雷公藤红素口腔溃疡膜剂的制备及其质量初步评价-中国药房

雷公藤红素口腔溃疡膜剂的制备及其质量初步评价

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篇名：	雷公藤红素口腔溃疡膜剂的制备及其质量初步评价
TITLE：	Preparation and Primary Quality Evaluation of Celastrol Oral Ulcer Film
摘要：	目的：制备雷公藤红素口腔溃疡膜剂，并初步评价其质量。方法：以药膜外观、成膜性、韧性的综合评分为指标，控制处方中主药雷公藤红素的用量为0.05％，通过正交试验优选口腔溃疡膜剂中辅料淀粉、羧甲基纤维素钠、甘油、炼蜜的用量，筛选最佳处方，并进行验证试验。测定按最优处方制备的膜剂的黏附力，并采用紫外-可见分光光度法测定膜剂中雷公藤红素的含量。结果：雷公藤红素口腔溃疡膜剂中各辅料的最佳处方用量分别为淀粉1.0g、羧甲基纤维素钠0.2g、甘油0.4g、炼蜜1.5g；3次验证试验中，所制膜剂的外观形态均较好。按最优处方制备的膜剂的平均黏附力为4.2g，雷公藤红素的平均含量为0.1353mg/cm（2RSD＝1.90％，n＝3）。结论：本研究优选出了可用于治疗口腔溃疡的雷公藤红素膜剂的最佳处方，所制膜剂成膜性好、质量稳定均一。
ABSTRACT：	OBJECTIVE：To prepar e Celastrol oral u lcer film ，and to evalute its quality primarily. METHODS ：The comprehensive scores of the appearance ，film formation and toughness of the drug film were used as indicators ，and the amount of celastrol was controlled to 0.05％. Orthogonal test was used to optimize the amount of excipients as starch ，sodium carboxymethyl cellulose，glycerol and condensed honey ，so as to optimize the formulation ；the validation test was performed. The adhesion force of the film prepared by the optimal formulation were determined. UV spectrophotometer was used to detect the content of celastrol in the film. RESULTS ：The optimal dosage of each excipient in Celastrol oral ulcer film was starch 1.0 g，sodium carboxymethyl cellulose 0.2 g，glycerin 0.4 g，condensed honey 1.5 g. In 3 times of validation tests ，the appearance of the prepared film was good. The average adhesion of the film prepared by the optimal formulation was 4.2 g，and the average content of celastrol was 0.135 3 mg/cm2（RSD＝1.90％，n＝3）. CONCLUSIONS ：In this study ，the best formulation of Celastrol oral ulcer film was optimized，and the film forming ability of the prepared film is good and the quality is stable and uniform.
期刊：	2020年第31卷第21期
作者：	龚琴琴，王倩，郭玲，徐剑，张永萍
AUTHORS：	GONG Qinqin ，WANG Qian，GUO Ling，XU Jian，ZHANG Yongping
关键字：	雷公藤红素；口腔溃疡；膜剂；质量评价
KEYWORDS：	Celastrol；Oral ulcer ；Film；Quality evaluation
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