RS20120386A1 - COMPOSITION OF MEDICINAL HERBS EXTRACTS FOR APPLICATION IN PERIPHERAL CIRCULATION PROBLEMS - Google Patents
COMPOSITION OF MEDICINAL HERBS EXTRACTS FOR APPLICATION IN PERIPHERAL CIRCULATION PROBLEMSInfo
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Abstract
Predmetni pronalazak pripada oblasti farmaceutskih kompozicija i preparata (fitopreparata), odnosno medicinskih proizvoda u obliku kapsula, tečnih preparata za oralnu primenu, kremova i gelova na bazi ekstrakata semena divljeg kestena Aaesculus hippocastani, herbe hajdučke trave Achillea millefolium, herbe žive trave Geranium robertianum, herbe žutog kokotca Melilotus officinalis, herbe belog kokotca Melilotus alba, cveta nevena Calendula officinalis, herbe zdravinjaka Geranium pheum, herbe lanilista Linaria vulgaris i herbe i/ili rizoma lopuha Petasites hybridus, namenjenih održavanju fiziološkog protoka krvi kroz venske sudove donjih ekstremiteta i unapređenju zdravlja venskih sudova i kapilara.The present invention relates to the field of pharmaceutical compositions and preparations (phytopreparations), that is, medical products in the form of capsules, liquid preparations for oral administration, creams and gels based on extracts of wild chestnut seeds Aaesculus hippocastani, herb roegrass Achillea millefolium, herbs live herb Gerani herbs yellow cocktail Melilotus officinalis, white cocktail Melilotus alba herb, Calendula officinalis calendula, Geranium pheum geranium, Linaria vulgaris herb and / or Petasites hybridus herb rhizome and / or rhizome of petasites hybridus, intended to maintain physiological blood flow through venous vessels and venous vessels and capillaries.
Description
KOMPOZICIJA EKSTRAKATA LEKOVITOG BILJA ZA PRIMENU KODCOMPOSITION OF EXTRACTS OF MEDICINAL PLANTS FOR APPLICATION IN
PROBLEMA PERIFERNE CIRKULACIJEPROBLEMS OF PERIPHERAL CIRCULATION
Oblast tehnikeTechnical field
Predmetni pronalazak pripada oblasti farmaceutskih kompozicija i preparata (fitopreparata), odnosno medicinskih proizvoda u obliku kapsula, tečnih preparata za oralnu primenu, kremova i gelova na bazi ekstrakata semena divljeg kestenaAesculus hippocastani,herbe hajdučke traveAchillea millefolium,herbe žive traveGeranium robertianum,herbe žutog kokotcaMelilotus officinalis,herbe belog kokotcaMelilotus albacveta nevenaCalendula officinalis,herbe zdravinjakaGeranium pheum,herbe lanilistaLinaria vulgarisi herbe i/ili rizoma lopuhaPelasiles hybridus,namenjenih održavanju fiziološkog protoka krvi kroz venske sudove donjih ekstremiteta i unapređenju zdravlja venskih sudova i kapilara. The invention in question belongs to the field of pharmaceutical compositions and preparations (phytopreparations), i.e. medical products in the form of capsules, liquid preparations for oral administration, creams and gels based on horse chestnut seed extracts Aesculus hippocastani, yarrow herb Achillea millefolium, live grass herb Geranium robertianum, yellow marigold herb Melilotus officinalis, white marigold herb Melilotus albacveta marigold Calendula officinalis, medicinal herbs Geranium pheum, herbs lanilista Linaria vulgarisi herbs and/or rhizomes of burdock Pelasiles hybridus, intended to maintain physiological blood flow through the venous vessels of the lower extremities and improve the health of venous vessels and capillaries.
Prema Međunarodnoj klasifikaciji patenata (MKP) pripada klasama: A 61K (9/06, 9/08, 9/66, 9/10, 9/12, 36/20); A 61P 31/00. According to the International Patent Classification (IPC) it belongs to the following classes: A 61K (9/06, 9/08, 9/66, 9/10, 9/12, 36/20); A 61P 31/00.
Tehnički problemTechnical problem
Tehnički problem koji se rešava ovim pronalaskom je dobijanje optimalne kompozicije lekovitog bilja i njihovih ekstrakata, koja pomaže održavanju fiziološkog protoka krvi kroz venske sudove donjih ekstremiteta i unapređuje zdravlje venskih sudova i kapilara, i njeno inkorporiranje u odgovarajuće vehikulume radi dobijanja fitopreparata u različitim farmaceutskim oblicima (kapsule, tečni preparati za oralnu primenu, kremovi, gelovi), čime se stvaraju uslovi za sinergistički efekat aktivnih materija navedenih biljnih vrsta i komponenata vehikuluma. The technical problem that is solved by this invention is obtaining an optimal composition of medicinal plants and their extracts, which helps maintain physiological blood flow through the venous vessels of the lower extremities and improves the health of venous vessels and capillaries, and its incorporation into suitable vehicles to obtain phytopreparations in various pharmaceutical forms (capsules, liquid preparations for oral administration, creams, gels), which creates the conditions for a synergistic effect of the active substances of the mentioned plant species and vehicle components.
Stanje tehnikeState of the art
Karakteristike i delovanje odabranih biljnih komponenata: semenjače divljeg kestena, herbe hajdučke trave, herbe žive trave, herbe žutog i belog kokotca, herbe zdravinjaka. herbe lanilista, herbe i/ili rizoma lopuha i cveta nevena kao i njihovih ekstrakata opisani su u stručnoj literaturi, kroz farmakopejske propise, monografije Svetske zdravstvene organizacije i nemačke Komisije E, ESCOP monografije. Kroz sopstvena razvojna istraživanja potvrđen je kvalitet izrađenih ekstrakata (izvršena identifikacija aktivnih principa, njihova kvantifikacija) i praćena njihova stabilnost. Takođe, izvršena je i karakterizacija gotovih proizvoda (kapsule, tečni preparati za oralnu primenu, kremovi, gelovi) u čiji sastav ulaze odabrane biljne sirovine odnosno njihovi ekstrakti. Characteristics and action of selected plant components: seeds of wild chestnut, herbs of yarrow grass, herbs of live grass, herbs of yellow and white kokotac, herbs of salvia. lanilista herbs, herbs and/or rhizomes of burdock and calendula flowers as well as their extracts are described in professional literature, through pharmacopoeial regulations, monographs of the World Health Organization and German Commission E, ESCOP monographs. Through our own development research, the quality of the produced extracts was confirmed (identification of active principles, their quantification) and their stability was monitored. Also, the characterization of the finished products (capsules, liquid preparations for oral use, creams, gels) which contain selected plant raw materials, i.e. their extracts, was carried out.
