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Ondansijiong hydrochleride freeze dried powder ampoule for injection and its preparation method

A technology of ondansetron hydrochloride and freeze-dried powder injection, applied in the field of ondansetron hydrochloride freeze-dried powder injection for injection and its preparation, which can solve the inconvenience of transportation and storage of injection preparations, the decline of curative effect, and the instability of active ingredients and other problems, to achieve the effect of long validity period, reasonable composition and convenient transportation

Inactive Publication Date: 2004-12-22
陈庆财 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, only its injection preparations are in use in China. Because the injections can destabilize the active ingredients during high-temperature sterilization, the curative effect is reduced, and the injection preparations are also inconvenient in transportation and storage.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1: 4mg / bottle specification, 1000 freeze-dried powder injection formulations:

[0016] Ondansetron Hydrochloride 5g

[0017] Mannitol 30g

[0018] Add water for injection to 2000ml, make 1000 tubes in total

[0019] Among them, ondansetron hydrochloride is the main drug, and the specification in this embodiment is that each bottle contains ondansetron 4mg, because ondansetron hydrochloride contains 2 molecules of crystal water, according to molecular weight conversion, ondansetron hydrochloride 5g is equivalent to Ondansetron 4g, so it should be ondansetron hydrochloride 5g when feeding.

[0020] Mannitol is an excipient, which is used as the skeleton supporting part of ondansetron powder for injection. According to literature reports and combined with our company's production practice experience of other freeze-dried preparations. The test is carried out by simulating the actual production, and the ratio of the main drug to the mannitol is determined: th...

Embodiment 2

[0024] Embodiment 2: 8mg / bottle specification, 1000 freeze-dried powder injection formulations:

[0025] Ondansetron Hydrochloride 10g

[0026] Mannitol 10g

[0027] Add water for injection to 2000ml, make 1000 tubes in total

[0028] Among them, ondansetron hydrochloride is the main drug, and the specification in this embodiment is that each bottle contains ondansetron 8mg, because ondansetron hydrochloride contains 2 molecules of crystal water, according to molecular weight conversion, ondansetron hydrochloride 10g is equivalent to Ondansetron 8g, so it should be ondansetron hydrochloride 10g when feeding.

[0029] Mannitol is an excipient, which is used as the skeleton supporting part of ondansetron powder for injection. Determine the ratio of the main drug ondansetron hydrochloride to mannitol: the ratio of 10:10. Water for injection is used as a solvent for dissolving raw materials, and an appropriate amount is added according to the concentration of the liquid medici...

Embodiment 3

[0033] Embodiment 3: 1.6mg / bottle specification, 1000 freeze-dried powder injection formulations:

[0034] Ondansetron Hydrochloride 2g

[0035] Mannitol 50g

[0036] Add water for injection to 2000ml, make 1000 tubes in total

[0037] Among them, ondansetron hydrochloride is the main drug, and the specification in this embodiment is that each bottle contains ondansetron 1.6mg, because ondansetron hydrochloride contains 2 molecules of crystal water, according to molecular weight conversion, ondansetron hydrochloride 2g is equivalent to Ondansetron 1.6g, so it should be ondansetron hydrochloride 2g when feeding.

[0038] Mannitol is an excipient, which is used as the skeleton supporting part of ondansetron powder for injection. Determine the ratio of the main drug ondansetron hydrochloride to mannitol: the ratio of 2:50. Water for injection is used as a solvent for dissolving raw materials, and an appropriate amount is added according to the concentration of the liquid medi...

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PUM

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Abstract

An ondansetron hydrochloride injection in the form of freeze dried powder for treating the nausea and emesis caused by chemicotherapy or radiotherapy is prepared from ondansetron hydrochloride, pharmacological acceptable excipient and water for injection through dissolving ondansetron hydrochloride in the water, adding excipient, stirring, regulating pH value, filtering, and freeze drying.

Description

technical field [0001] The invention belongs to ondansetron hydrochloride pharmaceutical preparations, in particular to an ondansetron hydrochloride freeze-dried powder injection for injection and a preparation method thereof. Background technique [0002] Ondansetron hydrochloride is a highly selective serotonin 5HT 3 Receptor antagonists are new powerful antiemetics. It is suitable for the treatment of nausea and vomiting caused by cytotoxic drug chemotherapy and radiation therapy, and also for the prevention and treatment of nausea and vomiting after surgery. Ondansetron mainly antagonizes peripheral and central neurons 5-hydroxytryptamine 5HT 3 receptors, blocking chemotherapy or radiotherapy and other factors that cause the release of 5HT in the small intestine 3 Combined with the receptor to play an antiemetic effect. The drug has good clinical curative effect, few side effects, and no adverse reactions such as extrapyramidal system reaction and excessive sedation....

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4178A61P1/08
Inventor 陈庆财赵俊
Owner 陈庆财
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