NZ598235B - Anti-wart pharmaceutical composition and method for treating wart - Google Patents
Anti-wart pharmaceutical composition and method for treating wart Download PDFInfo
- Publication number
- NZ598235B NZ598235B NZ598235A NZ59823512A NZ598235B NZ 598235 B NZ598235 B NZ 598235B NZ 598235 A NZ598235 A NZ 598235A NZ 59823512 A NZ59823512 A NZ 59823512A NZ 598235 B NZ598235 B NZ 598235B
- Authority
- NZ
- New Zealand
- Prior art keywords
- wart
- solanum
- water
- soluble extract
- agents
- Prior art date
Links
- 201000010153 skin papilloma Diseases 0.000 title claims abstract description 59
- 208000000260 Warts Diseases 0.000 title claims abstract description 53
- 239000008194 pharmaceutical composition Substances 0.000 title description 17
- 239000000284 extract Substances 0.000 claims abstract description 43
- 241000207763 Solanum Species 0.000 claims abstract description 26
- 235000002634 Solanum Nutrition 0.000 claims abstract description 26
- 241000196324 Embryophyta Species 0.000 claims abstract description 25
- MBWUSSKCCUMJHO-ZGXDEBHDSA-N Solamargine Chemical compound O([C@@H]1[C@@H](CO)O[C@H]([C@@H]([C@H]1O)O[C@H]1[C@@H]([C@H](O)[C@@H](O)[C@H](C)O1)O)O[C@@H]1CC2=CC[C@H]3[C@@H]4C[C@H]5[C@@H]([C@]4(CC[C@@H]3[C@@]2(C)CC1)C)[C@@H]([C@]1(NC[C@H](C)CC1)O5)C)[C@@H]1O[C@@H](C)[C@H](O)[C@@H](O)[C@H]1O MBWUSSKCCUMJHO-ZGXDEBHDSA-N 0.000 claims abstract description 14
- MBWUSSKCCUMJHO-DVDUUUGDSA-N Solamargine Natural products O([C@@H]1[C@@H](O)[C@@H](O[C@H]2[C@H](O)[C@H](O)[C@@H](O)[C@H](C)O2)[C@H](CO)O[C@@H]1O[C@@H]1CC=2[C@@](C)([C@@H]3[C@H]([C@H]4[C@@](C)([C@H]5[C@@H](C)[C@@]6(O[C@H]5C4)NC[C@H](C)CC6)CC3)CC=2)CC1)[C@H]1[C@H](O)[C@H](O)[C@@H](O)[C@@H](C)O1 MBWUSSKCCUMJHO-DVDUUUGDSA-N 0.000 claims abstract description 14
- QCTMYNGDIBTNSK-QCNFCIKQSA-N Solasonine Natural products O([C@@H]1[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](C)O2)[C@@H](O[C@@H]2CC=3[C@@](C)([C@@H]4[C@H]([C@H]5[C@@](C)([C@H]6[C@@H](C)[C@@]7(O[C@H]6C5)NC[C@H](C)CC7)CC4)CC=3)CC2)O[C@@H](CO)[C@@H]1O)[C@H]1[C@@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 QCTMYNGDIBTNSK-QCNFCIKQSA-N 0.000 claims abstract description 14
- 239000003814 drug Substances 0.000 claims abstract description 14
- QCTMYNGDIBTNSK-XEAAVONHSA-N α-Solamarine Chemical compound O([C@H]1[C@@H](O)[C@@H](CO)O[C@H]([C@@H]1O[C@H]1[C@@H]([C@H](O)[C@@H](O)[C@H](C)O1)O)O[C@@H]1CC2=CC[C@H]3[C@@H]4C[C@H]5[C@@H]([C@]4(CC[C@@H]3[C@@]2(C)CC1)C)[C@@H]([C@]1(NC[C@H](C)CC1)O5)C)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O QCTMYNGDIBTNSK-XEAAVONHSA-N 0.000 claims abstract description 14
- 230000000699 topical Effects 0.000 claims abstract description 11
- 238000004519 manufacturing process Methods 0.000 claims abstract description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- 239000000203 mixture Substances 0.000 claims description 11
- 210000004392 Genitalia Anatomy 0.000 claims description 6
- 201000004303 plantar wart Diseases 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- 239000003623 enhancer Substances 0.000 claims description 4
- 230000002708 enhancing Effects 0.000 claims description 4
- 239000003349 gelling agent Substances 0.000 claims description 4
- 239000002738 chelating agent Substances 0.000 claims description 3
- 201000004196 common wart Diseases 0.000 claims description 3
- 239000003995 emulsifying agent Substances 0.000 claims description 3
- LYCAIKOWRPUZTN-UHFFFAOYSA-N glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 3
- 239000003002 pH adjusting agent Substances 0.000 claims description 3
- 239000003755 preservative agent Substances 0.000 claims description 3
- 239000003381 stabilizer Substances 0.000 claims description 3
- 239000001993 wax Substances 0.000 claims description 3
- 239000006096 absorbing agent Substances 0.000 claims description 2
- 238000010521 absorption reaction Methods 0.000 claims description 2
- 150000001298 alcohols Chemical class 0.000 claims description 2
- 230000003078 antioxidant Effects 0.000 claims description 2
- 239000003963 antioxidant agent Substances 0.000 claims description 2
- 239000003086 colorant Substances 0.000 claims description 2
- 239000003974 emollient agent Substances 0.000 claims description 2
- 239000003205 fragrance Substances 0.000 claims description 2
