Improvement on Quality Standard of Yuanhu Zhitong Oral Liquid / 中国实验方剂学杂志

ObjectiveTo improve the quality standard of Yuanhu Zhitong oral liquid in order to strengthen the quality control of this oral liquid. MethodThin layer chromatography（TLC） was used for the qualitative identification of Corydalis Rhizoma and Angelicae Dahuricae Radix in Yuanhu Zhitong oral liquid by taking tetrahydropalmatine， corydaline reference substances and Corydalis Rhizoma reference medicinal materials as reference， and cyclohexane-trichloromethane-methanol（5∶3∶0.5） as developing solvent， Corydalis Rhizoma was identified using GF254 glass thin layer plate under ultraviolet light（365 nm）. And taking petroleum ether（60-90 ℃） -ether-formic acid（10∶10∶1） as developing solvent， Angelicae Dahuricae Radix was identified using a silica gel G TLC plate under ultraviolet light（305 nm）. High performance liquid chromatography（HPLC） was performed on a Waters XSelect HSS T3 column（4.6 mm×250 mm， 5 μm） with acetonitrile（A）-0.1% glacial acetic acid solution（adjusted pH to 6.1 by triethylamine）（B） as the mobile phase for gradient elution（0-10 min， 20%-30%A； 10-25 min， 30%-40%A； 25-40 min， 40%-50%A； 40-60 min， 50%-60%A）， the detection wavelength was set at 280 nm， then the fingerprint of Yuanhu Zhitong oral liquid was established， and the contents of tetrahydropalmatine and corydaline were determined. ResultIn the thin layer chromatograms， the corresponding spots of Yuanhu Zhitong oral liquid， the reference substances and reference medicinal materials were clear， with good separation and strong specificity. A total of 12 common peaks were identified in 10 batches of Yuanhu Zhitong oral liquid samples， and the peaks of berberine hydrochloride， dehydrocorydaline， glaucine， tetrahydropalmatine and corydaline. The similarities between the 10 batches of samples and the control fingerprint were all >0.90. The results of determination showed that the concentrations of corydaline and tetrahydropalmatine had good linearity with paek area in the range of 0.038 6-0.193 0， 0.034 0-0.170 0 g·L-1， respectively. The methodological investigation was qualified， and the contents of corydaline and tetrahydropalmatine in 10 batches of Yuanhu Zhitong oral liquid samples were 0.077 5-0.142 9、0.126 1-0.178 2 g·L-1， respectively. ConclusionThe established TLC， fingerprint and determination are simple， specific and reproducible， which can be used to improve the quality control standard of Yuanhu Zhitong oral liquid.

Chromatographic fingerprint and quality consistency of colistimethate sodium / 中国药科大学学报

@#The UPLC fingerprint of colistimethate sodium was established for the study of quality consistency.The chromatographic column was Acquity UPLC? Peptide CSH C18 (2.1 mm × 150 mm, 1.7 μm).The mobile phase A was phosphate buffer-acetonitrile (19∶1), and the mobile phase B was phosphate buffer-acetonitrile (1∶1).The mobile phase was in gradient elution at a flow rate of 0.3 mL/min.The column temperature was set at 30 °C and the detection wavelength was 210 nm.The similarity of the fingerprints was analyzed with the Similarity Evaluation System for Chromatographic Fingerprint of Tradition Chinese Medicine (Version 2012) in combination with content determination of multiple index components to evaluate the quality consistency of imported and domestic bulk drugs.The result showed that both the original and generic bulk drugs met the specified limit requirements in the European Pharmacopoeia standards, and that their UPLC fingerprints were highly similar, indicating that the quality of the two substances was consistent.Establishing a fingerprint for similarity evaluation and combining it with the results of indicator component content determination as a comprehensive evaluation method for the study of drug quality consistency of complex components has the characteristics of fast, accurate, and comprehensive, which is helpful for drug quality evaluation and provides ideas for the evaluation of antibiotic quality consistency of complex components.

