1.Establishment and verification of risk assessment scale for clinical safety medication of aconitine.
Rui JIN ; Yu-Guang WANG ; Bing ZHANG
China Journal of Chinese Materia Medica 2018;43(2):222-226
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
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adverse effects
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pharmacology
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Aconitum
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chemistry
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Drugs, Chinese Herbal
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adverse effects
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pharmacology
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Humans
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Nonprescription Drugs
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adverse effects
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pharmacology
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Risk Assessment
2.Discussion on safety evaluation and risk control measures of Epimedii Folium.
Dan WANG ; De-Xian JIA ; Zhen-Zhen LI ; Ming-Yue NIU ; Wang-Chu XIE ; Xiao-Kai WANG ; Xue-Min GAO ; Jing-Xia WANG
China Journal of Chinese Materia Medica 2019;44(8):1715-1723
Epimedii Folium,a commonly used traditional Chinese medicine,has the effect of tonifying kidney Yang,strengthening bones and treating rheumatism. However,in recent years,the number of reports on adverse reactions of Epimedii Folium and its Chinese patent medicines such as Xianling Gubao Capsules and Zhuanggu Guanjie Pills has been gradually increased,and the toxicity of Epimedii Folium has attracted more and more attention. In this article,the ancient and modern literature on Epimedii Folium was traced through a comprehensive and systematic literature analysis method. According to the 2015 edition of the Chinese Pharmacopoeia,Epimedii Folium refers to the dried leaves of Epimedii Folium brevicomu,E. sugittutum,E. pubescens or E. koreuuum. The Chinese Pharmacopoeia also includes E. wushanense of Wushan Epimedium,which is the same plant variety as Epimedium. The study showed that there were differences in the geographical distribution,composition and toxicity among five species of Epimedium. This paper also explained the toxicity mechanism as well as efficacy enhancing and toxicity reducing effects of Epimedii Folium,and reported its related adverse reaction cases. Through a retrospective comparative study on the toxicity of the modern Chinese patent medicines Xianling Gubao Capsules and Zhuanggu Guanjie Pills containing Epimedii Folium,it was believed that Epimedii Folium had cardiovascular system toxicity,neurotoxicity,hepatotoxicity,long-term toxicity,acute toxicity,genotoxicity and special toxicity; its safe medication factors included patient syndrome,doctor factors,drug factors,processing and compatibility factors. Meanwhile,strategies were proposed to improve patient safety medication awareness,standardize Epimedii Folium varieties and quality supervision,and the toxicity of Epimedii Folium was studied,hoping to draw attention from scholars to the safety of Epimedii Folium,improve the safe use of Epimedii Folium,and prevent adverse reactions.
Drugs, Chinese Herbal
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adverse effects
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Epimedium
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chemistry
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Humans
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Medicine, Chinese Traditional
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Plant Leaves
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chemistry
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Retrospective Studies
3.Review of pharmacological effects and toxicological information of Arecae Semen.
Dong-Lin LIU ; Xiao-Ying WANG ; Bing YANG ; Han ZHNAG
China Journal of Chinese Materia Medica 2013;38(14):2273-2275
The main chemical composition of Arecae Semen has been summarized, which can bring the pharmacological action and toxicological action to the nervous system, digestive system, cardiovascular system, urinary and reproductive system. Arecae Semen has inhibition and killing effect to most parasite. It can also activate the cholinergic receptor, promote gastrointestinal propulsive motility in mice and inhibit helicobacter pylori, Xu Lang schoenleinii, influenza virus. Arecae Semen chewing results in oral mucositis fibrosis, which has not only carcinogenic mutagenic effect but also eproductive and nervous system toxicity. And Chinese medicine Yinpian use Arecae Semen of compatibility has no adverse reaction reports.
Animals
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Areca
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chemistry
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Drugs, Chinese Herbal
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adverse effects
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chemistry
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pharmacology
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toxicity
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Humans
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Plants, Medicinal
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chemistry
4.Advance in study on pharmacological effect of Eucommiae Folium.
Tian-Yi YUAN ; Lian-Hua FANG ; Yang LV ; Guan-Hu DU
China Journal of Chinese Materia Medica 2013;38(6):781-785
Eucommia ulmoides is a valuable traditional Chinese medicine, whose cortexes have long been used as medi cines. Due to the scarcity of its resources, people began using its leaves instead of cortexes in medicines. Eucommiae Folium and its leaves have many pharmacological effects and thereby being clinically applied as genuine traditional Chinese medicines. Modern pharmological studies have showed that Eucommiae Folium leaves have such effects as blood pressure reduction, blood lipid regulation, cardiovascular protection, anti-obesity, anti-inflammation, anti-virus, enhancement of immunologic function, resistance against senility and anti-fatigue. In clinic, Eucommiae Folium is mainly used to treat hypertention and obstetrical and gynecological disease. The essay summarizes the latest advance in domestic and foreign studie on pharmacological effeets and clinical applications of Eucommiae Folium leaves, and thus providing reference for studies on new drugs of Eucommiae Folium leave.
