CN1224399C - Medicinal Compsition for treating verrucosis - Google Patents

Medicinal Compsition for treating verrucosis Download PDF

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CN1224399C
CN1224399C CN 02146812 CN02146812A CN1224399C CN 1224399 C CN1224399 C CN 1224399C CN 02146812 CN02146812 CN 02146812 CN 02146812 A CN02146812 A CN 02146812A CN 1224399 C CN1224399 C CN 1224399C
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wart
present
sodium carbonate
treatment
condyloma acuminatum
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CN1488358A (en
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王传航
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Abstract

The present invention relates to a medicinal composition for treating verrucosis, particularly for treating condyloma acuminatum, and more specifically, the present invention relates to a medicinal composition with alkaline substances as the main active components for treating verrucosis, particularly for treating condyloma acuminatum. In the medicinal composition, the alkaline substances can also be combined with traditional Chinese medicines with the efficacy for clearing heat, removing dampness, cooling blood and detoxifying toxic substances. On the other hand, the present invention relates to the use of the medicinal composition with alkaline substances as the main active components for treating verrucosis, particularly for treating condyloma acuminatum.

Description

A kind of pharmaceutical composition for the treatment of Verrucosis
Technical field:
The present invention relates to a kind of particularly pharmaceutical composition of condyloma acuminatum of Verrucosis for the treatment of.Specifically, the present invention relates to particularly treat as the treatment Verrucosis of main active the pharmaceutical composition of condyloma acuminatum with alkaline matter.In pharmaceutical composition of the present invention, described alkaline matter can also combine with the Chinese medicine with heat clearing and damp drying removing pathogenic heat from blood and toxic substance from the body effect.On the other hand, the present invention relates to alkaline matter and be used for preparing the purposes that the treatment Verrucosis is particularly treated the pharmaceutical composition of condyloma acuminatum as main active.
Background technology:
Wart (verruca) is by human papillomavirus's selectivity skin infection or the caused epidermis benign neoplasm of mucous epithelium.Clinical four types that are divided into: i.e. verruca vulgaris, verruca plana, plantar wart and condyloma acuminatum.
Human papillomavirus (human papilloma virus, HPV) be that the papillary tumor vacuolating virus A of section belongs to the member, diameter 50nm~55nm has no peplos, symmetric 20 three-dimensional capsids that 72 viral shell microgranules are formed, contains the double-stranded cyclic DNA with 7900 base pairs.HPV still can not breed in tissue culture or experimental animal model at present, and the people is its unique host, mainly infects epithelium.The type of HPV is a lot, 77 kinds have been found at present, the hypotype difference of HPV can cause verruca plana (HPV3,10,27,28,41), verruca vulgaris (HPV1,2,4,7,27,19,25,38,46,47,49,50), condyloma acuminatum (HPV6,11,16,18,31,33,34,35,39,45,51,64-68,70,73).HPV mainly is an immediate contagion, but also has report to infect through the contact stain thing.Immunologic hypofunction and outer the wounded easily suffer from this disease.
(condyloma acuminatum CA) is called sharp Gui condyloma latum, genital wart, genital wart or anogenital wart again to condyloma acuminatum, mainly occurs in the mucocutaneous of men and women's external genitalia and anus position, is one of at present common sexually transmitted disease (STD) of China.Main trafficability characteristic contagion, minority infects by mediate contact, and is closely related with the generation of anogenital cancer.
According to China's official statistics, the sickness rate of China's condyloma acuminatum in 1987: 2.2/10 ten thousand; Nineteen ninety is 22.97/10 ten thousand; 1996 is 41,/10 ten thousand.The whole nation 1999 annual morbidities increased by 46.36% than 1998.But in fact this numeral can not truly reflect the sickness rate of China's condyloma acuminatum all sidedly, and reason is that a large amount of or even most condyloma acuminatum cases does not report as epidemic situation at all.If included by present condyloma acuminatum morbidity growth trend or with the subclinical performance of condyloma acuminatum, can be inferred that condyloma acuminatum will become the modal disease of sickness rate ranking first in the sexually transmitted disease (STD).
Therapeutic Principle to wart mainly comprises 3 aspects:
1. directly destroy and remove the wart tissue.
2. the Verrucosis change is embrocated in medication repeatedly, makes intraepidermal HPV antigen-exposed in intradermal immune system, thereby sets up and bring into play complete immunologic function, to remove the wart tissue.
