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Method for determining in-vitro dissolution of felodipine sustained-release tablets

A felodipine and gentle technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that cannot truly reflect the dissolution behavior, achieve the simulation of physiological peristalsis and food friction, ensure accuracy, and promote the dissolution/release process Effect

Active Publication Date: 2021-03-19
HUNAN HUIZE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] Chinese patent application CN201510155510.0 discloses a felodipine slow-release tablet and its preparation process. Through the quality inspection experiment of felodipine tablet, the dissolution test is carried out by the paddle plate method, which cannot truly reflect the actual dissolution behavior in the body. certain limitations

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  • Method for determining in-vitro dissolution of felodipine sustained-release tablets
  • Method for determining in-vitro dissolution of felodipine sustained-release tablets
  • Method for determining in-vitro dissolution of felodipine sustained-release tablets

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Embodiment 1

[0043] A method for measuring the in vitro dissolution of felodipine sustained-release tablets, the felodipine sustained-release tablets are dissolved using a two-chamber model experimental device that simulates the in vivo dissolution and transmembrane absorption process of insoluble oral pharmaceutical preparations, and the specific steps are:

[0044] 1) The dissolution medium enters the porous membrane cup through the action of the inlet pump. When the volume of the dissolution medium in the porous membrane cup and the outer chamber dissolution cup is the same, the outlet pump is turned on. The working frequency of the inlet pump and the outlet pump are consistent, keeping The total volume of the dissolution medium remains unchanged; the dissolution medium is pH 6.8 phosphate buffer with 0.3% sodium lauryl sulfate, and the pore size of the filter membrane coated on the porous filter cup is 0.45 μm;

[0045] 2) Put Felodipine Sustained-release Tablets in the rotating basket,...

Embodiment 2

[0053] A randomized, open, three-period, cross-over experimental design was used to conduct a bioequivalence study on 12 healthy volunteers before meals. Preparation or test preparation 5mg / time, once a day, blood collection time is designed as before administration (0h) and after administration 10min, 20min, 30min, 45min, 1.0h, 1.25h, 1.5h, 1.75h, 2h, At 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, and 36h, 4 mL of upper limb venous blood was collected respectively. The samples were centrifuged (3,500 rpm, 10 min) to separate the plasma and stored in a -80°C ultra-low temperature freezer. Specifically, take 100 μL of plasma sample, add 600 μL of anhydrous methanol (including internal standard), vortex for 5 minutes, mix well, centrifuge at 12,000 rpm for 10 minutes, take the supernatant and analyze the non- Lodipine content.

[0054] The conclusion is shown in Table 1:

[0055] Table 1 Summary of main pharmacokinetic parameters of fasting felodipine

[0056]

[0057] ...

Embodiment 3

[0061] A method for measuring the in vitro dissolution of felodipine sustained-release tablets, the felodipine sustained-release tablets are dissolved using a two-chamber model experimental device that simulates the in vivo dissolution and transmembrane absorption process of insoluble oral pharmaceutical preparations, and the specific steps are:

[0062] 1) The dissolution medium enters the porous membrane cup through the action of the inlet pump. When the volume of the dissolution medium in the porous membrane cup and the outer chamber dissolution cup is the same, the outlet pump is turned on. The working frequency of the inlet pump and the outlet pump are consistent, keeping The total volume of the dissolution medium remains unchanged; the dissolution medium is pH 6.8 phosphate buffer with 0.3% sodium lauryl sulfate, and the pore size of the filter membrane coated on the porous filter cup is 0.45 μm;

[0063] 2) Put Felodipine Sustained-release Tablets in the rotating basket,...

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, and discloses a method for determining in-vitro dissolution of felodipine sustained-release tablets, wherein the method comprises the steps: dissolving out felodipine sustained-release tablets by using a two-chamber model experiment device, dissolving out a pH 6.8 phosphate buffer solution of which the medium is 0.3% lauryl sodium sulfate, and putting the felodipine sustained-release tablets into a rotating basket at the rotating basket rotating speed of 100 rpm; filtering the dissolution solution by a filter membrane, continuously extracting the dissolution solution, and measuring the concentration of the felodipine in the dissolution solution at the extraction speed of the dissolution solution and the supplementingspeed of a dissolution medium of 5-12 mL / min until the dissolution of the felodipine sustained-release tablets is completed; and determining the average dissolution concentration of the felodipine inthe dissolution solution at different time points by adopting a high performance liquid chromatography. According to the in-vitro dissolution method, the in-vivo absorption process is simulated, so that the accuracy of the in-vitro dissolution experiment is guaranteed, the consistency of a dissolution curve measured by the in-vitro dissolution experiment and the in-vivo absorption process is realized, and a guarantee is provided for realizing good prediction of the bioequivalence of a human body.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for measuring the in vitro dissolution of felodipine sustained-release tablets. Background technique [0002] At present, the in vitro dissolution test is considered to be able to predict the dissolution behavior and absorption in vivo. However, the environment in the human body is complex, and it is easy to cause the phenomenon that the in vitro dissolution behavior of the preparations is similar but the in vivo BE is not equivalent. to financial burden. [0003] Felodipine, the chemical name is 2,6-dimethyl-4-(2,3-dichlorophenyl)-1,4-dihydro-3,5-pyridine dicarboxylic acid methyl ethyl ester, the molecular formula is C 18 h 19 Cl 2 NO 4 , is a selective calcium antagonist with good antihypertensive effect. The antihypertensive mechanism of felodipine is mainly by inhibiting the inflow of extracellular calcium in arteriolar smooth muscle, selectively dilating ...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/06G01N30/88G01N2030/8809
Inventor 王磊谭月香黄建国
Owner HUNAN HUIZE BIO PHARMA CO LTD
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