陕西市售国产头孢克洛口服制剂质量评价

Quality Evaluation of Domestic Cefaclor Oral Preparations Sold in Shaanxi Province

目的评价市售国产头孢克洛口服制剂的质量。方法结合现行质量标准,建立头孢克洛有关物质的检查方法并给出各杂质限度参考值,同时对颗粒剂进行有关物质检查,综合评价产品质量及现行质量标准对产品质量的可控性。结果市售国产头孢克洛口服制剂质量良好;各生产企业产品虽有差异,但质量基本保持在良好水平;现行质量标准基本可行。结论市售国产头孢克洛口服制剂质量总体良好,但颗粒剂质控标准仍需进一步完善。

Objective To evaluate the quality of domestic and marketed cefaclor oral preparations. Methods According to the current quality standards,the inspection methods of cefaclor related substances were established and the reference values of impurity limits were showed. At the same time,the related substances of granules were checked to comprehensively evaluate the quality of products and the controllability of the current quality standards for quality of products. Results The domestic and marketed cefaclor oral preparations had good quality. Although the products from various production enterprises were different,the quality was basically maintained at a good level. The quality standards were basically feasible. Conclusion The quality of domestic and marketed cefaclor oral preparations is generally good,but the quality standard of granules needs to be further improved.