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以 DL-聚乳酸(PLA)为囊材,醋炔诺酮肟(NAO)为主药的微球,可望作为长效避孕注射剂。由于 PLA 的玻璃化温度(T_g)较低,该微球不能采用一般的加热灭菌方法。本文采用10和25kGy 的两种~(60)Co辐照剂量对微球灭菌。对灭菌效果、NAO 和 PLA 以及微球灭菌前后的理化特性和体外释药速率等的比较,表明辐照剂量以10kGy 为宜。
The microspheres with DL-polylactic acid (PLA) as the capsule material and acetoxynil-oxime (NAO) as the main drug are expected to be used as long-acting contraceptive injection. Due to the lower glass transition temperature (T_g) of PLA, the microspheres can not be heat-sterilized in general. The microspheres were sterilized with two doses of 60Co at 10 and 25 kGy. Comparison of the sterilization effect, the physico-chemical properties of NAO and PLA before and after sterilization, and the in vitro release rate of the microspheres showed that the radiation dose should be 10 kGy.