Study on HPLC fingerprint and chemical pattern recognition of Mongolian medicine Sanzisan / 中国药房

OBJECTIVE To establish the HPLC fingerprint of Mongolian medicine Sanzisan ，and to evaluate its internal quality by chemical pattern recognition technique comprehensively. METHODS HPLC method was used. Using geniposide as reference，HPLC fingerprints of 15 batches of Sanzisan were drawn with Similarity Evaluation System of TCM Chromatogram Fingerprint（2012 edition）. Similarity evaluation and common peaks identification were conducted. Combined with cluster analysis （CA），principal component analysis （PCA），and orthogonal partial least squares-discriminant analysis （OPLS-DA），the quality of 15 batches of Sanzisan was evaluated ，and the differential markers that affected its quality were screened. RESULTS There were 29 common peaks in 15 batches of Sanzisan ，and the similarity was no less than 0.952，indicating that the chemical composition of the 15 batches of Sanzisan had good consistency. A total of 13 common peaks were identified ，which were chebulic acid ，gallic acid，punicalin，punicalagin A ，punicalagin B ，jasminoside B ，caffeic acid ，corilagin，geniposide，chebulagic acid ，1，2，3，4，6- O-galloylglucose，chebulinic acid ，ellagic acid. Both CA and PCA could divide 15 batches of Sanzisan into four categories ，and the classification results were consistent ，indicating that the quality of 15 batches of Sanzisan had certain differences. Fourteen differential markers （chebulic acid ，gallic acid ，ellagic acid ，etc）that lead to the quality difference between batches were screened out by OPLS-DA. CONCLUSIONS Established HPLC fingerprint analysis method is simple and stable. Combined with chemical pattern recognition analysis ，it can be used for the quality control of Sanzisan.

Establishment of UPLC Fingerprint and Quantitative Analysis of Multi-components of Shengyutang / 中国实验方剂学杂志

Objective:To establish ultra performance liquid chromatography （UPLC） fingerprint of Shengyutang and quantitative analysis method of 11 index components in this famous classical formula. Method:UPLC-diode array detector/evaporative light scattering detector （UPLC-PDA/ELSD） was used， two chromatographic conditions were established by different detectors according to the polarity of chemical components. Conditions of fingerprint 1 were as follows：ACQUITY UPLC HSS T₃ column （2.1 mm×100 mm， 1.8 µm） with the mobile phase of acetonitrile （A）-0.6% formic acid solution （C） for gradient elution （0-4 min， 0-4%A； 4-8 min， 4%A； 8-9 min， 4%-8%A； 9-14 min， 8%-9%A； 14-21 min， 9%-15%A； 21-26 min， 15%-17%A； 26-30 min， 17%-20%A； 30-35 min， 20%-32%A； 35-40 min， 32%-40%A； 40-50 min， 40%-80%A； 50-55 min， 80%A）， the flow rate of 0.3 mL·min^-1， PDA with detection wavelengths of 280 nm and 321 nm， the column temperature at 30 ℃. Conditions of fingerprint 2 were as follows：the CORTECS C₁₈ column （3.0 mm×100 mm， 2.7 µm） with the mobile phase of acetonitrile （A）-water （D） for gradient elution （0-11 min， 19%A； 11-16 min， 19%-25%A； 16-34 min， 25%-28%A； 34-47 min， 28%-47%A； 47-60 min， 47%-80%A）， the flow rate of 0.4 mL·min^-1， ELSD with drift tube temperature of 95 ℃， the carrier gas （air） flow rate of 2.0 L·min^-1， and the column temperature at 30 ℃. UPLC-PDA/ELSD fingerprints of 15 batches of Shengyutang were established， and the similarity was evaluated by similarity evaluation system of chromatographic fingerprint of traditional Chinese medicine （2012 edition） issued by the Chinese Pharmacopoeia Commission， and the contents of eleven index components in this famous classical formula were determined. Result:The similarities of UPLC-PDA/ELSD fingerprints of 15 batches of Shengyutang were >0.98 by comparing with the control fingerprint， 27 and 16 common peaks were identified in fingerprint 1， 2， respectively. It was tested and verified that the precision， repeatability， stability， linear relationship and other results of this method all met the requirements of the 2020 edition of <italic>Chinese Pharmacopoeia</italic>. The contents of chlorogenic acid， ferulic acid， calycosin glucoside， verbascoside， senkyunolide I， senkyunolide H， senkyunolide A， ginsenoside Rg₁， ginsenoside Re， ginsenoside Rb₁ and astragaloside A in 15 batches of Shengyutang were 0.063-0.193， 0.509-0.638， 0.160-0.318， 0.012-0.056， 0.394-0.519， 0.110-0.143， 0.031-0.097， 0.382-0.595， 0.292-0.505， 0.590-0.803， 0.142-0.367 mg·g^-1， respectively. Conclusion:The established detection method meets the requirements of the 2020 edition of <italic>Chinese Pharmacopoeia</italic>， which can characterize the overall characteristics of chemical components in Shengyutang， and provide experimental basis for the quality standard research of this famous classical formula.

