CN101485779A - Medicinal composition for treating psoriasis as well as preparation method and quality detection method - Google Patents
Medicinal composition for treating psoriasis as well as preparation method and quality detection method Download PDFInfo
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Abstract
The invention discloses a medicine composition, and in particular relates to a traditional Chinese medicine composition for treating psoriasis, a method for preparing the traditional Chinese medicine composition, and a quality testing method thereof, and belongs to the field of traditional Chinese medicine. The effective components of the medicine composition are prepared from Rehmannia glutinosa, angelica dahurica, tortoiseshells, Paeonia lactiflora, artificial bezoar, schizonepeta spikes and other raw material medicines, and prepared into tablets, capsules, granules, pills and other preparation formulations according to clinical demands. The medicine composition has obvious function of treating or improving psoriasis.
Description
Technical field
The present invention relates to the psoriatic pharmaceutical composition of a kind of treatment, especially a kind of Chinese medicine composition of being made by the raw material of Chinese medicine medicine belongs to the field of Chinese medicines.
Background technology
Psoriasis is commonly called as " psoriasis ", belongs to “ Bai Mange in the Chinese medicine ", " psoriasis ", " stubborn dermatitis " wait the category of disease.Be more common in person between twenty and fifty, good sending out stretched side in extremity, and scalp, trunk etc. are located, be symmetrically distributed more.This disease course of disease is more of a specified duration, and is easy to recurrence, and doctor trained in Western medicine lacks effective Therapeutic Method, how should control with hormone, though the temporary transient mitigation symptoms of energy can not fundamentally be cured primary disease, and easily be produced serious hormone sequela.
Summary of the invention
Primary and foremost purpose of the present invention provides a kind of pharmaceutical composition, is used for the treatment of psoriasis; This preparation of drug combination method and quality determining method is provided simultaneously.
The present invention seeks to realize like this:
The inventor provides a kind of pharmaceutical composition, and the effective ingredient of this pharmaceutical composition is made by following crude drug: Radix Rehmanniae 80～120 weight portions, the Radix Angelicae Dahuricae 50～70 weight portions, Carapax Eretmochelydis 30～50 weight portions, Radix Paeoniae Rubra 80～120 weight portions, artificial Calculus Bovis's 4～8 weight portions, Herba Schizonepetae 50～70 weight portions.
Definite says, the consisting of of its crude drug: Radix Rehmanniae 100 weight portions, the Radix Angelicae Dahuricae 60 weight portions, Carapax Eretmochelydis 40 weight portions, Radix Paeoniae Rubra 100 weight portions, artificial Calculus Bovis's 6 weight portions, Herba Schizonepetae 60 weight portions.
Its equivalent proportioning is: Radix Rehmanniae 5560 weight portions, the Radix Angelicae Dahuricae 3330 weight portions, Carapax Eretmochelydis 2220 weight portions, Radix Paeoniae Rubra 5560 weight portions, artificial Calculus Bovis's 333 weight portions, Herba Schizonepetae 3330 weight portions.
Artificial Calculus Bovis in the above-mentioned raw materials medicine also can replace with the Calculus Bovis of equivalent; Herba Schizonepetae can replace with the Herba Schizonepetae of equivalent.
In the above-mentioned raw materials medicine:
Radix Rehmanniae is a Radix Rehmanniae, refers to the dried root of scrophulariaceae rehmannia glutinosa plant Rehmannia glutinosa Libosch..
The Radix Angelicae Dahuricae is the dry root of the plant Radix Angelicae Dahuricae Angelica dahurica of umbellate form section (Fisch.ex Hoffm.) Benth.et Hook.f..
Carapax Eretmochelydis is the carapace of Cheloniidae animal Carapax Eretmochelydis Erctmochelys imbricata (Linnaeus), wears into fine powder before the use.
Radix Paeoniae Rubra is the dry root of ranunculaceae plant Radix Paeoniae Paeonia lactifora Pall..
Herba Schizonepetae is labiate Herba Schizonepetae Schizonepeta tenuifolia Briq. ground dry aerial parts.
Calculus Bovis is the dry cholelithiasis of bovid cattle Bos Taurus domesticus Gmelin.The artificial Calculus Bovis is the succedaneum of Calculus Bovis, is made by bilein, cholic acid, Hyodeoxycholic Acid, taurine, bilirubin, cholesterol and trace element etc., and its quality should meet the Chinese Pharmacopoeia relevant regulations.
In the above-mentioned raw materials medicine composition, the Radix Rehmanniae is sweet in flavor and cold in property, kind clearing away heat and cooling blood, and nourishing YIN to relieve dryness, skin care is monarch drug.Carapax Eretmochelydis is sweet cold, and merit be apt to heat-clearing and toxic substances removing, can play the effect of removing pathogenic heat from blood and toxic substance from the body with Radix Rehmanniae compatibility, and to cure the disease this, the while, this medicine also had the merit of tranquillizing and allaying excitement, can treat vexed disease; The hot temperature of the Radix Angelicae Dahuricae is the demulcen in the wind, and the merit of dispelling wind for relieving itching is arranged; So Carapax Eretmochelydis, the Radix Angelicae Dahuricae be the ministerial drug in the side of being altogether.The Radix Paeoniae Rubra hardship is slightly cold, and has the effect of clearing away heat and cooling blood, with Radix Rehmanniae compatibility to strengthen the strength of our clearing away heat and cooling blood; Calculus Bovis or artificial Calculus Bovis are bitter sweet and cool, heat-clearing and toxic substances removing, with the Carapax Eretmochelydis compatibility to strengthen the merit of our heat-clearing and toxic substances removing; The hot temperature of Herba Schizonepetae is got its fragrance and is loose, and the property that abnormal smells from the patient lightly floats is to reach the effect of dispelling wind for relieving itching; So Radix Paeoniae Rubra, Calculus Bovis/or artificial Calculus Bovis, Herba Schizonepetae be adjuvant drug altogether.All medicine compatibilities are played removing pathogenic heat from blood and toxic substance from the body altogether, and the effect of dispelling wind for relieving itching is applicable to the wind-dryness of treatment psoriasis vulgaris heat in blood, skin cervical carcinoma with cachexia card.
