Improvement of Quality Standard of Shenwei Gubi Tablets and Changes of Transfer Rates of Its Quality Control Indicators in Production Based on Chemical Pattern Recognition Technology

Jiang LI; Jiao LI; Peng FU; Shuang PENG; Ling-yun CHEN; Xiao-ling YU

doi:10.13422/j.cnki.syfjx.20201053

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Improvement of Quality Standard of Shenwei Gubi Tablets and Changes of Transfer Rates of Its Quality Control Indicators in Production Based on Chemical Pattern Recognition Technology

Pharmacy Fundamentals | 更新时间：2020-08-11

- Improvement of Quality Standard of Shenwei Gubi Tablets and Changes of Transfer Rates of Its Quality Control Indicators in Production Based on Chemical Pattern Recognition Technology
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 26, Issue 15, Pages: 130-136(2020)
- 作者机构：
  
  1.云南中医药大学云南省高校外用给药系统与制剂技术研究重点实验室，昆明 650500
  2.昆明市中医医院，昆明 650500
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20201053
  CLC： R22;R94;R28;C37;O657.7
- Revised：01 November 2019，
  
  Published Online：05 February 2020，
  
  Published：05 August 2020
- 稿件说明：
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李江,李娇,付鹏等.基于化学模式识别技术提升参威骨痹片的质量标准并监测其生产中质控指标的转移率变化[J].中国实验方剂学杂志,2020,26(15):130-136.

LI Jiang,LI Jiao,FU Peng,et al.Improvement of Quality Standard of Shenwei Gubi Tablets and Changes of Transfer Rates of Its Quality Control Indicators in Production Based on Chemical Pattern Recognition Technology[J].Chinese Journal of Experimental Traditional Medical Formulae,2020,26(15):130-136.
李江,李娇,付鹏等.基于化学模式识别技术提升参威骨痹片的质量标准并监测其生产中质控指标的转移率变化[J].中国实验方剂学杂志,2020,26(15):130-136. DOI： 10.13422/j.cnki.syfjx.20201053.

LI Jiang,LI Jiao,FU Peng,et al.Improvement of Quality Standard of Shenwei Gubi Tablets and Changes of Transfer Rates of Its Quality Control Indicators in Production Based on Chemical Pattern Recognition Technology[J].Chinese Journal of Experimental Traditional Medical Formulae,2020,26(15):130-136. DOI： 10.13422/j.cnki.syfjx.20201053.

摘要

目的

提升参威骨痹片的质量标准，初步探索其质量控制指标成分在批间含量差异较大的原因。

方法

采用HPLC建立参威骨痹片的指纹图谱，以Diamonsil C

（4.6 mm×250 mm，5 μm）为色谱柱，流动相乙腈（A）-0.1%磷酸水溶液（B）梯度洗脱（0～5 min，10%A；5～15 min，10%～12%A；15～30 min，12%～26%A；30～43 min，26%～31%A，43～50 min，31%～40%A，50～70 min，40%～55%A；70～84 min，55%～72.5%A），检测波长230 nm。以共有峰为自变量绘制正交偏最小二乘法-判别分析-变量重要性投影（OPLS-DA-VIP）图，将共有峰对该制剂各批次间指纹图谱差异的贡献度量化，寻找差异较大的色谱峰，结合相关文献，筛选出与参威骨痹片临床适应症相关的成分并进行其含量测定的专属性试验，最终选定质控指标。通过HPLC-二极管阵列检测器（DAD）同时对本品及其生产过程中间体中质控指标进行测定，检测波长236，276，230，322 nm，其他条件同HPLC指纹图谱检测方法。

结果

HPLC指纹图谱共标定了26个共有峰，各批次样品指纹图谱与对照指纹图谱的相似度均≥0.950。优选出马钱苷酸、龙胆苦苷、芍药苷、蛇床子素为参威骨痹片的质控指标，四者的平均质量分数分别为161.02，401.80，255.54，80.68 μg·g

-1

。

结论

所建立的指纹图谱及多指标定量分析方法稳定、可靠，可用于参威骨痹片的质量控制。原料药批间质控指标成分含量差异和生产过程中间体的质控方法不够完善是引起该制剂批间质控指标成分含量差异较大的主要原因。

Abstract

Objective

To improve the quality standard of Shenwei Gubi tablets， and to explore the reasons for the great difference in the contents of quality control index components between batches of this product.

Method

The fingerprint of this product was established by HPLC， the determination was performed on Diamonsil C

column （4.6 mm×250 mm， 5 μm） with acetonitrile （A）-0.1% phosphoric acid solution （B） for gradient elution （0-5 min， 10%A； 5-15 min， 10%-12%A； 15-30 min， 12%-26%A； 30-43 min， 26%-31%A， 43-50 min， 31%-40%A， 50-70 min， 40%-55%A； 70-84 min， 55%-72.5%A） as the mobile phase at detection wavelength of 230 nm. The orthogonal partial least squares-discriminant analysis-variable importance in the projection （OPLS-DA-VIP） map was drawn with the common peak as the independent variable. The contribution of 26 common peaks to the fingerprint differences among different batches of this product was quantified. By searching for the chromatographic peaks with great differences， combined with relevant literature， the components related to the clinical indications of the product were screened out and their contents were determined by specificity experiment， and the quantitative indicators were finally selected. HPLC-doide array detector （DAD） was employed to determine the contents of the above preferred indexes with detection wavelengths of 236， 276， 230， 322 nm， other conditions were the same as HPLC fingerprint detection method.

Result

A total of 26 common peaks were calibrated on the HPLC fingerprint of Shenwei Gubi tablets. The similarity between the fingerprint of each batch samples and the reference fingerprint was≥0.950. Loganic acid， gentiopicroside， paeoniflorin and osthole were optimized as the quantitative indicators of this product， their average contents were 161.02， 401.80， 255.54， 80.68 μg·g

-1

Conclusion

The established fingerprint and multi-index quantitative analysis method are stable and reliable， and can be used for quality control of Shenwei Gubi tablets. Difference in contents of quality control components between batches of raw materials and the imperfect quality control method of intermediates in the production process are the main reasons for the great difference in the contents of quality control indicators between batches of this product.

关键词

Keywords

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