Earticle

한국의 항생제 소비량은 경제협력개발기구(OECD) 회원국 평균 사용량과 심한 격차를 보인다. OECD Health Statistics 2020에 따르면 우리나라의 경우 항생제 소비량이 집계된 27개국 중 1위 터키와 2위 그리스 다음으로 많다. 우리나라의 전신성 항감염약 의약품 소비량은 일일 규정 용량 기준 38.7로 OECD 평균 소비량인 20.1의 1.9배에 이 른다. 이에 따라 약전에 수재된 항생제의 품질관리를 엄격히 하여 양질의 의약품임을 입증하고 품질에 대한 신뢰도 를 향상해야 할 필요성이 대두된다. 대한민국약전 제 12개정의「의약품 각조」에는 총 185개의 항생제 원료의약품 에 대한 역가시험법이 수록되어있다. 역가시험법을 통해 항생제의 원료가 되는 항생물질의 함량과 역가를 측정할 수 있으며, 정확한 시험 결과를 통해 항생제의 부작용을 줄이는 효과를 기대할 수 있다. 대한민국약전에서 사용한 역가 시험법으로는 원통평판법, 비탁법, 적정종말점검출법의 전위차적정법, 액체 크로마토그래프법, 자외가시부흡광도 측 정법, 요오드적정법, 표준곡선법, 기체 크로마토그래프법이 있다. 본 연구에서는 대한민국약전에 수록된 185개의 항 생제 원료의약품에 대해 미국약전, 일본약전, 유럽약전에서는 어떠한 역가시험법이 사용되고 있는지를 비교하였다. 국 내외 약전을 비교한 결과, 정확성과 정밀도가 높은 분석방법인 액체 크로마토그래피를 이용한 역가시험법이 가장 높 은 빈도로 사용됨을 알 수 있었다. 본 연구를 토대로 각국에서 공통적으로 사용되는 의약품 품질관리 시험법의 현황 을 파악하여 의약품 품질관리 시험법을 선진화 및 표준화하고 해외 시장에서의 경쟁력을 갖출 것을 기대한다.

Antibiotics are drugs that are specifically used to treat and prevent bacterial infections. Antibiotic consumption is much higher in Korea than in other OECD countries. According to the OECD Health Statistics 2020, antibiotic consumption was reported to be the third highest in Korea following Turkey and Greece. The exact amount of systematic antibiotic consumption in Korea is 38.7 daily defined doses, approximately 1.9 times higher than the average antibiotic consumption in all OECD countries. The potency test of a total of 185 antibiotics has been included in the Korean Pharmacopoeia (Twelfth edition)「Monographs」section. Evaluating the exact content and potency of antibiotics can assist in minimizing associated side effects. Microbiological assay, potentiometric titration, liquid chromatography, UV-Visible spectrophotometry, redox titration using iodine, standard curve method, and gas chromatography have been used previously to evaluate antibiotic potency in the Korean Pharmacopeia. Herein, we compared the antibiotic potency tests in the Korean Pharmacopeia with the United States, Japanese, and European Pharmacopeias for these 185 antibiotics as the starting material. We found that liquid chromatography, a contemporary analytical technique with high precision and accuracy, has been frequently used in other countries. Following the general trend, it is expected that there will be advancement and standardization of quality control methods, further strengthening the competitiveness in the overseas market.

To investigate a relation between vortex clusters and large-scale structures in the outer layer of wall turbulence, direct numerical simulations of turbulent channel flows have been conducted up to $Re^{\tau}$= 1270. The vortex clusters in the outer layer consist coherent fine scale eddies (CFSEs) of which diameter and maximum azimuthal velocity are scaled by the Kolmogorov length and the Kolmogorov velocity. The CFSE clusters are inside the large-scale structure, which contributes to the streamwise velocity deficit. The scale of those clusters tends to be enlarged with the increase of a distance from the wall. The CFSE clusters are composed of the relatively strong CFSEs, which play an important role in the production of the Reynolds shear stress and the dissipation rate of the turbulent kinetic energy. The most expected maximum azimuthal velocity of the CFSEs in these low-momentum regions of the outer layer is 30 ${\sim}$70% faster compared with those of the CFSEs in unconditioned regions (i.e. all regions of the outer layer), while the most expected diameter of the CFSEs is not changed greatly.

