喉康散质量标准提升研究  

Improvement of Quality Standard of Houkang Powder

作　　者：郝爽洁 李广生 李慧勇 笔雪艳 吉田 HAO Shuangjie;LI Guangsheng;LI Huiyong;BI Xueyan;JI Tian(Heilongjiang Academy of Traditional Chinese Medicine,Harbin,Heilongjiang,China 150036;Heilongjiang Institute of Drug Inspection,Harbin,Heilongjiang,China 150088;National Medical Products Administration Key Laboratory of Quality Research and Evaluation of Traditional Chinese Medicine,Harbin,Heilongjiang,China 150088;Key Laboratory of Quality Research and Evaluation of Traditional Chinese Medicine in Heilongjiang Province,Harbin,Heilongjiang,China 150088)

机构地区：[1]黑龙江省中医药科学院,黑龙江哈尔滨150036 [2]黑龙江省药品检验研究院,黑龙江哈尔滨150088 [3]国家药品监督管理局中药质量研究与评价重点实验室,黑龙江哈尔滨150088 [4]黑龙江省中药质量研究与评价重点实验室,黑龙江哈尔滨150088

出　　处：《中国药业》2024年第14期87-91,共5页China Pharmaceuticals

基　　金：国家药典委员会药品标准制修订项目[2019Z037]。

摘　　要：目的 提升喉康散的质量标准。方法 采用显微鉴别法对珍珠层粉进行定性鉴别;采用薄层色谱(TLC)法对制剂中的生晒参、甘草、穿心莲叶进行定性鉴别;采用气相色谱法对薄荷脑、异龙脑、龙脑进行含量测定,色谱柱为PEG-20M毛细管柱(30 m×0.25 mm,0.25μm),柱温为140℃,进样口温度为230℃,检测器温度为280℃,分流进样的分流比为20∶1(V/V),进样量为1μL。结果 制剂中珍珠层粉显微特征明显;生晒参、穿心莲叶、甘草的TLC图斑点清晰,分离度好,阴性对照无干扰;薄荷脑、异龙脑、龙脑质量浓度分别在0.184~2.946 mg/mL(r=1.000 0)、0.039~0.972 mg/mL(r=0.999 8)、0.048~1.210 mg/mL(r=0.999 8)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于3.0%;平均加样回收率分别为99.84%,99.76%,99.74%,RSD分别为0.18%,0.21%,0.21%(n=6)。结论 该方法操作简便,专属性强,重复性好,可为喉康散的质量控制提供参考。Objective To improve the quality standard of Houkang Powder.Methods Nacre powder in the preparation was identified qualitatively by the microscopic identification method.Sun-dried Ginseng Radix et Rhizoma,Glycyrrhizae Radix et Rhizoma and Andrographis Herba leaves in the preparation were identified qualitatively by the thin-layer chromatography(TLC)method.The contents of menthol,isoborneol and borneol were determined by the gas chromatography(GC)method;the chromatographic column was the PEG-20M capillary column(30 m×0.25 mm,0.25μm),the column temperature was 140℃,the inlet temperature was 230℃,the detector temperature was 280℃,the split injection was adopted with a split ratio of 20∶1(V/V),and the injection volume was 1μL.Results The microscopic characteristics of the nacre powder in the preparation were obvious.The TLC chromatograms of sun-dried Ginseng Radix et Rhizoma,Andrographis Herba leaves and Glycyrrhizae Radix et Rhizoma had clear spots,good resolution,and there was no interference from negative reference.The linear ranges of menthol,isoborneol and borneol were 0.184-2.946 mg/mL(r=1.0000),0.039-0.972 mg/mL(r=0.9998),0.048-1.210 mg/mL(r=0.9998),respectively.The RSDs of precision,stability and repeatability tests were all lower than 3.0%.The average recovery rates of the above three components were 99.84%,99.76%,99.74%,with RSDs of 0.18%,0.21%,0.21%(n=6)respectively.Conclusion This method is easy,specific and repeatable,which can provide a reference for the quality control of Houkang Powder.

关 键 词：喉康散 质量标准 显微鉴别法 薄层色谱法 气相色谱法 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]