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Cefepime hydrochloride composition for injection and its preparation method

A composition and a technology for injection, applied in the field of medicinal chemistry, can solve the problems of nutritional anemia, dysplasia, central nervous system obstruction, etc., and achieve the effects of good stability, reasonable composition and simple preparation process

Active Publication Date: 2014-03-12
上海欣峰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If lack of lysine, it will cause insufficient secretion of gastric juice and cause anorexia and nutritional anemia, resulting in central nervous system obstruction and dysplasia.

Method used

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  • Cefepime hydrochloride composition for injection and its preparation method
  • Cefepime hydrochloride composition for injection and its preparation method
  • Cefepime hydrochloride composition for injection and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] prescription:

[0045] Cefuroxime hydrochloride (calculated as cefoxime) 1000g

[0046] L-Arginine 710g

[0047] L-Lysine 10g

[0048] Preparation process (see attached figure 1 ):

[0049] (1) After the original and auxiliary materials are removed from the outer packaging, they are dust-cleaned, wiped and sterilized, and put into a sterile room for standby;

[0050] (2) In the 100-level clean area, cefoxime hydrochloride, L-arginine and L-lysine were respectively pulverized and passed through an 80-mesh sieve;

[0051] (3) Weigh cefoxime hydrochloride, L-arginine and L-lysine in a 100-level clean area, mix them evenly according to the prescription ratio, and pack them into control bottles after the measured content is qualified, press the stopper, roll the cap, After passing the light inspection and inspection, it can be labeled and packaged.

Embodiment 2

[0053] prescription:

[0054] Cefuroxime hydrochloride (calculated as cefoxime) 1000g

[0055] L-Arginine 710g

[0056] L-Lysine 15g

[0057] Preparation Process:

[0058] (4) After the original and auxiliary materials are removed from the outer packaging, they are dust-cleaned, wiped and sterilized, and put into a sterile room for standby;

[0059] (5) In the 100-level clean area, cefoxime hydrochloride, L-arginine and L-lysine were respectively pulverized and passed through an 80-mesh sieve;

[0060] (6) Weigh cefoxime hydrochloride, L-arginine and L-lysine in a 100-level clean area, mix them evenly according to the prescription ratio, and subpackage them in control bottles after the measured content is qualified. After passing the light inspection and inspection, it can be labeled and packaged.

Embodiment 3

[0062] prescription:

[0063] Cefuroxime hydrochloride (calculated as cefoxime) 1000g

[0064] L-Arginine 710g

[0065] L-Lysine 20g

[0066] Preparation Process:

[0067] (7) After the original and auxiliary materials are removed from the outer packaging, they are dust-cleaned, wiped and sterilized, and put into a sterile room for standby;

[0068] (8) In a 100-level clean area, cefoxime hydrochloride, L-arginine and L-lysine are respectively pulverized and passed through an 80-mesh sieve;

[0069] (9) Take cefoxime hydrochloride, L-arginine and L-lysine in a 100-level clean area, mix them evenly according to the prescription ratio, and pack them in control bottles after the measured content is qualified, press the stopper, roll the cap, After passing the light inspection and inspection, it can be labeled and packaged.

[0070] The beneficial effects of the present invention are described through the following experimental examples and comparative examples.

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Abstract

The invention discloses a cefepime hydrochloride composition for injection. The composition comprises a raw material and auxiliary materials, wherein the raw material is 1000 parts by weight of cefepime hydrochloride and the auxiliary materials contain 710 parts by weight of L-arginine and 10-20 parts by weight of L-lysine. The pH value of the cefepime hydrochloride composition can maintain between 4.0 and 6.0 for a long time. After 12 months of an accelerated test and 24 months of long-term sample storage for observation, contents of related substances are all less than 1%. The invention also aims to provide a preparation method of the cefepime hydrochloride composition for injection. According to the preparation method, the raw materials of cefepime hydrochloride, L-arginine and L-lysine are directly mixed. The preparation technology is simple, and the quality is stable and reliable.

Description

[technical field] [0001] The invention belongs to the technical field of medicinal chemistry, and in particular relates to a cefepime hydrochloride composition for injection and a preparation method thereof. [Background technique] [0002] Cefepime hydrochloride (Cefepim, BMY-28142, CFPM), trade name Maspin, is a fourth-generation cephalosporin antibiotic successfully developed by Bristol-Myers Squibb. It was launched in Switzerland in 1993, and has since been launched in France, Italy, Japan, Canada, the United States and other countries. The dosage forms are dry powder injections of 0.5g and 1.0g. [0003] On August 6, 1999, my country approved the administrative protection of Maspine powder injection for Bristol-Myers Squibb, and terminated the administrative protection of Maspine powder injection in China on September 27, 2000. [0004] In 1998, Shanghai Bristol-Myers Squibb introduced it and sold it in my country for clinical use. It mainly acts on the cell wall, inte...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/546A61K47/18A61P31/04
Inventor 杨磊
Owner 上海欣峰制药有限公司
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