• 약학회지
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• 제47권5호
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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.

• 한국전자파학회논문지
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• 제28권8호
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• pp.628-635
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• 2017

의약품은 인간의 건강 및 생명과 밀접한 관련이 있기 때문에 증상에 맞는 의약품을 처방받아 복용하는 것은 매우 중요한 문제이다. 더욱이 세계적으로 위조 의약품이 증가하는 상황에서 정품 의약품들을 정확하게 분류하는 기술은 점점 중요해진다. 그러나 의약품을 제대로 분류할 수 있는 전문적인 지식을 갖춘 인력이 제한적이라는 측면에서 의약품을 자동적으로 분류하는 기술이 필요하다. 본 논문에서는 휴대용 분광기를 이용하여 의약품의 근적외선 및 가시광선 스펙트럼을 추출하고, Support Vector Machine(SVM) 기법을 이용하여 추출한 스펙트럼 데이터를 학습시켜 분류하는 방법을 제안하였다. 모의실험을 통해 근적외선과 가시광선 스펙트럼 데이터를 사용하여 6종의 의약품을 학습시키고 분류하였을 때 평균적으로 99.9 %의 정확도를 얻었다. 또한 본 논문에서는 위조 의약품 검출을 위한 2단계 SVM 분류 기법을 제안하였으며, 이를 통해 정품과 위조 의약품을 구분하는 정확도가 향상되고, 처리속도가 개선되는 것을 확인하였다.

• 대한본초학회지
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• 제33권2호
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• pp.9-18
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• 2018

Objectives : Hwangryunhaedok-tang (HRHDT) is one of the well-known prescription herbal drugs of Korean herbal medicine, which has been widely used for the treatment of various bacterial and inflammatory diseases. This study was conducted in order to develop the tablet formulations of HRHDT and compare its efficacy with the other commercial formulations. Methods : Corresponding herbal medicines comprising of HRHDT were extracted with water for 3 hr at $95{\sim}100^{\circ}C$ and then vacuum dried. Subsequently, some pharmaceutical excipients such as microcrystalline cellulose, croscarmellose sodium, magnesium stearate, etc were used to prepare the HRHDT tablets. The contents with characterizing components of HRHDT tablet was compared with the HRHDT decoction. The contents of characterizing components were analyzed with HPLC. Furthermore, we investigated the anti-inflammatory and anti-oxidative abilities of two different commercial HRHDT granules (HJP-1 and HJP-2) and were compared with that of the formulated HRHDT tablets. The anti-oxidant properties of HRHDR were studied using the 1,1-diphenyl-2-picryhydrazyl (DPPH) radical, contents of total flavonoid and polyphenol. In addition, based on this result the anti-inflammatory effects have verified by mechanism from LPS- treated Raw264.7 macrophages. Results : The results demonstrated that HRHDT tablets showed more anti-inflammatory and anti-oxidative effects than HJP-1, HJP-2. Moreover, it showed more superior effects in terms of dose, usability and stability than the granules. Conclusion : Hence, we concluded that in order to improve the quality and efficacy of the Korean herbal medicine, it is necessary to develop appropriate methods and establish standardized techniques for the development of good formulations.

• 대한화학회지
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• 제52권6호
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• pp.622-629
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• 2008

• Archives of Pharmacal Research
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• 제25권6호
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• pp.964-968
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• 2002

Colon drug delivery is advantageous in the treatment of colonic disease and oral delivery of drugs unstable or suceptible to enzymatic degradation in upper GI tract. In this study, multilayer coated system that is resistant to gastric and small intestinal conditions but can be easily degraded by colonic bacterial enzymes was designed to achieve effective colon delivery of prednisolone. Variously coated tablets containing prednisolone were fabricated using chitosan and cellulose acetate phthalate (CAP) as coating materials. Release aspects of prednisolone in simulated gastrointestinal fluid and rat colonic extracts (CERM) were investigated. Also, colonic bacterial degradation study of chitosan was performed in CERM. From these results, a three layer (CAP/Chitosan/CAP) coated system exhibited gastric and small intestinal resistance to the release of prednisolone in vitro most effectively. The rapid increase of prednisolone in CERM was revealed as due to the degradation of the chitosan membrane by bacterial enzymes. The designed system could be used potentially used as a carrier for colon delivery of prednisolone by regulating drug release in stomach and the small intestine.

