黄芩苷泡腾片制备工艺研究

Study on the preparation of Baicalin Effervescent Tablets

目的优选黄芩苷泡腾片的制备工艺和处方,并进行该制剂的质量考察。方法采用多指标综合评价法和正交实验法筛选黄芩苷泡腾片的制备工艺与处方辅料,并考察了制剂的稳定性。结果最优制备工艺为酸碱分别制粒法;最优处方为PEG6000的质量分数为5%,黄芩苷的质量分数为40%,酸碱总量的质量分数为45%,酸碱比为1∶3,甘露醇的质量分数为10%,黄芩苷泡腾片应避光密封保存在阴凉干燥处。结论制得的黄芩苷泡腾片质量符合《中国药典》规定,具有一定的推广价值。

To optimize the prescription, preparation and quality inspection of Baicalin Effervescent Tablets. Themulti-index comprehensive evaluation method and orthogonal experiment method were used to screen the prescription and prepara-tion of Baicalin Effervescent Tablets. The stability of the preparation was investigated. The optimal prescription was as fol-lows： mass fraction 5% PEG 6000, baicalin mass fraction 40 %, 45 % mass fraction of total acid and alkali, acid and alkali ratio of 1 ： 3, mannitol, the mass fraction of 10%. The Baicalin Effervescent Tablets should be prepared avoid light and should be stored in a cool and dry place. The quality of the prepared Baicalin Effervescent Tablets conformed with the requirement ofChinese Pharmacopoeia.