제약업계의 한약제제 연구개발 현황 및 허가에 대한 인식도 조사 연구

신현규,김윤경,강창희,최선미 한국한의학연구원 2001 한국한의학연구원논문집 Vol.7 No.1

A survey was conducted to investigate the attitudes of pharmaceutical companies toward the status and permission of R&D of herbal products. The survey's results showed that some of them(42.9%) was conducting the R&D, and others(57.1%) were not conducting. As the results of analysis on the reason of R&D conducting, some of them(42.3%) answered that R&D of herbal products is more effective and powerful than these of synthetic products. And 23.1% answered that the cost of R&D is low and the time required is short. And another 23.1% answered that it has marketability and competitive power. As the results of analysis on the marketability of herbal products in Pharmaceutical Market, most of them(78.6%) answered that it seems enough. As the results of the comparison of synthetic drug and herbal products, the proportion of R&D investment on herbal products was lower than synthetic products in the preclinical study, the first clinical study and the second clinical study, and higher than the in the third clinical study and the DNA. And the periods of R&D was long in most procedure except synthesis of new materials. As the results of analysis on the recognition of related regulation, most of the (73%) was yes. And 35.2% of the subjects thinks it enough.

법제 부자와 감초의 배합 비율에 대한 HPLC 분석 및 면역 활성 비교 연구

신현규 ( Hyeun Kyoo Shin ),이진아 ( Jin Ah Lee ),하혜경 ( Hye Kyung Ha ),정다영 ( Da Young Jung ),서창섭 ( Chang Seob Seo ),이호영 ( Ho Young Lee ) 대한본초학회 2010 大韓本草學會誌 Vol.25 No.4

Objectives: To investigate the immunological activities, we evaluated the combination ratio of Aconiti Lateralis Radix Preparata and Glycyrrhizae Radix (AG) on murine macrophage cell line (RAW 264.7) and ovalbumin/aluminium (OVA/Alum)-immunized mice. Methods: The cellular proliferation and the production of nitric oxide were examined in a macrophage cell line, RAW 264.7 cells, in the presence of the combination ratio of Aconiti Lateralis Radix Preparata and Glycyrrhizae Radix. C57BL/6 mice were immunized intraperitonially with ovalbumin/aluminium (100 ug/200ug) on day 1, 8, and 15. The combination ratio of Aconiti Lateralis Radix Preparata and Glycyrrhizae Radix (1g/kg/day) was orally administrated for 3 weeks. On day 22, splenocyte and plasma were collected for mitogen-induced proliferation, lymphocyte subpopulation by flow cytometry and measurement of AST (Aspirate aminotransferase), ALT (Alanine aminotransferase), and antibodies (OVA-specific antibodies of the IgG, IgG1, and total IgM classes) Results: Aconiti Lateralis Radix Preparata treatment had no influence on immune responses. The proliferation and NO production of macrophage and proliferation of splenocyte were increased as the higher ratio of Glycrrhizae Radix. The proliferation of splenocyte, lymphocyte subpopulation and production of antibody (total IgM, OVA-specific IgG and OVA-specific IgG1) were increased as the higher ratio of Glycrrhizae Radix on OVA-immunzed mice. Conclusions: These results suggest that the higher ratio of Glycyrrhizae Radix can increase immunological activities such as NO production in RAW264.7 cells, splenocyte proliferation and immunoglobulin production in OVA-immunized mice.

한약 및 한약제제 관리와 연구개발 정책방향에 관한 연구

신현규(Hyeun-Kyoo Shin) 대한한의학회 2000 대한한의학회지 Vol.21 No.2

삼출건비탕의 HPLC-PDA 동시 분석법 설정 및 세포독성

신현규 ( Hyeun Kyoo Shin ),서창섭 ( Chang Seob Seo ),이미영 ( Mee Young Lee ),김정훈 ( Jung Hoon Kim ),이진아 ( Jin Ah Lee ) 대한본초학회 2010 大韓本草學會誌 Vol.25 No.3

Objectives: To develop and validate HPLC-PDA methods for simultaneous determination of seven constituents in Samchulkunbi-tang (SKT). Additionally, we investigated the cytotoxicity against BEAS-2B cell line and splenocytes of SKT. Methods: Reverse-phase chromatography using a Gemini C18 column operating at 40℃, and photodiode array (PDA) detection at 230, 254 and 280nm, were used for quantification of the three marker components of SKT. The mobile phase using a gradient flow consisted of two solvent systems. Solvent A was 1.0% (v/v) aqueous acetic acid and solvent B was acetonitrile with 1.0% (v/v) acetic acid. The cytotoxicity of SKT were measured by the CCK-8 assay method. Results: Calibration curves were acquired with r2>0.9999, and the relative standard deviation (RSD) values (%) for intra- and inter-day precision were less than 6.0%. The recovery rate of each compound was in the range of 86.89-109.78%, with an RSD less than 4.0%. The contents of seven compounds in SKT were 1.39-6.84mg/g. SKT had no cytotoxicity effect at 50-200ug/mL concentrations. Conclusions: The established method will be helpful to improve quality control and in vitro efficacy study of SKT.

