Method for preparing ceftezole sodium for injection

Abstract

The invention provides a ceftezole sodium preparation for injection. Ceftezole sodium asepsis powder is put in an injection bottle molded by soda-lime glass, a halogenated butyl rubber stopper is used for packaging, and an aluminum plastic combined cap for an antibiotic bottle is rolled at the opening of the bottle. The invention further provides a method for preparing the ceftezole sodium preparation for injection. The ceftezole sodium preparation is simple in production process, stable in product quality and convenient to store, has validity up to 24 months, and is suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a preparation method of cephalosporins, in particular to a preparation method of ceftezole sodium for injection. Background technique [0002] Ceftezole Sodium for Injection, alias Yi Tixin, molecular weight 462.47, molecular formula C 13 h 11 N 8 NaO 4 S 3 , the chemical name is (6R,7R)-3-{[(1,3,4-thiadiazol-2-yl)thio]methyl}-7-[(1H-tetrazol-1-yl)acetamido ]-8-Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, CAS number 41136-22-5. Its chemical structural formula is as follows: [0003] [0004] Ceftezole sodium is the first generation of cephalosporin antibiotics for injection. It is a semi-synthetic cephalosporin derivative. Its mechanism of action is to exert antibacterial activity by inhibiting the synthesis of bacterial cell walls. Gram-positive bacteria, especially cocci, including penicillinase-producing and non-penicillinase-producing Staphylococcus a...

AI Technical Summary

Problems solved by technology

Because ceftezole sodium is susceptible to quality changes due to the influence of external environmental conditions, especially the stability is greatly affected by temperature, humidity, light and air conditions, and carelessness during packaging, transportation and storage can easily lead to color changes. Deep, serious deterioration of quality, or even loss of medicinal value, increasing the unsafety of clinical medication

[0007] Chinese patent document CN101229129A discloses a kind of ceftezole sodium powder injection, and the scheme that it adopts is that ceftezole sodium and sodium bicarbonate are dissolved together, and recrystallization is prepared to obtain ceftezole sodium powder injection, and it does not fundamentally Ceftezole sodium is specially protected, it will be hydrolyzed and oxidized quickly in aqueous solution, and the disadvantage of instability cannot be changed, and isopropanol and ethanol are used in the crystallization process, which is difficult to completely remove from the preparation, resulting in potential safety hazards for medication , the preparation cannot be allowed to be industrialized

[0008] Chinese patent document CN102525924A discloses a kind of ceftezole sodium liposome lyophilized preparation, and this liposome preparation is prepared from neutral phospholipid, cholesterol, excipient and buffer salt, but its preparation process is more complicated, wherein adds A large number of pharmaceutical excipients, resulting in an increase in the content of impurities in injections, greatly increasing the safety hazards of the drugs used, and the content of related substances is difficult to meet the requirements of the Pharmacopoeia in the test, and cannot be industrialized.

In addition, the preparation yield of liposome is very low, which causes the cost of medicine to increase greatly, which is also another reason why the product cannot be industrialized.

Images