• Title/Summary/Keyword: medical formulation

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Effectiveness of Additional Administration of a Banha-sasim-tang Formulation to Patients with Gastrointestinal Symptoms (KCD K-code) Not Improved by Western Medicines: A Retrospective Chart Review (합성의약품으로 호전되지 않은 소화기 증상 환자(KCD K-코드)에 대한 반하사심탕 제제 병용의 효과 : 후향적 차트 분석)

  • Kim, Cheol-hyun;Kim, Kwangho;Lee, Young-ung;Kang, Sunny;Kang, Geonhui
    • The Journal of Internal Korean Medicine
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    • v.42 no.6
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    • pp.1349-1355
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    • 2021
  • Objectives: The aim of this study was to evaluate the effectiveness of additional administration of Banha-sasim-tang formulation to patients with gastrointestinal symptoms that did not improve with Western medicines. Methods: The patients who met the inclusion and exclusion criteria were analyzed retrospectively. A paired t-test was performed on the Nepean Dyspepsia Index-Korean version (NDI-K) scores before and after administering the Banha-sasim-tang formulation. Results: A total of 27 subjects were included. The mean duration of taking the Banha-sasim-tang formulation was 15.6±3.1 days. The most commonly used Western medicine before taking the Banha-sasim-tang formulation was rebamipide. The means of the NDI-K score were 57.4±21.8 before administering Banha-sasim-tang formulation and 34.9±16.5 after administration, and the difference was statistically significant (p<0.0001). No serious side effects were encountered while taking the Banha-sasim-tang formulation. Conclusions: For patients whose gastrointestinal symptoms do not improve with Western medicines, additional administration of Banha-sasim-tang formulation may be an option. However, as this study is a retrospective chart review, prospective, large-scale, double-blind studies are needed in the future.

The Clinical Study on the Effect of the Sulguanjul-bang No.1 According to Formulation (퇴행성 슬관절염 환자에 대한 슬관절방(膝關節方) 1호(號)의 제형변화 유효성 임상연구)

  • Park, Min-Jung;Seo, Jin-Woo;Sung, In-Hyung;Kim, Nam-Ok;Sung, Su-Min;Chung, Ae-Kyung;Shin, Dae-Hee;Park, Koae-Hwan
    • Herbal Formula Science
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    • v.13 no.2
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    • pp.193-206
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    • 2005
  • Objective: This study is designed to compare the effects of Sulguanjul-Bang No.1 on osteoarthritis in knee joint according to formulation. Methods: 47 patients with symptomatic osteoarthritis of the knee joint were enrolled in a open clinical trial. The 47 patients were devided into two groups at random and taken Sulguanjul-bang No.1 with decoction type, suspension type respectively for8 weeks. After 8-week treatment period, the following parameters were analyzed ; Visual analogue Scale(VAS), Lysholm index score, patients' global assessment. Results: Sulguanjul-bang No.1 treatment led to significant improvement in the pain and symptoms of osteoarthritis as determined by all efficacy measures. After 8 weeks of therapy, there was significant improvement in VAS, Lysholm index and patients' global assessment. But there is no significant difference between two groups. Conclusions: Sulguanjul-bang No.1 was very beneficial pain relief effect and functional improvement irrespect of formulation, decoction type or suspension type.

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A Study on the Changes in Regulations Regarding Approval, Notification and Review of Herbal Medicinal Preparations and Crude Drug Preparations - From 1948 to 2012 - (한약・생약제제 품목허가신고심사 규정 변화에 관한 고찰 - 건국이후부터 2012년까지 -)

  • Eom, Seok-Ki
    • The Journal of Korean Medical History
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    • v.27 no.2
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    • pp.11-37
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    • 2014
  • Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

