• Title/Summary/Keyword: Quality control guidelines

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Study on Developing Assessment Guideline for Safety and Performance of Electric Moxibustion Apparatus (전기식 온구기에 대한 안전성 및 성능 평가 가이드라인 개발 연구)

  • Yi, Seung-Ho;Kang, Jung-Won;Nam, Dong-Woo;Kim, Eun-Jung;Lee, Hye-Jung;Kim, Kap-Sung;Lee, Jae-Dong
    • Journal of Acupuncture Research
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    • v.27 no.1
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    • pp.75-86
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    • 2010
  • Objectives : We developed and proposed a guideline for safety and performance assessment of electric moxibustion apparatus (class II medical device). Methods : We drafted the guideline for safety and performance assessment of electric moxibustion apparatus by referring the existing standards, guidelines and measurement data from commercially available products. Temperature characteristics such as maximum temperature and ramp time, and physical characteristics such as weight, noise and diameter were measured. User friendliness was also evaluated for commercial devices. Results : This guideline only can be applied to the electric moxibustion apparatus where moxa is being heated by electricity for medical proposes. Maximum temperature of higher than $50^{\circ}C$ can be achieved mostly. Ramp rate of temperature seems to be reliable. Control of temperature is needed to be improved. Moxa and its derivative products seem to be regulated for reliable temperature performance for clinical application. Requirements for design and development of electric moxibustion apparatus are suggested : temperature indicator, temperature control and its accuracy, safety measure, surge protection, user friendliness and instruction for use (IFU). Design recommendation of the reduction of noise level and energy loss are suggested for better products. Conclusions : We proposed a guideline for safety and performance assessment of electric moxibustion apparatus to improve the quality of relating products and aid their commercialization by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

Effects of Herbs and Green Tea on the Sensory and the Antioxidative Qualities of Beef-Yukwonjeon (서양 향신료 및 녹차를 첨가한 쇠고기 육원전의 관능적 특성과 항산화 효과)

  • Lee, Joo-Hee;An, Lee-Hwa
    • Journal of the East Asian Society of Dietary Life
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    • v.17 no.6
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    • pp.808-815
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    • 2007
  • Four different herbs, including rosemary, oregano, basil and sage, along with green tea were individually added to ground beef at different percentages: 0.5, 1.0, and 1.5, respectively. The sensory qualities of the five natural herbs and their antioxidant effects were evaluated using Beef-Yukwonjeon. For the sensory evaluation results, the 0.5% herb addition and the control group generally showed higher acceptability scores than the 1.0% or 1.5% herb addition groups. In particular, the Yukwonjeon made with 0.5% green tea showed higher preferences in the acceptance tests and ranking tests. However, the sensory differences among samples were reduced after 3 days of storage at $6^{\circ}C$. For the results of lipid oxidation without storage, the TBARS values of the herb addition groups were slightly lower than the value of the control group, but not significantly(p>0.05). However, the antioxidant effects of each herb showed higher values over a longer storage period as well as at the higher herb concentrations. The antioxidant effects of the herbs during 7 days' of storage at $6^{\circ}C$ were evaluated as $10.0{\sim}38.5%$ reductions in TBARS values as compared to the group without herbs. Furthermore, the antioxidant effects of the herbs during 30 days' of storage at $-20^{\circ}C$ were shown as $16.8{\sim}27.8%$ reductions in the TBARS value. The green tea showed the highest antioxidant activity against lipid oxidation, because it was acceptable at higher concentrations in the sensory evaluation. These results indicate the potential to produce better quality beef-Yukwonjeon, with herbs, especially green tea.

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Analysis of Use of Government Support for Palliative Care Units in Korea (말기암환자 완화의료 전문기관 운영 지원비 사용 평가)

