Production and Evaluation of the stability of Tetrathiomolibdate Capsules (Non GMP study)

为了确定气体对四硫钼酸盐胶囊稳定性和保质期的影响，建议采用以下实验设计： 1.从Sigma/Aldrich购买两瓶50克的四硫钼酸钙。 2.用1瓶制作150 mg强度胶囊，将25粒胶囊连同棉卷放入合适大小的瓶中，用感应封口封口，并贴上“对照组”的标签。 3.将另一瓶放入氩气吹扫下，制成150 mg强度胶囊，将25粒胶囊与棉卷一起放入合适大小的瓶子中，用足够长的足以从瓶中排出氧气的氩气吹扫瓶子，并用感应密封器密封，并将其标记为“试验组”。 4.首次化验(仅限化验)将使用免费胶囊，采用已公布的分光光度法。 5.将每组各2瓶置于-20oC、2-8oC环境中，控制室温，分别于3个月和6个月后测定每组2瓶(4个测定结果)。

To determine the effect of Argon gas on the stability and shelf life of Tetrathiomolibdate capsules the following experimental design is suggested: 1. Buy two 50 gram bottles of Tetrathiomolibdate from Sigma/Aldrich. 2. Using one bottle produce 150 mg strength capsules and place 25 capsule in suitable size bottle along with cotton coil and seal them with induction seal and label them as “control group.” 3. Using the other bottle under argon gas purge and produce 150 mg strength capsules and place 25 capsules in suitable size bottles along with cotton coil and the purge the bottles with argon gas long enough to deplete as much oxygen as possible from the bottle and seal them with induction sealer and label them as “test group.” 4. Free capsules will be used for the initial assay (only assay) using the published spectrophotometric method. 5. Place two bottles of each group in the -20oC, 2-8oC, and Controlled Room Temperature and assay two bottles each group separately (four assay results) at 3 months and 6 months’ time point.