TR201807313T4 - Eklampsiye yönelik sindirim enzimi hazırlanışı. - Google Patents
Eklampsiye yönelik sindirim enzimi hazırlanışı. Download PDFInfo
- Publication number
- TR201807313T4 TR201807313T4 TR2018/07313T TR201807313T TR201807313T4 TR 201807313 T4 TR201807313 T4 TR 201807313T4 TR 2018/07313 T TR2018/07313 T TR 2018/07313T TR 201807313 T TR201807313 T TR 201807313T TR 201807313 T4 TR201807313 T4 TR 201807313T4
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- pharmaceutical preparation
- use according
- enzymes
- eclampsia
- preeclampsia
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Classifications
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- C12Y—ENZYMES
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Toksemi, preeklampsi ve eklampsi tedavisine yönelik terapötik bir ajan ve terapötik ajanların hazırlanmasına yönelik yöntem açıklanmaktadır. Terapötik ajan, bunlarla sınırlı olmamak üzere sindirim/pankreas enzimlerini içeren stabil bir farmasötik preparattır. Terapötik ajan, birçok enkapsülasyon teknolojisi ile üretilebilir. Terapötik ajanın uygulanması, oral olarak, enjeksiyon yoluyla, ilaçlı bir yamanın yapıştırılması veya başka bir yöntem ile yapılabilir. Ayrıca preeklampsi, gebelik ile indüklenen hipertansiyon ve eklampsi/toksemi geliştirme ihtimalini belirlemek üzere anne sindirim yolunda kimotripsin varlığının biyomarkör olarak kullanılmasına yönelik yöntem açıklanmaktadır.
Description
TARIFNAME
EKLAMPSIYE YÖNELIK SINDIRIM ENZIMI HAZIRLANISI
BULUS SAHASI
Bulus, eklampsi tedavisi ve daha da özellikle eklampsi tedavisinde
sindirim/pankreas enzimlerinin kullanimi ile ilgilidir.
BULUSUN ALTYAPISI
Her yil binlerce kadin, gebelik ile indüklenen hipertansiyondan sikayetçidir.
Gebelik sirasinda kan basinci genel olarak gebe oluninayan duruma göre daha
düsük oldugundan bazi gebe kadinlar hipertansiyon gelistirecektir. Gebelik
sirasinda hipertansiyon, bunlarla sinirli olmamak üzere felç veya diger
kardiyovasküler komplikasyonlar dahil olmak üzere anne ve fetüs üzerinde
önemli bir etkiye sahip olabilir. Her 100 gebe kadindan Tsinin, hipertansiyonun
görülen ana semptomu oldugu toksemi/eklampsi ve/veya eklampsi gelistirecegi
hesaplanmaktadir. Ayni zamanda preeklampsi olarak bilinen hafif toksemi,
yakindan gözlenir ve genellikle anne veya çocugunda bazi problemlere yol açar.
Toksemi ve eklampsi genellikle ayni durumu refere etmek üzere birbirleri yerine
kullanilir ve bu basvuru içinde birbirleri yerine kullanilacaktir.
Toksemi için bilinen hiçbir neden yoktur. Gebeligin sonlarina yaklasilana kadar
bu durumun tespit edilmemesine ragmen plasenta gelismeye basladiginda
tokseminin de gelismeye baslamadigi bilinmektedir. Birçok toksemi vakasi,
birinci gebeliklerde görülür. Kadinin, yeni bir partner ile olmamasi halinde ikinci
ve sonraki gebelikler daha düsük risklidir. Toksemi için bilinen hiçbir neden
olmadigindan, gebe kalmadan önce bir kadinin bu durum için risk tasiyip
tasimadigini belirleme yolu yoktur.