- 239000003906 humectant Substances 0.000 claims description 2
- 150000002430 hydrocarbons Chemical class 0.000 claims description 2
- 239000002085 irritant Substances 0.000 claims description 2
- 230000035515 penetration Effects 0.000 claims description 2
- 239000003380 propellant Substances 0.000 claims description 2
- 239000002904 solvent Substances 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 239000002562 thickening agent Substances 0.000 claims description 2
- 235000000208 Solanum incanum Nutrition 0.000 description 23
- 240000006096 Solanum incanum Species 0.000 description 23
- 230000003902 lesions Effects 0.000 description 23
- 239000000499 gel Substances 0.000 description 21
- 238000011156 evaluation Methods 0.000 description 15
- HEDRZPFGACZZDS-UHFFFAOYSA-N chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 10
- 239000006228 supernatant Substances 0.000 description 9
- 239000000463 material Substances 0.000 description 7
- 239000002244 precipitate Substances 0.000 description 7
- 235000001254 Solanum anguivi Nutrition 0.000 description 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 238000002360 preparation method Methods 0.000 description 6
- 231100000486 side effect Toxicity 0.000 description 6
- 206010059313 Anogenital warts Diseases 0.000 description 5
- 206010033733 Papule Diseases 0.000 description 5
- 210000003491 Skin Anatomy 0.000 description 5
- 238000007792 addition Methods 0.000 description 5
- 239000007864 aqueous solution Substances 0.000 description 5
- -1 for example Natural products 0.000 description 5
- 238000002347 injection Methods 0.000 description 5
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- 238000000034 method Methods 0.000 description 5
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- 239000000047 product Substances 0.000 description 5
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- 230000036269 ulceration Effects 0.000 description 3
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- DOUYETYNHWVLEO-UHFFFAOYSA-N Imiquimod Chemical compound C1=CC=CC2=C3N(CC(C)C)C=NC3=C(N)N=C21 DOUYETYNHWVLEO-UHFFFAOYSA-N 0.000 description 2
- 206010040490 Sexually transmitted disease Diseases 0.000 description 2
- 235000000333 Solanum abutiloides Nutrition 0.000 description 2
- 241000193251 Solanum abutiloides Species 0.000 description 2
- 235000001238 Solanum aculeastrum Nutrition 0.000 description 2
- 241000047359 Solanum aculeastrum Species 0.000 description 2
- 235000004790 Solanum aculeatissimum Nutrition 0.000 description 2
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- 235000005166 Solanum capsicastrum Nutrition 0.000 description 2
- 244000070669 Solanum ferox Species 0.000 description 2
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- 235000000212 Solanum linnaeanum Nutrition 0.000 description 2
- 235000000204 Solanum lycocarpum Nutrition 0.000 description 2
- 241000047047 Solanum lycocarpum Species 0.000 description 2
- 235000013146 Solanum mammosum Nutrition 0.000 description 2
- 240000007710 Solanum mammosum Species 0.000 description 2
- 235000002597 Solanum melongena Nutrition 0.000 description 2
- 240000002686 Solanum melongena Species 0.000 description 2
- 240000006258 Solanum nigrum Species 0.000 description 2
- 235000014503 Solanum robustum Nutrition 0.000 description 2
- 241000689107 Solanum robustum Species 0.000 description 2
- 235000002878 Solanum suaveolens Nutrition 0.000 description 2
- 241001312092 Solanum suaveolens Species 0.000 description 2
- 235000005619 Solanum unguiculatum Nutrition 0.000 description 2
- 235000005189 Solanum uporo Nutrition 0.000 description 2
- 240000001686 Solanum uporo Species 0.000 description 2
- 235000007375 Solanum viride Nutrition 0.000 description 2
- 244000066511 Solanum xanthocarpum Species 0.000 description 2
- 235000017622 Solanum xanthocarpum Nutrition 0.000 description 2
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- 239000000654 additive Substances 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 239000003637 basic solution Substances 0.000 description 2
