CS276818B6 - Preparation for treating nasal mucosa inflammations - Google Patents
Preparation for treating nasal mucosa inflammations Download PDFInfo
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- CS276818B6 CS276818B6 CS902498A CS249890A CS276818B6 CS 276818 B6 CS276818 B6 CS 276818B6 CS 902498 A CS902498 A CS 902498A CS 249890 A CS249890 A CS 249890A CS 276818 B6 CS276818 B6 CS 276818B6
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Abstract
Prostriedok obsahuje 67,60 až 95,12 % hmot. rastlinného oleja, v ktorom je rozpuštěné 4,77 až 12,10 % hmot. zmesi prírodných účinných látok a 0,11 až 30,60 % hmot. pomocných látok pričom účinná zmes pozostáva z 3,00 až 6,00 % hmot. borovicového oleja /oleum pini silvestris/, 0,50 až 2,00 % hmot. mátového oleja /oleum menthae piperitae/, 0,25 až 1,00 % hmot. eukalyptového oleja /oleum eucalypti/, 0,01 až 0,05 % hmot. tymolu, 0,01 až 0,05 % hmot. azulénu a 1,00 až 3,00 % hmot. vitamín E acetátu vztiahnuté k celkovej hmotnosti prostriedku. Ako pomocné látky prostriedok obsahuje % hmot. lecitinu a/alebo hmot. etoxylovaného a glyrastllnného oleja a 0,01 až butylhydroxyanizolu a/alebo % hmot. dltercbutyl-p-krezolu celkovej hmotnosti prostriedku. Prostriedok sa používá na liečenie zápalov nosovej sliznice vo formě kvapiekThe composition contains from 67.60 to 95.12% by weight. vegetable oil in which it is dissolved 4.77 to 12.10 wt. natural blends % of active compounds and 0.11 to 30.60 wt. auxiliary of the active ingredient from 3.00 to 6.00 wt. pine oil / oleum pini silvestris /, 0.50 to 2.00% wt. mint oil / oleum menthae % piperitae, 0.25 to 1.00 wt. eucalyptus oil / oleum eucalypti /, 0.01 to 0.05 % wt. % thymol, 0.01 to 0.05 wt. azulene and 1.00 to 3.00 wt. vitamin E acetate relative to the total weight of the composition. The composition contains as excipients % wt. lecithin and / or wt. ethoxylated and glyrastinic oil and 0.01 to butylhydroxyanisole and / or % wt. dltercbutyl-p-cresol total weight of the composition. The composition is used to treat inflammation nasal mucosa in the form of drops
Description
Prostriedok na liečenie zápalov nosovej slizniceAn agent for the treatment of inflammation of the nasal mucosa
Ohlásí technikyReport techniques
Vynález se týká prostriedku na liečenie zápalov nosovej sliznice.The invention relates to a composition for the treatment of inflammation of the nasal mucosa.
Potěrajší stav technikyMore agile state of the art
Na liečenie zápalov sliznice nosa v súčasnosti používajú jednak syntetické prostriedky, například Sanorin, čo je vodný roztok dusičnanu nafazolínia alebo Mukoseptonex, čo je roztok bromidu karbetopendecínia resp. zmes s chloridom efedrínu, jednak prostriedky s obsahom prírodných látok, například Inhalex, čo je liehový roztok éterických olejov, mentolu a gáfru alebo Inhalol pini obsahujúci olej z kosodřeviny, tanín, chlorofyl a gáfor. V zahraničí sa používajú prostriedky s obsahom éterických olejov v kombinácii s rastlinnými extraktami ako například Rhino-loges, čo je vodný roztok guajazulénu, eukalyptového, šalviového a kosodrevinového oleja v kombinácii s extraktami z rastlín rodu Thuja, Armoracia a Hydrastis alebo nosové kvapky Rhino-Vasogen, čo je výluh z rumančeka v kombinácii s mentolom a eukalyptovým olejom rozpuštěný vo viskóznom parafíne.For the treatment of inflammation of the nasal mucosa, synthetic agents are currently used, for example Sanorin, which is an aqueous solution of naphazolinium nitrate, or Mucoseptonex, which is a solution of carbetopendecin bromide and carbetopendecin bromide, respectively. a mixture with ephedrine chloride, on the one hand, compositions containing natural substances, for example Inhalex, which is an alcoholic solution of essential oils, menthol and camphor, or Inhalol pini containing cypress oil, tannin, chlorophyll and camphor. Abroad, essential oil formulations are used in combination with plant extracts such as Rhinologes, an aqueous solution of guayazulene, eucalyptus, sage and rhododendron oil in combination with extracts from plants of the genus Thuja, Armoracia and Hydrastis or Rhino-Vasogen nasal drops. , which is a chamomile extract in combination with menthol and eucalyptus oil dissolved in viscous paraffin.
