• Journal of Pharmacopuncture
• /
• v.23 no.2
• /
• pp.71-78
• /
• 2020

Objectives: This study was conducted to development of hazardous materials management standards for the decoction type of personalized herbal medicines (PHMs). Methods: This study was conducted in two stages. We searched documents about criteria to use words such as 'Herb', 'Herbal medicine', and 'Botanical Drug' and summarized the results. We organized the committee consisted of seven experts, and held two meetings to reach an agreement on hazardous management standards of the decoction type of PHMs. Results: The seven documents were presented in the literature review and six items related to hazardous management standards of decoction were identified. The second expert meeting brought that a total of six items, including heavy metal, pesticide residues, sulfur dioxide, benzopyrene, mycotoxin, and micro-organism limits, were selected for safety management of decoction type of PHMs. Also, the criteria and test methods for each standard were suggested for monitoring the decoction type of PHMs. Conclusion: The study suggested hazardous material management standards and criteria for the decoction types of PHMs. In the future, it would be necessary to conduct a pilot test to ensure the validity and credibility of the safety management standard and criteria. Furthermore, the government level safety management system should be introduced to verify the safety of decoction medicines.

• The Korea Journal of Herbology
• /
• v.28 no.2
• /
• pp.61-65
• /
• 2013

Objectives : Samchulgeonbi-tang (shenzhujianpi-tang) has been prescribed as one of traditional herbal medicine for treatment of stomach diseases since ancient time in Korea. Samchulgeonbi-tang extract was fermented by Lactobacillus spp. for improving the effect. However, the toxicity and safety of fermented Samchulgeonbi-tang (FS) extract were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of FS extract. Methods : To evaluate the acute toxicity and safety of FS extract, several doses of FS extract, 0, 500, 1000 and 2000 mg/kg, were orally administered to 20 male and 20 female ICR mice, respectively. After treatment with FS extract, we observed mortality, general toxicity, behavior and change of body weight for the 14 days. After 14 days of oral administration, all mice were sacrificed and hematological parameters were analyzed from blood serum. Results : In present study, the toxic signs such as mortality or abnormal behaviors by FS extract were not observed. There are no significant differences between FS-treated group and control group in body weight, organ weights, and hematological parameters. Conclusions : The remarkable adverse effects by FS extract were not observed in ICR mice. Also, any death was not occurred at all treated FS doses, 500, 1000 and 2000 mg/kg. Therefore, the approximate lethal dose (ALD) of FS extract may be more than 2000 mg/kg.

• The Journal of Internal Korean Medicine
• /
• v.33 no.4
• /
• pp.485-497
• /
• 2012

Objectives : The aim of this study was to systematically investigate herbal-drug-associated adverse drug reactions (herbal ADRs) reports submitted by a single oriental hospital and to analyze the general characteristics, causative agents, clinical manifestations, severity and types of herbal medicines which caused herbal ADRs. Methods : This study proceeded with IRB approval. The data on herbal ADR were collected prospectively from January 2008 to February 2012 by EMR of Dongguk University Ilsan Oriental Hospital. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to determinate causality for each herbal ADR. WHO-Adverse Reaction Terminology (WHO-ART) System Organ Class (SOC) code and WHO severity category were also used in this study. Results : A total of twenty eight cases were reported. Twenty two cases were assessed to have over possible relations with herbal medication. The gender ratio of these cases were 64.6 percent female and 36.4 percent male, demonstrating no statistical significance. Patients aged over 60 were 59.1%. Gastro-intestinal system was reported to be the most frequently affected organ (38.8%), and followed by psychiatric system (22.4%), and integumentary system (22.4%). The most common clinical symptom was headache (12.2%), followed by diarrhea (10.2%), and pruritus (10.2%). The severity of most cases was assessed to be mild (89.8%). The percentage of moderate ones was 10.2%, and there were no severe cases. Conclusions : Progressive study and further analysis on herbal ADRs are warranted for safety in the clinical use of herbal medicines.

