CN100400085C - Chinese-medicinal compound preparation for treating gynecological cutaneous diseases and its making method - Google Patents
Chinese-medicinal compound preparation for treating gynecological cutaneous diseases and its making method Download PDFInfo
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Abstract
A Chinese medicine in the form of spray, gel, suppository, ointment, or lotion for treating vaginitis, vulvitis, pudendal eczema and skin eczema is prepared from 6 Chinese-medicinal materials including coptis root, coix seed, China root, Chinese prickly ash, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of compound Chinese medicinal preparation for the treatment of gynecological and cutaneous diseases, comprise prescription of this compound Chinese medicinal preparation and preparation method thereof.
Background technology
Pruritus diseases such as gynaecopathia such as various vaginitis, vulvitis and cutaneous diseases such as Hand and Foot Eczema, male and female pudendum eczema, anal eczema are commonly encountered diseases, frequently-occurring disease, symptom see more sufferer place pruritus unbearably, suppurate, red and swollen, pain, female vagina, vulvitis are stench etc. with purulent leukorrhea, abnormal smells from the patient.These disease grievous injuries patient's body health, make the patient suffering can't bear, had a strong impact on that they live normally, study and work.The medicine that is used for above-mentioned all diseases at present mostly is antibiotic and contains hormone preparation, easily produces drug resistance and anaphylaxis; Chinese medicine mostly is washing liquid greatly, uses inconvenience, and it is not lasting to act on, though can alleviate the patient's condition, therapeutical effect is not good enough, and using has limitation.Therefore, existing market needs more determined curative effects, easy to use, the medicine that has no side effect to satisfy the demand of extensive patients.
Summary of the invention
The applicant is according to Chinese medical theory and experience for many years, determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, and clear and definite above-mentioned all diseases mainly are that dampness-heat of the liver is made a bet, or the dirty institute of pyretic toxicity worm causes, therefore, control suitable heat-clearing and toxic substances removing, removing dampness and killing parasites, relieving itching and eliminating swelling.By meticulous screening and test, determine to adopt Cortex Phellodendri, Rhizoma Coptidis, Fructus Cnidii, Semen Coicis, Rhizoma Smilacis Glabrae, Pericarpium Zanthoxyli Six-element medicine composition of prescription.Wherein, Cortex Phellodendri nature and flavor bitter cold, effect heat clearing away, detoxifcation, pathogenic fire purging, dampness; Cure mainly hematodiarrhoea, stranguria with turbid discharge, worm skin ulcer, leucorrhea with red and white discharge, skin ulcer struma poison." herbal classic " record: Cortex Phellodendri " main woman's whitish metrorrhagia, the turbid skin ulcer of negative and positive ".Supplement to the Herbal record: Cortex Phellodendri " main herpes simplex bleb rises, and the worm skin ulcer is killed moth ".The Cortex Phellodendri washout can be controlled the suppurative of skin and mucosal sites and apyetous illness, is the key medicine of clear damp-heat in lower-JIAO, and the product that consolidate are monarch drug with the Cortex Phellodendri.Rhizoma Coptidis nature and flavor bitter cold focuses on heat clearing away, pathogenic fire purging, detoxifcation in the side; The arduous temperature of Fructus Cnidii focuses on dampness, parasite killing, antipruritic, and two medicines are principal drug assistance heat-clearing and toxic substances removing, pathogenic fire purging, dampness altogether, and the merit of killing parasites for relieving itching is ministerial drug altogether." herbal classic " record: Rhizoma Coptidis " pain in housewife people's the moon ", " herbal diagram " are said " allly control outer disease pruritus and swell and ache, the wind skin ulcer all should the soup fumigation and wash method ".Semen Coicis slightly sweet flavor in the side, cold nature, light with eliminating dampness by diuresis, sweet with spleen invigorating, the effect of spleen invigorating, dampness removing, detumescence is arranged; The Rhizoma Smilacis Glabrae slightly sweet flavor is held concurrently among dampness removing heat conduction and can be detoxified, and is longer than treatment malignant boil, prunus mume (sieb.) sieb.et zucc. poison; The two helps the merit of monarch-minister drug removing dampness and detoxicating detumescence.Hot dry loose of Pericarpium Zanthoxyli, it is antipruritic to be longer than removing dampness and killing parasites, but dispersing cold for relieving pain again both can help the antipruritic merit of monarch-minister drug removing dampness and killing parasites, can delay the property of monarch-minister drug bitter cold again, with italian-jobi jen, Rhizoma Smilacis Glabrae be adjuvant drug altogether.By above-mentioned all medicine compatibilities, full side receives the merit of heat-clearing and toxic substances removing, removing dampness and killing parasites, relieving itching and eliminating swelling altogether, is used for the treatment of itching skin disease such as skin eczema, various female vagina, vulvitis, male and female pudendum eczema.
