Study on the whole chain microbial load in the production of one traditional Chinese medicine pills*

doi:10.16155/j.0254-1793.2024-0192

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Chinese Journal of Pharmaceutical Analysis ›› 2024, Vol. 44 ›› Issue (8) : 1394-1399. DOI: 10.16155/j.0254-1793.2024-0192

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Study on the whole chain microbial load in the production of one traditional Chinese medicine pills^*

LI Qu-chang, JIANG Yan-fang, LAI Shan, LI Wen-jing, LIN Tie-hao

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Abstract

Objective: To study the whole chain microbial load in the production of a traditional Chinese medicine pill. Methods: A type of traditional Chinese medicine pills prescription was selected as the research object, including the medicinal materials and their purified medicinal materials, intermediates (mixed powder, waiting for inner packaging pills), and finished products. The microbial limit test method was established according to the 2020 edition of the Chinese Pharmacopoeia(ChP), to detect and analyze the microbial loads of all samples collected throughout the entire chain from medicinal materials to finished products of the traditional Chinese medicine pills. Results: The microbial content of different medicinal materials varies greatly, and the varieties with higer risk factors for microbial contamination in medicinal materials were Perillae Folium, Pogostemonis Herba, and Angelicae Dahuricae Radix. The production process of Perillae Folium and Pogostemonis Herba needed to be improved and adjusted from “medicinal material to pure medicinal material”. There was a positive correlation between the microbial load of medicinal materials and intermediate and finished products. Conclusion: The study on the microbial load throughout the entire production chain of traditional Chinese patent medicines can help us to understand the transmission of microorganisms at each stage. This knowledge is crucial for identifying weak links in the production process and the key areas for process control, and has an important guiding significance for traditional Chinese patent medicines manufacturers to improve and explore their production process.

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traditional Chinese medicine pills / medicinal material / microorganisms / production chain / load

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LI Qu-chang, JIANG Yan-fang, LAI Shan, LI Wen-jing, LIN Tie-hao. Study on the whole chain microbial load in the production of one traditional Chinese medicine pills^*[J]. Chinese Journal of Pharmaceutical Analysis, 2024, 44(8): 1394-1399 https://doi.org/10.16155/j.0254-1793.2024-0192

References

[1] 沈泓, 孙晗, 何凯伦, 等. 10种常见中药饮片微生物污染相关因素研究[J]. 现代应用药学, 2022, 39(10): 1317
SHEN H, SUN H, HE KL, et al. Study on the related factors of microbial contamination in 10 kinds of Chinese materia medica decoction[J]. Chin J Mod Appl Pharm, 2022, 39(10): 1317
[2] 杨昊, 周爽, 杨戈, 等. 市售11种煎煮类中药饮片微生物污染情况考察[J]. 药学研究, 2023,42(5): 321
YANG H, ZHOU S, YANG G, et al. Investigation of microbial contamination for 11 kinds of traditional Chinese medicine decoction pieces for sale[J]. J Pharm Res, 2023, 42(5): 321
[3] 杨美琴, 胡昌勤,刘鹏,等. 中药饮片微生物污染量调查分析[J]. 中国药学杂志, 2021, 56(20): 1671
YANG MQ, HU CQ, LIU P, et al. Research and analysis about microbial quantity contamination of prepared slices of Chinese crude drugs[J]. Chin Pharm J, 2021, 56(20): 1671
[4] 孙莺, 王玉梅, 尉鹏, 等. 甘肃两种地道药材当归及党参中药饮片中微生物污染状况研究[J]. 西部中医药, 2022, 35(4): 17
SUN Y, WANG YM, WEI P, et al. Study on microbial contamination of two genuine medicinal materials Danggui and Dangshen in Gansu province[J]. Western J Tradit Chin Med, 2022, 35(4):17
[5] 孙晓朋, 张丹, 刘菊, 等. 中药饮片虎掌南星微生物污染状况分析[J]. 中国药品标准,2023, 24(1): 25
SUN XP, ZHANG D, LIU J, et al. Analysis of microbial contamination of Pinellia pedatisecta in prepared slices of Chinese crude drugs[J]. Drug Stand China, 2023, 24(1): 25
[6] 朱文娟, 黎丽敏, 李锦妹, 等. 3种半夏饮片的微生物污染状况考察[J]. 中南药学, 2022, 20(5): 1153
ZHU WJ, LI LM, LI JM, et al. Microbial contamination of 3 kinds of Pinelliae Rhizome[J]. Central South Pharm, 2022, 20(5):1153
[7] 尹良军, 杨晓莉, 王文娟, 等. 中药饮片金银花、菊花微生物限度检查方法研究[J]. 药品评价, 2022,19 (10): 585
YIN LJ, YANG XL, WANG WJ, et al. Study on microbial limit test method of honeysuckle and chrysanthemum[J]. Drug Eval, 2022, 19(10): 585
[8] 甘永琦, 农浚, 零文超, 等. 广西等地区9种中药饮片微生物污染状况分析[J]. 中国药师, 2018,21(5): 922
GAN YQ, NONG J, LING WC, et al. Analysis of microbial con-tamination of 9 kinds of Chinese herbal pieces in Guangxi and other areas[J]. China Pharm, 2018, 21(5):922
[9] 中华人民共和国药典2020年版. 四部[S]. 2020:140 ChP 2020.Vol Ⅳ[S]. 2020:140
[10] EP 10.0[S]. 2019:201
[11] JP 17[S]. 2016:138
[12] 张丹丹. 中药材储存中存在的问题及管理措施[J]. 中国民康医学, 2021,33(7):123
ZHANG DD. Brief discussion on problems and management measures in storage of Chinese medicinal materials[J]. Med J Chin People's Health, 2021, 33(7): 123
[13] 李秀珍, 刘风琴, 李婷婷, 等. 水活度用于中药饮片微生物污染控制的探讨[J]. 中国药事, 2021, 35(5): 552
LI XZ, LIU FQ, LI TT, et al. On the use of water activity to control microbial contamination of TCM decoction pieces[J]. Chin Pharm Aff, 2021, 35(5): 552
[14] 史亚, 赵红霞, 刘程智, 等. 中药饮片中微生物的快速检测技术研究及风险评估方法初探[J]. 中国现代应用药学, 2019, 36(4): 461
SHI Y, ZHAO HX, LIU CZ, et al. Study on microorganism rapid detection technology and risk assessment of Chinese herbal medicines[J]. Chin J Mod Appl Pharm, 2019, 36(4): 461
[15] 李琼琼, 范一灵, 宋明辉, 等. 基于高通量测序的6 类中药饮片污染微生物群落特征分析[J]. 药物分析杂志, 2019, 39(11): 1945
LI QQ, FAN YL, SONG MH, et al. Microbial community composition analysis of six Chinese herbal pieces through 16S rRNA high-throughput sequencing[J]. Chin J Pharm Anal, 2019, 39(11): 1945
[16] 陈玲, 陈维, 刘振杰, 等. 中药饮片有害微生物负载及鉴定技术研究进展[J]. 微生物学通报,2022,49(7): 2838
CHEN L,CHEN W,LIU ZJ,et al. Progress on contamination and identification methods of harmful microorganisms in Chinese herbal medicines[J]. Microbiol China, 2022, 49(7): 2838
[17] 郑海, 王如意, 郑怡, 等. 干燥和储存方式对广藿香有效成分的影响[J]. 安徽农业科学,2024,52(6): 170
ZHENG H,WANG RY,ZHENG Y,et al. Effect of drying and storage on the active ingredients of Pogostemon cablin [J]. Anhui Agric Sci, 2024, 52(6): 170