LV10576B - Medicinal preparation - Google Patents

Medicinal preparation Download PDF

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LV10576B
LV10576B LVP-93-1234A LV931234A LV10576B LV 10576 B LV10576 B LV 10576B LV 931234 A LV931234 A LV 931234A LV 10576 B LV10576 B LV 10576B
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treatment
paradontosis
toothpaste
extract
agents
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LVP-93-1234A
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LV10576A (en
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Cizevska Merija
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Latvijas Organiskas Sintezes Instituts
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Abstract

The invention is related to a medicinal composition for parodontitis prophylaxis and treatment in the form of toothpaste, which contains an antibacterial cure from the nitrofuran group, an anti-parasitical cure from the nitroimidazole group and an extract from vegetable raw materials is used as the resolvent.

Description

Izgudrojums attiecas uz medicīnu, konkrēti uz stomatoloģiju paradontozes ārstniecību un profilaksi.The invention relates to medicine, in particular to the treatment and prevention of paradontosis in dentistry.

Zināms, ka paradontoze ir viena no izplatītākajām un postošākajām zobus noturošā aparāta saslimšanām. kuras etioloģijā lielu lomu spēlē parazīti, konkrēti protozoas. Tāpēc paradontozes ārstēšana pēc akūtā procesa ierobežošanas paralēli citiem ārstniecības līdzekļiem pielieto arī pretparazitāros līdzekļus, piemēram trihopolu /1-3/. mēģinot panākt iespējami augstu ārstniecības līdzekļu koncentrāciju tieši parazītu invadētajos reģionos, tai skaitā paradonta audos. Tam nolūkam pielieto polimēru materiālu plāksnītes, plēves vai pildmateriālus paradonta kabatu pildīšanai, kas satur dažādus antibakteriālus līdzekļus /4-11/. Šādu ārstniecisko formu pielietošanas nepieciešamību savukārt nosaka perorāio ārstniecisko preparātu nepietiekama efektivitāte tieš ’ pie paradontozes ārstēšanas. Taču galvenais šo kompozīciju trūkums ir tas, ka to pielietošanu var veikt tikai zobārstniecības kabinetā.Paradontosis is known to be one of the most common and devastating diseases of the tooth-holding apparatus. in the etiology of which parasites, especially protozoa, play a major role. Therefore, in the treatment of paradontosis after limiting the acute process, antiparasitic agents, such as trihopol / 1-3 /, are used in parallel with other treatments. seeking to achieve the highest possible concentration of cure in the affected areas, including paradontal tissue. For this purpose, sheets of polymeric material, films or fillers are used for filling paradontal pockets containing various antibacterial agents / 4-11 /. The need for such forms of treatment, in turn, is determined by the inefficiency of oral therapies directly in the treatment of paradontosis. However, the main disadvantage of these compositions is that they can only be used in a dental office.

No otras puses ir zināmi citi mutes dobuma un zobu kopšanas līdzekļi, piemēram skalojamie ūdeņi un pastas, kas satur antibakteriālus līdzekļus. piemēram neksadecilpiridīηija bromīdu vai citus vietējas iedarbības preparātus. Taču zināmo skalojamo ūdeņu sastāvā neietilpst antiparazitāras tiešas iedarbības līdzekļi, un tāpēc to iedarbība uz protozojām ir nepietiekoša. Ir pazīstamas arī dažādas ārstnieciski-profilaktiskās zobu pastas. To sastāvā parasti tiek ieslēgti fluora atvasinājumi, minerālsāļi, augu valsts produktu ekstrakti, ēteriskās eļļas un atsevišķos gadījumos arī antibakteriāli preparāti. Taču zināmo pastu sastāvā nav iedarbīgu pret.parazitāru preparātu, tāpēc to efektivitāte pie parazitārām infekcijām ir nepietiekoša.On the other hand, other oral and dental care products are known, such as rinsing water and pastes containing antibacterial agents. such as non-adadecylpyridium bromide or other topical preparations. However, the known rinse waters do not contain direct antiparasitic agents and therefore their action on protozoa is inadequate. Various curative-preventive toothpastes are also known. They usually include fluorine derivatives, mineral salts, extracts of plant products, essential oils and, in some cases, antibacterial agents. However, the known pastes do not contain antiparasitic agents, therefore their efficacy against parasitic infections is insufficient.

