• Journal of the Korean Chemical Society
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• v.55 no.4
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• pp.620-625
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• 2011

A simple, rapid potentiometric back titration of Isoniazid (INH) in the presence of Rifampicin (RIF) in tablets and syrups is described. The method is based on the oxidation of INH by a known excess of copper (II) ion and the back titration of unreacted copper (II) ion potentiometrically with ascorbic acid using a lab-made Copper Based Mercury Film Electrode (CBMFE). The titration conditions have been optimized for the determination of 1.0-10.0 mg of INH in pure and dosage forms. The precision and accuracy of the method have been assessed by the application of lack-of-fit test and other statistical methods. Interference was not caused by RIF and other excipients present in dosage forms. Application of the method for INH assay in tablets and syrups was validated by comparison of the results of proposed method with that of the British Pharmacopoeia (BP) method using F- and t- statistical tests of significance.

• Korean Journal of Oriental Medicine
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• v.8 no.1
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• pp.55-63
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• 2002

The plant origines of Atractylodis Rhizoma Alba and Atractylodis Rhizoma are genus Atractylodes*Compositae). Their origines in pharmacopoeia are slightly different among Korea, Japan, North Korea and China. The species of Atractylodis Rhizoma Alba are Atrctylodes japonica $K_{OIDZ}$. A. ovata $T_{HUNB}$.. Atractylodis Rhizoma are A. lancea DC., A. chinensis DC. and A. koreana $K_{ITM}$. But the texonomic genealogy of Atractylodis Rhizoma Alba is different from that of Atractylodis Rhizoma. The herbal origines of Atractylodis Rhizoma Alba and Atractylodis Rhizoma were not different at the early days. Since Tao-Hong-Jing(陶弘景) distinguished between Atractylodis Rhizoma Alba and Atractylodis Rhizoma at the very beginning, theri medicinal usages are different, Atractylodis Rhizoma have been used to remove pathogenic dampness in the digestive organs and Atractylodis Rhizoma Alba have been used to invigorate the digestive system and replenish qi. In additions, the figures and historical records of herbal appearance are different between Atractylodis Rhizoma Alba and Atractylodis Rhizoma. The diagnostics of them are in accord with the texonomic genealogies.

• Analytical Science and Technology
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• v.33 no.6
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• pp.252-261
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• 2020

Currently, the potentiometric titration and the high pressure liquid chromatography (HPLC) method were utilized in Korean Pharmacopoeia XII (KP XII) as well as other pharmacopoeias (USP, EP, BP) for determination of loperamide hydrochloride in raw materials and capsules, respectively. The research objective is to overcome the remaining drawbacks from current methods such as solubility of mobile phase (KP XII), less scientific approach (USP 43) or using paired-ion chromatography reagent which shows some limitations (BP2017 and other formulation monographs). The proposed method was optimized by Design of Experiment (DoE) tool to obtain the satisfied method for determination of loperamide hydrochloride. The optimal condition was performed on the common C18 column (150 mm × 4.6 mm; 5 ㎛) using isocratic elution with the mobile phase containing 40 mM of potassium phosphate monobasic (pH 3.0) and acetonitrile (56:44), at a flow rate of 0.7 mL/min. The optimized method was validated and met the requirements of the International Conference on Harmonization. The developed method was applied to determine loperamide hydrochloride in capsules and can be used to update the current monograph in KP XII.

• KSBB Journal
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• v.29 no.5
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• pp.361-371
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• 2014

Mycoplasma is well recognized as one of the most prevalent and serious microbial contaminants of biologic manufacturing processes. Conventional methods for mycoplasma testing, direct culture method and indirect indicator cell culture method, are lengthy, costly and less sensitive to noncultivable species. In this report, we describe a new TaqMan probe-based real-time PCR method for rapid and quantitative detection of mycoplasma contamination during manufacture of biologics. Universal mycoplasma primers were used for mycoplasma PCR and mycoplasma DNA was quantified by use of a specific TaqMan probe. Specificity, sensitivity, and robustness of the real-time PCR method was validated according to the European Pharmacopoeia. The validation results met required criteria to justify its use as a replacement for the culture method. The established real-time PCR assay was successfully applied to the detection of mycoplasma from human keratinocyte and mesenchymal stem cell as well as Vero cell lines artificially infected with mycoplasma. The overall results indicated that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of mycoplasma contamination during manufacture of biologics.

