葛根素脉冲胶囊的制备及影响释药时滞的因素研究

PREPARATION OF PUERARIN PULSE CAPSULES AND THE FACTORS AFFECTING DRUG RELEASE DELAY

目的制备葛根素脉冲胶囊,并对影响释药时滞的因素进行研究。方法采用灌注法制备不溶性囊壳体,滴制法制备葛根素滴丸,湿法制粒压片法压制柱塞片,将其组装成柱塞型胶囊,考察影响释药时滞的各种因素,评价其体外释药行为。结果柱塞片的乳糖与HPMC_(K15M)质量比为30%,片重为80 mg,硬度为65 N,Φ为6.0 mm,可满足葛根素脉冲胶囊释药时滞5 h的设计要求。结论通过调节柱塞片中乳糖-HPMC_(K15M)质量比、片重、硬度及片茎等因素可获得具有适当释药时滞的脉冲胶囊。

Objective:To prepare puerarin pulse capsules and study the factors that affect the release delay.Methods:The insoluble capsules were prepared by infusion method,puerarin dripping pills were prepared by dripping method,plunger tablets were compressed by wet granulation and tableting method,and assembled into plunger-type capsules.Various factors affecting drug release time lag were investigated and evaluated.Results:The mass ratio of lactose to HPMCK15M of the plunger tablet was 30%,the tablet weight was 80 mg,the hardness was 65 N,and the Φ was 6.0 mm,which could meet the design requirements of the puerarin pulse capsule with a drug release delay of 5 hours.Conclusion:By adjusting the prescription composition and tablet weight of plunger tablets,pulsed capsules with appropriate release time lag can be obtained.