Šī izgudrojuma mērķis ir radīt ārstnieciski profilaktisku kompozīciju, kas nodrošinātu pietiekoši augstu efektivitāti paradontozes ārstēšanā un profilaksē slimniekiem, kuriem paradontozes etioloģijā būtisku lomu spēlē parazitārās infekcijas. Šī mērķa sasniegšanai radīta kompozīcija uz zināmo zobu pastu bāzes, kuras satāvā papildus tiek ievadītas pretparazitāras vielas, piemēram no nitroimidazola grupas - metronidazols, trinidazols, nitazols, vai to analogi, kā arī no nitrofurāna atvasinājumu rindas - piemēram furadonīns, furaglns, šķīstošais furagins vai to analogi un pretiekaisuma un hemostatiskas iedarbības līdzeklis, piemēram ceļmallapu izvilkums, kā arī bufervielu vides skābuma normalizēšanai, piemēram acidonormu (pienskābo nūjiņu producēto organisko skābju maisījuma kalcija sāls). Ārstniecisko preparātu specifiskās piegaršas nomākšanai kompozīcijā tika ievadītas attiecīgi uzturam atļautas saldun garšvielas. Šāda ārstnieciskā kompozīcija zobu pastas formā nodrošina ievērojamas priekšrocības pret zināmajām paradontozes ārstniecībai paredzētajām kompozīcijām, jo divu dažāda darbības spektra antibakteriālo un antparazitāro līdzekļu ievadīšana starpzobu telpā un smaganu kabatās, uz mutes dobuma gļotādām vienlaicīgi mehāniskas iedarbības rezultātā noņemot gļotu un citu baktērijām un parazītiem viegli pieejamu barības substrātu paliekas, ka arī izvadot daļu no kabatās uzkrājušos detrīta tiek nodrošināta augsta ārstniecisko līdzekļu vietēja koncentrācija parazītu invadētajā reģionā. Tādējādi tiek iznīcināta patogēnā mikroflora, bet pretiekaisuma līdzeklis samazina infiltrācijas intensitāti, nodrošinot paaugstinātu kabatu pieejamību ārstnieciskajai kompozīcijai.The object of the present invention is to provide a therapeutically preventive composition which provides a sufficiently high efficacy in the treatment and prevention of paradontosis in patients who play an important role in the etiology of paradontosis by parasitic infections. To this end, a composition has been developed based on known toothpastes which additionally comprises antiparasitic agents such as the nitroimidazole group metronidazole, trinidazole, nitazole, or analogs thereof, as well as a series of nitrofuran derivatives such as furadonin, furaglin, soluble furagin. analogues and anti-inflammatory and haemostatic agents, such as extract of plantain leaves, and buffering agents for the normalization of environmental acidity, such as acidonorm (calcium salt of a mixture of organic acids produced by lactic acid sticks). In order to suppress the specific flavor of the medicinal preparations, appropriate nutritionally authorized sweet and spices were introduced into the composition. Such a therapeutic composition in the form of a toothpaste provides significant advantages over known compositions for the treatment of paradontosis, as the administration of two different spectrum antibacterial and antiparasitic agents to the interdental space and to the pockets of the oral cavity and the mucous membrane remnants of substrates, and even removing some of the accumulated detritus in the pockets ensures high local concentrations of the remedies in the parasite-infested region. Thus, the pathogenic microflora is destroyed, but the anti-inflammatory agent reduces the infiltration rate, providing an increased pocket availability for the therapeutic composition.

Ārstnieciskās kompozīcijas efektivitāti var raksturot ar sekojošajiem piemēriem:The effectiveness of the therapeutic composition can be characterized by the following examples:

Kompozīcijas efektivitāte tika pētīta uz trijām grupām slimnieku ar pirmās pakāpes paradontozi. Smaganu paradontozes ārstēšanas laikā 3-5 dienas pēc kārtas tika sanēts mutes dobums un paradonts ar propolisa 10% emulsiju eļļā, kuram pievienots 4 % metronidazola. Emulsijā piesūcinātus vates torundus ievadījām starpzobu spraugās un pataloģiskajās smaganu kabatās uz 2 st. Papildus tam 2.The efficacy of the composition was investigated in three groups of patients with first degree paradontosis. During treatment of gingival paradontosis, the oral cavity and the paradont were repaired for 3 to 5 consecutive days with a 10% propolis in oil emulsion supplemented with 4% metronidazole. The emulsion-impregnated cotton torunds were inserted into the interdental slits and in the pathological gingival pockets for 2 hours. In addition, 2.

