With the development of molecular pharmacognosy, the advantages of DNA molecular markers in the identification of original plants of Chinese medicinal materials are becoming increasingly significant. To compensate for the limitations of existing markers in the quality supervision of Chinese medicinal materials, our team has independently designed a new molecular marker named DNA signature sequence(DSS). This marker is a nucleotide sequence that only appears in a specific taxonomic unit, with a length of 40 bp and high identification accuracy. This article aims to screen and verify the DSS markers that can accurately identify the original plants of the medicinal materials included in the volume one of the Chinese Pharmacopoeia, establish the operating procedure for developing standard nucleotide sequences, and lay a foundation for the widespread application of polymerase chain reaction in the quality supervision of traditional Chinese medicine. Firstly, the Chloroplast Genome Information Resource(CGIR) was searched for the chloroplast genome sequences of the test samples, species of the same genus, and common background species. IdenDSS was used to obtain the DSS tags and specific identification primers of the tested species. After DNA extraction, PCR amplification, sequencing, and sequence alignments, a total of 203 DSS markers of Chinese medicinal materials were obtained for validation. The above sequences were uploaded to the Traditional Chinese Medicine Molecular Identification Platform(www.herbsdna.com), and a standard DSS library was established for identifying the original plants of medicinal materials, serving as an important tool for quality supervision of Chinese materia medica. On this basis, an operating procedure for DSS development is formed, laying a foundation for further DSS screening and application based on more diverse genome sequences.
Plants, Medicinal/classification* ; DNA, Plant/genetics* ; Drugs, Chinese Herbal ; Pharmacopoeias as Topic ; Genetic Markers ; Medicine, Chinese Traditional

The improvement of the harvest period standards is critical in the quality control of Chinese medicinal materials. The present study statistically analyzed the harvest period standards of plant medicinal materials in the 2020 edition of Chinese Pharmacopoeia(Vol.Ⅰ) and put forward the existing problems and suggestions based on herbal records and modern research to provide references for the improvement of the standards. According to the statistical analysis, in 499 types of plant medicinal materials, harvest period standards are recorded under 486 types, accounting for 97.4%, and are lacking in the remaining. Only one medicinal material(Stellariae Radix) is recorded with the standard of the harvest year. The standards of the harvest season and phenological period are recorded under 233 types, accounting for 46.7%. For 237 types, only harvest season is specified, accounting for 47.5%, and for 15 types, only harvest phenological period is specified, accounting for 3.0%. Among 222 types mainly derived from cultivation and 51 types from wild resources and cultivation, only 11 types are recorded with harvest period of cultivated products. Only Stellariae Radix is recorded with the harvest period standards for the wild and cultivated products separately. The harvest period standards of plant medicinal materials with different medicinal parts have certain rules to follow. The main problems about the harvest period standards are discovered. Specifically, no harvest period standards are recorded under 13 types of plant medicinal materials. Almost all perennial cultivated medicinal materials are not recorded with harvest year standard. No phenological period standard is found under 250 types of plant medicinal materials. There is no clear distinction between the harvest period standards of cultivated and wild products. The evidence for harvest period standards of 26 types of plant medicinal materials that can be harvested all year round is insufficient. As a result, it is proposed to strengthen basic research in response to the above-mentioned problems and improve the harvest period standards as soon as possible to ensure the quality of Chinese medicinal materials.
China ; Drugs, Chinese Herbal/standards* ; Medicine, Chinese Traditional ; Pharmacopoeias as Topic ; Plants, Medicinal ; Quality Control

To clarify the change and development of original plants of " Manjingzi"( Viticis Fructus),a traditional Chinese medicine,we investigated Vitex species on the ancient Chinese herbal texts. The study concluded that the Vitex trifolia and V. trifolia var.simplicifolia included in the Chinese Pharmacopoeia( 2015 edition) are only two sources of ancient medicinal Viticis Fructus. There are many sources of vines used in ancient times,which are not fixed and unified. The early use of Viticis Fructus is likely to be the V. quinate var. quinata,V. negundo var. cannabifolia and V. negundo var. negundo. From the Tang Dynasty,the use of V. trifolia var. simplicifolia has been appeared. Until Li Shizhen of the Ming Dynasty,the V. trifolia has been used as a source of medicine for the Viticis Fructus,but even so,the source of medicinal plants of Viticis Fructus has not been unified. We suggested V. trifolia var. simplicifolia be used as mainly species for " Manjingzi" due to its widely used in ancient China.
China ; Drugs, Chinese Herbal/history* ; Fruit ; History, 15th Century ; History, Medieval ; Medicine, Chinese Traditional ; Pharmacopoeias as Topic ; Plants, Medicinal ; Vitex

To clarify the origin and application development of the traditional Chinese medicine " Zi-hua Qianhu" and " Qianhu", the medicinal literatures of past dynasties and modern researches were analysed. The plant Angelica decursivum was used as a substitute for traditional Chinese medicine "Angelica sinensis Radix" for a long historical period, it is used incorrectly for traditional Chinese medicine "Qianhu" due to origin research in modern times. The plant origin of "Qianhu" is Peucedanum praeruptorum. There are significant differences in clinical applications and chemical composition of the two drugs. The same efficacy description of "Zi-huaQianhu" and "Qianhu" could not stop "Zi-huaQianhu" used as "Qianhu" in practical application. Therefore, we need to further research for the plant A. decursivum, delimit its medicinal attribution.
Angelica ; anatomy & histology ; chemistry ; China ; Drugs, Chinese Herbal ; chemistry ; history ; pharmacology ; History, 21st Century ; History, Ancient ; Humans ; Pharmacopoeias as Topic ; history ; Phytotherapy ; history

