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目的:探讨盐酸地尔硫缓释片的生产工艺、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定范围内。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 investigate the production technology and stability of diltiazem hydrochloride sustained release tablets and to understand the results of clinical validation studies. Methods: To analyze and compare the factors influencing the release rate in different stages of the process, and then to determine the related process parameters; to investigate the stability of the product stored at room temperature; to observe the clinical efficacy and resistance of this product to light and moderate essential hypertension by using open- By sexual. Results: The product produced more than 20 batches, stored at room temperature for 2 to 3 years, the quality indicators are within the specified range. Clinical validation shows that taking this product once daily dose of 1, the total effective rate of 70.37% step-down; dose of 2, the total effective rate was 88.88%. Conclusion: The production process of this product is feasible and the product quality is stable. It can be satisfied with the blood pressure control once a day and has good tolerance and safety.