• The Journal of Pediatrics of Korean Medicine
• /
• v.34 no.3
• /
• pp.18-36
• /
• 2020

Objectives The purpose of this study is to analyze Chinese randomized controlled trials (RCTs), and to evaluate the effectiveness and safety of the oral herbal medicine treatment for pediatric chickenpox. Methods We searched RCTs after 2000s from the China National Knowledge Infrastructure (CNKI). Afterwards, the year of publication, demographic information, duration of chickenpox, intervention, treatment duration, outcome measure, results and adverse events were investigated and analyzed for this study. Results 21 RCTs out of 219 studies were collected and analyzed. Although each composition of the herbal medicine was different, they have common ingredients such as 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風 in order to make efficacy of 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風. The oral herbal medicine showed better efficacy and safety to improve clinical symptoms such as total efficacy, cure rate, antipyretic time, antipruritic time, scab time, anti-rash time, hospitalization period and herpes recovery time compared to the western medicine treatment. Conclusions These results show that the oral herbal medicine treatment on chickenpox in children may be more effective in reducing of clinical symptoms compared to the western medicine treatment.

• Journal of Food Hygiene and Safety
• /
• v.32 no.3
• /
• pp.187-192
• /
• 2017

The consumption of herbal medicines has been increasing with growing interest in health. However, due to recent climate change and the complex distribution process of herbal medicines with high import dependence the likelihood of contamination with mycotoxin has been increased. Mycotoxins are emerging as key indicators for ensuring safety of herbal medicines. A total of 498 herbal medicine samples were screened for mycotoxin contamination in this study. Aflatoxin in the herbal medicine samples was extracted by using immunoaffinity column, then the extracted aflatoxin was quantified via high performance liquid chromatography coupled with fluorescence detection (HPLC-FLD) method. The extraction method was verified by linearity, recovery, LOD and LOQ. Aflatoxins were detected in 39/498 samples in an average of $7.670{\mu}g/kg$ ($0.610-77.452{\mu}g/kg$ range). Although safety standards for Corydalis Tuber is not currently available in korea, five of the 39 samples had high concentration of aflatoxins (average of $14.9{\pm}4.1{\mu}g/kg$). In conclusion, it is urgent to establish safety criteria of aflatoxin in Corydalis Tuber. The results of the current study suggest that continuous monitoring is necessary for proactive management of herbal medicine safety.

• Herbal Formula Science
• /
• v.27 no.1
• /
• pp.31-44
• /
• 2019

Objective : Herbal dispensaries, where medications are prepared for patients, require specific preparation and operations management for safe herbal medicines. This study aims to propose improvements in the herbal medicine preparation and operation of the herbal dispensaries as series study of the "A Survey on the Management Status of Extramural Herbal Dispensaries" Methods : We first checked current management regulations. In addition, we compared and analyzed related laws which are "State management norm of Traditional Chinese Medicine dispensaries", "Enforcement Rule of Medicinal Product Safety" and " Hazard Analysis and Critical Control Point(HACCP)", to introduce the assessment items of herbal dispenses evaluation and certification system. Results : In this study, we found that the current regulations, "Guideline on Installation and Utilization of Extremal Herbal Pharmaceutical Facility and Shared-use of Herbal Dispensary", are insufficient to ensure the quality and safety of herbal medicines. We suggested articles for the proper management of herbal dispensaries and these were introduced to the Herbal dispensary evaluation and certification system. Conclusion : We recommend evaluation articles in Herbal dispensary evaluation and certification systems need to be popular among herbal dispensaries, then Korean herbal medicine could restore credibility from the people.

• The Journal of Internal Korean Medicine
• /
• v.44 no.4
• /
• pp.635-644
• /
• 2023

Objectives: This study analyzed laboratory serum data results before and after patients took herbal medicine to confirm the clinical safety of herbal medicine. In addition, in the event of liver damage, the case was analyzed to confirm the characteristics of liver damage and the possibility of liver damage caused by herbal medicine. Methods: A retrospective chart review of the effects of herbal medicine on liver function in patients diagnosed with functional dyspepsia was conducted. The electronic medical records of 128 patients in a single hospital were reviewed. Results: The statistical analysis revealed a statistically significant decrease in liver function-related laboratory serum data after taking herbal medicine (p<0.05). In addition, among 128 patients, there were two cases of drug-induced liver injury (DILI) (1.56%). Conclusion: Taking herbal medicine prescribed by experts does not significantly affect liver function in patients with functional dyspepsia. Rather, the liver levels of the subjects showed a significant decrease after taking herbal medicine. To support these results, further large-scale multicenter prospective studies are necessary.