• 한국임상약학회지
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• 제7권2호
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• pp.67-72
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• 1997

The bioequivalence of two lomefloxacin tablets was evaluated in 16 normal male volunteers (age $21\sim30$ yrs) following oral administration. Test product was 'Lomaxacin tablet' made by Kolon Pharmaceutical Co. and reference product was 'Maxaquin tablet' made by Searle Ciba-Geigy Korea Co. After one tablet containing 400 mg of lomefloxacin was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was determined with an HPLC method using fluorescence detector. AUC, $C_{max},\;and\;T_{max}$ were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, $C_{max},\;and\;T_{max}$ between two products were $0.90\%,\;1.09\%,\;and\;2.44\%$, respectively. The powers (1-${\beta}$) for AUC, $C_{max},\;and\;T_{max}\;were\;>95\%,\;>95\%,\;and\;93.8\%$, respectively Detectable differences $(\Delta)$ and confidence intervals were all less than $20\%$. All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Lomaxacin tablet' is bioequivalent to 'Maxaquin tablet'.

• 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.

• Journal of Pharmaceutical Investigation
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• 제12권3호
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• pp.55-63
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• 1982

The dissolution kinetics for polymorphs of sulpiride, the effect of polyethylene glycol 4000 on the dissolution kinetics of sulpiride polymorphs and the dissolution rate difference between the tablets of polymorph form I and form II were investigated. The results could be summerized as followings: 1. The dissolution rates of two polymorphs of sulpiride were significantly different and the thermodynamic parameters calculated from dissolution kinetics were as follows; transition temperature $98^{\circ}C$, enthalpy change, -2.108 kcal/mole, free energy change, -783 cal/mole $(31.0^{\circ}C)$. 2. The dissolution rates of the two polymorphs of sulpiride containing polyethylene glycol 4000 were significantly diefferent in 0.01N HCl but the effect of polyethylene glycol on the dissolution rates of two polymorphs was not significant at low concentration of polyethylene glycol 4000. The study on the effect by stirring speed showed that at lower stirring speed the promotion rate of dissolution of polymorph form I is greater than that of form II. 3. In the case of tablets the dissolution rates of polymorph form I of sulpiride was two fold as compared with the results obtained from form II.

• 한국산학기술학회논문지
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• 제14권12호
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• pp.6324-6329
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• 2013

본 연구에서는 액상 형태인 콜린알포세레이트를 알루미늄마그네슘규산화합물에 흡착시켜 고형의 제형화가 가능한 콜린알포세레이트를 함유하는 정제의 제조하고 평가하였다. 정제는 콜린알포세레이트 대비 흡착제의 비율을 달리하여 제조하고, 물리적 특성 및 용출률을 조사하였다. 정제의 타정성과 용출률을 고려할 때 흡착제는 주성분 대비 50~75%가 적절하였다. 주성분 대비 62.5%의 흡착제를 사용한 제제에서 정제의 경도, 붕해, 마손도 시험, 용출곡선하면적 비율 결과가 가장 우수하였다. 알루미늄마스네슘규산화합물은 액상 약물의 고형화 설계 시 좋은 소재가 될 수 있을 것이다.

• Asian-Australasian Journal of Animal Sciences
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• 제19권10호
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• pp.1503-1507
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• 2006

Goats' milk adulteration with cows' milk is becoming a big problem. In the past, the urea-polyacrylamide gel electrophoresis assay with different motility of ${\alpha}S1$-casein has been applied for the identification of cows' milk adulteration. The detection sensitivity is 1.0%. The aim of this study was to develop a faster and more sensitive method to detect cows' milk which may be present in adulterated goats' milk and goats' milk powder. The published primer was targeted at highly conserved regions in bovine mitochondrial DNA (a 271 bp amplicon). This amplicon was cloned and sequenced to further confirm bovine specific sequence. The chelex-100 was used to separate bovine somatic cells from goats' milk or goats' milk powder samples. Random sampling of different brands of goats' milk powder and tablets from various regions of Taiwan showed the adulterated rate was 20 out of 80 (25%) in goats' milk powders and 12 out of 24 (50%) in goats' milk tablets. With this system, as low as 0.1% cows' milk or cows' milk powder in goat milk or goat milk powder could be identified. This chelex DNA isolation approach provides a fast, highly reproducible and sensitive method for detecting the adulteration of goats' milk products.