Tropisetron composition for injection
A technology of tropisetron and composition, which is applied in the field of freeze-dried compositions for injection containing tropisetron and melatonin, can solve the problem of low absolute bioavailability, short maintenance time in vivo, strong first-pass effect, etc. problems, to shorten the course of treatment, reduce the first-pass effect, and improve the effect of treatment
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Embodiment 1
[0019] Embodiment 1, preparation of tropisetron composition freeze-dried powder for injection, in 1000 pieces
[0020] 1. Prescription
[0021]
[0022] 2. Preparation process
[0023] a) Add 5 g of tropisetron hydrochloride (calculated as tropisetron) and 30 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 tropisetron, 5 mg per bottle;
[0026] d) Fill acco...
Embodiment 2
[0027] Embodiment 2, preparation of tropisetron composition freeze-dried powder for injection, in 1000 pieces
[0028] 1. Prescription
[0029]
[0030] 2. Preparation process
[0031] a) Add 5 g of tropisetron hydrochloride (calculated as tropisetron) and 30 g of mannitol into 1500 ml of water for injection and stir to dissolve, then add 2 g 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 tropisetron, 5 mg per bottle;
[0034] d) Fill acco...
Embodiment 3
[0035] Embodiment 3, preparation of tropisetron composition freeze-dried powder for injection, in 1000 pieces
[0036] 1. Prescription
[0037]
[0038] 2. Preparation process
[0039] a) Add 5 g of tropisetron hydrochloride (calculated as tropisetron) and 30 g of mannitol into 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 tropisetron, 5 mg per bottle;
[0042] d) Fill ac...
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