The object of the invention is that the pure Chinese medicine medicine for external use liquid medicine ' Fujieye ' of development is based on Pericarpium Granati, Herba Sophorae alopecuroidis, Corallium Japonicum Kishinouye, is aided with compositions such as Galla Turcica (Galla Helepensis), Fructus Zanthoxyli, Fructus Cnidii, Borneolum Syntheticum; Adopt to pulverize, soak filter, decoct, filter, concentrate, supercritical CO
2Extraction, accent PH, filtration, sterilization reach and take Different Extraction Method to make to different medical materials; Through pharmacodynamics test and clinical verification, every index of this liquid medicine ' Fujieye ' all is better than " JIEERYIN " washing liquid; Simultaneously without any side effects, safe and reliable, be the first-use drug of treatment gynaecopathia, also can be used as preventative medicine life-time service.This medicine for external use has been listed the health ministry ministry standard in, and has issued the accurate word authentication code of medicine.
Liquid medicine ' Fujieye ' of the present invention is based on Pericarpium Granati, Herba Sophorae alopecuroidis, Corallium Japonicum Kishinouye, is aided with pure Chinese medicine such as Galla Turcica (Galla Helepensis), Fructus Zanthoxyli, Fructus Cnidii, Borneolum Syntheticum and forms; Adopt to pulverize, soak filter, decoct, filter, concentrate, supercritical CO
2Extraction, accent PH, filtration, sterilization reach and take Different Extraction Method to make to different medical materials; Wherein this drug prescription compatibility is: make 1000 milliliters
Pericarpium Granati 100-180 gram, Herba Sophorae alopecuroidis 300-370 restrain, Fructus Cnidii 150-210 restrains,
Galla Turcica (Galla Helepensis) 100-180 gram, Fructus Zanthoxyli 30-80 restrain, Corallium Japonicum Kishinouye 70-100 restrains,
Borneolum Syntheticum 5-15 gram.
The preparation method of liquid medicine ' Fujieye ' follows these steps to carry out:
A, at first take by weighing after Pericarpium Granati, Galla Turcica (Galla Helepensis), Corallium Japonicum Kishinouye pulverize, add 8-10 times of water gaging and decoct three times, time 1-2 hour, filter, merge, be concentrated into 1: 1, transfer PH4-6 standby;
B, take by weighing and put into extraction kettle respectively after Herba Sophorae alopecuroidis, Fructus Cnidii, Fructus Zanthoxyli are pulverized again, extraction kettle, extraction-container, detached dowel, basin are heated respectively or cool off unlatching CO
2Bottle adds CO by high-pressure pump to extraction kettle, extraction-container, detached dowel
2, close CO
2Bottle, the beginning cycling extraction is regulated CO
2Flow, keep constant temperature and pressure; It is standby to treat to get ointment shape extract from the extraction-container discharging opening after extraction finishes; Wherein extraction temperature is 20-60 ℃, and extracting pressure is 10-35Mpa; Separation temperature is 50-60 ℃, and separating pressure is 5-6Mpa;
C, will extract the hydrochloric acid 6-8 that the back Herba Sophorae alopecuroidis adds 0.3% concentration then and doubly measure, percolation is concentrated into 1: 1 with percolate till the effluent inanimate object alkali, transfers PH4-6 standby;
D, to take by weighing Borneolum Syntheticum standby with the dissolve with ethanol of 95% concentration 10-20ml;
E, at last with a, b, c, the abundant mixing and stirring of d reserve liquid, transfer PH, placement, filtration, sterilization, quality inspection, packing 100ml/ bottle to get final product.This liquid medicine ' Fujieye ' is brown to dark-brown liquid.
