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13C mexetine crystal form alpha as well as preparation method and application thereof
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A 1.13C and 4.13C technology, applied in the field of pharmaceutical crystal forms, can solve the problems of low liver reserve and compensatory ability, and achieve the effects of being conducive to storage and production of subsequent preparations, simple operation, and good stability
Inactive Publication Date: 2020-06-09
BEIJING HUAGEN ANBANG TECH CO LTD +1
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Problems solved by technology
[0002] The liver is an important metabolic organ of the human body. Although there are many liver function test indicators currently used clinically, there are few tests that can quantitatively reflect the liver reserve and compensatory capacity in the early stage of liver cirrhosis
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Embodiment 1
[0044] This example provides a preparation method for 13C methacetin crystal form α, comprising the following steps:
[0045] (1) Weigh 1 g of 13C methacetin crude product into a container, add 5 mL of methanol, stir until dissolved, and obtain a clear solution;
[0046] (2) Add 20 mL of water to the clear solution obtained in step (1), crystallize at room temperature, filter after crystallization for 4 hours, collect the solid, place it in a vacuum drying oven, and dry it at 60°C for 6 hours to obtain 0.78 g of 13C methacetin crystal form α, the yield was 78%, the purity was 99.8%, and the abundance was 99.2%.
Embodiment 2
[0048] This example provides a preparation method for 13C methacetin crystal form α, comprising the following steps:
[0049] (1) Weigh 1 g of 13C methacetin crude product into a container, add 5 mL of absolute ethanol, stir until dissolved, and obtain a clear solution;
[0050] (2) Add 30 mL of water to the clear solution obtained in step (1), crystallize at room temperature, filter after 8 hours of crystallization, collect the solid, place it in a vacuum drying oven, and dry it at 60°C for 4 hours to obtain 0.85 g of 13C methacetin crystal form α, the yield was 85%, the purity was 99.7%, and the abundance was 99.2%.
Embodiment 3
[0052] This example provides a preparation method for 13C methacetin crystal form α, comprising the following steps:
[0053] (1) Weigh 1 g of 13C methacetin crude product into a container, add 5 mL of ethyl acetate, stir until dissolved, and obtain a clear solution;
[0054](2) Add 20 mL of n-hexane to the clear solution obtained in step (1), crystallize at room temperature, filter after crystallization for 8 hours, collect the solid, place it in a vacuum drying oven, and dry it at 60° C. for 4 hours to obtain 0.83g of 13C methacetin crystal form α has a yield of 83%, a purity of 99.8%, and an abundance of 99.2%.
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Abstract
The invention relates to the technical field of medicinecrystal forms, in particular to a 13C mexetine crystal form alpha as well as a preparation method and an application thereof. In an X-raypowderdiffraction pattern of the crystal form, characteristic peaks exist at 7.19 degrees, 14.33 degrees, 21.53 degrees, 23.63 degrees, 28.81 degrees and 36.20 degrees when the crystal form is expressed by 2 theta+ / -0.2 degrees. The preparation method comprises the following steps: dissolving a 13C methacetin crude product in a solvent A at 20-30 DEG C, then adding a solvent B for crystallization, collecting a solid, and drying; wherein the solvent A is selected from ethanol and methanol, and the solvent B is water; or the solvent A is ethyl acetate, and the solvent B is normal hexane. The 13C mexetine crystal form alpha disclosed by the invention has good stability and is beneficial to storage, subsequent preparation production and the like.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical crystal forms, in particular to a 13C methacetin crystal form α, a preparation method and application thereof. Background technique [0002] The liver is an important metabolic organ of the human body. Although there are many liver function test indicators currently used in clinical practice, there are few tests that can quantitatively reflect the liver reserve and compensatory capacity in the early stage of cirrhosis. 13C methacetin breath test is a new method for detecting liver reserve function, which has high practical value. Through experiments, it was found that the 13C methacetin breath test value can distinguish liver cirrhosis from non-cirrhosis. [0003] Wherein, 13C methacetin, the chemical name is p-acetamido anisole (methoxy-13C), and its structural formula is as follows: [0004] [0005] In the research of pharmaceutical preparations, more and more attention is paid to t...
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