目的 評價單面帶刻痕的格列喹酮片的分劑量藥學特性。方法 分別采用切藥器和手工對自研品和參比制劑進行分割，以分割前后質量損失為評價指標，考察自研品和參比制劑的可分割性；取在硬度上限（8 kg）和下限（4 kg）處的自研格列喹酮片分別用切藥器分割后，考察分割質量損失；按照《中國藥典》2020年版片劑脆碎度檢查法研究分割后的片劑脆碎度；參考《歐洲藥典》，隨機取30片，分割后檢測單一半片占半片平均片質量百分比；高效液相色譜法測定格列喹酮整片、半片在pH 8.5磷酸鹽緩沖液中的溶出曲線；參照《中國藥典》含量均勻度檢查法（通則0941），對切藥器分割后的30片自研品進行含量均勻度測定。結果 質量損失結果表明手工分割和切藥器分割無顯著性差異；硬度上限與下限時片劑分割后的脆碎度和質量損失均符合要求；分割后片劑質量差異、脆碎度和含量均勻度均符合藥典要求；自研品與參比制劑的半片溶出行為一致；與整片溶出量相比，分割后的自研品60 min溶出量為51.46%，參比制劑為49.12%。結論 自研品和參比制劑分割后的藥學特性相同。

Objective To evaluate the pharmaceutical properties of scored gliquidone tablets. Methods The self-developed product and reference preparation were segmented by cutting device and by hand, respectively. The quality loss before and after segmentation was taken as the evaluation index to investigate the separability of the self-developed product and reference preparation. Gliquidone tablets at the upper limit of hardness (8 kg) and lower limit of hardness (4 kg) were divided with drug cutters respectively, and the loss of segmentation quality was investigated. The fragility of tablets after segmentation was studied according to the test method of fragility of tablets of Chinese Pharmacopoeia 2020 edition. Referring to the European Pharmacopoeia, 30 tablets were randomly selected. After segmentation, the weight percentage of single half tablet to average half tablet was detected. The dissolution curves of the whole tablet and half tablet of gliquidone in phosphate buffer solution with pH 8.5 were detected by HPLC. According to the content uniformity test method of Chinese Pharmacopoeia (general rule 0941), the content uniformity of 30 self-developed tablets after drug cutter segmentation was detected. Results The results of loss of mass and uniformity of dosage units showed that there was no significant difference between splitting by hand and by the tablet splitter. The content uniformity and friability of the split tablet were in line with the requirements of Chinese Pharmacopoeia. The friability and loss of mass of the split tablet at the upper and lower limits of hardness were in line with the requirements. The generic drug product and the reference listed drug had the same half-tablet dissolution behavior. Compared with the whole-tablet dissolution, the dissolution of the split generic drug product was 51.46% in 60 minutes, and the split reference listed drug was 49.12%. Conclusion The pharmaceutical properties of the split generic drug product were the same as the split reference listed drug.

R927.11

天津市科技計劃項目（19ZXYXSY00120）