• The Journal of Korean Medicine
• /
• v.29 no.2
• /
• pp.41-46
• /
• 2008

Objective: To build a basis of strategy for development of herbal drug as a preventive medicine during dynamic innovation of Korean Oriental medicine. Methods: Via telephone interview, 101 subjects prescribed with deer antler were asked to provide us their reflections about five topics: points of satisfaction, physical improvement, improved symptoms, annual times of taking restorative herbal medicine, and aspect of complaints about taking the herbal drugs. Results: Around 68% of subjects usually take a restorative herbal medicine with deer antler less than once per year. 63% of subjects were satisfied with herbal restoratives. They answered the physical energetic feeling (52%) as the most benefit while expensive price (43%) as the most frequent complaint. Conclusion: Scientifically designed restorative herbal medicine needs to be developed for competitiveness of Korean Oriental medicine as a preventive medicine. In addition, more reasonable price and confirmative data for safety and quality control should be equipped in Korean Oriental medical market.

• The Journal of Korean Medicine
• /
• v.40 no.3
• /
• pp.139-176
• /
• 2019

Objectives: This study aims to review the herbal medicines containing substances banned by World Anti-Doping Agency(WADA), and to consider criteria for the using of herbal medicines. Methods: Using foreign(Pubmed, Cochrane, Embase, Google Scholar, WANFANG, CiNii) and domestic databases (NDSL, OASIS, RISS), we analyzed the content and pharmacokinetics of the prohibited substances in herbal medicines. Results: Herbal medicines containing the prohibited substances proposed in Korea, China, and Japan are Ephedrae Herba, Cannabis Semen, Strychni Semen, Strychni Ignatii Semen, Pinelliae Tuber, Rhizoma Pinelliae, Chelidonii Herba, Papaveris Fructus Deseminatus, Liriopis Tuber, Rehmanniae Radix Recens, Cistanchis Herba, Ponciri Fructus Immaturus, Aurantii Fructus Immaturus, Moschus, Testudinis Plastrum, Otariae Testis et Penis, and Hominis Placenta. Of these, when using Ephedrae Herba, Cannabis Semen, Strychni Semen, Moschus, Strychni Ignatii Semen, and Otariae Testis et Penis, caution is needed in relation to the doping test. Other herbal medicines are considered safe for the doping test. In addition, by analyzing data related to higenamine added to the WADA's prohibited list of doping since 2017, we don't recommend using Nelumbinis Plumula. And in the case of the other herbal medicines containing higenamine, it is considered that care should be taken in doping test depending on the amount of usage. Conclusions: As a result of analyzing the herbal medicines which are in prohibited list about doping, we were able to know the criteria and precautions to use when prescribing the herbal medicines. Further research will be needed about common used herbal medicines and the amount of detection depending on extraction and boiling method.

• Journal of Pharmacopuncture
• /
• v.17 no.4
• /
• pp.55-60
• /
• 2014

Objectives: This study was designed to evaluate the efficacy and the safety of constitutional herbal tea for treating chronic fatigue with no diagnosed cause, which is called Mibyeong in Korea. Methods: Males and females with ages between 40 and 59 years who had complained of fatigue for 1 month consistently or for 6 months intermittently without a definite cause were recruited. At the same time, a Chalder fatigue scale (CFS) score of 19 was essential for participation in this study. Sixty five subjects completed the entire process, including blood tests and tests with medical devices. Five assessments of health status were accomplished over 8 weeks by using the CFS and the visual analogue scale (VAS). To ensure that the constitutional herbal tea was being safely used, we conducted and analyzed renal function and liver function tests. For the diagnosis of the Sasang constitution, the Sasang Constitutional Analysis Tool (SCAT) was used, and a specialist in Sasang constitutional medicine made the final diagnosis based on the SCAT result. Constitutional herbal tea was served four weeks after the first visit. The subjects took the constitutional herbal tea twice a day for one month. Results: The results are as follows: The CFS and the VAS scores were significantly improved for the subjects in the constitutional herbal tea. No abnormalities were found on the blood tests to evaluate safety after taking the constitutional herbal tea. The improvements in the CFS and the VAS scores due to the constitutional herbal tea had no significant differences according to the Sasang constitution. Conclusion: Constitutional herbal tea may be used to reduce fatigue and improve health and has no adverse effect on either the kidney or the liver.