Aforementioned pharmaceutical compositions is equipped with corresponding adjuvant, can be made into multiple dosage form be applied to clinical, as granule, capsule, tablet etc.Another object of the present invention promptly provides preparation of drug combination method of the present invention, steps of the method are:
A, get crude drug, the artificial Calculus Bovis is ground into fine powder, sieve, standby;
B, the Radix Angelicae Dahuricae, Herba Schizonepetae are added water reflux, extract, volatile oil, collect volatile oil and preserve standby; Water liquid after the distillation filters, filtrate for later use;
Three flavor medical materials such as the medicinal residues after C, the distillation and all the other Radix Rehmanniae decoct with water 2～3 times, each 1～2 hour, filter collecting decoction, add filtrate among the B, concentrate, centrifugal, relative density is the thick paste of 1.20-1.25 when getting supernatant and continuing to be concentrated into 60 ℃, vacuum drying is ground into fine powder, and is standby;
D, with dry extract mixing mixing among volatile oil among artificial Calculus Bovis's fine powder and the B and the C, add the conventional adjuvant of preparation, make required dosage form according to conventional formulation technology.
Gained volatile oil in above-mentioned steps B both can be according to the use of directly being used as medicine of the method for step D, after also can handling by following arbitrary method earlier more set by step the method for D use:
A, with volatile oil and betacyclodextrin and water, press the mixed of 1:7～9:70～90, stirred 1～3 hour down in 55～65 ℃, cold preservation filters, the betacyclodextrin clathrate of volatile oil is made in cold drying;
B, volatile oil is dissolved in the dehydrated alcohol of capacity, makes the alcoholic solution of volatile oil.
Through experimentation repeatedly, the inventor provides the method for this pharmaceutical composition being made multiple dosage form, and wherein the preparation method of granule is:
A, get crude drug, the artificial Calculus Bovis is ground into fine powder, sieve, standby;
B, the Radix Angelicae Dahuricae, Herba Schizonepetae are added 6 times of water gaging reflux, extract, volatile oil 8 hours, volatile oil and betacyclodextrin and water with the mixed of 1:8:80, were stirred 2 hours under 60 ℃ of conditions, cold preservation filters cold drying, be ground into fine powder, promptly get the betacyclodextrin clathrate of volatile oil, standby; Aqueous solution after the distillation filters, filtrate for later use;
Three flavor medical materials such as the medicinal residues after C, the distillation and all the other Radix Rehmanniae decoct with water 3 times, add 8 times of water gagings at every turn, decocted 1 hour, filter, collecting decoction, add filtrate among the B, relative density 1.02-1.05 is centrifugal when being concentrated into 60 ℃, relative density is the thick paste of 1.20-1.25 when getting supernatant and continuing to be concentrated into 60 ℃, vacuum drying is ground into fine powder, and is standby;
D, with dry extract facing-up among clathrate dry powder, the C among artificial Calculus Bovis's fine powder and the B, sieve, mixing adds required conventional formulation adjuvant again, makes granule.
At last, the inventor has also extracted the quality determining method of this pharmaceutical composition, wherein outside the conventional sense project of a good appetite suddenly appearing in a serious disease state pharmacopeia regulation, also comprises the content assaying method and the qualitative identification method of this pharmaceutical composition.
Specifically, content assaying method is an index with n-butanol extract content, and step is: take by weighing pharmaceutical composition 3～6g of the present invention, the accurate title, decide, put in the 250ml conical flask, accurate n-butyl alcohol 100ml, jam-pack, the merceration of adding, jolting constantly in preceding 6 hours, left standstill 18 hours again, and filtered rapidly with dry filter, precision is measured filtrate 20ml, put in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath,, move in the exsiccator in 105 ℃ of dryings 3 hours, cooled off 30 minutes, weight decided in accurate rapidly title, calculates, promptly; Wherein contain the n-butyl alcohol extractum and should be no less than 1.5%.
The qualitative identification method then comprises following test item:
A, get pharmaceutical composition 3～5g of the present invention, add water 25～35ml dissolving, extract with ether 20～40ml, discard ether layer, water layer extracts 1～2 time with water saturated n-butyl alcohol 25～35ml, discard water layer, n-butanol layer washes with water 2～3 times, each 20～30ml, and n-butyl alcohol liquid is put evaporate to dryness in the water-bath, residue is with methanol 1～2ml dissolving, as need testing solution; Other gets the peoniflorin reference substance and adds methanol and make the solution that every 1ml contains 1～2mg, in contrast product solution; Test according to thin layer chromatography, draw each 3～5ul of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with volume ratio is that the chloroform-ethyl acetate-methanol-ammonia water mixture of 7～9:1～2:3～5:1～2 is developing solvent, saturated 15 minutes, launch, take out, dry, spray is with the vanillin ethanol solution of sulfuric acid; On the corresponding position of reference substance chromatograph, show the same color speckle in the test sample chromatograph;
B, get pharmaceutical composition 3～5g of the present invention, hydro-oxidation sodium solution adjust pH to 12 extracts 2～3 times with the chloroform jolting, each 20～30ml, and combined chloroform layer, evaporate to dryness, residue add chloroform 1～2ml makes dissolving, as need testing solution; Other gets Radix Angelicae Dahuricae control medicinal material 1～3g, decocts with water 20～40 minutes, puts coldly, filters, and filtrate is shone medical material solution in pairs with legal system; Test according to thin layer chromatography, draw above-mentioned two kinds of solution 3～5ul, putting respectively on same silica gel g thin-layer plate, is that the chloroform-methanol mixed liquor of 8～10:1 is developing solvent with volume ratio, saturated with strong ammonia solution, launch, take out, put under the 365nm ultra-violet lamp and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
C, get pharmaceutical composition 3～5g of the present invention, add chloroform 15～30ml, supersound extraction 20～40 minutes filters, and filtrate volatilizes, and residue adds ethanol 1～2ml makes dissolving, as need testing solution; Other gets artificial Calculus Bovis's reference substance 100mg, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, draw each 3～5ul of above-mentioned two kinds of solution, putting respectively on same silica gel g thin-layer plate, is that the isobutyltrimethylmethane .-ethyl acetate-glacial acetic acid mixed liquor of 14～16:6～8:4～6 is developing solvent with volume ratio, launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were heated about 5 minutes, on the corresponding position of control medicinal material chromatograph, show the same color speckle in the test sample chromatograph.