- OYVAGSVQBOHSSS-UAPAGMARSA-O bleomycin A2 Chemical compound N([C@H](C(=O)N[C@H](C)[C@@H](O)[C@H](C)C(=O)N[C@@H]([C@H](O)C)C(=O)NCCC=1SC=C(N=1)C=1SC=C(N=1)C(=O)NCCC[S+](C)C)[C@@H](O[C@H]1[C@H]([C@@H](O)[C@H](O)[C@H](CO)O1)O[C@@H]1[C@H]([C@@H](OC(N)=O)[C@H](O)[C@@H](CO)O1)O)C=1N=CNC=1)C(=O)C1=NC([C@H](CC(N)=O)NC[C@H](N)C(N)=O)=NC(N)=C1C OYVAGSVQBOHSSS-UAPAGMARSA-O 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
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- 201000009910 diseases by infectious agent Diseases 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
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- 229960002751 imiquimod Drugs 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 235000019271 petrolatum Nutrition 0.000 description 2
- DNIAPMSPPWPWGF-UHFFFAOYSA-N propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 2
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- 229960001561 Bleomycin Drugs 0.000 description 1
- 108010006654 Bleomycin Proteins 0.000 description 1
- 206010006187 Breast cancer Diseases 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 235000015844 Citrullus colocynthis Nutrition 0.000 description 1
- 240000002694 Clidemia hirta Species 0.000 description 1
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- 206010048768 Dermatosis Diseases 0.000 description 1
- 229960002949 Fluorouracil Drugs 0.000 description 1
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- YJGVMLPVUAXIQN-XVVDYKMHSA-N Podophyllotoxin Chemical compound COC1=C(OC)C(OC)=CC([C@@H]2C3=CC=4OCOC=4C=C3[C@H](O)[C@@H]3[C@@H]2C(OC3)=O)=C1 YJGVMLPVUAXIQN-XVVDYKMHSA-N 0.000 description 1
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- 230000002378 acidificating Effects 0.000 description 1
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- 230000001093 anti-cancer Effects 0.000 description 1
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- 230000015572 biosynthetic process Effects 0.000 description 1
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- 238000005755 formation reaction Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 235000008216 herbs Nutrition 0.000 description 1
- 230000001329 hyperkeratotic Effects 0.000 description 1
- 230000000670 limiting Effects 0.000 description 1
- 239000000865 liniment Substances 0.000 description 1
- 239000002502 liposome Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000006210 lotion Substances 0.000 description 1
- 201000005202 lung cancer Diseases 0.000 description 1
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- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 230000017066 negative regulation of growth Effects 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 239000006072 paste Substances 0.000 description 1
- 239000002953 phosphate buffered saline Substances 0.000 description 1
- 229940068582 podophyllin Drugs 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/12—Keratolytics, e.g. wart or anti-corn preparations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/18—Antioxidants, e.g. antiradicals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
Abstract
598235 Disclosed is the use of a water-soluble extract from a plant of Solanum genus in the manufacture of a medicament for treating a wart, wherein said water-soluble extract comprises solamargine and solasonine and wherein said medicament is to be administered by a topical route.
Description
ANTI-WART PHARMACEUTICAL COMPOSITION AND METHOD FOR
TREATING WART
This application claims priority of Taiwanese
application no. 100115591, filed on May 4, 2011.
This invention relates generally to the use of an
anti-wart pharmaceutical composition containing a
water-soluble extract from a plant of Solanum genus in
the manufacture of a medicament for topical
administration. Also described is a method for treating
wart using the water-soluble extract.
Wart is a kind of dermatosis that occurs on the skin
or mucous of human or animal subjects, and is a benign
epidermal hyperplasia caused by infection of Human
papilloma virus (HPVs). In general, based on the site
where the wart forms, wart can be divided into cutaneous
wart and mucosal wart. The epidermal cells of skin or
mucosa affected by HPVs are subjected to benign
proliferation and hyperkeratosis, thereby resulting in
formation of papules or nodules with roughened surfaces
on the skin or mucosa.
