Objective To identify whole ingredients in Niuhuang Qingwei Pills (NQP) and give primary grade evaluation of NQP. Methods Firstly, microscopic characteristics specified by the statutory standard of NQP were summarized. Then new microscopic identification methods were established for Sennae Folium and Gypsum Fibrosum while new thin layer chromatography (TLC) identification methods were established for Bovis Calculus Artifactus, Borneolum Syntheticum, and Rhei Radix et Rhizoma. In addition, microscopic identification method for Menthae Haplocalycis Herba was improved. In this way, whole-ingredient identification of 17 materials were realized. NQP reference drug was developed and applied as accompanying control in whole-ingredient identification and primary grade evaluation of the samples. Results According to the results of 48 samples from 18 manufactures by primary grade evaluation, 10, 37, and 1 samples were classified as superior, qualified, and unqualified, respectively. Conclusion The proposed methods are accurate, simple, and objective, which offers a more comprehensive approach for quality control of NQP. And the methods provide research strategy and experimental basis for further work on establishment of grade standard.

OBJECTIVE: To discuss the quality status of TCM raw powder preparations based on TCM raw powder preparation special project of national post-market drug surveillance in 2018. METHODS: The statutory standards of seven TCM raw powder preparations, including Qingwei Huanglian pills, Jianpi pills, Qipi pills, Shangqing pills, Renshen Guipi pills, Yimu pills and Niuhuang Qingwei pills, were analyzed. The test methods for adulteration, dyeing, sulfur dioxide, pesticide residues, aflatoxins, heavy metals and harmful elements and irradiation were established to reveal the safety risk. Whole-ingredient identification methods were developed to evaluate the authenticity of the drug. RESULTS: The statutory standards of the TCM raw powder preparations tested in national post market surveillance in 2018 are simple and inadequate to comprehensively control the quality of the drugs. Unqualified feeding, adulteration, and contamination with Pb, As and Hg were the main problems currently. Dyeing, aflatoxins and pesticide residues were found in very few samples. Contamination risk of sulfur dioxide was low in TCM raw powder preparations. Most manufacturers adopted irradiation for sterilization. CONCLUSION: The standards of TCM raw powder preparations should be improved to realize whole-ingredient identification. And heavy metals and harmful elements should be investigated. The manufacturers should enhance quality control of the raw material and pay attention to the risk of adulteration and harmful residues. Special project of national post-market surveillance can reveal common problems of similar drugs, which is a powerful measure for drug regulation.

OBJECTIVE： To conduct a comprehensive and systematic qualitative investigation on chemical components in Shengmai injection. METHODS： Gas chromatography-mass spectroscopy (GC-MS) with pre-column derivatization, rapid resolution liquid chromatography-ion trap-tandem mass spectroscopy (RRLC-IT-MSn) and ion exchange chromatography (IEC) with post-column derivatization were applied in identification of saccharides, saponins, lignins and amino acids in the sample. Furthermore, preliminary investigation on test of macromolecules was performed using size exclusion chromatography-evaporative light scattering detection (SEC-ELSD). RESULTS： Fructose, glucose, sucrose, maltose, 5-hydroxymethyl-2-furaldehyde, 19 saponins, 14 lignins and 16 amino acids were found in Shengmai injection. CONCLUSION： The proposed methods are simple and accurate. The main chemical substantial basis of Shengmai injection is clarified, laying a foundation for further assay of chemical components.

OBJECTIVE: To investigate a rapid approach for quality evaluation of Huoxiang Zhengqi Tincture. METHODS: Hesperidin, glycyrrhizic acid, imperatorin, honokiol, isoimperatorin, magnolol and atractylodin in Huoxiang Zhengqi Tincture were determined by ultra performance liquid chromatography (UPLC) method combined with wavelength switching detection technology. The sample was injected directly without preprocessing. The separation was performed on an ACQUITY UPLC BEH C18 (2.1 mm×100 mm, 1.8 μm) and the column temperature was maitained at 40℃. The mobile phase was composed of acetonitrile and 0.1% phosphoric acid with gradient elution at a flaw rate of 0.3 mL·min-1. Hesperidin was detected at 284 nm; glycyrrhizic acid was detected at 250 nm; imperatorin, honokiol, isoimperatorin and magnolol were detected at 300 nm; atractylodin was detected at 340 nm. RESULTS: The calibration curves of the seven components showed good linearity within their test ranges. The average recoveries for hesperidin, glycyrrhizic acid, imperatorin, honokiol, isoimperatorin, magnolol and atractylodin were 99.3%, 99.5%, 101.5%, 99.3%, 100.6%, 99.0% and 99.6%, respectively. And there were great variations among the contents of glycyrrhizic acid, imperatorin, isoimperatorin and atractylodin in 28 batches of samples from 13 manufactures. CONCLUSION: The proposed method is accurate, simple and rapid, thus providing basis for comprehensive quality control of Huoxiang Zhengqi Tincture.

