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Development of the Dissolution Tests for Nafronyl Oxalate Capsules and Tramadol Hydrochloride Capsules (수산나프로닐 캡슐 및 염산트라마돌 캡슐의 용출시험에 관한 연구)

  • Hwang, Joung-Boon;Moon, Hyun-Ju;Go, Seo-Youn;Jang, Gi-Uk;Lee, Kyu-Ha;Sohn, Kyung-Hee;Kim, In-Kyu;Cho, Dae-Hyun
    • YAKHAK HOEJI
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    • v.55 no.5
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    • pp.411-418
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    • 2011
  • The dissolution test method and an analytical procedure by HPLC were developed and validated for nafronyl oxalate capsules and tramadol hydrochloride capsules. These drugs were not yet characterized by the dissolution specifications in the 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 nafronyl oxalate capsules was carried out under sink conditions as follows: dissolution medium phosphate buffer pH 6.8, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 80% of its label amount was released within 30 min in this method. Also the dissolution test for tramadol hydrochloride capsules was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 15 min in this method. The dissolution samples were analyzed with a validated HPLC analytical procedure. The analytical methodology showed acceptable values in terms of specificity, linearity, precision and accuracy. The dissolution test methods described above were adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of nafronyl oxalate capsules and tramadol hydrochloride capsules. Furthermore, the outcomes of this study were expected to help create an environment where safe and high quality drugs would be distributed on the domestic market making contributions to advancing public health.

A Bayesian Poisson model for analyzing adverse drug reaction in self-controlled case series studies (베이지안 포아송 모형을 적용한 자기-대조 환자군 연구에서의 약물상호작용 위험도 분석)

  • Lee, Eunchae;Hwang, Beom Seuk
    • The Korean Journal of Applied Statistics
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    • v.33 no.2
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    • pp.203-213
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    • 2020
  • The self-controlled case series (SCCS) study measures the relative risk of exposure to exposure period by setting the non-exposure period of the patient as the control period without a separate control group. This method minimizes the bias that occurs when selecting a control group and is often used to measure the risk of adverse events after taking a drug. This study used SCCS to examine the increased risk of side effects when two or more drugs are used in combination. A conditional Poisson model is assumed and analyzed for drug interaction between the narcotic analgesic, tramadol and multi-frequency combination drugs. Bayesian inference is used to solve the overfitting problem of MLE and the normal or Laplace prior distributions are used to measure the sensitivity of the prior distribution.

Effect of Infra-red laser irradiation on pain relive in rats (적외선 레이저 자극이 흰쥐의 진통 작용에 미치는 영향)

  • Lee In-Hak
    • The Journal of Korean Physical Therapy
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    • v.9 no.1
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    • pp.89-96
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    • 1997
  • The purpose of this study was to determine the effect of Ga-Al-As (Gallium-Aluminum-Arsenid) laser radiation on the tail-flick latency in rat. Thirty Sprague-Dawley male and female rats Were divided into five groups : that is control, laser 15sec radiation, laser 30sec radiation, laser 60sec radiation, and Tramadol Hcl injection groups. The continuous Ga-Al-As laser with, wave length 780-830nm and diameter of probe in the 3mm, averse output of 100mw radiation was applied to the meridian point(Gv 1 : Governing vessel) of the rats. Tail-flick latency were measured with hot plate at $55^{\circ}C$ : before treatment and immediately, 30 minutes, 1 hour, 2 hours, 24 hours, 24 hours and 48 hours after treatment. The result were as follows ; 1. The tail-flick latency according to time varition, control group was not significance. 2. The tail-flick latency according to time varition, laser 15 sec irradiate rats in post-treared was significance(P<0.05). 3. The tail-flick latency according to time varition, laser 30 sec irradiate rats group was not significance. 4. The tail-flick latency according to time varition, laser 60 sec irradiate rats in post 30 minute was significance(P<0.05). 5. The tail-flick latency according to time varition, Tramadol Hcl injection rats in post-treated (P<0.05), post 30 minute(P<0.05), post 60 minute (P<0.01) and 2 hour(P<0.05) was significance. This study suggest that Ga-Al-As (Gallium-Aluminum-Arsenid) laser applied to meridian point of the rat with 15 sec, 30 sec, and 60 set radiation could induc no analgesic effect, but Tramadol Hcl injection rat is good analgesic effect.

