1) Name and Structure
a) Chemical Name:Spiramycin Base
b) Molecular Formula: C43H74N2O14
c) Molecular Weight: 843
A white or slightly yellowish powder, Slightly odorless, Slightly hygroscopic, slightly soluble in water, freely soluble in acetone, in alcohol and in methanol.
3) Function and Use:
It can be used for the infections in ears, nasus, larynx and respiratory tract system caused by gram-positive bacterium and some gram-negative bacterium such as acute bronchitic, acute bout of acute bronchitis, pneumonia, scarlet fever, tonsillitis, tympanitis, periodontitis and acute nososinusitis.
It also shows suitable to non-gonococcal urethritis.
It possesses strong internal antibacterial function and Post-Antibiotic Effect (PAE) . Its able to improve the phagocytosis of phagocyte and is widely distributed in body. The concentration in histiocyte is higher than erythromycin and is less adverse reaction as well.
4) Quality Standard
The product complies with FP 1986 and EP2000.
Main analysis items:
Characteristics: A white or slightly yellow powder, slightly odorless, slightly hygroscopic.
Specific Optical rotation: -800~-850
PH value: 8.5-10.5
Loss on drying: <=3.5%
Sulphated ash: <=0.1%
Heavy metals: <=20P. P. M.
Related Substances: Conform
5) Preparation and Package:
a) Preparation: Spiramycin tablet.
b) Package: Packed in cardboard drums, 25kg per drum. .
Be kept in tight containers.