• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.33 no.1
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• pp.34-39
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• 2023

Objectives: In this study, the safety of alcohol-based hand sanitizers (ABHSs) for quasi-drugs and cosmetics was investigated by analyzing the ethanol content, which is an active ingredient with a sterilizing effect, and methanol, which is toxic. Methods: Forty-one ABHSs were purchased at large supermarkets and online stores. Ethanol quantification was performed by gas chromatography-flame ionization detector, and methanol quantification was performed by headspace-gas chromatography-mass spectrometry. Results: The ethanol content of ABHS in quasi-drugs was 49.6-67.8%, which was suitable for standard manufacturing procedures for external disinfectants, and the ethanol content of ABHS in cosmetics was 9.1-61.3%. The methanol content of ABHS in quasi-drugs ranged from not detected(N.D.)-131.8 ppm, which was suitable for the methanol detection standard of ethanol raw materials in the Korean Pharmacopoeia. The methanol content of ABHS in cosmetics was 23.4-859.7 ppm, which was suitable for the detection limit of methanol in cosmetics. Conclusions: The ethanol and methanol content of ABHS was judged to be safe. When selecting an ABHS to be used for sterilization, it seems necessary to check the content of ethanol, an active ingredient, and use it according to its intended purpose.

• Herbal Formula Science
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• v.11 no.2
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• pp.1-18
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• 2003

The Theory for Monarch, Minister, Adjuvant and Dispatcher (or the Theory of Principal, Assistant, Adjuvant and Guiding Korean Oriental Herbal Medicines) has served as a standard principle for newly developed prescription formulas as well as established ones. Despite its significance, however, this theory hasn't been thoroughly studied and covered in the academic journals of Korean Oriental Herbal Medicines (KOHM) yet. This paper inquires into the origin of the theory while presenting the definitions and functions of Principal, Assistant, Adjuvant, and Guiding KOHM. In the end, the recommended doses and number of the KOHM comprising each of Principal, Assistant, Adjuvant, and Guiding KOHM are suggested. The compatibility theory of Principal, Assistant, Adjuvant, and Guiding KOHM can be traced back to the Warring States Period during which it was recorded in the treatise of the various schools of thoughts and their exponents. The theory was firmly established as a full system in ${\ulcorner}Shinnong's\;Pharmacopoeia{\lrcorner}\;and\;{\ulcorner}Yellow\;Emperor's\;Cannon\;of\;Internal\;Medicine{\lrcorner}$. While ${\ulcorner}Shinnong's\;Pharmacopoeia{\lrcorner}$ focuses on the classification of the properties of KOHM, ${\ulcorner}Yellow\;Emperor's\;Cannon\;of\;Internal\;Medicine{\lrcorner}$ mainly deals with the principles for writing prescriptions. In this regard, it is ${\ulcorner}Yellow\;Emperor's\;Cannon\;of\;Internal\;Medicine{\lrcorner}$ that systemized the Theory of Principal, Assistant, Adjuvant, and Guiding KOHM in a real sense. Principal KOHM aims at the causes of diseases and treat main symptoms. The doses are greater than Assistant, Adjuvant and Guiding KOHM. With their comprehensive effects, Principal KOHM is a leading ingredient of any prescription formula. Assistant KOHM are similar to Principal KOHM in its natures and flavors. Although its natures, flavors as well as efficacies may slightly differ from those of Principal KOHM, Assistant KOHM strengthens the therapeutic effects, jointly working with Principal KOHM. They mainly treat accompanying diseases and symptoms. Adjuvant KOHM is divided into two types: facilitator and inhibitor. Facilitators with the similar properties to those of Principal and Assistant KOHM help strengthen the therapeutic effects. Since they usually treat accompanying symptoms or secondary accompanying symptoms (minor accompanying symptoms), there are two kinds of facilitators. (1) The first kind of facilitators assists Principal KOHM, targeting accompanying symptoms. (2) The second ones supporting Assistant KOHM are for accompanying or secondary accompanying symptoms (or minor accompanying symptoms). Inhibitors counteract and thereby complement Principal and Assistant KOHM. Some of them inhibit the side effects or toxicity of Principal KOHM for the sake of the safety of the whole prescription formula while the others generate induced interactions. Guiding KOHM can be used for two purposes: guiding and mediating. The Guiding KOHM for the former purpose leads the other KOHM in a prescription formula to the lesion. But, the Guiding KOHM for mediating coodinate and harmonize all the ingredients in a prescription formula. The number of KOHM for those Principal, Assistant, Adjuvant and Guiding KOHM and their doses are different, depending on the types of prescriptions: classical prescriptions, prescriptions after ${\ulcorner}$Treatise of Cold-Induced Diseases${\lrcorner}$ and prescriptions of Sasang Constitutions Medicines. In the case of the prescriptions after ${\ulcorner}$Treatise of Cold-Induced Diseases${\lrcorner}$, it is highly recommended to follow the view of ${\ulcorner}$Thesaurus of Korean Oriental Medicine Doctors in Chosun Dynasty${\lrcorner}$ for the number of KOHM to be used. For the doses, however, ${\ulcorner}$Elementary Course for Medicine${\lrcorner}$, is found to be more accurate. The most appropriate number of KOHM per prescription is 11-13. To be more specific, for one prescription formula, it is recommended to administer one kind of KOHM for Principal KOHM, 2-3 for Assistant KOHM, 3-4 for Adjuvant KOHM and 5 for Guiding KOHM. As for the proportion of the doses, when 10 units are to be administered for Principal KOHM in a formula, the doses for the other three should be 7-8 units for Assistant KOHM, 5-6 for Adjuvant KOHM and 3-4 for Guiding KOHM. The doses of the KOHM added to or taken out of the prescription correspond to those of Adjuvant and Guiding KOHM.

