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      • KCI등재SCOPUS
      • KCI등재

        도네페질 유리염기가 균질하게 함유된 신규 구강붕해필름의 제제 설계 및 평가

        길명철 한국산학기술학회 2023 한국산학기술학회논문지 Vol.24 No.11

        본 연구의 목적은 알츠하이머 병 치료제로 사용되고 있는 도네페질 유리염기가 균질하게 함유된 새로운 구강붕해필름(Orodispersible Film, ODF)을 제제 설계 및 평가하는 것이다. 도네페질 유리염기는 심한 난용성으로 인해 ODF 제조액의 층분리, 비균질화 등의 문제를 일으킨다. 이에 본 연구진의 상기 문제를 해결하기 위하여 점증제, 비이온성 계면활성제 및 비닐폴리머계 첨가제를 활용하여 난용성 약물인 도네페질의 분산 안정화도를 해결하고자 하였다. 그 결과, 비닐폴리머계 분산 안정화제 중 Polyvinyl alcohol(PVA)을 0.24% 첨가시 도네페질 ODF 내에서 도네페질 유리염기가 균질화 됨을 확인하였다. 시험약과 대조약(아리셉트 정®)을 정제수, pH 1.2, 4.0 및 6.8에서 비교용출시험 진행 결과 유사성인자(ƒ2)는 각각 65.2, 59.4, 52.4 및 61.8로서 제제학적으로 동등하였다. 개발된 시험약은 12개월 동안 장기조건에서 성상 변화 없이 99% 이상의 함량을 유지하면서 용출률의 큰 변화가 없이 안정하였다. 또한 시험약인 최종 개발된 도네페질 유리염기가 함유된 ODF 10 mg과 대조약(아리셉트 정®10 mg)의 생물학적 동등성 시험 결과 기준 항목(AUCt 및 Cmax)에서 모두 동등한 것으로 확인되어져 생물학적으로 동등함을 확인하였다. 본 연구 결과를 바탕으로 난용성인 약물에 비닐폴리머계 첨가제를 첨가하여 균질화된 ODF를 제조 할 수 있음을 확인하였으며 난용성 약물 제제 연구에 유용하게 활용될 수 있을 것으로 기대 되어진다.

      • KCI등재

        흡습성이 개선된 수산나프로닐 함유 속방성 정제의 개발 및 평가

        길명철,이계원 한국산학기술학회 2023 한국산학기술학회논문지 Vol.24 No.11

        Manufacturing immediate-release tablets (IR-T) containing highly hygroscopic active pharmaceutical ingredients (API) is associated with delayed disintegration and poor tableting and stability. This study developed an IR-T that can overcome the barrier in manufacturing by evaluating the physical properties (moisture absorption, hydration capacity, and bulk density) of excipients and disintegrants. Nafronyl oxalate (NF) was selected as the API. A formulation with the best fluidity, tableting properties, and disintegration was established using crospovidone and croscarmellose Na at 26 and 10%. In the test drug and reference (Dusoril Capsule®) drugs, more than 80% dissolved within 30 minutes in each medium, with equivalent similarity factors. The developed IR-T was stable under accelerated conditions for six months, maintaining a more than 97% content. In addition, there was no change in color or dissolution rate. This study confirmed the possibility of developing a new formulation in which NF, which is highly hygroscopic, is unaffected by the hygroscopicity of the excipients and disintegrants and ensures equivalence without tableting problems. In addition, when developing hygroscopic drugs, moisture absorption, hydration capacity, and the bulk density of the excipients and disintegrants are expected to be helpful as a standard for predicting and evaluating the disintegration or variables in tableting.

      • KCI등재

        실험 토끼의 일측 VX2 신종양 모델에서 고주파파괴술의 평가

        길명철,하정민,윤성국,정재일,정세일,윤진한 대한비뇨의학회 2008 Investigative and Clinical Urology Vol.49 No.3

