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目的:研制盐酸青藤碱延迟起释型缓释片。方法:采用干法压制包衣法制得盐酸青藤碱延迟起释型缓释片,以片芯和衣膜中HPMC用量比例为影响因素,以释药时滞和释药速度常数为评价指标,采用星点设计试验,多元线性回归及二项式方程拟合建立指标与因素之间的数学关系,通过效应面法优化其处方,并对优化结果进行验证;对延迟缓释片时滞后6~15 h的释药数据进行零级、Higuchi和Peppas方程拟合,解析其释药机制。结果:释药时滞和释药速度常数与两因素之间均可用二项式方程拟合,相关系数分别为0.990 1和0.987 6,优化处方的释药时滞和释药速度常数实测值与预测值偏差分别为-3.15%和-0.34%,优化处方制得盐酸青藤碱延迟起释型缓释片释药时滞约6 h,药物在6~15 h内近似于零级释放,释药机制为骨架溶蚀释药。结论:盐酸青藤碱延迟片具有时滞后药物缓慢释放的释药特性,所建立的数学模型预测性良好。
Objective: To develop a sinomenine hydrochloride delayed release sustained-release tablets. Methods: Sinomenine delayed-release sustained-release tablets were prepared by dry-compression coating method. Influencing factors of the HPMC dosage in the core and the coating were determined. Taking drug release delay and drug release rate constant as evaluation indexes, The star point design experiment, multivariate linear regression and binomial equation fitting were used to establish the mathematical relationship between the index and the factors. The prescriptions were optimized by response surface methodology and the optimization results were validated. The release data of 15 h were subjected to zero order, fitted by Higuchi and Peppas equations, and their release mechanism was analyzed. Results: The drug release delay and the drug release rate constant and the two factors can be used to fit the binomial equation, the correlation coefficients were 0.990 1 and 0.987 6, the optimal prescription drug release delay and release rate constant measured values and The predicted values deviations were -3.15% and -0.34%, respectively. The time delay of drug release from sinomenine hydrochloride delayed release sustained-release tablets was about 6 h. The drug release was similar to zero-order release within 6 ~ 15 h. Drug mechanism for the dissolution of the skeleton release. CONCLUSION: Sinomenine hydrochloride delayed-release tablets have a slow release drug release characteristics after lag time, and the established mathematical model has good predictability.