小儿咽扁颗粒质量评价与监管建议

Quality Evaluation and Supervision Suggestions of Xiaoer Yanbian Granules

目的针对小儿咽扁颗粒的现行质量标准及质量状况进行综合评价,提出监管建议。方法本研究收集了全国范围生产、流通及使用环节的小儿咽扁颗粒样品,按现行质量标准及探索性研究检验,对该品种的投料真实性、安全性、稳定性等方面进行综合考察。结果共收集275批次样品,来源广泛,代表性强。按现行质量标准检验,合格率为97.5%,经探索性研究检验,合格率降为66.9%,发现两项重大问题及若干其他问题。结论现行质量标准有缺项,薄层鉴别方法需优化,含量测定指标单一,质量标准对产品的质量控制能力“一般”;本品质量评价为“差”,共95批次样品不合格,总合格率为65.4%,发现两个重大问题,样品均一性差;总体评价为“差”。建议监管部门尽快将该品种纳入国家药品标准提高行动计划,加大药材饮片监管力度,建议生产企业提高企业的风险意识,严把药材质量关;制定合理的生产工艺操作规程,保证产品质量的稳定及均一。

Objective To evaluate the current quality standard and quality status of xiaoer yanbian granules,and put forward supervision suggestions.Methods The samples of production,circulation and use in the whole country were collected,and the authenticity,safety and stability of the variety were comprehensively investigated through the inspection according to the current quality standards and exploratory research.Results A total of 275 batches of samples were collected.According to the current quality standard,the qualified rate was 97.5%.After exploratory research,the qualified rate was reduced to 66.9%.Two major problems and some other problems were found.Conclusion The current quality standard evaluation is"general",there are missing items in the quality standard,the TLC identification method needs to be optimized,and the content determination index is single;the quality evaluation is"poor",a total of 95 batches of samples are unqualified,the total qualified rate is 65.4%,two major problems are found,the sample homogeneity is poor,and the overall evaluation is"poor".It is suggested that the regulatory authorities should incorporate this variety into the national drug standards as soon as possible,improve the action plan and strengthen the supervision of herbal pieces.It is suggested that the regulatory authorities should include this variety into the national action plan for raising drug standards as soon as possible,strengthen the supervision over medicinal materials prepared in readymade slices,and suggest that the production enterprises should raise their risk awareness and strictly control the quality of medicinal materials.Strengthen the management of the internal production site,conduct in-depth research on the process parameters,stabilize the production process parameters,formulate the most reasonable production process operation rules,ensure the stability and uniformity of product quality.