Omeprazole is a potent proton pump inhibitor with powerful inhibition of secretion of gastric juice. Oral site-specific drug delivery systems have recently attracted a great interest for the local treatment of bowel d...Omeprazole is a potent proton pump inhibitor with powerful inhibition of secretion of gastric juice. Oral site-specific drug delivery systems have recently attracted a great interest for the local treatment of bowel disease and for improving systemic absorption of drugs which are unstable in the stomach. However, microenvironment in the gastrointestinal tract and varying absorption mechanisms cause hindrance for the formulation and optimization of oral drug delivery. The objective of the study was to develop and optimize enteric coating process for omeprazole tablets. Different batches of core tablets were sub coated, one set sub coated with opadry and another with a mixture of light magnesium oxide, magnesium stearate and absolute alcohol omeprazole magnesium. Seal coating was applied by using opadry to achieve certain weight gain and to protect omeprazole from acidic coating polymers. A comparative dissolution test was performed. The variation of thickness and diameter were observed to be minimal with a weight gain of 3% - 4% of enteric polymer. Disintegration test showed that in each tested batch the enteric coated layer remained intact in 0.1N HCl for 2 hours and when exposed to alkaline media of phosphate buffer pH 6.8, it dissolved within few minutes. Dissolution release was 98.8% to 102.4% within two hours when the product was exposed to phosphate buffer pH 6.8 after 2 hours. The similarity and dis-similarity factors were calculated and observed to be 54 to 61 and 4 to 5 respectively. Therefore a simple and good enteric coating process was developed and tested with potential for transfer this technology into local pharmaceutical industries using cheap and easily available materials.展开更多
目的观察和胃降逆止嗽方治疗胃食管反流性咳嗽(胃气上逆证)临床效果。方法96例胃食管反流性咳嗽(胃气上逆证)患者按照随机数字表法分为对照组和观察组各48例。对照组采用调整生活方式联合常规西药治疗,观察组采用调整生活方式联合和胃...目的观察和胃降逆止嗽方治疗胃食管反流性咳嗽(胃气上逆证)临床效果。方法96例胃食管反流性咳嗽(胃气上逆证)患者按照随机数字表法分为对照组和观察组各48例。对照组采用调整生活方式联合常规西药治疗,观察组采用调整生活方式联合和胃降逆止嗽方治疗。治疗12周后,评价两组中医证候积分(阵发性咳嗽、咳嗽时泛酸水、嘈杂、上腹不适)、莱塞斯特咳嗽生命质量问卷(lesser cough quality of life questionnaire,LCQ)评分、反流性疾病问卷(reflux disease questionnaire,RDQ)评分、食管运动功能(食管收缩波幅、食管蠕动波传导速度、平均收缩持续时间)、临床治疗效果、疾病复发概率以及治疗安全性。结果比较发现观察组治疗有效率明显高于对照组,对比有统计学差异;对比两组患者治疗后出现阵发性咳嗽等临床症状的概率,发现患者RDQ评分均有下降,但是观察组评分下降较为明显(P<0.05)。两组治疗后LCQ评分均升高(P<0.05),且观察组LCQ评分高于对照组(P<0.05)。治疗后,发现两组患者食管收缩波幅、食管蠕动波传导速度都出现了升高的情况(P<0.05),持续收缩时间明显缩短(P<0.05),且观察组食管运动功能指标改善情况都高于对照组,两组患者对比有统计学差异P<0.05,观察组3个月复发率和治疗后6个月复发率都较低,分别低于对照组3个月复发率(16.67%)和治疗后6个月的复发率(39.58%)(P<0.05)。治疗期间两组患者不良反应发生率相比无统计学意义。结论和胃降逆止嗽方可以有效缓解患者临床症状,同时,还能够促进患者食管运动,减少临床复发,改善生活质量,且治疗安全性高。展开更多
文摘Omeprazole is a potent proton pump inhibitor with powerful inhibition of secretion of gastric juice. Oral site-specific drug delivery systems have recently attracted a great interest for the local treatment of bowel disease and for improving systemic absorption of drugs which are unstable in the stomach. However, microenvironment in the gastrointestinal tract and varying absorption mechanisms cause hindrance for the formulation and optimization of oral drug delivery. The objective of the study was to develop and optimize enteric coating process for omeprazole tablets. Different batches of core tablets were sub coated, one set sub coated with opadry and another with a mixture of light magnesium oxide, magnesium stearate and absolute alcohol omeprazole magnesium. Seal coating was applied by using opadry to achieve certain weight gain and to protect omeprazole from acidic coating polymers. A comparative dissolution test was performed. The variation of thickness and diameter were observed to be minimal with a weight gain of 3% - 4% of enteric polymer. Disintegration test showed that in each tested batch the enteric coated layer remained intact in 0.1N HCl for 2 hours and when exposed to alkaline media of phosphate buffer pH 6.8, it dissolved within few minutes. Dissolution release was 98.8% to 102.4% within two hours when the product was exposed to phosphate buffer pH 6.8 after 2 hours. The similarity and dis-similarity factors were calculated and observed to be 54 to 61 and 4 to 5 respectively. Therefore a simple and good enteric coating process was developed and tested with potential for transfer this technology into local pharmaceutical industries using cheap and easily available materials.
文摘目的观察和胃降逆止嗽方治疗胃食管反流性咳嗽(胃气上逆证)临床效果。方法96例胃食管反流性咳嗽(胃气上逆证)患者按照随机数字表法分为对照组和观察组各48例。对照组采用调整生活方式联合常规西药治疗,观察组采用调整生活方式联合和胃降逆止嗽方治疗。治疗12周后,评价两组中医证候积分(阵发性咳嗽、咳嗽时泛酸水、嘈杂、上腹不适)、莱塞斯特咳嗽生命质量问卷(lesser cough quality of life questionnaire,LCQ)评分、反流性疾病问卷(reflux disease questionnaire,RDQ)评分、食管运动功能(食管收缩波幅、食管蠕动波传导速度、平均收缩持续时间)、临床治疗效果、疾病复发概率以及治疗安全性。结果比较发现观察组治疗有效率明显高于对照组,对比有统计学差异;对比两组患者治疗后出现阵发性咳嗽等临床症状的概率,发现患者RDQ评分均有下降,但是观察组评分下降较为明显(P<0.05)。两组治疗后LCQ评分均升高(P<0.05),且观察组LCQ评分高于对照组(P<0.05)。治疗后,发现两组患者食管收缩波幅、食管蠕动波传导速度都出现了升高的情况(P<0.05),持续收缩时间明显缩短(P<0.05),且观察组食管运动功能指标改善情况都高于对照组,两组患者对比有统计学差异P<0.05,观察组3个月复发率和治疗后6个月复发率都较低,分别低于对照组3个月复发率(16.67%)和治疗后6个月的复发率(39.58%)(P<0.05)。治疗期间两组患者不良反应发生率相比无统计学意义。结论和胃降逆止嗽方可以有效缓解患者临床症状,同时,还能够促进患者食管运动,减少临床复发,改善生活质量,且治疗安全性高。
