Method for preparing metronidazole injection
A technology for metronidazole sodium chloride and injection, which is applied in the field of preparing metronidazole sodium chloride injection, can solve the problems of white spot of injection, poor stability, easy crystallization of metronidazole, etc., and achieves reduction of adsorption , improve the stability, control the effect of quality
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Embodiment 1
[0029] Prescription of Metronidazole Sodium Chloride Injection:
[0030] Specification:
[0031] 1 preparation
[0032] 1.1 Pre-production inspection
[0033] 1.2 Picking
[0034] 1.3 Calculation: Calculate the actual feeding amount according to the batch and prescription, and check it.
[0035] Metronidazole actual feed amount (Kg) = Feed amount per liter (Kg) × Dosing amount (L)
[0036] Actual feeding amount of sodium chloride (Kg) = feeding amount per liter (Kg) × liquid dosage (L)
[0037] Actual dosage of activated carbon in concentrated formulation (Kg) = volume (L) × 0.02% (Kg / L)
[0038] Actual dosage of activated carbon (Kg) = volume (L) × 0.01% (Kg / L)
[0039] 1.4 Weighing and carbon adjustment
[0040] Weighing: open the raw and auxiliary materials weighing room to ventilate outside, weigh and check the metronidazole and sodium chloride according to the calculated batch actual feeding amount.
[0041] Carbon adjustment: Open the activated carbon fume hood...
Embodiment 2
[0062] Operate in the same way as in Example 1, the difference is only in:
[0063] Under step 1.5.1, add 1000L water for injection into the concentrated preparation tank, boil and filter back for 15 minutes, send the water for injection into the dilute preparation tank, and filter back for 15 minutes;
[0064] Under step 1.5.2, adsorb on activated carbon for 30 minutes, boil the liquid medicine and keep boiling for 20 minutes, close the steam valve, and cool the temperature of the liquid medicine to 75°C;
[0065] Under step 1.5.3, use a 0.45 μm filter to filter back for 30 minutes, while cooling the liquid medicine to 60°C;
[0066] Under step 2.3, the compressed air bottle washing pressure is 0.4MPa;
[0067] Under step 3.3, sterilize at 120°C for 40 minutes.
[0068] The product batch number is 090731136.
Embodiment 3
[0070] Operate in the same way as in Example 1, the difference is only in:
[0071] Under step 1.5.1, add 1000L water for injection into the concentrated preparation tank, boil for 12 minutes and back-filter, send the water for injection into the dilute preparation tank, and back-filter for 12 minutes;
[0072] Under step 1.5.2, adsorb on activated carbon for 20 minutes, boil the liquid medicine and keep boiling for 15 minutes, close the steam valve, and cool the temperature of the liquid medicine to 50°C;
[0073] Under step 1.5.3, backfilter with a 0.45 μm filter for 30 minutes, while cooling the liquid medicine to 40°C;
[0074] Under step 2.3, the compressed air bottle washing pressure is 0.6MPa;
[0075] Under step 3.3, sterilize at 122°C for 38 minutes.
[0076] The product batch number is 090731137.
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