  • Kim, Hyo-Young;Yoo, Eun-Sil;Kim, Yeol;Kong, Kyoung-Ae;Song, Hye-Young;Choi, Jin-Young
    • Journal of Hospice and Palliative Care
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    • v.14 no.4
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    • pp.212-217
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    • 2011
  • Purpose: Since 2005, the Ministry of Health & Welfare has provided financial support to promote palliative care for terminal cancer patients. We analyzed how palliative care facilities used the funding between 2006 and 2010. Methods: Frequency analysis was conducted by the item of expenditure based on fiscal reports of the palliative care facilities. Linear regression analysis was performed to examine a trend over time. Kruskal-Wallis test and Wilcoxon rank-sum test were used to compare expenditure items, the number of provision of financial support and type of palliative care units. Results: About a half of the fund was spent to pay care givers salary, improve facilities and purchase equipment regardless of the year, the number of financial support provided or facility type. By year, the operation cost for palliative care program and the education cost for health care workers have significantly increased in linear regression analysis (P<0.01). However, the amount of financial support for the low income group has decreased over years (P=0.024). This trend was affected by evaluation criteria and weight. Conclusion: The government aid for palliative care units has been used to improve facilities and equipment. Moreover, desirable changes were noted such as a higher portion of expenses for program operation and care giver training to enhance the quality of care. However, the evaluation criteria need to be adjusted to prevent any further decrease in the support provided to the low income group.

Home hospice palliative care service in Korea: Based on focus group interview (가정 호스피스완화의료 서비스 현황 조사: 실무자 포커스 그룹 인터뷰를 중심으로)

  • Koh, Su-Jin;Kim, Yeol;Song, Mi Ok;Choi, Youngsim;Choi, Sung Eun;Jho, Hyun Jung;Huh, Yun Jung;Park, Myung-Hee;Park, Seon Ju;Kwon, So-Hi
    • Journal of the Korean Data and Information Science Society
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    • v.25 no.1
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    • pp.37-52
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    • 2014
  • The aim of this study was to understand home hospice care status and problem in Korea, and ultimately to develop the home hospice standard. This study was conducted as a part of a study on the institutionalization of the home hospice in Korea. A focus group interview with representatives of seven home hospice agency where have provided home hospice service for years was conducted. All of the participants agreed to the essential components for home hospice service including 24 hour on call service, multidisciplinary team visiting, and periodical team meeting. Visiting frequency was 1-3 times per week mostly by nurses. And they agreed requisitely to fulfill an office for home visiting nurses, storage space, and home visiting bags. The obstacles of providing home hospice were 1) no reimbursement system, 2) difficulties to change medication at home, 3) lack of inpatient beds for symptom control. Standardization of home hospice is critical to improve service quality and to develop reimbursement system. The findings of this study could be used as a basic data to develop home hospice standards and guidelines.

HPLC Method for Simultaneous Quantitative Detection of Quercetin and Curcuminoids in Traditional Chinese Medicines

  • Ang, Lee Fung;Yam, Mun Fei;Fung, Yvonne Tan Tze;Kiang, Peh Kok;Darwin, Yusrida
    • Journal of Pharmacopuncture
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    • v.17 no.4
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    • pp.36-49
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    • 2014
  • Objectives: Quercetin and curcuminoids are important bioactive compounds found in many herbs. Previously reported high performance liquid chromatography ultraviolet (HPLC-UV) methods for the detection of quercetin and curcuminoids have several disadvantages, including unsatisfactory separation times and lack of validation according the standard guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Methods: A rapid, specific, reversed phase, HPLC-UV method with an isocratic elution of acetonitrile and 2% v/v acetic acid (40% : 60% v/v) (pH 2.6) at a flow rate of 1.3 mL/minutes, a column temperature of $35^{\circ}C$, and ultraviolet (UV) detection at 370 nm was developed. The method was validated and applied to the quantification of different types of market available Chinese medicine extracts, pills and tablets. Results: The method allowed simultaneous determination of quercetin, bisdemethoxycurcumin, demethoxycurcumin and curcumin in the concentration ranges of $0.00488-200{\mu}g/mL$, $0.625-320{\mu}g/mL$, $0.07813-320{\mu}g/mL$ and $0.03906-320{\mu}g/mL$, respectively. The limits of detection and quantification, respectively, were 0.00488 and $0.03906{\mu}g/mL$ for quercetin, 0.62500 and $2.50000{\mu}g/mL$ for bisdemethoxycurcumin, 0.07813 and $0.31250{\mu}g/mL$ for demethoxycurcumin, and 0.03906 and $0.07813{\mu}g/mL$ for curcumin. The percent relative intra day standard deviation (% RSD) values were $0.432-0.806{\mu}g/mL$, $0.576-0.723{\mu}g/mL$, $0.635-0.752{\mu}g/mL$ and $0.655-0.732{\mu}g/mL$ for quercetin, bisdemethoxycurcumin, demethoxycurcumin and curcumin, respectively, and those for intra day precision were $0.323-0.968{\mu}g/mL$, $0.805-0.854{\mu}g/mL$, $0.078-0.844{\mu}g/mL$ and $0.275-0.829{\mu}g/mL$, respectively. The intra day accuracies were 99.589%-100.821%, 98.588%-101.084%, 9.289%-100.88%, and 98.292%-101.022% for quercetin, bisdemethoxycurcumin, demethoxycurcumin and curcumin, respectively, and the inter day accuracy were 99.665%-103.06%, 97.669%-103.513%, 99.569%-103.617%, and 97.929%-103.606%, respectively. Conclusion: The method was found to be simple, accurate and precise and is recommended for routine quality control analysis of commercial Chinese medicine products containing the flour flavonoids as their principle components in the extracts.

