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Safe and stable palonosetron injection

A technology of palonosetron and composition, which is applied in the direction of drug combination, medical preparations containing active ingredients, digestive system, etc. It can solve the problems of poor stability and unqualified color, and achieve the effect of low toxicity and small side effects

Active Publication Date: 2009-09-30
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, in the workshop trial production, due to some influencing factors that must be produced under large-scale production and storage conditions, the injection solution without EDTA disodium salt showed unqualified color and poor stability.
How to solve the safety and stability problems of palonosetron injection at the same time has become a difficult problem

Method used

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  • Safe and stable palonosetron injection
  • Safe and stable palonosetron injection
  • Safe and stable palonosetron injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1 Palonosetron Hydrochloride Injection

[0034] Preparation prescription (based on 1000ml):

[0035] Palonosetron Hydrochloride 0.0112g (contains Palonosetron 0.01g)

[0036] Sodium citrate 1g

[0037] Glucose 60g

[0038] Calcium Disodium EDTA 0.1g

[0039] Proper amount of dilute hydrochloric acid

[0040]

[0041] Add water for injection to 1000ml

[0042] It is prepared according to the following steps: dissolve sodium citrate, glucose and calcium disodium EDTA in water for injection and dilute appropriately, adjust the pH of the solution to 4.5 with dilute hydrochloric acid, and then add activated carbon for adsorption. After coarse filtration, add the prescribed amount of palonosetron hydrochloride to dissolve and stir evenly to replenish the water for injection to the full amount. After filtering, test the content and pH, fill and seal after passing the test, and sterilize.

Embodiment 2

[0043] Embodiment 2 Palonosetron Hydrochloride Injection

[0044] Preparation prescription (calculated in 1000ml)

[0045] Palonosetron Hydrochloride 0.5615g (contains Palonosetron 0.5g)

[0046] Sodium dihydrogen phosphate 50g

[0047] Sodium chloride 9.0g

[0048] Calcium Disodium EDTA 0.75g

[0049] Appropriate amount of sodium hydroxide

[0050]

[0051] Add water for injection to 1000ml

[0052] It is prepared according to the following steps: dissolve and dilute the prescription amount of sodium dihydrogen phosphate, sodium chloride and calcium disodium EDTA with water for injection, adjust the pH of the solution to 5.5 with sodium hydroxide, and then add activated carbon for adsorption. After coarse filtration, add the prescribed amount of palonosetron hydrochloride to dissolve and stir evenly to replenish the water for injection to the full amount. After filtering, test the content and pH, fill and seal after passing the test,...

Embodiment 3

[0053] Embodiment 3 palonosetron hydrochloride injection

[0054] Preparation prescription (calculated in 1000ml)

[0055] Palonosetron Hydrochloride 0.0562g (contains Palonosetron 0.05g)

[0056] Citric acid 20g

[0057] Mannitol 41.5g

[0058] Calcium Disodium EDTA 0.5g

[0059] Appropriate amount of sodium hydroxide

[0060]

[0061] Add water for injection to 1000ml

[0062] It is prepared according to the following steps: dissolving and properly diluting the prescribed amount of citric acid, mannitol and calcium disodium EDTA with water for injection, adjusting the pH of the solution to 5.5 with sodium hydroxide, and then adding activated carbon for adsorption. After coarse filtration, add the prescribed amount of palonosetron hydrochloride to dissolve and stir evenly to replenish the water for injection to the full amount. After filtering, test the content and pH, fill and seal after passing the test, and sterilize.

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Abstract

The invention provides a safe and stable injection of palonosetron or its pharmaceutically acceptable salt, which contains palonosetron or its pharmaceutically acceptable salt, pH buffering agent, pH regulator and Isotonic regulator, metal complexing agent.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a pharmaceutical preparation and a preparation process thereof. In particular, it relates to a palonosetron injection preparation and a preparation process thereof. Background technique [0002] Tumor chemotherapeutic drugs can cause nausea and vomiting in varying degrees, affecting the compliance of cancer patients to treatment. The mechanism of chemotherapy-induced vomiting has been preliminarily clarified. When chemotherapy drugs reach the chromaffin cells in the small intestinal mucosa, they cause a large amount of 5-HT (5-hydroxytryptamine, 5-Hydroxytryptamine) to be released, activating a large amount of 5-HT in the small intestine. 3 Receptors, the stimulation is transmitted to the chemoemetic sensing zone (CTZ) through the vagus afferent nerve, and the CTZ is then transmitted to the vomiting center of the medulla oblongata, where the brainstem receptor is activated, and the signal ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/473A61P1/08
Inventor 董平张来芳杨玲
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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