• 제목/요약/키워드: Stability After Opening

검색결과 39건 처리시간 0.03초

다회용 점안제의 개봉 후 안정성 평가 -올로파타딘, 플루오로메톨론, 도르졸라미드, 티몰롤 약물 중심- (The in-use stability study of multi-use ophthalmic solutions -Focused on Olopatadine, Fluorometholone, Dorzolamide, Timolol-)

  • 신서영;장경원;선상욱;하동문
    • 한국산학기술학회논문지
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    • 제20권2호
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    • pp.681-693
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    • 2019
  • 다회용 점안제는 개봉 후 여러 번 사용되기 때문에 사용 중 품질저하 가능성이 높다. 다회용 점안제의 개봉 후 안정성 평가 관련 국내외 규정의 비교분석을 통해 제제별 안정성을 평가하여 개봉 후 안전한 사용기간을 제안하고자 한다. 국내에서 다빈도로 사용중인 다회용 점안제 4종(올로파타딘염산염(Olo), 플루오로메톨론(Flu), 도르졸라미드염산염(Dor), 티몰롤말레산염(Timol))을 대상으로 개봉 후 실제 사용방법에 따른 보관조건을 통해 안정성을 평가하였다. 연구결과 Olo는 개봉 2개월 이후 주성분 및 보존제 함량이 감소하였고, Flu는 개봉 후 28일 차부터 함량이 감소되었다. Dor와 Timol 복합점안제의 경우 Dor은 함량 및 유연물질이 개봉 후 14일부터, Timol의 함량은 개봉 후 28일부터 안정성 저하를 보였다. Olo, Flu은 개봉 후 28일 이내로, Dor, Timol은 개봉 후 14일 이내에만 사용되어야 한다. 무균제제인 다회용 점안제는 개봉 후 안정성 평가를 통해 사용기간 설정에 대한 규제제도 개선이 필요함을 제언하고자 한다.

국내외 의약품 개봉 후 안정성 규정 비교와 국내 시럽제의 안정성 적용 현황 분석 - 미국, 유럽, 한국의 가이드라인을 중심으로 - (Comparative Study on the Regulations about In-Use Stability, and Analysis the In-Use Stability Application on Approved Syrups - Focused on the Guidelines in US, Europe and Korea -)

  • 박온누리;장경원;하동문
    • 한국산학기술학회논문지
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    • 제21권3호
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    • pp.137-146
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    • 2020
  • 의약품에 기재되어 있는 보관조건 및 사용기간은 안정성 시험 결과에 따라 결정된다. 특히, 시럽제 의약품의 경우 개봉 후 자주 사용됨에 따라 의약품 품질 저하의 발생 가능성이 높다. 식품의약품안전처에서도 의약품의 안전한 사용을 위해 2016년 12월 '완제의약품 개봉 후 사용기간 설정을 위한 가이드라인'을 발표하였다. 이에 본 연구에서는 미국, 유럽과 한국의 관련 가이드라인을 비교해보고 가이드라인 제정 전후 품목허가(신고)된 시럽제중 건조시럽 4성분 및 덕용시럽 3개 성분의 허가사항을 검토하여 개봉 후 사용기간 또는 보관조건 기재여부 현황을 분석하였다. 그 결과 첫째 미국과 유럽은 포장용기의 라벨에 유효기간과 더불어 개봉 후 사용기간 및 보관조건을 기재하도록 하였으나, 한국의 경우 '사용상의 주의사항'에 기재토록 하는 차이가 있었다. 둘째, 분석한 모든 의약품이 새로 도입한 개봉 후 사용기간 설정을 위한 가이드라인에 의해 변경되지 않았고 가이드라인 제정 이전의 유효기간에 대해서만 제시되었다. 개봉 후 다회용으로 사용되는 의약품들은 개봉 후 안정성 평가를 통해 사용기간과 보관조건이 의약품의 포장 용기에 기재하도록 하는 제도 개선이 필요할 것으로 사료된다.