Carry out quality testing as granule, except that the conventional sense project that should satisfy the Chinese Pharmacopoeia regulation, also should satisfy following detection requirement pharmaceutical composition of the present invention:
The assay of n-butanol extract:
Take by weighing granule 4g, put in the 250ml conical flask, the accurate n-butyl alcohol 100ml that adds, jam-pack, merceration, jolting constantly in preceding 6 hours, left standstill 18 hours again, and filtered rapidly with dry filter, precision is measured filtrate 20ml, put in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath, in 105 ℃ of dryings 3 hours, move in the exsiccator, cooled off 30 minutes, weight decided in accurate rapidly title, calculate, that is, wherein contain the n-butyl alcohol extractum and should be no less than 1.5%;
Qualitative identification:
A, get granule 5g of the present invention, add water 30ml dissolving, extract with ether 30ml, discard ether layer, water layer extracts 1 time with water saturated n-butyl alcohol 30ml, discard water layer, n-butanol layer washes with water 3 times, each 20ml, and n-butyl alcohol liquid is put evaporate to dryness in the water-bath, residue is with methanol 1ml dissolving, as need testing solution; Other gets the peoniflorin reference substance and adds methanol and make the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel g thin-layer plate, chloroform-ethyl acetate-methanol-the ammonia water mixture that with the volume ratio is 8:1:4:1 is developing solvent, saturated 15 minutes, launches, take out, dry, spray is with the vanillin ethanol solution of sulfuric acid; On the corresponding position of reference substance chromatograph, show the same color speckle in the test sample chromatograph;
B, get granule 5g of the present invention, add the 20% sodium hydroxide solution adjust pH to 12 of 20ml, extract 2 times with the chloroform jolting, each 20ml, combined chloroform layer, evaporate to dryness, residue add chloroform 1ml makes dissolving, as need testing solution; Other gets Radix Angelicae Dahuricae control medicinal material 1g, decocts with water 30 minutes, puts coldly, filters, and filtrate is shone medical material solution in pairs with legal system; Test according to thin layer chromatography, draw above-mentioned two kinds of solution 4ul, putting respectively on same silica gel g thin-layer plate, is that the chloroform-methanol mixed liquor of 9:1 is developing solvent with the volume, saturated with strong ammonia solution, launch, take out, put under the 365nm ultra-violet lamp and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
C, get granule 5g of the present invention, add chloroform 20ml, supersound extraction 30 minutes filters, and filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, as need testing solution; Other gets artificial Calculus Bovis's reference substance 100mg, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, draw above-mentioned two kinds of solution 4ul, putting respectively on same silica gel g thin-layer plate, is that isobutyltrimethylmethane .-ethyl acetate-glacial acetic acid mixed liquor of 15:7:5 is developing solvent with the volume ratio, launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were heated about 5 minutes, on the corresponding position of control medicinal material chromatograph, show the same color speckle in the test sample chromatograph.
Pharmaceutical composition of the present invention has removing pathogenic heat from blood and toxic substance from the body, and the effect of dispelling wind for relieving itching can be used for treating the wind-dryness of psoriasis vulgaris heat in blood, skin cervical carcinoma with cachexia card.For proving the effect of this pharmaceutical composition, the inventor has carried out following zoopery.
[experiment material]
Be subjected to the reagent thing: medicament composition granule agent of the present invention (silver bits granule), preparation as follows:
Crude drug: Radix Rehmanniae 5560g, Radix Angelicae Dahuricae 3330g, Carapax Eretmochelydis (powder) 2220g, Radix Paeoniae Rubra 5560g, artificial Calculus Bovis 333g, Herba Schizonepetae 3330g.
Method for making: above Six-element, the artificial Calculus Bovis is ground into fine powder, sieves, and is standby.The Radix Angelicae Dahuricae, Herba Schizonepetae add 6 times of water gaging reflux, extract, volatile oil 8 hours, and three flavors such as the medicinal residues after the distillation and all the other Radix Rehmanniae add 8 times of water gagings and decoct 3 times, each 1 hour, filter collecting decoction.Aqueous solution after the distillation filters, and filtrate is integrated with in the above-mentioned decocting liquid, is concentrated into relative density 1.02-1.05 (60 ℃), centrifugal (2500rpm), supernatant continues to be concentrated into the thick paste that relative density is 1.20-1.25 (60 ℃), vacuum drying is ground into fine powder, and is standby.Volatile oil betacyclodextrin enclose (oil-β-CD-water=1:8:80,60 ℃ were stirred 2 hours), cold preservation filters, and the clathrate cold drying is ground into fine powder, sieving for standby.With Calculus Bovis fine powder and clathrate dry powder and above-mentioned dry extract facing-up, sieve, mixing adds an amount of dextrin and 10g stevioside again, and mixing is granulated with 90% alcoholic solution that contains 3% polyvidone in right amount, and drying is made granule 1000g altogether.
The dosage design: the clinical consumption per day of silver bits granule people is the 18.3g crude drug, calculates by 60 kg body weight, and dosage is 0.305g crude drug/kg; In the conversion of animals and human beings kg body weight ratio, the mice dosage is 6.72g, 3.36g, three dosage of 1.68g crude drug/kg.Middle dosage is equivalent to clinical equivalent dosage, and high dose is the twice of middle dosage, and low dose is 1/2 of a middle dosage.The methotrexate sheet, clinical consumption per day is 10mg, amounts to 0.17mg/kg body weight, mice consumption 3.7mg/kg is the twice of clinical equivalent dosage.