Liquid medicine ' Fujieye ' of the present invention, based on Pericarpium Granati, Herba Sophorae alopecuroidis, Corallium Japonicum Kishinouye, be aided with the liquid medicine ' Fujieye ' that pure Chinese medicine such as Galla Turcica (Galla Helepensis), Fructus Zanthoxyli, Fructus Cnidii, Borneolum Syntheticum is formed, according to the Uygur medicine theory, the compatibility of these several medicines can neutralize that it is done, the effect of wet, cold, hot attribute and the dampness that has, convergence, astringent or styptic treatment for spontaneous sweating, antiinflammatory, detoxifcation, anti-rotten, hemostasis, is used for the treatment of various inflammation, infection, tinea, gynaecopathia, hemorrhoid, bleeds incessantly, disease such as diarrhoea.Wherein the pharmacological action of each component is: Pericarpium Granati: nourish blood, beneficial blood, warm organ, antidiarrheal, heat-clearing and toxic substances removing, anthelmintic.
Fructus Cnidii: heat-clearing and toxic substances removing, anti-inflammatory analgetic, parasite killing, dampness pathogenic fire purging.
Galla Turcica (Galla Helepensis): drying, convergence, astringent or styptic treatment for spontaneous sweating.
Fructus Zanthoxyli: nourishing organ, antidiarrheal, pleasant, dehumidifying, pain relieving, parasite killing.
Corallium Japonicum Kishinouye: puckery meat, the nerve that stops blooding, loosens, calm the nerves, antiinflammatory.
Borneolum Syntheticum: causing resuscitation with aromatic drugs, reducing swelling and alleviating pain.
Liquid medicine ' Fujieye ' of the present invention is as follows through its result of animal acute toxicity test:
The vaginal irritation test:
Compare with vehicle group, matched group, liquid medicine ' Fujieye ' 0.90g/ day, 0.63g/ day and 0.441g/ day, rabbit vaginadouche administration continuous 10 days, does not see that mucosa has obvious erythema, redness or congested the generation.Therefore this liquid medicine ' Fujieye ' does not have obvious stimulation to mucosa.
The vagina medicinal acute toxicity test:
Give the rabbit vagina medicinal with liquid medicine ' Fujieye ' 15g/kg, breathing, heart rate and the body weight change of animal do not made significant difference.The rabbit vaginal wall begins to contact behind the medicine slight erythema again, after recover normal gradually.Viewing duration is not seen redness or hyperemia.Animal activity, hair color, feed, feces, body weight change no abnormality seen, no animal dead.
Skin anaphylactic test:
In observing time, administration group and matched group compare in regulation, and the guinea pig skin local response is situation such as show speckle and edema not.Therefore, liquid medicine ' Fujieye ' does not have sensitization to skin.
The skin irritation test:
In observing time, 5 guinea pig skins are tried the thing district in regulation, and damaged skin is tried the thing district and compare the check plot, does not see obvious skin erythema and edema.The skin injury place is only washed at medicinal liquid had slight erythema in back 1 hour, and 6 as a child disappeared.Consider that the micromechanics breakage causes, irrelevant with drug effect.Therefore, this medicine external does not have local irritant effect.
The skin acute toxicity test:
Stipulating observing time, various dose administration Cavia porcellus does not all have death.Compare with matched group, coating position skin does not have obvious redness and erythra produces, and does not see drug-induced irritant reaction.
After the administration, Cavia porcellus activity, hair, feed, the no abnormal variation of metabolism also do not have influence to the activity of damaged skin Cavia porcellus, hair, feed, feces etc., and the damaged skin healing is good, do not see that inflammation, necrosis or healing delay generation.
With matched group relatively, the continuous coating of liquid medicine ' Fujieye ' 10 days is to Cavia porcellus body weight gain do not make significant difference (P>0.05).
Experiment showed, liquid medicine ' Fujieye ' 0.143g/cm
2, 0.100g/cm
2, 0.070g/cm
2External is hindered the guinea pig skin avirulence is damaged, uses not cause acute toxic reaction on complete or damaged skin.