방사선 투시를 이용한 개폐구 운동에 따른 수직 고경 계측점의 안정성에 관한 연구 (A FLUOROSCOPIC STUDY ON THE STABILITY OF SKIN REFERENCE POINTS DURING JAW OPENING AND CLOSING MOVEMENT)

  • 안형준;김창회;김영수;김용호
    • 대한치과보철학회지
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    • 제37권4호
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    • pp.516-530
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    • 1999
  • The current clinical technique for occlusal vertical dimension recording is based on marking the skin reference points on the patient's face and measuring between these points using caliper-like device. And it is difficult to achieve reliable measurements by this technique because of movable soft tissue. The purpose of this study is to reveal the stability of skin reference points by comparing the relative movement between extra-oral skin reference points and intra-oral reference points using X-ray fluoroscope. 10 test subjects were divided into 2 groups : Group I (natural dentition) and Group II (denture-wearer whose vertical dimension was lost) and Group III consists of identical test subjects to Group II with their upper denture removed and record base inserted. Attaching the 3 mm diameter steel ball to nose tip, lower lip, chin and to existing denture (or record base), fluoroscopic examination and recording were taken during 2 jaw opening and closing movements. After subsequent digitization using personal computer, 1219 still pictures with 0.1 second interval were made. Using the 2 dimensional graphic software, measurements between reference points were executed. Dividing the entire jaw movement into 3 ranges (total, 1st half opening, 2nd half opening), rate of movement and relative movement between extra-oral and intra-oral reference points were calculated and statistically analyzed. The results of this study are as follows. 1 Within the same experimental group, no statistical difference was found in the stability of skin reference between lower lip point and chin point during total range of jaw opening and closing movement (p>.05) 2. In the first half range of jaw opening, statistical difference was found between Group I (natural dentition) and Group II (denture wearer) (p<.05) Group I has greater skin reference stability than Group II. 3. In the first half range of jaw opening, statistical difference was found between Group I and Group III (record base wearer) (p<.05). Group I has greater skin reference stability than Group III. 4. In the first half range of jaw opening, no statistical difference was found in the stability of skin reference between Group II and Group III (p>.05). 5. In the second half range of jaw opening, no statistical difference was found in the stability of skin reference between any experimental groups (p>.05). 6. In patients with their occlusal vertical dimension lost, employing other measuring references rather than skin is recommended because of low stability.

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TiN 코팅된 지대주 나사의 반복 착탈 후 표면 변화와 적합도에 관한 연구 (SURFACE CHANGE AND FIT OF TIN-COATED ABUTMENT SCREW AFTER REPEATED CLOSING AND OPENING)

  • 김종남;정재헌;김희중
    • 대한치과보철학회지
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    • 제45권1호
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    • pp.119-130
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    • 2007
  • Statement of problem: A few dry lubricants were applied to abutment screws for the improvement of joint stability. Purpose: The purpose of this study was to evaluate the surface change and fit of TiN-Coated abutment screw through the examination of tested screws in the field emission scanning electron microscope(FE-SEM;Netherland, Phillips co., model:XL 30 SFEG) after repeated closing and opening. Materials and method: Titanium(3i/implant Innovations Inc, USA) and Gold-Tite abutment screws(3i/implant Innovations Inc, USA) were selected for Group A and C respectively. TiN coated titanium abutment screws were also divided into two groups, Group B and D. Abutment screws of each group and the fit of abutment screw/implant fixture/abutment were observed on FE-SEM after repeated closing and opening test respectively. Results: 1. The abutment screws of TiN coated groups(Group B and D) showed more remarkable wear resistance in the threads of the screw than those of the other group(Group A and C). 2. There were more severe wear and defect of TiN coating in Group D tightened to 32 Ncm than Group B to 20 Ncm. 3. There was no difference in the fit of abutment screw/fixture/abutment among four groups, Group A, Group B, Group C and Group D. Conclusion: Under the conditions of this study, it is suggested that TiN coating of abutment screw be clinically acceptable and be expected to reduce the risk of abutment screw loosening. TiN coating of abutment screw showed good resistance against wear and the adequate fit of abutment screw/implant fixture/abutment.