1. Aesculus hippocastani- divlji kesten 1. Aesculus hippocastani - horse chestnut
Seme divljeg kestena sadrži 40-50% škroba, šećere, belančevine, masno ulje, flavonske i kumarinske derivate, tanine i dr. Ekstrakt semena divljeg kestena, sadrži kao najvažniju aktivnu materiju triterpenski saponin escin koji deluje vazokonstiktorno, vazoprotektivno i antiinflamatorno, smanjuje permeabilket krvnih sudova i sprečava nastanak edema. Pored toga, sadrži flavonske glukozide, kumarinske derivate i katehine koji pojačavaju antiedematozno delovanje escina, a flavonoidi pojačavaju tonus vena. Komponente sinergistički smanjuju stazu u venskom delu kapilara i nagomilavanje tečnosti u tkivu jačajući rezistenciju kapilara. Posledica takvog dejstvaje ubrzani krvotok, što povoljno deluje kod venskog zastoja. Eksperimentalno je pokazano da je antiinflamatorna aktivnost ekstrakta semena kestena jača od one postignute primenom samog escina, što dokazuje zajedničko delovanje prisutnih aktivnih materija. Antioksidativno delovanje flavonoida omogućava neutralizaciju slobodnih radikala čije formiranje u ćelijama destruktivno deluje na integritet gradivnih elemenata ćelije (na proteine, ugljene hidrate i masti). Ekstrakt divljeg kestena se koristi kao vazotonik, antiedematik, hemostatik i antiflogistik. Biljni preparati se preporučuju kod proširenih vena, naročito u nogama (napetost i bolovi), hemoroida, tromboflebitisa i dr. Odobrena je upotreba od Komisije E kod hronične venske insuficijencije (1-13). Str. 453 Horse chestnut seeds contain 40-50% starch, sugars, proteins, fatty oil, flavone and coumarin derivatives, tannins, etc. Horse chestnut seed extract contains as the most important active substance the triterpene saponin escin, which has a vasoconstrictive, vasoprotective and anti-inflammatory effect, reduces the permeability of blood vessels and prevents the formation of edema. In addition, it contains flavone glucosides, coumarin derivatives and catechins that enhance the anti-edematous effect of escin, and flavonoids increase the tone of the veins. The components synergistically reduce the path in the venous part of the capillaries and the accumulation of liquid in the tissue, strengthening the resistance of the capillaries. The consequence of such an effect is accelerated blood flow, which has a favorable effect on venous congestion. It has been experimentally shown that the anti-inflammatory activity of chestnut seed extract is stronger than that achieved by the use of escin alone, which proves the joint action of the active substances present. The antioxidant action of flavonoids enables the neutralization of free radicals whose formation in cells has a destructive effect on the integrity of the cell's building elements (proteins, carbohydrates and fats). Horse chestnut extract is used as a vasotonic, antiedematous, hemostatic and antiphlogistic. Herbal preparations are recommended for varicose veins, especially in the legs (tension and pain), hemorrhoids, thrombophlebitis, etc. It is approved for use by Commission E in chronic venous insufficiency (1-13). p. 453
2. Achillea millefolium -hajdučka trava 2. Achillea millefolium - yarrow grass
Nadzemni deo biljke u cvetu (herba) hajdučke trave koristi se kao aromatično gorka sirovina. Fiziološki aktivni sastojci su etarsko ulje, seskviterpenski laktoni, poliini, alkamidi, flavonoidi, betaini i dr. Oni deluju antiinflamatorno, antiedematozno i spazmolitično. Povoljno deluju kod rana nastalih usled proširenih vena (1-13). Str 917 The above-ground part of the plant in flower (herb) is used as an aromatically bitter raw material. Physiologically active ingredients are essential oil, sesquiterpene lactones, polyins, alkamides, flavonoids, betaines, etc. They have an anti-inflammatory, anti-edematous and spasmolytic effect. They have a beneficial effect on wounds caused by varicose veins (1-13). Page 917
3. Geranium robertianum- živa trava 3. Geranium robertianum - living grass
Glavni aktivni principi sadržani u herbi žive trave su flavonoidi i tanini. Ovi agensi predstavljaju prirodne antioksidanse sposobne da neutrališu slobodne radikale nastale u toku fizoloških procesa ili kao posledica patoloških promena. Pored ovih materija herba žive trave sadrži gorka jedinjenja, smole, organske kiseline i dr. koje doprinose sveukupnom delovanju sirovine. Cenjenaje kao adstringentno i hemostiptično sredstvo (1-13). Str. 441 The main active principles contained in the herb of living grass are flavonoids and tannins. These agents are natural antioxidants capable of neutralizing free radicals generated during physiological processes or as a consequence of pathological changes. In addition to these substances, the herb of living grass contains bitter compounds, resins, organic acids, etc. which contribute to the overall effect of the raw material. It is more appreciated as an astringent and hemostyptic agent (1-13). p. 441
4. Melilotus officinalis- žuti kokotac 4. Melilotus officinalis - yellow coot
Nadzemni deo biljke u cvetu sadrži 0,4-0,9% kumarina kao glavnodelujuću supstancu, zatim hidrokumarine, flavonoide, triterpenske saponine, etarsko ulje. Ove aktivne materije deluju protivupalno, anticksudativno i antiedematozno. Upotreba ove droge kao antivarikoznog sredstva uglavnom bazira na dugogodišnjoj tradicionalnoj upotrebi kod hronične venske insuficijencije, praćene bolovima i težinom u nogama, sa noćnim grčevima, svrabom i otocima. Takođe, herba ždraljike (kako se još u narodu naziva) se upotrebljava i kod hemoroida, upaljenih limfnih čvorova, uganuća i uboja. Dokazana su i povoljna dejstva na zarastanje rana. Smatra se da su nosioci ovog efekta kumarinski heterozidi i flavonoidi, koji smanjuju permeabilnost krvnih sudova, poboljšavaju vensku cirkulaciju i limfnu drenažu. Zbog toga se ždraljika danas koristi kod poremećaja venske i limfne cirkulacije, kod zapaljenja, otoka i grčeva u donjim ekstremitetima, a spolja kod uboja, uganuća i hematoma. Komisija E odobrila je upotrebu kokotca kod povreda, hemoroida i problema sa venama (1-13). Str. 829 The aerial part of the plant in flower contains 0.4-0.9% coumarin as the main active substance, followed by hydrocoumarins, flavonoids, triterpene saponins, essential oil. These active substances have an anti-inflammatory, anti-exudative and anti-edematous effect. The use of this drug as an anti-varicose agent is mainly based on long-standing traditional use in chronic venous insufficiency, accompanied by pain and heaviness in the legs, with night cramps, itching and swelling. Also, the crane's herb (as it is still popularly called) is also used for hemorrhoids, inflamed lymph nodes, sprains and sprains. Favorable effects on wound healing have also been proven. It is believed that the carriers of this effect are coumarin heterosides and flavonoids, which reduce the permeability of blood vessels, improve venous circulation and lymphatic drainage. For this reason, cranesbill is used today for disorders of venous and lymphatic circulation, for inflammation, swelling and spasms in the lower extremities, and externally for bruises, sprains and hematomas. Commission E approved the use of coccinea in injuries, hemorrhoids, and vein problems (1-13). p. 829
5. Mellilotus alba- beli kokotac 5. Mellilotus alba - white cicada
Sastav i upotreba su slični žutoj ždraljiki. The composition and use are similar to yellow crane.
