Method for detecting dissolution rate of benidipine hydrochloride tablet

Abstract

The invention relates to a method for detecting the dissolution rate of a benidipine hydrochloride tablet. The method can better simulate the reflection environment and reflect the quality difference of samples. And the technical problems of low detection data result and large overall difference due to various adsorption and different degrees of decomposition of the benidipine hydrochloride in the existing detection method of the dissolution rate of the benidipine hydrochloride tablet are solved. The method for detecting the dissolution rate of the benidipine hydrochloride tablet comprises the following steps: taking the benidipine hydrochloride tablet, taking 900ml of hydrochloric acid solution of sodium chloride as a dissolution medium according to a dissolution rate determination method (four general rules 0931 second method of Chinese Pharmacopoeia 2015, using a settling basket), and operating according to the method at the rotating speed of 50 r / min; and taking a proper amount of the solution by using a sampling needle made of a PEEK material, centrifuging, and taking supernatant as a test solution. The method is applied to detection of the dissolution rate of the benidipine hydrochloride tablet.

Description

Technical field[0001]The present invention relates to the field of pharmaceutical techniques, and more particularly to a method of detecting a melodide of a hydrochloride.Background technique[0002]Beni-laminate is a dihydrozopyridine calcium antagonist which prevents blood vessels from flowing into the cells by binding to a dihydropyridine receptor that blocks the cell membrane potential dependent calcium channel. Beni-terrain hydrochloride is therapeutic drugs such as hypertension, kidney substantive hypertension, angina, because of safe, effective and widely used.[0003]The dissolution result of the mensite flattened hydrochloride is a key detection standard for investigating the in vitro of hydrochloride. It is also the most important detection indicator of the quality standards of the salt-based quality standard of hydrochloride. But its existing testing technology has the following issues:[0004](1) The solubility method for the domestic hydrochloride in China is: the dissolution...

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Problems solved by technology

[0006] (3) The Japanese Pharmacopoeia tests the dissolution rate of benidipine hydrochloride tablets and most of the Chinese Pharmacopoeia stipulate that the dissolution liquid should be sampled and filtered with a 0.45 μm filter membrane, but the filter membrane has adsorption for most active ingredients, and the quality difference between the filter membranes The degree of adsorption is different, which affects the accuracy of the dissolution test results

[0007] (4) Benidipine hydrochloride belongs to the dihydropyridine calcium ion antagonists. When the dissolution test is carried out in a medium of about PH1, the stainless steel sampling needle of the dissolution apparatus will cause the decomposition of benidipine hydrochloride, and the degree of decomposition is different. High performance liquid phase Chromatography cannot be analyzed normally, and the dissolution results cannot be accurately detected, resulting in misjudgment

[0008] (5) Chromatographic conditions include the composition and ratio of mobile phase, flow rate, and column type. If improperly selected, it will cause problems such as too long analysis time and poor symmetry of chromatographic peaks.