中国临床药学杂志

目的确定制备散结止痛巴布膏的冰片加入工艺并测定巴布膏中的冰片含量。方法建立气相色谱法测定冰片含量的方法学;比较4种冰片加入工艺对基质中冰片含量和混合均匀度的影响;测定巴布膏中试样品的冰片含量。结果气相色谱法测定冰片线性关系良好、准确、重复度好。采用冰片直接加入甘油中混匀的工艺所制备的基质,其实测冰片含量与投料量一致,且混合均匀度最好。3批巴布膏中试样品的冰片平均含量为101.34%,批间差异小。结论采用冰片直接加入甘油中混匀的巴布膏制备工艺简单方便、工艺重复性好、质量可控。

AIM To determine the best way of adding borneol and the content of borneol in Sanjie Zhitong cataplasm. METHODS The determination methodology of borneol by gas chromatography was established. The four kinds of adding borneol were compared by the uniformity of borneol in the base of cataplasm. The content of borneol in the cataplasm was determinated. RESULTS The determination of borneol by gas chromatography had a good liner range,good accuracy and reproducibility. By the method of suspending in glycerol directly borneol showed mixing homogeneity and the content of borneol in the base was consistent with theoretical value. The average borneol content was 101. 34% in Sanjie Zhitong cataplasm with small intra-batch difference. CONCLUSION The adding way of borneol suspended into glycerol directly was simple and convenient,reproducible and quality control.