Фармацевтическое сырье Фладрафинил: 120014-06-4
Абстрактный
Donepezil is a centrally acting reversible acetylcholinesterase inhibitor. Its main therapeutic use is in the palliative treatment of Alzheimer’s disease. Common side effects include gastrointestinal upset. It has an oral bioavailability of 100% and easily crosses the blood-brain barrier. Because it has a biological half-life of about 70 часы, it can be taken once a day.
Donepezil has been tested in other cognitive disorders (and is sometimes used off label) including Lewy body dementia and vascular dementia, but it is not currently approved for these indications. Donepezil has been found to improve sleep apnea in Alzheimer’s patients. Donepezil has also been studied in patients with Mild Cognitive Impairment, schizophrenia, attention deficit disorder, post-coronary bypass cognitive impairment, cognitive impairment associated with multiple sclerosis, CADASIL, and Down syndrome.
А 3 year NIH trial in patients with mild cognitive impairment reported that donepezil was superior to placebo in delaying rate of progression to dementia during the initial 18 months of the study but this was not sustained at 36 месяцы. In a secondary analysis, a subgroup of individuals with the Apolipoprotein E4 genotype showed sustained benefits with donepezil throughout the study. However at this time donepezil is not indicated for prevention of dementia. Recent studies suggest that Donepezil can improve speech in children with autism. The studies found that speech of autistic children who were mild to moderately affected appeared to improve from the use of Donepezil.
Технические характеристики
| TEST ITEM |
ТЕХНИЧЕСКИЕ ХАРАКТЕРИСТИКИ |
РЕЗУЛЬТАТ |
| Появление |
Off white to white crystalline powder |
Соответствует |
| Растворимость |
freely Freely soluble in chloroform, soluble
in water and Acetic acid, slightly soluble in
Acetonitrile and ethanol, insoluble in
Ethylacetoacetate and n-hexane |
Соответствует |
| Идентификация |
(1)By IR absorption ,To match with working
standard |
Соответствует |
(2) The retention time of the major peak of
the sample should accord with that of the
working standard. |
Соответствует |
(3) Test for chlorides. Reponds to the test
for Chlorides. |
Соответствует |
| РН |
4.0-7.0 |
6.10 |
| Остаток при прокаливании |
≤0,1% |
0.03% |
| Связанное вещество |
Any Unkonwn single impurity≤0.3%
Total ≤0.5% |
0.04%
0.18% |
| Heavy metal |
≤10 частей на миллион |
<10промилле |
| Остаточные растворители |
Methanol≤0.3%
Ethanol≤0.5%
Ethyl acetate≤0.5%
Toluene≤0.089%
Acetic acid≤0.5% |
Not detected
Not detected
Not detected
Not detected
Not detected |
| Убыток от высыхания |
≤0,5% |
0.20% |
| Анализ |
On dried base, C24H29NO3·HCl
should be 98.0% к 102.0% |
100.20% |
| Заключение: The product complies to Enterprise standard |
заявка
Donepezil is used to treat confusion (dementia) related to Alzheimer’s disease. It does not cure Alzheimer’s disease, but it may improve memory, awareness, and the ability to function. This medication is an enzyme blocker that works by restoring the balance of natural substances (neurotransmitters) in the brain.
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