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Preeklampsi, en çok gebeligin on ikinci haftasindan sonra görülmek üzere
hipertansiyon ve proteinüriye neden olur. Geçmiste ödem, tanisal bir kriter olarak
görülmüstür. Ancak yakin zamanda, teshis için bir gereklilik olarak görülinekten
cikarilmistir. Preeklampsi, kan damarlarinizin sikistigi ve akabinde bir kas spazmi
gibi gevsedigi bir vaka olan vazospazma neden olur. Bu durum, kan damarlarinin
düz kaplamasinin zarar görmesine pürüzlü hale gelmesine neden olur. Bu hasar
görüldügünde vücut, hasari onarmasi için hücreleri gönderecektir. Ilk ulasan
hücreler plateletlerdir. Plateletler ve diger kan ürünleri, hasari onarmaya
çalisirken, kan damarinin çok daha daralmasina ve organlara daha az kan alisi
olmasina neden olarak kan damari duvari boyunca biraz pihti olusturur. Vücut
sürekli olarak yeni plateletler yapar; ancak tek sefer Vücutta sinirli bir platelet
saglama vardir. Tükendiklerinde spontane kanama görülebilir.
Kan damarlarinin hasarli kaplainasini geçen diger hücreler, genellikle toksik
içeriklerini birakarak geçerler. Bu toksik atik ürünleri, yüksek kan basincina ve
hatta diger organlarda daha fazla hasara neden olur. Vazospazm ve minyatür kan
pihtilari, kan akisini düsürerek ve böylelikle beyin, böbrek ve karaciger gibi
hayati önem tasiyan organlara oksijen tedarikini düsürerek daha fazla hasara yol
Preeklampsi, bir nöbetten Önceki hastalik durumuna refere eder. Bir kadin bu
hastalik ile ilgili bir nöbet geçirdiyse, akabinde bu eklampsi olur. Eklampsi,
hipertansiyon ve proteinüreyi içerir. Preeklampsi, hafif veya agir olarak
siniflandirilabilir. Agir preeklampsi, (l) bilinen bir normotansif kadinda 140-160
mm Hglden yüksek bir sistolik kan basinci veya yatak istirahatinde olan bir
kadinda en az 6 saatlik araliklarla 2 sefer görülen 90-110 mm Hg”den yüksek
diastolik kan basinci ve (2) önemli proteinüri varligi ile karakterize edilir.
Preeklampsi ile baglantili proteinüri konsantrasyonu, 300mg/24 saat ürin
araligindadir. Belirgin proteinüri, 24 saatlik bir ürin toplamada 5 g veya daha fazla
protein olarak tanimlanir.
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Agir preeklampsi bazen oligüri, serebral veya görme bozukluklari, pulmoner
Ödem veya siyanoz, epigastrik veya sag üst kadran abdominal agri, bozulmus
karaciger fonksiyonu, troinbositopeni veya intraüterin gelisme geriligi ile
baglantili olabilir. Hafif preeklampside, hipertansiyon ve proteinüri görülür ancak
bu kadar ekstrem seviyelerde degildir ve hastanin, baska bir organ bozukluguna
dair kanit yoktur. Preeklampsi, eklampsi/toksemiye dönüstügünde, oligüri ve
diger semptomlar da görülebilir. Eklampsi/toksemi ile baglantili birçok saglik
problemi, anne ve çocuk için oldukça tehlikeli olabilir ve anne ve/veya çocuk için
ciddi morbidite ve potansiyel olarak mortalite ile sonuçlanabilir. Toksemi,
karaciger ve/veya böbrek hasari veya yetmezligine neden olabilir. Görme ile ilgili
problemlere yol açabilir ve uzun süre tedavi edilmez ise, anne hastanin nöbet
geçirmesine neden olabilir. Bu nöbetler, koma ve hatta ölüme yol açabilir.
Genellikle bu semptomlarin ilerlemesi durdurulamaz ve böbrek yetmezligi ile
birlikte tam gelismis toksemi görülür.
