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Bioequivalenee of Samchundang Atenolol Tablet to Tenolmin Tablet (테놀민 정에 대한 삼천당아테놀올 정의 생물학적동등성)

  • Cho, Hea-Young;Kang, Hyun-Ah;Lee, Suk;Baek, Seung-Hee;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.47 no.5
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    • pp.339-344
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    • 2003
  • Atenolol is a water soluble, ${\beta}_1$ selective adrenoceptor antagonist used in the treatment of angina and hypertension. It is primarily eliminated renally with minimal hepatic metabolism. The purpose of the present study was to evaluate the bioequivalence of Samchundang Atenolol (Samchundang Pharmaceutical Co., Korea.) to Tenolmin(Hyundai Pharmaceutical Ind. Co., Korea). The atenolol release from the two atenolol tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, 22.83$\pm$1.99 years in age and 65.82$\pm$7.15 kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 50 mg of atenolol was orally administered, blood was taken at predetermined time intervals and the concentrations of atenolol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two atenolol tablets were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_{t}$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_{t}$ and $C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AUC_{t}$, $C_{max}$ and $T_{max}$ between two tablets based on the Tenolmin were 3.74%, 4.38% and 17.77%, respectively. There were no sequence effects between two tablets in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., log(0.98)∼log(1.l1) and log(0.95)∼log(1.l5) for $AUC_{t}$ and $C_{max}$ respectively), indicating that Samchundang Atenolol tablet is bioequivalent to Tenolmin tablet.

A Study on Signal Analysis of the Data Aquisition System for Photosensor (데이터 획득장치에 이용되는 포토센서에 대한 DAS의 신호분석연구)

  • Hwang, InHo;Yoo, Sun Kook
    • Journal of rehabilitation welfare engineering & assistive technology
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    • v.10 no.3
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    • pp.237-242
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    • 2016
  • The major advantage of slip-ring technology in Spiral CT is that it facilitates continuous rotation of the x-ray tube, so that volume data can be acquired from a patient quickly. Not only for such a fast scan, but also for the dose reduction purpose, high signal-to-noise ratio and fast data acquisition system is required. In this study, we have built a multi-channel photodetector and multi-channel data acquisition system for CT application. The detector module consisted of CdWO4 crystal and Si photodiode in 16 channels. For the performance test of the preamplifier stage, both the transimpedance and switched integrator types are optimized for the photodetector modules. Switched integrator showed better noise performance in the limited bandwidth which is suitable for the current CT application. The control sequence for data acquisition and 20 bit ADC is designed with VHDL(Very High Speed Integrated Circuit Hardware Description Language) and implemented on FPGA(Field Programmable Gate Array) chip. Our Si photodiode detector module coupled to CdWO4 crystal showed comparable signal with other commercially available photodiode for CT. Switched integrator type showed higher SNR but narrower bandwidth compared to transimpedance preamplifier. Digital hardware is designed by FPGA, so that the control signal could be redesigned without hardware alteration.

Novel Thin Film Composite Forward Osmosis Membranes of Highly Enhanced Water Flux with Interlayer Polysiloxane Between Polysulfone and Polyamide (폴리술폰과 폴리아미드 경계층에 형성된 폴리실록산을 이용한 정삼투 복합 박막의 유량 향상)

  • Jung, Boram;Kim, Nowon
    • Membrane Journal
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    • v.26 no.5
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    • pp.391-400
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    • 2016
  • In this work, novel thin film composite (TFC) forward osmosis (FO) membranes are developed via interfacial polymerization on the polysulfone (PS) substrate, using TEOS as the a sol-gel reagent to form hydrophilic interlayer polymer between PS and polyamide (PA). The PS substrate was cast on a very thin polyester nonwoven to reduce membrane resistance. With the incorporation of TEOS (tetraethoxy silane) polymer in the interface between PS and PA, the formed TFC FO membrane exhibits better hydrophilicity and improved water flux, and therefore superior membrane performance. By changing the polymerization sequence of PA interfacial polymerization and TEOS sol-gel condensation, the surface properties and performance of FO membranes are changed significantly. The permeability of FO membranes were estimated using the bench-scale FO test equipment. The distribution of the polysiloxane on composite membrane and morphology are also studied with FE-SEM and EDAX. The PS_PA_TEOS membrane showed highly enhanced water flux (79.2 LMH) but reverse salt flux (RSF) value (7.10 GMH) also increased. However, the flux of PS_TEOS_PA membrane increased moderately (54.1 LMH) without increasing RSF value (1.60 GMH) compare with PS_PA membrane.

