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 change and development of the original plants， medicinal organs， traditional functions， resource distribution of "Huangjing"(Polygonati Rhizome)， a traditional Chinese medicine， we investigated Polygonatum species on the ancient Chinese herbal texts. The name of "Nüwei" was first carried out in the book of Sheng Nong's Herbal Classic. Its effects included two aspects： one was similar to "Weirui"(Polygonati Odorati Rhizome， "Yuzhu")， that was tonifying， nourishing one's vitality， removing wind and dampness， settling five organs， making body lightness， keeping longevity and not being hungry; the second was alike to "Huangjing" recorded in the book of Ming Yi Bie Lu(Appendant Records of Famous Physicians). Specifically， "Weirui" possesses the therapeutic effect of "Nüwei"， while "Huangjing" possesses the tonic effect of " Nüwei". Thereafter， the following ancient Chinese herbal texts kept those two names and function records. Accordingly， we hold the point of view that "Huangjing" was first carried out in the book of Sheng Nong's Herbal Classic in the synonym of "Nüwei". "Yuzhu" included the "Huangjing" in ancient herbal text before Qing Dynasty， that was further confirmed by the research on change and development of the original plants. The identification between "Yuzhu" and "Huangjing" was based on the shape of rhizome and size before early Tang Dynasty. The shape was a key character and used up to now， but size was not reasonable. The opposite phyllotaxy was an important character of authentic "Huangjing" from Tang to Qing Dynasty. The seedling of Polygonatum sibiricum and P. kingianum， the adult plant of P. cyrtonema with alternate leaves were misused as "Yuzhu"("Nüwei" and "Weirui") at that time. Therefore， both "Yuzhu" and "Huangjing" should be used as key words during the search of ancient prescriptions and development of new drugs and health foods. The leaves， flowers， fruits and seedlings could be used as food or medicine other than the rhizomes in ancient China， but they haven't been developed in modern times. The culture of "Huangjing" had a long history starting with Tang Dynasty， which was recorded in Tang poetry. Then in Ming Dynasty， the culture method was described in Compendium of Materia Medica， that was cutting the rhizomes into 2 feet， planting sparsely(they would be grown densely in the next year)， or sowing the seeds. The harvesting and processing were first recorded in Ming Yi Bie Lu： "harvest the roots in February， dry in the shade". Then the processing method was changed to "steaming and drying in the sun， repeatedly for nine times" in Shi Liao Ben Cao(Dietetic Materia Medica) and "harvesting in August as well" in Ben Cao Tu Jing(Commentaries on the Illustrations). No breakthrough has been taken in the breeding of cultivars and key cultivation technologies yet. As to the geo-authentic habitats， Mount Songshan and Maoshan were firstly recorded as the best producing areas of "Huangjing" in Ben Cao Tu Jing. But Maoshan， Jiangsu province and Mount Songshan， Henan province， are not main producing areas in modern China. Consequently， the plantation plan of Polygonati Rhizome needs further study.
China ; Drugs, Chinese Herbal ; Herbals as Topic ; Materia Medica ; Medicine, Chinese Traditional ; Polygonatum ; chemistry ; Rhizome ; chemistry

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

Wuyi is one of the Chinese medicine recorded in Shennong's Herbal Classic and many other herbal books during the long history period. Up to now, Wuyi is still an important medicine used for insecticidal and removing food retention. Recent researches indicated that Wuyi also had the function of anti-malaria and treating herpetic simplex keratitis. Therefore, Wuyi had notable value on clinic and development of new medicine. The herbalogical textual research on Wuyi was conducted through investigation of the literature of materia medica during the long historical period from Han Dynasty. It was demonstrated by this work that the original plants of Wuyi include Ulmus macrocarpa Hance and Hemiptelea davidii (Hance) Planch, in which, U. macrocarpa was the quality specie. U. pumila was the false specie which cause confusing. The medicine Wuyi was the processed product made from the nutlet of the plants through fermentation with other additive agents.
China ; Drugs, Chinese Herbal ; analysis ; Herbals as Topic ; history ; History, Ancient ; Plants, Medicinal ; anatomy & histology ; chemistry ; classification

The achievement of Qimin Yaoshu in the area of herbalogical textual research was illustrated in this paper. Qimin Yaoshu quoted and keeped many contents from ancient agriculture books related in herbalogical literature. It also recorded the information of lots of tropical and subtropical plants. The author bringed forwarded many experiences indistinguishing plants and clarified some long last confused or wrong opinions. The studying philosophy and methods of the authors gave us much enlightenment in our herbalogical textual research. It should be taken into account when the herbalogical textual research was carried out.
China ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; Herbals as Topic ; history ; History, Ancient ; Medicine in Literature ; Plants, Medicinal ; anatomy & histology ; chemistry ; classification

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

Professor Jin Shi-yuan has been worked in traditional Chinese medicine (TCM) over 70 years. He made prominent contributions in identification, processing, dispensing of TCM and reasonable use proprietary Chinese medicine. In over 70 years, he has mastered herbal medicine and traditional Chinese Medicine. It is also professor JIN's academic characteristic. Professor JIN's practical experiences were summarized according to the current situation about clinical medication, change of species of Juhong and Chenpi has been different from species of medical history. The quality is lower than before. Medicinal parts of Danggui, Gancao, Huangqin and Wuyao has been changed. So the actions of these herbal medicines have been changed also. Fresh herbal Qianchangpu has disappeared but it should be used clinically. Medical history, change of species, change of medicinal part, and change of preparing process in professor JIN's academic idea were be summarized periodically. The result is hoped to be referred by administration, manufacture, medical treatment of TCM.
Chemistry, Pharmaceutical ; education ; history ; standards ; Drugs, Chinese Herbal ; chemistry ; standards ; Herbals as Topic ; history ; standards ; History, 20th Century ; History, 21st Century ; Humans ; Medicine, Chinese Traditional ; history

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