中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2014年
19期
18-20
,共3页
呋喃西林%溶解度%灭菌%稳定性
呋喃西林%溶解度%滅菌%穩定性
부남서림%용해도%멸균%은정성
furacilin%solubility%sterilization%stability
目的：比较加入苯甲酸、吐温－80、聚维酮及聚乙烯醇1750±50对呋喃西林溶解度的影响，并进行呋喃西林溶液制备工艺及制剂的稳定性研究。方法在呋喃西林溶液中分别加入苯甲酸、吐温－80、聚维酮及聚乙烯醇1750±50，观察其溶解度的变化。采用紫外分光光度法测定呋喃西林的含量，考察不同灭菌时间、不同灭菌温度下呋喃西林溶液的含量变化，确定合理的灭菌温度和时间；通过留样观察法对呋喃西林溶液的稳定性进行考察。结果苯甲酸、吐温－80、聚维酮及聚乙烯醇1750±50均能使呋喃西林的溶解度提高；灭菌温度100℃以下、灭菌时间15~30 min对呋喃西林含量无显著性影响，灭菌温度100℃~121℃、灭菌时间30~60 min对呋喃西林含量有显著性影响。结论聚乙烯醇1750±50可显著提高呋喃西林的溶解度且稳定性好；采用灭菌温度100℃、灭菌时间30 min、及时出锅散热等措施，能提高呋喃西林溶液的稳定性。
目的：比較加入苯甲痠、吐溫－80、聚維酮及聚乙烯醇1750±50對呋喃西林溶解度的影響，併進行呋喃西林溶液製備工藝及製劑的穩定性研究。方法在呋喃西林溶液中分彆加入苯甲痠、吐溫－80、聚維酮及聚乙烯醇1750±50，觀察其溶解度的變化。採用紫外分光光度法測定呋喃西林的含量，攷察不同滅菌時間、不同滅菌溫度下呋喃西林溶液的含量變化，確定閤理的滅菌溫度和時間；通過留樣觀察法對呋喃西林溶液的穩定性進行攷察。結果苯甲痠、吐溫－80、聚維酮及聚乙烯醇1750±50均能使呋喃西林的溶解度提高；滅菌溫度100℃以下、滅菌時間15~30 min對呋喃西林含量無顯著性影響，滅菌溫度100℃~121℃、滅菌時間30~60 min對呋喃西林含量有顯著性影響。結論聚乙烯醇1750±50可顯著提高呋喃西林的溶解度且穩定性好；採用滅菌溫度100℃、滅菌時間30 min、及時齣鍋散熱等措施，能提高呋喃西林溶液的穩定性。
목적：비교가입분갑산、토온－80、취유동급취을희순1750±50대부남서림용해도적영향，병진행부남서림용액제비공예급제제적은정성연구。방법재부남서림용액중분별가입분갑산、토온－80、취유동급취을희순1750±50，관찰기용해도적변화。채용자외분광광도법측정부남서림적함량，고찰불동멸균시간、불동멸균온도하부남서림용액적함량변화，학정합리적멸균온도화시간；통과류양관찰법대부남서림용액적은정성진행고찰。결과분갑산、토온－80、취유동급취을희순1750±50균능사부남서림적용해도제고；멸균온도100℃이하、멸균시간15~30 min대부남서림함량무현저성영향，멸균온도100℃~121℃、멸균시간30~60 min대부남서림함량유현저성영향。결론취을희순1750±50가현저제고부남서림적용해도차은정성호；채용멸균온도100℃、멸균시간30 min、급시출과산열등조시，능제고부남서림용액적은정성。
Objective To compare the influence of adding benzoic acid, Tween-80, povidone and polyvinyl alcohol 1 750 ± 50 on the fu-racilin solubility, and to study the preparation technology and preparation stability of furacilin solution. Methods The furacilin solution was added with benzoic acid, Tween-80, povidone and polyvinyl alcohol 1 750 ± 50 respectively. The change of furacilin solubility was observed. The furacilin content was determined by the UV spectrophotometry. The content change of furacilin solution was investigated under different sterilizing time, different sterilizing temperatures for determining the rational sterilizing temperature and time. Its stability was investigated by the reserving sample method. Results Benzoic acid, Tween-80, povidone and polyvinyl alcohol 1 750 ± 50 could in-crease the furacilin solubility;the sterilizing temperature under 100℃ and the sterilizing time of 15-30 min had no significant influ-ence on the furacilin content. However, the sterilizing temperature of 100-121 ℃ and the sterilizing time of 30-60 min had significant influence on the furacilin content. Conclusion Polyvinyl alcohol 1 750 ± 50 can significantly increase the furacilin solubility with good stability;adopting the measures of the sterilizing temperature of 100℃, sterilizing time of 30 min and timely heat dissipation can increase the stability of furacilin solution.