In this paper, the characteristics in mechanical properties of ultrasonic cold forging treatment (UCFT) used for the trimming knife and the effects of ultrasonic vibration energy (UVE) into the trimming process on the state of the strip cutting face were studied, And a diagnosis system to quality control for trimming knife and strip cutting face was developed and installed in plant. By the plant application of UCFT, service life of knife was more increased over 100% than that of conventional knife and using the developed diagnosis system, the knife breakage and saw ear have been perfectly detected and quality control of trimming face is effectively obtained.

수자원 설계 및 홍수 예 경보 등을 위한 수문분석 시, 강우자료는 필수요소이다. 현재 수문분석 시 비교적 장기간의 자료를 보유하고 있는 기상청, 국토교통부 등의 지상기상관측지점(SSS, Surface Synoptic Stations)에 시 강우자료를 이용하고 있으나, 집중호우가 빈번히 발생하는 현실정과 집중호우의 발생빈도가 증가할 것으로 예상되는 향후에는 더욱 조밀한 관측망을 구성하고 있는 방재기상관측지점(AWS, Automatic Weather Stations)의 분 단위 강우자료를 이용한 분석이 필요하다. 그러나 방재기상관측지점의 분 단위 강우자료는 자동으로 관측되고 있어, 자료품질에 대한 문제점이 매번 지적되고 있다. 본 연구에서는 서울지역을 중심으로 기상청 방재기상관측지점의 분 단위 강우자료의 품질개선 방안에 관한 연구를 실시하였다. 분 단위 강우자료의 품질관리방안은 크게 3단계로 결측치 품질관리, 이상치 품질관리 그리고 강우 보완 품질관리로 구분하여 품질관리 방안을 제시하고 분석을 수행하였다. 마지막으로 서울지점의 분 단위 강우자료와 시 단위 강우자료의 비교분석을 통해 강우 품질관리에 대한 평가를 실시하였다. 이는 향후 분 단위 강우자료를 이용한 수문분석 시, 강우자료 품질관리 방안으로 활용될 것으로 판단된다.

Rainfall data is necessary component for water resources design and flood warning system. Most analysis are used long-term hourly data of surface synoptic stations from the Meteorological Administration, Ministry of land, Infrastructure and Transport and others. However, It will be used minutely data of more high density automatic weather stations than surface synoptic stations expecting to increase the frequency of heavy precipitation. But minutely data has a problem about quality of rainfall data by auto observation. This study analyzed about quality control method using automatic weather station's minutely rainfall data of meteorological administration. It was performed assessment of the quality control that was classified quality control of miss Data, outlier data and rainfall interpolation. This method will be utilized when hydrological analysis uses minute rainfall data.

바이오의약품의 연구개발 및 제조 과정에서 품질 분석을 위한 시험법은 변경될 수 있다. 품질시험법 변경의 원 인에는 시험방법의 개선, 시험에 사용되는 중요 요소의 교체 등 여러 가지 경우가 있을 수 있으나 제품의 안전성 및 유효성 확보를 위해 현재 시험법과 대체 시험법 간 동등성이 과학적으로 검증되어야 한다. 본 연구에서는 바이오의 약품 품질시험법 변경 시 연구개발자 및 현장의 분석실무자가 합리적인 동등성 검증 결과를 도출할 수 있도록 타당 한 통계적 논리 및 사례를 제시하고자 하였다. 이를 위해 참고할만한 내용이 포함된 논문 및 자료를 조사하였으며 이 를 토대로 시험법 간 동등성 검증을 위한 통계학적 논리의 변천 과정을 정리하고 최근 가장 보편적인 것으로 인정받고 있는 논리를 제시하였다. 아울러 규제기관에 시험법 변경을 요청한 사례를 조사하여 범하기 쉬운 통계 검증의 오 류를 논하였으며 타당한 동등성 검증 논리를 예시로서 제시하였다.

Analytical methods for quality control may be changed in development and manufacturing process of biologics. Analytical method change can result from various factors such as analytical method improvement and exchange of important component. Equivalence between current method and new method in analytical method change should verified for safety and efficacy in final products. This study aims to present proper statistical logic and cases so that developers and quality analyzers on site of biologics draw reasonable outcomes of equivalence testing. For this purpose, related papers and documents were investigated and statistical logics and cases of equivalence testing subject to analytical method change were organized. And TOST was presented as most common logic of equivalence testing in change of analytical method. This results can be useful to developer and quality analyzer on site of biologics.

