中华实验眼科杂志
中華實驗眼科雜誌
중화실험안과잡지
Chinese Journal of Experimental Ophthalmology
2015年
9期
816-819
,共4页
宫瑞中%张红%王丽%王峻峰%王婧%张琳%冀明
宮瑞中%張紅%王麗%王峻峰%王婧%張琳%冀明
궁서중%장홍%왕려%왕준봉%왕청%장림%기명
滴眼液%药物污染%药品保存%细菌/分离和纯化%甲基纤维素滴眼液%杀菌防腐剂%尼泊金乙酯
滴眼液%藥物汙染%藥品保存%細菌/分離和純化%甲基纖維素滴眼液%殺菌防腐劑%尼泊金乙酯
적안액%약물오염%약품보존%세균/분리화순화%갑기섬유소적안액%살균방부제%니박금을지
Ophthalmic solutions%Drug contamination%Preservatives,pharmaceutical%Bacteria/isolation & purification%Methylcellulose eye drops%Antibacterial preservative%Ethylparaben
背景 目前大多数滴眼剂为多剂量包装,为保证滴眼液在使用中的安全性,对滴眼液瓶开启后使用过程中的微生物相关研究很有必要. 目的 研究甲基纤维素(MC)滴眼液开启后在社区常温、社区冷藏及病区常温3种环境下使用和存放时微生物污染情况及保持无菌的时间. 方法 将MC滴眼液按照模拟试验的温度、湿度和污染指数等环境的不同分为社区常温组、社区冷藏组和病区常温组,每个环境组取含或不含防腐剂尼泊金乙酯的MC滴眼液各200支,其中分为启封药物和不启封药物.由专业人员开启滴眼液瓶并标注开启时间,模拟点眼操作每次1滴,每日3次,每次药液空气中暴露时间为5～10s,用后分别在相应环境中存放.分别于药瓶开启后1、2、3、4、5、6、7、8、9和10 d的8:00取样,由同一检验员进行细菌培养和真菌培养,并通过全自动微生物分析系统进行菌种鉴定.结果 药瓶开启后社区常温组、社区冷藏组和病区常温组无防腐剂启封药细菌阳性率均在30％左右,而未启封药物未见微生物生长.药瓶开启后10 d,社区常温组、社区冷藏组和病区常温组无防腐剂的启封药细菌培养阳性率分别为30％、32％和36％,而含防腐剂药物的启封药细菌阳性率分别为15％、19％和23％,组内比较差异均有统计学意义(x2=6.452、4.448、4.063,均P＜0.05);根据Scheffe法计算社区常温组与社区冷藏组、病区常温组与社区冷藏组以及病区常温组与社区常温组间无防腐剂启封药细菌阳性率差值的95％可信区间(CI)分别为-0.166 ～ 0.126、-0.110 ～0.190和-0.088 ～0.208,而含防腐剂启封药物细菌阳性率差值的95％ CI分别为-0.159～0.079、-0.089～0.169和-0.043 ～0.203,尚不能认为不同环境间差异有统计学意义.培养的微生物经鉴定分别为藤黄微球菌、鲁氏不动杆菌、枯草芽孢杆菌、抗辐射不动杆菌、香味菌和木糖葡萄球菌.结论 防腐剂尼泊金乙酯可以降低MC滴眼液使用过程中的微生物污染率;滴眼液的常见使用环境对MC滴眼液的微生物污染情况无明显影响.MC滴眼液污染的菌群均属于大气、土壤等环境菌种,并非眼部常见致病菌.
揹景 目前大多數滴眼劑為多劑量包裝,為保證滴眼液在使用中的安全性,對滴眼液瓶開啟後使用過程中的微生物相關研究很有必要. 目的 研究甲基纖維素(MC)滴眼液開啟後在社區常溫、社區冷藏及病區常溫3種環境下使用和存放時微生物汙染情況及保持無菌的時間. 方法 將MC滴眼液按照模擬試驗的溫度、濕度和汙染指數等環境的不同分為社區常溫組、社區冷藏組和病區常溫組,每箇環境組取含或不含防腐劑尼泊金乙酯的MC滴眼液各200支,其中分為啟封藥物和不啟封藥物.由專業人員開啟滴眼液瓶併標註開啟時間,模擬點眼操作每次1滴,每日3次,每次藥液空氣中暴露時間為5～10s,用後分彆在相應環境中存放.分彆于藥瓶開啟後1、2、3、4、5、6、7、8、9和10 d的8:00取樣,由同一檢驗員進行細菌培養和真菌培養,併通過全自動微生物分析繫統進行菌種鑒定.結果 藥瓶開啟後社區常溫組、社區冷藏組和病區常溫組無防腐劑啟封藥細菌暘性率均在30％左右,而未啟封藥物未見微生物生長.藥瓶開啟後10 d,社區常溫組、社區冷藏組和病區常溫組無防腐劑的啟封藥細菌培養暘性率分彆為30％、32％和36％,而含防腐劑藥物的啟封藥細菌暘性率分彆為15％、19％和23％,組內比較差異均有統計學意義(x2=6.452、4.448、4.063,均P＜0.05);根據Scheffe法計算社區常溫組與社區冷藏組、病區常溫組與社區冷藏組以及病區常溫組與社區常溫組間無防腐劑啟封藥細菌暘性率差值的95％可信區間(CI)分彆為-0.166 ～ 0.126、-0.110 ～0.190和-0.088 ～0.208,而含防腐劑啟封藥物細菌暘性率差值的95％ CI分彆為-0.159～0.079、-0.089～0.169和-0.043 ～0.203,尚不能認為不同環境間差異有統計學意義.培養的微生物經鑒定分彆為籐黃微毬菌、魯氏不動桿菌、枯草芽孢桿菌、抗輻射不動桿菌、香味菌和木糖葡萄毬菌.結論 防腐劑尼泊金乙酯可以降低MC滴眼液使用過程中的微生物汙染率;滴眼液的常見使用環境對MC滴眼液的微生物汙染情況無明顯影響.MC滴眼液汙染的菌群均屬于大氣、土壤等環境菌種,併非眼部常見緻病菌.
