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目的:选用高分子材料制备复方丹参(CD)脉冲控释片,并进行体外释放度考察。方法:采用干包衣控释法制备CD脉冲控释片,应用HPLC法进行体外释放度考察。结果:HPMC用量或黏度增大,释药时滞延长;稀释剂用量增大,释药时滞缩短;在包衣处方组成比例不变的情况下,包衣层用量增加,释药时滞延长。结论:CD脉冲控释片能实现体外定时脉冲释药,并可通过调整处方实现不同时滞的控释效果。
Objective: To prepare the compound Danshen (CD) pulsed controlled release tablets with polymer materials and investigate the in vitro release. Methods: CD pulsed controlled release tablets were prepared by dry coating controlled release method. The in vitro release rate was investigated by HPLC method. Results: The dosage or viscosity of HPMC increased, the delay of drug release prolonged, the dosage of diluent increased, and the delay of drug release shortened. When the proportion of coating composition was the same, the dosage of coating increased and the delay of drug release prolonged . Conclusion: The CD pulsed controlled release tablet can release the sustained release drug in time and adjust the prescription to achieve controlled release with different time delay.