3. improve body whole body or local immunity power, improve the ability of anti-HPV.
Present Therapeutic Method has:
1. physics and operative therapy: as: fulgerize, freezing, laser, microwave, strike off etc., for bigger wart body and function excision.The advantage of this therapy is to remove visible wart body quickly and accurately; Shortcoming is to cause pain easily, needs anesthesia, and some operation is comparatively complicated, and damage is bigger, and bacterial infection etc. takes place postoperative easily.
2. external chemicals: solution, cream or the ointment of phthiobuzone, 5-fluorouracil, podophyllum ester, podophyllum ester element, iodouracil desoxyriboside, trichloroacetic acid, Bleomycin A5 etc.Its advantage is 1. easy to use, and some medicine patient oneself can grasp use; 2. the patient is damaged little.Its deficiency is: 1. administration time is long, needs a few days, several weeks, even the several months; 2. relatively poor to the condyloma acuminatum curative effect on the skin big, that hypertrophy speed is very fast and horny layer is thicker; 3. cause local edema, erosion in various degree after the medication, in addition downright bad.
3. constitutional treatment: use antiviral agents, as: acyclovir, interferon, antiviral Chinese medicine such as Folium Isatidis, Radix Isatidis, Radix Bupleuri etc.Weak curative effect, the course of treatment are long.
4. external Chinese medicine: in order to Fructus Bruceae is that the preparation of main component is coated with outward, with the medicine fumigation and wash method with heat-clearing and toxic substances removing dispelling wind eliminating stagnation (antiviral) effect.Need multiple dosing, the course of treatment is long, and Fructus Bruceae is big to the zest of normal skin, mucosa.
In a word, based on topical therapeutic, systemic administration is auxilliary to the treatment of wart.Effectively local therapeutic approaches is a lot, but lacks a kind of to all very ideal Therapeutic Method of all warts.
Summary of the invention:
The pharmaceutical composition that the purpose of this invention is to provide a kind of treatment Verrucosis, particularly condyloma acuminatum.
Another object of the present invention provides a kind of method of treatment Verrucosis, particularly condyloma acuminatum.
Pharmaceutical composition of the present invention is to utilize the corrosiveness of alkaline matter to destroy wart soma, changes the conditions of existence of virus, thereby kills or suppress virus, makes other medicines be easy to infiltration simultaneously, reaches the purpose of the wart that disappears fast.
In the pharmaceutical composition of treatment Verrucosis of the present invention, described alkaline matter as active component comprises oxide, hydroxide, carbonate, bicarbonate, sulfide or the weak acid salt of alkali metal or alkaline-earth metal, and described weak acid salt for example is an acetate.Wherein preferred described alkaline matter is sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium oxide, calcium hydroxide, preferred especially sodium carbonate, sodium bicarbonate, calcium oxide, calcium hydroxide.
In the pharmaceutical composition of the present invention, the alkaline matter of above-mentioned alkali metal or alkaline-earth metal can use separately, also can mix use.Alkaline matter can use powder, aqueous solution or supersaturated aqueous solution.Preferably use its aqueous solution for sodium carbonate (or sodium bicarbonate), potassium carbonate (or potassium bicarbonate), then preferably use its powder or supersaturated aqueous solution for calcium hydroxide (or calcium oxide).
Contain in a preferred embodiment of the invention:
Calx (calcium hydroxide or calcium oxide): 1~80 part (weight meter), preferred 20~60 parts
Sodium carbonate or sodium bicarbonate: 1~60 part (weight meter), preferred 10~40 parts
Can regulate the consumption of above-mentioned alkaline matter according to the requirement of preparation different dosage form.
Solution of the present invention is based on the understanding of Chinese medicine to " wart ".
Condyloma acuminatum is called " condyloma acuminatum ", " shy wart " or " warty vegetation " in Chinese medicine.It is unclean that its cause of disease mostly is chamber, and diseases caused by exogenous pathogenic factor turbid damp poison is evil; Or plain happiness delicious food savoury, damp and hot interior giving birth to followed through making a bet, and fights and ties in pudendum, accumulates one-tenth poison of a specified duration.Treatment is with heat clearing and damp drying, and it is main that detoxicating and resolving stagnation of pathogens, rotten wart lose superfluous.The present composition has above-mentioned effect and can remove wart fast.