6. Calendulae officinalis- neven 6. Calendulae officinalis - calendula
Koriste se cele ili delimično razložene cvetne glavice. Delotvorni sastojci su triterpenski saponini, triterpenski alkoholi, flavonoidi, hidrokumarini, karotenoidi, etarsko ulje, vodorastvorni polisaharidi, poliini. Antiinflamatorno delovanje ove droge eksperimentalno je potvrđeno. Faradiol monoestar se pokazao kao najrelevantniji antiinflamatorni princip pre svega zbog značajne zastupljenosti u biljnom materijalu dok se neesterifikovani oblik smatra najaktivnijim sastojkom ekvivalentnog delovanja kao indometacin. Zbog ovog ali i zbog antiviralnog efekta i uticaja na zarašćivanje rana neven se upotrebljava kao dermatik (1-13). Str. 559 Whole or partially decomposed flower heads are used. The active ingredients are triterpene saponins, triterpene alcohols, flavonoids, hydrocoumarins, carotenoids, essential oil, water-soluble polysaccharides, polyins. The anti-inflammatory action of this drug has been confirmed experimentally. Faradiol monoester proved to be the most relevant anti-inflammatory principle primarily due to its significant presence in the plant material, while the non-esterified form is considered the most active ingredient with equivalent action as indomethacin. Because of this, but also because of its antiviral effect and its effect on wound healing, calendula is used as a dermatological agent (1-13). p. 559
7. Petasides hybridus- lopuh 7. Petasides hybridus- burdock
Rizom i herba sadrže grupu seskviterpenskih jedinjenja, tzv. petasina, za koje se smatra da deluju miorelaksantno i analgetski (petazin, neopetazin, isopetazin ili furanopetazin i 9-hidroksifuranoeremofilon) i etarsko ulje. Flavonoidi, sluzi i tanini nalaze se u herbi lopuha. Herba sadrži i pirazolidinske alkaloide (senecionin, integerimin, senkirkin, najčešće u tragovima) a rizom senecionin i integerimin. Biljka, pogotovo njen rizom, tradicionalno se koristi kod kamena u bubregu i kao pomoćno sredstvo u slučaju bubrežnih kolika. Spazmolitični efekat dokazan je eksperimentalno na životinjama. Postoje podaci i o njenoj primeni kod kašlja, glavobolje, migrene, astme i stresa. U narodu se koristi i kod stanja stresa, za umirenje i olakšano nastupanje sna. Primena rizoma odobrena je od strane Komisije E kod kamena u bubregu i bešici. U narodu se koristi u tretmanu akutnih, spastičnih bolova kod urinarnih infekcija a naričito kod bolova izazvanih prisustvom kamena u urinarnim putevima. Koristi se kod migrene i glavobolja izazvani/praćenih povećanim pritiskom. Str. 646 The rhizome and herb contain a group of sesquiterpene compounds, the so-called petasins, which are considered to have muscle relaxant and analgesic effects (petasin, neopetasin, isopetasin or furanopetasin and 9-hydroxyfuranoeremophilon) and essential oil. Flavonoids, mucilages and tannins are found in the burdock herb. The herb also contains pyrazolidine alkaloids (senecionine, integerimine, senkirquine, mostly in traces), and the rhizome contains senecionine and integerimine. The plant, especially its rhizome, is traditionally used for kidney stones and as an aid in case of renal colic. The spasmolytic effect has been proven experimentally on animals. There are also data on its use in cough, headache, migraine, asthma and stress. It is also used in people's situations of stress, for calming and facilitating sleep. The use of rhizomes is approved by Commission E for kidney and bladder stones. It is popularly used in the treatment of acute, spastic pain in urinary infections, and especially in pain caused by the presence of stones in the urinary tract. It is used for migraines and headaches caused/followed by increased pressure. p. 646
8. Geranium feum- zdravinjak 8. Geranium feum- medicinal plant
Sastav i upotreba slični kao za živu travu. Composition and use similar to live grass.
9. Linaria vulgaris- lanilist 9. Linaria vulgaris - lanilis
Herba lanilista kao glavne komponente sadrži flavonoide (linarin, pektolinarin, linariin) a zatim i monoterpenske iridoide (antirinozid), taninsku kiselinu, fitosterole, aurone kao i alkaloid peganin. Zbog navedenih sastojaka ispoljava antiinflamatorno delovanje. Dokumentovan je i diaforetični i diuretični efekat ove biljke. Str. 923 The herb lanilista as its main components contains flavonoids (linarin, pectolinarin, linariin) and then monoterpene iridoids (antirinoside), tannic acid, phytosterols, aurones as well as the alkaloid peganine. Due to the mentioned ingredients, it exhibits anti-inflammatory action. The diaphoretic and diuretic effect of this plant has been documented. p. 923
KapsuleCapsules
Kapsule su čvrsti preparati namenjeni za oralnu upotrebu. Sastoje se od tvrde čaure u kojoj se nalazi jedna doza lekovite supstance. U kontaktu sa digestivnim tečnostima zid čaure se rastvara i oslobađa sadržaj tj. lekovite principe. Tvrde želatinske kapsule se sastoje iz dva šuplja cilindrična dela koji su s jedne strane zaobljeni i zatvoreni a sa druge su otvoreni. Aktivne materije u tvrdim kapsulama su u obliku praška ili granulata. Capsules are solid preparations intended for oral use. They consist of a hard shell containing one dose of medicinal substance. In contact with digestive fluids, the wall of the capsule dissolves and releases the contents, i.e. medicinal principles. Hard gelatin capsules consist of two hollow cylindrical parts that are rounded and closed on one side and open on the other. Active substances in hard capsules are in the form of powder or granules.
Kroz racionalno korišćenje optimalnih pomoćnih supstanci moguće je formulisati kapsule koje imaju odgovarajuću brzinu rastvaranja i zadovoljavajuću stabilnost. Nekoliko važnih aspekata proizvodnje kapsula su od ključnog značaja za sve željene performanse gotovog proizvoda. One uključuju osiguranje odgovarajuće veličine čestica mase za punjenje kapsula i njihovu distribuciju veličine, homogenu distribuciju aktivnih materija, održavanje odgovarajućeg sadržaj vlažnosti mase i postizanje njene optimalne protočnosti. Formulacioni faktori koji su prvenstveno odgovorni za kontrolu ovih parametara su prisustvo punilaca posebno sredstva za klizanje u optimalnoj koncentraciji i usitnjavanje praškastih komponenata na zadovoljavajući nivo veličine čestica. Lubrikansi smanjuju tendenciju lepljenja čestica mase za kapsuliranje i formiranje agregata, što obezbeđuje optimalno proticanje mase u toku procesa kapsuliranja. Through the rational use of optimal excipients, it is possible to formulate capsules that have an appropriate dissolution rate and satisfactory stability. Several important aspects of capsule production are critical to any desired performance of the finished product. They include ensuring the appropriate particle size of the mass for filling the capsules and their size distribution, homogeneous distribution of active substances, maintaining the appropriate moisture content of the mass and achieving its optimal flowability. The formulation factors that are primarily responsible for the control of these parameters are the presence of fillers, especially lubricants in optimal concentration and the grinding of powder components to a satisfactory level of particle size. Lubricants reduce the tendency of encapsulating mass particles to stick together and form aggregates, which ensures optimal mass flow during the encapsulation process.
Tečni preparati za oralnu upotrebuLiquid preparations for oral use
Tečni preparati za oralnu upotrebu mogu biti rastvori koji sadrže jednu ili više delujućih supstanci u odgovarajućem vehikulumu. Rastvori se izrađuju mešanjem tečnih komponenata (sastojaka) ili rastvaranjem odmerenih delujućih supstanci i drugih supstanci (pomoćnih materija) u propisanoj količini rastvarača (ili smeše rastvarača), uz mešanje. Mogu da se pripremaju i iz koncentrovanih tečnih preparata, razblaživanjem. Nalaze se u višedoznim ili jednodoznim pakovanjima. Doziraju se na ml ili na kapi. Svako višedozno pakovanje mora da sadrži kašičicu ili kapaljku za tačno odmeravanje propisane količine preparata. Liquid preparations for oral use can be solutions containing one or more active substances in a suitable vehicle. Solutions are made by mixing liquid components (ingredients) or by dissolving measured active substances and other substances (excipients) in the prescribed amount of solvent (or mixture of solvents), with mixing. They can also be prepared from concentrated liquid preparations, by dilution. They are available in multi-dose or single-dose packages. They are dosed per ml or per drop. Each multi-dose package must contain a teaspoon or dropper for accurately measuring the prescribed amount of the preparation.