Podstata vynálezuThe essence of the invention
Prostriedok na liečenie zápalov nosovej sliznice, ktorého podstatou je, že obsahuje 67,60 až 95,12 % hmot, rastlinného oleja, v ktorom je rozpuštěné 4,77 až 12,10 % zmesi účinných prírodných látok pričom účinná zmes pozostáva z 3,00 až 6,00 % hmot, borovicového oleja /oleum pini silvestris/, 0,50 až 2,00 % hmot, mátového oleja /oleum menthae piperitae/, 0,25 až 1,00 % hmot, eukalyptového oleja /oleum eucalypti/, 0,01 až 0,05 % hmot, tymolu, 0,01 až 0,05 % hmot, azulénu a 1,00 až 3,00 % hmot, vitamín E acetátu vztiahnuté k celkovej hmotnosti prostriedku. Prostriedok obsahuje dalej pomocné látky 0,10 až 10,00 % hmot, lecitinu a/alebo 1,00 až 20,00 % hmot, etoxylovaného a glykolizovaného rastlinného oleja a 0,01 až 0,30 % hmot, butylhydroxyanizolu a/alebo 0,01 až 0,3 % hmot, diterbutyl-p-krezolu vztiahnuté k celkovej hmotnosti prostriedku. Hlavně výhody uvedeného prostriedku spočívajú v jeho protizápalovom, antimikrobiálnom a epitelizáciu a regeneráciu nosovej sliznice podpornom účinku, ktorý je vyšší ako doposial známe prostriedky. Prostriedok má aj mierny imunomodulačný účinok, nie je dráždivý ani návykový a nemá vedla jšie nepriaznivé účinky. Uvedených vlastností prostriedku podlá vynálezu bolo dosiahnuté kvalitatívnym a kvantitativným výberom synergicky pósobiacich účinných prírodných látok.A composition for the treatment of inflammation of the nasal mucosa, the essence of which is to contain 67.60 to 95.12% by weight of a vegetable oil in which 4.77 to 12.10% of a mixture of active natural substances is dissolved, the active mixture consisting of 3.00 up to 6.00% by weight, pine oil (oleum pini silvestris), 0.50 to 2.00% by weight, peppermint oil (oleum menthae piperitae), 0.25 to 1.00% by weight, eucalyptus oil (oleum eucalypti), 0.01 to 0.05% by weight of thymol, 0.01 to 0.05% by weight of azulene and 1.00 to 3.00% by weight of vitamin E acetate based on the total weight of the composition. The composition further comprises 0.10 to 10.00% by weight of lecithin and / or 1.00 to 20.00% by weight of ethoxylated and glycolized vegetable oil and 0.01 to 0.30% by weight of butylhydroxyanisole and / or 0% by weight of the excipient. 01 to 0.3% by weight, of diterbutyl-β-cresol, based on the total weight of the composition. The main advantages of said composition lie in its anti-inflammatory, antimicrobial and epithelialization and regeneration of the nasal mucosa, a supportive effect which is higher than hitherto known compositions. The composition also has a mild immunomodulatory effect, is not irritating or addictive and does not have other adverse effects. Said properties of the composition according to the invention were achieved by qualitative and quantitative selection of synergistically acting active natural substances.
