• Title/Summary/Keyword: excipient

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

  • Kim, Young-Jin;Lim, Chung-San;Kwon, Ki-Rok
    • Journal of Pharmacopuncture
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    • v.12 no.4
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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.

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

  • Shin, Sang-Chul;Cho, Cheong-Weon
    • Journal of Pharmaceutical Investigation
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    • v.27 no.1
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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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    • v.27 no.3
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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.

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

  • Cha, Jae-Uk;Cha, Ja-Hyun;Hong, Jun-Kee;Lee, Sung-Wan;Ko, Won-Hwa;Beak, Hyun-Ho
    • Polymer(Korea)
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    • v.36 no.3
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    • pp.332-337
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    • 2012
  • The primary objective of this work is to find the properties of sustained release dissolution pattern depending on solubility of drugs, so venlafaxine HCl and carbamazepine tablets were made by using polymer wich various particle size. Hydroxy propyl methyl cellulose (HPMC) has been utilized in this study as an excipient that is one of the most widely used polymers for an oral sustained release formulation, and drug release pattern was strongly influenced by swelling rate depending on particle size of HPMC. Scanning electron microscope (SEM) was employed to investigate the surface of tablets with various HPMC particle size, and differential scanning calorimeter (DSC) was employed to investigate the crystallization of drugs in tablets. The release model equation was applied to analyze the main mechanism of drug release pattern. The results demonstrate that drug release pattern is controlled by the drug solubility and HPMC particle size.

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

  • Park, Do Su;Jeong, Cheon Soon
    • Food Science and Preservation
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    • v.23 no.2
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    • pp.162-165
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    • 2016
  • Ethylene ($C_2H_4$) is a naturally occurring hormone in some fruit. This study was carried out to manufacture ethylene-producing tablets. The Ethylene-producing tablets were manufactured from ethephon and excipient mixtures, including Prosolv, Hydroxypropylmethylcellulose (HPMC) and Crosscamellose. Ethylene production increased with the increases in temperature. In the aspect of pH condition, ethylene productions at pH 7.0 and pH 9.0 were less than 2 ppm. On the other hand, at pH 13.0, ethylene production from the Prosolv, HPMC, and Crosscamellose tablets was 94.05, 126.28, and 100.11 ppm, respectively. The friability of the Prosolv and HPMC tablets were 0.1 and 0.3%, respectively, while the Crosscamellose tablet was 54.1%. indicating that the Crosscarmellose tablet was not appropriate as an ethylene production tablet. In addition, there were huge variations in disintegration times; the Prosolv, Crosscamelose, and HPMC tablets took 1, 5 min, and 7 min more than respectively. Ethylene production was gradually increased up to 20 hr for the Prosolv tablet and then remained stable.

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

  • Oh, Myung-Sook;Kim, Do-Rim;Kang, Ji-Ung;Chang, Mun-Seog;Park, Sun-Min;Ko, Byoung-Seob;Park, Seong-Kyu
    • Herbal Formula Science
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    • v.13 no.1
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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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Evaluation of Sustained-release Dosage Form with Novel Metformin Salts (새로운 메트포르민 산부가염을 이용한 서방성 제형 평가)

  • Kim, Dong-Wook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.16 no.11
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    • pp.7838-7843
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    • 2015
  • In this study, metformin hydrochloride for first choice of type 2 diabetes patient is administered relatively high dose, 1000 to 2000 mg orally once a day, and had very high water solubility, so it make difficult to swallow tablet to requires high amount of sustained release agent. To overcome these challenges, we used novel metformin salts had relatively low water solubility to minimize sustaining excipient for small size of dosage form. six novel metformin salts were synthesized by making metformin free form under reaction with NaOH and adding acid salts. we confirmed metformin stearate had the lowest water solubility and showed half drug release in dissolution study at 12hour. In conclusion, novel metformin salts had low water solubility can be used to reduce the size of sustained metformin tablet for improving patient compliance.

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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    • v.12 no.1
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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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    • v.51 no.1
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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.

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

  • Lee, Eung-Seok;Han, Jong-Min;Kim, Min-Hee;Namgung, Uk;Yeo, Yoon;Park, Yang-Chun
    • The Journal of Korean Medicine
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    • v.34 no.3
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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.