Polučvrsti preparati za spoljašnju upotrebuSemi-solid preparations for external use
Polučvrsti preparati za spoljašnju upotrebu su namenjeni za primenu na koži ili određenoj sluzokoži, u cilju lokalnog delovanja ili perkutane penetracije lekovite supstance ili zbog zaštitnog delovanja. Moraju da budu homogenog izgleda. Sastoje se iz jednostavnih ili složenih podloga u kojima je jedna ili više aktivnih supstanci rastvorena ili dispergovana (suspendovana). Podloge mogu da utiču na delovanje preparata i oslobađanje aktivnih principa. Formulacija savremenih fitopreparata sa biljnim ekstraktima u optimalnoj koncentraciji koja omogućava efikasno delovanje uz konfornu primenu, podrazumeva definisanje tehnološkog postupka izrade takvog preparata koji omogućava tretman određenih stanja jednostavnom aplikacijom preparata koji može da se nanosi i na veće površine kože kao i na mesta na koja nije jednostavno nanositi oblog, koji se lako razmazuje, ne masti kožu koja ga nakon primene brzo upija i omogućava delovanje aktivnih materija. Semi-solid preparations for external use are intended for use on the skin or a specific mucous membrane, for the purpose of local action or percutaneous penetration of the medicinal substance or for protective action. They must have a homogeneous appearance. They consist of simple or complex bases in which one or more active substances are dissolved or dispersed (suspended). Substrates can influence the action of the preparation and the release of active principles. The formulation of modern phytopreparations with plant extracts in an optimal concentration that enables effective action with comfortable application, implies defining the technological procedure of making such a preparation that enables the treatment of certain conditions with a simple application of the preparation that can be applied to larger areas of the skin as well as to places where it is not easy to apply a poultice, which is easily spread, does not oil the skin, which quickly absorbs it after application and enables the action of active substances.
Vrste polučvrstih preparata za spoljašnju primenu su: masti, kremovi, geli i paste. Types of semi-solid preparations for external use are: ointments, creams, gels and pastes.
Kremovi su višefazni preparati koji se sastoje iz masne (lipofilne) i vodene faze. Oni su polifazni, disperzni sistemi gde je jedna faza homogeno dispergovana u drugoj. Creams are multiphase preparations consisting of a fatty (lipophilic) and aqueous phase. They are polyphase, dispersed systems where one phase is homogeneously dispersed in another.
Geli se sastoje od tečnosti geliranih pogodnim gelirajućim sredstvima. Za izradu gela koriste se gradioci gelova, sredstvo za geliranje, tečna faza-vehikulum i, po potrebi, ostali sastojci (solubilizatori, emolijensi, ubrzivači penetracije, konzervansi, antioksidansi...). Kao sredstva gradioci gela koriste se brojne materije prirodnog, polusintetskog i sintetskog porekla. Najčešće su u upotrebi derivati celuloze (metil celuloza, hidroksietilceluloza, karboksimetilceluloza), kabroksivinil polimer, ali i škrob, želatina, alginati, polivinilpirolidon, poloksameri i dr. Tečna faza gela je najčešće voda ili smeša vode i etanola ili vode i izopropranola. U sastav tečne faze često ulaze i humektansi (glicerol, sorbitol, propilenglikol) koji sprečavaju isušivanje gela i predstavljaju plastifikatore filma. Geli i kremovi su pogodan medijum za razvoj mikroorganizama, zbog visokog sardžaja vode, pa ih treba konzervisati. Lekovita supstanca/e, u skladu sa svojim fizičko-hemijskim osobinama, može da se rastvori u delu ili celokupnoj količini tečne faze, ili suspenduje u pripremljenu gel ili krem podlogu. Gels consist of liquids gelled with suitable gelling agents. Gel builders, gelling agent, liquid phase-vehicle and, if necessary, other ingredients (solubilizers, emollients, penetration accelerators, preservatives, antioxidants...) are used to make the gel. Numerous substances of natural, semi-synthetic and synthetic origin are used as gel builders. The most commonly used are cellulose derivatives (methyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose), cabroxyvinyl polymer, but also starch, gelatin, alginates, polyvinylpyrrolidone, poloxamers, etc. The liquid phase of the gel is usually water or a mixture of water and ethanol or water and isopropranol. The composition of the liquid phase often includes humectants (glycerol, sorbitol, propylene glycol) that prevent the gel from drying out and are film plasticizers. Gels and creams are a suitable medium for the development of microorganisms, due to their high water content, so they should be preserved. The medicinal substance/s, in accordance with its physico-chemical properties, can be dissolved in part or the entire amount of the liquid phase, or suspended in a prepared gel or cream base.
Hodrosolubilne lekovite supstance mogu da se rastvore u delu ili ukupnoj količini tečne faze. Povećanje rastvorljivosti lipofilnih lekovitih susptanci može da se postigne upotrebom solubilizatora. Kada se radi o izuzeno hidrofobnim supstancama, preporučuje se upotreba sredstava za kvašenje. Water-soluble medicinal substances can be dissolved in part or all of the liquid phase. Increasing the solubility of lipophilic medicinal substances can be achieved by using solubilizers. When dealing with extremely hydrophobic substances, the use of wetting agents is recommended.
Stanje tehnike(dostupna patentna dokumentacija) State of the art (patent documentation available)
U cilju utvrđivanja stanja tehnike pregledana je dostupna patentna literatura. U nekoliko patentnih zahteva traži se zaštita za jednu, ili kombinaciju dve ili tri biljne vrste navedene u našem patentu. In order to determine the state of the art, the available patent literature was reviewed. Several patent applications seek protection for one or a combination of two or three plant species listed in our patent.
Tako se patentnim zahtevom EP1707213 (Al), 2006-10-04: "Herbal composition for the treatment of cutaneous Ervthema" (prijavilac Kern Elizabeth), traži zaštita postupka izrade ekstrakta nevena, odnosno alkoholne tinkture ove biljke. Thus, the patent application EP1707213 (Al), 2006-10-04: "Herbal composition for the treatment of cutaneous Ervthema" (applicant Kern Elizabeth), seeks protection of the process of making calendula extract, i.e. alcoholic tincture of this plant.
Zaštita ekstrakata hajdučke trave i nevena traži se u patentnom zahtevu WO/2006/032091,30.03.2006: (prijavilac R.P. Scherer Holdings Pty.Ltd). Kao ekstragensi navode se voda, etanol, metanol, aceton. Protection of extracts of yarrow and calendula is claimed in patent application WO/2006/032091, 30.03.2006: (applicant R.P. Scherer Holdings Pty.Ltd). Water, ethanol, methanol, acetone are listed as extractants.
Biljne kompozicije kao mešavine tinktura nevena, divljeg kestena i hajdučke trave patentno se štite kroz patentnu prijavu podnosioca Lavcnder hill Projects Pty Ltd. Herbal compositions such as mixtures of tinctures of calendula, horse chestnut and yarrow are patent protected through the patent application of the applicant Lavnder hill Projects Pty Ltd.
U patentu CA2437259 (Al), 2002-09-12, tražena je zaštita biljne kompozicije koja sadrži 6 biljnih komponenata (kesten, neven, lanilist, beli i žuti kokotac i gavez). Naša kompozicija od navedene razlikuje se po odsustvu gaveza (koji se ne preporučuje za internu primenu) i prisustvu drugih biljnih komponenata odgovornih za efikasnost delovanja (živa trava, zdravinjak, lopuh). In the patent CA2437259 (Al), 2002-09-12, the protection of a herbal composition containing 6 herbal components (chestnut, calendula, lanifolia, white and yellow cocotac and comfrey) is requested. Our composition differs from the above in the absence of comfrey (which is not recommended for internal use) and the presence of other plant components responsible for the effectiveness of the action (live grass, sedum, burdock).
