 times of 80% medicinal ethanol of the total weight of the components, performing reflux extraction for 3 times, wherein the extraction time is respectively 2 hours, 1.5 hours and 1.0 hour, combining the 3 times of extraction solution, performing sedimentation separation, filtering by using a plurality of layers of gauze, performing centrifugal separation on turbid parts at the bottom layer, concentrating the extraction solution at the temperature of below 60 ℃ under reduced pressure to obtain thick paste, and drying the thick paste in a vacuum dryer to obtain the extract.

Preparation of the formulations

EXAMPLE 10 preparation of gels (two ingredients)

The raw materials of the preparation are as follows: 30g of the raw material drug (extract) obtained in example 1 was taken, pulverized and sieved with a 100-mesh sieve.

Preparation of the preparation: selecting 2g carbopol-974 as gel matrix, adding 50ml of purified water, swelling for 24 hours, adjusting pH to 4 with triethanolamine, and stirring uniformly in a stirrer; taking 30g of the extract in example 1, dissolving the raw material powder with 40ml of propylene glycol, 5ml of glycerol and 5ml of ethanol respectively, adding the raw material powder into the carbomer gel matrix in portions, and stirring uniformly while adding; adding 4% of laurocapram as transdermal absorbent, 3 ‰ of ethylparaben antiseptic (ground) and 3 ‰ of sodium thiosulfate antioxidant under stirring, adjusting pH to 7 with triethanolamine, and stirring in the same direction to obtain uniform and fine hydrophilic gel.

EXAMPLE 11 preparation of gels (three ingredients)

The raw materials of the preparation are as follows: 10g of the "refined product" obtained in example 6 was taken, pulverized and sieved with a 100-mesh sieve.

Preparation of the preparation: dissolving sodium alginate 3g in 50ml purified water to form viscous gel, dissolving the fine powder with 35ml propylene glycol and 10ml glycerol, and stirring; dissolving 3 ‰ of ground ethylparaben antiseptic in 5ml propylene glycol under ultrasonic wave, adding 3% laurocapram transdermal absorbent, and stirring in the same direction; slowly adding sodium alginate viscous gel, stirring and mixing well in a stirrer to obtain the final product.

EXAMPLE 12 preparation of gel (five ingredients)

Preparation raw materials: 30g of the "extract" obtained in example 8 was ground and sieved through a 120-mesh sieve.

Preparation of the preparation: mixing the above 30g raw material powder, 2ml polysorbate 80, 10g polyethylene glycol 400 and 40ml propylene glycol, heating to 80 deg.C to obtain transparent solution, stirring with a stirrer, and adding 3 ‰ antiseptic ethylparaben and 3% laurocapram; dissolving 1g of xanthan gum and 2g of sodium carboxymethylcellulose in 45ml of water, heating to 85 ℃ to prepare a matrix solution, gradually adding the matrix solution into the medicinal solution while stirring uniformly, finally adding water to 100ml, and cooling at room temperature to obtain semitransparent gel.

EXAMPLE 13 preparation of film coating Agents

Preparation raw materials: taking the refined product prepared in the above example 2 as a raw material medicine, sieving with a 120-mesh sieve

Preparation of the preparation: respectively taking PVA17-88 (with the concentration of 10%) and carbopol-940, placing the PVA17-88 and the carbopol-940 into two beakers respectively, swelling the PVA17-88 with 5 times of purified water and the carbopol-940 with 60% ethanol under magnetic stirring, respectively heating and swelling in a water bath at 90 ℃ to form mucilage (taking the condition that no block is seen as a standard), and filtering with gauze for later use. Adding glycerol, tween-80 and ethyl p-hydroxybenzoate into ethanol, stirring to dissolve, adding the above fine powder under stirring, adding PVA17-88 and carbopol-940 mucilage, mixing, adding ethanol and purified water to full dose, adding triethanolamine solution to adjust pH to 7, and ultrasonic oscillating until no bubbles.

EXAMPLE 14 preparation of tablets

Preparation raw materials: the extract of the above example 8 is used as the raw material of the preparation

The preparation method of the preparation comprises the following steps: pulverizing the dried extract to 100-120 mesh, adding appropriate amount of starch, mixing, granulating, drying, and tabletting.

