Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia.

As an important branch of medicine, Traditional Chinese Medicine (TCM) has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia. The Chinese Pharmacopoeia (ChP) is a drug code formulated by the Chinese government, and it includes a special volume for the monographs of TCM, which plays an important role in ensuring the quality of drugs. The use of quality control technology has always been a complex and important factor in TCM. Owing to the chemical diversity of TCM, chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP. This article provides an overview of the classical and modern chromatographic technologies applied in the ChP, and summarizes the advantages and disadvantages of each technique in the TCM monographs. In 2020, the new edition of the ChP (the 2020 edition) has been implemented at the end of 2020. This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.

[Ingredients changes in Rehmanniae Radix processing based by HPLC-ELSD specific chromatogram].

To establish the HPLC-ELSD specific chromatogram analysis method of Rehmanniae Radix and Rehmanniae Radix Prae-parata, and analyze and compare their chemical compositions, so as to reveal the change regularity of compositions during the proces-sing. By HPLC-ELSD method, the chromatographic column for Prevail Carbohydrate ES(4.6 mm ×250 mm, 5 µm) was adopted, with acetonitrile(A)-water(B) as mobile phase for gradient elution, and the evaporative light-scattering detector was used. A total of 23 batches of Rehmannia Radix samples, and 25 batches of Rehmanniae Radix Praeparata samples and processing dynamic samples were compared. The established method had a great repeatability, precision and stability. Eight common chromatographic peaks were extracted from 23 batches of Rehmanniae Radix samples, 8 common peaks were extracted from 25 Rehmanniae Radix Praeparata, and 7 chromatographic peaks were identified. The composition ratio of Rehmannia Radix was changed greatly during the processing. When the simila-rity≥0.95 and the fructose peak area was more than 2 times of stachyose tetrahydrate or more than 20 times of raffinose, the processing degree conformed to the requirements of empirical identification. The three main oligosaccharides of Rehmanniae Radix were sucrose that was heated to generate fructose and glucose, stachyose tetrahydrate that was heated to generate melibiose, sucrose and fructose, and stachyose tetrahydrate that was heated to generate manninotriose. The change in the index of proportion between monosaccharides and oligosaccharides can be used as the quantitative criterion for the processing quality of Rehmanniae Radix Praeparata.

Innovative health risk assessment of heavy metals in Chinese herbal medicines based on extensive data.

In the present study, the concentrations of lead (Pb), cadmium (Cd), arsenic (As), mercury (Hg), and copper (Cu) in 2245 batches of Chinese herbal medicines (CHMs) were measured using inductively coupled plasma-mass spectroscopy (ICP-MS). We developed a risk assessment strategy that assessed the heavy metal-associated health risk of CHMs based on our large dataset. Using a combination of the mean and 95th percentile (P95) values of the chronic daily intake (CDI), hazard quotient (HQ), hazard index (HI), and lifetime cancer risk (CR), the health risks of the average exposure population and the high exposure population were estimated, respectively. To obtain a precise and realistic risk assessment, the exposure frequency and exposure duration were determined using questionnaire data from 20,917 randomly selected volunteers. Additionally, given the specific ingestion characteristics of CHMs, the safety factor and the transfer rates of heavy metals were highlighted as well. The concentrations of Pb, Cd, As, Hg, and Cu in 2245 batches of CHMs were 1.566, 0.299, 0.391, 0.074, and 8.386 mg/kg, respectively. The mean HI values indicated that consumption of most CHMs would not pose an unacceptable health risk to the average exposure population, except for argy wormwood leaf (1.326), morinda root (2.095), plantain herb (1.540), chrysanthemum flower (1.146), and Indian madder root (2.826). In addition, CR assessment for Pb and As revealed that, for the average exposure population, the risk of developing cancers was lower than the acceptable levels (1 × 10-4) in the clinic. However, the P95 of the HI and CR values indicated that more attention should be paid to the systemic effects of CHMs in terms of both non-carcinogenic and carcinogenic health risks for the high exposure population. Furthermore, in order to serve population health better, national and international guidelines have now been established. The risk assessment strategy developed in this study is the first of its kind, and contributed to the risk assessment, guidelines, and safety standards for heavy metals in CHMs.

[Herbalogical study on merit rating of Forsythiae Fructus based on near-mature fruit and hyper-mature fruit].

