• Journal of Korean Medical classics
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• v.21 no.2
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• pp.29-37
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• 2008

Based on 11 Classics of Materia Medica designated by Ministry of health and welfare bulletin 1995-15 as legal basis in scope and preparation of herbal prescription, we reviewed indication, property and processing of Rhus Verniciflua Stokes which appear extensively in literature since earlier Joseon Dynasty. Following is the conclusion of this review after comparing with 'Korean Pharmacopoeia: commentary on herbal product standard'. 1. The properties of Rhus Verniciflua Stokes in 'Korean Pharmacopoeia :commentary on herbal product standard' should be changed as 'Tonifying the middle, restoring the muscle, fulfilling marrow, breaking old static blood, tonifying and activating after removing mass, unblocking the meridian, killing worms' and indication should be changed as 'Old static blood, deep rooted mass, wind-cold-dampness arthralgia, cough, 9 types of chest pain, abdominal or flank accumulation of stagnated qi[氣], amenorrhea, hernia mass, small bowel or bladder colic pain, abdominal pain due to worm accumulation'. 2. The processing of Rhus Verniciflua Stokes in 'Korean Pharmacopoeia: commentary on herbal product standard' should include 'natural drying or steaming drying followed by grinding and stir-baking until ripened or smoking appears'.

• Korean Journal of Medicinal Crop Science
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• v.21 no.4
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• pp.268-275
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• 2013

This text was analyzed and investigated the distribution of medicinal plants in Cheongoksan Bonghwagun Korea, in order to search the medicinal resources that are used in modern medicine. Medicinal plants of the Korean Pharmacopoeia (10th edition) distributed in Cheongoksan Bonghwagun were consisted of 93 taxa ; 82 species, 10 varieties, 1 forma of 79 genus, 50 families. In medicinal plants of the Korean Pharmacopoeia, rate of native species and exotic species was 89.2% (83 taxa) and 10.8% (10 taxa) respectively. Family classification was the most of compositae of 8 taxa, and life form classification was most of herb of hemicryptophyte species. The classification by using parts were 34 taxa of root use and the classification of efficacy utilization was 24 taxa of Cheongyeolyak (heat-clearing drug) use.

• Analytical Science and Technology
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• v.30 no.5
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• pp.221-225
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• 2017

Thioctic acid is a vitamin-like antioxidant which is prepared as tablets and injection. The Korean Pharmacopoeia (KP XI) contains monograph for the quality control of raw thioctic acid using ultra-violet visible spectrophotometry and its formulations using high performance liquid chromatography (HPLC). In British Pharmacopoeia 2013 (BP2013), another HPLC method is used for the assay test of thioctic acid material. For the international harmonization, we present an HPLC method for quantitation of thioctic acid in both raw material and tablets. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2=0.9995$), while the RSDs for intra- and inter-day precision were 0.93 ~ 1.26 % and 1.40 ~ 1.76 %, respectively. Accuracies ranged from 98.13-100.00 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

• Journal of Pharmaceutical Investigation
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• v.23 no.4
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• pp.231-254
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• 1993

These days, it is not uncommon that a same kind of drug is circulated globally. However, the qualities of excipients used in the same drug have to be sometimes different depending on the different requirements in the qualities stipulated by each country. For a supplier of pharmaceutical excipients, it is generally necessary to carry out different tests on the same kind of testing criteria depending on the country of destination. Thus, the discrepancies between compendium requirements of pharmaceutical excipients create severe problems in various area of industrial activities. The decision of the United States Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia Commissions to harmonize the requirements is a unique chance for the industries to overcome these problems. On the other hand, discrepancies of general test methods and requirements in each monograph of pharmaceutical excipient between the compendia valid at present are in most cases extensive. Consequently their harmonization needs a lot of detailed work requiring strong support from the industry. Based on these circumstances, pharmaceutical excipients councils have been established first in U.S.A. and successively in Europe and in Japan to contribute to the harmorization process. We should like to review here the progress since the Orlando Conference in 1991 and comment about the matters at issue with regard to the international harmonization of pharmaceutical excipients.