Pharmacodynamics test of the present invention
Experiment material is a liquid medicine ' Fujieye ', and reference substance is JIEERYIN (commercially available)
Experimental result:
Liquid medicine ' Fujieye ' MIC JIEERYIN MIC
(mg/ml) (mg/ml)
Anti-gonococcus 4.375 12.082
Chinese People's Anti-Japanese Military and Political College enterobacteria 5.625 12.918
Anti-staphylococcus aureus 12.082 25.0
Anti-candida albicans 36.664 66.67
Trichomonacide 9.582 34.168
Conclusion: liquid medicine ' Fujieye ' has same inhibition and bactericidal action to gonococcus, escherichia coli, and its Cmin MIC is respectively 4.375mg/ml, 5.625mg/ml.
The MIC of the anti-staphylococcus aureus of liquid medicine ' Fujieye ' is 12.082mg/ml, and a little less than gonococcus and escherichia coli, and liquid medicine ' Fujieye ' is also strong to aureus with inhibition than JIEERYIN to the sensitivity of liquid medicine ' Fujieye ' for this bacterium.
Though liquid medicine ' Fujieye ' is higher than JIEERYIN to the oidiomycetic antibacterial power of white, its sensitivity is still too late in gonococcus, escherichia coli and staphylococcus aureus.
Therefore, liquid medicine ' Fujieye ' all has different inhibition of degree and bactericidal action as vulva wash to gonococcus, escherichia coli, staphylococcus aureus, Candida albicans and trichomonal vaginitis.Through the test contrast, liquid medicine ' Fujieye ' is better than the fungistatic effect of JIEERYIN simultaneously.
Clinical research of the present invention:
Through the clinical research and the clinical trial of place various big hospital, the treatment group is a liquid medicine ' Fujieye ', and matched group is a JIEERYIN, and its conclusion is:
According to the X2 check, liquid medicine ' Fujieye ' all has identical curative effect with JIEERYIN in treatment vulvitis, vaginitis cervical erosion.Both there was no significant differences (P>0.05), total effective rate is respectively 86.54%, 81.52%.But significant difference is arranged on cure rate.Through u-test, total cure rate has significant difference (P<0.05), and cure rate is respectively 58.33%, 44.57%.
Antipruritic effect is obvious, can very fast minimizing leucorrhea, remove stench, with the back vagina clean, the comfortable sensation that refrigerant frankness is arranged.
During medication severe being washed concentration 10% with slight patient gets final product; To critically ill patient vagina drug applying concentration be 50% or stock solution can reach curative effect.General treatment 1-2 course of treatment.Then should grow a little 3-4 to chronic cervicitis is advisable a course of treatment.
In sum, liquid medicine ' Fujieye ' can compare favourably with JIEERYIN fully as the all-natural national medicine.Be to have tap value, collection treatment and prevention in the national medicine to be gynecological's good medicine of one.
Embodiment 1 (making 1000 milliliters)
A, at first take by weighing after Pericarpium Granati 100 gram, Galla Turcica (Galla Helepensis) 100 grams, Corallium Japonicum Kishinouye 70 grams pulverize, add 8-10 times of water gaging and decoct three times, time 1-2 hour, filter, merge, be concentrated into 1: 1, transfer PH4-6 standby;
B, take by weighing Herba Sophorae alopecuroidis 300 gram, Fructus Cnidii 150 grams, Fructus Zanthoxyli 30 grams again and put into extraction kettle respectively after pulverizing, extraction kettle, extraction-container, detached dowel, basin are heated respectively or cool off unlatching CO
2Bottle adds CO by high-pressure pump to extraction kettle, extraction-container, detached dowel
2, close CO
2Bottle, the beginning cycling extraction is regulated CO
2Flow, keep constant temperature and pressure; It is standby to treat to get ointment shape extract from the extraction-container discharging opening after extraction finishes; Wherein extraction temperature is 20-60 ℃, and extracting pressure is 10-35Mpa; Separation temperature is 50-60 ℃, and separating pressure is 5-6Mpa;
C, will extract the hydrochloric acid 6-8 that the back Herba Sophorae alopecuroidis adds 0.3% concentration then and doubly measure, percolation is concentrated into 1: 1 with percolate till the effluent inanimate object alkali, transfers PH4-6 standby;
D, to take by weighing Borneolum Syntheticum 5 gram standby with the dissolve with ethanol of 95% concentration 10ml;
E, at last with a, b, c, the abundant mixing and stirring of d reserve liquid, transfer PH, placement, filtration, sterilization, quality inspection, packing 100ml/ bottle to get final product.This liquid medicine ' Fujieye ' is brown to dark-brown liquid.