Preeklampsinin etiyolojisi hala bilinmemektedir. Renin-anjiyotensin sisteminin
incelenmesi, epinefrin, norepinefrin ve vazpresin gibi selektif horinonal inceleme
dahil birçok alan arastirilmistir. Diger inceleme, hepsinin, preeklampsi ve
potansiyel olarak ortaya çikan eklampsi/toksemi için sonuçsuz veya etkili bir
tedavisiz kaldigi endotelin ve prostaglandinleri de içennektedir.
Plasenta] uygulama, preeklampsi semptomlarini tersine çevirdiginden, plasentanin
bu vakada öneinli bir rol oynayabilecegini gösterir. Ayrica gestasyonel yas için
yüksek plasenta dokusu olan kadinlar, hidatiform moller ve/veya ikiz veya çoklu
gebelikleri olanlar, yüksek preeklampsi yayginligina sahiptir. Bu nedenle bu
durum, hidatiform molde yüksek olan insan koryonik gonadotropin gibi
maddelerin de var olabilme ihtimalinin düsünülmesine yol açar. Plasenta ve
preeklampsi gelisimi arasindaki bu bag önemlidir.
Dölleninis yuinurta bölünmeye basladiginda on alti hücreli asamada morula
olarak bilinir. Morula, fallop tüplerinden üterin bosluguna girdiginde, blastosist
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olarak adlandirildigi yedi gestasyon gününe kadar implante olmaz. Blastosistin
trofoblastik hücreleri, bosluk olarak bilinen büyük cepler olusturmak üzere üterin
kaplamasini asindirir. Bu sekilde trofoblast, hücresel kisimda ve sinsisyal kisimda
bir bölünme olusturur. Sinsisyal kismin dis kaplamasi, koryon olarak bilinir.
Koryon, anneden gelen bagisiklik atagini önleyen insan koryonik gonadotrpin
salgilar ve maternal/fötal degisim, plasenta ile gerçeklesebilene kadar gebeligin
korpus luteumunu muhafaza etmeye yardimci olur. Bu, plasenta olusumunun
baslangicidir.
Sinsisyal trofoblastik aktiviteye düzgün bir geçis olmaksizin çogalmaya
basladiginda hücresel trofoblast, muhtemel sinsisyal ölüme yol açabilir, böylelikle
üretilen steroid hormonu miktarini düsürür ve ayni zamanda plasentanin dogru bir
sekilde olusmasi ihtimalini düsürür. Sinsisyal trofoblast ayrica ekstravillöz
trofoblast olarak bilinen oldukça özel bir trofoblasta çogalir. Ekstravillöz
trofoblast, endometriyum içinden desiduaya ve uterusun miyometriyumuna
uzanir. Bu ekstravillöz trofoblastlar, uterusun spiral küçük atar damalarina dogru
isgallerini sürdürür ve üterin vaskülatürünün vazodilasyonuna yol açarak küçük
üterin atar damalarinin endotelyal ve müsküler kaplamalarini degistirir. Bu
degisim, intervillöz bosluga inatemal kan akisi yogunlugunu artiran ve gelisen
fetüsün yeterli perü'izyonunu muhafaza eden sürekli bir düsük direnç sistemini
Sinsisyal trofoblast devralacak sekilde hücresel trofoblastin, proliferasyonda
düsürülmesini saglayan mekanizma, özellikle kimotripsin olmak üzere proteolitik
enzimlerin varligidir. Anne tarafindan üretilen bu proteazlar, özellikle
kimotripsin, hücresel trofoblastin proliferasyonunu ve insan koryonik
gonadotropinin asiri üretimini sinirlayabilir. Bu mekanizma, 1949 yilinda Ernest
T. Krebs (Medical Record, Vol. 162, No. 10, October 1949) tarafindan
özetlenmistir.
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Preeklampside, sinsisyal trofoblastlarin proliferasyon eksikligi, ekstravillöz
trofoblast eksikligine ve küçük üterin atar dainalarinin müsküler kaplamasinda
uygun olmayan bir delik açilmasina yol açar. Bu, üterin endometriyum arterlerinin
vazospazmina yol açar ve iskemi, anoksi, nekroz, histamin ve tiramin salimi ile
sonuçlanir. Damarlarin belirgin vazodilasyonu ve lümen eksikligi ile birlikte,
fetüse giden kan akisi ve oksijen transferi düser, preeklampsinin matemal
belirtilerine ve oligohidramniyoz ve intraüterin gelisme geriliginin (IUGR) fotal
belirtilerine yol açar.
