• 제목/요약/키워드: excipient

검색결과 45건 처리시간 0.027초

Sweet BV의 rat를 이용한 단회 근육시술 독성시험 (Study of single dose test of Sweet Bee Venom in rats)

  • 김영진;임청산;권기록
    • 대한약침학회지
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    • 제12권4호
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    • pp.5-32
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    • 2009
  • Objectives: This study was performed to analyse single dose toxicity of pure melittin(Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods: All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Six weeks old female Sprague-Dawley rats were chosen for the pilot study and determined 30㎎/㎏ which is 4285 times higher than the clinical application dosage as the high dosage, followed by 15 and 7.5㎎/㎏ as mid and lose dosage, respectively. Equal amount of excipient to the Sweet BV experiment groups was administered as the control group. Results: 1. No mortality was witnessed in all of the experiment groups. 2. Hyperemia and movement disorder were observed around the area of administration in all groups, and higher occurrence in the higher dosage groups. Hyperemia and movement disorder diminished with elapsed time. 3. For the weight measurement, male groups showed larger reduction in weight in accordance with higher dosage. Female groups didn't s how significant changes. 4. To verify abnormalities of organs and tissues, cerebellum, cerebrum, liver, lung, kidney, and spinal nerves were removed and conducted histological observation with H-E staining. No abnormalities were detected in any of organs and tissues. 5. One female rat in the 30㎎/㎏ group had amputated toe near the administered area and histopathological finding was hemorrhage with inflammation. This is presumed as a secondary infection after the administration of Sweet BV. Conclusion: Above findings suggest Sweet BV is relatively s safe treatment medium. Further studies on the subject should be conducted to yield more concrete evidences.

니코틴 산의 다공성 분체 흡착 (Adsorption of Nicotinic Acid on the Porous Powders)

  • 신상철;조정원
    • Journal of Pharmaceutical Investigation
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    • 제27권1호
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    • pp.39-49
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    • 1997
  • Nicotinic acid was mixed with glass powders such as controlled pore glass (CPG), glyceryl controlled pore glass (GPG) and glass beads (GB) at room temperature. The physicochemical properties of nicotinic acid in the various mixtures were examined by differential thermal analysis, X-ray diffraction study. Infrared spectroscopy and BET gas adsorption measurements. The peak area at the melting point from the various mixtures of nicotinic acid and CPG was increased with an increase of nicotinic acid concentration while the broad peak area was remained unchanged in the DTA curve. As shown in the powder X-ray diffraction patterns, the crystalline peaks of nicotinic acid disappeared in mixture with CPG, suggesting the interaction of nicotinic acid and porous powders. It was found that the larger the content of CPG, the higher the ratio of an amorphous state to a crystalline state. BET isotherm showed that as the amount of nicotinic acid was increased, the specific surface area was reduced proportionally to nicotinic acid content of up to 40% and remained constant thereafter. Sublimation of nicotinic acid from the mixture of nicotinic acid and CPG was examined. A large quantity of nicotinic acid was retained in the mixture when stored on various temperatures in vacuo for 10 hours. The nicotinic acid mixtures with CPG or GPG showed a high dissolution rates of nicotinic acid in aqueous solution, especially in the initial dissolution stage. CPG is expected to be a good pharmaceutical excipient to reduce the crystallinity of drugs and to prevent sublimation of drugs.

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Heme Derived from Corynebacterium glutamicum: A Potential Iron Additive for Swine and an Electron Carrier Additive for Lactic Acid Bacterial Culture

