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摘要目的采用三维（3D）打印技术制备复方丹参口腔崩解片（ODT）及其初步评价。方法以丹参、三七、冰片、乳糖、PVP K30、甘露醇、阿斯巴甜、微粉硅胶作为铺层粉末，以含2% PVP K30 的乙醇水溶液为粘结剂。通过3D 打印技术，制备复方丹参口腔崩解片，设定ODT 半径5 mm，铺粉喷涂层高0.1 mm，打印层数30 层。并检测口腔崩解片的崩解时限、硬度、质量、外观口感及内部结构特征等指标。结果打印的复方丹参ODT 半径为（5.1±0.1）mm，厚度为（3.2±0.2）mm。药片的平均质量为167.6 mg（RSD=3.40%），药片硬度为（1.72±0.20）kg。所制得片剂在1 min以内崩解，孔隙度高，外观及口感良好，微甜。扫描电镜观察结果提示，药片内部微观结构较均匀。结论 3D 打印的复方丹参ODT 孔隙度高，载药量高，工艺简易，崩解时限短，口感及外观良好。3D 打印复方丹参口腔崩解片具有一定的可行性。

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	李跃中
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	张文元

关键词 ： 3D 打印, 复方丹参, 口腔崩解片, 崩解时限, 硬度

Abstract：Objective To prepare Orally Disintegrating Tablets (ODT) of Compound Salvia Miltiorrhiza by three dimensions (3D) printing technology and make a preliminary evaluation.Methods Salvia Miltiorrhiza, Panax Notoginseng,Borneol, lactose, povidone K30, mannitol, aspartame, and silicon dioxide were mixed and used as the printing powders,and alcohol aqueous solution containing 2% PVP K30 was used as the binder.ODT of Compound Salvia Miltiorrhiza was prepared by 3D printing technology.The ODT was set 5 mm in radius, 0.1 mm in coating layer height, and 30 layers in layer number.Then the disintegration time, hardness, weight, taste, appearance, and internal structure of the ODT were detected.Results The ODT radius of Compound Salvia Miltiorrhiza was about (5.1±0.1) mm in radius, the thickness was (3.2±0.2) mm.The average mass of the tablets was 167.6 mg (RSD=3.40%) and the hardness of the tablets was (1.72±0.20) kg.The prepared tablets disintegrated within 1 min, with high porosity, good appearance and taste, slightly sweet.The results of scanning electron microscopy indicated that the microstructure of the tablets was uniform.Conclusion The 3D printed ODT of Compound Salvia Miltiorrhiza has high porosity, simple process, short disintegration time, good taste and appearance.It shows that 3D printed ODT of Compound Salvia Miltiorrhiza is feasible to some extent.

Key words： 3D printing Compound Salvia Miltiorrhiza Orally Disintegrating Tablets Disintegration time Hardness

基金资助:浙江省自然科学基金项目（LY17H280008，LY18H 180010）；
浙江省中医药科技计划项目（2015ZA045，2016 ZA044）；
浙江省医药卫生科技计划项目（2017KY299，2017 KY307）

通讯作者: 张文元（1961-），男，浙江温岭人，硕士，研究员，研究方向：组织工程及生物材料研究

作者简介: 李跃中（1981-），男，浙江湖州人，本科，助理研究员，研究方向：保健食品及中药研究

引用本文:

李跃中；唐靓；杨亚冬；张文元.

三维打印复方丹参口腔崩解片的制备工艺及初步评价

[J]. 中国当代医药, 2019, 26(12): 48-51.
LI Yue-zhong；TANG Liang；YANG Ya-dong；ZHANG Wen-yuan. Preparation technology and preliminary evaluation of Orally Disintegrating Tablets of Compound Salvia Miltiorrhiza by three dimensions printing. 中国当代医药, 2019, 26(12): 48-51.

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http://dangdaiyiyao.com/CN/ 或 http://dangdaiyiyao.com/CN/Y2019/V26/I12/48

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