Gallopropyl ester injection and its production
A production process, the technology of propyl gallate, which is applied in the field of drug injection dosage forms and production process, can solve the problems of secondary pollution, complicated operation, etc., and achieve the effect of convenient clinical use, clinical practicality and good stability
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Embodiment 1
[0020] Weigh 60g of propyl gallate and mix with 800ml of 1,2-propylene glycol, heat in a water bath at 60°C to dissolve, then add water for injection to about 1800ml, and stir evenly;
[0021] Add 1.0 g of activated carbon for needles (0.05%, W / V) to the above solution, stir evenly, stir in a water bath at 80° C. for 15 minutes, let cool slightly, and remove the activated carbon by coarse filtration; or filter by ultrafiltration.
[0022] Add water for injection to nearly full amount, adjust the pH value to 3.0 with 0.1mol / L hydrochloric acid, and then add water for injection to full amount.
[0023] Under the condition of 10,000 grades and local grades 100, after filtering through 0.8μm+0.22μm microporous membranes, put them in 5ml vials, line them with film, add stoppers, cap them, and sterilize them by circulating steam at 105°C for 30 minutes , to get injection 5000ml (1000) of the present invention.
Embodiment 2
[0025] Weigh 60g of propyl gallate and mix it with 1000ml of 1,3-propanediol, heat in a water bath at 50°C to dissolve, then add water for injection to about 800ml, and stir evenly;
[0026] Add 1.0 g of activated carbon for needles (0.05%, W / V) to the above solution, stir evenly, stir in a water bath at 50°C for 15 minutes, let cool slightly, and remove the activated carbon by coarse filtration; or filter by ultrafiltration.
[0027] Add water for injection to nearly full amount, adjust the pH value to 4.0 with 0.1mol / L hydrochloric acid, and then add water for injection to full amount.
[0028] Under the condition of 10,000 grades and local grades 100, after filtering through 0.8μm+0.22μm microporous membranes, put them in 5ml vials, line them with film, add stoppers, cap them, and sterilize them by circulating steam at 105°C for 30 minutes , to get 5000ml (1000) injections of the present invention.
Embodiment 3
[0030] Weigh 60g of propyl gallate and mix it with 3000ml of 1,2-propanediol, heat in a water bath at 55°C to dissolve, then add water for injection to about 1800ml, and stir evenly;
[0031] Add 1.0 g of activated carbon for needles (0.05%, W / V) to the above solution, stir evenly, stir in a water bath at 80° C. for 15 minutes, let cool slightly, and remove the activated carbon by coarse filtration; or filter by ultrafiltration.
[0032] Add water for injection to nearly full amount, adjust the pH value to 5.0 with 0.1mol / L hydrochloric acid, and add water for injection to full amount.
[0033] Under the condition of 10,000 grades and local grades 100, after filtering through 0.8μm+0.22μm microporous membranes, put them in 5ml vials, line them with film, add stoppers, cap them, and sterilize them by circulating steam at 105°C for 30 minutes , to get injection 5000ml (1000) of the present invention.
[0034] batch number
PUM
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