• YAKHAK HOEJI
• /
• v.12 no.1_2
• /
• pp.35-39
• /
• 1968

Alkalinity of pharmaceutical containers is to be highly influenced for liquid pharmaceuticals. The criteria of the alkalinity of ampoules and vials used as pharmaceutical containers is established in the Korean Pharmacopoeia. However, the criteria of general containers for liquid pharmaceuticals is not eatablished in the Korean Pharmacopoeia. Therefore, we tried to perform comparing test for domestic products and foreign products of following group: 1) vials 2) general containers for liquid pharmaceutical 3) general containers for tablet pharmaceuticals It was found that the domestically produced vials were good enough for criteria, while almost fifty percent of non-established containers was unsaticefactory.

• Proceedings of the PSK Conference
• /
• 2003.10b
• /
• pp.66.1-66.1
• /
• 2003

Rhizomes of Polygonatum species belong to Liliaceae are important herbal drugs in the traditional medical practice of Asian region. Two representative Chinese drugs derived from this genus are Hwangjeong and Okjuk. Though botanical origins of these drugs are officially listed as P. falcatum, P. sibiricum and P. kingianum for Hwangjeong and P. odoratum var. pluriflorum for Okjuk in the Korean Pharmacopoeia and Korean Herbal Pharmacopoeia, respectively, they are often sold as a mixture of several different species in the market. (omitted)

• Korean Journal of Oriental Medicine
• /
• v.11 no.2
• /
• pp.155-165
• /
• 2005

This study was investigated to determine the quality control of Oriental medicine from stores dealing in Oriental medicine around Seoul and Daegu. We tested total 120 samples that widely used 15 species in herbal medicine (Lycii Fructus, Platycodi Radix, Angelicae Gigantis Radix and 12 others) being collected from Oriental medicine clinic, pharmacy, Oriental pharmacy, Oriental medical hospital and Oriental drug store. We have estimated Oriental medicine by K.P. (Korean Pharmacopoeia), K.H.P(Korean Herbal Pharmacopoeia) and announcement of KFDA. The items of examination were identification, purity, loss on drying, ash, acid insoluble ash, extract content, essential oil content, assay, heavy metal limit, and pesticides residue(BHC, DDT, Aldrin, Endrin, Dieldrin). As a result, 20 samples in total 120 samples were not satisfied with the standard and 7 species in total 15 species were not satisfied with the standard. Identification test, extract content test and pesticides residue(BHC, DDT, Aldrin, Endrin, Dieldrin) were satisfied with the standard. The result will be the basic data for the quality control of Oriental medicine.

• Analytical Science and Technology
• /
• v.31 no.3
• /
• pp.107-111
• /
• 2018

Currently, ultraviolet-visible spectrophotometry and titration methods are used for assay tests of tramadol hydrochloride injection and raw material in the Korean Pharmacopoeia XI (KP XI). Titration has also been used in the British Pharmacopoeia (BP 2013) for the assay test of tramadol hydrochloride, and the HPLC assay for tramadol hydrochloride raw material has been used in the United States Pharmacopeia (USP 39). In this study, we developed an alternative HPLC assay method for tramadol hydrochloride injection that is up to date and specific, and employs the same method as tramadol hydrochloride capsules. Validation of the HPLC method was conducted to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of the calibration curves in the desired concentration range was good ($r^2$ > 0.9999). RSDs of intra-day precision obtained were 0.05-0.08 % and inter-day precision obtained were 0.08-0.19 %. Accuracy was obtained with recoveries in the range of 98.16 % and 100.90 %. As a result of the system's suitability, the RSD of both retention time and the peak area obtained were 0.07 %. The values of the plate number and tailing factor of tramadol hydrochloride obtained were 7076 and 1.16, respectively. Because of the intermediate precision and robustness of the developed assay, it is expected to become a valuable tool for revising the Korean Pharmacopoeia (KP XI).

• Journal of Korean Medical classics
• /
• v.21 no.2
• /
• pp.29-37
• /
• 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
• /
• v.21 no.4
• /
• pp.268-275
• /
• 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.

• Herbal Formula Science
• /
• v.30 no.3
• /
• pp.191-203
• /
• 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
• /
• v.30 no.5
• /
• pp.221-225
• /
• 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).

• Korean Journal of Clinical Pharmacy
• /
• v.24 no.3
• /
• pp.219-228
• /
• 2014

Objectives: This paper was aimed to investigate the adhesion control standards of pain relieving patch (PRP) drugs and to survey it's adverse effects on the skin of patients for safe use of PRP drugs. Methods: In this study, the related documents of PRP drugs of Korea pharmacopoeia (KP), United States pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European pharmacopoeia (EP), and information web sites of the Ministry of Food and Drug Safety (MFDS) were surveyed. Also, the past and current labeling of PRP drugs marketed in the pharmacy was investigated and compared. Results: In KP and JP, the lower limit standard for PRP's adhesion control is established, but the upper limit standard is not designated. In USP and EP, neither the lower nor upper limit standard is established. The main reasons of skin adverse effects are considered as inherent adverse reactions of the applied drugs for PRP. Another reason is involved in patient's medication mistakes related to PRP's adhesion control, respiratory depression of skin according to physical skin closure, and microbial growth, etc. Conclusion: For safe use of PRP drugs, we proposed ensured guidelines like additional instructions of pharmacist's prescription and detailed labeling systems for usage of PRP drugs applied on skin.

• The Korea Journal of Herbology
• /
• v.27 no.4
• /
• pp.25-31
• /
• 2012

Objectives : The purpose of this study is searching for grounds of new regulations about submerging properties of Aquilariae Lignum described in the Korean Herbal Pharmacopoeia. Methods : Through the investigation of the various Chinese histories and herbal classics, the definitions of Aquilariae Lignum and documents on actual trade and discrimination methods by sinking under water. Results : In Jiaozhouyiwuzhi(交州異物志) written in the early 2nd century, Aquilariae Lignum was defined as heart wood part or knots sinking under water due to hard and dark deposition of resins. Also, which are not sinking were defined as zhan xiang(棧香), and which are floating were named as qian xiang(槧香). The definitions of Aquilariae Lignum had not been changed till Ching Dynasty era, but the classification and the names about not-sinking and floating Lignum materials were a little changed. Conclusions : These results indicate that it is reasonable to make a regulation that "Aquilariae Lignum sinks under water" in the property description of The Korean Herbal Pharmacopoeia.