Forsythiae Fructus( Lianqiao) is classed from near-mature fruit and hyper-mature fruit,which are named as Qingqiao and Laoqiao,respectively. This article was based on the different views of which was better,Qingqiao or Laoqiao. Acorrding to the naming,varieties,habitat,harvesting and processing,used parts,medicinal properties and clinical efficacy,the herbalogical study was carried out. The results showed that Lianqiao had been sourced from the areial part of Hypericum ascyron and H. erectum of Clusiaceae before Tang Dynasty. Beside the former,and the fruit of Forsythia suspensa of Oleaceae was newly used as Lianqiao during the Southern and Northern Dynasties to the Tang Dynasty. The later had been the only origin of Lianqiao since the Song Dynasty. With the change of the medicinal varieties,the habitats of Lianqiao has also changed. The varieties of Clusiaceae were mainly produced in the Yellow River Basin from the Han Dynasty to the Tang Dynasty. After the Song Dynasty,they were produced in the south of the Yangtze River. The variety of Oleaceae was mainly produced in Shanxi,Henan,Shandong,Shaanxi,and northern Sichuan from the Tang and Song Dynasties. Currently,Shanxi and Henan have the largest output. Traditionally,there were two commercial varieties including Qingqiao and Laoqiao of Lianqiao based on the harvesting time. In traditional Chinese medicine( TCM) theory,Lianqiao removes evil heat and relieves toxicity,removes swelling and resolves enlarged nodes. Accroding to the effects of Lianqiao,Qingqiao was considered to be better than Laoqiao in TCM clinic. The modern research on main medicinal constituents and pharmacodynamic effects also confirmed the above mentioned facts. This paper can provide literature support for the rationalities of Qingqiao's mainstream medication and assay standard of Lianqiao in the Chinese Pharmacopoeia.

[Residual status and risk assessment of forbidden and restricted pesticides of organophosphorus in Loincerae Japonicae Flos].

This paper reports the residual status of forbidden and restricted pesticides of organophosphorus in Loincerae Japonicae Flos to provide reference for the risk control and the formulation of maximum residue limits of the flower. A method for the determination of residues of 23 forbidden and restricted pesticides of organophosphorus was established, and 64 collected samples were tested. Then a risk assessment based on the maximum residue limit was carried out. Results showed that the detection rate of samples was 58%. 6 of 23 pesticides were detected and the ratio was chlorpyrifos 41%, omethoate 23%, triazophos 11%, isofenphos-methyl 6.3%, methamidophos 1.6%, isocarbophos 1.6%, respectively. And the median of pesticide residues in the positive samples was chlorpyrifos 0.037 mg·kg⁻¹, omethoate 0.043 mg·kg⁻¹, triazophos 0.030 mg·kg⁻¹, isofenphos-methyl 0.18 mg·kg⁻¹, methamidophos 0.041 mg·kg⁻¹, isocarbophos 0.041 mg·kg⁻¹, respectively. In the samples with pesticide residues, the residue amount of methamidophos and isocarbophos was lower than the theoretical maximum residue limit, and the residue amount of chlorpyrifos, isofenphos-methyl, triazophos were higher than it individually, while, all the residue amount of omethoate was higher than it. According to the assessment result of theoretical maximum residue limit, it is suggested that relevant departments should accelerate the formulation of the maximum residue limit standard, and strengthen the supervision of the use of forbidden and restricted pesticides of organophosphorus in Loincerae Japonicae Flos.

[Principles for molecular identification of traditional Chinese materia medica using DNA barcoding].

Since the research of molecular identification of Chinese Materia Medica (CMM) using DNA barcode is rapidly developing and popularizing, the principle of this method is approved to be listed in the Supplement of the Pharmacopoeia of the People's Republic of China. Based on the study on comprehensive samples, the DNA barcoding systems have been established to identify CMM, i.e. ITS2 as a core barcode and psbA-trnH as a complementary locus for identification of planta medica, and COI as a core barcode and ITS2 as a complementary locus for identification of animal medica. This article introduced the principle of molecular identification of CMM using DNA barcoding and its drafting instructions. Furthermore, its application perspective was discussed.

[Study on the detecting methods of the imported materia medica--olibanum].

OBJECTIVE: To analyse the chemical components of the essential oil of Gum olibanum somalilnds and Gum olibanum Ethiopia, and to set up determination methods of their main components. METHOD: Two kinds of essential oil are identified by GC-MS, and assayed by Gas chromatography, using SE-54 as the packing material (column 2.1 m x 3.2 mm), with column temperature starting from 80 degrees C, holding for 1 min, and then rising at the rate of 15 degrees C per minute to 170 degrees C. RESULT: 40 kinds of chemical compounds in the essential oil of Gum olibanum somalilnds and 22 kinds of those of Gum olibanum Ethiopia were identified by GC-MS, the main component in the essential oil of Gum olibanum somalilnds being alpha-pinene, and the main one of Gum olibanum Ethiopia being Octyl acetate 17 batches of samples were determined with the linear range of alpha-pinene being 0-10.80 micrograms, the correlation coefficient being 0.9995, the recovery being 98.16%, RSD being 1.83%; the linear range of Octyl acetate being 0-10.32 micrograms, the correlation coefficient being 0.9996, the recovery being 99.56%, and RSD being 1.36%. CONCLUSION: This study can be used for the setting up of the specification of Olibanum.