Reagent: diethylstilbestrol injection, Shanghai the 9th pharmaceutical factory produces, 2mg/ml, lot number 020102;
Colchicine, Kunming Medicine Group Stock Co., Ltd, 0.5mg/ sheet, lot number 030828;
The methotrexate sheet, Shanghai Xinyi Pharmaceutical Co., Ltd, 2.5mg/ sheet, lot number 030601.
Animal: mice, the Kunming kind, 20～21g, 25～30g, female, provide by Beijing Vital River Experimental Animals Technology Co., Ltd., the animal quality certification number is SCXK (capital) 2002-0003.
[method and result]
Silver bits granule to the mouse vagina epithelial cell mitotic influence choose the 25-30g female mice, be divided into 6 groups at random by body weight, matched group, model group, three dosage groups of silver bits granule high, medium and low (6.72,3.36,1.68g/kg), methotrexate (3.7mg/kg), 10 every group.All the other organize lumbar injection diethylstilbestrol for three days on end except that matched group, and once a day, each every 0.2mg causes the mouse vagina epithelium to be in rutting period.The 4th day, to irritate stomach respectively and give medicinal liquid, matched group, model group give the distilled water of equal volume, for three days on end, and once a day, the 0.2ml/10g body weight.Behind the last medicine, mouse stomach colchicine 4mg/kg put to death mice after 8 hours, cut vagina tissue, formaldehyde fixed, paraffin embedding, mitotic counting in the basal cell is carried out in HE dyeing under optical microscope, relatively the mitotic index of vaginal epithelial cell between the mice group.See Table 1.
Table 1 silver bits granule is to the mitotic influence of mouse vagina epithelial cell (X ± SD)
Annotate: compare with matched group
*P＜0.05,
*P＜0.01.
Experimental result shows that in 100 basal cells, the mitotic index of the vaginal epithelial cell of silver bits granule institute amount of reagent group mice is starkly lower than matched group.
2. silver bits granule is to the influence of mouse tail scale granular layer of epidermis formation
Get 50 of 20-22g female mices, divide 5 groups at random by body weight, matched group, three dosage groups of silver bits granule high, medium and low (6.72,3.36,1.68g/kg body weight), positive control drug methotrexate group (3.7mg/kg), 10 every group, every day gastric infusion once, 0.2ml/10g body weight (matched group gives the distilled water of equal volume), continuous 14 days.Put to death mice in second day behind the last medicine, it is rectangular to get the about 1.8cm of Mus back range heel place skin one, formaldehyde fixed, and paraffin embedding, HE dyeing, optical microscope is observed the afterbody scale of mice down.The scale epidermis has the granular cell person who embarks on journey continuously, for the scale that has granular layer to form, counts the scale number that granular layer is arranged in per 100 scales, compares between organizing with t check among the Excel.See Table 2.
The influence that table 2 silver bits granule forms mouse tail scale granular layer of epidermis
Annotate: compare with matched group
*P＜0.01.
Experimental result shows that silver bits granule height, middle dosage obviously promote mouse tail scale granular layer of epidermis to form, and the scale digital display work that granular layer forms in 100 Mus tail scales is more than matched group.
As fully visible, silver bits granule can obviously suppress to inject the mouse vagina epithelial cell mitosis that estrogen causes, significantly increases mouse tail scale granular layer and forms, and this conclusion provides the pharmacodynamics foundation for the clinical treatment psoriasis.Simultaneously, the prepared pharmaceutical composition of the present invention of following examples all can reach above-mentioned therapeutic effect.
The specific embodiment
Embodiment 1:
Crude drug: Radix Rehmanniae 8kg, Radix Angelicae Dahuricae 5kg, Carapax Eretmochelydis 3kg, Radix Paeoniae Rubra 8kg, artificial Calculus Bovis 0.4kg, Herba Schizonepetae 5kg
Preparation technology: above Six-element, the artificial Calculus Bovis is ground into fine powder, sieves, and is standby; The Radix Angelicae Dahuricae, Herba Schizonepetae add 8 times of water gaging reflux, extract, volatile oil to there not being oil droplet to produce, and it is standby to collect volatile oil; Aqueous solution after the distillation filters, filtrate for later use; Three flavors such as the medicinal residues after the distillation and all the other Radix Rehmanniae add decoction 2 times; add 10 times of amounts of water at every turn; decocted 2 hours; filter; collecting decoction; add above-mentioned standby filtrate; be concentrated into relative density 1.00-1.02 (60 ℃); centrifugal (2500rpm) gets supernatant and continues to be concentrated into the thick paste that relative density is 1.15-1.20 (60 ℃), is spray dried to fine powder; with Calculus Bovis fine powder, above-mentioned dry extract and volatile oil mix homogeneously; in the ratio of 1:5:0.4 and Polyethylene Glycol, mixed with propylene glycol, make soft capsule content again, be pressed into soft capsule.
Embodiment 2:
Crude drug: Radix Rehmanniae 12kg, Radix Angelicae Dahuricae 7kg, Carapax Eretmochelydis 5kg, Radix Paeoniae Rubra 12kg, artificial Calculus Bovis 0.8kg, Herba Schizonepetae 7kg
Preparation technology: above Six-element, the artificial Calculus Bovis is ground into fine powder, sieves, and is standby; The Radix Angelicae Dahuricae, Herba Schizonepetae add 10 times of water gaging reflux, extract, volatile oil 6 hours, collect volatile oil, are dissolved in the alcoholic solution that makes volatile oil in the dehydrated alcohol of capacity, and be standby; Aqueous solution after the distillation filters, filtrate for later use; Three flavors such as the medicinal residues after the distillation and all the other Radix Rehmanniae decoct with water 3 times, add 6 times of amounts at every turn and decoct 1 hour, filter; collecting decoction adds above-mentioned standby filtrate, is concentrated into relative density 1.02-1.05 (60 ℃); filter, filtrate continuation is concentrated into the thick paste that relative density is 1.20-1.25 (60 ℃), vacuum drying; be ground into fine powder; with artificial Calculus Bovis's fine powder mixing, spray into the alcoholic solution of volatile oil, granulate; granule is made in cold drying.
