银黄分散片的制备及质量控制

目的利用正交设计筛选出银黄分散片的最佳处方。方法通过调节崩解剂的含量，粘合剂的浓度等因素，制备银黄分散片，考察崩解时限，混悬性等因素，对处方进行筛选。结果优选处方为AlB3Cl。即：微晶纤维素含量为8％，CMS．Na含量为15％，聚乙烯吡咯烷酮K30浓度为5％。对优选处方的实验表明：崩解时间小于3min，分散均匀性试验能通过2号筛网，混悬性较好。结论本方法简单，可靠，优选处方的银黄分散片迭到中国药典要求。

Preparnation and Quality Control of Yinhuang Dispersible Tablets

OBJECTIVE To screen the optimum formula for Yinhuang dispersible tablets by orthogonal de- sign. METHODS Yinhuang dispersible tablets was prepared by adjusting the content of disintogrant and the uncen- tration of adhesive. The disintegration Time and suspension were inspected to select. RESULTS The optimized for- mula was A1B3CI. The percentage of Microerystalline CE and CMS-Na were 8% and 15% respectively,and the con- centration of PVP30 was 5% . The disintegration time was less than 3rain, and it could pass through a No. 2 sieve. CONCLUSION This method is simple and reliable,and the formula optimization of the Yinhuang dispersed tablets reached the standard listed in Ch. P 2005 edition.