배경 목전대다수적안제위다제량포장,위보증적안액재사용중적안전성,대적안액병개계후사용과정중적미생물상관연구흔유필요. 목적 연구갑기섬유소(MC)적안액개계후재사구상온、사구랭장급병구상온3충배경하사용화존방시미생물오염정황급보지무균적시간. 방법 장MC적안액안조모의시험적온도、습도화오염지수등배경적불동분위사구상온조、사구랭장조화병구상온조,매개배경조취함혹불함방부제니박금을지적MC적안액각200지,기중분위계봉약물화불계봉약물.유전업인원개계적안액병병표주개계시간,모의점안조작매차1적,매일3차,매차약액공기중폭로시간위5～10s,용후분별재상응배경중존방.분별우약병개계후1、2、3、4、5、6、7、8、9화10 d적8:00취양,유동일검험원진행세균배양화진균배양,병통과전자동미생물분석계통진행균충감정.결과 약병개계후사구상온조、사구랭장조화병구상온조무방부제계봉약세균양성솔균재30％좌우,이미계봉약물미견미생물생장.약병개계후10 d,사구상온조、사구랭장조화병구상온조무방부제적계봉약세균배양양성솔분별위30％、32％화36％,이함방부제약물적계봉약세균양성솔분별위15％、19％화23％,조내비교차이균유통계학의의(x2=6.452、4.448、4.063,균P＜0.05);근거Scheffe법계산사구상온조여사구랭장조、병구상온조여사구랭장조이급병구상온조여사구상온조간무방부제계봉약세균양성솔차치적95％가신구간(CI)분별위-0.166 ～ 0.126、-0.110 ～0.190화-0.088 ～0.208,이함방부제계봉약물세균양성솔차치적95％ CI분별위-0.159～0.079、-0.089～0.169화-0.043 ～0.203,상불능인위불동배경간차이유통계학의의.배양적미생물경감정분별위등황미구균、로씨불동간균、고초아포간균、항복사불동간균、향미균화목당포도구균.결론 방부제니박금을지가이강저MC적안액사용과정중적미생물오염솔;적안액적상견사용배경대MC적안액적미생물오염정황무명현영향.MC적안액오염적균군균속우대기、토양등배경균충,병비안부상견치병균.
Background It is imperative for the microbial monitor after opening the bottle of eyedrops in order to ensure the safety during use of ophthalmic solutions with multi-dose packaging.Objective This study was to research the microbiological properties and sterile duration of methylcellulose (MC) eye drops in three common environmental conditions,including room temperature condition of community,refrigeration condition of community and room temperature condition of hospital.Methods MC eye drops were assigned to the community room temperature group,community refrigeration group and hospital room temperature group,and 200 bottles of MC eye drops with or without ethylparaben were collected in each group,including sealed or unsealed drugs at average.The containers of all the eye drops were opened and the opening times were record.The drugs was admistered 1 drop for 3 times per day,with the opening period for 5-10 seconds.Then the drugs were preserved in different environments based on grouping.Microbial isolation and purification were performed by the same lab technician at 8:00 from 1 through 10 days after opening of drugs with automatic microbial analyzer.Results In the unsealed MC eye drops without ethylparaben,the bacterial positive rates were about 30％ in the community room temperature group,community refrigeration group and hospital room temperature group,but no microbial colony was seen in the sealed eye drops.Ten days after opening of containers,the bacterial cultured rates were 30％,32％ and 36％ in the eye drops without ethylparaben in the community room temperature group,community refrigeration group and hospital room temperature group,and those in the eye drops with ethylparaben were 15％,19％ and 23％,respectively,showing significant differences between the eye drops with and without ethylparaben (x2 =6.452,4.448,4.063,all at P＜0.05).The 95％ confidence interval (CI) of difference values of intergroup bacterial rates were-0.166-0.126,-0.110-0.190 and-0.088-0.208 between the community room temperature group and the community refrigeration group,between the hospital room temperature group and the community refrigeration group,between the hospital room temperature group and the community room temperature group respectively in the unsealed eye drops without ethylparaben,and those in the unsealed eye drops with ethylparaben were-0.159-0.079,-0.089-0.169 and-0.043-0.203 respectively,indicating insignificant differences among the groups.Cultured bacteria were identified as Micrococcus luteus,Acinetobacter lwoffii,Bacillus subtilis,Acinetobacter radioresistens,Myroides and Staptococcus xylosus.Conclusions Ethylparaben can reduce the contamination rate of microorganisms after opening of MC eye drops.Three environmental conditions do not play an influence on microbial contamination of MC eye drops after opening.The bacteria of contaminated eye drops appear to be common microorganisms in atmosphere and soil,rather than eye common pathogens.
