过敏康颗粒质量控制方法研究

Study on method of quality control for Guominkang Granules

目的:建立过敏康颗粒质量控制方法。方法:采用薄层色谱法对过敏康颗粒中乌梅、首乌藤、防风、灵芝、天麻药材进行定性鉴别,通过高效液相色谱法(HPLC)法对过敏康颗粒中升麻素苷和5-O-甲基维斯阿米醇苷总量进行含量测定。结果:薄层色谱法鉴别的5种供试品色谱中,在与对照品和对照药材相应位置呈现相同斑点或荧光,阴性无干扰,专属性强。升麻素苷和5-O-甲基维斯阿米醇苷进样量分别在0.072-0.72μg,0.048-0.48μg范围内与峰面积呈良好线性关系(r=0.9999,n=6),精密度、稳定性、重复性试验的RSD≤1.95%,升麻素苷平均回收率为97.16%,RSD值为1.94%,5-D-甲基维斯阿米醇苷平均回收率为95.00%,RSD值为2.26%;3批颗粒含量测定平均值1.42mg/g,拟定含量每1g含升麻素苷和5-O-甲基维斯阿米醇苷总量计,不得少于1.10mg。结论:所采用的质量控制方法操作简单、准确可靠、重复性好,为过敏康颗粒剂的质量控制提供了科学依据。

Objective： To establish the method of quality control of Guominkang Granules. Methods： Qualitative identification of Fructus Mume, Caulis Polygoni Multiflori, Radix Saposhnikoviae, and Rhizoma Gastrodiae in Guominkang Granules was studied by TLC. The total amount of Prim-o-glucosylcimifugin and 5-O-methylvisammioside in Guominkang Granules was conducted the determination of content by HPLC. Results： The fingerprints of five identified herbs were indicated by TLC, which could show the same spot or fluorescencecolor as the control herbs and control standard in the same position with negative non-interference and specificity. Injection volume of Prim-o-glucosylcimifugin and 5-O-methylvisammioside and peak area showed a good linear relationship in the range of 0.072-0.72μg, 0.048-0.48μg, respectively. The RSD≤1.95% for the test of precision, stability and repeatability. The average recovery of Prim-o-glucosylcimifugin was 97.16% and RSD was 1.94%, and the average recovery of 5-O-methylvisammioside was 95.00%and RSD was 2.26%. The average of the three batches of granules was 1.42 mg/g, and the proposed content for Prim-o-glucosylcimifugin and 5-O-methylvisammioside per gram was not less than 1.10 mg/g. Conclusion： The quality control method is simple, accurate, reliable and reproducible, which provided a scientific basis for the quality control of Guominkang Granules.