• Title/Summary/Keyword: sterile preparation

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

  • Shin, Seo-young;Jang, Kyoung won;Sun, Sangouk;Ha, Dongmun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.2
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    • pp.681-693
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    • 2019
  • Multi-use ophthalmic solutions are used many times after opening; therefore, there is a high possibility of decreased quality during use. This study was conducted to determine the recommended use period of multi-use ophthalmic solutions based on evaluation of the stability by comparing stability evaluation regulations of the USA, EU and Korea We selected four types of multi-use ophthalmic solutions (Olopatadine (Olo), Fluorometholone (Flu), Dorzolamide (Dor), Timolol (Timol)) that are frequently marketed in Korea and evaluated their stability during storage according to the actual usage method after opening. The Olo had a decrease in assay and preservative content at 2 months after opening, while Flu showed a significant difference from day 28 after opening. For Dor, significant differences were observed from day 14 after opening in the assay and impurity test item and Timol showed a significant difference from day 28 after opening. Based on the results of the stability test Olo and Flu should only be used within 28 days of opening, while Dor and Timol should be used within 14 days of opening. Therefore, we suggest that regulations system related use periods of multi-use ophthalmic solutions designed as aseptic preparations should be improved based on the results of stability tests after opening.

Effects of Cotton Balls of Alcohol and Povidone for Disinfectoin of Skin in Newborns (신생아에서 알코올 솜 및 포비돈 솜의 피부 소독효과 비교)

  • Park, Kyu Chang;Kim, Chang Ryul;Kim, Eun A;Oh, Jae Won;Yum, Myung Kul;Oh, Sung Hee;Moon, Soo Jee;Kang, Jung Oak
    • Pediatric Infection and Vaccine
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    • v.6 no.1
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    • pp.116-122
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    • 1999
  • Purpose : Despite of development of neonatal intensive care, infections, especially catheter-related infection, have been a major problem in newborns on intensive care. Catheter-related infection is closely related to skin colonization so that skin disinfection is crucial to protect newborns from the infection. Cotton balls of seventy percent alcohol made by hospital frequently open to air so that composition of alcohol may be easily evaporated. We hypothesized that 10% povidone would have better disinfection compared to 70% alcohol and normal saline. Methods : The effect of skin disinfection was evaluated in newborn infants who were admitted to the neonatal intensive care unit(NICU) of Hanyang University Kuri Hospital by a skin swab culture before and after disinfectant exposure. Before skin disinfective preparation, the peripheral intravenous catheter insertion sites were swabbed for culture with sterile cotton moistened with normal saline. Cotton balls of 70% alcohol(Alcohol group, n=20) or 10% povidone and 70% alcohol(povidone group, n=20) were randomly selected. Normal saline swabs were used for controls(n=10). After swabbing, the skin swab culture was done on same sites with same procedure. Results : Before skin disinfection, culture-positivity was shown in 9 of 20 leases of alcohol and povidone groups, respectively and in 8 of 10 cases of the controls. After skin disinfection, culture-positivity was still shown in 3 of 9 cases of the Alcohol group, in 2 of 9 of the Povidone group, and in 6 of 8 cases of the controls. Disinfective effect was significantly different among the 3 groups(p=0.0387). The povidone group had significantly better disinfection than the controls(p=0.0156), but the alcohol group was not significantly different from the controls. Conclusion : The cotton balls of povidone had similar effect of disinfection compared to those of alcohol, but better disinfection than the controls. A disinfective effect of the cotton balls of alcohol was not, however, significantly different from the controls. We suggest that purity of alcohol, quality control of cotton balls of alcohol, and disinfection method should be reevaluated.

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