目的 優(yōu)化五味益心顆粒成型工藝，并構(gòu)建其物理指紋圖譜。方法 采用D-最優(yōu)混料設(shè)計(jì)以顆粒一次成型率、溶化率、吸濕率（H）、休止角（α）為考察指標(biāo)篩選最佳輔料比例；采用Box-Behnken實(shí)驗(yàn)結(jié)合AHP-CRITIC混合加權(quán)法優(yōu)化干法制粒機(jī)工藝參數(shù)；建立由松裝密度（D_a）、振實(shí)密度（D_c）、α、豪斯納比（IH）、H、含水量（HR）、顆粒間孔隙率（I_e）、卡爾指數(shù)（IC）、比表面積（SSA）、粒徑＜50µm百分比（P_f）、分布寬度（Span）、分布范圍（Width）、均勻性（HG）共13個(gè)顆粒物性指標(biāo)構(gòu)建物理指紋圖譜，評(píng)價(jià)批次間顆粒質(zhì)量的相似性。結(jié)果 五味益心顆粒輔料最佳比例：糊精49%、麥芽糊精23%、可溶性淀粉28%；最佳制粒工藝參數(shù)：輸料轉(zhuǎn)速64.1 r·min⁻¹、壓輪轉(zhuǎn)速6.7 r·min⁻¹、液壓壓力6.1 MPa；15批樣品物理指紋圖譜相似度均大于0.99。結(jié)論 優(yōu)化后干法制粒工藝穩(wěn)定可行，可為后續(xù)中試放大以及大生產(chǎn)提供參考。

Objective Optimize the forming process of Wuwei Yixin Granules and construct its physical fingerprint. Methods The D-optimal mixture design was used to screen the best excipient ratio with the primary forming rate, melting rate, moisture absorption rate and angle of repose of the particles as the indexes. The process parameters of dry granulator were optimized by Box-Behnken experiment combined with AHP-CRITIC hybrid weighting method, the physical fingerprint of the granules consisting of 13 secondary physical quality indexes, including bulk density (D_a), tap density (D_c), α, Hausner ratio (IH), H, water content (HR), interparticle porosity (I_e), Karl index (IC), specific surface area (SSA), particle size < 50 µm percent (P_f), Span, Width and homogeneity (HG), was established to evaluate the consistency of granule quality among different batches. Results The best proportion of excipients of Wuwei Yixin Granules: dextrin 49%, maltodextrin 23%, soluble starch 28%. The best granulation process parameters: feeding speed 64.1 r·min⁻¹, pressure wheel speed 6.7 r·min⁻¹, hydraulic pressure 6.1 Mpa. The physical fingerprint had good similarity between 15 batches. Conclusion The optimized dry granulation process is stable and feasible, which can provide reference for subsequent pilot scale-up and large-scale production.

R283.6

國(guó)家長(zhǎng)三角科技創(chuàng)新共同體聯(lián)合攻關(guān)項(xiàng)目（2023CSJGG1700）