CN101856409A - Medicinal composition for treating skin itch, preparation method and application thereof - Google Patents
Medicinal composition for treating skin itch, preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a medicinal composition for treating skin itch, which is a preparation prepared from the raw material medicaments of cortex moutan radicis, densefruit pittany root-bark, lightyellow sophora root, liquorice root, borneol and menthol crystal. The invention also provides an external medicament which is prepared by taking paeonol extract used as active ingredients in the cortex moutan radicis, dictamnine extract used as active ingredients in the densefruit pittany root-bark, matrine extract used as active ingredients in the lightyellow sophora root, glycyrrhetinic acid extract used as active ingredients in the liquorice root, the borneol and the menthol crystal as active ingredients and adding pharmaceutically-acceptable auxiliary materials or auxiliary components. The invention also provides a preparation method of the medicinal composition. The medicament of the invention can treat the symptom of pruritus caused by accumulating evils of wind heat, moist heat and blood heat in the skin, comprising the pruritus caused by eczema. The medicinal composition of the invention has a refining formula of raw materials, definite material basis, definite curative effect and little toxic or side effect, and particularly has the unique curative effect on pruritus symptom of which the course of disease is lingering and repeated.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of skin pruritus, belong to drug world.
Background technology
Skin pruritus, modern medicine claim " pruritus disease " or " pruritus " again, are meant the dermatosis that the skin gargalesthesia is only arranged and do not have significant primary cutaneous infringement, and the branch of general and limitation is arranged, and it is belonged in the delayed ischemic neurological deficits dermatoses.
Pathogeny and therapeutic scheme about skin pruritus, Chinese and western medicine has nothing in common with each other, doctor trained in Western medicine is thought, pruritus is the same with pain to be to be served as by epidermis and epidermis-non-specific free nerve endings of corium intersection, pruritus and pain are usually along identical neuron transmission, owing to the excited different obvious differences that cause feeling with process of inhibition of central nervous system under the normal condition.In fact tickle and itch is regulated by maincenter, this adjusting is by being arranged in the neuronic excitement of ridge basin dorsal horn substantia gelatinosa [of Rolando and suppressing the loop, and opium sample system realizes.Inflammatory mediator plays an important role in the pathophysiological process of pruritus, and wherein histamine, kassinin kinin and protease are the modal chemical mediators that causes pruritus.Have the scholar to think that histamine is even more important, discover, histamine intradermal injection can cause pruritus, the degree that the injection of 5-hydroxy tryptamine intradermal causes pruritus a little less than than histamine many.Neuropeptide makes the skin mastocyte discharge histamine, is still waiting further confirmation but neuropeptide is whether relevant with clinical pruritus.Prostaglandin can strengthen the pruritus that causes of injection histamine (and 5-hydroxy tryptamine), but this as weak cause itch former.Lymphokine may be relevant with the pruritus pathogeny.Existing evidence explanation, opiod peptide may transmit relevant with the maincenter of pruritus.Antihistaminic medicine clinically enters body and histamine competition receptor, reduces the stimulation of teleneuron, alleviates allergic generation, thereby alleviate the pruritus symptom, so doctor trained in Western medicine antihistaminic medicine, calm neuroleptic agent have mainly been adopted clinically, antipruritic, vitamin C, E and corticosteroid hormone wait treats, and following kind is arranged: cetirizine, chlorphenamine, halcinonidedcorten, thiophene pyridine in heptan, clemastine, the thunder Buddhist nun is for stining, mizolastine, diphenhydramine, hismanal, promethazine, Pevisone, PIYANPING, ware is controlled woods.Its advantage is an instant effect, can improve patient skin pruritus symptom fast, but because of being chemicals, so bigger to skin damage, and the state of an illness often has repeatedly.The traditional Chinese medical science is thought: " have Zhu Neibi shape all outer ", though skin is in close relations with the internal organs pathological changes at external table, if the body visceral dysfunction, disharmony between QI and blood can be reflected to body surface and causes dermatosis and take place, and produces symptoms such as pruritus.The traditional Chinese medical science think the reason of dermatosis generation pruritus be the heresy visitor of wind, wet, heat, worm in skin flesh table, cause between skin due to the disharmony between QI and blood, or because blood-deficiency and wind-dry, deficiency of YIN-blood, skin lose in moistening foster forming.Be divided into following several types according to dialectical: wind-cold type, anemopyretic, wet type, blood-heat type, worm type, blood-deficiency type, blood stasis type, qi-deficiency type, cold type, fire-toxin type.Except according to the above-mentioned classification determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, the clinical combined therapy of Chinese and Western medicine that also adopted, acupuncture and moxibustion treatment, the stellate ganglion block therapy, the hyperbaric oxygen composite treatment, drug injection therapy, the herbal fumigation therapy waits treats; Compare with Western medicine, the Chinese traditional treatment primary disease have dialectical flexibly, method of treatment is various, curative effect is objective, toxic and side effects is few advantage, especially for the touching person repeatedly of the course of disease, special effect.
