紫丹活血滴丸的成型工艺及其体外释放度的考察

Molding technology and in vitro release of Zidan Huoxue dropping pills

目的优化紫丹活血滴丸的制备工艺并考察其体外药物释放度。方法采用单因素及L_(9)(3^(3))正交试验,以外观综合评分为考察指标筛选紫丹活血滴丸的成型工艺。采用药典中小杯法,以纯化水、磷酸缓冲液、人工肠液及人工胃液为溶出介质,评价紫丹活血滴丸的体外释放度。结果成功筛选出紫丹活血滴丸的处方及工艺,制备了质量均一、稳定可靠的紫丹活血滴丸。制备的滴丸在纯化水、磷酸缓冲液、人工肠液等溶出介质中9 min内的累积释放度均超过80%。结论所用工艺适用于制备紫丹活血滴丸,且所得紫丹活血滴丸具有良好的体外释放效果。

OBJECTIVE To optimize the preparation process of Zidan Huoxue dropping pills(ZHDP),establish its in vitro drug release analysis method,and study its in vitro release characteristics.METHODS The single-factor and L_(9)(3^(3))orthogonal experiments were used to select the best preparation process of ZHDP by using the comprehensive score of appearance as the index finger.The characteristics of ZHDP in vitro were studied using small cup method with purified water,phosphate buffer solution,artificial intestinal fluid and artificial gastric juice as dissolution media.RESULTS A reasonable and scientific prescription of ZHDP was successfully screened,and a uniform,stable and reliable ZHDP was prepared.The cumulative release of drip pills in dissolution media such as purified water,phosphate buffer solution,artificial intestinal fluid and artificial gastric juice within 9 minutes reached 80%.CONCLUSION The preparation process is suitable for the preparation of ZHDP,and the obtained ZHDP has good in vitro release effect.