The Calx beginning in the preferred prescription of the present invention sees Shennong's Herbal, and limestone adds the hyperpyrexia calcining and generates quicklime, and main component is a calcium oxide, and the quicklime suction then becomes Calx, and composition is a calcium hydroxide.Calx can " remove the black mole polyp " (Shennong's Herbal), because of its " the Xin Wenneng wind heat poison that looses, and can etching off dislike meat and tissue regeneration promoting meat " (" Bencao Jingshu ").Recording calcium hydroxide in Ministry of Health of the People's Republic of China's " drug standard " (1996) is astringency, makes solution and is used for scalding or burning.Alkalium head is stated from " Amplification on Materia Medica addendum ", and for the lixivia that extracts from the peats composed of rotten mosses such as Artemisia, knotweed with flour, the solid that processes from strand is called grey alkali, flower alkali etc. again, and main component is sodium carbonate, potassium carbonate.Recording sodium carbonate in Ministry of Health of the People's Republic of China's " drug standard " (1996) is the external antacid, is used for the corrosive ulcer of acids.Two kinds of alkaline matters in the prescription have the effect of corrosion warty vegetation, directly destroy wart soma, and make other medicines be easy to infiltration, reach the purpose of the wart that disappears fast.
In pharmaceutical composition of the present invention, can also be equipped with the Chinese medicine that one or more have heat clearing and damp drying removing pathogenic heat from blood and toxic substance from the body effect, comprise: Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi), Ramulus Mori, Flos Lonicerae, Radix Isatidis, Cortex Phellodendri, Radix Scutellariae, Radix Gentianae, Herba Centellae etc., preferred Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi), mulberry twig charcoal.
The contained chemical constituent of Radix Sophorae Flavescentis is mainly alkaloid and Flavonoid substances in the prescription, has multiple pharmacological effect.Its contained alkaloid has anti-multiple pathogen, antiinflammatory and immunoregulation effect.The traditional Chinese medical science thinks that Radix Sophorae Flavescentis has the effect of heat clearing and damp drying, wind dispelling insecticide, can be used for pudendum pruritus due to damp pathogen, malignant boil.Radix Arnebiae (Radix Lithospermi) contains naphthoquinone class pigment, and its pharmacological action comprises antipathogen (antibacterial and some virus), antiinflammatory and antiallergic action.The traditional Chinese medical science thinks that Radix Arnebiae (Radix Lithospermi) has removing heat from blood, invigorates blood circulation, the effect of heat-clearing and toxic substances removing, can be used for treating malignant boil, damp and hot macule.Mulberry twig charcoal has two kinds of effects in prescription: one, the traditional Chinese medical science think that it can stop blooding, granulation promoting; Its two, be the excipient in liniment or the paste (ointment).
In the pharmaceutical composition of the present invention, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) can be used crude drug powder, and also the extract of available water or different concentration ethanol comprises concentrated solution, extracts extractum or extract dry powder, selects according to the needs of dosage form.Mulberry twig charcoal can be selected according to dosage form with its powder or water extract.Then preferred charcoal powder of mulberry twigs or its water extract concentrated solution in liniment or paste.
The powder of Chinese medicinal components described in the present invention can be by the preparation of general pharmaceutical technology, comprises clean, step such as dry, pulverize, sieve.
The extract of Chinese medicinal components described in the invention can adopt extraction process commonly used preparation, comprises pulverizings, extractions, operation such as concentrated, and extraction then can be adopted infusion method, percolation or heating extraction etc.Concentrating of extracting solution then can be adopted atmospheric evaporation or vacuum evaporation, can directly use after obtaining extracting concentrated solution or extracting extractum, also can further use, also extracting solution can be adopted spray drying method or freeze-drying to make extract powder and use by making extract powder behind the bake drying.
In the preferred embodiment of pharmaceutical composition of the present invention, the weight proportion scope with Chinese medicinal components of heat clearing and damp drying removing pathogenic heat from blood and toxic substance from the body effect is:
Radix Sophorae Flavescentis: 1~60 part (weight meter), preferred 20~40 parts
Radix Arnebiae (Radix Lithospermi): 1~40 part (weight meter), preferred 10~30 parts
Mulberry twig charcoal: 1~30 part (weight meter), preferred 5~20 parts
In the preferred embodiment of the present invention, alkaline matter and other Chinese medicinal components weight proportion scope are:
1~140 part of alkaline matter
1~60 part of Radix Sophorae Flavescentis
1~40 part of Radix Arnebiae (Radix Lithospermi)
1~30 part of mulberry twig charcoal
In pharmaceutical composition further preferred embodiment of the present invention, the preferred weight proportion scope of alkaline matter and other Chinese medicinal components is:
20~100 parts of alkaline matters
20~40 parts of Radix Sophorae Flavescentiss
10~30 parts of Radix Arnebiae (Radix Lithospermi)s
5~20 parts of mulberry twig charcoals
In the most preferred pharmaceutical composition embodiment of the present invention, Calx, sodium carbonate, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi), the most preferred weight proportion of mulberry twig charcoal are: 50: 15: 18: 10: 4.
