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|本期目录/Table of Contents|

中药注射剂中药材的微生物污染*(PDF)

《云南中医学院学报》[ISSN:1000-2723/CN:53-1048/R]

期数:
2019年04期
页码:
1-8
栏目:
实验研究
出版日期:
2020-05-18

文章信息/Info

Title:
Identification and Removal of Microbial Contaminants from Herbal Drugs for Traditional Chinese Medicine Injection
文章编号:
1000 - 2723(2019)04- 0001 - 08
作者:
段金连1#李 月1#张路梅1董鲜祥1杨 榕1殷 华1郭 良2段为钢1△
(1. 云南中医药大学中医药学分子生物学实验室,云南 昆明 650500;2. 石药银湖制药有限公司,山西 运城 044000)
Author(s):
DUAN Jinlian1#LI Yue1#ZHANG Lumei1DONG Xianxiang1YANG Rong1YIN Hua1 GUO Liang2DUAN Weigang1△
(1. Key Laboratory of Molecular Biology for Sinomedicine, Yunnan University of Chinese Medicine, Kunming 650500, China; 2. Institute of Pharmaceutical Research, Shiyao Yinhu Pharmaceutical Co., Ltd., Yuncheng 044000, China)
关键词:
微生物沾染细菌真菌脂多糖中药注射剂
Keywords:
microbial contamination bacteria fungi lipopolysaccharide traditional Chinese medicine injection
分类号:
R285.5
DOI:
10.19288/j.cnki.issn.1000-2723.2019.04.001
文献标识码:
A
摘要:
目的本研究主要探究药材的沾染性微生物及其去除的可行性,以提高中药注射剂的安全性。方法 选取药用部位为地下部分的丹参和药用部位为地上部分的红花。模拟注射剂的生产步骤检测主要步骤药材沾染的微生物杂质。通过洗涤和冷冻干燥收集药材沾染的微生物,通过16S rRNA(细菌)和18S rRNA(真菌)高通量测序鉴定微生物的种类和丰度。通过鲎试剂检测各步骤样品中的脂多糖(LPS)的量。结果 2种中药材均沾染有高丰度的细菌和真菌,其中真菌沾染更为严重;相比之下,红花的微生物沾染比丹参严重。且沾染的LPS很大程度上可被洗除。结论 中药材的微生物及大分子沾染不容忽视,但可被洗涤进行大部分去除。
Abstract:
Objective The main aim of the present study was to limit contaminant microbes and their macromolecules in raw herbal drugs, then decrease TCMIs’ safety problems. Methods A raw herbal drug from underground part (Danshen, root and rhizome of Salvia miltiorrhiza Bge.) and that from aboveground part(Honghua, flower of Carthamus tinctorius L.) were introduced. The contaminant microbes were assayed at steps of the mimic process of TCMI manufacturing. Microbes adhered to raw herbal drugs Honghua or Danshen were collected, and their DNA encoded 16S rRNA(for bacteria) and 18S rRNA (for fungi) were identified by high-throughput sequencing. The feasibility of removable lipopolysaccharide(LPS) adhered to the raw drugs was investigated with TAL(Tachypleus Amebocyte Lysate) kits by detecting flushing fluid and the mimic injections. Results The results showed that both raw drugs were contaminated with microbes, and the abundance of fungi was heavier than that of bacteria. As a raw herbal drug from aerial part, Honghua contained more bacteria and fungi than Danshen. The contaminant LPS was able to be largely removed by washing. Conclusion All the results suggested that the contaminant microbes, especially fungi, and their macromolecular impurities should be taken into account for TCMI manufacturing, and they were able to be removed largely by washing.

参考文献/References

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备注/Memo

备注/Memo:
收稿日期: 2019 - 07- 01
* 基金项目:国家自然科学基金(81560645);云南省科技厅—云南中医学院应用基础研究联合专项(2017FF117-032)
第一作者简介:段金连(1994-),女,在读硕士研究生,研究方向:中药注射剂的安全性评价; 李 月(1992-),女,在读硕士研究生,研究方向:中药注射剂的安全性评价。 #同为文章并列第一作者
△通信作者:段为钢,E-mail: deardwg@126.com
更新日期/Last Update: 2020-06-04