Animals
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Chemistry, Pharmaceutical
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Drugs, Chinese Herbal
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adverse effects
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chemistry
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pharmacology
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therapeutic use
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Eucommiaceae
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chemistry
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Humans
5.Phytochemical and pharmacological studies on Radix Angelica sinensis.
Xiao-Peng CHEN ; Wei LI ; Xue-Feng XIAO ; Lan-Lan ZHANG ; Chang-Xiao LIU
Chinese Journal of Natural Medicines (English Ed.) 2013;11(6):577-587
The roots of Angelica sinensis (RAS), are a Chinese herbal medicine traditionally used in prescriptions for replenishing blood, treating abnormal menstruation, and other women's diseases. It has also been widely marketed as health food for women's care in Asia, and as a dietary supplement in Europe and America. RAS is well-known for its hematopoietic, antioxidant, and immunoregulatory activities. RAS also possesses anti-cancer, memory, radioprotective, and neuroprotective effects. Phytochemical investigations on this plant led to organic acids, phthalides, polysaccharides, and other metabolites. Based on recent animal studies and clinical trials, RAS has been used in the treatment of gynecologic diseases, cardio-cerebrovascular disease, nervous system diseases, and nephrotic syndrome. In this review, the recent phytochemical and pharmacological studies, drug-drug interactions, clinical applications, and toxicity of RAS are summarized.
Angelica sinensis
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adverse effects
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chemistry
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Animals
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Drugs, Chinese Herbal
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adverse effects
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chemistry
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pharmacology
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Humans
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Phytotherapy
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Plant Roots
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chemistry
6.Understanding differences between Rheum palmatum and R. franzenbachii from perspective of chemistry, efficacy and toxicity.
Xiao-Jin YAN ; Tian-Shi FENG ; Yu-Gang WANG ; Zhi-Yi YUAN ; Fan LEI ; Xin-Yue XIAO ; Dong-Ming XING ; Li-Jun DU
China Journal of Chinese Materia Medica 2014;39(19):3876-3880
Rheum franzenbachii (called Tudahuang in local) has some similarities with R. palmatum (rhubarb) collected by "China Pharmacopoeia" and is often used as a substitute of rhubarb. Can Tudahuang simply replace rhubarb in the application or whether is there difference between Tudahuang and rhubarb, and what is the difference it is important to verify the difference and understand its proper application in the field of clinical practice. In this paper, we discussed the differences of the two herbs from the views of chemistry, efficacy and toxicity based on the author's previous research work as well as literatures, by using the major role of the rhubarb "diarrhea" as the basic point. The analysis result showed that the role of diarrhea Tudahuang was much weaker than that of rhubarb. The reason lies in the difference between the contents of combined anthraquinones component. While acute toxicity in mice of Tudahuang is stronger than that of rhubarb. Thus, Tudahuang should not simply replace rhubarb in practice.
Animals
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Drugs, Chinese Herbal
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chemistry
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pharmacology
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toxicity
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Humans
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Mice
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Rheum
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adverse effects
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chemistry
7.Advances in studies of renal adverse reactions of Leonurus heterophyllus.
Jie YU ; Jing WANG ; Ronghua ZHAO ; Zhaorigetu BAO ; Shaoqing CAI
China Journal of Chinese Materia Medica 2010;35(9):1213-1216
Motherwort (Herb of Leonurus heterophyllus) was a traditional Chinese medicine used for the treatment of various kinds of gynaecological diseases, which was considered as non-toxic medicine since ancient times. However, adverse effects such as kidney damage, uterus damage, allergy and diarrhea were frequently reported recently. This paper reviews the possible target site, toxic dosage, chemical substance and other related factors of these kidney damage caused by motherwort from both the clinic and animal experiment view.
Animals
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Drugs, Chinese Herbal
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adverse effects
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Humans
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Kidney
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drug effects
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pathology
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Leonurus
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chemistry
8.Research on quality standards of herbs of Peganum harmala.
Fang-fang WEN ; Li-ming ZHENG ; Xiao-jing LI ; Yan LI ; Lei ZHANG ; Xue-mei CHENG ; Chang-hong WANG ; Zheng-taou WANG
China Journal of Chinese Materia Medica 2012;37(19):2971-2976
OBJECTIVETo establish the quality standards of the herbs of Peganum harmala.
