Method for optimizing freeze-drying curve of chorionic gonadotrophin freeze-drying preparation for injection
A technology of chorionic gonadotropin and freeze-dried preparations, applied in the field of pharmaceutical preparations, can solve the problems of reduced productivity, reduced sublimation speed, drug shrinkage and foaming, etc., and achieve the effect of improving product properties and optimizing freeze-drying curves
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Embodiment 1
[0027] (1), pre-freezing:
[0028] The temperature of the heat transfer oil reaches -40°C in 30 minutes and is maintained for 2 hours;
[0029] (2), a sublimation:
[0030] In the first stage, the temperature of the heat transfer oil reaches -20°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 6 hours;
[0031] In the second stage, the temperature of the heat transfer oil reaches -10°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 1 hour;
[0032] In the third stage, the temperature of the heat transfer oil reaches 0°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 0.5 hours;
[0033] (3), analytical drying:
[0034] In the first stage, the temperature of the heat transfer oil reaches 30°C in 2 hours, and the vacuum degree is about 30 Pa, and it is kept for 1 hour;
[0035] In the second stage, the temperature of the heat transfer oil reaches 30°C in 1 minute, and the vacuum degree is about 10 Pa, and...
Embodiment 2
[0038] (1), pre-freezing:
[0039] The temperature of the heat transfer oil reaches -40°C in 40 minutes and keeps for 2 hours;
[0040] (2), a sublimation:
[0041] In the first stage, the temperature of the heat transfer oil reaches -25°C in 1.5 hours, and the vacuum degree is about 35 Pa, and it is kept for 6 hours;
[0042] In the second stage, the temperature of the heat transfer oil reaches -15°C in 1.5 hours, and the vacuum degree is about 35 Pa, and it is kept for 1 hour;
[0043] In the third stage, the temperature of the heat transfer oil reaches -5°C in 1.5 hours, and the vacuum degree is about 35 Pa, and it is kept for 1 hour;
[0044] (3), analytical drying:
[0045] In the first stage, the temperature of the heat transfer oil reaches 30°C in 2 hours, and the vacuum degree is about 35 Pa, and it is kept for 1 hour;
[0046] In the second stage, the temperature of the heat transfer oil reaches 30°C in 2 minutes, and the vacuum degree is about 15 Pa, and it is ke...
Embodiment 3
[0049] (1), pre-freezing:
[0050] The temperature of the heat transfer oil reaches -40°C in 60 minutes and is maintained for 2 hours;
[0051] (2), a sublimation:
[0052] In the first stage, the temperature of the heat transfer oil reaches -20°C in 1 hour, and the vacuum degree is about 40 Pa, and it is kept for 6 hours;
[0053] In the second stage, the temperature of the heat transfer oil reaches -8°C in 1 hour, and the vacuum degree is about 40 Pa, and it is kept for 1.5 hours;
[0054] In the third stage, the temperature of the heat transfer oil reaches 0°C in 1 hour, and the vacuum degree is about 40 Pa, and it is kept for 1 hour;
[0055] (3), analytical drying:
[0056]In the first stage, the temperature of the heat transfer oil reaches 35°C in 1 hour, and the vacuum degree is about 40 Pa, and it is kept for 1.5 hours;
[0057] In the second stage, the temperature of the heat transfer oil reaches 35°C in 1 minute, and the vacuum degree is about 15 Pa, and it is ke...
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