小剂量氢氯噻嗪肠溶片的制备及体外释放度测定

The preparation and the release in vitro determination of small dosage of hydrochlorothiazide enteric-coated tablets

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 Manufacturing small dosage of hydrochlorothiazide enteric-coated tablets and determining its release in vitro.Method Choosing condign accessories to manufacture hydrochlorothiazide tablets,and selecting the model No.II acrylic acid polymers as enteric-coating material to produce enteric-coated tablets,and then,mensurating the contains and the release rate of hydrochlorothiazide enteric-coated tablets with the uv-speetrophotometric method.Result The manufactured enteric-coated tablets,when its coating gains 6% weight and has the rotational speed between 20 and 30 r/min,and the heat-treatment time reaches 2h,don＇t split and collapse in the hydrochloric acid solution,furthermore,its release rate in the sodium diphosphate solution meets the standard of the chinese pharmacopoeia 2005 edition.Conclusion This technics,introduced to produce the hydrochlorothiazide enteric-coated tablets,is practical and has great reproducibility,moreover,when the produced enteric-coated tablets are put in the hydrochloric acid solution or sodium diphosphate solution,its release rate is up to the standard of the chinese pharmacopoeia 2005 edition.