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Comparison of 4 mg dexamethasone versus 8 mg dexamethasone as an adjuvant to levobupivacaine in fascia iliaca block-a prospective study

  • Acharya, Ranjita;Sriramka, Bhavna;Panigrahi, Sandeep
    • The Korean Journal of Pain
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    • v.31 no.4
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    • pp.261-267
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    • 2018
  • Background: To compare the effects of adding two different doses of dexamethasone on the duration and quality of the fascia iliaca block in patients undergoing proximal femoral fracture surgery. Methods: A total of 60 patients (age 18-70 years) undergoing proximal femoral nailing surgery under spinal anesthesia were given fascia iliaca block after random assignment to one of the two groups: Group H received an injection of levobupivacaine (0.5%) 28 ml with 2 ml (8 mg) dexamethasone, and Group L received an injection of levobupivacaine (0.5%) 28 ml with dexamethasone 1 ml (4 mg) with 1 ml normal saline. Assessment of the duration of analgesia and the total tramadol requirement over 48 hours were noted after a successful block. Results: The duration of analgesia was found to be significantly longer in Group H ($17.02{\pm}0.45h$) than in the Group L patients ($14.29{\pm}0.45h$) with a p-value of 0.000. Postoperative analgesic requirement (amount of tramadol in mg) was significantly higher in Group L (Q2: 200.0; IQR: 100.0, 200.0) as compared to Group H (Q2: 100.0; IQR: 100.0, 200.0) with a p-value of 0.034. No patient showed any sign of neurotoxicity. Conclusions: Dexamethasone, in a dose of 8 mg, is superior to 4 mg when used as an adjuvant with levobupivacaine in the FIB. Though both prolonged analgesia and were effective in reducing oral/intravenous analgesics, 8 mg dexamethasone can be recommended as a more efficacious adjuvant to local anesthetics in the FIB.

Effect of Surgical-Site, Multimodal Drug Injection on Pain and Stress Biomarkers in Patients Undergoing Plate Fixation for Clavicular Fractures

  • Yoo, Jae-Sung;Heo, Kang;Kwon, Soon-Min;Lee, Dong-Ho;Seo, Joong-Bae
    • Clinics in Orthopedic Surgery
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    • v.10 no.4
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    • pp.455-461
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    • 2018
  • Background: Surgical-site, multimodal drug injection has recently evolved to be a safe and useful method for multimodal pain management even in patients with musculoskeletal trauma. Methods: Fifty consecutive patients who underwent plating for mid-shaft and distal clavicular fractures were included in the study. To evaluate whether surgical-site injections (SIs) have pain management benefits, the patients were divided into two groups (SI and no-SI groups). The injection was administered between the deep and superficial tissues prior to wound closure. The mixture of anesthetics consisted of epinephrine hydrochloride (HCL), morphine sulfate, ropivacaine HCL, and normal saline. The visual analogue scale (VAS) pain scores were measured at 6-hour intervals until postoperative hour (POH) 72; stress biomarkers (dehydroepiandrosterone sulfate [DHEA-S], insulin, and fibrinogen) were measured preoperatively and at POH 24, 48, and 72. In patients who wanted further pain control or had a VAS pain score of 7 points until POH 72, 75 mg of intravenous tramadol was administered, and the intravenous tramadol requirements were also recorded. Other medications were not used for pain management. Results: The SI group showed significantly lower VAS pain scores until POH 24, except for POH 18. Tramadol requirement was significantly lower in the SI group until POH 24, except for POH 12 and 18. The mean DHEA-S level significantly decreased in the no-SI group ($74.2{\pm}47.0{\mu}g/dL$) at POH 72 compared to that in the SI group ($110.1{\pm}87.1{\mu}g/dL$; p = 0.046). There was no significant difference in the insulin and fibrinogen levels between the groups. The correlation values between all the biomarkers and VAS pain scores were not significantly different between the two groups (p > 0.05). Conclusions: After internal fixation of the clavicular fracture, the surgical-site, multimodal drug injection effectively relieved pain on the day of the surgery without any complications. Therefore, we believe that SI is a safe and effective method for pain management after internal fixation of a clavicular fracture.

