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目的制备小剂量氢氯噻嗪肠溶片,并对其体外释放度进行测定。方法选用适宜的辅料制备氢氯噻嗪片芯,用Ⅱ号丙烯酸树脂为肠溶包衣材料制备肠溶片,采用紫外分光光度法测定氢氯噻嗪肠溶片的含量和释放度。结果在包衣增重6%,包衣转速20～30r/min,热处理时间为2小时时,制备的肠溶衣在盐酸溶液中2小时不裂片不崩解,在磷酸钠缓冲液中释放度符合2005版中国药典要求。结论采用该工艺制备氢氯噻嗪肠溶片,方法可行,重现性好,制备的肠溶片在盐酸溶液中和磷酸缓冲液中的释放度符合2005版中国药典标准。
Objective To prepare low-dose hydrochlorothiazide enteric-coated tablets and determine its in vitro release. Methods The suitable excipients were used to prepare hydrochlorothiazide tablets core. The enteric coating tablets were prepared by using Ⅱ acrylic resin as enteric coating material. The content and release of hydrochlorothiazide enteric-coated tablets were determined by UV spectrophotometry. Results In the coating weight gain of 6%, the coating speed of 20 ~ 30r / min, heat treatment time of 2 hours, the enteric coating prepared in hydrochloric acid solution 2 hours without rupture does not disintegrate in sodium phosphate buffer release In line with 2005 Chinese Pharmacopoeia requirements. Conclusion The preparation of hydrochlorothiazide enteric-coated tablets by this method is feasible and reproducible. The release of prepared enteric-coated tablets in hydrochloric acid solution and phosphate buffer conforms to the 2005 edition of Chinese Pharmacopoeia.