OBJECTIVE: To establish a rapid approach for quality evaluation of Huoxiang Zhengqi Tincture. METHODS: Fingerprint was established by ultra performance liquid chromatography (UPLC) method and method evaluation was performed. By comparing with reference substances, reference drugs and reference extractives, the characteristic peaks and their ascriptions were investigated. Twenty-eight batches of samples from 13 manufactures were determined and their fingerprints were compared. Then two dimensional hierarchical cluster analysis (2D-HCA) and principal analysis (PCA)were applied in pattern recognition. RESULTS: Eighteen characteristic peaks were mainly related to Magnoliae Officinalis Cortex, Citri Pericarpium Reticulatae, Angelicae Dahuricae Radix, Extractum Glycyrrhizae, Atractylodis Rhizoma and patchouli oil. The UPLC fingerprints of samples from different manufacturers differed a lot. The results of 2D-HCA and PCA were consistent, which indicated that the fingerprints of the samples from the same manufacturer could cluster to their own group and the characteristic peaks of honokiol, magnolol and hesperidin showed the greatest impact on the fingerprints. CONCLUSION: UPLC fingerprinting with aid of chemometric analysis is rapid, simple, objective and easy to realize digitalization, thus providing a novel way for quality evaluation of Huoxiang Zhengqi Tincture.

OBJECTIVE: To discuss quality control of Chinese patent medicine with animal ingredients, providing reference for standards improvement, quality supervision and regulated production. METHODS: Statutory standards and exploratory studies of Chinese patent medicines with animal ingredients tested in national post market surveillance between 2010 and 2014 were summarized. And technologies and methods developed for specific drugs were analyzed from the perspectives of safety, authenticity, effectiveness and controllability. RESULTS: Use of HPLC and GC is becoming more mature. Traditional microscopic and TLC methods can play a positive role in identification of animal drugs without index component. Mass spectrometry has been successfully applied in quality control of Chinese patent medicine with animal ingredients. CONCLUSION: National post market surveillance can provide comprehensive and elaborate evaluation on drug quality and can reveal potential risks. It's a powerful measure to promote quality of animal medicine.

OBJECTIVE: To evaluate and analyze the quality status of Huoxuezhitong powders and Huoxuezhitong capsules, providing reference for standards improvement, quality supervision and regulated production of related drugs. METHODS: Samples were tested according to the statutory standards. And exploratory study were carried out concerning safety, effectiveness, homogeneity and stability, using TLC, HPLC, UPLC, GC, LC-MS, ICP-MS, NIR and other techniques. New methods were established and adopted to investigate the quality of the preparations and their raw materials. RESULTS: All the samples met the requirements of the current specifications while the exploratory study could reflect the quality of the drugs in a more comprehensive way. CONCLUSION: The results suggest that the quality standards for Huoxuezhitong powders/capsules need to be improved and unified, and the manufacturers should pay attention to the quality of raw materials like olibanum, Eupolyphaga Steleophaga, pyritum, and borneolum syntheticum.

OBJECTIVE: To investigate the influence of extracting methods on the content of soluble arsenic in Chinese traditional patent medicine containing realgar. METHODS: Soluble arsenic in traditional Chinese medicines niuhuang xiaoyan tablets was determined by atomic fluorescence spectrometry. The impact of several factors on the determination result was discussed, such as extraction solvents, extraction methods, extraction time, compound extraction and purification method. Then methodological study on the optimized method was carried out. RESULTS: Samples from 14 different manufactures were extracted with simulated intestinal fluid for 24 h at 37°C and the contents of soluble arsenic were between 200 and 1353 mg · kg-1. CONCLUSION: The proposed method is simple, sensitive and accurate, and can provide reference for the quality assessment of TCM products containing realgar.

OBJECTIVE: To improve the quality standards of Huoxue Zhitong Powders and Huoxue Zhitong Capsules. METHODS: Angelicae Sinensis Radix, Olibanum and Borneolum Syntheticum were identified simultaneously by TLC method. Ferulic acid was detected by HPLC method. RESULTS: Clear spots were obtained with good separation in TLC identification. For the HPLC determination of ferulic acid, the calibration curve was linear in the range of 0.2-200 μg · mL-1, the limit of detection was 0.054 μg · mL-1 and recoveries were between 95%-105%. CONCLUSION: The proposed method is specific, accurate, simple and applicable for better control of Huoxue Zhitong Preparations' quality.

ObjectiveTo explore the effects of the serum of traditional Chinese medicine Nao Yi An on glutamate induced cell death in cultured hippocampal neurons of rat and the underlying mechanisms. MethodsHippocampal neurons were cultured. The excitatory amino acid induced toxicity on cultured neurons was investigated. The viability of injured neurons was determined with the measurement of Lactate dehydrogenase (LDH) activity. Mitogen activated protein kinase (MAPK) were determined by immunoprecipitation /kinase assays /western blot detection.ResultsThe serum of Nao Yi-An raised cell viability. The serum of Nao Yi-An upregulated the expression of extracellular regulated protein kinases(ERK) and downregulated the expression of c-Jun N terminal kinase/stress activited protein kinase(JNK) in cultured neurons. The serum of Nao Yi-An induced upregulation of ERK and its anti death action were prevented with the specific ERKs inhibitor PD98059. Conclusions Activation of ERK signaling together with inhibition of JNK signaling by Chinese medicine Nao Yi-An appears to be an important mechanism for its survival effects on cultured hippocampal neurons.