Trollius chinensis Bunge: A Comprehensive Review of Research on Botany, Materia Medica, Ethnopharmacological Use, Phytochemistry, Pharmacology, and Quality Control.

Trollius chinensis Bunge, a perennial herb belonging to the Ranunculaceae family, has been extensively used in traditional Chinese medicine. Documented in the Supplements to the Compendium of Materia Medica, its medicinal properties encompass a spectrum of applications, including heat clearance, detoxification, alleviation of oral/throat sores, earaches, eye pain, cold-induced fever, and vision improvement. Furthermore, T. chinensis is used in clinical settings to treat upper respiratory infections, pharyngitis, tonsillitis, esoenteritis, canker, bronchitis, etc. It is mainly used to treat inflammation, such as inflammation of the upper respiratory tract and nasal mucosa. This comprehensive review explores the evolving scientific understanding of T. chinensis, covering facets of botany, materia medica, ethnopharmacological use, phytochemistry, pharmacology, and quality control. In particular, the chemical constituents and pharmacological research are reviewed. Polyphenols, mainly flavonoids and phenolic acids, are highly abundant among T. chinensis and are responsible for antiviral, antimicrobial, and antioxidant activities. The flower additionally harbors trace amounts of volatile oil, polysaccharides, and other bioactive compounds. The active ingredients of the flower have fewer side effects, and it is used in children because of its minimal side effects, which has great research potential. These findings validate the traditional uses of T. chinensis and lay the groundwork for further scientific exploration. The sources utilized in this study encompass Web of Science, Pubmed, CNKI site, classic monographs, Chinese Pharmacopoeia, Chinese Medicine Dictionary, and doctoral and master's theses.

[Medicinal evolution and modern research progress on Mume Fructus].

Prunus mume is an edible and medicinal material, and Mume Fructus is its processed product, which was first recorded in Shennong's Classic of Materia Medica(Shen Nong Ben Cao Jing). It is an effective drug for stopping diarrhea with astringents and promoting fluid production to quiet ascaris. By consulting the ancient herbal works of the past dynasties, modern codes, and other rela-ted literature, this paper sorted out the medicinal evolution of Mume Fructus, examined the ancient efficacy of Mume Fructus and the main indications, and summarized the inclusion of Mume Fructus in national and provincial standards. It is recorded in the ancient herbal works of the past dynasties that Mume Fructus can be processed by various methods such as roasting, stir-frying or micro-frying, stir-frying with charcoal, single steaming, steaming with wine, and steaming after soaking in wine or vinegar, and prepared into pills, powders, and ointments, which are used in the treatment of fatigue, diabetes, malaria, dysentery, ascariasis, and other diseases. Mume Fructus has been included in nine editions of Chinese Pharmacopoeia and 19 provincial and municipal preparation specifications. The processing method of Mume Fructus is determined, namely, clean P. mume should be softened by moistening in water or steaming and pitted. By reviewing the effects of processing on its chemical composition, pharmacological effects, and its modern clinical application, this paper identified the following issues. The ancient application methods of Mume Fructus are diverse but less commonly used in modern times, there is a lack of standardized research on the processing, and the research on the changes caused by the difference in Mume Fructus before and after processing is not deep. Therefore, it is necessary to further investigate the change pattern of its chemical composition before and after processing and its correlation between its medicinal activity to standardize the processing technology and provide a solid basis for the use of Mume Fructus in parts and its quality control.

Features and development trends in international standardization of Chinese materia medica in ISO/TC 249.

Chinese materia medica (CMM) is indispensable component of Traditional Chinese Medicine (TCM) therapy. With the widespread of TCM around the world, the quality control and safe use of CMM become a major concern. This paper introduces the role of ISO standards for industrial development and current development status of CMM standards in ISO/TC 249. Through the comparison of similarities and differences between CMM standards in ISO/TC 249 and pharmacopoeias of main stakeholders, this paper suggests strengthening standard formulation in the following areas to provide more appropriate documents to facilitate the international trade and promote the industrial development of CMM: (1) Develop standards to fill the blanks among the whole industry chain of CMM; (2) Develop standards for new forms of CMM and services; (3) Develop specification and grade standards for CMM with large quantity and high value.

Exploitation of HPLC Analytical Method for Simultaneous Determination of Six Principal Unsaturated Fatty Acids in Oviductus Ranae Based on Quantitative Analysis of Multi-Components by Single-Marker (QAMS).