시판 Hydrogen Peroxide, Sodium Hypochlorite, Glutaraldehyde 및 Didecyl Dimethyl Ammonium Chloride (DDAC)의 보존 안전성 (Storage Stability of the Commercial Hydrogen Peroxide, Sodium Hypochlorite, Glutaraldehyde and Didecyl Dimethyl Ammonium Chloride (DDAC))

  • 박경희;김석렬;강소영;정성주;김흥윤;김도형;오명주
    • 한국양식학회지
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    • 제21권3호
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    • pp.172-175
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    • 2008
  • 본 연구에서는 양식장에서 질병예방용으로 시판되고 있는 hydrogen peroxide, sodium hypochlorite, glutaraldehyde 및 didecyl dimethyl ammonium chloride (DDAC)의 저장 안정을 평가하였다. Hydrogen peroxide와 DDAC는 개봉 후 6개월간 실온저장 및 $4^{\circ}C$ 저장에서 유효 성분의 변화가 없어 안정하였다. 그렇지만, sodium hypochlorite와 glutaraldehyde는 개봉 후 $4^{\circ}C$에서 저장하더라도 각각 15%와 39%의 유효성분이 감소하였다. 이와 같은 결과에 따라 hydrogen peroxide과 DDAC는 개봉 후 6개월까지 보관은 유효하지만, 양식장에서 적용시에는 수질의 유기물 양, pH 등의 조건을 고려해서 사용해야 할 것으로 판단되었다.

Simultaneous gap arthroplasty and intraoral distraction and secondary contouring surgery for unilateral temporomandibular joint ankylosis

  • Sharma, Aditi;Paeng, Jun-Young;Yamada, Tomohiro;Kwon, Tae-Geon
    • Maxillofacial Plastic and Reconstructive Surgery
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    • 제38권
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    • pp.12.1-12.6
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    • 2016
  • Background: Temporomandibular joint (TMJ) ankylosis can be accompanied by various degrees of functional and esthetic problems. Adequate mouth opening, occlusal stability, and harmonious facial form are the main goals of treatment for ankylosis. Distraction osteogenesis has proven to be an excellent treatment for lengthening the ramus-condyle unit. However, various timings for distraction have been suggested, and there is no consensus on selection criteria for performing the procedure in stages or simultaneously with other treatments. Case presentation: In this case report, concomitant intraoral distraction and gap arthroplasty was planned to treat TMJ ankylosis and associated facial asymmetry. After gap arthroplasty and 23 mm of distraction, the ramus-condyle segment was successfully lengthened and mouth opening range was significantly increased. The resultant interocclusal space was stably maintained with an occlusal splint for 4 months after distraction. Finally, good occlusion was achieved after prosthetic treatment. The remaining mandibular asymmetry was corrected with osseous contouring and augmentation surgery. The mouth-opening range was maintained at 35 mm 24 months after treatment. Conclusion: Gap arthroplasty with intraoral distraction as a one-stage treatment and subsequent contouring surgery can be applied to correct ankylosis with moderate malocclusion and facial asymmetry.

경기도 해수욕장 모래의 안전성 확보를 위한 선행연구 (Preliminary Research on Securing the Stability of Sandy Beaches in Gyeonggi Province)