Ortaya çikan uygunsuz plasenta gelisimi, plasental vasküler endotelyal islev
bozuklugi ve buna bagli uteroplasental yetmezlik ile sonuçlanir. Vasküler
endotelyal islev bozuklugu, artan geçirgenlik, hiperkoagulabilite ve difüze
vazospazm ile sonuçlanir.
Böbrekler ve ürin bosaltimi ile protein kaybi ve potansiyel endotelyal islev
bozuklugu nedeniyle vasküler sistemin geçirgenligindeki degisimler, vasküler
geçirgenlikte bir artis ile sonuçlanir. Artan bu vasküler geçirgenlik sonuç olarak
proteinlerin, özellikle de büyük moleküller olan büyük proteinlerin, böbregin
kilcal dainalari ve glomerulu içinden geçmesine izin verir. Bu protein kaybi,
gebelik sirasinda büyük protein alimi miktarina duyulan potansiyel bir ihtiyaci
dogumr.
Artan vasküler sistem geçirgenligi ve büyük molekülleri vasküler sisteme
girmesine izin verme kapasitesi nedeniyle yetersiz protein yikimi ile birlikte
gebelik sirasinda vücudun protein gereksinimleri, gebelik disi duruma göre çok
daha yüksektir. Ayrica Önemli bir protein kaybi ve gebe kadinlarda bulunan amino
asitlerin baglantili eksikligi ile birlikte organ yetmezligi ve potansiyel organ
ölümüne yönelik bir potansiyel vardir.
Sindirim enzimlerinin kullanimi, vücudun, negatif bir protein dengesine girmesine
izin vermeyecek sekilde yetersiz protein varligini kolaylastirabilir. Vücut, plasenta
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olusumunu ve gebelik sirasinda vücut tarafindan kaybedilen proteinlerin
replasinanini kolaylastiracak sekilde proteaz ihtiyaci nedeniyle oldukça istenen ve
gerekli bir durumdur.
Bu tür bulgular açisindan, gebe kadinlarda eklampsi/toksemi görülmeyecek
sekilde preeklampsisi olan kisilerin tedavi yönteinine ihtiyaç duyulmaktadir.
Mevcut bulus toksemi, preeklampsi ve eklampsinin tedavisine yönelik terapötik
ajan ve bu ajanlarin hazirlanmasina yönelik yöntem ile ilgilidir. Ayrica, mevcut
bulus hidatiform mollerinin (mol gebelikler) olusumunun azaltilmasi ile ilgilidir.
olan bir bireye etkili miktarda sindirim/pankreas enzimi uygulanmasini içeren,
sindirim/pankreas enzimleri olan bir Parkinson hastasinin tedavisine yönelik bir
yöntemi açiklar.
Mevcut bulus, eklampsisi olan bir bireyin tedavisinde kullanilmaya yönelik
farmasötik bir preparat ile ilgilidir, burada farmasötik preparat, terapötik olarak
etkili miktarda sindirim enzimi içerir, burada sindirim enzimleri, bir amilaz, bir
lipaz ve bir proteazi içerir.
