包装材料与几种中成药卫生学质量稳定性考察  

Investigation of Hygienic Stability for Packing Meterial and Several Traditional Materia Medica

作　　者：吴晓玲[1] 李春蓉[1] 刘晓玲[1] 

机构地区：[1]福建省药品检验所,福州市350001

出　　处：《中国药师》2003年第3期147-148,共2页China Pharmacist

摘　　要：目的:通过几种中成药药物相容性试验对其卫生学稳定性进行考察。方法:按中国药典2000年版“药物稳定性试验指导原则”的要求采用加速试验法。结果:5种不同包装材料中成药卫生学指标均符合规定,但随着放置时间的延长,同一品种、同包装材料、同批次药品的细菌数逐渐减少。结论:考察5种中成药卫生学质量基本稳定,中成药卫生学稳定性试验符合规定。Objective: To investigate the hygienic stability of packing meterial and some kinds of Traditional Materia Medica (TMM)by a pharmacy by the pharmaceutical compatibilizing tests. Method: A accelerated test was used according to 'the Guiding Principle of Pharmaceutical stability Test' of 'Chinese Pharmacopoeia', 2000 ed. Result: All the hygienic indicators of the five types of the testing TMM with the different packing materials in accordance with the requirement. However, the number of bacterium of the same kind, the same packing meterial and same batch will be decreased gradually along with the prolonged time. Conclusion: The hygienic quality of the five types of TMM was primarily stable. The pharmaceutical compatibility test showed that the hygienic stabilities in accordance with the requirement.

关 键 词：包装材料 中成药 卫生学 质量 稳定性 考察 

分 类 号：R286[医药卫生—中药学]