CN111721729A - 一种基于紫外光谱的醒脑静注射液的快速分析方法 - Google Patents
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Abstract
本发明公开了一种基于紫外光谱的醒脑静注射液的快速分析方法，该方法为：以乙腈为流动相A，以0.1wt％磷酸‑水溶液为流动相B进行线性梯度洗脱，洗脱程序为：0min，30％A；10min，55％A；24min，55％A；24.1min，70％A；35min，70％A；40min，100％A。流速0.6mL/min，柱温40℃，进样量50μL，PDA检测波长范围为200‑400nm。各成分检测波长为：异佛尔酮，238nm；4‑亚甲基‑异佛尔酮，275nm；莪术双环烯酮，256nm；莪术烯醇，261nm；莪术二酮，220nm；莪术酮，274nm；莪术呋喃二烯酮，274nm；莪术醇，210nm；吉马酮，210nm。本发明建立的分析方法具有快速、简便、低成本的优点，可用于提取过程监测和提取终点判断，以提高生产效率、减少产品质量缺陷和质量差异。
Description
技术领域
本发明涉及中药生产领域，特别地，涉及一种基于紫外光谱的醒脑静注射液的快速分析方法。
背景技术
目前对醒脑静注射液生产过程快速分析方法研究主要集中于检测成品质量和测定倍半萜类等生物活性成分。对于醒脑静注射液生产过程分析方法较少运用于工业生产。紫外光谱是一种快速、无损的分析方法，具有灵敏度高、仪器价格便宜的优点。为了合理判断提取过程终点，提升生产过程质量监控水平，本发明建立了一种基于紫外光谱的醒脑静注射液生产过程快速分析方法。
发明内容
本发明的目的在于针对现有技术的不足，提供了一种基于紫外光谱的醒脑静注射液的快速分析方法。
本发明采用如下技术方案：一种基于紫外光谱的醒脑静注射液的快速分析方法，该方法为：以乙腈为流动相A，以0.1wt％磷酸-水溶液为流动相B进行线性梯度洗脱，洗脱程序为：0min，30％A(即30wt％的A+70wt％的B)；10min，55％A；24min，55％A；24.1min，70％A；35min，70％A；40min，100％A。流速0.6mL/min，柱温40℃，进样量50μL，PDA检测波长范围为200-400nm。各成分检测波长为：异佛尔酮，238nm；4-亚甲基-异佛尔酮，275nm；莪术双环烯酮，256nm；莪术烯醇，261nm；莪术二酮，220nm；莪术酮，274nm；莪术呋喃二烯酮，274nm；莪术醇，210nm；吉马酮，210nm。
本发明建立的分析方法具有快速、简便、低成本的优点，可用于提取过程监测和提取终点判断，以提高生产效率、减少产品质量缺陷和质量差异。
附图说明
图1为用于提取过程监测和提取终点判断的系统结构示意图。
图2为郁金-栀子蒸馏液中9种成分的高效液相图；
图3为郁金-栀子蒸馏液紫外光谱图；
图4为批次1(正常批次)与批次11(药材颗粒偏大批次)各时间点蒸馏液中9种成分含量。
具体实施方式
下面结合附图和实施例对本发明进一步说明；
本发明一种基于紫外光谱的醒脑静注射液的快速分析方法，该方法为：以乙腈为流动相A，以0.1wt％磷酸-水溶液为流动相B进行线性梯度洗脱，洗脱程序为：0min，30％A；10min，55％A；24min，55％A；24.1min，70％A；35min，70％A；40min，100％A。流速0.6mL/min，柱温40℃，进样量50μL，PDA检测波长范围为200-400nm。各成分检测波长为：异佛尔酮，238nm；4-亚甲基-异佛尔酮，275nm；莪术双环烯酮，256nm；莪术烯醇，261nm；莪术二酮，220nm；莪术酮，274nm；莪术呋喃二烯酮，274nm；莪术醇，210nm；吉马酮，210nm。
本发明液相色谱图条件如下：波长：0-15.5min，238nm；15.5-19min，275nm；19-20min，256nm；20-24min，261nm；24-26min，220nm；26-30.5min，274nm；30.5min后，210nm。图2中(a)对照品溶液；(b)供试品溶液；(c)栀子蒸馏液；(d)郁金蒸馏液。峰1：异佛尔酮；峰2：4-亚甲基-异佛尔酮；峰3：莪术双环烯酮；峰4：莪术烯醇；峰5：莪术二酮；峰6：莪术酮；峰7：莪术呋喃二烯酮；峰8：莪术醇；峰9：吉马酮。从液相色谱图中可知，两种药材的9种成分测定是基本互不干扰，这种情况可尝试建立一测多评法对9中成分进行含量测定。
