Method for preparing ceftezole sodium for injection

A technology for ceftizole sodium and injection, which is applied in the field of pharmacy, can solve the problems of complex preparation process, inability to industrialize production, poor quality and the like, and achieve the effects of simple production process, stable product quality and easy storage.

Inactive Publication Date: 2014-12-10
SICHUAN PHARMA
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  • Claims
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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

Method used

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  • Method for preparing ceftezole sodium for injection
  • Method for preparing ceftezole sodium for injection
  • Method for preparing ceftezole sodium for injection

Examples

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Embodiment Construction

[0042] The present invention will be further illustrated below by way of examples, but the present invention is not limited thereto. For the experimental methods without specific conditions indicated in the following examples, the conventional conditions or the conditions suggested by the manufacturer are usually followed. The percentages appearing below are all mass percentages.

[0043] The list of materials used is shown in Table 1.

[0044] Table 1

[0045]

[0046]

[0047] See Table 2 for the operating room and main equipment of each process.

[0048] Table 2

[0049]

[0050] 1. Raw material preparation:

[0051] (1) Check the name, batch number and quantity of raw materials.

[0052](2) According to figure 2 The process flow shown is for raw material delivery.

[0053] 2. Cleaning and sterilization of soda-lime glass molded injection bottles:

[0054] (1) Soda-lime glass molded injection bottle is unpacked to check the appearance, and after confirming...

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61J1/00A61P31/04
Inventor 李穿江
Owner SICHUAN PHARMA
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