Quality Control Method of Impurities in Felodipine Metoprolol Succinate Sustained Release Tablets
A technology for metoprolol succinate and dipine succinic acid is applied in the field of quality control of chemical pharmaceutical preparations, and can solve the problems of complex system, no simple simultaneous measurement, inapplicability and the like
Active Publication Date: 2019-08-06
广西厚德药业有限公司
View PDF2 Cites 0 Cited by
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
But for the felodipine metoprolol succinate sustained-release tablet in the present invention and the product in the prior art (felodipine sustained-release tablet, metoprolol succinate sustained-release tablet) is not the same, raw material, auxiliary material , formulas are all different, the establishment of impurity control method needs to consider the degradation of raw materials, the interaction between raw materials and raw materials, the interaction between raw materials and auxiliary materials, and the impurities generated by the interaction between raw materials and packaging materials. The system is more complex and needs to be further studied. , so the existing technical solution is not applicable
There is no simple method for simultaneous determination of impurities in felodipine and metoprolol succinate in compound preparations
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 moreImage
Smart Image Click on the blue labels to locate them in the text.
Smart ImageViewing Examples
Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0023] Take three batches of homemade felodipine metoprolol succinate sustained-release tablets (batch numbers: 20131201, 20131202, 20131203), and the original research product felodipine metoprolol succinate produced by AstraZeneca Pharmaceutical Co., Ltd. purchased in Hong Kong One batch of sustained-release tablets (batch number: 60004066), respectively take appropriate amount of fine powder (approximately equivalent to 47.5mg of metoprolol succinate and 5mg of felodipine), put them in a 25ml measuring bottle, add 10ml of acetonitrile, and ultrasonicate for 5 minutes. Metoprolol succinate and felodipine were dissolved, allowed to cool, diluted to the mark with mobile phase A, shaken up, centrifuged for 5 minutes (10,000 rpm), and the supernatant was taken as the test solution. Accurately measure 1ml, put it in a 100ml measuring bottle, dilute to the mark with solvent [sodium octane sulfonate solution-acetonitrile (60:40)], shake well, and use it as a control solution. Accor...
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
Login to View More Abstract
The invention provides a method for mass control of impurities in felodipine metoprolol succinate sustained-release tablets. By adoption of the method for mass control, contents of felodipine impurities and metoprolol succinate impurities in the felodipine metoprolol succinate sustained-release tablets can be detected simultaneously. Owing to adoption of high performance liquid chromatography, the method has advantages of simplification, time saving, energy saving and high operability and is quite beneficial to application in industrial production.
Description
technical field [0001] The invention belongs to the quality control of chemical preparations, in particular to a quality control method for impurities in felodipine and metoprolol succinate sustained-release tablets. Background technique [0002] Felodipine (Felodipine) is a dihydropyridine calcium channel blocker, clinically used for the treatment of hypertension and stable angina pectoris. Its role is to reversibly compete for dihydropyridine binding sites and block voltage-dependent Ca in vascular smooth muscle and cultured rabbit atrial cells 2+ current, and blocks the K + Induced murine portal vein contracture. [0003] Metoprolol is a selective beta 1 Beta-blockers, which have an effect on cardiac beta 1 Receptor effects require lower doses than its peripheral vascular and bronchial beta 2 The dose required to produce an effect on the receptor. Treatment with metoprolol attenuates the effects of catecholamines associated with physical and psychological stress, re...
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
Login to View More Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 黄园白秋菊阮碧芳张竺英梁霞
Owner 广西厚德药业有限公司