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Methylergometrine maleate injection and preparation method thereof

A technology of methylergometrine maleate and injection, which can be used in pharmaceutical formulations, medical preparations with inactive ingredients, sexual diseases, etc., and can solve problems such as boosting blood pressure and vomiting.

Active Publication Date: 2015-12-09
HEBEI ZHITONG BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ergometrine injection can cause side effects such as vomiting and pressurization

Method used

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  • Methylergometrine maleate injection and preparation method thereof
  • Methylergometrine maleate injection and preparation method thereof
  • Methylergometrine maleate injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0034] The preparation of the methysergide maleate used in the injection of the present invention in embodiment 1

[0035]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 methysergide maleate, with a yield of 82%.

[0036] The HPLC peak area normalized method content was 99.88%.

[0037] Carry out X-ray powder diffraction to the methysergide maleate prepared in the present embodiment 1, use Cu-Ka radiation, use the X-ray powder diffraction that 2θ angle represents at 9.459 °, 17.820 °, 18.740 °, 21.159 ° There are characteristic peaks; further, there are characteristic peaks at 10.861°, 15.219°, 20.920°, 21.801°, 23.680°, 27.079°, 28.538° in the X-ray powder diffraction represented...

Embodiment 2

[0040] The preparation of the methysergide maleate used in the injection of the present invention in embodiment 2

[0041] Weigh 10g of methysergide maleate, 25g of methanol, and 25g of ethanol into a 250mL single-port reaction flask in turn, heat to 50°C to dissolve; add 0.5g of activated clay, stir for 30 minutes, filter while hot, and cool the filtrate to 5°C , separated by filtration to obtain a solid, and dried to obtain 7.3 g of methysergide maleate, with a yield of 73%.

[0042] The HPLC peak area normalized method content was 99.87%.

Embodiment 3

[0043] The preparation of the methysergide maleate used in the injection of the present invention in embodiment 3

[0044] Weigh 10g of methysergide maleate, 45g of methanol, and 450g of ethanol into a 1000mL single-port reaction flask in turn, heat to 70°C to dissolve; add 2g of activated clay, stir for 30 minutes, filter while hot, and cool the filtrate to -5°C , separated by filtration to obtain a solid, and dried to obtain 6.9 g of methysergide maleate, with a yield of 69%.

[0045] The HPLC peak area normalized method content was 99.88%.

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Abstract

The invention relates to a methylergometrine maleate injection and a preparation method thereof and belongs to the technical field of pharmaceutical preparations. The methylergometrine maleate injection comprises isoosmotic adjusting agent, buffer agent, antioxygen, metal ion complexing agent, analgesic and the like. Due to high stability of methylergometrine maleate and prescription ratio which is selected precisely and verified repeatedly, the methylergometrine maleate injection has more remarkable stability. The preparation method of the methylergometrine maleate injection is easy, in other words, the methylergometrine maleate injection can be produced by a conventional preparation method without any special equipment. Therefore advantages such as industrialization feasibility, high production efficiency, sterility guarantee, low adverse effect, controllable quality and excellent stability are achieved.

Description

technical field [0001] The invention relates to an injection and a preparation method thereof, in particular to a methylergide maleate injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Postpartum hemorrhage is a serious complication during childbirth if the amount of bleeding exceeds 500mL within 24 hours after delivery. Postpartum hemorrhage is the leading cause of maternal death in my country, and its incidence accounts for 2%-3% of the total number of deliveries. Through active treatment, 90% of these maternal deaths could be avoided. Active treatment and prevention of postpartum hemorrhage are very important measures to reduce maternal mortality. At present, in addition to stimulating uterine contraction with mechanical and physical methods to treat postpartum hemorrhage, drug treatment is very important. Drug treatment mainly includes oxytocin, ergot preparations and prostaglandin ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08C07D457/06A61K31/48A61K47/12A61P15/04
Inventor 何庆国孙树玲相瑞静刘科攀王云然张敏夏彤
Owner HEBEI ZHITONG BIOLOGICAL PHARMA
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