双氯芬酸钠肠溶片片芯处方筛选研究

Study on the Prescription Screening of Diclofenac Sodium Enteric Coated Tablet Core

通过片芯处方筛选研究确定双氯芬酸钠肠溶片片芯处方。以有关物质、溶出度及含量等为技术指标,筛选了填充剂乳糖、玉米淀粉和微晶纤维素的用量,崩解剂交联聚维酮、羧甲淀粉钠的加入方式和用量,及片芯硬度。经筛选拟定的片芯处方放大,体外溶出曲线与原研药一致,并通过全面的质量评价,自研制剂与原研药具有质量一致性。通过高湿、高温、光照等影响因素实验考察,在60℃高温条件下,自研制剂比原研药品更加稳定。最终拟定的双氯芬酸钠肠溶片片芯处方工艺可行,颗粒可压性好,素片完整、光滑、无毛边,薄膜粘附性佳利于包衣,工艺稳定。

The determination of the formulation of diclofenac sodium enteric coated tablets was achieved using the core prescription screening method.Relevant substances,dissolution rate,and content as technical indicators,the dosage of filling agents lactose,corn starch,and microcrystalline cellulose,the addition method and dosage of disintegrating agents cross-linked polyvinylketone,sodium carboxymethyl starch,and core hardness were selected.After screening,the prepared tablet core formula was amplified,and the in vitro dissolution curve was consistent with the original drug.Through comprehensive quality evaluation,the self-developed preparation and the original drug had quality consistency.Through experiments on factors such as high humidity,high temperature,and light exposure,it was found that the self-developed formulation was more stable than the original drug under accelerated stability conditions at 60 C.The final formulation process for diclofenac sodium enteric coated tablets was feasible,with good particle compressibility,intact,smooth,and without burrs.The film adhesion was better than the coating,and the process was stable.