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目的:制备山楂叶总黄酮固体自乳化颗粒,并对其进行质量评价。方法:通过溶解度考察、伪三元相图的绘制,以形成自乳化效果和自乳化时间为指标,选择最佳自乳化处方。通过对不同处方比例成型率、重分散性及体外溶出度进行综合考察,筛选山楂叶总黄酮固体自乳化颗粒的处方,并对其粒径、Zeta电位、DSC、X-衍射、溶出度进行考察。结果:优化的最佳处方为山楂叶总黄酮-聚山梨醇酯80-Transcutol P-蓖麻油-淀粉-乳糖-甘露醇的质量比为1∶1.5∶1.35∶0.15∶12∶2∶2,其分散后平均粒径(169.3±7.6)nm,30 min溶出度达89.5%。结论:山楂叶总黄酮固体自乳化颗粒制备简单,质量稳定,可以提高药物的溶出度。
Objective: To prepare the hawthorn leaf flavonoids solid self-emulsifying granules and to evaluate its quality. Methods: Based on the solubility study and the pseudo-ternary phase diagram, the best self-emulsifying prescription was selected based on the self-emulsifying effect and the self-emulsifying time as the index. The prescription of hawthorn leaf total flavonoids self-emulsifying granules was screened through comprehensive study on the proportioning rate, redispersibility and in vitro dissolution rate of different prescriptions, and their particle size, Zeta potential, DSC, X-ray diffraction and dissolution were investigated . Results: The optimal prescription was hawthorn leaf flavonoids polysorbate 80-Transcutol P-castor oil-starch-lactose mannitol mass ratio of 1: 1.5: 1.35: 0.15: 12: 2: After dispersion, the average particle size (169.3 ± 7.6) nm, 30 min dissolution rate of 89.5%. Conclusion: The hawthorn leaves total flavonoids solid self-emulsifying particles preparation is simple, stable quality, can improve the drug dissolution.