Moxifloxacin hydrochloride glucose injection and preparation method and use thereof

A technology of moxifloxacin hydrochloride and glucose, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as poor stability of preparations

Inactive Publication Date: 2010-09-22
HC SYNTHETIC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Adding metal ion complexing agent to moxifloxacin hydrochloride glucose injection of the present in

Method used

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  • Moxifloxacin hydrochloride glucose injection and preparation method and use thereof
  • Moxifloxacin hydrochloride glucose injection and preparation method and use thereof
  • Moxifloxacin hydrochloride glucose injection and preparation method and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1: the preparation of moxifloxacin hydrochloride glucose injection (0.4g / 250ml)

[0018] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0019] Glucose 12.5kg

[0020] Edetate Calcium Sodium 25g

[0021] Add water for injection to 250L

[0022]

[0023] 1000 bottles

[0024] 1) Obtain qualified moxifloxacin hydrochloride raw materials, glucose and edetate calcium sodium according to the ingredient list;

[0025] 2) Add water for injection with a batch volume of 95% in the batching tank, add the batching amount of glucose, edetate calcium sodium and moxifloxacin hydrochloride, stir to fully dissolve, then oxidize with 1mol / L hydrochloric acid solution or 1mol / L hydroxide Adjust the pH value to 4.0-4.5 with sodium, add medicinal charcoal according to 0.05% (W / V) of the total volume, stir evenly, keep warm at 70°C-80°C for 20 minutes, and...

Embodiment 2

[0032] Embodiment 2: the preparation of moxifloxacin hydrochloride glucose injection (0.4g / 100ml)

[0033] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0034] Glucose 5kg

[0035] Edetate Disodium 25g

[0036] Add water for injection to 100L

[0037]

[0038] 1000 bottles

[0039] 1) Obtain qualified moxifloxacin hydrochloride raw materials, glucose and edetate disodium according to the ingredient list;

[0040]2) Add water for injection with a batch volume of 90% in the batching tank, add glucose, edetate calcium sodium and moxifloxacin hydrochloride in batches, stir to fully dissolve, then oxidize with 1mol / L hydrochloric acid solution or 1mol / L hydroxide Adjust the pH value to 4.0-4.5 with sodium, add medicinal charcoal according to 0.05% (W / V) of the total volume, stir evenly, keep warm at 70°C-80°C for 20 minutes, and circulate and filter for more than ...

Embodiment 3

[0047] Embodiment 3: the preparation of moxifloxacin hydrochloride glucose injection (0.4g / 250ml)

[0048] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0049] Glucose 12.5kg

[0050] Edetic acid 20g

[0051] Water for injection plus 250L

[0052]

[0053] 1000 bottles

[0054] 1) Obtain qualified moxifloxacin hydrochloride raw materials, glucose and edetate calcium sodium according to the ingredient list;

[0055] 2) Add water for injection with a batch volume of 70% in the batching tank, add the batching amount of glucose, edetic acid and moxifloxacin hydrochloride, stir to fully dissolve, adjust the pH value to 4.0-4.5 with 1mol / L sodium hydroxide, Add medicinal charcoal according to 0.05% (W / V) of the total volume, stir evenly, keep warm at 70°C to 80°C for 20 minutes, and circulate and filter for more than 20 minutes;

[0056] 3) Add water for inject...

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Abstract

The invention provides moxifloxacin hydrochloride glucose injection and a preparation method and use thereof. The method for preparing the injection comprises the following steps of: adding water for injection accounting for 20 to 98 percent of the batch volume into an ingredient tank, and adding glucose, a metal complexing agent and the moxifloxacin hydrochloride in a ratio; after stirring to fully dissolve the components, regulating the pH value to between 4.0 and 4.5 by using 1mol/L hydrochloric acid solution or 1mol/L sodium hydroxide, adding medicinal carbon accounting for 0.05 percent (W/V) of the total volume, uniformly stirring, maintaining the temperature of between 70 and 80 DEG C for 20 minutes, and performing circular filtering for over 20 minutes; replenishing the water for injection to the batch scale, stirring for 5 to 10 minutes, and detecting the pH value of the prepared solution (controlling to between 4.0 and 4.5); after determining that no residual water is present in an elevated tank and a pipeline, opening a valve of the elevated tank, and sampling liquid medicament at a self-circulation pipeline sampling port after the liquid medicament circulates for 20 minutes through a filter element and the elevated tank; detecting according to the intermediate quality standard, requiring that the content of the moxifloxacin hydrochloride is between 1.52 and 1.68 mg/ml, the glucose content is between 47.5 and 52.5 mg/ml, and the pH value is between 4.0 and 4.5; after the intermediate is detected to be qualified, beginning to fill; and conveying the filled semi-finished products into a sterilizing cabinet for sterilization, wherein the sterilization condition is to sterilize for 8 to 30 minutes at 121 DEG C through thermal pressure steam.

Description

Technical field: [0001] The invention relates to a preparation of an injection containing moxifloxacin hydrochloride as a main medicinal component, a preparation method and an application thereof. technical background: [0002] Fluoroquinolones are fully synthetic antibacterial drugs that have developed very rapidly in the past two decades. They mainly act on the helicase and topoisomerase of bacterial DNA. They have the characteristics of broad antibacterial spectrum, strong antibacterial effect, and high safety. It is widely used clinically to treat respiratory, urinary tract, skin and soft tissue, ENT, gynecology, tuberculosis and other infections caused by Gram-positive bacteria, negative bacteria, and anaerobic bacteria. According to the chemical structure, antibacterial effect and in vivo process of quinolones, they can be divided into first, second, third and fourth generations, among which the third generation drugs such as ciprofloxacin and levofloxacin have excelle...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4709A61K47/24A61P31/04
Inventor 施维强建华
Owner HC SYNTHETIC PHARMA CO LTD
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