Method for measuring in-vitro dissolution rate of nifedipine controlled release tablets

A determination method and technology of nifedipine, which can be used in measuring devices, testing pharmaceutical preparations, instruments, etc., can solve problems such as inability to correlate with actual situations and inability to fully simulate the drug dissolution/absorption process.

Inactive Publication Date: 2021-05-18
HUNAN HUIZE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The conventional dissolution modes of nifedipine are basket method or paddle method, which have many defects in structure and performance, and cannot fully simulate the drug dissolution / absorption process in vivo, so that the dissolution test is only used as a quality method for drug in vitro control, and cannot be compared with The actual situation in the body is related to

Method used

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  • Method for measuring in-vitro dissolution rate of nifedipine controlled release tablets
  • Method for measuring in-vitro dissolution rate of nifedipine controlled release tablets
  • Method for measuring in-vitro dissolution rate of nifedipine controlled release tablets

Examples

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Effect test

Embodiment 1

[0049] A kind of assay method of in vitro dissolution rate of nifedipine controlled-release tablet adopts differential dissolution apparatus to measure, and concrete steps are:

[0050] 1) The temperature is controlled at (37±0.5) ℃, the pH 6.8 phosphate buffer solution of 0.2% SDS of the dissolution medium enters the dissolution vessel from the liquid inlet at a speed of 8 mL / min, and the nifedipine controlled-release tablets in the dissolution vessel Carry out stripping, the stripping solution that dissolves nifedipine is exported to sampling device at the speed of 8 mL / min, respectively in 30, 60, 120, 180, 240, 300, 360, 420, 480 min to the sample in the sampling device. collection;

[0051] 2) Precisely measure 20 μL of the eluate, inject it into the high-performance liquid chromatograph, record the chromatogram, calculate the corresponding concentration of nifedipine, and obtain the concentration of nifedipine and the dissolution time based on the relationship between th...

Embodiment 2

[0056] A kind of assay method of in vitro dissolution rate of nifedipine controlled-release tablet adopts differential dissolution apparatus to measure, and concrete steps are:

[0057] 1) The temperature is controlled at (37±0.5) ℃, the pH 6.8 phosphate buffer solution of 0.2% SDS of the dissolution medium enters the dissolution vessel from the liquid inlet at a speed of 8 mL / min, and the nifedipine controlled-release tablets in the dissolution vessel Carry out stripping, the stripping solution that dissolves nifedipine is exported to sampling device at the speed of 8 mL / min, respectively in 30, 60, 120, 180, 240, 300, 360, 420, 480 min to the sample in the sampling device. collection;

[0058] 2) Precisely measure 20 μL of the eluate, inject it into the high-performance liquid chromatograph, record the chromatogram, calculate the corresponding concentration of nifedipine, and obtain the concentration of nifedipine and the dissolution time based on the relationship between th...

Embodiment 3

[0062] p-nifedipine controlled-release tablets (test preparation T (reference preparation 3 in Example 2), specification: 30 mg; reference preparation, trade name: Adalat ® , specification: 30mg) to conduct absorption kinetics study, to preliminarily evaluate the consistency of absorption kinetics between the test preparation and the reference preparation.

[0063] The postprandial trial plans to enroll 12 subjects, and adopts a randomized, open, two-drug, two-period (T-R, R-T), double-crossover self-controlled trial design, with a washout period of 7 days between cycles, and a single oral dose per cycle 1 nifedipine controlled-release tablet (test preparation T, strength: 30 mg) or 1 nifedipine controlled-release tablet (reference preparation, trade name: Adalat ® , specification: 30mg).

[0064] The postprandial test blood collection time is designed as: before administration (0h) and after administration 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 11h, 12h, 14h, 16h, 18h, 20h, 24...

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Abstract

The invention belongs to the technical field of medicine analysis, and discloses a method for measuring the in-vitro dissolution rate of nifedipine controlled release tablets, which comprises the following specific steps: (1) a dissolution medium enters a dissolution container from a liquid inlet, the nifedipine controlled release tablets in the dissolution container are dissolved out, and a dissolution liquid dissolved with nifedipine is output to a sampling device to complete sampling; and (2) the concentration of nifedipine in the collected sample is measured by using a high performance liquid chromatograph, an average differential dissolution curve graph between the concentration of nifedipine and the dissolution time is drawn, and a cumulative dissolution curve graph between the cumulative dissolution mass fraction and the dissolution time is obtained according to the differential dissolution relation. According to the method, the dissolution concentration of the nifedipine controlled-release tablets is measured by simulating the dynamic continuous process of in-vivo dissolution and absorption, different nifedipine controlled-release tablets are distinguished by quality, so that the BE experiment passing rate of the nifedipine controlled-release tablets is improved, and the research and development risk is reduced.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for measuring the dissolution rate of nifedipine controlled-release tablets in vitro. 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] Nifedipine is a dihydropyridine calcium channel blocker. It is a yellow crystal at room temperature, insoluble in water, easily soluble in acetone or chloroform, slightly soluble in ethanol, and highly sensitive to light. The logP of nifedipine is 2.20, it has good fat solubility and is a BCS2 drug. Nifedipine does not ionize within the pH range of the gastrointestinal system, and its solubility i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N33/15
CPCG01N30/02G01N33/15G01N2030/027
Inventor 王磊谭月香黄建国
Owner HUNAN HUIZE BIO PHARMA CO LTD
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