[1]梁欣健,姜倩娥,王叶茗.乳疾清合剂的质量标准提高研究[J].西部中医药,2022,35(05):25-28.[doi:10.12174/j.issn.2096-9600.2022.05.06]
　LIANG Xinjian,JIANG Qian'e,WANG Yeming.Study on the Quality Standard Improvement of Rujiqing Mixture[J].Western Journal of Traditional Chinese Medicine,2022,35(05):25-28.[doi:10.12174/j.issn.2096-9600.2022.05.06]
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乳疾清合剂的质量标准提高研究
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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
35
期数:
2022年05期
页码:
25-28
栏目:
质量分析
出版日期:
2022-05-15

文章信息/Info

Title:
Study on the Quality Standard Improvement of Rujiqing Mixture
作者:
梁欣健1, 姜倩娥2, 王叶茗1
1.广州市中西医结合医院，广东 广州 510801
2.广州市天河区中医医院
Author(s):
LIANG Xinjian1, JIANG Qian'e2, WANG Yeming1
1.Guangzhou Hospital of Integrated Traditional and Western Medicine, Guangzhou 510801, China
2.Guangzhou City Tianhe District Hospital of TCM
关键词:
乳疾清合剂; 质量标准; 薄层色谱法; 微生物限度检查
Keywords:
mixture; quality standard; TLC; microbial limit inspection method
分类号:
R284.1
DOI:
10.12174/j.issn.2096-9600.2022.05.06
文献标志码:
A
摘要:
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。
Abstract:
ObjectiveTo improve the quality standard of Rujiqing mixture by establishing thin-layer chromatography (TLC) identification method and microbial limit inspection method of the mixture. MethodsYanhusuo (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. ResultsTLC 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 of 0.5~2, the control bacteria inspection method is feasible, and no Escherichia coli and Salmonella are detected. ConclusionTLC 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.

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备注/Memo

备注/Memo:
梁欣健（1986—），男，硕士学位，主管中药师。研究方向：医院制剂的开发与应用研究。花都区医疗卫生一般科研专项（19-HDWS-024）。
更新日期/Last Update: 2022-06-24