Mangiferin crystal V type substance and its preparation method as well as its composition and use
A composition, the technology of mangiferin, applied in the directions of drug combination, organic chemical method, pharmaceutical formula, etc., can solve the problem of no patent or literature report of mangiferin crystal form, and achieve the effect of good biological absorption advantage and fast absorption speed.
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Embodiment 1
[0066] Preparation method 1 of mangiferin crystal type V sample:
[0067] Use ethanol: water (1:1) solvent to completely dissolve the mangiferin sample at 50°C, and quickly remove the solvent or prepare a solid mangiferin sample by cold / hot spraying under vacuum conditions at a temperature of 60°C. Carry out powder X-ray diffraction analysis to it, its diffraction pattern and image 3 Consistent, indicating that the obtained sample is mangiferin crystal type V solid matter.
[0068] Preparation method 2 of mangiferin crystal type V sample:
[0069] Use methanol: water (1:2) solvent to completely dissolve the mangiferin sample at 30°C, and quickly remove the solvent or prepare a solid mangiferin sample by cold / hot spraying under vacuum at a temperature of 50°C. Carry out powder X-ray diffraction analysis to it, its diffraction pattern and image 3 Consistent, indicating that the obtained sample is mangiferin crystal type V solid matter.
[0070] Preparation method 3 of mang...
Embodiment 2
[0087] Stability characteristics of mangiferin crystal type V solid matter:
[0088] High temperature test: put the crystal form sample in an open clean watch glass, place it at 60°C for 10 days, and take samples on the 0th day, the 5th day and the 10th day. Powder X-ray diffraction analysis is carried out to the sample obtained by the above-mentioned sampling points, and its diffraction patterns are all consistent with image 3 Consistent, indicating that the mangiferin crystal type V solid substance is stable under the high temperature influence factor test.
[0089] Illumination test: The crystal sample is placed in an open clean watch glass, placed in a light box equipped with a fluorescent lamp, and placed under the condition of an illumination of 4500lx±500lx for 10 days, and samples are taken on the 0th day, the 5th day and the 10th day. Powder X-ray diffraction analysis is carried out to the sample obtained by the above-mentioned sampling points, and its diffraction p...
Embodiment 3
[0093] Solubility characteristics of mangiferin crystal type Ⅰ and crystal Ⅴ solid substances in four solvent systems:
[0094] Selection of solvent system: ①Refer to the solvent system used in the dissolution method in the appendix of the Pharmacopoeia; ②Refer to the pH value of the digestive juice of different organs in the organism; ③Improve the solubility of poorly water-soluble drugs. According to the above 3 references, solvent systems with 4 pH values were set up: 0.1N hydrochloric acid solution with a pH value of 1.2; acetate buffer solution with a pH value of 4.5; phosphate buffer solution with a pH value of 6.5; 6.7 in aqueous solution.
[0095] Refer to the solubility determination method ("Technical Guidelines for Dissolution Test of Ordinary Oral Solid Preparations (Draft)", 2012.10 Drug Evaluation Center) for determination. Adopt high-performance liquid chromatography to measure the mass percentage of sample dissolution to calculate the peak area, take time as...
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