复方氯己定含漱液评价性抽验结果及质量评价

Sampling Test Results and Quality Assessment of Compound Chlorhexidine Gargle Solution

目的评价复方氯己定含漱液的质量现状及存在问题。方法按照法定标准方法结合探索性研究进行样品检验,统计分析检验结果,对复方氯己定含漱液的质量现状进行评价。探索性研究采用HPLC方法测定两组分的含量,并将测定结果与UV法测定结果进行比较。结果按法定标准方法检验显示,48批均合格,合格率100%。HPLC法测定的结果与原法定UV法相比有显著性差异。结论复方氯己定含漱液按法定标准检验,总体合格率较好。从环保的角度,通过探索性研究,建议修订2个主药成分的含量测定方法,将原法定UV法修订为HPLC法,提高方法的精密度和准确性,从而更好地控制产品质量。

Objective To evaluate the quality status of compound chlorhexidine gargle solution and existing problems. Methods In accordance with the statutory standard method combined with the exploratory research to examine samples, the quality of compound chlorhexidine gargle solution was evaluated by statistical analysis of the results. HPLC was used to determine two components in compound chlorhexidine gargle solution during exploratory studies. The measured results by HPLC were compared with the results by UV. Results The statutory standard method showed 48 batches of samples were qualified, the qualified rate was 100%. The measured results by HPLC and the results by UV had significant difference. Conclusion At present the quality of most domestic compound chlorhexidine gargle solutions can meet the current specifications. From the perspective of environmental protection, the explorative study suggested revising the determination method for the two main medicinal compositions, and the legal UV method could be changed into HPLC to improve the precision and accuracy of detection, so as to better control the quality of products.