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目的:研制与上市品具有相似体外溶出的复方缬沙坦/苯磺酸氨氯地平片。方法:采用湿法制粒压片工艺制备自制品,通过单因素试验初步筛选处方,中心复合设计优化处方。比较不同pH溶出介质(pH 1.2盐酸、pH 4.5乙酸缓冲液和0.1%聚山梨酯80-pH 6.8磷酸缓冲液)中自制品与市售复方片的溶出行为,通过相似因子f2计算,评价2种药物体外溶出的相似性。结果:与市售片比较,以优化处方制备的复方片中缬沙坦和苯磺酸氨氯地平在不同pH值溶出介质中的溶出度相似因子f 2均>50。结论:自制的复方片与市售片体外溶出行为相似。
OBJECTIVE: To develop a compound valsartan / amlodipine besylate tablet with similar in vitro dissolution as the listed product. Methods: The wet granulation and tabletting process were used to prepare self-made products. The single-factor test was used to screen the prescriptions and the central composite design was optimized. The dissolution behavior of self-made and commercial compound tablets in different pH dissolution media (pH 1.2 hydrochloric acid, pH 4.5 acetate buffer and 0.1% polysorbate 80-pH 6.8 phosphate buffer) was compared. Two compounds were evaluated by similarity factor f2 Dissolution of drugs in vitro similarities. Results: Compared with the commercial tablets, the dissolution factors of valsartan and amlodipine besilate in different pH dissolution media were> 50. Conclusion: Self-made compound tablets have similar dissolution behavior in vitro and in vivo.