U okviru patentne prijave RO121671 (BI): "Higiene gel composition and process for preparing the same" (prijavioci lord Echel Radu i saradnici); štiti se sastav i izrada gela sa tinkturama hajdučke trave i nevena i ekstraktom divljeg kestena. Within the patent application RO121671 (BI): "Hygiene gel composition and process for preparing the same" (applicants Lord Echel Radu and collaborators); the composition and preparation of the gel with tinctures of St. John's wort and calendula and horse chestnut extract are protected.
Oznaka LV11434 (B) se odnosi na patentni zahtev: "Extracts of plants for preparation of medicines, velerinarv preparative and cosmelics" (prijavilac Kirsfelds Karlis) kojim se traži zaštita procesa izrade etanolnog ekstrakta Melilotus albus, Melilotus albus annus, Melilotus altissima or Melilotus albus altissima fruit, flower, seed, seed-coat, fruit cortex, za primenu za poboljšanje cirkulacije i sprečavanje oštećenja krvnih sudova. The designation LV11434 (B) refers to the patent application: "Extracts of plants for preparation of medicines, velerinarv preparative and cosmelics" (applicant Kirsfelds Karlis) which seeks protection of the process of making an ethanolic extract of Melilotus albus, Melilotus albus annus, Melilotus altissima or Melilotus albus altissima fruit, flower, seed, seed-coat, fruit cortex, for use to improve circulation and prevent damage to blood vessels.
Prijavilioci Secara Vasile i Ungureanu Gheorghe u svom patentnom zahtevu: "Dressing containing a naturopathic medicinal product for treating vvound", traže patentnu zaštitu za ekstrakt koji je mešavina ekstrakata četiri biljke: lopuh, hajdučka trava, neven i gavez. In their patent application: "Dressing containing a naturopathic medicinal product for treating wound", applicants Secar Vasile and Ungureanu Gheorghe seek patent protection for an extract that is a mixture of extracts of four plants: burdock, yarrow, calendula and comfrey.
U patentnoj prijavi VVO/2006/032091, 30.03.2006.: "Herbal composition" (Prijavilac Lavender Hill projects Ltd, traži se zaštita biljne kompozicije. Sadržaj ove kompozicije obuhvata neven, divlji kesten i hajdučku travu. In the patent application VVO/2006/032091, 30/03/2006: "Herbal composition" (Applicant Lavender Hill projects Ltd, protection of the herbal composition is sought. The content of this composition includes calendula, wild chestnut and yarrow.
Specifične karakteristike našeg pronalaska u rešavanju predmetnog tehničkog problema u odnosu na slične preparate čija je patentna zaštita tražena kao i onih koji se nalaze u prometu su sledeće: originalna kombinacija biljnih komonenata, procentualna zastupljenost ekstrakata/tinktura/odabranih biljnih droga u finalnim proizvodima, njihova uspešna i bezbedna primena u predviđenim/preporučenim indikacijama što je naučno i potvrđeno. The specific characteristics of our invention in solving the technical problem in question in relation to similar preparations for which patent protection is sought and those in circulation are the following: the original combination of herbal components, the percentage representation of extracts/tinctures/selected herbal drugs in the final products, their successful and safe application in the intended/recommended indications, which is scientifically and confirmed.
Opis rešenja tehničkog problema sa primerima izvođenjaDescription of the solution to the technical problem with implementation examples
Suštinu pronalaska čini kompozicija biljnih sirovina, tehnologija izrade ekstrakata, formulacija i tehnologija izrade fitopreparata na bazi biljnih sirovina namenjenih održavanju fiziološkog protoka krvi kroz venske sudove donjih ekstremiteta i unapređenju zdravlja venskih sudova i kapilara. Pri tome se obuhvata primena ove farmaceutske kompozicije u fitopreparatima različititog farmaceutskog oblika (kapsule, tečni preparati za oralnu primenu, kremovi, gelovi) koji obezbeđuju efikasno delovanje svih komponenata i najbolji efekat. Primenljivost ove kompozicije, zasnovana je na naučno potvrđenim biološkim svojstvima aktivnih komponenata. Iako su lekovita svojstva aktivnih principa sastavnih biljnih komponenata pojedinačno velikim delom poznata iz tradicionalne primene a u novije vreme i naučno potvrđena, predložena biljna kompozicija je nova i originalna a formulacija fitopreparata takva da aktivni principi mogu da ostvare maksimalan učinak. The essence of the invention is the composition of plant raw materials, the technology of making extracts, the formulation and the technology of making phytopreparations based on plant raw materials intended for maintaining physiological blood flow through the venous vessels of the lower extremities and improving the health of venous vessels and capillaries. This includes the application of this pharmaceutical composition in phytopreparations of different pharmaceutical forms (capsules, liquid preparations for oral administration, creams, gels) that ensure the effective action of all components and the best effect. The applicability of this composition is based on the scientifically confirmed biological properties of the active components. Although the medicinal properties of the active principles of the plant components are individually known to a large extent from traditional application and recently scientifically confirmed, the proposed herbal composition is new and original, and the formulation of the phytopreparation is such that the active principles can achieve maximum effect.
Za izradu fitopreparata iz odabranog lekovitog bilja:Aesculus hippocastani, AchileaFor the preparation of phytopreparations from selected medicinal plants: Aesculus hippocastani, Achilea
millefolium, Geranium robertianum, Geranium pheum, Melilotus officinalis, Melilotus albus,millefolium, Geranium robertianum, Geranium pheum, Melilotus officinalis, Melilotus albus,
Linaria vulgaris, Petazites hybridusiCalendula officinalis,pripremljeni su ekstrakti metodom koja je optimizovana kroz seriju eksperimenata. Linaria vulgaris, Petazites hybridusi Calendula officinalis, extracts were prepared by a method that was optimized through a series of experiments.
Pronalazakće dalje biti prikazan kroz sledeće primere koji ne ograničavaju pronalazak. The invention will be further illustrated by the following non-limiting examples.
Primer 1. Example 1.
Izrada biljnih ekstrakata Production of herbal extracts
Za potrebe izrade fitopreparata koji predstavljaju pronalazak, upotrebljeni su ekstrakti navedenih biljnih lekovitih sirovina dobijeni upotrebom voćnog destilata kao ekstragensa. Kao polazni biljni materijal koriste se droge dobijene iz biljnog materijala sakupljenog na području šire okoline planine Cer. Za izradu ekstrakta cvasti nevena polazni biljni materijal je kutivisan na sopstvenim plantažama. Osušen biljni materijal za ekstrakciju se prvo usitni do stepena koji omogućava maksimalno izdvajanje aktivnih jedinjenja (stepen usitnjenosti od 0,30 do 2). Ekstrakcija biljnih sastojaka traje od 2 do 12 sati na sobnoj temperaturi, nakon čega se gotov ekstrakt odvoji od biljne mase ceđenjem i filtriranjem. Odnos droga:ekstrakt je u rasponu od 1:2 do 1:5. Ekstrakti su odležavali od 1-5 dana na sobnoj temperaturi da bi se istaložile balastne materije, posle čega su filtrirani. Proizvodi ekstrakcije su ekstrakti karakteristične boje, specifičnog ukusa i mirisa koji zavise od upotrtebljene biljne sirovine. For the purposes of making phytopreparations that represent the invention, extracts of the mentioned plant medicinal raw materials obtained by using fruit distillate as an extractant were used. Drugs obtained from plant material collected in the wider area of Mount Cer are used as starting plant material. For the production of marigold flower extract, the starting plant material is grown on our own plantations. The dried plant material for extraction is first crushed to a degree that allows maximum extraction of active compounds (degree of comminution from 0.30 to 2). The extraction of plant ingredients lasts from 2 to 12 hours at room temperature, after which the finished extract is separated from the plant mass by squeezing and filtering. The drug:extract ratio ranges from 1:2 to 1:5. The extracts were aged for 1-5 days at room temperature to precipitate ballast substances, after which they were filtered. Extraction products are extracts with a characteristic color, specific taste and smell that depend on the plant raw material used.
