格列喹酮片的分剂量评价

目的 评价单面带刻痕的格列喹酮片的分剂量药学特性。方法 分别采用切药器和手工对自研品和参比制剂进行分割，以分割前后质量损失为评价指标，考察自研品和参比制剂的可分割性；取在硬度上限（8 kg）和下限（4 kg）处的自研格列喹酮片分别用切药器分割后，考察分割质量损失；按照《中国药典》2020年版片剂脆碎度检查法研究分割后的片剂脆碎度；参考《欧洲药典》，随机取30片，分割后检测单一半片占半片平均片质量百分比；高效液相色谱法测定格列喹酮整片、半片在pH 8.5磷酸盐缓冲液中的溶出曲线；参照《中国药典》含量均匀度检查法（通则0941），对切药器分割后的30片自研品进行含量均匀度测定。结果 质量损失结果表明手工分割和切药器分割无显著性差异；硬度上限与下限时片剂分割后的脆碎度和质量损失均符合要求；分割后片剂质量差异、脆碎度和含量均匀度均符合药典要求；自研品与参比制剂的半片溶出行为一致；与整片溶出量相比，分割后的自研品60 min溶出量为51.46%，参比制剂为49.12%。结论 自研品和参比制剂分割后的药学特性相同。

Evaluation of divided dose of scored gliquidone tablets

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.