EXAMPLE 15 preparation of granules

Preparation raw materials: the extract of the above example 4 is used as the raw material of the preparation

The preparation method comprises the following steps: pulverizing the dried extract of example 4 and sieving with 80 mesh sieve to obtain dried extract powder; taking the dry extract powder and dextrin according to the weight part ratio of 2: 1, adding 85% ethanol accounting for 30% of the total weight of the dry powder and the dextrin as a wetting agent, adding stevioside accounting for 2% of the total weight of the dry powder and the dextrin, preparing a soft material, sieving with a 16-mesh sieve, granulating, drying at 50 ℃, finishing granules, and subpackaging to obtain a finished granule product.

Experimental example 1 comparative study of the effects of topical administration of samples 1-4 on treatment of an experimental psoriasis model

Preparation of a sample: weighing refined dry medicinal powder of 1-4 samples (the specific medicinal composition and proportion of each sample are shown in Table 1), mixing with propylene glycol to obtain corresponding soft extract, and adding appropriate amount of percutaneous absorption enhancer.

TABLE 1 pharmaceutical compositions and ratios of test substance samples 1-4 (refined products)

Note: 1) sample 1 was prepared as in sample 2.

2) Sample 1 served as a unilateral control of rhubarb.

1.1 Effect of samples 1-4 on Propranolol hydrochloride-induced model of psoriatic lesions in the auricle skin of guinea pigs

60 guinea pigs with the weight of 300-350 g are taken, and the male and female guinea pigs are randomly divided into 10 normal control groups and 50 model groups according to sex and weight. The normal control group did not have any treatment, and the left auricle back skin of each animal in the model group was quantitatively coated with 5% propranolol hydrochloride emulsion by a 1ml syringe to make a model, 0.1ml/cm2, 2 times daily (interval 6h or more) for 2 weeks. After 24h of the last molding, the molding lateral auricle skin specimens of 2 guinea pigs in each of the normal group and the model group were removed, fixed with 10% formaldehyde, and subjected to HE staining and light-lens observation to evaluate the molding quality.

The 48 guinea pigs of the model building set were divided into 6 groups of 8 animals each based on the thickness of the auricle on the model building side, and the experiment was divided into a model group, a positive drug halometasone ointment control group, and samples 1 to 4 groups. The sample group and the positive control group are respectively applied and administrated for 2 times (more than 6h interval) every day for 2 weeks. The normal control group was not treated and the model group was given an equal volume of the drug matrix propylene glycol. In each group of experiments during the administration period, the thickness of the auricle of the animal is measured every other day by using a vernier caliper, and the hardness, the skin color and the scale change condition of the auricle at the administration side are observed by naked eyes. After 2 weeks of administration, the left (application) auricular skin of guinea pigs was surgically removed, fixed with 10% formaldehyde, embedded in paraffin, HE stained, and the changes of the cornified, granular, spinous, basal and lamina layers of the auricular skin were observed under a light microscope. After statistical treatment, samples 2-3 were compared for significant differences from the rhubarb khaki (sample 1).

As a result: visual observation shows that the auricle thickness of each tested medicament shows thinning and softening to different degrees, the color also tends to be normal, and silvery scales gradually disappear on the 7 th day after the medicament is applied to the samples 1, 2, 3 and 4 and the positive medicament halometasone ointment group. The auricle thickness of each sample was significantly reduced after 14 days of administration as compared with the model group, and the results are shown in Table 1-1.

Table 1-1 comparison of the effects of samples 1-4 on guinea pig pinna thickness (X ± SD, n ═ 8)

Note: comparing P with model control group to be less than 0.05; p < 0.01; p < 0.005; p < 0.001;

② compared with the sample 1 group, # P < 0.05; the same applies below.

As can be seen from the results in tables 1-1, the thickness of auricles of mice in the model group of propranolol hydrochloride is obviously higher than that of the normal control group (P is less than 0.001), which indicates that the model of psoriasis-like skin damage of auricles of guinea pigs caused by propranolol hydrochloride is successful. Samples 1, 2, 3, and 4 significantly reduced the pinna thickness of model guinea pigs (P < 0.05 or P < 0.01) when compared to the model control group; the action strength of the samples 2 and 3 is obviously better than that of the sample 1(P is less than 0.05); sample 4 showed a certain trend of action compared to sample 1, but was not statistically different (P > 0.05).

