It is the core of the development for Chinese patent medicine enterprises to cultivate large varieties of Chinese patent medicine, and the selection of potential "seed" products is the prerequisite for the cultivation strategy. By constructing the evaluation model from multiple dimensions of value and risk, we can conduct specialized evaluation of Chinese patent medicines to effectively, professionally and objectively select the "seed" products with large variety cultivation potential. In this paper, the establishment of a multidimensional evaluation system would be discussed from the aspects of drug naming and prescription composition, safety risk and supply guarantee of raw materials and medicinal materials, competition situation, access to policy catalogue, scientific and technological support, clinical evidence and recognition, systematical and standardized collection of information on product instructions, quality standards, policy catalogue, scientific and technological literature, market competition and clinical application of Chinese patent medicines. Through the objective evaluation index and the range of objective index, the multi-dimensional evaluation model on values and risks of Chinese patent medicine products was discussed. Based on this model, a batch of Chinese patent medicine products can be quickly and comprehensively analyzed, and quantitative comparison can be formed among different types and fields of products. According to the evaluation results of the model and the comprehensive evaluation of experts, high-quality "seed" products can be selec-ted, laying a solid foundation for the next step of large variety cultivation. With use of this model, we can further clarify the external competitive advantages and internal priority levels of each product, and provide support for enterprises to optimize product structure and improve product strategic layout.
China ; Drugs, Chinese Herbal/adverse effects* ; Medicine, Chinese Traditional ; Nonprescription Drugs/adverse effects* ; Quality Control

Arecae Semen, as the first place among "Four South Medicines" in China, has great dual-use value of medicine and food. The research of Arecae Semen was mainly focused on the active ingredients and efficacy value, and its potential safety hazards were also concerned. Until now, there is still a lack of clear boundaries between medicine and food, resulting in its safety cannot be guaranteed. Therefore, it is of great significance to establish clear boundaries of medicine and food use and health risk assessment. In this paper, the differences of pretreatment and application methods of Arecae Semen were analyzed, and the research progress of Arecae Semen in chemical composition identification and toxicology research and safety evaluation were reviewed emphatically. Finally, the differences of quality control and safety evaluation of Arecae Semen in pharmacopoeias or standards were analyzed at home and abroad. It was expected to provide reference value for quality control, safety evaluation and international standardization research of Arecae Semen.
Areca ; China ; Drugs, Chinese Herbal/adverse effects* ; Seeds ; Semen

To systematically evaluate the efficacy and safety of Ningxinbao Capsules in treatment of arrhythmia by Meta-analysis. Randomized controlled trial(RCT) or quasi-randomized control trial(Quasi-RCT) on Ningxinbao Capsules treating arrhythmia were obtained by computer-based retrieval in CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science, Cochrane Library and EMbase as well as manual retrieval, with time limit from database establishment to April 7, 2020. According to the inclusion and exclusion criteria of trials, all RCTs were screened and evaluated. Then the effective data were collected and RevMan 5.3 Meta-analysis software was used for analysis. Thirteen trials were included, involving 1 379 patients in total. Ningxinbao Capsules combined with anti-arrhythmia Western medicine were adopted as the intervention, and the patients in control group were treated with the anti-arrhythmia Western medicine alone. Meta-analysis results showed that as compared to control group, Ningxinbao Capsules combined with anti-arrhythmia Western medicine group was superior in clinical efficacy, dynamic electrocardiogram and average heart rate in patients with bradycardia, with indicated statistically significant differences. Ningxinbao Capsules had fewer adverse reactions and could relieve the toxic and side effects of anti-arrhythmia medicine possibly. The study showed that Ningxinbao Capsules played a role in treatment of arrhythmia and was relatively safe. However, due to the limited quality of the included studies, high-quality clinical trials are needed to verify the conclusions.
Bradycardia ; Capsules ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Treatment Outcome

Traditional Chinese medicine injections have advantages on cardiovascular, respiratory critical treatment fields that cannot be irreplaceable by chemical medicines. In particular, they show good clinical efficacy in critical and severe cases caused by viral infection. However, in recent years, traditional Chinese medicine injections have frequently caused serious adverse effects and even fatalities, which made the safety of traditional Chinese medicine injections doubtful. This is mainly resulted from the quality of drugs themselves and rational clinical administration. Therefore, this essay summarizes literature materials starting from the development history of traditional Chinese medicine injections and suggests rationally using traditional Chinese medicine injections under the guidance with traditional Chinese medicine theories.
Animals ; Drug Therapy ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Medicine, Chinese Traditional ; adverse effects