Embodiment 2 (making 1000 milliliters)
A, at first take by weighing after Pericarpium Granati 150 gram, Galla Turcica (Galla Helepensis) 150 grams, Corallium Japonicum Kishinouye 85 grams pulverize, add 8-10 times of water gaging and decoct three times, time 1-2 hour, filter, merge, be concentrated into 1: 1, transfer PH4-6 standby;
B, take by weighing Herba Sophorae alopecuroidis 350 gram, Fructus Cnidii 180 grams, Fructus Zanthoxyli 50 grams again and put into extraction kettle respectively after pulverizing, extraction kettle, extraction-container, detached dowel, basin are heated respectively or cool off unlatching CO
2Bottle adds CO by high-pressure pump to extraction kettle, extraction-container, detached dowel
2, close CO
2Bottle, the beginning cycling extraction is regulated CO
2Flow, keep constant temperature and pressure; It is standby to treat to get ointment shape extract from the extraction-container discharging opening after extraction finishes; Wherein extraction temperature is 20-60 ℃, and extracting pressure is 10-35Mpa; Separation temperature is 50-60 ℃, and separating pressure is 5-6Mpa;
C, will extract the hydrochloric acid 6-8 that the back Herba Sophorae alopecuroidis adds 0.3% concentration then and doubly measure, percolation is concentrated into 1: 1 with percolate till the effluent inanimate object alkali, transfers PH4-6 standby;
D, to take by weighing Borneolum Syntheticum 10 gram standby with the dissolve with ethanol of 95% concentration 15ml;
E, at last with a, b, c, the abundant mixing and stirring of d reserve liquid, transfer PH, placement, filtration, sterilization, quality inspection, packing 100ml/ bottle to get final product.This liquid medicine ' Fujieye ' is brown to dark-brown liquid.
Embodiment 3 (making 1000 milliliters)
A, at first take by weighing after Pericarpium Granati 180 gram, Galla Turcica (Galla Helepensis) 180 grams, Corallium Japonicum Kishinouye 100 grams pulverize, add 8-10 times of water gaging and decoct three times, time 1-2 hour, filter, merge, be concentrated into 1: 1, transfer PH4-6 standby;
B, take by weighing Herba Sophorae alopecuroidis 370 gram, Fructus Cnidii 210 grams, Fructus Zanthoxyli 80 grams again and put into extraction kettle respectively after pulverizing, extraction kettle, extraction-container, detached dowel, basin are heated respectively or cool off unlatching CO
2Bottle adds CO by high-pressure pump to extraction kettle, extraction-container, detached dowel
2, close CO
2Bottle, the beginning cycling extraction is regulated CO
2Flow, keep constant temperature and pressure; It is standby to treat to get ointment shape extract from the extraction-container discharging opening after extraction finishes; Wherein extraction temperature is 20-60 ℃, and extracting pressure is 10-35Mpa; Separation temperature is 50-60 ℃, and separating pressure is 5-6Mpa;
C, will extract the hydrochloric acid 6-8 that the back Herba Sophorae alopecuroidis adds 0.3% concentration then and doubly measure, percolation is concentrated into 1: 1 with percolate till the effluent inanimate object alkali, transfers PH4-6 standby;
D, to take by weighing Borneolum Syntheticum 15 gram standby with the dissolve with ethanol of 95% concentration 20ml;
E, at last with a, b, c, the abundant mixing and stirring of d reserve liquid, transfer PH, placement, filtration, sterilization, quality inspection, packing 100ml/ bottle to get final product.This liquid medicine ' Fujieye ' is brown to dark-brown liquid.