Red ginseng extract protects against carbon tetrachloride-induced liver fibrosis

  • Ki, Sung Hwan;Yang, Ji Hye;Ku, Sae Kwang;Kim, Sang Chan;Kim, Young Woo;Cho, Il Je
    • Journal of Ginseng Research
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    • v.37 no.1
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    • pp.45-53
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    • 2013
  • Korean red ginseng, the processed root of Panax ginseng Meyer, has been frequently used for various therapeutic purposes in oriental medicine. The present study investigated the possible effect of Korean red ginseng extract (RGE) for the treatment of liver fibrosis in mice injected with carbon tetrachloride ($CCl_4$) for 4 wk. Liver injuries were assessed by blood biochemistry and histopathology in mice treated with $CCl_4$ alone or $CCl_4$+ RGE (30, 100, and 300 mg/kg). Concomitant treatment with RGE and $CCl_4$ (three times/wk for 4 wk) effectively inhibited liver fibrosis as evidenced by decreases in plasma alanine and aspartate aminotransferases, as well as by the percentages of degenerative regions, numbers of degenerative hepatocytes, and collagen accumulation in hepatic parenchyma. Treatment with $CCl_4$ for 4 wk increased mRNA levels of transforming growth factor ${\beta}1$ and plasminogen activator inhibitor 1 in fibrogenic liver, whereas RGE (30, 100, and 300 mg/kg) significantly blocked the induction of fibrogenic genes by $CCl_4$. Similarly, RGE also prevented transforming growth factor ${\beta}1$-mediated induction of fibrogenic genes in human hepatic stellate cell lines. More importantly, RGE markedly reduced the number of ${\alpha}$-smooth muscle actin-positive cells in liver tissue. This study implies that RGE efficaciously protects against the liver fibrosis induced by chronic $CCl_4$ treatment, and may therefore have potential to treat liver disease.

Formulation of Industrial Policy for Nurturing the Bio-medical Sector: A Case Study on the Construction the Bio-medical Complexes of Korea (첨단 의료산업분야 정책형성과정 연구 -첨단의료복합단지 조성정책을 중심으로-)

  • Jeong, Yong-Il;Kim, Sang-Tae
    • Journal of Korea Technology Innovation Society
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    • v.16 no.3
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    • pp.839-860
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    • 2013
  • Drawing on a case of the construction of high-tech medical complexes, this study demonstrates the process of policy formuation. Beause the construction of high-tech medical complexes involves various analytic elements, and changes of political, economic and social environment, Kingdon's Policy Stream Framework is employed for analysis. The analysis ranges from the embarkment of the Presidential Committee on Healthcare Industry Innovation (PCHII) in August, 2005, to the enactment of High-tech Medical Complex Special Act in March, 2008. The analysis illuminates that policy formulation from agenda setting to enactment in the area of biomedical industry involves multiple factors and policy streams. An enactment of policy agenda particularly depends on the roles of multiple stakeholders as welll as policy leaders.

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Effect of Gongjindan-gamibang on the Pharmacokinetics Profiles of Sorafenib in Male SD Rats (2) - Single Oral Combination Treatment of Sorafenib 50mg/kg with Gongjindan-gamibang 100 mg/kg, 3.5hr-intervals with 7-day Repeated Treatment -