In clinical diagnosis, wart is divided into four types
according to symptoms thereof: (1) common wart (Verruca
vulgaris), scaly and roughened papule(s) or nodule(s)
which usually occur on hands or fingers ; (2) flat wart
(Verruca plana juvenilis), slightly raised and
flat-topped papule(s) which usually occurs on faces,
hands, and lower legs; (3) plantar wart (Verruca
plantaris), a thick and hyperkeratotic papule which
usually occurs at pressure points of soles and toes and
causes painful feeling for a patient when the papule is
pressed; and (4) genital wart (Condyloma acuminatum), a
cauliflower-like lump formed on skin or mucosa of
genitalia and anus, which is a highly infectious and
sexually transmitted disease (STD).
Nowadays, warts are treated using the following
remedies based on the type, size, number, and lesion site
thereof:
(1) Topical therapy, e.g., podophyllin (Trade name:
Wartec ) and imiquimod (trade name: Aldara ) for treating
genital wart, 5-fluorouracil for treating genital wart
and cutaneous wart, and bleomycin (Trade name: Bleocin )
for treating plantar wart and warts formed on palm;
(2) Laser treatment, e.g., pulsed dye laser and carbon
dioxide laser, especially for treating plantar wart and
warts formed on palm; and
(3) Cryotherapy using liquid nitrogen and suitable
for treating most warts, less effective for warts formed
on palm, sole, and toe.
Each of the aforesaid remedies is suitable only for
a specific type of wart, rather than all types of warts.
Moreover, in clinical diagnosis, there are inferior
effect problem and side effect drawback for the aforesaid
remedies. For example, topical therapy used for a long
period of time will cause recurrence of warts and treating
effect thereof is unsatisfactory. Laser treatment and
cryotherapy will cause severe side effects, such as pain,
ulceration, and scarring. Some patients, especially
children, are likely to refuse treatment due to the
unendurable severe side effects.
To overcome the aforesaid drawbacks, researches have
focused on finding active components from traditional
Chinese medicines or herbs to develop a drug that is
effective for treating warts and that has no undesired
side effects.
It is known that Solanum incanum L. (also known as
Solanum incanum Ruiz. & Pav., Solanum undatum, Solanum
coagulans Forsskal in Latin, and bitter apple in English)
contains steroidal glycoalkaloid which exhibits
anti-cancer activity. In addition, many plants of the
Solanum genus are reported to contain steroidal
glycoalkaloid, including, for example, Solanum indicum,
Solanum nigrum, also known as Long Kui in Chinese and black
nightshade in English, Solanum capsicastrum (known as
false Jerusalem cherry in English), Solanum xanthocarpum,
Solanum melongena, Solanum coagulans, Solanum tuberosum,
Solanum sodomeum, Solanum turburosum, Solanum
aculeastrum, Solanum lycocarpum, Solanum khasianum,
Solanum suaveolens, Solanum uporo, Solanum abutiloides,
Solanum coccineum, Solanum unguiculatum, Solanum
robustum, Solanum anguivi, Solanum platanifolium,
Solanum mammosum, etc. The common steroidal
glycoalkaloids contained in plants of Solanum genus
include solamargine and solasonine.
US 7,078,063 B2 issued to the inventors of this
invention discloses a water soluble extract from a plant
of Solanum genus, especially Solanum incanum L., and a
process for preparing the same. The water soluble extract
consists essentially of at least 60 wt% of solamargine
and solasonine. This patent is hereby incorporated by
reference in its entirety.
In the aforesaid US patent, the inventors found that
the water soluble extract exhibits inhibition of growth
of tumor/cancer cells, in particular liver tumor cells,
lung cancer cells, and breast cancer cells. In this
invention, the inventors unexpectedly found that the
water soluble extract is effective in treating warts.
Summary of the Invention
Therefore, according to a first aspect, this
invention provides for the use of a water-soluble extract
from a plant of Solanum genus in the manufacture of a
medicament for treating a wart, wherein said
water-soluble extract comprises solamargine and
solasonine and wherein said medicament is to be
administered by a topical route.
Also described herein is an anti-wart pharmaceutical
composition which includes a water-soluble extract from
a plant of Solanum genus, the water-soluble extract
comprising solamargine and solasonine.
Also described is a method for treating wart, which
comprises applying to a subject in need of such treatment
a water-soluble extract from a plant of Solanum genus,
the water-soluble extract comprising solamargine and
solasonine.
Also described is the use of a water-soluble extract
from a plant of Solanum genus in the manufacture of a
medicament for treating wart, the water-soluble extract
comprising solamargine and solasonine.
