舒筋外洗颗粒质量稳定性研究

目的 考察舒筋外洗颗粒的稳定性,探讨舒筋外洗颗粒的贮存条件,为颗粒剂的内包装材料选择提供依据,确保医院制剂质量稳定.方法 通过影响因素试验,加速试验和长期试验,考察项目包括性状、鉴别、粒度、水分、溶化性,装量差异,微生物限度检查.结果 样品经影响因素试验,加速试验和长期试验,各考察项目均符合规定.结论 舒筋外洗颗粒在现有包装下可于常温条件下密封贮存,有效期12个月内稳定性良好.

Study on the Quality Stability of Shujin Waixi Granules

Objective To investigate the stability and storage conditions of hospital preparations of Shujin Waixi granules, supply proof of choosing inner packing for granules, ensure the stable quality of hospital preparation. Methods Factors affecting test, accelerated test and long-term test, project including character, identification, grain size, moisture, melt, fiUing quantity differences and microbial limit tests. Results Through factors affecting test, accelerated test and long-term test, all the project within the rules. Conclusion Shujin Waixi granules under the existing packaging can be sealed storage at room temperature, valid for 12 months stability is good.