• Journal of Radiopharmaceuticals and Molecular Probes
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• v.3 no.2
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• pp.85-90
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• 2017

$^{68}Ga-PET$ is of growing importance in the practice of nuclear medicine diagnostic imaging for neuroendocrine tumors as well as prostate cancers. Following this interests, we herein present the radiosynthesis process of [$^{68}Ga$]edotreotide ([$^{68}Ga$]DOTA-TOC) based on the fully automated procedure for clinical doses that can be provided the reduction of radiation exposure and high reproducibility. The quality controls of clinical doses in compliant with European Pharmacopoeia are also discussed.

• Natural Product Sciences
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• v.25 no.3
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• pp.222-227
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• 2019

Quantitative nuclear magnetic resonance (qNMR) is a well-established method adopted by international pharmacopoeia for quantitative and purity analyses. Emodin is a type of anthraquinone, well known as the main active component of Fabaceae, Polygonaceae and Rhamnaceae. Purity analysis of emodin is usually performed by using the high-performance liquid chromatography (HPLC)-UV method. However, it cannot detect impurities such as salts, volatile matter, and trace elements. Using the qNMR method, it is possible to determine the compound content as well as the nature of the impurities. Several experimental parameters were optimized for the quantification, such as relaxation delay, spectral width, number of scans, temperature, pulse width, and acquisition time. The method was validated, and the results of the qNMR method were compared with those obtained by the HPLC and mass balance analysis methods. The qNMR method is specific, rapid, simple, and therefore, a valuable and reliable method for the purity analysis of emodin.

• Proceedings of the Plant Resources Society of Korea Conference
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• 2019.10a
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• pp.87-87
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• 2019

The consumption of herbal medicine and related products (herbal products) have increased in South Korea. At the same time the quality, safety, and efficacy of herbal products is being raised. Currently, the herbal products are standardized and controlled according to the requirements of the Korean Pharmacopoeia, the National Institute of Health and the Ministry of Public Health and Social Affairs. The validation of herbal products and their medicinal component is important, since many of these herbal products are composed of two or more medicinal plants. However, there are no tools to support the validation process. Interest in deep learning has exploded over the past decade, for herbal medicine using algorithms to achieve herb recognition, symptom related target prediction, and drug repositioning have been reported. In this study, individual images of four herbs (Panax ginseng C.A. Meyer, Atractylodes macrocephala Koidz, Poria cocos Wolf, Glycyrrhiza uralensis Fischer), actually sold in the market, were achieved. Certain image preprocessing steps such as noise reduction and resize were formatted. After the features are optimized, we applied GoogLeNet_Inception v4 model for herb image recognition. Experimental results show that our method achieved test accuracy of 95%. However, there are two limitations in the current study. Firstly, due to the relatively small data collection (100 images), the training loss is much lower than validation loss which possess overfitting problem. Secondly, herbal products are mostly in a mixture, the applied method cannot be reliable to detect a single herb from a mixture. Thus, further large data collection and improved object detection is needed for better classification.

• Herbal Formula Science
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• v.22 no.2
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• pp.55-61
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• 2014