A kind of compound Chinese medicinal preparation for the treatment of gynecological and cutaneous diseases of the present invention and preparation method thereof, it is by the Chinese crude drug feedstock production of following weight percent:
Cortex Phellodendri 15.00-18.34
Rhizoma Coptidis 7.50-9.16
Fructus Cnidii 30.00-36.66
Semen Coicis 15.00-18.34
Rhizoma Smilacis Glabrae 15.00-18.34
Pericarpium Zanthoxyli 7.50-9.16
A kind of compound Chinese medicinal preparation for the treatment of gynecological and cutaneous diseases of the present invention of above-mentioned indication and preparation method thereof, its Chinese crude drug raw material optimum weight percentage composition proportioning is:
Cortex Phellodendri 16.67
Rhizoma Coptidis 8.33
Fructus Cnidii 33.33
Semen Coicis 16.67
Rhizoma Smilacis Glabrae 16.67
Pericarpium Zanthoxyli 8.33
Above-mentioned compound Chinese medicinal preparation, can be clinical suitable dosage forms such as spray, gel, ointment, suppository, liniment, membrane, liniment, lotion, preparation method can be carried out with reference to the method for the Chinese medicine preparation of routine, but is the performance optimum curative effect, preferably adopts following preparation method:
(1) Chinese crude drug that takes by weighing by following weight percent proportioning is a raw material:
Cortex Phellodendri 15.00-18.34
Rhizoma Coptidis 7.50-9.16
Fructus Cnidii 30.00-36.66
Semen Coicis 15.00-18.34
Rhizoma Smilacis Glabrae 15.00-18.34
Pericarpium Zanthoxyli 7.50-9.16
(2) Six-element medical materials such as above-mentioned Cortex Phellodendri are decocted with water.
Decoct (extraction) number of times and be divided into secondary, 1.5 hours for the first time, 1 hour for the second time, quantity of solvent was 8 times of amounts first time, 6 times of amounts for the second time.
(3) merge extractive liquid, filters, and filtrate is condensed into the clear paste that relative density is 1.02～1.10 (50 ℃ of surveys).
Above-mentioned clear paste or add ethanol makes that concentration of alcohol is 40～70% in the solution, leaves standstill 12-24 hour, gets supernatant and filters, and decompression filtrate recycling ethanol and simmer down to relative density are the clear paste of 1.02～1.10 (50 ℃ of surveys).
(4) above-mentioned clear paste adds corresponding excipient and adjuvant, can be made into clinical suitable dosage forms such as spray, gel, ointment, suppository, liniment, membrane, liniment, lotion.
The used Chinese crude drug of the present invention source:
Cortex Phellodendri: be the dry bark of rutaceae wampee Phellodendron chinense Schneid. or Cortex Phellodendri Phellodendronamurense Rupr..The former practises title " Cortex Phellodendri ", and the latter practises title " Cortex Phellodendri ".After stripping bark, remove rough bark, dry.
Rhizoma Coptidis: be the dry rhizome of ranunculaceae plant Rhizoma Coptidis Coptis chinensis Franch., Coptis deltoidea C.Y.Cheng et Hsiao Coptis deltoidea C.Y.Cheng etHsiao or Coptis Teeta Wall Coptis teeta Wall..More than three kinds practise to claim " flavor connects ", " refined company ", " Coptis Teeta Wall " respectively.Excavate autumn, removes fibrous root and silt, and drying is hit residual fibrous root.
Fructus Cnidii: be the dry mature fruit of samphire cnidium monnieri Cnidium monnieri (L.) Cuss..Summer, two season of autumn gather during fruit maturation, remove impurity, dry.
Semen Coicis: be the dry mature kernal of grass Semen Coicis Coix lacryma-jobi L.var.ma-yuen (Roman.) Stapf.Tap plant during fruit maturation autumn, dries, and lays fruit, dries again, removes decapsidate, yellowish-brown kind skin and impurity, collects kernel.
Rhizoma Smilacis Glabrae: be the dry rhizome of liliaceous plant smilacis glabra Smilax glabra Roxb..Summer, Qiu Erji excavate, and remove fibrous root, cleaning, drying; Or take advantage of fresh-cut flakiness, drying.
Pericarpium Zanthoxyli: this product is the dry mature skin of rutaceae green pepper Zanthoxylum schinifolium Sieb.et Zucc. or Pericarpium Zanthoxyli Zanthoxylum bungeanum Maxim..The mature fruit of gathering autumn is dried, and removes seed and impurity.
