新脑灵颗粒的质量标准研究

任新新; 王先友; 陆文铨; 朴淑娟; 高守红

doi:10.3969/j.issn.1006-0111.2016.04.014

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新脑灵颗粒的质量标准研究

任新新, 王先友, 陆文铨, 朴淑娟, 高守红

文章导航 > 药学实践与服务 > 2016 > 34(4): 338-342

倪晓霞, 刘晓玲, 叶财发, 王庆芬. 气相色谱法测定复方樟脑搽剂中樟脑与薄荷脑含量及其不确定度评估[J]. 药学实践与服务, 2018, 36(6): 522-528. doi: 10.3969/j.issn.1006-0111.2018.06.010

引用本文:

任新新, 王先友, 陆文铨, 朴淑娟, 高守红. 新脑灵颗粒的质量标准研究[J]. 药学实践与服务, 2016, 34(4): 338-342. doi: 10.3969/j.issn.1006-0111.2016.04.014

NI Xiaoxia, LIU Xiaoling, YE Caifa, WANG Qingfen. Determination of camphor and menthol in compound camphor liniment by GC and evaluation of uncertainty[J]. Journal of Pharmaceutical Practice and Service, 2018, 36(6): 522-528. doi: 10.3969/j.issn.1006-0111.2018.06.010

Citation:

REN Xinxin, WANG Xianyou, LU Wenquan, Piao Shujuan, GAO Shouhong. Study on quality control of Xinnaoling granules[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(4): 338-342. doi: 10.3969/j.issn.1006-0111.2016.04.014

新脑灵颗粒的质量标准研究

doi: 10.3969/j.issn.1006-0111.2016.04.014

1.
第二军医大学附属长征医院药学部, 上海 200003;河南大学药学院, 河南开封 475000
2.
河南大学药学院, 河南开封 475000
3.
第二军医大学附属长征医院药学部, 上海 200003

Study on quality control of Xinnaoling granules

1.
Department of Pharmacy, Changzheng Hospital Affiliated to Second Military Medical University, Shanghai 200433, China;School of Pharmacy, Henan University, Kaifeng 475000, China
2.
School of Pharmacy, Henan University, Kaifeng 475000, China
3.
Department of Pharmacy, Changzheng Hospital Affiliated to Second Military Medical University, Shanghai 200433, China

摘要: 目的建立新脑灵颗粒的质量标准。方法采用薄层色谱（TLC）法对该处方中的延胡索、白芷、厚朴、甘草、当归、川芎、五味子和菊花进行鉴别；采用高效液相色谱（HPLC）法测定丹酚酸B的含量，色谱柱：Agilent Eclipse XDB-C₁₈（4.6 mm×250 mm，5μm）；流动相：0.5%甲酸水溶液（A）-乙腈（B），梯度洗脱（0～5 min，24%B；5～6 min，24%～19%B；6～25 min，19%～20% B）；流速：1.0 ml/min；柱温：25℃；检测波长：286 nm；进样量：10μl。结果 TLC图中特征斑点清晰，专属性强。丹酚酸B在20～1280μg/ml范围内线性关系良好，其回归方程为Y=13.304X-117.50（r=0.9999，n=7），平均回收率96.17%（RSD=1.10%）。结论该方法简便可行、准确可靠、重复性好，可用于新脑灵颗粒的质量控制。
- 新脑灵颗粒 /
- 丹酚酸B /
- 高效液相色谱 /
- 薄层色谱
Abstract: Objective To establish quality control of Xinnaoling granules. Methods Thin layer chromatography (TLC) methods were used to identify Rhizoma Corydalis, Radix Angelicae dahuricae, Cortex Magnoliae officinalis, Radix Glycyrrhizae, Rhizoma Ligusticum, Ligusticum wallichii, Schisandra Chinensis, Dendranthema morifolium. The concentration of salvianolic acid B was determined by high performance liquid chromatography (HPLC). The method employed a column of Agilent Eclipse XDB-C₁₈(4.6 mm×250 mm,5 μm) with a mobile phase of 0.5% formic acid (A)-acetonitrile (B) at a temperature 25℃. The gradient elution program was as follow:0~5 min 24% B, 5~6 min 24%~19% B, 6~25 min 19~20% B. The flow rate was 1.0 ml/min, and the injection volume was 10 μl and the detection wavelength was 286 nm. Results The spots in TLC plates were clear and specific. As for salvianolic acid B, the linear range was 20-1280 μg/ml and the equation of linear regression of salvianolic acid B was Y=13.304 X-117.50 (r=0.9999, n=7). The average recovery rate was 96.17% (RSD=1.10%). Conclusion The method was proved to be simple, reliable, reproducible, and could be used in the quality control of Xinnaoling granules.
- Xinnaoling granules /
- salvianolic acid B /
- HPLC /
- TLC

