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Methergonovine maleate compound and preparation method thereof
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A technology of methysergide maleate and compound, applied in the field of chemical medicine
Active Publication Date: 2016-09-28
HEBEI ZHITONG BIOLOGICAL PHARMA
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[0006] At present, the development of new forms of solid drugs in the development of new drugs has become a hot spot, because the new forms of solid drugs may lead to the improvement of the stability and dissolution rate of the solid drugs
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Embodiment 1
[0028] Embodiment 1 Preparation of metergide maleate compound of the present invention
[0029] Weigh 10g of crude methylergonovine maleate, add 30g of methanol, and 120g of ethanol into a 250mL single-port reaction flask in turn, heat to 60°C to dissolve; add 1g of activated clay, stir for 30 minutes, filter while it is hot, and cool the filtrate to 0°C with stirring , separated by filtration to obtain a solid, and dried to obtain 8.2 g of a methysergide maleate compound, with a yield of 82%.
[0030] The HPLC peak area normalized method content was 99.88%.
[0031] Carry out X-raypowderdiffraction to the methysergide maleate compound prepared in the present embodiment 1, use Cu-Ka radiation, use the X-raypowderdiffraction that 2θ angle represents in 9.459 °, 17.820 °, 18.740 °, 21.159 There are characteristic peaks at °; further, there are characteristic peaks at 10.861°, 15.219°, 20.920°, 21.801°, 23.680°, 27.079°, 28.538° in X-ray powder diffraction represented by 2θ ...
Embodiment 2
[0034] Embodiment 2 Preparation of metergide maleate compound of the present invention
[0035] Weigh 10g of crude methylergonovine maleate, add 25g of methanol and 25g of ethanol in turn into a 250mL single-port reaction flask, heat to 50°C to dissolve; add 0.5g of activated clay, stir for 30 minutes, filter while it is hot, and cool the filtrate to 5 °C, the solid was separated by filtration, and dried to obtain 7.3 g of metergide maleate compound, with a yield of 73%.
[0036] The HPLC peak area normalized method content was 99.87%.
Embodiment 3
[0037] Embodiment 3 Preparation of metergide maleate compound of the present invention
[0038] Weigh 10g of crude methylergonovine maleate, add 45g of methanol and 450g of ethanol in turn into a 1000mL single-port reaction flask, heat to 70°C to dissolve; add 2g of activated clay, stir for 30 minutes, filter while it is hot, and cool the filtrate to -5 °C, the solid was separated by filtration, and dried to obtain 6.9 g of metergide maleate compound, with a yield of 69%.
[0039] The HPLC peak area normalized method content was 99.88%.
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Abstract
The invention relates to a methyl ergometrine maleate compound and a preparation method thereof, belonging to the technical field of chemical medicines. The compound is subjected to Cu-Ka radiation and characteristic peaks exist at 9.459 degrees, 17.820 degrees, 18.740 degrees and 21.159 degrees in an X-raypowderdiffraction pattern shown with a 2theta angle. The methyl ergometrine maleate compound has the characteristics of high stability, good reproducibility, insensitivity to harsh conditions, convenience in long-term storage, and the like. Besides, the method for preparing the methyl ergometrine maleate compound has the characteristics of low cost, easiness in operation, high yield and good purity.
Description
technical field [0001] The invention relates to a compound and a preparation method thereof, in particular to a methysergide maleate compound and a preparation method thereof, belonging to the technical field of chemistry and medicine. Background technique [0002] Methergonovine maleate, the chemical name is (8S) 6-methyl-N-[(S)-1-hydroxymethylpropyl]-9,10-didehydroergoline-8-carboxamide cis Butenedioate (1:1), its chemical structure is shown in I. [0003] [0004] Methergonovine maleate was first developed by the Swiss company Sandoz (now Novartis), and it went on the market in November 1946. It has been sold in many countries under the trade name of Methergine. There are two dosage forms of tablet and injection, and it is clinically applicable to the prevention and treatment of uterine bleeding caused by postpartum or post-abortionuterine contractionweakness or poor recovery. [0005] Methergonovine maleate is a semi-synthetic derivative of ergonovine, a powerful ...
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