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A kind of fosaprepitant dimeglumine composition for injection and preparation method thereof

A technology of fosaprepitant dimeglumine and its composition, which is applied in the direction of drug combination, medical preparations without active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of decreased blood calcium concentration and lactose intolerance Symptoms, potential safety hazards, etc., to achieve strong solubilization ability, eliminate blood calcium concentration drop, and use safely

Active Publication Date: 2017-03-29
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is well known that edetate disodium can combine with calcium ions to form a soluble complex to cause a decrease in calcium, and its use in intravenous preparations will lead to a decrease in blood calcium concentration; polysorbate-80 has a better solubilizing effect, but The manual of pharmaceutical excipients clearly states that the intravenous toxicity of polysorbate-80 is moderate, so it should be used as little as possible or not used in intravenous preparations.
The patent with application number 201310105381.5 uses lactose as an excipient, but as we all know, each person’s constitution is different, and sometimes severe lactose intolerance may occur, and lactose is an animal-derived excipient, which may come from diseases such as mad cow disease Animal milk, used in pharmaceuticals, especially injections, has potential safety hazards

Method used

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  • A kind of fosaprepitant dimeglumine composition for injection and preparation method thereof
  • A kind of fosaprepitant dimeglumine composition for injection and preparation method thereof
  • A kind of fosaprepitant dimeglumine composition for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0038] Preparation process: inject 2100ml of water for injection into the liquid mixing tank, the temperature of the water for injection is within the range of 20°C to 30°C, first add 55g of polyethylene glycol 15-hydroxystearate and 13g of calcium sodium edetate to dissolve Finally, add 150 g of fosaprepitant dimeglumine, stir to dissolve it completely, adjust the pH to 8.0 with 1mol / L hydrochloric acid solution or 1mol / L sodium hydroxide solution, add water for injection to 3000ml, stir evenly, and add the prepared total Measure 0.1% activated carbon for needles, stir and let it stand for 20 minutes, filter and sterilize the liquid medicine with a 0.22μm+0.22μm cartridge filter; fill and half-tamp; the product is stored at -20°C in a freeze dryer drying oven Pre-freeze for 4 hours, vacuumize the box, dry at a vacuum degree of 9-13 Pa, and a temperature of -20°C to 0°C for 10 hours, keep the vacuum condition at 0°C-15°C for 5 hours, and dry at 20°C Dry under the conditions fo...

Embodiment 2

[0040] Preparation process: inject 2500ml of water for injection into the liquid mixing tank, the temperature of the water for injection is within the range of 20°C to 30°C, first add 65g of polyethylene glycol 15-hydroxystearate and 16g of calcium sodium edetate to dissolve Finally, add 170g of fosaprepitant dimeglumine, stir to dissolve it completely, adjust the pH to 8.2 with 1mol / L hydrochloric acid solution or 1mol / L sodium hydroxide solution, add water for injection to 3000ml, stir evenly, and add the prepared total Measure 0.1% activated carbon for needles, stir and let it stand for 20 minutes, filter and sterilize the medicinal solution with a 0.22μm+0.22μm cartridge filter; fill and half-tamp; the product is stored at -30°C in a freeze dryer drying oven Pre-freeze for 4 hours, vacuumize the box, dry for 13 hours at a vacuum degree of 9 to 13 Pa, and a temperature of -20°C to 0°C, keep the vacuum condition at 0°C to 15°C for 6 hours, and dry at 25°C Dry under condition...

Embodiment 3

[0042] Preparation process: Inject 2500ml of water for injection into the liquid mixing tank. The temperature of the water for injection is within the range of 20°C to 30°C. First, add 70g of polyethylene glycol 15-hydroxystearate and 18g of calcium sodium edetate to dissolve Finally, add 180 g of fosaprepitant dimeglumine, stir to dissolve it completely, adjust the pH to 8.2 with 1mol / L hydrochloric acid solution or 1mol / L sodium hydroxide solution, add water for injection to 3000ml, stir evenly, and add the prepared total Measure 0.1% activated carbon for needles, stir and let it stand for 20 minutes, filter and sterilize the medicinal solution with a 0.22μm+0.22μm cartridge filter; fill and half-tamp; the product is stored at -30°C in a freeze dryer drying oven Pre-freeze for 3 hours, vacuumize the box, dry at a vacuum degree of 9-13 Pa, and a temperature of -20°C to 0°C for 14 hours, keep the vacuum condition at 0°C-15°C for 7 hours, and dry at 25°C Dry under conditions fo...

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Abstract

The invention relates to a fosaprepitant dimeglumine composition for injection and a preparation method thereof, the pharmaceutical composition is composed of fosaprepitant dimeglumine, 15-polyethylene glycol hydroxystearate and sodium calcium edentate, prescription is simple, technology is simple, and the prepared product has the advantages of stable quality, safety and reliability.

Description

technical field [0001] The invention relates to a pharmaceutical composition for injection and a preparation process thereof, in particular to a fosaprepitant dimeglumine composition for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Chemotherapy drugs such as platinum, doxorubicin and other antineoplastic drugs can cause severe nausea and vomiting (CIVN) during use. Acute and severe nausea and vomiting may lead to dehydration, electrolyte imbalance, and malnutrition in patients. Severe cases may Bleeding, infection and even death due to damage to the gastrointestinal mucosa make patients fearful of chemotherapy and significantly reduce their compliance, affecting the efficacy of treatment. Therefore, antiemetic drugs are important adjuvant drugs for antitumor therapy. At present, the main chemotherapy antiemetic drugs used clinically are 5-HT antagonists, and the representative drugs are ondansetron an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/14A61K31/675A61K47/18A61P1/08A61P35/00
Inventor 周元浩伍熹王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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