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目的 :考察影响盐酸维拉帕米脉冲片控时效果的因素。方法 :通过体外溶出的方法考察脉冲控释片的时滞 ,主要包括溶出条件和处方因素两方面。结果 :介质的酸碱度不影响制剂的控时效果 ;转速不影响制剂起崩时间 ,但对溶出速度有一定的影响 ;粘度越大的介质 ,释药时滞也越大。包衣用量增加、控时层中亲水性成分PEG 60 0 0含量减小、控时层中PEG类型的分子量的增加 ,均能使药物释放滞后时间明显增大 ;包衣颗粒大小对控时效果基本没有影响。结论 :溶出条件作用因素的考察为进一步的体内研究奠定了基础 ;处方因素的考察为制剂的时滞调控和释药特征研究作了准备
Objective: To investigate the factors affecting the effect of verapamil hydrochloride pulse sheet. Methods: The delay of pulse controlled release tablets was investigated by in vitro dissolution method, including dissolution conditions and prescription factors. Results: The pH value of the medium did not affect the time-controlled effect of the preparation. The rotation speed did not affect the onset time of the preparation but had a certain influence on the dissolution rate. The larger the viscosity medium was, the longer the release delay was. The amount of coating increased, when the control layer hydrophilic PEG 60 0 0 content decreases, the control layer PEG type molecular weight increase, can make the drug release lag time significantly increased; coated particle size of the control The effect is basically no effect. Conclusion: The investigation of factors influencing dissolution conditions lays the foundation for further study in vivo. The study of prescription factors prepares for the study of time-lag control and drug release characteristics