Embodiment 3:
Crude drug: Radix Rehmanniae 8kg, Radix Angelicae Dahuricae 5kg, Carapax Eretmochelydis 5kg, Radix Paeoniae Rubra 8kg, Calculus Bovis 0.4kg, Herba Schizonepetae 7kg
Preparation technology: above Six-element, the artificial Calculus Bovis is ground into fine powder, sieves, and is standby; The Radix Angelicae Dahuricae, Herba Schizonepetae add 6 times of water gaging reflux, extract, volatile oil 8 hours, and three flavors such as the medicinal residues after the distillation and all the other Radix Rehmanniae decoct with water 3 times, add 8 times of amounts at every turn and decoct 1 hour, filter collecting decoction; Aqueous solution after the distillation filters, and filtrate is integrated with in the above-mentioned decocting liquid, is concentrated into relative density 1.03-1.05 (60 ℃), centrifugal (2500rpm), supernatant continue to be concentrated into the thick paste that relative density is 1.20-1.23 (60 ℃), vacuum drying, be ground into fine powder, standby; Volatile oil betacyclodextrin enclose (oil-β-CD-water=1:8:80,60 ℃ were stirred 2 hours), cold preservation filters, and the clathrate cold drying is ground into fine powder, sieving for standby; With Calculus Bovis fine powder and clathrate dry powder and above-mentioned dry extract mixing, add appropriate amount of starch and microcrystalline Cellulose again, mixing, filling capsule, promptly.
Embodiment 4:
Crude drug: Radix Rehmanniae 9kg, Radix Angelicae Dahuricae 6.5kg, Carapax Eretmochelydis 3.5kg, Radix Paeoniae Rubra 11kg, Calculus Bovis 0.5kg, Herba Schizonepetae 5kg
Preparation technology: above Six-element, the artificial Calculus Bovis is ground into fine powder, sieves, and is standby; The Radix Angelicae Dahuricae, Herba Schizonepetae add 6 times of water gaging reflux, extract, volatile oil 8 hours, and three flavors such as the medicinal residues after the distillation and all the other Radix Rehmanniae add 8 times of water gagings and decoct 3 times, each 1 hour, filter collecting decoction; Aqueous solution after the distillation filters, and filtrate is integrated with in the above-mentioned decocting liquid, is concentrated into relative density 1.02-1.05 (60 ℃), centrifugal (2500rpm), supernatant continue to be concentrated into the thick paste that relative density is 1.20-1.25 (60 ℃), vacuum drying, be ground into fine powder, standby; Volatile oil betacyclodextrin enclose (oil-β-CD-water=1:7:90,60 ℃ were stirred 2 hours), cold preservation filters, and the clathrate cold drying is ground into fine powder, sieving for standby; With Calculus Bovis fine powder and clathrate dry powder and above-mentioned dry extract mixing, add appropriate amount of starch, sodium carboxymethyl cellulose again, mix homogeneously, compacting is in flakes.
Embodiment 5:
Crude drug: Radix Rehmanniae 10kg, Radix Angelicae Dahuricae 6kg, Carapax Eretmochelydis 4kg, Radix Paeoniae Rubra 10kg, artificial Calculus Bovis 0.6kg, Herba Schizonepetae 6kg
Preparation method: above Six-element, the artificial Calculus Bovis is ground into fine powder, sieves, and is standby; The Radix Angelicae Dahuricae, Herba Schizonepetae add 8 times of water gaging reflux, extract, volatile oil and produce to there being oil droplet, volatile oil betacyclodextrin enclose (oil-β-CD-water=1:7:90,60 ℃ were stirred 2 hours), and cold preservation filters, and the clathrate cold drying is ground into fine powder, sieving for standby; Three flavors such as the medicinal residues after the distillation and all the other Radix Rehmanniae decoct with water 2 times, add 8 times of amounts at every turn and decoct 1.5 hours, filter collecting decoction; Aqueous solution after the distillation filters, and filtrate is integrated with in the above-mentioned decocting liquid, is concentrated into relative density 1.02-1.05 (60 ℃), centrifugal (2500rpm), supernatant continue to be concentrated into the thick paste that relative density is 1.20-1.25 (60 ℃), vacuum drying, be ground into fine powder, standby; With Calculus Bovis fine powder and clathrate dry powder and above-mentioned dry extract mixing, add appropriate amount of starch again, the system soft material is pressed into ball.
Embodiment 6: the granule to embodiment 2 carries out quality examination
[discriminating]
(1) gets this product 5g, add water 30ml dissolving, extract, discard ether layer with ether 30ml, water layer extracts 1 time with water saturated n-butyl alcohol 30ml, discard water layer, n-butanol layer washes (30ml, 20ml with water 3 times, 20ml), n-butyl alcohol liquid is put evaporate to dryness in the water-bath, and residue is with methanol 1ml dissolving, as need testing solution.Other gets the peoniflorin reference substance and adds methanol and make the solution that every 1ml contains 1mg, in contrast product solution.According to the thin layer chromatography test, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel g thin-layer plate, with chloroform-ethyl acetate-methanol-ammonia (8:1:4:1) is developing solvent, saturated 15 minutes, launches, take out, dry, spray is with the vanillin ethanol solution of sulfuric acid.On the corresponding position of reference substance chromatograph, show the same color speckle in the test sample chromatograph.