Form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example, all technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Embodiment one
1, the preparation of medicinal herb spray a of the present invention:
Get Cortex Phellodendri 170g, Rhizoma Coptidis 85g, Fructus Cnidii 340g, Semen Coicis 170g, Rhizoma Smilacis Glabrae 170g, Pericarpium Zanthoxyli 85g decoct with water secondary, add 8 times of amounts of water for the first time, decocted 1.5 hours, for the second time add 6 times of amounts of water, decocted collecting decoction 1 hour, filter, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, cold preservation 12 hours, filter, filtrate adds an amount of antiseptic, essence etc., stir evenly, add water to 1000ml, be sub-packed in the spray bottle, promptly.
2, the preparation of medicinal herb spray b of the present invention:
Get Cortex Phellodendri 187g, Rhizoma Coptidis 93.5g, Fructus Cnidii 374g, Semen Coicis 187g, Rhizoma Smilacis Glabrae 187g, Pericarpium Zanthoxyli 93.5g decocts with water secondary, for the first time add 8 times of amounts of water, decocted 1.5 hours, add 6 times of amounts of water for the second time, decocted 1 hour, collecting decoction filters, and it is 1.05 (50 ℃) that filtrate is concentrated into relative density, add ethanol and make that concentration of alcohol is 45% in the solution, left standstill 24 hours, and got supernatant and filter, decompression filtrate recycling ethanol to relative density is 1.05 (50 ℃), cold preservation 12 hours, filter, filtrate adds an amount of antiseptic, essence etc., stir evenly, add water to 1000ml, be sub-packed in the spray bottle, promptly.
Above spray institute adding preservative agent is a potassium sorbate 0.1～1%; The essence consumption is 0.5%.
Embodiment two
1, the preparation of Chinese medicine gel a of the present invention:
Get Cortex Phellodendri 170g, Rhizoma Coptidis 85g, Fructus Cnidii 340g, Semen Coicis 170g, Rhizoma Smilacis Glabrae 170g, Pericarpium Zanthoxyli 85g decoct with water secondary, add 8 times of amounts of water for the first time, decocted 1.5 hours, for the second time add 6 times of amounts of water, decocted collecting decoction 1 hour, filter, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, and cold preservation 12 hours filters, filtrate adds an amount of gel-type vehicle, antiseptic, essence, add water to 1000g, be stirred to complete homodisperse, promptly.
2, the preparation of Chinese medicine gel b of the present invention:
Get Cortex Phellodendri 178.5g, Rhizoma Coptidis 89.3g, Fructus Cnidii 357g, Semen Coicis 178.5g, Rhizoma Smilacis Glabrae 178.5g, Pericarpium Zanthoxyli 89.3g decocts with water secondary, add for the first time 8 times of amounts of water, decocted 1.5 hours, for the second time add 6 times of amounts of water, decocted collecting decoction 1 hour, filter, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, adds ethanol and makes that concentration of alcohol is 50% in the solution, leaves standstill 24 hours, getting supernatant filters, decompression filtrate recycling ethanol to relative density is 1.05 (50 ℃), and cold preservation 12 hours filters, filtrate adds an amount of gel-type vehicle, antiseptic, essence, add water to 1000g, be stirred to complete homodisperse, promptly.
The used gel-type vehicle of above gel is a carbomer 1.0%～1.5%; Antiseptic is an ethyl hydroxybenzoate 0.1%; The essence consumption is 0.5%.
Embodiment three
1, the preparation of Chinese medicine ointment a of the present invention:
Get Cortex Phellodendri 153g, Rhizoma Coptidis 76.5g, Fructus Cnidii 306g, Semen Coicis 153g, Rhizoma Smilacis Glabrae 153g, Pericarpium Zanthoxyli 76.5g decoct with water secondary, add 8 times of amounts of water for the first time, decocted 1.5 hours, for the second time add 6 times of amounts of water, decocted collecting decoction 1 hour, filter, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, cold preservation 12 hours, filter, filtrate is concentrated, dry, makes dry extract, be ground into fine powder,, add an amount of antiseptic etc. with an amount of ointment base mixing, make 1000g ointment, promptly.
2, the preparation of Chinese medicine ointment b of the present invention:
Get Cortex Phellodendri 170g, Rhizoma Coptidis 85g, Fructus Cnidii 340g, Semen Coicis 170g, Rhizoma Smilacis Glabrae 170g, Pericarpium Zanthoxyli 85g decocts with water secondary, adds 8 times of amounts of water for the first time, decocts 1.5 hours, for the second time add 6 times of amounts of water, decocted collecting decoction 1 hour, filter, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, adds ethanol and makes that concentration of alcohol is 60% in the solution, leaves standstill 24 hours, getting supernatant filters, decompression filtrate recycling ethanol to relative density is 1.05 (50 ℃), and cold preservation 12 hours filters, filter, filtrate concentrates, drying is made dry extract, is ground into fine powder, with an amount of ointment base mixing, add an amount of antiseptic etc., make 1000g ointment, promptly.
