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Moxifloxacin hydrochloride sodium chloride injection and preparation process thereof

A technology of moxifloxacin hydrochloride and sodium chloride injection, which is applied to medical preparations containing active ingredients, drug delivery, antibacterial drugs, etc., can solve the problems of loss of drug efficacy, increase of filtration costs, etc., and reduce the total number of bacteria Quantity, good sterilization effect, good therapeutic effect

Inactive Publication Date: 2020-01-24
SICHUAN TAIPINGYANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Therefore, in the existing production method of Moxifloxacin Hydrochloride Sodium Chloride Injection, it is desired to better control the number of bacteria, but also to worry about the loss of drug efficacy and increase the cost of filtration, which is a problem that is difficult to solve.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1: Prepare moxifloxacin hydrochloride sodium chloride injection in a 250ml infusion bag.

[0053] Raw materials Manufacturer g / bag Moxifloxacin hydrochloride Shenyang Zhonghai Pharmaceutical Co., Ltd. 0.437 Sodium chloride 2.0g (W / V0.8%) Water for Injection 250ml

Embodiment 2

[0055] Preparation of Moxifloxacin Hydrochloride Sodium Chloride Injection.

[0056] 1. Before preparing samples, passivate stainless steel container equipment with 1% EDTA-2Na solution. The passivation method is as follows: inject water for injection at 65°C-66°C into the stainless steel container equipment, the volume accounts for 60% of the total volume of the stainless steel container equipment; weigh EDTA-2Na and add it into the tank and stir until dissolved. Stop stirring and continue to add water for injection until the tank is full, so that the solution is filled with stainless steel container equipment, the passivation temperature is 70°C, and the passivation time is 1h. Then drain the solution from the stainless steel container equipment and clean the passivated equipment.

[0057] 2. Weigh the prescribed amount of moxifloxacin hydrochloride, add it to the prescribed amount of water for injection, the water temperature is 60°C, stir to dissolve.

[0058] 3. Weigh t...

Embodiment 3

[0066] Preparation of Moxifloxacin Hydrochloride Sodium Chloride Injection.

[0067] 1. Before preparing samples, passivate stainless steel container equipment with 1% EDTA-2Na solution. The passivation method is as follows: inject water for injection at 70°C-73°C into the stainless steel container equipment, the volume accounts for 70% of the total volume of the stainless steel container equipment; weigh EDTA-2Na and add it into the tank and stir until dissolved. Stop stirring and continue to add water for injection until the tank is full, so that the solution is filled with stainless steel container equipment, the passivation temperature is 70°C, and the passivation time is 1h. Then drain the solution from the stainless steel container equipment and clean the passivated equipment.

[0068] 2. Weigh the prescribed amount of moxifloxacin hydrochloride, add it to the prescribed amount of 65°C water for injection, and stir to dissolve.

[0069] 3. Weigh the prescribed amount o...

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Abstract

The invention provides moxifloxacin hydrochloride sodium chloride injection and a preparation process, and the moxifloxacin hydrochloride sodium chloride injection is prepared according to the following proportion: 0.437 part of moxifloxacin hydrochloride and 2 parts of sodium chloride are added into 250 parts of water for injection. The preparation process comprises the following steps: passivating stainless steel container equipment, filling water for injection, adding moxifloxacin hydrochloride into the water for injection, stirring the materials to dissolve moxifloxacin hydrochloride, adding activated carbon, performing adsorbing, and filtering the material to remove carbon to obtain a primary filtrate; detecting the content of an intermediate, and supplementing the water for injectionto a prescription dosage; and finely filtering, filling and sterilizing. The invention provides a novel proportioning component and proportioning proportion of the moxifloxacin hydrochloride sodium chloride injection. The preparation process disclosed by the invention has the good sterilization effect.

Description

technical field [0001] The invention relates to an injection and a preparation process. It belongs to the field of injection medicine production. Background technique [0002] Moxifloxacin hydrochloride sodium chloride injection is indicated for adults (≥18 years old) with upper and lower respiratory tract infections, such as: acute sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia; and skin and soft tissue infections. Complicated abdominal infections include mixed bacterial infections such as abscesses. The human preparation ratio of Moxifloxacin Hydrochloride Sodium Chloride Injection has never been better, which makes the existing Moxifloxacin Hydrochloride Sodium Chloride Injection less effective, and the therapeutic effect needs to be further improved. [0003] In the production process of injections, aseptic production has always been the key to the production of injections. During the production of injections, multiple sterilizations ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K31/4709A61P31/04
CPCA61K9/0019A61K9/08A61K31/4709A61K47/02A61P31/04
Inventor 张加宇许艳春文娟王利华
Owner SICHUAN TAIPINGYANG PHARMA
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