• Journal of Korean Ophthalmic Optics Society
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• v.19 no.1
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• pp.51-57
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• 2014

Purpose: The present study was conducted to establish the experimental condition for the proper evaluation of protein removal efficacy when developing protein removal agents. Its protein removal efficacy was further analyzed and compared with the result from protein removal efficacy against protein deposition on contact lens to suggest the evaluation method for efficacy of protein removal agents. Methods: Protein digestibility assay presented in the Korean pharmacopoeia was selected to establish the evaluation method for efficacy of papain, pancreatin, subtilisin A and protease itself as a ingredient and protein removal tablets or solution containing those enzymes and find a suitable test conditions. Furthermore, the cleaning efficacy of commercially available protein removal tablets and solution on balafilcon A lens deposited with protein artificially was measured and the correlation between two evaluation methods was further analyzed. Results: When pancreatin itself and the product containing pancreatin was evaluated by protein digestibility assay, both reached 28 IU/mg, the standard value of protein digestibility suggested by the Korean pharmacopoeia. In case of protease and subtilisin A tested with trichloroacetic acid B solution, both of them met the enzyme activity level proposed by the manufacturers when they were evaluated by protein digestibility assay however, papain and subtilisin A tested with trichloroacetic acid A solution were not reached the enzyme activity level. Among protein removal agents, three products except a product containing pancreatin did not meet the enzyme activity value specified by the manufacturer when they were evaluated by protein digestibility assay. However, actual protein removal efficacy of three products except a papain-containing product on the lens was greater than 90% protein removal. In the case of papain-containing protein removal product, its effect was not measured by protein digestibility assay however, its actual protein removal efficacy on the lens reached 73.72%. Conclusions: From the results, it was confirmed that the efficacy of protein removal agents for contact lens should be evaluated by different method according to the type of proteolytic enzyme contained. That is, the protein removal agents containing pancreatin, protease and subtilisin A can be evaluated by protein digestibility assay and protein removal efficiency evaluation and the products containing papain can be effectively evaluated by only the evaluation method for protein removal efficiency employing the lens.

• Journal of Ginseng Culture
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• v.1
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• pp.93-109
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• 2019

This study aims to look at the process of ginseng being removed from the Western pharmacopoeia in the 19th century, experiencing a crisis as an export product in the America in the 20th century, and eventually settling in the U.S. society and the military as a dietary supplement in the 21th century. In this process, the legislation of provided a bridgehead for ginseng and other botanical dietary supplements to enter the U.S. market. As a result, ginseng could be re-listed in the U.S. pharmacopoeia as a dietary supplement. However, this did not mean a complete soft landing of ginseng and other botanical dietary supplements in the America. The U.S. medical community, which has been afraid of the indiscriminate spread of botanical dietary supplements, has constantly raised "the risk-discourse" and expressed concerns over the use and abuse of botanical dietary supplements that have not been scientifically verified. This involved not only the fundamental problems caused by the lax verification process of , but also a new atmosphere in the U.S. where the public sought information about botanical dietary supplements rather than seeking professional clinicians related to their health. Against this situation, "the advocate-discourse" suggested by dietary supplement manufacturers and the people in charge of botanical products seemed rather relaxed. As consumers are taking this side, the advocates had only to stress that botanical dietary supplements have been used worldwide for a long time without any problems and were made from 'natural' materials. The fact that ginseng and other botanical dietary supplements were able to advance to the U.S. Military's dietary supplement manual, which is strict in controlling food, seems to have jumped on the bandwagon of this atmosphere in the U.S. Society. In the early U.S. dietary supplement manual reviewed in this paper, ginseng was the most detailed among many botanical dietary supplements. Although there are some 'safety concerns' that still exist in the civilian society, but there are also certainly good scientific explanations for the efficacy and references to the popularity and influence of ginseng in the American society. Given this, the U.S. society and military's interest in ginseng as a dietary supplement seem quite high.