The used substrate of above ointment is vaseline, liquid Paraffin etc.; Antiseptic is an ethyl hydroxybenzoate 0.1%.
Embodiment four
1, the preparation of Chinese medicine suppository a of the present invention:
Get Cortex Phellodendri 170g, Rhizoma Coptidis 85g, Fructus Cnidii 340g, Semen Coicis 170g, Rhizoma Smilacis Glabrae 170g, Pericarpium Zanthoxyli 85g decoct with water secondary, add 8 times of amounts of water for the first time, decocted 1.5 hours, add for the second time 6 times of amounts of water, decocted 1 hour, collecting decoction filters, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, cold preservation 12 hours filters, and filtrate is concentrated, dry, make dry extract, be ground into fine powder,, in about 40 ℃, inject the suppository mould with an amount of suppository base mixing, cold slightly, scrape mould, put into 5～10 ℃ of refrigerator and cooled but 5～10 minutes, take out, the demoulding, promptly.
2, the preparation of Chinese medicine suppository b of the present invention:
Get Cortex Phellodendri 178.5g, Rhizoma Coptidis 89.3g, Fructus Cnidii 357g, Semen Coicis 178.5g, Rhizoma Smilacis Glabrae 178.5g, Pericarpium Zanthoxyli 893g decocts with water secondary, adds 8 times of amounts of water for the first time, decocts 1.5 hours, add for the second time 6 times of amounts of water, decocted 1 hour, collecting decoction filters, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, add ethanol and make that concentration of alcohol is 65% in the solution, left standstill 24 hours, get supernatant and filter, decompression filtrate recycling ethanol to relative density is 1.05 (50 ℃), cold preservation 12 hours filters, and filtrate concentrates, dry, make dry extract, be ground into fine powder,, in about 40 ℃, inject the suppository mould with an amount of suppository base mixing, cold slightly, scrape mould, put into 5～10 ℃ of refrigerator and cooled but 5～10 minutes, take out, the demoulding, promptly.
The used substrate of above suppository is semi-synthetic fatty acid ester, and consumption is 75-95%.
Embodiment five
1, the preparation of medicine film a among the present invention:
Get Cortex Phellodendri 153g, Rhizoma Coptidis 76.5g, Fructus Cnidii 306g, Semen Coicis 153g, Rhizoma Smilacis Glabrae 153g, Pericarpium Zanthoxyli 76.5g decoct with water secondary, add 8 times of amounts of water for the first time, decocted 1.5 hours, for the second time add 6 times of amounts of water, decocted collecting decoction 1 hour, filter, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, cold preservation 12 hours, filter, filtrate is concentrated, dry, makes dry extract, be ground into fine powder, with an amount of filmogen mixing, the system film, promptly.
2, the preparation of medicine film b among the present invention:
Get Cortex Phellodendri 170g, Rhizoma Coptidis 85g, Fructus Cnidii 340g, Semen Coicis 170g, Rhizoma Smilacis Glabrae 170g, Pericarpium Zanthoxyli 85g decocts with water secondary, for the first time add 8 times of amounts of water, decocted 1.5 hours, add 6 times of amounts of water for the second time, decocted 1 hour, collecting decoction filters, and it is 1.05 (50 ℃) that filtrate is concentrated into relative density, add ethanol and make that concentration of alcohol is 70% in the solution, left standstill 24 hours, and got supernatant and filter, decompression filtrate recycling ethanol to relative density is 1.05 (50 ℃), cold preservation 12 hours, filter, filtrate concentrates, drying is made dry extract, be ground into fine powder, with an amount of filmogen mixing, the system film, promptly.
Above membrane used film forming material is a polyvinyl alcohol, consumption 75-95%.
Embodiment six
1, the preparation of Chinese medicine lotion a of the present invention:
Get Cortex Phellodendri 187g, Rhizoma Coptidis 93.5g, Fructus Cnidii 374g, Semen Coicis 187g, Rhizoma Smilacis Glabrae 187g, Pericarpium Zanthoxyli 93.5g decoct with water secondary, add 8 times of amounts of water for the first time, decocted 1.5 hours, for the second time add 6 times of amounts of water, decocted collecting decoction 1 hour, filter, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, cold preservation 12 hours, filter, filtrate adds an amount of antiseptic, and essence etc. stir evenly, add water to 1000ml, promptly.
