- 期刊
由長期安定性試驗推估「倍達康β-葡聚醣」膠囊的架儲期
Determination of the Shelf Life of ＂TTL BIO-TECHβ-glucan Capsules＂
摘要
臺灣菸酒股份有限公司竹南啤酒廠宣稱所生產的產品「倍達康-葡聚醣」膠囊的保健指標成分為-葡聚醣（β-glucans），為了建立此產品的有效期（架儲期，shelf life），本研究首先根據衛生福利部藥物管理署公告的「食品化學檢驗方法之確效規劃（2014）」與ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2（R1）（2005）對-葡聚醣含量分析方法進行各項參數的確效，結果指出分析方法的專一性、檢量線線性與範圍、準確度（回收率）、重複性精密度、中間精密度以及定量極限皆符合允收標準。接著參考衛生福利部公告之「健康食品安定性試驗指引（2018）」與「藥品安定性試驗基準（2016）」規範進行「倍達康β-葡聚醣」試驗物質的長期安定性試驗，測試時，將三批次之400 mg膠囊試驗物質（倍達康LOT TJB-1602、LOT TJB-1603及LOT TJB-1604）儲存於一般環境（25±2℃/60±5% RH），然後分別於第0、1、3、6、9、12、18、24及36個月利用經確效的分析方法測定β-葡聚醣含量。結果顯示三批次之試驗物質於儲存前（第0個月），其含量分別為251.65±3.07、252.47±3.10及257.13±3.99 mg/400 mg；而儲存36個月後，含量則分別為229.89±6.04、219.76±5.34及227.79±5.79 mg/400 mg。根據廠家預先訂立之β-葡聚醣品管規格標準範圍225.0±45.0 mg/400 mg推估三批次倍達康試驗物質之架儲期（shelf-life）分別為109.7、69.1及89.9個月。總之，「倍達康β-葡聚醣」膠囊之架儲期至少可達到69個月。
並列摘要
The main component of ＂TTL BIO-TECHβ-glucan Capsules＂ produced bythe Taiwan Tobacco and Alcohol Co., Ltd. Zhunan Brewery is β-glucan. This study was conducted to determine the shelf life (expiration date) of this product. The method for analysis of β-glucan was first evaluated for its specificity, linearity and range of calibration curve, accuracy (recovery rate), repeatability, intermediate precision, and quantitative limit following the Validation Plan of Food Chemical Testing Methods (2014) published by Taiwan Food and Drug Bureau(TFDA) and the ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2(R1) (2005). Results indicated that all of these parameters conformed to the acceptance criteria. The long-term stability test was then conducted following the ＂Health Food Stability Test Guidelines (2018)＂ and ＂Drug Stability Test Standards (2016)＂ published by TFDA. Three batches of the product (LOT TJB-1602, LOT TJB-1603, and LOT TJB-1604) were stored in ambient environments (25 ± 2℃/60 ± 5% RH) for 0, 1, 3, 6, 9, 12, 18, 24, and 36 months before being tested with the aforementioned analytic method forβ-glucan. Results showed that the averageβ-glucan content in a 400 mg capsule of the 3 batches at time 0 (before storage) was 251.65 ± 3.07, 252.47 ± 3.10, and 257.13 ± 3.99 mg and 229.89 ± 6.04, 219.76 ± 5.34, and 227.79 ± 5.79 mg, respectively, after 36 months of storage. Based on the claimed 225.0 ± 45.0 mg β-glucan per 400 mg capsule, the shelf lives of the three batches were determined to be 109.7, 69.1, and 89.9 months, respectively. In conclusion, ＂TTL BIO-TECHβ-glucan Capsules＂ have a shelf life of at least 69 months.