1.Department of Pharmacy, Anhui University of Chinese Medicine, Anhui Province, Hefei 230012, China;
2.Department of Pharmacy, Anhui Provincial Hospital, Anhui Province, Hefei 230001, China;
3.Institute of Pharmaceutics Anhui Academy of Chinese Medicine, Anhui Province, Hefei 230012, China;
4.National Institutes for Food and Drug Control, Beijing 100050, China
Abstract：Objective To establish the method for determine the dissolution rate of Sodium Ferulate Tablets and to provide basis for the in vitro and in vivo dissolution consistency. Methods Five batches of Sodium Ferulate Tablets from two manufacturers in three dissolution media were determined by high performance liquid chromatograph spectrometer. Then the dissolution curves were drawn, and similarity factor (f2) was used to evaluate the similarity of dissolution curves. Model dependent method as complementary tools was evaluated the in vitro dissolution consistency. Results Sodium Ferulate Tablets were ideally dissolved in water, pH 4.5 acetate buffer and pH 6.8 phosphate buffer solution. The dissolution behavior of pH 4.5 acetate buffer and pH 6.8 phosphate buffer solution (f2> 50) had high similarity. All tested batches of Sodium Ferulate Tablets were dissolved rapidly within 50 minutes and they were stabilized at 180 minutes. The cumulative dissolution percentages of Sodium Ferulate Tablet were more than 85% and conformed to the Weibull model. Conclusion The method used in this study is stable and reliable, which can provide theoretical reference for the consistency evaluation of Sodium Ferulic Tablets.
[1] 王伟，李韶静，朱天慧，等.天然药物化学史话：天然产物的生物合成[J].中草药，2018，49（14）：3193-3207.
[2] 林茂，朱朝德，孙庆民，等.当归化学成分的研究[J].药学学报，1979（9）：529-534.
[3] 王立霞，王枫，陈欣，等.阿魏酸钠的心脑血管药理作用研究进展[J].中草药，2019，50（3）：772-777.
[4] Vashisth P，Kumar N，Sharma M，et al. Biomedical applications of ferulic acid encapsulated electrospun nanofibers [J]. Biotechnol Rep（Amst），2015，8：36-44.
[5] Liu W，Li YL，Feng MT，et al. Application of Feedback System Control Optimization Technique in Combined Use of Dual Antiplatelet Therapy and Herbal Medicines [J]. Front Physiol，2018，9：491.
[6] Panwar R，Sharma AK，Kaloti M，et al. Characterization and anticancer potential of ferulic acid-loaded chitosan nanoparticles against ME-180 human cervical cancer cell lines [J]. Applied Nanoscience，2016，6：803-813.
[7] Nankar R，Prabhakar PK，Doble M. Hybrid drug combination：Combination of ferulic acid and metformin as anti-diabetic therapy[J]. Phytomedicine，2017，37：10-13.
[8] Gerin F，Erman H，Erboga M，et al. The Effects of Ferulic Acid Against Oxidative Stress and Inflammation in Formaldehyde-Induced Hepatotoxicity [J]. Inflammation，2016，39（4）：1377-1386.
[9] 国家药典委员会.中华人民共和国药典[S].二部.北京：中国医药科技出版社，2015：577.
[10] 周浓，杨敏，白志川，等.HPLC测定不同来源川楝子中阿魏酸的含量[J].中国实验方剂学杂志，2012，18（3）：84-87.
[11] 袁利杰.RP-HPLC法测定阿魏酸钠胶囊的含量和有关物质[J].中国药事，2009，23（5）：464-466.
[12] 骆媱，潘娉娉，章建华，等.HPLC法同时测定丹参-当归药对中7个成分的含量[J].药物分析杂志，2018，38（10）：1689-1696.
[13] 国家药典委员会.中华人民共和国药典[S].四部.北京：中国医药科技出版社，2015：121.
[14] 国家食品药品监督管理总局.普通口服固体制剂溶出度试验技术指导原则 [EB/OL]. [2015-02-05]. http://samr.cfda.gov.cn/WS01/CL1616/114288.html.
[15] Paix?觔o P，Gouveia LF，Silva N，et al. Evaluation of dissolution profile similarity-Comparison between the f2，the multivariate statistical distance and the f2 bootstrapping methods [J]. Eur J Pharm Biopharm，2017，112：67-74.
[16] Simionato LD，Petrone L，Baldut M，et al. Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires，Argentina [J]. Saudi Pharm J，2018，26（4）：578-584.
[17] 胡昌勤，潘瑞雪.溶出度试验评价/预测固体口服制剂生物等效性的研究进展[J].中国新药杂志，2014，23（1）：44-51.
[18] 侯迪旭，吴学萍，李树英，等.基于体外释放的半固体制剂透皮吸收及其影响因素探讨[J].中国新药杂志，2018， 27（15）：1807-1812.
[19] Zhang Y，Huo M，Zhou J，et al. DDSolver：An Add-In Program for Modeling and Comparison of Drug Dissolution Profiles [J]. AAPS J，2010，12（3）：263-271.
[20] 张海龙，严全鸿，朱海健，等.多变量置信区间法和模型依赖法在溶出曲线相似性比较中的应用[J].药学进展，2016，40（12）：916-923.
[21] 康冰亚，聂书慧，李瑞颖，等.f2法评价通脉浓缩丸与原制剂体外释放曲线相似性[J].中国医院药学杂志，2018， 38（15）：1605-1608.
2019, Vol. 16 
京公网安备 11010502046598号