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

Potassium magnesium aspartate injection and preparation method thereof

A technology of potassium magnesium aspartate and potassium aspartate, applied in the field of medicine, can solve problems such as precipitation of raw materials

Inactive Publication Date: 2015-11-18
REYOUNG PHARMA
View PDF5 Cites 3 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to provide a kind of potassium magnesium aspartate injection, has solved the deficiency that adopts aspartic acid and sylvite (potassium hydroxide) and magnesium oxide reaction feed intake, also solved simultaneously the problem that raw material separates out in storage process Problem; The present invention also provides its preparation method

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
  • Potassium magnesium aspartate injection and preparation method thereof
  • Potassium magnesium aspartate injection and preparation method thereof
  • Potassium magnesium aspartate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-5

[0032] Add water for injection of 2 / 3 of the total volume of the prepared medicinal solution, add 400 g of magnesium aspartate, and stir until dissolved. Add 450 g of potassium aspartate and stir until dissolved. Weigh 5 g of activated carbon, add it to the above solution, and stir for 15 min. Add water for injection to 10000ml, stir well. Store the filtered medicinal solution at 25-40°C. Fill and seal the filtered medicinal solution in glass ampoules. The intermediate product after potting is sterilized (121°C for 15min) and leak tested.

[0033] See Table 1 for the stirring speeds of adding magnesium aspartate and potassium aspartate and the time required for the complete dissolution of magnesium aspartate in Examples 1-5.

[0034] Table 1 embodiment 1-5 stirring speed and magnesium aspartate all dissolve required time

[0035]

[0036]

[0037] It can be seen from the data in Table 1 that the preferred process parameters are: stirring speed 100 rpm, temperature o...

Embodiment 6-10

[0039] Add 70°C water for injection of 2 / 3 of the total volume of the prepared drug solution, add 400 g of magnesium aspartate, and stir at 100 rpm for 15 min. Add 450 g of potassium aspartate and stir until dissolved. Take the gac of embodiment amount, add in the above-mentioned solution, stir. Add water for injection to 10000ml, stir well. Store the filtered medicinal solution at 25-40°C. Fill and seal the filtered medicinal solution in glass ampoules. The intermediate product after potting is sterilized (121°C for 15min) and leak tested.

[0040] See Table 2 for activated carbon consumption and time in Examples 6-10.

[0041] Active carbon consumption and time in table 2 embodiment 6-10

[0042] project

[0043] The purpose of adding activated carbon in the production process of injections is to adsorb pyrogens and decolorize. If the amount is too small, it may not be able to remove pyrogens and decolorize. If the amount is too large, it may cause drug adsor...

Embodiment 11-13

[0045] Add 2 / 3 of the total volume of the prepared drug solution with 70°C water for injection, add 400 g of magnesium aspartate, and stir at 100 rpm for 10 min. Add 450 g of potassium aspartate and stir until dissolved. Weigh 5 g of activated carbon, and add it into the above solution, and stir. Add water for injection to 10000ml, stir well. In order to facilitate the storage of the medicinal solution at different temperatures, the medicinal solution was filled in 10ml glass ampoules, and 200 ampoules were stored at each temperature.

[0046] See Table 3 for the solution storage temperature and time during the filling process of Examples 11-13.

[0047] As can be seen from the data in Table 3, the storage temperature of the potassium magnesium aspartate solution during the filling process is 25-40°C, and the preferred storage temperature is 30°C.

[0048] Solution storage temperature and time in the filling process of table 3 embodiment 11-13

[0049] project

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 medicine and particularly relates to a potassium magnesium aspartate injection and a preparation method thereof. The injection comprises raw and auxiliary materials in parts by weight as follows: 400-500 parts of potassium aspartate, 350-450 parts of magnesium aspartate and 10,000 parts of water for injection. The potassium magnesium aspartate injection overcomes the defect about batch charging for reaction of aspartate with sylvite (potassium hydroxide) and magnesium oxide and solves the problems about raw material dissolution in a storage process simultaneously. The invention further provides a preparation method of the potassium magnesium aspartate injection. The preparation method comprises the following steps: the water for injection accounting for 2 / 3 of the total volume of a prepared medical solution is added, and magnesium aspartate is added and stirred until magnesium aspartate is dissolved; potassium aspartate is added and stirred until potassium aspartate is dissolved; activated carbon is weighed and added to the solution, and the mixture is stirred for 15 min; the water for injection is added to the total volume, and uniform stirring is performed; filtered medical solution is subjected to heat-preservation storage at the temperature of 25-40 DEG C; the filtered medical solution is encapsulated in a glass ampule, and an intermediate product after encapsulation is subjected to sterilization and leak detection; the process is simple and easy to implement.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a potassium magnesium aspartate injection and a preparation method thereof. Background technique [0002] Potassium magnesium aspartate is a sugar, salt and acid-base balance regulating drug, used for the treatment of arrhythmia caused by hypokalemia, hypokalemia and digitalis poisoning, viral hepatitis, liver cirrhosis and hepatic encephalopathy. [0003] Potassium and magnesium aspartate compound preparations mostly use the production process of feeding aspartic acid, potassium salt (such as potassium hydroxide) and magnesium oxide. This production process is prone to quality problems in actual production, which may cause safety hazards and affect clinical practice. Application effects, such as inaccurate feeding, uneven quality between different batches, and the introduction of a large number of impurities, etc., especially for injections, this feeding method cannot remove ...

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): A61K31/198A61K9/08A61P9/06A61P1/16A61P31/12A61P25/00
Inventor 赵玉山黄京山翟乃明孙兆宾邵伟
Owner REYOUNG PHARMA
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