2, the preparation of Chinese medicine lotion b of the present invention:
Get Cortex Phellodendri 170g, Rhizoma Coptidis 85g, Fructus Cnidii 340g, Semen Coicis 170g, Rhizoma Smilacis Glabrae 170g, Pericarpium Zanthoxyli 85g decoct with water secondary, add for the first time 8 times of amounts of water, decocted 1.5 hours, and added 6 times of amounts of water for the second time, decocted 1 hour, collecting decoction, filter, it is 1.05 (50 ℃) that filtrate is concentrated into relative density, adds ethanol and makes that concentration of alcohol is 40% in the solution, left standstill 24 hours, get supernatant and filter, decompression filtrate recycling ethanol to relative density is 1.05 (50 ℃), cold preservation 12 hours, filter, filtrate adds an amount of antiseptic, and essence etc. stir evenly, add water to 1000ml, promptly.
Above lotion institute adding preservative agent is a potassium sorbate 0.1～1%; The essence consumption is 0.5%.
Toxicology test, pharmacodynamics test and clinical trial that the present invention is relevant
One, Chinese medicine preparation toxicology test report of the present invention
1, summary
For guaranteeing drug safety, adopt Chinese medicine preparation of the present invention, acute toxicity test, vaginal mucosa irritation test, skin anaphylactic test, skin irritation test have been carried out, the result shows, Chinese medicine preparation of the present invention, acute toxicity test no abnormality seen and pathological change are to skin, mucosa is non-stimulated and toxic and side effects such as sensitization
2, test method and result
2.1 acute toxicity test
(1) medicine: by the medicinal herb spray a that embodiment one makes, every 1ml contains crude drug amount 1.0g.
(2) animal: 8 of white rabbits, body weight 2.0 ± 0.2kg plant in New Zealand.Provide by China Academy of TCM's animal center.
(3) method: animal is divided into two groups at random, 4 every group.The disposable vaginal administration, the medicine group gives medicinal herb spray 2ml (1ml/kg of the present invention, be Coming-of-Age Day 60.24 times of dosage), matched group gives the distilled water with volume, makes medicine fully contact 4 hours with mucosa, reaches at once to observe once every day, observe continuously 7 days parts and general reaction, put to death animal subsequently, take out vagina tissue, observation has or not phenomenons such as hyperemia, redness.
(4) result: diet is good after the two treated animal administrations, and fur gloss is movable as usual, and pudendum is the untoward reaction of the swollen grade of show not, weight increase, and all animals is strong to be deposited.Whole vagina tissue and mucosa pinkiness or lavender, do not see redness is arranged, petechia, irritant reaction such as fester; Because toxicity is little, do not measure the LD50 of this preparation, this product external safety.
2.2 the irritant test of vaginal mucosa
(1) medicine: by the medicinal herb spray a that embodiment one makes, every 1ml contains crude drug amount 1g.
(2) animal: 8 of white female rabbit, body weight 2.0 ± 0.2kg plant in New Zealand.Provide by China Academy of TCM's animal center.
(3) method: animal is divided into two groups at random, 4 every group.Spray 1ml is injected administration treated animal vagina, and matched group gives the distilled water with volume, once a day, successive administration 7 days is observed part and general reaction, 24 hours execution animals after the last administration, take out vagina tissue, carry out outward appearance and histopathologic examination.
(4) result: two treated animals there is no unusual systemic reaction after the administration, and external genital does not have phenomenons such as hyperemia, redness, vagina tissue and mucosa pinkiness or lavender, do not see hyperemia is arranged, irritant reaction such as redness.The tissue slice mirror is observed down, does not see that spray group and matched group have pathological change, and test shows that medicinal herb spray of the present invention does not have bad stimulation to vaginal mucosa.
2.3 skin anaphylactic test
(1) medicine: by the medicinal herb spray a that embodiment one makes, every 1ml contains crude drug amount 1g.
(2) positive sensitizer: 2.4-dinitrochlorobenzene (chemical pure).What be mixed with 1% sensitization concentration and 0.1% excites concentration standby.
(3) animal: 30 of albino guinea-pigs, male and female half and half, body weight 250～300g.Provide by China Academy of TCM's animal center.
