Berberine hydrochloride and fumaric acid eutectic substance as well as preparation method, composition and application thereof
A technology of fumaric acid and berberine hydrochloride, which is applied in the directions of drug combination, separation/purification of carboxylic acid compounds, and pharmaceutical formulations
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Embodiment 1
[0060] Preparation method 1 of berberine hydrochloride and fumaric acid cocrystal:
[0061] According to the table below, take an appropriate amount of berberine hydrochloride and fumaric acid and put them into a mortar according to the molar ratio of 2:1, add an appropriate amount of organic solvent, and manually grind for an appropriate time. Carry out powder X-ray diffraction analysis to it, its diffraction pattern and image 3 Consistent, indicating that the obtained sample is a cocrystal of berberine hydrochloride and fumaric acid.
[0062]
[0063] Preparation method 2 of berberine hydrochloride and fumaric acid cocrystal:
[0064] As shown in the table below, take an appropriate amount of berberine hydrochloride and fumaric acid and put them into a ball mill tank at a molar ratio of 2:1, add an appropriate amount of organic solvent, select an appropriate ball-to-material ratio, set an appropriate speed, and grind for an appropriate time . Carry out powder X-ray di...
Embodiment 2
[0070] Stability characteristics of berberine hydrochloride and fumaric acid cocrystal:
[0071] High temperature test: Put the samples of berberine hydrochloride and berberine hydrochloride and fumaric acid eutectic in an open clean watch glass, place them at 60°C for 10 days, and test them on the 0th day, the 5th day and the second day 10 days for sampling. Powder X-ray diffraction analysis was carried out on the samples obtained at the above sampling points, and the results showed that berberine hydrochloride and berberine hydrochloride and fumaric acid eutectic were stable under the high temperature influence factor test.
[0072] High humidity test: Put the samples of berberine hydrochloride and berberine hydrochloride and fumaric acid eutectic in an open clean watch glass, place them at 25°C for 10 days at a relative humidity of 90%±5%, and then Samples were taken on days 0, 5 and 10. The powder X-ray diffraction analysis of the samples obtained at the above sampling p...
Embodiment 3
[0076] Solubility characteristics of berberine hydrochloride and fumaric acid co-crystal and berberine hydrochloride API in four solvent systems: selection of solvent system: ①Refer to the solvent system used in the dissolution method in the appendix of the Pharmacopoeia; ② Refer to the pH value of the digestive juice of different organs in the organism; set up 4 solvent systems according to the above two references: 0.1N hydrochloric acid solution with a pH value of 1.0; acetate buffer solution with a pH value of 4.5; pH value of 6.8 phosphate buffered saline; aqueous solution. With reference to the "Technical Guidelines for Dissolution Test of Ordinary Oral Solid Preparations" for determination, the dissolution curve comparison adopts the model-independent similarity factor (f2) method, and the calculation of f2 value compares the berberine hydrochloride and its fumaric acid eutectic samples in The similarity of the dissolution curves in the four solvent systems, when the f2...
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