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[7]	马慧萍, 李兰茹, 董志臣,等. HPLC法测定安神益智胶囊中丹酚酸B的含量[J]. 中国药师, 2014, 17(2):314-316.

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新脑灵颗粒的质量标准研究

doi: 10.3969/j.issn.1006-0111.2016.04.014

1. 第二军医大学附属长征医院药学部, 上海 200003;河南大学药学院, 河南开封 475000

2. 河南大学药学院, 河南开封 475000

3. 第二军医大学附属长征医院药学部, 上海 200003

收稿日期: 2015-09-28
修回日期: 2015-12-01

关键词:

新脑灵颗粒 /

丹酚酸B /

高效液相色谱 /

薄层色谱

摘要: 目的建立新脑灵颗粒的质量标准。方法采用薄层色谱（TLC）法对该处方中的延胡索、白芷、厚朴、甘草、当归、川芎、五味子和菊花进行鉴别；采用高效液相色谱（HPLC）法测定丹酚酸B的含量，色谱柱：Agilent Eclipse XDB-C₁₈（4.6 mm×250 mm，5μm）；流动相：0.5%甲酸水溶液（A）-乙腈（B），梯度洗脱（0～5 min，24%B；5～6 min，24%～19%B；6～25 min，19%～20% B）；流速：1.0 ml/min；柱温：25℃；检测波长：286 nm；进样量：10μl。结果 TLC图中特征斑点清晰，专属性强。丹酚酸B在20～1280μg/ml范围内线性关系良好，其回归方程为Y=13.304X-117.50（r=0.9999，n=7），平均回收率96.17%（RSD=1.10%）。结论该方法简便可行、准确可靠、重复性好，可用于新脑灵颗粒的质量控制。

English Abstract

Study on quality control of Xinnaoling granules

1. Department of Pharmacy, Changzheng Hospital Affiliated to Second Military Medical University, Shanghai 200433, China;School of Pharmacy, Henan University, Kaifeng 475000, China

2. School of Pharmacy, Henan University, Kaifeng 475000, China

3. Department of Pharmacy, Changzheng Hospital Affiliated to Second Military Medical University, Shanghai 200433, China

Received Date: 2015-09-28
Rev Recd Date: 2015-12-01

Keywords:

Abstract: Objective To establish quality control of Xinnaoling granules. Methods Thin layer chromatography (TLC) methods were used to identify Rhizoma Corydalis, Radix Angelicae dahuricae, Cortex Magnoliae officinalis, Radix Glycyrrhizae, Rhizoma Ligusticum, Ligusticum wallichii, Schisandra Chinensis, Dendranthema morifolium. The concentration of salvianolic acid B was determined by high performance liquid chromatography (HPLC). The method employed a column of Agilent Eclipse XDB-C₁₈(4.6 mm×250 mm,5 μm) with a mobile phase of 0.5% formic acid (A)-acetonitrile (B) at a temperature 25℃. The gradient elution program was as follow:0~5 min 24% B, 5~6 min 24%~19% B, 6~25 min 19~20% B. The flow rate was 1.0 ml/min, and the injection volume was 10 μl and the detection wavelength was 286 nm. Results The spots in TLC plates were clear and specific. As for salvianolic acid B, the linear range was 20-1280 μg/ml and the equation of linear regression of salvianolic acid B was Y=13.304 X-117.50 (r=0.9999, n=7). The average recovery rate was 96.17% (RSD=1.10%). Conclusion The method was proved to be simple, reliable, reproducible, and could be used in the quality control of Xinnaoling granules.