Ganciclovir freeze-dry preparation for injection and preparation method thereof
A technology for ganciclovir and freeze-dried preparations, which is applied in the field of ganciclovir freeze-dried preparations for injection and their preparation, can solve the problems of low solubility of ganciclovir, unstable product quality, patient discomfort and the like, Achieve the effect of shortening freeze-drying time, increasing hardware investment, and avoiding content reduction
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Embodiment 1
[0044]The ganciclovir freeze-dried preparation for injection of the present invention is prepared from the following components: 50 g of ganciclovir; 100 g of hydroxypropyl-β-cyclodextrin; and 2600 ml of water for injection.
[0045] Its preparation method is as follows:
[0046] 1) Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add about 1300ml of water for injection, stir until completely dissolved, add activated carbon with a prepared volume of 0.2%, stir for 30 minutes, filter and decarbonize to obtain the filtrate ①.
[0047] 2) Measure about 1000ml of water for injection, adjust the pH value to 9.0-9.5, add the prescribed amount of ganciclovir, stir well, add the filtrate ①stir quickly to dissolve it completely, add water for injection to the full amount, and adjust the pH value to 8.5 ~9.5, filtered through a sterilizing filter to the storage tank, and after the semi-finished product is qualified, it is divided into 10ml control bottles according to 2.6ml ...
Embodiment 2
[0055] The ganciclovir freeze-dried preparation for injection of the present invention is prepared from the following components: 250 g of ganciclovir; 200 g of hydroxypropyl-β-cyclodextrin; and 2600 ml of water for injection.
[0056] Its preparation method is as follows:
[0057] 1) Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add about 1300ml of water for injection, stir until completely dissolved, add activated carbon with a prepared volume of 0.2%, stir for 30 minutes, filter and decarbonize to obtain the filtrate ①.
[0058] 2) Measure about 1000ml of water for injection, adjust the pH value to 9.0-9.5, add the prescribed amount of ganciclovir, stir well, add the filtrate ①stir quickly to dissolve it completely, add water for injection to the full amount, and adjust the pH value to 8.5 ~9.5, filtered through a sterilizing filter to the storage tank, and after the semi-finished product is qualified, it is divided into 10ml control bottles according to 2.6m...
Embodiment 3
[0066] The ganciclovir freeze-dried preparation for injection of the present invention is prepared from the following components: 50 g of ganciclovir; 100 g of hydroxypropyl-β-cyclodextrin; and 2600 ml of water for injection.
[0067] Its preparation method is as follows:
[0068] 1) Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add about 1300ml of water for injection, stir until completely dissolved, add activated carbon with a prepared volume of 0.2%, stir for 30 minutes, filter and decarbonize to obtain the filtrate ①.
[0069] 2) Measure about 1000ml of water for injection, adjust the pH value to 9.0-9.5, add the prescribed amount of ganciclovir, stir well, add the filtrate ①stir quickly to dissolve it completely, add water for injection to the full amount, and adjust the pH value to 8.5 ~9.5, filtered through a sterilizing filter to the storage tank, and after the semi-finished product is qualified, it is divided into 10ml control bottles according to 2.6ml...
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