The Analgesic Effects of Apitoxin and its Mechanism via JOR and Measuring Expression of mRNA in Phospholipase and TPH using RT-PCR (Jaw Opening Reflex 및 RT-PCR을 이용한 봉독의 진통효과)

  • Cho, Kwang-Ho;Lee, Jae-Dong;Park, Dong-Suk;Ahn, Byoung-Choul
    • Journal of Pharmacopuncture
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    • v.3 no.1
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    • pp.35-51
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    • 2000
  • The purpose of this study is to prove the analgesic effects of apitoxin and its mechanism via jaw-opening reflex(JOR) and measuring expression of mRNA in Phospholipase and Tryptophan hydroxylase(TPH) using RT-PCR. The experiments were carried out on Sprague-Dawley rats(300-400g) and mastocytoma(P-185 HTR) for JOR and RT-PCR, respectively. Rats anesthetized with thiopental sodium (80mg/kg) were used in the Tooth Pulp stimulation induced JOR. The amplitude of a digastric electromyogram (dEMG) was recorded during the stimulation at an intensity of 1.5 times the threshold for JOR. Apitoxin used in this experiment was diluted with normal saline by 1:1000. Apitoxin was injected intravenously into the test group while normal saline to the control group. However, it was injected directly into the cell of mastocytoma. We referred to base sequence registered in Genbank in designing primers for RT-PCR. The results were as follows; (1)Compared with control group, analgesic effect started to show right after Sprague-Dawely rats were treated with apitoxin($71.50{\pm}8.08$) and lasted for 50 minutes. (2)As a result of the experiment of RT-PCR, we witnessed significant changes in the degree of expression of phospholipase or rate-limiting enzyme of biosynthesis of prostaglandins with $10{\mu}g/ml$ apitoxin.($31.74{\pm}18.98%$, P<0.05) (3)As a result of the experiment of RT-PCR, we witnessed significant changes in the degree of expression of TPH or rate-limiting enzyme in biosynthesis of serotonin with $10{\mu}g/ml$ apitoxin.($131.37{\pm}16.87%$, P<0.05). These results suggest that $10{\mu}g/ml$ apitoxin have the most analgesic effects. This study showed that apitoxin has analgesic effects and held good for 50 minutes. The injection of apitoxin has brought out changes in the degree of expression of phospholipase and TPH. These results strongly suggest that analgesic mechanism by apitoxin is closely related to prostaglandins and serotonin.

Bioequivalence of Alpit Tablet to Algiron Tablet (Cimetropium Bromide 50 mg) (알기론 정(브롬화 시메트로피움 50 mg)에 대한 알피트 정의 생물학적 동등성)

  • Cho, Hea-Young;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.32 no.1
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    • pp.47-54
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    • 2002
  • Cimetropium bromide, a quaternary ammonium compound which is chemically related to scopolamine, exhibits its antispasmodic activity by competing with acetylcholine for the muscarinic receptors of the smooth muscle of gastrointestinal tract. The drug has been used for the treatment of various disorders involving spasms of the musculature of the gastrointestinal, biliary and genitourinary tracts. The purpose of the present study was to evaluate the bioequivalence of two cimetropium bromide tablets, $Algiron^{TM}$ (Boehringer Ingelheim Korea Ltd.) and $Alpit^{TM}$ (Hana Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The cimetropium bromide release from the two cimetropium bromide tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, $25.25{\pm}2.10$ years in age and $65.76{\pm}6.39$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three tablets containing 50 mg of cimetropium bromide per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of cimetropium bromide in serum were determined using HPLC method with UV detector. The dissolution profiles of two cimetropium bromide tablets were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using non-transformed and logarithmically transformed $AUC_t\;and\;C_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on the $Algiron^{TM}$ were 2.19%, -5.97% and 3.49%, respectively. Minimum detectable differences $({\Delta})\;at \;{\alpha}=0.05\;and\;1-{\beta}=0.8$ were less than 20% (e.g., 13.71 %, 19.05% and 15.11% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The powers $(1-{\beta})\;at\;{\alpha}=0.05,\;{\Delta}=0.2\;for\;AUC_t$, $C_{max}\;and\;T_{max}$ were 97.79%, 83.22% and 95.60%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.84{\sim}10.21,\;-17.11{\sim}5.18\;and\;-5.35{\sim}12.33\;for\;AUC_t,\;C_{max}\;and\;T_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t\;and\;C_{max}$. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.94{\sim}1.10\;and\;0.85{\sim}1.05\;for\;AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Alpit^{TM}$ tablet is bioequivalent to $Algiron^{TM}$ tablet.

