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Fosaprepitant dimeglumine injection composition and preparation method thereof

A technology of saprepitant dimeglumine injection and fosaprepitant dimeglumine injection, applied in the field of fosaprepitant dimeglumine injection composition and its preparation, capable of solving poor patient compliance and delayed vomiting The problem of slight effect, etc., to achieve the effect of low drug cost

Inactive Publication Date: 2013-06-19
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

5-HT 3 Receptor antagonists are very effective in acute CINV, but have little effect on delayed emesis
In terms of tolerability compliance, patient compliance is poor due to the need for daily medication

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] This embodiment provides a fosaprepitant dimeglumine injection composition, the active ingredients of which include the following components:

[0036] Fosaprepitant dimeglumine 188g (equivalent to fosaprepitant 115g), edetate disodium 14.4g, polysorbate 57.5g, lactose 287.5g, water for injection 2500g.

[0037] 1000 bottles of fosaprepitant dimeglumine injection were prepared from the above components.

[0038] The method for preparing the above-mentioned fosaprepitant dimeglumine injection composition is:

[0039] Dissolution: Weigh 80% of the total amount of water for injection in the dosing room and add it to the dosing tank, add disodium edetate, polysorbate 80 and anhydrous lactose while stirring, stir and dissolve, then add 1M sodium hydroxide The pH value of the solution is adjusted in the range of 8.5-9.5.

[0040] Preparation: add fosaprepitant dimeglumine to the above solution, stir and dissolve, adjust the pH with the 1M sodium hydroxide solution to ensure th...

Embodiment 2

[0047] This embodiment provides a fosaprepitant dimeglumine injection composition, the active ingredients of which include the following components:

[0048] Fosaprepitant dimeglumine 245.3g (equivalent to fosaprepitant 150g), edetate disodium 18.8g, polysorbate 75g, lactose 375g, water for injection 3000ml.

[0049] 1000 bottles of fosaprepitant dimeglumine injection were prepared from the above components.

[0050] The method for preparing the above-mentioned fosaprepitant dimeglumine injection composition is:

[0051] Dissolution: Weigh 80% of the total amount of water for injection in the dosing room and add it to the dosing tank, add disodium edetate, polysorbate 80 and anhydrous lactose while stirring, stir and dissolve, then add 1M sodium hydroxide The pH value of the solution is adjusted in the range of 8.5-9.5.

[0052] Preparation: add fosaprepitant dimeglumine to the above solution, stir and dissolve, adjust the pH with the 1M sodium hydroxide solution to ensure t...

Embodiment 3

[0059] This embodiment provides a fosaprepitant dimeglumine injection composition, the active ingredients of which include the following components:

[0060] Fosaprepitant dimeglumine 185g (equivalent to fosaprepitant 150g), edetate disodium 15g, polysorbate 50g, lactose 250g, water for injection 2500ml.

[0061] 1000 bottles of fosaprepitant dimeglumine injection were prepared from the above components.

[0062] The method for preparing the above-mentioned fosaprepitant dimeglumine injection composition is:

[0063] Dissolution: Weigh 75% of the total amount of water for injection in the dosing room and add it to the dosing tank, while stirring, add edetate disodium, polysorbate 80 and anhydrous lactose, stir to dissolve, then add 1M sodium hydroxide The pH value of the solution is adjusted in the range of 8.5-9.5.

[0064] Preparation: add fosaprepitant dimeglumine to the above solution, stir and dissolve, adjust the pH with the 1M sodium hydroxide solution to ensure that ...

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Abstract

The invention relates to the field of medicament preparation, and particularly relates to a fosaprepitant dimeglumine injection composition and a preparation method thereof. The pharmaceutical active ingredients of the fosaprepitant dimeglumine injection composition include the following components in parts by weight: 180-250 parts of fosaprepitant dimeglumine, 12.0-20.0 parts of disodium edetate, 50.0-80.0 parts of polysorbate-80, 250-400 parts of lactose and 2000-3000 parts of water for injection. The preparation method comprises the following steps: dissolving, preparing, adsorbing, pre-freezing, performing sublimation drying and mounting an injection piston. The fosaprepitant dimeglumine injection composition provided by the invention is prepared from the low low-cost auxiliary materials according to a self-developed formula, has the same medicament effect in comparison with the existing fosaprepitant medicament available in America, is low in medicament cost and has no side effect basically; and the lactose used as excipient resists infection and is easy to absorb, so that favorable pharmaceutical effect can be achieved, and crushing of the medicament during storage can be avoided.

Description

Technical field [0001] The invention involves the field of drugs and especially involves a composition and preparation method of Fushalin. Background technique [0002] A variety of anti -tumor drugs such as chemotherapy drugs such as platinum and gyrumin will cause serious nausea and vomiting reactions during use.Cinv has a CINV in patients with chemotherapy, which is also one of the important reasons for many tumor patients' fear of chemotherapy.Acute and severe nausea, vomiting may lead to dehydration, electrolyte disorders, and malnutrition of patients. In severe cases, it may be bleeding, infection, and even death due to the damage to the digestive tract mucosa, which causes the patient to be afraid of chemotherapy, which is significantly reduced.The amount of quantity or stopping treatment seriously affects the treatment effect. Therefore, antivirus is an important auxiliary therapy drug for anti -tumor treatment. Especially for the use of medium and severe vomiting treatme...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/675A61K47/26A61P1/08
Inventor 曹传郭磊徐志刚朱玉青
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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