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目的:优选小儿咽扁泡腾片最佳制备工艺。方法:以pH值、崩解时限、泡腾时间、口感及硬度作为考察指标,采用正交试验设计法对泡腾片中柠檬酸与碳酸氢钠的配比、聚乙二醇6000的用量、乳糖及甜菊糖的用量进行优化;同时用HPLC法测定泡腾片中绿原酸的含量。结果:最佳处方(1000片)为柠檬酸:碳酸氢钠=50∶50(g∶g),聚乙二醇6000用量为50g,甜菊糖用量为5g。制得泡腾片pH值、崩解时限及硬度等指标均符合规定,口感酸甜适中,有清凉感。结论:该小儿咽扁泡腾片的制备工艺合理、稳定、可靠。
Objective: To optimize the preparation of children pharynx effervescent tablets. Methods: The pH value, disintegration time, effervescence time, taste and hardness were taken as the indexes. The ratio of citric acid to sodium bicarbonate in effervescent tablets, the dosage of PEG 6000, Lactose and stevioside were optimized. Meanwhile, the content of chlorogenic acid in effervescent tablets was determined by HPLC. Results: The best prescription (1000 tablets) is citric acid: sodium bicarbonate = 50:50 (g: g), polyethylene glycol 6000 is 50g, and stevioside is 5g. Effervescent tablets prepared pH, disintegration time and hardness and other indicators are in line with the provisions of moderate sweet and sour taste, a sense of cool. Conclusion: The preparation process of pharyngeal effervescent tablets in children is reasonable, stable and reliable.