The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugs / 药学学报

Based on the "requirements on the submitted documents for consistency evaluation of generic oral solid dosage forms of chemical drugs" and relevant guidance, this article summarized and formulated the decision tree of in vitro consistency evaluation of oral solid generic drugs, discussed the differences and common problems of in vitro evaluation research projects under different conditions, selective analyzed the technical requirements and concern problems of unconventional research projects, and proposed corresponding recommendations for concern problems, in order to provide more references for the follow-up study on consistency evaluation of oral solid generic drugs.

Comprehensive analysis of components in Chinese medicines derived from Apocynum venetum and Poacynum pictum in Xinjiang based on HPLC fingerprint and chemometrics / 中国中药杂志

This study established high-performance liquid chromatography(HPLC) fingerprints of Chinese medicines derived from Apocynum venetum and Poacynum pictum in Xinjiang and explored their composition differences with the combination of content determination, similarity analysis, cluster analysis and principal component analysis. The HPLC conditions included Phenomenex Kinetex C_(18) column(4.6 mm ×100 mm, 2.6 μm), acetonitrile-0.01% trifluoroacetic acid aqueous solution as mobile phase, gradient elution, flow rate of 0.6 mL·min~(-1), detection wavelength of 281 nm and column temperature of 25 ℃. The content of chlorogenic acid, quercetin-3-O-sophoroside, rutin, hyperin, isoquercitrin, trifolin and astragalin was determined in 31 batches of medicinal materials, and fingerprint research and chemometric analysis were performed with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2004 A) and SPSS 21.0. In the Chinese Pharmacopoeia 2020, the quality of Apocyni Veneti Folium is controlled by character identification, microscopic identification, thin layer chromatography identification and quantitative determination of hyperin. There were 21 common peaks of A. venetum and P. pictum in the HPLC fingerprints, 5 of which were identified as chlorogenic acid, hyperin, isoquercitrin, trifolin and astragalin, with their content also determined. Except for 3 batches of medicinal materials, the similarity of other 28 batches was higher than 0.83, indicating good similarity. Two categories were formed in the cluster analysis based on content determination, which showed that some differences existed in similarities between different regions of Xinjiang. The medicinal materials were ranked by quality with principal component analysis, and the results indicated that the top 15 all came from northern Xinjiang. The quality difference of A. venetum and P. pictum had a correlation with the place of origin. This study provides a reference for the analysis and evaluation of A. venetum and P. pictum from different habitats and the selection of introduction and cultivation areas.

Quality evaluation of Erigeron breviscapus from different origins and its related species by HPLC coupled with chemometrics / 中草药

Objective: To establish the HPLC fingerprint for effective quality control and scientific evaluation of Erigeron breviscapus. Methods: Separation was performed on a Zorbax SB-C18 column (150 mm × 4.6 mm, 5 μm) and the mobile phase was methanol-0.1% phosphoric acid with gradient elution. The flow rate at 1 mL/min, the column temperature at 30 oC, and the detection wavelength at 335 nm. A total of 19 batches of E. breviscapus and its related species were analyzed. Similarity evaluation combined with hierarchical clustering analysis (HCA) and principal components analysis (PCA) were used to evaluate the quality of herbs from different batches. Results: The HPLC fingerprint of E. breviscapus was established with 11 common peaks, and five peaks were identified. Similarities of the 19 batches of samples were 0.873-0.978. Two batches of samples from its related species were high similarity. These 19 batches of samples could be classified into three clusters. The PCA result was consistent with HCA. The comprehensive score of S5 was the highest and the quality was the best. There was possibility for using E. multiradiatus as herbs instead of E. breviscapus. Conclusion: The establishment of HPLC fingerprint and the recognition of chemical pattern can provide a more comprehensive reference for the quality control of herbs.

