基于对照制剂的抗宫炎片质量评价新模式的探讨

目的：探讨抗宫炎片的质量评价新模式。方法：采用薄层色谱法对抗宫炎片进行全方药味鉴别研究，采用高效液相色谱法对方中广东紫珠、乌药进行含量测定以及指纹图谱相似度研究，并将对照制剂作为随行对照，对不同企业的抗宫炎片样品进行质量优劣评价。结果：5个生产企业18批样品中有7批的含量及相似度测定值均高于对照制剂测定值的90%，6批的去甲异波尔定含量低于拟定限度（1.12 mg·g^-1），其他5批样品均符合拟定限度要求。结论：所建立的方法能更加全面地控制抗宫炎片的质量，并可对其质量优劣进行初评价，为进一步建立中成药质量评价新模式提供了示范和参考。

Objective: To explore a new quality evaluation model for Kanggongyan tablets. Methods: TLC was used to identify whole ingredients in Kanggongyan tablets,and HPLC was used to analyze the contents of Callicarpae Caulis et Folium and Linderae Radix,and the similarities of the fingerprints. With reference drug as the accompanying control,the quality of Kanggongyan tablets from different enterprises was evaluated. Results: According to the results of 18 samples from 5 manufactures by quality evaluation,the contents and similarities of 7 batches of samples were higher than 90% of those values of the reference drug. The contents of norisoboldine in 6 batches of samples failed the proposed limit (1.12 mg·g^-1). The other 5 batches of samples met the proposed limit. Conclusion: The proposed method offers a more comprehensive approach for quality control of Kanggongyan tablets,and the quality of the product can be evaluated preliminarily. And it provides a model and reference for the further establishment of a new quality evaluation model of Chinese patent medicine.

[1] 中华人民共和国药典2015年版.一部[S].2015:952 ChP 2015.Vol Ⅰ[S].2015:952
[2] 马廷升,朱兰翠.抗宫炎片临床应用进展[J].中国现代医学杂志,2004,14(10):69 MA TS,ZHU LC.Clinical application of progress of Kanggongyan tablets[J].China J Mod Med,2004,14(10):69
[3] 袁铭铭,周雷罡,钟瑞建,等.广东紫珠中抗凝血活性成分的薄层色谱鉴别及含量测定[J].药物分析杂志,2016,36(5):811 YUAN MM,ZHOU LG,ZHONG RJ,et al.Identification and determination of the anticoagulant active component from Callicarpa kwangtungensis by TLC and HPLC-ELSD[J].Chin J Pharm Anal,2017,37(1):811
[4] 乔晶晶,吴啟南,薛敏,等.益母草化学成分与药理作用研究进展[J].中草药,2018,49(23):5691 QIAO JJ,WU QN,XUE M,et al.Research progress on chemical components and pharmacological effects of Leonurus japonicas[J].Chin Tradit Herb Drugs,2018,49(23):5691
[5] 吴伟建,王燕,王斌,等.基于聚类、主成份和判别分析的海龙红外指纹图谱研究[J].中国药学杂志,2013,48(18):1540 WU WJ,WANG Y,WANG B,et al.Infrared fingerprint analysis of Syngnathus's ethanol extracts coupled with cluster analysis,principal component analysis and discriminant analysis[J].Chin Pharm J,2013,48(18):1540
[6] 多杰扎西,吴启勋.不同产地枸杞子中微量元素的因子分析[J].西南民族大学学报(自然科学版),2008,34(3):514 DUOJIE ZX,WU QX.Factor analysis of trace elements in Chinese wolfberry in different regions[J].J Southwest Univ Natl (Nat Sci Ed),2008,34(3):514
[7] 李少泓,夏鹏飞,马肖,等.基于灰色关联分析方法评价当归药材质量[J].中药材,2012,35(11):1742 LI SH,XIA PF,MA X,et al.Study on quality evaluation of Angelica sinensis by grey incidence degree method[J].J Chin Med Mater,2012,35(11):1742
[8] 吕惠玲,万茶艳,程存归.ATR-FTIR及人工神经网络分类法鉴别薏苡仁与伪品草珠子种仁[J].中国药房,2015,26(6):845 Lü HL,WANG CY,CHENG CG.Identification between Coicis Semen and Coix lachrymal-jobi by ATR-FTIR and ANN classification[J].China Pharm,2015,26(6):845
[9] 李琦.常用多变量数值分析法在中药质量控制方面的研究概况[J].中国民族民间医药,2018,27(17):68 LI Q.Research progress on common multivariate numerical analysis in quality control of traditional Chinese medicine[J].Chin J Ethnomed Ethnopharm,2018,27(17):68
[10] 邓哲,焦梦娇,章军,等.基于质量常数评价方法划分黄柏饮片等级研究[J].中国中药杂志,2017,42(17):3356 DENG Z,JIAO MJ,ZHANG J,et al.Grades evaluation of Phellodendri Chinensis Cortex pieces based on quality constant[J].China J Chin Mater Med,2017,42(17):3356
[11] 聂黎行,戴忠,马双成.中药对照制剂研制指导原则和技术要求[J].中国中药杂志,2017,42(19):3672 NIE LX,DAI Z,MA SC.Guideline principle and technical requirement for preparing traditional Chinese medicine reference drug[J].China J Chin Mater Med,2017,42(19):3672
[12] 聂黎行,查祎凡,陈玉红,等.基于ICP-MS和对照制剂的牛黄清胃丸中石膏的质量评价[J].环境化学,2018,37(10):2322 NIE LX,ZHA YF,CHEN YH,et al.Quality evaluation of gypsum fibrosum in Niuhuang Qingwei pills based on ICP-MS and reference drug[J].Environ Chem,2018,37(10):2322
[13] 聂黎行,查祎凡,左甜甜,等.基于ICP-MS和对照制剂的牛黄清胃丸中重金属及有害元素残留量测定及风险评估[J].中国中药杂志,2019,44(1):82 NIE LX,ZHA YF,ZUO TT,et al.Determination and risk assessment of heavy metals and harmful elements residues in Niuhuang Qingwei pills based on ICP-MS[J].China J Chin Mater Med,2019,44(1):82
[14] 聂黎行,查祎凡,胡晓茹,等.基于对照制剂的牛黄清胃丸全处方鉴别研究和等级初评价[J].中草药,2018,49(22):5320 NIE LX,ZHA YF,HU XR,et al.Whole-ingredient identification and primary grade evaluation of Niuhuang Qingwei pills based on reference drug[J].Chin Tradit Herb Drugs,2018,49(22):5320
[15] 查祎凡,聂黎行,王赵,等.基于对照制剂和光释光法检测牛黄清胃丸⁶⁰Co-γ射线辐照情况[J].中国药师,2018,21(11):1898 ZHA YF,NIE LX,WANG Z,et al.Detection of ⁶⁰Co-γ irradiated Niuhuang Qingwei pills based on reference drug and photostimulated luminescence[J].China Pharm,2018,21(11):1898