• YAKHAK HOEJI
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• v.56 no.4
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• pp.211-216
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• 2012

Drug dissolution test has been used for the purpose of both quality control of solid oral dosage forms and predicting in vivo drug release profiles. In this study, the dissolution profiles of buflomedil hydrochloride tablets and ticlopidine hydrochloride tablets were investigated according to the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korean Pharmacopoeia (KP). The analytical method using HPLC was validated. The validation was performed in terms of specificity, linearity, accuracy, precision and limit of quantitation.

• YAKHAK HOEJI
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• v.54 no.1
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• pp.39-48
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• 2010

The objective of this study was to analyze sennoside A and rhaponticin simultaneously according to sennoside A of Rhei Rhizoma determination in Korean Pharmacopoeia. $NaHCO_3$ solution in KP was compared with methanol which usually used as solution to extract rhaponticin in Rhei Rhizoma. The method was validated through the guidelines of linearity, LOD, LOQ, specificity and accuracy. Two solution weren't different about validation parameter and passed. So this method were applied to the determination of 6 commercial Rhei Rhizoma samples and 2 samples were suitable for the legal standards.

• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.453-457
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• 2004

Atenolol and related compounds found in raw materials and commercial products were analyzed by reversed-phase high-performance liquid chromatography. A mixed solution of phosphate buffer (3.4 g/l, pH 3.0), tetrahydrofurane and methanol (800:20:180, v/v/v) including sodium octanesulfonate (1 g/l) and tetrabutylammonium-hydrogensulfate (0.4 g/l) was used as mobile phase at the flow rate of 0.25 ml/min. Detection was carried out at UV 226 nm. Atenolol related compounds, such as bis ether, tertiary amine and blocker acid were identified by comparing the retention time of the standard. The within-day and between-day precisions of the separated compounds were less than 1.2% and 3.4%, respectively. The contents of related compounds of the tested samples were under the limit prescribed in the European Pharmacopoeia. The pattern of the related compounds showed that atenolol raw materials and products could be classified in three different groups, indicating that the materials originated from different source or treated in different way.

• Journal of Pharmaceutical Investigation
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• v.37 no.6
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• pp.403-411
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• 2007

The importance of pharmaceutical additives is increasing and the sorts and application categories are being classified in detail. International pharmaceutical council based on IPEC-America, IPEC-Europe and JPEC was established for specifications, safety and efficacy, approval regulations of pharmaceutical additives in 1992. Therefore, scrutinized examination of pharmaceutical additives used for already approved domestic drug was performed under the supervision of KFDA and nomenclature on application categories of pharmaceutical additives was summarized and endowed their glossary. Additionally, the boundaries of pharmaceutical additives according to the dosage forms based on the principle of the dosage forms of Korean pharmacopoeia were classified. These informations could be available for standards & experimental methods, approval, evaluation, audit of drug and contribution for national welfare.

• The Korea Journal of Herbology
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• v.31 no.6
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• pp.11-20
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• 2016

Objectives : This study aims to examine validity of the following guideline for Zanthoxyli Pericarpium in the Korean Pharmacopoeia regarding foreign materials: "the seeds of Zanthoxyli Pericarpium that are mixed should not exceed 20%." Methods : Varied compliance guidelines for and original plants of Zanthoxyli Pericarpium across countries were compared and contrasted. In order to do this, pharmacopoeias from a number of different countries including Korea were used as references. Results : The weights including seed parts were Z. piperitum 3.48g, Z. schinifolium 2.94g, and Z. bungeanum 2.16g; while the weights of peel parts were Z. piperitum 1.45g, Z. schinifolium 1.69g, and Z. bungeanum 0.98g. In terms of weight, Z. piperitum was the heaviest with its entire part including the seed, whereas Z. schinifolium was the heaviest with its peel part. The proportions of each seed in the whole part were Z. piperitum 58.33%, Z. schinifolium 42.52%, and Z. bungeanum 54.63%. Considering these figures, including seed parts in the guideline up to 20% is inappropriate; however, this guideline is inevitable in order to use seed parts for medicinal purpose. Conclusion : In this article, the author argues if any changes were to made on the guideline for Zanthoxyli Pericarpium with respect to foreign materials - "the seeds of Zanthoxyli Pericarpium that are mixed should not exceed 20%" - its seed part should firsthand be separated from its peel part and be designated as one kind of medicine. Then, revisions on the foreign materials compliance guidelines for Zanthoxyli Pericarpium should also be made.

• 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.