Pharmaceutical composition of the present invention can be made multiple exterior-applied formulation, comprises liniment, paste, Emulsion, cream, lotion, membranous patch and ointment.Different pharmaceutically suitable carrier can be equipped with according to the dosage form needs, antioxidant, transdermal enhancer, wetting agent, emulsifying agent, stabilizing agent, antifungus agent, spice and pigment can be added simultaneously.Preferred carrier is active component bigger those of dissolubility therein.The pharmaceutically suitable carrier that is most commonly used to medicament of the present invention is water, ethanol and composition thereof, thereby medicament of the present invention can be made liniment, paste, Emulsion.Can also comprise the reagent of giving color or fragrance in the pharmaceutical composition of the present invention.In addition, these compositionss can comprise other medicines, wound sealant, carrier etc., and they are for well known by persons skilled in the art or conspicuous.
Pharmaceutical composition of the present invention can be used for the acute wart that removes of condyloma acuminatum and other type wart body.Using method: above-mentioned preparation is applied on the wart body, keeps appropriate time (several minutes), with the slightly firmly wiping of aseptic dry cotton ball, the wart body promptly comes off.The general 2-3 of mucosa days, skin wound healing in general 1 week, preventing from scar.Pharmaceutical preparation of the present invention has following advantage:
1. medication is easy: after liniment of the present invention is coated in the wart surface 3-5 minute, with the slightly firmly wiping of aseptic dry cotton ball, the wart body promptly came off, and patient oneself can grasp use.
2. onset is rapid, one-time treatment: be not subjected to wart body size, what restriction, all can come off at that time after coating liniment of the present invention, and need not medication repeatedly in a few days.
3. rehabilitation is fast, the treatment preventing from scar: after the medication the general 2-3 of mucosa days, skin in general 1 week skin lesion can recover preventing from scar fully.
4. side reaction is little: the part is the dryness wound surface after the medication, edema, ooze out not obvious.
5. do not find toxic reaction:, do not find the serious adverse reaction of local and whole body in the medication process and in following up a case by regular visits to.
6. do not influence bathing: after treatment finished, a little medicine that the position of treatment is left over can form the medicament protection layer of natural drying, and was not water funk, do not influence patient's bathing.
7. relapse rate is low: the someone adds up, in Therapeutic Method commonly used at present, the relapse rate of condyloma acuminatum is up to 33%, and we follow up a case by regular visits to the patient of liniment treated of the present invention, relapse rate only is 4.55%, and recurrence back reuse liniment treated of the present invention still can have the curative effect of getting instant result.
The specific embodiment:
Example of formulations
The preparation method of embodiment 1, liniment:
Prescription: Radix Sophorae Flavescentis aqueous extract 18.0ml (folding crude drug 18g)
Radix Arnebiae (Radix Lithospermi) powder 10.0g
Mulberry twig charcoal 4.0g
Calcium hydroxide 50.0g
Sodium carbonate 15.0g
Water adds to 200g
Method for making:
1. Radix Sophorae Flavescentis grinds coarse powder, uses water extraction, is concentrated into the concentrated solution that 1ml contains the 1g crude drug.
2. Radix Arnebiae (Radix Lithospermi), calcium hydroxide grind respectively, cross 200 mesh sieves, and fine powder is preserved standby respectively.
3. the Ramulus Mori stir-baked the crude drugs into black on outside and brown in inside grinds the back and crosses 200 mesh sieves, preserves standby.
4. water intaking 100ml adds sodium carbonate, makes dissolving, adds Radix Sophorae Flavescentis extractive liquid then, and mix homogeneously adds Radix Arnebiae (Radix Lithospermi) powder, charcoal powder of mulberry twigs and calcium hydroxide powder again, adds water to 200g.Behind the preliminary mix homogeneously, in colloid mill, fully grind promptly.
