We previously determined 'Tableting properties' by using a multi-functional single-punch tablet press(GTP-1). We proposed plotting 'Compactability' on the x-axis against'Manufacturability' on t...We previously determined 'Tableting properties' by using a multi-functional single-punch tablet press(GTP-1). We proposed plotting 'Compactability' on the x-axis against'Manufacturability' on the y-axis to allow visual evaluation of 'Tableting properties'. Various types of tableting failure occur in commercial drug production and are influenced by the amount of lubricant used and the shape of the punch. We used the GTP-1 to measure'Tableting properties' with different amounts of lubricant and compared the results with those of tableting on a commercial rotary tableting machine. Tablets compressed with a small amount of lubricant showed bad 'Manufacturability', leading to sticking of powder on punches.We also tested various punch shapes. The GTP-1 correctly predicted the actual tableting results for all punch shapes. With punches that were more likely to cause tableting failure, our system predicted the effects of lubricant quantity in the tablet formulation and the occurrence of sticking in the rotary tableting machine.展开更多
We previously determined "Tableting properties" by using a multi-functional single-punch tablet press(GTP-1). We plotted "Compactability" on the x-axis against "Manufacturability"on the y...We previously determined "Tableting properties" by using a multi-functional single-punch tablet press(GTP-1). We plotted "Compactability" on the x-axis against "Manufacturability"on the y-axis to allow visual evaluation of "Tableting properties". Here, we examined whether this evaluation method can be used in the formulation design of tablets prepared by wet granulation. We used the GTP-1 to measure "Tableting properties" with different amounts of binder, disintegrant, and lubricant, and compared the results with those of tableting on a commercial rotary tableting machine. Tableting failures(capping and binding in particular) occurred when samples that had been evaluated as having poor "Compactability" or"Manufacturability" on the GTP-1 were compressed on the rotary tableting machine. Thus,our evaluation method predicted tableting failure at the commercial scale. The method will prove useful for scaling up production.展开更多
In this investigation, the effect of formulation variables on the release properties of timed- release press-coated tablets was studied using the Taguchi method of experimental design. Formulations were prepared based...In this investigation, the effect of formulation variables on the release properties of timed- release press-coated tablets was studied using the Taguchi method of experimental design. Formulations were prepared based on Taguchi orthogonal array design with different types of hydrophilic polymers (X1), varying hydrophilic polymer/ethyl cellulose ratio (X2), and addition of magnesium stearate (X3) as independent variables. The design was quantitatively evalu-ated by best fit mathematical model. The results from the statistical analysis revealed that factor X1, X3 and interaction factors between X1X2 and X1X3 were found to be significant on the re-sponse lag time (Y1), where as only factor X1 was found to be significant on the response percent drug release at 8 hrs (Y2). A numerical optimization technique by desirability function was used to optimize the response variables, each having a different target. Based on the re-sults of optimization study, HPC was identified as the most suitable hydrophilic polymer and incorporation of hydrophobic agent magnesium stearate, could significantly improve the lag time of the timed-release press-coated tablet.展开更多
目的观察耳穴埋豆联合柴术汤治疗2型糖尿病(Type 2 diabetes mellitus,T2DM)伴抑郁患者的临床疗效及对神经内分泌指标的影响。方法选取2019年9月—2020年5月期间石家庄市中医院收治的90例T2DM伴抑郁患者,按简单随机化法分为治疗组、对照...目的观察耳穴埋豆联合柴术汤治疗2型糖尿病(Type 2 diabetes mellitus,T2DM)伴抑郁患者的临床疗效及对神经内分泌指标的影响。方法选取2019年9月—2020年5月期间石家庄市中医院收治的90例T2DM伴抑郁患者,按简单随机化法分为治疗组、对照1组和对照2组,各30例。治疗组采取氟哌噻吨美利曲辛片联合柴术汤、耳穴埋豆,对照1组采取氟哌噻吨美利曲辛片联合柴术汤,对照2组采取氟哌噻吨美利曲辛片。治疗3个月后,比较3组患者治疗效果、中医证候积分(心情抑郁、胸肋胀满、心烦易怒)、汉密尔顿抑郁量表24项(Hamilton depresssion scale-24,HAMD-24)、血糖指标[糖化血红蛋白(Gglycosylated hemoglobin,HbA1c)、空腹血糖(Fasting plasma glucose,FPG)、餐后2 h血糖(2 h blood glucose after meal,2 h PG)]、神经内分泌指标[5-羟色氨酸(5-hydroxytryptamine,5-HT)、多巴胺(Dopamine,DA)、促肾上腺皮质激素(Adrenocorticotrophic hormone,ACTH)]及不良反应情况。结果治疗3个月后,治疗组总有效率93.10%(27/29)高于对照2组55.17%(16/29)、对照1组65.52%(19/29),差异有统计学意义(P<0.05);对照2组和对照1组治疗总有效率比较,差异无统计学意义(P>0.05)。治疗3个月后3组患者中医证候积分及HAMD-24评分均低于治疗前,差异有统计学意义(P<0.05);且治疗组HAMD-24及心情抑郁、心烦易怒、胸肋胀满评分均低于对照2组、对照1组,对照1组低于对照2组,差异有统计学意义(P<0.05)。治疗3个月后3组患者FPG、2 h PG、HbA1c水平均低于治疗前,差异有统计学意义(P<0.05);且治疗组FPG、2 h PG、HbA1c水平均低于对照2组、对照1组,对照1组低于对照2组,差异有统计学意义(P<0.05)。治疗3个月后3组患者5-HT、DA水平均高于治疗前,ACTH水平均低于治疗前,差异有统计学意义(P<0.05);且治疗组5-HT、DA水平均高于对照2组、对照1组,ACTH水平均低于对照2组、对照1组,对照1组5-HT、DA水平均高于对照2组,ACTH水平低于对照2组,差异有统计学意义(P<0.05)。3组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论耳穴埋豆联合柴术汤有利于控制T2DM伴抑郁患者血糖和抑郁,提高治疗效果,且安全性高,机制可能与调节神经内分泌有关。展开更多
文摘We previously determined 'Tableting properties' by using a multi-functional single-punch tablet press(GTP-1). We proposed plotting 'Compactability' on the x-axis against'Manufacturability' on the y-axis to allow visual evaluation of 'Tableting properties'. Various types of tableting failure occur in commercial drug production and are influenced by the amount of lubricant used and the shape of the punch. We used the GTP-1 to measure'Tableting properties' with different amounts of lubricant and compared the results with those of tableting on a commercial rotary tableting machine. Tablets compressed with a small amount of lubricant showed bad 'Manufacturability', leading to sticking of powder on punches.We also tested various punch shapes. The GTP-1 correctly predicted the actual tableting results for all punch shapes. With punches that were more likely to cause tableting failure, our system predicted the effects of lubricant quantity in the tablet formulation and the occurrence of sticking in the rotary tableting machine.