The Chinese herbs have been used for thousands years, their effects were certified in clinic. The compatibility of Chinese medicine prescriptions is the basis principle in clinical application. In order to enhance efficacy and reduce toxicity, reasonable compatibility of the Chinese herbs is the main method for the safety and effective use. However, it is not clear about its mechanism. So it is necessary to study their mechanisms by using the modern pharmacological technology. At present, there are some studies on the mechanisms of the compatibility relating with toxicity or adverse effect attenuation, for instance, reducing the dose of toxic Chinese herbs, changing their pharmacokinetic parameter and resisting the damage to human body system. In this paper, we planed to review the attenuation mechanism of the prescription compatibility from relevant studies.
Drug Prescriptions ; Drug Therapy ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Medicine, Chinese Traditional ; adverse effects

At the premise of ensuring efficacy and minimizing adverse reactions as far as possible, it doesn't achieve to the treatment purpose at the cost of physiological function injury in normal tissue, which is the characteristic of the symptoms and signs targeted theory of the formula corresponding to syndromes in traditional Chinese medicine (TCM). The occurrence of the adverse reactions of Chinese and western drugs is related to formula not corresponding to syndromes to a large extent. It is beneficial to minimizing the occurrence of the adverse reactions when the indication of western drugs is screened in the macroscopic level for patients by using the idea of formula corresponding to syndromes for reference.
Drugs, Chinese Herbal ; adverse effects ; pharmacology ; Humans ; Medicine, Chinese Traditional ; adverse effects

Improve the Medication methods and the efficacy of Chinese medicines with western medicines. Read the according article, compare the advantage and disadvantge of Chinese medicines and western medicines interaction and describe the mechanism of medicines in effect. It shows that using Chinese medicines with western medicines have more disadvantage than adavntage. The clinical Chinese medicines with western medicines should according physical properties and pharmacological effects of drug at first, after taking, general the interval is from 1 hour to 3 hours to prevent medicine has physical reactions or toxicity in stomach, ensure taking medicines safety.
Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Medicine ; methods ; Medicine, Chinese Traditional ; adverse effects ; methods

Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.
China ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Hypersensitivity/etiology* ; Injections ; Medicine, Chinese Traditional/adverse effects*

Profound changes have taken place in human disease spectrum, constitution spectrum, and drug use behavior, and the safety of traditional Chinese medicine(TCM) faces new trends and problems. In particular, serious adverse reactions/events such as liver injury and kidney injury caused by non-toxic TCM have been frequently reported, overturning people's understanding of TCM safety, and even shaking the public's confidence in the development of TCM. In the new era of globalization, correctly understanding the situation and problems of TCM safety and addressing the dilemmas in safety evaluation and risk prevention of TCM are the key missions to be undertaken by TCM practitioners. This paper suggests that the situation and problems of TCM safety should be viewed objectively and dialectically, and the use standard of TCM should be advanced with the times. Furthermore, this paper puts forward the new conception and methodology of TCM safety(including one innovative understanding, two types of evaluation modes, tri-elements injury hypothesis; four-quadrant risk decision processes, and five-grade safety evidence body) for the first time, hoping to provide new theories, new strategies, new methods and successful examples for solving the safety problems of TCM.
Humans ; Medicine, Chinese Traditional/adverse effects* ; Internationality ; Drugs, Chinese Herbal/adverse effects*

Chinese patent medicine containing aconitine is the key in clinical rational drug use. These drugs contain Chuanwu, Caowu or Fuzi, and Aconitum brachypodum with functions of expelling wind-dampness or tonifying Yang, all of which shall be used by strictly following the indications and dosage. However, there are many kinds of such drugs. Not only the unfamiliar knowledge of some Chinese and Western physicians about the characteristics of them, but also the combination of multiple drugs from different clinical departments, would increase the risk of aconitine poisoning. Based on the previous research, this paper proposed three core elements "syndrome differentiation-dosage differentiation-toxicity differentiation" from the prescription review and pharmacy consulting work, and objective and standardized evaluation was used to build a risk assessment scale containing 3 categories, 9 items and 36 indicators with Hulisan Jiaonang and Qufeng Zhitong Jiaonang as the example. This scale was used to evaluate the risk of a therapeutic regimen before and after the implementation. According to the verification of the existing adverse reaction cases, the risk assessment scale can be used to indicate the risk of drug treatment program and identify the risk level of drug treatment status. This paper tried to provide a methodological paradigm for scientific and objective evaluation on the safety of Chinese patent medicines, and help to identify the key links and risk prevention in the rational use by Chinese medicine physicians and pharmacists.
Aconitine ; adverse effects ; pharmacology ; Aconitum ; chemistry ; Drugs, Chinese Herbal ; adverse effects ; pharmacology ; Humans ; Nonprescription Drugs ; adverse effects ; pharmacology ; Risk Assessment