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Potassium aspartate pharmaceutical composition and preparation method thereof

A technology of potassium aspartate and magnesium aspartate, which is applied in the field of pharmaceutical compositions, and can solve the problem of inability to complete capsule and powder filling and tablet compression process, poor fluidity of potassium aspartate agglomerated particles , environmental humidity and high requirements for pharmaceutical equipment, etc., to achieve the effect of stable and reliable product quality, reasonable proportion and good compressibility

Active Publication Date: 2013-07-03
内蒙古白医制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Due to the strong hygroscopicity of potassium aspartate, large dose, poor compressibility and formability, the preparation of this preparation requires high environmental humidity and pharmaceutical equipment.
For example, the pre-test was carried out under the conditions of relative humidity (RH) 45%-65% in the production environment of general solid preparations according to the "Good Manufacturing Practice (GMP)", and it was found that potassium aspartate was in the process of crushing, mixing, and granulation. Medium and large areas of agglomeration, wall sticking, and poor fluidity of particles cannot complete the filling process such as capsules and powders and tablet compression. However, in the pharmaceutical production workshop specially designed to strengthen the dehumidification function, for example, reduce the humidity of the pharmaceutical production environment to RH30 % below, it can meet the requirements of the preparation process, but it will inevitably increase the production cost

Method used

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  • Potassium aspartate pharmaceutical composition and preparation method thereof
  • Potassium aspartate pharmaceutical composition and preparation method thereof
  • Potassium aspartate pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1、2、3、5、6、9

[0097] Embodiment 1,2,3,5,6,9 preparation method is:

[0098] a. Take potassium aspartate or magnesium aspartate and micropowder silica gel, pulverize

[0099] b. Pass through a 100-mesh sieve, add microcrystalline cellulose, starch, croscarmellose sodium, magnesium stearate, and mix well

[0100] c. Configure 5% ethyl cellulose ethanol solution as a binder

[0101] d. Add an appropriate amount of binder to make soft materials, pass through a 20-mesh sieve and granulate

[0102] e. Dry the wet granules in a blast oven at 60°C for 1 hour, and sort through a 18-mesh sieve

[0103] f. Inspection of semi-finished products, with Die pressing

[0104] g. Film-coat the plain tablets, the coating powder is Colorcon OY-S-28827, to increase the weight by 2-3%

[0105] h. Aluminum-plastic packaging, ready to use

Embodiment 4

[0106] Embodiment 4 preparation method is:

[0107] a. Take potassium aspartate or micronized silica gel, pulverize

[0108] b. Pass through a 100-mesh sieve, add microcrystalline cellulose, and mix well

[0109] c. configure 5% povidone ethanol solution as adhesive

[0110] d. Add an appropriate amount of binder to make soft materials, pass through a 20-mesh sieve and granulate

[0111] e. Dry the wet granules in a blast oven at 60°C for 1 hour, sort through a 18-mesh sieve, add croscarmellose sodium and magnesium stearate, and mix

[0112] f. Inspection of semi-finished products, with Die pressing

[0113] g. Film-coat the plain tablets, the coating powder is Colorcon OY-S-28827, to increase the weight by 2-3%

[0114] h. Aluminum-plastic packaging, ready to use

Embodiment 7、 Embodiment 8

[0115] Embodiment 7, embodiment 8 preparation method are:

[0116] a. Mix potassium aspartate with micropowder silica gel and pulverize

[0117] b. Through 100 mesh sieve

[0118] c. Configure 5% ethyl cellulose ethanol solution as a binder

[0119] d. Add an appropriate amount of binder to make a suitable soft material, pass through a 20-mesh standard sieve, and granulate

[0120] e. Wet granules are dried at 60°C±5°C and crushed through a 60-mesh sieve

[0121] f. Inspection of semi-finished products

[0122] g. Aluminum foil bags are directly subpackaged (Example 7, granules) or filled with capsules (Example 8, Capsules), and packed in aluminum and plastic, to get final product.

[0123] The embodiment sample prepared under humidity 60%RH environment, according to Chinese Pharmacopoeia 2010 edition appendix XIX C stability test guiding principle, carries out influence factor experiment: sample removes aluminum-plastic packaging, respectively under strong light irradiati...

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PUM

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Abstract

The invention relates to a pharmaceutical composition, and particularly relates to a pharmaceutical composition comprising potassium aspartate, aerosol, and medically acceptable carriers, a preparation method and applications thereof.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition containing potassium aspartate, micropowder silica gel and a medically acceptable carrier, as well as a preparation method and application. Background technique [0002] Potassium aspartate is the potassium salt of aspartic acid and is an electrolyte supplement. Aspartic acid is the precursor of oxaloacetate in the body, plays an important role in the tricarboxylic acid cycle, promotes energy metabolism, and is a catalyst for the synthesis and decomposition of high-energy phosphate compounds; participates in the production of nucleotides, and is an important substance for cell repair and regeneration ; Can promote the excretion of bile and bile pigment, have the effects of jaundice, reduce liver fat, increase liver glycogen, etc.; promote the development and differentiation of T lymphocytes into mature T lymphocytes, and have antiviral and antitumor eff...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/198A61P3/12
Inventor 彭博胡军栗庆玲刘烽张勇
Owner 内蒙古白医制药股份有限公司
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