• Journal of Food Hygiene and Safety
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• v.39 no.2
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• pp.118-127
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• 2024

This study investigated the levels of 345 pesticide residues in 50 herbal medicines sold in Incheon metropolitan city to determine their safety. Pesticide residues are harmful substances that can cause serious health problems owing to their toxicity and carcinogenicity. The analysis of pesticide residues in the samples was conducted using the quick, easy, cheap, effective, rugged, and safe (QuEChERS) method, known for its high analysis efficiency, to analyze a wide range of pesticides for which no standards have been set. The analysis was cross-validated with the pretreatment method outlined in the Korea Pharmacopoeia. Among the 50 samples encompassing 24 different herbs, 22 pesticide residues were detected in 24 samples, covering 7 distinct herbs, resulting in a detection rate of 48%. It is noteworthy that, except for two cases, all detected pesticides were those for which no standards were set. However, after conducting a risk evaluation considering the daily dosage of herb, it was determined that the levels of pesticide residues were within safe limits. Pesticides with high frequency within the same category of herbs were detected, indicating the necessity for continuous monitoring and regulation. In addition, comparative analysis using the pretreatment method outlined in the Korean Pharmacopoeia, yielded similar results, suggesting the possibility of analyzing pesticide residues in herbs using the QuEChERS method. The study emphasizes the importance of continuous monitoring of pesticide residues in herbs and the development of high-efficiency reliability analysis methods should continue to ensure consumer safety.

• Korean Journal of Medicinal Crop Science
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• v.14 no.3
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• pp.158-162
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• 2006

Achyranthes bidentata was recorded to new medicinal crop in a revised 8th edition of the Korean pharmacopoeia. Therefore, A. bidentata began to use for same purpose with Achyranthes japonica which was cultivated since old times in Korea. This study was conducted to investigate the adaptability of A. bidentata in Korea. The germination rate and speed of A. bidentata seeds were higher than those of A. japonica in $15^{\circ}C\;and\;25^{\circ}C$. The growth of A. bidentata was greater than that of A. japonica until the 60 days after transplanting, but growth after that was the opposite. There were remarkable differences between two species in growth characteristics such as flowering date, leaf fall date, plant height, stem color and no. of branches. The flowering and leaf fall date of A. bidentata were earlier than A. japonica by July 7 and September 26. The plant height and number of branches of A.japonica were longer and more than A. bidentata, but the cluster length and no. of flowers per cluster of that were shorter and fewer than this. Number of supporting roots of A. bidentata and A. japonica was 10.7 and 14.6 per plant, respectively. The average yield was not different between two species. The yield of A. bidentata was 166 kg/l0 a in Suwon and 309 kg/10 a in Naju of Korea. The suitable cultivation region of A. bidentata was judged to southern area of Korea.

• Microbiology and Biotechnology Letters
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• v.41 no.4
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• pp.416-424
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• 2013

In the course of a study for the development of functional foods utilizing Woosul (Achyranthis radix), the components and various biological activities of Korean Woosul (AJN: Achyranthes japonica Nakai) and Chinese Woosul (ABB: Achyranthes bidentata Blume) were compared. Woosul in Korea, including AJN and ABB, are regulated and part of the Korean Pharmacopoeia. From AJN and ABB, ethanol extracts and their subsequent organic solvent fractions were prepared and their in-vitro antimicrobial, antioxidant and anti-diabetes activities were evaluated. Although AJN and ABB have no clear distinction in terms of usage in Korea, our results suggest that AJN has higher quantities of lipid-soluble components and lower amounts of water-soluble sugars than does ABB. ABB also appears to possess greater amounts of flavonoid and polyphenol substances than AJN. Analyses of biological activities showed that the fractions of AJN were more active as antibacterial agents, and possessed more pronounced ${\alpha}$-glucosidase inhibitory activities than those of the ABB fractions. However, the antioxidant activities of the ABB fractions, as determined by DPPH anion-, ABTS cation-, nitrite-scavenging activity and reducing power, were higher than those of the AJN fractions. Our results suggest that the components and bioactivity of the extracts and subsequent fractions of AJN and ABB are different. Therefore, usage of either AJN or ABB should be carefully considered, as regards their individual properties, when the active fractions of Woosul are employed in the development of functional foods or novel plant-derived medicines.