The report of the Chinese medicine of treatment skin pruritus is more at present, " control wind and control blood earlier " as bases such as Zhang Guoan, from intending blood wind soup (Radix Rehmanniae, Cortex Moutan, Radix Angelicae Sinensis, the red Radix Paeoniae Alba, Radix Polygoni Multiflori, Radix Arnebiae (Radix Lithospermi), Periostracum Cicadae, Fructus Atriplicis Sibiricae, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae) treatment 52 examples, all effectively (blood wind soup is treated skin pruritus 52 routine Hunan Journals of Traditional Chinese Medicine, 2000,16 (1): 42); Yang Xuejing skin moistening and itch stopping soup (Caulis Polygoni Multiflori, Caulis Spatholobi, living Radix Rehmanniae Preparata, Radix Angelicae Sinensis, the red Radix Paeoniae Alba, Radix Saposhnikoviae, Fructus Tribuli, Radix Sophorae Flavescentis) plus-minus treatment senile skin pruritus 30 examples, 24 examples of fully recovering, produce effects 2 examples, progressive 4 examples (skin moistening and itch stopping soup treatment senile skin pruritus 30 routine Chinese country doctor's magazines, 2001, (7): 42); Substantially square (the Radix Rehmanniae of the positive national expenditures expelling wind and activating blood circulation of Pu, Rhizoma Paridis, Cortex Dictamni, the Fructus Kochiae, Radix Angelicae Sinensis, Radix Arnebiae (Radix Lithospermi), Bombyx Batryticatus, Radix Glycyrrhizae) treatment skin pruritus 92 examples, (expelling wind and activating blood circulation is treated pruritus Heilungkiang Chinese medicine to effective percentage 93.48%, 1997, (6): 30) Liu Zongyan drinks (Radix Salviae Miltiorrhizae with red chicken YINQIAO, Caulis Spatholobi, Flos Lonicerae, Fructus Forsythiae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the red Radix Paeoniae Alba, Radix Rehmanniae, Herba Schizonepetae, Radix Saposhnikoviae, Herba Menthae, the Fructus Kochiae) treatment skin pruritus 80 examples, and establish western medicine group 50 examples and give oral Cyproheptadine 4mg, vitamin C 0.2, Tid, 10% calcium gluconate 10ml+50%GS20ml, IV.Effective rates group 989%, matched group 60% (red chicken YINQIAO drink treatment skin pruritus 80 routine Inner Mongol Chinese medicines, 2001, (2): 7) usefulness such as Li Hanzhou is from intending the blood stasis dispelling (Semen Persicae that looses, Flos Carthami, Semen Armeniacae Amarum, Fructus Gardeniae, Borneolum Syntheticum) navel-applying therapeutic skin pruritus 27 examples, effective percentage 89% (is intended the diffusing navel-applying therapeutic skin pruritus 27 routine Hunan Journals of Traditional Chinese Medicine of blood stasis dispelling certainly, 1998,14 (6): 40), Cortex Acanthopanacis Radicis kuh-seng soup (Cortex Dictamni such as Li Shuying, Radix Sophorae Flavescentis, Fructus Tribuli, Radix Paeoniae Rubra, Bombyx Batryticatus, Cortex Moutan, the Fructus Kochiae, Radix Angelicae Sinensis, Periostracum Cicadae, Radix Glycyrrhizae) treatment skin pruritus 132 examples, 58 examples of fully recovering, produce effects 52 examples, invalid 2 examples (Cortex Acanthopanacis Radicis kuh-seng soup treatment skin pruritus Hubei Journal of Traditional Chinese Medicine, 1998,20 (1): 40).In addition, number of patent application is: 200610156942.4, denomination of invention: a kind of preparation method for the treatment of the medicine and the ointment thereof of eczema, a kind of preparation method for the treatment of the medicine and the ointment thereof of eczema is disclosed, the Chinese medicine for outer use of treatment eczema, particularly a kind of ointment formulation, this medicine is the medicament of being made by the following weight parts proportion raw material: Radix Sophorae Flavescentis 150～600, Cortex Dictamni 100～300, Cortex Moutan 150～600, Borneolum Syntheticum 5～25.The processing step that adopts is Radix Sophorae Flavescentis, Cortex Dictamni, add 10 times of water gagings at every turn, decoct each 2 hours 3 times, get decocting liquid respectively, Cortex Moutan adds 20 times of water gagings, be heated to 45 ℃, warm macerating 1 hour, distillation, collect 10 times of amounts of medical material distillate, filter, add the distillation of 5% sodium chloride in the filtrate, collect 3 times of amounts of medical material distillate, cold preservation, crystallize, merge crystallization, get paeonol, add 6 times of water gagings in the medicinal residues, decocted 1 hour, and filtered merging filtrate, other puts stand-by, and merging filtrate is concentrated into relative density and is about 1.06-1.10 (60 ℃), adding ethanol makes and contains alcohol amount and reach 60%, cold preservation, filter decompression recycling ethanol, promptly get the medicine thick paste, get stearic acid, lanoline, liquid paraffin, glycerol, triethanolamine, sodium lauryl sulphate, water is made substrate, with paeonol, medicine thick paste and Borneolum Syntheticum mix homogeneously, get final product the treatment eczema drug ointment.This prescription discloses Radix Sophorae Flavescentis, Cortex Dictamni, Cortex Moutan, Borneolum Syntheticum four Chinese medicine thing prescription therapeutic eczema.In the technology contents of above-mentioned document or patent report, prescription is according to theory of Chinese medical science, and at the different causes of disease, pathogenesis, the different method of treatment rule of treatment is determined.
Summary of the invention
Technical scheme of the present invention has provided a kind of pharmaceutical composition for the treatment of skin pruritus, and another technical scheme of the present invention provides this preparation of drug combination method and purposes.
The invention provides a kind of pharmaceutical composition for the treatment of skin pruritus, it is the medicament that is prepared from by following raw materials by weight proportions:
Cortex Moutan 100-600 part, Cortex Dictamni 100-300 part, Radix Sophorae Flavescentis 10-100 part, Radix Glycyrrhizae 500-1000 part, Borneolum Syntheticum 10-30 part, Mentholum 5-30 part.
Further preferably, it is the medicament that is prepared from by following raw materials by weight proportions:
200 parts of Cortex Moutans, 160 parts of Cortex Dictamni, 28 parts of Radix Sophorae Flavescentiss, 840 parts in Radix Glycyrrhizae, 20 parts of Borneolum Syntheticums, 10 parts of Mentholums.
Wherein, it is to be active component by the active component paeonol crude extract in the Cortex Moutan, the active component dictamine extract in the Cortex Dictamni, the active component matrine extract in the Radix Sophorae Flavescentis, active component enoxolone crude extract, Borneolum Syntheticum, the Mentholum in the Radix Glycyrrhizae, add the topical agent that acceptable accessories or complementary composition are prepared from, wherein the weight proportion of active component is:
Paeonol extract 1-6 part, dictamine extract 0.04-0.15 part, matrine extract 0.1-3 part, enoxolone extract 5-15 part, Borneolum Syntheticum 10-30 part, Mentholum 5-30 part.
Further preferably, the weight proportion of active component is:
2 parts of paeonol extracts, 0.07 part of dictamine extract, 0.2 part of matrine extract, 10 parts of enoxolone extracts, 20 parts of Borneolum Syntheticums, 10 parts of Mentholums.