The preparation method of embodiment 2, paste:
Prescription: Radix Sophorae Flavescentis aqueous extract 20.0ml (folding crude drug 20g)
Radix Arnebiae (Radix Lithospermi) ethanol extract 15.0ml (folding crude drug 15g)
Mulberry twig charcoal 5.5g
Calcium hydroxide 40.0g
Sodium carbonate 14.0g
Sodium carboxymethyl cellulose 0.5g
Water adds to 200g
Method for making:
1. Radix Sophorae Flavescentis grinds coarse powder, uses water extraction, is concentrated into the concentrated solution that 1ml contains the 1g crude drug.
2. Radix Arnebiae (Radix Lithospermi) is ground coarse powder, uses ethanol extraction, is concentrated into the concentrated solution that 1ml contains the 1g crude drug.
3. calcium hydroxide grinds, and crosses 200 mesh sieves, and fine powder is preserved standby.
4. the Ramulus Mori stir-baked the crude drugs into black on outside and brown in inside grinds the back and crosses 200 mesh sieves, preserves standby.
5. water intaking 100ml adds sodium carboxymethyl cellulose (CMC-Na), makes dissolving, adds Radix Sophorae Flavescentis extractive liquid, shikonin extract, mix homogeneously adds sodium carbonate again, makes dissolving, and then add charcoal powder of mulberry twigs and calcium hydroxide powder, and adding water to 200g, mixing is after fully grind promptly in the colloid mill.
The preparation method of embodiment 3, ointment (Emulsion):
Prescription: Radix Sophorae Flavescentis aqueous extract 28.0ml (folding crude drug 28g)
Radix Arnebiae (Radix Lithospermi) ethanol extract 15.0ml (folding crude drug 15g)
Mulberry twig charcoal aqueous extract 5.0ml (folding crude drug 10g)
Calcium hydroxide 32.0g
Sodium carbonate 15.0g
The I emulsifiable paste matrix adds to 300g
Method for making:
1 Radix Sophorae Flavescentis grinds coarse powder, uses water extraction, is concentrated into the concentrated solution that 1ml contains the 1g crude drug.Radix Arnebiae (Radix Lithospermi) is ground coarse powder, uses ethanol extraction, is concentrated into the concentrated solution that 1ml contains the 1g crude drug.The Ramulus Mori stir-baked the crude drugs into black on outside and brown in inside concentrates with water extraction, makes concentrated solution 1ml contain crude drug 2g.
2 are dissolved in sodium carbonate in the mixed liquor of above-mentioned concentrated solution.
3 calcium hydroxide porphyrize powder are crossed 200 mesh sieves, get impalpable powder.Add aforesaid liquid and grind mixing jointly.
4 press the general preparation method of ointment, and said components is added in the I emulsifiable paste matrix, and mixing gets oil in water emulsion.
Annotate: the I emulsifiable paste matrix: stearic acid 150.0g, lanoline 20.0g, vaseline 250.0g, glycerol 50.0ml, triethanolamine 18.0ml, water add to 1000.0g.
Can replace I emulsifiable paste matrix preparation ointment with other emulsifiable paste matrix.
The preparation method of embodiment 4, membrane:
Prescription: Radix Sophorae Flavescentis water extraction concentrated solution 25.0ml (folding crude drug 25g)
Radix Arnebiae (Radix Lithospermi) ethanol extraction concentrated solution 10.0ml (folding crude drug 10g)
Mulberry twig charcoal water extraction concentrated solution 2.0ml (folding crude drug 10g)
Calcium hydroxide 40.0g
Sodium carbonate 15.0g
Filmogen: polyvinyl alcohol (PVA) 2.0g, glycerol 1.5ml, distilled water are an amount of.
Method for making:
Each Chinese medicinal components is pressed the method for preparing emulsion processing in 1 prescription, stores for future use respectively.
After 2 polyvinyl alcohol 2.0g added an amount of distilled water immersion swelling, heating in water bath agglutination liquid added glycerol 1.5ml and makes mixing.
3 are dissolved in sodium carbonate in Radix Sophorae Flavescentis, the mulberry twig charcoal water extraction concentrated solution, add Radix Arnebiae (Radix Lithospermi) ethanol extraction concentrated solution, stirring and evenly mixing.
4 add 3 gained mixed liquors in the 2 gained Colloidal fluids, and stirring and evenly mixing adds the sodium hydroxide fine powder, stirs into suspension, in order to be easy to sprawl film forming, can add an amount of distilled water, the restir mixing.
5 according to general film-forming method system film commonly used.