논문(論文) : 한의학 미래예측(2000년∼2010년) 문헌 분야 실현 최종 평가

신현규 ( Hyeun Kyoo Shin ),김용진 ( Yong Jin Kim ) 대한한의학원전학회(구 대한원전의사학회) 2013 대한한의학원전학회지 Vol.26 No.1

Objectives: Final assessment of realized on forecasting studies of the literature sector on traditional Korean medicine (2000-2010) revealed results as follows. Methods: We investigated the related peer-reviewed papers and research project reports through Oriental Medicine Advanced Searching Integrated System(OASIS) of Korea Institute of Oriental Medicine(KIOM) and several publishers. Results: Of total five projects, two were realized and three were partially done. The projects ``It wil be standardized by establishing the concept of traditional Korean medical terms`` and ``CDs containing traditional medicine books from China, Japan and Korea wiil be released`` were decided to be realized. In addition to those, the projects ``Systematic database will be build up for TKM books``, ``translation and annotation versions on TKM old books will be completed``, and ``A wide range of literature related to traditional medicine of each Asian countries`` were concluded to be partially realized. Five projects on predicting TKM in the year 2006-2007 analyzed in 1996 were evaluated as realized or partially realized. Likewise, the five predictions should be reviewed whether it will be necessary in the future after assessment on their realization. Conclusion: Furthermore, it should be studies if the new projects are needed for the future in addition to the existing challenges.

양방 질병명에 대한 한의사들의 인식도 조사

신현규,조경숙,최선미 대한동의생리학회,대한동의병리학회 2001 동의생리병리학회지 Vol.15 No.6

A survey was conducted to investigate the attitudes of the oriental medicine doctors to the name of a disease in western medicine. This survey was distributed to 500 oriental medicine doctors and received 214 from December 20th 1999 to January 10th 2000, a response rate of 42.8%, 76.1%, 59.7%, 34.0%, 50.2%, and 50.5% of the respondents answered "yes" for IDS, Intoxication, Injury, Cancer of the larynx, Uterine cancer, respectively. Most of the respondents point out necessity of including these names in Korea Classification of Diseases (Oriental Medicine), On the other hand they suggested further discussions about the diagnosis of the nature of a disease on the view of Oriental Medicine. The results was analyzed by wether he has experience in lesidence or not. The respondents who have experience in lesidence were more positive than who have not toward the name of a disease in western. In conclusion, it is urgently required to record substantially through further clinical study about oriental medicine diagnosis and treatment follow the name of a disease in western.

「한국표준질병사인분류(한의)」의 질병분류체계에 대한 한의사의 인식도 조사

신현규,조경숙,최선미 대한동의병리학회 2001 동의생리병리학회지 Vol.15 No.3

We wished to learn what oriental doctors have to say about the official oriental medicine legislations of disease classification, 『International Classification of Diseases(Oriental Medicine)』. Also find out the coefficient of utilization, rate of satisfaction, problems and reform measures. We questioned 500 oriental medicine doctors during the period of time starting from December 20th, 1999 to January 10th 2000. of these doctors 42.8 percent, 214 answered. We analyzed this data through the SPSS program. They have full understanding of the objectives of the classifications and analyzation. They were also very familiar with the composition system of the 『International Classification of Diseases (Oriental Medicine)』. They most often use this classification booklet when they record their patient charts. The rate of satisfaction showed that 8% of the doctors felt satisfied, 35.9% so-so, 17% unsatisfied and 17% answered that they did not know. This proves that many of the answerers are unsatisfied with the present 『International Classification of Diseases(Oriental Medicine)』. About the reason of dissatisfaction, 54.5% answered that the classification system is too complex or inefficient. Among the 54.5%, 20.2% quoted that the names of the symptoms and the names of a diseases are being mingled, 17.8% quoted there is no standard of classification, 28.6% quoted etc. 75.1% suggested that the disease names of the oriental medicine and western medicine should be printed together in the present 『International Classification of Diseases(Oriental Medicine)』, and 51.8% of these people answered that the purpose of this is to help the patients and the third party, for example the insurance company. The rate of satisfaction towards the present 『International Classification of Diseases(Oriental Medicine)』 composition showed to be rather low. As this research proves, efforts to satisfy the unsatisfied oriental doctors, studies to establish a more efficient standard of classification, and co-printing of the oriental and western disease names is needed. This research showed the weakness of oriental medicine. Even the definitions of terms and standards of classification which is said to be the fundamental of studies, has not yet been fully established. In result the identity of Oriental medicine is being weakened.