Wherein, contain enoxolone in the described enoxolone extract, press dry product and calculate, the content of enoxolone should be less than 97.0%w/w; The paeonol extract contains paeonol, presses dry product and calculates, and the content of paeonol should be 98%-103%w/w; Contain content of matrine in the matrine extract and should be less than 98.0%w/w; In the dictamine extract, press dry product and calculate, contain dictamine and must not be less than 55%w/w.
Wherein, described topical agent is ointment, powder, lotion, liniment, tincture, paste, liniment, gel, spray or transdermal patch.
The present invention also provides a kind of method of pharmaceutical compositions, and it comprises the steps:
A, take off and state materials of weight proportions:
Cortex Moutan 100-600 part, Cortex Dictamni 100-300 part, Radix Sophorae Flavescentis 10-100 part, Radix Glycyrrhizae 500-1000 part, Borneolum Syntheticum 10-30 part, Mentholum 5-30 part.
B, Cortex Dictamni, Cortex Moutan, Radix Sophorae Flavescentis, Radix Glycyrrhizae are mixed, water or organic solvent extraction add external preparation adjuvant pharmaceutically commonly used, are prepared into topical agent commonly used.
Wherein, the b step is specially: Cortex Moutan extracts paeonol; Powder is used the sodium chloride water infiltration, vapor distillation, and 4 ℃ of cold preservation 24h of distillation get Cortex Dictamni and extract the dictamine extract; Extract the matrine extract in the Radix Sophorae Flavescentis; Extract enoxolone in the Radix Glycyrrhizae; Add Borneolum Syntheticum, Mentholum again, after the mixing, add pharmaceutically acceptable external preparation adjuvant, be prepared into external preparation commonly used.
Wherein, described topical agent is ointment, powder, lotion, liniment, tincture, paste, liniment, gel, spray or transdermal patch.
Wherein, the preparation method of described soft capsule is:
(1) paeonol, dictamine extract use dissolve with ethanol standby; The matrine extract is dissolved in the water; Borneolum Syntheticum, that Mentholum is ground to congruent melting with liquid paraffin is standby; The enoxolone extract grinds standby with glycerol;
(2) with oil phase: weight proportion is: stearic acid 80-150 part, white vaseline 100-150 part, with water: triethanolamine 20-40 part, the red 5-15 part of Gloriosa saperba L., water 400-450 part, be heated to 80 ℃ respectively, water slowly adds in the oil phase water and stirring a little more than oil phase, treats to add above-mentioned paeonol, dictamine, enoxolone extract after the biphase mix homogeneously, the limit edged stirs, treat that temperature reduces to 50 ℃, add Borneolum Syntheticum and Herba Menthae, continue to be stirred to condensation promptly.
Wherein, in the step (2) be: 100 parts of stearic acid, 135 parts of white vaseline with the weight proportion of oil phase; The weight proportion of water is: 30 parts of triethanolamine, red 10 parts of Gloriosa saperba L., 425 parts in water.
The present invention also provides the purposes of described pharmaceutical composition in the medicine of preparation treatment skin pruritus.
Medicine material prescription of the present invention is controlled card and is accumulate in skin by wind heat, heresy damp and hot, heat in blood, must not catharsis, and fire-transformation is given birth to dry, so that Tianjin blood depletion is puckery, even blood stasis, due to the failure of skin and muscle to be nourished.Control suitable heat clearing and damp drying, removing heat from blood and promoting blood circulation is main, and it is antipruritic to be aided with dispelling wind.The Cortex Moutan toil is slightly cold in the side, goes into the conscience kidney, and clearing away heat and cooling blood, promoting blood circulation to remove blood stasis are monarch drug.Cortex Dictamni bitter in the mouth cold in nature, heat clearing and damp drying, dispelling wind for relieving itching; Radix Sophorae Flavescentis is also had an effect of heat clearing and damp drying, again can killing parasites for relieving itching, with Cortex Dictamni be ministerial drug altogether.Assistant is with Herba Menthae, Borneolum Syntheticum dispelling wind for relieving itching.The Radix Glycyrrhizae heat-clearing and toxic substances removing, coordinating the actions of various ingredients in a prescription is messenger drug.All medicine phases 5, damp and hot as to separate, skin is itched from removing.
Medicine of the present invention can be treated all and be accumulate the disease of the pruritus that causes in skin by wind heat, damp and hot heresy, comprises the pruritus that eczema causes.Drug regimen raw material refining formula of the present invention, material base are clear and definite, determined curative effect, and toxic and side effects is little, especially the touching pruritus repeatedly of the course of disease is had original curative effect.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
Specific implementation method
The preparation of embodiment 1 drug ointment agent of the present invention
1, the preparation method of each flavour of a drug crude extract
(1) paeonol crude extract preparation method
Get the Cortex Moutan decoction pieces, add the water of 15 times of amounts of decoction pieces weight, add the sodium chloride of 5% water gross weight, the wet 2h that soaks with the distilled water distillation, collects the distillate of 9 times of amounts of decoction pieces weight, and liquid is crossed in cold preservation, filters, and gets crystal; Filtrate is added the sodium chloride of the amount of stating, and carries out redistillation, collects the re-distilled liquid of 3 times of amounts of medical material weight, and cold preservation is spent the night, and filters, and gets crystal.Two cold crystallization things are merged, in 40 ℃ of dryings, promptly.
(2) preparation method of dictamine crude extract
Get the Cortex Dictamni coarse powder, the alcohol reflux of 10 times of amounts 90% of adding medical material weight 2 times, each 1 hour, merge extractive liquid, is concentrated into 1: 1 density under 60 ℃, use equal volume of ethyl acetate 3 times, the combined ethyl acetate layer, be concentrated into former concentrated solution 60% volume, use isopyknic 2% hcl as extraction agent then 3 times, merge the hydrochloric acid layer, be concentrated into 60% volume, use 5%NaOH then, transfer pH=10, reuse equal volume of ethyl acetate 3 times, the combined ethyl acetate extracting solution, concentrating under reduced pressure, vacuum drying, promptly.
