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目的:优化龙须藤分散片的处方工艺并建立其质量控制方法。方法:以崩解时限为指标,采用星点设计-效应面法考察微晶纤维素(MCC)、低取代羟丙基纤维素(L-HPC)及交联聚乙烯吡咯烷酮(PVPP)质量分数对龙须藤分散片处方工艺的影响;采用HPLC测定3’,4’,5’,5,7-五甲氧基黄酮和3’,4’-亚甲二氧基-5’,5,6,7-四甲氧基黄酮含量,流动相乙腈(A)-水(B)洗脱梯度(0~20 min,30%~40%A;20~36 min,40%~48%A),检测波长324 nm,并考察分散片的体外溶出度。结果:最佳处方工艺为MCC,L-HPC,PVPP及硬脂酸镁用量分别为58%,9.2%,9.8%,1.0%;龙须藤分散片崩解时间40 s,30 min内溶出度已达90%。结论:制备的龙须藤分散片具有崩解快、溶出度高的特性,适于临床应用需要。
Objective: To optimize the formulation process and establish the quality control method of Long Xu vine dispersible tablets. Methods: The disintegration time was taken as an index and the mass fraction of microcrystalline cellulose (MCC), low-substituted hydroxypropyl cellulose (L-HPC) and crosslinked polyvinylpyrrolidone (PVPP) The effects of 3 ’, 4’, 5 ’, 5,7-pentamethoxyflavone and 3’, 4’-methylenedioxy-5 ’, 5, 6 , The content of 7-tetramethoxyflavone and the mobile phase of acetonitrile (A) -water (B) (0-20 min, 30-40% A, 20-36 min, 40-48% A) The detection wavelength was 324 nm and the in vitro dissolution of the dispersible tablets was investigated. Results: The optimum prescription was MCC, L-HPC, PVPP and magnesium stearate were 58%, 9.2%, 9.8% and 1.0%, respectively. Has reached 90%. Conclusion: The prepared dispersible tablets have the characteristics of fast disintegration and high dissolution, which are suitable for clinical application.