A Method for Analyzing Uniformity of Borneol in Manufactory Process of Compound Danshen Tablets by Near-infrared Spectroscopy

KUANG Yan-hui; TANG Hai-jiao; WANG De-qin; LIU Xiao-qian; QIN Ren-an; WANG Zhi-min; LI Chu-yuan

doi:10.13422/j.cnki.syfjx.20180602

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A Method for Analyzing Uniformity of Borneol in Manufactory Process of Compound Danshen Tablets by Near-infrared Spectroscopy

更新时间：2024-01-04

- A Method for Analyzing Uniformity of Borneol in Manufactory Process of Compound Danshen Tablets by Near-infrared Spectroscopy
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 24, Issue 6, Pages: 7-11(2018)
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- DOI：10.13422/j.cnki.syfjx.20180602
  CLC： R286.0
- Published：2018
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KUANG Yan-hui, TANG Hai-jiao, WANG De-qin, et al. A Method for Analyzing Uniformity of Borneol in Manufactory Process of Compound Danshen Tablets by Near-infrared Spectroscopy[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(6): 7-11.
DOI：

KUANG Yan-hui, TANG Hai-jiao, WANG De-qin, et al. A Method for Analyzing Uniformity of Borneol in Manufactory Process of Compound Danshen Tablets by Near-infrared Spectroscopy[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(6): 7-11. DOI： 10.13422/j.cnki.syfjx.20180602.

摘要

目的：探索一种近红外光谱用于判定复方丹参片生产过程中微量冰片混合均匀性的方法，为该制剂的质量改进提供参考。方法：收集混合过程中所需原料，按照一定的比例配制成不同的组分，采用研磨和喷雾2种方式将冰片混入干膏粉中，在不同部位均匀取样，所得样品进行近红外光谱扫描并计算其阈值及欧式距离，采用气相色谱法（GC）检验每份样品中冰片的含量，DB-FFAP毛细管柱（0.32 mm×30 m，0.25 μm），柱温110℃，进样口和检测器温度均为200℃，分流比1：1。结果：当阈值或欧式距离<0.01时，GC结果显示冰片含量的RSD<10%，表明冰片混合均匀；当阈值或欧式距离>0.01时，GC结果显示冰片含量的RSD>30%，表明冰片混合不均匀。结论：所建立的方法能有效快速判定复方丹参片生产过程中冰片混合的均匀性，建议纳入企业内控或国家标准中。

Abstract

Objective: A near-infrared method for determining the uniformity of micro-borneol in the production process of compound Danshen tablets was investigated.Method: The raw materials required for the mixing process were collected and prepared into different fractions according to a certain ratio

two ways of grinding and spraying were used to mix borneol into the dry extract.Uniform samples were sampled at different locations

the samples were scanned by near-infrared

and their thresholds and Euclidean distance parameters were calculated.The content of borneol in each sample was detected by GC.Result: When the threshold or the Euclidean distance was <0.01

GC results showed that RSD of borneol content was <10%

indicating that the borneol was uniformly mixed.When the threshold or the Euclidean distance was >0.01

GC results showed that RSD of borneol content was >30%

indicating that the borneol was mixed unevenly.Conclusion: The established method can effectively and quickly determine the uniformity of borneol mixing in compound Danshen tablets

it is recommended to be incorporated into internal control or national standards.

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