Gemcitabine hydrochloride lyophilized preparation
A technology of gemcitabine hydrochloride and freeze-dried preparations is applied in the field of gemcitabine hydrochloride freeze-dried preparations, which can solve the problems of inability to reduce the risk of patients, and achieve the effects of reducing the risk of medication, simple preparation process and low cost.
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Embodiment 1
[0018] formula:
[0019] Preparation: First, dissolve the prescribed amount of antioxidant in an enamel or glass container with an appropriate amount of water for injection, filter and add the prescribed amount of gemcitabine hydrochloride, lyoprotectant and appropriate amount of water for injection, stir to dissolve completely, and then add injection Use water to make the total volume 1000ml, then stir to make the mixture even, and finally filter, sub-package, and freeze-dry to obtain.
[0020] Stability test: place the finished gemcitabine hydrochloride freeze-dried preparation for 12 months under the conditions of 25°C and relative humidity of 60±5%. , the content of gemcitabine hydrochloride and the content of the single largest / total impurity in the sample were detected every 3 months. The test data are shown in Table 1.
Embodiment 2
[0022] formula:
[0023] The rest of the content is the same as described in Example 1.
Embodiment 3
[0025] formula:
[0026] The rest of the content is the same as described in Example 1.
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