PMID- 31713245
OWN - NLM
STAT- MEDLINE
DCOM- 20200601
LR  - 20200601
IS  - 2042-7158 (Electronic)
IS  - 0022-3573 (Linking)
VI  - 72
IP  - 1
DP  - 2020 Jan
TI  - Development of an on-line Raman spectral analytical method for monitoring and 
      endpoint determination of the Cornu Caprae Hircus hydrolysis process.
PG  - 132-148
LID - 10.1111/jphp.13186 [doi]
AB  - OBJECTIVES: Cornu Caprae Hircus (goat horn, GH), a medicinal animal horn, is 
      frequently used in traditional Chinese medicine, and hydrolysis is one of the 
      most important processes for GH pretreatment in pharmaceutical manufacturing. In 
      this study, on-line Raman spectroscopy was applied to monitor the GH hydrolysis 
      process by the development of partial least squares (PLS) calibration models for 
      different groups of amino acids. METHODS: Three steps were considered in model 
      development. In the first step, design of experiments (DOE)-based preprocessing 
      method selection was conducted. In the second step, the optimal spectral 
      co-addition number was determined. In the third step, sample selection or 
      reconstruction methods based on hierarchical clustering analysis (HCA) were used 
      to extract or reconstruct representative calibration sets from the pool of 
      hydrolysis process samples and investigated for their ability to improve model 
      performance. KEY FINDINGS: This study has shown the feasibility of using on-line 
      Raman spectral analysis for monitoring the GH hydrolysis process based on the 
      designed measurement system and appropriate model development steps. CONCLUSIONS: 
      The proposed Raman-based calibration models are expected to be used in GH 
      hydrolysis process monitoring, leading to more rapid material information 
      acquisition, deeper process understanding, more accurate endpoint determination 
      and thus better product quality consistency.
CI  - (c) 2019 Royal Pharmaceutical Society.
FAU - Yan, Xu
AU  - Yan X
AD  - Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, 
      Zhejiang University, Hangzhou, China.
FAU - Li, Wenlong
AU  - Li W
AD  - Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, 
      Zhejiang University, Hangzhou, China.
AD  - College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin 
      University of Traditional Chinese Medicine, Tianjin, China.
FAU - Zhang, Xiaoli
AU  - Zhang X
AD  - Shanghai Kaibao Pharmaceutical Co., Ltd, Shanghai, China.
FAU - Liu, Shaoyong
AU  - Liu S
AD  - Shanghai Kaibao Pharmaceutical Co., Ltd, Shanghai, China.
FAU - Qu, Haibin
AU  - Qu H
AUID- ORCID: 0000-0002-9877-4316
AD  - Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, 
      Zhejiang University, Hangzhou, China.
LA  - eng
GR  - 2018ZX09201011-002/National Science and Technology Major Project of China/
GR  - ZYBZH-C-SH-48/National Project for Standardization of Chinese Materia Medica/
PT  - Journal Article
DEP - 20191111
PL  - England
TA  - J Pharm Pharmacol
JT  - The Journal of pharmacy and pharmacology
JID - 0376363
RN  - 0 (Amino Acids)
RN  - 0 (Tissue Extracts)
SB  - IM
MH  - Amino Acids/*analysis
MH  - Animals
MH  - Cluster Analysis
MH  - Endpoint Determination
MH  - Feasibility Studies
MH  - *Goats
MH  - Horns/*chemistry
MH  - Hydrolysis
MH  - Least-Squares Analysis
MH  - Medicine, Chinese Traditional
MH  - *Spectrum Analysis, Raman
MH  - Tissue Extracts/*chemistry
OTO - NOTNLM
OT  - Raman spectroscopy
OT  - hydrolysis process monitoring
OT  - preprocessing method selection
OT  - sample selection or reconstruction
OT  - traditional Chinese medicine
EDAT- 2019/11/13 06:00
MHDA- 2020/06/02 06:00
CRDT- 2019/11/13 06:00
PHST- 2019/08/17 00:00 [received]
PHST- 2019/10/21 00:00 [accepted]
PHST- 2019/11/13 06:00 [pubmed]
PHST- 2020/06/02 06:00 [medline]
PHST- 2019/11/13 06:00 [entrez]
AID - 10.1111/jphp.13186 [doi]
PST - ppublish
SO  - J Pharm Pharmacol. 2020 Jan;72(1):132-148. doi: 10.1111/jphp.13186. Epub 2019 Nov 
      11.