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目的:采用正交试验筛选金莲花分散片的处方和制备工艺。方法:以微晶纤维素(A)、低取代羟丙基纤维素(B)、交联聚维酮(C)及微粉硅胶(D)的用量为考察因素,以崩解时限为评价指标,进行正交试验,确定最佳处方;用HPLC对分散片进行质量控制。结果:当加入30%A,5%B,8%C及8%D制备的金莲花分散片剂外观光洁、口感良好、平均崩解时间为80 s,分散均匀性符合规定。分散片含荭草苷的量为16.02 mg/片,15 min溶出量达到90%以上。结论:按优选处方和工艺制得的金莲花分散片,具有一定硬度,遇水迅速崩解并均匀分散,质量可控,满足速释的要求。
Objective: To use orthogonal test to screen the prescription and preparation technology of Trollius Chinensis dispersible tablets. Methods: Taking the amount of microcrystalline cellulose (A), low-substituted hydroxypropyl cellulose (B), crospovidone (C) and silica powder (D) as the investigation factors and the disintegration time as the evaluation index, The orthogonal test was carried out to determine the best prescription. The quality control of dispersible tablets was carried out by HPLC. Results: When adding 30% A, 5% B, 8% C and 8% D, the golden lotus dispersible tablets showed smooth appearance and good mouthfeel with an average disintegration time of 80 s, and the dispersion uniformity was within the prescribed range. Dispersible tablets containing tyloside amount of 16.02 mg / tablet, 15 min dissolution rate of more than 90%. Conclusion: According to the prescription and technology, the Golden Lotus dispersible tablets have a certain degree of hardness, quickly disintegrate and disperse uniformly with water, and the quality can be controlled to meet the requirements of immediate release.