SeDeM 专家系统在红景天提取物与辅料混合物直接压片适用性研究中的应用。
Application of the SeDeM Expert System in Studies for Direct Compression Suitability on Mixture of Rhodiola Extract and an Excipient.
机构信息
Chongqing University of Science and Technology, No. 20, University City East Road, Chongqing, 401331, China.
National Institutes for Food and Drug Control, No. 2, Tiantan Xili Road, Beijing, 100050, China.
出版信息
AAPS PharmSciTech. 2019 Feb 11;20(3):105. doi: 10.1208/s12249-019-1320-4.
The SeDeM expert system is used to reveal direct compression (DC) suitability of the active ingredients and excipients in preformulation. In this study, the system was used to predict compressibility of rhodiola extract (RhE) and its mixture with excipients. The parameter index (IP), parameter profile index (IPP), and good compressibility index (IGC) of RhE mixtures with different fillers were investigated. The results showed that RhE and mixture with lactose or starch were not suitable for DC according to the values of IP, IPP, and IGC, which can be corrected by pregelatinized starch (P-STA). The quality of tablets corrected by P-STA all satisfied the USP monograph limit. The findings from this study showed that the system is a useful tool to predict DC suitability on the mixture of RhE and an excipient.
SeDeM 专家系统用于揭示预配方中活性成分和赋形剂的直接压缩（DC）适用性。在这项研究中，该系统用于预测红景天提取物（RhE）及其与赋形剂混合物的可压缩性。研究了 RhE 与不同填充剂混合物的参数指数（IP）、参数分布指数（IPP）和良好可压缩性指数（IGC）。结果表明，根据 IP、IPP 和 IGC 的值，RhE 及其与乳糖或淀粉的混合物不适合 DC，可以通过预胶化淀粉（P-STA）进行修正。用 P-STA 修正的片剂质量均符合 USP 专论的限度。本研究结果表明，该系统是一种有用的工具，可用于预测 RhE 与赋形剂混合物的 DC 适用性。
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