中藥濃縮製劑製程中微生物污染之探討   全文下載

Study of Microbial Contamination in Concentrated Chinese Medicine

本研究報告就五家藥廠其產製之小建中湯、黃連解毒湯、葛根湯、大青龍湯及小柴胡湯等五種濃縮製劑，就其原料藥材（119件）、賦形劑（23件）、煎煮液（20件）、濃縮液（25件）、半製品（61件）、成品（20件）、作業室室內落菌試驗檢體（95件）及接觸容器塗抹試驗檢體（104件）等進行生菌數、大腸桿菌群、仙人掌桿菌及孢子、長桿菌屬孢子、金黃色葡萄球菌、沙門氏桿菌、變形菌、酵母菌及黴菌等項目之檢驗，以探討製程中微生物污染之原因。實驗結果數據顯示原料藥材均受重度污染，賦形劑中單用澱粉或乳糖者，則結果頗佳。製程中造粒製程是重要的污染關鍵，與使用生藥粉末或添加生藥粉末作賦形劑、機械普受污染及作業室落菌程度高有關。五種製劑及五藥廠之污染情形經統計分析，顯示具有顯著之差異。作業室落菌試驗顯示以易造成粉塵者污染率高。塗抹試驗顯示作業人員易造成高度之污染。

To better understand sources of microbial contamination during manufacturing of traditional concentrated Chinese medicines, examinations of total plate count, coliforms, Bacillus cereus, spore count of bacilli, spore count of Bacillus cereus, Staphylococcus aureus, Salmonella, Proteus, yeasts and molds were made on crude drugs (119 samples), decoctions (20 samples), concentrated decoctions (25 samples), excipients (23 samples), semiproducts (61 samples), products (20 samples), container contact swab tests (104 samples) and settling plate tests (95 samples) from five pharmaceutical factories. They were Sheau-Jiann-Jong-Tang (小建中湯), Hwang -Lian-Jiee-Dwu-Tang (黃連解毒湯) , GerGen- Tang (葛根湯), Dah-Ching-Long-Tang (大青龍湯 ) and Sheau-Chair-Hwu-Tang (小柴胡湯). Results showed that crude drugs such as Ginseng Radix, Glycyrrhizae Radix and Zingiber Rhizoma had serious contamination, while using starch of lactose as excipients showed lesser degree of microbial contamination. Granulation process during pharmaceutical manufacturing was the key source of contamination, as well as affected by using crude drug powder as excipients, or using contaminated tools, containers and/or processing rooms. Based on statistical analysis, there existed significant differences among the five pharmaceutical products and five factories concerning microbial contamination. Container contact swab test indicated that the workers themselves had a high degree of contamination, while settling plate tests showed that the processing rooms producing flying powders had increased risk of contamination.