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Ulipristal acetate tablet and method for determining dissolution of ulipristal acetate tablet

A technology for ulipristal acetate and its determination method, which is applied in the field of medicine and can solve problems such as inability to distinguish dissolution differences and improvement of dissolution methods

Inactive Publication Date: 2015-08-26
NANJING HEALTHNICE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The Chinese patent application whose publication number is CN102245173A discloses a ulipristal acetate tablet, and the patent describes the dissolution of the product in 0.1mol / ml hydrochloric acid, but the solubility of ulipristal acetate in this medium is excellent , this method cannot distinguish the dissolution difference of samples prepared from raw materials with different physical and chemical properties (particle size)
[0005] The Chinese patent application with the publication number CN103006603B discloses a solid dispersion and solid preparation of ulipristal acetate. This patent improves the dissolution rate by preparing ulipristal acetate into a solid dispersion, but does not improve the dissolution method. , to objectively reflect the quality of the preparation

Method used

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  • Ulipristal acetate tablet and method for determining dissolution of ulipristal acetate tablet
  • Ulipristal acetate tablet and method for determining dissolution of ulipristal acetate tablet
  • Ulipristal acetate tablet and method for determining dissolution of ulipristal acetate tablet

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Embodiment 1

[0018] Single-dose prescription composition

[0019]

[0020] In particular, the raw material drug ulipristal acetate is micronized ulipristal acetate, and its particle size distribution is: d(0.1)=0.857 μm, d(0.5)=3.163 μm, d(0.9)=6.666 μm

[0021] Preparation:

[0022] Weigh the prescribed amount of ulipristal acetate, lactose and povidone K30, mix evenly, add purified water for wet granulation, dry at 50°C until the water content is about 3.0%, add croscarmellose sodium and micropowder silica gel It is mixed with magnesium stearate and compressed into tablets.

Embodiment 2

[0024] Single-dose prescription composition

[0025]

[0026]

[0027] In particular, the raw material drug ulipristal acetate is unmicronized ulipristal acetate, and its particle size distribution is: d(0.1)=3.176 μm, d(0.5)=34.290 μm, d(0.9)=150.350 μm

[0028] Preparation method is the same as embodiment 1

Embodiment 3

[0030] Get respectively the sample prepared by embodiment 1 and embodiment 2 and carry out cumulative dissolution measurement, and concrete determination method is as follows:

[0031] 1) Preparation of dissolution medium: prepare sodium lauryl sulfate solution with a mass percentage of 0.3%, ultrasonically dissolve and degas.

[0032] 2) preparation of need testing solution: according to dissolution assay (Chinese Pharmacopoeia edition in 2010 two appendix X C the second method), get 6 ulipristal acetate tablets, add 900ml into the dissolution medium of step 1), The dissolution test was carried out at a speed of 50 rpm, and the test temperature was 37±0.5°C. Take 5ml of the dissolution solution at 5, 10, 15, 20, 30 and 45 minutes of the test respectively, and add the same volume of fresh medium, filter, and The dissolution medium was diluted 3 times.

[0033] 3) Preparation of reference substance solution: Take ulipristal acetate reference substance and dilute it with dissol...

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Abstract

The invention discloses a method for determining the dissolution of an ulipristal acetate tablet. The method adopts a sodium dodecyl sulfate solution as a dissolution medium for determination and comprises the following steps: preparing the dissolution medium, preparing a test solution, and preparing and determining a reference solution. The method can reflect the dissolution behavior and the quality of the preparation objectively.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for measuring the dissolution rate of ulipristal acetate tablet. Background technique: [0002] Ulipristal acetate has antiprogestogen and antiglucocorticoid activity, and is clinically used for emergency contraception and preoperative treatment of patients with uterine fibroids with moderate to severe symptoms. The solubility of ulipristal acetate is pH-dependent, slightly soluble in 0.1mol / L hydrochloric acid solution, but insoluble in pH4.5 acetate buffer, pH6.8 phosphate buffer and water. [0003] Oral solid preparations can be absorbed by the body only when they dissolve in the body. The dissolution of preparations is a key factor affecting the absorption of drugs in the body. The dissolution behavior of solid preparations in vitro can reflect the dissolution behavior of preparations in vivo and can be used as one of the evaluation indicators for prepar...

Claims

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Application Information

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IPC IPC(8): G01N21/33A61K31/57A61K9/20A61P15/18
Inventor 杨丹王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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