首页|粉防己碱固体分散体的制备及体外评价

粉防己碱固体分散体的制备及体外评价

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目的:制备粉防己碱(tetrandrine,TET)固体分散体(solid dispersion,SD),以增加TET的溶解度及体外溶出度。方法:以PVPVA64为载体,通过溶剂法制备TET-SD,分别以差示扫描量热法(DSC)、X-射线衍射法(XRD)、傅立叶变换红外光谱法(FTIR)、扫描电镜(SEM)以及热重分析(TG)对TET原料药及TET-SD进行表征,并研究其理化性质及体外溶出度。结果:DSC、XRD、FTIR、SEM和TG的结果显示,所制备的TET-SD处于无定型状态,TET与PVPVA64之间存在分子间相互作用。TET-SD在120 min内的体外累积溶出度为92。95%,与TET和二者的物理混合物相比,体外溶出度在120 min内显著提高。结论:TET-SD的制备方法简单、可靠,提高了 TET的体外溶出度。
Preparation and in vitro evaluation of tetrandrine solid dispersion
OBJECTIVE To prepare tetrandrine(TET)solid dispersion(SD)to boost the solubility and in vitro dissolution of TET.METHODS After preparation by solvent method with PVPVA64,TET-SD was characterized by differential scanning calorimetry(DSC),X-ray diffraction(XRD),Fourier transform infrared spectroscopy(FTIR),scanning electron microscopy(SEM),glass transition temperature(TG)and dissolution in vitro.And physicochemical properties and dissolution in vitro were examined.RESULTS The results of DSC,XRD,FTIR,SEM and TG indicated that prepared TET-SD was amorphous and intermolecular interaction existed between TET and PVPVA64.In vitro cumulative dissolution of TET-SD within 120 min was 92.95%.As compared with physical mixture of TET-SD and TET,dissolution rate spiked markedly within 120 min and water contact angle shrank.CONCLUSION The preparation method of TET-SD is both simple and reliable.And dissolution rate in vitro of TET improves.

tetrandrinesolid dispersionpreparation technologyquality assessment

杨岚、常金花、刘沛、马帅、刘喜纲、王汝兴

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承德医学院中药研究所/河北省中药研究与开发重点实验室,河北承德 067000

粉防己碱 固体分散体 制备工艺 质量评价

河北省高等学校科学技术研究重点项目河北省自然科学基金中医药联合基金培育项目承德医学院高层次人才科研启动基金

ZD2021004H2022406073201705

2024

中国医院药学杂志
中国药学会

中国医院药学杂志

CSTPCD北大核心
影响因子:1.198
ISSN:1001-5213
年,卷(期):2024.44(20)