Daha spesifik olarak mevcut bulus, bunlarla sinirli olmamak üzere amilazlar,
proteazlar selülaz, papaya, papain, bromelain, lipazlar, kimotripsin ve hidrolazlar
dahil olinak üzere bunlarla sinirli olmamak üzere sindirim/pankreas enziinlerini
içeren stabil farmasötik preparatlar ile ilgilidir. Bu kombinasyon, bunlarla sinirli
olmamak üzere direkt sikistirma, mikroenkapsülasyon, lipid enkapsülasyonu, islak
granülasyon veya Pr0s01v® kullanimi, mikroenkapsülasyon, lipid enkapsülasyon
teknolojisi veya diger uygun teknolojiler gibi diger yöntemler ile yapilir. Bu
teknoloji, hizli çözünme (hizli çözme), zaman salinimi veya oral, enjeksiyon,
yama veya diger yöntemler gibi diger uygulama yöntemlerinin kullanimi
içerebilir. Ayrica enzimlerin uygulanmasi, bir tablet, mikro-pellet, sase, kapsül,
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kapsülümsü tablet veya diger sikistirilmis tablet uygulamalari veya diger oral
uygulama yöntemleri formunda olabilir.
BULUSUN KISA AÇIKLAMASI
Mevcut bulusun bir amaci, eklampsi tedavisine yönelik terapötik bir ajan
saglanmasidir.
Mevcut bulusun bir diger amaci, bunlarla sinirli olmamak üzere amilazlar,
proteazlar, selülaz, papaya, papain, bromelain, lipaz, kimotripsin; ve hidrolazlar
gibi bunlarla sinirli olmamak üzere sindirim/pankreas enzimlerini içeren stabil
farmasötik preparatlar formüle edilmesidir.
Mevcut bulusun bir baska amaci, bunlarla sinirli olmamak üzere: direkt sikistirma,
mikroenkapsülasyon, lipid enkapsülasyon, islak granülasyon veya
mikroenkapsülasyon, lipid enkapsülasyon, direkt sikistirma, islak veya kuru
granülasyon veya diger uygun bir teknolojiyi saglamak üzere Prosolv® ve bilinen
diger eksipiyan ve katki maddelerinin kullanimi gibi diger yöntemler ile
sindirim/pankreas enzimlerinin bir kombinasyonunun hazirlanmasidir.
Mevcut bulusun bir diger amaci, hizli çözünme (hizli çözme), zamanli salim veya
oral, enjeksiyon, yama veya diger yöntemler gibi diger uygulama yöntemlerinin
kullanimini içerebilen yollar ile preparatin uygulanmasidir. Ayrica enzimlerin
uygulamasi, bir tablet, kapsül, mikro-pellet, sase veya diger oral uygulama
yöntemi formunda olabilir.
Dolayisiyla mevcut bulus, eklampsisi olan bir bireyin tedavisinde kullanilmaya
yönelik farmasötik bir preparat ile ilgilidir, burada farmasötik preparat, terapötik
olarak etkili miktarda sindirim enzimi içerir, burada sindirim enzimleri, bir
amilaz, bir lipaz ve bir proteazi içerir.
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Burada açiklanan özellikler ve avantajlar, genis kapsamli degildir ve özellikle
birçok ek özellik ve avantaj, çizimler, tarifname ve istemler açisindan teknikte
uzman bir kisi tarafindan anlasilacaktir. Ayrica tarifnamede kullanilan dilin,
aslinda anlasilirlik ve ögretici amaçlar için seçildigi ve bulusun konusunun
kapsamini sinirlama amaçli olmadigi bilinmelidir.
SEKILLERIN KISA AÇIKLAMASI
Sekil 1, pankreas enzimleri uygulanan preeklampsisi olan gebe
kadinlardaki hem diastolik hem sistolik kan basinci, ürin protein seviyesi
ve fekal kimotripsin seviyesindeki degisiklikleri gösteren bir tablodur.
Sekil 2, pankreas enzimleri uygulandiktan sonra 30 günlük bir süre içinde
preeklainptik kadinlarin kan basincindaki degisimleri gösteren bir
gratîktir.
Sekil 3, pankreas enzimleri uygulandiktan sonra 30 günlük bir süre içinde
preeklamptik kadinlarin ürin protein seviyesindeki degisimleri gösteren bir
grafiktir.
Sekil 4, 12 haftalik gebelik ila 40 haftalik gebelik arasindaki on yedi gebe
kadinda fekal kimotripsin seviyelerini gösteren bir semadir.
