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.

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.

한약 및 한약제제 관리와 연구개발 정책방향에 관한 연구

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

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.

Palmul-tang, a Traditional Herbal Formula, Protects against Ethanol-induced Acute Gastric Injury in Rats

Shin, In-Sik,Lee, Mee-Young,Seo, Chang-Seob,Lim, Hye-Sun,Kim, Jung-Hoon,Jeon, Woo-Young,Shin, Hyeun-Kyoo The Society of Korean Medicine 2011 대한한의학회지 Vol.32 No.6

Objectives: Palmul-tang (hachimotsu-to in Japanese and bawu-tang in Chinese) is a mixture of eight herbs. It is traditionally used for the treatment of anemia, anorexia, general weakness, and female infertility in China, Japan, and Korea. In this study, we investigated the protective effects of Palmul-tang water extract (PTE) against ethanol-induced acute gastric injury in rats. Material and Methods: Acute gastric lesions were induced by intragastric administration of 5mL/kg body weight of absolute ethanol to each rat. Control group rats were given PBS orally and the ethanol group (EtOH group) received absolute ethanol (5mL/kg) by oral gavage. The positive control group and the PTE group were given oral doses of omeprazole (50mg/kg) or PTE (400mg/kg), respectively, 2 h prior to the administration of absolute ethanol. The stomach of each animal was excised and examined for gastric mucosal lesions. To confirm the protective effects of PTE, we evaluated the degree of lipid peroxidation, the level of reduced glutathione (GSH), and the activities of the antioxidant enzymes catalase, glutathione-S-transferase, glutathione peroxidase, and glutathione reductase in the stomach. Results: PTE reduced ethanol-induced hemorrhage and hyperemia in the gastric mucosa. PTE reduced the increase in lipid peroxidation associated with ethanol-induced acute gastric lesions and increased mucosal GSH content and the activities of antioxidant enzymes. Conclusion: These results indicate that PTE protects gastric mucosa against ethanol-induced acute gastric injury by increasing antioxidant status. We suggest that PTE could be developed as an effective drug for the treatment of acute gastric injury.

Jaeumganghwa-tang, a Traditional Herbal Formula Inhibits the Development of Benign Prostatic Hyperplasia in Rats

Shin, In-Sik,Lee, Mee-Young,Lim, Hye-Sun,Seo, Chang-Seob,Ha, Hye-Kyung,Shin, Hyeun-Kyoo The Korean Society for Applied Biological Chemisty 2012 Applied Biological Chemistry (Appl Biol Chem) Vol.55 No.2

Benign prostate hyperplasia (BPH) is the most common proliferative disorder affecting older men and results in prostate enlargement and lowered urinary tract symptoms. Jaeumganghwa-tang (JGT), an oriental traditional herbal formula, has been used in China (Zi-yin-jiang-huo-tang in Chinese), Japan (Jiin-koka-to in Japanese), and Korea for many years. Effects of JGT on prostate dihydrotestosterone (DHT) level and prostatic hyperplasia were investigated using a rat model, in which BPH was induced using testosterone propionate (TP). Rats were divided into five groups. One group was used as a normal, and four groups received subcutaneous injections of TP for 4 weeks to induce BPH. JGT (200 or 400 mg/kg) was administered daily for 4 weeks by oral gavage concurrently with TP injections, and rats were sacrificed at scheduled times. Prostates were weighed, and histopathologic examination was conducted. DHT levels in serum and the prostate were measured, and the expression of proliferating cell nuclear antigen (PCNA) protein was investigated using Western blotting. BPH animals showed increases in absolute and relative weights of the prostate, levels of DHT in serum and the prostate, and expression of PCNA in the prostate, whereas JGT-treated animals showed significant reductions in these indices compared with the BPH animals. Administration of JGT attenuated TP-induced epithelial hyperplasia. These findings indicate that JGT inhibits the development of BPH, an effect closely associated with a reduction in DHT level.

Gastroprotective effects of Leejung-tang, an oriental traditional herbal formula, on ethanol-induced acute gastric injury in rats.

Shin, In-Sik,Lee, Mee-Young,Lim, Hye-Sun,Seo, Chang-Seob,Ha, Hye-Kyung,Shin, Hyeun-Kyoo African Networks on Ethnomedicines] 2013 African journal of traditional, complementary, and Vol.10 No.2

<P>Leejung-tang (LJT, Rechu-to in Japanese and Lizhong-tang in Chinese) is an oriental traditional traditional herbal formula. LJT has been used for treatment of gastrointestinal disorders in Korea, Japan, and China for a long time. In present study, we investigated the protective effects of LJT against absolute ethanol induced gastric injuries. Rats in the control group were given PBS orally (5 mL/kg body weight) as the vehicle, and the absolute-ethanol group (EtOH group) received absolute ethanol (5 mL/kg body weight) by oral gavage. Rats in the positive control group were given omeprazole orally (50 mg/kg body weight) 2 h prior to the administration of absolute ethanol. The treatment groups received LJT (400 mg/kg body weight) 2 h prior to absolute ethanol administration. All rats were sacrificed 1 h after receiving the ethanol treatment. The stomach was excised for macroscopic examination and biochemical analysis. The administration of LJT protected gastric mucosa against ethanol-induced acute gastric injury, including hemorrhage and hyperemia. LJT reduced the increase in lipid peroxidation in ethanol-induced acute gastric lesions. LJT increased GSH content and activities of the antioxidant enzymes, catalase, glutathione-S-transferase, glutathione reductase, glutathione peroxidase, and superoxide dismutase. These results indicate that LJT protects gastric mucosa against ethanol-induced acute gastric injury by increasing their antioxidant content. We suggest that LJT can be developed as an effective drug for the treatment of acute gastric injury.</P>

Yijin-tang, an Oriental Herbal Formula Reduces Ethanol-induced Acute Gastric Injury in Rats

Shin, In-Sik,Lee, Mee-Young,Seo, Chang-Seob,Lim, Hye-Sun,Ha, Hye-Kyung,Shin, Hyeun-Kyoo The Korean Society for Applied Biological Chemisty 2012 Applied Biological Chemistry (Appl Biol Chem) Vol.55 No.2

Protective effects of Yijin-tang extract (YTE) were investigated on ethanol-induced acute gastric injury. Simultaneous determination of six components, homogentisic aicd, liquiritin, hesperidin, neohesperidin, poncirin, and glycyrrhizin was performed in YTE by high performance liquid chromatography-photodiode. Acute gastric lesion was induced by oral administration of absolute ethanol (5 mL/kg). The positive control (omeprazole, 50 mg/kg) and YTE groups (200 and 400 mg/kg) were administered by oral gavage 2 h prior to ethanol treatment. The animals were sacrificed 1 h after receiving ethanol treatment. Acute toxicity study was performed to evaluate the safety of YTE. YTE protected gastric mucosa against ethanol-induced acute gastric injury including hemorrhage and hyperemia. YTE reduced the elevated lipid peroxidation of stomach and increased the activities of antioxidant enzyme. In the acute toxicity study, YTE did not cause any toxic effect at the dose level of 2000 mg/kg in rats. These results showed that YTE protects gastric mucosa from ethanol-induced acute gastric injury via increasing the antioxidant status. We suggest that YTE has a potential as a therapeutic agent for acute gastric injury.

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.