骨伤外洗散的薄层色谱及微生物限度检查法适用性实验研究

Applicability Experimental Study on Thin Layer Chromatography and Microbiological Limit Test for Gushang Waixi Powder

目的对骨伤外洗散的薄层色谱、微生物限度检查的方法进行适用性实验研究。方法采用薄层色谱(TLC)法鉴别骨伤外洗散中苏木、桂枝、当归尾三味药材;照微生物限度检查法(《中华人民共和国药典》2020年版四部通则1105与通则1106)对骨伤外洗散的微生物限度进行实验研究。结果建立的TLC法能检出苏木、当归尾、桂枝,且斑点清晰,阴性无干扰;建立的微生物限度检查法,经过适用性实验验证,符合《中华人民共和国药典》的要求,方法可行。结论建立的TLC法及微生物限度检查方法合理可行,可为骨伤外洗散的质量控制提供实验依据。

Objective To study on thin layer chromatography(TLC)and microbial limit test of Gushang Waixi powder.Methods By TLC,the three herbs of Sappan Wood,Tangkuei tail and Cassia Twig were identified.According to the microbial limit test method(General Rule 1105 and General Rule 1106,Volume IV,Chinese Pharmacopoeia,2020 Edition),the microbial limit test method of Gushang Waixi powder was experimentally studied.Results The established TLC method could detect Sappan Wood,Tangkuei tail and Cassia Twig with clear spots and no interference.The established microbial limit test method meets the requirements of Chinese Pharmacopoeia through applicability test,and the method is feasible.Conclusion The established TLC method is specific,simple and accurate.The microbial limit test method is reasonable and feasible,which can provide an experimental basis for the quality control of Gushang Waixi powder.