金铃子散滴丸成型工艺研究

Preparation of drop pills of Jinglingzisan

目的通过试验选择金铃子散有效部位滴丸的成型工艺。方法以滴丸的溶散时间、丸重差异变异系数及外观质量作为综合评定指标,优选出滴丸最佳成型工艺。结果对滴丸成型因素的排列由大到小为A>C>B>D。优化条件为A3、B2、C3、D1,即药物基质=1∶3〔PFG6000∶泊洛沙姆〕=3∶1,滴速为45滴.min-1,药液湿度为75℃。结论本试验筛选出的滴丸的最佳成型工艺,滴丸外观质量好、溶散度较好,丸重差异小,符合滴丸剂的质量标准。

OBJECTIVE To confirm the preparation of Jinglingzisan.METHODS The preparation of drop pills of Jinglingzisan was optimized using both single factor test and orthogonal design with solution time,weight difference and appearance characters as evaluation parameters.CONCLUSION The indexes of solution time and weight difference w ere consistent with the standards of the pharmacopoeia.