止血镇痛散的生产工艺参数与稳定性研究

Studies on the Process and Quality Standard of Zhixuezhentong Powder

目的研究止血镇痛散的生产工艺及稳定性。方法通过测定内容物的临界相对湿度、休止角、堆密度等确定该制剂的成型工艺。考察本品在高温、高湿度、强光照射条件下性状、水分及主成分含量的变化。结果温度、光照对产品性状和主成分含量无影响,湿度对其影响较大。结论温度及光照对本品的稳定性无影响。本品生产环境的湿度应控制在79%以下,应采用密封好的外包装,并贮存在通风、干燥处。此工艺制备止血镇痛散质量符合相关规定。

Objective To investigate the optimum process and quality standard of Zhixuezhentong Powder.Methods The critical relative humidity,repose angle and stack density of the Zhixuezhentong Powder were measured.The diversification of the character,moisture content and active ingredients were studied while this product was in the high-temperature,high-humidity and light-struck environment.Results Humidity affects the content of active ingredients of Zhixuezhentong Powder.Conclusion Temperature and light don′t influence the stability of this product,but humidity should be controlled,and the package of this product should be sealed.An optimum process is applied to control the quality of Zhixuezhentong Powder.