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目的考察欣泰胶囊的稳定性。方法根据《中药、天然药物稳定性研究技术指导原则》和相关要求,分别对3批中试样品进行了24个月长期稳定性试验与6个月的加速稳定性试验考察。结果性状、鉴别、水分、崩解时限、含量测定、微生物限度检查这些考察项目均符合该品种质量标准草案和《中国药典》2010年版一部的相关规定,并且考察结果与零月比较均无明显变化。结论欣泰胶囊稳定性良好,目前所采用的铝塑泡罩包装能保证产品的内在质量。
Objective To investigate the stability of Xintai capsules. Methods According to the Technical Guidelines for the Study of Stability of Traditional Chinese Medicine and Natural Medicine and the related requirements, the long-term stability test of 24 months and the accelerated stability test of 6 months were conducted on three batches of pilot samples. Results traits, identification, moisture, disintegration time limit, content determination, microbial limit inspection of these projects are in line with the draft quality standards and the Chinese Pharmacopoeia 2010 edition of a relevant provisions, and the findings were no significant compared with the zero month Variety. Conclusion Xintai capsule stability is good, the current use of aluminum-plastic blister packaging can guarantee the intrinsic quality of the product.