Analysis of HPLC Fingerprint and Their Multicomponent Chemical Pattern Recognition of Puerariae Lobatae Radix from Different Habitats and Puerariae Thomsonii Radix / 中国实验方剂学杂志

Objective: To establish HPLC specific chromatograms of Puerariae Lobatae Radix(PLR) and Puerariae Thomsonii Radix(PTR), and make a distinction about their species and different habitats of PLR by chemical pattern recognition, provide reliable methods for scientific evaluation and effective control of their quality. Method: HPLC was employed to determine the contents of chemical ingredients in 23 batches of PLR and PTR.The similarity analyzed with "Similarity Evaluation System for Chromatographic Fingerprint of Chinese Materia Medica"(version of 2004A), then a common pattern was established.Based on its chemical fingerprint information, the quality of PLR and PTR was comprehensively analyzed by three kinds of chemical pattern recognition methods. Result: In addition to sample S22(from Shaanxi province), the similarities of 23 batches of samples were more than 0.9, which showed that similarity of PLR and PTR was good, this method can not differentiate them.Principal component analysis(PCA) could only identify PLR and PTR, but partial least squares-discriminant analysis(PLS-DA) could distinguish PLR from PTR and the producing areas of PLR with model interpretation of 96.4% and prediction of 74.6%.The result of hierarchical cluster analysis(HCA) was consistent with PLS-DA. Conclusion: Chemical pattern recognition method can make a distinction between PLR and PTR, as well as different habitats of PLR;it is suitable for quality control of their medicinal materials.

Investigation of Compatible Stability of Xingnaojing Injection Based on HPLC Fingerprint and Principal Component Analysis / 中国实验方剂学杂志

Objective:To investigate the compatible stability of Xingnaojing injection in combination with 9 common medicines, and to provide a reference for clinical application of this injection. Method:According to the clinical application, Xingnaojing injection was mixed with 9 common medicines and placed in the room under dark and light conditions for 6 h. The appearance of compatible solutions was observed, and the HPLC fingerprint was analyzed by similarity evaluation and principal component analysis(PCA). Result:There were no significant changes in the appearance of compatibility of Xingnaojing injection and 9 common medicines, including piracetam and sodium chloride injection, sodium chloride injection and others. The similarities of fingerprint among compatibility of Xingnaojing injection and 9 common medicines were >0.98 at 0 h of compatibility, 6 h of placement and 6 h of illumination. The results of PCA showed that 9 groups of compatible solutions were clustered into 2 categories, the compatibility of Xingnaojing injection and 8 groups including piracetam and sodium chloride injection clustered into one category, and the relative peak areas of the characteristic components of Xingnaojing injection did not change significantly after compatibility, the compatibility of Xingnaojing injection and Danshen Chuanxiongqin injection clustered into another category, the relative peak areas of some characteristic components of Xingnaojing injection increased after compatibility of 0 h and 6 h,and it was more obvious after 6 h of illumination. Conclusion:The compatibility of Xingnaojing injection and 8 common medicines including piracetam and sodium chloride injection has good stability, while the compatibility has stability problems after Xingnaojing injection mixed with Danshen Chuanxiongqin injection. It is suggested that clinical attention should be paid to their compatibility and rational combination of medicines.

Qualitative evaluation of Forsythia suspensa by HPLC-PDA fingerprint combined with UFLC-Q-TOF-MS qualitative identification / 中国中药杂志

The analysis of Forsythia suspensa was performed on Waters Symmetry C18 column( 4. 6 mm×250 mm,5 μm) and mobile phase was methanol( A)-0. 1% formic acid aqueous solution( B) with the elution gradient. Column temperature was maintained at 30℃,and the flow rate was 1. 0 m L·min-1 with detection wavelength 265 nm. The HPLC-PDA fingerprint of F. suspensa was optimized.Chemical constituents in F. suspensa were analyzed by UFLC-Q-TOF-MS in positive and negative ion mode. The quality of 48 batches of F. suspensa from different habitats,processing methods and specifications was evaluated by similarity evaluation and cluster analysis.The 18 common peaks were confirmed. The similarity of F. suspensa from different habitats was more than 0. 98,and 56 chemical constituents were identified. Different processing methods had great influence on the quality of F. suspensa. Compared with boiled and direct drying,the quality of F. suspensa processed by sun-drying was obviously decreased. The similarity was about 0. 58. Different specifications of F. suspensa also had obvious distinction,and the similarity was about 0. 78. The effective components of grown F. suspensa,such as forsythoside A and phillyrin,were significantly reduced. The results of cluster analysis were basically consistent with the results of similarity evaluation. The establishment of fingerprint and the recognition of chemical pattern of F. suspensa can provide a more comprehensive reference for the quality control of herbs.

