枸橼酸坦度螺酮口腔速溶膜的制备与质量评价  

Preparation and Quality Evaluation of Tandospirone Citrate Orodispersible Films

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作  者:刘圆圆 杜欢欢 尹民 施斌 贺敦伟 LIU Yuanyuan;DU Huanhuan;YIN Min;SHI Bin;HE Dunwei(School of Medicine and Pharmacy,Ocean University of China,Qingdao 266003;Zezheng(Shanghai)Biotechnology Co.,Ltd.,Shanghai 201807)

机构地区:[1]中国海洋大学医药学院,山东青岛266003 [2]则正(上海)生物科技有限公司,上海201807

出  处:《中国医药工业杂志》2024年第3期385-391,共7页Chinese Journal of Pharmaceuticals

摘  要:采用溶剂浇铸法制备枸橼酸坦度螺酮口腔速溶膜(ODFs)。通过单因素试验筛选了成膜材料、掩味剂和增塑剂,确定优化处方为:10.8%的枸橼酸坦度螺酮、37.5%的HPMCE5、7.5%的羟丙纤维素、27.0%的羟丙基倍他环糊精、15%的甘油和2.2%的三氯蔗糖。所得ODFs成膜性好,崩解时间约40 s,含量均匀度和有关物质符合规定,15 min时水中的溶出率超过85%,与市售片剂的溶出行为相似。基于羟丙基倍他环糊精的包合作用,药物的掩味效果较好。在光照、高温和高湿条件下进行ODFs的稳定性试验。结果显示,除60℃高温条件外,ODFs在其他条件下稳定性良好,外观、含量和有关物质未发生显著变化。在40℃、相对湿度75%条件下放置1个月,ODFs中的药物晶型保持稳定。The orodispersible films(ODFs)of tandospirone citrate were prepared by solvent casting method.The film-forming materials,taste masking agent and plasticizer were screened and optimized by single factor tests.The optimal formulation was as follows:10.8%of tandospirone citrate,37.5%of HPMC E5,7.5%of hydroxypropyl cellulose,27.0%of hydroxypropyl-β-cyclodextrin,15%of glycerin,and 2.2%of sucralose.The obtained ODFs had good film properties with a disintegration time of about 40 s.The requirements for content uniformity and related substances were met.The dissolution rate in water at 15 min exceeded 85%,which was similar to that of the commercially available tablets.The bitterness of the drug was well masked on the basis of the inclusion effect of hydroxypropyl-β-cyclodextrin.The stability tests were conducted under photolysis,high temperature,and high humidity conditions.The results showed that the ODFs had good stability except for high temperature at 60℃.The appearance,drug content and related substances of the ODFs stored under other conditions had not significantly changed.After being stored for one month under accelerated test condition(40℃and 75%of relative humidity),the API crystal form remained stable.

关 键 词:枸橼酸坦度螺酮 口腔速溶膜 掩味 溶剂浇铸法 体外溶出 稳定性 

分 类 号:R944.9[医药卫生—药剂学] R971[医药卫生—药学]

 

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