TERCIH EDILEN DÜZENLEMENIN DETAYLI AÇIKLAMASI
Plasenta uygulamasi, preeklampsi semptomlarini tersine çevirdiginden,
plasentanin bu vakada önemli bir rol oynayabilecegini gösterir. Ayrica
gestasyonel yas için yüksek plasenta dokusu olan kadinlar veya hidatiform moller
ve ikiz gebelikleri olanlar, yüksek preeklampsi yayginligina sahiptir. Bu nedenle
bu durum, hidatiform molde yüksek miktarda olan insan koryonik gonadotropin
gibi maddelerin de var olabilme ihtimalinin düsünülmesine yol açar. Plasenta ve
preeklampsi gelisimi arasindaki bu bag önemlidir.
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Sinsisyal trofoblast olusumu ve steroid hormonunun salgilanmasi, insan koryonik
gonadotropin seviyelerini düsük tutar ve böylelikle preeklampsi gelistirme
ihtimalini düsürür. Sinsisyal trofoblast ayrica ekstravillöz trofoblast olarak bilinen
oldukça özel bir trofoblasta çogalir. Ekstravillöz trofoblast, endometriyum içinden
desiduaya ve miyometriyuma uzanir. Bu ekstravillöz trofoblastlar, spiral küçük
atar damalara dogru isgallerini sürdürür ve üterin vaskülatürünün vazodilasyonuna
yol açarak küçük üterin atar damalarinin endotelyal ve müsküler kaplamalarini
degistirir. Bu degisim, intervillöz bosluga matemal kan akisi yogunlugunu artiran
ve gelisen fetüsün yeterli perfüzyonunu muhafaza eden sürekli bir düsük direnç
sistemini korur.
Sinsisyal trofoblast devralacak sekilde hücresel trofoblastin, proliferasyonda
düsürülmesini saglayan mekanizma, özellikle kimotripsin olmak üzere proteolitik
enzimlerin varligidir. Anne proteazlari, özellikle kimotripsin, hücresel trofoblastin
proliferasyonunu ve insan koryonik gonadotropinin asiri üretimini sinirlayabilir.
Bir düzenlemede sindirim/pankreas enzimlerinin stabil bir preparati, terapötik
olarak etkili miktarda proteaz, amilaz ve lipaz içeren bir dozaj formülasyonu
haline getirilir. Bu formülasyon, pankreatin, kimotripsin, tripsin, papain ve/veya
papaya gibi ek enzimleri de içerebilir. Sindirim enzimlerinin baska
kombinasyonlari da kullanilabilir. Bu enzimler, dogal veya sentetik hayvan veya
bitki türevleri formunda olabilir.
Asagidaki kisim, preeklampsi/toksemiye yönelik sindirim/pankreas enzimlerine
yönelik bir formülü açiklar:
Lipaz 4,000-30,000 U.S.P
Pankreatin LOGO-6,000 U.S.P
Kimotripsin 2-5 mg
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Tripsin 60-100 mg
Papain 3,000-10,000 USP birim/mg
Papaya 30-60 mg
Dozaj formülasyonu, bunlarla sinirli olmamak üzere enkapsüle bir tablet, mini-
tabletler, mikroenkapsüle, mini-kapsül, zaman salinimli kapsül, mikro-pellet veya
baska bir metodolojiyi içeren oral bir preparat ile uygulanabilir. Bir düzenlemede
oral preparat, Prosolv teknolojisinin kullanilmasi ile enkapsüle edilir. Alternatif
olarak oral preparat, enterik kaplama, lipid enkapsülasyon, direkt sikistirma, kuru
granülasyon, islak granülasyon ve/veya bu yöntemlerin bir kombinasyonu
kullanilarak enkapsüle edilebilir.
