Preparation method of cefodizime sodium for injection

A technology for cefodizime sodium and injection, which is applied in the field of pharmacy, can solve the problems of increasing the content of impurities, increasing the hidden danger of drug use, and reducing the content of active ingredients, and achieves the effects of simple production process, stable product quality, and easy storage.

Inactive Publication Date: 2014-11-26
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] In order to solve its stability problem, Chinese patent ZL200910016147.9 discloses a liposomal freeze-dried preparation of cefodizime and its preparation method, but its preparation process is relatively complicated, wherein a large number of pharmaceutical excipients are added, which leads to The increase in impurity content will greatly increase the hidden dangers of drug safety. Due to the increase in impurities, it is difficult for the content of related substances to meet the requirements of the Pharmacopoeia in the test and cannot be industrialized.
In addition, the preparation yield of liposomes is very low, which causes the cost of medicines to increase greatly, and is not suitable for industrial production.
[0008] Chinese patent application document CN102258521A discloses a kind of cefodizime sodium for injection, which is prepared from cefodizime sodium, potassium clavulanate and hydroxypropyl-β-cyclodextrin (HP-β-CD), but, The injection needs to add at least 2 to 6 times the amount of potassium clavulanate and at least 1 to 4 times the amount of hydroxypropyl-β-cyclodextrin as the active ingredient cefodizime, which not only g

Method used

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  • Preparation method of cefodizime sodium for injection
  • Preparation method of cefodizime sodium for injection
  • Preparation method of cefodizime sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1 Trial Production of Cefodizime Sodium for Injection

[0022] Prescription: 1.0g / bottle and 2.0g / bottle (in C 20 h 20 N 6 o 7 S 4 count), according to 1000 feeding.

[0023] according to figure 1 The process flow chart shown is for production, and the process is as follows:

[0024] (1) Disassemble the outer packaging of the sterile original powder of cefdizime sodium in the buffer room, first wipe the surface of the original powder bucket (bag) with drinking water, and then wipe and disinfect it with 75% alcohol. Enter the 10,000-level sterile area after being irradiated with ultraviolet light at the transfer window for 30 minutes.

[0025] (2) Soda-lime glass molded injection bottles and halogenated butyl rubber stoppers for sterile powders for injections are washed, dried and sterilized before use.

[0026] (3) Calculate the loading volume according to the converted dry content of the raw material medicine, and adjust the loading volume and machine s...

Embodiment 2

[0034] Example 2 Verification of culture medium simulated packaging process

[0035] Sterile glucose powder was selected as the powder for simulated packaging, and the test medium was trypticase casein soybean broth medium. According to the "Guidelines for the Validation of Drug Production", the contamination rate was 0.10% when the confidence limit was 95% as the qualified standard , select the number of simulated subpackages > 3500 bottles, (that is, the qualified standard is the number of contaminated bottles < 1 bottle).

[0036] 1. Preparation of medium: The medium used for the simulated aliquot test is trypticase casein soybean broth medium (SCMD liquid medium).

[0037] Culture medium sterility test: Divide the sterilized sterile medium for dispensing into 20 sterile test tubes, and culture them at 30-35°C and 20-25°C for 7 days after capping and sealing.

[0038] Test results: After being cultured within 7 days, there was no microbial growth in the culture medium in e...

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Abstract

The invention provides a preparation method of cefodizime sodium for injection. Cefodizime sodium for injection provided by the invention is simple in production process, stable in quality, convenient to store and suitable for industrialized production on a large scale.

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 cefodizime sodium for injection. Background technique [0002] Cefodizime sodium, English name: Cefodizime Sodium, its chemical name is (6R,7R)-7-[(2-amino-4-thiazolyl)-(methoxyimino)acetamido]-3-{[ (5-Carboxymethyl-4-methyl-2-thiazolyl)thio]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2 - Formic acid disodium salt, molecular formula: C 20 h 18 N 6 Na 2 o 7 S 4 , molecular weight: 628.64, the chemical structure is as follows: [0003] [0004] Cefodizime sodium is a third-generation cephalosporin antibiotic for injection jointly developed by Hearst Company of Germany and Russell Company of France. It is also the first third-generation cephalosporin with immune-enhancing function in the world. It was first launched in Japan under the trade name "Neucef" in 1990. [0005] Cefodizime is the world'...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61P31/04
Inventor 李家成
Owner SICHUAN PHARMA
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