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Ondansetron composition for injection

A technology for composition and injection, which is applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of low absolute bioavailability, short maintenance time in vivo, and strong first-pass effect To shorten the course of treatment, reduce the first-pass effect, and improve the effect of treatment

Inactive Publication Date: 2013-10-02
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although MT has a variety of physiological functions and pharmacological effects, it has unstable oral absorption kinetics, rapid distribution and clearance, and t 1 / 2 Short (30-50min), large individual differences, strong first-pass effect, low absolute bioavailability (1%-37%), and short maintenance time in vivo (1-3h)

Method used

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  • Ondansetron composition for injection
  • Ondansetron composition for injection
  • Ondansetron composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1, preparation of ondansetron composition freeze-dried powder for injection, in 1000 pieces

[0020] 1. Prescription

[0021]

[0022] 2. Preparation process

[0023] a) Add 4 g of ondansetron hydrochloride (calculated as ondansetron) and 20 g of mannitol into 1500 ml of water for injection and stir to dissolve, then add 1 g of melatonin and stir evenly;

[0024] b) Add 3g of melatonin and 14.66g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 6 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0025] c) Add NaOH solution to adjust the pH value after mixing the above-mentioned group a and b solutions, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, filter the liquid medicine through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates, According to ondansetron, 4mg per bottle;

[0026] d) Fill accor...

Embodiment 2

[0027] Embodiment 2, preparation of ondansetron composition freeze-dried powder for injection, in 1000 pieces

[0028] 1. Prescription

[0029]

[0030] 2. Preparation process

[0031] a) Add 4g of ondansetron hydrochloride (calculated as ondansetron) and 20g of mannitol to 1500ml of water for injection and stir to dissolve, then add 2g of melatonin and stir evenly;

[0032] b) Add 6g of melatonin and 29.32g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 8 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0033] c) Add NaOH solution to adjust the pH value after mixing the above-mentioned group a and b solutions, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, filter the liquid medicine through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates, According to ondansetron, 4mg per bottle;

[0034] d) Fill according t...

Embodiment 3

[0035] Embodiment 3, preparation of ondansetron composition freeze-dried powder for injection, in 1000 pieces

[0036] 1. Prescription

[0037]

[0038] 2. Preparation process

[0039] a) Add 4 g of ondansetron hydrochloride (calculated as ondansetron) and 20 g of mannitol to 1500 ml of water for injection and stir to dissolve, then add 0.6 g of melatonin and stir evenly;

[0040] b) Add 1.8g of melatonin and 8.8g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 5 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0041] c) Add NaOH solution to adjust the pH value after mixing the above-mentioned group a and b solutions, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, filter the liquid medicine through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates, According to ondansetron, 4mg per bottle;

[0042] d) Fill accor...

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Abstract

The invention provides an andansetron composition for injection, relating to the technical field of drugs and drug preparation. The main drugs of the andansetron composition include andansetron and melatonin, wherein the melatonin comprises a quick-release part and a cyclodextrin encapsulated slow-release part. The andansetron composition for injection, provided by the invention, has the advantages that the treatment effect of the andansetron is improved, the instability of the MT (melatonin), caused by the oral absorption of the MT and the fast distribution and elimination of the MT are avoided, the first-pass effect of the MT is reduced, the dosage of the andansetron is reduced, the quick-release and slow-release combined drug administration design is in line with the physiological secretion characteristic of the MT, the problem of short half-life period of the MT is solved, the biological availability of the product is improved, the melatonin has a synergistic effect on the andansetron for CINV (Chemotherapy Induced Nausea And Vomiting) treatment, after the melatonin and the andansetron are combined, the CINV can be treated, the treatment effect of the andansetron on the CINV are improved, the treatment course is shortened, the usage and the side effect of the andansetron are reduced, and the immunity of human bodies can be improved; and a certain concentration of melatonin maintained in the blood of the human body can be used for effectively reducing the stress reaction of organisms and is facilitated to the treatment of the CINV.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to an ondansetron composition for injection, and more specifically, to a freeze-dried composition for injection containing ondansetron and melatonin. Background technique: [0002] Because platinum, doxorubicin and other anti-tumor drugs will cause severe vomiting during the use, acute and severe nausea and vomiting may lead to dehydration, electrolyte imbalance, and malnutrition in patients, and severe cases may be caused by damage to the digestive tract mucosa. Bleeding, infection, and even death will make patients fear chemotherapy and significantly reduce their compliance. As a result, chemotherapy will be reduced or discontinued, which will seriously affect the therapeutic effect. Therefore, antiemetic drugs are important adjuvant drugs for antitumor therapy, especially The use of drugs for the treatment of moderate and severe vomiting is also mainly ...

Claims

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Application Information

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IPC IPC(8): A61K31/4178A61K47/48A61K9/19A61P1/08A61P37/04A61K31/4045
Inventor 汪六一汪金灿郝结兵李彪吴函峰
Owner HAINAN WEI KANG PHARMA QIANSHAN
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