Svi ekstrakti su definisani kroz određivanje relativne gustine, indeksa refrakcije, sadržaja etanola, suvog ostatak i pH vrednosti. Kao nosioci vazotoničnog, vazokonstriktornog, spazmolitičnog i antiinflamatomog delovanja ekstrakti semena divljeg kestena, herbe kokotca, hajdučke trave i rizoma lopuha o karakteri san i su i kroz određivanje sadržaja escina (seme divljeg kestena, ekstrakt semena divljeg kestena), kumarina (herba kokotca, ekstrakt herbe kokotca), petazina (rizom lopuha i ekstrakt rizoma lopuha) i antioksidativne aktivnosti (herba hajdučke trave, ekstrakt herbe hajdučke trave). All extracts were defined through the determination of relative density, refractive index, ethanol content, dry residue and pH value. As carriers of vasotonic, vasoconstrictor, spasmolytic and anti-inflammatory effects, extracts of horse chestnut seeds, kokotca herb, burdock root and burdock rhizome are characterized by the determination of the content of escin (horse chestnut seed, horse chestnut seed extract), coumarin (kokotka herb, kokotka herb extract), petazine (burdock rhizome and burdock rhizome extract) and antioxidant activity (bordock herb, extract yarrow herb).
Primer 2. Example 2.
Postupak izrade kapsula Capsule manufacturing process
Izrada mase za kapsuliranje Making encapsulation mass
Izrađeni tečni ekstrakti uparavaju se na vakuum uparivaču do sadržaja suve materije min.75%. Osušeni, samleveni ekstrakti se prosejavaju (veličina promera sita 0,3 mm) i mešaju međusobno u tačno definisanom odnosu: ekstrakat semena divljeg kestena( Aesculus hypocastani)u opsegu 0,5-35,0 %, ekstrakt herbe hajdučke trave( Achillea millefolium)u opsegu 1,0-25,0 %, ekstrakt herbe žive trave( Geranium robertianum)u opsegu 0,0-15,0 %, ekstrakt herbe žutog kokotca( Melilotus officinalis)u opsegu 0,0-12,5%, ekstrakt herbe belog kokotca( Melilotus alba)u opsegu 0,0-15,0%, ekstrakt herbe zdravinjka( Geranium feum)u opsegu 0,0-12,5%, ekstrakt herbe lanilista( Linarium vulgaris)u opsegu 0,0-10,0%), ekstrakt rizoma i/ili herbe lopuha( Petasides hybridus)u opsegu 0,0-10,0%, ekstrakt cveta nevena( Calendula officinalis)u opsegu 1,5-15%). Zatim se odmerenoj smeši ekstrakata dodaju punioci: škrob, mikrokristalna celuloza pH 101, laktoza, koloidni Si02i masa meša 5-15 minuta. Na kraju se dodaje magnezijum-stearat i mešanje nastavi još 1-10 minuta. The prepared liquid extracts are evaporated on a vacuum evaporator until the content of dry matter is min. 75%. The dried, ground extracts are sieved (sieve diameter 0.3 mm) and mixed with each other in a precisely defined ratio: horse chestnut seed extract (Aesculus hypocastani) in the range 0.5-35.0%, yarrow herb extract (Achillea millefolium) in the range 1.0-25.0%, geranium robertianum extract in the range 0.0-15.0 %, Melilotus officinalis herb extract in the range of 0.0-12.5%, Melilotus alba extract in the range of 0.0-15.0%, Geranium feum extract in the range of 0.0-12.5%, Lanilista herb extract (Linarium vulgaris) in the range of 0.0-10.0%), rhizome and/or burdock herb extract ( Petasides hybridus) in the range 0.0-10.0%, calendula flower extract (Calendula officinalis) in the range of 1.5-15%). Then fillers are added to the measured mixture of extracts: starch, microcrystalline cellulose pH 101, lactose, colloidal SiO2 and the mass is mixed for 5-15 minutes. At the end, magnesium stearate is added and mixing continues for another 1-10 minutes.
Kapsuliranje Encapsulation
Prethodno pripremljena masa kapsulira se na mašini u kapsule veličine 0, pri čemu se formiraju kapsule sledećih karakteristika: The previously prepared mass is encapsulated on the machine into capsules of size 0, whereby capsules with the following characteristics are formed:
Teorijska masa kapsula: 450,00 mg Theoretical mass of capsules: 450.00 mg
Dozvoljeno odstupanje: Permissible deviation:
- variranje mase pojedinačnih kapsula: ±5% (dve kapsule ±10%) - weight variation of individual capsules: ±5% (two capsules ±10%)
- prosečne mase: ±3% - average mass: ±3%
- raspadljivosti: vreme raspadanja 15 min. (za sve kapsule) - degradability: decomposition time 15 min. (for all capsules)
Kapsule se pune u adekvatnu ambalažu i signiraju. Capsules are filled in adequate packaging and signed.
Primer 3. Example 3.
Postupak izrade rastvora ( tečni preparat za oralnu primenu) Procedure for making a solution (liquid preparation for oral administration)
Rastvor na bazi odabranih ekstrakata, namenjenih održavanju fiziološkog protoka krvi kroz venske sudove donjih ekstremiteta i unapređenju zdravlja venskih sudova i kapilara izrađuje se njihovim mešanjem i po potrebi dodavanjem korastvarača i solubilizatora. A solution based on selected extracts, intended for maintaining physiological blood flow through the venous vessels of the lower extremities and improving the health of venous vessels and capillaries, is made by mixing them and, if necessary, adding co-solvents and solubilizers.
Ekstrakat semena divljeg kestena( Aesculus hypocastani)u opsegu 0,5-35,0 %, ekstrakt herbe hajdučke trave( Achillea millefolium)u opsegu 1,0-25,0 %, ekstrakt herbe žive trave( Geranium robertianum)u opsegu 0,0-15,0 %, ekstrakt herbe žutog kokotca( Melilotus officinalis)u opsegu 0,0-12,5%, ekstrakt herbe belog kokotca( Melilotus alba)u opsegu 0,5-15,0%, ekstrakt herbe zdravinjka( Geranium feum)u opsegu 0,0-12,5%, ekstrakt herbe lanilista( Linarium vulgaris)u opsegu 0,0-10,0%), ekstrakt rizoma i/ili herbe lopuha Horse chestnut seed extract (Aesculus hypocastani) in the range of 0.5-35.0%, yarrow herb extract (Achillea millefolium) in the range of 1.0-25.0%, Geranium robertianum herb extract in the range of 0.0-15.0%, Melilotus officinalis herb extract in the range of 0.0-12.5%, herb extract Melilotus alba in the range of 0.5-15.0%, Geranium feum extract in the range of 0.0-12.5%, Linarium vulgaris extract in the range of 0.0-10.0%), rhizome and/or burdock root extract
( Petasides hybridus)u opsegu 0,5-10,0%, ekstrakt cveta nevena( Calendula officinalis)u opsegu 1,5-15% i po potrebi korastvarači i solubilizatori: etanol u opsegu 0,0-15,0%, voda u opsegu 0,0-15,0%, propilenglikol u opsegu 0,0-15,0% i polisorbat 20 u opsegu 0,0-15,0%) se izmešaju u sudu sa propelerskom mešalicom, pri brzini 500-700 rpm, da se formira homogeni rastvor (15-45 minuta). Rastvor odležava 24 sata da se istalože eventualno formirane nerastvorne čestice a zatim se filtrira i puni u staklene ili plastične bočiće sa ili bez raspršivača. (Petasides hybridus) in the range of 0.5-10.0%, calendula flower extract (Calendula officinalis) in the range of 1.5-15% and, if necessary, co-solvents and solubilizers: ethanol in the range of 0.0-15.0%, water in the range of 0.0-15.0%, propylene glycol in the range of 0.0-15.0% and polysorbate 20 in the range 0.0-15.0%) are mixed in a vessel with a propeller mixer, at a speed of 500-700 rpm, to form a homogeneous solution (15-45 minutes). The solution is left for 24 hours to settle any insoluble particles that may have formed, and then it is filtered and filled into glass or plastic bottles with or without a sprayer.
