白癜搽剂的制备和质量控制研究

Study on Preparation and Quality Control of Baidian Tincture

目的制备白癜搽剂并对其主要成分进行定性和定量检测。方法以补骨脂、栀子等药材为主要原料加75%乙醇浸泡1周制成搽剂,同时采用薄层色谱法(TLC法)对处方中的补骨脂、栀子进行定性鉴别,并用薄层扫描法对补骨脂素和异补骨脂素进行含量控制。结果薄层色谱上均鉴别出制剂和各自药材的特征斑点,而空白对照色谱无此斑点;补骨脂素和异补骨脂素点样量线性范围是2～6μg,方法的平均回收率补骨脂素为97.13%(RSD=5.84%),异补骨脂素为97.55%(RSD=5.2%)。结论制剂处方及制备工艺合理、简便,质量控制方法操作简单、重现性好,适用于该制剂的质量控制。

Objective To prepare Baidian tincture and to control the quality of Baidian tincture. Methods The tincture was prepared by immersing the medicinal materials in 75% ethanol for 7 d. Psoralea corylifolia L. and Gardenia jasminoides Ellis in Baidian tincture were identified by TLC ,and the content was determined by TLC scanner. Results The characteristic dots of the medicinal materials were found on TLC chromatogram of sample, but not shown in negative sample. There was a good linear relationship 2-6μg. The average recovery rate of Psoralen was 97. 13%, RSD = 5.84%, and the average recovery rate of isopsoralen was 97.55%, RSD = 5.2%. Conclusion The methods are simple, rapid and accurate. They could be used for quality control of Baidian tincture.