文摘We previously determined "Tableting properties" by using a multi-functional single-punch tablet press(GTP-1). We plotted "Compactability" on the x-axis against "Manufacturability"on the y-axis to allow visual evaluation of "Tableting properties". Here, we examined whether this evaluation method can be used in the formulation design of tablets prepared by wet granulation. We used the GTP-1 to measure "Tableting properties" with different amounts of binder, disintegrant, and lubricant, and compared the results with those of tableting on a commercial rotary tableting machine. Tableting failures(capping and binding in particular) occurred when samples that had been evaluated as having poor "Compactability" or"Manufacturability" on the GTP-1 were compressed on the rotary tableting machine. Thus,our evaluation method predicted tableting failure at the commercial scale. The method will prove useful for scaling up production.
文摘In this investigation, the effect of formulation variables on the release properties of timed- release press-coated tablets was studied using the Taguchi method of experimental design. Formulations were prepared based on Taguchi orthogonal array design with different types of hydrophilic polymers (X1), varying hydrophilic polymer/ethyl cellulose ratio (X2), and addition of magnesium stearate (X3) as independent variables. The design was quantitatively evalu-ated by best fit mathematical model. The results from the statistical analysis revealed that factor X1, X3 and interaction factors between X1X2 and X1X3 were found to be significant on the re-sponse lag time (Y1), where as only factor X1 was found to be significant on the response percent drug release at 8 hrs (Y2). A numerical optimization technique by desirability function was used to optimize the response variables, each having a different target. Based on the re-sults of optimization study, HPC was identified as the most suitable hydrophilic polymer and incorporation of hydrophobic agent magnesium stearate, could significantly improve the lag time of the timed-release press-coated tablet.
文摘目的观察耳穴埋豆联合柴术汤治疗2型糖尿病(Type 2 diabetes mellitus,T2DM)伴抑郁患者的临床疗效及对神经内分泌指标的影响。方法选取2019年9月—2020年5月期间石家庄市中医院收治的90例T2DM伴抑郁患者,按简单随机化法分为治疗组、对照1组和对照2组,各30例。治疗组采取氟哌噻吨美利曲辛片联合柴术汤、耳穴埋豆,对照1组采取氟哌噻吨美利曲辛片联合柴术汤,对照2组采取氟哌噻吨美利曲辛片。治疗3个月后,比较3组患者治疗效果、中医证候积分(心情抑郁、胸肋胀满、心烦易怒)、汉密尔顿抑郁量表24项(Hamilton depresssion scale-24,HAMD-24)、血糖指标[糖化血红蛋白(Gglycosylated hemoglobin,HbA1c)、空腹血糖(Fasting plasma glucose,FPG)、餐后2 h血糖(2 h blood glucose after meal,2 h PG)]、神经内分泌指标[5-羟色氨酸(5-hydroxytryptamine,5-HT)、多巴胺(Dopamine,DA)、促肾上腺皮质激素(Adrenocorticotrophic hormone,ACTH)]及不良反应情况。结果治疗3个月后,治疗组总有效率93.10%(27/29)高于对照2组55.17%(16/29)、对照1组65.52%(19/29),差异有统计学意义(P<0.05);对照2组和对照1组治疗总有效率比较,差异无统计学意义(P>0.05)。治疗3个月后3组患者中医证候积分及HAMD-24评分均低于治疗前,差异有统计学意义(P<0.05);且治疗组HAMD-24及心情抑郁、心烦易怒、胸肋胀满评分均低于对照2组、对照1组,对照1组低于对照2组,差异有统计学意义(P<0.05)。治疗3个月后3组患者FPG、2 h PG、HbA1c水平均低于治疗前,差异有统计学意义(P<0.05);且治疗组FPG、2 h PG、HbA1c水平均低于对照2组、对照1组,对照1组低于对照2组,差异有统计学意义(P<0.05)。治疗3个月后3组患者5-HT、DA水平均高于治疗前,ACTH水平均低于治疗前,差异有统计学意义(P<0.05);且治疗组5-HT、DA水平均高于对照2组、对照1组,ACTH水平均低于对照2组、对照1组,对照1组5-HT、DA水平均高于对照2组,ACTH水平低于对照2组,差异有统计学意义(P<0.05)。3组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论耳穴埋豆联合柴术汤有利于控制T2DM伴抑郁患者血糖和抑郁,提高治疗效果,且安全性高,机制可能与调节神经内分泌有关。