Establishment of UPLC Fingerprint ，Cluster Analysis and Principal Component Analysis of Fortunella margarita / 中国药房

OBJECTIVE： To establish UPLC fingerprint of Fortunella margarita， and to conduct its cluster analysis and principal component analysis. METHODS： UPLC method was adopted. The determination was performed on Waters Acquity UPLC BEH C18 column with mobile phase consisted of acetonitrile-0.1％ phosphoric acid solution （gradient elution） at the flow rate of 0.3 mL/min. The detection wavelength was set at 330 nm， and sample size was 2 μL. Using fortunellin as reference， UPLC fingerprints of 8 batches of F. margarita were determined. The similarity of 8 batches of samples was evaluated by TCM Chromatographic Fingerprint Similarity Evaluation System（2012 edition） to confirm common peak. Cluster analysis and principal component analysis were performed by using SPSS 24.0 software. RESULTS： There were 24 common peaks in UPLC fingerprints of 8 batches of sample，the similarity of which was higher than 0.97. Cluster analysis showed that 8 batches of samples were clustered into 2 categories. S1， S2， S3， S4， S6， S7 and S8 were clustered into one category； S5 was clustered into the other category. By principal component analysis， the accumulative contribution rate of three main components was 81.366％. CONCLUSIONS： Established UPLC fingerprint， the results of cluster analysis and principal component analysis can provide reference for quality control of F. margarita.

Fingerprint study of Picrorhiza scrophulariiflora by UPLC coupled with chemometrics method / 中草药

Objective To establish the UPLC fingerprint for effective quality control and scientific evaluation of Picrorhiza scrophulariiflora. Methods The analysis was performed on Waters ACQUITY UPLC BEH C18 column (100 mm × 2.1 mm, 1.7 μm), using acetonitrile-0.5% glacial acetic acid aqueous solution as mobile phase for gradient elution, with the flow rate at 0.3 mL/min, the column temperature at 32 ℃, and the detection wavelength at 295 nm. Total of 25 batches of P. scrophulariiflora and its adulterants were analyzed. Similarity evaluation combined with hierarchical clustering analysis (HCA) and principal components analysis (PCA) were used to evaluate the quality of herbs from different batches. Ultra-performance liquid chromatography- quadrupole time-of-flight tandem mass spectrometry (UPLC-Q-TOF/MS) was used for qualitative analysis in the positive and negative ion modes. Results There were significant differences in fingerprint chromatogram among P. scrophulariiflora and its adulterants. There were 16 common peaks in UPLC fingerprint of 22 batches of P. scrophulariiflora, and 12 peaks among which were carried out for chemical components identification with the similarity at 0.939-0.998. Twenty-two samples could be classified into three clusters. The PCA result was consistent with that of HCA. The four symbolic compounds in samples were verified by PLS-DA analysis, which identified that No.1, 12, 9 peaks were picroside I, picroside III, and scrophenoside C. Conclusion The establishment of UPLC fingerprint and the recognition of chemical pattern of P. scrophulariiflora can provide a more comprehensive reference for the quality control of herbs.

Quality Assessment on Zhengtian Pills Based on HPLC Fingerprint and Multi-components Simultaneous Determination / 中国药师

Objective:To establish an HPLC fingerprint and determine five compounds in Zhengtian pills to provide reference for the effective quality control.Methods:The analysis was carried out on an Agilent XDB-C18analytical column (250 mm × 4.6 mm,5 μm) with gradient elution by acetonitrile (A) -0.19% phosphoric acid solution (B) (0-8 min,10 % A→15% A;10-23 min,15 % A→45 % A;23-50 min,45 % A;50-60 min,45 % A→70 % A;60-70 min,70 % A),the detection wavelength was 310 nm and the flow rate was 1.0 ml/min. The column temperature was 30 ℃. Similarity evaluation was used to evaluate the fingerprints of 12 batches of Zhengtian pills,and five marker components were quantified. Results:There were 33 common peaks in the fingerprints of twelve batches of Zhengtian pills, and five of them (ferulic acid, prim-O-glucosylcimifugin, 5-O-methylvisammioside,imperatorin and isoimperatorin) were identified by comparison with the reference. The similarity of the 12 batches of samples was over 0.99. The linear ranges were 0.050-0.605 μg(r = 0.999 8),0.008-0.100 μg(r = 0.999 2), 0.013-0.150 μg(r = 0.998 6), 0.171- 2.049 μg(r = 0.999 7)and 0.113- 1.352 μg(r = 0.999 6) for ferulic acid, prim-O-glucosylcimifugin,5-O-methylvisammioside, imperatorin and isoimperatorin, respectively. The content of ferulic acid, prim-O-glucosylcimifugin,5-O-methylvisammioside,imperatorin and isoimperatorin was 0.78-0.84 mg/g,0.10-0.13 mg·g-1, 0.18-0.20 mg·g-1,2.44-2.51 mg·g-1and 1.70-1.78 mg·g-1in the 12 batches of samples, respectively. Conclusion:The established method has high sensitivity and specificity,which can be used for the quality control of Zhengtian pills.