Bulusçu tarafindan yürütülen bir çalismada, gebeliklerinin 28-34. haftalarinda
olan preeklainpsi teshisi koyulan alti kadin incelenmistir. Kadin dogum uzmanlari
tarafindan gözlem altinda olmak üzere gebelikleri süresince preeklampsi
teshisinden sonraki iki gün içinde her birine, lipaz, amilaz ve proteaz gibi
pankreas enzimleri verilmistir. Çalismanin sonuçlari, kadinlarin hem diastolik
hem de sistolik kan basinci, ürin protein seviyesi ve fekal kimotripsin
seviyelerindeki degisimleri gösteren Sekil lide gösterilmektedir.
Sekil 2'de gösterildigi üzere gebe kadinlarin kan basinçlarinin, pankreas
enzimlerinin uygulamasindan sonraki 30 gün içinde büyük oranda düstügü sonucu
açiktir. Her durumda kan basinçlari, genellikle 120/80 olan normal degerlere
dönmüstür. Bazi durumlarda normal kan basinci okumaya dönüs, 15 gün içinde
görülmüstür.
Ayrica ürinlerindeki protein seviyeleri, Sekil 3”te görüldügü gibi 30-35 gün içinde
normale dönmüstür. Proteinüri, basit bir idrar tahlili ile ürinin incelenmesi ile
teshis edilmistir. Normal ürinde oldukça az miktarda protein vardir. Yüksek
miktarlar genellikle l+ ila 4+ olarak rapor edilir.
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Sekil 4,te gösterilen baska bir çalismada, gebe olan on yedi kadina, ilk üç aylik
süreçlerinde ilk defa (primipar), gebeliklerinin 12 ila 40. Haftalari arasinda her
hafta fekal kimotripsin testi uygulanmistir. Bir kadin, Özne 6, preeklamptik
semptomlar gelistirmistir ve fekal kimotripsin testi, preeklampsi teshisinden bir
hafta önce anormal hale gelmistir.
Fekal kimotripsin, proteolitik aktivitenin hassas ve spesifik bir ölçütüdür. Normal
kimotripsin seviyelerinin, 8.4 U/gramdan yüksek oldugu düsünülmektedir. Düsük
degerler (4.2 U/gramdan düsük), azalan pankreas çikisi (pankreas yetmezligi),
mide asit yetersizligi veya kistik fibrozu gösterir. Yüksek kimotripsin degerleri,
hizli bir geçis süresini veya daha az muhtemel olarak pankreastan büyük bir
Fekal kimotripsin testi için, her özneden diski örnegi alinmistir. Her diski örnegi,
diskidaki fekal kimotripsin seviyesini belirlemek için enzimatik fotospektrometri
analizi kullanilarak analiz edilmistir. Alternatif olarak kolorimetrik yöntem,
substrat kullanimi, analiz kullanimi gibi diger yöntemler ve/veya diger uygun
yöntemler, fekal kimotripsin seviyelerini ölçmek için kullanilabilir. Primipar gebe
kadinlarin ömeklerindeki fekal kimotripsin seviyeleri, primipar gebe kadinlarin,
sindirim enzimlerinin uygulanmasindan fayda saglayip saglamadigini belirlemek
üzere preeklampsi teshisi koyulan gebe kadinlardaki fekal kimotripsin seviyeleri
ile karsilastirilmistir.
