10种外用制剂的质量稳定性监测

Monitoring of Quality Stability of 10 Preparation for External Application

目的监测10种外用制剂的质量稳定性,为制定有效期提供依据,并据此采取措施,提高制剂质量。方法选取本中心10种外用制剂,对其外观性状、含量测定、微生物限度等项目进行8~12 m的稳定性监测。结果10种制剂在有效期内各项检查均符合规定;同时也考察到部分制剂稳定性欠佳。结论1~7号制剂质量稳定可延长有效期至1 y,8~10号制剂需采取措施提高质量稳定性。

Objective To monitor the quality stability of 10 preparations for external application,so as to provide reference for the establishing the validity of the preparation,and to improve its quality. Methods A total of 10 preparations that made by Guangdong provincial centre for skin disease and STD control were choosen.The stability of their appearance,character,content,microbiology limit in 8~12 m was detected.Results All those 10 preparations were in accordance with requirements,but some of preparations′ stability were not good enough.Conclusion All preparations were qualified.The validity of No.1~7 can prolong to 1 y,while the stability of No.8~10 should be further improvd.