(3) preparation method of matrine crude extract
Get the Radix Sophorae Flavescentis decoction pieces, add 6 times of amounts of medical material weight, 1% aqueous acetic acid merceration 3 times, each 8h, filter, merging filtrate is by the 732 strong acid type cationic resin posts of 1BV, with 4BV distillation washing, take out resin, measure 80～85 ℃ of water-bath reflux, extract, of 5% ammonia alcoholic solution 3 times for 1.5 times, each 1h with medical material weight.Merge alcoholic solution, decompression recycling ethanol, vacuum drying gets Radix Sophorae Flavescentis total alkaloids.Radix Sophorae Flavescentis total alkaloids is dissolved with minimum of chloroform, add the ether of 10 times of amounts of Radix Sophorae Flavescentis total alkaloids weight again, the molten part peroxidating of ether aluminum post, with ether-methanol (volume ratio 19: 1) eluting, eluent concentrating under reduced pressure, vacuum drying promptly get the matrine crude extract.
(4) preparation method of enoxolone crude extract
The extracting liquorice coarse powder contains 60% alcohol reflux 7h of ammonia 0.5% at 85 ℃ with 8 times of amounts of medical material weight, filters, and filtrate is concentrated into 1/5 of original volume, filter, filtrate adds an amount of 5% concentrated sulphuric acid, and to be adjusted to pH value be 3, leaves standstill 12h, sucking filtration, precipitate washing 3 times, drying under reduced pressure promptly gets glycyrrhizic acid inclusion compound.Glycyrrhizic acid inclusion compound is dissolved in an amount of chloroform, sucking filtration while hot, filtrate is put cold, and peroxidating aluminum post is used the chloroform eluting, and eluent reclaims chloroform, and drying under reduced pressure gets the enoxolone crude product, and this crude product promptly gets the enoxolone crystallization with ethyl alcohol recrystallization.
The quality standard of the extract of method for preparing is:
1, enoxolone: according to " State Food and Drug Administration's national drug standards " the 12 enoxolone quality standard, press dry product and calculate, the content of enoxolone should be less than 97.0% in this product
2, paeonol: according to " State Food and Drug Administration's national drug standards " the 4th matrine quality standard, press dry product and calculate, the content of paeonol should be 98%-103% in this product
3, matrine: according to " State Food and Drug Administration's national drug standards " first matrine quality standard, press dry product and calculate, content of matrine should be less than 98.0% in this product
4, dictamine (Furo[2,3-b] quinoline, 4-methoxy)
Dictamine
C
12H
9NO
2?199.20
Press dry product and calculate, contain C
12H
9NO
2Must not be less than 55%.
Medicine material paeonol crude extract of the present invention, dictamine crude extract, matrine crude extract, enoxolone crude extract can adopt method for preparing, also can adopt other method of bibliographical information to be prepared into the extract that meets quality standard, also can directly use the commercially available prod.
2, the kind of adjuvant and consumption
Preparation were established:
Get paeonol extract 2g, dictamine extract 0.07g, matrine extract 0.2g, enoxolone extract 10g, Borneolum Syntheticum 20g, Mentholum 10g;
Medicine adds mode: paeonol, dictamine extract dissolve standby with small amount of ethanol; The matrine extract is dissolved in the water; Borneolum Syntheticum, that Mentholum is ground to congruent melting with liquid paraffin is standby; The enoxolone extract grinds standby with glycerol.
With oil phase (stearic acid, white vaseline) with water (triethanolamine, the Gloriosa saperba L. pellet, water) be heated to 80 ℃ respectively, water is a little more than oil phase, slowly add in the oil phase water and stirring, treat to add after the biphase mix homogeneously above-mentioned paeonol, dictamine, enoxolone extract, the limit edged stirs, and treats that temperature reduces to 50 ℃, add Borneolum Syntheticum and Herba Menthae, continue to be stirred to condensation promptly.
The preparation of embodiment 2 drug powders of the present invention
Get Cortex Moutan 150g, Cortex Dictamni 150g, Radix Sophorae Flavescentis 50g, Radix Glycyrrhizae 600g pulverize separately becomes the fine powder mixing, Borneolum Syntheticum 25g, Mentholum 25g grind and form eutectic, absorb eutectic with mixing fine powders, making becomes 1000g, crosses No. 7 sieves (120 order) promptly.
The preparation of embodiment 3 drug lotions of the present invention
Get Cortex Moutan 20g, Cortex Dictamni 20g, Radix Sophorae Flavescentis 10g, Radix Glycyrrhizae 50g, the decocting that adds 8 times of amounts boiled 2 hours, and filtrate adds the 2g Borneolum Syntheticum, the 1g Mentholum, and glycerol 100ml stirs, and adds water to 1000ml promptly.
The preparation of embodiment 4 medicine liniments of the present invention
Getting paeonol extract 3g, dictamine extract 0.08g, Borneolum Syntheticum 15g, Mentholum 12g is dissolved in the 200ml ethanol successively; Matrine extract 1g is dissolved in the low amounts of water; Enoxolone extract 8g grinds and is dissolved in the 300g glycerol, and above-mentioned three merges, and adds dimethyl sulfoxide 100ml, adds water to 1000ml at last promptly.
The preparation of embodiment 5 medicinal tinctures of the present invention
Get Cortex Moutan 55g, Cortex Dictamni 30g, Radix Sophorae Flavescentis 8g, Radix Glycyrrhizae 90g, Borneolum Syntheticum 2g, Mentholum 3g and add 75% ethanol 1000ml, leach promptly after placing 1 week of hermetic container (stirring every day 1 time).
The preparation of embodiment 6 drug pastes of the present invention
Get paeonol extract 2g, dictamine extract 0.06g, that Radix Sophorae Flavescentis extract 1g Radix Glycyrrhizae extract 5g grinds to form fine powder respectively is standby; Borneolum Syntheticum 11g, Mentholum 7g are ground to eutectic; Get vaseline 50g heat fused, add the extract fine powder, treat to add 20g starch when temperature is reduced to below 50 ℃, stir, condensation, promptly.
The preparation of embodiment 7 medicine liniment of the present invention
Get Cortex Moutan 45g, Cortex Dictamni 25g, Radix Sophorae Flavescentis 6g, Radix Glycyrrhizae 70g are broken into coarse powder, with 85%-90% alcohol dipping percolation after 36-48 hour, collect percolate, be evaporated to total amount and be about 500g, add Mentholum 3g, Borneolum Syntheticum 2g, dibutyl phthalate 30g, acetone 100ml after waiting to dissolve, adds polyvinyl formal 13g again, the limit edged stirs, to all dissolvings, add 70% ethanol again to 1000g, promptly.