• Herbal Formula Science
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• v.30 no.3
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• pp.191-203
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• 2022

Purpose : In 『Herbal Formula Science in Korean Medicine (HFSKM)』, the weight unit of Shanghanlun '1 Liǎng (一兩)' is mostly converted to 3 g. We tried to confirm whether the usages of the Shanghanlun prescriptions of HFSKM are valid in the view of safety and efficacy. Method : The toxicity of herbs in Shanghanlun were summarized. The prescriptions of HFSKM including herbs recorded by weight in Shanghanlun were compared with the pharmacopoeia usage. Domestic clinical case studies were analyzed to confirm the clinical evidence for safety and efficacy. Results : Glycyrrhizae Radix, Rhei Radix et Rhizoma, Persicae Semen, Ephedrae Herba, Pinelliae Tuber, Aconiti Lateralis Radix Preparata, Asiasari Radix et Rhizoma, Armeniacae Semen and Scutellariae Radix have been reported to have toxicity. As a result of analyzing the 39 Shanghanlun prescriptions of HFSKM, 26 prescriptions were identified when they were within the pharmacopoeia usage, and 13 prescriptions were found in excess. As a result of analyzing the domestic clinical research papers, symptoms considered to be side effects were not mentioned, and improvement of the diseases was confirmed. As a result of measuring the actual weight, it was confirmed that the usage greatly exceeded the pharmacopoeia usage, such as 57.23 g for Pinelliae Tuber and 45.77 g for Armeniacae Semen. Conclusion : The composition of the prescription for Shanghanlun proposed in HFSKM is considered to be a reasonable dose, but continuous review and standard supplementation are necessary.

• Analytical Science and Technology
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• v.29 no.6
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• pp.277-282
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• 2016

British Pharmacopoeia (BP 2013), the United States Pharmacopoeia (USP 39) and the Korean Pharmacopoeia (KP XI) contain monographs for the quality control of raw diosmin using high performance liquid chromatography (HPLC). However, official monographs detailing pharmaceutical formulations for diosmin are not available in foreign pharmacopoeias. In the KP XI, ultraviolet-visible (UV-Vis) spectroscopy-which is less specific than HPLC-is reported for the testing of diosmin capsules. In this study, we present an alternative HPLC assay for such testing that is more specific than UV-Vis methods. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2$>0.999), while the RSDs for intra- and inter-day precision were 0.15-0.29 % and 1.05-1.74%, respectively. Accuracies ranged from 101.2-103.2 %, while the retention time and peak area RSDs were 0.37 % and 0.06 %, respectively. Additionally, the plate number and asymmetry factor values for diosmin were 3591.293 and 1.35, respectively. Since the intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.13 no.2
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• pp.182-187
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• 2000

Current status and quality administration of botanical products in America which has one of the biggest market need to be analyzed for the internationalization of oriental medicine. In this study, current status of botanical products as dietary supplements was analyzed and quality adminstration by United States Pharmacopoeia and National Formulary(USP-NF) was compared with The Korea Pharmacopoeia and botanical drug standard collection(KP), Even though the number of botanical products in USP-NF is small, it is rapidly increasing and more detailed compared with KP. Especially, reference standard compound should be determined for each botanical drugs, and more detailed standard for other items should be established in KP considering international trends. Though the history of botanical drugs in America is short, its annual market is about 3.2 billion dollar, so American administration system should be examined carefully for the internationalization of oriental medicine and related industry.

• The Korea Journal of Herbology
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• v.21 no.3
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• pp.83-89
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• 2006

Objectives : To compare limonene, menthone and pulegone content from different part of Schizonepeta tenuifolia Briquet. Methods : The quantitative content of essential oil was determined according to the method of Chinese Pharmacopoeia. GC analysis of essential oil was carried out using a flame ionization detector. The results obtained were confirmed by GC/MS. Results : The content of essential was high on the leaf part. The content of menthone was higher than other ingredients. When compare the content observed by harvesting time, the highest pick was shown on middle of August. Conclusion : This research can be used to modify or feedbackthe article in the Korean Pharmacopoeia.

• Korean Journal of Oriental Medicine
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• v.10 no.2
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• pp.101-108
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• 2004

A variety of Rhei Rhizoma are in circulation in the herbal medicine markets. The most of them were below the standard according to the Korea Pharmacopoeia. The rhizomes of Rheum undulatum, which is not recorded as the origin of Rhei Rhizoma in the Korea Pharmacopoeia, were the most common in Korean herbal medicine markets.

• Korea Trade Review
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• v.47 no.5
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• pp.95-113
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• 2022

Tariffs on pharmaceuticals are generally low, but the time-consuming and costly licensing procedures of importing countries may act as barriers to trade. Accordingly, in terms of improving export competitiveness through cost reduction of exporting countries and improving public health for importing countries, international regulatory collaboration is effective for both countries. However, little is known about the impact of cross-border cooperation in pharmaceutical regulation on international trade. This study empirically analyzed the effect of cross-border regulatory collaboration on pharmaceutical trade using the gravity model. It was confirmed that the regulatory collaboration measures had a trade promotion effect in all drugs(HS29+HS30), finished drugs (HS30), and vaccines (HS300220). This study is meaningful in that it empirically analyzed with the consideration of the reference pharmacopoeia, safety and effectiveness in addition to the GMP inspection used in the previous study.