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Cefepime hydrochloride powder injection and preparing method thereof

A technology of cefepime hydrochloride and powder injection, applied in the field of pharmaceutical preparations, can solve the problems of poor stability, difficult to meet the requirements of pH value and clarity, and achieve the effects of reasonable composition, good stability and feasible preparation process

Active Publication Date: 2008-07-30
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that the prior art generally believes that when the amount of L-arginine per 1 g of cefepime in cefepime hydrochloride powder for injection is greater than 800 mg, it is difficult to meet the requirements for pH value and clarity
[0014] In addition, "Studies on the Stability of Cefepime Hydrochloride for Injection" (referring to Wang Haiyang et al. Stability Studies of Cefepime Hydrochloride for Injection, Drug Identification, Volume 14, No. 12, 2005) has the effect on Cefepime Hydrochloride for Injection. From the study, it can be seen that in the accelerated test of Cefepime Hydrochloride for Injection, the content of related substances in the commercially available cefepime hydrochloride for injection was more than 1%, and the change was obvious. , and in the long-term retention sample investigation test, the change of the content of related substances is also obvious, which shows that its stability is not good

Method used

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  • Cefepime hydrochloride powder injection and preparing method thereof
  • Cefepime hydrochloride powder injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] prescription:

[0035] Cefepime hydrochloride (calculated as cefepime) 500g

[0036] L-Arginine 417.5g

[0037]

[0038] Packed into 1000 sticks

[0039] Preparation Process:

[0040] (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;

[0041] (2) In a 100-level clean area, cefepime hydrochloride and L-arginine are respectively pulverized and passed through an 80-mesh sieve;

[0042] (3) Weigh cefepime hydrochloride and L-arginine in a 100-level clean area, mix them evenly according to the ratio of the prescription, and pack them into control bottles after the content is qualified, and press the stopper, cap, light inspection, and pass the inspection , label and package.

Embodiment 2

[0044] prescription:

[0045] Cefepime hydrochloride (calculated as cefepime) 1000g

[0046] L-Arginine 835g

[0047]

[0048] Packed into 1000 sticks

[0049] Preparation Process:

[0050] (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;

[0051] (2) In a 100-level clean area, cefepime hydrochloride and L-arginine are respectively pulverized and passed through an 80-mesh sieve;

[0052] (3) Weigh cefepime hydrochloride and L-arginine in a 100-level clean area, mix them evenly according to the ratio of the prescription, and pack them into control bottles after the content is qualified, and press the stopper, cap, light inspection, and pass the inspection , label and package.

Embodiment 3

[0054] prescription:

[0055] Cefepime hydrochloride (calculated as cefepime) 2000g

[0056] L-Arginine 1670g

[0057]

[0058] Packed into 1000 sticks

[0059] Preparation Process:

[0060] (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;

[0061] (2) In a 100-level clean area, cefepime hydrochloride and L-arginine are respectively pulverized and passed through an 80-mesh sieve;

[0062] (3) Weigh cefepime hydrochloride and L-arginine in a 100-level clean area, mix them evenly according to the ratio of the prescription, and pack them into control bottles after the content is qualified, and press the stopper, cap, light inspection, and pass the inspection , label and package.

[0063] The beneficial effects of the present invention are described below through test examples and comparative examples....

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Abstract

The invention which discloses a hydrochloric acid cefepime powder injection consists of the raw material hydrochloric acid cefepime and supplemental material L-arginine and is characterized in that in the hydrochloric acid cefepime powder injection for injection, the content of the supplemental material L-arginine is 83.5 percent of the raw material hydrochloric acid cefepime; the hydrochloric acid cefepime powder injection provided by the invention is provided with a pH value about 4.5 and is good in stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a cefepime hydrochloride powder injection and a preparation method thereof. Background technique [0002] Cefepime (Cefepim, BMY-28142, CFPM) is a fourth-generation cephalosporin for injection developed by Bristol-Myerssquibb. It was first launched in Sweden in 1993 and entered the Chinese market in 1998. [0003] Name: Cefepime Hydrochloride for Injection (English Name: Cefepime Hydrochloride for Injection) [0004] Molecular formula: C 19 h 25 ClN 6 o 5 S 2 ·HCl·H 2 o [0005] Molecular weight: 571.50 [0006] Chemical name: 1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1 -Azabicyclo[4,2,0]oct-2-en-3-yl]methyl]-1-methylpyrrolidine chloride, 72-(Z)-(0-methyloxime)hydrochloride-hydration thing [0007] Chemical Structure: [0008] [0009] Cefepime hydrochloride for injection is a fourth-generation cephalosporin a...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61K47/18A61P31/04
Inventor 刘保起李明华孙松
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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