Gemcitabine hydrochloride for injection as well as preparation method thereof
A technology for gemcitabine hydrochloride and injection, which is applied in the field of gemcitabine hydrochloride for injection and its preparation, which can solve the problems of introducing allergens and the safety of preparations cannot be guaranteed, so as to increase stability, avoid water degradation, and improve product quality Effect
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[0029] Example 1
[0030] Dissolve 1kg of gemcitabine hydrochloride and 1.6kg of gelatin in 25L of water, dissolve and mix as the inner water phase (W1 phase); 25kg of polylactic acid-glycolic acid (the ratio of lactide to glycolide in polylactic acid-glycolic acid is: 75 / 25, molecular weight 6000) was dissolved in 180L dichloromethane as the oil phase (O phase); 22kg of polyvinyl alcohol was dissolved in water for injection at 80°C, so that the mass volume concentration of polyvinyl alcohol was 1.0% (w / v), as the outer water phase (W2 phase); slowly drop the W1 phase into the O phase, emulsification at a high speed of 18000r / min for about 4 minutes, cool down to 10 °C as colostrum, and add it to the W2 phase, 15000r / min high-speed vibration emulsification for about 5min, 5000r / min for 3-5h to remove dichloromethane, high-speed centrifugation at 10000r / min, wash with water for injection 3-5 times to remove polyvinyl alcohol, subpackage, half stopper, sample into the box, Fr...
Example Embodiment
[0034] Example 2
[0035] Dissolve 1kg of gemcitabine hydrochloride and 1.8kg of gelatin in 30L of water, dissolve and mix as the inner water phase (phase W1); 30kg of polylactic acid-glycolic acid (the ratio of lactide to glycolide in polylactic acid-glycolic acid is: 75 / 25, molecular weight 6000) was dissolved in 200L of dichloromethane as the oil phase (O phase); 25kg of polyvinyl alcohol was dissolved in water for injection at 80°C, so that the mass volume concentration of polyvinyl alcohol was 0.98% (w / v), as the external water phase (W2 phase); slowly drop the W1 phase into the O phase, emulsification at a high speed of 15000r / min for about 5 minutes, cool down to 10 °C as colostrum, and add it to the W2 phase, 15000r / min high-speed vibration emulsification for about 5min, 5000r / min for 3-5h to remove dichloromethane, high-speed centrifugation at 15000r / min, washing with water for injection 4-7 times to remove polyvinyl alcohol, subpackage, half stopper, sample into th...
Example Embodiment
[0036] Example 3
[0037]Dissolve 1kg of gemcitabine hydrochloride and 1kg of gelatin in 20L of water, dissolve and mix as the inner water phase (W1 phase); 15kg of polylactic acid-glycolic acid (the ratio of lactide to glycolide in polylactic acid-glycolic acid is 75 / 25, molecular weight 6000) was dissolved in 100L of dichloromethane as the oil phase (O phase); 16kg of polyvinyl alcohol was dissolved in water for injection at 80°C, so that the mass volume concentration of polyvinyl alcohol was 1.05% (w / v ), as the external water phase (W2 phase); slowly drop the W1 phase into the O phase, emulsification at a high speed of 15000r / min for about 5min, cool it to 10 °C, and add it to the W2 phase as the colostrum, 20000r / min min high-speed vibration emulsification for about 3min, 4000r / min for 3-5h to remove dichloromethane, high-speed centrifugation at 10000r / min, wash with water for injection 3-5 times to remove polyvinyl alcohol, sub-pack, half stopper, put the sample into th...
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