As one of the featured products in northeast China, Oviductus Ranae has been widely used as a nutritious food, which contains a variety of bioactive unsaturated fatty acids (UFAs). It is necessary to establish a scientific and reliable determination method of UFA contents in Oviductus Ranae. In this work, six principal UFAs in Oviductus Ranae, namely eicosapentaenoic acid (EPA), linolenic acid (ALA), docosahexaenoic acid (DHA), arachidonic acid (ARA), linoleic acid (LA) and oleic acid (OA), were identified using UPLC-MS/MS. The UFAs identified in Oviductus Ranae were further separated based on the optimized RP-HPLC conditions. Quantitative analysis of multi-components by single-marker (QAMS) method was implemented in content determination of EPA, ALA, DHA, ARA and OA, where LA was used as the internal standard. The experiments based on Taguchi design verified the robustness of the QAMS method on different HPLC instruments and chromatographic columns. The QAMS and external standard method (ESM) were used to calculate the UFA content of 15 batches of Oviductus Ranae samples from different regions. The relative error (r < 0.73%) and cosine coefficient showed that the two methods obtained similar contents, and the method validations met the requirements. The results showed that QAMS can comprehensively and effectively control the quality of UFAs in Oviductus Ranae which provides new ideas and solutions for studying the active components in Oviductus Ranae.

Analysis on the current quality standards of Chinese materia Medica used in COVID-19 prevention and treatment.

PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.

Safety assessment of homeopathic medicines: The Adonis vernalis paradox and the 'analysis trap' of using different pharmacopeias.

Regulatory agencies have to ensure the end-user safety of botanically derived homeopathic medicines prepared with diluted starting materials derived even from toxic plants. In the case of plant-derived homeopathic products, assessment must consider the particular characteristics of an extract and its component molecules, even if diluted. The identification and quantification of these molecules have a crucial role in risk assessment, as it allows complete toxicological evaluation in a regulatory perspective. Different results can be achieved using different approaches and references supported by the same regulatory framework, as different methods of preparation used, assays and test analysis performed in compliance with different referent pharmacopoeias. All these facts can introduce a bias in the safety assessment and the paradoxical outcome for homeopathic Adonis vernalis underlines the need for caution. The case also demonstrates the relevance of considering the analytical method for assessment of all herbal medicinal products or herbal supplements, with the purpose of finding the total amount of toxicants as a good approach.

Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and the United States: A Critical Review.

BACKGROUND: Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States. FINDINGS: Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a maximum expiry of 5 years for both potencies and finished products, Brazil adopts a 5-year expiry for finished products only, potencies used in manufacture being exempted from an assigned expiry date. In India, all homeopathic medicines except dilutions and back potencies have a maximum of 5 years' shelf-life, including those supplied to consumers. In the United States, homeopathic medicines are exempted from expiry dates. COMMENTS: There is neither a rational basis nor scientific evidence for assigning a short (3-5 years) expiry period for homeopathic medicines as followed in some of the countries, particularly in light of the fact that some studies have shown homeopathic medications to be effective even after 25 years. Homeopathic ultra-dilutions seem to contain non-material activity that is maintained over time and, since these exhibit different chemical properties compared to the original starting material, it is quite possible they possess properties of longer activity than conventional medicines. Regulators should acknowledge this feature and differentiate expiry of homeopathic medicinal products from that of conventional drugs.

[Comparative study on standard decoctions of Ophiopogonis Radix and Liriopes Radix].

Standard decoction is the core of the pharmacodynamics for water-soluble substance of Chinese materia medica. Its research is of great significance to the research and development of some single ingredients and the classical prescriptions,and it is the only way to transform traditional medication experience into industrial products. In this article,standard decoction research strategies were used for the comparison analysis of Ophiopogonis Radix from Zhejiang province(ZMD),Ophiopogonis Radix from Sichuan province(CMD),and Liriopes Radix(SMD). Regularities were present among different grades of CMD; potential quality markers and pH differences associated with SO2 residues were also found. Finally,the extract powder of Ophiopogonis Radix prepared by mass production process was analyzed and validated,and the results showed that the standard system could be used for the quality control of intermediates and final products. In conclusion,this study can provide reference for the clinical application of Ophiopogonis Radix medicines and provide testing method for higher quality with higher price.

[Current situation and research strategy of quality control of health food containing Chinese materia medica].

Health food containing Chinese materia medica has many advantages in health preservation and reducing the risk of disease occurrence,which meets people's demands for " great health" and " preventive treatment of disease". However,due to its complex ingredients,diverse quality of raw materials,as well as the vagueness and lack of integrity for existing quality standards,chaos is caused in the health food market,which restricts its healthy development and also poses new challenges to the quality control of healthy food. At present,the total component content or single component content is determined in most functional/marker component examinations. Safety and microbial detection methods fail to cover the contamination range of the raw materials of Chinese materia medica.Therefore,it is impossible to meet the purpose of ensuring authenticity,safety and efficacy. In recent years,a lot of Chinese materia medica extracts have been used as raw materials for food products,but many extracts lack standards. The author believes that the quality control of health food containing Chinese materia medicas should start with the quality control of Chinese materia medica extracts. In this way,product quality is controlled from source to ensure product consistency; secondly,the overall quality control should be strengthened to ensure the authenticity of the products; the scope of safety inspection shall be expanded to fundamentally ensure the safety of products. At the same time,we should strengthen the quality control of whole process and strengthen the overall quality control of raw materials to produce health food of high quality.