In recent years, studies on various 3D scanner applications, including those on quality control and reverse engineering, have been conducted in the shipbuilding industry. Appropriate scanner selection, scanning environment setting by targets, and data postprocessing are essential for effective 3D scanning projects for small crafts. In this study, a non-contact handheld-type 3D scanner was used for molds and hull products for the 10–30-ft class of small crafts. Small crafts have fewer geometric features and several glare surfaces; thus, anti-glare and texture feature addition preprocessing is critical. The 3D scanning results are used for geometry quality control of single panels and curved surfaces in craft hulls. Consequently, international rule-based weight estimation calculation sheets have been developed and applied for product weight quality control.

본 연구의 목적은 상이한 피드백 제공방식과 피드백 제공자와 수용자 간의 강화경험이 품질관리 수행에 미치는 영향을 검증하는 것이었다. C 대학 및 대학원의 재학생 100명을 대상으로 실험을 수행하였다. 본 연구에서는 컴퓨터를 사용하여 상품을 생산하는 가상의 휴대폰 조립과제를 사용하였다. 본 연구의 독립변인은 두 가지의 피드백 제공방식(면대면과 이메일)과 강화경험의 유무였으며, 종속변인으로는 참가자들의 수행 정확도를 측정하였다. $2{\times}2$ 집단 간 설계가 적용되었으며 실험은 총 4회기로써 사전회기 1회기와 실험회기 3회기로 각 회기는 30분으로 구성되었다. 연구 결과 강화경험을 가지고 있는 경우 두 가지 피드백의 품질관리 정확도 향상 효과가 유사하게 나타났으나 강화경험이 없는 경우에는 면대면 피드백이 품질관리 정확도 향상에 더 효과적인 것으로 나타났다. 이러한 결과를 통해 두 가지 피드백 제공방식과 피드백 제공자와 수용자 간의 강화경험에 따라 수행에 미치는 피드백의 효과가 달라질 수 있음을 알 수 있다.

This study examined the relative effects of different feedback delivery method (face-to-face vs. e-mail) and reinforcement history on work performance. Participants were asked to work on a simulated mobile phone assembly task. They performed for 30 minutes per session and attended 4 sessions. The dependents variable was the percentage of correctly completed work tasks. Of 100 participants recruited, 50 had a reinforcement history and another 50 had no reinforcement history with the feedback provider in this study. The participants in each group were randomly assigned into two experimental conditions: face-to-face feedback and e-mail feedback. The results showed that for the participants who had reinforcement history, the two feedback delivery methods did not produce a significant difference in the percentage of correctly completed work tasks. However, for those who had no reinforcement history, the two feedback methods did produce a significant difference.

OBJECTIVES: The aim of effective data quality control and management is to minimize the impact of errors on study results by identifying and correcting them. This study presents the results of a data quality control system for the Korea HIV/AIDS Cohort Study that took into account the characteristics of the data. METHODS: The HIV/AIDS Cohort Study in Korea conducts repeated measurements every 6 months using an electronic survey administered to voluntarily consenting participants and collects data from 21 hospitals. In total, 5,795 sets of data from 1,442 participants were collected from the first investigation in 2006 to 2016. The data refining results of 2015 and 2019 were converted into the data refining rate and compared. RESULTS: The quality control system involved 3 steps at different points in the process, and each step contributed to data quality management and results. By improving data quality control in the pre-phase and the data collection phase, the estimated error value in 2019 was 1,803, reflecting a 53.9% reduction from 2015. Due to improvements in the stage after data collection, the data refining rate was 92.7% in 2019, a 24.21%p increase from 2015. CONCLUSIONS: Despite this quality management strategy, errors may still exist at each stage. Logically possible errors for the post-review refining of downloaded data should be actively identified with appropriate consideration of the purpose and epidemiological characteristics of the study data. To improve data quality and reliability, data management strategies should be systematically implemented.