ārstēšanas dienā tika noņemts zobakmens. Pēc trešās dienas citoloģiski tika kontrolēta ārstēšanas efektivitāte un smaganu audu reģenerācija. Ārstēšanu turpinājām, līdz tika panākta klīniska izveseļošanās. Tālāk pirmajā grupā (492 pacienti) tika lietoti tradicionālie ārstnieciski profilaktiskie zobu kopšanas līdzekļi- zobu pastas Aira, Remodents vai Buratino, mutes dobuma skalošana ar Maraslavīnu. Mutes dobuma un paradonta kontroli izdarīja pēc 6 mēnešiem. Iegūtie rezultāti apkopoti tabulā No 1.on the day of treatment, tartar was removed. After the third day, treatment efficacy and gingival tissue regeneration were monitored cytologically. We continued treatment until clinical recovery was achieved. Next, in the first group (492 patients), conventional curative prophylactic dental care products were used - toothpaste Aira, Remodents or Buratino, mouthwash with Maraslavin. Oral and paradontal control was performed at 6 months. The results are summarized in Table 1.

Otrajā grupā (302 pacienti) paralēli iepriekšminētajiem līdzekļiem tika nozīmēts orāli trihopols. Iegūtie rezultāti apkopoti tabulā No 2.In the second group (302 patients), oral trophol was administered in addition to the above agents. The results are summarized in Table.

Trešajā grupā (292 pacienti) tika pielietota ārstnieciski-profilaktiskā kompozīcija uz zobu pastas bāzes, kas saturēja 0,75 - 1,25 g (optimāli 1,0 g) metronidazola (vai tā analoga), 0,1 - 0,3 g (optimāli 0,2 g) furadonīna (vai tā analoga) un 2 g Plantago laceelata (ceļmallapu) pulvera vai tam atbilstoša daudzuma ceļmallapu izvilkuma. Zobu pastu slimnieki lietoja zobu tīrīšanai 1-2 reiz dienā pēc ēšanas. Iegūtie rezultāti atspoguļoti tabulā No 3.The third group (292 patients) used a toothpaste-based composition containing 0.75-1.25 g (optimally 1.0 g) of metronidazole (or its analog), 0.1-0.3 g ( optimally 0.2 g) of furadonin (or its analogue) and 2 g of extract of Plantago laceelata (plantain) or an equivalent amount of plantain extract. Patients used toothpaste to clean their teeth 1-2 times a day after meals. The results are shown in Table 3.

Kā izriet no iegūtajiem rezultātiem, patentējamā ārstnieciskā kompozīcija izdevīgi atšķiras no zināmajiem paradontozes ārstniecības un profilakses līdzekļiem ar to, ka pēc akūtā procesa likvidācijas tā nodrošina ievērojami ilgāku paradontozes remisiju salīdzinājumā ar tradicionālajiem paradont<-ozes ārstniecības un profilakses līdzekļiem.As a result of the obtained results, the patentable therapeutic composition differs advantageously from the known treatments and prevention of paradontosis in that it provides significantly longer paradontal remission after the elimination of the acute process compared to the traditional treatment and prevention of paradontosis.

