Specifications:
Name of product:
Metronidazole
Expiry Date:
4 years
ITEMS
STANDARDS
RESULTS
Characteristics
a white or yellowish crystalline powder, slighting sobube in water, in acetone, in alcohol and in methylene, chloride, very slightly solube in ether
COMPLY
Identification
a) Melting point 159-163℃
161.1-161.3℃
b) Specific absorbance 365-395
b) 375
c) IR
c) COMPLY
d) The solution gives the reaction of primary aromatic amines
d) COMPLY
Appearance of solution
SUSPENSION Ⅱ
COMPLY
AND SOLUTION GY6
Related substances
Impurity:0.1MAX
0.02%
Total impurity:0.2MAX
0.06%
Heavy Metal
20PPM MAX
<20PPM
Loss on drying
0.5% MAX
0.19%
Particle size
40-80mesh
COMPLY
Assay
99.0%-101.0%
99.4%
Description of Metronidazole
Pharmacology
In addition to anti-trichomonas and anti-amoeba, in recent years, widely used in anti-anaerobic infections. This product nitro, anaerobic environment in the reduction of amino and anti-anaerobic bacteria show the role of aerobic bacteria or facultative aerobic bacteria is invalid. The following anaerobic bacteria have good antibacterial effect: ① Bacteroides, including Bacteroides fragilis; ② Fusobacterium; ③ Clostridium, including tetanus; ④ partial eubacteria; ⑤ digestive bacteria and digestion Streptococcus and so on. Oral absorption of good (> 80%), oral 250mg or 500mg, 1 ~ 2 hours serum drug concentration peak, respectively 6μg / ml and 12μg / ml. Intravenous infusion of the goods 15mg / kg, after every 6 hours infusion of 7.5mg / kg, plasma drug concentration reached a peak concentration of 25μg / ml, trough concentration of up to 18μg / ml. This product is widely distributed in the body, can enter the saliva, milk, liver abscess pus, can also enter the cerebrospinal fluid (normal CSF concentration of up to 50% of blood). In the body, the side chain oxidation or metabolism with glucuronic acid binding, 20% of the drug is not metabolized. Its metabolites also have a certain activity. Metronidazole and its metabolites by a large number of urinary excretion (60% of the total ~ 80%), a small amount of excretion from the feces (6% ~ 15%). T1 / 2 is about 8 hours.
Indications
Mainly for the treatment or prevention of anaerobic bacteria caused by the system or local infection, such as the abdominal cavity, digestive tract, female genital tract, lower respiratory tract, skin and soft tissue, bone and joint parts of anaerobic infections, sepsis, Membranitis, meningeal infection and the use of antibiotics caused by colitis is also effective. Treatment of tetanus and tetanus antitoxin (TAT) in combination. Can also be used for oral anaerobic infections.
China
