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Triamcinolone tablet and polymorphs and preparation method

A technology of Xilong tablet and Longjing, which is applied in the field of steroids, can solve the problems of increased energy consumption, breakage, poor quality, and the need to stir for a long time to achieve uniform content when mixing with excipients.

Active Publication Date: 2014-06-11
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, in the production of tablet preparations, we found that the use of triamcinolone raw materials regardless of the A crystal form or the B crystal form has many disadvantages that are not conducive to production when used in tablet production, such as poor fluidity of raw materials , when mixed with auxiliary materials, it needs to be stirred for a long time to reach the content uniformity requirement, which seriously reduces the efficiency of production and increases the consumption of energy and equipment; the stability of the prepared triamcinolone tablet is relatively poor, and it can During the process, due to the poor fluidity of the triamcinolone raw material, problems such as sticking, pockmarking, and breakage are prone to occur during tablet compression, and the yield of the resulting tablet is low, etc.

Method used

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  • Triamcinolone tablet and polymorphs and preparation method
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specific Embodiment approach

[0029] Specific implementation method: X-ray powder diffraction test carried out in the embodiment of the present invention adopts X-ray wavelength λ=1.540598 ?

Embodiment 1

[0033] Dissolve 1 g of triamcinolone in 7 mL of butanol: tetrahydrofuran = 1:3 (volume ratio) mixed solvent, slowly add 50 ml of cyclohexane dropwise over 30 minutes, and slowly cool down to 0°C while adding cyclohexane dropwise. Keep stirring at 0°C for 1 h, filter and dry the precipitated crystals, and perform X-ray powder diffraction measurement. X-ray powder diffraction measurement, the measured characteristic peak positions are 2θ=9.0°, 15.6°, 18.6°, 21.7° The spectrogram is as follows image 3 shown.

Embodiment 2

[0035] Take 1g of triamcinolone and dissolve it in 7mL of ethanol: tetrahydrofuran = 1:1 (volume ratio) mixed solvent, slowly add 50ml of n-hexane dropwise, and slowly cool down to 0°C while adding cyclohexane dropwise. Keep stirring at 0°C for 2 hours, filter and dry the precipitated crystals, and perform X-ray powder diffraction measurement. X-ray powder diffraction measurement, the measured characteristic peak positions are 2θ=8.9°, 15.6°, 18.6°, 21.8° The spectrogram is as follows Figure 4 shown.

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Abstract

The invention discloses a triamcinolone tablet, a triamcinolone polymorphs and a preparation method. The triamcinolone tablet comprises a triamcinolone polymorphs 1 serving as active ingredients and one or more pharmaceutic adjuvants applicable to tablets, X-ray powder diffraction of the triamcinolone polymorphs 1 has characteristic peaks at diffraction angles 2theta=9.0 degrees, 15.6 degrees, 18.5 degrees and 21.7 degrees.

Description

Field of invention: [0001] The invention relates to a steroid compound, in particular to a new crystal form of triamcinolone, a preparation method thereof and an application in a preparation. Background technique: [0002] The chemical structure of Triamcinolone (CAS: 124-94-7, Triamcinolone) is as follows: [0003] [0004] Triamcinolone is a medium-acting glucocorticoid drug with pharmacological effects such as anti-inflammatory, immunosuppressive, anti-allergic, and anti-shock. U.S. Patent US 2789118; US 3021347 discloses the synthesis method of triamcinolone, document Investigations on the Polymorphism and Pseudopolymorphism of the Glucocorticoid Triamcinolone: ​​New Findings for a Well-Known Drug (Viktor Suitchmezian .etc, CRYSTAL GROWTH & DESIGN, 2007 VE 7, NO.1, 69-74, hereinafter referred to as document 1) disclosed two existing triamcinolone crystal forms A and B, and a triamcinolone hydrate crystal form, of which A crystal form was purchased from The existing ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/58A61P29/00A61P37/06A61P37/08A61P9/02C07J71/00
Inventor 孙亮陈松赵琳
Owner TIANJIN JINYAO GRP
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