• Food Engineering Progress
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• v.13 no.4
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• pp.243-250
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• 2009

Pravastatin sodium, competitive inhibitors of HMG-CoA(3-hydroxy-3-methylglutaryl coenzyme A) reductase, is produced from the culture broth of Streptomyces carbophilus KCCM 10370, The production of Pravastatin sodium was increased about 45 fold compared to wild type by UV mutation. Production of Pravastatin was also improved by continuous feeding of Compactin sodium to 24% and bioconversion ratio was also increased to 4.3% by intermittent addition. In main culture, concentration of Compactin sodium was kept less than 0.1%(w/v) under continuous feeding of Compactin sodium then product was 0.49% and bioconversion was 70%. After finishing the fermentation, Pravastatin was purified by various chromatographies such as Diaion HP20 resin column, Partition, and ODS(Octa-Decylsilyl Silicagel) resin column with a final yield of 70~72% and over 99.7% purity. The IR, UV, and NMR study of the purified Pravastatin sodium showed the same pattern as that of EP(European Pharmacopoeia).

• The Korea Journal of Herbology
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• v.36 no.1
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• pp.51-57
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• 2021

Objects : In this study, I aimed to determine the size and administration Method of pills preparation in Treatise on Cold Damage Diseases. Methods : I investigated the Treatise on Cold Damage Diseases, Newly Revised Materia Medica, Variorum of the Classic of Materia Medica, The Korean Herbal Pharmacopoeia, and recent studies. Results : There were four kinds of pills preparation. Each size of pill preparation was equal to the Odongja, Tanwhan, Yolk, and quarter of daily dosage of Decoction. One pill of Tanwhan was equivalent to 16 pills of Odongja, and one Yolk was equal to 40 pills of Odongja. The Diameter of Odongja was 6.5 mm, Tanwhan was 16.37897 mm, and Yolk was 22.11484 mm. Jeodangwhan was equal to one quarter daily dosage of Jeodangtang. Maximum size to swallow with water was Odongja and daily dosage, which was 16 pills, includes one square-inch-spoon of powder preparation. When we made the pill preparation, it is difficult to make 16 pills using one square-inch-spoon of powder. Therefore, Zhang Zhongjing made one dosage started from 10 pills to 20 pills to find out optimum dose. Due to the difficulty of making precise size of pills and considerable amount of daily dosage, there was no smaller size than Odongja. When the size of Pill preparation was larger than Odongja, it was ground or boiled slightly to make suspensions. Conclusions : These results suggest that the sizes of Pill preparation in the Treatise on Cold Damage Diseases were true compared with reality.

• Korean Journal of Plant Resources
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• v.34 no.1
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• pp.52-58
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• 2021

Homogenization of quality was important in order to use herbal medicines as pharmaceuticals. To solve this problem, it was important to establish quality standards. Atractylodis Rhizoma Alba has no quantitative method in the Korean Pharmacopoeia. Thus, we have researched to improve the quality evaluation method of Atractylodis Rhizoma Alba with an HPLC. Atractylenolide III and atracylodin were selected as potential marker compounds. This analytical procedure was subject to validation. According to validation guideline of South Korea's Ministry of Food and Drugs Safety, the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy were measured. Because the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy meet criteria of the guideline, the analytic method was validated. With this analysis, Atractylodis Rhizoma Alba and Atractylodis Rhizoma analyzed. As a result, both atractylenolide III and atracylodin appear to be suitable standard compounds. it confirmed that tractylodes Rhizome, similar to Atractylodes Rhizome Alba, could be distinguished.

• Korean Journal of Acupuncture
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• v.38 no.4
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• pp.250-266
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• 2021

Objectives : This study was conducted to suggest new alternative methods to improve pharmacopuncture and Korean medicine research by analyzing the injection route, pharmacological effect, and status studies of Chinese herbal injections. Methods : 130 types of marketed and licensed Chinese herbal injection were searched from National Medical Products Administration (NMPA) of China. CNKI, PubMed, EMBASE, and the 2020 edition of the Chinese Pharmacopoeia were used to collect additional information. 'Herbal injection' and 'Chinese herbal injection' were used as keywords. All data were collected mainly on the treatment of Chinese herbal injection. But data which were not related to the relevant research or Chinese herbal injection were excluded. Results : Intramuscular injection accounted for more than half of the single injection route (51%). Acupoint and intramuscular injections accounted for 55% of dual injection routes. Acupoint, intravenous, and intramuscular injections accounted for the largest proportion (76%) of the multiple routes of injections. As for the pharmacological effect, injection for cardiovascular diseases accounted for 29%. About the number of raw herbal materials, single herbal material was the most common. Twelve intervention studies all tested intravenous injections, and half of them investigated cardiocerebrovascular diseases. All were given by intravenous injection. In the side effect section, the most common symptoms were nausea and vomiting. Conclusions : Through the results, it is expected to be used for research and development of new pharmacopuncture and herbal medicine.