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目的:确定川射干总黄酮片的最佳处方,并研究其稳定性,为其质量标准的制定及包装、贮存提供科学依据。方法:选用PVPP和CMS-Na作为崩解剂,以体外崩解时间为指标,正交试验优化处方,并进行影响因素试验和加速试验,重点考察性状、水分、崩解时限和总黄酮含量的变化。结果:最佳处方为:川射干总黄酮提取物525g,交联聚维酮(PVPP)42g,羧甲基淀粉钠(CMS-Na)10.5g,硬脂酸镁2.625g,压片力为5 kg/cm2,且稳定性良好。结论:本实验所得的处方和工艺可以制备质量稳定的川射干总黄酮片。
OBJECTIVE: To determine the best formulation of total flavonoids tablets of Radix Astragali and to study its stability, providing a scientific basis for the formulation, packaging and storage of its quality standards. Methods: PVPP and CMS-Na were selected as disintegrants. The disintegration time in vitro was used as an index. The orthogonal test was used to optimize the prescription. Influencing factor tests and accelerated tests were conducted. The traits, water content, disintegration time and total flavonoid content Variety. Results: The best prescription was as follows: 525 g of total flavonoids of Radix scutellae, 42 g of PVPP, 10.5 g of sodium carboxymethyl starch (CMS-Na), 2.625 g of magnesium stearate and 5 kg / cm2, and good stability. Conclusion: The prescription and the process obtained in this experiment can be prepared with stable quality Chuan Shegan total flavonoids tablets.