OBJECTIVEEnable to make the origin of some medicinal materials from animals-national-standard Chinese Pharmacopoeia subdivision 1 more complete, to protect and utilize the wild medicinal animal resources, and to improve the quality of traditional Chinese medicines materials materials.

METHODIn accordance with author's over two decades of studies in medicinal material from animals and medicinal animals, combining with modern animal classification findings, comparing the contents of medicinal material origin from animals in Pharmacopoeia new edition.

RESULTGive amendment advices on gallnut, concha arcae, zaocys dhumnade, gadfly, and so forth the fifteen kinds of medicinal material origin from animals' taxonomic status, Chinese names and their Latin scientific names.

CONCLUSIONThe origin of accuracy of medicinal material origin from animals is critical to ensure the quality of traditional Chinese medicine. As a national-level traditional Chinese medicine code of laws, it should advance with times, actively absorb and adopt the latest achievements in scientific research. Meanwhile, modern molecular biology techniques should be used to develop the research of conventional medicinal material origin from animals in a planned and systematic manner.

Term of medicinal materials and decoction pieces in Chinese pharmacopoeia (2010 edition, Volume I) have been analyzed and d. 374 among 593 medicinal materials in Chinese pharmacopoeia has determination term including 461 determination indexes, 323 compositions and 9 s; 417 kinds of decoction pieces among 822 in Chinese pharmacopoeia has determination term. Eight kinds of decoction pieces with limit requirements were found with no determination term. Content and style of term of and cutting crude drugs were inconsistent. Suggestions related have also been given for pharmacopoeia revision.
Drugs, Chinese Herbal ; Medicine, Chinese Traditional ; Pharmacopoeias as Topic

To better standardize clinical standard of medicinal materials and cut crude drugs in Chinese Pharmacopoeia (2010 edition, Volume I) and finish compiling work of relevant matching book named Clinical Guide to the Chinese Pharmacopoeia, based on analyzing the problems in clinical standard of medicinal materials and cut crude drugs in Chinese Pharmacopoeia (2005 edition, Volume I), feasibly practicable revising suggestion of standardizing clinical standard of medicinal materials and cut crude drugs in Chinese Pharmacopoeia (2010 edition, Volume I) is proposed.
China ; Drug and Narcotic Control ; Drugs, Chinese Herbal ; standards ; Pharmacopoeias as Topic

Based on the Chinese pharmacopeia 2000 ed and Japanese pharmacopeia 14st ed., the original plant differencesof Chinese raditional medicines and Japanese Kampo medicines were compared by making list. The differences and reasons were analyzed.
China ; Drugs, Chinese Herbal ; Japan ; Medicine, Chinese Traditional ; Medicine, Kampo ; Pharmacopoeias as Topic ; Plants, Medicinal

Because of many reasons, big changes occur in the varieties of ancient and modern Chinese herbs. Besides a significant increase in the number, there are many other features, such as significant differences among mainstream varieties, partly resolving the chaotic situation of uncoincidence of different herb names, increasing proportion of plant herbs, and herbal multi-polarization, etc.
China ; Drugs, Chinese Herbal ; classification ; history ; History, Ancient ; Pharmacopoeias as Topic ; history ; Plants, Medicinal ; classification

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

This article reviews rectification and protection of Chinese patent medicines, establishment and improvement of the new drug approval, and historical evolution of the pharmacopoeia of the People's Republic of China. The article analyzes the present situation and the challenges of quality standardization of Chinese patent medicines in the new era. The article also points out strategies and guidelines to be taken to promote the globalization of Chinese patent medicines and compliance with the international standards.
China ; Drug Approval ; legislation & jurisprudence ; Drug Contamination ; Drugs, Chinese Herbal ; administration & dosage ; standards ; Nonprescription Drugs ; standards ; Pharmacopoeias as Topic ; standards ; Quality Control

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

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