Normal cavy auricle skin can be seen as complete and homogeneous horny layer under a light microscope; the granular layer is linear, obvious black granules are arranged on two sides, and about 1-3 layers are formed; most of the echinocyte layer is angular cells, and the number of the echinocyte layer is about 4-6; the basal layer is a monolayer of columnar cells, and the mitotic term is reduced; the lamina propria is loose connective tissue; no obvious abnormalities were observed in the hair follicles. The keratosis of the stratum corneum of the model group is incomplete or excessive, the acanthocyte layer becomes thick, about 5-8 layers, and 2/3 cell nuclei are vacuolated; the mitotic phase of the basal layer is less, and more dark brown granular cells exist in the cytoplasm of the basal layer of a part of segments; the lamina propria is engorged with individual segments. Each sample group can see the whole horned layer, and only individual animals can see the uneven thickness or the loose network shape; the granular layer is composed of more black brown granules; thinning the acanthocyte layer, about 3-7 layers, and about 1/5 cell nuclei vacuolation (limitation); the stratum basale cell division phase is reduced, no obvious brown particles are seen, and no obvious abnormality is seen in the submucosal hair follicle. The result indicates that the samples 1 to 4 have obvious inhibiting effect on the psoriasis-like skin damage of the auricles of the guinea pigs caused by the drug-induced propranolol hydrochloride, and the samples 1 to 4 can obviously improve the pathological damage of the auricles of the guinea pigs. And the treatment effects of samples 2-4 are all significantly better than sample 1. The specific results are shown in figure 1.

1.2 Effect on mouse Tail scaly epidermis

60 healthy ICR mice with the weight of 18-22 g and half of each sex are divided into 6 groups of 10 mice each according to sex and body mass balance. The group is divided into a substrate control group, a positive control drug clobetasol propionate group (0.02%) and a sample 1-4 group. Experiment mice in each group are applied with medicine on tail skin for 2 times (more than 6h interval) every day, the mice are sacrificed after continuously applying the medicine for 14 days, the dorsal epidermis at the position about 1.5cm away from the tail root is taken and fixed by 10 percent formaldehyde, and conventional tissue section and HE staining are carried out. Changes of the cutinized layer, the granular layer, the spinous cell layer, the dermal layer and the hair follicle of the skin of the rat tail epidermis were observed under an optical microscope, and the number of scales formed with the granular layer among 100 scales was counted (the scale formed with the granular layer was counted when the scale epidermis between two hair follicle mouths had the granular layer arranged in a row). The pathological histological observation result shows that the tail epidermal granular cells of the mice in the normal group are fewer and the structure is normal. The horny layer of the positive medicine group is uneven, some sections disappear, the granular layer has more small granules, and the thickness of the spinous cell layer is 4-5 layers. The visible part of the angular layer of the section in the groups 1-4 of the samples disappears, the particles in the particle layer are more, and the thickness of the echinocyte layer is 3-4 layers. The results show that samples 1-4 and the positive control drug can obviously induce the formation of the epidermal granular layer of the tail scales of the mice 2 weeks after the external smearing drug is applied, and the results suggest that each sample group has a good treatment effect on the main pathological manifestations of keratosis and the like. The drug effect of the groups 2-4 is more obvious than that of the group 1. The results are shown in tables 1-2.

Table 1-2 effect of samples 1-4 on formation of epidermal grain layer of tail scales in mice (n ═ 10)

1.3 inhibitory Effect on Balsamine oil-induced auricle inflammation in mice

In patients with severe psoriasis, inflammation phenomena such as redness, swelling, heat, pain, etc., are present in different degrees at the skin lesion site due to long-term skin lesions of the skin, and thus the inhibitory effect of samples 1 to 4 on exudative inflammation is experimentally observed and compared with the anti-inflammatory effect of sample 1.

70 Kunming mice with the weight of 18-22 g are respectively half female and half male. The groups were randomly divided into 7 groups of 10 individuals according to body mass. The test method comprises the steps of dividing the test animal into a normal control group, an inflammation model group, a positive halometasone ointment group and a sample 1-4 groups, applying the test animal to the back of the right auricle of the mouse every day (taking the left ear as the self control), and continuously applying the test animal for 7 days 1 time every day. The normal control group auricles were not treated and the croton oil model group mice were given the drug matrix propylene glycol. 1 hour after the last application of the drug, each test object is washed by warm water, 50ul of croton oil samples with the amount of 2% are respectively smeared on the right side auricle front side and the back side of each group of mice except a normal control group, each test object group is smeared once again after 3 hours, 1 hour after the last application of the drug, the mice are killed, double ears are cut off, ear pieces are punched by a puncher with the diameter of 8mm, the weight difference between the two ears is accurately weighed, and the weight difference value between the two ears is taken as a swelling value. After statistical treatment, a t-test was performed between groups to compare the significance of the anti-inflammatory effect. The results are shown in tables 1-3.