Bioequivalence of Rispen Tablet to Risperdal Tablet (Risperidone 2 mg) (리스페달 정(리스페리돈 2mg)에 대한 리스펜 정의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Lee, Suk;Park, Chan-Ho;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.2
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    • pp.139-145
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd.) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperidone release from the two risperidone formulations in vitro was tested using KP VIII Apparatus II method with various of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $23.33\;{\pm}2.10$ years in age and $69.24{\pm}8.05\;kg$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross over study was employed. After one tablet containing 2 mg as risperidone was orally administered, blood was taken at predetermined time intervals and the concentrations of risperidone in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$,$C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the analysis of the parameters using logarithmically transformed $AUC_t$,$C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Risperdal were 0.20, -1.29 and -11-09% for $AUC_t$,$C_{max},\;and\;T_{max}$, respectively There were no sequence effects two formulations in parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g.,$log(0.90){\sim}log(1.30)$ and $log(0.84){\sim}log(1.09)$ for$AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.

Bioequivalence of Glimed Tablet to Amaryl Tablet (Glimepiride 2 mg) (아마릴 정(글리메피리드 2mg)에 대한 글리메드 정의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Lee, Suk;Kim, Se-Mi;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.2
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    • pp.147-153
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two glimepiride tablets, $Amaryl^{\circledR}$ (Handok/Aventis Pharm. Co., Ltd.) and Glimed (Kuhn II Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The glimepiride release from the two glimepiride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB 80 into each dissolution medium). Twenty six healthy male subjects, $22.65{\pm}2.19$ years in age and $66.55{\pm}8.85$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 2 mg as glimepiride was orally administered, blood was taken at predetermined time intervals and the concentrations of glimepiride in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Amaryl were -3.70, -8.28 and 0.61% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., $log(0.84){\sim}log(1.04)$ for $log(0.82){\sim}log(1.03)$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Glimed tablet and Amaryl tablet were bioequivalent.

A Newly Identified Glutaminase-Free L-Asparaginase (L-ASPG86) from the Marine Bacterium Mesoflavibacter zeaxanthinifaciens

  • Lee, Su-Jin;Lee, Youngdeuk;Park, Gun-Hoo;Umasuthan, Navaneethaiyer;Heo, Soo-Jin;Zoysa, Mahanama De;Jung, Won-Kyo;Lee, Dae-Won;Kim, Hanjun;Kang, Do-Hyung;Oh, Chulhong
    • Journal of Microbiology and Biotechnology
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    • v.26 no.6
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    • pp.1115-1123
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    • 2016
  • L-Asparaginase (E.C. 3.5.1.1) is an enzyme involved in asparagine hydrolysis and has the potential to effect leukemic cells and various other cancer cells. We identified the L-asparaginase gene (L-ASPG86) in the genus Mesoflavibacter, which consists of a 1,035 bp open reading frame encoding 344 amino acids. Following phylogenetic analysis, the deduced amino acid sequence of L-ASPG86 (L-ASPG86) was grouped as a type I asparaginase with respective homologs in Escherichia coli and Yersinia pseudotuberculosis. The L-ASPG86 gene was cloned into the pET-16b vector to express the respective protein in E. coli BL21 (DE3) cells. Recombinant L-asparaginase (r-L-ASPG86) showed optimum conditions at 37-40℃, pH 9. Moreover, r-L-ASPG86 did not exhibit glutaminase activity. In the metal ions test, its enzymatic activity was highly improved upon addition of 5 mM manganese (3.97-fold) and magnesium (3.35-fold) compared with the untreated control. The specific activity of r-L-ASPG86 was 687.1 units/mg under optimum conditions (37℃, pH 9, and 5 mM MnSO4).

