• 제목/요약/키워드: Pharmaceutical samples

검색결과 653건 처리시간 0.033초

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

  • Kandpal, Lalit Mohan;Park, Eunsoo;Tewari, Jagdish;Cho, Byoung-Kwan
    • Journal of Biosystems Engineering
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    • 제40권4호
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    • pp.394-408
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    • 2015
  • Spectroscopy is an emerging technology for the quality assessment of pharmaceutical samples, from tablet manufacturing to final quality assurance. The traditional methods for the quality management of pharmaceutical tablets are time consuming and destructive, while spectroscopic techniques allow rapid analysis in a non-destructive manner. The advantage of spectroscopy is that it collects both spatial and spectral information (called hyperspectral imaging), which is useful for the chemical imaging of pharmaceutical samples. These chemical images provide both qualitative and quantitative information on tablet samples. In the pharmaceutics, spectroscopic techniques are used for a variety of applications, such as analysis of the homogeneity of powder samples as well as determination of particle size, product composition, and the concentration, uniformity, and distribution of the active pharmaceutical ingredient in solid tablets. This review paper presents an introduction to the applications of various spectroscopic techniques such as hyperspectroscopy and vibrational spectroscopies (Raman spectroscopy, FT-NIR, and IR spectroscopy) for the quality and safety assessment of pharmaceutical solid dosage forms. In addition, various chemometric techniques that are highly essential for analyzing the spectroscopic data of pharmaceutical samples are also reviewed.

천연물질 사용 화장품의 잔류농약과 보존제 모니터링 (Monitoring of Pesticide Residues and Preservatives in Cosmetics Using Natural Materials)

  • 박은미;엄미나;김범호;조상훈;박신희;조현례;윤미혜;이정복
    • 한국식품위생안전성학회지
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    • 제27권3호
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    • pp.257-263
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    • 2012
  • Cosmetics using natural materials which was purchased in retail stores, distributed in Gyeonggi province(32 samples) and online through internet(24 samples) were analyzed by pesticide residues and target preservatives for assessing the safety of it. Natural or organic certifications was identified in 22 samples among 56 samples and most of them were Ecocert. Pesticide residues was detected in 3 samples among 56 samples and each compound and concentration was permethrin(0.6 mg/kg), tricyclazole(11.7 mg/kg) and malathion(0.05 mg/kg). All of it was purchased through internet. Target preservatives was detected in 13 samples among 56 samples and one of them was over the maximum allowed concentration and the rest of them were within the maximum allowed concentration of the respective preservatives. The compound which was over the maximum allowed concentration was benzoic acid and compounds which were within the maximum allowed concentration were sorbic acid, benzoic acid and methylparaben. They were all identified substances in products and the number of detected preservatives in retail stores were higher than online samples purchased through internet. As a result of this study, The method of analyzing pesticide residues and limit in cosmetics using natural materials should be set up as soon as possible and the monitoring about preservatives in cosmetics using natural materials should be conducted on continuously.

유통 중인 물휴지의 안전성 조사 연구 (A Study on the Safety of Commercial Wet Tissues)

  • 배호정;정홍래;이소현;이성봉;송서현;홍미연;김범호;박광희;윤미혜
    • 한국식품위생안전성학회지
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    • 제33권1호
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    • pp.83-88
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    • 2018
  • 시중에 유통 중인 물휴지 62 품목을 선정하여 살균보존제 성분 및 유해물질 함유 여부 등의 안전성을 조사하였다. 일반적으로 화장품 및 식품에 가장 많이 사용하는 살균 보존제인 안식향산나트륨은 46 품목에서 200~3500 ppm 검출되었고 파라벤류는 1 품목에서 파라옥시안식향산메칠이 9 ppm 검출되었다. 사용할 수 없는 살균보존제인 메칠클로로이소치아졸리논과 메칠이소치아졸리논(3:1)혼합물이 1 품목에서 검출되어 부적합 판정되었으며, 메칠클로로이소치아졸리논 5 ppm, 메칠이소치아졸리논 140 ppm 검출되었다. 염화세틸피리디늄은 5 품목에서 7~13 ppm 검출되었으며, 모두 허용기준 이내로 나타났다. 잔류유해물질인 포름알데히드 검사결과는 $0.069{\sim}1.796{\mu}g/g$로 허용기준인 $20{\mu}g/g$ 이하였다. 메탄올은 5~51 ppm 검출되었으며, 이 중 4 품목에서 허용기준인 20 ppm보다 2배 이상의 농도가 나타났다. 안전한 제품이 유통될 수 있도록 메탄올의 잔류경로에 대한 지속적인 조사 및 모니터링이 필요하다고 판단된다. 물휴지의 pH를 측정한 결과 4.0~8.2로 나타나 유통화장품의 pH 3.0~9.0 기준에 적합하였으나, 물휴지에는 pH 기준이 설정되어 있지 않으므로 안전관리를 위해서는 pH 기준을 설정하는 고시개정이 필요할 것이다.