Comparison of ultrasonography guided serratus anterior plane block and thoracic paravertebral block in video-assisted thoracoscopic surgery: a prospective randomized double-blind study

  • Baytar, Merve Sena;Yilmaz, Canan;Karasu, Derya;Baytar, Cagdas
    • The Korean Journal of Pain
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    • v.34 no.2
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    • pp.234-240
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    • 2021
  • Background: Various truncal block techniques with ultrasonography (USG) are becoming widespread to reduce postoperative pain and opioid requirements in video-assisted thoracoscopic surgery (VATS). The primary aim of our study was to determine whether the USG-guided serratus anterior plane block (SAPB) is as effective as the thoracic paravertebral block (TPVB) in VATS. Our secondary aim was to evaluate patient and surgeon satisfaction, block application time, first analgesic time, and length of hospital stay. Methods: Patients in Group SAPB received 0.4 mL/kg bupivacaine with a USG-guided SAPB, and patients in Group TPVB received 0.4 mL/kg bupivacaine with a USG-guided TPVB. We recorded the pain scores, the timing of the first analgesic requirement, the amount of tramadol consumption, and postoperative complications for 24 hours. We also recorded the block application time and length of hospital stay. Results: A total of 62 patients, with 31 in each group (Group SAPB and Group TPVB) completed the study. Between the two groups, there were no significant differences in rest and dynamic pain visual analog scale scores at 0, 1, 6, 12, and 24 hours after surgery. The total consumption of tramadol was significantly lower in the TPVB group (P = 0.026). The block application time was significantly shorter in Group SAPB (P < 0.001). Conclusions: An SAPB that is applied safely and rapidly as a part of multimodal analgesia in patients who undergo VATS is not inferior to the TPVB and can be an alternative to it.

Comparison of the Effects of an Adductor Canal Block and Periarticular Multimodal Drug Local Injection on Pain after a Medial Opening High Tibial Osteotomy (내측 개방 근위 경골 절골술 후 통증 조절에서 관절 주위 다중 약물 국소 주사와 내전근관 차단술의 효과 비교)

  • Kim, Ok-Gul;Kim, Do-Hun;Seo, Seung-Suk;Lee, In-Seung
    • Journal of the Korean Orthopaedic Association
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    • v.54 no.2
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    • pp.120-126
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    • 2019
  • Purpose: The efficacy of periarticular multimodal drug injection and adductor canal block after a medial opening-wedge high tibial osteotomy was compared in terms of the postoperative pain level. Materials and Methods: From November 2016 to March 2017, 60 patients underwent a medial opening-wedge high tibial osteotomy under spinal anesthesia. Preemptive analgesic medication, intravenous patient controlled anesthesia were used for pain control in all patients. Thirty patients received a periarticular multimodal drug injection (group I), and 30 patients received an adductor canal block (group II). These two groups were compared regarding the postoperative pain level, frequency of additional tramadol injections, total amount of patient-controlled analgesia, and number of times that the patients pushed the patient-controlled analgesia button at each time interval. Results: The visual analogue scale scores over the two-week postoperative period showed no statistical significance. The frequency of additional tramadol hydrochloride injections was similar in the two groups over time. The mean number of times that patients pushed the patient-controlled analgesia button was similar in two groups over time. The total amount of patient-controlled analgesia was similar in the two groups over time. Conclusion: This study shows that intraoperative periarticular multimodal drug injections and adductor canal block may have a similar effect on postoperative pain control in patients who have undergone a medial opening-wedge high tibial osteotomy for unicompartmental osteoarthritis of the knee.