Primer 4. Example 4.
Postupak izrade gela sa biljnim ekstrakatima The process of making gel with plant extracts
Ekstrakat semena divljeg kestena( Aesculus hypocastani)u opsegu 0,5-15,0 %, ekstrakt herbe hajdučke trave( Achillea millefolium)u opsegu 1,0-15,0 %, ekstrakt herbe žive trave( Geranium robertianum)u opsegu 0,1-5,0 %, ekstrakt herbe žutog kokotca( Melilotus officinalis)u opsegu 0,5-12,5%, ekstrakt herbe belog kokotca( Melilotus alba)u opsegu 0,5-5,0%, ekstrakt herbe zdravinjka( Geranium feum)u opsegu 0,0-12,5%, ekstrakt herbe lanilista( Linarium vulgaris)u opsegu 0,0-5,0%>, ekstrakt rizoma i/ili herbe lopuha( Petasides hybridus)u opsegu 0,5-5,0% i ekstrakt cveta nevena( Calendula officinalis)u opsegu 1,5-15% se izmešaju sa fosfatidil-holinom u količini od 0,0-5,0% u sudu sa propelerskom mešalicom pri brzini od 500-700 rpm (5-15 minuta). Zatim se masi doda po potrebi etanol u opsegu 0,0-15,0%, voda u opsegu 0,0-15,0%, propilenglikol u opsegu 0,0-15,0%, glicerol u opsegu 0,0-5,0% i polisorbat 20 u opsegu 0,0-15%. U masi se rastvore antioksidans (tokoferol-acetat u količini od 1,0-5,0%) i konzervans (natrijum-benzoat 0,1-0,2%) a nakon toga po površini rastvora se pospe gelirajući agens (karbomer) u količini od 0,5-1,2%. Nakon bubrenja polimera (15 minuta) i mešanja (ista brzina, 15 minuta) dodaje se agens za geliranje (10 % rastvor natrijum-hidroksida). Formirani gel se homogenizuje (700 rpm) i ostavi da odstoji na sobnoj temperaturi 24 sata radi potpunog strukturiranja sistema. Puni se u plastične, laminat ili aluminijumske tube. Horse chestnut seed extract (Aesculus hypocastani) in the range of 0.5-15.0%, yarrow herb extract (Achillea millefolium) in the range of 1.0-15.0%, Geranium robertianum herb extract in the range of 0.1-5.0%, Melilotus officinalis extract in the range of 0.5-12.5%, white herb extract Melilotus alba in the range of 0.5-5.0%, Geranium feum extract in the range of 0.0-12.5%, Linarium vulgaris extract in the range of 0.0-5.0%>, rhizome and/or burdock herb extract (Petasides hybridus) in the range of 0.5-5.0% and calendula flower extract (Calendula officinalis) in the range of 1.5-15% are mixed with with phosphatidyl-choline in the amount of 0.0-5.0% in a vessel with a propeller mixer at a speed of 500-700 rpm (5-15 minutes). Then ethanol in the range of 0.0-15.0%, water in the range of 0.0-15.0%, propylene glycol in the range of 0.0-15.0%, glycerol in the range of 0.0-5.0% and polysorbate 20 in the range of 0.0-15% are added to the mass as needed. An antioxidant (tocopherol-acetate in the amount of 1.0-5.0%) and a preservative (sodium benzoate 0.1-0.2%) are dissolved in the mass, and then a gelling agent (carbomer) is spread over the surface of the solution in an amount of 0.5-1.2%. After swelling of the polymer (15 minutes) and mixing (same speed, 15 minutes), a gelling agent (10% sodium hydroxide solution) is added. The formed gel is homogenized (700 rpm) and left to stand at room temperature for 24 hours for complete structuring of the system. It is filled in plastic, laminate or aluminum tubes.
Primer 5. Example 5.
Postupak dobijanja krema sa biljnim ekstraktima The process of obtaining creams with plant extracts
U duplicirani sud sa mešalicom i homogenizerom ubace se odmerene količine komponenata masne faze: Laurvl Glucoside (and) Polyglyceryl-2 Dipolyhydroxystearatc (and) Glycerin 0,0-5,0%, Cetil alcohol 0,1-2,5%, Stearil alcohol 0,1-2,5%), Silikonsko ulje DC 200 0,0-5%o, Shea butter 0,1-5,0%, Triglvceridi kaprilne i kapronske kiseline 0,0-7%) i zagreju do temperature topljenja a zatim se temperatura mase dotera do 70°C. In a duplicate vessel with a mixer and a homogenizer, measured amounts of the fatty phase components are added: Laurvl Glucoside (and) Polyglyceryl-2 Dipolyhydroxystearac (and) Glycerin 0.0-5.0%, Cetyl alcohol 0.1-2.5%, Stearyl alcohol 0.1-2.5%), Silicon oil DC 200 0.0-5%o, Shea butter 0.1-5.0%, Triglucerides caprylic and caproic acids 0.0-7%) and heated to the melting temperature and then the temperature of the mass is adjusted to 70°C.
Potrebna količina prečišćene vode ubaci se u sud od nerđajućeg čelika (25-75%), doda se propilenglikol u količini od 0,1-12%, Na2EDTA 0,01-0,1%, Carbomer (0,1-0,5%), proveri pH (potrebno je da rastvor ima pH u opsegu 4,5-6,5), ostavi da sobnoj temperaturi 15 minuta a zatim zagreje do 72°C. Ukoliko je pH vrednost ispod propisane granice doterati je dodatkom 10%o rastvora NaOH. Ukoliko je pH vrednost iznad propisane granice koriguje se dodatkom 1% rastvora EDTA koji treba dodavati postepeno u porcijama. Nakon dodavanja baze ili kiseline meša se i homogenizuje masa 15 minuta i izmeri pH. The required amount of purified water is put into a stainless steel vessel (25-75%), propylene glycol in the amount of 0.1-12%, Na2EDTA 0.01-0.1%, Carbomer (0.1-0.5%), check the pH (it is necessary that the solution has a pH in the range 4.5-6.5), leave it at room temperature for 15 minutes and then heat it to 72°C. If the pH value is below the prescribed limit, adjust it by adding a 10% NaOH solution. If the pH value is above the prescribed limit, it is corrected by adding 1% EDTA solution, which should be added gradually in portions. After adding the base or acid, mix and homogenize the mass for 15 minutes and measure the pH.