액상한약제제의 보존제 모니터링 (Monitoring of preservatives in herbal liquid preparations)

  • 전종섭;조현례;김범호;조상훈;박신희;김영숙;윤미혜;이정복
    • 분석과학
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    • 제24권2호
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    • pp.127-134
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    • 2011
  • 본 연구에서는 기존 대한약전외 일반시험법 중 파라옥시안식향산에스텔 및 그 염류의 함량시험법의 이동상의 조성을 acetonitrile water (containing 1% glacial acetic acid) mixture (30:70 v/v)로 변화시켜 첨가제로 사용된 보존제성분과 제품에서 기인하는 방해물질과의 완전한 분리를 통하여 액상한약제제 분석의 효율성을 기하였다. 유통되고 있는 한약제제 중 액상제품 총 47품목을 대상으로 안식향산나트륨, 디히드로 초산나트륨, 파라옥시안식향산메칠, 파라옥시안식향산에칠, 파라옥시안식향산프로필 등 5종의 함량을 모니터링 하였다. 그 결과 액상한약제제 37품목 중 보존제가 표시된 31품목은 보존제가 표시된 함량에 맞게 함유되어 있었다. 안식향산과 디히드로초산이 함유된 7품목 중 6품목은 디히드로초산이 표시량에 비해 낮게 검출되었거나 검출되지 않았다. 보존제가 미표시된 10품목 중 3품목에서 보존제가 검출되었다. 3건 모두 안식향산이 검출되었고 그 중 2건에서 디히드로초산이 검출되었으며 1건에서 메틸파라벤이 검출되었다.

Investigating chemical features of Panax notoginseng based on integrating HPLC fingerprinting and determination of multiconstituents by single reference standard

  • Yang, Zhenzhong;Zhu, Jieqiang;Zhang, Han;Fan, Xiaohui
    • Journal of Ginseng Research
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    • 제42권3호
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    • pp.334-342
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    • 2018
  • Background: Panax notoginseng is a highly valued medicine and functional food, whose quality is considered to be influenced by the size, botanical parts, and growth environments. Methods: In this study, a HPLC method integrating fingerprinting and determination of multiconstituents by single reference standard was established and adopted to investigate the chemical profiles and active constituent contents of 215 notoginseng samples with different sizes, from different botanical parts and geographical regions. Results: Chemical differences among main root, branch root, and rotten root were not distinct, while rhizome and fibrous root could be discriminated from other parts. The notoginseng samples from Wenshan Autonomous Prefecture and cities nearby were similar, whereas samples from cities far away were not. The contents of major active constituents in main root did not correlate with the market price. Conclusion: This study provided comprehensive chemical evidence for the rational usage of different parts, sizes, and growth regions of notoginseng in practice.

Mutagenicity Assessment of Drinking Water in Combination with Flavored Black Tea Bags: a Cross Sectional Study in Tehran

  • Alebouyeh, Farzaneh;Bidgoli, Sepideh Arbabi;Ziarati, Parisa;Heshmati, Masoomeh;Qomi, Mahnaz
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권17호
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    • pp.7479-7484
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    • 2015
  • Diseases related to water impurities may present as major public health burdens. The present study aimed to assess the mutagenicity of drinking water from different zones of Tehran, and evaluate possible health risks through making tea with tea bags, by Ames mutagenicity test using TA 100, TA 98 and YG1029 strains. For this purpose, 450 water samples were collected over the period of July to December 2014 from 5 different zones of Tehran. Except for one sample, no mutagenic potential was detected during these two seasons and the MI scores were almost normal (${\leq}1-1.6$) in TA 100, TA 98 and YG1029 strains. Although no mutagenic effects were considered in TA 98 and TA 100 in the test samples of our three evaluated tea bag brands, one sample from a local company showed mutagenic effects in the YG1029 strain (MI=1.7-1.9 and 2) after prolonged (10-15 min.) steeping. Despite the mild mutagenic effect discovered for one of the brand, this cross sectional study showed relative safety of water samples and black tea bags in Tehran. According to the sensitivity of YG1029 to the mutagenic potential of water and black tea, even without metabolic activation by s9 fraction, this metabolizer strain could be considered as sensitive and applicable to food samples for quantitative analysis of mutagens.

