• 제목/요약/키워드: Soft capsule

검색결과 65건 처리시간 0.024초

유한세프라딘 캅셀(세프라딘 500 mg)에 대한 브로드세프 캅셀의 생물학적 동등성 (Bioequivalence of Broadcef Capsule to Cefradine Yuhan Capsule (Cephradine 500 mg))

  • 조혜영;이석;강현아;오인준;임동구;문재동;이용복
    • Journal of Pharmaceutical Investigation
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    • 제32권3호
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    • pp.215-221
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    • 2002
  • Cephradine is a first generation cephalosporin and has broad spectrum antibacterial activity against gram-positive and gram-negative microorganisms, through inhibition of bacterial cell wall synthesis. Cephradine is useful for treatment of infections of the urinary and respiratory tract, skin and soft tissues. The purpose of the present study was to evaluate the bioequivalence of two cephradine capsules, Cefradine Yuhan (YuHan Corporation) and Broadcef (Ilsung Pharmaceuticals Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cephradine release from the two cephradine capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, $23.10{\pm}2.90$ years in age and $67.69{\pm}8.04\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cephradine was orally administered, blood was taken at predetermined time intervals and the concentrations of cephradine in serum were determined using HPLC method with UV detector. The dissolution profiles of two cephradine capsules were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AVC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AVC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AVC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Cefradine Yuhan were -2.87%, -0.96% and -4.85%, respectively. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of 1og(0.8) to log(1.25) $(e.g.,\;log(0.93){\sim}log(1.02)\;and\;log(0.88){\sim}log(1.13)\;for \;AVC_t\;and\;C_{max},\;respectively)$. The 90% confidence interval using untransformed data was within ${\pm}20%$ $(e.g., \;-17.54{\sim}7.78\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Broadcef capsule is bioequivalent to Cefradine Yuhan capsule.

자가유화 약물전달시스템을 이용한 이부프로펜의 용출개선 및 흰쥐에서의 생체이용률 평가 (Improved Dissolution Characteristics of Ibuprofen Employing Self-Microemulsifying Drug Delivery System and Their Bioavailability in Rats)

  • 김형수;이상길;최성업;박혜숙;전현주;최영욱
    • Journal of Pharmaceutical Investigation
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    • 제32권1호
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    • pp.27-33
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    • 2002
  • A self-microemulsifying drug delivery system(SMEDDS) composed of Cremophor $EL^{\circledR},\;Labrasol^{circledR}$, and Lauroglycol $FCC^{circledR}$ was prepared for the enhancement of solubility, dissolution rate and bioavailability of ibuprofen(IBP), which is water-insoluble but soluble in oils and surfactants. Phase diagram with various regions including microemulsion area was depicted. The SMEDDS was encapsulated in soft gelatin capsules and their dissolution characteristics in various media were observed in comparison to the generic products commercially available in the market. Soft capsules of SMEDDS formulation showed better dissolution profiles, especially in acidic condition, than the others. For the period of 1 hr dissolution in pH 1.2 medium, it reached over 70% dissolution from soft capsules, compared to less than 40% dissolution from commercial reference tablets. On the other hand, in vivo pharmacokinetic parameters were obtained after oral administrations of different IBP preparations to Sprague Dawley rats. SMEDDS formulation showed higher $C_{max}$ and greater $AUC_{0-5hr}$ than the suspension of reference tablet or IBP powder. Therefore, it is possible to conclude that a newly developed soft capsules employing SMEDDS provides an alternative preparation to improve oral bioavailability of IBP.

심부 급경사 연약층의 채굴 진행에 따른 주변 암반 거동의 탄소성 해석 및 현장계측 (Elasto-plastic Analysis and In-situ Measurement on Rock Behaviors with Stepwise Excavation of the Steep Soft Seam at a Great Depth)

  • 정소걸;신중호
    • 터널과지하공간
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    • 제14권4호
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    • pp.295-303
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    • 2004
  • 연약층과 견고한 암반층이 습곡형태로 혼재된 지질조건의 지하 심부 채굴 현장을 대상으로, 심부 급경사 연약층의 단계적 굴착 진행에 따른 갱도 및 주변 암반의 거동 양상을 전산해석과 현장계측을 통하여 비교 분석하였다. 전산해석에서는 Hoek & Brown의 경험적 파괴기준 및 변형률연화모델을 적용한 탄소성 해석 기법을 이용하였다. 현장계측에서는 유압캡슐, 지중변위계, 내공변위계를 갱도 및 주변 암반에 설치하여 응력과 변위를 계측하였다. 경험적 파괴조건 및 변형률연화모델을 이용한 탄소성 해석은, 현장 지질조건 및 채굴과정의 복잡함에도 불구하고 현장계측결과와 유사한 양상을 보여주어 타당성을 검증할 수 있었다. 이러한 전산해석 및 현장계측의 비교를 통해 지하 굴착 갱도의 변형 거동 과정을 예측하고 이후의 굴착 및 지보보강 설계의 지침을 제공할 수 있을 것이다.