Physicochemical Characteristics and Analysis of Pollution Potential in the Sediments of the Rivers Flowing into the Saemangeum Reservoir (새만금호 유입 하천 하상 퇴적물의 물리화학적 특성과 오염도 분석)

  • Oh, Kyoung-Hee;Yu, Mi-Na;Cho, Young-Cheol
    • Journal of Korean Society of Environmental Engineers
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    • v.33 no.12
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    • pp.861-867
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    • 2011
  • In order to understand the extent of contamination of the sediments on the Mankyoung and Dongjin Rivers flowing into the Saemangeum Reservoir, the concentrations of ignition loss (IL), COD, total nitrogen (T-N), total phosphorus (T-P), and heavy metals (As, Cd, Cr, Pb, Zn) were measured. The average concentrations of IL, COD, and T-P were 2.40 (${\pm}2.18$)%, 2.97 (${\pm}3.06$) mg/g sediment, 0.370 (${\pm}0.351$) mg/g sediment, respectively, showing the extent of contamination is not serious. However, the concentrations of these parameters in the samples taken in year 2009 were higher than those in year 2008, indicating the contamination of sediments goes on gradually. The concentrations of T-N were in the range of 0.59~13.11 mg/g sediment with variation of locations and seasons. It was determined that the T-N contamination is serious when the concentrations were compared with the dredging guidelines of sediments in the Korean freshwaters, indicating the countermeasures are required to maintain the water quality of the Saemangeum Reservoir. The concentrations of heavy metals except chromium did not exceed the worrisome level of soil contamination stipulated by the Soil Environment Conservation Act of Korea. The high concentration of chromium to be concerned in some samples from the upstream of Mankyoung River requires source analysis and countermeasure to control the contamination.

A Proposal for Research Process of Botanical Drug based Clinical Traditional Korean Medicine - Historical Evidence-Based Medicine II - (한의학임상에 기초를 둔 천연물신약 연구과정에 대한 소고 - 역사적 근거 발굴부터 천연물신약 임상시험계획승인신청까지 -)

  • Eom, Seok-ki;Kim, Se-hyun;Kim, Kyung-suk;Park, Sang-jae;Eo, Wan-kyu;Choi, Won-cheol
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.63-102
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    • 2010
  • Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

Improvement of Inspection Methods using Lighting Signals and Guidebook for Non-English speaking Foreign Visitors (For chest X-ray Screening Examinees) (비영어권 외국인 내원객의 조명 신호와 안내서를 이용한 검사방법 개선 효과(흉부 방사선 검사자를 대상으로))

  • Kwak, Jong Hyeok;Choi, Min Gyeong;Kim, Neung Kyun;Kim, A Yeon;Kim, Gyeong Rip
    • Journal of the Korean Society of Radiology
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    • v.14 no.5
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    • pp.577-584
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    • 2020
  • In this study, the number of non-English speaking visitors is increasing day by day, and accordingly, there was a limitation in language communication and communication during radiographic examination. To this end, after distributing the handbook produced for inspection, the improvement effect of before and after explanation was examined. The score scale was not statistically significant as to whether it was the test site or not, and the degree of discomfort of the test, the degree of understanding of the breathing guidelines, and the satisfaction of the test description were improved and the score scale was improved before and after the description of the guide. Non-English-speaking foreign visitors were more satisfied with explanations in their own text than in English or Korean, and the method was also able to conduct effective inspections by informing the foreign guests when to control their breathing by using the lighting signals in the laboratory. In the future, the quality of medical services and imaging medical examinations can be improved only when communication methods are implemented from various perspectives, such as developing various language interpretation programs, developing guides for various test sites, and developing tools and improving foreign language skills of radiologists and medical staff. There will be. In the future, it may be used as a basic resource to prepare a manual that can be used to examine non-English speaking foreigners who do not understand English or Korean in other radiology labs.