The main active components of Panax ginseng are ginsenosides. Ginsenoside Rb1 and Rg1 are accepted as marker substances for quality control worldwide. The analytical methods currently used to detect these two compounds unfairly penalize steamed and dried (red) P. ginseng preparations, because it has a lower content of those ginsenosides than white ginseng. To manufacture red ginseng products from fresh ginseng, the ginseng roots are exposed to high temperatures for many hours. This heating process converts the naturally occurring ginsenoside Rb1 and Rg1 into artifact ginsenosides such as ginsenoside Rg3, Rg5, Rh1, and Rh2, among others. This study highlights the absurdity of the current analytical practice by investigating the time-dependent changes in the crude saponin and the major natural and artifact ginsenosides contents during simmering. The results lead us to recommend (20S)- and (20R)-ginsenoside Rg3 as new reference materials to complement the current P. ginseng preparation reference materials ginsenoside Rb1 and Rg1. An attempt has also been made to establish validated qualitative and quantitative analytical procedures for these four compounds that meet International Conference of Harmonization (ICH) guidelines for specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, robustness and system suitability. Based on these results, we suggest a validated analytical procedure which conforms to ICH guidelines and equally values the contents of ginsenosides in white and red ginseng preparations.

Agastache rugosa, known as Korean mint, is a medicinal plant with many beneficial health effects. In this study, a simple and reliable HPLC-UV method was proposed for the quantification of rosmarinic acid (RA) in the aqueous extracts of A. rugosa. RA was selected as a quantification marker due to its easiness in procurement and analysis. The developed method involved chromatographic separation on a $C_{18}$ column ($250{\times}4.6mm$, $5{\mu}m$) at room temperature. The mobile phase consisted of water and acetonitrile both containing 2 % acetic acid and was run at a flow rate of $1mL\;min^{-1}$. The method was validated for specificity, linearity, precision, and accuracy. It was specific to RA and linear in the range of $50-300{\mu}g\;mL^{-1}$ ($r^2=0.9994$). Intra-day, inter-day, and inter-analyst precisions were ${\leq}0.91%\;RSD$, ${\leq}1.40%\;RSD$, and 1.94 % RSD, respectively. Accuracy was 93.3-95.9 % (${\leq}1.21%\;RSD$). The method could be applied to three batches of bulk samples and three batches of lab scale samples, which were found to be $0.64({\pm}0.04)mg\;g^{-1}$ and $0.48({\pm}0.02)mg\;g^{-1}$ for the dried raw materials of A. rugosa. The results show that the proposed method can be used as a readily applicable method for QC of health functional foods containing the aqueous extracts of A. rugosa.

For the quality control procedure of diagnostic x ray units, a method for simultaneous measurement of air kerma, half value layer and tube potential was developed utilizing a computed radiography system for intraoral radiography and film badge case. The response of average pixel values under the windows were calibrated by x rays generated at tube potentials from 40 to 140 kV with filtration from 1.5 to 3.7 mmAl. The calibration curves for half value layer and tube potential were derived as functions of attenuation factors by the 1.4 mmAl filter and the 0.2 mmCu filter. The energy dependency of the open window response was corrected by the calibration factor as a function of the attenuation factor by the 1.4 mmAl filter. The uncertainty of the estimated half value layer, tube potential and air kerma were 0.2 mmAl, 3.6 % and 5 %, respectively. It was thus suggested that this system could be applied to quality control program to detect the variation of working condition of x ray units in clinical use.

Background: Delta checks increase patient safety by identifying automated hematology analyzer errors. International standards and guidelines for the complete blood count (CBC) delta check method have not been established. We established an effective, practical CBC delta check method and criteria. Methods: We assessed five delta check methods for nine CBC items (Hb, mean corpuscular volume, platelet count, white blood cell [WBC] count, and five-part WBC differential counts) using 219,804 blood samples from outpatients and inpatients collected over nine months. We adopted the best method and criteria and evaluated them using 42,652 CBC samples collected over two weeks with a new workflow algorithm for identifying test errors and corrections for Hb and platelet count. Results: The median delta check time interval was 1 and 21 days for inpatients and outpatients (range, 1?20 and 1?222 days), respectively. We used delta values at 99.5% as delta check criteria; the criteria varied among the five methods and between outpatients and inpatients. The delta percent change (DPC)/reference range (RR) rate performed best as the delta check for CBC items. Using the new DPC/RR rate method, 1.7% of total test results exceeded the delta check criteria; the retesting and resampling rates were 0.5% and 0.001%, respectively. Conclusions: We developed an effective, practical delta check method, including RRs and delta check time intervals, and delta check criteria for nine CBC items. The criteria differ between outpatients and inpatients. Using the new workflow algorithm, we can identify the causes of criterion exceedance and report correct test results.