무지 외반증의 수술적 방법에 대한 임상적 고찰 (A Clinical Study of the Operative Treatment in Hallux Valgus)

  • 박인헌;이기병;송경원;이진영;김익지
    • 대한족부족관절학회지
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    • 제1권1호
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    • pp.65-73
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    • 1997
  • Hallux valgus deformity has been slowly getting popular in Korea. Many surgical procedures are available for treating the hallux valgus, but it is still controversial for the best treatment. We operated 25 feet(15 patients) of hallux valgus between May. 88 and December. 94. The clinical results were as follow ; 1. Age distribution was 25 to 82, and all female. 10 patients have bilateral hallux valgus. 2. 19 feet were treated by soft tissue procedures only and 6 feet by combined soft tissue and bony procedures. 3. Bunion deformity was recurred in 2 feet (1 Patient) which were treated with modified McBride Method. 4. Lateral sesamoidectomies were performed in 7 feet without development of hallux varus. 5. The cosmetic and functional results were good in 6 cases treated by proximal metatarsal osteotomy. 6. 9 feet had other digits deformities, which need surgical correction. 7. Tightening repair of medial capsule seems to be important for prevention of recurrence of bunion.

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약화된 내측 관절낭을 가진 중증 무지 외반증에 대해 Internal Brace를 이용한 보강술의 수술적 치료 결과 (Surgical Outcomes of the Reinforcing Technique of a Weakened Medial Capsule in Severe Hallux Valgus Using Internal Brace)

  • 이정길;강찬;황득수;이기수;황정모;서강원;김동환
    • 대한족부족관절학회지
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    • 제23권4호
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    • pp.166-172
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    • 2019
  • Purpose: This study evaluated the clinical and radiological results after reinforcement of the weakened medial joint capsule using Internal Brace (Arthrex) for treating severe hallux valgus. Materials and Methods: This study reviewed 56 cases of 50 patients that were followed-up postoperatively for at least 12 months, from September 2017 until August 2018. An extended distal chevron osteotomy combined with a distal soft-tissue release was performed by a single surgeon to treat severe hallux valgus. Internal Brace was applied in 12 cases (group A) who had weakened medial joint capsules, and capsulorrhaphy was performed in 44 cases (group B), and these two groups were compared postoperatively for the clinical and radiological results. The postoperative complications were also investigated. Results: No significant differences at 1-year follow-up on the Manchester-Oxford Foot Questionnaire and the patients' satisfaction scores were found between the two groups (p=0.905 and p=0.668, respectively). For the radiology, the changes of the values between before surgery and at 1-year follow-up according to the group showed no significant differences in the hallux valgus angle, intermetatarsal angle, and the hallux interphalangeal angle (p=0.986, p=0.516, p=0.754, respectively). Recurrence of hallux valgus was reported in two cases in group A, and in three cases in group B. Transfer metatarsalgia occurred in 4 cases in group B. Conclusion: Based on these results, we recommend the capsule reinforcing technique using Internal Brace as a successful operative option for treating a weakened medial capsule in patients with severe hallux valgus.

Effect of bFGF and fibroblasts combined with hyaluronic acid-based hydrogels on soft tissue augmentation: an experimental study in rats

  • Lee, Su Yeon;Park, Yongdoo;Hwang, Soon Jung
    • Maxillofacial Plastic and Reconstructive Surgery
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    • 제41권
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    • pp.47.1-47.10
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    • 2019
  • Background: Hyaluronic acid (HA) has been applied as a primary biomaterial for temporary soft tissue augmentation and as a carrier for cells and the delivery of growth factors to promote tissue regeneration. Although HA derivatives are the most versatile soft tissue fillers on the market, they are resorbed early, within 3 to 12 months. To overcome their short duration, they can be combined with cells or growth factors. The purpose of this study was to investigate the stimulating effects of human fibroblasts and basic fibroblast growth factors (bFGF) on collagen synthesis during soft tissue augmentation by HA hydrogels and to compare these with the effects of a commercial HA derivative (Restylane®). Methods: The hydrogel group included four conditions. The first condition consisted of hydrogel (H) alone as a negative control, and the other three conditions were bFGF-containing hydrogel (HB), human fibroblast-containing hydrogel (HF), and human fibroblast/bFGF-containing hydrogel (HBF). In the Restylane® group (HGF), the hydrogel was replaced with Restylane® (R, RB, RF, RBF). The gels were implanted subdermally into the back of each nude mouse at four separate sites. Twelve nude mice were used for the hydrogel (n = 6) and Restylane® groups (n = 6). The specimens were harvested 8 weeks after implantation and assessed histomorphometrically, and collagen synthesis was evaluated by RT-PCR. Results: The hydrogel group showed good biocompatibility with the surrounding tissues and stimulated the formation of a fibrous matrix. HBF and HF showed significantly higher soft tissue synthesis compared to H (p < 0.05), and human collagen type I was well expressed in HB, HF, and HBF; HBF showed the strongest expression. The Restylane® filler was surrounded by a fibrous capsule without any soft tissue infiltration from the neighboring tissue, and collagen synthesis within the Restylane® filler could not be observed, even though no inflammatory reactions were observed. Conclusion: This study revealed that HA-based hydrogel alone or hydrogel combined with fibroblasts and/or bFGF can be effectively used for soft tissue augmentation.

