A kind of iodixanol injection and preparation method thereof
A technology of iodixanol and injection, which is applied in the preparation of X-ray contrast agents, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of iodixanol's strong hygroscopicity and difficulty in stirring and dissolving, and achieve Avoid easy aggregation and adhesion into agglomerates, enhance shrinkage, and slow down the effect of impact
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Embodiment 1
[0026] Injection prescription:
[0027]
[0028] In the scale-up production according to the above ratio, the one-time preparation volume of iodixanol is 20L.
[0029] Preparation method: (1) Add 1 / 4 of the boiled water for injection into the liquid mixing tank, cool down to 58-63°C, put in the prescribed amount of sodium tartrate and stir to dissolve for 0.5h, add iodixanol in batches, stir Dissolve; (2) cool down to 35-40°C, add the prescribed amount of sodium chloride into the batching tank, and at the same time add water for injection to the full amount in the batching tank, add tartaric acid to adjust the pH to 7.2-7.4; (3) add Activated carbon, the dosage is 0.2-0.8wt% of the injection, after stirring for 15min, filter with 0.5μm titanium rod and 0.45μm filter to remove activated carbon; Sign, pack.
Embodiment 2
[0031] Injection prescription:
[0032]
[0033] In the scale-up production according to the above ratio, the one-time preparation volume of iodixanol is 20L.
[0034] Preparation method: (1) Add 1 / 4 of the boiled water for injection into the liquid mixing tank, cool down to 58-63°C, put in the prescribed amount of sodium tartrate and stir to dissolve for 0.5h, add iodixanol in batches, stir Dissolve; (2) cool down to 35-40°C, add the prescribed amount of sodium chloride into the batching tank, and at the same time add water for injection to the full amount in the batching tank, add tartaric acid to adjust the pH to 7.2-7.4; (3) add Activated carbon, the dosage is 0.2~0.8wt% of the injection, after stirring for 15min, filter with 0.5μm titanium rod and 0.45μm filter to remove activated carbon; Sign, pack.
Embodiment 3
[0036] Injection prescription:
[0037]
[0038]In the scale-up production according to the above ratio, the one-time preparation volume of iodixanol is 20L.
[0039] Preparation method: (1) Add 1 / 4 of the boiled water for injection into the liquid mixing tank, cool down to 58-63°C, put in the prescribed amount of sodium tartrate and stir to dissolve for 0.5h, add iodixanol in batches, stir Dissolve; (2) cool down to 35-40°C, add the prescribed amount of sodium chloride into the batching tank, and at the same time add water for injection to the full amount in the batching tank, add phosphoric acid to adjust the pH to 6.5-7.0; (3) add Activated carbon, the dosage is 0.2~0.8wt% of the injection, after stirring for 15min, filter with 0.5μm titanium rod and 0.45μm filter to remove activated carbon; Sign, pack.
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