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Determination method for dissolution curve of ulipristal acetate solid preparation

A technology of ulipristal acetate and solid preparations, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve problems such as high purity and manufacturer requirements, large differences in sodium lauryl sulfate, unfavorable test activities, etc.

Pending Publication Date: 2021-09-17
HENAN TAIFENG BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In daily work, sodium lauryl sulfate varies greatly among different purities, manufacturers and different batch numbers in the process of use, and the requirements for its purity and manufacturers are relatively high, which is not conducive to daily test activities.
In addition, during the dissolution test operation, as the temperature of the solution decreases, SDS will form a precipitate with the potassium salt compatibility, which will affect the determination of the test solution.

Method used

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  • Determination method for dissolution curve of ulipristal acetate solid preparation
  • Determination method for dissolution curve of ulipristal acetate solid preparation
  • Determination method for dissolution curve of ulipristal acetate solid preparation

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Embodiment 1

[0039] The method for measuring the dissolution curve of ulipristal acetate tablets according to the embodiment of the present invention comprises the following steps:

[0040] 1. Paddle method

[0041] Take the reference preparation or the preparation to be tested, respectively in water, pH4.5 phosphate buffer, pH6.8 phosphate buffer 900mL, using the paddle method, 50 rpm, respectively, at 5, 10, 15, 20, At 30, 45, 60, and 90 minutes, 10 mL was sampled, filtered, and the dissolution medium at the same temperature and volume was replenished immediately. The cumulative dissolution rate of the samples was determined.

[0042] 2. Dissolution testing chromatographic conditions

[0043] Refer to the chromatographic conditions under the content determination item of ulipristal acetate tablets: with buffer solution (take 4.7 g of potassium dihydrogen phosphate, dissolve in 1000 mL of water, adjust the pH value to 7.0 with triethylamine)-organic phase (acetonitrile-tetrahydrofuran=40:...

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Abstract

The invention relates to the technical field of medicine quality control, in particular to a determination method for a dissolution curve of an ulipristal acetate solid preparation. The method comprises the following steps: by taking a solvent containing Tween 80 as a dissolution medium, detecting the accumulated dissolution rates of an ulipristal acetate solid preparation in the dissolution medium at different dissolution time points by adopting a paddle method in a stirring state, and then drawing a dissolution curve, wherein the volume percentage concentration of the Tween 80 in the dissolution medium is 0.1-2%. According to the method, the surfactant Tween 80 is added into the dissolution medium to evaluate the dissolution curve of the ulipristal acetate tablet, so that the quality of the ulipristal acetate tablet is scientifically and objectively evaluated, the method can be used for evaluating the quality consistency (similarity) of a generic drug and an original drug, and the quality consistency between batches of drugs can be guaranteed.

Description

technical field [0001] The invention relates to the technical field of drug quality control, in particular to a method for determining the dissolution curve of a solid preparation of ulipristal acetate. Background technique [0002] Ulipristal acetate Tablets main ingredient is Ulipristal acetate, chemical name: 17A-acetoxy-11B-(4-N,N-dimethylaminophenyl)19-norpregnant -4,9-diene-3,20-dione, molecular formula C 30 H 37 NO 4 . Ulipristal acetate is a selective progesterone receptor modulator that acts as an emergency contraceptive mainly by inhibiting ovulation. The drug can not only be taken within 120 hours after unprotected intercourse or contraceptive failure, but also the efficacy of emergency contraception will not decline with the delay of drug use. The safety and tolerance are very good, and the most commonly used emergency contraceptive levonorgest. Compared with ketones, ulipristal acetate has the potential benefit of preventing more unintended pregnancies and ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679
Inventor 沙薇苗海敏吕中超杨燕磊李逸凡汤璐璐
Owner HENAN TAIFENG BIOTECH CO LTD
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