Claims (1)
- ISTEMLER . Eklampsisi olan bir bireyin tedavisinde kullanilmaya yönelik farmasötik bir preparattir, burada farmasötik preparat, sindirim enzimlerinin terapötik olarak etkili bir miktarini içerir, burada sindirim enzimleri, bir amilaz, bir lipaz ve bir proteazi içerir. . Istem l'e göre kullanima yönelik farmasötik preparattir, burada amilaz . Istem 1,e göre kullanima yönelik farmasötik preparattir, burada lipaz miktari 4,000 ila 30,000 USP mg/doz arasindadir. . Istem l°e göre kullanima yönelik farmasötik preparattir, burada proteaz . Önceki istemlerden herhangi birine göre kullanima yönelik farmasötik preparattir, ayrica kimotripsin veya tripsin içerir. . Istem 5°e göre göre kullanima yönelik farmasötik preparattir, burada kimotripsin miktari 2 ila 5 mg/doz arasindadir. . 5”e göre göre kullanima yönelik farmasötik preparattir, burada tripsin miktari 60 ila 100 mg/doz arasindadir. . Önceki istemlerden herhangi birine göre kullanima yönelik farmasötik preparattir, burada sindirim enzimleri, ayrica pankreatin içerir. . Önceki istemlerden herhangi birine göre kullanima yönelik farmasötik preparattir, burada en az bir enzim, hayvan enzimleri, bitki enzimleri, sentetik enzimler ve bunlarin bir kombinasyonundan olusan gruptan seçilen bir kaynaktan türetilir. Önceki istemlerden herhangi birine göre kullanima yönelik farmasötik preparattir, burada preparat, enterik kaplama, lipid enkapsülasyon, direkt sikistirma, kuru granülasyon, islak granülasyon ve bunlarin bir kombinasyonundan olusan gruptan seçilen bir teknoloji kullanilarak üretilir. Önceki isteinlerden herhangi birine göre kullanima yönelik farmasötik preparattir, burada preparat, bir hap, bir tablet, bir kapsül, bir mikrokapsül, bir mini-kapsül, bir zaman salinimli kapsül, bir mini-tablet, bir mikro- pellet ve bunlarin bir koinbinasyonundan olusan gruptan seçilen bir dozaj formülasyonu ile oral olarak uygulanmaya yöneliktir.
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| Application Number | Priority Date | Filing Date | Title |
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| US12/047,818 US8658163B2 (en) | 2008-03-13 | 2008-03-13 | Compositions and use thereof for treating symptoms of preeclampsia |
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| TR2018/07313T TR201807313T4 (tr) | 2008-03-13 | 2009-03-13 | Eklampsiye yönelik sindirim enzimi hazırlanışı. |
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|---|---|
| US (5) | US8658163B2 (tr) |
| EP (2) | EP3050571B1 (tr) |
| CA (1) | CA2719102C (tr) |
| CY (1) | CY1117759T1 (tr) |
| DK (2) | DK2257305T3 (tr) |
| ES (2) | ES2572160T3 (tr) |
| HR (1) | HRP20160507T1 (tr) |
| HU (2) | HUE028466T2 (tr) |
| LT (1) | LT3050571T (tr) |
| PL (2) | PL2257305T3 (tr) |
| SI (1) | SI2257305T1 (tr) |
| TR (1) | TR201807313T4 (tr) |
| WO (1) | WO2009114757A2 (tr) |
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| US20110081320A1 (en) * | 2009-10-06 | 2011-04-07 | Nubiome, Inc. | Treatment/Cure of Autoimmune Disease |
| WO2011050135A1 (en) | 2009-10-21 | 2011-04-28 | Curemark Llc | Methods and compositions for the prevention and treatment of influenza |
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| JP5914357B2 (ja) | 2010-01-15 | 2016-05-11 | インセルム（インスティチュート ナショナル デ ラ サンテ エ デ ラ リシェルシェ メディカル） | 自閉症の治療のための化合物 |
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| US20160287683A1 (en) | 2016-10-06 |
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| US20140030333A1 (en) | 2014-01-30 |
| SI2257305T1 (sl) | 2016-08-31 |
| LT3050571T (lt) | 2018-06-11 |
| US9408895B2 (en) | 2016-08-09 |
| HRP20160507T1 (hr) | 2016-07-15 |
| CA2719102A1 (en) | 2009-09-17 |
| PL2257305T3 (pl) | 2016-09-30 |
| PL3050571T3 (pl) | 2018-08-31 |
| CA2719102C (en) | 2016-06-07 |
| EP3050571B1 (en) | 2018-05-09 |
| US20090232789A1 (en) | 2009-09-17 |
| DK2257305T3 (en) | 2016-05-23 |
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