  • Choi, Su-In;Park, Jihoon;Kim, Pil
    • Journal of Microbiology and Biotechnology
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    • 제27권3호
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    • pp.500-506
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    • 2017
  • To investigate the potential applications of bacterial heme, aminolevulinic acid synthase (HemA) was expressed in a Corynebacterium glutamicum HA strain that had been adaptively evolved against oxidative stress. The red pigment from the constructed strain was extracted and it exhibited the typical heme absorbance at 408 nm from the spectrum. To investigate the potential of this strain as an iron additive for swine, a prototype feed additive was manufactured in pilot scale by culturing the strain in a 5 ton fermenter followed by spray-drying the biomass with flour as an excipient (biomass: flour = 1:10 (w/w)). The 10% prototype additive along with regular feed was supplied to a pig, resulting in a 1.1 kg greater increase in weight gain with no diarrhea in 3 weeks as compared with that in a control pig that was fed an additive containing only flour. To verify if C. glutamicum-synthesized heme is a potential electron carrier, lactic acid bacteria were cultured under aerobic conditions with the extracted heme. The biomasses of the aerobically grown Lactococcus lactis, Lactobacillus rhamosus, and Lactobacillus casei were 97%, 15%, and 4% greater, respectively, than those under fermentative growth conditions. As a potential preservative, cultures of the four strains of lactic acid bacteria were stored at $4^{\circ}C$ with the extracted heme and living lactic acid bacterial cells were counted. There were more L. lactis and L. plantarum live cells when stored with heme, whereas L. rhamosus and L. casei showed no significant differences in live-cell numbers. The potential uses of the heme from C. glutamicum are further discussed.

HPMC의 입도에 따른 염산벤라팍신 및 카바마제핀 서방성 정제의 용출 특성 (Effect of Particle Size of HPMC on Dissolution Rate of Venlafaxine HCl and Carbamazepine Sustained Release Tablet)

  • 차재욱;차자현;홍준기;이성완;고원화;백현호
    • 폴리머
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    • 제36권3호
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    • pp.332-337
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    • 2012
  • 본 연구는 약물의 용해도에 따른 서방성 용출 거동의 특성을 파악하기 위해 수행되었으며, 이에 따라 고분자의 입도에 따른 염산벤라팍신과 카바마제핀의 정제를 제조하였다. 사용된 고분자는 경구를 통한 서방성 약물전달 시스템 설계에 가장 널리 사용되는 히드록시 프로필 메틸셀룰로오스(HPMC)이며, HPMC의 입도 분포에 따른 팽윤 속도의 차이는 중요한 특성으로 약물의 용출에 큰 영향을 미친다. HPMC 입도에 따른 정제 표면을 분석하기 위해 SEM을 사용하였으며, 결정학적 특성을 파악하기 위해 DSC를 이용하여 분석하였고, 용출 특성의 주요 메카니즘을 파악하기 위해 용출 모델식을 적용하였다. 본 연구를 통해 약물의 용해도 및 HPMC의 입도에 따라 약물의 용출 거동을 조절할 수 있었다.

에틸렌 발생 tablet 제조 및 활성 최적 조건 구명 (Fabrication and optimization of ethylene-producing tablet)

  • 박도수;정천순
    • 한국식품저장유통학회지
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    • 제23권2호
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    • pp.162-165
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    • 2016
  • 본 연구는 에테폰과 부형제를 혼합하여 에틸렌 발생 타블렛을 제조하였고, 에틸렌 가스 활성조건을 구명한 결과는 다음과 같다. 온도조건별 타블렛의 에틸렌 발생량은 온도가 높을수록 많은 발생을 보였다. Activator pH 조건별 에틸렌 발생량은 pH 7.0 및 9.0 조건에서는 발생량이 약 2 ppm으로 미미하였으나, pH 13.0에서 타블렛의 에틸렌 발생량은 Prosolv 부형제 94.05 ppm, HPMC 부형제 126.28 ppm, Crosscamellose 부형제 100.11 ppm으로 각각 나타났다. 제조된 타블렛의 마손도는 Prosolv 부형제 0.1%, HPMC 부형제 0.3%, Crosscamellose 부형제 54.1%로 나타나 Crosscamellose 타블렛은 부적합하다고 판단되었다. 붕해도의 경우 각각의 부형제에 따라 큰 차이를 보였으며, Prosolv 부형제 1분, HPMC 부형제 7분 이상, Crosscamellose 부형제 5분으로 각각 나타났다. 최종 선정된 부형제인 Prosolv 타블렛의 시간대별 에틸렌 발생 측정결과 가스포집 20시간 까지 에틸렌 발생량은 꾸준히 증가하였지만 20시 이후의 발생은 미미하였고 지속적인 가스 발생은 처리 후 20시간으로 나타났다.