(2) get this product 5g, add the 20% sodium hydroxide solution adjust pH to 12 of 20ml, extract 2 times with the chloroform jolting, each 20ml, combined chloroform layer, evaporate to dryness, residue add chloroform 1ml makes dissolving, as need testing solution; Other gets Radix Angelicae Dahuricae control medicinal material 1g, decocts with water 30 minutes, puts coldly, filters, and filtrate is shone medical material solution in pairs with legal system.Test according to thin layer chromatography, draw above-mentioned two kinds of solution 4ul, putting respectively on same silica gel g thin-layer plate, is developing solvent with chloroform-methanol (9:1), saturated with strong ammonia solution, launch, take out, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(3) get this product 5g, add chloroform 20ml, supersound extraction 30 minutes filters, and filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, as need testing solution; Other gets artificial Calculus Bovis's reference substance 100mg, shines medical material solution in pairs with legal system.Test according to thin layer chromatography, draw above-mentioned two kinds of solution 4ul, putting respectively on same silica gel g thin-layer plate, is developing solvent with isobutyltrimethylmethane .-ethyl acetate-glacial acetic acid (15:7:5), launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were heated about 5 minutes, on the corresponding position of control medicinal material chromatograph, show the same color speckle in the test sample chromatograph.
[n-butyl alcohol extractum] precision takes by weighing this product 4g, puts in the 250ml conical flask, the accurate n-butyl alcohol 100ml that adds, jam-pack, merceration, jolting constantly in preceding 6 hours, left standstill 18 hours again, and filtered rapidly with dry filter, precision is measured filtrate 20ml, put in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath, in 105 ℃ of dryings 3 hours, move in the exsiccator, cooled off 30 minutes, weight decided in accurate rapidly title, calculate, promptly.This product contains n-butyl alcohol extractum 1.62%.
Embodiment 7: the capsule to embodiment 3 carries out quality examination
[discriminating]
(1) gets capsule 's content 3g, add water 25ml dissolving, extract with ether 40ml, discard ether layer, water layer extracts 2 times with water saturated n-butyl alcohol 35ml, discard water layer, n-butanol layer washes with water 3 times, each 30ml, and n-butyl alcohol liquid is put evaporate to dryness in the water-bath, residue is with methanol 1ml dissolving, as need testing solution; Other gets the peoniflorin reference substance and adds methanol and make the solution that every 1ml contains 2mg, in contrast product solution; According to the thin layer chromatography test, draw above-mentioned two kinds of each 3ul of solution, put respectively on same silica gel g thin-layer plate, chloroform-ethyl acetate-methanol-the ammonia water mixture that with the volume ratio is 7:1:3:2 is developing solvent, saturated 15 minutes, launches, take out, dry, spray is with the vanillin ethanol solution of sulfuric acid; On the corresponding position of reference substance chromatograph, show the same color speckle in the test sample chromatograph;
(2) get capsule 's content 5g, hydro-oxidation sodium solution 10ml and adjust pH to 12 extract 2 times with the chloroform jolting, each 30ml, and combined chloroform layer, evaporate to dryness, residue add chloroform 1ml makes dissolving, as need testing solution; Other gets Radix Angelicae Dahuricae control medicinal material 3g, decocts with water 20 minutes, puts coldly, filters, and filtrate is shone medical material solution in pairs with legal system; Test according to thin layer chromatography, draw above-mentioned two kinds of solution 3ul, putting respectively on same silica gel g thin-layer plate, is that the chloroform-methanol mixed liquor of 10:1 is developing solvent with the volume ratio, saturated with strong ammonia solution, launch, take out, put under the 365nm ultra-violet lamp and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) get capsule 's content 5g, add chloroform 30ml, supersound extraction 20 minutes filters, and filtrate volatilizes, and residue adds ethanol 2ml makes dissolving, as need testing solution; Other gets artificial Calculus Bovis's reference substance 100mg, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, draw above-mentioned two kinds of each 3ul of solution, putting respectively on same silica gel g thin-layer plate, is that isobutyltrimethylmethane .-ethyl acetate-glacial acetic acid mixed liquor of 14:8:6 is developing solvent with the volume ratio, launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were heated about 6 minutes, on the corresponding position of control medicinal material chromatograph, show the same color speckle in the test sample chromatograph.
[n-butyl alcohol extractum] precision takes by weighing capsule 's content 5g, puts in the 250ml conical flask, the accurate n-butyl alcohol 100ml that adds, jam-pack, merceration, jolting constantly in preceding 6 hours, left standstill 18 hours again, and filtered rapidly with dry filter, precision is measured filtrate 20ml, put in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath, in 105 ℃ of dryings 3 hours, move in the exsiccator, cooled off 30 minutes, weight decided in accurate rapidly title, calculate, promptly.This product contains n-butyl alcohol extractum 1.58%.
Embodiment 8: granule of the present invention (silver bits granule) is treated psoriatic model case
Example one: the patient pays certain, man, 42 years old, suffered from psoriasis 20 years, outbreak increases the weight of gradually repeatedly, show effect twice in four months before going to a doctor, all use hormone therapy, the back recurrence is the whole body dispersed, the utmost point is itched, moving difficulty, emergency is gone to a doctor, and checks that the discovery whole body is more sparse except that (facial) shirtfront skin lesion, all the other positions are abound with, the skin lesion substrate is scarlet, on have thicker silvery white squama easily to come off, remove the thin film of visible light after the squama, under the film petechial hemorrhage is arranged, the swelling of part nail matrix does not see that fingernail is impaired, and maximum skin lesion area is 30 * 30cm, Western medicine diagnose: the psoriasis homeliness type carries out the phase, Chinese medical discrimination: heat in blood wind-dryness disease.Treatment: silver bits granule, each one bag (4.5g), twice of every day.Warm boiled water.Patient takes back two all pruritus degree and obviously alleviates, the squama attenuation, and restlessness and thirst alleviates.After six weeks, except that the shallow place of skin table has a spot of erythema all the other normal substantially; After eight weeks, all symptoms and sign all disappear, clinical recovery.
