目的研究防茄软膏的制备工艺及其质量控制标准。方法采用了正交试验设计来寻找防茄软膏制备工艺的最佳方案,并进行的主要药效学及毒理学试验。结果对软膏中所用基质的种类、每种基质的用量,油相和水相的比例,调制的湿度及方法等方面,进行了多次试验比较,以研究得到最佳的软膏的调配方法及疗效。结论完成了制备工艺后,对防茄软膏的原料药和成药进行了薄层色谱定性和高效液相色谱定量的研究,采用了薄层色谱法鉴别制剂中的赤芍、桂枝、防己、白芷四味药材,结果表明薄层色谱斑点清晰,特征性强,重现性好,阴性无干扰。
Objective To study the preparation procedure and quality control standards of Fang Qie Ointment.Methods To find the available proposal by orthogonal test, and primary preview Fang Qie Ointment''s toxicology and medical effects.Results After many experiment comparative,the group qualitative beautiful match ratio.The degree and the ways to research the perfect degree and effect of ointment.Conclusion After research for its preparation procedure,we also work out the strictly quality control ways and standards by TLC and HPLC duringthe process,the experiment proved that the stability,recovery. reproducibility and accuracy are satisfactory.