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Meropenem medicinal composition for injection and preparation method thereof

A technology of meropenem and composition, which is applied in the field of medicine, can solve the problems of poor fluidity, easy hydrolysis, oxidation and other problems of direct filling, and achieve the effects of stable product quality, poor stability and large loss

Active Publication Date: 2013-06-12
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] The purpose of the present invention is to provide a meropenem pharmaceutical composition for injection and its preparation method, which can overcome the deficiencies of the prior art, and effectively solve the problems of poor stability of meropenem, easy hydrolysis, oxidation, poor direct filling fluidity, etc.

Method used

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  • Meropenem medicinal composition for injection and preparation method thereof
  • Meropenem medicinal composition for injection and preparation method thereof
  • Meropenem medicinal composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Meropenem injections are prepared in 1,000 vials, of which:

[0092] Meropenem 500g

[0093] Disodium hydrogen phosphate 250g

[0094] Preparation Process:

[0095] 1) Preparation: re-inspect meropenem and disodium hydrogen phosphate, meet the requirements of sterility and particle size, and set aside;

[0096] 2) Preparation: carry out aseptic treatment on the antibiotic bottle and the operation container, and after the water content of the antibiotic bottle is qualified, set aside;

[0097] 3) Mixing: Mix the prescribed amount of meropenem and disodium hydrogen phosphate evenly with a high-efficiency mixer;

[0098] 4) Central control: carry out intermediate product inspection and calculate the loading range;

[0099] 5) Filling: Adjust the filling volume range of the filling machine and fill them in antibiotic bottles respectively;

[0100] 6) stopper;

[0101] 7) Gland;

[0102] 8) Light inspection: check for visible foreign matter;

[0103] 9) Packing and s...

Embodiment 2

[0105] Meropenem injections are prepared in 1,000 vials, of which:

[0106] Meropenem 1000g

[0107] Disodium hydrogen phosphate 500g

[0108] Preparation process: with embodiment 1.

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Abstract

The invention provides a meropenem medicinal composition for injection and a preparation method thereof. The medicinal composition consists of meropenem and disodium hydrogen phosphate, wherein 1000 pieces of the medicinal composition are prepared from 500 to 1,000g of the meropenem, and 250 to 500g of disodium hydrogen phosphate. The preparation method of the medicinal composition comprises the following steps: rechecking whether the meropenem and disodium hydrogen phosphate are in accordance with the requirements of asepsis and granularity for later use; performing asepsis treatment on an antibiotic bottle and an operation vessel, standing after the moisture of the antibiotic bottle is qualified; mixing; filling; plugging; screwing a cover; testing by use of a lamp; and packaging and sending into a warehouse. The meropenem medicinal composition has simple prescription and excellent stability, and is suitable for long-term storage and industrial large-scale production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a meropenem pharmaceutical composition for injection and a preparation method thereof. Background technique [0002] Meropenem is a variety developed by Sumitomo Co., Ltd. of Japan. It was launched in January 1995 under the trade name "Merrem" (美平), and it was jointly developed with AstraZeneca Pharmaceuticals. It was first launched in June 1996. Due to the carbapenem with a methyl group in the first position of the chemical structure of meropenem, it is stable to renal dehydropeptidase and does not need to be combined with enzyme inhibitors. The antibacterial spectrum and antibacterial effect are similar to imipenem, and have certain post-antibiotic effects. Meropenem is a very broad range of injectable antibiotics used to treat a number of different infections, including meningitis and pneumonia. It is a beta-lactam antibiotic that falls under the class of carbapenems. Unlike subampe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/407A61K47/02A61P31/04
Inventor 张昊
Owner HAINAN GENERAL & KANGLI PHARMA