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Faropenem sodium freeze-drying powder and preparation method thereof

A technology of faropenem sodium and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of insufficient pharmacokinetics and bioavailability, difficulty in ensuring stability, and poor fluidity of drug powder, and achieve stable physical and chemical properties , quality control, and the effect of reducing the production of polymer impurities

Active Publication Date: 2010-12-08
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to research, oral preparations are far inferior to injections in terms of pharmacokinetics and bioavailability, especially when rescuing critically ill patients and patients with severe infections, injections have more advantages than oral preparations because of their fast onset of action and ease of use; Sterile powder for injection has not been prepared. According to research, when the molecular formula of faropenem sodium contains 2.5 crystal water, it is relatively stable. At this time, the moisture content of the raw material is about 15%. It is difficult to control the amount of bacteria in the process of sub-packaging; and the large water content of faropenem raw materials is used to directly sub-pack sterile powder preparations for injection, making it difficult to ensure its stability, so faropenem is not conducive to the preparation of sterile powder for injection. Bacteria powder unprepared

Method used

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  • Faropenem sodium freeze-drying powder and preparation method thereof
  • Faropenem sodium freeze-drying powder and preparation method thereof
  • Faropenem sodium freeze-drying powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 Preparation of Faropenem Sodium Freeze-dried Powder Injection

[0036] Faropenem Sodium 125g

[0037] Mannitol 100g

[0038]Sodium bisulfite 2g

[0039] Sodium hydroxide solution (0.05mol / l) appropriate amount

[0040] Add water for injection to 2000ml

[0041] Preparation Process:

[0042] (1) Weigh the prescribed amount of faropenem sodium, mannitol, and sodium bisulfite, dissolve them in an appropriate amount of water for injection cooled to below 30°C, then add an appropriate amount of activated carbon for needles, stir for 15 minutes, filter and decarbonize, and replenish Add water for injection to the full amount, stir evenly, adjust the pH to 6.5-7.5 with sodium hydroxide solution, then filter the liquid medicine through a 0.22 μm microporous membrane to sterilize, and fill the filtrate into a vial after passing the test , each bottle is filled with about 2ml, then half stoppered, and put into a freeze-drying box.

[0043] (2) Turn on the freeze d...

Embodiment 2

[0045] Example 2 Preparation of Faropenem Sodium Freeze-dried Powder Injection

[0046] Faropenem Sodium 125g

[0047] Mannitol 120g

[0048] Sodium thiosulfate 2g

[0049] Sodium bisulfite 1g

[0050] Sodium hydroxide solution (0.05mol / l) appropriate amount

[0051] Add water for injection to 2000ml

[0052] Preparation Process

[0053] Preparation Process:

[0054] (1) Weigh the prescribed amount of faropenem sodium, mannitol, sodium thiosulfate, and sodium bisulfite, dissolve in an appropriate amount of water for injection cooled to below 30°C, then add an appropriate amount of activated carbon for needles, and stir for 15 minutes. Filter and decarbonize, add water for injection to the full amount, stir evenly, adjust the pH to 6.5-7.5 with sodium hydroxide solution, then filter the medicinal solution through a 0.18 μm microporous membrane to sterilize, and pour the filtrate after passing the test. Packed in vials, each bottle filled with about 2ml, then half stopper...

Embodiment 3

[0057] Example 3 Preparation of Faropenem Sodium Freeze-dried Powder Injection

[0058] Faropenem Sodium 125g

[0059] Mannitol 100g

[0060] Glutathione 40g

[0061] Sodium hydroxide solution (0.05mol / l) appropriate amount

[0062] Add water for injection to 2000ml

[0063] Preparation Process:

[0064] (1) Weigh the prescribed amount of faropenem sodium, mannitol, and glutathione, dissolve them in an appropriate amount of water for injection cooled to below 30°C, then add an appropriate amount of activated carbon for needles, stir for 15 minutes, filter and decarbonize, and replenish Add water for injection to the full amount, stir evenly, adjust the pH to 6.5-7.5 with sodium hydroxide solution, then filter the liquid medicine through a 0.26 μm microporous membrane to sterilize, and fill the filtrate into a vial after passing the test , each bottle is filled with about 2ml, then half stoppered, and put into a freeze-drying box.

[0065] (2) Turn on the freeze dryer to ...

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Abstract

The invention belongs to the medicinal preparation field, and relates to faropenem sodium freeze-drying powder and a preparation method thereof. The invention provides the faropenem sodium freeze-drying powder with simple preparation, controllable quality, stable and physical and chemical properties and safe and effective use, wherein the freeze-drying powder contains 0.1 to 10 weight percent of faropenem sodium, 3 to 25 weight percent of excipient and 0.005 to 3 weight percent of antioxidant. The stability of the faropenem sodium freeze-drying powder prepared by a freeze-drying process is greatly improved, quality indexes of related substances, polymers and the like of main medicaments are well controlled, and the administration safety is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a faropenem sodium freeze-dried powder injection and a preparation method thereof. Background technique [0002] Faropenem is an atypical β-lactam antibiotic that is a derivative of penems. Two types of compounds, carbapenems and penems, have attracted great interest, and penems have more unique advantages. Currently, five penem derivatives are under development, and faropenem is convenient. is one of them. In addition to being weak against Pseudomonas aeruginosa, it has a broad antibacterial spectrum and is particularly effective against anaerobic bacteria, which is better than carbapenem antibiotics. It shows broad-spectrum antibacterial activity against aerobic and anaerobic Gram-positive bacteria and Gram-negative bacteria, especially against drug-resistant Staphylococcus, Enterococcus and other Gram-positive bacteria and Bacteroides and other anaerobic bacteria Al...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/431A61K47/42A61P31/04A61K47/18
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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