The preparation of embodiment 8 medicament gelling agents of the present invention
Earlier 15g Borneolum Syntheticum and 10g Mentholum are ground to eutectic, prepare following solution then: A liquid: get carbomer 8g and add swelling 24h in the 200ml pure water; It is transparent that B liquid: PEG-40015g places the 70ml pure water to be heated to; C liquid: ethyl hydroxybenzoate 0.5g and paeonol extract 5g, dictamine extract 0.1g are dissolved in the 50ml dehydrated alcohol; D liquid: matrine 1.5g is dissolved in the 100ml water B, the abundant mixing of C liquid is added in the A liquid, fully stirs, and adds eutectic and 7.5g enoxolone extract, stirs promptly.
The preparation of embodiment 9 medicament spraying agents of the present invention
1g matrine extract, the dissolving of 8g enoxolone extract are ground into impalpable powder, 3g paeonol extract, 0.12g dictamine extract, 20g Borneolum Syntheticum, 10g Mentholum are dissolved in the 300ml dehydrated alcohol, Radix Sophorae Flavescentis extract and enoxolone extract are dissolved in the above-mentioned ethanol solution, and add 15% non-ionic surface active agent ethanol solution 100ml, miscible back quantitatively is sub-packed in the spray pressure vessel promptly under continuous stirring condition.
The preparation of embodiment 10 drug transdermal patches of the present invention
Take by weighing 1gHPMC, add an amount of swelling of water, with 2g paeonol extract, 0.06g dictamine extract, 15g Borneolum Syntheticum, an amount of dissolve with ethanol of 10g Mentholum, 1g matrine extract dissolves with suitable quantity of water, pour above-mentioned alcoholic solution into swelling good HPMC, add 3g laurocapram and 5g tween 80, add matrine water solution and 8g enoxolone extract, add water at last, obtain containing the gel of alcohol amount 30% behind the mix homogeneously.In the bank of being made up of ethylene-vinyl acetate copolymer film (EVA) and backing film, effectively diffusion area is 2.8cm with the heat-sealing of 0.4mL gel
2Coat an amount of pressure sensitive adhesive at anti-glutinous layer, dry in 60 ℃ of baking ovens, the cooling back is superimposed with storage layer, promptly.
The preparation of embodiment 11 drug ointment agent of the present invention
Get Cortex Moutan 100g, Cortex Dictamni 100g, Radix Sophorae Flavescentis 10g, Radix Glycyrrhizae 500g, Borneolum Syntheticum 10g, Mentholum 5g, be prepared into ointment by the method for embodiment 1.
The preparation of embodiment 12 drug ointment agent of the present invention
Get Cortex Moutan 600g, Cortex Dictamni 300g, Radix Sophorae Flavescentis 100g, Radix Glycyrrhizae 1000g, Borneolum Syntheticum 30g, Mentholum 30g, be prepared into ointment by the method for embodiment 1.
The preparation of embodiment 13 drug pastes of the present invention
Paeonol extract 1g, dictamine extract 0.04g, Borneolum Syntheticum 10g, Mentholum 5g, matrine extract 0.1g, enoxolone extract 5g are prepared into paste by the method for embodiment 6.
The preparation of embodiment 14 drug pastes of the present invention
Paeonol extract 6g, dictamine extract 0.15g, Borneolum Syntheticum 30g, Mentholum 30g, matrine extract 3g, enoxolone extract 15g are prepared into paste by the method for embodiment 6.
The method of quality control of embodiment 15 medicines of the present invention
1. assay:
1.1 the assay of paeonol
1.1.1 instrument and reagent
Instrument: Tianjin, island high performance liquid chromatograph (SPD-10Avp UV-VIS DETECTOR, binary LC-10ATvp LIQUID CHROMATOGRAPH, CTO-10ASvp COLUMN OVEN, N2000 chromatographic work station); Electronic balance (sensibility reciprocal 0.01mg); The automatic dual pure water distillator of SZ-93 type (Shanghai Yarong Biochemical Instrument Plant).
Reagent: methanol is chromatographically pure, and water is double distilled water, and all the other reagent are analytical pure.
Reference substance: the paeonol reference substance (the biological Tetramune calibrating of Chinese medicine institute, lot number: 110708-200505, for assay with), use in the preposition silica gel drier and be dried to constant weight.
1.1.2 chromatographic condition
Chromatographic column: Agilent C
18(250 * 4.6mm, 5 μ m); Mobile phase: methanol-water (70: 30); Flow velocity: 1ml/min; Column temperature is 30 ℃; Detect wavelength: 274nm; The range of linearity: 0.019-0.152 μ g.
1.1.3 the preparation of sample preparation methods and reference substance solution
The preparation of reference substance solution: precision takes by weighing paeonol reference substance 4.75mg, puts in the 10ml volumetric flask, and dissolve with methanol, and add methanol to scale, and shake up, as storing solution, precision pipettes in storing solution 1ml to the 50ml volumetric flask, adds methanol to scale and shakes up.
The preparation of sample solution: get the about 0.5g of this product, the accurate title, decide, and puts in the conical flask, the accurate respectively methanol 50ml that adds claims to decide weight, supersound process 20 minutes, put coldly, claim decide weight again, usefulness is supplied the weight that subtracts mistake, shake up, filter, precision is measured subsequent filtrate 5mL, puts in the 10mL measuring bottle, add methanol to scale, shake up.
1.1.4 the assay of paeonol in the sample
Under above-mentioned chromatographic condition, each 10 μ l of sample introduction product solution and reference substance solution measure peak area, calculate the content of paeonol in the medicine, and the content results that records paeonol in three batch samples sees Table 1
The content of paeonol in table 1 three batch samples
The content that contains paeonol in the ointment of the present invention is 1.7-1.78mg/g.
The assay of 2 dictamines
2.1 instrument and reagent
Instrument: Tianjin, island high performance liquid chromatograph (SPD-10Avp UV-VIS DETECTOR, binary LC-10ATvp LIQUID CHROMATOGRAPH, CTO-10ASvp COLUMN OVEN, N2000 chromatographic work station); Electronic balance (sensibility reciprocal 0.01mg); The automatic dual pure water distillator of SZ-93 type (Shanghai Yarong Biochemical Instrument Plant).