Example two: patient Zhang, man, 55 years old, suffered from psoriasis 12 years, outbreak increases the weight of gradually repeatedly, 2 years causes, the two upper limb skin lesion of having a fever increase, and the utmost point is itched, and checks and finds the visible lamellar skin lesion of two upper limb, in the form of sheets intensive with two the back of the hand and wrist, the fusion of part skin lesion is the map shape, and the accidental skin lesion substrate of two lower limb is light red, squama is more, melts skin surface, scrapes the thin film of the visible light of district's squama, visible petechial hemorrhage under the film does not see that fingernail is impaired.Western medicine diagnose: psoriasis homeliness type resting stage, Chinese medical discrimination: heat in blood wind-dryness disease.Treatment: silver bits granule, each one bag (4.5g), twice of every day.Warm boiled water.Patient takes two week back prurituss, thirsty, constipation disappears, 6 weeks basic the recovery, 8 weeks promptly reached clinical recovery.
Claims (10)
1, a kind ofly is used for the treatment of psoriatic pharmaceutical composition, it is characterized in that the effective ingredient of this pharmaceutical composition is made by following raw material medicaments: Radix Rehmanniae 80～120 weight portions, the Radix Angelicae Dahuricae 50～70 weight portions, Carapax Eretmochelydis 30～50 weight portions, Radix Paeoniae Rubra 80～120 weight portions, artificial Calculus Bovis's 4～8 weight portions, Herba Schizonepetae 50～70 weight portions.
2, pharmaceutical composition according to claim 1 is characterized in that consisting of of each crude drug: Radix Rehmanniae 5560 weight portions, the Radix Angelicae Dahuricae 3330 weight portions, Carapax Eretmochelydis 2220 weight portions, Radix Paeoniae Rubra 5560 weight portions, artificial Calculus Bovis's 333 weight portions, Herba Schizonepetae 3330 weight portions.
3, pharmaceutical composition according to claim 1 and 2 is characterized in that the artificial Calculus Bovis in the crude drug uses the Calculus Bovis of equivalent to replace; Herba Schizonepetae replaces with the Herba Schizonepetae of equivalent.
4, preparation is characterized in that as the method for pharmaceutical composition as described in the claim 1,2 or 3 this method is:
A, get crude drug, the artificial Calculus Bovis is ground into fine powder, sieve, standby;
B, the Radix Angelicae Dahuricae, Herba Schizonepetae are added water reflux, extract, volatile oil, collect volatile oil and preserve standby; Water liquid after the distillation filters, filtrate for later use;
Three flavor medical materials such as the medicinal residues after C, the distillation and all the other Radix Rehmanniae decoct with water 2～3 times, each 1～2 hour, filter collecting decoction, add filtrate among the B, concentrate, centrifugal, relative density is the thick paste of 1.20-1.25 when getting supernatant and continuing to be concentrated into 60 ℃, vacuum drying is ground into fine powder, and is standby;
D, with dry extract mixing mixing among volatile oil among artificial Calculus Bovis's fine powder and the B and the C, add the conventional adjuvant of preparation, make required dosage form according to conventional formulation technology.
5, preparation of drug combination method according to claim 4 is characterized in that being applied among the step D after the volatile oil that will extract is handled by following arbitrary method again:
A, with volatile oil and betacyclodextrin and water, press the mixed of 1:7～9:70～90, stirred 1～3 hour down in 55～65 ℃, cold preservation filters, the betacyclodextrin clathrate of volatile oil is made in cold drying;
B, volatile oil is dissolved in the dehydrated alcohol of capacity, makes the alcoholic solution of volatile oil.
6, preparation of drug combination method according to claim 4 is characterized in that the preparation method of granule is:
A, get crude drug, the artificial Calculus Bovis is ground into fine powder, sieve, standby;
B, the Radix Angelicae Dahuricae, Herba Schizonepetae are added 6 times of water gaging reflux, extract, volatile oil 8 hours, volatile oil and betacyclodextrin and water with the mixed of 1:8:80, were stirred 2 hours under 60 ℃ of conditions, cold preservation filters cold drying, be ground into fine powder, promptly get the betacyclodextrin clathrate of volatile oil, standby; Aqueous solution after the distillation filters, filtrate for later use;
Three flavor medical materials such as the medicinal residues after C, the distillation and all the other Radix Rehmanniae decoct with water 3 times, add 8 times of water gagings at every turn, decocted 1 hour, filter, collecting decoction, add filtrate among the B, relative density 1.02-1.05 is centrifugal when being concentrated into 60 ℃, relative density is the thick paste of 1.20-1.25 when getting supernatant and continuing to be concentrated into 60 ℃, vacuum drying is ground into fine powder, and is standby;
D, with dry extract facing-up among clathrate dry powder, the C among artificial Calculus Bovis's fine powder and the B, sieve, mixing adds required conventional formulation adjuvant again, makes granule.
7, as claim 1, the quality determining method of 2 or 3 described pharmaceutical compositions, it is characterized in that containing in this method the content assaying method of following n-butanol extract: take by weighing pharmaceutical composition 3～6g of the present invention, the accurate title, decide, and puts in the 250ml conical flask, the accurate n-butyl alcohol 100ml that adds, jam-pack, merceration, jolting constantly in preceding 6 hours was left standstill 18 hours again, filter rapidly with dry filter, precision is measured filtrate 20ml, puts in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath, in 105 ℃ of dryings 3 hours, move in the exsiccator, cooled off 30 minutes, weight decided in accurate rapidly title, calculate, promptly; Wherein contain the n-butyl alcohol extractum and should be no less than 1.5%.