(4) method: animal is divided into three groups at random, is respectively medicinal herb spray group of the present invention, distilled water blank group, positive sensitization matched group, 10 every group.Test the preceding hair that carefully cut off the guinea pig back both sides in 24 hours, every side unhairing about 3 * 3cm in district.During experiment, press the administration of skin semar technique, each group is coated with medicinal liquid respectively in back part of animal left side depilation district, and twice on the one (be coated with 0.2ml at every turn, need 3 hours at interval) tests the 7th day and the 14th day repeat administration in kind.Excited administration on the 28th day, several thing (the positive 0.1%2.4-dinitrochlorobenzene of using) 0.2ml that tried are applied to depilation district, back part of animal right side.Flush away was tried thing after 6 hours, observes at once, observed the skin allergy situation then once more in 24 hours, 48 hours, 72 hours.
(5) result:, and estimate the sensitization degree by " skin allergy standards of grading " in " new drug preclinical study guideline compilation " scoring.The results are shown in following table
Medicinal herb spray of the present invention is to guinea pig skin influence hypersensitive
By test as seen, positive drug 2.4-dinitrochlorobenzene treated animal skin is subjected to examination to distinguish the self-excitation administration to be had obviously after 6 hours and slightly occurs through speckle, and edema is not obvious, obvious mild skin damage appears in individual animal, erythema takes a turn for the better after 72 hours, but skin injury does not recover sensitization rate 100% fully.Medicinal herb spray treated animal skin of the present invention is subjected to 6～72 hours ends of self-excitation administration, examination district erythema and edema to occur, does not have difference with the blank group, and visible medicinal herb spray of the present invention does not produce sensitization.
2.4 skin irritation test
(1) medicine: by the medicinal herb spray a that embodiment one makes, every 1ml contains crude drug amount 1g.
(2) animal: 20 of albino guinea-pigs, body weight 300 ± 20g.Provide by China Academy of TCM's animal center.
(3) method: animal is divided into 4 groups at random, 5 every group, is respectively normal skin blank group, normal skin administration group, injured skin blank group, injured skin administration group.Test and carefully cut in preceding 24 hours from the hair that removes guinea pig back and injured skin not, the unhairing area is 5 * 5cm; The injured skin group marks the scratch of " well " shape with syringe needle on unhairing district skin, diameter 2cm is to stab epidermis, do not hinder corium, slight ginseng blood degree of being is arranged.Press the administration of skin semar technique during experiment, each organize every day respectively coating 1ml (divide and be coated with for three times, each 1 hour at interval, the blank group is coated with the distilled water with equivalent), smeared continuously 7 days, after the last administration 1 hour, with the residual thing that tried of warm water flush away, respectively at 1 hour, 24 hours, 48 hour records smearing medicine position erythema and edema situation.
(4) result:, and estimate stimulus intensity by " skin irritation reaction standards of grading " in " new drug preclinical study guideline compilation " scoring.The results are shown in following table
The average response value that medicinal herb spray of the present invention stimulates guinea pig skin
Test as seen, this Chinese medicine preparation has slight stimulation to the normal skin nonirritant to injured skin, but recovers substantially after 24 hours, recovers fully after 48 hours, does not have significant difference with blank.Illustrate that medicinal herb spray of the present invention is to normal skin and the equal nonirritant of injured skin.
Two, Chinese medicine preparation pharmacodynamics test report of the present invention
1, summary
For observing Chinese medicine preparation drug effect of the present invention, extracorporeal bacteria inhibitor test and antiinflammatory, antipruritic test have been carried out, the result shows that medicinal herb spray of the present invention is to escherichia coli, and staphylococcus aureus, gonococcus, bacteroid, yeast-like fungi all have bacteriostasis in various degree.And stronger antiinflammatory, itching-relieving action arranged.
2, test method and result
2.1, extracorporeal bacteria inhibitor test
(1) medicine: the medicinal herb spray a that makes by embodiment one
(2) culture medium MH culture medium, Sabouraud's agar culture medium, chocolate agar medium and anaerobism bag
(3) experimental strain staphylococcus aureus, escherichia coli, gonococcus, bacteroid, each 5 strain of yeast-like fungi; Provide by Nat'l Pharmaceutical ﹠ Biological Products Control Institute.
(4) method: with medicinal herb spray of the present invention be diluted to 1: 2,1: 4 and three kinds of concentration of stock solution, when doing bacteriostatic experiment to staphylococcus aureus, escherichia coli, gonococcus, bacteroid, yeast-like fungi, experiment with Klthy-Bauer steel pipe method by the preparation of K-B standard technique, inoculation bacterium liquid, with swab bacterium liquid is coated whole media surface, add medicine 0.2ml in the steel pipe, cultivate 24 hours (bacteroid is put in people's anaerobism bag) in the calorstat, measure antibacterial circle diameter, judge fungistatic effect.
