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目的:制备新型咀嚼胶以解决西地碘含片顺应性差等问题。方法:以包合物包合率、质量收率和载药量的综合评分为评价指标,采用单因素考察和正交实验设计优选饱和水溶液法制备包合物的最佳工艺,用差示扫描量热分析法确证包合物的形成,并进行稳定性考察;以胶基含量、糖与山梨醇的质量比和薄荷粉含量为考察因素,以顺应性综合评分为评价指标,优选热熔法制备咀嚼胶的最佳处方,并分别对最佳处方制备的咀嚼胶与西地碘含片的顺应性进行评分。用紫外-可见分光光度法测定咀嚼胶中碘含量,并进行方法学考察。结果:最佳包合条件为:I2、KI和β-环糊精的物质的量比为1∶1∶1,40℃包合1 h,所得包合物包合率为(83.50±1.17)%,质量收率为(82.06±1.21)%,载药量为(18.58±0.02)%,稳定性较好。最佳咀嚼胶处方为胶基含量25%,薄荷粉含量0.8%,糖与山梨醇的质量比为1∶1,所得咀嚼胶顺应性评分结果较西地碘含片有显著提高。3批西地碘咀嚼胶样品中碘含量分别为标示量的105.60%、110.81%和110.86%。结论:西地碘包合物提高了碘的稳定性,显著改善了西地碘咀嚼胶的顺应性。紫外-可见分光光度法测定咀嚼胶中的碘含量准确可靠。
OBJECTIVE: To prepare a new type of chewing gum to solve the problem of poor compliance of iodine in western tablets. Methods: The inclusion compound inclusion rate, mass yield and drug load of the composite score as the evaluation index, single factor study and orthogonal experiment design the best saturated aqueous solution of the best preparation of inclusion complex, with differential scanning The formation of inclusion complex was confirmed by calorimetry and the stability was investigated. The gum base content, the mass ratio of sugar to sorbitol and the content of mint powder were taken as the investigation factors and the compliance score was taken as the evaluation index. Hot melt method The best prescription of chewing gum was prepared, and the compliance of chewing gum prepared with the best prescription and the iodine lozenge tablet were respectively scored. The iodine content in chewing gum was determined by UV-Vis spectrophotometry and the methodological study was conducted. Results: The optimum inclusion conditions were as follows: the molar ratio of I2, KI and β-cyclodextrin was 1: 1: 1, the inclusion of 1 h at 40 ℃, the entrapment ratio of inclusion complex was (83.50 ± 1.17) %, The mass yield was (82.06 ± 1.21)%, the drug loading was (18.58 ± 0.02)%, the stability was better. The best chewing gum prescription gum base content of 25%, mint powder content of 0.8%, sugar and sorbitol mass ratio of 1: 1, the resulting chewing gum compliance score than western iodine tablets significantly increased. The contents of iodine in the three batches of iridoid chewing gum sample were 105.60%, 110.81% and 110.86% respectively of the labeled amount. CONCLUSION: Xidi inclusion complexes improve the stability of iodine and significantly improve the compliance of Xidi Iodine chewing gum. Determination of iodine in chewing gum by UV-Vis spectrophotometry is accurate and reliable.