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目的:考察丹皮酚片溶出度影响因素,提高其溶出度,从而提高产品质量。方法:通过实验,研究各种参数对丹皮酚片溶出度的影响,选择最佳制备条件,如改进处方、增加粉碎度、控制包衣温度、改变包衣设备等参数,提高片剂溶出度。结果:最优处方所制片剂在10min内崩解,溶出度均在80%以上,符合要求,而工艺因素对溶出度没有明显影响。结论:优选制剂条件制备的丹皮酚片溶出度好。
Objective: To investigate the influencing factors of dissolution of paeonol tablets, improve its dissolution rate and improve product quality. Methods: The effects of various parameters on the dissolution of paeonol tablets were studied through experiments. The best preparation conditions were selected, such as improving the prescription, increasing the degree of grinding, controlling the temperature of the coating, changing the parameters of the coating equipment and improving the dissolution rate . Results: The tablets prepared by the best prescription were disintegrated within 10 min, the dissolution rates were above 80%, which met the requirements, while the process factors had no obvious effect on the dissolution rate. Conclusion: Paeonol tablets prepared by the best preparation conditions have good dissolution rate.