Prostriedok podlá vynálezu je číra olejovitá kvapalina svetlemodrej farby, mentolovo-eukalyptovej vóne. Vyhovuje požiadavke na mikrobiologickú nezávadnost podlá ČsL 4. Za normálnzch skladovacích podmienok nedocháza ani po 24 mesiacoch k fyzikálnym a chemickým změnám, ktoré by nepriaznivo ovplyvnili kvalitu prostriedku.The composition according to the invention is a clear, light blue oily liquid with a menthol-eucalyptus scent. It complies with the requirement for microbiological safety according to ČSL 4. Under normal storage conditions, there are no physical and chemical changes even after 24 months that would adversely affect the quality of the product.
Antimikrobiálna účinnost prostriedku bola testovaná na klinicCS 276818 B6 kých izolátoch kmeňov z horných ciest dýchacích /Klebsiella sp.,The antimicrobial efficacy of the composition was tested on clinical isolates of upper respiratory tract strains / Klebsiella sp.,
Staphylococcus aureus, Staphylococcus epidermitis, enterococcus sp. a Streptococcus sp./ metodou stanovujúcou redukciu počtu životaschopných buniek po 24 hodinovej kultivácii s testovanou látkou. Pre každý testovaný kmeň boli stanovené % inhibície kmeňa voči kontrole pre 4 testované koncentrácie v rozsahu 62,5 až 500 ul.ml-1/t.j. 2 až 16 násobné riadenie vzorky účinných látok/. Pri váčšine kmeňov bola počítaná hodnota ED50, ktorá je definovaná ako koncentrácia testovanéj látky, ktorá inhibuje prežívanie 50 % ovplyvnených bakteriálnych buniek. Dvojnásobné riedenie testované j vzorky málo 100 %ný cídny efekt a štvornásobné riedenie inhibovalo viac ako 90 % buniek všetkých testovacích kmeňov.Staphylococcus aureus, Staphylococcus epidermitis, enterococcus sp. and Streptococcus sp./ by a method for reducing the number of viable cells after culturing for 24 hours with a test substance. For each test strain, the% inhibition of the strain relative to the control was determined for 4 test concentrations in the range of 62.5 to 500 [mu] m / l -1 (i.e. 2 to 16-fold control of the active substance sample). For most strains, the ED 50 value was calculated, which is defined as the concentration of test substance that inhibits the survival of 50% of the affected bacterial cells. A two-fold dilution of the test sample had a low 100% side effect and a four-fold dilution inhibited more than 90% of the cells of all test strains.
Z histopatologických vyšetření respiračného systému potkanov po aplikácii prostriedku vyplývá, že v množstve 0,1 až 0,2 ml nespósobuje změny na epiteli nosovéj sliznice ani na vrstevnom dlaždicovom epiteli vo vestibulum naši, ani na sliznici priedušnice a ani na plucnom tkanive. Má mierny lokálny imunomodulačný efekt prejavujúci sa infiltráciou steny priedušnice neutrofilnými polymorfonukleárnymi granulocytmi, makrofágmi a lymfocytmi. LD^0 na myšiach a potkanoch po perorálnej aplikácii prostriedku podlá vynálezu bola viac ako 20.000 mg.kg“1. Prostriedok podlá vynálezu bol klinicky odskúšaný formou jednoduchéj otvorenej štúdie na súbore 137 pacientov, z toho 51 dětí. Cielom štúdie bolo odsledovat terapeutická účinnost a znášanlivost prostriedku pri zápalových ochoreniach sliznice nosa, nosohltana a stavoch po chirurgických výkonoch v dutině nosa. Prostriedok bol aplikovaný 3 až 5 krát denne po 1 až dvoch kvapkách do každej nosovej dierky po dobu 5 až 7 dní. Prostriedok preukázal 80%nú účinnost pri liečbe zápalov sliznice nosa u dětí aj dospělých, čo sa prejavilo výrazným ústupom až vymiznutím sekrécie z nosa, uvolněním priachodnosti a tým ulahčením dýchania. Bola potvrdená aj antimikrobiálna účinnost prostriedku. Pacientmi bol prípravok dobré tolerovaný bez vedlejších nepriaznivých účinkov a pozitivně hodnotený pre rýchly ústup subjektivných tažkostí,príjemnú aplikáciu a dezodoračné vlastnosti.Histopathological examinations of the respiratory system of rats after application of the composition show that in an amount of 0.1 to 0.2 ml it does not cause changes in the epithelium of the nasal mucosa or in the layered squamous epithelium in our vestibule, in the tracheal mucosa or in lung tissue. It has a mild local immunomodulatory effect manifested