Certain statements that appear below are broader than
what appears in the statements of the invention above.
These statements are provided in the interests of
providing the reader with a better understanding of the
invention and its practice. The reader is directed to the
accompanying claim set which defines the scope of the
invention.
Brief description of the drawings
The above and other objects, features and advantages
of this invention will become apparent with reference to
the following detailed description and the preferred
embodiments taken in conjunction with the accompanying
drawings, in which:
Fig. 1 shows photos illustrating that lesions
(indicated by arrows) of test subject C are gradually
ameliorated by treating the same with a Solanum incanum
L. gel;
Fig. 2 shows photos illustrating that lesions
(indicated by arrows) of test subject D are gradually
ameliorated by treating the same with a Solanum incanum
L. gel;
Fig. 3 shows photos illustrating that lesions
(indicated by arrows) of test subject E are gradually
ameliorated by treating the same with a Solanum incanum
L. gel; and
Fig. 4 shows photos illustrating that lesions
(indicated by arrows) of test subject F are gradually
ameliorated by treating the same with a Solanum incanum
L. gel.
Detailed Description
It is to be understood that, if any prior art
publication is referred to herein, such reference does
not constitute an admission that the publication forms
a part of the common general knowledge in the art, in
Taiwan or any other country.
For the purpose of this specification, it will be
clearly understood that the word “comprising” means
“including but not limited to”, and that the words
“comprises,” “contain” and variants thereof have a
corresponding meaning.
Unless otherwise defined, all technical and
scientific terms used herein have the meaning commonly
understood by a person skilled in the art to which this
invention belongs. One skilled in the art will recognize
many methods and materials similar or equivalent to those
described herein, which could be used in the practice of
this invention. Indeed, this invention is in no way
limited to the methods and materials described. For
clarity, the following definitions are used herein.
Described herein is an anti-wart pharmaceutical
composition, which includes a water-soluble extract from
a plant of Solanum genus. The water-soluble extract
comprises solamargine and solasonine. Preferably, the
water-soluble extract comprises at least 60 wt% of
solamargine and solasonine, more preferably, 60wt%-90wt%
of solamargine and solasonine.
The process for preparing the water-soluble extract
has been disclosed in US 7,078,063 B2 and includes the
steps of:
(a) subjecting a plant material of a plant of Solanum
genus to an extraction treatment using an acidic
aqueous solution with a pH value of 3~5, such that
an aqueous solution is obtained;
(b) adjusting the pH value of the aqueous solution
obtained in step (a) to pH 8~10 with a base, such
that a precipitate is formed;
(c) washing the precipitate formed in step (b) with
water, followed by drying, such that a dried product
is obtained;
(d) admixing the dried product obtained in step (c)
with chloroform, followed by addition of a suitable
amount of a 100% alcohol, such that a
chloroform-alcohol mixture is formed;
(e) mixing the chloroform-alcohol mixture formed in
step (d) with a water/alcohol solution having a
predetermined water:alcohol ratio, such that a
mixture containing a chloroform-based layer and a
non-chloroform-based layer is obtained;
(f) removing the chloroform-based layer from the
mixture obtained in step (e), followed by addition
of a suitable amount of water; and
(g) obtaining a supernatant from the resultant mixture
of step (f), followed by drying the supernatant,
wherein the resultant dried product is able to be
directly dissolved in water to form a yellowish
clear and transparent aqueous solution.
Preferably, in step (a), the plant material of the
plant of Solanum genus has been chopped in a preliminary
treatment.
Preferably, in step (a), the plant material is at
least one of the fruit, root, stem, and leaf of the plant
of Solanum genus. In a preferred embodiment of this
invention, the plant material used in step (a) is the fruit
of the plant of Solanum genus.
The inventors found that certain factors might affect
the content and proportion of solasonine and solamargine
in the water-soluble extract obtained using the aforesaid
process. These factors include the species of the plant
of Solanum genus and the part/parts of the plant used in
the extracting process, as well as the types of alcohol
and base used. Therefore, a skilled artisan can prepare
a desired water-soluble extract by selecting a suitable
species of the plant of Solanum genus and using a suitable
part or parts of the plant, in conjunction with
appropriate operating conditions.
