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Preparation method for ciprofloxacin sodium chloride injection

A technology for ciprofloxacin lactate and sodium chloride injection, which is applied to medical preparations containing active ingredients, the digestive system, and pharmaceutical formulas, and can solve problems such as low medicinal value, potential safety hazards, and unqualified foreign bodies

Inactive Publication Date: 2018-12-07
GUIZHOU TIANDI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after the products produced by the existing production process are stored for several months, flocs will appear, causing visible foreign matter to be unqualified, affecting the quality of ciprofloxacin lactate injection, lowering its medicinal value, and possibly It will bring unsafe medication and other safety hazards

Method used

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  • Preparation method for ciprofloxacin sodium chloride injection
  • Preparation method for ciprofloxacin sodium chloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The present embodiment provides a kind of preparation method of ciprofloxacin lactate sodium chloride injection, comprising the following steps:

[0032] a. Preparation of water for injection: take drinking water, filter through quartz sand and activated carbon, pass through a 0.5 μm sieve, and the water under the sieve is processed by a reverse osmosis device to obtain purified water; At ℃, the conductivity is 3.8μs / cm, the total organic carbon is 0.38mg / L, and the flow rate is 1.89m / s;

[0033] Purified water is taken, distilled through a multi-effect distilled water machine, and then filtered through a 0.2 μm sterilizing filter to obtain water for injection, which is used as a solvent or other water; the pH value of the water for injection is 5, and at a temperature of 25°C, The conductivity is 0.6μs / cm, the total organic carbon is 0.42mg / L, the flow rate is 2.04m / s, and placed in a constant temperature circulation at a temperature of 75°C for standby; the circulatio...

Embodiment 2

[0050] The present embodiment provides a kind of preparation method of ciprofloxacin lactate sodium chloride injection, comprising the following steps:

[0051] a. Preparation of water for injection: take drinking water, filter through quartz sand and activated carbon, pass through a 0.5 μm sieve, and the water under the sieve is treated with a reverse osmosis device to obtain purified water; At ℃, the conductivity is 4.03μs / cm, the total organic carbon is 0.28mg / L, and the flow rate is 1.69m / s;

[0052] Take part of the purified water, sterilize it with ultraviolet light for 35 minutes, and then filter it through a 0.2 μm sterilizing filter to obtain water for each water point, such as washing water, soaking water, etc.;

[0053] Then take part of the purified water, carry out distillation treatment through a multi-effect distilled water machine, and then filter through a 0.2 μm sterilizing filter to obtain water for injection, which can be used as a solvent or other water; ...

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Abstract

The invention relates to the technical field of medical injection preparation and specially relates to a preparation method for a ciprofloxacin sodium chloride injection. The preparation method comprises the following preparation processes: preparing water for injection, weighting solute, preparing a concentrated solution, preparing a rare solution and encapsulating, sterilizing, inspecting with alamp, packaging, and the like. The dissolving uniformity of solutes in the water for injection is effectively increased under the mixing effect of special concentrated solution and rare solution andthrough the special preparation of the water for injection and the appropriate formula of ciprofloxacin injection; the purity of the processed ciprofloxacin injection is 99.0+ / -0.2%, through high-temperature and high-pressure sterilization, strict quality control and qualified packaging; the guarantee period is 24 months; no floccules or any visible suspended solids appear in the guarantee period;the medicinal value and the quality are both kept unchanged.

Description

technical field [0001] The invention relates to the technical field of preparation of medical injections, in particular to a preparation method of ciprofloxacin lactate sodium chloride injection. Background technique [0002] Ciprofloxacin Lactate Injection is used for the treatment of genitourinary system infections caused by sensitive bacteria, including simple and complicated urinary tract infections, bacterial prostatitis, Neisseria gonorrhoeae urethritis or cervicitis (including enzyme-producing strains) Respiratory tract infection, including acute attack of bronchial infection and pulmonary infection caused by sensitive Gram-negative bacilli; Gastrointestinal tract infection, caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophilia , Vibrio parahaemolyticus, etc.; typhoid fever; bone and joint infection; skin and soft tissue infection; systemic infection such as sepsis. [0003] Ciprofloxacin lactate, chemical name: 1-cyclopropyl-6-fluor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K9/08A61K47/02A61P31/04A61P13/02A61P13/08A61P15/00A61P11/00A61P1/00A61P19/08A61P19/02A61P17/00A61P43/00
CPCA61K9/0019A61K9/08A61K31/496A61K47/02A61P1/00A61P11/00A61P13/02A61P13/08A61P15/00A61P17/00A61P19/02A61P19/08A61P31/04A61P43/00
Inventor 钟明王万平
Owner GUIZHOU TIANDI PHARMA
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