Freeze-dried preparation containing fosaprepitant and preparation method of freeze-dried preparation

A freeze-dried preparation, fosaprepitant dimeglumine technology, applied in the field of medicine, can solve problems such as irritation of histamine release, secondary injury to patients, etc., and achieve the effects of improving compliance, low hemolysis rate, and stable properties

Active Publication Date: 2015-10-14
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Polysorbate 80 is hemolytic and histamine release stimulating. For tumor patients with low bod

Method used

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  • Freeze-dried preparation containing fosaprepitant and preparation method of freeze-dried preparation
  • Freeze-dried preparation containing fosaprepitant and preparation method of freeze-dried preparation
  • Freeze-dried preparation containing fosaprepitant and preparation method of freeze-dried preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: the preparation of fosaprepitant freeze-dried preparation

[0027] Prescription: 1000 sticks (calculated as fosaprepitant)

[0028]

[0029] Preparation:

[0030] Dissolve lactose and edetate disodium in 3500ml of water for injection, add 0.1% activated carbon (w / v), stir for 30 minutes, filter to remove carbon, then add polyethylene glycol lauryl lithium stearate, stir to dissolve, and then Add the main drug fosaprepitant dimeglumine and stir to dissolve. Use 2% sodium hydroxide solution to adjust the pH value of the liquid to 8.0-9.0, make up water for injection to 4000ml, add 0.05% activated carbon (w / v), stir for 30min, filter to remove carbon, sterilize and filter, subpackage, freeze-dry, Defusapitant freeze-dried preparation, the freeze-drying parameters are as follows: the vial is heat-treated at about -40~-30°C for about 2~4 hours, then the plate layer of the freeze dryer is heated to about -20~-10°C, and the low-pressure freeze-drying The c...

Embodiment 2~3

[0031] Embodiment 2~3: the investigation of solubilizer consumption

[0032] With reference to the prescription and preparation process thereof of Example 1, only the dosage of the solubilizing agent is changed to 40g and 80g respectively.

Embodiment 4~15

[0033] Embodiment 4~15: the investigation of solubilizing agent kind

[0034] Referring to the prescription and preparation process of Examples 1, 2 and 3, only the solubilizing agent was changed to hydroxypropyl-β-cyclodextrin, polyethylene glycol 400, poloxamer 188, and lecithin.

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PUM

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Abstract

The invention provides a freeze-dried preparation containing fosaprepitant and a preparation method of the freeze-dried preparation. The freeze-dried preparation contains an active ingredient and other carriers, wherein the active ingredient is an effective amount for treatment of fosaprepitant dimeglumine, and the other carriers include a solubilizing agent, a complexing agent and a freeze-drying excipient; before freeze-drying, an acidity regulator is used for regulating the pH value of a liquid medicine to be 6.5-9.5; and the solubilizing agent is selected from one or more of polyethylene glycol dodecahydroxyl lithium stearate, hydroxypropyl-beta-cyclodextrin and polyethylene glycol. The freeze-dried preparation containing fosaprepitant, provided by the invention, is stable in property and low in hemolysis rate, and improves the compliance of clinical medication of patients.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a freeze-dried preparation containing fosaprepitant and a preparation method thereof. Background technique [0002] Tumor is a disease that seriously threatens human life and quality of life. In 2009, more than 10 million patients worldwide received radiotherapy and chemotherapy for this reason. Nausea and vomiting are the most common side effects associated with cancer chemotherapy, affecting approximately 85% of patients. If the control is not ideal, it will affect the quality of life of patients and reduce the compliance of treatment. [0003] Fosaprepitant dimeglumine for injection (trade name: EMEND) is a substance P / neurokinin 1 (NK-1) selective high-affinity receptor blocker developed by Merck, It works primarily by blocking nausea and vomiting signals in the brain. Clinically combined with other antiemetic drugs for intravenous injection, prevention and tr...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/675A61K47/34A61K47/40
Inventor 郝卫华白敏陈亚平马玉秀赵倩杨敏金晓利
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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