DESCRIPTION A drug of plant origin with hepatoprotective action. The active component of Carsil, Silymarin stabilizes the cell membrane of the liver and stimulates protein synthesis, which restores the functions of the damaged cells and protects the liver parenchyma from destructive action of noxae.
MOLECULAR MASS: (Silymarin main component) 500.47
PHYSICOCHEMICAL INDICES OF THE FINISHED PRODUCT
¤ Appearance
amorphous powder
¤ Color
yellow to yellow-brown
¤ Odor
slight, specific
¤ Solubility
in water
practically insoluble
in dioxane
soluble
in methanol
slightly soluble
¤ Tanning substances
content (mg/g)
not more than 100.00
¤ Content of substances extracted
in petroleum ether (mg/g)
not more than 10.00
¤ Sulphate ash (mg/g)
not more than 5.0
¤ Heavy metals (mg/g)
not more than 20.0
¤ Water content (mg/g)
not more than 60.0
¤ Silymarin content calculated as dry substance (%)
not less than 65.0
¤ Total content of silybine and isosilybine (%)
not less than 25.0
¤ Total content of silycristine and silydianine (%)
not less than 12.0
¤ Residual solvents content (mg/g)
in methanol
not more than 1.0
in hexane
not more than 1.5
¤ Microbial content
total microorganisms (number/g)
not more than 10-3
moulds and yeast (number/g)
not more than 10-2
Enterobacteriaceae
Ps. aeruginosa, St. aureus
not allowed
¤ Supplied
The substance is filled in double polyethylene bags of 25 kg and 40 kg and place in cardboard barrels.
¤ Quality
Bulgarian standard
¤ Expiry term
3 years
¤ Medicinal form and package
Carsil s.c. tablets, original Bulgarian drug of 35 mg in packs of 80.