本发明建立的分析方法具有快速、简便、低成本的优点，可用于提取过程监测和提取终点判断，系统结构参见图1，由Waters e2695高效液相色谱仪2(美国Waters公司)、UV-2600紫外光谱仪1(上海尤尼科仪器有限公司)和计算机工作站3组成，三者之间都通过电路相连接。以中药中成分的HPLC测定值作为参考值Y，各波长下的吸光度作为自变量X，采用SPXY算法将全部样本划分为训练集和预测集。利用计算机工作站分别采用PLS、LS-SVM和RBF-ANN方法对训练集样本数据建立多元校正模型，具体见《紫外光谱法快速测定醒脑静注射液一次提取过程中9种成分》。
实施例1，采用本发明建立的一种基于紫外光谱的生产过程快速分析方法对不同工艺条件下各中药成分提取情况进行监测。为了扩大样品中各成分含量变化范围，同时为了考察所建立的分析方法在异常提取条件下是否适用，开展6个异常批次提取实验，对提取条件进行的改变如表1所示。批次11药材颗粒大小异常(10～20目)，批次12药材提取前未浸泡，批次13、14提取溶剂异常，批次15药材投入量错误，批次16加热功率异常。共开展16个批次实验，取样166份。各批次的检测方法为：
以乙腈为流动相A，以0.1wt％磷酸-水溶液为流动相B进行线性梯度洗脱，洗脱程序为：0min，30％A；10min，55％A；24min，55％A；24.1min，70％A；35min，70％A；40min，100％A。流速0.6mL/min，柱温40℃，进样量50μL，PDA检测波长范围为200-400nm。各成分检测波长为：异佛尔酮，238nm；4-亚甲基-异佛尔酮，275nm；莪术双环烯酮，256nm；莪术烯醇，261nm；莪术二酮，220nm；莪术酮，274nm；莪术呋喃二烯酮，274nm；莪术醇，210nm；吉马酮，210nm。
表1异常提取批次
| 批次 | 异常条件 |
| 11 | 药材颗粒偏大(10～20目) |
| 12 | 药材未浸泡 |
| 13 | 20％(v/v)乙醇提取 |
| 14 | 0.1％(m/m)盐酸提取 |
| 15 | 郁金60g，栀子30g |
| 16 | 加热功率偏大 |
图4以批次1(正常批次)与批次11(药材颗粒偏大批次)为例进行了比较，当药材颗粒偏大时，提取液中莪术二酮、莪术酮、莪术呋喃二烯酮、吉马酮的含量明显偏低，原因可能是这些成分亲水性相对较弱，从药材内部扩散到表面是其提取过程中的限速步骤，大颗粒药材中这些成分扩散相对较慢。本发明的分析方法能有效地辅助区分正常和异常操作批次，可用于提取过程监测。
Claims (1)
1.一种基于紫外光谱的醒脑静注射液的快速分析方法，其特征在于：该方法为：以乙腈为流动相A，以0.1wt％磷酸-水溶液为流动相B进行线性梯度洗脱，洗脱程序为：0min，30％A；10min，55％A；24min，55％A；24.1min，70％A；35min，70％A；40min，100％A。流速0.6mL/min，柱温40℃，进样量50μL，PDA检测波长范围为200-400nm。各成分检测波长为：异佛尔酮，238nm；4-亚甲基-异佛尔酮，275nm；莪术双环烯酮，256nm；莪术烯醇，261nm；莪术二酮，220nm；莪术酮，274nm；莪术呋喃二烯酮，274nm；莪术醇，210nm；吉马酮，210nm。
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| CN107655841A (zh) * | 2017-08-11 | 2018-02-02 | 浙江中医药大学 | 一种基于紫外光谱快速测定郁金‑栀子水蒸气蒸馏提取过程多种成分含量的方法 |
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| CN103048409A (zh) * | 2013-01-08 | 2013-04-17 | 广东台城制药股份有限公司 | 一种同时检测止咳宝片中四种有效成分含量的方法 |
| CN107655841A (zh) * | 2017-08-11 | 2018-02-02 | 浙江中医药大学 | 一种基于紫外光谱快速测定郁金‑栀子水蒸气蒸馏提取过程多种成分含量的方法 |
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