• 분석과학
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• 제31권3호
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• pp.107-111
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• 2018

Currently, ultraviolet-visible spectrophotometry and titration methods are used for assay tests of tramadol hydrochloride injection and raw material in the Korean Pharmacopoeia XI (KP XI). Titration has also been used in the British Pharmacopoeia (BP 2013) for the assay test of tramadol hydrochloride, and the HPLC assay for tramadol hydrochloride raw material has been used in the United States Pharmacopeia (USP 39). In this study, we developed an alternative HPLC assay method for tramadol hydrochloride injection that is up to date and specific, and employs the same method as tramadol hydrochloride capsules. Validation of the HPLC method was conducted to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of the calibration curves in the desired concentration range was good ($r^2$ > 0.9999). RSDs of intra-day precision obtained were 0.05-0.08 % and inter-day precision obtained were 0.08-0.19 %. Accuracy was obtained with recoveries in the range of 98.16 % and 100.90 %. As a result of the system's suitability, the RSD of both retention time and the peak area obtained were 0.07 %. The values of the plate number and tailing factor of tramadol hydrochloride obtained were 7076 and 1.16, respectively. Because of the intermediate precision and robustness of the developed assay, it is expected to become a valuable tool for revising the Korean Pharmacopoeia (KP XI).

• 대한정형외과학회지
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• 제54권2호
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• pp.120-126
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• 2019

목적: 내측 개방 근위 경골 절골술 후 통증 조절에서 관절 주위 다중 약물 국소 주사와 내전근관 차단술의 효과를 비교하고자 하였다. 대상 및 방법: 2016년 11월부터 2017년 3월까지 개방형 내측 근위 경골 절골술을 시행한 환자 60명을 대상으로 하여 후향적으로 분석하였다. 전 예에서 척추 마취를 시행하였으며, 수술 직전 선제 약물 투여 후 정맥내 자가 통증 조절 장치를 시행하였다. 30명의 환자(I군)는 관절 주위 다중 약물 국소 주사를 맞았고, 다른 30명의 환자(II군)는 내전근관 차단술을 시행 받았다. 두 그룹에 대해 수술 후 통증 수준, 추가적인 tramadol hydrochloride 주사의 빈도, 자가 통증 조절 장치 사용 총량 및 버튼을 누른 횟수 등을 비교하였다. 결과: 수술 후 2주째까지 시각통증점수(visual analogue scale)는 두 군 간에 유의한 차이를 보이지 않았다. 추가 tramadol hydrochloride 주사의 빈도는 두 군 간에 유의한 차이가 없었다. 자가 통증 조절 장치 버튼을 누르는 횟수와 평균 총 fentanyl 소비량에서도 그룹 간에 유의한 차이가 없었다. 결론: 내측 개방적 근위 경골 절골술을 시행한 환자의 급성기 통증 조절에 있어서 관절 주위 다중 약물 주입 및 내전근관 신경 차단술은 비슷한 효과를 가지는 것으로 생각된다.

• Clinics in Orthopedic Surgery
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• 제10권4호
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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.