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目的:确定北豆根总碱分散片的处方并考察其稳定性。方法:采用单因素考察和正交实验法,确定北豆根总碱分散片的处方;同时制备3批样品,进行质量考察和稳定性实验。结果:优化后的处方可以满足《中国药典》对分散片体外溶出结果的要求。结论:该分散片制剂制备工艺简单易行,适合工业化生产。
OBJECTIVE: To determine the prescription of total alkaloids dispersible tablets and investigate its stability. Methods: Single factor test and orthogonal experiment were used to determine the prescription of total alkaloids dispersible tablets of Radix et Rhizoma. At the same time, three batches of samples were prepared for quality inspection and stability experiment. Results: The optimized prescription can meet the requirements of “Chinese Pharmacopoeia” for the in vitro dissolution results of dispersible tablets. Conclusion: The dispersible tablet preparation process is simple and easy, suitable for industrial production.