by infiltration of the tracheal wall by neutrophilic polymorphonuclear granulocytes, macrophages and lymphocytes. LD ^ 0 in mice and rats following oral administration of a composition of the invention was more than 20,000 mg.kg '1. The composition of the invention was clinically tested in a simple open-label study in a cohort of 137 patients, 51 children. The aim of the study was to monitor the therapeutic efficacy and tolerability of the composition in inflammatory diseases of the nasal mucosa, nasopharynx and conditions after surgery in the nasal cavity. The composition was applied 3 to 5 times a day in increments of 1 to two drops to each nostril for 5 to 7 days. The composition proved to be 80% effective in the treatment of inflammation of the nasal mucosa in children and adults, which manifested itself in a significant decline to the disappearance of secretion from the nose, loosening of patency and thus easier breathing. The antimicrobial efficacy of the composition was also confirmed. The preparation was well tolerated by patients without side effects and positively evaluated for rapid remission of subjective difficulties, pleasant application and deodorizing properties.
Příklady uskutočnenia vynálezuExamples of embodiments of the invention
Příklad 1Example 1
Do skleněného kotlíka opatřeného miešadlom sa našaržuje 8 298,4 g oleja vyrobeného winterizáciou parciálně hydrogenovaného nízkoerukového oleja, ktorom sa za laboratornéj teploty rozpustí 1,2 g butylhydroxyanizolu, 1 000,0 g etoxylovaného a glykolizovaného rastlinného oleja, 170,0 g vitamín E acetátu a 3,2 g tymolu. Po rozpuštění všetkých zložiek sa k zmesi postupné přidá 375,2 g borovicového oleja, 100,0 g mátového oleja a 50,0 g eukalyptového oleja. Nakoniec sa přidá 2,0 g azulénu a zmes sa nechá miešat ešte 30 minút do úplného rozpustenia. Hotový prostriedok sa přefiltruje a rozplní po 10 ml do SÁNO liekoviek z hnědého skla,ktoré sa uzavrú SÁNO uzáverom.8 298.4 g of oil produced by winterization of a partially hydrogenated low-erucer oil are charged to a glass kettle equipped with a stirrer, which dissolves 1.2 g of butylhydroxyanisole, 1000.0 g of ethoxylated and glycolized vegetable oil, 170.0 g of vitamin E acetate at room temperature. and 3.2 g of thymol. After all the components had dissolved, 375.2 g of pine oil, 100.0 g of peppermint oil and 50.0 g of eucalyptus oil were added successively to the mixture. Finally, 2.0 g of azulene is added and the mixture is allowed to stir for a further 30 minutes until complete dissolution. The finished product is filtered and filled in 10 ml portions into SANO amber glass vials, which are closed with a SANO cap.
Pre analýzu účinných látok v prostriedku bol použitý plynový chromatograf s FID detektorem. Ako separačný systém bola použitá skleněná kapilárna kolona 100 m x 0,25 mm s Carbowaxom 20M ako stacionárnou fázou. Kvalitatívna analýza bola vykonaná pomocnou referenčných látok mentolu, 1,8-cineolu, tymolu, bornylacetátu,A gas chromatograph with an FID detector was used to analyze the active ingredients in the composition. A 100 m x 0.25 mm glass capillary column with a Carbowax 20M as stationary phase was used as the separation system. Qualitative analysis was performed with the reference substances menthol, 1,8-cineole, thymol, bornyl acetate,
F alfa-pinénu, azulénu a vitamín E acetátu. Kvantitativné stanovenie bolo vykonané metodou externého standardu integrátora. Prostriedok obsahuje 0,345 % hmot. mentolu, 0,562 % hmot. 1,8-cineolu, 0,011 % hmot, tymolu, 0,106 % hmot, bornylacetátu, 1,29 % hmot, alfa-pinénu, 0,015 % hmot, azulénu a 0,171 % hmot, alfa-pinénu, 0,015 % hmot, azulénu a 0,171 % hmot, vitamín E acetátu .F alpha-pinene, azulene and vitamin E acetate. Quantitative determination was performed using the integrator's external standard method. The composition contains 0.345% by weight. of menthol, 0.562 wt. 1,8-cineole, 0,011% by weight, thymol, 0,106% by weight, bornyl acetate, 1,29% by weight, alpha-pinene, 0.015% by weight, azulene and 0.171% by weight, alpha-pinene, 0.015% by weight, azulene and 0.171% by weight mass, vitamin E acetate.