Self-management levels of diet and metabolic risk factors according to disease duration in patients with type 2 diabetes

  • Cho, Sukyung;Kim, Minkyeong;Park, Kyong
    • Nutrition Research and Practice
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    • v.12 no.1
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    • pp.69-77
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    • 2018
  • BACKGROUND/OBJECTIVES: Metabolic risk factors should be managed effectively in patients with type 2 diabetes mellitus (T2DM) to prevent or delay diabetic complications. This study aimed to compare the self-management levels of diet and metabolic risk factors in patients with T2DM, according to the duration of illness, and to examine the trends in self-management levels during the recent decades. SUBJECTS/METHODS: Data were collected from the Korea National Health and Nutrition Examination Surveys (KNHANES, 1998-2014). In our analysis, 4,148 patients with T2DM, aged ${\geq}30years$, were categorized according to the duration of their illness (< 5 years, 5-9 years, and ${\geq}10years$). Demographic and lifestyle information was assessed through self-administered questionnaires, and biomarker levels (e.g., fasting glucose level, blood pressure, or lipid level) were obtained from a health examination. Dietary intake was assessed by a 24-recall, and adherence level to dietary guidelines (meal patterns and intake levels of calories, carbohydrates, vegetable/seaweed, sodium, and alcohol) were assessed. Multivariable generalized linear regression and unconditional logistic regression models were used to compare the prevalence rates of hyperglycemia, dyslipidemia, and hypertension according to the duration of patients' illness, accounting for the complex survey design of the KNHANES. RESULTS: In the multivariable adjusted models, patients with a longer duration (${\geq}10years$) of T2DM had a higher prevalence of hyperglycemia than those with a shorter duration of T2DM (< 5 years) (odds ratio 2.20, 95% confidence interval 1.61-3.01, P for trend < 0.001). We did not observe any associations of disease duration with the prevalence of hypertension and dyslipidemia. In addition, the adherence levels to dietary recommendations did not significantly differ according to disease duration, except adherence to moderate alcohol consumption. There were significant decreasing trends in the prevalence of hyperglycemia in patients with a duration of illness ${\geq}10years$ (P for trend = 0.004). CONCLUSION: Although the proportion of patients with adequate control of glucose levels has improved in recent decades, poorer self-management has been found in those with a longer disease duration. These findings suggest the need for well-planned and individualized patient education programs to improve self-management levels and quality of life by preventing or delaying diabetic complications.

Development of Dissolution Testing Method for Piracetam Tablets and Fenoterol Hydrobromide Tablets in Korean Pharmaceutical Codex (고시 수재 의약품 중 피라세탐 정 및 브롬화수소산페노테롤 정의 용출시험법 개발)

  • Kim, Eun-Jung;Lee, Jin-Ha;Park, Chan-Ho;Sohn, Kyung-Hee;Kim, In-Kyu;Kim, Dong-Sup;Sah, Hong-Kee;Choi, Hoo-Kyun
    • YAKHAK HOEJI
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    • v.55 no.4
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    • pp.324-331
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    • 2011
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specifications in Korean Pharmaceutical Codex (KPC). Among those commercially available, Piracetam Tablets and Fenoterol hydrobromide Tablets were selected to develop the dissolution testing method. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korea Food & Drug Administration (KFDA). The dissolution test for Piracetam Tablets was carried out under sink condition with distilled water as dissolution medium, paddle rotation speed at 50 rpm and medium volume of 900 ml. More than 80% of its label claim was released within 30 min. In case of Fenoterol hydrobromide Tablets, distilled water was also found to be suitable to ensure sink condition. The rotation speed of 50 rpm and 900 ml of dissolution medium were used to evaluate the dissolution profile. The dissolution rate of fenoterol hydrobromide was over 90% in 15 min. The HPLC analysis methods were validated in terms of accuracy, precision, specificity, linearity, quantitation limit and range. The results suggested that the analytical methods used are simple and suitable to measure the dissolution rate of piracetam and fenoterol hydrobromide. Therefore, the analysis methods could be utilized in setting dissolution specifications of Piracetam Tablets and Fenoterol hydrobromide Tablets in the revised version of KPC.