乳疾清合剂的质量标准提高研究

Study on the Quality Standard Improvement of Rujiqing Mixture

目的:建立乳疾清合剂的薄层鉴别方法和微生物限度检查方法,完善其质量标准。方法:通过薄层色谱法对乳疾清合剂处方中的延胡索、玄参和青皮进行定性鉴别;同时参考《中华人民共和国药典》2015年版四部通则中的微生物限度检查方法进行验证性考察,并建立微生物限度检查方法。结果:实验建立的薄层鉴别方法,特征斑点明显,阴性对照无干扰;3批乳疾清合剂的需氧菌总数、霉菌及酵母菌总数计数方法可行,其回收试验结果显示试验组菌落数减去供试品对照组菌落数的值与菌液组菌落数比值在0.5~2范围内,且控制菌检查方法可行,均未检出大肠埃希菌和沙门菌。结论:本研究建立的乳疾清合剂中延胡索、玄参和青皮的薄层鉴别方法和微生物限度检查方法专属性强,可作为该制剂质量标准项目。

Objective:To improve the quality standard of Rujiqing mixture by establishing thin-layer chromatography(TLC) identification method and microbial limit inspection method of the mixture.Methods:Yanhusuo(Rhizoma corydalis),Xuanshen(Radix scrophulariae) and Qingpi(Pericarpium citri reticulatae viride)in the prescription of Rujiqing mixture were qualitatively identified;meanwhile confirmatory investigation was performed by consulting microbial limit inspection method in the general principles of pharmacopoeia of the People’s Republic of China(edition 2015),to establish microbial limit inspection method.Results:TLC method established in the experiment showed obvious characteristic spots and no interference in the negative control;the counting method of total aerobic bacteria,molds and yeasts in three batches of Rujiqing mixture was practicable,and its recovery test results displayed that the ratio of the number of colonies in the test group minus the number of colonies in the test sample control group to the number of colonies in the bacterial solution group is in the range of0.5~2,the control bacteria inspection method is feasible,and no Escherichia coli and Salmonella are detected.Conclusion:TLC identification method and microbial limit inspection method for Yanhusuo,Xuanshen and Qingpi in Rujiqing mixture,founded in the experiment,show strong specificity,which could be taken as the item of quality standard for the preparation.