  • Lee, Chang Hyeong;Kim, Seung Mo;Kang, Su Jin;Park, Soo Jin;Song, Chang Hyun;Han, Chang Hyun;Lee, Young Joon;Ku, Sae Kwang
    • Journal of Society of Preventive Korean Medicine
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    • v.19 no.1
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    • pp.145-159
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    • 2015
  • Objective : In the previous study, co-administration of Gongjindan-gamibang (GJD) with sorafenib increased oral bioavailability of sorafenib through augment the absorption, therefore, the effects of GJD co-administration on the pharmacokinetics of sorafenib were observed after single and 7-day repeated oral co-administration with 3.5 hr-intervals in the present study. Method : After 50 mg/kg of sorafenib treatment, GJD 100 mg/kg was administered with 3.5 hr-intervals. The plasma were collected at 30 min before administration, 30 min, 1, 2, 3, 4, 6, 8 and 24 hrs after end of first and last 7th sorafenib treatment, and plasma concentrations of sorafenib were analyzed using LC-MS/MS methods. PK parameters of sorafenib ($T_{max}$, $C_{max}$, AUC, $t_{1/2}$ and $MRT_{inf}$) were analysis as compared with sorafenib single administered rats. Results : GJD markedly inhibited the absorption of sorafenib, from 1 hr to 24 hrs after end of first 3.5 hr-interval co-administration, the $C_{max}$ (-43.27%), $AUC_{0-t}$ (-56.29%) and $AUC_{0-inf}$ (-66.70%) of sorafenib in co-administered rats were dramatically decreased as compared with sorafenib single treated rats. However, GJD significantly increased the absorption of sorafenib, from 4 hr to 8 hrs after end of last 7th 3.5 hr-interval co-administration, the $AUC_{0-t}$ (34.08%) and $AUC_{0-inf}$ (37.31%) of sorafenib in co-administered rats were dramatically increased as compared with sorafenib single treated rats. Conclusion : Although GJD decreased the oral bioavailability of sorafenib through inhibition of gastrointestinal absorptions after end of first 3.5 hr-interval co-administration, it is observed that GJD increases the oral bioavailability of sorafenib as facilitated the absorption after end of last 7th repeated co-administration. Hence, the co-administration of GJD and sorafenib should be avoided in the combination therapy of sorafenib with GJD on anticancer therapy.

A study on easy-to-use drug formulation for emergency medical technicians (응급구조사들이 사용하는 약물의 제형 개발에 관한 연구)

  • Kim, Hoon;Kim, Chul-Tae
    • The Korean Journal of Emergency Medical Services
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    • v.24 no.2
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    • pp.89-97
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    • 2020
  • Purpose: In this study we aimed to manufacture and evaluate an oral disintegrating film containing ibuprofen. Methods: Optimal oral ventilation was manufactured using ibuprofen 3g, polyvinyl alcohol #500 4.2g, HPMC K 100M 1.6g, glycerol 4g, TWEEN #20 0.3g, PEG #20 0.3g, citric acid 0.5g, sucralose 0.1g, ethamol 10mL, and distilled water 30mL. Results: Film mass ranged from 110 to 130mg in all prescriptions, showing general uniformity while the water content ranged from 6 to 12%. Measurement of ibuprofen content in all manufactured film solutions averaged 100.12% (98.0-102.0%). The elution test predicted the time taken from the body and the film agent of all prescriptions was released 100% within 5 minutes to confirm the rapid elution. Conclusion: Based on the results of all test, prescription E was proved to be the most suitable.

Physicochemical Analysis according to Temperature Changes of Iopamidol and Ioversol Formulation Contrast Agents (Iopamidol과 Ioversol 제제 조영제의 온도변화에 따른 물리화학적 분석)

  • Han, Beom-Hee
    • Journal of radiological science and technology
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    • v.43 no.4
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    • pp.273-280
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    • 2020
  • In this study, the P contrast agent of Iopamidol, which is a nonionic iodide contrast agent most commonly used as a vascular contrast agent in medical institutions, and the O contrast agent of Ioversol, were studied. The physicochemical changes according to the temperature change were compared and analyzed using the Bruker Avance 500MHz Nuclear Magnetic Resonance Spectrometer owned by the Korea Basic Science Institute (KBSI). There was no physical or chemical change in the O contrast medium of Ioversol formulation in temperature change. However, in the P contrast agent of Iopamidol, a doublet peak began to appear in the 1.1 ppm region of the sample at 60℃, and the doublet peak was clearly observed in the sample at 80℃. As a result of this study, 1H-NMR analysis revealed that the P contrast agent of the Iopamidol formulation was dissociated from chemical bonds as it rose to a high temperature of 60℃ or higher, resulting in the formation of foreign substances. It was evaluated that the O contrast agent of Ioversol formulation had physico-chemical stability than the P contrast agent of Iopamidol formulation. As shown in this study, it is necessary to analyze the physical and chemical changes of contrast agents according to various environmental factors.