复方芩醌乳膏的制备与质量控制

Preparation and Quality Control of FU FANG QIN KUN Cream

目的探讨复方芩醌乳膏的制备、质量控制方法。方法以黄芩、氢醌和维生素E为主要原料，选择适宜的乳化剂，制成O／W型乳膏，采用高效液相色谱法测定该乳膏中黄芩苷的含量。结果 复方芩醌乳膏制剂稳定性较好，无刺激性。含量测定方法快速准确，黄芩苷在0．25-2．5μg范围内，进样量与吸收面积分值呈良好的线性关系。平均回收率为98．9％，RSD为0．73％（n=5），结果准确，重复性好。结论复方氢醌乳膏处方及制备工艺合理，质量可控。

Objective To investigate the methods of preparation and quality control for FU FANG QIN KUN Cream. Methods Baiealin, hydroquinone and vitamin E were serving as main raw material to produce O/W cream by adding suitable emulsifier, HPLC method was used to determine content of baiealin in the cream. Results FU FANG QIN KUN Cream is stable without irritation. The assay method was rapid and accurate. When the dosage of Baiealin was controlled in 0.25μg to 2.5 μg, the sample volume and absorption area percentile showed a good linear relationship. The average recovery was 98.9% and the RSD was 0.73% （n=5）. This result was accurate and reproducible. Conclusion The formulation and preparation of FU FANG QIN KUN Cream are reasonable and its quality can be well controlled.