Reagent: methanol is chromatographically pure, and water is double distilled water, and all the other reagent are analytical pure.
Reference substance: the dictamine reference substance (the biological Tetramune calibrating of Chinese medicine institute, lot number: 111654-200301, for assay with), use in the preposition silica gel drier and be dried to constant weight.
2.2 chromatographic condition
Chromatographic column: Agilent C
18(250 * 4.6mm, 5 μ m); Mobile phase: methanol-water (58: 42); Flow velocity: 1ml/min; Column temperature is 30 ℃; Detect wavelength: 237nm; Range of linearity 0.0048-0.0384 μ g.
2.3 the preparation of sample preparation methods and reference substance solution
The preparation of reference substance solution: precision takes by weighing dictamine reference substance 2.40mg, puts in the 100ml volumetric flask, and dissolve with methanol, and add methanol to scale, shake up, promptly.
The preparation of sample solution: get this product 0.5g, the accurate title, decide, and adds ethanol 50ml, adding ammonia, to make PH be 8, supersound process 20min filters decompression and solvent recovery, residue adds dissolve with methanol and is transferred in the 10ml volumetric flask, add methanol to scale, shake up, filter with 0.2 μ m microporous filter membrane, get subsequent filtrate, promptly.
2.4 the assay of dictamine in the sample
Under above-mentioned chromatographic condition, each 10 μ l of sample introduction product solution and reference substance solution measure peak area, calculate the content of dictamine in the medicine, and the content results that records dictamine in three batch samples sees Table 2
The content of dictamine in table 2 three batch samples
Containing dictamine in the ointment of the present invention is 0.036-0.04mg/g.
The assay of 3 enoxolone
3.1 instrument and reagent
Instrument: Tianjin, island high performance liquid chromatograph (SPD-10Avp UV-VIS DETECTOR, binary LC-10ATvp LIQUID CHROMATOGRAPH, CTO-10ASvp COLUMN OVEN, N2000 chromatographic work station); Electronic balance (sensibility reciprocal 0.01mg); The automatic dual pure water distillator of SZ-93 type (Shanghai Yarong Biochemical Instrument Plant).
Reagent: methanol is chromatographically pure, and water is double distilled water, and all the other reagent are analytical pure.
Reference substance: the enoxolone reference substance (the biological Tetramune calibrating of Chinese medicine institute, lot number: 110723-200411, for assay with), use in the preposition silica gel drier and be dried to constant weight.
3.2 chromatographic condition
Chromatographic column: Agilent C
18(250 * 4.6mm, 5 μ m); Mobile phase: methanol-water-glacial acetic acid (85: 14.5: 0.5); Flow velocity: 1ml/min; Column temperature is 25 ℃; Detect wavelength: 250nm; The range of linearity: 0.102～1.015 μ g.
3.3 the preparation of sample preparation methods and reference substance solution
The preparation of reference substance solution: precision takes by weighing the about in right amount 2mg of enoxolone reference substance, puts in the 10ml volumetric flask, and dissolve with methanol, and add methanol to scale, shake up, promptly.
The preparation of sample solution: get the about 0.5g of this product, the accurate title, decide, and puts in the 100mL tool plug flask, contain 15% isopropyl alcohol chloroform 30ml, close plug, backflow 30min accurate respectively the adding, put cold after-filtration, with chloroform cyclic washing residue and filter paper, merging filtrate and washing chloroform, steam near and do, add methanol on a small quantity repeatedly solution transfer to the 25mL measuring bottle, be diluted to scale, shake up, precision is measured in 5ml to the 10ml measuring bottle, is diluted to scale with methanol, shake up, cross 0.2 μ m microporous filter membrane, promptly.
3.4 the assay of enoxolone in the sample
Under above-mentioned chromatographic condition, each 10 μ l of sample introduction product solution and reference substance solution measure peak area, calculate the content of enoxolone in the medicine, and the content results that records enoxolone in three batch samples sees Table 3
The content of enoxolone in table 3 three batch samples
Containing enoxolone in the ointment of the present invention is 9.2-9.3mg/g.
4 content of matrine are measured
4.1 instrument and reagent
Instrument: Tianjin, island high performance liquid chromatograph (SPD-10Avp UV-VIS DETECTOR, binary LC-10ATvp LIQUID CHROMATOGRAPH, CTO-10ASvp COLUMN OVEN, N2000 chromatographic work station); Electronic balance (sensibility reciprocal 0.01mg); The automatic dual pure water distillator of SZ-93 type (Shanghai Yarong Biochemical Instrument Plant).
Reagent: methanol, acetonitrile are chromatographically pure, and water is double distilled water, and all the other reagent are analytical pure.
Reference substance: the matrine reference substance (Nat'l Pharmaceutical ﹠ Biological Products Control Institute, lot number: 110805-200306, for assay with), use in the preposition silica gel drier and be dried to constant weight.
4.2 chromatographic condition
Chromatographic column: Agilent C
18(250 * 4.6mm, 5 μ m); Mobile phase: methanol: acetonitrile: PH6.8 buffer=(8: 8: 84); Flow velocity: 1ml/min; Column temperature is 40 ℃; Detect wavelength: 210nm; The range of linearity: 0.200～2.000g.
4.3 the preparation of sample preparation methods and reference substance solution
Sample preparation methods: get the about 5g of this product, add 2ml ammonia, add methanol 50ml then, supersound extraction 20min filters, and filtrate is put water-bath respectively and volatilized, and puts coldly, and residue dissolves with mobile phase, is settled to 10mL, shakes up, and crosses the 0.2um microporous filter membrane.
The preparation of reference substance solution: precision takes by weighing the about in right amount 1.00mg of matrine reference substance, puts in the 10ml volumetric flask, is dissolved to scale with mobile phase, shakes up, promptly.
4.4 content of matrine is measured in the sample
Under above-mentioned chromatographic condition, each 10 μ l of sample introduction product solution and reference substance solution measure peak area, calculate content of matrine in the medicine, record that content of matrine the results are shown in Table 4 in three batch samples
Content of matrine in table 4 three batch samples
Containing matrine in the ointment of the present invention is 0.145-0.175mg/g.
Below further specify beneficial effect of the present invention by clinical trial.