Development of Nested-PCR Assay to Detect Acidovorax citrulli, a Causal Agent of Bacterial Fruit Blotch at Cucurbitaceae (박과 작물에 과일썩음병을 일으키는 Acidovorax citrulli 검출을 위한 nested-PCR 검사법 개발)

  • Kim, Young-Tak;Park, Kyoung-Soo;Kim, Hye-Seong;Lee, Hyok-In;Cha, Jae-Soon
    • Research in Plant Disease
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    • v.21 no.2
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    • pp.74-81
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    • 2015
  • The specific and sensitive nested-PCR method to detect Acidovorax citrulli, a causal agent of bacterial fruit blotch on cucurbitaceae, was developed. PCR primers were designed from the draft genome sequence which was obtained with the Next Generation Sequencing of A. citrulli KACC10651, and the nested-PCR primer set (Ac-ORF 21F/Ac-ORF 21R) were selected by checking of specificity to A. citrulli with PCR assays. The selected nested-PCR primer amplified the 140 bp DNA only from A. citrulli strains, and detection sensitivity of the nested PCR increased 10,000 times of $1^{st}$ PCR detection limit (10 ng genomic DNA/PCR). The nested PCR detected A. citrulli from the all samples of seed surface wash (external seed detection) of the artificially inoculated watermelon seeds with $10^1cfu/ml$ and above population of A. citrulli while the nested PCR could not detected A. citrulli from the mashed seed suspension (internal seed detection) of the all artificially inoculated watermelon seeds. When the naturally infested watermelon seeds (10% seed infested rate with grow-out test) used, the nested PCR detected A. citrulli from 2 seed samples out of 10 replication samples externally and 5 seed samples out of 10 replication samples internally. We believe that the nested-PCR developed in this study will be useful method to detect A. citrulli from the Cucurbitaceae seeds.

Immunocytochemistry, In situ hybridization and electron microscopy for early diagnosis of Aujeszky's in living pigs (오제스키병의 생체 조기진단을 위한 면역세포화학, In situ hybridization 및 전자현미경적 연구)

  • Moon, Oun-kyong;Kim, Soon-bok;Sur, Jung-hyang;Song, Geun-suk;Nho, Whan-gook
    • Korean Journal of Veterinary Research
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    • v.36 no.4
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    • pp.845-858
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    • 1996
  • The purpose of this study was to establish early diagnostic methods for the detection of Aujeszky's disease viral antigens and nucleic acid in nasal cells, and buffy coats from experimentally infected living pigs by a combination of immunocytochemistry, in situ hybridization with digoxigenin(DIG)-labled probe and electron microscopy. Forty days old piglets were inoculated intranasally with $10^{7.0}TCID_{50}$ of Aujeszky's disease virus (ADV, NYJ-1-87 strain). The viral antigens and nucleic acid of ADV were detected in nasal cells, and buffy coat for 20 days after inoculation by immunocytochemistry, in situ hybridization with DIG-labeled probe and electron microscopical method. The results were compared with conventional methods such as a porcine Aujeszky's disease serodiagnostic(PAD) kit, neutralization test(NT) and virus isolation. 1. The viral antigens, nucleic acids and capsids of ADV were detected in nasal cells, buffy coats from 3 days to 20 days after inoculation by immunocytochemistry, in situ hybridization with DIG-labeled probe and electron microscopy, respectively. 2. When viral antigens were detected by the immunocytochemical technique, a diffuse brown deposit was observed in the nucleus and cytoplasm of nasal cells, buffy coats and PK-15 cells under a microscope. 3. DIG-labeled DNA probe was prepared by amplification of conserved sequence of recombinant ADV-gp50 clone with polymerase chain reacction. When ADV-DNA was detected by ISH with DIG-labeled probe, purplish blue pigmentation were observed in the nuclei and cytoplasms of ADV-infected cells under a microscope. Positive signals were observed in nasal cells and in the buffy coat and PK-15 cells at the first day after inoculation. 4. Where ADV-capsids were detected by transmission electron microscopical method, aggregation of capsids was observed in the nuclei and cytoplasms of nasal cells, buffy coats and PK-15 cells. The results suggested that these methods were considered as the highly sensitive and reliable tools for rapid and confirmative diagnosis of Aujeszky's disease in living pigs.

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