痰热清注射液中可见异物成因及检查方法探讨

Study on cause and inspection method of visible foreign particles in Tanreqing Injection

目的收集痰热清注射液样品,了解其可见异物的基本情况,从而对其可见异物的成因及检查方法进行探讨研究。方法对收集到的不同生产年份、不同生产批号的痰热清注射液样品,分别采用灯检法及光散射法进行可见异物检查,汇总检测结果,并予以数据分析;同时考察了痰热清注射液的可见异物成因中外源性因素(如光照、高温等)及内源性因素(如p H值、辅料等)的影响。结果市面上流通的痰热清注射液样品可见异物检查的阳性检出率较低。外源性因素对痰热清注射液的可见异物指标基本没有影响,而内源性因素中p H值对痰热清注射液的可见异物有显著影响。结论痰热清注射液作为独家生产品种,其生产企业在可见异物控制方面措施有效,质量控制比较成功。另外,灯检法和光散射法应用于痰热清注射液的可见异物检查需要进一步进行考察对比。

Objective The samples of Tanreqing Injection were collected to understand the basic conditions of visible foreign particles,so as to investigate the causes and inspection methods of visible foreign particles. Methods The samples of Tanreqing Injection with different production years and batch numbers were collected and analyzed respectively by artificial lights method and light scattering method. The test results were summarized and analyzed. The effects of exogenous factors（ such as light,high temperature,etc.） and endogenous factors（ such as p H value,excipients,etc.） on visible foreign particles in Tanreqing Injection were also investigated. Results The positive rate of visible particles inspection in Tanreqing Injection samples was low. Exogenous factors had no effect on the visible particles,but p H value of the endogenous factors had a great influence on it. Conclusion The quality control of visible particles is effective in enterprise. In addition,artificial lights method and light scattering method used in investigation of visible particles in Tanreqing Injection need further discussion and comparison.