Amidžić Klarić Daniela, Kovačić Jelena, Jeličić Mario-Livio, Zubčić Snježana, Stankov Vladimir, Gulan Čičak Marija, Bučar Boris, Klarić Ilija, Mornar Ana
Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovačića 1, 10 000 Zagreb, Croatia.
Agency for Medicinal Products and Medicinal Devices of Croatia, Ksaverska Cesta 4, 10 000 Zagreb, Croatia.
Pharmaceuticals (Basel). 2023 Jun 18;16(6):893. doi: 10.3390/ph16060893.
Inflammatory bowel disease is a complex disorder characterized by chronic gastrointestinal inflammation. Thus, patients prefer to use herbal dietary supplements containing turmeric, Indian frankincense, green chiretta, and black pepper in an attempt to cope better with their chronic condition. The dietary supplements' dosage forms and herbal ingredients were assessed in terms of the products' physicochemical parameters (weight uniformity, friability, disintegration, rupture test, tablet's breaking force, and powder flowability) in view of the USP-NF requirements. In addition, contaminants such as organic solvents and ethylene oxide were evaluated using gas chromatography. Assessment of gluten via an Enzyme-Linked Immunosorbent Assay was also performed. Most of the products met USP requirements. The high average weight of one multicomponent tablet sample with a high breaking force value can explain the observed negative results of the disintegration test. A total of 26% of samples tested positive for gluten, but the most alarming fact is that the ethylene oxide levels found in two samples were up to 30 times higher than the EU limit. Accordingly, dietary supplement quality control is of fundamental importance.
炎症性肠病是一种以慢性胃肠道炎症为特征的复杂疾病。因此，患者倾向于使用含有姜黄、印度乳香、绿线草和黑胡椒的草药膳食补充剂，试图更好地应对他们的慢性疾病。根据美国药典-国家处方集（USP-NF）的要求，从产品的物理化学参数（重量均匀度、脆碎度、崩解度、破裂试验、片剂的断裂力和粉末流动性）方面对膳食补充剂的剂型和草药成分进行了评估。此外，使用气相色谱法对有机溶剂和环氧乙烷等污染物进行了评估。还通过酶联免疫吸附测定法对麸质进行了评估。大多数产品符合USP要求。一个具有高断裂力值的多组分片剂样品的平均重量较高，可以解释崩解试验中观察到的负面结果。共有26%的样品麸质检测呈阳性，但最令人担忧的事实是，在两个样品中发现的环氧乙烷含量比欧盟限量高出30倍。因此，膳食补充剂的质量控制至关重要。
