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Preparation method of pemetrexed disodium for injection

A technique for metrexed disodium injection and preparation process, applied in the field of medicine, can solve the problems of reduced clearance rate, increased dosage and the like, and achieve the effect of improving formability

Inactive Publication Date: 2012-07-04
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The overall clearance rate of pemetrexed is 91.8mL / min (creatinine elimination rate is 90mL / min). For patients with normal renal function, the in vivo half-life is 3.5 hours; with the decrease of renal function, the clearance rate will decrease, but the internal dose will decrease Increase

Method used

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Examples

Experimental program
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Effect test

Embodiment Construction

[0026] The solutions of the present invention will be further described below in conjunction with specific examples. For the convenience of expression, the compounds mentioned are represented by their common names.

[0027]

[0028] Raw materials Specification 200mg / bottle Specification 500mg / bottle Pemetrexed disodium 200g 500g Mannitol 200g 500g hydrochloric acid or sodium hydroxide Appropriate amount Appropriate amount Add water for injection to 10000ml 10000ml production 1000 bottles 1000 bottles

[0029] 2. Preparation process

[0030] (1) Rubber stopper cleaning and sterilization:

[0031] Send the rubber stoppers to a rubber stopper cleaning machine for cleaning, rinse until the visible foreign matter is qualified, put them into a vacuum sterilization oven, sterilize at 121°C for 30 minutes, put them into a special stainless steel barrel, and seal them.

[0032] (2) Cleaning and sterilization of vials:

[003...

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PUM

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Abstract

The invention provides a preparation method of pemetrexed disodium for injection, which comprises the following steps: (1) cleaning rubber plugs, and sterilizing; (2) cleaning and sterilizing vials; (3) disinfecting aluminum-plastic caps; (4) preparing solution; (5) filling medicinal solution passing tests into the vials, and half capping; (6) vacuum freeze drying; (7) pressing the rubber plugs, boxing, rolling the caps, and carrying out visual inspection; and (8) packaging, inspecting finished products, and storing after finished product inspection is passed.

Description

[0001] technical field [0002] The invention relates to the field of medicine, in particular to a preparation process of pemetrexed disodium for injection. Background technique [0003] The World Health Organization predicts that cancer deaths will increase significantly in the coming decades, from an estimated 9 million cases in 2015 to 11.4 million in 2030. The global antineoplastic drug market is the third largest pharmaceutical market after cardiovascular drugs and central nervous system drugs, and is currently developing rapidly. It is predicted that by 2010, the sales of tumor drugs will increase to more than 50 billion US dollars, with a growth rate of more than 11%. [0004] Pemetrexed disodium (pemetrexed disodium, MTA, LY231514) is a new generation of anti-metabolite developed on the basis of the classic anti-metabolite drugs methotrexate and fluorouracil, developed by Eli Lily (Eli Lily, Inc), The trade name is Alimta. It acts on folate-dependent metabolic p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/519A61P35/00
Inventor 王宁颜彦李励
Owner SUZHOU ERYE PHARMA CO LTD
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