Citicoline sodium tablets and preparation method for directly compressing powder of citicoline sodium into tablets
A technology for citicoline sodium and citicoline sodium, which is applied in the field of citicoline sodium tablets and their preparation, can solve the problems of poor powder fluidity and the like, and achieves good powder fluidity, controllable quality, and good dissolution uniformity. Effect
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Embodiment 1
[0027] Example 1 The effect of different fillers and filler content on citicoline sodium tablets
[0028] In this example, the effects of different fillers and filler content on citicoline sodium tablets were tested.
[0029] Table 1. Selection prescription table of different fillers and filler content of citicoline sodium tablets
[0030]
[0031] Preparation Process:
[0032] 1) Take citicoline sodium and cross-linked polyvinylpyrrolidone XL through a 60-mesh sieve respectively, and then take lactose, spray-dried lactose Flowlac100, microcrystalline cellulose Avicel PH102, and cellactose80 through a 60-mesh sieve respectively, and set aside.
[0033] 2) Take 1 / 2 citicoline sodium and add lactose and microcrystalline cellulose Avicel PH102, spray-dried lactose Flowlac100 and microcrystalline cellulose Avicel PH102, or cellactose80 to the total mixer at 20r / min, and mix for 10 Minutes, spare.
[0034] 3) Take the above-mixed powder, add the remaining 1 / 2 citicoline sodium, cross-linked...
Embodiment 2
[0046] Example 2: The effect of different glidants / lubricants on citicoline sodium tablets
[0047] In this example, the effects of different glidants / lubricants on citicoline sodium tablets were tested.
[0048] Table 3. Citicoline sodium tablets glidant / lubricant dosage selection prescription table
[0049]
[0050] Preparation Process:
[0051] 1) Take citicoline sodium and cross-linked polyvinylpyrrolidone XL through a 60 mesh sieve, and then take cellactose 80 through a 60 mesh sieve for use.
[0052] 2) Add 1 / 2 citicoline sodium to the micro-powder silica gel and cellactose 80 in the prescription in a total mixer at 20 r / min, mix for 10 minutes, and then set aside.
[0053] 3) Take the above-mixed powder, add the remaining 1 / 2 citicoline sodium, cross-linked polyvinylpyrrolidone XL and magnesium stearate in the total mixer for 20 r / min, mix for 20 minutes, and conduct intermediate inspection.
[0054] 4) Use a die with a diameter of 6mm to press tablets with a core hardness of 5-6k...
Embodiment 3
[0060] Example 3: The effect of different disintegrants on citicoline sodium tablets
[0061] Table 5: Selection prescription table for different disintegrants of citicoline sodium tablets
[0062]
[0063]
[0064] Preparation Process:
[0065] 1) Take citicoline sodium, cross-linked polyvinylpyrrolidone XL, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose through a 60-mesh sieve respectively, and then take cellactose 80 through a 60-mesh sieve for use.
[0066] 2) Add 1 / 2 citicoline sodium to the micro-powder silica gel and cellactose 80 in the prescription in a total mixer at 20 r / min, mix for 10 minutes, and then set aside.
[0067] 3) Take the above mixed powder, add the remaining 1 / 2 citicoline sodium, cross-linked polyvinylpyrrolidone XL (or sodium carboxymethyl starch or low-substituted hydroxypropyl cellulose) and magnesium stearate to the total 20r / min in the mixer, mixing for 20 minutes, check the intermediate.
[0068] 4) Use a die with a diameter of...
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