동결 건조법을 이용한 옥천산 캡슐 제형 개발에 관한 연구 (A Study of Okchun-San Formulation for Freeze Drying Capsulation)

  • 오명숙;김도림;강지웅;장문석;박선민;고병섭;박성규
    • 대한한의학방제학회지
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    • 제13권1호
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    • pp.1-7
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    • 2005
  • Objective : Okchun-San(OCS) is known as an effective herbal medicine on Type 2 diabetes. We performed to change OCS formulation for freeze drying capsulation. Methods The mixtures of OCS were extracted with water. finally, the filtered solution were evaporated and lyophilized to dry granules. The various ratio of excipients were studied to determine the formation for capsulizing. The samples were inspected for any difference in color, taste and appearance. Results: The prepared form of OCS were dried and weighted 260kg. The lyophilized dry powder yielding 40kg. The suitable ratio of OCS-dry powder and excipient was 10:1. The average weights of On and placebo capsules were $440{\pm}5.28mg$, $465{\pm}7.95mg$, respectively. There was no notable change in color and appearance for both capsuled samples throughout the study period. Conclusions: Therefore in can be concluded that freeze drying capsulation is appropriate form of OCS.

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새로운 메트포르민 산부가염을 이용한 서방성 제형 평가 (Evaluation of Sustained-release Dosage Form with Novel Metformin Salts)

  • 김동욱
    • 한국산학기술학회논문지
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    • 제16권11호
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    • pp.7838-7843
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    • 2015
  • 본 논문에서는 제 2형 당뇨병의 1차 선택약으로 사용되는 메트포르민 염산염이 통상적으로 1일 1000mg~2000mg의 고용량으로 투여되고 동시에 매우 높은 수성용해도를 가지므로 1일 1회 복용을 위한 약물방출제어시스템에 다량의 서방성 부형제를 필요로 하여 제형의 크기가 커져 복용이 어려운 문제점이 있다. 따라서 이를 개선하고자 상대적으로 수성용해도가 낮은 새로운 메트포르민 산부가염을 합성하여 서방성 정제에 적용하여 메트포르민의 방출을 확인하고자 하였다. 이를 위해 메트포르민 염산염을 원료로 하여 NaOH하에서 메트포르민 base를 만들고 여기에 산부가염을 반응시켜 6개의 새로운 메트포르민 산부가염들을 합성하였다. 또한 이들의 수성용해도를 측정하여 메트포르민 염산염에 비해 현저히 낮은 수성용해도를 가지는 메트포르민 스테아린산염을 확인하였고 메트포르민 서방성 제형에 적용하여 실제 약물의 방출제어에도 용출시험 결과, 12시간에서 약 2배의 약물방출제어 효과를 확인하였다. 결론적으로 새로운 메트포르민 산부가염을 통해 서방성 부형제의 양을 줄여 제형의 크기를 줄임으로써 보다 높은 환자의 복약순응도를 기대할 수 있을 것이다.

Fertility and General Reproductive Ability Test of Ginkgo Biloba Extract (EGb 761) in Rats

  • Lee,Yong-Soon;Nam, Jeong-Seok;Yang, Jae-Man;Che, Jeong-Hwan;Kang, Byeong-Chul;Lee, Hak-Mo;Park, Jae-Hak;Kim, Dai-Yong;Kang, Sung-An
    • Toxicological Research
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    • 제12권1호
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    • pp.129-136
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    • 1996
  • A fertility and general reproductive a. bility study was performed in Sparque-Dawley rats intravenously injected with Ginkgo biloba extract (EGb 761), a potential pharmaceutical excipient, at dose levels of 7.5, 15, and 30 mg/kg/day. Male rats were treated with Ginkgo biloba extract (EGb 761)from 14 days before mating until 21 days after delivery. Female rats received extract for 2 months prior to mating. No abnormal signs were noted in mating or fertility of the rats treated with Ginkgo biloba extract (EGb 761). No significant external, visceral, and skeletal anomalies or mental and physical development attributable to treatment was noted in any fetuses examined. The fertility of F1 generation was not affected by the treatment also. It was concluded that Ginkgo biloba extract (EGb 761) has no harmful effect on mating, fertilization, implantation, embryonic development and normal physical development.

