论文部分内容阅读
目的:采用多元定时释药技术制备复方中药舒胸缓释制剂。方法:将处方药材精制后的制备成舒胸微丸,使用流化床包衣设备,先以一定比例的羧丙基甲基纤维素(HPMC)、十二烷基硫酸钠(SDS)分别与低取代羟丙基纤维索(L-HPC)配成包衣液进行包衣作为溶胀层,然后以乙基纤维素水分散体(Surelease)进行包衣作为控释层,制备包衣微丸。等量称取控释层包衣增重分别为0%、9%、15%、18%和20%的包衣微丸,混合均匀,装入硬胶囊中,即得舒胸缓释胶囊。结果:当溶胀层处方及用量固定后。通过控制控释层的厚度,可使包衣微丸在预期的不同时间定时释药。将几种控释层增重不同的包衣微丸混合后制成舒胸缓释胶囊,在溶出介质中,各种包衣微丸可以在不同时间依次释药,从而在整体上呈现出一种缓释特征。在模拟人体胃肠道pH变化条件下,舒胸缓释胶囊中红花黄色素和三七总皂苷体外释放的?2值为90.1,红花黄色素和阿魏酸的?2值为77.3,三七总皂苷与阿魏酸的?2值为87.0,表明三者的释放度差异无显著性,而且均呈现出明显的缓释特征。结论:采用定时释药技术制备而成的复方中药舒胸缓释微丸制剂中理化性质不同的各成分在缓释的同时可以达到同步释放,遵循了中药制剂复方配伍的整体观和用药思想。
OBJECTIVE: To prepare compound Chinese medicine Shuxiong sustained-release preparation by using multiple time-release techniques. Methods: After the prescription herbs were refined, they were prepared into the thoracoabdominal pellets by using the fluidized bed coating equipment. First, a certain proportion of hydroxypropyl methylcellulose (HPMC) and sodium dodecyl sulfate (SDS) The coated pellets were prepared by coating with a low-substituted hydroxypropylcellulose cord (L-HPC) coating solution as a swollen layer and then coating with Surelease as a controlled release layer. Weigh the same amount of controlled-release coating weight gain were 0%, 9%, 15%, 18% and 20% of the coated pellets, mixed, filled into hard capsules, namely Shuxiong sustained-release capsules. Results: When the swelling layer prescription and the amount of fixed. By controlling the thickness of the controlled release layer, the coated pellets can be periodically released at different expected times. In the dissolution medium, various coated pellets can be sequentially dispensed at different times, so as to show a whole Slow release characteristics. In simulated human gastrointestinal pH changes under conditions, Shu Cheung sustained release capsules in safflower yellow and notoginseng saponins in vitro release? 2 value of 90.1, safflower yellow and ferulic acid? 2 value of 77.3, Panax notoginseng saponins and ferulic acid? 2 value of 87.0, indicating no significant difference in the release of the three, and showed a sustained release characteristics. CONCLUSIONS: The components with different physicochemical properties in the preparation of compound traditional Chinese medicine Shuxiong sustained-release pellets prepared by the timed release technique can achieve simultaneous release with sustained release, and follow the holistic concept and medication idea of compound compatibility of traditional Chinese medicine preparations.