Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof

A technology of moxifloxacin hydrochloride and sodium chloride injection, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of uneven production and quality standards of activated carbon, concentration It is not easy to dissolve, and the activated carbon is flying, so as to ensure the effectiveness and safety, stable product quality, and reduce the pressure of environmental protection.

Pending Publication Date: 2020-07-10
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the two-step preparation, the concentrated preparation is not easy to dissolve, and two preparation tanks are required, the consumption of equipment cleaning and cleaning control is large, and the risk of contamination is high
Activated carbon has an adsorption effect on moxifloxacin, and excessive feeding is required to meet the quality requirements. Moreover,...

Method used

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  • Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof
  • Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof
  • Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof

Examples

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preparation example Construction

[0028] The embodiment of the present invention provides a preparation method of moxifloxacin hydrochloride sodium chloride injection, comprising the following steps:

[0029] Add moxifloxacin hydrochloride, sodium chloride and pH regulator into the water for injection, control the temperature at 65-75°C, stir for 10-15min, after dissolving evenly, test according to the intermediate quality standard, test the content, pH value, visible foreign matter , after passing the test, filter through 3 or 4 groups of polyethersulfone filter elements with sequentially decreasing pore diameters, fill, sterilize, and pack after passing the light inspection to obtain the moxifloxacin hydrochloride sodium chloride injection product.

Embodiment 1

[0032] A preparation method of moxifloxacin hydrochloride sodium chloride injection, comprising the steps of:

[0033] Prescription: Moxifloxacin hydrochloride (calculated as moxifloxacin) 400mg, sodium chloride 2.0g, water for injection 250mL, pH adjuster (sodium hydroxide or hydrochloric acid) appropriate amount, filling specification 0.4g / 250mL, calculated in 1000 bags.

[0034] S1: Add water for injection with 50% of the total volume of the injection in the concentrated preparation tank, control the temperature at 65°C, add the prescribed amount of moxifloxacin hydrochloride and sodium chloride in sequence, stir to dissolve, and pass through the polyether with a pore size of 1.0 μm The sulfone filter element A is used for filtering, and the polyethersulfone filter element A is washed with water for injection with 15% of the total volume of the injection solution, and the flushing solution and the filtrate are sent to the dilute distribution tank together;

[0035] S2: Add ...

Embodiment 2

[0037] A preparation method of moxifloxacin hydrochloride sodium chloride injection, comprising the steps of:

[0038] Prescription: Moxifloxacin hydrochloride (calculated as moxifloxacin) 413mg, sodium chloride 2.1g, water for injection 255mL, appropriate amount of pH regulator (sodium hydroxide or hydrochloric acid), the filling specification is 0.4g / 250mL, calculated in 1000 bags.

[0039] S1: Add water for injection with 30% of the total volume of the injection in the concentrated preparation tank, control the temperature at 75°C, add the prescribed amount of moxifloxacin hydrochloride and sodium chloride in sequence, stir to dissolve, and pass through the polyether with a pore size of 1.0 μm The sulfone filter element A is used for filtering, and the polyethersulfone filter element A is washed with water for injection with 20% of the total volume of the injection solution, and the flushing solution and the filtrate are sent to the dilute distribution tank together;

[004...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses a moxifloxacin hydrochloride sodium chloride injection and a preparation method thereof. The preparation method comprises the following steps: adding moxifloxacin hydrochloride, sodium chloride and a pH regulator into water for injection, stirring for dissolving, filtering through 3 or 4 groupsof polyether sulfone filter elements with sequentially reduced pore diameters, performing filling, and sterilizing to obtain the moxifloxacin hydrochloride sodium chloride injection. The injection provided by the invention is stable in batch content, low in related substance content, high in effectiveness and safety and good in stability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a moxifloxacin hydrochloride sodium chloride injection and a preparation method thereof. Background technique [0002] Moxifloxacin hydrochloride is a broad-spectrum and 8-methoxyfluoroquinolone antibacterial drug with antibacterial activity. Clinically, it is mainly used for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, complicated intra-abdominal infection, and skin and skin tissue infection. Clinically, Moxifloxacin Hydrochloride Sodium Chloride Injection for intravenous infusion is a 250ml large-volume injection; it is used to rescue critically ill patients, and has a quick onset and remarkable curative effect. [0003] The existing Moxifloxacin Hydrochloride Sodium Chloride Injection is packaged in a semi-open glass bottle, and the preparation method is divided into two steps of concen...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4709A61K47/02A61K47/04A61P31/04B65D30/08
CPCA61K9/0019A61K9/08A61K31/4709A61K47/02A61P31/04B65D31/04
Inventor 王立江赵勇征王晖王恰茹杨义
Owner SHIJIAZHUANG NO 4 PHARMA
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