[Research status of Periplaneta americana with analyses and prospects of key issues].

Periplaneta americana is one of the common traditional Chinese medicines, which has a long application history. It can tonify spleen, promote blood circulation, induce diuresis to alleviate edema, and promote granulation. It is clinically used for the treatment of alimentary canal diseases, chronic heart failure, cutaneous lesion, periodontitis and other diseases. There are some representative prescriptions, such as Kangfu Xinye, Xinmailong injection, Ganlong capsule, and Xiaozheng Yigan tablet. This paper reviewed the chemical components, pharmacological effects and clinical applications of P. americana, firstly summarized standards for the quality control of P. americana, found out and analyzed the key problems in the research. The aim of this paper is to provide the references for the further development and application of P. americana.

[HPLC fingerprints of pig, cattle and sheep biles].

To establish the fingerprints of biles of pig, cattle and sheep, HPLC was used with Acclaim™ RSLC 120 C18 column (3.0 mm×100 mm, 2.2 µm, 120 Å), the column temperature 35 °C, acetonitrile-1% perchloric acid as mobile phase, gradient elution, 0.5 mL·min⁻¹ flow rate, and detection wavelength at 200 nm. The fingerprint was generated by using Similarity Evaluation Software of Chromatographic Fingerprint of Chinese Medicine (2004A Edition). The fingerprint peaks were identified by reference substances and verified by ELSD and LC-MS/MS. Then, the biles of pig, cattle and sheep were detected to contain 14, 9 and 8 common fingerprint peaks respectively, and the similarity was greater than 0.92. To analyze each technical parameter, GHDCA in pig bile and TCA in cattle and sheep bile were selected as reference peak. The precision, repeatability and stability all meet the requirements of fingerprint establishment. The RSD of the relative retention time of the fingerprint peaks was less than 1.5%, and the RSD of the relative peak area was less than 5%. The fingerprint peaks in pig bile were THDCA, TCDCA, GHDCA and GCDCA, and TCA, TCDCA, GCA, GCDCA and GDCA in cattle and sheep bile. The main components of pig, cattle and sheep bile were conjugated bile acids, but there were significant differences in bile acids between pig bile and cattle, sheep biles. The HPLC method established in this paper is simple, rapid and reproducible, and could be applied to the identification and quality control of biles.

[Study on quality control of Holotrichia diomphalia larvae by TLC and HPLC].

The TLC method was established for identification of Holotricha diomphalia larvae and the HPLC method was used to determine the content of inosine and guanosine in H. diomphalia larvae. The HPLC analysis was performed on a Waters HSS T3（4.6 mm×250 mm, 5 µm） column of with mobile phase consisting of acetonitrile (A) and 0.08% trifluoroacetic acid (B) in gradient elution. The detection wavelength was 260 nm. The flow rate was 1.0 mL·min⁻¹. The column temperature was 30 °C. As a result, TLC identification method had a good reproducibility and highly specificity. The linear equations of inosine and guanosine were in good linear range (r>0.999 8). The average recovery of inosine and guanosine was 96.53% (RSD=1.6%), 99.71% (RSD=2.7%). The method is simple, accurate and reproducible, which can provide a basis for quality standard improvement H. diomphalia larvae.

[Identification of Fel Serpentis and its adulterants with specific PCR method].

The study aims at developing a convenient and specific method for the identification of Fel Serpentis DNA. The methods of Fel Serpentis genomic DNA purification were tested and optimized, four pairs of specific primers for the amplification of COⅠ, Cyt b and 16S were designed. Then the best pair of primers were selected according to the specificity and efficiency. The DNA fragment about 400 bp was amplified from 20 kinds of Fel Serpentis, whereas no DNA fragment was amplified from other animal samples under the same condition. This method is specific,accurate and reproducible, which provides a useful tool for the quality control of Fel Serpentis.

From Pharmacognosia to DNA-Based Medicinal Plant Authentication - Pharmacognosy through the Centuries.

For centuries, pharmacognosy was essential for the identification, quality, purity, and, until the end of the 18th century, even for the efficacy of medicinal plants. Since the 19th century, it concentrated on authenticity, purity, quality and the analysis of active substances, and was established as an academic branch discipline within pharmacy and continuously developed into a modern, highly sophisticated science. Even though the paradigm in pharmacy changed in the 19th century with the discovery of morphine and concentrated on single substances that could be synthesized fast by the upcoming industry, medicinal plants always remained an important element of the Materia medica, and during the last decades, medicinal plants continue to be a source of remedies, and natural products are an inspiration for new medicine. In this research, pharmacognostic skills remain an essential element, both with regards to identity, quality assurance of botanicals (both herbal medicines and supplements), and the discovery and development of new medicines. Over the years, the specific pharmacognostical tools have changed dramatically, and most recently, DNA-based techniques have become another element of our spectrum of scientific methods.