Usage: press wart body size and shear " wart is clean " medicine film, one side water slightly sticks on the wart body, with immobilization with adhesive tape after moistening.
Clinical experimental study
One. Calx treatment condyloma acuminatum 23 examples
The applicant adopts the Calx treatment to 23 routine condyloma acuminatum from JIUYUE, 1996~1997 year January, obtains satisfactory effect.
1 physical data
23 patients of this group are the male patient, and the age is 20~55 years old, 28.5 years old mean age, the course of disease 5 days~1 year, average 18 days.Wherein 20 examples admit to have unclean sexual intercourse history or spouse to infect history, and 3 examples are denied obvious inducement.Condyloma latum is mainly in around coronary sulcus, urethral orifice, prepuce of penis and the anus.Single or multiple pale reds or dirty gray vegetation appear in the affected part, are cauliflower form, mamillary, cockscomb shape and pimple shape, the base of a fruit is arranged or do not have the base of a fruit.All patient's skin lesion 5% acetic acid is tested the positive in vain.
2 Therapeutic Method
Calx 100g, add water 400ml, soaking and stirring, with before shaking up, special-purpose spoon dips in to be got a little medicinal liquid and is applied to the wart surface, and attention is not applied to medicinal liquid wart body normal skin or mucosa on every side, treat medicinal liquid dry naturally (according to wart body size and institute's medicinal liquid that is coated with what, need 2~10 minutes approximately) after, with the aseptic dry cotton ball wiping wart body of exerting oneself slightly, little wart body, 1 time is promptly tear-away; Bigger wart body need be coated with medicinal liquid 2~3 times, can come off.
3 results
23 routine patients, the wart body all came off at that time, clinical cure rate 100%.After the wart body came off, the ulcer surface bigger than the wart body all appearred in therapentic part.The skin ulcer face is not wrapping and without other external used medicine all, advises the patient can bathing but do not bath, and skin lesion recovered after 2~7 days, did not see local infection.
Two. sodium carbonate treatment condyloma acuminatum 39 examples
The applicant adopts sodium carbonate to treat 39 routine condyloma acuminatum from May, 1997~1997 year November, and satisfactory effect now is reported as follows:
1 physical data
39 patients of this group are the male, minimum 22 years old of age, maximum 55 years old, 30 years old mean age; The course of disease is the shortest 3 days, the longest August; Married 30 examples, unmarried 9 examples, all sexual life cycle.Clinical manifestation is that coronary sulcus, urethral orifice, penis, scrotum and crissum etc. locate to occur red excipuliform pimple, and surface irregularity is the vegetation of papillary tumor sample, cauliflower form, cockscomb shape and gill fungus sample, and single-shot or pilosity, acetic acid are tested the positive in vain.
2 Therapeutic Method
Sodium carbonate 18g adds water 200ml, and is standby after the stirring and dissolving.Cotton swab dips in taking liquid and is applied to the wart surface, and notes medicinal liquid not being applied to normal skin or mucosa around the wart body, treat that medicinal liquid dries naturally after, with the aseptic dry cotton ball wiping wart body of exerting oneself slightly, little wart body, 1 time is promptly tear-away; Bigger wart body, embrocate 2~3 times also tear-away.
3 results
39 routine wart bodies all come off clinical cure rate 100% fully.After the wart body came off, oozing of blood appearred in 5 routine skin ulcer faces, dry cotton ball compressing hemostasis in 1~3 minute, capable special handling, the healing in 2~5 days of general skin ulcer face.
Three. sodium carbonate and Calx therapeutic alliance condyloma acuminatum 42 examples
The applicant adopts Calx and sodium carbonate therapeutic alliance to 42 routine condyloma acuminatum patients from March, 1998~1999 year January, and satisfactory effect is now reported as follows:
1 physical data
In 42 examples, male's 40 examples, women's 2 examples; Age is 18~46 years old, 26 years old mean age; The course of disease 2 days~1 year, average 12 days.Wherein 38 examples admit to have unclean sexual intercourse history, and 4 examples are denied obvious inducement.The condyloma latum single-shot is in coronary sulcus 13 examples, urethral orifice 6 examples, prepuce of penis skin 6 examples, glans penis 3 examples, crissum 2 examples, multiple person's 10 examples.2 routine female patient site of pathological change are external genital.Erythra is a pale red, and surface wettability is cauliflower form, mamillary, cockscomb shape and pimple shape vegetation, and skin lesion 5% acetic acid is tested the positive in vain.