Preferably, the water-soluble extract is obtained
from a plant of Solanum genus selected from the group
consisting of Solanum incanum L., Solanum indicum,
Solanum nigrum, Solanum capsicastrum, Solanum
xanthocarpum, Solanum melongena, Solanum coagulans,
Solanum tunigrum, Solanum sodomeum, Solanum turburosum,
Solanum aculeastrum, Solanum lycocarpum, Solanum
khasianum, Solanum suaveolens, Solanum uporo, Solanum
abutiloides, Solanum coccineum, Solanum unguiculatum,
Solanum robustum, Solanum anguivi, Solanum platanifolium,
and Solanum mammosum. In a preferred embodiment of this
invention, the water-soluble extract is obtained from
Solanum incanum L..
In preliminary human tests done by the inventors, the
results show that the water-soluble extract is effective
in treating or alleviating warts including cutaneous
warts and mucosal warts without undesired side effects,
e.g., ulceration or erythema. Therefore, described herein
is a method for treating wart, which comprises applying
to a subject in need of such treatment the water-soluble
extract.
The wart that can be treated by the anti-wart
pharmaceutical composition as described herein includes
common wart, flat wart, plantar wart, and genital wart.
The anti-wart pharmaceutical composition described
herein can be administered via e.g., parenteral,
transmucosal, transdermal, or topical route.
The parenteral route includes subcutaneous injection,
intraepidermal injection, intradermal injection, and
intralesional injection.
For the parenteral route, the anti-wart
pharmaceutical composition described herein can be
formulated into an injection product using techniques
known to a skilled artisan, e.g., sterile aqueous solution
or dispersion.
As described herein, the injection product can be
prepared by mixing the water-soluble extract with a
pharmaceutically acceptable carrier that is widely
employed in drug-manufacturing technology.
The pharmaceutically acceptable carrier comprises
one or more reagents, including, for example, water,
saline, buffer solution (Phosphate Buffered Saline (PBS),
Ringer’s solution or Hank’s solution), emulsifier,
suspending agent, decomposer, pH adjusting agents,
stabilizing agent, chelating agent, preservative,
diluents, absorption delaying agent, liposome, etc. The
choice and amount of these pharmaceutically acceptable
carriers are within the expertise of those skilled in the
art.
Moreover, the anti-wart pharmaceutical composition
described herein can be administered by topical routes,
e.g., dermal, buccal, genital, vaginal, anal, and rectal
routes. In an embodiment described herein, the anti-wart
pharmaceutical composition described herein is
administered by dermal route. In another embodiment
described herein, the anti-wart pharmaceutical
composition described herein is administered by genital
route.
The pharmaceutical composition described herein can
be formulated into a suitable dosage form for topical
administration using technology well known to those
skilled in the art, which includes, but is not limited
to, external preparations, effervescent tablets,
suppositories, and the like.
In a preferred embodiment described herein, the
anti-wart pharmaceutical composition is formulated into
an external preparation by admixing the water-soluble
extract as described herein with a base that is well known
and commonly used in the art.
As described herein, the external preparation
includes, but is not limited to, emulsion, gel, ointment,
cream, patch, liniment, powder, aerosol, spray, lotion,
serum, paste, foam, drop, suspension, and tincture. In
an embodiment described herein, the anti-wart
pharmaceutical composition is in the form of gel.
For example, the base suitable for producing the
external preparation described herein may include one or
more of the following additives: water, alcohols, glycol,
hydrocarbons (e.g., petroleum jelly and white petrolatum),
wax (e.g., paraffin and yellow wax), preserving agents,
antioxidant, surfactants, absorption enhancers,
stabilizing agents, gelling agents (e.g., carbopol 974P,
microcrystalline cellulose, and carboxymethyl
cellulose), active agents, humectants, odor absorbers,
fragrances, pH adjusting agents, chelating agent,
emulsifier, occlusive agents, emollients, thickeners,
solubilizing agents, penetration enhancers,
anti-irritants, colorants, and propellants. The choice
and amount of these additives are within the expertise
of those skilled in the art.
Also described herein is a method for treating wart,
which comprises applying to a subject in need of such
treatment the water-soluble extract or the anti-wart
pharmaceutical composition.
The dosage and the frequency of administration of the
anti-wart pharmaceutical composition as described herein
may vary depending on the following factors: the severity
of the disease to be treated, the route of administration,
and the weight, age, physical condition and response of
the subject to be treated. For instance, the daily dosage
of the pharmaceutical composition described herein may
be 10 to 20 mg/cm of the lesion area and one to six times
per day.
This invention will be further described by way of
the following examples. However, it should be understood
that the following examples are solely intended for the
purpose of illustration and should not be construed as
limiting the invention in practice.