Tabula Nr.1Table 1

Diagnoze Slimnieku Ārstēšanas rezultāti Recidīvi skaits ______seansos________ pēc 6 mēn.Diagnosis Patient Treatment Result Number of relapses in ______ sessions________ after 6 months

3-4 4-6 6-83-4 4-6 6-8

Paradontozes I-II stadija ar pato- 492 372 80 40 246 loģiskām smaganu kabatām, strutu 75,6% 16,2% 8,1% 50% izdalīš., zobu kustīguma I pak.Phase I-II of paradontosis with patho- 492 372 80 40 246 logical gingival pockets, pus 75.6% 16.2% 8.1% 50% release, tooth motility I

Tabula Nr. 2Table No. 2

Diagnoze Diagnosis Slimnieku skaits Patient number of Ārstēšanas rezultāti seansos Treatment results in sessions Recidīvi pēc 6 mēn. Relapses after 6 months 3-4 3-4 4-6 6-8 4-6 6-8 Paradontozes I-II Paradontosis I-II stadija ar patoloģiskām smaganu stage with abnormal gums 302 302 132 132 92 78 92 78 73 73 kabatām, strutu izdalīš., zobu kustīguma I pak. pockets, pus extraction, tooth mobility I 43,7% 43.7% 30,4% 25,8% 30.4% 25.8% 24,1% 24.1%

Tabula Nr. 3Table No. 3

Diagnoze Diagnosis Slimnieku skaits Patient number of Ārstēšanas rezultāti seansos Treatment results in sessions Recidīvi no 6 mēn. līdz 1 gadai Relapses from 6 months up to 1 year 3-4 3-4 4-6 6-8 4-6 6-8 Paradontozes I-II stadija ar pato- Stage I-II of paradontosis with patho- 292 292 198 198 87 7 87 7 nav bijuši has not been loģiskām smaganu kabatām, strutu izdalīš., zobu kustīguma I pak. logical gums pockets, pus extraction, tooth movement I 67,8% 67.8% 29,7% 2,3% 29.7% 2.3%

LITERATŪRAS SARAKSTSLIST OF LITERATURE

1. Deasv P.B. et al . , J.Pharj®, 69-1- 1. Deasv P.B. et al. , J.Pharj®, 69-1- Ptļņrmajcol. Ptļņrmajcol. 1989, 1989, 41( 10) , 41 (10), 2. Vado V.G., et al , J.Appl 455-457. 2. Vado V.G., et al., J.Appl 455-457. .BacterIol., .BacterIol., 1987, 1987, 63(5) , 63 (5), 3. Jousimes-Somer H. et al. , Oral 3(1), 32-34. 3. Jousimes-Somer H. et al. , Oral 3 (1), 32-34. Microbiol. Microbiol. Immunol Immunol . , 1988, . , 1988,

4. AU, DK, JP, IL, US 5.023.082 (9126)4. AU, DK, JP, IL, US 5,023,082 (9126)

5. VO 87-07.140 (8749)5. VO 87-07.140 (8749)

6. EP 246.809 (8747)6. EP 246.809 (8747)

7. EP 304.374 (8909)7. EP 304.374 (8909)

8. Fr 2.619.508 (8915)8. Fr 2.619.508 (8915)

9. EP 304.374-B (9203)9. EP 304.374-B (9203)

10. DE 3.867.569-G (9209)10. DE 3.867.569-G (9209)

11. VO 92-00.104 (9205)11. VO 92-00.104 (9205)

Claims (1)

Ārstnieciskā kompozīcija paradontozes ārstēšanai un profilaksei remisijas fāzē uz zobu pastas bāzes, kas paradontozes remisijas ilguma palielināšanas nolūkā papildus zināmajiem zobu pastas komponentiem satur pretparazitārus un antibakteriālus līdzekļus no nitroimidazola un nitrofurāna grupām, konkrēti metrindazolu un furadonīnu vai to analogus koncentrācijas 0,5-2,0% un 0,05-1,0% attiecīgi un pretiekaisuma līdzekli, piemēram ceļmallapu pulveri (1-4%) vai to izvilkumu , vai analogas iedarbības līdzekli efektīvā koncentrācijā.A pharmaceutical composition for the treatment and prevention of paradontosis in the remission phase based on toothpaste comprising, in addition to known toothpaste components, anti-parasitic and antibacterial agents of the nitroimidazole and nitrofuran groups, in particular metrindazole and furadonin, in addition to known toothpaste components % and 0.05-1.0%, respectively, and an effective amount of anti-inflammatory agent, such as plantain powder (1-4%) or extract thereof, or analogous agent.
LVP-93-1234A 1993-11-16 1993-11-16 Medicinal preparation LV10576B (en)

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