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开心颗粒成型工艺优化及其物理指纹图谱构建
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| 篇名： | 开心颗粒成型工艺优化及其物理指纹图谱构建 |
| TITLE： | Optimization of the forming process and establishment of a physical fingerprint for Kaixin granules |
| 摘要： | 目的 优化开心颗粒成型工艺，并建立其物理指纹图谱。方法以颗粒的成型率、吸湿率、溶化率、休止角为评价指标，采用Plackett-Burman设计筛选颗粒成型工艺的关键工艺参数，采用层次分析（AHP）-熵权法对各指标进行综合赋权，通过Box-Behnken响应面法优化开心颗粒的成型工艺并进行验证。以休止角、豪斯纳比、松密度、振实密度、含水量、吸湿率、相对均齐指数为物理指标，建立开心颗粒的物理指纹图谱并进行相似度分析；采用SPSS20.0软件及SPSSPRO在线分析工具分别进行聚类分析及偏最小二乘判别分析。结果关键工艺参数为乙醇体积分数、乙醇用量和药辅比。最佳成型工艺为乙醇体积分数87%，乙醇用量27%，药辅比1∶1。经验证，3批样品的平均综合评分为97.82分，RSD为0.19%。按最佳成型工艺制备所得10批开心颗粒物理指纹图谱的相似度均大于0.98；聚类分析结果显示，10批样品聚为2类，S4、S5、S7、S8、S10为一类，S1～S3、S6、S9为一类；豪斯纳比、相对均齐指数、松密度及含水量的变量投影重要性值＞1。结论所得最佳成型工艺稳定、可行；所建物理指纹图谱能有效表征开心颗粒的整体物理属性；豪斯纳比、相对均齐指数、松密度及含水量为关键物理指标。 |
| ABSTRACT： | OBJECTIVE To optimize the forming process of Kaixin granules and establish its physical fingerprint.METHODS Using particle forming rate， hygroscopicity rate， dissolution rate， and angle of repose as indices， the key process parameters of the granule forming process were determined by Plackett-Burman design. The analytic hierarchy process （AHP） combined with the entropy weight method was used to comprehensively weight the indices， and the forming process of Kaixin granules was optimized and validated by Box-Behnken response surface methodology. A physical fingerprint of Kaixin granules was established based on the following physical indices： angle of repose， Hausner ratio， bulk density， tapped density， moisture content， hygroscopicity ratio， and relative uniformity index， with similarity evaluation was performed. Cluster analysis and partial least squares discriminant analysis （PLS-DA） were performed using SPSS 20.0 and the SPSSPRO online analysis platform， respectively.RESULTS The key process parameters were ethanol volume fraction， ethanol amount， and the drug-excipient ratio. The optimal forming conditions were as follows： ethanol volume fraction of 87%， ethanol amount of 27%， and a drug-excipient ratio of 1∶1. Validation showed that the average comprehensive scores of three batches were 97.82， with an RSD of 0.19%. The similarity of the physical fingerprints of ten batches of Kaixin granules prepared under the optimal forming process were greater than 0.98. The results of cluster analysis showed that the ten batches were divided into two groups： S4， S5， S7， S8 and S10 in one cluster， and S1-S3， S6 and S9 in another. The variable importance in projection values of Hausner ratio， relative uniformity index， bulk density， and moisture content were greater than 1.CONCLUSIONS The optimized forming process is stable and feasible. The established physical fingerprint can effectively characterize the overall physical properties of Kaixin granules. Hausner ratio， relative uniformity index， bulk density， and moisture content are the key physical indices. |
| 期刊： | 2026年第37卷第20期 |
| 作者： | 吴作敏；王韵旨；宁萌；白淑贤；马慧芬；谢治深；张振强；于晓涛；董敬远 |
| AUTHORS： | WU Zuomin，WANG Yunzhi， NING Meng，BAI Shuxian，MA Huifen，XIE Zhishen，ZHANG Zhenqiang，YU Xiaotao，DONG Jingyuan |
| 关键字： | 开心颗粒;成型工艺;物理指纹图谱;Plackett-burman设计;Box-Behnken响应面法;层次分析-熵权法 |
| KEYWORDS： | Kaixin granules;forming process;physical fingerprint;Plackett-burman design;Box-Behnken response surface methodology;analytic hierarchy process-entropy weight method |
| 阅读数： | 1 次 |
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