Levofloxacin hydrochloride injection and preparation method thereof

A technology of levofloxacin hydrochloride and injection, which is applied in the field of medicine, can solve the problems of improper sterilization temperature and method, difficulty in avoiding light, poor stability, etc., and achieve the goal of solving the loss of metal elements, increasing the content of the main drug, and stabilizing the injection Effect

Active Publication Date: 2018-10-23
JIANGXI GUOYAO PHARMA LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to solve the above problems, the following measures can be taken: no contact with metal during the production process, but it is difficult to guarantee in the whole production line; add metal ion complexing agent to avoid the combination of metal ion and levofloxacin hydrochloride, but it will easily lead to the loss of metal in the human body; avoid light Preservation, but only suitable for prepared products, it is difficult to completely avoid light during the product preparation process
[0004] The traditional method of preparing levofloxacin hydrochloride sodium chloride injection, due to the defects in the process, such as the conventional use of medicinal charcoal is directly added to the liquid medicine, and the main drug will be adsorbed while adsorbing impurities. The adsorption amount of the main drug is too large, which affects the content of the drug
In the conventional process, there may also be improper selection or adjustment of the pH range, insufficient filtration, improper sterilization temperature and method, etc., resulting in dark color, poor clarity, many particles, and low stability of levofloxacin hydrochloride injection prepared by the traditional method. Poor, resulting in poor clinical effect and safety

Method used

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Examples

Experimental program
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Effect test

preparation example Construction

[0031] The invention provides a preparation method of levofloxacin hydrochloride injection, and the specific preparation steps include:

[0032] S1. Take the full amount of 45-55% water for injection, add glycerin by 0.1-2.0% (v / v) of the full amount of volume, then add lipoic acid and / or edetate calcium sodium 0.05-0.15 parts by weight, and sodium sulfite 0.1-0.3 Parts by weight, after dissolving, add diatomaceous earth and / or pretreated activated carbon for needles according to the weight to volume ratio of 0.1-0.2% (g / mL), heat and boil for 5-10min, cool to 35-40°C, and filter with a titanium rod filter, and then add pretreated activated carbon for needles to the filtrate according to the weight-to-volume ratio of 0.02-0.04% (g / mL), stir, and filter with a titanium rod filter to obtain liquid A;

[0033] S2. Take the full amount of 40-45% water for injection, add 10-15 parts by weight of levofloxacin hydrochloride, after dissolving, add the pretreated active carbon for need...

Embodiment 1

[0047] A preparation method of levofloxacin hydrochloride injection, the specific preparation steps are as follows:

[0048]S1. Take the full amount of 50% water for injection, add glycerol with a volume of 1.0% (v / v) of the total volume, then add 0.1 parts by weight of lipoic acid, and 0.2 parts by weight of sodium sulfite, stir to dissolve, and then add the water according to the weight to volume ratio (g / mL) ) 0.15% of diatomite and pretreated activated carbon for needles (the weight ratio of diatomite to activated carbon is 2:1), heated and boiled for 8min, cooled to 35°C, filtered with a titanium rod filter, and then filtered according to weight volume Ratio (g / mL) 0.03% Add pretreated activated carbon for needles to the filtrate, stir at a speed of 60r / min for 10min, and filter with a titanium rod filter to obtain liquid A.

[0049] S2. Take the full amount of 40% water for injection, add 12 parts by weight of levofloxacin hydrochloride, add the pretreated active carbon ...

Embodiment 2

[0053] A preparation method of levofloxacin hydrochloride injection, the specific preparation steps are as follows:

[0054] S1. Get the full amount of 45% water for injection, add the glycerol whose volume accounts for 0.1% (v / v) of the total volume, then add 0.15 parts by weight of calcium sodium edetate, and 0.3 parts by weight of sodium sulfite, stir and dissolve, and then according to the weight to volume ratio ( g / mL) 0.2%, add diatomaceous earth, heat and boil for 10min, cool to 35°C, filter with a titanium rod filter, and then add pretreated activated carbon for needles to the filtrate according to the weight-to-volume ratio (g / mL) 0.04% , stirred at a rotational speed of 50r / min for 10min, and filtered through a titanium rod filter to obtain liquid A.

[0055] S2. Take the full amount of 45% water for injection, add 15 parts by weight of levofloxacin hydrochloride, after dissolving, add the pretreated activated carbon for needles according to the weight volume ratio (...

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PUM

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Abstract

The invention relates to a preparation method of a levofloxacin hydrochloride injection. The method comprises the following steps: adding glycerin, lipoic acid and / or sodium calcium edetate, and sodium sulfite into water for injection, adding pre-treated activated carbon used for needles in two batches, and decarbonizing to obtain a solution A; adding levofloxacin hydrochloride into the water forinjection, dissolving, then adding the pre-treated activated carbon used for needles, and decarbonizing to obtain a solution B; adding the solution B into the solution A, supplementing the water for injection to a full dose, adjusting the pH to 4.0-4.6, filtering, carrying out ultrafiltration, sampling and inspecting ultrafiltrate, filling after the product is qualified, filling nitrogen, carryingout fused sealing, sterilizing, carrying out lamp inspection after cooling, packaging, and testing to obtain the finished product. The product prepared by the method is high in content of principal agents and good in stability, no visible foreign matter appears in a storage process, and the color of the product does not change.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a levofloxacin hydrochloride injection and a preparation method thereof. Background technique [0002] In the field of medical technology, levofloxacin injection is a quinolone antibacterial drug, which is the levorotatory form of ofloxacin, and its antibacterial activity is about twice that of ofloxacin. Its main mechanism of action is to inhibit the activity of bacterial DNA gyrase, inhibit Replication of bacterial DNA. Levofloxacin has the characteristics of broad antibacterial spectrum and strong antibacterial effect. [0003] Levofloxacin hydrochloride injection has the problem of easy photodegradation, and the color changes from yellow to yellow-green clear liquid to green clear liquid after light exposure. Studies have found that levofloxacin hydrochloride is easy to react with metal ions in the injection solution to form a transition state intermediate substance, whic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/10A61K47/02A61K31/5383A61P31/04
CPCA61K9/0019A61K9/08A61K31/5383A61K47/02A61K47/10A61P31/04
Inventor 高欢万义斌葛友群左飞鸿关媛媛周莉萍
Owner JIANGXI GUOYAO PHARMA LLC
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