(5) result: measurement result sees the following form
The external bacteriostatic experiment of medicinal herb spray of the present invention
R: do not see bacteriostasis
Result of the test as seen, medicinal herb spray of the present invention has bacteriostasis in various degree to escherichia coli, staphylococcus aureus, gonococcus, bacteroid, yeast-like fungi, and is proportionate with dosage.
2.2 antiinflammatory action
(1) medicine: the medicinal herb spray a that makes by embodiment one
(2) proinflammatory agent is made up of 2% Oleum Tiglii, 20% dehydrated alcohol, 5% distilled water and 70% ether.
(3) animal, Kunming kind white mice, male and female dual-purpose, body weight 20 ± 2g.
(4) method: Mice Auricle Oleum Tiglii causes scorching test
Animal is divided into 4 groups at random, 10 every group, is respectively the blank group of shining of three dosage groups of medicinal herb spray of the present invention (50%, 25%, 12.5%) and distilled water.Experiment was respectively organized in left ear coating once the same day, and 0.05ml/ only.Each administration group is cleaned with dry cotton ball with distilled water flush away medicinal liquid after half an hour.Be coated with Oleum Tiglii proinflammatory agent 0.05ml for mice left side ear positive and negative, coating is once again after half an hour, auris dextra compares, put to death animal in being coated with Oleum Tiglii after 4 hours, with about two ears connect root and cut, flatten, use the stainless steel metal of diameter 0.8cm to dash ears coordination homalographic downcut, precision is weighed respectively, is the swelling degree with the difference of left and right auricle weight.
(5) result: also the swelling degree is respectively organized in calculating after measured, inhibitory rate of intumesce the results are shown in following table:
Medicinal herb spray of the present invention is to the influence of Oleum Tiglii induced mice auricle edema
| Group | Dosage | The animal number of elements | Swelling degree (mg) X ± SD | P | Suppression ratio % |
| Matched group | 10 | 13.78±0.66 | |||
| The spray high dose group | 50％ | 10 | 6.64±0.58 | ＜0.01 | 51.81 |
| Dosage group in the spray | 25％ | 10 | 10.00±5.9 | ＜0.05 | 27.43 |
| The spray low dose group | 12.5％ | 10 | 11.68±4.7 | ＞0.05 | 15.23 |
Result of the test as seen, medicinal herb spray 50% dosage group inhibitory rate of intumesce of the present invention is 51.81%; 25% dosage group inhibitory rate of intumesce is 27.48%; 12.5% dosage group inhibitory rate of intumesce is 15.23%; Matched group is not seen has inhibition to swelling.Prompting, this preparation has the effect of obvious inhibition mouse ear vestibule swelling, and the intensity and the dosage of effect are proportionate.
2.3 itching-relieving action
(1) medicine: medicinal herb spray of the present invention
(2) cause the agent of itching: histamine phosphate, face the time spent to be mixed with desired concn with distilled water.
(3) animal: 40 male and female dual-purposes of Cavia porcellus, body weight 250-300g.
(4) method: Cavia porcellus is divided into 4 groups at random, 10 every group, is respectively the blank group of shining of three dosage groups of medicinal herb spray of the present invention (50%, 25%, 12.5%) and distilled water.The experiment proxima luce (prox. luc) is shaved hair to each group Cavia porcellus right back instep, coating once, 0.1ml/100g.Experiment same day abrades right back instep with coarse sandpaper and shaves hair place, area 1cm2, the part again coating once, 0.1ml/100g.Behind the last coating 10 minutes, beginning was only dripped 0.01% 0.05ml/ of histamine phosphate at the wound surface place, after this every 3 minutes successively 0.01%, 0.02%, 0.03%, the 0.04%---progressive concentration, only be 0.05ml/ at every turn.Later lick right back foot until Cavia porcellus occurring, later to lick the right back histamine phosphate's total amount that is given when sufficient be itch-threshold Cavia porcellus to occur, record and itch-threshold of each group relatively.
(5) result: result of the test sees the following form:
Medicinal herb spray of the present invention causes the influence of the reaction of itching to histamine phosphate
| Group | Dosage | The animal number of elements | Itch-threshold (the total amount μ g of histamine phosphate) X ± SD | P |
| Matched group | 10 | 40.5±3.45 | ||
| The spray high dose group | 50％ | 10 | 182.5±6.65 | ＜0.01 |
| Dosage group in the spray | 25％ | 10 | 112.0±9.95 | ＜0.05 |
| The spray low dose group | 12.5％ | 10 | 60.75±10.85 | ＞0.05 |
Test as seen, the average itch-threshold of medicinal herb spray 50% dosage group of the present invention is 182.5 μ g; The average itch-threshold of 25% dosage group is 112.0 μ g; The average itch-threshold of 12.5% dosage group is 60.75 μ g; The average itch-threshold of blank group is 40.5 μ g.As seen, the be significantly improved effect of the antipruritic threshold of Cavia porcellus of this preparation, its antipruritic intensity and dosage are proportionate.
