Abstract: The aim of this study was to explore the influence of preparation process on the mechanical, puncture and moisture absorption perfor-mance of dissolving microneedles, and optimize the preparation process. The Plackett-Burman design was adopted to screen the major influential factors, then the preparation process of microneedles was optimized by Box-Behnken design-response surface methodology. 3D microscope and scanning electron microscope were used to observe the morphological appearance of the microneedles. The puncture perfor-mance was examined by parafilm puncturing method, the moisture absorption performance was calculated by weighing method, and a texture analyzer was applied to investigate the mechanical properties, the feasibility of microneedles puncturing into the skin was verified by histological sections. The results showed that the ratio of tough and brittle material of the microneedles (P=0.002 3), the percentage of the drug (P=0.007 5), dry temperature (P=0.001 3), air velocity (P=0.002 7) and centrifugal time (P=0.002 8) had a significant effect on the puncture performance, the ratio of tough and brittle material (P=0.017 7) had a significant effect on the mechanical properties, and various parameters in the test had no significant in-fluence on the moisture absorption performance. The optimal preparation process parameters of microneedles was as follows, the ratio of the tough and brittle material was 9,50, the percentage of drug was 6.0%, the percentage of solvent was 60%, centrifugal speed was 4 000 r/min, centrifugal time was 28 min, centrifugal temperature was 25 ℃, drying temperature was 38 ℃, drying humidity was 10%, air velocity was 0.5 L·min-1, the puncture depth of the microneedles was (412.03±2.85) μm, the deviation between the verification values and the predicted value was less than 1%. The force of the optimal microneedles can reach 1.3 N/needle, which can successfully puncture the stratum corneum.
刘哲, 刘勇, 高广志, 李奇贵, 包阳阳, 马凤森. Plackett-Burman设计结合响应面法优化可溶性微针的制备工艺[J]. 材料导报, 2021, 35(z2): 593-599.
LIU Zhe, LIU Yong, GAO Guangzhi, LI Qigui, BAO Yangyang, MA Fengsen. Optimization of Preparation Process of Dissolving Microneedles by Plackett-Burman Design and Response Surface Analysis. Materials Reports, 2021, 35(z2): 593-599.
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2021, Vol. 35 