In the present report, we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies, including the International Conference of Harmonization (ICH), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the China Food and Drug Administration (CFDA). Progresses with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Chinese Pharmacopoeia (ChP) to control impurities in antibiotics are also presented. Next, our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics, and the implementation of ICH, FDA and other technical guidelines for generic drugs impurity control in China. Existing problems are further reviewed, in order to improve the overall process for the control of antibiotic purity.
Anti-Bacterial Agents ; standards ; China ; Drug Contamination ; Drug and Narcotic Control ; Drugs, Generic ; Europe ; Humans ; Pharmaceutical Preparations ; standards ; Pharmacopoeias as Topic ; Quality Control ; Research ; United States ; United States Food and Drug Administration

The content of SO2 in Paeoniae Radix Alba (RPA) was determined by the method documented in Chinese Pharmacopoeia (CP) 2010 edition to validate the repeatability of the method for evaluating RPA, and the contents of paeoniflorin sulfonate in both the residual material and distilled solution of RPA were determined by HPLC to study the transformation of paeoniflorin sulfonate to SO2 by HCl. It was found that the repeatability of the method in CP for evaluating RPA is unacceptable, and paeoniflorin sulfonate was detectable in both the residual material and distilled solution of RPA even at "the end point" of SO2 determination, merely about 50% of paeoniflorin sulfonate was transformed to SO2 by HCl, indicating that the current SO2 determination method in CP is not able to accurately quantify SO2 in RPA. It is recommended that more special method for determining SO2 content in RPA should be developed regarding the chemical characteristics of sulfur-fumigated RPA.
Chemistry Techniques, Analytical ; methods ; Chemistry, Pharmaceutical ; Drugs, Chinese Herbal ; analysis ; Fumigation ; Glucosides ; analysis ; Monoterpenes ; analysis ; Paeonia ; chemistry ; Pharmacopoeias as Topic ; standards ; Sulfur Dioxide ; chemistry

In 2010, Chinese Pharmacopoeia Committee officially enacted Chinese Pharmacopoeia (2010 edition). The Volume 1 of the pharmacopoeia is comprised of the medicinal materials and the decoction pieces, the essential oils and extracts of medicinal plants, prescription preparations and single preparation, etc., which not only provides Latin names of Chinese medicinal materials, also provided Latin names of the original medicinal plants to effectively control the quality of Chinese medicinal materials. In order to raise awareness of correctly citation and maintain the authority and standardization of Chinese Pharmacopoeia, this paper briefly describes abbreviations rules of authors' name of plant scientific name according to the 'International Code of Botanical Nomenclature, ICBN'. Through comparing with the rules of ICBN, 'Flora of China' (Chinese edition and English edition), and authority international plant catalogue databases, the authors made statistic and analysis of the non-standard cited authors' names phenomena of the original plant scientific names recorded in the Chinese Pharmacopoeia (2010 edition), and the revision suggestions are proposed.
Asian Continental Ancestry Group ; Authorship ; China ; Databases, Factual ; Drugs, Chinese Herbal ; classification ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; methods ; Pharmacopoeias as Topic ; standards ; Plants, Medicinal ; chemistry ; classification ; Reference Standards ; Terminology as Topic

The essay summarizes the current development and application of reference extracts from traditional Chinese medicines (TCMs). Through the analysis on problems in the quality control of TCMs, and on the basis of the current application of reference extracts in Chinese Pharmacopoeia, it investigates reference extracts from TCMs and forecasts the study orientation on TCM quality standards. Despite a wide prospect for the application of reference extracts in quality control of TCMs, there remain problems in varieties and standards. It is of great significance for the TCM understanding to further promote the development of reference extracts.
China ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; standards ; Medicine, Chinese Traditional ; methods ; standards ; Pharmacopoeias as Topic ; standards ; Quality Control ; Technology, Pharmaceutical ; methods ; standards

Anti-Bacterial Agents ; administration & dosage ; Child ; Child, Preschool ; Drug Administration Routes ; Drug Utilization ; standards ; Humans ; Infant ; Pediatrics ; Pharmaceutical Preparations ; administration & dosage ; Pharmacopoeias as Topic ; Pharmacy Administration

It has been well-known that many medicinal plants used in traditional Chinese medicine contain hepatotoxic pyrrolizidine alkaloids (HPAs), and some even have been recorded in many editions of the Chinese Pharmacopoeia (ChP). In order to clarify the current status of these PAs-containing Chinese materia medica and proprietary Chinese formulae, the ChP 2010, the newest version, and the related safety issues were thoroughly investigated and analyzed on the current advances in research. Total nine crude drugs (not including the processed slices) were found to contain HPAs, which may be present in tens of Chinese proprietary drugs prepared with these crude drugs. Because of the lack of the alkaloid limitation in most monographs, their potential threats to human health may be underestimated. For this reason, attention should be drawn to the importance of the issue. The key point is to conduct the basic studies immediately on these PA-containing herbal plants or products, whose possible hazards need to be carefully assessed. Further efforts should also be made to elevate the criteria for quality control and ensure the drugs' safety in clinic for human health.
China ; Drugs, Chinese Herbal ; adverse effects ; chemistry ; Medicine, Chinese Traditional ; Pharmacopoeias as Topic ; Plants, Medicinal ; adverse effects ; chemistry ; Pyrrolizidine Alkaloids ; analysis ; toxicity ; Quality Control ; Safety