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A kind of pharmaceutical composition of pemetrexed disodium

A technology of pemetrexed disodium and composition, applied in the field of freeze-dried medicinal compositions, can solve problems such as lack

Inactive Publication Date: 2011-12-07
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] Therefore it can be seen that there is a lack of a preparation composition that can effectively improve the infusion pain during pemetrexed disodium injection and alleviate the adverse reactions of its local irritation in the prior art.

Method used

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  • A kind of pharmaceutical composition of pemetrexed disodium
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  • A kind of pharmaceutical composition of pemetrexed disodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～9 and comparative example 1～8

[0036] The freeze-dried products of Examples 1-9 and Comparative Examples 1-8 were prepared according to the following methods.

[0037]Preparation method: Weigh the corresponding pemetrexed disodium raw materials and auxiliary materials as shown in Table 1, add sterilized water for injection to 2.5L, stir and dissolve, adjust the pH value of the solution with 0.1N sodium hydroxide solution or hydrochloric acid solution To 7.5, add 2.29 g of activated carbon for needles, stir, filter, and then filter the filtrate with a 0.22 μm microporous membrane, and distribute it into type I glass bottles. Freeze in a freeze-drying cabinet to about -40°C for 4 hours, sublimate and dry at -30 to -20°C for 30 hours, and then dry at 25°C for 12 hours, fill with nitrogen, plug, take out of the box, seal with a gland, and pack to get the example 1-9 and the pemetrexed disodium lyophilized powder for injection of comparative examples 1-8.

[0038] Table 1 Embodiment 1~9, comparative examples 1~...

Embodiment 10

[0041] Example 10: Vascular stimulation test of powder injections prepared according to Examples 1-9 and Comparative Examples 1-8 and pemetrexed disodium freeze-dried powder injections on the market

[0042] 1. Test method: Take 108 New Zealand rabbits qualified for quarantine, weighing 2.5-3kg, half male and half male, and divide them into 18 groups on average, with 6 rabbits in each group, and prepare according to the methods of Examples 1-9 and Comparative Examples 1-8 respectively Pemetrexed disodium powder injection and listed pemetrexed disodium powder injection, using the same body left and right sides of the self-contrast method, the rabbit's left ear vein was given the corresponding injection of pemetrexed disodium solution, the concentration is 1mg / ml, approximately equivalent to clinical It is planned to use 1.2 times the concentration of the maximum intravenous administration, give normal saline to the vein of the right ear margin of the rabbit, the administration v...

Embodiment 11

[0067] Example 11: Muscle stimulation test of powder injections prepared according to Examples 1-9 and Comparative Examples 1-8 and marketed preparations

[0068] 1. Test method: 108 New Zealand white rabbits were shared with the vascular stimulation test, grouped into the same blood vessel stimulation test, using the same body left and right muscle self-comparison method, the left quadriceps muscle was given the test substance, and the administration concentration was 1mg / mL ( It is approximately equivalent to 1.2 times the concentration of intravenous administration intended for clinical use), the administration volume is 1.0mL / side, and an equal volume of normal saline is administered to the right side as a control, administered once every 2 days, a total of 2 times. Necropsy was performed 48 hours and 14 days after the last administration, respectively.

[0069] 2. Observation indicators

[0070] Weighing of animals: Animals were divided into groups at the end of the quar...

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Abstract

The invention relates to a freeze-dried pharmaceutical composition of pemetrexed disodium and a preparation method thereof. The invention provides a pemetrexed disodium freeze-dried composition containing pemetrexed disodium, trehalose and freeze-dried excipients, the parts by mass are 110 parts of pemetrexed disodium, 60-60 parts of trehalose 105 parts, 0-40 parts of freeze-dried excipients. The preparation process is: dissolving pemetrexed disodium, trehalose and lyophilized excipients in water, stirring until the solution is clear, adjusting the pH to 7.5-8.0 with sodium hydroxide or hydrochloric acid solution, and removing the pyrogen from the above clear solution and filter to sterilize, freeze-dry to make a sterile powdery solid pharmaceutical composition, seal the container under nitrogen protection, and pack to obtain a finished product. The pharmaceutical composition of the present invention can obviously improve local stimulation effects such as discomfort, pain and even inflammatory reaction during pemetrexed disodium infusion, and improve patient compliance.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a freeze-dried medicinal composition of pemetrexed disodium available for injection. Background technique [0002] Pemetrexed disodium (Pemetrexed disodium), the chemical name is N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidine) -5-Alkyl)ethyl]benzoyl]-L-glutamate disodium. [0003] Pemetrexed disodium is a multi-target folic acid antagonist developed by Eli Lilly and Company for the treatment of tumors. It can be used in combination with cisplatin to treat inoperable malignant pleural mesothelioma (MPM). Currently, pemetrexed disodium It is the only drug for the treatment of malignant pleural mesothelioma in the world, and it is also used for the second-line treatment of metastatic non-small cell lung cancer. Pemetrexed alone or in combination with chemotherapy has obvious therapeutic effects on a variety of tumors, especially for patients who have failed previous treatme...

Claims

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Application Information

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IPC IPC(8): A61P35/00A61K47/26A61K9/19A61K31/519
Inventor 樊俊红耿佳陈静敏刘翠艳陈欣然吕晶晶
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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