Cuscuta chinensis Lam. and Cuscuta japonica Choisy are parasitic plants. C. chinensis seeds were traditionally used for treatment of kidney and liver deficiencies. C. japonica seeds were used as tonic medicine to improve liver function and strengthen kidneys, treatment of high blood pressure, chronic diarrhea, and sore eyes. Cuscutae Semen are seeds of only C. chinensis in Korean Herbal Pharmacopoeia (K.H.P.). The developed HPLC-PDA method easily, accurately, and sensitively quantified using eight marker compounds [hyperoside (1), astragalin, (2), quercetin (3), kaempferol (4), chlorogenic acid (5), 3,4-di-O-caffeoylquinic acid (6), 1,5-di-O-caffeoylquinic acid (7), and 4,5-di-O-caffeoylquinic acid (8)]. In addition, the method may be used to distinguish seeds between C. chinensis Lam. and C. japonica Choisy. Furthermore, the result from the current study was applied to clarify samples between steam processed and unprocessed samples of C. chinensis by pattern analysis.

The hourly volatile organic compounds(VOCs) concentrations between 2005 and 2008 at Bulgwang photochemical assessment monitoring station were investigated to establish a method for quality assurance and quality control(QA/QC) procedure. Systematic error, erratic error, and random error, which was manifested by outlier and highly fluctuated data, were checked and removed. About 17.3% of the raw data were excluded according to the proposed QA/QC procedure. After QA/QC, relative standard deviation for representing 15 species concentrations decreased from 94.7-548.0% to 63.4-125.8%, implying the QA/QC procedure is proper. For further evaluation about the adequacy of QA/QC procedure, principal components analysis(PCA) was carried out. When the data after QA/QC procedure was used for PCA, the extracted principal components were different from the result from the raw data and could logically explain the major emission sources(gasoline vapor, vehicle exhaust, and solvent usage). The QA/QC procedure based on the concept of errors is inferred to proper to be applied on VOCs. However, an additional QA/QC step considering the relationship between species in the atmosphere needs to be further considered.

콘크리트의 특징은 그 품질을 확보함에 있어서 시멘트, 모래, 자갈, 물, 혼화재료 등 구성재료 개개의 품질 및 그 배합비 그리고 생산관리 및 시공관리, 양생 등에 의해 영향을 받는다는 점이다. 콘크리트 배합설계에 따라 시공연도와 강도가 변화하게 된다. 대부분의 건설현장은 동일구간에 여러 레미콘 회사의 제품을 동시에 타설하는 것이 일반적이나 표준시방서에는 혼합타설을 원칙적으로 금지하고 있으며 필요시 책임기술자의 확인을 받도록 규정되어 있다. 이 연구는 불가피한 혼합타설시 콘크리트 품질확보를 하기 위한 방안을 제시하고자 하였으며, 연구방법은 문헌검토, 설문조사를 통하여 혼합타설의 문제점을 파악하고 불가피함을 확인하였으며, 사례현장의 콘크리트 타설계획과 군산지역의 레미콘 회사의 현황을 통하여 혼합타설의 문제점을 파악하고 불가피함을 확인하였다. 혼합타설을 하지 않는 방법으로 5가지 안을 제시하여 그 중에서 지역별 표준배합설계를 작성하여 동일한 배합비로 11개 레미콘 회사로 하여금 생산하도록 하여 혼합타설의 위험성을 배제하였으며 그 과정의 문제점을 제시하였다. 향후 연구과제로는 본 연구를 통하여 검증되지 않은 방안인 레미콘 회사의 규모확장 및 통폐합, 혼합타설된 콘크리트의 품질 추적조사, 혼화제의 상응성테스트 그리고 콘크리트 강도의 조기판정기법의 개발 및 골재등의 재료 통일방안등을 연구하여 혼합타설시 피해를 최소화할 수있도록 해야 할 것이다.

