http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
고시 수재 의약품 중 피라세탐 정 및 브롬화수소산페노테롤 정의 용출시험법 개발
김은정,이진하,박찬호,손경희,김인규,김동섭,사홍기,최후균,Kim, Eun-Jung,Lee, Jin-Ha,Park, Chan-Ho,Sohn, Kyung-Hee,Kim, In-Kyu,Kim, Dong-Sup,Sah, Hong-Kee,Choi, Hoo-Kyun 대한약학회 2011 약학회지 Vol.55 No.4
Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specifications in Korean Pharmaceutical Codex (KPC). Among those commercially available, Piracetam Tablets and Fenoterol hydrobromide Tablets were selected to develop the dissolution testing method. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korea Food & Drug Administration (KFDA). The dissolution test for Piracetam Tablets was carried out under sink condition with distilled water as dissolution medium, paddle rotation speed at 50 rpm and medium volume of 900 ml. More than 80% of its label claim was released within 30 min. In case of Fenoterol hydrobromide Tablets, distilled water was also found to be suitable to ensure sink condition. The rotation speed of 50 rpm and 900 ml of dissolution medium were used to evaluate the dissolution profile. The dissolution rate of fenoterol hydrobromide was over 90% in 15 min. The HPLC analysis methods were validated in terms of accuracy, precision, specificity, linearity, quantitation limit and range. The results suggested that the analytical methods used are simple and suitable to measure the dissolution rate of piracetam and fenoterol hydrobromide. Therefore, the analysis methods could be utilized in setting dissolution specifications of Piracetam Tablets and Fenoterol hydrobromide Tablets in the revised version of KPC.
헬리코박터 파이로리 균 진단용 <sup>13</sup>C-요소 캅셀의 개발
용철순,김용일,김지만,강성훈,권기철,이종달,김종국,사홍기,최한곤,Yong, Chul-Soon,Kim, Yong-Il,Kim, Chi-Man,Kang, Sung-Hoon,Quan, Qi-Zhe,Rhee, Jong-Dal,Kim, Chong-Kook,Sah, Hong-Kee,Choi, Han-Gon 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.1
The purpose of this study was to develop a new $^{l3}C-urea-containing$ capsule for diagnosis of H. pylori. The urea-containing capsules were prepared with various diluents such as polyethylene glycol (PEG), microcrystalline cellulose, sodium lauryl sulfate and citric acid. The dissolution test, $^{l3}C-urea$ breath test and stability test were then performed on the capsules. Microcrystalline cellulose and sodium lauryl sulfate retarded the initial dissolution rates of urea. However, PEG increased the initial dissolution rates of urea. Furthermore, two formulae composed of PEG, [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] and [$^{l3}C-urea/PEG/citric$ acid (38/1.9/1.9 mg/cap)] had the maximum DOB value, about 16 at 20 mim, while the formula composed of only 38 mg $^{l3}C-urea$ had the maximum DOB value at 30 min. The results indicated that PEG improved the, sensitivity of $^{l3}C-urea$ in the human volunteers. The capsule [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] was stable for at least six months in 25 and $37^{\circ}C$. Thus, a PEG-containing capsule, [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] would be a more economical, sensitive and stable preparation for diagnosis of H. pylori.
박찬호(Chan Ho Park),이진하(Jin Ha Lee),김은정(Kim Eun Jung),김동섭(Dong Sup Kim),김영옥(Young Ok Kim),손경희(Kyung Hee Sohn),송영미(Young Me Song),사홍기(Hong Kee Sah),최후균(Hoo-Kyun Choi) 대한약학회 2011 약학회지 Vol.55 No.2
The dissolution test method and an analytical procedure by HPLC were developed and validated for dobesilate calcium tablets and acepifylline tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for dobesilate calcium tablets was carried out under sink conditions as following: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for acepifylline tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of dobesilate calcium tablets and acepifylline tablets.
고시 수재 의약품의 용출규격 설정 - 구연산니카메테이트 정, 노르플록사신 캡슐
김희연(Hee Yun Kim),최선희(Seon Hee Choi),방수진(Su Jin Bang),한경진(Kyung Jin Han),최승희(Sung Hee Choi),백지윤(Ji Yun Baek),김동섭(Dong Sup Kim),김영옥(Young Ok Kim),손경희(Kyung Hee Sohn),송영미(Young Me Song),사홍기(Hong Kee Sah) 大韓藥學會 2010 약학회지 Vol.54 No.5
Despite the fact that the dissolution test can serve as an effective tool for drug quality control and prediction of in vivo drug performance, there are a number of drugs with no established dissolution specifications because they were developed quite a long time ago. Under this circumstances, KFDA started the new project that establishes dissolution method and specifications for drugs with no dissolution specifications listed in the Korea Pharmaceutical Codex (KPC). This project aims for promoting the appropriate management of oral solid dosage forms. Seoul regional KFDA selected 2 items, Nicametate citrate tablet and Norfloxacin capsule, for establishing dissolution specifications. We went through the following procedures to develop the dissolution method and specifications: (1) Validation of dissolution test equipment, (2) Purchase of test drugs, (3) Preliminary test with one of the test products (1 lot), (4) Validation of analysis methods (3 lots), (5) Final tests and cross tests among other laboratory to establish dissolution specifications, (6) Additional test with the other test drugs. The outcome of this study will be reflected in revision of the KPC. It is believed that the quality control and evaluation of oral solid dosage forms listed in KPC will be advanced with the revision which adds additional dissolution test and specifications for the drugs with no established dissolution specifications.
이륜경(Ryun-Kyung Lee),이윤애(Yoon-Ae Lee),심지연(Jee-Youn Shim),김민아(Min-A Kim),손경희(Kyung-Hee Sohn),박혜림(Hye-Rim Park),김희성(Hee-Sung Kim),송영미(Young-Mi Song),이수정(Su-Jung Lee),사홍기(Hong-Kee Sah),최후균(Hoo-Kyun Choi) 대한약학회 2011 약학회지 Vol.55 No.5
To secure the good quality of pharmaceutical products, dissolution specifications for Octylonium bromide tablets and Pinaverium bromide tablets are needed to be established, which are enrolled in KPC (Korea Pharmaceutical Codex) with having no appropriate specifications. For establishing dissolution specifications, a number of experiments based on the“Guideline of Dissolution Testing for Solide Oral Dosage Forms” were performed. The results of this study will be used for revising KPC and it is expected to contribute to the incessant production of quality ensured drugs.