Enoxacin Glyconate little volume injection and its preparation method

A technology of enoxacin and enoxacin, which is applied in the field of small-volume injection of enoxacin gluconate and its preparation, can solve the problems of limited clinical application range, insufficient stability, easy oxidation, etc., and achieve definite curative effect , good stability and easy to use

Inactive Publication Date: 2004-12-29
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Enoxacin Gluconate (English name: Enoxacin Gluconate; chemical name: 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-1,8 -Naphthyridine-3-carboxylic acid-D-gluconate-hydrate) is a salt compound of quinolone antibacterial drug enoxacin, and the large-volume injection of enoxacin gluconate has been used clinically and has achieved good results. However, because enoxacin gluconate large-volume injection is affected by its packaging method, its solution is directly exposed to air, easy to oxidize, and the stability is not good enough, while small-volume injection can solve the above problems very well and improve the drug quality. stability
[0003] In addition, currently only enoxacin gluconate injection is used clinically in the market, which limits the scope of clinical application. According to the pharmacological and pharmacodynamic characteristics of enoxacin gluconate, various dosage forms can also be developed, such as small volume injection, powder Injections, eye drops, etc. for clinicians to choose

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Enoxacin Gluconate 167.5g

[0015] Water for injection 2000ml

[0016] A total of 1000 injections were made

[0017] Preparation process and preparation of liquid medicine:

[0018] Add 1000ml of water for injection at 50-60°C in the batching pot, then add the prescribed amount of enoxacin gluconate, stir, add 10g of activated carbon for needles after fully dissolved, heat and boil for 15 minutes, filter, and use 0.1N hydrochloric acid for the filtrate After adjusting the pH to 4.0-5.5, add water to the full amount, and the measured content should be 93.0%-107.0% of the marked amount. After passing the test, filter it with a 0.45μm microporous membrane, and hand the filtrate to the potting group;

[0019] Filling and sealing: the ampoules used for filling are washed with water for injection, dried, and the liquid medicine enters the injection filling and sealing machine, filled in the ampoules, and then filled with nitrogen gas to seal.

[0020] Sterilization: Steril...

Embodiment 2

[0055] Enoxacin Gluconate 167.5g

[0056] Glucose 100g

[0057] Water for injection 2000ml

[0058] A total of 1000 pieces were made

[0059] The preparation method is the same as in Example 1 except that the auxiliary materials are added according to the prescription amount.

Embodiment 3

[0061] Enoxacin Gluconate 167.5g

[0062] Sodium chloride 18g

[0063] Water for injection 2000ml

[0064] A total of 1000 pieces were made

[0065] The preparation method is the same as in Example 2 except that the auxiliary materials are added according to the prescription amount.

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Abstract

The present invention relates to new Enoxacin gluconate preparation, and is especially small dosage Enoxacin gluconate injection and its preparation process. The injection consists of Enoxacin gluconate as active component pharmacologically acceptable carrier component. The injection of the present invention has stability superior to that of great dosage Enoxacin gluconate injection, and the active component may be also prepared into powder for injection and eye drop.

Description

technical field [0001] The invention relates to a new preparation of the antibacterial drug enoxacin gluconate, in particular to a small-capacity injection of enoxacin gluconate and a preparation method. Background technique [0002] Enoxacin Gluconate (English name: Enoxacin Gluconate; chemical name: 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-1,8 -Naphthyridine-3-carboxylic acid-D-gluconate-hydrate) is a salt compound of quinolone antibacterial drug enoxacin, and the large-volume injection of enoxacin gluconate has been used clinically and has achieved good results. However, because enoxacin gluconate large-volume injection is affected by its packaging method, its solution is directly exposed to air, easy to oxidize, and the stability is not good enough, while small-volume injection can solve the above problems very well and improve the drug quality. stability. [0003] In addition, currently only enoxacin gluconate injection is used cl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61P27/02A61P31/04
Inventor 杨波耿海明周建明
Owner GRAND PHARM (CHINA) CO LTD
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