8, quality determining method according to claim 7 is characterized in that also containing in this method following qualitative identification project:
A, get pharmaceutical composition 3～5g of the present invention, add water 25～35ml dissolving, extract with ether 20～40ml, discard ether layer, water layer extracts 1～2 time with water saturated n-butyl alcohol 25～35ml, discard water layer, n-butanol layer washes with water 2～3 times, each 20～30ml, and n-butyl alcohol liquid is put evaporate to dryness in the water-bath, residue is with methanol 1～2ml dissolving, as need testing solution; Other gets the peoniflorin reference substance and adds methanol and make the solution that every 1ml contains 1～2mg, in contrast product solution; Test according to thin layer chromatography, draw each 3～5ul of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with volume ratio is that the chloroform-ethyl acetate-methanol-ammonia water mixture of 7～9:1～2:3～5:1～2 is developing solvent, saturated 15 minutes, launch, take out, dry, spray is with the vanillin ethanol solution of sulfuric acid; On the corresponding position of reference substance chromatograph, show the same color speckle in the test sample chromatograph;
B, get pharmaceutical composition 3～5g of the present invention, hydro-oxidation sodium solution adjust pH to 12 extracts 2～3 times with the chloroform jolting, each 20～30ml, and combined chloroform layer, evaporate to dryness, residue add chloroform 1～2ml makes dissolving, as need testing solution; Other gets Radix Angelicae Dahuricae control medicinal material 1～3g, decocts with water 20～40 minutes, puts coldly, filters, and filtrate is shone medical material solution in pairs with legal system; Test according to thin layer chromatography, draw above-mentioned two kinds of solution 3～5ul, putting respectively on same silica gel g thin-layer plate, is that the chloroform-methanol mixed liquor of 8～10:1 is developing solvent with volume ratio, saturated with strong ammonia solution, launch, take out, put under the 365nm ultra-violet lamp and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
C, get pharmaceutical composition 3～5g of the present invention, add chloroform 15～30ml, supersound extraction 20～40 minutes filters, and filtrate volatilizes, and residue adds ethanol 1～2ml makes dissolving, as need testing solution; Other gets artificial Calculus Bovis's reference substance 100mg, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, draw each 3～5ul of above-mentioned two kinds of solution, putting respectively on same silica gel g thin-layer plate, is that the isobutyltrimethylmethane .-ethyl acetate-glacial acetic acid mixed liquor of 14～16:6～8:4～6 is developing solvent with volume ratio, launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were heated about 5 minutes, on the corresponding position of control medicinal material chromatograph, show the same color speckle in the test sample chromatograph.
9,, it is characterized in that containing in the quality determining method of granule following project according to the quality determining method of claim 7 or 8 described pharmaceutical compositions:
The assay of n-butanol extract:
Take by weighing granule 4g, put in the 250ml conical flask, the accurate n-butyl alcohol 100ml that adds, jam-pack, merceration, jolting constantly in preceding 6 hours, left standstill 18 hours again, and filtered rapidly with dry filter, precision is measured filtrate 20ml, put in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath, in 105 ℃ of dryings 3 hours, move in the exsiccator, cooled off 30 minutes, weight decided in accurate rapidly title, calculate, that is, wherein contain the n-butyl alcohol extractum and should be no less than 1.5%;
Qualitative identification:
A, get granule 5g of the present invention, add water 30ml dissolving, extract with ether 30ml, discard ether layer, water layer extracts 1 time with water saturated n-butyl alcohol 30ml, discard water layer, n-butanol layer washes with water 3 times, each 20ml, and n-butyl alcohol liquid is put evaporate to dryness in the water-bath, residue is with methanol 1ml dissolving, as need testing solution; Other gets the peoniflorin reference substance and adds methanol and make the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel g thin-layer plate, chloroform-ethyl acetate-methanol-the ammonia water mixture that with the volume ratio is 8:1:4:1 is developing solvent, saturated 15 minutes, launches, take out, dry, spray is with the vanillin ethanol solution of sulfuric acid; On the corresponding position of reference substance chromatograph, show the same color speckle in the test sample chromatograph;
B, get granule 5g of the present invention, add the 20% sodium hydroxide solution adjust pH to 12 of 20ml, extract 2 times with the chloroform jolting, each 20ml, combined chloroform layer, evaporate to dryness, residue add chloroform 1ml makes dissolving, as need testing solution; Other gets Radix Angelicae Dahuricae control medicinal material 1g, decocts with water 30 minutes, puts coldly, filters, and filtrate is shone medical material solution in pairs with legal system; Test according to thin layer chromatography, draw above-mentioned two kinds of solution 4ul, putting respectively on same silica gel g thin-layer plate, is that the chloroform-methanol mixed liquor of 9:1 is developing solvent with the volume, saturated with strong ammonia solution, launch, take out, put under the 365nm ultra-violet lamp and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
C, get granule 5g of the present invention, add chloroform 20ml, supersound extraction 30 minutes filters, and filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, as need testing solution; Other gets artificial Calculus Bovis's reference substance 100mg, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, draw above-mentioned two kinds of solution 4ul, putting respectively on same silica gel g thin-layer plate, is that isobutyltrimethylmethane .-ethyl acetate-glacial acetic acid mixed liquor of 15:7:5 is developing solvent with the volume ratio, launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were heated about 5 minutes, on the corresponding position of control medicinal material chromatograph, show the same color speckle in the test sample chromatograph.
10, claim 1,2 or 3 described pharmaceutical compositions are used for the treatment of or improve application in the psoriatic medicine in preparation.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104359788A (en) * | 2014-12-01 | 2015-02-18 | 江苏辰星海洋生物科技有限公司 | Method for determining moisture of soft capsule rubber |
| CN105998164A (en) * | 2016-06-20 | 2016-10-12 | 中国人民解放军空军总医院 | Traditional Chinese medicine composition and granules for treating atopic dermatitis and preparation method |
| CN114081934A (en) * | 2022-01-20 | 2022-02-25 | 江西省中医药研究院 | Traditional Chinese medicine composition and quality detection method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104359788A (en) * | 2014-12-01 | 2015-02-18 | 江苏辰星海洋生物科技有限公司 | Method for determining moisture of soft capsule rubber |
| CN105998164A (en) * | 2016-06-20 | 2016-10-12 | 中国人民解放军空军总医院 | Traditional Chinese medicine composition and granules for treating atopic dermatitis and preparation method |
| CN105998164B (en) * | 2016-06-20 | 2020-03-17 | 中国人民解放军空军总医院 | Traditional Chinese medicine composition for treating atopic dermatitis and granules and preparation method thereof |
| CN114081934A (en) * | 2022-01-20 | 2022-02-25 | 江西省中医药研究院 | Traditional Chinese medicine composition and quality detection method thereof |
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