黄芩苷口腔贴片的制备及质量初步评价  

Preparation and Quality Evaluation of Baicalin Oral Patch(黄芩苷口腔贴片)

作　　者：杨东[1] 毕建云[2] 刘文静[2] YANG Dong;BI Jian-yun;LIU Wen-jing(Weifang Yidu Central Hospital,Weifang Shandong 262500,China;Shandong University of Traditional Chinese Medicine,Ji'nan Shandong 250355,China)

机构地区：[1]潍坊市益都中心医院,山东潍坊262500 [2]山东中医药大学,山东济南250355

出　　处：《中医药导报》2022年第5期64-69,共6页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：山东中医药大学2021年度创新创业教育教学研究课题(CXCY202115);2021年山东中医药大学中药学专业认证专项教学改革团队项目。

摘　　要：目的:优选黄芩苷口腔贴片的成型工艺,并研究其质量评价。方法:以羟丙甲基纤维素、卡波姆和微晶纤维素的用量为考察因素,以外观、黏附力和扩散系数为考察指标,采用Box-Behnken-响应面法优选黄芩苷口腔贴片的最佳成型工艺。采用薄层色谱(TLC)法、高效液相色谱(HPLC)法对黄芩苷口腔贴片中的黄芩苷进行定性定量测定;考察该黄芩苷贴片的片重均匀度、黏附力、扩散系数。结果:黄芩苷口腔贴片最佳成型工艺为采用6 mm冲模,粉末直接压片法,且m(黄芩苷提取物)∶m(羟丙甲基纤维素)∶m(卡波姆)∶m(微晶纤维素)∶m(甘露醇)∶m(硬脂酸镁)=7∶13.2∶6∶8∶3∶2。在新制备的3批样品中,TLC鉴别中的供试品与对照品在相应位置有相同斑点,阴性对照无明显斑点;含量测定显示该制剂中黄芩苷的含量不得少于8.0 mg/片,黏附力不得小于10 g,扩散系数不得小于10。结论:黄芩苷口腔贴片的成型工艺简单、合理可行,适合工业化生产。以上质量评价体系可用于黄芩苷口腔贴片的质量考察,为其质量标准的建立提供参考。Objective:To optimize the molding process of Baicalin Oral Patch and to do a preliminary study on its quality evaluation.Methods:The dosages of hydroxypropyl methylcellulose,carbomer and microcrystalline cellulose were used as investigating factors,and appearance,adhesion and diffusion coefficient were used as investigating indicators.The BOX-Behnken response surface method was used to optimize the optimal molding process of Baicalin Oral Patch.TLC and HPLC were used to qualitatively and quantitatively determine the baicalin in Baicalin Oral Patch.The weight uniformity,adhesion and diffusion coefficient of the Baicalin Oral Patch were investigated.Results:The optimal molding process of Baicalin Oral Patch was 6 mm punch,powder direct compression method,and m(baicalin extract):m(hydroxypropyl methyl cellulose):m(carbomer):m(microcrystalline cellulose):m(mannitol):m(magnesium stearate)=7∶13.2∶6∶8∶3∶2.In the three batches of samples newly prepared,the test substance and the reference substance in the TLC identification have the same spots in the corresponding positions,and the negative control has no obvious spots.The content determination showed that the content of baicalin in the preparation should not be less than 8.0 mg/tablet.The adhesive force should not be less than 10 g,and the diffusion coefficient should not be less than 10.Conclusion:The molding process of Baicalin Oral Patch is simple,reasonable and feasible,and suitable for industrial production.The above quality evaluation system can be used for the quality inspection of Baicalin Oral Patch,and provides a reference for the establishment of its quality standard.

关 键 词：黄芩苷口腔贴片 黄芩苷 响应面法 成型工艺 质量评价 薄层色谱法 高效液相色谱法 

分 类 号：R284.2[医药卫生—中药学]