Table 1-3 study of inhibition of croton oil-induced auricular inflammation in mice (X ± SD, n ═ 10) in samples 1-4

The results show that samples 1-4 have obvious inhibition effect on croton oil-induced mouse auricle exudative inflammation (compared with a model group, P is less than 0.05, P is less than 0.01 or P is less than 0.005), and the anti-inflammatory effect of samples 2, 3 and 4 is stronger than that of sample 1. Anti-inflammatory intensity sample 2 > sample 3 > sample 4 > sample 1.

In summary, each sample of each composition of the present invention showed significant anti-psoriasis effect, and samples 2-4 were approximately close in intensity.

Experimental example 2 comparative study of the Effect of oral administration of samples 1-4 on treatment of Experimental psoriasis models

Preparation of a sample: the dry medicinal powder of the refined products of the samples 1 to 4 is weighed according to the experimental example table 1, and is prepared into uniform suspension liquid medicine by purified water.

2.1 therapeutic Effect of intragastric administration of samples 1-4 on Propranolol hydrochloride-induced psoriasis-like skin lesions of cavy auricle skin

60 guinea pigs with the weight approximately same as that of the experiment 1.1 are selected, the molding method and the grouping condition are the same as the experiment 1.1, and the psoriasis is used as the positive control drug for oral administration in the experiment. The model group is not treated at all during the administration period and is used as a skin lesion model natural recovery control group; each sample group was administered by gavage 1 time a day, 0.333ml/100g body weight, continuously for 2 weeks, and the thickness of auricle of each test animal was measured with a vernier caliper every other day during the administration period, and the color and hardness change of auricle epidermis was observed. On day 14 post-dose, guinea pig left auricle skin was surgically dissected, fixed with 10% formaldehyde, paraffin embedded, HE stained, and changes in the cornified, granular, echinocyte, basal and lamina layers of the ear were observed with light microscopy.

As a result: the samples 1 to 4 and the positive medicine psoriasis group are observed by naked eyes, the auricle thickness of the guinea pig is thinned and softened in different degrees in 7 days after the medicine is taken, and the skin color is obviously improved compared with the condition of the model group; samples 1-4 and the positive drugs showed a clear decrease in pinna thickness of each of the tested drugs in the psoriasis treatment group compared to the model group by visual observation 14 days after the drug administration (the results are shown in tables 2-1). The pathological histology optical microscopy results prove that the auricle skin tissues of the normal control group are normal; extensive or focal parakeratosis can be seen in auricles on the model side of animals with the model group, the stratum granulosum becomes thinner or disappears, and most animals have the characteristics of thickened spinous layer, prolonged epicutaneous process, infiltration of single and multi-shaped nucleus cells of dermis, expansion of capillary vessels and the like. However, samples 1-3 all had significant improvement over the model group, which resulted in decreased parakeratosis, decreased inflammatory cell infiltration, and a thinner epidermal layer. The results of the normal control and the model control group in the light microscope are basically the same as those of experiment 1.1. The thickness of the pinna in the guinea pigs in each of the groups of samples 1-4 was significantly lower than in the model group (P < 0.01, P < 0.005 or P < 0.001). However, no statistical difference was observed between samples 2-4 compared to sample 1. The results are shown in Table 2-1.

TABLE 2-1 Effect of intragastric administration of samples 1-4 Propranolol hydrochloride on psoriasis-like lesions in guinea pigs (X + -SD, n ═ 8)

Note: p < 0.05, P < 0.01, P < 0.005, P < 0.001, as compared to the model control group, as follows.

2.2 Effect of intragastric administration of samples 1-4 on mouse Tail scale epidermis

60 ICR mice with the weight of 18-22 g are respectively taken, and the weight is half of that of the ICR mice. The animals were divided into groups and the experiment 1.2 was identical except for the positive control drug, psoriatin. Experiment each group of animals adopts gastric lavage for administration for 1 time per day, the administration is continuously carried out for 14 days, the mice are killed 24 hours after the last administration, the dorsal epidermis at the position about 1.5cm away from the tail root is taken, and the conventional tissue section and HE staining are carried out. Changes in the horny layer, granular layer, spinous cell layer, dermal layer and hair follicle of the skin of the rat tail were observed under an optical microscope, and the number of scales formed with granular layer among 100 scales was counted. The result shows that the epidermis of the tail scales of the normal mice naturally lacks a granular layer, the horny layer keratinocytes of the epidermis of the tail scales of the mice retain cell nuclei, granular cells of the granular layer are absent, only a small amount of granular cells exist at hair follicles, and the epidermis is thinner. The tested samples 1, 2, 3 and 4 all have obvious promotion effect on the formation of epidermal granular layer of the rat tail scales (compared with a blank control group, P is less than 0.05 or P is less than 0.01). The results suggest that samples 1-4 have obvious therapeutic effects on major pathological manifestations such as mouse caudal keratosis incompetence, and the action strengths of sample 2 and sample 3 are relatively superior to those of sample 1 and sample 4. The results are shown in Table 2-2.

