An optimized formulation of capsules containing Lansoprazole enteric-coated pellets using D-Optimal design with a polynomial statistical model were prepared by using Eudragit?L100 as an enteric coated polymer to provi...An optimized formulation of capsules containing Lansoprazole enteric-coated pellets using D-Optimal design with a polynomial statistical model were prepared by using Eudragit?L100 as an enteric coated polymer to provide resistance to simulated gastric acid dissolution in buffer media. D-Optimal experimental design was used to determine the optimal level for three coating layers that were applied to formulate the enteric-coated pellets including a drug loading layer, a sub-coating, and an outer enteric coating. Dissolution studies were performed on the prepared Lansoprazole capsules. Less than 5 percent of Lansoprazole was released in 60 minutes in an acidic dissolution medium (pH 1.2) and greater than 90 percent of active ingredient was released in the next 60 minutes in a buffer dissolution medium (pH 6.8). The Lansoprazole capsules were stable with no observable change in physico-chemical properties in accelerated and normal storage conditions for 6 and 18 months, respectively. The pharmacokinetic parameters Cmax, Tmax, AUC0-t, and AUC0-∞ were determined after administration of the D-Optimal design optimized capsules of LPZ to healthy beagle dogs and were statistically compared to Gastevin? capsules as a reference (KRKA, Slovenia) using the non-compartmental method with the aid of WinNonlin 5.2 software. The analysis of variance showed that the two formulations did not demonstrate bioequivalence using a 90% confidence interval range (80% - 120%) of Cmax, AUC0-t, and AUC0-∞. No significant difference in Tmax was found at the 0.95 significance level using the Wilcoxon signed-rank test. D-Optimal Experimental Design provided definitive direction for an optimal formulation of capsules containing enteric-coated pellets of lansoprazole loaded within the coating of pellets that provided similar bioequivalence to Gastevin.展开更多
Objective: To investigate the influence of Xiaoshuan enteric-coated capsules + aniracetam therapy on cerebral blood perfusion and nerve function in patients with convalescent cerebral infarction. Methods: A total of 1...Objective: To investigate the influence of Xiaoshuan enteric-coated capsules + aniracetam therapy on cerebral blood perfusion and nerve function in patients with convalescent cerebral infarction. Methods: A total of 177 cases of patients with convalescent cerebral infarction were retrospectively reviewed and then divided into the control group (n=109) and the Xiaoshuan enteric-coated capsules group (n=68). Control group received aniracetam therapy on the basis of routine treatment, and Xiaoshuan enteric-coated capsules group received Xiaoshuan enteric-coated capsules + aniracetam therapy on the basis of routine treatment. The differences in ultrasound cerebral blood perfusion parameter levels as well as serum neurotrophy index and nerve injury index contents were compared between the two groups. Results: Before treatment, there was no statistically significant difference in ultrasound cerebral blood perfusion parameter levels as well as serum neurotrophy index and nerve injury index contents between the two groups. After treatment, ultrasound cerebral blood perfusion parameters PSV and TMV levels in Xiaoshuan enteric-coated capsules group were higher than those in control group whereas RI level was lower than that in control group;serum neurotrophy indexes bFGF, BDNF and VEGF contents were higher than those of control group;serum nerve injury indexes GFAP, NSE, UCH-L1 and S100B contents were lower than those of control group. Conclusion: Xiaoshuan enteric-coated capsules + aniracetam therapy can significantly increase cerebral blood perfusion and optimize nerve function in patients with convalescent cerebral infarction.展开更多
文摘An optimized formulation of capsules containing Lansoprazole enteric-coated pellets using D-Optimal design with a polynomial statistical model were prepared by using Eudragit?L100 as an enteric coated polymer to provide resistance to simulated gastric acid dissolution in buffer media. D-Optimal experimental design was used to determine the optimal level for three coating layers that were applied to formulate the enteric-coated pellets including a drug loading layer, a sub-coating, and an outer enteric coating. Dissolution studies were performed on the prepared Lansoprazole capsules. Less than 5 percent of Lansoprazole was released in 60 minutes in an acidic dissolution medium (pH 1.2) and greater than 90 percent of active ingredient was released in the next 60 minutes in a buffer dissolution medium (pH 6.8). The Lansoprazole capsules were stable with no observable change in physico-chemical properties in accelerated and normal storage conditions for 6 and 18 months, respectively. The pharmacokinetic parameters Cmax, Tmax, AUC0-t, and AUC0-∞ were determined after administration of the D-Optimal design optimized capsules of LPZ to healthy beagle dogs and were statistically compared to Gastevin? capsules as a reference (KRKA, Slovenia) using the non-compartmental method with the aid of WinNonlin 5.2 software. The analysis of variance showed that the two formulations did not demonstrate bioequivalence using a 90% confidence interval range (80% - 120%) of Cmax, AUC0-t, and AUC0-∞. No significant difference in Tmax was found at the 0.95 significance level using the Wilcoxon signed-rank test. D-Optimal Experimental Design provided definitive direction for an optimal formulation of capsules containing enteric-coated pellets of lansoprazole loaded within the coating of pellets that provided similar bioequivalence to Gastevin.
文摘Objective: To investigate the influence of Xiaoshuan enteric-coated capsules + aniracetam therapy on cerebral blood perfusion and nerve function in patients with convalescent cerebral infarction. Methods: A total of 177 cases of patients with convalescent cerebral infarction were retrospectively reviewed and then divided into the control group (n=109) and the Xiaoshuan enteric-coated capsules group (n=68). Control group received aniracetam therapy on the basis of routine treatment, and Xiaoshuan enteric-coated capsules group received Xiaoshuan enteric-coated capsules + aniracetam therapy on the basis of routine treatment. The differences in ultrasound cerebral blood perfusion parameter levels as well as serum neurotrophy index and nerve injury index contents were compared between the two groups. Results: Before treatment, there was no statistically significant difference in ultrasound cerebral blood perfusion parameter levels as well as serum neurotrophy index and nerve injury index contents between the two groups. After treatment, ultrasound cerebral blood perfusion parameters PSV and TMV levels in Xiaoshuan enteric-coated capsules group were higher than those in control group whereas RI level was lower than that in control group;serum neurotrophy indexes bFGF, BDNF and VEGF contents were higher than those of control group;serum nerve injury indexes GFAP, NSE, UCH-L1 and S100B contents were lower than those of control group. Conclusion: Xiaoshuan enteric-coated capsules + aniracetam therapy can significantly increase cerebral blood perfusion and optimize nerve function in patients with convalescent cerebral infarction.