인천지역 유통 생약 중 Ochratoxin A 오염실태 조사 (A Survey on Ochratoxin a Contamination of Commercial Medicinal Herbs in Incheon)

  • 임수선;주광식;최은정;이수연;임윤선;엄선아;조남규;이성모
    • 생약학회지
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    • 제48권1호
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    • pp.56-62
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    • 2017
  • The aim of this study was to screen the contamination by ochratoxin A of mycotoxins in various medicinal herbs. We conducted a survey of ochratoxin A in medicinal herb on the retail market in Incheon in 2016. 116 medicinal herb samples were evaluated for the ochratoxin A contamination. They were analyzed for ochratoxin A using immunoaffinity column and high-performance liquid chromatography(HPLC)-fluorescence detection and the positive samples were confirmed using HPLC-tandem mass spectrometry. Ochratoxin A was detected in 4 medicinal herb samples; the concentrations of ochratoxin A were containing between 20.11 and $372.90{\mu}g/kg$. This study shows that in general, this kind of commodity may be contaminated by mycotoxins. Also this contamination is not limited to only aflatoxin of mycotoxins.

불법유통 발기부전치료제 유사제품 조사 연구 (Monitoring of Fake Anti-impotence Drugs)

  • 김범호;전종섭;이명진;박은미;조상훈;권혜정;윤미혜;이정복
    • 한국식품위생안전성학회지
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    • 제29권2호
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    • pp.92-98
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    • 2014
  • 경기도내 유통되고 있는 발기부전치료제 유사제품 51건(유사비아그라 26품목, 유사시알리스 25품목)에 대하여 발기부전치료제성분 및 그 유사물질을 조사하여 안전성을 평가하였다. 발기부전치료제성분 4종과 그 유사물질 17종에 대하여 HPLC/PDA, LC-MS/MS를 이용하여 정량 및 정성시험을 실시하였다. 유사비아그라의 경우에는 sildenafil 성분이 40~199 mg/정의 범위를 나타냈으며, 함량이 150 mg/정 넘는 제품이 65% 이상 이었다. Tadalafil과 sildenafil을 동시에 사용한 경우는 3개 제품에서 나타났다. 유사시알리스의 경우에는 주성분인 tadalafil이 모두 검출되지 않았고 비아그라의 주성분인 sildenafil만 102 mg/정~249 mg/정 검출되었다. 이 중 sildenafil 함량이 150 mg/정 넘는 제품이 88% 이상 이었으며, 1개 제품에서 발기부전치료제유사물질인 demethylhongdenafil이 90 mg/정 검출되었다. 이러한 발기부전치료제 유사제품은 권장 복용량보다 3배가 넘는 고 함량 제품이 대부분이었으며, 지속적인 감시와 유통차단이 요구된다고 본다.

Characterization of Nonaflatoxigenic Aspergillus flavus/oryzae Strains Isolated from Korean Traditional Soybean Meju

  • Sang-Cheol Jun;Yu-Kyung Kim;Kap-Hoon Han
    • Mycobiology
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    • 제50권6호
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    • pp.408-419
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    • 2022
  • Filamentous fungi that could be classified into Aspergillus flavus/oryzae were isolated from traditionally fermented meju commercially available in Korea. The samples were analyzed for aflatoxin B1 and ochratoxin A contamination by HPLC; however, no toxin was detected. In addition, fungal and bacterial metagenomic sequencing were performed to analyze the microbial distribution in the samples. The results revealed that the distribution and abundance of fungi and bacteria differed considerably depending on the production regions and fermentation conditions of the meju samples. Through morphological analysis, ITS region sequencing, and assessment of the aflatoxin-producing ability, a total of 32 A. flavus/oryzae strains were identified. PCR analysis of six regions with a high mutation frequency in the aflatoxin gene cluster (AGC) revealed a total of six types of AGC breaking point patterns. The A. flavus/oryzae strains did not exhibit the high amylase activity detected in the commercial yellow koji strain (starter mold). However, their peptidase and lipase activities were generally higher than that of the koji isolates. We verified the safety of the traditionally fermented meju samples by analyzing the AGC breaking point pattern and the enzyme activities of A. flavus/oryzae strains isolated from the samples. The isolated strains could possibly be used as starter molds for soybean fermentation.

근적외선분광법을 이용한 택사의 산지 판별법 연구 (Discrimination of Alismatis Rhizoma According to Geographical Origins using Near Infrared Spectroscopy)

  • 이동영;김승현;김효진;성상현
    • 생약학회지
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    • 제44권4호
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    • pp.344-349
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    • 2013
  • Near infrared spectroscopy (NIRS) combined with multivariate analysis was used to discriminate the geographical origin of Alisma orientale from Korea (n=94) and China (n=72). Two-thirds of samples were selected randomly for the training set, and one-third of samples for the test set. Second derivative was used for the pretreatment of NIR spectra. Partial least square discriminant analysis (PLS-DA) models correctly discriminated 100% of the Korean and Chinese A. orientale samples. These results demonstrate the potential use of NIR spectroscopy combined with multivariate analysis as a rapid and accurate method to discriminate A. orientale according to their geographical origin.