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-t

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

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

[0016] Ondansetron Hydrochloride 5g

[0017] Mannitol 30g

[0018] Add the water for injection to 2000ml to make a total of 1000 bottles

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

[0020] Mannitol is an excipient and serves as the backbone support part of ondansetron powder injection for injection. According to literature reports and combined with our company's other freeze-dried preparations production practice experience. Experiments were carried out by simulating actual production to determine the ratio of the main drug to mannitol: the ratio of 2-10:10-50...

Example Embodiment

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

[0025] Ondansetron Hydrochloride 10g

[0026] Mannitol 10g

[0027] Add the water for injection to 2000ml to make a total of 1000 bottles

[0028] Among them, ondansetron hydrochloride is the main drug. The specification in this example is 8mg per bottle. Ondansetron hydrochloride contains 2 molecules of crystal water. Based on the molecular weight conversion, ondansetron hydrochloride 10g is equivalent to Ondansetron 8g, so ondansetron hydrochloride 10g should be used when feeding.

[0029] Mannitol is an excipient and serves as the backbone support part of ondansetron powder injection for injection. Determine the ratio of the main drug ondansetron hydrochloride to mannitol: 10:10. Water for injection is used as a solvent to dissolve the raw materials, and an appropriate amount is added according to the concentration of the drug solution and the amount of each drug. The preparation process o...

Example Embodiment

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

[0034] Ondansetron Hydrochloride 2g

[0035] Mannitol 50g

[0036] Add the water for injection to 2000ml to make a total of 1000 bottles

[0037] Among them, ondansetron hydrochloride is the main drug, and the specification in this example is 1.6 mg per bottle. Because ondansetron hydrochloride contains 2 molecules of crystal water, based on molecular weight conversion, ondansetron hydrochloride 2 g is equivalent It is 1.6g ondansetron, so ondansetron hydrochloride 2g should be used when feeding.

[0038] Mannitol is an excipient and serves as the backbone support part of ondansetron powder injection for injection. Determine the ratio of the main drug ondansetron hydrochloride to mannitol: 2:50. Water for injection is used as a solvent to dissolve the raw materials, and an appropriate amount is added according to the concentration of the drug solution and the amount of each drug. The prepa...

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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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