한방산업의 정의와 분류에 대한 연구

신현규,Shin, Hyeun-Kyoo 한국한의학연구원 2004 한국한의학연구원논문집 Vol.10 No.1

1. To define 'Korean medicine industry' through study on existing medicine related industries, Korean medicine industry means all industrial activities related to Korean medicine. It covers material resources such as herbs and products made with herbs, medical instruments, Korean medical service and related information service based on Korean medicine theories. 2. According to Korea National Statistical Office standard industrial branch, Korean medicine industry was classified as a large branch. There were industries such as agriculture, food and beverage manufacture, publishing, copy of prints and record media, manufacture of compound and chemical products, medical service, manufacture of precise optical instruments, wholesale trade and product mediation, retail trade, restaurant, research and development, education service, health preservation service, entertainment, culture and sports industry related to the Korean medicine industry. 3. If we classify this according to the industry branch of English economists Clark, Colin Grant, herb cultivating industry will be classified as primary industry, manufacture of foot and beverage related to Korean medicine, secondary industry and wholesale and retail sales of herb, research and development, education, health preservation, social welfare, tertiary industries.

Simultaneous Determination of the Five Marker Compounds in Melandrium firmum using High-Performance Liquid Chromatography with Photodiode-Array Detection

Seo, Chang-Seob,Shin, Hyeun-Kyoo NATURAL PRODUCT COMMUNICATIONS 2016 Natural product communications Vol.11 No.11

<P>In Korean folk medicine, Melandrium firmum Rohrbach (Caryophyllaceae) has been used to treat various diseases, including anuria, breast cancer, and gonorrhea. In this study, a high-performance liquid chromatography method with photodiode-array UV detection (HPLC-PDA) was established and then validated for the simultaneous determination of five flavonoids in M. firmum: schaftoside, homoorientin, cytisoside, vitexin, and isovitexin. Separation of the five compounds was performed on a Gemini C-18 column at 40 degrees C by gradient elution of two mobile phases. The flow rate and injection volume were 1.0 mL/min and 10 mu L, respectively. The HPLC-PDA method showed excellent linear regression with r(2) values of 0.9999 within the test ranges. The limits of detection and quantification of all components were 0.01-0.11 and 0.04-0.34 mu g/mL, respectively. The extraction recovery of the five analytes was 97.6-105.6% and the RSD values were < 2.0%. The relative standard deviation values of intra- and interday precision for all analytes were < 1.71 and < 1.46%, respectively. As determined using the established and validated HPLC-PDA method described here, the amounts of the five marker compounds in M firmum were 0.02-2.54 mg/g.</P>

Perception of Traditional Medical Doctors on Policy Issues in Korea: Cooperation with Western Medicine, and the Demand and Supply of Practitioners

Huang, Dae Sun,Shin, Hyeun-Kyoo The Society of Korean Medicine 2012 대한한의학회지 Vol.33 No.4

Objectives: This study was conducted to explore the contemporary perception of traditional Korean medical doctors (TKMDs) on traditional Korean medicine (TKM) policies and issues. Methods: A questionnaire that included traditional medicine policy- and treatment-related issues was sent to 130 TKM medical centers and 4,300 TKM local clinical offices in Korea, and received responses from total 648 TKMDs in 122 TKM medical centers and 465 TKM local clinical offices. Results: Of the responding TKMDs, 40% believed that unification of Western and traditional medicines would benefit both modes of medical treatment, 67.6% were against allowing Chinese doctor certification to be effective in Korea through the Korea-China FTA (Free Trade Agreement), and 57.8% believed that the number of TKMDs should be reduced. We also found that 46.1% of TKMDs believed that more lectures on Western medicine would be needed in schools of TKM. Moreover, 87.5% of respondents regarded medical knowledge as necessary for treatment, and 49.4% believed National Certification Commission for Acupuncture and Traditional Medicine (NCCAOM) would be not necessary. TKMDs regarded governmental efforts as more vital than education in schools or individual efforts for enhancement of the traditional medical care market in Korea. To efficiently provide the advantages of complementary CAM, such as cost and safety, detailed research is required when policy is made. Conclusions: The TKM industry must implement policies how the relationship with Western medicine can be better defined under the current dual medical system. On the issue of human resources, more research will be needed on the current policy, which serves to maintain the status quo by blocking the importation of Chinese practitioners and by reducing the number of new practitioners.