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Injection for treating complex urinary tract infection and preparation method thereof

A technology for urinary tract infection and injection, applied in the field of medicine, can solve the problems of difficulty in achieving clarity and visible foreign matter, increase production costs, inconvenience in transportation, etc., and achieve the effects of convenient transportation, saving production costs, and improving solubility

Inactive Publication Date: 2020-09-22
WEIHAI OCEAN VOCATIONAL COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The inventor found in the test that the concentration of Zemdri (plazomicin) injection of Achaogen Company is 50mg / ml, and the filling volume is 10ml, which greatly increases the production cost and brings inconvenience to the transportation. The author solved this problem by increasing the concentration of plazomicin sulfate in the preparation, but found in the test that with the increase of the concentration of plazomicin sulfate, its solubility in the preparation was poor. At the same time, it was found through the test of influencing factors that high concentration The clarification and visible foreign matter of plazomicin sulfate preparations are difficult to meet the regulations as the storage time prolongs

Method used

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  • Injection for treating complex urinary tract infection and preparation method thereof
  • Injection for treating complex urinary tract infection and preparation method thereof
  • Injection for treating complex urinary tract infection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] plazomicin sulfate (calculated as plazomicin freebase) 250g Sodium thiosulfate 2.0g Dilute acetic acid solution to adjust pH 4.0 Diluted to water for injection 1000ml

[0032] Preparation Process

[0033] (1) Dissolve the prescribed amount of sodium thiosulfate and plazomicin sulfate in water for injection accounting for 55% of the total volume, raise the temperature to 60°C, and stir to dissolve for 13 minutes;

[0034] (2) Cool down to room temperature, adjust the pH value with an appropriate amount of dilute acetic acid solution, dilute to the total volume with water for injection, stir to mix and dissolve;

[0035] (3) Filtration, filling, sterilization, and visual inspection to obtain the finished product.

[0036] The finished preparation obtained in Example 1 of the present invention was placed in a constant temperature and humidity chamber at 25°C, and samples were taken at the 0th, 3rd, and 6th months to investigate changes in i...

Embodiment 2

[0040] prescription

[0041] plazomicin sulfate (calculated as plazomicin freebase) 200g Sodium thiosulfate 1.5g Dilute acetic acid solution to adjust pH 3.5 Diluted to water for injection 1000ml

[0042] Preparation Process

[0043] (1) Dissolve the prescribed amount of sodium thiosulfate and plazomicin sulfate in water for injection accounting for 50% of the total volume, raise the temperature to 55°C, and stir to dissolve for 10 minutes;

[0044] (2) Cool down to room temperature, adjust the pH value with an appropriate amount of dilute acetic acid solution, dilute to the total volume with water for injection, stir to mix and dissolve;

[0045] (3) Filtration, filling, sterilization, and visual inspection to obtain the finished product.

[0046] The finished preparation obtained in Example 2 of the present invention was placed in a constant temperature and humidity chamber at 25°C, and samples were taken at the 0th, 3rd, and 6th months to i...

Embodiment 3

[0050] prescription

[0051] plazomicin sulfate (calculated as plazomicin freebase) 300g Sodium thiosulfate 2.5g Dilute acetic acid solution to adjust pH 4.5 Diluted to water for injection 1000ml

[0052] Preparation Process

[0053] (1) Dissolve the prescribed amount of sodium thiosulfate and plazomicin sulfate in water for injection accounting for 60% of the total volume, raise the temperature to 65°C, and stir to dissolve for 16 minutes;

[0054] (2) Cool down to room temperature, adjust the pH value with an appropriate amount of dilute acetic acid solution, dilute to the total volume with water for injection, stir to mix and dissolve;

[0055] (3) Filtration, filling, sterilization, and visual inspection to obtain the finished product.

[0056] The finished preparation obtained in Example 3 of the present invention was placed in a constant temperature and humidity chamber at 25°C, and samples were taken at the 0th, 3rd, and 6th months to inv...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to an injection for treating complex urinary tract infection and a preparation method thereof. The invention relatesto an injection for treating complex urinary tract infection. The injection is mainly composed of an active component plazomicin sulfates, sodium thiosulfate, a dilute acetic acid solution and waterfor injection. According to the prepared injection for treating complex urinary tract infection, the solubility of the active ingredient plazomicin sulfates in a prescription is improved, the production cost in the preparation process of the preparation is saved, the product transportation is facilitated, and meanwhile, convenience is brought to clinical medication.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an injection for treating complicated urinary tract infection and a preparation method thereof. Background technique [0002] Complicated urinary tract infection refers to the occurrence of recurrent urinary tract infection when there are anatomical or functional abnormalities in the urinary tract system (such as obstruction, stones, etc.) Or continuous episodes of urinary tract infection caused severe damage to renal function. [0003] More than 95% of UTIs are caused by a single bacterium. Among them, 90% of the outpatients and about 50% of the inpatients have Escherichia coli as the pathogenic bacteria. The serotype of this bacteria can reach more than 140 kinds. Helicobacter belongs to the same type of bacteria, which are mostly seen in asymptomatic bacteriuria or uncomplicated urinary infection; Catheters, patients with complications of urine infection; Can...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61P13/02A61P31/04
CPCA61K31/7048A61P13/02A61P31/04
Inventor 孙亚敏李锡勇刘振华董济军
Owner WEIHAI OCEAN VOCATIONAL COLLEGE
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