Neostigmine methylsulfate frozen-dried preparation for injection and preparation method of neostigmine methylsulfate frozen-dried preparation

A technology of neostigmine methylsulfate and freeze-dried preparation, applied in the field of medicine, can solve problems such as unfavorable product storage or long-distance transportation

Active Publication Date: 2019-12-20
JIANGSU JIUXU PHARMA +1
View PDF4 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is not good for product stora

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
  • Neostigmine methylsulfate frozen-dried preparation for injection and preparation method of neostigmine methylsulfate frozen-dried preparation
  • Neostigmine methylsulfate frozen-dried preparation for injection and preparation method of neostigmine methylsulfate frozen-dried preparation
  • Neostigmine methylsulfate frozen-dried preparation for injection and preparation method of neostigmine methylsulfate frozen-dried preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] a. Weigh 1g neostigmine methylsulfate, 20g mannitol, dissolve and dilute to 1000ml with water for injection;

[0053] b. Filter with a 0.22um filter element, and fill 1ml of the filtrate into a 3ml vial;

[0054] c. Put the control bottle of sub-package liquid into the freeze dryer;

[0055] d. Reduce the shelf temperature of the freeze dryer to below -35°C at a rate of 30°C per hour;

[0056] e. When the temperature of the product drops below -40°C, keep it warm for 2 hours;

[0057] f. Raise the shelf temperature to -20°C and keep it warm for 1 hour;

[0058] g. Lower the shelf temperature to -40°C and keep it warm for 2 hours;

[0059] h. Raise the shelf temperature to -25°C and keep it warm for 1 hour;

[0060] i. Lower the shelf temperature to -45°C and keep it warm for 4 hours;

[0061] j. Start vacuuming, when the vacuum degree is below 10-20Pa, start to heat up;

[0062] k. Raise the shelf temperature to -15°C and keep it for 15 hours;

[0063] l. Raise the...

Embodiment 2

[0067] a. Weigh 1g neostigmine methylsulfate, 50g mannitol, dissolve and dilute to 1500ml with water for injection;

[0068] b. Filter with a 0.22um filter element, and fill 1.5ml of the filtrate into a 3ml vial;

[0069] c. Put the control bottle of sub-package liquid into the freeze dryer;

[0070] d. Reduce the shelf temperature of the freeze dryer to below -35°C at a rate of 30°C per hour;

[0071] e. When the temperature of the product drops below -40°C, keep it warm for 2 hours;

[0072] f. Raise the shelf temperature to -20°C and keep it warm for 2 hours;

[0073] g. Lower the shelf temperature to -40°C and keep it warm for 2 hours;

[0074] h. Raise the shelf temperature to -25°C and keep it warm for 2 hours;

[0075] i. Then lower the shelf temperature to -45°C and keep it warm for 5 hours;

[0076] j. Start vacuuming, when the vacuum degree is below 10-20Pa, start to heat up;

[0077] k. Raise the shelf temperature to -15°C and keep it for 17 hours;

[0078] l...

Embodiment 3

[0082] a. Weigh 1g neostigmine methosulfate, 100g mannitol, dissolve and dilute to 2000ml with water for injection;

[0083] b. Filter with a 0.22um filter element, and fill 2ml of the filtrate into a 5ml vial;

[0084] c. Put the control bottle of sub-package liquid into the freeze dryer;

[0085] d. Reduce the shelf temperature of the freeze dryer to below -35°C at a rate of 30°C per hour;

[0086] e. When the temperature of the product drops below -45°C, keep it warm for 3 hours;

[0087] f. Raise the shelf temperature to -20°C and keep it warm for 2 hours;

[0088] g. Lower the shelf temperature to -40°C and keep it warm for 3 hours;

[0089] h. Raise the shelf temperature to -25°C and keep it warm for 2 hours;

[0090] i. Then lower the shelf temperature to -50°C and keep it warm for 5 hours;

[0091] j. Start vacuuming, when the vacuum degree is below 10-20Pa, start to heat up;

[0092] k. Raise the shelf temperature to -15°C and keep it for 20 hours;

[0093] l. ...

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

PropertyMeasurementUnit
Diameteraaaaaaaaaa
Login to view more

Abstract

The invention relates to a neostigmine methylsulfate frozen-dried preparation for injection and a preparation method of the neostigmine methylsulfate frozen-dried preparation. Neostigmine methylsulfate injection is instable when meeting light and heat, and a mainly degradation impurity namely 3-hydroxy tricresylamine neostigmine methylsulfate has a genotoxicity warning structure. In order to improve stability, the inventor improves the preparation formulation, and the frozen-dried preparation is prepared. Through recipe screening and process improvement, the frozen-dried preparation product isobtained. The obtained product is good in appearance, good in redissolution properties and good in clarity, and the main degradation impurity namely 3-hydroxy tricresylamine neostigmine methylsulfateis greatly reduced, so that the product safety and stability are improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a freeze-dried preparation of neostigmine methylsulfate for injection and a preparation method thereof. [0002] technical background [0003] Neostigmine methosulfate is a category A variety in the national basic medical insurance catalogue, and it is widely used clinically to antagonize the residual effect of non-polarizing muscle relaxants, diagnose myasthenia gravis, prevent and treat functional paralytic ileus and contractile urinary tract obstruction. retention. [0004] At present, the main dosage forms of neostigmine methosulfate are tablets or injections. For example, CN201610105070.2 discloses a neostigmine methosulfate injection, which dissolves neostigmine methosulfate in water, filters, controls pH, encapsulates and sterilizes, and obtains an injection. [0005] However, neostigmine methosulfate injection is likely to cause some troubles to production and storage due...

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
IPC IPC(8): A61K9/19A61K31/27A61K47/26A61P1/00A61P13/10A61P21/04F26B5/06
CPCA61K31/27A61K9/19A61K9/0019A61K47/26A61P21/04A61P1/00A61P13/10F26B5/06
Inventor 李宏毛黎静理广洲
Owner JIANGSU JIUXU PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap