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目的:优选乳核分散片的处方和制备工艺参数。方法:以崩解时限和片剂外观作为考察指标,采用均匀设计法优选乳核分散片的处方和制备工艺参数。结果:最佳乳核分散片处方为:38%浸膏粉、46%微晶纤维素(MCC)、8%低取代羟丙基纤维素(L-HPC)、4%羧甲基淀粉钠(CMS-Na)、2%交联聚乙烯吡咯烷酮(PVPP)、2%微粉硅胶;优选的分散片处方崩解时间小于3 mim,分散均匀。结论:优选处方合理,工艺可行,所制备的乳核分散片质量符合相关要求。
Objective: To prescribe and prepare process parameters of latex dispersible tablets. Methods: According to the disintegration time limit and tablet appearance, the uniform design method was adopted to prescribe and prepare process parameters of latex dispersible tablets. Results: The best prescription of latex dispersible tablets was: 38% extract powder, 46% microcrystalline cellulose (MCC), 8% low substituted hydroxypropyl cellulose (L-HPC), 4% sodium carboxymethyl starch CMS-Na), 2% cross-linked polyvinylpyrrolidone (PVPP), 2% silica gel; the preferred dispersible tablets prescription disintegration time less than 3 mim, evenly dispersed. Conclusion: The prescription is reasonable and the technology is feasible. The quality of the dispersible tablets prepared meets the relevant requirements.