2 Therapeutic Method
Dissolve in the sodium carbonate 30g adding 400ml water, add Calx 100g then, soaking and stirring, make suspension, with preceding shaking up, special-purpose spoon dips in taking liquid and is applied to the wart surface, and notes medicinal liquid not being applied to wart body normal skin or mucosa on every side, after treating that medicinal liquid dries naturally, with aseptic dry cotton ball wiping coating position slightly firmly.It is promptly tear-away generally to embrocate 1 wart body, bigger 1 person that fully comes off of wart body, embrocate 2~3 times also tear-away.
3 results
42 routine patients, the wart body all came off at that time, clinical cure rate 100%.Most of wart body coatings can come off for 1 time fully, and minority wart body the greater needs coating 2~3 times.During treatment, most patients tell therapentic part pain, but degree is lighter, can tolerate.The all capable local anaesthesia of all patients, treatment finishes back pain and disappears.After the wart body came off, the dryness skin ulcer face big slightly than the wart body all appearred in therapentic part, need not wrap up or other external used medicine, and skin lesion recovered after 2~7 days, did not see local infection.Follow up a case by regular visits to half a year, 3 example recurrences, relapse rate 7.14%.
4 discuss
Condyloma acuminatum is treated in this ruling by law, and is not easy and simple to handle, once removes wart, and wound surface is little, and pain is lighter, hemorrhage or go out insufficiency of blood, recovers fast, local preventing from scar.
Four. the liniment and the wart of the embodiment of the invention 1 are taken off glad clinical test results of comparing
In January, 2000~January calendar year 2001, use liniment treated condyloma acuminatum 110 examples of the present invention, and treat these disease 110 examples with " wart takes off glad " (0.5% podophyllotoxin tincture) that Hua Wei pharmaceutical factory in Liaoning produces and compare, existing observed result is reported as follows.
1 data and method
1.1 physical data 220 routine patients all are diagnosed as condyloma acuminatum through white test of clinical, 5% acetic acid or tissue pathology checking.At 17~66 years old age, average 29 years old, be the male.Research approach adopts randomized controlled trial, distributes observing case district group randomization, makes two groups of clinical baseline data equilibrium (seeing Table 1).
The harmony check of the table 1. liang clinical baseline data of group
Age Focus Wart body diameter The course of disease Medicining condition
<40 years old 〉=40 years old Single-shot Multiple <0.5cm ≥0.5cm <1 week 〉=1 week Do not use Once used
The test group matched group 82 82 28 28 24 24 86 86 81 81 29 29 41 43 69 67 96 93 14 17
Add up to 164 56 48 172 162 58 84 136 189 31
Yates x 2=0.024 x 2=0.027 x 2=0.023 x 2=0.019 x 2=0.15
p>0.05 p>0.05 p>0.05 p>0.05 p>0.05
x 2Statistic of test NDST computed in software, the equilibrium of two groups of clinical baseline data.
1.2 Therapeutic Method liniment of the present invention is organized by examination: all patients are all treated by the doctor in outpatient service.Treatment step: dip in special-purpose spoon and to get liniment medicinal liquid of the present invention a little is applied to the wart surface, note medicinal liquid not being diffused into normal skin on every side, treat that medicinal liquid dries naturally afterwards with aseptic dry cotton ball wiping coating position.If because of the wart body is big, the person that once fully comes off then is coated with the 2nd time or the 3rd time medicinal liquid.Wart takes off glad matched group: all patients carry out the demonstration treatment first time in outpatient service by the doctor, and later patient takes back medicine oneself treatment, dips in taking liquid with aseptic dried cotton swab and coats the wart surface, be not diffused into normal skin on every side, keep medicine, 2 times/day, continuous 7 days.
1.3 curative effect determinate standard is cured: treat a week, the complete obiteration of clinical observation wart body, former lesions position 5% acetic acid is tested feminine gender in vain; Invalid: the wart body not exclusively disappears after one week of treatment; Recurrence: healing interior former wart body region later six months has meat to obey visible newborn wart body, and 5% acetic acid is tested the positive in vain.
2 results
2.1 efficacy analysis (seeing Table 2)
The curative effect that table 2. liniment of the present invention and wart take off glad treatment condyloma acuminatum
Cure Cure rate (%) Invalid Add up to
Liniment treated group of the present invention 109 99.1 1 110
Wart takes off glad matched group 108 98.2 2 110
Add up to 217 3 220
OR=2.02 95%CI (WoolfShi method)=0.18-23.25
Fisher direct probability P=1.0000>0.025
x 2Statistic of test NDST computed in software, two groups of cure rates do not have significant difference.
