Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Preparation process of sterilized lidocaine hydrochloride injection packaged by plastic ampoule

A technology of lidocaine hydrochloride and preparation process, which is applied in the research field of lidocaine hydrochloride sterilization process and packaging materials, can solve the problems of inconvenient transportation of glass ampoules, easy adverse events caused by clinical use, large loss, etc., and achieve the reduction of particles The risk of contamination, good sealing performance, and the effect of improving work efficiency

Pending Publication Date: 2022-03-29
NANJING GRITPHARMA CO LTD
View PDF0 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problems of inconvenient transportation, high loss and adverse events in clinical use of glass ampoules existing in the prior art, the present invention provides a method of using polypropylene plastic ampoule as packaging material and sterilizing with superheated water at 121°C for 15 minutes , it can solve a series of problems caused by glass ampoules and ensure stable product quality

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Preparation process of sterilized lidocaine hydrochloride injection packaged by plastic ampoule
  • Preparation process of sterilized lidocaine hydrochloride injection packaged by plastic ampoule
  • Preparation process of sterilized lidocaine hydrochloride injection packaged by plastic ampoule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Preparation of lidocaine hydrochloride injection

[0023]

[0024] ①Put 80L of water for injection into the liquid mixing tank, and the temperature of the water for injection is 30°C-90°C.

[0025] ②Add sodium chloride and lidocaine hydrochloride into the liquid mixing tank and stir to dissolve completely.

[0026] ③ Use 1mol / L sodium hydroxide solution to adjust the pH of the solution to 4.0-6.0.

[0027] ④Add water for injection to make up to 1L.

[0028] ⑤ The liquid medicine is filtered through 0.45μm and 0.22μm microporous cartridge filters.

[0029] ⑥ The liquid medicine is filled in polypropylene ampoules.

[0030] ⑦The medicinal solution is sterilized by hot water, and the sterilization conditions are 121°C and 15min.

Embodiment 2

[0031] (2) embodiment 2 prepares lidocaine hydrochloride injection

[0032] Preparation of lidocaine hydrochloride injection

[0033]

[0034] ①Put 80L of water for injection into the liquid mixing tank, and the temperature of the water for injection is 30°C-90°C.

[0035] ②Add sodium chloride and lidocaine hydrochloride into the liquid mixing tank and stir to dissolve completely.

[0036] ③ Use 1mol / L sodium hydroxide solution to adjust the pH of the solution to 4.0-6.0.

[0037] ④Add water for injection to make up to 1L.

[0038] ⑤ The liquid medicine is filtered through 0.45μm and 0.22μm microporous cartridge filters.

[0039] ⑥ The liquid medicine is filled in glass ampoules.

[0040] ⑦The medicinal solution is sterilized by hot water, and the sterilization conditions are 121°C and 15min.

Embodiment 3

[0041] (3) embodiment 3 prepares lidocaine hydrochloride injection

[0042] Preparation of lidocaine hydrochloride injection

[0043]

[0044] ①Put 80L of water for injection into the liquid mixing tank, and the temperature of the water for injection is 30°C-90°C.

[0045] ②Add sodium chloride and lidocaine hydrochloride into the liquid mixing tank and stir to dissolve completely.

[0046] ③ Use 1mol / L sodium hydroxide solution to adjust the pH of the solution to 4.0-6.0.

[0047] ④Add water for injection to make up to 1L.

[0048] ⑤ The liquid medicine is filtered through 0.45μm and 0.22μm microporous cartridge filters.

[0049] ⑥ The liquid medicine is filled in polypropylene ampoules.

[0050] ⑦ The liquid medicine is sterilized by high-pressure steam, and the sterilization conditions are 121°C and 12min.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to research on a lidocaine hydrochloride sterilization process and a packing material. According to the lidocaine hydrochloride injection disclosed by the invention, the polypropylene plastic ampoule is used as a packing material of the lidocaine hydrochloride injection, and the sterilization process is that superheated water is sterilized for 15 minutes at 121 DEG C. The product quality is stable, the problems caused by the glass ampoule can be well solved, the clinical configuration process is optimized, and the lidocaine hydrochloride injection is convenient to transport and meets the environmental protection requirement.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to the research on lidocaine hydrochloride sterilization process and packaging materials. Background technique [0002] Lidocaine hydrochloride injection is an amide local anesthetic and antiarrhythmic drug. Administered by intravenous injection or intravenous drip, it has obvious excitatory and inhibitory biphasic effects on the central nervous system. At low doses, this product can promote the outflow of K+ in myocardial cells, reduce the self-discipline of the myocardium, and have anti-ventricular properties. Arrhythmia effect; at therapeutic dose, it has no obvious effect on the electrical activity of myocardial cells, atrioventricular conduction and myocardial contraction; further increase of blood drug concentration can cause slowing of cardiac conduction velocity, atrioventricular block, and inhibition of myocardial Contractility and decreased cardiac output. Main...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/04A61K31/167A61K9/08A61K47/02A61P23/02A61P9/06B67C7/00
CPCA61L2/0023A61K31/167A61K9/0019A61K9/08A61K47/02A61P23/02A61P9/06B67C7/0073A61L2202/21
Inventor 芦彩萍何红燕张倩倩罗琦吴小涛赵卿霍立茹李战
Owner NANJING GRITPHARMA CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com