The clinical trial of test example 1 Drug therapy skin pruritus of the present invention
Medicine of the present invention (by the ointment of embodiment 1 preparation) is used for various types of skin pruritus, clinical application number: 6 people: using method: under the normal condition, early, middle and late each use once (evenly was applied in medicine in the affected part and gently rubbed a moment) every day, use immediately when in addition, pruritus is shown effect.(concrete consumption and day access times according to the weight of conditions of patients and difference) to some extent
Treatment standard: recovery from illness: after using a week, gargalesthesia disappears, and follows up a case by regular visits to and does not have recurrence in three months; Take a turn for the better: after using a week, gargalesthesia alleviates, and can stand, and need not to take any antipruritic; Effectively: after using a week, gargalesthesia alleviates, but still needs to take antipruritic sometimes.
Concrete case is as follows:
Clinical case 1:
The patient man, 72 years old age, geroderma pruritus, the course of disease 3 years.Clinical manifestation: the whole body pruritus, first time-out skin does not have the constitutional erythra.Pruritus is paroxysmal, and time stops when doing, and often begins from a certain position, spreads all over whole body then, later on PD, increases the weight of gradually, and light night in daytime is heavy, the autumn and winter morbidity, and the spring is warm to alleviate gradually or disappears.The most dry desquamation of skin, coarse plumpness.Use promptly take a turn for the better one week of medicine of the present invention.
Clinical case 2
Patient woman, 4 years old age, course of disease January, the anemopyretic pruritus, clinical manifestation: the shank acute pruritus is paroxysmal, because of long-term scabies is grabbed, so skin rubefaction, plumpness and harder.Use promptly fully recover one week of medicine of the present invention.
Clinical case 3
Patient woman, 36 years old age, the course of disease one day, allergic dermatitis (being caused) clinical manifestation by the medicated clothing trade mark: waist and medicated clothing trade mark contact position redness, pruritus, bitterly, the most serious with pruritus especially, even scabies is grabbed to wounded and bleeding.Use this week recovery from illness of medicine of the present invention.
Clinical case 4
The patient man, at 37 years old age, in two weeks of the course of disease, rheumatism is accumulate the resistance type pruritus, clinical manifestation: back pruritus, acute attack do not have regularly, and grab the back and play vesicle, and with sepage.Use take a turn for the better one week of medicine of the present invention.
Clinical case 5
The patient man, 29 years old age, course of disease January, the blood-heat type pruritus, clinical manifestation: skin of lumbar region is rubescent, itch, and meets heat and increases the weight of, and repeatedly if scabies is grabbed back pachyderma, shape lichen.Use one week of medicine of the present invention effectively.
Clinical case 6
Patient woman, 23 years old, mosquito bite type pruritus, clinical manifestation: shank, arm many places are by mosquito bite, and scabies is grabbed the back skin rubefaction, and pruritus is local even wounded and bleeding.Use back 2 minutes scratchiness promptly to alleviate, adhere to week back recovery from illness.
Above-mentioned test shows that medicine of the present invention all has effect preferably for various types of skin pruritus (comprising: geroderma pruritus, anemopyretic pruritus, allergic dermatitis, rheumatism are accumulate resistance type pruritus, blood-heat type pruritus, mosquito bite type pruritus).
Below further specify beneficial effect of the present invention by pharmacodynamics test.
Test example 1 Drug therapy 4-aminopyridine of the present invention (4-AP) causes the experiment of itching
1, laboratory animal: Kunming mouse, male and female half and half, body weight 18-22g
2, reagent: 4-AP (be made into normal saline 0.01% solution), normal saline, Na
2S, dehydrated alcohol, depilatory prescription: 8g Na
2S is dissolved in 30ml dehydrated alcohol and the 70ml distilled water
3, medicine: three nine-day periods after the winter solstice PIYANPING, blank substrate, 50% concentration medicine of the present invention (by embodiment 1 preparation) (low dose group), medicine of the present invention (middle dosage group), 200% concentration medicine of the present invention (high dose group)
4, method: mice is by sex, and body weight is divided into six groups (blank group, model group, positive controls, low dose group, middle dosage group, high dose group) at random.Earlier at the mouse carotid back with depilatory depilation 2cm*3cm size, administration respectively behind the 24h, blank group and model group are coated with blank substrate, positive group is coated with PIYANPING, high, in, low dose group is coated with 200% concentration medicine of the present invention respectively, medicine of the present invention, 50% concentration medicine of the present invention, every each consumption of mice is 0.1g, blank group mouse carotid back subcutaneous injection normal saline (injection volume is the 1%ml of body weight) behind the 30min, all the other every mouse carotid backs of group subcutaneous injection 0.01%4-AP (1mg/kg) are observed immediately and are licked body number of times (mice occur turning one's head the repeatedly behavior of licking the back, both sides " is promptly licked precursor reactant " and licked body continuously with mice and causes and minibreak occurs " doing to lick body once calculates) in the 10min
Experimental result sees Table 5
This medicine of table 5 4-AP brings out the influence (mean ± S.D.) of mouse skin pruritus
Annotate: compare with model group: * p＜0.05, #p＜0.01
The result shows, be subjected to the reagent object height, in, low dose group, positive group and model group relatively, all can significantly reduce and lick the precursor reactant number, illustrate that this medicine has good curative effect to skin pruritus.
Test example 3. Drug therapy dextrans of the present invention cause the test of itching
1, laboratory animal: Kunming mouse, male and female half and half, body weight 18-22g
2, reagent: dextran-40 (being made into the solution of 1.25mg/ml with normal saline), normal saline, Na2S, dehydrated alcohol, the depilatory prescription: 8g Na2S is dissolved in 30ml dehydrated alcohol and the 70ml distilled water
3, medicine: three nine-day periods after the winter solstice PIYANPING, blank substrate, 50% medicine of the present invention, medicine of the present invention, 200% medicine of the present invention
4, method: mice is by sex, and body weight is divided into six groups (blank group, model group, positive controls, low dose group, middle dosage group, high dose group) at random.Earlier at the mouse carotid back with depilatory depilation 2cm*3cm size, administration respectively behind the 24h, one week of successive administration, blank group and model group are coated with blank substrate, positive group is coated with PIYANPING, high, in, low dose group is coated with 200% concentration medicine of the present invention respectively, medicine of the present invention, 50% concentration medicine of the present invention, every each consumption of mice is 0.1g, blank group mouse tail vein injection normal saline (injection volume is the 1%ml of body weight) behind the last administration 30min, all the other organize every mouse tail vein injection dextran 1.25mg/Kg, observe pruritus paroxysm number of times in the 30min (show as the fore paw portion of scratching one's head, rear solid end is scratched trunk, chews each one of health of stinging) and pruritus immediately and continue total time.Experimental result sees Table 6
This medicine of table 6 brings out the influence (mean ± S.D.) of mouse skin pruritus to dextran
Annotate: compare with model group: #p＜0.01
The result shows, be subjected to the reagent object height, in, low dose group, positive group and model group relatively, all can significantly reduce pruritus paroxysm number of times and pruritus and continue total time, illustrate that medicine of the present invention has good antipruritic curative effect.
