Effects of alga polysaccharide capsule shells on in-vivo bioavailability and disintegration
Effects of alga polysaccharide capsule shells on in-vivo bioavailability and disintegration
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DOI：
10.1007/s00343-012-1011-4
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发表时间：
2012-11
影响因子：
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通讯作者：
Ting Li;Shuju Guo;Lin Ma;Yi Yuan;Lijun Han
中科院分区：
文献类型：
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作者：
Ting Li;Shuju Guo;Lin Ma;Yi Yuan;Lijun Han
明胶用于硬胶囊壳已经有世纪多了，出现了一些缺点，如水分含量高，有将动物源性疾病传播给人的风险。在对明胶和植物壳研究的基础上，研制了一种新型的海藻多糖胶囊壳。为了测试我们的产品是否可以替代商业明胶壳，我们使用高效液相色谱法（HPLC）测量了12名选定志愿者的体内血浆浓度，使用模型药物布洛芬，通过计算APPC和Qualicaps®相对于明胶胶囊的相对生物利用度并评估三种类型壳的生物等效性，用DAS 2.0软件计算药动学参数。结果表明，APPC壳与Qualicaps®和明胶壳具有生物等效性。此外，通过γ-射线照相图像观察了四种类型的壳（APPC、Vegcaps®、Qualicaps®和明胶壳）在乳糖和放射性元素（99 mTc）含量下的崩解行为。生物利用度和γ射线照相研究表明，APPC在体内行为方面与其他植物和明胶胶囊壳无统计学差异。因此，可以得出结论，APPC可以与其他植物和明胶壳进行交换。
Gelatin has been used in hard capsule shells for more than a century, and some shortcomings have appeared, such as high moisture content and risk of transmitting diseases of animal origin to people. Based on available studies regarding gelatin and vegetable shells, we developed a new type of algal polysaccharide capsule (APPC) shells. To test whether our products can replace commercial gelatin shells, we measured in-vivo plasma concentration of 12 selected volunteers with a model drug, ibuprofen, using high performance liquid chromatography (HPLC), by calculating the relative bioavailability of APPC and Qualicaps® referenced to gelatin capsules and assessing bioequivalence of the three types of shells, and calculated pharmacokinetic parameters with the software DAS 2.0 (China). The results show that APPC shells possess bioequivalence with Qualicaps® and gelatin shells. Moreover, the disintegration behavior of four types of shells (APPC, Vegcaps®, Qualicaps® and gelatin shells) with the content of lactose and radioactive element (99mTc) was observed via gamma-scintigraphic images. The bioavailability and gamma-scintigraphic studies showed that APPC was not statistically different from other vegetable and gelatin capsule shells with respect to in-vivo behavior. Hence, it can be concluded that APPCs are exchangeable with other vegetable and gelatin shells.