Table 2-2 effect of intragastric administration on epidermal granulation at the tail of mice (X ± sd, n ═ 10)

2.3 anti-inflammatory action of intragastric gavage 1-4 on croton oil-induced auricular inflammation in mice

70 male Kunming mice with the weight of 18-22 g are taken, and the grouping conditions of the animals are the same as those in experiment 1.3. Each group of experiment is administrated by intragastric administration every day, and the medicine is continuously administrated for 7 days. 1 hour after the last administration, 50ul of croton oil samples with 2% of each amount are smeared on the front and back surfaces of auricles of the other groups of mice except for a normal control group by using an injector, each test group is administered once after 3 hours, the mice are killed 1 hour after the last administration, both ears are cut off, the ears are punched by a puncher with the diameter of 8mm, the weight is accurately weighed, and the difference value between the two ears is taken as a swelling value. After statistical treatment, a t-test was performed between groups to compare the significance of the anti-inflammatory effect. The results are shown in tables 2-3.

Table 2-3 effect of intragastric administration of samples 1-4 on croton oil-induced auricular inflammation in mice (X ± SD, n ═ 10)

The results in tables 2-3 show that samples 1-4 have obvious inhibition effect on the mouse auricle inflammation caused by croton oil after gastric administration for 7 days (P is less than 0.05, P is less than 0.01 or P is less than 0.005). Sample 4 compared with sample 1, P < 0.05, and the anti-inflammatory action intensity of each sample was, in order, sample 4 > sample 2 > sample 3 > sample 1.

Claims (18)

1. The traditional Chinese medicine composition for treating psoriasis is characterized in that the composition is prepared from rhubarb horsetails and flavescent sophora root; the weight portion of the material is as follows: 60 parts of rhubarb root and 40 parts of lightyellow sophora root.

2. The traditional Chinese medicine composition for treating psoriasis is characterized by being prepared from rheum officinale, radix sophorae flavescentis and artemisia anomala in parts by weight: 20 to 80 portions of rhubarb root, 20 to 80 portions of lightyellow sophora root and 10 to 35 portions of north diverse wormwood herb.

3. The traditional Chinese medicine composition according to claim 2, wherein the rhubarb is 20 to 50 parts, the sophora flavescens is 20 to 50 parts, and the artemisia anomala is 15 to 35 parts.

4. The traditional Chinese medicine composition as claimed in claim 3, wherein the rhubarb is 25 to 45 parts, the sophora flavescens is 25 to 45 parts, and the artemisia anomala is 20 to 35 parts.

5. The traditional Chinese medicine composition for treating psoriasis is characterized by being prepared from rheum officinale, radix sophorae flavescentis, artemisia anomala, the root of Chinese pulsatilla and catechu in parts by weight: 20 to 80 portions of rhubarb root, 20 to 80 portions of kuh-seng, 10 to 35 portions of Siphonostegia chinensis Benth, 10 to 40 portions of Chinese pulsatilla root and 5 to 30 portions of catechu.

6. The traditional Chinese medicine composition according to claim 5, wherein the rhubarb is 20 to 50 parts, the sophora flavescens is 20 to 50 parts, the artemisia anomala is 15 to 35 parts, the pulsatilla chinensis is 10 to 40 parts, and the catechu is 10 to 30 parts.

7. The traditional Chinese medicine composition according to claim 6, wherein the rhubarb is 20 to 40 parts, the sophora flavescens is 20 to 40 parts, the artemisia anomala is 15 to 30 parts, the pulsatilla chinensis is 15 to 30 parts, and the catechu is 10 to 20 parts.

8. The traditional Chinese medicine composition according to claim 7, wherein the rhubarb is 25 to 35 parts, the sophora flavescens is 25 to 35 parts, the artemisia anomala is 15 to 25 parts, the pulsatilla chinensis is 15 to 25 parts, and the catechu is 10 to 15 parts.

