摘要
目的：探讨盐酸地尔硫Zhuo缓释片的生产工艺、稳定性，了解临床验证研究结果。方法：分析比较不同工艺阶段影响释放度的因素，进而确定相关工艺参数；考察产品室温贮存的稳定性；采用开放自身对照试验观察本品对轻、中度原发性高血压的临床疗效和耐受性。结果：本品共生产20多批，室温下贮存2－3年，其各项质量指标均在规范范围内。临床验证表明，每日服用本品1次，剂量为1片，降压总有效率为70．37％；剂量为2片，降压总有效率为88．88％。结论：本品生产工艺可行，产品质量稳定，日服1次能获满意血压控制，有良好的耐受性和安全性。
Objective:To study the production technique, stability and clinical validation on the sustained-release Diltiazem hydrochloride tablets. Methods:The factors affecting the release degree in different technique stages were analyzed and relative parameters were determined. The stability of this product in storage under room temperature was examined, and the clinical curative effect and tolerance of this product for the low-grade and moderate primary hypertension by the opening oneself-contrast test were observed. Results:More than 20 batches of the product were stored under room temperature for 2 to 3 years, the quality indexes of the product were within the fixed limit. The clinical validation showed that 1 tablet once daily, the total effective rate was 70.37%, and 2 tablets once daily, the total errective rate was 88.88%. Conclusion:The production technique of this product is feasible. The quality of this product is stable. To take the tablet once daily, fine result for the control of blood pressure may be observed, and it has fine tolerance and safety.
出处
《上海医药》
CAS
2002年第9期417-419,共3页
Shanghai Medical & Pharmaceutical Journal
关键词
盐酸地尔硫Zhuo缓释片
产业化研究
释放度
生产工艺
稳定性
临床疗效
Diltiazem hydrochloride
sustained release tablets
Release degree
production technique
stability
clinical curative effect
