• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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• pp.123-130
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• 2006

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

• YAKHAK HOEJI
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• v.45 no.5
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• pp.437-441
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• 2001

The quasi-drugs including nonwoven fabric and gauze were sterilized using ethylene oxide (EO) gas. Residual EO in the quasi-drugs was extracted with water (20 mL of water for 1 g of sample) for 24h at 37$^{\circ}C$. Residual EO was determined using GC. The optimal analytical conditions were as follows : column, Carbowax 20M (1.D. 0.2 mm); mobile phase, helium with 30 mL/min; oven temperature 57$^{\circ}C$, injector temperature 18$0^{\circ}C$, detector temperature 20$0^{\circ}C$. The detection limit for EO was 0.10$\mu$g/mL. When the residual EO extracted from nonwoven fabric and gauze was determined, it took more than 9h to get the lower level than 25 ppm which is the limit value of FDA guideline. When the EO residues, ethylene chlorohydrine (ECH) and ethylene glycol (EG) in the 7 commercially available quasi-drugs were determined, no residual EO, ECH, EG were found from the seven commercially available quasi-drugs analyzed by this method.

• Korean Journal of Clinical Pharmacy
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• v.23 no.2
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• pp.97-105
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• 2013

Background: This study was aimed to establish the systematic management methods of tar color additives used in Korea for drugs and quasi-drugs. Although tar color additives have been used in various areas, safety problems are continuously being reported by several studies. For that reason, major countries like US, Japan, Europe are trying to update the safety information of tar color additives and the related management methods, and Korea also need to complement them based on the updated information for their safer use. Method: This report includes the compared information of all legally used tar color additives of each country, such as color additive name, compound name and chemical abstracts service registry number. Conclusion: It is expected that these investigated results will be useful as the basic materials for proper management guidelines of tar color additives in Korea.

• 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.

• Journal of Environmental Health Sciences
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• v.9 no.2
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• pp.55-65
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• 1983

This survey was carried out to investigate the pattern of taking psychotropic drugs for 618 cases who visited 48 drugstores located as such four types of areas as business sections, gay quarters, residential sections and quasi-industrial areas from May, 1982 to March, 1983. The results are summarized as follows: I. The age distribution: The age group of 20-29 showed the highest distribution covering 35.6% as 220 out of 618 cases. The age groups of thirties and forties covered 23.0% and 19.0% respectively. The sex ratio was estimated as 1:1.86. 2. The occupational distribution: The unemployees composed the largest portion covering 53.7% as 332 out of 618. Above all the class of the housewives was 32.7%. 3. The marital status: The degree of distribution was higher on the sides of the group of married people than that of single and its percentage was 30.1. 4. The educational level: Most of the people who purchased the drugs had no knowledge of the effect of the drugs, and they covered 80.9%. 5. As for the motives, the twenties took psychotropic drugs in order to relief insomnia and that was the biggest major motive at the portion of 59.1%, 130 out of 618. 6. The age group of twenties who took the drugs for about 6 months showed the highest percentage of 52.7%. 7. The highest distribution appeared in the case that takes one or two tablets a day for less than 6 months. 8. The dosage distribution by the number of times taking the drugs The group of people that took the drugs more than 3 to 4 tablets a day as the number of 1 to 3 times covered 41.7\ulcorner0 of 187. 9. The most favorite psychotropic drugs: Lorazepam was showed to be the most favorite drugs by either male or female covered 50.9o70, 54.2\ulcornero respectively. 10. The motives of selecting drugs: The optional motives of selecting psychotropic drugs were showed 269 (43.5%) out of 618 cases that chose the drugs for themselves.

• Journal of Korean Public Health Nursing
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• v.27 no.2
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• pp.338-356
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• 2013

Purpose: This study critically reviewed nursing research psychotropic drugs that has been published in Korean journals. Another aim of this study was to identify trends in nursing research on psychotropic drugs and make suggestions for further study in Korea. Methods: Data were collected from degree theses and original articles on psychotropic drugs published in Korean journals from 1992 to 2013. Thirty-four articles were analyzed of which at least one nursing author participated in the study. Search keywords were "psychotropic drug" and "mentally ill patient & medication". Results: For the research design, quasi-experimental study was 58.8%, descriptive study was 17.7%, descriptive correlational study was 8.8%, qualitative study was 8.8% and model development research was 5.9%. Variables measured were knowledge of medication & symptom management, knowledge of disease, side effects, drug attitude, medication pattern, diet & activity, quality of life, and self-care. Conclusion: Despite recent increased interest in psychiatric medication, research on psychotropic drugs remains very limited, particularly regarding findings from a nurse's perspective. More research project should be designed to develop programs for the treatment of side effects from a nursing view-point.

• Journal of the Korean Society of School Health
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• v.19 no.2
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• pp.89-104
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• 2006

Purpose： This study was to develop and verify the effects of drug misuse and abuse preventive program for middle school students. Methods：This research was a quasi experimental study under the nonequivalent control group with pretest-post test design which tried to protect children from the detrimental effect of drugs and develop a drug abuse prevention program for middle school students. Data was collected from October 10th to 21th, 2005. Subject consisted of 145 middle school students in Kyeonggi, experimental group-72, control group-73. Dick & Carey's(1996) educational system was applied, based on documents and materials online related to drug abuse in order to develop drug abuse prevention program. It's composed of 4 parts, 45 minute each. The evaluation instrument testing for the knowledge about drugs was a criterion of referenced test items modeled by Dick & Carey. The instrument for attitudes about drugs was modeled by Kim, Soyaja. A pre-test was taken on the knowledge and attitudes to drugs. The experimental students were given four sessions of drug abuse prevention education. A post-test similar to the pre-test questionnaire was given in 1 week, 4 weeks following the last session. Collected data was analyzed by using SAS 9.1 program. Results：Followings are the summarized result of study 1. The experimental group, that attended the drug abuse prevention program will have more knowledgable about drugs than the control group (F=27.31, p<.0001). 2. The experimental group, that attended the drug abuse prevention program displayed greater negativism attitude than the control group (F=0.58, p=0.4477). Conclusion：The results conclude that drug abuse prevention programs increase the knowledge of middle school students but doesn't change their attitude toward drugs. Therefore we need to offer them more systematic education to increase their knowledge so it will also improve their attitudes as well.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.26 no.2
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• pp.9-12
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• 2000

Certain types of anti-inflammatory components and whitening components were in practical use as the active ingredients of quasi drugs expected to display their pharmacological actions. However, only twenty years at most have past since the introduction of cosmetics that not only physically change the condition of the surface of the skin, but also promote skin homeostasis from by acting on the physiological mechanisms of the skin. Since then, much effort hasa been made to find new active ingredients suitable for full-scale development, and the term "cosmeceutical" has often been coined to describe cosmetics containing pharmacologically active components. In this report, the prospects of cosmeceuticals will be discussed on the basis of a review of the history of the development of current skin-care products.

• Biomedical Science Letters
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• v.27 no.4
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• pp.231-238
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• 2021

Several structural proteins present in keratinocytes of the skin are known to play an important role in the formation of epidermal tissue and barrier function, and the absence of structural proteins in keratinocytes causes various skin diseases. In this study, 42 types of tetrapeptides derived from the sequence of Loricrin, a kind of terminally differentiating structural protein, were synthesized, and skin anti-aging properties were measured by measuring the elastase inhibition, proliferation of skin cells. The anti-aging efficacy was verified and, based on this, it succeeded in selecting one of the most excellent peptides. It is expected that the selected tetrapeptide can be used as a raw material for various cosmetics and quasi-drugs based on anti-aging and skin cell proliferation effects.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.