Research progress on chromatographic fingerprint similarity evaluation method for traditional Chinese medicine in the past 30 years（1988-2017）and its prospect / 中国中药杂志

Over the past 30 years, the chromatographic fingerprint technology of traditional Chinese medicine (TCM) has been developed from academic discussion to application for the research and development of TCM which has promoted the technological innovation of Chinese medicine industry and the progress of quality standard of TCM. The similarity evaluation method of chromatographic fingerprint of TCM has played a key role in this process. According to the number of literature and research tendency in terms of the chromatographic fingerprint in the last 30 years, the chromatographic fingerprint evaluation could be divided into three stages: the direct comparison stage (1988-1999), similarity evaluation stage (2000-2009) and the similarity evaluation development stage (2010-2017). In this paper, the research progress of chromatographic fingerprints similarity evaluation of TCM in the last 30 years and its prospect were discussed, which may lead to a more mature stage for this method.

Study on the HPLC Fingerprint of Gynecological Lotion / 中国药师

Objective:To establish the HPLC fingerprint detection method for gynecological lotion. Methods:Wondasil C18 (250 mm × 4. 6 mm,5 μm)was selected as the analytical column. The mobile phase was composed of acetonitrile-0. 3% phosphric acid and 0. 3% diethylamine solution with gradient elution at a flow rate of 1. 0 ml·min-1 . The detection wavelength was set at 284 nm and the column temperature was 30℃. Ten batches of gynecological lotion were detected by the HPLC fingerprint and evaluated by Chromato-graphic Fingerprint Evaluation System of Chinese Medicine (2004 edition). Results: The separated peaks were clear and 15 common peaks were identified in the fingerprint of 10 batches of gynecological lotion. Conclusion: The HPLC fingerprint is with good repeat-ability and stability, which can provide evidence for the quality control of gynecological lotion.

HPLC fingerprint identification of Lonicera Japonica Flos and Lonicera Flos / 中草药

Objective: To compare the differences between Lonicera Japonica Flos and Lonicera Flos by establishing HPLC fingerprint and calculating the similarity. Methods: The columns was Phenomenex Luna 5 μm C18 (2) 100 A, 250 mm×4.6 mm; The column temperature was 40℃. The mobile phase was acetonitrile-0.5% phosphoric acid, the flow rate was 1 mL/min, and the wavelength was 350 nm. Results: HPLC fingerprint of Lonicera Japonica and similarity evaluation by screening large peak integration were established. The similarity of 12 batches of Lonicera Japonica Flos were all above 0.95, and four batches of Lonicera Flos were less than 0.80. Conclusion: HPLC fingerprint profiles under 350 nm can reflex the differences between Lonicera Japonica Flos and Lonicera Flos effectively; Similarity evaluation by screening large peak integration shows the tiny differences of chemical component.

Studies on correlation for GC-MS fingerprints of Blumea balsamifera and its extracts / 中草药

Objective: To establish a GC-MS fingerprint method of Blumea balsamifera (BB), Aifen, and Blumea balsamifera oil (BBO), and make a correlation study of the results. Methods: A GC-MS method was developed for the fingerprint analysis of BB, Aifen, and BBO. Then the CHROMAP 1.5 fingerprint system software was used for processing the results as setting up their common patterns, painting the common peaks and evaluating the similarity, and according to the NIST11 standard mass spectrometry database the common peaks would be analyzed. Results: The GC-MS fingerprints of BB, Aifen, and BBO were established. There were 40 common peaks in common fingerprints of BB, 17 of Aifen, and 31 of BBO were painted and all of BB, 13 of Aifen, and 25 of BBO were identified. The similarty of BB was 0.632-0.989, the extractions were greater than 0.900. BB and its extract had a good correlation between fingerprints. Conclusion: The study is simple, accurate, and reliable, which can be used for identification and quality control of BB, Aifen, and BBO.