Examples
Example 1: Preparation of the water-soluble extract
The water-soluble extract was prepared based on the
procedure as disclosed in Example 1 of US 7,078,063 B2.
Specifically, 500 g of ripe fruit of Solanum incanum L.
was ground subsequent to addition of 1000 ml pure water.
To the resultant aqueous mixture, 99.5% of acetic acid
was added dropwise to adjust the pH value to 4.0, followed
by shaking at room temperature for 12 hrs. A supernatant
was obtained by centrifuging the aqueous mixture at 4500
rpm for 12 hours, and 33% NH OH basic solution was added
thereto dropwise to adjust the pH value of the supernatant
to 9.0, and a precipitate was formed. The precipitate was
obtained by conducting centrifugation at 4,500 rpm for
minutes(Beckman Coulter, Avanti J-25, JA-14 Rotor),
and the residual basic solution present therein was
removed by washing the precipitate with water, followed
by centrifugation at 4,500 rpm. The precipitate thus
obtained was suspended in distilled water and subjected
to lyophilization (Virtis, Freezemobile 12ES) to obtain
g of dried powder.
2 g of the dried powder was dissolved in 50 ml
chloroform in reagent grade, followed by addition of 40
ml of 100% methanol and shaking to form a uniform
suspension. A supernatant was obtained by centrifugation
at 4,500 rpm. 70 ml of methanol:water solution (1:1) was
added to the supernatant and mixed well. The mixture
obtained was centrifuged at 12,000 rpm for 10 min. The
resultant supernatant was taken out, and 120 ml distilled
water was added thereto and shaken well. The supernatant
was further centrifuged at 12,000 rpm for 10 min so as
to remove the precipitate. The resultant supernatant was
subjected to concentration under reduced pressure at 55
to remove methanol, followed by lyophilization to obtain
dried powder of the water-soluble extract.
Example 2: Therapeutic effect and safety of the
water-soluble extract in treating human cutaneous wart
and mucosal wart
In order to examine the therapeutic effect and safety
of the water-soluble extract as prepared in the above
Example 1 in treating human cutaneous wart and mucosal
wart, the following tests were conducted.
A. Preparation of gel containing the water-soluble
extract
4 g of carbopol 974P, which was used as a gelling agent
and is commercially available from Lubrizol Advanced
Materials, Inc., KY 40258, USA, was dissolved in 50 g pure
water, followed by sequential addition of 30 g of
propylene glycol and 7 g of the dried powder of the
water-soluble extract obtained in Example 1 and mixing
well. The mixture was heated in a heating vessel at a
temperature of 50 to 60 for 20 minutes, followed by
cooling at room temperature. The cooled mixture was added
with triethanolamine to adjust pH to 7.0±0.5.
Subsequently, water was added until the total weight of
the mixture reached 100 g, thereby obtaining a gel
containing 7% (w/w) of the water-soluble extract
(hereinafter referred to as Solanum incanum L. gel).
B. Test subjects and clinical information thereof
Six test subjects (test subjects A to F) participating
in the following tests were enrolled from the outpatient
department of National Cheng Kung University Hospital,
Taiwan. The test subjects A and B suffered from mucosal
wart, and the test subjects C to F suffered from cutaneous
wart. The clinical information of the six test subjects,
including gender, age, wart type, and lesion location,
are outlined in Table 1.
Table 1
Test Age Wart type Lesion location
Gender
subject (y/o)
A 32 Female Mucosal wart External genital
B 21 Female Mucosal wart External genital
C 28 Female Cutaneous wart Finger tip
D 21 Male Cutaneous wart Finger tip, finger
E 26 Male Cutaneous wart Finger
F 33 Male Cutaneous wart Finger tip, palm
C. Pre-clinical test
Prior to the start of the test (i.e., on Week 0),
selected lesions on each of the enrolled test subjects
were photographed. The Solanum incanum L. gel prepared
in section A of Example 2 was applied to the selected
lesions and normal skin areas that surround the selected
lesions. Each of the normal skin areas had inner and outer
peripheries and the distance between the inner and outer
peripheries of each of the normal skin areas was not
greater than 0.5 cm. The treated dosage was 10~20 mg/cm ,
and twice a day. The selected lesions of each of the test
subjects were photographed at predetermined evaluation
times (i.e., at the ends of weeks 1, 2, 3, 4, 7, 8, 13,
and 29, see Table 2), and evaluations for therapeutic
effect and safety of the Solanum incanum L. gel were
conducted according to the procedures set forth in
sections D and E below. The test was finished when the
lesions of each of the test subjects were completely cured
and the outer appearance of the lesion skin was recovered
to a normal state.