Concrete mix design controls the various concrete properties such as workability and strength. Fresh concrete requires workability and the hardened concrete requires compressive strength. If using the concrete from different supplier concurrently, the concrete placed can show different properties unlike originally designed. However most of construction sites place the concrete from several companies. One of the predictable problems is whether the ultimate performance of concrete achieves the originally designed performance after placing the concrete from several companies. Therefore this research aims to keep the concrete quality in the above cases. This research has been done through literature review, questionnaire and the verification at the sample construction site. A literature review describes the general characteristics and quality control of concrete and a questionnaire describes the awareness and implementation of Korean Construction Specification(KCS). The production capacity and the delivery capacity of concrete suppliers is smaller than the daily quantity required on the sample site, therefore the placing of the concrete with different mixing ratio is inevitable and it can not keep the KCS. As a conclusion, this research proposed 5 alternatives and one of them has been adopted, i.e. to unify the concrete mix design of multiple concrete suppliers.

정지영상 및 동영상내의 화면에서 관심영역이 설정되고, 비관심영역에 비하여 관심영역에 높은 화질이 제공되면 전체적으로 주관적 화질이 증대하게 된다. 관심영역은 색상 카메라만을 이용하여 추출하게 되면 계산이 복잡해질 뿐만아니라 추출의 정확도도 떨어지게 된다. 따라서 본 논문에서는 관심영역을 설정하기 위하여 깊이 카메라를 이용하며, 카메라와 관심영역 객체별 거리를 산출하고, 거리에 따라 객체의 화질을 차별적으로 제어하는 방법을 제안한다. 즉, 거리가 먼 객체에는 높은 양자화 계단크기를 적용하지만, 상대적으로 거리가 가까운 객체에는 낮은 양자화 계단크기를 적용하여 화질을 좋게 한다. 본 논문에서 제안된 방법에 의해 객체의 거리별로 양자화계단의 크기를 차등적으로 적용함으로써 주관적 화질의 개선이 이루어졌으며 모의실험을 바탕으로 확인할 수 있다.

If the region of interest (ROI) is set within the picture of image and video and the high quality is provided in ROI compared to Non ROI, then overall subjective picture quality can be increased. ROI extracted by the color camera only increases the calculation complexity and reduces the extraction accuracy. In this paper, we use depth camera to set the ROI and calculate the object distance from camera, then propose a method that the different picture quality is controlled by depending on the distance of an object. That is, we apply a high quantization step size to the far object, but relatively a low quantization step size to the close object, so better picture quality can be provided. Simulation results show that applying the differential quantization step size to the distance of objects by the proposed method can improve the subjective picture quality.

This paper proposes a quality control method of assembly parts based on parts inspection information. We use the parts inspection information for reduction of defective fraction in assembly and prediction of assembly quality. At first, we build the functional relationship between parts and assembled unit by regression analysis. Secondly, if we use the inspection informations of parts which are estimators of means and variances, we can predict the nonconforming probability of assembled unit and propose the best assembly method. In a case study, we showed the efficency of the proposed method in two part assembly.

Objectives : HPL-1, a novel herbal medicine which is composed of five herbs such as Kalopanacis Cortex, Chaenomelis Fructus, Raphani Semen, Atractylodis Rhizoma and Pulvis Aconiti Tuberis Purificatum, was developed for treatment of osteoarthritis. This study is aimed to develop analytical method for consistent quality control of HPL-1 and validate chromatographic method. Methods : Chromatographic analysis was performed using ultra-high performance liquid chromatography - diode array detector (UHPLC-DAD) equipped with RP-amide column, column oven, and auto sampler. Marker compounds [protocatechuic acid, chlorogenic acid, liriodendrin, 3,5-dicaffeoylquinic acid, ${\beta}$-D-(3-O-sinapoyl)-fructofuranosyl-$\alpha$-D-(6-O-sinapoyl)glucopyranoside and benzoylmesaconine] were separated by step gradient elution of acetonitrile and 0.1% phosphoric acid/water. The method validation was evaluated by quantitative validation parameters of linearity, accuracy, precision, limit of detection (LOD) and limit of quantification (LOQ) according to KFDA guideline.Results : An optimized method for six marker compounds in HPL-1 was established by UHPLC-DAD. The correlation coefficient (R²) with each calibration curve was greater than 0.99. The LOD and LOQ were within the range of 0.008-0.090 and $0.023-0.274{\mu}g/mL$, respectively. The relative standard deviation (RSD) of intra- and inter-day variability were less than 4.0%. The result of recovery test was range from 93.3-106.3% with RSD < 4.0%.Conclusions : These results suggest that the quantitative UHPLC method is precise, accurate, effective for quality evaluation of HPL-1. The method may also contribute to improve quality of crude drug preparations used for treatment of various diseases.