摘要
目的从显微鉴别、薄层鉴别、含量测定3个方面,对小儿珍贝散标准进行完善与提高。方法该研究起止时间为2020年1—10月。采用显微鉴别方法对珍珠、川贝母、沉香进行定性鉴别;采用薄层色谱法(TLC),对人工牛黄、沉香、川贝母进行定性鉴别;采用高效液相色谱法(HPLC),以胆红素作为质控指标,进行含量测定。结果薄层色谱法能有效地鉴别小儿珍贝散中的人工牛黄、沉香、川贝母,阴性无干扰;胆红素在0.004~0.160µg范围内线性关系良好,回归方程为Y=31476X−984.42,平均加样回收率为102.78%,相对标准差(RSD)为1.2%,测定样品17批,含量测定平均值为0.5484 mg/g。结论新建立的质量控制方法增加了显微鉴别、薄层色谱及含量测定的质量控制研究,实验方法准确可靠,简便快捷,适用性良好,可用于该制剂的质量控制和质量评价。
Objective To improve the standard of Xiaoerzhenbei powder from three aspects:microscopic identification,thin-layer identification,and content determination.Methods This study lasted from January 2020 to October 2020.Microscopic identification methods were used to qualitatively identify pearl,Fritillaria cirrhosa and Agarwood;thin layer chromatography(TLC)was used to qualitatively identify artificial bezoar,agarwood and Fritillaria cirrhosa;high performance liquid method(HPLC)was employed for content determination,with bilirubin as a quality control index.Results TLC could effectively identify the artificial bezoar,agarwood,and Fritillaria in Xiaoerzhenbei powder,negative without interference;bilirubin had a good linear relationship in the range of 0.004~0.160μg,and the regression equation was Y=31476X−984.42.The average recovery was 102.78%,and the relative standard deviation(RSD)was 1.2%.The mean content of 17 batches of bilirubin was 0.5484 mg/g.Conclusions The newly established quality standard has increased the quality control research of pearl,artificial bezoar,fritillaria cirrhosa and agarwood in the prescription.The experimental method is accurate and reliable,simple and fast,and has good applicability.It can be used for the quality control and quality evaluation of the preparation.
作者
汪安
程桂林
蒲婧哲
陶冶
王多梅
WANG An;CHENG Guilin;PU Jingzhe;TAO Ye;WANG Duomei(Chizhou City Quality Supervision and Inspection Research Institute,Chizhou,Anhui 247100,China;Anhui Institute for Food and Drug Control,Hefei,Anhui 230051,China)
出处
《安徽医药》
CAS
2022年第6期1094-1098,I0003,共6页
Anhui Medical and Pharmaceutical Journal
基金
安徽省自然科学基金项目(2108085MB63)。
关键词
中草药
质量控制
胆红素
小儿珍贝散
色谱法
薄层
色谱法
高压液相
质量标准
人工牛黄
胆南星
沉香
Drugs,Chinese herbal
Quality control
Bilirubin
Xiaoerzhenbei powder
Chromatography,thin layer
Chromatography,high pressure liquid
Quality standard
Artificial cow-bezoar
Cholanacin
Aloes