Above-mentioned two tests adopt 4-aminopyridines, dextran to cause and itch, and it causes the mechanism of itching and is and brings out mast cell degranulation and discharge the endogenous histamine, and histamine be cause that pruritus is modal, also be topmost chemical mediator.The pruritus that medicine of the present invention causes histamine has special curative effect.
Claims (11)
1. pharmaceutical composition for the treatment of skin pruritus, it is characterized in that: it is the topical agent that is prepared from by following raw materials by weight proportions:
Cortex Moutan 100-600 part, Cortex Dictamni 100-300 part, Radix Sophorae Flavescentis 10-100 part, Radix Glycyrrhizae 500-1000 part, Borneolum Syntheticum 10-30 part, Mentholum 5-30 part.
2. the pharmaceutical composition of treatment skin pruritus according to claim 1 is characterized in that: it is the topical agent that is prepared from by following raw materials by weight proportions:
200 parts of Cortex Moutans, 160 parts of Cortex Dictamni, 28 parts of Radix Sophorae Flavescentiss, 840 parts in Radix Glycyrrhizae, 20 parts of Borneolum Syntheticums, 10 parts of Mentholums.
3. the pharmaceutical composition of treatment skin pruritus according to claim 1 and 2, it is characterized in that: it is to be active component by the active component paeonol extract in the Cortex Moutan, the active component dictamine extract in the Cortex Dictamni, the active component matrine extract in the Radix Sophorae Flavescentis, active component enoxolone extract, Borneolum Syntheticum, the Mentholum in the Radix Glycyrrhizae, add the topical agent that acceptable accessories or complementary composition are prepared from, wherein the weight proportion of active component is:
Paeonol extract 1-6 part, dictamine extract 0.04-0.15 part, matrine extract 0.1-3 part, enoxolone extract 5-15 part, Borneolum Syntheticum 10-30 part, Mentholum 5-30 part.
4. the pharmaceutical composition of treatment skin pruritus according to claim 3 is characterized in that: the weight proportion of active component is:
2 parts of paeonol extracts, 0.07 part of dictamine extract, 0.2 part of matrine extract, 10 parts of enoxolone extracts, 20 parts of Borneolum Syntheticums, 10 parts of Mentholums.
5. according to the pharmaceutical composition of claim 3 or 4 described treatment skin pruritus, it is characterized in that: contain enoxolone in the described enoxolone extract, press dry product and calculate, the content of enoxolone should be less than 97.0%w/w; The paeonol extract contains paeonol, presses dry product and calculates, and the content of paeonol should be 98%-103%w/w; Contain content of matrine in the matrine extract and should be less than 98.0%w/w; In the dictamine extract, press dry product and calculate, contain dictamine and must not be less than 55%w/w.
6. according to the pharmaceutical composition of the arbitrary described treatment skin pruritus of claim 1-5, it is characterized in that: described topical agent is ointment, powder, lotion, liniment, tincture, paste, liniment, gel, spray or transdermal patch.
7. the pharmaceutical composition of treatment skin pruritus according to claim 6 is characterized in that: the content that contains paeonol in the described ointment is 1.7-1.78mg/g; Dictamine is 0.036-0.04mg/g; Enoxolone is 9.2-9.3mg/g; Matrine is 0.145-0.175mg/g.
8. method for preparing claim 1 or 2 described pharmaceutical compositions, it comprises the steps:
A, take off and state materials of weight proportions:
Cortex Moutan 100-600 part, Cortex Dictamni 100-300 part, Radix Sophorae Flavescentis 10-100 part, Radix Glycyrrhizae 500-1000 part, Borneolum Syntheticum 10-30 part, Mentholum 5-30 part;
B, Cortex Dictamni, Cortex Moutan, Radix Sophorae Flavescentis, Radix Glycyrrhizae are mixed, water or organic solvent extraction add external preparation adjuvant pharmaceutically commonly used, are prepared into topical agent commonly used.
9. preparation of drug combination method according to claim 8 is characterized in that: the b step is specially: Cortex Moutan extracts paeonol; Cortex Dictamni extracts the dictamine extract; Extract the matrine extract in the Radix Sophorae Flavescentis; Extract enoxolone in the Radix Glycyrrhizae; Add Borneolum Syntheticum, Mentholum again, after the mixing, add pharmaceutically acceptable external preparation adjuvant, be prepared into external preparation commonly used.
10. preparation of drug combination method according to claim 9 is characterized in that: the preparation method of described soft capsule is:
(1) paeonol, dictamine extract use dissolve with ethanol standby; The matrine extract is dissolved in the water; Borneolum Syntheticum, that Mentholum is ground to congruent melting with liquid paraffin is standby; The enoxolone extract grinds standby with glycerol;
(2) with oil phase: weight proportion is: stearic acid 80-150 part, white vaseline 100-150 part, with water: triethanolamine 20-40 part, the red 5-15 part of Gloriosa saperba L., water 400-450 part, be heated to 80 ℃ respectively, water slowly adds in the oil phase water and stirring a little more than oil phase, treats to add above-mentioned paeonol, dictamine, enoxolone extract after the biphase mix homogeneously, the limit edged stirs, treat that temperature reduces to 50 ℃, add Borneolum Syntheticum and Herba Menthae, continue to be stirred to condensation promptly.
11. the purposes of any described pharmaceutical composition of claim 1-7 in the medicine of preparation treatment skin pruritus.
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Application publication date: 20101013 |