Vodena faza u porcijama se dodaje u sud sa pripremljenom masnom fazom uz rad mešalice i povremeno uključivanje homogenizera. Pod navedenim uslovima meša se sistem 30 minuta a zatim počinje hlađenje uz nepromenjene uslove mešanja i homogenizacije. Na temperaturi mase od 45°C dodaju se ekstrakti: semena divljeg kestena( Aesculus hypocastani)u opsegu 0,5-25,0%, herbe hajdučke trave( Achillea millefolium)u opsegu 1,0-15,0%, herbe žive trave( Geranium robertianum)u opsegu 0,1-5,0 %, herbe žutog kokotca( Melilotus officinalis)u opsegu 0,5-12,5%, herbe belog kokotca( Melilotus alba)u opsegu 0,5-5,0%, ekstrakt herbe zdravinjka( Geranium feum)u opsegu 0,1-12,5%, ekstrakt herbe lanilista( Linarium vulgaris)u opsegu 0,1-5,0%, ekstrakt rizoma i/ili herbe lopuha( Petasides hybridus)u opsegu 0,1-15,0%, cveta nevena( Calendula officinalis)u opsegu 1,5-15% i ostale komponente osetljive na povišenu temperaturu (tokoferol-acetat 1,0-5,0%, askorbinska kiselina 0,1-1,5%), ulje avokada 0,1-5,0%, ulje soje 0,1-5,0%, maslinovo ulje 0,1-5,0%). Hladi se masa uz nepromenjene uslove mešanja i homogenizacije do sobne temperature. The water phase in portions is added to the vessel with the prepared fatty phase while the mixer is running and the homogenizer is occasionally turned on. Under the mentioned conditions, the system is mixed for 30 minutes and then cooling begins with unchanged mixing and homogenization conditions. At a mass temperature of 45°C, extracts are added: horse chestnut seeds (Aesculus hypocastani) in the range of 0.5-25.0%, yarrow herbs (Achillea millefolium) in the range of 1.0-15.0%, wild grass herbs (Geranium robertianum) in the range of 0.1-5.0%, yellow cockle grass (Melilotus officinalis) in the range 0.5-12.5%, Melilotus alba herb in the range of 0.5-5.0%, Geranium feum extract in the range of 0.1-12.5%, Linarium vulgaris herb extract in the range of 0.1-5.0%, rhizome and/or burdock herb extract (Petasides hybridus) in the range of 0.1-15.0%, flowers calendula (Calendula officinalis) in the range of 1.5-15% and other components sensitive to elevated temperature (tocopherol-acetate 1.0-5.0%, ascorbic acid 0.1-1.5%), avocado oil 0.1-5.0%, soybean oil 0.1-5.0%, olive oil 0.1-5.0%). Cool the mass with unchanged mixing and homogenization conditions to room temperature.
Primer 6.Example 6.
Postupak dobijanja krema sa kombinacijom(dvadodevet)biljnih ekstrakataThe procedure for obtaining creams with a combination of (twenty-nine) plant extracts
U duplicirani sud sa mešalicom i homogenizerom ubace se odmerene količine komponenata masne faze: Glyceryl Stearate (and) Ceteareth-20 (and) Ceteareth-12 (and) Cetearyl Alkohol (and) Cetyl Palmitate 0,0-5,0%, Cetil alcohol 0,1-2,5%, Stearil alcohol 0,1-2,5%, Silikonsko ulje DC 200 0,0-5%, Shea butter0,l-5,0%>, Triglyceridi kaprilne i kapronske kiseline 0,0-7%>) i zagreju do temperature topljenja a zatim temperaturu mase dotera do 70°C. In a duplicate vessel with a mixer and a homogenizer, measured amounts of the fatty phase components are added: Glyceryl Stearate (and) Ceteareth-20 (and) Ceteareth-12 (and) Cetearyl Alcohol (and) Cetyl Palmitate 0.0-5.0%, Cetyl alcohol 0.1-2.5%, Stearyl alcohol 0.1-2.5%, Silicon oil DC 200 0.0-5%, Shea butter0.1-5.0%>, Triglycerides of caprylic and caproic acid 0.0-7%>) and heat to the melting temperature and then adjust the temperature of the mass to 70°C.
Potrebna količina prečišćene vode ubaci se u sud od nerđajućeg čelika (25-75%), doda se propilenglikol u količini od 0,1-12%, Na2EDTA 0,01-0,1%), proveri pH (potrebno je da rastvor ima pH u opsegu 4,5-6,5) i zagreje do 72°C. Ukoliko je pH vrednost ispod propisane granice doterati je dodatkom 10% rastvora NaOH. Ukoliko je pH vrednost iznad propisane granice koriguje se dodatkom \% rastvora EDTA koji treba dodavati postepeno u porcijama. Nakon dodavanja baze ili kiseline meša se i homogenizuje masa 15 minuta i izmeri pH. The required amount of purified water is put into a stainless steel vessel (25-75%), propylene glycol in the amount of 0.1-12%, Na2EDTA 0.01-0.1% is added, the pH is checked (it is necessary that the solution has a pH in the range of 4.5-6.5) and heated to 72°C. If the pH value is below the prescribed limit, adjust it by adding a 10% NaOH solution. If the pH value is above the prescribed limit, it is corrected by adding \% EDTA solution, which should be added gradually in portions. After adding the base or acid, mix and homogenize the mass for 15 minutes and measure the pH.
Vodena faza u porcijama se dodaje u sud sa pripremljenom masnom fazom uz rad mešalice i povremeno uključivanje homogenizera. Pod navedenim uslovima meša se sistem 30 minuta a zatim počinje hlađenje uz nepromenjene uslove mešanja i homogenizacije. Na temperaturi mase od 45°C dodaju se ekstrakti: semena divljeg kestena( Aesculus hypocastani)u opsegu 0,5-25,0%, herbe hajdučke trave( Achillea millefolium)u opsegu 1,0-15,0%, herbe žive trave( Geranium robertianum)u opsegu 0,1-5,0 %, herbe žutog kokotca( Melilotus officinalis)u opsegu 0,5-12,5%), herbe belog kokotca( Melilotus alba)u opsegu 0,5-5,0%, ekstrakt herbe zdravinjka( Geranium feum)u opsegu 0,1-12,5%, ekstrakt herbe lanilista( Linarium vulgaris)u opsegu 0,1-5,0%, ekstrakt rizoma i/ili herbe lopuha( Petasides hybridus)u opsegu 0,1-15,0%, cveta nevena( Calendula officinalis)u opsegu 1,5-15% i ostale komponente osetljive na povišenu temperaturu (tokoferol-acetat 1,0-5,0%, askorbinska kiselina 0,1-1,5%), ulje avokada 0,1-5,0%, ulje soje 0,1-5,0%), maslinovo ulje 0,1-5,0%). Hladi se masa uz nepromenjene uslove mešanja i homogenizacije do sobne temperature. The water phase in portions is added to the vessel with the prepared fatty phase while the mixer is running and the homogenizer is occasionally turned on. Under the mentioned conditions, the system is mixed for 30 minutes and then cooling begins with unchanged mixing and homogenization conditions. At a mass temperature of 45°C, extracts are added: horse chestnut seeds (Aesculus hypocastani) in the range of 0.5-25.0%, yarrow herbs (Achillea millefolium) in the range of 1.0-15.0%, wild grass herbs (Geranium robertianum) in the range of 0.1-5.0%, yellow cockle grass (Melilotus officinalis) in the range 0.5-12.5%), Melilotus alba herb in the range of 0.5-5.0%, Geranium feum extract in the range of 0.1-12.5%, Linarium vulgaris herb extract in the range of 0.1-5.0%, rhizome and/or burdock herb extract (Petasides hybridus) in the range of 0.1-15.0%, flowers marigold (Calendula officinalis) in the range of 1.5-15% and other components sensitive to elevated temperature (tocopherol-acetate 1.0-5.0%, ascorbic acid 0.1-1.5%), avocado oil 0.1-5.0%, soybean oil 0.1-5.0%), olive oil 0.1-5.0%). Cool the mass with unchanged mixing and homogenization conditions to room temperature.
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