9. The Chinese medicinal composition according to any one of claims 1 to 8, wherein in the composition:

the rhubarb is the dried root of the basic source of Rumex japonicus (R.Patientia), Rumex crispus (R.crispus), Rumex japonicus (R.nepalensis), Rumex japonicus (R.japonica), Rumex japonicus (R.japonicum), Rumex dentata (R.dentatus), Rumex blumea (R.obtusifolia), Rumex acetosa (R.acetosa), Rumex reticuli (R.challepenis), Rumex crispus (R.gmelini), Rumex trichocarpa (R.trichotilefolia) and Rumex japonicus (R.hastatus) of Rumex (Rumex) of the family Polygonaceae, and comprises wild and/or cultivated medicinal materials, decoction pieces and/or processed products thereof;

the radix Sophorae Flavescentis is dried root of Sophora flavescens ait, and comprises wild and/or cultivated medicinal materials, decoction pieces and/or processed products thereof.

10. The Chinese medicinal composition according to any one of claims 2 to 8, wherein in the composition:

the herba Artemisiae Anomalae is dry whole plant of Siphonostegia chinensis Benth of Scrophulariaceae, including wild and/or cultivated medicinal materials, decoction pieces and/or processed products thereof.

11. The Chinese medicinal composition according to any one of claims 5 to 8, wherein in the composition:

the radix Pulsatillae is dried root of Pulsatilla chinensis (Bge) Regel of Ranunculaceae, including wild and/or cultivated medicinal materials, and decoction pieces and/or processed products thereof; or

The Catechu is the barked branch of Acacia catechu (L.f.) of Leguminosae, Willd, dried soft extract and/or processed product thereof.

12. The traditional Chinese medicine composition of claim 9, wherein the rheum officinale is selected from dried roots of one or more of rumex patientia (r.patientia), rumex crispatus (r.crispus), rumex nepalensis (r.nepalensis), rumex japonicus (r.japonica), rumex dentata (r.dentatus) and/or rumex blumea (r.obtusifolia).

13. The preparation method of the traditional Chinese medicine composition as claimed in any one of claims 1 to 12, wherein the method is to prepare the traditional Chinese medicine composition according to an "extract" preparation process, wherein the "extract" preparation process comprises the following steps:

extraction: the extraction solvent is water or a 50-100% medicinal ethanol solution; the extraction method comprises soaking, heating and refluxing, percolating after soaking, ultrasonic extracting, microwave extracting or decocting; the extraction times are 2-4 times; the extraction time is 1.0-2.0 hours, and the total amount of the solvent used for extraction is 15-20L/kg;

and (3) filtering: settling separation under normal pressure, pressurizing or vacuum filtering, centrifugal separation or ultrafiltration;

concentration: concentrating by reduced pressure evaporation, film concentration or evaporation with a film evaporator, wherein the concentration temperature is below 60 ℃; and

and (3) drying: vacuum drying, spray drying, freeze drying or microwave drying.

14. The method for preparing the traditional Chinese medicine composition according to claim 13, wherein the method comprises the following steps:

I) preparation of "extract": respectively taking the components in the composition according to the corresponding weight parts, crushing, uniformly mixing, soaking for 0.5-1 hour by using water or 50-100% medicinal ethanol as a solvent at about 40 ℃, and extracting for three times by adopting a heating reflux method, wherein the extraction time is 1.0-2.0 hours each time, and the total solvent amount is 15-20L/kg; after the reflux liquid is subjected to normal pressure sedimentation separation, one or two methods of suction filtration or centrifugation at 4000rpm for 30min are adopted to process the reflux liquid to obtain an extracting solution; recovering solvent from the extractive solution at below 60 deg.C by one or two methods of vacuum evaporation and concentration or thin film concentration to obtain concentrate; vacuum drying the concentrate at below 60 deg.C to obtain extract; the extract is prepared into a proper preparation after being crushed into fine powder; or also comprises

II) preparation of "refined product":

(A) the method comprises the following steps The refining method of the alcohol extract comprises the following steps: the 'extract' is treated by a water precipitation method, the treated 'water precipitate' is stored after vacuum drying, the rest water soluble substance passes through an AB-8, SP-825 or X-5 macroporous adsorption resin column, the height ratio of the resin column diameter is 1: 6-1: 10, the water with the flow rate of 2-9BV/h is firstly used for eluting to remove sugar and inorganic salt impurities, then the water with the flow rate of 5-100 percent ethanol is used for gradient elution, the flow rate is 3-10BV/h, the eluent is collected, the vacuum drying is carried out after the pressure reduction and the concentration, and the eluent is combined with the 'water precipitate', so as to obtain a 'refined substance'; or

