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咀嚼片适口性及可咀嚼性的体外口腔模拟评估
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| 篇名： | 咀嚼片适口性及可咀嚼性的体外口腔模拟评估 |
| TITLE： | In vitro oral simulation evaluation of palatability and chewability of chewable tablets |
| 摘要： | 目的 评估咀嚼片的适口性及可咀嚼性，为各类咀嚼片的质量评价提供参考。方法以自制盐酸氨基葡萄糖咀嚼片为模型药，并进行质量检测。通过质构仪及流变仪建立咀嚼片体外模拟体系，对咀嚼片进行口腔模拟实验。采用质构仪测定咀嚼片咀嚼所需的力及模拟静态崩解过程，采用流变仪测定咀嚼片咀嚼过程中的黏弹性、触变性及变形性。结果自制盐酸氨基葡萄糖咀嚼片的崩解时限、主成分含量、溶出等结果均符合限度要求。质构仪体外模拟结果显示，自制咀嚼片无论轴向或径向咀嚼均易被嚼碎，咀嚼所需的力在牙齿咀嚼力承受范围内；咀嚼片不经咀嚼仅含服于口腔中也可在适宜时间内崩解完成。流变仪体外模拟结果显示，咀嚼片在口腔中通过舌头不断搅动，表现出以弹性为主、黏性为辅的行为，且咀嚼片的黏度会随着舌头的搅动或牙齿咀嚼而逐渐下降；牙齿咀嚼时，咀嚼片内部应力降低，发生塑性变形被压碎，被嚼碎后形状不可恢复，易于咀嚼吞咽。结论通过质构仪及流变仪联合运用模拟口腔咀嚼过程可对自制盐酸氨基葡萄糖咀嚼片的适口性及可咀嚼性进行评估，该模型可为各类咀嚼片的评价提供参考。 |
| ABSTRACT： | OBJECTIVE To evaluate the palatability and chewability of chewable tablets， and provide reference for the quality evaluation of various types of chewable tablets. METHODS Using self-made Glucosamine hydrochloride chewable tablets as the model drug， the quality test was conducted. The in vitro simulation system for chewable tablets was established by using a texture analyzer and rheometer， and an oral simulation experiment was conducted on chewable tablets. The texture analyzer was used to measure the force required for chewing and simulate the static disintegration process of chewable tablets； the rheometer was adopted to measure the viscoelasticity， thixotropy， and deformability of chewable tablets during the chewing process. RESULTS The disintegration time limit， principal component content， and dissolution of self-made Glucosamine hydrochloride chewable tablets all met the limit requirements. The in vitro simulation results of the texture analyzer showed that self-made chewable tablets were easy to chew in both axial and radial directions， and the force required for chewing was within the range of the chewing force of the teeth； chewable tablets could disintegrate at an appropriate time without being chewed and only taken in the oral cavity. The in vitro simulation results of the rheometer showed that the chewable tablets in the oral cavity exhibited a behavior of elasticity as the main factor and viscosity as the secondary factor through the continuous stirring of the tongue， and the viscosity of the chewable tablets gradually decreased with tongue stirring or tooth chewing； when chewing with teeth， the internal force of the chewing tablets decreased， causing plastic deformation and crushing. After being crushed， the shape couldn’t be restored， making it easy to chew and swallow. CONCLUSIONS The combination of texture analyzer and rheometer can be used to simulate the oral chewing process and evaluate the palatability and chewability of self-made Glucosamine hydrochloride chewable tablets. This model can provide reference for the evaluation of various chewable tablets. |
| 期刊： | 2024年第35卷第14期 |
| 作者： | 钟傲男；李聪慧；王增明；韩晓璐；张慧；刘楠；张郃；林锦涛；刘春艳；郑爱萍 |
| AUTHORS： | ZHONG Aonan，LI Conghui， WANG Zengming，HAN Xiaolu，ZHANG Hui，LIU Nan，ZHANG He，LIN Jintao，LIU Chunyan，ZHENG Aiping |
| 关键字： | 咀嚼片；质构仪；流变仪；体外模拟；口腔咀嚼；质量评价 |
| KEYWORDS： | chewable tablets； texture analyzer； rheometer； in vitro simulation； oral chewing； quality evaluation |
| 阅读数： | 4 次 |
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