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目的：针对高血压、心绞痛常在凌晨发作的特点，研制夜间服药、凌晨释放的维拉帕米（ＶＲ）脉冲控释片。方法：全面考察影响药物释放滞后时间的因素。选用３种强崩解剂的不同用量，考察片芯崩解剂对时滞的影响。通过均匀设计实验考察外层包衣的组成和片剂的硬度，多元回归筛选最优处方，并考察不同溶出条件对控释效果的影响。结果：片芯所用的３种崩解剂以羧甲基淀粉钠的崩解性能较好，用量设计在２５％左右。外层包衣处方中ＰＥＧ６０００增加，氢化蓖麻油（ＨＣＯ）、乙烯－醋酸乙烯共聚物（ＥＶＡ）用量减少，硬度减小，释放滞后时间减少。由此确定释放滞后时间为３和５ｈ的两个基本处方。结论：ＶＲ压制包衣片在体外溶出实验中能实现脉冲释药，并能通过调节辅料用量实现不同控释效果。
Objective: To study the characteristics of hypertension and angina pectoris often occurring in the early morning, and to develop verapamil (VR) pulse controlled release tablets which were taken at night and released in the early morning. Methods: A comprehensive examination of the factors that affect the lag time of drug release. Choose three kinds of strong disintegrant of different dosage, examine the core tablet disintegrator on the lag effect. The composition of the outer coating and the hardness of the tablets were investigated through uniform design experiments. The optimal prescriptions were screened by multiple regression analysis and the effects of different dissolution conditions on the controlled release were investigated. Results: The three kinds of disintegrants used in tablet cores had good disintegration properties of sodium carboxymethyl starch and the dosage was designed at about 25%. PEG6000 increased in the outer coating prescription, the amount of hydrogenated castor oil (HCO) and ethylene-vinyl acetate copolymer (EVA) decreased, the hardness decreased, and the release lag time decreased. From this it is determined that two basic prescriptions with lag times of 3 and 5h are released. CONCLUSION: The VR-coated tablets can achieve pulse release in in vitro dissolution experiments and achieve different controlled-release effects by adjusting the dosage of adjuvants.