Cefdinir dispersible tablet
A technology for cefdinir and dispersible tablets, applied in the field of oral preparations, can solve the problems of increasing the complexity of the preparation process, reducing the strength of the tablet body, swelling and dispersing, etc., and achieves high disintegration speed and effective ingredient dissolution speed. Poor thermal performance, the effect of improving moisture and heat resistance
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[0010] The preparation technology of the cefdinir dispersible tablet provided by the invention comprises the following steps:
[0011] Preparation of pretreatment crospovidone: Povidone (PVP) K30 is dissolved in absolute ethanol to make a PVP solution with a weight percent concentration of 2.5%, and PVP will be mixed with PVP in a ratio of 1:10 by weight of PVP and PVPP. Solution is mixed with PVPP and then spray-dried to obtain pretreatment crospovidone (pretreatment PVPP);
[0012] Screening: pass the raw and auxiliary materials through a 40-mesh sieve for later use, to prevent the agglomeration of the raw materials and various auxiliary materials during the placement process
[0013] Mixing: put crospovidone and pretreated crospovidone, and cefdinir, micronized silica gel, aspartame, and microcrystalline cellulose in the prescribed amount into the square cone mixer in turn, and mix for 20 minutes Then add the prescribed amount of magnesium stearate and continue mixing for ...
Embodiment 1
[0019] Pharmacological Example 1, Uniformity of Dispersion Test
[0020] Test method: Take 6 cefdinir dispersible tablets prepared in Examples and Comparative Examples, place them in 100ml water in a 250mL beaker and shake them respectively. At a temperature of about 20°C, they should be completely disintegrated and uniformly dispersed in 3 minutes. State, through the No. 2 sieve, the test results are shown in the table below.
[0021]
[0022] Experimental result shows, although the dispersible tablet provided by embodiment and comparative example all can disintegrate within 3min, but the dispersion time of comparative example 3 is significantly higher than remaining examples, shows that the ratio that the pretreatment crospovidone adds is too high High will have adverse effects on the disintegration speed and dispersion uniformity of cefdinir dispersible tablets. And when the proportion of pretreated crospovidone is 30-70%, the obtained dispersible tablets can also be ra...
Embodiment 3
[0027] Pharmacological Example 3, high temperature and high humidity environment experiment
[0028] Get the dispersible tablet sample that embodiment and comparative example make, every group of 20, put watch glass through under condition is high humidity RH90% (40 ℃) condition, in 1h, 2h, 4h, 8h respectively, each sampling 5 Calculate the average moisture absorption weight gain rate of the sample, because it was found in the previous experiment that when the dispersible tablet absorbs moisture to a weight gain of more than 5%, the tablet body expands more obviously and the strength decreases obviously, so the weight gain rate exceeds 5% as the end of the experiment condition. Experimental result is as follows table (unit %):
[0029]
[0030] Experimental results show that the weight gain of the dispersible tablet obtained in Example 1 is lower than 5% at 4 hours, while the weight gain of the dispersible tablet obtained in Examples 3-4 can be kept lower than 5% at 8 hour...
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