接骨丹片的薄层色谱及微生物限度检查方法适用性实验研究

Applicability Experimental Study on Thin Layer Chromatography and Microbiological Limit Test for Jiegudan Tablets

目的对接骨丹片的薄层色谱和微生物限度检查的方法进行适用性研究。方法采用薄层色谱法(TLC)鉴别接骨丹片中制马钱子和熟大黄;根据微生物限度检查法对接骨丹片的微生物限度进行研究。结果建立的TLC法能检出制马钱子和熟大黄,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,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,可为接骨丹片的质量控制提供实验依据。

Objective To study on thin layer chromatography(TLC)and microbial limit test of Jiegudan tablets.Methods Processed Strychnine Semen and Rhei Radix et Rhizoma were qualitatively identified by the thin-layer chromatography method.According to the microbial limit test method,the microbial limit method of Jiegudan tablets was experimentally studied.Results The established TLC and method could detect processed Strychnine Semen and Rhei Radix et Rhizoma 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 Jiegudan tablets.