METHODAccording to the Chinese Pharmacopoeia (2010 version, volume 1) and its appendix method, the water, total ash, acid insoluble ash, water-soluble extractives, and heavy metal were analyzed for herbs of P. harmala. TLC method was used to separate harmaline, harmine and vasicine from the herb samples by mixture of ethyl acetate-methanol-ammonia (10: 1.5: 0.5) as a developing solvent on high performance silica gel precoated plate (HSGF254) and to identify them inspected under UV 366 nm, visualized by spraying with both Dragendorff reagent, and by bioautographic assay. In the HPLC method, vasicine was separated on a C18 (4.6 mm x 250 mm, 5 microm) column with metnanol-0.1% trifluoroacetic acid (15:85) as the mobile phase and detected at at 280 nm.
RESULTIn the TLC procedures, 254 nm fluorescent and bioautographic assay for the detection of acetylcholinesterase inhibitor can be used for the qualitative identification of the active ingredients. For the HPLC quantitation method, the calibration curve of vasicine displayed ideal linearity over the range of 0.7923-792.3 mg x L(-1) with the regression equation of Y = 18,227X - 24.879 (r = 0.9999). The average recovery of vasicine was 101.6% with a RSD of 1.9%. The RSD values of intra-day and inter-day precision were less than 2%. The content of vasicine in 10 batches of herbs of P. harmala fluctuates between 0.23% and 1.47%.
CONCLUSIONThe results indicated that the limit of vasicine was not lower than 0.6%, and the water, total ash, acid insoluble ash, and water-soluble extractives were not more than 10.0%, 20.0%, 1.7%, and 30.0%, respectively. The heavy metal of plumbum, cadmium, arsenic, mercury, and copper were not more than 5, 3, 2, 2, and 20 mg x kg(-1), respectively. The qualitative and quantitative method established was suitable for the quality evaluation and assessment of herbs of P. harmala.
Alkaloids ; chemistry ; Drugs, Chinese Herbal ; adverse effects ; chemistry ; standards ; Humans ; Metals, Heavy ; chemistry ; Peganum ; chemistry ; Quality Control ; Quinazolines ; chemistry
9.Advance in studies on effect of Glycyrrhizae Radix et Rhizoma in relieving purgative activity of Rhei Radix et Rhizoma.
China Journal of Chinese Materia Medica 2015;40(4):577-581
Rhei Radix et Rhizoma, as a commonly used traditional Chinese medicine, has been widely applied in clinic. Its major purgative constituent is anthraquinones, which are believed to be a toxic ingredient. Glycyrrhizae Radix et Rhizoma has been reputed as the best alexipharmic to moderate medicine natures. In this paper, the effect of Glycyrrhizae Radix et Rhizoma in relieving purgative activity of Rhei Radix et Rhizoma was studied in two aspects--the boiling process and intestinal metabolism; Studies on combined administration of Glycyrrhizae Radix et Rhizoma and Rhei Radix et Rhizoma in recent years were summarized according to chemical constituent, intestinal flora, I/II phase metabolism and drug transport. However, the material basis and mechanism for their compatibility remain unclear, further studies will be made in the future.
Animals
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Cathartics
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adverse effects
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analysis
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pharmacology
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Chemistry, Pharmaceutical
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Drugs, Chinese Herbal
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adverse effects
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analysis
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pharmacology
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Glycyrrhiza
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chemistry
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Humans
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Rheum
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adverse effects
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chemistry
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Rhizome
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chemistry
10.Role of traditional Chinese medicine injection infusion with precise infusion apparatus.
China Journal of Chinese Materia Medica 2012;37(18):2758-2759
The adverse reactions caused by the traditional Chinese medicine has become increasingly aroused great attention. Traditional Chinese medicine injection may produce insoluble particles in the process of production, preparation and infusion, which is one of the reasons caused some adverse drug reactions such as phlebitis, allergic reactions, so it is essential that how to control Chinese medicine injection of insoluble drug particles enter human clinical safety. The author retrieve a large number of paper, from the infusion of particles, analysis traditional Chinese medicine injection and insoluble particles in the liquid compatibility increased occurrence and cause, comparative advantages and disadvantages of the ordinary infusion and precision infusion, which found that using sophisticated filters infusion of traditional Chinese medicine injection control of traditional Chinese medicine injection of insoluble particles enter the blood vessels, thereby reducing the occurrence of adverse drug reactions part of the traditional Chinese medicine injection, is the best, most effective, most secure way of infusion.
Drug Delivery Systems
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instrumentation
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Drugs, Chinese Herbal
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administration & dosage
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adverse effects
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chemistry
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Humans
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Infusions, Parenteral
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instrumentation