Příklad 2Example 2
Do skleněného kotlíka opatřeného miešadlom sa našaržuje 9 198,7 g olivového oleja, v ktorom sa za laboratorněj teploty rozpustí 1,3 g ditercutyl-p-krezolu, 100,0 g sójového lecitinu, 170,0 g vitamín E acetátu a 3,0 g tymolu. Po rozpuštění všetkých zložiek sa k zmesi postupné přidá 300,0 g borovicového oleja, 100,0 g mátového oleja a 50,0 g eukalyptového oleja.Po dokonalom premiešaní sa přidá 2,0 g azulénu a zmes sa ešte mieša 30 minút. Hotový prostriedok sa přefiltruje a rozplní do 10 ml hnědých sáno liekoviek, ktoré sa uzavrú sáno uzáverom. Prostriedok bol analyzovaný spósob uvedeným v příklade 1 a obsahuje 0,461 % hmot, mentolu, 0,530 % hmot. 1,8-cineolu, 0,085 % hmot, tymolu, 0,095 % hmot, bornylacetátu, 1,262 % hmot, alfa-pinénu, 0,015 % hmot, azulénu a 0,164 % hmot, vitamín E acetátu.9 198.7 g of olive oil are weighed into a glass kettle equipped with a stirrer, in which 1.3 g of ditercutyl-p-cresol, 100.0 g of soya lecithin, 170.0 g of vitamin E acetate and 3.0 g are dissolved at room temperature. g thymol. After all the components had dissolved, 300.0 g of pine oil, 100.0 g of peppermint oil and 50.0 g of eucalyptus oil were added successively to the mixture. After thorough mixing, 2.0 g of azulene was added and the mixture was further stirred for 30 minutes. The finished composition is filtered and filled into 10 ml brown sleeve vials, which are closed with a sleeve cap. The composition was analyzed as described in Example 1 and contained 0.461% by weight, menthol, 0.530% by weight. 1,8-cineole, 0.085% by weight, thymol, 0.095% by weight, bornyl acetate, 1.262% by weight, alpha-pinene, 0.015% by weight, azulene and 0.164% by weight, vitamin E acetate.
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Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CS902498A CS276818B6 (en) | 1990-05-23 | 1990-05-23 | Preparation for treating nasal mucosa inflammations |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CS902498A CS276818B6 (en) | 1990-05-23 | 1990-05-23 | Preparation for treating nasal mucosa inflammations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CS249890A3 CS249890A3 (en) | 1992-03-18 |
| CS276818B6 true CS276818B6 (en) | 1992-08-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CS902498A CS276818B6 (en) | 1990-05-23 | 1990-05-23 | Preparation for treating nasal mucosa inflammations |
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| Country | Link |
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| CS (1) | CS276818B6 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001070215A1 (en) * | 2000-03-20 | 2001-09-27 | Harry Boeck | Bactericidal preparation |
-
1990
- 1990-05-23 CS CS902498A patent/CS276818B6/en not_active IP Right Cessation
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001070215A1 (en) * | 2000-03-20 | 2001-09-27 | Harry Boeck | Bactericidal preparation |
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| Publication number | Publication date |
|---|---|
| CS249890A3 (en) | 1992-03-18 |
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Effective date: 20100523 |