Three, Chinese medicine preparation clinical observation test of the present invention
1, summary
Clinical efficacy for checking this product, adopt Chinese medicine preparation of the present invention to carry out 108 routine clinical observations, the result shows, Chinese medicine preparation of the present invention is used for the treatment of itching skin disease such as skin eczema, various female vagina, vulvitis, male and female pudendum eczema and obtains satisfactory effect.
2, clinical trial data
Adopt medicinal herb spray of the present invention, 108 routine patients carried out external spraying treatment, and examine requirement, diagnose and efficacy evaluation, the results are shown in following table by new Chinese medicine:
Medicinal herb spray total effects result of the present invention
Clinical observation as seen, multiple gynecological such as medicinal herb spray of the present invention treatment infusorian property, mycotic, senile, nonspecific vaginitis, simple property pruritus vulvae, pudendum eczema, scrotum, skin eczema and department of dermatologry illness be totally 108 examples, total effective rate 88.0%, wherein produce effects is more than 57%.In addition, as seen, the antipruritic analgesic effect of this product is especially obvious in the clinical observation, and antipruritic effect was fast after the patient reacted medication, and it is comfortable that the part is felt.This product is not found toxic and side effects in using, and is the good medicine of prevention and treatment gynecological, department of dermatologry inflammation, is worthy of popularization.
Claims (4)
1. compound Chinese medicinal preparation for the treatment of gynecological and cutaneous diseases is characterized in that it is by the Chinese crude drug feedstock production of following weight percent:
Cortex Phellodendri ` 15.00-18.34
Rhizoma Coptidis 7.50-9.16
Fructus Cnidii 30.00-36.66
Semen Coicis 15.00-18.34
Rhizoma Smilacis Glabrae 15.00-18.34
Pericarpium Zanthoxyli 7.50-9.16.
2. compound Chinese medicinal preparation according to claim 1 is characterized in that it is by the Chinese crude drug feedstock production of following weight percent:
Cortex Phellodendri 16.67
Rhizoma Coptidis 8.33
Fructus Cnidii 33.33
Semen Coicis 16.67
Rhizoma Smilacis Glabrae 16.67
Pericarpium Zanthoxyli 8.33.
3. compound Chinese medicinal preparation according to claim 1 and 2 is characterized in that said compound Chinese medicinal preparation is said spray or gel or ointment or suppository or membrane or liniment or a lotion on the pharmaceutics.
4. the preparation method of a compound Chinese medicinal preparation as claimed in claim 1 or 2 is characterized in that:
Take by weighing the Six-element medical material in the prescription, decoct with water secondary, decocted 1.5 hours for the first time, decocted 1 hour for the second time, collecting decoction, filter, it is 1.02～1.10 o'clock that filtrate is concentrated into 50 ℃ of mensuration relative densities, cold preservation 12 hours, filter, get filtrate or filtrate and add ethanol to make pure content be 40～70% o'clock supernatant, after suitably concentrating, be prepared into clinical suitable spray or gel or ointment or suppository or membrane or liniment or lotion with reference to conventional method of Chinese medicinal.
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| CN110123903A (en) * | 2018-02-02 | 2019-08-16 | 刘光毕 | A kind of volatility Chinese medicine suppository and preparation method thereof for treating vaginitis |
| CN108837096A (en) * | 2018-09-28 | 2018-11-20 | 福建农林大学 | A kind of compound heat clearing dampness removing eczema spray and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1321494A (en) * | 2001-04-11 | 2001-11-14 | 王蕊 | Lotion for controlling crab louses |
| CN1323627A (en) * | 2001-04-25 | 2001-11-28 | 白玉珍 | Vaginitis treating traditional Chinese medicine prepn. |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1321494A (en) * | 2001-04-11 | 2001-11-14 | 王蕊 | Lotion for controlling crab louses |
| CN1323627A (en) * | 2001-04-25 | 2001-11-28 | 白玉珍 | Vaginitis treating traditional Chinese medicine prepn. |
Non-Patent Citations (2)
| Title |
|---|
| 妇康洗剂治疗外阴白色病变癌前病变的临床与病理研究. 李淑玲，杨竞.山东中医杂志，第17卷第10期. 1998 |
| 妇康洗剂治疗外阴白色病变癌前病变的临床与病理研究. 李淑玲，杨竞.山东中医杂志，第17卷第10期. 1998 * |
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