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黄芩苷单层渗透泵片的制备工艺及体外释药行为研究
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| 篇名： | 黄芩苷单层渗透泵片的制备工艺及体外释药行为研究 |
| TITLE： | |
| 摘要： | 目的：制备黄芩苷单层渗透泵片并考察其体外释药行为。方法：以体外累积释放度为评价指标，在将黄芩苷制备成固体分散体以提高其溶解度的基础上，通过单因素及正交试验优化以黄芩苷固体分散体为中间体制备单层渗透泵片的处方制备工艺条件（促渗剂、致孔剂用量及包衣膜增质量）；另考察优化工艺所制样品在3种不同释放介质（水、0.1 mol/L盐酸溶液、人工胃液）中的释放速率及释放机制。结果：最优处方制备工艺为促渗剂氯化钠的用量为30 mg、致孔剂聚乙二醇 400的用量为辅料醋酸纤维素质量的20％、包衣膜增质量为2％；优化工艺所制3批黄芩苷单层渗透泵片在12 h时的累积释放度的RSD为1.06％（n＝3）。其在3种介质中12 h内的累积释放度相似，均达80％以上；释药方程符合零级释药模型（r＝0.998 5）。结论：经优化后的工艺制备的黄芩苷单层渗透泵片可在12 h内恒速释药。 |
| ABSTRACT： | OBJECTIVE： To prepare Baicalin monolithic osmotic pump tablets and investigate its in vitro drug release behavior. METHODS： Using accumulative release rate as evaluation index， baicalin solid dispersion was prepared to improve solubility， single factor test and orthogonal test were used to optimize preparation technology （the amount of penetrating agent and pore-forming agent， weight gaining of coating film） of monolithic osmotic pump tablets using baicalin solid dispersion as intermediate. Release rate and mechanism of samples prepared by optimized technology were investigated in 3 kinds of release medium （water， 0.1 mol/L HCl， simulated gastric fluid）. RESULTS： The optimal preparation technology was that penetrating agent sodium chloride was 30 mg； pore-forming agent polyethylene glycol 400 was 20％ amount of excipient cellulose acetate； weight gaining of coating film was 2％. RSD of 12 h accumulative release rate was 1.06％ （n＝3） for 3 batches of Baicalin monolithic osmotic pump tablets prepared by optimized technology. 12 h accumulative release rate of them in 3 kinds of medium were similar to each other， being all more than 80％. Release equation was in line with zero-order drug release model （r＝0.998 5）. CONCLUSIONS： Prepared Baicalin monolithic osmotic pump tablets after optimization can release drug at controlled rate. |
| 期刊： | 2017年第28卷第1期 |
| 作者： | 王汝兴，于海龙，薛禾菲，刘喜纲，刘翠哲 |
| AUTHORS： | WANG Ruxing，YU Hailong，XUE Hefei，LIU Xigang，LIU Cuizhe |
| 关键字： | 黄芩苷单层渗透泵片；固体分散体；制备工艺； 正交试验；体外释药 |
| KEYWORDS： | Baicalin monolithic osmotic pump tablets； Solid dispersion； Preparation technology； Orthogonal test； in vitro drug release |
| 阅读数： | 500 次 |
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