Current Status of Herbal Drug Standards in the Indian Pharmacopoeia.

The benefits of herbal drugs were well understood way back. They have been used for the promotion of health and medical purposes - in disease conditions. It is a conventional belief that herbal drugs have no side effects, are cheaper and locally available. Among Indian systems of medicines, herbs/herbal formulations are used to a larger extent. The quality control of the marketed herbs/herbal formulations is important for acquiring optimum therapeutic benefit as well as for expanding global outreach. Therefore, herbal drug standards are important. Reference standards, the Indian Pharmacopoeia Reference Substances especially the botanical reference substances and the phytochemical reference substances are required for comparison of quality of herbal drugs. The Indian Pharmacopoeia Commission has initiated the process of providing Indian Pharmacopoeia Reference Substances to the stakeholders. Therefore, this article provides an overview of the history and the status of herbal drug standards in the current and forthcoming issues of Indian Pharmacopoeia. In Indian Pharmacopeia, efforts have been made for the harmonization of standards with international counterparts wherever possible. Copyright © 2017 John Wiley & Sons, Ltd.

[Biological assay in quality control of animal medicines].

Animal medicine is a unique part of traditional Chinese medicine. They have strong effects, but their effective compounds are not entirely known. The efficiency and safety of animal medicines can't be effectively controlled by current quality assurance system and evaluation method, which has deeply influenced the development of animal medicines. Biological assay does not focus on efficacy of single component, but directly reflects the pharmacodynamics and safety of animal medicines by biological effect. With the development of biotechnology, many new technologies have emerged, such as biochip and high content analysis. Based on the related targets, pathways and key biochemical factors, the field of biological assay has been expanded. With advantages of pharmacology andoverall controllability, as well as the characteristics of in line with the quality control of Chinese Medicine, biological assay will become one of the important development directionsfor quality standardization of animal medicines.

[Advance on quality control of toad venom and its key influence factors].

Toad venom (Chansu) is prepared from the dried secretion of Bufo bufo gargarizans or B. melanostictus. It is not only one of the famous and expensive traditional Chinese medicines(TCMs) from animal origin, but also one of 28 kinds of toxic TCMs to be required for special management issued by the State Council of the People's Republic of China. Chansu contains the rich bufadienolides and indole alkaloids, and displays various bioactivity including cardiotonic, anti-tumor, analgesia, and local anesthesia. Based on the published references in the recent years, the advance on the identification of adulterants and quality evaluation as well as the influence factors on the quality of toad venom was summarized to improve the quality standards and promote the level of quality control of toad venom and its preparations.

[Research progress on identification and quality control of Cervi Cornu Pantotrichum].

Cervi Cornu Pantotrichum, as a traditional Chinese medicine, has great potential for development. However, the identification and quality control system is not perfect, leading to the market chaos and chronic slow growth in deep processing of Cervi Cornu Pantotrichum. This paper gives an overview of present situation in identification and quality control system of the Cervi Cornu Pantotrichum, and analyzes present problems. Based on these results, the feasibility study scheme in identification and quality control system for Cervi Cornu Pantotrichum would be then put forward, providing ideas to establish its comprehensive evaluation system.

[Research model on commodity specification standard of radix Chinese materia medica].

As an important part of the market commodity circulation, the standard grade of Chinese traditional medicine commodity is very important to restrict the market order and guarantee the quality of the medicinal material. The State Council issuing the "protection and development of Chinese herbal medicine (2015-2020)" also make clear that the important task of improving the circulation of Chinese herbal medicine industry norms and the commodity specification standard of common traditional Chinese medicinal materials. However, as a large class of Chinese herbal medicines, the standard grade of the radix is more confused in the market circulation, and lack of a more reasonable study model in the development of the standard. Thus, this paper summarizes the research background, present situation and problems, and several key points of the commodity specification and grade standard in radix herbs. Then, the research model is introduced as an example of Pseudostellariae Radix, so as to provide technical support and reference for formulating commodity specifications and grades standard in other radix traditional Chinese medicinal materials.

Giant tuberculin reaction associated with the homeopathic drug tuberculinum: a case report.

Giant reactions to the tuberculin skin test are extremely rare and have been previously reported almost exclusively in patients with lepromatous leprosy. We herein report a giant tuberculin reaction associated with the homeopathic drug Tuberculinum in a patient with no evidence of active tuberculosis or leprosy.