Faculty of Pharmacy, University Teknologi MARA (UiTM), 42300, Bandar Puncak Alam, Selangor Darul Ehsan, Malaysia.
Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences Community of Research, Universiti Teknologi MARA (UiTM), 40450, Shah Alam, Selangor Darul Ehsan, Malaysia.
Probiotics Antimicrob Proteins. 2019 Jun;11(2):447-459. doi: 10.1007/s12602-018-9442-7.
Lactic acid bacteria (LAB) with probiotic properties are useful options for prophylactic and therapeutic applications against gastrointestinal diseases. The safety of probiotics should, however, be verified before incorporation into food or drinks. The present study had encapsulated Lactobacillus plantarum LAB12 within microcapsules that could withstand extremely high temperature (up to 100 °C) during pelletisation. The microencapsulated LAB12 were then tested for their acute (single dosing) and sub-chronic (a 90-day feeding) toxicity. For acute toxicity study, six male Sprague-Dawley rats were being administered with a single dose of freeze-dried microencapsulated LAB12 at 11 log CFU/kg BW through oral gavage. No clear treatment-related effects were observed after 14 days. For sub-chronic toxicity study, rodents were randomly divided into four groups (6 rats/sex/group) and treated with 0, 8, 9 and 10 log CFU/kg BW of microencapsulated LAB12 in pellet form. No mortality or treatment-related findings were observed in terms of clinical body weight, water intake, or food consumption. No treatment-related adverse effects were observed in blood and tissue samples. The no-observed-adverse-effect-level (NOAEL) for microencapsulated LAB12 was 2.5 × 10 CFU/kg BW for both genders. These results imply that LAB12 are likely non-pathogenic and non-toxic.
具有益生菌特性的乳酸菌（LAB）是预防和治疗胃肠道疾病的有用选择。然而，在将益生菌纳入食品或饮料之前，应验证其安全性。本研究将植物乳杆菌 LAB12 封装在微胶囊中，这些微胶囊能够承受制粒过程中高达 100°C 的极端高温。然后，对微囊化的 LAB12 进行了急性（单次给药）和亚慢性（90 天喂养）毒性测试。在急性毒性研究中，将 6 只雄性 Sprague-Dawley 大鼠通过口服灌胃给予冻干微囊化 LAB12 单次剂量 11 对数 CFU/kg BW。14 天后未观察到与处理相关的明显影响。在亚慢性毒性研究中，将啮齿动物随机分为四组（每组 6 只/性别），并以微囊化 LAB12 的形式给予 0、8、9 和 10 对数 CFU/kg BW。在临床体重、饮水量或食物摄入量方面，未观察到与处理相关的死亡或发现。在血液和组织样本中未观察到与处理相关的不良影响。微囊化 LAB12 的无明显不良效应水平（NOAEL）为男女两性均为 2.5×10 CFU/kg BW。这些结果表明 LAB12 可能是非致病性和非毒性的。
