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有没有人了解头孢洛宁的?

时间: 2008-09-20 02:41:00 作者: 来源: 字号:
有没有哪位仁兄对头孢洛宁有所了解,是人用还是兽用抗生素,还有一些详细的信息!!
头孢洛宁Cefalonium
英国药典BP2003
 

Cefalonium

C20H18N4O5S2,2H2O 494.5 5575-21-3 (anhydrous)



Definition



Cefalonium is 3-(4-carbamoyl-1-pyridiniomethyl)-7-(2-thienylacetamido)-3-cephem-4-carboxylate dihydrate. It contains not less than 95.0% and not more than 103.5% of C20H18N4O5S2, calculated with reference to the anhydrous substance.



Characteristics



A white or almost white crystalline powder.



Very slightly soluble in water and in methanol ; soluble in dimethyl sulphoxide; insoluble in dichloromethane, in ethanol (96%) and in ether . It dissolves in dilute acids and in alkaline solutions.



Identification



A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of cefalonium (RSV 09).



B. The light absorption, Appendix II B, in the range 220 to 350 nm of a 0.002% w/v solution in water exhibits two maxima, at 235 nm and at 262 nm. The absorbance at 235 nm is about 0.76 and at 262 nm is about 0.62.



Specific optical rotation



Dissolve 0.25 g with the aid of gentle heat in sufficient dimethyl sulphoxide to produce 50 ml. Allow the solution to stand for 30 minutes before measurement of the optical rotation. The specific optical rotation in the resulting solution is -50° to -56°, calculated with reference to the anhydrous substance, Appendix V F.



Related substances



Carry out the method for thin-layer chromatography, Appendix III A, using silica gel F254 as the coating substance and a mixture of 10 volumes of glacial acetic acid, 10 volumes of 1M sodium acetate and 30 volumes of propan-2-ol as the mobile phase but allowing the solvent front to ascend 12 cm above the line of application. Apply separately to the plate 4 µl of each of the following solutions in 8.3M acetic acid containing (1) 2.5% w/v of the substance being examined, (2) 0.05% w/v of the substance being examined, (3) 0.025% w/v of the substance being examined, (4) 0.005% w/v of the substance being examined and (5) 0.05% w/v of each of cefalotin sodium EPCRS and isonicotinamide. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (2%), not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) (1%) and not more than three such spots are more intense than the spot in the chromatogram obtained with solution (4) (0.2% each). The test is not valid unless the chromatogram obtained with solution (5) shows two clearly separated spots.



Sulphated ash



Not more than 0.2%, Appendix IX A.



Water



6.5 to 8.5% w/w, Appendix IX C. Use 0.5 g.



Assay



Measure the absorbance of a 0.002% w/v solution at the maximum at 262 nm, Appendix II B. Calculate the content of C20H18N4O5S2 taking 332 as the value of A(1%, 1 cm) at the maximum at 262 nm.



Storage



Cefalonium should be kept in a well-closed container , protected from light and stored at a temperature not exceeding 30°.



Action and use



Antibacterial.



Preparations

Cefalonium Eye Ointment



Cefalonium Intramammary Infusion (Dry Cow)



Cefalonium intended for use in the manufacture of either a parenteral dosage form or an intramammary infusion without a further appropriate sterilisation procedure complies with the following additional requirement.



Sterility



Complies with the test for sterility, Appendix XVI A.



IMPURITIES



A. cefalotin,



B. 3-hydroxymethyl-7b-(2-thienylacetamido)-3-cephem-4-carboxylic acid,



C. 3-hydroxymethyl-7b-(2-thienylacetamido)-3-cephem-4-carboxylic acid lactone,



D. isonicotinamide.
Cefalonium
Sub-sections

Drug Nomenclature
Drug Profile
Cefalonium
Drug Nomenclature
Date of monograph revision: 08-Apr-1997; 23-Jul-1998; 11-Oct-1999; 02-Oct-2001; 12-Nov-2003; 25-Jul-2006; (last modified: 07-Aug-2006)
Synonyms: 41071; Carbamoylcefaloridine; Cefalonio; Cephalonium
BAN: Cefalonium
INN: Cefalonium
INN: Cefalonio
INN: Cefalonium
INN: Cefalonium
INN: Цефалоний
Chemical name: (7R)-3-(4-Carbamoyl-1-pyridiniomethyl)-7--3-cephem-4-carboxylate
Molecular formula: C20H18N4O5S2 =458.5
CAS: 5575-21-3

Chemical Structure of Cefalonium

Pharmacopoeias:
BP(Vet) includes the dihydrate.

BP(Vet) 2005 (Cefalonium). The dihydrate is a white or almost white crystalline powder. Very slightly soluble in water and in methyl alcohol; insoluble in alcohol, in dichloromethane, and in ether; soluble in dimethyl sulfoxide. It dissolves in dilute acids and in alkaline solutions. Store at temperature not exceeding 30 degrees. Protect from light.

Drug Profile
Cefalonium is a cephalosporin antibacterial used in veterinary practice.
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