2.2 the comparison of relapse rate (seeing Table 3)
The relapse rate that table 3. liniment of the present invention and wart take off glad treatment condyloma acuminatum
Recurrence Relapse rate (%) Not recurrence Add up to
Liniment treated group wart of the present invention takes off glad matched group 5 36 4.55 32.73 105 74 110 110
Add up to 41 179 220
OR=0.10,95%CI (WoolfShi method)=0.04-0.27
Yates proofreaies and correct x 2=26.98, p<0.01
x 2Statistic of test NDST computed in software, two groups have highly significant difference, and the relapse rate of liniment treated group of the present invention is lower than wart and takes off glad matched group.
2.3 the comparison of untoward reaction (seeing Table 4)
The untoward reaction that table 4. liniment of the present invention and wart take off glad treatment condyloma acuminatum
Untoward reaction Liniment treated group of the present invention Wart takes off glad matched group The u value The p value
Treat the back incidence rate before treating Before the treatment After the treatment Incidence rate
The big acute foreskin glans penis edema of local pain ulcer area 0 110 100% 0 11 10.00% 0 0 0 0 0 0 110 82 12 100% 77.55% 10.91% 1.00 91.77 9.40 >0.05 <0.01 <0.01
Focus all has sustainable local pain two groups of whens treatment, and skin or mucosal ulcer's area significantly surpass the ratio of focus basilar part, and liniment treated group of the present invention and wart take off glad matched group and be respectively 10.00% and 77.55%, and highly significant difference is arranged.The incidence rate of the acute foreskin glans penis of medicine secondary edema during the treatment, liniment treated group of the present invention does not take place, and it is 10.91% that wart takes off glad matched group, and highly significant difference is arranged.
3 discuss and conclusion
Podophyllotoxin is the medicine that WHO recommends.Its advantage is can to regenerate by blocking virus after smearing focus, and clinical cure rate is near 100%; Shortcoming is to need the repeated multiple times medication, and local normal structure large tracts of land appears in most patients festers, and glans penis, foreskin acute edema take place about 1/3 patient, small number of patients even the general untoward reaction occurs.
Be respectively 99.1%, 98.2% 3.1 take off glad cure rate about curative effect liniment of the present invention and wart, determined curative effect, but wart takes off the repeatedly medication of glad need, and liniment one-time treatment of the present invention is easy to be quick-acting.
3.2 about the relapse rate of relapse rate liniment of the present invention in half a year only is 4.55%, wart takes off glad up to 32.73%, and the former is more efficient than the latter.
3.3 do not have the generation of local acute edema about untoward reaction liniment treated group of the present invention, and wart takes off the glad partial acute edema that can cause, incidence rate is 10.91%.For normal skin, mucosa around the damage after the medication, cause the ulcer enlarged areas, liniment treated group of the present invention only is 10.00%, wart takes off glad treatment group up to 77.55%, points out liniment of the present invention safer.
3.4 conclusion liniment of the present invention is a kind of efficient, quick-acting, safe, low medicine that recurs for the treatment of condyloma acuminatum, is worth further exploitation, promotes.

Claims (5)

1. following compositions is used to prepare the purposes of the pharmaceutical preparation for the treatment of Verrucosis separately as active substance, described compositions is made up of Calx and sodium carbonate or sodium bicarbonate, and wherein the amount of Calx and sodium carbonate or sodium bicarbonate is:
Calx 1-80 weight portion
Sodium carbonate or sodium bicarbonate 1-60 weight portion
2. the purposes of claim 1, wherein the amount of Calx and sodium carbonate is:
Calx 20-60 weight portion
Sodium carbonate or sodium bicarbonate 10-40 weight portion
3. claim 1 or 2 purposes, wherein said Calx and sodium carbonate or sodium bicarbonate can be with its powder, aqueous solution or supersaturated aqueous solutions.
4. claim 1 or 2 purposes, wherein said compositions is made into the local topical agent, and described dosage form comprises liniment, paste, ointment, Emulsion, membrane.
5. claim 1 or 2 purposes, wherein said compositions is used to prepare the pharmaceutical preparation for the treatment of condyloma acuminatum as active substance.
CN 02146812 2002-10-11 2002-10-11 Medicinal Compsition for treating verrucosis Expired - Fee Related CN1224399C (en)

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