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Hyaluronic acid reduces inflammation and crevicular fluid IL-1β concentrations in peri-implantitis: a randomized controlled clinical trial

  • Sanchez-Fernandez, Elena;Magan-Fernandez, Antonio;O'Valle, Francisco;Bravo, Manuel;Mesa, Francisco
    • Journal of Periodontal and Implant Science
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    • 제51권1호
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    • pp.63-74
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    • 2021
  • Purpose: This study investigated the effects of hyaluronic acid (HA) on peri-implant clinical variables and crevicular concentrations of the proinflammatory biomarkers interleukin (IL)-1β and tumor necrosis factor (TNF)-α in patients with peri-implantitis. Methods: A randomized controlled trial was conducted in peri-implantitis patients. Patients were randomized to receive a 0.8% HA gel (test group), an excipient-based gel (control group 1), or no gel (control group 2). Clinical periodontal variables and marginal bone loss after 0, 45, and 90 days of treatment were assessed. IL-1β and TNF-α levels in crevicular fluid were measured by enzyme-linked immunosorbent assays at baseline and after 45 days of treatment. Clustering analysis was performed, considering the possibility of multiple implants in a single patient. Results: Sixty-one patients with 100 dental implants were assigned to the test group, control group 1, or control group 2. Probing pocket depth (PPD) was significantly lower in the test group than in both control groups at 45 days (control 1: 95% CI, -1.66, -0.40 mm; control 2: 95% CI, -1.07, -0.01 mm) and 90 days (control 1: 95% CI, -1.72, -0.54 mm; control 2: 95% CI, -1.13, -0.15 mm). There was a trend towards less bleeding on probing in the test group than in control group 2 at 90 days (P=0.07). Implants with a PPD ≥5 mm showed higher levels of IL-1β in the control group 2 at 45 days than in the test group (P=0.04). Conclusions: This study demonstrates for the first time that the topical application of a HA gel in the peri-implant pocket and around implants with peri-implantitis may reduce inflammation and crevicular fluid IL-1β levels.

COPD 동물 모델에서 소청룡탕 흡입제형의 효과 (Effects of Inhalable Microparticles of Socheongryong-tang on Chronic Obstructive Pulmonary Disease in a Mouse Model)

  • 이응석;한종민;김민희;남궁욱;여윤;박양춘
    • 대한한의학회지
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    • 제34권3호
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    • pp.54-68
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    • 2013
  • Objectives: This study aimed to evaluate the effects of microparticles of Socheongryong-tang (SCRT) on chronic obstructive pulmonary disease (COPD) in a mouse model. Methods: The inhalable microparticles containing SCRT were produced by spray-drying with leucine as an excipient, and evaluated with respect to the aerodynamic properties of the powder by Andersen cascade impactor (ACI). Its equivalence to SCRT extract was evaluated using lipopolysaccharide (LPS) and a cigarette-smoking (CS)-induced murine COPD model. Results: SCRT microparticles provided desirable aerodynamic properties (fine particle fraction of $49.6{\pm}5.5%$ and mass median aerodynamic diameter of $4.8{\pm}0.3{\mu}m$). SCRT microparticles did not show mortality or clinical signs over 14 days. Also there were no significant differences in body weight, organ weights or serum chemical parameters between SCRT microparticle-treated and non-treated groups. After 14 days the platelet count significantly increased compared with the non-treated group, but the values were within the normal range. Inhalation of SCRT microparticles decreased the rate of neutrophils in blood, granulocytes in peripheral blood mononuclear cells (PBMC) and bronchoalveolar lavage fluid (BALF) and level of TNF-${\alpha}$ and IL-6 in BALF on COPD mouse model induced by LPS plus CS. This effect was verified by histological findings including immunofluorescence staining of elastin, collagen, and caspase 3 protein in lung tissue. Conclusions: These data demonstrate that SCRT microparticles are equivalent to SCRT extract in pharmaceutical properties for COPD. This study suggests that SCRT microparticles would be a potential agent of inhalation therapy for the treatment of COPD.