        Purpose: The aim of this study was to evaluate the effectiveness and indication of radiofrequency ablation(RFA) using renal VX2 tumors by implantation of VX2 tumor cells under the renal capsule in rabbits. Materials and Methods: Ten rabbits were injected with 30-40μl VX2 tumor cells(1.2x107 viable cells/ml) under the renal capsule of the right kidney by right subcostal incision. On the 14th day after the tumor cells were implanted, we checked for the development of renal tumors, and the sizes and shapes(exophytic or central) of the tumors by the use of computed tomography. We performed RFA in the renal VX2 tumors with a 17G StarBurst electrode through kidney exposure. After the first and third day following RFA, renal function was checked. On the third day, we performed CT and harvested the kidneys for gross and microscopic evaluation. Results: We confirmed the development of renal VX2 tumors in nine cases. Tumor shapes were exophytic in seven cases and central in two cases; the mean size of the tumors was 2.1cm(range, 1.1-3.8cm). In all tumors, RFA was performed. From the use of enhanced CT after RFA on the third day, all of the lesions treated with RFA showed no enhancement. From the pathological findings, coagulative necroses were seen on all of the lesions treated with RFA. The necrotized tumor size after RFA was not different statistically as measured by CT and a pathological examination (p=0.833). Conclusions: In centrally located renal tumors, we experienced thermal injury in pelvocalyceal systems. RFA is an effective method for nephron sparing surgery as the tumor cells completely disappear and there is preserved renal function and the procedure is easy to apply. We suggest that the RFA method for exophytic renal tumors is more effective than other procedures. (Korean J Urol 2008;49:208-214) Purpose: The aim of this study was to evaluate the effectiveness and indication of radiofrequency ablation(RFA) using renal VX2 tumors by implantation of VX2 tumor cells under the renal capsule in rabbits. Materials and Methods: Ten rabbits were injected with 30-40μl VX2 tumor cells(1.2x107 viable cells/ml) under the renal capsule of the right kidney by right subcostal incision. On the 14th day after the tumor cells were implanted, we checked for the development of renal tumors, and the sizes and shapes(exophytic or central) of the tumors by the use of computed tomography. We performed RFA in the renal VX2 tumors with a 17G StarBurst electrode through kidney exposure. After the first and third day following RFA, renal function was checked. On the third day, we performed CT and harvested the kidneys for gross and microscopic evaluation. Results: We confirmed the development of renal VX2 tumors in nine cases. Tumor shapes were exophytic in seven cases and central in two cases; the mean size of the tumors was 2.1cm(range, 1.1-3.8cm). In all tumors, RFA was performed. From the use of enhanced CT after RFA on the third day, all of the lesions treated with RFA showed no enhancement. From the pathological findings, coagulative necroses were seen on all of the lesions treated with RFA. The necrotized tumor size after RFA was not different statistically as measured by CT and a pathological examination (p=0.833). Conclusions: In centrally located renal tumors, we experienced thermal injury in pelvocalyceal systems. RFA is an effective method for nephron sparing surgery as the tumor cells completely disappear and there is preserved renal function and the procedure is easy to apply. We suggest that the RFA method for exophytic renal tumors is more effective than other procedures. (Korean J Urol 2008;49:208-214)

      • KCI등재

        하복부 지방과 유경피판으로 외음부 동맥을 이용한 음경확대술의 경험

        길명철,김두홍,정세일,황경원,정재일 대한남성과학회 2010 The World Journal of Men's Health Vol.28 No.3

        Purpose: Many men are to some degree unsatisfied with the size of their penis, whether it is normal in size and appearance or not. We report a novel surgical technique for penile augmentation using a superficial external pudendal artery pedicle. Materials and Methods: In total, 8 patients underwent penile augmentation from March 2003 to February 2004. Their mean age was 37.3 years. Five patients were unsatisfied about the size of their penis, and three patients had complications after insertion of foreign material. This penile augmentation technique was developed by using a low abdominal fat-flap where blood is supplied from the external pudendal artery. Spinal or epidural anesthesia was done during the operation, and the fat-flap was elevated and transpositioned to the site of lesion. Results: All cases of patients were performed successfully by autografting using adipose tissue where blood flow was supplied from the external pudendal artery. There were no complications except one case of hematoma after the operation. The mean operative time was 80 min. The mean follow-up period after operation was about 6 months and all patients had a normal sexual life and no voiding dysfunctions. Conclusions: This novel surgical technique has several advantages. First, reconstruction without skin necrosis was possible even though the defect was large, because the blood supply was favorable. Second, there was no size limitation in augmentation with dermoplasty. Third, there was no evidence of atrophy of the flap.

      • KCI등재후보

        정계정맥류 환자에서 수술 후 정액지표의 변화: 복강경술식과 서혜부 접근 미세수술의 비교

        길명철,신찬욱,조재욱,김수동,강도영,정재일,정세일 대한남성과학회 2008 The World Journal of Men's Health Vol.26 No.3

        Purpose: The purpose of this study was to compare the surgical outcomes of two different surgical methods for varicocelectomy, and to assess the effects of varicocelectomy on semen parameters in subinfertile men. Materials and Methods: This study included 63 patients with clinically palpable varicocele and abnormal semen parameters who underwent varicocelectomy. Thirty-three patients underwent laparoscopic varicocelectomy, and 30 received microsurgical inguinal varicocelectomy. Semen analyses were performed 5.3 months later, and compared with the pre-operative data. Results: The mean age of patients was 32.1±1.3 years old. Comparison of the semen parameters between pre and post-varicocelectomy revealed significant improvement in the sperm count (p<0.05). In laparoscopic and microsurgical inguinal varicocelectomy, the sperm counts were increased from 16.2±4.3 to 30.6±7.5 and from 15.4±3.8 to 37.5±7.7, respectively. Sperm motility also tended to improve. Conclusions: Varicocelectomy enhanced semen parameters after both laparoscopic and microsurgical methods. In subfertile men, early varicocelectomy is recommended.

      • KCI등재
      • KCI등재
      • KCI등재

        Progression of Prostate Cancer Despite an Extremely Low Serum Level of Prostate-Specific Antigen

        이동,박정현,김재한,이승준,조문기,길명철,송강현,박종욱 대한비뇨의학회 2010 Investigative and Clinical Urology Vol.51 No.5

        A 61-year-old man who had been diagnosed with prostate cancer 9 years ago and had been treated with pelvic irradiation and intermittent androgen deprivation therapy visited the emergency room because of back pain and weakness in both legs. Spine magnetic resonance imaging showed a lumbar epidural mass and spine metastasis. The whole-body workup revealed multiple metastases to the lymph nodes, bone, liver, and lung. The serum prostate-specific antigen was 0.02 ng/ml. He underwent laminectomy, posterior fixation, and epidural mass excision, and metastatic adenocarcinoma from the prostate was diagnosed. The patient underwent 1 cycle of docetaxel-based chemotherapy. More chemotherapy could not be done because of his general weakness. The patient died one month later of multiple organ failure.

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