(B) The method comprises the following steps The refining method of the water extract comprises the following steps: precipitating the water extract with ethanol in multiple times to obtain ethanol precipitate and ethanol soluble substance, and discarding macromolecular impurities in the ethanol precipitate; removing impurities from the alcohol soluble part by macroporous resin adsorption, polyamide chromatography or membrane separation to remove small molecular monosaccharide, disaccharide, oligosaccharide and inorganic salt; the ratio of the solvent to the height of the resin column is 1: 6-1: 10 when the impurities are removed and refined by a macroporous resin adsorption method; when polyamide chromatography is adopted for separation, the alcohol soluble part concentrated to a small volume is repeatedly dissolved by water to obtain a water soluble substance and a water insoluble substance, the water insoluble substance is dried and stored, the water soluble substance is separated by a polyamide chromatography column, water is used as a solvent for elution, sugar-free substances are detected in time, medicinal ethanol with different concentrations is used for gradient elution, finally 95-100% ethanol is used for washing off the adsorbate in the column, ethanol eluent is collected, the ethanol eluent is concentrated and subjected to reduced pressure drying treatment, and the water insoluble substance is combined to obtain a refined substance; when the membrane separation technology is adopted, the ultrafiltration is adopted to intercept macromolecular impurity components such as pectin, mucus, protein, resin and the like, and then the reverse osmosis is used to intercept micromolecular impurity components such as saccharides, inorganic salt and the like in the extract, so as to obtain a refined product.

15. A preparation containing the traditional Chinese medicine composition as claimed in any one of claims 1 to 12 or the "extract" or the "refined product" as claimed in any one of claims 13 to 14, wherein the preparation comprises an external preparation or an internal preparation, wherein the external preparation is a gel, an ointment, a cream, a film coating agent, a powder preparation, a lotion, a liniment, a paste, an aerosol, a spray or a patch; the oral preparation is tablet, granule, powder, pill, capsule, syrup, dripping pill, fluid extract, extract or tea.

16. The formulation of claim 15, wherein the matrix for the gel, ointment or cream comprises a water-soluble matrix, a water-insoluble matrix, or a combination thereof, and the water-soluble matrix comprises: carbomer, glycerogelatin, starch glycerol, cellulose derivatives, polyethylene glycol, alginate, tragacanth or gelatin, or any combination thereof; the matrix of the film coating agent comprises polyvinyl alcohol, polyvinyl formal acetaldehyde, polyvinylpyrrolidone, carboxymethyl chitosan or carbomer, or any combination thereof; the plasticizer used in the film coating agent comprises glycerin, propylene glycol or dibutyl phthalate, or any combination thereof.

17. A method for preparing the Chinese medicinal preparation of claim 15 or 16, which is characterized in that:

(1) the preparation method of the gel of the water-soluble matrix comprises the following steps: taking the composition as claimed in any one of claims 1 to 12 or the extract or refined product of the Chinese medicinal composition prepared by the method as claimed in any one of claims 13 to 14 as a raw material medicine, and pulverizing an appropriate amount of the raw material medicine into fine powder; weighing a proper amount of carbomer, soaking the carbomer in distilled water for 24 hours until the carbomer is completely swelled to obtain 2% -3% of carbomer transparent gel, transferring the carbomer transparent gel to a stirrer for stirring in the whole process, and dropwise adding triethanolamine to adjust the pH value to 3.5-4; adding the obtained fine powder in portions, or dissolving the fine powder in propylene glycol or propylene glycol and ethanol, adding the fine powder into carbomer gel in portions, wherein the ethanol in the propylene glycol and the ethanol accounts for about 10% of the solvent, uniformly stirring, dissolving the fine powder of the preservative ethylparaben in the propylene glycol, ultrasonically dissolving, adding the fine powder of the preservative ethylparaben, adding the humectant glycerol, the sodium thiosulfate antioxidant and the laurocapram transdermal absorbent, uniformly stirring, dropwise adding triethanolamine to adjust the pH value to 7, and uniformly stirring in the same direction until a viscous gel is formed, thus obtaining a gel preparation; the content of the extract in the preparation taking the extract as the raw material medicine is 20-30%; the content of the refined substance in the preparation taking the refined substance as the raw material medicine is 10 to 20 percent;