• YAKHAK HOEJI
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• v.57 no.3
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• pp.205-212
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• 2013

Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of solid dosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosage forms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessary to set the specification of dissolution test. In this study, we developed the specification and test method of dissolution test for itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet. According to the "Manual for Guideline Application for Validation of Analytical Procedures" and "Guidelines on Specification of Dissolution test for Oral dosage form" of Korean Pharmacopoeia (KP), we validated and established each development method. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2 media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%). Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods will be included the next supplement of KPC and also contributed to the quality control of medicines.

• Journal of Ginseng Research
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• v.37 no.1
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• pp.124-134
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• 2013

The authentication of the physico-chemical properties of ginsenosides reference materials as well as qualitative and quantitative batch analytical data based on validated analytical procedures is a prerequisite for certifying good manufacturing practice (GMP). Ginsenoside Rb1 and Rg1, representing protopanaxadiol and protopanaxatriol ginsenosides, respectively, are accepted as marker substances in quality control standards worldwide. However, the current analytical methods for these two compounds recommended by Korean, Chinese, European, and Japanese pharmacopoeia do not apply to red ginseng preparations, particularly the extract, because of the relatively low content of the two agents in red ginseng compared to white ginseng. In manufacturing fresh ginseng into red ginseng products, ginseng roots are exposed to a high temperature for many hours, and the naturally occurring ginsenoside Rb1 and Rg1 are converted to artifact ginsenosides such as Rg3, Rg5, Rh1, and Rh2 during the heating process. The analysis of ginsenosides in commercially available ginseng products in Korea led us to propose the inclusion of the (20S)- and (20R)-ginsenoside Rg3, including ginsenoside Rb1 and Rg1, as additional reference materials for ginseng preparations. (20S)- and (20R)-ginsenoside Rg3 were isolated by Diaion HP-20 adsorption chromatography, silica gel flash chromatography, recrystallization, and preparative HPLC. HPLC fractions corresponding to those two ginsenosides were recrystallized in appropriate solvents for the analysis of physico-chemical properties. Documentation of those isolated ginsenosides was achieved according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantification, and mass balance tests. The isolated ginsenosides showed 100% purity when determined by the three HPLC systems. Also, the water content was found to be 0.534% for (20S)-Rg3 and 0.920% for (20R)-Rg3, meaning that the net mass balances for (20S)-Rg3 and (20R)-Rg3 were 99.466% and 99.080%, respectively. From these results, we could assess and propose a full spectrum of physico-chemical properties of (20S)- and (20R)-ginsenoside Rg3 as standard reference materials for GMP-based quality control.

• Journal of Korean Medicine Rehabilitation
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• v.26 no.2
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• pp.51-59
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• 2016

Objectives We studied long-term preservation in stability of a mixed preparation of distilled and 70% alcohol extracted Hwangnyunhaedok-tang pharmacopuncture to establish standards for expiration date and quality control. Methods Three lots of consecutively prepared Hwangnyunhaedok-tang pharmacopuncture were each tested in triplicate to a total 5 tests at 3 month intervals over a period of 12 months for analysis of appearance, pH, specific gravity, index component content, endotoxins, microbial sterility, residual organic solvents, heavy metals, and pesticides. Items with no difference by elapsed time were tested at the initial and final timepoints, and data of items with potential difference by elapsed time were analyzed for trends to establish individual quality control standards. Results All tested items were stable over the study period, and therefore the expiration date was set as 12 months. pH quality control standards were set as 3.66~5.69, and that of specific gravity as 0.802~1.203, respectively. In index component content standards, berberine was set at $4.96{\sim}8.98{\mu}g/vial$, baicalin at $6.47{\sim}10.31{\mu}g/vial$, and geniposide at $116.03{\sim}189.55{\mu}g/vial$, respectively. Standards for other items with no difference by elapsed time were set according to general Korean herbal medicine standards in the Korean Pharmacopoeia. Conclusions Manageable expiration date and quality control standards were established through long-term preservation testing of Hwangnyunhaedok-tang pharmacopuncture, furthering standardization of Korean medicine pharmacopuncture.