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Powder and injection preparation of left ofloxacin hydrochloric acid, and preparation method

A technology of levofloxacin hydrochloride and powder injection, which is applied in the field of western medicine, can solve the problems of poor stability, deterioration of levofloxacin, and influence on drug quality, and achieve stable drug properties, good product stability, and low toxicity antibacterial efficacy

Inactive Publication Date: 2006-12-06
汤玉生
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the currently used injections have poor stability, short product shelf life, low batch pass rate, and are difficult to put into large-scale production, which brings inconvenience to the wide application in clinical practice.
Considering that levofloxacin in the injection is prone to deterioration and other phenomena, which will affect the quality of the drug and may cause adverse reactions during the medication process, it is necessary to develop a powder injection of levofloxacin to solve the above hidden dangers, but there is still a lack of relatively mature ones. Products and their preparation process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The levofloxacin hydrochloride powder injection of the present invention comprises levofloxacin hydrochloride and excipient, and the excipient used in the present embodiment is sorbitol, and its formula is:

[0028] Levofloxacin Hydrochloride 100g

[0029] Sorbitol for injection 50g

[0030] Add water for injection to 3000ml

[0031] Makes 1000 bottles

[0032] The preparation method adopted in this embodiment comprises the following steps:

[0033] 1) Weigh 100g of levofloxacin hydrochloride and 50g of sorbitol in the aseptic operation room, add them to 2400ml of hot water for injection, stir at 60°C to dissolve, and add water for injection to the full amount, that is, 3000ml;

[0034] 2) Add 0.05% activated carbon for needles and stir at 60°C for 15 minutes;

[0035] 3) decarbonize by filtering with a sterilized sand core filter stick of outsourcing filter paper;

[0036] 4) Sterilize and filter with a sterilized 0.22 microporous membrane;

[0037] 5) After the ...

Embodiment 2

[0045] The levofloxacin hydrochloride powder injection of the present invention comprises levofloxacin hydrochloride and excipient, and the excipient used in the present embodiment is glucose, and its formula is:

[0046] Levofloxacin Hydrochloride 200g

[0047] Glucose for injection 100g

[0048] Add water for injection to 3000ml

[0049] Makes 1000 bottles

[0050] The preparation method adopted in this embodiment comprises the following steps:

[0051] 1) Weigh 200g of levofloxacin hydrochloride and 100g of glucose in the aseptic operation room, add them to 2400ml of hot water for injection, stir at 60°C to dissolve, and add water for injection to the full amount of 3000ml;

[0052] 2) Add 0.05% activated carbon for needles and stir at 60°C for 15 minutes;

[0053] 3) decarbonize by filtering with a sterilized sand core filter stick of outsourcing filter paper;

[0054] 4) Sterilize and filter with a sterilized 0.22 microporous membrane;

[0055] 5) After the filtrate...

Embodiment 3

[0060] The levofloxacin hydrochloride powder injection of the present invention comprises levofloxacin hydrochloride and an excipient, and the excipient used in this embodiment is dextran, and its formula is:

[0061] Levofloxacin Hydrochloride 300g

[0062] Dextran for Injection 150g

[0063] Add water for injection to 3000ml

[0064] Makes 1000 bottles

[0065] The preparation method adopted in this embodiment comprises the following steps:

[0066] 1) Weigh 300g of levofloxacin hydrochloride and 150g of dextran in the aseptic operation room, add them to 2400ml of hot water for injection, stir at 60°C to dissolve, and add water for injection to the full amount, namely 3000ml;

[0067] 2) Add 0.05% activated carbon for needles and stir at 60°C for 15 minutes;

[0068] 3) decarbonize by filtering with a sterilized sand core filter stick of outsourcing filter paper;

[0069] 4) Sterilize and filter with a sterilized 0.22 microporous membrane;

[0070] 5) After the filtrate ...

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Abstract

A powder injection of lavo-ofloxacin hydrochloride with high antibacterial effect is prepared from lavo-ofloxacin hydrochloride and excipient in weight ratio of 2:1. Its preparing process is also disclosed.

Description

technical field [0001] The invention belongs to the field of western medicine, and relates to a levofloxacin hydrochloride powder injection and a preparation method thereof. Background technique [0002] Levofloxacin (LVFX) is a fluoroquinolone antibacterial drug. It is the optically active levoisomer of the new quinolone ofloxacin (OFLX) developed in the late 1980s and was launched as a drug in the mid-1990s. The in vitro antibacterial activity of levofloxacin is about 2 times that of OFLX, 8-128 times that of the dextro isomer, and has less toxic and side effects. The dose of levofloxacin is small and the indications are wide, and it is widely used clinically for infection symptoms of the respiratory system, gastrointestinal tract, urinary tract, and ENT. [0003] Many domestic pharmaceutical companies have been approved to produce tablets and injections of levofloxacin, which has become another excellent broad-spectrum antibacterial drug due to its high efficiency, low t...

Claims

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Application Information

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IPC IPC(8): A61K31/5383A61K9/19A61P31/04
Inventor 汤玉生张贞良刘铁球
Owner 汤玉生
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