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目的:制备双氯芬酸钠控释片,并对其药物释放机制进行了研究。方法:采用硬脂酸和乙基纤维为释放阻滞剂,以羧甲基淀粉钠等为崩解剂,制粒干燥后制备控释片,根据中国药典1995年版所载的溶出方法测定其释放度。结果:所制备的控释片在t0.9之前的释放为零级动力学过程;片剂中主药含量(在35%~60%范围内)、片剂形状及硬度(5~10kg)等对该控释片的药物溶出无明显影响。结论:改变该控释片中崩解剂或阻滞剂用量均可改变其药物释放的t1/2。
OBJECTIVE: To prepare diclofenac sodium controlled release tablets and study its drug release mechanism. Methods: Stearic acid and ethyl cellulose were used as releasing blockers, sodium carboxymethyl starch as disintegrating agent, granulated and dried to prepare controlled release tablets. The release tablets were determined according to the dissolution method of Chinese Pharmacopoeia 1995 edition degree. Results: The release of controlled release tablets before t0.9 was zero-order kinetics. The main drug content (within the range of 35% ~ 60%), tablet shape and hardness (5 ~ 10kg) and so on The controlled release tablets of drug dissolution no significant effect. Conclusion: Changing the amount of disintegrant or retarder in the controlled release tablets can change t1 / 2 of drug release.