주관절의 이학적 검사 (Physical Examination of the Elbow)

  • 김풍택;경희수;전인호
    • 대한견주관절학회:학술대회논문집
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    • 대한견주관절학회 2003년도 연수강좌
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    • pp.51-56
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    • 2003
  • The trained examiner can gain considerable information from visual inspections of the elbow joint, Because much of the joint is subcutaneous, any appreciable alteration in the skeletal anatomy often is detectable. Gross soft tissue swelling or muscle atrophy is also early observed. Inspection and palpation of the medial and lateral epicondyles and the tip of the otecranon from an equilateral triangle with the elbow is flexed. Normally, the arc of flexion extension, although variable, ranges from about O to 140 degrees plus or minus 10 degrees. The posterolateral rotatory instability(PLRI) of the elbow is most common pattern of elbow instability. The lateral collateral ligament complex also includes a narrow but stout band of ligamentous tissue blending with the distal and proterior fibers of the capsule to insert distally on the crista supinatoris of the ulna. This is the lateral ulnar collateral ligament(LUCL). A clinical elbow pivot shift test confirms the PLRI. There are also two active apprehension signs.

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견관절 전방 불안정에 대한 관절경적 최신 치료 경향 (Current Concepts in Arthroscopic Treatment of Anterior Shoulder Instability)

  • 서재성
    • Journal of Yeungnam Medical Science
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    • 제20권1호
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    • pp.13-27
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    • 2003
  • In the past, the report of shoulder instability undergoing open shoulder stabilization had satisfactory outcomes of greater than 90%. However, the functional loss of open procedure is severe in abduction and external rotation especially. Current arthroscopic techniques for shoulder instability result in success rate equal to open surgical procedure when the labrum is properly fixed to the glenoid rim using suture anchors, the capsule is tightened, and associated bony and soft tissue pathology is addressed. The arthroscopic surgery facilitates the view within shoulder joint for more accurate diagnosis, reduces operating time, minimises postoperative pain, reduces operative morbidity, improves shoulder function, and provides the possibility to perform other procedure simultaneously. However, to accomplish a successful arthroscopic stabilization procedure and to prevent complications, numerous advanced arthroscopic skill must be mastered. Although the arthroscope provides means to visualize new lesions, the pathomechanism and biomechanical explanation is not clear yet. Further studies are necessary to develop for shoulder reconstruction.

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늑간신경에 발생한 신경초종 1예 (A Case of Neurilemmoma of Intercostal Nerve)

  • 이두연;계기식;송계용
    • Journal of Chest Surgery
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    • 제11권3호
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    • pp.239-245
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    • 1978
  • Recently, we experienced a case of rare neurilemmoma originated from intercostal nerve [9th] in the right chest wall in a 25 year old male officer. The tumor was incidentally found in the routine chest X ray, where the round well circumscribed mass tumor the ninth rib with notching and sclerotic margin, suggesting slowly growing benign benign of chest wall was revealed and the tumor mass was easily extirpated in the exploratory thoracotomy, with uneventful recovery. Grossly, the tumor was firm, partly soft and well circumscribed, measuring 4.5X3.0X 3.0 cm with yellowish smooth outer surface, attached with intercostal nerve trunk. Cut surface exhibits partly grayish white and largely hemorrhagic areas. Microscopically, the characteristic palisading arrangement of schwann cells and Verocay bodies are seen but dominant features are cystic degeneration and hemorrhage with organization and fibrosis. The sheath of intercostal nerve and capsule of neurilemmoma were con joined. There is no evidence of malignancy. The tumor was confirmed as neurilemmoma of intercostal nerve, Antony type B.

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Chronic dislocation of temporomandibular joint persisting for 6 months: a case report

  • Kim, Chul-Hwan;Kim, Dae-Hyun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제38권5호
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    • pp.305-309
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    • 2012
  • Temporomandibular joint (TMJ) subluxation and dislocation are uncommon but very unpleasant and distressing conditions to patients. Subluxation of the TMJ is an excessively abnormal condylar excursion secondary to flaccidity and laxity of the capsule. When the condyle head excurses anterior to the eminence upon wide opening, it can return to the fossa by self-manipulation or non-surgical conservative reduction. Surgery is recommended if a complete dislocation, so-called open lock, occurs as a chronic or recurrent protracted condition that cannot be reduced voluntarily. A range of surgical procedures can be performed to limit condylar hypermobility inclusing soft tissue tethering, creation of articular obstacles, removal of mechanical blockade and augmentation of articular eminence using different kinds of grafts. In the present case, a 74-year-old woman was diagnosed with a chronic TMJ dislocation that had lasted for 6 months. Bilateral condylectomy was performed and the post-operative results were good without functional limitations or recurrence.