(2) the preparation method of the coating agent comprises the following steps: selecting PVA124, PVA1750, PVA1788 or polyvinyl formal acetaldehyde water-soluble film-forming material, adding purified water or 80% ethanol, heating and soaking in water bath at 80 ℃ to fully swell the film-forming material into light yellow semi-flowable liquid, moving the liquid to a stirrer, stirring the liquid in the whole process, adding a proper amount of diethyl phthalate plasticizer, and uniformly mixing the liquid to obtain a liquid (1); taking the composition as claimed in any one of claims 1 to 12 or the extract or refined product of the Chinese medicinal composition prepared by the method as claimed in any one of claims 13 to 14 as a raw material medicine, pulverizing into superfine powder, and dissolving in propylene glycol-ethanol; adding the mixture into the solution (1) in portions, and uniformly mixing; adding ethylparaben antiseptic, moisturizer, penetration enhancer and antioxidant dissolved in propylene glycol, stirring, standing until no bubble exists, packaging in glass bottle, and sealing;

(3) the preparation method of the ointment or cream comprises the following steps: taking the composition as claimed in any one of claims 1 to 12 or the extract or refined product of the Chinese medicinal composition prepared by the method as claimed in any one of claims 13 to 14 as a raw material medicine, pulverizing into fine powder, adding appropriate amount of propylene glycol-ethanol, and dissolving for use; heating oil phase matrix of stearic acid, glyceryl monostearate, liquid paraffin, and azone and water phase matrix selected from glycerol, water soluble lanolin and ethylparaben to 80 deg.C respectively, adding water phase into oil phase under stirring, cooling to 40 deg.C, adding the above medicinal material solution under stirring, and stirring to completely homogenize;

(4) the preparation method of the tablet comprises the following steps: taking the composition of any one of claims 1 to 12 or the extract or refined product of the traditional Chinese medicine composition prepared by the method of any one of claims 13 to 14 as a raw material medicine, crushing the raw material medicine into fine powder of 80 to 160 meshes, adding a proper amount of auxiliary materials including hydroxypropyl cellulose and hydroxy beta cyclodextrin, adopting ethanol as a wetting agent, granulating, drying under reduced pressure at 50 to 70 ℃, tabletting and coating to obtain the traditional Chinese medicine composition;

(5) the preparation method of the granules comprises the following steps: taking the composition as claimed in any one of claims 1 to 12 or the extract or refined product of the Chinese medicinal composition prepared by the method as claimed in any one of claims 13 to 14 as a raw material medicine, and crushing the raw material medicine into fine powder of 80 to 160 meshes; using oligolactose or dextrin as forming auxiliary material, and adopting spray drying and dry granulation technology to prepare granules;

(6) the preparation method of the powder comprises the following steps: taking the composition as claimed in any one of claims 1 to 12 or the extract or refined product of the Chinese medicinal composition prepared by the method as claimed in any one of claims 13 to 14 as a raw material medicine, crushing the raw material medicine into fine powder of 80 to 160 meshes, sieving and uniformly mixing to obtain the Chinese medicinal composition; or

(7) The preparation method of the capsule comprises the following steps: taking the composition of any one of claims 1 to 12 or the extract or refined product of the traditional Chinese medicine composition prepared by the method of any one of claims 13 to 14 as a raw material medicine, crushing the raw material medicine into fine powder of 80 to 160 meshes, and adding 1 to 2 percent of methyl cellulose, silicone or hydroxyethyl cellulose as an auxiliary material to ensure that the medicine powder has good fluidity and the medicine powder is rapidly and accurately filled into a gelatin hard capsule to obtain the composition; the filling process of the medicine needs to be carried out in an environment with the temperature of about 25 ℃ and the relative humidity of 35-45%.

18. The method for preparing a Chinese medicinal preparation according to claim 17, wherein the method comprises the following steps: the preparation method of the ointment or cream comprises the following steps: taking the composition as claimed in any one of claims 1 to 12 or the extract or refined product of the Chinese medicinal composition prepared by the method as claimed in any one of claims 13 to 14 as a raw material medicine, pulverizing into fine powder, adding appropriate amount of propylene glycol-ethanol, and dissolving for use; for psoriasis patients with erosive sore surfaces to better absorb tissue exudate, a water-soluble matrix is used, wherein the water-soluble matrix is selected from glycerogelatin, cellulose derivatives or polyethylene glycols; the preparation method comprises the following steps: selecting high-viscosity CMC-Na, adding glycerol, mixing, adding appropriate amount of purified water, standing to swell into gel, adding the above raw material solution, ethylparaben water solution, transdermal absorbent and antioxidant, stirring, and stirring to completely homogenize.

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