  • 최윤호;변주형;원종무;김종성;신종현;유창숙;정윤하;박민빈;오조교
    • 한국환경보건학회지
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    • 제46권6호
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    • pp.694-701
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    • 2020
  • Objectives: The main purpose of this study is to evaluate heavy metal concentrations (Cd, As, Hg, Pb, Cr6+), particle size distribution, hydrochloric acid solubility, and parasite eggs in sand in five non-designated sandy beaches in Gyeonggi Province. Methods: The sampling sites are five non-designated Gyeonggi-do sandy beaches located in Ansan and Hwaseong. ICP-OES and UV, a Vibratory Sieve Shaker, and PCM were respectively used to analyze heavy metal concentrations, particle size distribution, and parasite eggs in the sand. Results: Heavy metals were detected within the beach's safety management standards and some of the detected As and Pb before and after beach opening were lower than one-quarter of the average value. In addition, the results of the T-test to confirm the As and Pb concentration changes before and after opening showed a significant difference in some beaches. The composition of sand was 86.53% according to the particle size distribution standard (2.0-0.02 mm), and the hydrochloric acid solubility was the highest at Gubongsolsup (4.9%) and the lowest at Bangameo-li (0.2%). Parasite eggs were undetected in all beach sand before and after opening. Conclusions: The safety of heavy metal concentrations in sandy beaches was secured in the selected five beaches in Gyeonggi Province. However, continuous efforts are required to make Gyeonggi-do's beaches suitable according to the Act on the Use and Management of Beaches.

살충제제(殺蟲製劑)의 안정성(安定性)에 관(關)한 연구(硏究) (Studies on the Stabilities of Insectcides Combined with some Stabilizers)

  • 우종학;김재완
    • Journal of Pharmaceutical Investigation
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    • 제1권1호
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    • pp.101-108
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    • 1971
  • The stability and toxicity test for p.p'-DDT, DDVP and dipterex that put to used sample in this study effects is follows A. about p.p'-DDT (1) In elevating the stability of p.p'-DDT, best stabilizing solvent was benzene. (2) The stability-agent has no difficulty as long as it not contain metal ion for instance $Z_n^{2+}$,$C_r^{3+}$,$Al^{3+}$,and $Fe^{2+or3+}$ but in case of contain $F_e^{3+}$, the combination of salicylaminoguanidine is best effective. (3) Using this product for water-suspension, We must use span 40 for stability agent and adding it at the same time. (4) We must use container which does not week alkali and metal ion but it is to preserved in tight light-resistant container. (5) The stopper of container is adapted with above-mentioned condition of container, but it is better not to use metal material. (6) This product needs opening ventilation more than 30 minutes after diffusion or spray and in the room we remove cause of remained poison by cleaning the bottom. B. about DDVP and Dipterex (1) Benzene or toluene in best solvent to preserve stability of DDVP and Dipterex. (2) Span 40 is superior for stability agent of this product and second is span 80. (3) The pH of solution is very stable in pH 5-6 and comparative stable in alkali more than p,p'-DDT. (4) Container is to preserved in tight, lightresistant container and especially be careful of outflow and inflow of water. (5) Because this product is centeral stimulant poison, we must pay attention to prevent cause of contact diadermic toxicity after use.

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The Study of Stability of Oral Pharmaceutical Liquid Preparation II

  • Kang, Min-Kyung;Park, So-Min;Choi, So-Young;Kim, Kil-Soo
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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    • pp.226.1-226.1
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    • 2003
  • The available period of oral pharmaceutical liquid preparations was decided according to the study of the stability of unopened preparations. But if one reuses the drug after opening the sealed cap, the major components of the drug could change in quality. In addition, there isn`t any accurate information about the available period of opened oral pharmaceutical liquid preparations. In this study, a long term test, an accelerated test and a microbial limit test are run with C (pseudoephedrine and triprolidine), D (ibuprofen) that are marketed and used frequently. (omitted)

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The Study of Stability of Oral Pharmaceutical Liquid Preparations I

  • Um, So-Young;Han, Kyu-Won;Choi, Jung-Im;Kim, Kil-Soo
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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    • pp.233.1-233.1
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    • 2003
  • The available period of oral pharmaceutical liquid preparations was decided according to the study of the stability of unopened preparations. But if one reuses the drug after opening the sealed cap, the major components of the drug could change in quality. In addition, there isn`t any accurate information about the available period of opened oral pharmaceutical liquid preparations. In this study, a long term test, an accelerated test and a microbial limit test are run with A (acetaminophen), B (L-carbocysteine) that are markdted and used frequently. (omitted)

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