Objectives : The purpose of this study is to improve the fomula efficiency and prevent the resource abuse by clarifying the origin of kinds of Cinnamomum cassia Presl. Methods : 1. We researched "Shennongbencaojing", "Bencaogangmu", "Shanghanlun", "Jinguiyaolue", "Dongeuibogam", and other books. 2. Choosing a related words such as Cinnamomi ramulus(Gye-ji), Cassiae Cortex Interior(Gye-sim), Cinamomi Cortex(Yuk-gye). 3. Searching prescriptions: We searched prescriptions containing the Cinnamon in above books, and compared the differency among them. Conclusions : 1. Cinnamomi ramulus(Gye-ji) used for Shanghanlun contains Cinamomi Cortex(Yuk-gye), Cinnamomi ramulus(Gye-ji) and Cassiae Cortex Interior(Gye-sim) written in the Korean Pharmacopoeia. 2. Cinamomi Cortex(Yuk-gye) is the thick cortex of trunk of Cinnamomum cassia. It has functions like downwarding and warming-tonifying, and it is mainly used for Palmi-won(Bawei-yuan). 3. Cassiae Cortex Interior(Gye-sim) is about 30% of Cinamomi Cortex(Yuk-gye) middle layer, removing outer and inner cortex. Its main functions are regulating heart, coordinating the heart and kidney, and dispelling stastic blood and it is mainly used for Gyejibokryoung-hwan(Guizhifuling-wan) and Dangguisoo-san(Dangguixu-san). 4. Current Cinnamomi ramulus(Gye-ji) is a twig. thus, it means a small branch. Its main functions are upwarding, transversing, and exterior-effusing and it is mainly used for Gyeji-tang(Guizhijiagui-tang) and Gyejigagye-tang(Guizhi-tang).

• The Korea Journal of Herbology
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• v.31 no.3
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• pp.71-75
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• 2016

Objectives : Mori Ramulus is a young branch of Morus alba Linne, which has been used as traditional medicines for antidiarrhea, antibacteria, and antihypertension in Korea. With the basis on these medicinal activities, it is registered at the Korean Herbal Pharmacopoeia. The standard for quality control in use, however, is not yet validated.Methods : We experiment on heavy metals test, TLC, loss on drying, ash, acid-insoluble ash, contents of ethanolsoluble extracts and contents of oxyresveratrol by using the 15 samples of Mori Ramulus which are collected domestically. We tested items according to the General Test, processes and apparatus, Crude Drugs Test of KP(2011).Results : Purity test(Heavy metals) showed contents for Pb, As, Hg, and Cd range of 0.1~1.1 ppm, 0.0~0.2 ppm, 0.00~0.01 ppm, and 0.00~0.02 ppm. Identification test(Thin layer chromatography) was on comparing with morucine standard solution in R_f value, all samples showed morucine spot (dark blue, R_f : 0.3) as same as R_f value of morucine-standard solution. Loss on drying was ranged from 5.1 to 8.9 %, ash and acid-insoluble ash were between the range 3.0~6.3% and 0.3~0.8%. Contents of ethanol-soluble extracts was ranged from 6.2 to 12.0%. Content of oxyresveratrol was ranged from 0.01 to 0.16 % based on the oxyresveratrol standard curve.Conclusions : We sincerely hope that this study will be contributed to the standardization and quality control of Korean herbal medicines.

• Korean Journal of Medicinal Crop Science
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• v.24 no.6
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• pp.451-457
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• 2016

Background: Leonurine is a the aerial part of Leonurus japonicus Houttuyn, which has been used as a traditional medicines and is registered in the Korean Pharmacopoeia. Methods and Results: In the present study we performed a heavy metals and thin layer chromatography and measured loss on drying, as well as the contents of total ash, acid-insoluble ash, ethanol soluble compounds, and leonurine, using 15 domestically collected L. japonicus samples. The methods were performed according to the 'crude drugs test of the general test, processes and apparatus', published by MFDS, Korea (2014). The purity test (heavy metals) indicated that levels of Pb and Hg were 0.35 - 3.64, and 0.001 ppm, respectively, whereas the levels of As and Cd were undetectable, and stachydrine was identified by thin layer chromatography ($R_f$ : 0.15). We found that 5.93 - 10.62% (average: $8.58{\pm}1.8%$) of the sample mass was lost during drying, and the contents of total ash, acid-insoluble ash, ethanol soluble compounds, and leonurine were 7.87 - 10.84% (average: $9.62{\pm}0.82%$), 0.99 - 1.76% (average: $1.38{\pm}0.24%$), 16.70 - 23.11% (average: $19.49{\pm}2.14%$) and 0.04 - 0.17% (average: $0.11{\pm}0.04%$) respectively. In addition, HPLC profiling detected leonurine (5.94 min), rutin (16.43 min) and myricetin (26.78 min). Conclusions: We hope that this the rusult of the present study will contribute to the standardization and quality control of Korean herbal medicines.