HPLC fingerprint of Sinopodophylli Radix et Rhzoma / 中草药

Objective: The HPLC fingerprint of Sinopodophylli Radix et Rhzoma was established, which provided the basis for the identification and quality evaluation of the medicinal materials. Methods: The chromatographic separation was performed on a Thermo HyPURITY C18 column (250 mm × 4.6 mm, 5 μm) using methanol (A)-0.4% orthophosphoric acid (B) as mobile phase with gradient elution. The column temperature was 25 ℃, the flow rate was 0.8 mL/min, the detection wavelength was set at 290 nm, and the injection volume was 10 μL. The fingerprints were compared for similarity using "Traditional Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System" (2004 A) issued by Chinese Pharmacopoeia commission and cluster analysis in SPSS 19.0. Results: HPLC fingerprint of Sinopodophylli Radix et Rhzoma had 17 common peaks, and eight of them were identified. In the similarity evaluation, The HPLC fingerprint of 19 batches of Sinopodophylli Radix et Rhzoma had a similarity ratio of more than 0.9 when compared with the mutual mode HPLC fingerprints. The overall similarity was good, and the cluster analysis result was basically the same as the similarity evaluation result. Conclusion: The HPLC fingerprint of Sinopodophylli Radix et Rhzoma can provide more comprehensive reference for its identification and quality evaluation.

HPLC fingerprint and determination of multi-components in Chitong Xiaoyanling Granules / 中草药

Objective To establish an HPLC fingerprint and to determine six compounds in Chitong Xiaoyanling Granules (CXG) for reference of the effective quality control. Methods The analysis was carried out on an analytical column Dikma Luster ODS (250 mm × 4.6 mm, 5 μm) with gradient elution by methanol (A)-0.1% phosphoric acid solution (B) (0-15 min, 20%-30% A; 15-30 min, 30% A; 30-40 min, 30%-60% A; 40-55 min, 60% A), at the detection wavelengths of 254, 283, 274, and 300 nm and a flow rate of 1.0 mL/min. The column temperature was 30 ℃. Similarity evaluation software was used to evaluate the fingerprint of 10 batches of CXG, and the six marker components were quantified. Results The common mode of the fingerprint was set up with 18 common peaks, and six of them were identified by comparison with the reference. The similar degrees of 10 batches of samples were over 0.9, they were prim-O-glucosylcimifugin, 4'-O-β-D-glucosyl-5-O-methylvisamminol, pulegone, hesperidin, paeonol, and isoimperatorin. The linear ranges were 0.013-0.505 mg/mL (r = 0.999 8), 0.052-2.097 mg/mL (r = 0.999 2), 0.019-0.772 mg/mL (r = 0.998 9), 0.025-1.003 mg/mL (r = 0.999 1), 0.006-0.251 mg/mL (r = 0.999 5), and 0.014-0.576 mg/mL (r = 0.999 4) for prim- O-glucosylcimifugin, 4'-O-β-D-glucosyl-5-O-methylvisamminol, pulegone, hesperidin, paeonol, and isoimperatorin, respectively. The contents of prim-O-glucosylcimifugin, 4'-O-β-D-glucosyl-5-O-methylvisamminol, pulegone, hesperidin, paeonol, and isoimperatorin were 7.267-7.333, 4.260-4.522, 2.033-2.093, 12.234-12.771, 19.023-19.334, and 11.152-11.291 mg/g in 10 batches of samples, respectively. Conclusion The established method has high sensitivity and specificity, and can be used for the quality control of CXG.

Study on HPLC fingerprint of Valeriana jatamansi / 中草药

Objective To study the fingerprint of Valeriana jatamansi by HPLC, which can be used for the evaluation of its quality control. Methods The Phenomenex Gemini C18 (250 mm × 4.6 mm, 5 μm) column was used with a mobile phase of methyl acetonitrile (A)-0.1% phosphoric acid (B) gradient elution, the flow rate was 1.0 mL/min, the column temperature was 25 ℃, and the detection wavelength was 254 nm. Above all these would be used for determining the fingerprint. Results There were 17 common peaks were found in the fingerprint of V. jatamansi, within six peaks were identified. The similarity degrees of 15 batches of samples were more than 0.89. Three principal components were abstractly represented 17 components and evalusted. Conclusion The established method is simple, fast, reliable, and can be used for evaluating the quality of V. jatamansi.