Table 2
Evaluation time (week)
Test
subject
0 1 2 3 4 7 8 13 20 29
A + + - - - - - - - -
B + + - - - - - - - -
C + - - - + - + - - -
D + - + + - - + - - -
E + - + - - + - - - -
- e f
F + - - - + - ◎ ※ +
:“0” indicates week 0, i.e., prior to
application of the Solanum incanum L. gel
:“1” means week 1 after application of the
Solanum incanum L. gel
:“+” means evaluation was conducted
:“-”means no evaluation was conducted
:“◎” means evaluation was conducted only on
the lesions at finger tip
:“※”means evaluation was conducted only on the
lesion on palm
D. Evaluation of therapeutic effect
The photos of the selected lesions of the test
subjects as obtained at Week 0 (i.e., prior to the
application of the Solanum incanum L. gel) and as obtained
at the evaluation times were compared by a dermatologist
to determine the improvement of lesions treated with the
Solanum incanum L. gel.
E. Evaluation of safety
Evaluation of safety was conducted by a researcher
at the predetermined evaluation times. The test subjects
were interrogated by the researcher in respect to the
appearance of any adverse skin response (including
ulceration, irritation and erythema).
Results:
A. Evaluation of the therapeutic effects of the Solanum
incanum L. gel
Compared with the photos of the selected lesions of
each of the test subjects A and B as obtained at week 0
and other predetermined evaluation times, the selected
lesions of each of the test subjects A and B treated with
the Solanum incanum L. gel were significantly improved
after the end of week 1 (data not shown).
Figs. 1 to 4 respectively show photos of the selected
lesions of the test subjects C to F as obtained at
different evaluation times. The photos demonstrate that
the lesions of each of the test subjects C to F treated
with the Solanum incanum L. gel greatly improved with time.
After the test was finished, the test subjects C to F were
further subjected to the follow-up study for six months
to two years to determine whether the lesion area that
had already been cured by the Solanum incanum L. gel was
recurrent. Based on the results of the follow-up study,
no warts were found to have recurred for all of the test
subjects (data not shown).
The aforesaid results show that the Solanum incanum
L. gel of this invention could be effectively used to treat
cutaneous wart and mucosal wart.
B. Evaluation of the safety of the gel containing the
water-soluble extract
In the safety test, only a few of the test subjects
experienced temporary and mild adverse skin responses,
including irritation or erythema, which, however, did not
halt them from completing the test (data not shown).
In view of the aforesaid, the inventors contemplate
that the water-soluble extract from a plant of Solanum
genus used according to this invention can be developed
into an anti-wart drug for long-term use in treating warts
without adverse side effects.
Claims (9)
1. Use of a water-soluble extract from a plant of Solanum genus in the manufacture of a medicament for treating a wart, wherein said water-soluble extract 5 comprises solamargine and solasonine and wherein said medicament is to be administered by a topical route.
2. The use of claim 1, wherein said water-soluble extract comprises at least 60 wt% of solamargine and solasonine. 10
3. The use of claim 1, wherein said water-soluble extract comprises 60 wt%-90 wt% of solamargine and solasonine.
4. The use of any one of claims 1 to 3, wherein said wart is common wart, flat wart, plantar wart, or genital 15 wart.
5. The use of any one of claims 1 to 4, wherein when administered, the medicament is administered by a topical route.
6. The use of any one of claims 1 to 4, wherein the 20 medicament is in a form for topical administration.
7. The use of any one of claims 1 to 6, wherein said medicament further comprises a base selected from the group consisting of water, alcohols, glycol, hydrocarbons, wax, preserving agents, antioxidant, surfactants, 25 absorption enhancers, stabilizing agents, gelling agents, active agents, humectants, odor absorbers, fragrances, pH adjusting agents, chelating agent, emulsifier, occlusive agents, emollients, thickeners, solubilizing agents, penetration enhancers, anti-irritants, colorants, propellants, and combinations thereof.
8. The use of claim 7, wherein the base includes a 5 gelling agent and glycol.
9. A use as claimed in any one of claims 1 to 8, substantially as herein described with reference to any example thereof.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
TW100115591 | 2011-05-04 | ||
TW100115591A TWI414304B (en) | 2011-05-04 | 2011-05-04 | Treatment of wart with a water soluble extract from plant of solanum genus |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ598235A NZ598235A (en) | 2013-10-25 |
NZ598235B true NZ598235B (en) | 2014-01-28 |
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